UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
 
 
FORM 10-Q



[x]
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

[  ]
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: 000-51772
 
 
Cardica, Inc.
 
(Exact Name of Registrant as Specified in its Charter)
 
Delaware
 
94-3287832
(State or other jurisdiction of
 
(I.R.S. Employer
incorporation or organization)
 
Identification No.)
     
900 Saginaw Drive
   
Redwood City, California
 
94063
(Address of Principal Executive Offices)
 
(Zip Code)


(650) 364-9975
(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 [x] 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 [x] 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.
Large accelerated filer  [  ]
Accelerated filer  [x]
Non-accelerated filer  [  ]
(Do not check if a smaller reporting company)
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 [  ] No [x]

On November 7, 2011, there were 27,071,679 shares of common stock, par value $0.001 per share, of Cardica, Inc. outstanding.

 
 

 
CARDICA, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2011
INDEX
 
 
PART I. FINANCIAL INFORMATION
   
     
Item 1.   Condensed Financial Statements (unaudited)
   
     
a. Condensed Balance Sheets at September 30, 2011 and June 30, 2011
 
3
     
b. Condensed Statements of Operations for the three months ended September 30, 2011 and 2010
 
4
     
c. Condensed Statements of Cash Flows for the three months ended September 30, 2011 and 2010
 
5
     
d. Notes to Condensed Financial Statements
 
6
     
Item 2.   Management's Discussion and Analysis of Financial Condition and Results of Operations
 
13
     
Item 3.   Quantitative and Qualitative Disclosures About Market Risk
 
19
     
Item 4.   Controls and Procedures
 
19
     
PART II. OTHER INFORMATION
   
     
Item 1A. Risk Factors
 
20
     
Item 6.    Exhibits
 
40
     
SIGNATURES
 
41
 
 
2

 
PART I. FINANCIAL INFORMATION

ITEM 1. CONDENSED FINANCIAL STATEMENTS

CARDICA, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and per share data)
 
 
September 30, 2011
   
June 30, 2011
 
 
(Unaudited)
   
(Note 1)
 
Assets
         
Current assets
         
Cash and cash equivalents
$
5,912
   
$
7,832
 
Short-term investments
3,162
   
1,493
 
Accounts receivable
262
   
327
 
Inventories
778
   
840
 
Prepaid expenses and other current assets
289
   
160
 
Total current assets
10,403
   
10,652
 
           
Property and equipment, net
1,271
   
714
 
Restricted cash
104
   
104
 
Total assets
$
11,778
   
$
11,470
 
           
Liabilities and stockholders' equity
         
Current liabilities
         
Accounts payable
$
1,100
   
$
618
 
Accrued compensation
369
   
530
 
Other accrued liabilities
365
   
289
 
Current portion of deferred revenue
738
   
738
 
Total current liabilities
2,572
   
2,175
 
           
Note payable and other non-current liabilities
2,362
   
433
 
Total liabilities
4,934
   
2,608
 
           
Commitments and contingencies
         
           
Stockholders' equity
         
Preferred stock, $0.001 par value: 5,000,000 shares authorized: no shares issued and outstanding at September 30, 2011 and June 30, 2011
   
 
Common stock, $0.001 par value: 65,000,000 shares authorized: 27,071,679 and 26,635,115 shares issued and outstanding at September 30, 2011 and June 30, 2011, respectively
27
   
27
 
Additional paid-in capital
134,320
   
133,281
 
Treasury stock at cost (66,227 shares at September 30, 2011 and June 30, 2011)
(596
)  
(596
)
Accumulated comprehensive loss
(3
)  
(1
)
Accumulated deficit
(126,904
)  
(123,849
)
Total stockholders' equity
6,844
   
8,862
 
Total liabilities and stockholders' equity
$
11,778
   
$
11,470
 
 
See accompanying notes to the condensed financial statements.

 
3

 
CARDICA, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)

 
Three months ended
 
September 30,
 
2011
 
2010
Net revenue
     
Product sales, net
$
767
   
$
995
 
License and development revenue
84
   
9,025
 
Royalty revenue
19
   
22
 
Total net revenue
870
   
10,042
 
       
Operating costs and expenses
     
Cost of product sales
827
   
944
 
Research and development
1,557
   
1,375
 
Selling, general and administrative
1,541
   
1,495
 
Total operating costs and expenses
3,925
   
3,814
 
       
Income (loss) from operations
(3,055
)
 
6,228
 
       
Interest income
1
   
8
 
Interest expense
   
(11
)
Other income (expense), net
(1
)
 
(2
)
Net income (loss)
$
(3,055
)
 
$
6,223
 
Basic net income (loss) per common share
$
(0.11
)
 
$
0.25
 
Diluted net income (loss) per common share
$
(0.11
)
 
$
0.24
 
       
Shares used in computing net income (loss) per common share
         
Basic
       26,806
   
24,623
 
Diluted
       26,806
   
26,000
 
 
See accompanying notes to the condensed financial statements.
 
 
4

 
CARDICA, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)

 
Three months ended
 
September 30,
 
2011
 
2010
Operating activities:
     
Net income (loss)
$
(3,055
)
 
$
6,223
 
Adjustments to reconcile net cash provided by (used in) operating activities:
     
Depreciation and amortization
162
   
193
 
Stock-based compensation expenses
136
   
244
 
Changes in assets and liabilities:
     
Accounts receivable
65
   
12
 
Prepaid expenses and other current assets
(129
)
 
47
 
Inventories
62
   
280
 
Accounts payable and other accrued liabilities
558
   
(148
)
Accrued compensation
(161
)
 
(87
)
Deferred revenue
(83
)
 
963
 
Deferred rent
12
   
2
 
Net cash provided by (used in) operating activities
(2,433
)
 
7,729
 
       
Investing activities:
     
Purchases of property and equipment
(719
)
 
(7
)
Purchases of short-term investments
(1,671
)
 
 
Net cash used in investing activities
(2,390
)
 
(7
)
       
Financing activities:
     
Net proceeds from issuance of common stock
903
   
2,011
 
Proceeds from (Repayment of) notes payable
2,000
   
(1,400
)
Net cash provided by financing activities
2,903
   
611
 
       
Net increase (decrease) in cash and cash equivalents
(1,920
)
 
8,333
 
Cash and cash equivalents at beginning of period
7,832
   
6,561
 
Cash and cash equivalents at end of period
$
5,912
   
$
14,894
 
 
See accompanying notes to the condensed financial statements.
 
 
5

 

CARDICA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)

NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Organization

      Cardica, Inc. (“Cardica”, the “Company”, “we”, “our” or “us”) was incorporated in the state of Delaware on October 15, 1997, as Vascular Innovations, Inc. On November 26, 2001, the Company changed its name to Cardica, Inc.  Historically, the Company’s business focused on the design, manufacture and marketing of proprietary automated anastomotic systems used by cardiac surgeons to perform coronary bypass surgery. The Company has re-focused its business on the development of an endoscopic MicroCutter product line intended for use by thoracic, bariatric, colorectal and general surgeons. The first product that the Company is developing in its planned MicroCutter product line is the MicroCutter XPRESS™ 30, the first true multi-fire endolinear MicroCutter device based on the Company’s proprietary “staple-on-a-strip” technology, which would expand the Company’s commercial opportunity into additional surgical markets.  In addition, the Company is developing the MicroCutter XPRESS™ 45, a planned multi-fire endolinear MicroCutter device with a 45 millimeter staple line, the MicroCutter XCHANGE™ 30, a planned cartridge based MicroCutter device with a 5 millimeter shaft diameter and a 30 millimeter staple line, the MicroCutter FLEXCHANGE™ 30, a planned cartridge based MicroCutter device with a flexible shaft to facilitate endoscopic procedures requiring cutting and stapling, and the MicroCutter XPRESS™ 60, a planned cutting and stapling device specifically designed for the bariatric and thoracic surgery markets. The Company initiated first-in-man use of the current version of the MicroCutter XPRESS 30, with the Conformité Européene, in Europe in July 2011, and the Company continues to refine the product prior to commercial launch in Europe. Following the completion of the internal design verification process for the MicroCutter XPRESS 30 necessary to apply the Comformité Européene to this product for commercial use in Europe on June 30, 2011, the Company has determined that there is alternative future use in various research and development projects for equipment, tooling and materials related to the MicroCutter product line and has begun to capitalized such assets into prepaid expenses and other current assets or property and equipment.
 
Need for Additional Capital

The Company has incurred cumulative net losses of $126.9 million through September 30, 2011 and negative cash flows from operating activities and expects to incur losses for the next several years. Management plans to continue to finance the Company’s operations with equity or debt issuances or through collaboration arrangements. There is no guarantee that such funding will be available to the Company on acceptable terms, or at all, or that such funding will be received in a timely manner, if at all. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its development or commercialization programs. There is no guarantee that the Company will be able to reduce its expenditures without materially and adversely affecting the business.

      The accompanying financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty related to the Company’s ability to continue as a going concern.

Basis of Presentation

The accompanying unaudited condensed financial statements of Cardica have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for the fair statement of balances and results have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

The accompanying condensed financial statements should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended June 30, 2011 included in the Company’s Form 10-K filed with the Securities and Exchange Commission on September 12, 2011.

 
6

 
 
Use of Estimates

      The preparation of financial statements in conformity with GAAP generally requires management to make estimates and assumptions that affect the amounts reported in the financial statements. Actual results could differ from these estimates.

Revenue Recognition

      The Company recognizes revenue when four basic criteria are met: (1) persuasive evidence of an arrangement exists; (2) title or rights have transferred; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. The Company uses contracts and customer purchase orders to determine the existence of an arrangement. The Company uses contractual terms, shipping documents and third-party proof of delivery to verify that title or rights have transferred. The Company assesses whether the fee is fixed or determinable based upon the terms of the agreement associated with the transaction. To determine whether collection is probable, the Company assesses a number of factors, including past transaction history with the customer and the creditworthiness of the customer. If the Company determines that collection is not reasonably assured, then the recognition of revenue is deferred until collection becomes reasonably assured, which is generally upon receipt of payment.

The Company records product sales net of estimated product returns and discounts from the list prices for its products. The amounts of product returns and the discount amounts have not been material to date. The Company includes shipping and handling costs in cost of product sales.

Payments that are contingent upon the achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved subject to satisfaction of all revenue recognition criteria at that time.  Revenue generated from license fees and performing development services are recognized when it is earned and non-refundable upon receipt of payments, over the period of performance, or upon incurrence of the related development expenses in accordance with contractual terms, based on the actual costs incurred to date plus overhead costs for certain project activities. Amounts paid but not yet earned on a project are recorded as deferred revenue until such time as the related development expenses plus overhead costs for certain project activities are incurred.
 
Inventories

      Inventories are recorded at the lower of cost or market on a first-in, first-out basis. The Company periodically assesses the recoverability of all inventories, including materials, work-in-process and finished goods, to determine whether adjustments for impairment are required.  Inventory that is obsolete or in excess of forecasted usage is written down to its estimated net realizable value based on assumptions about future demand and market conditions.  Reduced demand may result in the need for  inventory write-downs in the near term. Inventory write-downs are charged to cost of product sales and establish a lower cost basis for the inventory.
 
 
 
 
7

 

NOTE 2 - STOCKHOLDERS' EQUITY
 
Common Stock
 
On December 14, 2010, the Company entered into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC, an Illinois limited liability company (“Aspire Capital”), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of shares of the Company’s common stock (the “Purchase Shares”) over the term of the Purchase Agreement at purchase prices determined in accordance with the Purchase Agreement. Pursuant to the Purchase Agreement, on any trading day on which the closing sale price of the Company’s common stock exceeds $1.00 per share, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice, directing Aspire Capital to purchase up to a certain number of shares dependent upon trading volume. The purchase price per Purchase Share will be equal to the lesser of (i) the lowest sale price of the Company’s common stock on the purchase date or (ii) the arithmetic average of the three lowest closing sale prices for the Company’s common stock during the twelve consecutive trading days ending on the trading day immediately preceding the purchase date.

The Purchase Agreement provides that the Company may not issue and sell more than 4,930,747 shares of the Company’s common stock, including the 295,567 commitment shares issued to Aspire Capital, under the Purchase Agreement. As of September 30, 2011, the Company had received $4.3 million from the sale of an aggregate of 1,300,000 shares of the Company’s common stock to Aspire Capital pursuant to the Purchase Agreement.

On August 3, 2011 , the Company entered into the At The Market Issuance Sales Agreement (the “ATM Agreement”) with McNicoll, Lewis & Vlak LLC (“MLV”), which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may issue and sell up to $10.0 million of the Company’s common stock through MLV as the Company’s sales agent over the term of the ATM Agreement. The ATM Agreement provides that the offering of shares of the Company’s common stock pursuant to the ATM Agreement will terminate upon the earlier of (1) the sale of all common stock subject to the ATM Agreement, (2) August 2, 2014 and (3) The Agreement may be terminated by MLV or the Company at any time upon 10 days notice to the other party. As of September 30, 2011, the Company had received net proceeds of $85,100 from the placement of an aggregate of 31,494 shares of common stock through MLV.

Stock-Based Compensation
      Included in the statement of operations are the following non-cash stock-based compensation amounts for the periods reported, including non-employee stock based compensation expense (in thousands):
 
 
Three months ended
 
September 30,
 
2011
 
2010
Cost of product sales
$
12
 
$
18
 
Research and development
39
 
54
 
Selling, general and administrative
85
 
172
 
Total
$
136
 
$
244
 

NOTE 3 - NET INCOME (LOSS) PER SHARE

Basic net income (loss) per common share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding for the period less the weighted-average unvested common shares subject to repurchase and without consideration of potential common shares.  Diluted net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding for the period less the weighted average unvested common shares and dilutive potential common shares for the period determined using the treasury-stock method.  For purposes of this calculation, options and warrants to purchase stock and unvested restricted stock awards are considered to be potential common shares and are only included in the calculation of diluted net income (loss) per share when their effect is dilutive.

 
8

 
 
The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands, except per share data):

   
Three months ended
   
September 30,
   
2011
 
2010
Numerator:
       
Net income (loss)
 
$
(3,055
)
 
$
6,223
 
Denominator:
       
     Weighted-average common shares outstanding
 
26,806
   
24,623
 
     Less: Weighted-average unvested restricted stock
 
   
 
Denominator for basic net income (loss) per common share
 
26,806
   
24,623
 
     Dilutive effect of stock options
 
   
403
 
     Dilutive effect of unvested restricted stock awards
 
   
43
 
     Dilutive effect of warrants
 
   
931
 
Denominator for diluted net income (loss) per share
   
26,806
     
26,000
 
Basic net income (loss) per common share
 
$
(0.11)
   
$
0.25
 
Diluted net income (loss) per common share
 
$
(0.11)
   
$
0.24
 

The following table sets forth the outstanding securities not included in the diluted net income (loss) per common share calculation for the three months ended September 30, 2011 and 2010 because their effect would be antidilutive (in thousands):

 
September 30,
  2011    
2010
Options to purchase common stock
3,629
   
1,519
 
Unvested restricted stock awards
21
   
 
Warrants
4,646
   
 
Total
8,296
   
1,519
 

NOTE 4 - COMPREHENSIVE INCOME (LOSS)

Comprehensive income (loss) is comprised of net income (loss) and unrealized gains/losses on available-for-sale securities, if any, as follows (in thousands):

   
September 30,
   
2011
 
2010
Net income (loss)
    (3,055 )     6,223  
Change in unrealized gain (loss) on investments
    (2 )      
Comprehensive income (loss)
    (3,057 )     6,223  
 
 
9

 

NOTE 5 - FAIR VALUE MEASUREMENTS

      Accounting Standards Codification (“ASC”) 820, “Fair Value Measurements and Disclosures,”   defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. ASC 820 establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. The three levels of inputs used to measure fair value are as follows:

Level 1 -
 
Quoted prices in active markets for identical assets or liabilities.
     
Level 2 -
 
Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
     
Level 3 -
 
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The Company does not have any liabilities that are measured at fair value. All assets that are measured at fair value have been segregated into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date. These assets measured at fair value are summarized below (in thousands):

 
As of September 30, 2011
 
Level 1
 
Level 2
 
Level 3
 
Total
Cash equivalents:
             
Money market funds
$
2,333
 
$
   
$
   
$
2,333
 
Short-term investments:
                           
Corporate debt securities
 
   
2,912
     
     
2,912
 
Federal agency bond
 
   
250
     
     
250
 
               
Total assets at fair value
$
2,333
 
$
3,162
   
$
   
$
5,495
 

 
As of June 30, 2011
 
Level 1
 
Level 2
 
Level 3
 
Total
Cash equivalents:
             
Money market funds
$
4,016
 
$
   
$
   
$
4,016
 
Short-term investments:
                           
Corporate debt securities
 
   
1,243
     
     
1,243
 
Federal agency bond
 
   
250
     
     
250
 
               
Total assets at fair value
$
4,016
 
$
1,493
   
$
   
$
5,509
 

Funds held in money market instruments, are included in Level 1 as their fair values are based on market prices/quotes for identical assets in active markets. Corporate debt securities and a federal agency bond are valued primarily using market prices/quotes for similar assets and/or other sources of observable information and are included in Level 2.

      As of September 30, 2011, the Company’s material current financial assets and liabilities not carried at fair value, including its trade accounts receivable and accounts payable, were reported at their current carrying values which approximate fair value given the short-term nature of these instruments with maturity dates of less than one year. We are currently assessing whether the carrying value of the note payable to Century Medical, Inc. (see Note 9 - Note Payable) approximates its fair value.
 
 
10

 

NOTE 6 – SHORT-TERM INVESTMENTS
 
The Company held investments in marketable securities as of September 30, 2011 and June 30, 2011 with maturity dates of less than one year.
Our short-term investments consisted of the following (in thousands):
 
    As of September 30, 2011  
   
Amortized
Cost
   
Gross
Unrealized
Gains
   
Gross
Unrealized
Losses
   
Fair Value
 
Available-for-sale securities:
                       
Corporate debt securities
  $ 2,915     $     $ (3 )   $ 2,915  
Federal agency bond
  $ 250                   250  
                                 
Total
  $ 3,165     $     $ (3 )   $ 3,162  
 
    As of June 30, 2011  
   
Amortized
Cost
   
Gross
Unrealized
Gains
   
Gross
Unrealized
Losses
   
Fair Value
 
Available-for-sale securities:
                       
Corporate debt securities
  $ 1,244     $     $ (1 )   $ 1,243  
Federal agency bond
    250                   250  
                                 
Total
  $ 1,494     $     $ (1 )   $ 1,493  
 
NOTE 7 - INVENTORIES
      Inventories consisted of the following (in thousands):

 
September 30,
2011
 
June 30,
2011
Raw materials
$
286
 
$
341
 
Work in progress
236
 
112
 
Finished goods
256
 
387
 
 
$
778
 
$
840
 

NOTE 8 – DISTRIBUTION, LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENTS

Century

On September 2, 2011, the Company signed a distribution agreement (the “Distribution Agreement”) with Century Medical, Inc. (“Century”) with respect to distribution of the Company’s planned MicroCutter products in Japan.  Under the terms of a secured note purchase agreement, Century agreed to loan the Company an aggregate of up to $4.0 million at a 5% annual interest rate, with principal due five years after the first draw by the Company under the agreement, subject to certain conditions.   On September 30, 2011, the Company received a $2.0 million loan from Century under this facility, which bears 5% annual interest.  Interest on the loan is payable quarterly in arrears on the last business day of March, June, September and December through to September 30, 2016, the maturity date.  Century’s obligation to provide an additional loan to the Company under the facility was subject to the successful deployment, in Century’s sole discretion, of certain of the Company’s MicroCutter products in wet lab environments, before a specified date, or at such other date as mutually agreed upon between the parties. The Company expects to complete the remaining deployments within the next several months. In return for the loan commitment, the Company granted Century exclusive distribution rights to the Company’s planned MicroCutter product line in Japan and a right of first negotiation for distribution rights in Japan to future products. Century will be responsible for securing regulatory approval from the Ministry of Health in Japan for the MicroCutter product line. After approval for marketing in Japan, the Company would sell MicroCutter units to Century, who would then sell the MicroCutter devices to their customers in Japan.

Intuitive Surgical

  On August 16, 2010, the Company entered into a license agreement with Intuitive Surgical (the “License Agreement”) pursuant to which the Company granted to Intuitive Surgical a worldwide, sublicenseable, exclusive license to use the Company’s intellectual property in the robotics field in diagnostic or therapeutic medical procedures, but excluding vascular anastomosis applications, for an upfront license fee of $9.0 million. The Company is also eligible to receive a contingent payment related to achieving a certain sales volume. Each party has the right to terminate the License Agreement in the event of the other party’s uncured material breach or bankruptcy. Following any termination of the License Agreement, the licenses granted to Intuitive Surgical will continue, and except in the case of termination for the Company’s uncured material breach or insolvency, Intuitive Surgical’s payment obligations will continue as well. Under the License Agreement, Intuitive Surgical has rights to improvements in the Company’s technology and intellectual property over a specified period of time.

 
11

 
 
The Company adopted Accounting Standards Update ("ASU") No. 2009-13, which addresses the accounting for multiple-element arrangements, on July 1, 2010 on a prospective basis. Under this guidance, the Company determined that there were two substantive deliverables under the License Agreement representing separate units of accounting: license rights to technology that existed as of August 16, 2010 and license rights to technology that may be developed over the following three years. The $9.0 million upfront license payment and $1.0 million premium on the stock purchase by Intuitive Surgical (see Note 2, Stockholders’ Equity) were aggregated and allocated to the two units of accounting based upon the relative estimated selling prices of the deliverables. The relative estimated selling prices of the deliverables were determined using a probability weighted expected return model with significant inputs relating to the nature of potential future outcomes and the probability of occurrence of future outcomes. Based upon the relative estimated selling prices of the deliverables, $9.0 million of the total consideration of $10.0 million was allocated to the license rights to technology that existed as of August 16, 2010 that has been recognized as revenue in the three months ended September 30, 2010 and $1.0 million was allocated to technology that may be developed over the following three years that is being recognized as revenue ratably over that three year period. In total, the revenue recognized for the three months ended September 30, 2011and 2010 related to this arrangement was $84,000 and $9.0 million, respectively, and, as of September 30, 2011, $628,000 had been recorded as deferred revenue related to this arrangement.
 
Cook Incorporated

In June 2007, the Company entered into, and in September 2007 and in June 2009 amended, a license, development and commercialization agreement with Cook Incorporated (“Cook”) to develop and commercialize a specialized device, referred to as the PFO device, designed to close holes in the heart from genetic heart defects known as patent foramen ovales, or PFOs. Under the agreement, Cook funded certain development activities and the Company and Cook jointly developed the device.  The Company’s significant deliverables under the arrangement were the license rights and the associated development activities.  These deliverables were determined to represent one unit of accounting as there was no stand-alone value to the license rights. If developed, Cook would receive an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, to make, have made, use, sell, offer for sale and import the PFO device.   Under this agreement, the Company received payments of $1.0 million and $1.7 million in fiscal years ended June 30, 2009 and 2008, respectively. The Company received no payments in fiscal 2011 or 2010 and did not record any license and development revenue under the agreement for the three months ended September 30, 2011 or 2010.  Amounts paid but not yet earned on the project are recorded as deferred revenue until such time as the related development expenses for certain project activities are incurred.  A total of $403,000 under this agreement had been recorded as deferred revenue as of September 30, 2011 and June 30, 2011.  The Company is entitled to receive from Cook up to a total of an additional $275,000 in future payments if development milestones under the agreement are achieved. The Company is also entitled to receive a royalty based on Cook's annual worldwide sales of the PFO device, if any.  On January 6, 2010, the Company and Cook mutually agreed to suspend work on the PFO project and, accordingly, the Company does not anticipate receiving any additional payments or recording any additional revenue related to this agreement in the foreseeable future.

NOTE 9 – NOTE PAYABLE
 
In connection with the Distribution Agreement with Century, the Company entered into a secured note purchase agreement and a related security agreement pursuant to which Century agreed to loan to the Company up to an aggregate of $4.0 million, drawable by the Company in one or more tranches, subject to certain conditions (see Note 8, Distribution, License, Development and Commercialization Agreements), upon written request to Century made before December 31, 2012.  On September 30, 2011, the Company received a $2.0 million loan from Century under this facility, which bears 5% annual interest. The note is secured by all of the Company's assets including its intellectual property excluding intellectual property related to the Company's MicroCutter product line. Interest on the loan is payable quarterly in arrears on the last business day of March, June, September and December through to September 30, 2016, the maturity date. Due to the timing of the receipt of the loan, the Company is evaluating whether the note is at a market rate of interest and whether, due to the exclusive distribution rights granted to Century under the Distribution Agreement, there are multiple elements associated with the arrangement with Century that should be accounted for separately. The Company will finalize its assessment during the second quarter of fiscal 2012.
 
 
 
12

 
 
NOTE 10 – AMENDED LEASE AGREEMENT

On November 11, 2010, the Company entered into an amendment to its facility lease (the “Lease Amendment”). Pursuant to the Lease Amendment, the term of the lease was extended by four years, through August 31, 2015, and the Company was granted an improvement allowance of $148,070 to be used in connection with the construction of alterations and refurbishment of improvements in the premises. In addition, under the Lease Amendment, the Company was granted an option to further extend the lease for a period of two years beyond August 31, 2015 (the “Option Term”), with the annual rent payable by the Company during the Option Term to be equal to the annual rent for comparable buildings, as described in the Lease Amendment. Under the operating lease, the Company is required to maintain a letter of credit with a restricted cash balance at the Company’s bank. A certificate of deposit of $100,000 was recorded as restricted cash in the condensed balance sheet as of September 30, 2011 and June 30, 2011, related to the letter of credit.

Future minimum lease payments under the Company’s non-cancelable operating leases having initial terms of a year or more as of  September 30, 2011, including the Lease Amendment, are as follows (in thousands):

 
Fiscal year ending June 30,
   
Operating
Leases
 
2012 (remaining nine months)
 
$
476
 
2013
   
652
 
2014
   
688
 
2015
   
728
 
2016
   
124
 
Total minimum lease payments
 
$
2,668
 

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

      This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements” for purposes of these provisions, including any projections of earnings, revenue, sufficiency of cash resources or other financial items, any statement of the plans and objectives of management for future operations, any statements concerning proposed new products or licensing or collaborative arrangements, any statements regarding future economic conditions or performance, and any statement of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential,” or “continue” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including but not limited to the risk factors set forth in Item 1A below, and for the reasons described elsewhere in this report. All forward-looking statements and reasons why results may differ included in this report are made as of the date hereof, and we assume no obligation to update these forward-looking statements or reasons why actual results might differ.

Overview

Historically, our business focused on the design, manufacture and marketing of proprietary automated anastomotic systems used by cardiac surgeons to perform coronary bypass surgery. We have re-focused our business on the development of an endoscopic MicroCutter product line intended for use by thoracic, bariatric, colorectal and general surgeons.

The first product that we are developing in our planned MicroCutter product line is the MicroCutter XPRESS™ 30, the first true multi-fire endolinear MicroCutter device based on our proprietary “staple-on-a-strip” technology, which would expand our commercial opportunity into additional surgical markets.  In addition, we are developing the MicroCutter XPRESS™ 45, a planned multi-fire endolinear MicroCutter device with a 45 millimeter staple line, the MicroCutter XCHANGE™ 30, a planned cartridge based MicroCutter device with a 5 millimeter shaft diameter and a 30 millimeter staple line, the MicroCutter FLEXCHANGE™ 30, a planned cartridge based MicroCutter device with a flexible shaft to facilitate endoscopic procedures requiring cutting and stapling, and the MicroCutter XPRESS™ 60, a planned cutting and stapling device specifically designed for the bariatric and thoracic surgery markets.  We estimate these planned devices expand our commercial opportunity to approximately 1.4 million additional procedures involving, we estimate, over 4 million staple cartridge deployments, 3 million of which we believe are deployed in laparoscopic procedures.  We initiated first-in-man use of the current version of the MicroCutter XPRESS 30, with the Conformité Européene, or CE Mark, in Europe in July 2011, and we continue to refine the product prior to commercial launch in Europe.

 
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        We have been advised by the U.S. Food and Drug Administration, or FDA, that the FDA would require clinical data with respect to the staple design used in the planned MicroCutter product line as part of a 510(k) submission to the FDA with respect to potential clearance of the MicroCutter XPRESS 30 and other products in the planned MicroCutter product line for marketing and sale in the United States.  We plan to commence a single-arm clinical trial of the MicroCutter XPRESS 30, and when available, the MicroCutter XCHANGE 30 in Europe during this calendar year to obtain the clinical data that we plan to include in our 510(k) submission.  We anticipate that the results of the clinical trial conducted under our currently planned protocol will be available within approximately six months of trial commencement.

Our C-Port® Distal Anastomosis Systems, or C-Port systems, are sold in the United States and Europe. The C-Port systems are used to perform a distal anastomosis, which is the connection between a bypass graft vessel and the target artery. As of September 30, 2011, more than 12,400 C-Port systems had been sold in the United States and Europe. We also currently sell our PAS-Port® Proximal Anastomosis System, or PAS-Port system, in the United States, Europe and Japan. The PAS-Port system is used to perform a proximal anastomosis, which is the connection of a bypass graft vessel to the aorta or other source of blood. As of September 30, 2011, more than 25,100 PAS-Port systems had been sold in the United States, Europe and Japan.

We use independent distributors and manufacturers’ representatives to augment a small core direct sales team for our C-Port systems and PAS-Port system in the United States to contain sales costs while continuing to serve our customers and potential customers for our automated anastomosis product line.

We manufacture our C-Port and PAS-Port systems with parts we manufacture and components supplied by vendors, which we then assemble, test and package. For the three months ended September 30 2011, we generated net revenue of $0.9 million, including $84,000 of license and development revenue, and incurred a net loss of $3.0 million.

Since our inception, we have incurred significant net losses, and we expect to continue to incur net losses for the foreseeable future. We have not generated any revenue from sales of any of the MicroCutter products that we are developing.  To date, our C-Port and PAS-Port systems have had limited commercial adoption, and sales have not met the levels that we had anticipated. Revenue from product sales and milestone payments were not sufficient to support the operation of our business as we had planned.  If we fail to obtain broader commercial adoption of our systems or to achieve commercial adoption of our MicroCutter products, we may be required to delay, further reduce the scope of or eliminate our commercialization efforts with respect to one or more of our products or one or more of our research and development programs.

As of September 30, 2011, we had cash, cash equivalents and short-term investments of $9.1 million. We believe that our existing cash, cash equivalents and short-term investments, together with the cash that we expect to generate from operations, will be sufficient to meet our anticipated cash needs to enable us to conduct our business substantially as currently conducted through April 30, 2012. We would extend this time period to the extent that we complete the milestones entitling us to access an additional $2.0 million of debt financing under our recently signed arrangement with Century Medical, Inc., or Century, decrease our planned expenditures, or access additional capital under the common stock purchase agreement, or Purchase Agreement, we entered into on December 14, 2010 with Aspire Capital Fund, LLC, an Illinois limited liability company, or Aspire Capital, or under the At The Market Issuance Sales Agreement, or ATM Agreement, we entered into on August 3, 2011 with McNicoll, Lewis & Vlak LLC, or MLV. Our independent registered public accounting firm has indicated in their audit report on our fiscal 2011 financial statements that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern.  We have based our estimate as to the sufficiency of our cash resources on assumptions that may prove to be wrong, including assumptions with respect to the level of revenue from product sales that we anticipate generating and the cost of product development, and we could exhaust our available financial resources sooner than we currently expect.  The sufficiency of our current cash resources and our need for additional capital, and the timing thereof, will depend on many factors, including the extent of our ongoing research and development programs and related costs, including costs related to the development of the MicroCutter XPRESS 30 and additional potential products in our anticipated MicroCutter product line, our ability to enter into additional license, development and/or collaboration agreements with respect to our technology, and the terms thereof, market acceptance and adoption of our current products or future products that we may commercialize, our level of revenue, costs associated with our sales and marketing initiatives and manufacturing activities, costs and timing of obtaining and maintaining FDA and other regulatory clearances and approvals for our products and potential additional products, securing, maintaining and enforcing intellectual property rights and the costs thereof, and the effects of competing technological and market developments.

 
14

 
 
We may seek to sell additional equity or debt securities, obtain a credit facility, enter into product development, license or distribution agreements with third parties or divest one or more of our commercialized products or products in development. The sale of additional equity or convertible debt securities could result in significant dilution to our stockholders, particularly in light of the prices at which our common stock has been recently trading. In addition, if we raise additional funds through the sale of equity securities, new investors could have rights superior to our existing stockholders. If additional funds are raised through the issuance of debt securities, these securities could have rights senior to those associated with our common stock and could contain covenants that would restrict our operations. Any product development, licensing, distribution or sale agreements that we enter into may require us to relinquish valuable rights, including with respect to commercialized products or products in development that we would otherwise seek to commercialize or develop ourselves. We may not be able to obtain sufficient additional financing or enter into a strategic transaction in a timely manner. Our need to raise capital may require us to accept terms that may harm our business or be disadvantageous to our current stockholders.

Agreements with Century

On September 2, 2011, we entered into a distribution agreement with Century with respect to distribution of our planned MicroCutter products in Japan.  Under the terms of a secured note purchase agreement, Century has agreed to loan us an aggregate of up to $4.0 million at a 5% annual interest rate, with principal due five years after the first draw by us under the agreement, subject to certain conditions. In return for the loan commitment, we granted Century distribution rights to our planned MicroCutter product line in Japan and a right of first negotiation for distribution rights in Japan to future products. Century will be responsible for securing regulatory approval from the Ministry of Health in Japan for the MicroCutter product line. After approval for marketing in Japan, we would sell MicroCutter units to Century, who would then sell the MicroCutter devices to their customers in Japan.

On September 30, 2011, we received a $2.0 million loan from Century under the facility described above, which bears 5% annual interest. Interest on the loan is payable quarterly in arrears on the last business day of March, June, September and December and on September 30, 2016, the maturity date. Century’s obligation to provide the loan to us is subject to the successful deployment, in Century’s sole discretion, of certain of our MicroCutter products in clinical and wet lab environments, before specified dates, or at such other date as mutually agreed upon between the parties. We expect to complete the remaining deployments within the next several months.

Agreements with Intuitive Surgical

On August 16, 2010, we entered into a license agreement, or License Agreement, with Intuitive Surgical Operations, Inc., or Intuitive Surgical, pursuant to which we granted to Intuitive Surgical a worldwide, sublicenseable, exclusive license to use our intellectual property in the robotics field in diagnostic or therapeutic medical procedures, but excluding vascular anastomosis applications for an upfront license fee of $9.0 million. We are also eligible to receive a milestone payment if sales of any products incorporating our patent rights achieve a specified level of net sales within a specified period after the date of the License Agreement as well as single-digit royalties on sales by Intuitive Surgical, its affiliates or its sublicensees of specified stapler and clip applier products covered by our patent rights as well as on sales of certain other products covered by our patent rights that may be developed in the future.  Each party has the right to terminate the License Agreement in the event of the other party’s uncured material breach or bankruptcy.  Following any termination of the License Agreement, the licenses granted to Intuitive Surgical will continue, and, except in the case of termination for our uncured material breach or insolvency, Intuitive Surgical’s payment obligations will continue as well.  Intuitive Surgical has rights to improvements in our technology and intellectual property over a specified period of time.

In addition, on the same date, we entered into a Stock Purchase Agreement with Intuitive Surgical pursuant to which Intuitive Surgical paid $3.0 million to purchase from us an aggregate of 1,249,541 newly-issued shares of the Company’s common stock, or the Stock Issuance.   The net proceeds recorded to stockholders’ equity based upon the fair value of our common stock on August 16, 2010 were approximately $2.0 million after offering expenses.  From the premium paid of $1.0 million and the upfront license fee payment of $9.0 million, $84,000 and $9.0 million had been recorded as license and development revenue for the three months ended September 30, 2011 and September 30, 2010, respectively, and $628,000 had been recorded as deferred revenue as of September 30, 2011.  There were no underwriters or placement agents involved with the Stock Issuance, and no underwriting discounts or commissions or similar fees were payable in connection with the Stock Issuance .

 
15

 
 
Agreements with Cook Incorporated

      In June 2007, we entered into, and in September 2007 and in June 2009 amended, a license, development and commercialization agreement with Cook Incorporated, or Cook, to develop and commercialize a specialized device, referred to as the PFO device, designed to close holes in the heart from genetic heart defects known as patent foramen ovales, or PFOs. Under the agreement, Cook funded certain development activities and we and Cook jointly developed the device.  Our significant deliverables under the arrangement were the license rights and the associated development activities.  These deliverables were determined to represent one unit of accounting as there was no stand-alone value to the license rights. If developed, Cook would receive an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, to make, have made, use, sell, offer for sale and import the PFO device.   Under this agreement, we received payments of $1.0 million and $1.7 million in fiscal years ended June 30, 2009 and 2008, respectively. We received no payments in fiscal 2011 or 2010 and did not record any license and development revenue under the agreement for the three months ended September 30, 2011 or 2010.  Amounts paid but not yet earned on the project are recorded as deferred revenue until such time as the related development expenses for certain project activities are incurred.  A total of $403,000 under this agreement had been recorded as deferred revenue as of September 30, 2011 and June 30, 2011. We are entitled to receive from Cook up to a total of an additional $275,000 in future payments if development milestones under the agreement are achieved. We are also entitled to receive a royalty based on Cook's annual worldwide sales of the PFO device, if any.  On January 6, 2010, we and Cook mutually agreed to suspend work on the PFO project and, accordingly, we do not anticipate receiving any additional payments or recording any additional revenue related to this agreement in the foreseeable future.

Critical Accounting Policies and Significant Judgments and Estimates
 
Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of our financial statements requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. Actual results could differ materially from those estimates.

There were no significant changes to our critical accounting policies and significant judgements and estimates as set forth in “Item 7. 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 June 30, 2011, filed with the Securities and Exchange Commission on September 12, 2011.
 
 
Results of Operations

Comparison of the three month periods ended September 30, 2011 and 2010

       Net Revenue. Total net revenue decreased by $9.2 million, or 91%, to $0.9 million for the three months ended September 30, 2011 compared to $10.0 million for the same period in 2010. Product sales decreased by $228,000, or 23%, to $0.8 million for the three months ended September 30, 2011 compared to $1.0 million for the same period in 2010. The decrease of $228,000 in product sales for the three months ended September 30, 2011 was primarily attributable to both lower PAS-Port and C-Port systems sales in the United States.  The decrease in license and development revenue of $8.9 million relates to the Intuitive Surgical License Agreement that we entered into in August 2010 under which we recognized $9.0 million upon entering into the agreement and transferring certain license rights in the three months ended September 30, 2010.

      For the three months ended September 30, 2011 and 2010, sales to Century Medical accounted for approximately 33% and 22%, respectively, of our total product sales.

       Cost of Product Sales. Cost of product sales consists primarily of material, labor and overhead costs. Cost of product sales decreased by $117,000, or 12%, to $0.8 million for the three months ended September 30, 2011 compared to $0.9 million for the same period in 2010. The decrease in cost of product sales resulted primarily from decreased unit sales. We recorded a lower of cost or market inventory write-down of $66,000 in the three months ended September 30, 2011 compared to $111,000 for the same period in 2010 primarily on our PAS-Port system inventory due to lower product cost of units manufactured in 2011. We released $12,000 of excess and obsolete inventory reserves as a result of units sold in the three months ended September 30, 2011.

       Research and Development Expense. Research and development expense relates primarily to the development of our MicroCutter product line and largely consists of personnel costs within our product development, regulatory and clinical groups and the costs for tooling used to facilitate research and development. Research and development expense increased by $182,000, or 13%, to $1.6 million for the three months ended September 30, 2011 compared to $1.4 million for the same period in 2010. The increase in expenses for the three months ended September 30, 2011 was attributable to an increase in salaries and benefits of $210,000 due primarily to an increase in the number of personnel, increased consulting and professional services expenses of $67,000 and increased prototype project materials of $274,000, partially offset by lower molds and tooling expenses of $377,000 related to the MicroCutter program development activities that were capitalized.

 
16

 
 
      We anticipate that research and development expenses will remain relatively consistent in absolute terms in future periods as we continue to develop the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and additional MicroCutter products.

Selling, General and Administrative Expense. Selling, general and administrative expense increased $46,000, or 3%, to $1.5 million for the three months ended September 30, 2011 compared to $1.5 million for the same period in 2010. The increase in selling, general and administrative expense in the three months ended September 30, 2011 was primarily attributable to an increase in salaries and benefits of $72,000, and an increase in professional services expenses of $60,000, partially offset by lower stock-based compensation charges of $87,000.

      We expect selling, general and administrative expense to increase slightly in absolute terms in future periods as we increase the number of individuals in sales and marketing.

Off Balance Sheet Arrangements

      As of September 30, 2011, except for a real estate operating lease for our headquarters in Redwood City, California expiring in August 2015, we did not have any off-balance sheet arrangements.

Liquidity and Capital Resources

As of September 30, 2011, our accumulated deficit was $126.9 million and we had cash, cash equivalents and short-term investments of $9.1 million. We currently invest some of our cash, cash equivalents and short-term investments in money market funds, corporate debt securities and a federal agency bond. Since inception, we have financed our operations primarily through private sales of convertible preferred stock, long-term notes payable, public and private sales of common stock, warrants to purchase common stock and license or collaboration agreements.

On September 2, 2011, we signed a distribution agreement with Century, with respect to distribution of our planned MicroCutter products in Japan.  Under the terms of a secured note purchase agreement, Century has agreed to loan us an aggregate of up to $4.0 million at a 5% annual interest rate, with principal due five years after the first draw by us under the agreement, subject to certain conditions. In return for the loan commitment, we granted Century distribution rights to our planned MicroCutter product line in Japan and a right of first negotiation for distribution rights in Japan to future products. Century will be responsible for securing regulatory approval from the Ministry of Health in Japan for the MicroCutter product line. After approval for marketing in Japan, Cardica would sell MicroCutter units to Century, who would then sell the MicroCutter devices to their customers in Japan.

On September 30, 2011, we received a $2.0 million loan from Century under the facility described above, which bears 5% annual interest. Interest on the loan is payable quarterly in arrears on the last business day of March, June, September and December and on September 30, 2016, the maturity date. Century’s obligation to provide the balance of the loan to us is subject to the successful deployment, in Century’s sole discretion, of certain of our MicroCutter products in clinical and wet lab environments, before specified dates, or at such other date as mutually agreed upon between the parties. We expect to complete the remaining deployments within the next several months.

On August 3, 2011 , we entered into the ATM Agreement with MLV, which provides that, upon the terms and subject to the conditions and limitations set forth therein, we may issue and sell up to $10.0 million of our common stock through MLV as our sales agent over the term of the ATM Agreement. The ATM Agreement provides that the offering of shares of our common stock pursuant to the ATM Agreement will terminate upon the earlier of (1) the sale of all common stock subject to the ATM Agreement, (2) August 2, 2014 and (3) termination of the ATM Agreement.  As of September 30, 2011, we had received net proceeds of $85,100 from the placement of an aggregate of 31,494 shares of common stock through MLV.

On December 14, 2010, we entered into the Purchase Agreement with Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of shares of our common stock over the term of the Purchase Agreement at purchase prices determined in accordance with the Purchase Agreement. In consideration for entering into the Purchase Agreement, we issued to Aspire Capital 295,567 shares of our common stock as a commitment fee, or the Commitment Shares. The Purchase Agreement provides that we may not issue and sell more than 4,930,747 shares of our common stock, including the Commitment Shares.   As of September 30, 2011, we have received $4.3 million from the sale of a total of 1,300,000 shares of common stock (excluding the 295,567 Commitment Shares) to Aspire Capital pursuant to the Purchase Agreement.  

 
17

 
 
Contractual Obligations

Our future contractual obligations at September 30, 2011 were as follows (in thousands):
 
Contractual Obligations:
 
Total
 
   
Less Than
1 Year
   
1-3
Years
   
4-5
Years
   
More Than
5 Years
 
Operating lease obligations
  $ 2,668     $ 476     $ 2,068     $ 124     $  
Notes payable, including interest
    2,500       75       300       2,125        
Total
  $ 5,168     $ 551     $ 2,368     $ 2,249     $  

      Summary cash flow data is as follows (in thousands):
 
 
Three months ended
 
September 30,
 
2011
 
2010
Net cash provided by (used in) operating activities
$
(2,433
)
 
$
7,729
 
Net cash used in investing activities
(2,390
)
 
(7
)
Net cash provided by financing activities
2,903
   
611
 

      Net cash used in operating activities for the three months ended September 30, 201 1 was $2.4 million and net cash provided by operating activities for the three months ended September 30, 2010 was $7.8 million. The use of cash for the three months ended September 30, 2011 was primarily attributable to our net loss adjusted for non-cash stock-based compensation charges and depreciation and a decrease in accrued compensation partially offset by an increase in accounts payable and other accrued liabilities. The cash provided in the three months ended September 30, 2010 was primarily attributable to our net income adjusted for non-cash stock-based compensation charges and depreciation, an increase in deferred revenue due to the Intuitive Surgical arrangement and a decrease in inventories, offset in part by a decrease in accounts payable and other accrued liabilities resulting from payments made during the period.

      Net cash used in investing activities for the three months ended September 30, 2011 and 2010 was $2.4 million and $7,000, respectively. Net cash used in investing activities in the three months ended September 30, 2011 reflects purchases of property and equipment of $0.7 million as well as purchases of $1.7 million of short-term investments.

      Net cash provided by financing activities for the three months ended September 30, 2011 and 2010 was $2.9 million and $611,000, respectively. Net cash provided by financing activities for the three months ended September 30, 2011 consisted of the $2.0 million loan from Century and aggregate net proceeds of $0.9 million received from the sale of shares of common stock to Aspire Capital and MLV. The net cash provided by financing activities for the three months ended September 30, 2010 consisted of the net proceeds from the sale of shares of common stock to Intuitive Surgical of $2.0 million, offset in part by our $1.4 million repayment of notes payable to Century.

We believe that our existing cash, cash equivalents and short-term investments, together with the cash that we expect to generate from operations will be sufficient to meet our anticipated cash needs to enable us to conduct our business substantially as currently conducted through April 30, 2012. We would be able to extend this time period to the extent that we complete the remaining milestones entitling us to access an additional $2.0 million of debt financing under our recently signed arrangement with Century, decrease our planned expenditures, or access additional capital under Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV. We have based our estimate on assumptions that may prove to be wrong, including assumptions with respect to the level of revenue from product sales, and the cost of product development, and we could exhaust our available financial resources sooner than we currently expect.

The sufficiency of our current cash resources and our need for additional capital, and the timing thereof, will depend upon numerous factors. These factors include, but are not limited to, the following:
 
18

 
 
 
the extent of our ongoing research and development programs and related costs, including costs related to the  continued development of the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and additional potential products in our anticipated MicroCutter product line;
 
 
 
our ability to enter into additional license, development and/or collaboration agreements with respect to our technology, and the terms thereof;
 
 
 
market acceptance and adoption of our current products or future products that we may commercialize;

 
our level of revenue;

 
costs associated with our sales and marketing initiatives and manufacturing activities;

 
costs and timing of obtaining and maintaining FDA and other regulatory clearances and approvals for our products and potential additional products;
 
 
 
securing, maintaining and enforcing intellectual property rights and the costs thereof;

 
the extent to which we access additional capital from Century, or under the Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV; and

 
the effects of competing technological and market developments.

       While we initiated first-in-man use of the current version of the MicroCutter XPRESS 30, with the CE Mark, in Europe in July 2011, we continue to refine this product prior to commercial launch, and we cannot predict when, if ever, we will generate commercial revenue from the sale of the MicroCutter XPRESS 30 or any other potential products in our anticipated MicroCutter product line.  Because we do not anticipate that we will generate sufficient product sales to achieve profitability for the foreseeable future, if at all, we need to raise substantial additional capital to finance our operations in the future.   Until we can generate significant continuing revenue, if ever, we expect to satisfy our future cash needs from Century, through our Purchase Agreement with Aspire Capital or our ATM Agreement with MLV, public or private equity offerings, debt financings or corporate collaboration and licensing arrangements, as well as through interest income earned on cash balances. To raise capital, we may seek to sell additional equity or debt securities, obtain a credit facility or enter into product development, license or distribution agreements with third parties or divest one or more of our commercialized products or products in development.  However, we cannot be certain that additional funding of any kind will be available on acceptable terms, or at all. The sale of additional equity or convertible debt securities could result in significant dilution to our stockholders, particularly in light of the prices at which our common stock has been recently trading. If additional funds are raised through the issuance of debt securities, these securities could have rights senior to those associated with our common stock and could contain covenants that would restrict our operations. Any product development, licensing, distribution or sale agreements that we enter into may require us to relinquish valuable rights, including with respect to commercialized products or products in development that we would otherwise seek to commercialize or develop ourselves. We may not be able to obtain sufficient additional funding or enter into a strategic transaction in a timely manner. Our need to raise capital may require us to accept terms that may harm our business or be disadvantageous to our current stockholders. If adequate funds are not available or revenue from product sales do not increase, we would be required to further reduce our workforce, delay, reduce the scope of or eliminate our commercialization efforts with respect to one or more of our products or one or more of our research and development programs in advance of April 30, 2012 to ensure that we have sufficient capital to meet our obligations and continue on a path designed to preserve stockholder value.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

      During the three months ended September 30, 2011, there were no material changes to our market risk disclosures as set forth in “Item 7A. Quantitative and Qualitative Disclosures about Market Risk” in our Annual Report on Form 10-K for the fiscal year ended June 30, 2011, filed with the Securities and Exchange Commission on September 12, 2011.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Effectiveness of Disclosure Controls and Procedures

 
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      Based on their evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) of the Securities Exchange Act of 1934, as amended) were effective as of September 30, 2011.

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.

Limitations on the Effectiveness of Controls

      A 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. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met. We continue to implement, improve and refine our disclosure controls and procedures and our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1A. RISK FACTORS

      We have identified the following risks and uncertainties that may have a material adverse effect on our business, financial condition or results of operations. The risks described below are not the only ones we face. Additional risks not presently known to us or that we currently believe are immaterial may also significantly impair our business operations. The risks described below that are marked with an asterisk (*) are those risks that contain substantive changes from the risks described in our Annual Report on Form 10-K for the fiscal year ended June 30, 2011.

Risks Related to Our Finances and Capital Requirements

*We have a history of net losses, which we expect to continue for the foreseeable future, and we are unable to predict the extent of future losses or when we will become profitable, if at all.

Except for the three months ended September 30, 2010, in which we recorded net income due to entering into the License Agreement with Intuitive Surgical, we have incurred net losses since our inception in October 1997.  As of September 30, 2011, our accumulated deficit was approximately $126.9 million.  We expect to incur substantial additional losses until we can achieve significant commercial sales of our products, which depend upon a number of factors, including increased commercial sales of our C-Port and PAS-Port systems, commercial launch and market adoption of our planned MicroCutter products in Europe and receipt of regulatory clearance or approval, commercial launch and market adoption of our planned MicroCutter products in the United States.

      Our ability to become and remain profitable depends upon our ability to generate higher product sales. Our ability to generate significant continuing revenue depends upon a number of factors, including:

 
achievement of broad acceptance for our current products or future products that we may commercialize;

 
achievement of U.S. regulatory clearance or approval for additional products; and

 
successful sales, manufacturing, marketing and distribution of our products.
 
      We have not generated any revenue from commercial sale of any of the MicroCutter products that we are developing.   While we initiated first-in-man use of the current version of the MicroCutter XPRESS 30, with the CE Mark, in Europe in July 2011, we continue to refine this product prior to commercial launch, and we cannot predict when, if ever, we will generate commercial revenue from the sale of the MicroCutter XPRESS 30 or any other potential products in our anticipated MicroCutter product line.   Sales of our C-Port and PAS-Port systems have not met the levels that we had anticipated, and to date our systems have had limited commercial adoption.  Sales of our products and license and development activities generated $0.9 million and $10.0 million for the three month periods ended September 30, 2011 and 2010, respectively. For fiscal years 2011, 2010 and 2009, sales of our products and license and development activities generated only $13.2 million, $4.0 million and $9.9 million of revenue, respectively. We do not anticipate that we will generate significantly higher product sales for the foreseeable future.

 
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        Our cost of product sales was 108% and 95% of our net product sales for the three month periods ended September 30, 2011 and 2010, respectively. Our cost of product sales was 86% and 98% of our net product sales for fiscal years 2011 and 2010, respectively. We expect higher cost relative to product sales for the foreseeable future due to the planned commercialization of our MicroCutter product line. If, over the long term, we are unable to reduce our cost of producing goods and expenses relative to our net revenue, we may not achieve profitability even if we are able to generate significant product sales.  Our failure to achieve and sustain profitability would negatively impact the market price of our common stock.

*We require substantial additional capital and may be unable to raise capital, which would force us to delay, reduce or eliminate our research and development programs or commercialization efforts and could cause us to cease operations. We cannot be certain that funds will be available and, if they are not available, we may not be able to continue as a going concern which may result in actions that could adversely impact our stockholders.

Our development efforts have consumed substantial capital to date. We believe that our existing cash, cash equivalents and short-term investments, together with the cash that we expect to generate from operations, will be sufficient to meet our anticipated cash needs to enable us to conduct our business substantially as currently conducted through April 30, 2012. We would be able to extend this time period to the extent that we complete the remaining milestones entitling us to access an additional $2.0 million of debt financing under our recently signed arrangement with Century, decrease our planned expenditures, or access additional capital under the Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV. We have based our estimate as to the sufficiency of our cash resources on assumptions that may prove to be wrong, including assumptions with respect to the level of revenue from product sales, and the cost of product development, and we could exhaust our available financial resources sooner than we currently expect.

      The sufficiency of our current cash resources and our need for additional capital, and the timing thereof, will depend upon numerous factors. These factors include, but are not limited to, the following:

 
the extent of our ongoing research and development programs and related costs, including costs related to the continued development of the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and additional potential products in our anticipated MicroCutter product line;

 
our ability to enter into additional license, development and/or collaboration agreements with respect to our technology, and the terms thereof;

 
market acceptance and adoption of our current products or future products that we may commercialize;

 
our level of revenue;

 
costs associated with our sales and marketing initiatives and manufacturing activities;

 
costs and timing of obtaining and maintaining FDA and other regulatory clearances and approvals for our products and potential additional products;

 
securing, maintaining and enforcing intellectual property rights and the costs thereof;

 
the extent to which we access additional capital from Century, or under the Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV; and

 
the effects of competing technological and market developments.
 
 
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      Because we do not anticipate that we will generate sufficient product sales to achieve profitability for the foreseeable future, if at all, we need to raise substantial additional capital to finance our operations in the future. Until we can generate significant continuing revenue, if ever, we expect to satisfy our future cash needs from Century, through our Purchase Agreement with Aspire Capital or our ATM Agreement with MLV, public or private equity offerings, debt financings or corporate collaboration and licensing arrangements, as well as through interest income earned on cash balances.  To raise capital, we may seek to sell additional equity or debt securities, obtain a credit facility or enter into product development, license or distribution agreements with third parties or divest one or more of our commercialized products or products in development. However, we cannot be certain that additional funding of any kind will be available on acceptable terms, or at all.  The sale of additional equity or convertible debt securities could result in significant dilution to our stockholders, particularly in light of the prices at which our common stock has been recently trading. If additional funds are raised through the issuance of debt securities, these securities could have rights senior to those associated with our common stock and could contain covenants that would restrict our operations. Any product development, licensing, distribution or sale agreements that we enter into may require us to relinquish valuable rights, including with respect to commercialized products or products in development that we would otherwise seek to commercialize or develop ourselves. We may not be able to obtain sufficient additional funding or enter into a strategic transaction in a timely manner. Our need to raise capital may require us to accept terms that may harm our business or be disadvantageous to our current stockholders. If adequate funds are not available or revenue from product sales do not increase, we would be required to further reduce our workforce, delay, reduce the scope of or eliminate our commercialization efforts with respect to one or more of our products or one or more of our research and development programs in advance of April 30, 2012 to ensure that we have sufficient capital to meet our obligations and continue on a path designed to create and preserve stockholder value.

On September 2, 2011, we signed a distribution agreement with Century with respect to distribution of our planned MicroCutter products in Japan.  Under the terms of a secured note purchase agreement, Century has agreed to loan us an aggregate of up to $4.0 million at a 5% annual interest rate, with principal due five years after the first draw by us under the agreement, subject to certain conditions. Century’s obligation to provide additional loans to us under the facility is subject to the successful deployment, in Century’s sole discretion, of certain of our MicroCutter products in clinical and wet lab environments, before specified dates, or at such other date as mutually agreed upon between the parties. In return for the loan commitment, we granted Century distribution rights to our planned MicroCutter product line in Japan and a right of first negotiation for distribution rights in Japan to future products. Century will be responsible for securing regulatory approval from the Ministry of Health in Japan. After approval for marketing in Japan, we would sell MicroCutter units to Century, who would then sell the MicroCutter devices to their customers in Japan.

Subject to the terms and conditions of the Purchase Agreement, we have a right to sell to Aspire Capital pursuant to the Purchase Agreement up to $10.0 million of our common stock at a maximum of 300,000 shares per day based on the trading price of our common stock. The extent to which we rely on Aspire Capital as a source of funding will depend on a number of factors, including the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources.  The Purchase Agreement provides that we may not issue and sell more than 4,930,747 shares of our common stock, including the Commitment Shares.  As of September 30, 2011, a total of 1,595,567 shares of common stock (including the 295,567 Commitment Shares) had been issued to Aspire Capital pursuant to the Purchase Agreement and $4.3 million of capital had been raised through the sale of 1,300,000 shares of common stock at an average price of $3.28 per share.

Subject to the terms and conditions of the ATM Agreement, we may issue and sell up to $10.0 million of our common stock through MLV as our sales agent.  The extent to which we rely on sales of common stock under the ATM Agreement as a source of funding will depend on a number of factors, including the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources.  The ATM Agreement provides that the offering of shares of our common stock pursuant to the ATM Agreement will terminate upon the earlier of (1) the sale of all common stock subject to the ATM Agreement, (2) August 2, 2014 and (3) termination of the ATM Agreement.   As of September 30, 2011, we had received net proceeds of $85,100 from the placement of an aggregate of 31,494 shares of common stock through MLV.

Sufficient additional financing through future public or private financings, strategic alliances and other arrangements or financing sources may not be available on acceptable terms, or at all. Additional equity financings would likely result in significant dilution or other adverse effects on the rights of existing stockholders. Failure to raise additional capital may result in our ceasing to be publicly traded or ceasing operations.

Our independent registered public accounting firm has indicated that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern.

 
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Our audited financial statements for the fiscal year ended June 30, 2011 were prepared on the basis that our business would continue as a going concern in accordance with United States generally accepted accounting principles. This basis of presentation assumes that we will continue in operation for the foreseeable future and will be able to realize our assets and discharge our liabilities and commitments in the normal course of business. However, our independent registered public accounting firm has indicated in their audit report on our fiscal 2011 financial statements that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern. We will be forced to delay or reduce the scope of our MicroCutter development program and/or limit or cease our operations if we are unable to raise substantial additional funding to meet our working capital needs. However, we cannot guarantee that we will be able to obtain sufficient additional funding when needed or that such funding, if available, will be obtainable on terms satisfactory to us. In the event that these plans cannot be effectively realized, there can be no assurance that we will be able to continue as a going concern.

*The sale of our common stock to Aspire Capital or through MLV may cause substantial dilution to our existing stockholders, and the sale of the shares of common stock acquired by Aspire Capital or issued through MLV could cause the price of our common stock to decline.

The Purchase Agreement provides for the issuance to Aspire Capital of the Commitment Shares and up to an additional $10.0 million of our common stock.  As of September 30, 2011, a total of 1,595,567 shares of common stock (including the 295,567 Commitment Shares) had been issued to Aspire Capital pursuant to the Purchase Agreement.  It is anticipated that the remaining shares will be sold to Aspire Capital over a period of up to 24 months from February 2011. The number of shares ultimately offered for sale by Aspire Capital is dependent upon the number of shares that we elect to sell to Aspire Capital under the Purchase Agreement. Depending upon market liquidity at the time, sales of shares of our common stock to Aspire Capital under the Purchase Agreement may cause the trading price of our common stock to decline.

Under the ATM Agreement, we may issue and sell up to $10.0 million of our common stock through MLV as our sales agent. It is anticipated that these additional shares will be sold through MLV over a period of up to 36 months from August 2011. The number of shares ultimately offered for sale by MLV is dependent upon the number of shares that we elect to sell to MLV under the ATM Agreement. Depending upon market liquidity at the time, sales of shares of our common stock through MLV under the ATM Agreement may cause the trading price of our common stock to decline.   As of September 30, 2011, we had received net proceeds of $85,100 from the placement of an aggregate of 31,494 shares of common stock through MLV.

Aspire Capital may not ultimately purchase all of the $10.0 million of our common stock issuable pursuant to the Purchase Agreement. Aspire Capital may sell all, some or none of the shares it acquires pursuant to the Purchase Agreement, including the Commitment Shares that have been issued to Aspire Capital. All, some or none of the $10.0 million of our common stock issuable pursuant to the ATM Agreement may be sold through MLV. We are not obligated to make any sales of common stock under the ATM Agreement.   Sales by Aspire Capital of shares acquired pursuant to the Purchase Agreement or sales made through MLV pursuant to the ATM Agreement may result in substantial dilution to the interests of other holders of our common stock. The sale of a substantial number of shares of our common stock to Aspire Capital pursuant to the Purchase Agreement or through MLV pursuant to the ATM Agreement, or anticipation of such sales, could make it more difficult for us to sell equity or equity−related securities in the future at a time and at a price that we might otherwise wish to effect sales. However, we have the right to control the timing and amount of any sales of our shares to Aspire Capital or made through MLV, and the Purchase Agreement and ATM Agreement may be terminated by us at any time at our discretion without any further cost to us.

*Existing creditors may have rights to our assets that are senior to our stockholders.

      An existing arrangement with our current lender Century, as well as future arrangements with other creditors, allow or may allow these creditors to liquidate our assets, which may include our intellectual property rights, if we are in default or breach of our debt obligations for a continued period of time. The proceeds of any sale or liquidation of our assets under these circumstances would be applied first to any of our debt obligations that would have priority over any of our capital stock. After satisfaction of our debt obligations, we could have little or no proceeds left to distribute to the holders of our capital stock.

Our quarterly operating results and stock price may fluctuate significantly.

      We expect our operating results to be subject to quarterly fluctuations. The revenue we generate, if any, and our operating results will be affected by numerous factors, many of which are beyond our control, including:

 
the extent of our ongoing research and development programs and related costs, including costs related to the continued development of the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and additional potential products in our anticipated MicroCutter product line;

 
our ability to enter into additional license, development and/or collaboration agreements with respect to our technology, and the terms thereof;

 
market acceptance and adoption of our current products or future products that we may commercialize;

 
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our level of revenue;

 
costs associated with our sales and marketing initiatives and manufacturing activities;

 
costs and timing of obtaining and maintaining FDA and other regulatory clearances and approvals for our products and potential additional products;

 
securing, maintaining and enforcing intellectual property rights and the costs thereof;

 
the extent to which we access capital from Century, or under the Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV; and

 
the effects of competing technological and market developments.
 
      Quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially.

Risks Related to Our Business

We are dependent upon the success of our current products to generate revenue in the near term, and we have U.S. regulatory clearance for our C-Port and PAS-Port systems only. We cannot be certain that the C-Port and PAS-Port systems will be successfully commercialized in the United States. If we are unable to successfully commercialize our products in the United States, our ability to generate higher revenue will be significantly delayed or halted, and our business will be harmed.

      We have expended significant time, money and effort in the development of our current commercial products, the C-Port systems and the PAS-Port system. If we are not successful in increasing commercial adoption of our C-Port and PAS-Port systems, we may never generate substantial revenue, our business, financial condition and results of operations would be materially and adversely affected, and we may be forced to cease operations. We commenced sales of our C-Port xA system in December 2006 (after introduction of our original C-Port system in January 2006), our C-Port Flex A in April 2007 and our C-Port X-CHANGE in December 2007. We commenced U.S. sales of our PAS-Port system in September 2008. We have not generated any revenue from sales of any of the MicroCutter products that we are developing.   While we initiated first-in-man use of the current version of the MicroCutter XPRESS 30, with the CE Mark, in Europe in July 2011, we continue to refine this product prior to commercial launch, and we cannot predict when, if ever, we will generate commercial revenue from the sale of the MicroCutter XPRESS 30 or any other potential products in our anticipated MicroCutter product line.   We anticipate that our ability to increase our revenue significantly will depend on the continued adoption of our current PAS-Port and C-Port systems in the United States and commercialization of planned MicroCutter products, including the MicroCutter XPRESS 30.

We may not be successful in our efforts to expand our product portfolio, and our failure to do so could cause our business and prospects to suffer.

We intend to use our knowledge and expertise in anastomotic technologies to discover, develop and commercialize new applications in additional markets. In particular, we are developing the MicroCutter XPRESS 30, an endoscopic MicroCutter intended for use by thoracic, bariatric, colorectal and general surgeons, the MicroCutter XCHANGE 30 and other potential products in our anticipated MicroCutter product line. Significant additional research and development and financial resources will be required to develop the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and other planned products in this planned product line into commercially viable products and to obtain necessary regulatory approvals to commercialize the devices. We cannot assure you that our development efforts will be successful or that they will be completed within our publicly stated anticipated timelines, and we may never be successful in developing a viable product for the markets intended to be addressed by the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 or other potential MicroCutter products. Our failure to successfully develop the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and/or other MicroCutter products would have a material adverse effect on our business, growth prospects and ability to raise additional capital.

Our products may never gain any significant degree of market acceptance, and a lack of market acceptance would have a material adverse effect on our business.

 
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      To date, our anastomoses products have not gained, and we cannot assure you that our anastomoses products or any other products that we may develop will gain, any significant degree of market acceptance among physicians or patients. We believe that recommendations by physicians will be essential for market acceptance of our products; however, we cannot assure you that significant recommendations will be obtained. Physicians will not recommend our products unless they conclude, based on clinical data and other factors, that the products represent a safe and acceptable alternative to other available options. In particular, physicians may elect not to recommend using our anastomoses products in surgical procedures until such time, if ever, as we successfully demonstrate with long-term data that our products result in patency rates comparable to or better than those achieved with hand-sewn anastomoses, and we resolve any technical limitations that may arise.

Assuming that we receive FDA clearance for one or more of our MicroCutter products, a number of factors will influence our ability to gain clinical adoption. In many surgical specialties, the use of laparoscopic and open surgical stapling devices is routine in clinical practice and an accepted standard of care. Two large companies, Johnson & Johnson and Covidien, dominate the market for surgical stapling devices. For our products to be clinically adopted, they must show benefits that are significant enough for surgeons to communicate their preference and to overcome any constraints on their hospitals’ ability to purchase competing products, such as purchasing contracts, to buy one of our stapling products to replace a competing device. In addition to this obstacle, our MicroCutter products must demonstrate the degree of reliability that surgeons have experienced with products that they have been using for years. Market acceptance of our products also depends on our ability to demonstrate consistent quality and safety of our products. Our anticipated initial lack of human clinical data with respect to the use of any MicroCutter products that we may commercialize is likely to negatively impact the rate and extent of clinical adoption of the products. Any future recalls may impact physicians’ and hospitals’ perception of our products.

Widespread use of our products will require the training of numerous physicians, and the time required to complete training could result in a delay or dampening of market acceptance. Even if the safety and efficacy of our products is established, physicians may elect not to use our products for a number of reasons beyond our control, including inadequate or no reimbursement from health care payors, physicians’ reluctance to use products that have not been proven through time in the market, the introduction of competing devices by our competitors and pricing for our products. Failure of our products to achieve any significant market acceptance would have a material adverse effect on our business, financial condition and results of operations.

Our PAS-Port and C-Port systems and future products may face future development and regulatory difficulties.

      Even though the current generations of the C-Port and PAS-Port systems have received U.S. regulatory clearance, the FDA may still impose significant restrictions on the indicated uses or marketing of these products or ongoing requirements for potentially costly post-clearance studies. The FDA permits commercial distribution of most new medical devices only after the device has received 510(k) clearance or is the subject of an approved PMA.  Any of our future products, including planned products in our MicroCutter product line and any future generations of the C-Port systems, may not obtain regulatory clearances or approvals required for marketing or may face these types of restrictions or requirements, particularly as the FDA is considering revising its 510(k) clearance system to, in certain cases, require human clinical data and to prohibit the combination of multiple predicate devices as the basis for a 510(k).  We have been advised by the FDA that it would require clinical data with respect to the staple design used in the planned MicroCutter product line as part of a 510(k) submission to the FDA with respect to potential clearance of the MicroCutter XPRESS 30 and other products in the planned MicroCutter product line for marketing and sale in the United States.  We plan to commence a single-arm clinical trial of the MicroCutter XPRESS 30, and when available, the MicroCutter XCHANGE 30 in Europe during this calendar year to obtain the clinical data that we plan to include in our 510(k) submission.  Our planned clinical trial will be focused on use of the MicroCutter XPRESS 30 in gastrointestinal surgical procedures.  It is possible that, in order to approve our 510(k) submission, the FDA will require data from a larger or different group of patients than the patients that we plan to enroll in our clinical trial.  It is also possible that the FDA would limit any approval of our MicroCutter XPRESS 30 to a narrower range of indications than we believe would be supported by our clinical data.

The process of obtaining regulatory clearances or approvals to market a medical device, particularly from the FDA, can be costly and time consuming, and there can be no assurance that such clearances or approvals will be granted on a timely basis, if at all. We rely substantially on the premarket notification process for FDA clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act.  This provision allows many medical devices to avoid human clinical trials if the product is “substantially equivalent” to another device already on the market.  Premarket notification requires a new device to be compared for safety, effectiveness and technological characteristics to another device (or multiple devices) already on the market.  A successful 510(k) submission results in FDA clearance for commercialization.  An Institute of Medicine (IOM) panel recently recommended that this 510(k) process be significantly revised to be more restrictive.  While the IOM report is non-binding, we do not know if or when the FDA will act on this recommendation.  If we can no longer use the 510(k) pathway in the future, we may be required to perform clinical trials for our new products in order to obtain approval for commercialization.  If so, our development costs will increase substantially, and the likelihood of approval for some of our products may be reduced.  The PMA approval process is more costly, lengthy and uncertain than the 510(k) clearance process and requires the development and submission of clinical studies supporting the safety and effectiveness of the device. Product modifications may also require the submission of a new 510(k) clearance or the approval of a PMA before the modified product can be marketed. Any products or product enhancements that we develop that require regulatory clearance or approval, including the MicroCutter XPRESS 30, may not be cleared or approved on the timelines that we currently anticipate, if approved at all. Any new products or any product enhancements that we develop may not be subject to the shorter 510(k) clearance process, but may instead be subject to the more lengthy PMA requirements. Additionally, even if 510(k) or other regulatory clearance is granted for the XPRESS 30 or any other potential product, the approved indications for use may be limited, and the FDA may require additional animal or human clinical data prior to any potential approval of additional indications. In particular, we anticipate that if 510(k) clearance is granted for the XPRESS 30, the initially approved indications for use would be limited, and that the FDA would require additional data prior to any potential approval of additional indications.      

 
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The EU requires that manufacturers of medical products obtain the right to affix the CE Mark to their products before selling them in member countries of the EU. We have received CE Mark certification for an initial MicroCutter surgical cutting and stapling device that we have developed. To maintain authorization to apply the CE Mark to future devices within the MicroCutter product line, we are subject to annual surveillance audits and periodic re-certification audits. If we modify the intended use of new products (relative to predicate products) or change the indication for use or develop new products in the future, we may need to apply for permission to affix the CE Mark to such products. We do not know whether we will be able to obtain permission to affix the CE Mark for new or modified products or whether we will continue to meet the quality and safety standards required to maintain the authorization that we have received. If we are unable to maintain authorization to affix the CE Mark to MicroCutter products, we will not be able to sell these products in member countries of the EU, which would have a material adverse effect on our results of operations.

Regulatory agencies subject a product, its manufacturer and the manufacturer’s facilities to continual review, regulation and periodic inspections. If a regulatory agency discovers previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, our collaborators or us, including requiring withdrawal of the product from the market. Our products will also be subject to ongoing FDA requirements for the labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information on the product. If our products fail to comply with applicable regulatory requirements, a regulatory agency may impose any of the following sanctions:

 
warning letters, fines, injunctions, consent decrees and civil penalties;

 
customer notifications, repair, replacement, refunds, recall or seizure of our products;

 
operating restrictions, partial suspension or total shutdown of production;

 
delay in processing marketing applications for new products or modifications to existing products;

 
withdrawing approvals that have already been granted; and

 
criminal prosecution.
 
      To market any products internationally, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA clearance or approval. The regulatory approval process in other countries may include all of the risks detailed above regarding FDA clearance or approval in the United States. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such approval could have the same adverse effects detailed above regarding FDA clearance or approval in the United States, including the risk that our products may not be approved for use under all of the circumstances requested, which could limit the uses of our products and adversely impact potential product sales, and that such clearance or approval may require costly, post-marketing follow-up studies. If we fail to comply with applicable foreign regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

 
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We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses.

In relation to our products that have received FDA clearance or approval, our promotional materials and training methods regarding physicians need to comply with FDA and other applicable laws and regulations. If the FDA determines that our promotional materials or training constitutes promotion of an unapproved use, it could request that we modify our training or promotional materials or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and/or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged and adoption of our products would be impaired.

*If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our product candidates may be delayed and, as a result, our stock price may decline.

      From time to time, we may estimate and publicly announce the timing anticipated for the accomplishment of various clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include an Investigational Device Exemption application to commence our enrollment of patients in our clinical trials, the release of data from our clinical trials, receipt of clearances or approvals from regulatory authorities, other clinical and regulatory events or the launch of new products. These estimates are based on a variety of assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, the commercialization of our products may be delayed and, as a result, our stock price may decline.

Our manufacturing facilities, and those of our suppliers, must comply with applicable regulatory requirements. Failure of our manufacturing facilities to comply with quality requirements would harm our business and our results of operations.

Our manufacturing facilities and processes are subject to periodic inspections and audits by various U.S. federal, U.S. state and foreign regulatory agencies. For example, our facilities have been inspected by State of California regulatory authorities pursuant to granting a California Device Manufacturing License and by the FDA. Additionally, to market products in Europe, we are required to maintain ISO 13485:2003 certification and are subject to periodic surveillance audits. We are currently ISO 13485:2003 certified; however, our failure to maintain necessary regulatory compliance and permits for our manufacturing facilities could prevent us from manufacturing and selling our products.

Additionally, our manufacturing processes and, in some cases, those of our suppliers, are required to comply with the FDA’s Quality QSR, which covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of our products, including the PAS-Port and C-Port systems and MicroCutter XPRESS 30. We are also subject to similar state requirements and licenses. In addition, we must engage in extensive record keeping and reporting and must make available our manufacturing facilities and records for periodic inspections by governmental agencies, including FDA, state authorities and comparable agencies in other countries. If we are given notice of significant violations in a QSR inspection, our operations could be disrupted and our manufacturing interrupted. Failure to take adequate corrective action in response to an adverse QSR inspection could result in, among other things, a shut-down of our manufacturing operations, significant fines, suspension of product distribution or other operating restrictions, seizures or recalls of our devices and criminal prosecutions, any of which would cause our business to suffer. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our products and cause our revenue to decline.

      We may also be required to recall our products due to manufacturing supply defects. If we issue recalls of our products in the future, our revenue and business could be harmed.

If we are unable to establish sales and marketing capabilities or enter into and maintain arrangements with third parties to market and sell our products, our business may be harmed.

 
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We have limited experience as a company in the sale, marketing and distribution of our products. Century is responsible for marketing and commercialization of cardiac products in Japan. To promote our current and future products in the United States and Europe, we must develop our sales, marketing and distribution capabilities or make arrangements with third parties to perform these services. Competition for qualified sales personnel is intense. Developing a sales force is expensive and time consuming and could delay any product launch. We may be unable to establish and manage an effective sales force in a timely or cost-effective manner, if at all, and any sales force we do establish may not be capable of generating sufficient demand for our products. We have entered into arrangements with third parties to perform sales and marketing services, which may result in lower product sales than if we directly marketed and sold our products. We expect to rely on third-party distributors for substantially all of our international sales. If we are unable to establish adequate sales and marketing capabilities, independently or with others, we may not be able to generate significant revenue and may not become profitable. For our MicroCutter products, we will have to compete for sales and acceptance of our products against two large companies, Johnson & Johnson and Covidien, with large sales forces and dominant market positions.

Lack of third-party coverage and reimbursement for our products could delay or limit their adoption.

We may experience limited sales growth resulting from limitations on reimbursements made to purchasers of our products by third-party payors, and we cannot assure you that our sales will not be impeded and our business harmed if third-party payors fail to provide reimbursement that hospitals view as adequate.

In the United States, our products are and will continue to be purchased primarily by medical institutions, which then bill various third-party payors, such as the Centers for Medicare & Medicaid Services, or CMS, which administer the Medicare program, and other government programs and private insurance plans, for the health care services provided to their patients. The process involved in applying for coverage and incremental reimbursement from CMS is lengthy and expensive. Under current CMS reimbursement policies, CMS offers a process to obtain add-on payment for a new medical technology when the existing Diagnosis-Related Group, or DRG, prospective payment rate is inadequate. To obtain add-on payment, a technology must be considered “new,” demonstrate substantial improvement in care and exceed certain payment thresholds. Add-on payments are made for no less than two years and no more than three years. We must demonstrate the safety and effectiveness of our technology to the FDA in addition to CMS requirements before add-on payments can be made. Further, Medicare coverage is based on our ability to demonstrate the treatment is “reasonable and necessary” for Medicare beneficiaries. In November 2006, CMS denied our request for an add-on payment with respect to our C-Port systems. According to CMS, we met the “new” criteria and exceeded the payment threshold but did not in their view demonstrate substantial improvement in care. Even if our products receive FDA and other regulatory clearance or approval, they may not be granted coverage and reimbursement in the foreseeable future, if at all. Moreover, many private payors look to CMS in setting their reimbursement policies and amounts. If CMS or other agencies limit coverage or decrease or limit reimbursement payments for doctors and hospitals, this may affect coverage and reimbursement determinations by many private payors.

We cannot assure you that CMS will provide coverage and reimbursement for our products. If a medical device does not receive incremental reimbursement from CMS, then a medical institution would have to absorb the cost of our products as part of the cost of the procedure in which the products are used. Acute care hospitals are now generally reimbursed by CMS for inpatient operating costs under a Medicare hospital inpatient prospective payment system. Under the Medicare hospital inpatient prospective payment system, acute care hospitals receive a fixed payment amount for each covered hospitalized patient based upon the DRG to which the inpatient stay is assigned, regardless of the actual cost of the services provided. At this time, we do not know the extent to which medical institutions would consider insurers’ payment levels adequate to cover the cost of our products. Failure by hospitals and physicians to receive an amount that they consider to be adequate reimbursement for procedures in which our products are used could deter them from purchasing our products and limit our revenue growth. In addition, pre-determined DRG payments may decline over time, which could deter medical institutions from purchasing our products. If medical institutions are unable to justify the costs of our products, they may refuse to purchase them, which would significantly harm our business.

We have limited data regarding the safety and efficacy of our MicroCutter products, PAS-Port and C-Port systems. Any data that is generated in the future may not be positive or consistent with our existing data, which would affect market acceptance and the rate at which our devices are adopted.

The success of our MicroCutter products depends on their acceptance by the surgical community as safe and effective.  Even if the data collected from future clinical studies or clinical experience indicates positive results, each surgeon’s actual experience with our devices outside the clinical study setting may vary. Clinical studies conducted with our initial MicroCutter may involve procedures performed by thoracic, bariatric, colorectal and general surgeons who are technically proficient, high-volume surgeons. Consequently, both short- and long-term results reported in these studies may be significantly more favorable than typical results of practicing surgeons, which could negatively impact rates of adoption of the MicroCutter if launched.  In addition, any adverse experiences of surgeons using the MicroCutter products, or adverse outcomes to patients, may deter surgeons from using our products and negatively impact product adoption.

 
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The C-Port and PAS-Port systems are innovative products, and our success depends upon their acceptance by the medical community as safe and effective. An important factor upon which the efficacy of the C-Port and PAS-Port systems will be measured is long-term data regarding the duration of patency, or openness, of the artery or the graft vessel. Equally important will be physicians’ perceptions of the safety of our products. Our technology is relatively new in cardiac bypass surgery, and the results of short-term clinical experience of the C-Port and PAS-Port systems do not necessarily predict long-term clinical benefit. We believe that physicians will compare long-term patency for the C-Port and PAS-Port devices against alternative procedures, such as hand-sewn anastomoses. If the long-term rates of patency do not meet physicians’ expectations, or if physicians find our devices unsafe, the C-Port and PAS-Port systems may not become widely adopted and physicians may recommend alternative treatments for their patients. In addition, any adverse experiences of physicians using the C-Port and PAS-Port systems, or adverse outcomes to patients, may deter physicians from using our products and negatively impact product adoption.

As a condition of its U.S market clearance, the C-Port system is subject to a mandatory Post Market Surveillance order under FDA Section 522 of the Federal Food Drug and Cosmetic Act (which we refer to as the 522 order) to demonstrate graft patency outcomes and technical failure rate in a clinical study.  Should the FDA decide that the C-Port system does not perform as anticipated, or if the FDA identifies new concerns related to the safety and effectiveness of the product, or if the FDA determines that the requirements of the 522 order are otherwise unmet, we may be required to withdraw the C-Port system from the market and may be subject to other enforcement action, which could harm our business.

Our C-Port and PAS-Port systems were designed for use with venous grafts. In addition, we have studied the use of the C-Port systems with venous grafts and arterial grafts. Using the C-Port systems with arterial grafts may not yield patency rates or material adverse cardiac event rates comparable to those found in our clinical trials using venous grafts, which could negatively affect market acceptance of our C-Port systems. In addition, the clips and staples deployed by our products are made of 316L medical-grade stainless steel, to which some patients are allergic. These allergies, especially if not previously diagnosed or unknown, may result in adverse reactions that negatively affect the patency of the anastomoses or the healing of the implants and may therefore adversely affect outcomes, particularly when compared to anastomoses performed with other materials, such as sutures. Additionally, in the event a surgeon, during the course of surgery, determines that it is necessary to convert to a hand-sewn anastomosis and to remove an anastomosis created by one of our products, the removal of the implants may result in more damage to the target vessel (such as the aorta or coronary artery) than would typically be encountered during removal of a hand-sewn anastomosis. Moreover, the removal may damage the target vessel to an extent that could further complicate construction of a replacement hand-sewn or automated anastomosis, which could be detrimental to patient outcome. These or other issues, if experienced, could limit physician adoption of our products.

Even if the data collected from future clinical studies or clinical experience indicates positive results, each physician’s actual experience with our devices outside the clinical study setting may vary. Clinical studies conducted with the C-Port and PAS-Port systems have involved procedures performed by physicians who are technically proficient, high-volume users of the C-Port and PAS-Port systems. Consequently, both short- and long-term results reported in these studies may be significantly more favorable than typical results of practicing physicians, which could negatively impact rates of adoption of the C-Port and PAS-Port systems.

Any clinical trials that we may conduct may not begin on time, or at all, and may not be completed on schedule, or at all.

      The commencement or completion of any of our clinical trials may be delayed or halted for numerous reasons, including, but not limited to, the following:

 
the FDA or other regulatory authorities suspend or place on hold a clinical trial, or do not approve a clinical trial protocol or a clinical trial;

 
the data and safety monitoring committee of a clinical trial recommends that a trial be placed on hold or suspended;

 
patients do not enroll in clinical trials at the rate we expect;

 
patients are not followed-up at the rate we expect;

 
clinical trial sites decide not to participate or cease participation in a clinical trial;

 
patients experience adverse side effects or events related to our products;

 
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patients die or suffer adverse medical effects during a clinical trial for a variety of reasons, which may not be related to our product candidates, including the advanced stage of their disease and other medical problems;

 
third-party clinical investigators do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol and good clinical practices, or other third-party organizations do not perform data collection and analysis in a timely or accurate manner;

 
regulatory inspections of our clinical trials or manufacturing facilities may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials if investigators find us not to be in compliance with regulatory requirements;

 
third-party suppliers fail to provide us with critical components that conform to design and performance specifications;

 
the failure of our manufacturing processes to produce finished products that conform to design and performance specifications;

 
changes in governmental regulations or administrative actions;

 
the interim results of the clinical trial are inconclusive or negative;

 
pre-clinical or clinical data is interpreted by third parties in different ways; or

 
our trial design, although approved, is inadequate to demonstrate safety and/or efficacy.
 
      In particular, we have been advised by the FDA that the FDA would require clinical data with respect to the staple design used in the planned MicroCutter product line as part of a 510(k) submission to the FDA with respect to potential clearance of the MicroCutter XPRESS 30 and other products in the planned MicroCutter product line for marketing and sale in the United States.  The extent of the clinical data to be required by the FDA is currently unknown and, accordingly, the current timing and path towards 510(k) clearance for the MicroCutter XPRESS 30 and, therefore, any marketing of the proposed product in U.S., are likewise unknown.  Any delays in our ability to obtain 510(k) clearance of the MicroCutter XPRESS 30 beyond our current expectations could materially harm our ability to generate additional revenue from this proposed product and our business as a whole.

Clinical trials sometimes experience delays related to outcomes experienced during the course of the trials, which may result in any material delay in the trial and could lead to more significant delays or other effects in future trials.

Clinical trials may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient follow-up in clinical trials depend on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites and the eligibility criteria for the study and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures to assess the safety and effectiveness of our product candidates, or they may be persuaded to participate in contemporaneous trials of competitive products. Delays in patient enrollment or failure of patients to continue to participate in a study may cause an increase in costs and delays or result in the failure of the trial.

      Our clinical trial costs will increase if we have material delays in our clinical trials or if we need to perform more or larger clinical trials than planned. Adverse events during a clinical trial could cause us to repeat a trial, terminate a trial or cancel an entire program.

If the third parties on whom we rely to conduct our clinical trials do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our product candidates.

      We do not have the ability to independently conduct clinical trials for our product candidates, and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories, to conduct our clinical trials. In addition, we rely on third parties to assist with our pre-clinical development of product candidates. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control, such as changes in regulations, delays in enrollment, and the like. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates on a timely basis, if at all.

 
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*Because one customer accounts for a substantial portion of our product sales, the loss of this significant customer would cause a substantial decline in our revenue.

      We derive a substantial portion of our revenue from sales to Century, our distributor in Japan. The loss of Century as a customer would cause a decrease in revenue and, consequently, an increase in net loss. For the three month periods ended September 30, 2011 and 2010, sales to Century accounted for approximately 33% and 22%, respectively, of our total product sales. For fiscal years 2011 and 2010 sales to Century Medical accounted for approximately 22% and 23%, respectively, of our total product sales. We expect that Century will continue to account for a substantial portion of our sales in the near term. As a result, if we lose Century as a customer, our revenue and net loss would be adversely affected. In addition, customers that have accounted for significant revenue in the past may not generate revenue in any future period. The failure to obtain new significant customers or additional orders from existing customers will materially affect our operating results.

If our competitors have products that are approved in advance of ours, marketed more effectively or demonstrated to be more effective than ours, our commercial opportunity will be reduced or eliminated and our business will be harmed.

The MicroCutter XPRESS 30 and other planned products in the MicroCutter product line, if they receive regulatory clearance and are successfully launched, would compete in the market for stapling and cutting devices within laparoscopic stapling and sealing devices currently marketed around the world. We believe the principal competitive factors in the market for laparascopic staplers include:

 
reduced product size;

 
ease of use;

 
product quality and reliability;

 
multi-fire capability;

 
device cost-effectiveness;

 
degree of articultaion;

 
surgeon relationships; and

 
sales and marketing capabilities.

Two large competitors, Ethicon Endo-Surgery, part of Johnson & Johnson, and Covidien currently control over 80% of this market. Other large competitors in the laparoscopic device market include Stryker Endoscopy and Olympus, which acquired another competitor, Gyrus Medical. Ethicon Endo-Surgery and Covidien, which recently acquired a small competitor, Power Medical, each have large direct sales forces in the United States and have been the largest participants in the market for single use disposable laparoscopic stapling devices for many years. Competing against large established competitors with significant resources may make establishing a market for any products that we develop difficult which would have a material adverse effect on our business.

The market for anastomotic solutions and cardiac bypass products is competitive. Competitors include a variety of public and private companies that currently offer or are developing cardiac surgery products generally and automated anastomotic systems specifically that would compete directly with ours.

      We believe that the primary competitive factors in the market for medical devices used in the treatment of coronary artery disease include:

 
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improved patient outcomes;

 
access to and acceptance by leading physicians;

 
product quality and reliability;

 
ease of use;

 
device cost-effectiveness;

 
training and support;

 
novelty;

 
physician relationships; and

 
sales and marketing capabilities.
 
      We may be unable to compete successfully on the basis of any one or more of these factors, which could have a material adverse affect on our business, financial condition and results of operations.

      A number of different technologies exist or are under development for performing anastomoses, including sutures, mechanical anastomotic devices, suture-based anastomotic devices and shunting devices. Currently, substantially all anastomoses are performed with sutures and, for the foreseeable future we believe that sutures will continue to be the principal alternative to our anastomotic products. Sutures are far less expensive than our automated anastomotic products, and other anastomotic devices may be less expensive than our own. Surgeons, who have been using sutures for their entire careers, may be reluctant to consider alternative technologies, despite potential advantages. Any resistance to change among practitioners could delay or hinder market acceptance of our products, which would have a material adverse effect on our business.

      Cardiovascular diseases may also be treated by other methods that do not require anastomoses, including, interventional techniques such as balloon angioplasty with or without the use of stents, pharmaceuticals, atherectomy catheters and lasers. Several of these alternative treatments are widely accepted in the medical community and have a long history of use. In addition, technological advances with other therapies for cardiovascular disease, such as drugs, or future innovations in cardiac surgery techniques could make other methods of treating these diseases more effective or lower cost than bypass procedures. For example, the number of bypass procedures in the United States and other major markets has declined in recent years and is expected to decline in the years ahead because competing treatments are, in many cases, far less invasive and provide acceptable clinical outcomes. Many companies working on treatments that do not require anastomoses may have significantly greater financial, manufacturing, marketing, distribution and technical resources and experience than we have. Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical testing, clinical trials, obtaining regulatory clearance or approval and marketing approved products than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Our competitors may succeed in developing technologies and therapies that are more effective, better tolerated or less costly than any that we are developing or that would render our product candidates obsolete and noncompetitive. Our competitors may succeed in obtaining clearance or approval from the FDA and foreign regulatory authorities for their products sooner than we do for ours. We will also face competition from these third parties in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient enrollment for clinical trials and in acquiring and in-licensing technologies and products complementary to our programs or advantageous to our business.
      
We are dependent upon a number of key suppliers, including single source suppliers, the loss of which would materially harm our business.

      We use or rely upon sole source suppliers for certain components and services used in manufacturing our products, and we utilize materials and components supplied by third parties with which we do not have any long-term contracts. In recent years, many suppliers have ceased supplying materials for use in implantable medical devices. We cannot assure you that materials required by us will not be restricted or that we will be able to obtain sufficient quantities of such materials or services in the future. Moreover, the continued use by us of materials manufactured by third parties could subject us to liability exposure. Because we do not have long-term contracts, none of our suppliers is required to provide us with any guaranteed minimum production levels.

 
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      We cannot quickly replace suppliers or establish additional new suppliers for some of our components, particularly due to both the complex nature of the manufacturing process used by our suppliers and the time and effort that may be required to obtain FDA clearance or approval or other regulatory approval to use materials from alternative suppliers. Any significant supply interruption or capacity constraints affecting our facilities or those of our suppliers would have a material adverse effect on our ability to manufacture our products and, therefore, a material adverse effect on our business, financial condition and results of operations.

We have limited manufacturing experience and may encounter difficulties in increasing production to provide an adequate supply to customers.

      To date, our manufacturing activities have consisted primarily of producing moderate quantities of our marketed products for commercial sales in Japan, Europe and the United States. Production in increased commercial quantities will require us to expand our manufacturing capabilities and to hire and train additional personnel. We may encounter difficulties in increasing our manufacturing capacity and in manufacturing larger commercial quantities, including:

 
maintaining product yields;

 
maintaining quality control and assurance;

 
providing component and service availability;

 
maintaining adequate control policies and procedures; and

 
hiring and retaining qualified personnel.
 
 
      Difficulties encountered in increasing our manufacturing could have a material adverse effect on our business, financial condition and results of operations.

      The manufacture of our products is a complex and costly operation involving a number of separate processes and components. Shipment delays may negatively impact physicians' and hospitals' perception of our products and have a material adverse impact on our results of operations.

      In addition, the current unit costs for our products, based on limited manufacturing volumes, are very high, and it will be necessary to achieve economies of scale to become profitable. Certain of our manufacturing processes are labor intensive, and achieving significant cost reductions will depend in part upon reducing the time required to complete these processes. We cannot assure you that we will be able to achieve cost reductions in the manufacture of our products and, without these cost reductions, our business may never achieve profitability.

      We have considered, and will continue to consider as appropriate, manufacturing in-house certain components currently provided by third parties, as well as implementing new production processes. Manufacturing yields or costs may be adversely affected by the transition to in-house production or to new production processes, when and if these efforts are undertaken, which would materially and adversely affect our business, financial condition and results of operations.

*If we fail to retain key personnel, including our executive management team, we may be unable to successfully develop or commercialize our products.

      Our business and future operating results depend significantly on the continued contributions of our key technical personnel and senior management, including those of our co-founder, CEO and President, Bernard Hausen, M.D., Ph.D. These services and individuals would be difficult or impossible to replace and none of these individuals is subject to a post-employment non-competition agreement. While we are subject to certain severance obligations to Dr. Hausen, either he or we may terminate his employment at any time and for any lawful reason or for no reason.  Additionally, although we have key-person life insurance in the amount of $3.0 million on the life of Dr. Hausen, we cannot assure you that this amount would fully compensate us for the loss of Dr. Hausen's services. The loss of key employees, the failure of any key employee to perform or our inability to attract and retain skilled employees, as needed, could materially adversely affect our business, financial condition and results of operations.

 
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      As of September 30, 2011, we had 50 employees. Our business and future operating results depend significantly on our ability to attract and retain qualified management, manufacturing, technical, marketing, sales and support personnel for our operations. Competition for such personnel is intense, and there can be no assurance that we will be successful in attracting or retaining such personnel. We will need to maintain an appropriate level of managerial, operational, financial and other resources to manage and fund our operations and clinical trials, continue our research and development activities and commercialize our products, and we expect our past reductions in force will impair our ability to maintain or increase our product sales. It is possible that our management and scientific personnel, systems and facilities currently in place may not be adequate to maintain future operating activities, and we may be required to effect additional reductions in force.

We may in the future be a party to patent litigation and administrative proceedings that could be costly and could interfere with our ability to sell our products.

      The medical device industry has been characterized by extensive litigation regarding patents and other intellectual property rights, and companies in the industry have used intellectual property litigation to gain a competitive advantage. We may become a party to patent infringement claims and litigation or interference proceedings declared by the U.S. Patent and Trademark Office to determine the priority of inventions. The defense and prosecution of these matters are both costly and time consuming. Additionally, we may need to commence proceedings against others to enforce our patents, to protect our trade secrets or know-how or to determine the enforceability, scope and validity of the proprietary rights of others. These proceedings would result in substantial expense to us and significant diversion of effort by our technical and management personnel.

      We are aware of patents issued to third parties that contain subject matter related to our technology. We cannot assure you that these or other third parties will not assert that our products and systems infringe the claims in their patents or seek to expand their patent claims to cover aspects of our products and systems. An adverse determination in litigation or interference proceedings to which we may become a party could subject us to significant liabilities or require us to seek licenses. In addition, if we are found to willfully infringe third-party patents, we could be required to pay treble damages in addition to other penalties. Although patent and intellectual property disputes in the medical device area have often been settled through licensing or similar arrangements, costs associated with these arrangements may be substantial and could include ongoing royalties. We may be unable to obtain necessary licenses on satisfactory terms, if at all. If we do not obtain necessary licenses, we may be required to redesign our products to avoid infringement, and it may not be possible to do so effectively. Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling the C-Port or PAS-Port systems or any other product we may develop, which would have a significant adverse impact on our business.

Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively.

      We rely upon patents, trade secret laws and confidentiality agreements to protect our technology and products. Our pending patent applications may not issue as patents or, if issued, may not issue in a form that will be advantageous to us. Any patents we have obtained or will obtain in the future might be invalidated or circumvented by third parties. If any challenges are successful, competitors might be able to market products and use manufacturing processes that are substantially similar to ours. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by consultants, vendors or former or current employees, despite the existence generally of confidentiality agreements and other contractual restrictions. Monitoring unauthorized use and disclosure of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be adequate. In addition, the laws of many foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States. To the extent that our intellectual property protection is inadequate, we are exposed to a greater risk of direct competition. In addition, competitors could purchase any of our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts or design around our protected technology. If our intellectual property is not adequately protected against competitors' products and methods, our competitive position could be adversely affected, as could our business.

 
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      We also rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position. We require our employees, consultants and advisors to execute appropriate confidentiality and assignment-of-inventions agreements with us. These agreements typically provide that all materials and confidential information developed or made known to the individual during the course of the individual's relationship with us be kept confidential and not disclosed to third parties except in specific circumstances and that all inventions arising out of the individual's relationship with us shall be our exclusive property. These agreements may be breached, and in some instances, we may not have an appropriate remedy available for breach of the agreements. Furthermore, our competitors may independently develop substantially equivalent proprietary information and techniques, reverse engineer our information and techniques, or otherwise gain access to our proprietary technology.
 
Our products face the risk of technological obsolescence, which, if realized, could have a material adverse effect on our business.

      The medical device industry is characterized by rapid and significant technological change. There can be no assurance that third parties will not succeed in developing or marketing technologies and products that are more effective than ours or that would render our technology and products obsolete or noncompetitive. Additionally, new, less invasive surgical procedures and medications could be developed that replace or reduce the importance of current procedures that use our products. Accordingly, our success will depend in part upon our ability to respond quickly to medical and technological changes through the development and introduction of new products. The relative speed with which we can develop products, complete clinical testing and regulatory clearance or approval processes, train physicians in the use of our products, gain reimbursement acceptance, and supply commercial quantities of products to the market are expected to be important competitive factors. Product development involves a high degree of risk, and we cannot assure you that our new product development efforts will result in any commercially successful products. We have experienced delays in completing the development and commercialization of our planned products, and there can be no assurance that these delays will not continue or recur in the future. Any delays could result in a loss of market acceptance and market share.

We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and, if we are unable to fully comply with such laws, could face substantial penalties.

      Our operations may be directly or indirectly affected by various broad state and federal healthcare fraud and abuse laws, including the federal healthcare program Anti-Kickback Statute, which prohibits any person from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, to induce or reward either the referral of an individual, or the furnishing or arranging for an item or service, for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. Foreign sales of our products are also subject to similar fraud and abuse laws, including application of the U.S. Foreign Corrupt Practices Act. If our operations, including any consulting arrangements we may enter into with physicians who use our products, are found to be in violation of these laws, we or our officers may be subject to civil or criminal penalties, including large monetary penalties, damages, fines, imprisonment and exclusion from Medicare and Medicaid program participation. If enforcement action were to occur, our business and financial condition would be harmed.

We could be exposed to significant product liability claims, which could be time consuming and costly to defend, divert management attention, and adversely impact our ability to obtain and maintain insurance coverage. The expense and potential unavailability of insurance coverage for our company or our customers could adversely affect our ability to sell our products, which would adversely affect our business.

The testing, manufacture, marketing, and sale of our products involve an inherent risk that product liability claims will be asserted against us. Additionally, we are currently training physicians in the United States on the use of our C-Port and PAS-Port systems and in Europe for the MicroCutter XPRESS 30.  During training, patients may be harmed, which could also lead to product liability claims. Product liability claims or other claims related to our products, or their off-label use, regardless of their merits or outcomes, could harm our reputation in the industry, reduce our product sales, lead to significant legal fees, and result in the diversion of management’s attention from managing our business.

      Although we maintain product liability insurance in the amount of $10,000,000, we may not have sufficient insurance coverage to fully cover the costs of any claim or any ultimate damages we might be required to pay. We may not be able to obtain insurance in amounts or scope sufficient to provide us with adequate coverage against all potential liabilities. Any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage. Product liability claims in excess of our insurance coverage would be paid out of cash reserves, harming our financial condition and adversely affecting our operating results.

 
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Some of our customers and prospective customers may have difficulty in procuring or maintaining liability insurance to cover their operations and use of the C-Port or PAS-Port systems or the MicroCutter product line. Medical malpractice carriers are withdrawing coverage in certain states or substantially increasing premiums. If this trend continues or worsens, our customers may discontinue using the C-Port or PAS-Port systems and potential customers may opt against purchasing the C-Port or PAS-Port systems due to the cost or inability to procure insurance coverage.

We sell our systems internationally and are subject to various risks relating to these international activities, which could adversely affect our revenue.

      To date, a substantial portion of our product sales has been attributable to sales in international markets. By doing business in international markets, we are exposed to risks separate and distinct from those we face in our domestic operations. Our international business may be adversely affected by changing economic conditions in foreign countries. Because most of our sales are currently denominated in U.S. dollars, if the value of the U.S. dollar increases relative to foreign currencies, our products could become more costly to the international customer and, therefore, less competitive in international markets, which could affect our results of operations. Engaging in international business inherently involves a number of other difficulties and risks, including:

 
export restrictions and controls relating to technology;

 
the availability and level of reimbursement within prevailing foreign healthcare payment systems;

 
pricing pressure that we may experience internationally;

 
required compliance with existing and changing foreign regulatory requirements and laws;

 
laws and business practices favoring local companies;

 
longer payment cycles;

 
difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;

 
political and economic instability;

 
potentially adverse tax consequences, tariffs and other trade barriers;

 
international terrorism and anti-American sentiment;

 
difficulties and costs of staffing and managing foreign operations; and

 
difficulties in enforcing intellectual property rights.
 
 
      Our exposure to each of these risks may increase our costs, impair our ability to market and sell our products and require significant management attention. We cannot assure you that one or more of these factors will not harm our business.
 
Our operations are currently conducted at a single location that may be at risk from earthquakes, terror attacks or other disasters.

      We currently conduct all of our manufacturing, development and management activities at a single location in Redwood City, California, near known earthquake fault zones. We have taken precautions to safeguard our facilities, including insurance, health and safety protocols, and off-site storage of computer data. However, any future natural disaster, such as an earthquake, or a terrorist attack, could cause substantial delays in our operations, damage or destroy our equipment or inventory and cause us to incur additional expenses. A disaster could seriously harm our business and results of operations. Our insurance does not cover earthquakes and floods and may not be adequate to cover our losses in any particular case.

 
36

 
 
If we use hazardous materials in a manner that causes injury, we may be liable for damages.

      Our research and development and manufacturing activities involve the use of hazardous materials. Although we believe that our safety procedures for handling and disposing of these materials comply with federal, state and local laws and regulations, we cannot entirely eliminate the risk of accidental injury or contamination from the use, storage, handling or disposal of these materials. We do not carry specific hazardous waste insurance coverage, and our property and casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory clearances or approvals could be suspended or terminated.

Changes in tax structures may negatively impact our industry in general, which could harm our business and the value of our stock.

Beginning in 2013, U.S. health care law reforms under the 2010 Affordable Health Care Act will impose a new 2.3% excise tax on certain medical technology companies regardless of whether the companies are profitable. Industry advocates anticipate the new tax will negatively impact innovation and U.S. competitiveness.  Despite the 2013 implementation date, the tax may already be having an adverse impact on U.S. medical device research and development investment activity and job creation, and may force affected companies to consider cutting manufacturing operations, research and development, and employment levels.  These new taxes may also adversely impact patient access to new and innovative medical technologies such as those we manufacture and develop.  If any of these risks materializes, then our business may be harmed and the value of our common stock could decline.

Risks Related to Our Common Stock

The price of our common stock may continue to be volatile, and the value of an investment in our common stock may decline.

      An active and liquid trading market for our common stock may not develop or be sustained. Factors that could cause volatility in the market price of our common stock include, but are not limited to:

 
completion of development and commercial launch of our MicroCutter products, and the timing thereof;

 
market acceptance and adoption of our products;

 
regulatory clearance or approvals of or other regulatory developments with rest to our products;

 
volume and timing of orders for our products;

 
changes in earnings estimates, investors' perceptions, recommendations by securities analysts or our failure to achieve analysts' earnings estimates;

 
quarterly variations in our or our competitors' results of operations;

 
general market conditions and other factors unrelated to our operating performance or the operating performance of our competitors;

 
the announcement of new products or product enhancements by us or our competitors;

 
announcements related to patents issued to us or our competitors and to litigation; and

 
developments in our industry.
 
 
      In addition, the stock prices of many companies in the medical device industry have experienced wide fluctuations that have often been unrelated to the operating performance of those companies. These factors may materially and adversely affect the market price of our common stock.
 
 
37

 
 
*The ownership of our common stock is highly concentrated, and your interests may conflict with the interests of our existing stockholders.

      Our executive officers and directors and their affiliates, together with other stockholders that own 5% or more of our outstanding common stock, beneficially owned approximately 25% of our outstanding common stock as of September 30, 2011. Accordingly, these stockholders have significant influence over the outcome of corporate actions requiring stockholder approval and continue to have significant influence over our operations. The interests of these stockholders may be different than the interests of other stockholders on these matters. This concentration of ownership could also have the effect of delaying or preventing a change in our control or otherwise discouraging a potential acquirer from attempting to obtain control of us, which in turn could reduce the price of our common stock.

Evolving regulation of corporate governance and public disclosure will result in additional expenses and continuing uncertainty.

      Changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, new Securities and Exchange Commision regulations and The Nasdaq Stock Market rules are creating uncertainty for public companies. We are presently evaluating and monitoring developments with respect to new and proposed rules and cannot predict or estimate the amount of the additional compliance costs we may incur or the timing of such costs. These new or changed laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and as a result, their application in practice may evolve over time as new guidance is provided by courts and regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. Maintaining appropriate standards of corporate governance and public disclosure will result in increased general and administrative expenses and a diversion of management time and attention from product-generating and revenue-generating activities to compliance activities. In addition, if we fail to comply with new or changed laws, regulations and standards, regulatory authorities may initiate legal proceedings against us and our business and reputation may be harmed.

Our future operating results may be below securities analysts' or investors' expectations, which could cause our stock price to decline.

      The revenue and income potential of our products and our business model are unproven, and we may be unable to generate significant revenue or grow at the rate expected by securities analysts or investors. In addition, our costs may be higher than we, securities analysts or investors expect. If we fail to generate sufficient revenue or our costs are higher than we expect, our results of operations will suffer, which in turn could cause our stock price to decline. Our results of operations will depend upon numerous factors, including:

 
completion of development, and commercialization, of our MicroCutter products, and the timing thereof;

 
FDA or other regulatory clearance or approval of our products;

 
demand for our products;

 
the performance of third-party contract manufacturers and component suppliers;

 
our ability to develop sales and marketing capabilities;

 
our ability to develop, introduce and market new or enhanced versions of our products on a timely basis; and

 
our ability to obtain and protect proprietary rights.
 
      Our operating results in any particular period may not be a reliable indication of our future performance. In some future quarters, our operating results may be below the expectations of securities analysts or investors.  If this occurs, the price of our common stock will likely decline.

 
38

 
 
Anti-takeover defenses that we have in place could prevent or frustrate attempts to change our direction or management.

      Provisions of our certificate of incorporation and bylaws and applicable provisions of Delaware law may make it more difficult for or prevent a third party from acquiring control of us without the approval of our board of directors. These provisions:

 
limit who may call a special meeting of stockholders;

 
establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings;

 
prohibit cumulative voting in the election of our directors, which would otherwise permit less than a majority of stockholders to elect directors;

 
prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; and

 
provide our board of directors with the ability to designate the terms of and issue a new series of preferred stock without stockholder approval.
 
      In addition, Section 203 of the Delaware General Corporation Law generally prohibits us from engaging in any business combination with certain persons who own 15% or more of our outstanding voting stock or any of our associates or affiliates who at any time in the past three years have owned 15% or more of our outstanding voting stock. These provisions may have the effect of entrenching our management team and may deprive our stockholders of the opportunity to sell their shares to potential acquirors at a premium over prevailing prices. This potential inability to obtain a control premium could reduce the price of our common stock.
 
 
We may become involved in securities class action litigation that could divert management's attention and harm our business.

      The stock market in general, the Nasdaq Global Market and the market for medical device companies in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Further, the market prices of securities of medical device companies have been particularly volatile. These broad market and industry factors may materially harm the market price of our common stock, regardless of our operating performance. In the past, following periods of volatility in the market price of a particular company's securities, securities class action litigation has often been brought against that company. We may become involved in this type of litigation in the future. Litigation often is expensive and diverts management's attention and resources, which could materially harm our financial condition and results of operations.
 
 
We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.

      We have paid no cash dividends on any of our classes of capital stock to date, and we currently intend to retain our future earnings to fund the development and growth of our business. As a result, capital appreciation, if any, of our common stock will be the sole source of gain to our stockholders for the foreseeable future.

 
39

 
ITEM 6. EXHIBITS

Exhibit
No.
 
Description.
3.1
 
Amended and Restated Certificate of Incorporation of Cardica, Inc. Ö
3.2
 
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (1)
3.3
 
Certificate of Correction of Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (2)
3.4
 
Amended and Restated Bylaws of Cardica, Inc. (3)
4.1
 
Warrant dated March 17, 2000 exercisable for 36,870 shares of common stock (on a pre-split basis). Ö
4.2
 
Warrant dated October 31, 2002 exercisable for 180,052 shares of common stock (on a pre-split basis). Ö
4.3
 
Form of Warrant dated June 2007. (4)
4.4
 
Form of Warrant dated September 30, 2009. (5)
10.35
 
At The Market Issuance Sales Agreement, dated August 3, 2011, by and between Cardica, Inc., and McNicoll, Lewis & Vlak LLC. (6)
10.36
 
Distribution Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
10.37
 
Secured Note Purchase Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
10.38
 
Security Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
10.39
 
Form of Secured Promissory Note to Century Medical, Inc.
31.1
 
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
31.2
 
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
32.1*
 
Certification required by Rule 13a-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).
101.INS#
 
XBRL Instance Document.
101.SCH#
 
XBRL Taxonomy Extension Schema Document.
101.CAL#
 
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF#
 
XBRL Taxonomy Extension Definition.
101.LAB#
 
XBRL Taxonomy Extension Labels Linkbase Document.
101.PRE#
 
XBRL Taxonomy Extension Presentation Linkbase Document.
Ö
 
Filed as exhibits to the Company's Registration Statement on Form S-1 filed with the Securities and Exchange Commission on November 4, 2005, as amended, and incorporated herein by reference.
*
 
The certification attached as Exhibit 32.1 accompanying this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Cardica, Inc., under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q and irrespective of any general incorporation language contained in any such filing.
 
#
 
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment. Omitted portions of this exhibit have been filed separately with the Securities and Exchange Commission.
Pursuant to applicable securities laws and regulations, Cardica, Inc. is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as Cardica, Inc. has made a good faith attempt to comply with the submission requirements and promptly amend the interactive data files after becoming aware that the interactive data files fail to comply with the submission requirements. In accordance with Rule 406T of Regulation S-T, the information in these exhibits is furnished and deemed not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
(1)
 
Filed as an exhibit to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 15, 2010 and incorporated herein by reference.
(2)
 
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 16, 2010 and incorporated herein by reference.
(3)
 
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 19, 2008 and incorporated herein by reference.
(4)
 
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2007 and incorporated herein by reference.
(5)
 
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 29, 2009 and incorporated herein by reference.
(6)
 
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 4, 2011 and incorporated herein by reference.
 
40

 
 
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.

 
Cardica, Inc.
 
 
Date: November 9, 2011                                                  
/s/ Bernard A. Hausen  
 
 
Bernard A. Hausen, M.D., Ph.D. 
 
 
President, Chief Executive Officer,
Chief Medical Officer and Director
(Principal Executive Officer) 
 
     
Date: November 9, 2011                                                  
/s/ Robert Y. Newell  
 
 
Robert Y. Newell 
 
 
Vice President, Finance and Chief Financial Officer
(Principal Financial and Accounting Officer) 
 


 
41

 
Exhibit Index

Exhibit
No.
 
Description.
3.1
 
Amended and Restated Certificate of Incorporation of Cardica, Inc. Ö
3.2
 
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (1)
3.3
 
Certificate of Correction of Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (2)
3.4
 
Amended and Restated Bylaws of Cardica, Inc. (3)
4.1
 
Warrant dated March 17, 2000 exercisable for 36,870 shares of common stock (on a pre-split basis). Ö
4.2
 
Warrant dated October 31, 2002 exercisable for 180,052 shares of common stock (on a pre-split basis). Ö
4.3
 
Form of Warrant dated June 2007. (4)
4.4
 
Form of Warrant dated September 30, 2009. (5)
10.35
 
At The Market Issuance Sales Agreement, dated August 3, 2011, by and between Cardica, Inc., and McNicoll, Lewis & Vlak LLC. (6)
10.36
 
Distribution Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
10.37
 
Secured Note Purchase Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
10.38
 
Security Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
10.39
 
Form of Secured Promissory Note to Century Medical, Inc.
31.1
 
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
31.2
 
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
32.1*
 
Certification required by Rule 13a-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).
101.INS#
 
XBRL Instance Document.
101.SCH#
 
XBRL Taxonomy Extension Schema Document.
101.CAL#
 
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF#
 
XBRL Taxonomy Extension Definition.
101.LAB#
 
XBRL Taxonomy Extension Labels Linkbase Document.
101.PRE#
 
XBRL Taxonomy Extension Presentation Linkbase Document.
Ö
 
Filed as exhibits to the Company's Registration Statement on Form S-1 filed with the Securities and Exchange Commission on November 4, 2005, as amended, and incorporated herein by reference.
*
 
The certification attached as Exhibit 32.1 accompanying this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Cardica, Inc., under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q and irrespective of any general incorporation language contained in any such filing.
 
#
 
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment. Omitted portions of this exhibit have been filed separately with the Securities and Exchange Commission.
Pursuant to applicable securities laws and regulations, Cardica, Inc. is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as Cardica, Inc. has made a good faith attempt to comply with the submission requirements and promptly amend the interactive data files after becoming aware that the interactive data files fail to comply with the submission requirements. In accordance with Rule 406T of Regulation S-T, the information in these exhibits is furnished and deemed not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
(1)
 
Filed as an exhibit to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 15, 2010 and incorporated herein by reference.
(2)
 
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 16, 2010 and incorporated herein by reference.
(3)
 
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 19, 2008 and incorporated herein by reference.
(4)
 
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2007 and incorporated herein by reference.
(5)
 
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 29, 2009 and incorporated herein by reference.
(6)
 
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 4, 2011 and incorporated herein by reference.
 
 
42
Exhibit 10.36

 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 
Distribution Agreement
 

 

 
by and between
 

 

 
Cardica, Inc.
 
a Delaware Corporation
 

 

 
and
 

 

 
Century Medical, Inc.
 
a Japanese Corporation
 

 

 
Dated as of September 2, 2011
 
 
 

 
 

 
 
DISTRIBUTION AGREEMENT
 
This DISTRIBUTION AGREEMENT (this “Agreement”) is made this 2nd day of September, 2011 (the “Effective Date”), by and between Cardica, Inc., a Delaware corporation with its principal place of business located at 900 Saginaw Drive, Redwood City, California 94063, USA (hereinafter referred to as “COMPANY”) and Century Medical, Inc., a Japanese Corporation with its principal place of business located at 1-11-2 Ohsaki, Shinagawa-Ku, Tokyo, 141-8588, Japan (hereinafter referred to as “DISTRIBUTOR”) in consideration of the mutual covenants and conditions hereinafter stated.
 
 
1.  DEFINITION OF TERMS
 
1.1
“Competing Products”
 
“Competing Products” shall mean stapling products that cut and seal tissue by means of applying a line of metallic staples to the tissue.
 
1.2
“Contract Year”
 
“Contract Year” shall mean a twelve (12) month period commencing on, and thereafter beginning on the anniversary of, the first day of the first full month following the date of First Commercial Sale in the Territory of any Product.
 
1.3
“First Commercial Sale”
 
“First Commercial Sale” shall mean the first sale of any Product by DISTRIBUTOR to a third-party in the Territory with all medical device approvals required to market and sell such Product from The Japanese Ministry of Health, Labour and Welfare (“MHLW”) (the “Shonin”) through the Pharmaceuticals and Medical Devices Agency (“PMDA”), an administrative agency under the control of the MHLW, including but not limited to, Facility Accreditation, QMS Investigation and registration in the Japanese Reimbursement Health Insurance System with the MHLW for the Products, all the foregoing of which are needed to import and market the Products in the Territory.
 
1.4
“Initial Term”
 
“Initial Term” shall mean the five (5) year period beginning on the date of expiration of the Premarketing Term.
 
1.5
“Note Agreement”
 
“Note Agreement” shall mean that certain secured note purchase agreement by and between COMPANY and DISTRIBUTOR dated as of even date herewith pursuant to which DISTRIBUTOR agrees to disburse in one or more tranches to COMPANY a secured loan in an aggregate amount up to four million U.S. dollars ($4,000,000) at a simple interest rate of five percent (5%), payable quarterly in arrears.
 
1.6
“Party” or “Parties”
 
“Party” or “Parties” shall mean COMPANY or DISTRIBUTOR, individually and collectively.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 1  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 

1.7
“Premarketing Term”
 
“Premarketing Term” shall mean the period beginning on the Effective Date and ending on the first day of the first full month following the date of First Commercial Sale.
 
1.8
“Products”
 
“Products” shall mean those Products specifically listed in Schedule 1 , whether manufactured by or for COMPANY or its affiliates, including any improvements or modifications thereto, as such schedule may be amended from time to time.  As used herein, “affiliate” means a person or entity that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a specified person or entity, where “control” means (a) fifty percent (50%) or more common equity ownership, or (b) the ability to direct the management or policies of a person or entity, whether by contract or otherwise.
 
1.9
  “Territory”
 
“Territory” shall mean Japan.
 
 
2.  APPOINTMENT OF DISTRIBUTOR
 
2.1
Appointment as DISTRIBUTOR by COMPANY.
 
COMPANY hereby appoints DISTRIBUTOR as its exclusive importer and distributor of COMPANY’s Products for the Territory, and DISTRIBUTOR hereby accepts such appointment on the terms and conditions set forth in this Agreement.  Under no circumstances shall DISTRIBUTOR have authority to sell or distribute any Products outside the Territory.  COMPANY shall also grant to DISTRIBUTOR a right of first negotiation for the import and distribution in the Territory of all new and future products with all line extensions, modifications and improvements thereto, manufactured and sold by COMPANY or products acquired by COMPANY or its affiliates for distribution by COMPANY.  Such distribution shall be in accordance with the terms and conditions of this Agreement, with a per unit purchase price and minimum purchase levels (“MPL”) mutually agreeable to COMPANY and DISTRIBUTOR.  If within thirty (30) days of COMPANY’s first written proposal to DISTRIBUTOR, COMPANY and DISTRIBUTOR cannot agree upon a per unit purchase price and MPL for such new products or if DISTRIBUTOR declines to distribute such products, then COMPANY will be permitted to distribute or cause to distribute by alternate means only such products as were first offered to DISTRIBUTOR for distribution in the Territory; provided , however , that COMPANY’s distribution of said products by alternate means shall be upon terms and conditions (including the per unit purchase price and MPL) to such alternate distributor no more favorable than the terms and conditions under which such products were last offered to DISTRIBUTOR for distribution.
 
2.2
Subdistributors.
 
DISTRIBUTOR may appoint subdistributors to make sales of Products within the Territory on such terms and conditions as DISTRIBUTOR determines to be necessary to fulfill its obligations under this Agreement; provided that no such appointment or delegation shall relieve DISTRIBUTOR from any obligations hereunder.  COMPANY acknowledges and agrees that DISTRIBUTOR will use subdistributors in the sale of Products, the use of said subdistributors being a normal business custom in the Territory.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 2  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
3.  TERM OF DISTRIBUTORSHIP
 
3.1
Consideration for Distribution Rights.
 
Concurrent with and contingent upon the execution of this Agreement, COMPANY and DISTRIBUTOR shall execute the Note Agreement.  All rights and obligations of the Parties under this Agreement, except for COMPANY’s obligation under Sections 5.1(x) and 5.1(xi) below, shall be conditioned upon, in the sole discretion of DISTRIBUTOR, successful deployment of the Products in a clinical case and satisfactory completion of a wet lab described therein.
 
3.2
Term.
 
Subject to the foregoing, this Agreement and the rights conferred on DISTRIBUTOR hereunder shall come into effect on the Effective Date and shall remain in effect until the expiration of the Initial Term.  At the end of the Initial Term, this Agreement shall automatically renew for an additional five (5) years (the “Renewal Period”) subject to DISTRIBUTOR having met the MPL for each Contract Year during the Initial Term as required under Section 8.6 below.
 
 
4.  DUTIES OF DISTRIBUTOR
 
4.1
Duties of DISTRIBUTOR.
 
DISTRIBUTOR covenants and agrees to do each of the following:
 
(i)           DISTRIBUTOR shall use commercially reasonable efforts to promote and sell the Products in the Territory;
 
(ii)           DISTRIBUTOR shall send one person from its sales and marketing organization to COMPANY for training prior to the First Commercial Sale of the Products in the Territory for a period of time mutually agreed upon by the Parties;
 
(iii)           DISTRIBUTOR shall maintain a commercially reasonable stock of the Products in order to promote the Products in the Territory;
 
(iv)           DISTRIBUTOR shall exhibit Products at industry meetings in the Territory;
 
(v)           DISTRIBUTOR shall create and develop a training program for end-user physician customers in the Territory in cooperation with COMPANY.  DISTRIBUTOR shall not sell Products to any end-users who have not been trained in the use of the Products;
 
(vi)           DISTRIBUTOR shall confer with COMPANY, from time to time, upon the written request of COMPANY, on matters relating to the marketing and promotion of the Products in the Territory;
 
(vii)           DISTRIBUTOR shall keep COMPANY informed regarding regulatory requirements in the Territory and shall, from time to time, provide COMPANY with updates to the Memorandum of Compliance;
 
(viii)           DISTRIBUTOR shall not solicit the sale of, promote the sale of, sell, exhibit for sale, distribute or manufacture any Competing Products in the Territory;
 
(ix)           (a) DISTRIBUTOR shall translate into the local languages of the Territory, at its own expense, any promotional materials, advertising or marketing information (“Marketing Materials”) supplied at the discretion of COMPANY which DISTRIBUTOR determines may be useful in the marketing of Products.  DISTRIBUTOR shall translate the Marketing Materials as is, and shall not make claims regarding the use of the Products that are not present in the English language materials.  DISTRIBUTOR will forward to COMPANY a copy of all translated Marketing Materials.  Any revision to such translated Marketing Materials must be sent to Company within thirty (30) days of release.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 3  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
(b) DISTRIBUTOR shall translate labeling, including instructions for use, for the Products into the official languages of the Territory.  DISTRIBUTOR will provide COMPANY with such translated labeling within five (5) days after such translation is complete, and before distributing Products bearing such labeling.  DISTRIBUTOR shall not distribute Products bearing translated labeling before receiving approval from COMPANY, which shall not be unreasonably withheld.  COMPANY and DISTRIBUTOR have communicated regarding translations and amendments of instructions for use for the Products, and both COMPANY and DISTRIBUTOR hereby acknowledge that the current translation of instructions for use for the Products under use by DISTRIBUTOR in the Territory is considered approved by COMPANY.
 
(c) Notwithstanding Section 4.1(ix)(b), DISTRIBUTOR shall amend the instructions for use as necessary in accordance with the Japanese Pharmaceutical Affairs Law and its related ordinances or guidance issued by the MHLW.  DISTRIBUTOR shall also amend the translation as necessary whenever requested by the MHLW or PMDA.  In addition, DISTRIBUTOR can amend the translation as a mean of preventive actions for adverse events or device malfunctions.  In any major amendments in the above cases, DISTRIBUTOR will provide for COMPANY’s review such translated instructions for use; and
 
(x)           during the term of this Agreement, and for a period of three (3) years from the expiration or termination of this Agreement, DISTRIBUTOR, its affiliates, successors and assigns shall not directly solicit or indirectly solicit for employment or hire in any capacity any personnel employed by COMPANY or any affiliate of COMPANY.
 
4.2
Product Approvals.
 
DISTRIBUTOR shall use its commercially reasonable efforts to obtain, at its own expense (except as otherwise provided herein), all Shonin required to market the Products in the Territory.  DISTRIBUTOR shall be under no obligation to conduct or perform any clinical trial for purposes of obtaining any Shonin or marketing the Products in the Territory.
 
In the event that DISTRIBUTOR is unable, within five (5) years of the Effective Date, to make First Commercial Sale, COMPANY shall have the sole and exclusive right to terminate this Agreement with immediate effect.
 
 
5.  DUTIES OF COMPANY
 
5.1
Duties of COMPANY.
 
COMPANY covenants and agrees to do each of the following:
 
(i)           COMPANY shall use its commercially reasonable efforts to research and respond to Product improvement needs of end-users in the Territory;
 
(ii)           COMPANY shall not (a) appoint any other distributor or importer of the Products in the Territory during the term of this Agreement or (b) make sales, directly or indirectly, of any of the Products to any person in the Territory other than DISTRIBUTOR or to any customer outside the Territory who is known to COMPANY, or who COMPANY should reasonably know, intends to introduce, directly or indirectly, the Products into the Territory.  Further, COMPANY shall not, directly or indirectly, import, manufacture, sell, market or otherwise distribute in the Territory (except pursuant to this Agreement) the Products or any products directly competitive with the Products;
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 4  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
(iii)           COMPANY shall provide DISTRIBUTOR with all materials necessary to obtain and maintain the Shonin for the import and sale of Products within the Territory by promptly furnishing to DISTRIBUTOR, at COMPANY’s cost, such technical descriptions, specifications, data, drawings, information, service manuals, quality control audits, facility inspection reports issued by governmental regulators or international quality control auditors, and so forth regarding the Products, in the English language, as DISTRIBUTOR may reasonably request;
 
(iv)           COMPANY shall provide DISTRIBUTOR, at no cost, all Products necessary for DISTRIBUTOR to fulfill its obligations under Section 4.2; however, the number of Products supplied at no charge to DISTRIBUTOR shall not exceed five   (5) units of sterile Products per Shonin application;
 
(v)           COMPANY shall provide DISTRIBUTOR with the information, documentation, data and certificates listed in the Memorandum of Compliance executed between the Parties, as amended from time to time, necessary for DISTRIBUTOR to remain in compliance with the Good Manufacturing Practices laws and regulations of the Territory;
 
(vi)           COMPANY shall inform DISTRIBUTOR, from time to time, of technical and other developments regarding the Products as they may occur;
 
(vii)           COMPANY shall furnish to DISTRIBUTOR on an on-going basis, at COMPANY’s cost, with a reasonable quantity of such technical, advertising and selling information and other promotional literature in the English language regarding the Products.  COMPANY shall review labeling translated by DISTRIBUTOR in accordance with Sections 4.1(ix)(b) and (c), including instructions for use, within ten (10) days of its receipt;
 
(viii)           COMPANY shall provide Product training to personnel of DISTRIBUTOR at times and places mutually agreed upon by both Parties, with each Party bearing its own expenses for attending such training;
 
(ix)           COMPANY shall provide DISTRIBUTOR sterile Product samples at a price equal to COMPANY’s manufacturing cost plus a fifteen percent (15%) handling fee.  DISTRIBUTOR’s sterile Product sample purchases shall be capped annually at an amount not to exceed ten percent (10%) of DISTRIBUTOR’s commercial Product purchases.  The total number of non-sterile non-functional Products given to DISTRIBUTOR at no charge shall initially be twenty (20) units and any additional quantities shall be provided at COMPANY’s sole discretion.  All such non-sterile Products shall be used for demonstration purposes only and may not be used for any other commercial activity (e.g., sale; lease; loaner; etc.) or implanted;
 
(x)           COMPANY shall reasonably afford an opportunity to DISTRIBUTOR to observe deployment of the [ * ] Product in a clinical case, currently scheduled in Germany for [ * ] , or at such other date or site as mutually agreed upon between the Parties;
 
(xi)           COMPANY shall reasonably afford an opportunity to DISTRIBUTOR to participate in a wet lab deployment of the [ * ] Products, currently planned at COMPANY’s facilities for [ * ] , or at such other date as mutually agreed upon between the Parties; and
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 5  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
(xii)           during the term of this Agreement and for a period of three (3) years from the expiration or termination of this Agreement, COMPANY, its affiliates, successors and assigns shall not directly solicit or indirectly solicit for employment or hire in any capacity any personnel employed by DISTRIBUTOR or any affiliate of DISTRIBUTOR.
 
 
6.  EXPENSES
 
6.1
DISTRIBUTOR’s Expenses.
 
Except as otherwise specifically provided herein, DISTRIBUTOR shall be responsible for all expenses incurred by it in connection with the implementation of this Agreement, including without limitation salaries, office and travel expenses of its employees, advertising and trade shows within the Territory and any and all taxes which may be imposed on DISTRIBUTOR within the Territory.  COMPANY shall bear only such of these expenses as to which it has given prior written approval.
 
6.2
COMPANY’s Expenses.
 
Except as otherwise specifically provided herein, COMPANY shall be responsible for payment of all expenses incurred by it including any taxes imposed on it and shall also pay those expenses incurred in connection with the implementation of this Agreement for which it has given prior written approval.
 
 
7.  RECORDS and REPORTS
 
7.1
Records and Reports.
 
Subject at all times to Section 11.2, DISTRIBUTOR shall maintain complete and accurate records of aggregate purchases and resales of the Products.  DISTRIBUTOR shall provide to COMPANY, by the thirtieth (30th) day of the first month following the end of each calendar quarter during the term of this Agreement, a quarterly report summarizing DISTRIBUTOR’s sales activities under this Agreement for the prior calendar quarter and containing such other information as COMPANY may reasonably request, including without limitation a description of and the amount of all Products in DISTRIBUTOR’s inventory as of the first day of each calendar month.
 
DISTRIBUTOR and COMPANY each shall, for tracking purposes, maintain accurate delivery, receiving and shipping records including model and lot numbers of the Products.
 
7.2
Adverse Experience Reporting.
 
COMPANY and DISTRIBUTOR shall follow the guidelines contained in the Memorandum of Compliance executed between the Parties regarding adverse events associated with the Products.
 
7.3
Recall.
 
If either Party believes or is notified that a recall in the Territory of any Product is desirable or required by law, it will notify the other Party within twenty-four (24) hours of any such notice.  The Parties will then discuss reasonably, expeditiously and in good faith whether such recall is appropriate or required and the manner in which any mutually agreed recall shall be handled.  The Party whose mistake, negligence or gross negligence results in such recall shall bear the expenses incurred in connection with such recall.  In addition, if COMPANY is the responsible Party, COMPANY shall reimburse DISTRIBUTOR for the price paid hereunder for such Products as may be recalled, plus all freight and related travel costs incurred by DISTRIBUTOR in connection with such recalled Products, including any costs incurred in disposing of or returning such recalled Products to COMPANY at COMPANY’s instruction.  The Parties will mutually agree upon the methods of disposal consistent with applicable laws in the Territory.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 6  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
8.  SALES OF PRODUCT TO DISTRIBUTOR
 
8.1
Purchase Prices and Terms.
 
COMPANY shall sell the Products to DISTRIBUTOR at the prices set forth in Schedule 1 .  Payments on purchase orders shall be due at the end of the month immediately following the month of shipment of the Products to DISTRIBUTOR.  Payment shall be made by wire transfer in U.S. funds to an account designated in writing by COMPANY.  All shipments of Products shall be billed to DISTRIBUTOR at the price in effect for each Product in accordance with this Section 8.1 and Schedule 1 , on the date of DISTRIBUTOR’s purchase order for such Products.  COMPANY shall have the right to change the prices of the Products no more than once each Contract Year consistent with prices charged to third-party international distributors of the Products, taking into consideration such factors as exchange rates, device-specific reimbursement rates for the Products in the Territory, if any, competition, and the like, by notifying DISTRIBUTOR in writing of any such change at least ninety (90) days prior to the effective date of any such change.  Notwithstanding the foregoing, in no event shall any price increase exceed five percent (5%) of the then current price for such Product.  Further, DISTRIBUTOR shall have the right to request a change in price, taking into consideration such factors as exchange rates, device-specific reimbursement rates for the Products or technical fees given to institutions for procedures where the Products are used in the Territory, if any, competition, and the like, by notifying COMPANY in writing of any such request and the reason for such request which request COMPANY shall consider in good faith.
 
8.2
Risk of Loss, Deliveries.
 
DISTRIBUTOR shall purchase the Products from COMPANY EXW (as defined under Incoterms 2010 of the International Chamber of Commerce) place of manufacture with risk of loss passing to DISTRIBUTOR upon delivery of the Products to the carrier.  DISTRIBUTOR shall be responsible for taxes (other than any taxes on COMPANY’s income) and import duties imposed in the Territory and for shipping fees.  COMPANY shall deliver accepted orders within the acknowledged time of shipment stated in COMPANY’s acceptance of the order.  All Products shall be packed for shipment and storage in accordance with COMPANY’s standard commercial practices, unless DISTRIBUTOR notifies COMPANY of special packaging requirements, in which event COMPANY shall be entitled to charge DISTRIBUTOR for any additional costs approved in advance by DISTRIBUTOR.
 
8.3
Acceptance and Cancellation of Orders.
 
All orders for Products by DISTRIBUTOR shall be initiated by DISTRIBUTOR’s issuance of a written purchase order sent via facsimile or mail to COMPANY or such other place as designated by COMPANY.  Such orders shall state unit quantities, unit descriptions, requested delivery dates, and shipping instructions.  The acceptance by COMPANY of an order shall be indicated by written acknowledgment thereof by COMPANY within five (5) business days following receipt of each order.  This Agreement shall control orders of Products by DISTRIBUTOR.  Any conflicting or different or additional terms or conditions contained in DISTRIBUTOR’s purchase order, COMPANY’s acknowledgment or other similar document shall not add to or modify the terms of this Agreement.  COMPANY shall have the right to cancel any order placed by DISTRIBUTOR or to refuse or delay the shipment thereof to the extent that DISTRIBUTOR is in default of any payment obligations hereunder.  DISTRIBUTOR may cancel an order, or any part thereof, for standard Products normally kept in COMPANY’s inventory which COMPANY has accepted only by providing written notice to COMPANY prior to the shipment of such Products and by paying such reasonable cancellation charge as requested by COMPANY.  DISTRIBUTOR may not cancel an order for non-inventory Products or custom made Products which COMPANY has accepted unless confirmed in writing by COMPANY and by paying such reasonable cancellation charge as requested by COMPANY, which cancellation charge may include, without limitation reasonable tooling and works-in-progress expenses requested by COMPANY.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 7  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
8.4
Product Specifications.
 
COMPANY shall be obligated to deliver Products of the specifications and quality standards in effect at the time and made known to DISTRIBUTOR and which contain a minimum shelf life of the greater of ten (10) months or eighty percent (80%) of the intended maximum shelf life for such Product at the time COMPANY delivers an order.  COMPANY shall use reasonable efforts to extend the intended maximum shelf life of Products to twenty-four (24) months or more for such Products by the end of 2012.  COMPANY reserves the right to change the design or specifications of any of the Products at any time with ninety (90) days’ prior written notice to DISTRIBUTOR.  COMPANY also reserves the right to discontinue the manufacture and distribution of any of the Products at any time, with ninety (90) days’ prior written notice to DISTRIBUTOR and, without substitution, in COMPANY’s sole discretion; provided that a discontinuation or cancellation of a Product or Product line for the purpose of transfer to a third-party or to an affiliate of COMPANY shall be deemed an assignment of COMPANY’s rights and obligations of this Agreement with respect to such Products, and COMPANY shall ensure that such transferee shall be bound by the terms and conditions of this Agreement to the same extent as COMPANY with respect to any such Products.  COMPANY acknowledges and understands that a substantial lead time is required to obtain Shonin for Product specification changes and COMPANY will use its commercially reasonable efforts to give DISTRIBUTOR as much advance notification as possible in excess of ninety (90) days concerning Product specification changes.  In the event COMPANY discontinues the manufacture or distribution of any Product or in the event of a Product specification change or in the event of COMPANY’s refusal to or failure to accept or fill any bona fide purchase orders for Products, DISTRIBUTOR’s MPL under Section 8.6 herein shall be amended and adjusted accordingly.
 
8.5
Taxes.
 
DISTRIBUTOR shall be responsible for all taxes levied and/or imposed by the Japanese government or Japanese taxing authority (other than any tax on COMPANY’s income) related to this Agreement; provided that DISTRIBUTOR may withhold from any payments to COMPANY any amounts required by Japanese law to be withheld, and shall provide to COMPANY receipts of any amounts so withheld issued by the proper authority, and such withholding taxes shall not be “grossed up”.  COMPANY shall be responsible for all taxes levied and/or imposed by the United States government or any taxing authority in the United States related to this Agreement.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 8  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
8.6
Purchase Levels.
 
DISTRIBUTOR’s right to maintain its exclusive distributorship as set forth in Section 2.1, herein, shall be subject to the following:
 
(i)           The MPL for Contract Year 1 shall be a best effort basis only.  Upon receipt of the Shonin, DISTRIBUTOR shall place an initial stocking order for one thousand (1,000) units of the Products, the composition of which order shall be determined at DISTRIBUTOR’s sole discretion.
 
(ii)           For Contract Year 2 and thereafter, DISTRIBUTOR and COMPANY shall prepare and agree upon an MPL ninety (90) days prior to the anticipated beginning of the Contract Year 2 of the Initial Term and ninety (90) days prior to the beginning of each subsequent Contract Year thereafter during Initial Term and any subsequent Renewal Periods.  With respect to Product line additions or extensions, the Parties shall make MPL adjustments as mutually agreed upon, commensurate with the expanded total available market opportunity associated with the expanded Product offerings.  If after exhausting all reasonable efforts COMPANY and DISTRIBUTOR are unable to mutually agree upon an MPL ten (10) days prior to the beginning of a subsequent Contract Year, then the default MPL for the subsequent Contract Year shall be the product of the actual purchases by DISTRIBUTOR during the Contract Year immediately preceding the subsequent Contract Year times one point one zero (1.10) for Contract Year 2-4 and one point zero five (1.05) for any subsequent Contract Year after Contract Year 4.
 
(iii)           For thirty (30) days following the conclusion of any Contract Year of the Agreement in which DISTRIBUTOR has not purchased the MPL for that Contract Year, DISTRIBUTOR shall have the discretionary right but not the obligation to purchase additional Products from COMPANY at the then applicable purchase prices in order to satisfy DISTRIBUTOR’s MPL for the prior Contract Year.  Any purchases credited towards the prior Contract Year’s MPL in accordance with the immediately preceding sentence shall not be credited towards the then current Contract Year’s MPL.
 
(iv)           Except as described in Section 8.6(iii) above, for purposes of this Section 8.6, a Product shall be deemed purchased during a designated Contract Year when a firm purchase order has been received and accepted by COMPANY during such Contract Year, and which order calls for delivery of Products within that Contract Year.
 
(v)           Notwithstanding any other provision of this Agreement to the contrary, any MPL then in effect shall be adjusted accordingly to reflect the effect of any new Products and any Product line extensions, any Product recall, any discontinuation of a Product or Product line, any change in design or specifications of any Product which has a material adverse impact on DISTRIBUTOR’s ability to market or sell such Product, any transfer to a third-party or affiliate of COMPANY of any Product as described in Section 8.4 that has a material adverse impact on DISTRIBUTOR’s ability to market or sell such Product, any termination of this Agreement with respect to a Product as described in Section 12.2, any refusal or failure by COMPANY to satisfy a bona fide purchase order made in accordance with the terms of Section 8.3, or any relevant event of force majeure as set forth in Section 14.1.
 
(vi)           COMPANY shall have the right but not the obligation to terminate this Agreement in the event that DISTRIBUTOR has not purchased the MPL for Contract Year 2 and any Contract Year thereafter during the term of this Agreement.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 9  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
(vii)           Notwithstanding any provision of this Agreement to the contrary, the MPL has been and will be established solely for the purpose of providing COMPANY with a contingent right to terminate the exclusive distributorship granted to DISTRIBUTOR under Section 2.1, in Contract Year 2 and any Contract Year thereafter, and failure to meet the MPL (1) shall not be deemed a material breach of this Agreement or (2) a fundamental breach under the United Nations Convention on Contracts for the International Sale of Goods.  COMPANY agrees that its sole remedy for any failure of DISTRIBUTOR to achieve the MPL for Contract Year 2 and any Contract Year thereafter shall be the termination of DISTRIBUTOR’s exclusive distributorship rights hereunder without any rights to claim against DISTRIBUTOR for any alleged losses or damages of any kind, for reimbursement of any costs of any kind, including attorneys’ fees, or for payment of any other kind; provided , however , that the obligations between DISTRIBUTOR and COMPANY under Section 13.2, which may include payments, shall survive a termination for failure of DISTRIBUTOR to fulfill the MPL.  This Section 8.6(vii) is not intended to, and shall not be construed to, create any obligation on the part of DISTRIBUTOR to purchase, or any right on the part of COMPANY to cause DISTRIBUTOR to purchase, Products in quantities necessary to satisfy any MPL for any Contract Year.
 
 
9.  PRODUCT LIABILITY
 
9.1
Claim, Suit or Action.
 
If any claim is made or any suit or action is instituted against DISTRIBUTOR arising out of or otherwise in connection with any defect or alleged defect in the Products sold by COMPANY to DISTRIBUTOR under this Agreement, COMPANY shall, without limiting the general indemnity provided by Section 12.1 of this Agreement, at its own expense and upon request by DISTRIBUTOR:
 
(i)           investigate or research the causes of accidents, occurrences, injuries or losses affecting any person or property as a result of the manner in which the Products are designed, manufactured, treated, packaged, labeled, delivered, sold or used, and use its best efforts to correct or eliminate such causes within a reasonable period; and
 
(ii)           provide to DISTRIBUTOR any and all assistance (including, without limitation, technical and other information, documents, data, materials and witnesses) which are, in the opinion of DISTRIBUTOR or its counsel, necessary or useful for DISTRIBUTOR’s defense to such claim, suit or action in relation to the Products sold by COMPANY to DISTRIBUTOR hereunder.
 
9.2
Product Liability Insurance.
 
COMPANY shall, at its own expense, obtain and maintain product liability insurance underwritten by a company or companies authorized to do business in the state, countries and Territory contemplated by this Agreement, subject to DISTRIBUTOR’s prior written approval, to cover any and all losses, damages (actual, consequential or indirect), liabilities, penalties, claims, demands, suits or actions, and related costs and expenses of any kind (including without limitation, expenses of investigation, counsel fees, judgments and settlements) for injury to or death of any person or property damages or any other loss suffered or allegedly suffered by any person or entity arising out of or otherwise in connection with the Products sold by COMPANY to DISTRIBUTOR pursuant to this Agreement.  COMPANY shall maintain such insurance in a minimum amount of five million U.S. dollars ($5,000,000.00) per occurrence in connection with such insurance.  COMPANY shall furnish DISTRIBUTOR with copies of all applicable insurance policies, which insurance policies shall not be canceled, modified or reduced without the prior written consent of DISTRIBUTOR.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 10  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
10.  WARRANTY POLICY
 
10.1
Warranties.
 
COMPANY warrants that the Products sold to DISTRIBUTOR shall be (1) free from any defects in material, design, workmanship, manufacture, treatment, packing, instruction manuals, labeling, warning or otherwise until the use before date (“UBD”) for sterile Products, (2) substantially in conformance with the written specifications maintained by COMPANY at the date of delivery of such Products, and (3) in compliance at all times with the requirements of and regulations adopted pursuant to the U.S. Federal Food, Drug and Cosmetic Act and applicable Japanese law.  COMPANY further warrants that it will convey good title to all Products delivered to DISTRIBUTOR free from any security interest, liens or other encumbrance.  COMPANY will provide, when requested by DISTRIBUTOR, certification that, to the best of its knowledge, it is in compliance with U.S. and applicable Japanese laws, statutes, rules, and regulations and relevant orders relating to the manufacture, use, distribution and sale of the Products.  COMPANY’S SOLE OBLIGATION UNDER THE FOREGOING WARRANTY SHALL BE, AT COMPANY’S SOLE ELECTION, TO EITHER REPLACE THE RELEVANT PRODUCT OR REFUND DISTRIBUTOR’S FULLY-LANDED PURCHASE PRICE FOR SUCH PRODUCT.  Such obligation shall be subject to COMPANY being granted the reasonable opportunity to inspect, at COMPANY’s expense, the defective Product at the location of its use or storage and, upon request in accordance with COMPANY’s instruction, return of the Product to COMPANY at COMPANY’s cost.  Any such replacement of Products may be made by substitution of any similar Product meeting substantially identical quality specifications and payment by COMPANY of all freight, handling and duty charges or taxes incident to the delivery of such replacement Products.  Upon request by COMPANY, in accordance with COMPANY’s instruction, DISTRIBUTOR shall return the Product to COMPANY at COMPANY’s cost; provided , however , that IN THE EVENT THAT THE RETURN OF A PRODUCT POSES A HEALTH RISK, DUE TO THE POSSIBILITY THAT SUCH PRODUCT HAS BEEN EXPOSED TO AN INFECTIOUS DISEASE OR OTHERWISE, COMPANY, DISTRIBUTOR AND THE END-USER SHALL DETERMINE A MUTUALLY SATISFACTORY METHOD FOR COMPANY TO INSPECT OR OTHERWISE OBTAIN ADDITIONAL INFORMATION ABOUT THE PRODUCT IN ORDER FOR COMPANY TO DETERMINE ITS OBLIGATION UNDER THE FOREGOING WARRANTY.  NOTWITHSTANDING THE FOREGOING, COMPANY MAKES NO WARRANTY, NOR SHALL IT HAVE ANY OTHER OBLIGATION TO DISTRIBUTOR WITH RESPECT TO ANY PRODUCT SOLD HEREUNDER, TO THE EXTENT THAT, PRIOR TO USE, SUCH PRODUCT HAS EXCEEDED ITS UBD ACCORDING TO THE PRODUCT’S LABEL OR HAS NOT BEEN USED, HANDLED OR STORED IN ACCORDANCE WITH COMPANY GUIDELINES AS COMMUNICATED BY COMPANY TO DISTRIBUTOR.
 
Without limiting the generality of the foregoing, and except as provided in Section 12.1, DISTRIBUTOR shall not purport to give, or assume on behalf of COMPANY, any other or different guarantee, warranty, obligation or liability whatsoever, including without limitation liability for loss or damage to person or property resulting from default or defect in design, workmanship or material or goods of any kind, other than stipulated in such warranties as COMPANY may specify from time to time.  Furthermore, DISTRIBUTOR shall only give such warranties as specified in this Section 10.1 or as specified by COMPANY from time to time on its own behalf and shall not give such other or different warranties or guarantees on its own behalf unless DISTRIBUTOR obtains the prior written consent of COMPANY on each such occasion.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 11  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
EXCEPT AS EXPRESSLY PROVIDED ABOVE AND IN SECTION 12.1 BELOW, COMPANY GRANTS DISTRIBUTOR NO OTHER WARRANTIES, WHETHER EXPRESS,  IMPLIED OR BY STATUTE  REGARDING THE PRODUCTS, THEIR FITNESS FOR ANY PARTICULAR PURPOSE, THEIR QUALITY, THEIR MERCHANTABILITY OR OTHERWISE.
 
10.2
Rejection of Products.
 
(i)           DISTRIBUTOR shall inspect all Products promptly upon receipt thereof and may reject any Product that fails in any material way to meet the then-current specifications for such Product.  Any Product not properly rejected within thirty (30) days of receipt of such Product by DISTRIBUTOR (the “Rejection Period”) shall be deemed accepted.  To reject a Product, DISTRIBUTOR shall, within the Rejection Period, notify COMPANY of its rejection and request a Material Return Authorization (“MRA”) number.  COMPANY shall provide the MRA number to DISTRIBUTOR within seven (7) days of receipt of the request.  Within seven (7) days of receipt of the MRA number, DISTRIBUTOR shall return to COMPANY the rejected Product, freight collect, with the MRA number displayed on the outside of the carton.  COMPANY reserves the right to refuse to accept any rejected Products that do not bear an MRA number on the outside of the carton.  As promptly as possible but no later than thirty (30) working days after receipt of properly rejected Products, COMPANY shall, at its option and expense, either replace the Products or refund DISTRIBUTOR’s original fully landed purchase price for the Products.  COMPANY shall pay the cost of shipping charges incurred by DISTRIBUTOR for properly rejected products.
 
(ii)           Notwithstanding the foregoing, Products which are found to be defective for failure to conform to COMPANY’s specifications at an end-user’s site shall be initially replaced by DISTRIBUTOR.  COMPANY shall then replace such defective Products with Products meeting specifications within thirty (30) days of (1) receipt of the defective Products, or (2) confirmation by DISTRIBUTOR that such defective Products have been disposed of by an end-user and receipt of a completed customer complaint form.  The final good faith determination concerning non-conformance of any Product shall rest solely with COMPANY.
 
 
11.  PATENTS, TRADEMARKS, COPYRIGHTS;
 
 
PROPRIETARY AND CONFIDENTIAL INFORMATION
 
11.1
Trademark License.
 
COMPANY hereby grants to DISTRIBUTOR a non-exclusive, royalty-free right and license (with right of sub-license to sub-distributors appointed under Section 2.2) to use the trademarks, trade names, copyrights, and other intellectual property (except patents which are expressly excluded from this Agreement) of COMPANY as communicated to DISTRIBUTOR from time to time (hereinafter referred to as the “Trademarks”) in connection with the sale or other distribution, promotion, advertising and maintenance of the Products under this Agreement.  DISTRIBUTOR may indicate in its advertising and promotion and on its stationery that it is an “authorized exclusive distributor” of the Products for the Territory.  DISTRIBUTOR has no permission to and will not adopt, use or register as a trademark, trade name, business name, or corporate name or part thereof, whether during the term of this Agreement or after its termination, any word, or symbol confusingly similar to any Trademarks.  Furthermore, upon request and at COMPANY’s expense, DISTRIBUTOR shall discontinue or cancel the registration of any and all Trademarks utilized and registered by DISTRIBUTOR in connection with the Products prior to or after the execution of this Agreement, except as provided in Section 13.2 (iii).
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 12  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
11.2
Duty to Preserve Confidentiality.
 
Without the prior written consent of the supplying Party, no receiving Party, its officers, agents, or employees shall, in any manner whatsoever for use in any way for its own account or for any third- party disclose or communicate to a third-party, any technical, engineering, manufacturing, business, financial, or other information or know-how (hereinafter referred to as the “Confidential Information”) generated by any Party hereto and acquired directly or indirectly by the other Party.  Nothing in this Section 11.2 shall prevent disclosure or use of information: (i) previously known to the receiving Party; (ii) which is or later becomes public knowledge, by publication or otherwise, through no breach of this Agreement by the receiving Party; (iii) which is properly acquired by the receiving Party from a third-party having the legal right to disclose such information; (iv) which is required to be disclosed by a governmental or judicial authority; or (v) which the receiving Party can demonstrate in writing was independently developed without reference to or reliance upon the other Party’s Confidential Information.  No receiving Party shall, in any manner whatsoever for use in any way for its own account or for the account of any third-party, disclose or communicate to a third-party, any Confidential Information for any purpose except for the purpose for which such Confidential Information was supplied, and such receiving Party shall take every reasonable precaution to protect the confidentiality of such information.  Each Party acknowledges that any breach of any obligation under this Section 11.2 is likely to cause or threaten irreparable harm to the other Party, and accordingly, each Party agrees that in such event the non-breaching Party shall be entitled to equitable relief to protect its interests, including, but not limited to, preliminary and permanent injunctive relief.
 
11.3
Proprietary.
 
DISTRIBUTOR acknowledges that the Products are proprietary to COMPANY and may not be copied and that all rights of design and invention are reserved by COMPANY.
 
 
12.  INDEMNITIES
 
12.1
Indemnity.
 
COMPANY shall, at its own expense, defend, indemnify and hold harmless DISTRIBUTOR, its officers, directors, employees, agents, successors and assigns (the “Indemnified Parties”) against any and all liabilities, claims, actions, suits, fines, penalties, losses, settlements, costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses) (collectively “Losses”) relating to or arising out of any suit, claim or proceeding instituted against any of the Indemnified Parties by any third-party or incurred in connection therewith, alleging that: (i) any patent, trademark or any other intellectual property right of COMPANY infringes the intellectual property rights of such third-party; or (ii) any defect in the Products or their design or manufacture caused bodily injury or death to any person or damage to any property.  Notwithstanding the foregoing, COMPANY shall not be responsible for such Losses as set forth in this section to the extent that: (a) such Product has been altered, modified or tampered with by DISTRIBUTOR directly resulting in such Product defect; or (b) such Product has been misused as a result of DISTRIBUTOR’s unauthorized representation about the Product directly resulting in such Losses; or (c) such Losses arise directly out of any negligence, recklessness or willful misconduct by DISTRIBUTOR or any of its employees; or (d) DISTRIBUTOR fails to give COMPANY reasonable written notice of any such claim as soon as is reasonably practicable.  COMPANY shall have the sole control of the defense and/or settlement of any claim subject to indemnification under this Section 12.1; provided, however, that COMPANY shall not control or settle any such claim without prior consultation with DISTRIBUTOR.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 13  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
12.2
Infringing Products.
 
If a claim of patent or other proprietary right infringement is made by a third-party with respect to a Product, then COMPANY, at its option and expense, shall (i) obtain for DISTRIBUTOR the right to continue to market and distribute the Product, (ii) replace the Product with a functionally-equivalent non-infringing Product, (iii) modify the Product so that it becomes non-infringing, so long as the functionality of the Product is not thereby adversely affected, and replace the infringing Product with such modified Product or (iv) have dismissed, settle or otherwise cause such claim to be withdrawn.  If COMPANY is unable to accomplish any of the foregoing within one hundred eighty (180) days of the initial infringement claim and the ability of DISTRIBUTOR to market such Product is effectively prevented by a court of relevant jurisdiction in the Territory, then COMPANY shall grant DISTRIBUTOR a full refund of DISTRIBUTOR’s fully-landed cost for all affected Products and accept return of such Products at COMPANY’s expense, the Parties shall remove all such affected Products from then current and future MPL and adjust DISTRIBUTOR’s MPL accordingly and this Agreement shall be terminated with respect to such affected Product.  If partial termination of this Agreement with respect to one or more Products pursuant to this Section 12.2 results in a greater than fifty percent (50%) decrease in DISTRIBUTOR’s total sales of Products in the three (3) month period following any such partial termination as compared to the average quarterly sales over the twelve-month period immediately preceding the third-party claim which precluded DISTRIBUTOR from marketing and distributing any Product, then DISTRIBUTOR shall have the option to terminate this Agreement in its entirety, subject to Section 13.2.
 
 
13.  TERMINATION
 
13.1
Cancellation for Cause.
 
COMPANY or DISTRIBUTOR, as the non-defaulting Party, may cancel this Agreement, immediately by providing written notice to the other Party, upon the occurrence of any of the following events:
 
(i)           The other Party becomes insolvent or is unable to pay its debts as they mature or ceases to pay in the ordinary course of business its debts as they mature; or the other Party makes an assignment for the benefit of its creditors; or a receiver, liquidator, custodian, trustee or the like is appointed for the other Party or its property; or the other Party commences a voluntary case under any applicable bankruptcy or insolvency law or consents to the entry of an order for relief in any involuntary case, or a court with jurisdiction enters a decree for relief in any involuntary case involving the other Party.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 14  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
(ii)           The other Party defaults in the material performance of any of its obligations under this Agreement and fails to cure such default within sixty (60) days after written notice thereof from the non-defaulting Party.
 
13.2
Obligations upon Cancellation or Termination.
 
Upon the expiration of this Agreement or its termination in accordance with Section 8.6(vi), Section 12.2 or Section 13.1 above, and after allowance for any applicable cure periods, DISTRIBUTOR and COMPANY each promise to do the following immediately:
 
(i)           DISTRIBUTOR shall pay to COMPANY all amounts which are then due and payable by DISTRIBUTOR to COMPANY under this Agreement less any such amounts which reasonably may be set-off by DISTRIBUTOR based on a dispute or otherwise arising out of or related to this Agreement.
 
(ii)           Each Party shall return to the other Party all Confidential Information of the other Party in its possession or under its control, together with a statement signed by an officer or duly authorized representative of the Party to the effect that all of the Confidential Information has been returned to the other Party.
 
(iii)           Except to the extent that DISTRIBUTOR requires use of the Trademarks in order to exercise DISTRIBUTOR’s right to sell any existing inventories of Products upon the expiration or termination of this Agreement, as provided for in Section 13.2(iv), DISTRIBUTOR shall cease to use any of the Trademarks and return to COMPANY all materials supplied to DISTRIBUTOR by COMPANY which contain any of the Trademarks.  Furthermore, upon receipt of written notice from COMPANY, DISTRIBUTOR shall dispose of all packaging, labels, brochures, lists, and other similar materials containing any of the Trademarks in accordance with COMPANY’s instructions, except for those materials necessary for DISTRIBUTOR’s continuing sale of existing inventories of Products provided for in Section 13.2(iv).  COMPANY shall reimburse DISTRIBUTOR for the direct costs (exclusive of overhead) and disposal costs of such materials.
 
(iv)           COMPANY or its successor (A) shall repurchase all sterile Products with a UBD at the date of termination or expiration of this Agreement of twenty-five percent (25%) of the intended maximum shelf life remaining or greater at DISTRIBUTOR’s original landed cost plus any consumption tax applicable in the Territory to sales or deliveries of Products to a third-party in the Territory; provided , however , that any Products with twenty-five percent (25%) or more of the UBD remaining but less than fifty percent (50%) of the UBD remaining shall be subject to a ten percent (10%) restocking fee to be charged by COMPANY, and (B) shall pay DISTRIBUTOR for all documented out of pocket expenses directly related to all Shonin then held by DISTRIBUTOR; provided , however , that DISTRIBUTOR shall have the absolute right to continue to sell any such Products not repurchased by COMPANY in accordance with this Section 13.2(iv).  All payments by COMPANY under this Section 13.2(iv) shall be made by wire transfer to an account to be specified by DISTRIBUTOR on or prior to thirty (30) days after DISTRIBUTOR has delivered the Products and provided COMPANY with an invoice.
 
For purposes of this Section 13.2(iv), “out of pocket expenses” shall include any Product costs, documentation, Product testing fees, and any clinical trial related expenses, etc.  Specifically excluded from “out of pocket expenses” are DISTRIBUTOR overhead, salary, travel expenses and other expenses, which derive from the operation of DISTRIBUTOR’s business as an ongoing business concern in the Territory.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 15  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
(v)           Subject to payment by COMPANY to DISTRIBUTOR of all out of pocket expenses, as described in Section 13.2(iv) above, DISTRIBUTOR shall diligently and expeditiously take the necessary steps to transfer any Shonin held by DISTRIBUTOR for the Products to a third-party affiliated with COMPANY, and located and organized under the law of the Territory, that is authorized and legally entitled to hold the Shonin.
 
(vi)           During the period that the Shonin are in the process of being transferred, DISTRIBUTOR shall otherwise cooperate with COMPANY by importing and reselling the Products to COMPANY’s next authorized distributor at DISTRIBUTOR’s fully landed cost for the Products plus a mark-up of twenty percent (20%) and any applicable consumption tax.  The general purchase and sales terms of this Agreement will govern the sale of Products during this transfer period.  COMPANY expressly agrees to indemnify DISTRIBUTOR for any non-payment by COMPANY’s next distributor for Products so resold by DISTRIBUTOR or for any other non-performance of DISTRIBUTOR out of DISTRIBUTOR’s immediate control during such transfer period.
 
(vii)           In the event that COMPANY or its successor exercises its right to terminate this Agreement pursuant to Section 14.3(ii) below, COMPANY shall be obligated to pay DISTRIBUTOR a termination fee which shall be calculated in accordance with the following table (the “Change of Control Termination Fee”):
 
If Change in Control termination occurs during:
Then the Change of Control Termination Fee shall be equal to:
Multiplied by a factor of
Period from the Effective Date up to the end of Contract Year 3
Termination not permitted due to a Change in Control (defined below).
 
Contract Years 4 or 5
DISTRIBUTOR’s gross profit from the Products in the twelve (12) month period immediately preceding termination of this Agreement
 
[ * ]
the Renewal Period
[ * ]

 
Gross profit shall mean net sales in YEN of the Products less the price of the Products paid by DISTRIBUTOR to COMPANY in YEN.
 
In the event that COMPANY challenges the applicability or efficacy of COMPANY’s Change of Control Termination Fee, or if this provision is held to be void or unenforceable for any reason, DISTRIBUTOR shall be entitled to all remedies provided at law, including attorney’s fees.  The Parties expressly acknowledge that substantial injury will result to DISTRIBUTOR upon a termination of this Agreement by COMPANY or its successor pursuant to Section 14.3(ii) below.  The Parties further expressly acknowledge that it may be difficult or impossible to determine with precision the amount of monetary damages that would be required to compensate DISTRIBUTOR for such injury.  Accordingly, the Parties have made a good-faith effort to accurately determine what those damages might be and the amount agreed to as reasonable by the Parties is COMPANY’s Change of Control Termination Fee.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 16  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
(viii)           If any portion of the Note is still outstanding, COMPANY shall immediately repay to DISTRIBUTOR the principal balance of the Note and any accrued interest owed at the time of such repayment.
 
 
14.  GENERAL PROVISIONS
 
14.1
Force Majeure.
 
Save in respect of payments due under this Agreement, neither Party to this Agreement is responsible to the other Party for nonperformance or delay in performance of the terms and conditions herein due to any event of force majeure, including without limitation acts of god, acts of government, wars, civil disturbances, strikes and other labor unrest, accidents in transportation or other cause beyond the control of the Parties.  The Party whose performance is prevented under this paragraph shall immediately inform the other Party of the state of affairs.  Notwithstanding the foregoing, should any Party be prevented from materially performing its obligations under this Agreement due to any such event of force majeure for a period in excess of four (4) months, then the other Party may elect to terminate this Agreement upon delivery of thirty (30) days’ prior written notice to such effect.
 
14.2
Relationship between Parties.
 
DISTRIBUTOR’s relationship to the COMPANY shall be that of an independent contractor.  Nothing contained in this Agreement shall make DISTRIBUTOR a partner, joint venturer, employee, or agent of COMPANY for any purpose whatsoever.  DISTRIBUTOR shall not sign any contract in the name of COMPANY, shall not purport to bind COMPANY in any way to any obligation, and shall not hold itself out or purport to act as COMPANY’s legal partner or legally empowered agent or representative for any purpose whatsoever.
 
14.3
Successors, Nonassignability.
 
(i)           This Agreement and each and every covenant, term and condition hereof is binding upon and inures to the benefit of the Parties hereto and their respective successors and permitted assigns.  Except as provided in Section 2.2 above, neither this Agreement nor any rights hereunder may be assigned by DISTRIBUTOR directly, indirectly, voluntarily or by operation of law, without first receiving the prior written consent of COMPANY.  In the event of (A) any consolidation of COMPANY with or merger of COMPANY with or into another entity, or (B) any sale, transfer or lease of all or substantially all the Product related assets of COMPANY, or (C) any event in which any person or group of persons acting in concert acquire more than fifty percent (50%) of the voting stock of COMPANY (each, a “Change in Control”), COMPANY shall to such extent assign its rights and obligations under this Agreement to such acquirer of COMPANY’s stock or assets.  COMPANY shall further provide DISTRIBUTOR with prior written notice of such assignment accompanied by a written undertaking of the assignee that the assignee shall be bound by this Agreement and assume all obligations of COMPANY under this Agreement.
 
(ii)           Provided that such Change in Control occurs, COMPANY or COMPANY’s successor shall have ninety (90) days from the date of such a Change in Control to notify DISTRIBUTOR in writing of its intention either to terminate this Agreement at any time on or after the beginning of the first day of Contact Year 4 or to accept the assignment of and assume all rights and obligations of COMPANY under the terms and conditions of this Agreement.  In the event that COMPANY or COMPANY’s successor notifies DISTRIBUTOR within ninety (90) days of the Change in Control that it has chosen to terminate this Agreement   at any time on or after the beginning of the first day of Contact Year 4, then COMPANY shall pay to DISTRIBUTOR by wire transfer to an account to be specified by DISTRIBUTOR the Change of Control Termination Fee set forth in Section 13.2(vii)   within seven (7) days after termination of this Agreement.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 17  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
14.4
Survival of Obligations.
 
Both Parties agree that the obligations described in Sections 4.1(x), 5.1(xii), 8.5, 10.1, 13.2 and Articles 7, 9, 11, 12 and 14 of this Agreement shall survive any termination, cancellation, or expiration of this Agreement.
 
14.5
Remedies.
 
The rights and remedies of each Party under this Agreement are not exclusive but shall be in addition to all of the rights and remedies to which a Party is entitled against the other Party under the law governing this Agreement.
 
14.6
Notices.
 
Unless otherwise specified, any notice required by this Agreement shall be made in a writing sent by prepaid certified mail, overnight courier or any means of electronic communications with confirmation copy sent by certified mail to the addresses first listed above, until notice of another address shall be given in the manner provided herein.  All notices, consents or requests shall be effective from the date of transmission if sent by facsimile, seven (7) days if sent by certified mail and when received if sent by international courier.
 
14.7
Disputes.
 
In the event there arises a dispute between the Parties as to the performance or interpretation of any of the provisions of this Agreement, or as to matters related to but not covered by this Agreement, the Parties shall first attempt to find a mutually agreeable solution by consultation in good faith.  If the matter has not been resolved within thirty (30) days of their first meeting to resolve a dispute, then any such dispute shall be determined finally by final and binding arbitration in accordance with the International Arbitration Rules of the American Arbitration Association.  The place of arbitration shall be either (a) Redwood City, California, U.S.A. if initiated and brought by DISTRIBUTOR or (b) Tokyo, Japan if initiated and brought by COMPANY and the language of the arbitration shall be English.  The arbitral tribunal shall consist of a single arbitrator.  If the Parties shall not have agreed upon an arbitrator within thirty (30) days of the notice of arbitration, then the Administrator of the American Arbitration Association shall appoint one.  At minimum, the arbitral tribunal shall be experienced in cross-border transactions in the area of medical devices.  The unsuccessful Party in an arbitration shall pay and discharge all reasonable costs and expenses (including reasonable attorneys’ fees) which are incurred by the other Party in enforcing this Agreement.
 
Judgment upon the award of the arbitrator may be entered in any court having jurisdiction thereof.  The Parties acknowledge that this Agreement and any award rendered pursuant to it shall be governed by the 1958 United Nations Convention on the Recognition and Enforcement of Foreign Arbitral Award.
 
Pending the submission to arbitrators and thereafter until the single arbitrator renders the award, the Parties shall, except in the event of termination, continue to perform all their obligations under this Agreement without prejudice to a final adjustment in accordance with the award.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 18  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
Nothing herein shall prevent any party from seeking injunctive relief from any court of competent jurisdiction, in order to preserve assets, prevent irreparable harm or as otherwise appropriate.
 
14.8
Unenforceable Terms.
 
In the event any term or provision of this Agreement shall for any reason be invalid, illegal or unenforceable in any respect, it shall be deemed separate and shall not affect any other provisions hereof or the validity hereof.  The Parties agree to re-negotiate in good faith any term or provision held invalid and to be bound by the mutually agreed substitute term or provision.
 
14.9
Waivers.
 
No waiver of any of the terms and conditions of this Agreement shall be effective for any purpose, unless expressed in a writing and signed by the Party thereto giving the same, and any such waiver shall be effective only in the specific instance and for the purpose given.
 
14.10
Governing Law; Headings.
 
This Agreement shall be governed by and construed in accordance with the substantive law of the State of California, U.S.A. excluding  (a) any conflict of laws rule, or principle therein contained under which any other law would be made applicable, and (b) the United Nations Convention on Contracts for the International Sale of Goods.  The headings to the paragraphs of this Agreement are for convenience of reference only, do not form a part of this Agreement, and shall not in any way affect the interpretation hereof.
 
14.11
Entire Agreement, Modification.
 
This Agreement constitutes the entire and final agreement between the Parties on the subject matter hereof and supersedes any and all prior oral or written agreements or discussions on the subject matter hereof.  This Agreement may not be modified in any respect except in a writing which states the modification and is signed by both Parties hereto.
 
14.12
Further Assurances.
 
The Parties agree to execute any and all such further agreements, instruments or documents, and to take any and all such further action as may be necessary or desirable to carry out the provisions hereof and to effectuate the purposes of this Agreement.
 
14.13
Schedule.
 
The schedule attached hereto is incorporated herein by this reference and expressly made a part hereof as fully as though completely set forth herein.
 
14.14
Counterparts.
 
This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument.
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 19  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
IN WITNESS WHEREOF, this Agreement has been prepared in two (2) original copies and the Parties and/or their duly authorized representatives have placed their signatures here below.
 

 
CARDICA, INC.
 

 

       
By:
/s/ Bernard Hausen    
       
Name:
Bernard Hausen, MD    
       
Title:
President & CEO    
 
 
CENTURY MEDICAL, INC.
 
 

 
       
By:
/s/ Akira Hoshino    
       
Name:
Akira Hoshino    
       
Title:
President & CEO    

 

 
 
 
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page- 20  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
 

 
 
Schedule 1 .   Products and Prices
 
 
Microcutter X press 30
EXW Transfer Price
 4 deployments
$ [ * ] each
 6 deployments
$ [ * ] each
 8 deployments
T.B.D.
Microcutter X press 45
 
4 deployments
$ [ * ] each
6 deployments
$ [ * ] each
8 deployments
T.B.D.
X change
T.B.D.
fle X change (5mm)
T.B.D.
 30mm
 
 45mm
 

 
Transfer Prices set forth above are estimated pricing to DISTRIBUTOR as of the Effective Date.  Transfer Prices under this Agreement will be determined once final specifications, configurations and manufacturing costs are known to COMPANY.
 
COMPANY shall on a case-by-case basis prepare price quotations for custom-made Products based upon DISTRIBUTOR’s specific inquiry, taking into consideration expected purchase volumes.
 
 
 
 
 
 
Distribution Agreement  
September 2, 2011
 
Cardica, Inc. Initial            BH         page-2 1  
Century Medical, Inc. Initial           AH             
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 10.37
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
Secured Note Purchase Agreement
 
This Secured Note Purchase Agreement   (this “ Agreement ”) is made as of September 2, 2011 (the “ Effective Date ”) by and between Cardica, Inc. , a Delaware corporation (the “ Company ”), and Century Medical, Inc. , a Japanese corporation, or its assigns (the “ Purchaser ”).
 
Capitalized terms used herein and not otherwise defined herein shall have the respective meanings given to them in the secured promissory note evidencing the Loan (as defined below) in substantially the form attached hereto as Exhibit A (the “ Note ) and the security agreement substantially in the form attached hereto as Exhibit B , pursuant to which the Company shall grant the Purchaser a security interest in the Collateral described therein (the “ Security Agreement ”).
 
The parties hereby agree as follows:
 
 
1.
Amount and Terms of the Secured Loan
 
1.1             The Loan. Subject to the terms of this Agreement, the Purchaser agrees to lend to the Company the maximum aggregate amount of four million dollars ($4,000,000) (the “ Maximum Loan Amount ”), and the Company shall issue the Note (the “ Loan ”). The Schedule to the Note shall be amended by the Purchaser to reflect the aggregate principal amount of the Loan outstanding at any particular time hereunder.
 
1.2             Interest on the Loan. The Loan shall bear interest on the unpaid principal amount thereof from the date made through the Maturity Date (as defined below) at a rate of five percent (5%) per annum. Interest on the Loan shall be payable quarterly in arrears on the last business day of March, June, September and December and on the Maturity Date. Interest shall be computed on the basis of a year of 365 days.
 
1.3             Maturity Date. The maturity date of the Loan shall be the date that is the fifth (5 th ) anniversary of the Initial Closing Date, unless accelerated hereunder, which shall include mandatory prepayment as described in Section 1.5(b) below (the “ Maturity Date ”).
 
1.4             Manner of Payment. The Company shall make all payments due hereunder by wire transfer of funds to an account designated by the Purchaser without setoff or counterclaim.
 
1.5           Prepayment.
 
(a)            The Company shall have the right, upon not less than ten (10) business days’ prior written notice, to prepay the outstanding Loan in whole or in part (but not in less than $1,000,000 increments) without premium or penalty.
 
(b)            In the event the Company obtains, in the aggregate, at least twenty-five million dollars ($25,000,000) of additional equity financing after the Effective Date (“ Additional Equity Financing ”), the Company shall prepay the outstanding Loan in whole, without premium or penalty, within ten (10) days of the date on which such Additional Equity Financing is received; provided , however , that equity funding to the Company under the purchase agreement with Aspire Capital Fund, LLC as described in the Company’s February 14, 2011 prospectus shall not be included in calculating the Additional Equity Financing. The Company shall provide notice to the Purchaser, promptly, but in any event within five (5) days, upon the Company obtaining the Additional Equity Financing.
 
 
1
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
1.6             Post-Maturity and Penalty Interest. Notwithstanding anything to the contrary contained herein, if any portion of the principal amount of the Loan or any interest accrued thereon shall not be paid when due and payable, any such overdue amount shall bear interest at a rate per annum equal to twelve percent (12%).
 
 
2.
The Closing s
 
2.1             Initial Closing Date. The initial closing of the purchase and sale of the Note (the “ Initial Closing ”) shall be held on the initial funding date of the Loan (the “ Initial Closing Date ”). On the Initial Closing Date, the Purchaser shall disburse to the Company the amount contained in the Company’s initial Funding Request delivered in accordance with Section 2.4 below (the “ Initial Tranche ”); provided that the amount of the Initial Tranche shall not exceed two million dollars ($2,000,000).
 
2.2             Additional Closings. In addition to funding the Initial Tranche, the Purchaser agrees to fund additional tranches (each an “ Additional Tranche ”) at additional closings (each, an “ Additional Closing ”) subject to and in accordance with the terms and provisions of this Agreement; provided, however, that the aggregate of all funding hereunder made at the Initial Closing and any Additional Closing shall not exceed the Maximum Loan Amount. The Initial Closing and any Additional Closing may hereafter be referred to as a “ Closing ” and the Initial Tranches and any Additional Tranche may hereafter be referred to as a “ Tranche .”
 
2.3             Delivery. Subject to the provisions hereof, at each Closing the parties shall deliver the following.
 
(a)            The Purchaser will deliver to the Company funds in the amount of the Loan being funded at such Closing in accordance with Section 2.4, below.
 
(b)            The Company shall deliver to the Purchaser: (i) the Note (at the Initial Closing only); (ii) a Funding Request; (iii) a certificate signed by the Chief Executive Officer of the Company and dated as of the date of such Closing certifying that the conditions specified in Section 6.1 (with respect to the Initial Closing) or Section 6.2 (with respect to an Additional Closing), have been satisfied; and (iv) the Company shall execute and deliver such other documents as the Purchaser shall reasonably require.
 
2.4           Mechanics of Funding the Loan.
 
 
2
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(a)            Whenever the Company desires that the Purchaser fund all or any portion of the Loan pursuant to the terms hereof, it shall deliver to the Purchaser a written notice (a “ Funding Request ”).
 
(b)            The Company shall indicate in the Funding Request the amount it desires the Purchaser to fund; provided, however, that the minimum amount of any Funding Request by the Company shall be $1,000,000, unless less than $1,000,000 is available, in which case the minimum amount shall be such lesser amount left to be drawn down to reach the Maximum Loan Amount.
 
(c)            Subject to Section 2.5 below, within ten (10) business days following a Funding Request, the Purchase shall fund such Tranche upon satisfaction of the other conditions contained in Section 6 hereof.
 
(d)            The Company may not deliver a Funding Request more than once in any thirty (30) day period, and the Purchaser shall not be obligated to honor any such excess Funding Request(s).
 
2.5             Termination of Commitment. The Purchaser’s obligation to fund any portion of the Loan under this Agreement shall terminate on December 31, 2012; provided, however, that in the event the Purchaser receives a valid Funding Request prior to December 31, 2012, subject to the satisfaction of the other conditions contained in Section 6 hereof, the Purchaser shall fund the relevant Tranche in accordance with Section 2.4 above, even after December 31, 2012. For the purposes of clarity, the Purchaser shall not be obligated to honor any Funding Request received on December 31, 2012 or later.
 
2.6             Expenses. The Company agrees to pay duplicating and printing costs and charges for shipping the Note, adequately insured, to the Purchaser at such place as the Purchaser may designate, and all reasonable expenses of the Purchaser (including, without limitation, reasonable attorneys’ fees) relating to any proposed or actual amendment, waivers or consents, including, without limitation, any proposed or actual amendments, waivers or consents resulting from any work-out, re-negotiations or restructuring relating to the performance by the Company of its obligations under this Agreement and the Note. The Company agrees to protect and indemnify the Purchaser against any liability for any and all brokerage fees and commissions payable or claimed to be payable to any person (other than any person engaged by the Holder (as defined in the Note)) in connection with the transactions contemplated by this Agreement.
 
 
3.
Representations And Warranties of the Company
 
A Schedule of Exceptions is attached hereto as Exhibit C (the “ Schedule of Exceptions ”). Except as set forth on the Schedule of Exceptions delivered to the Purchaser on the Effective Date, the Company hereby represents and warrants to the Purchaser as follows:
 
3.1             Organization; Good Standing and Qualification. The Company is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business as now conducted and as now proposed to be conducted. The Company is duly qualified to transact business and is in good standing in each jurisdiction in which the failure to be so qualified would have a material adverse effect on its business, operations, assets, liabilities, condition (financial or otherwise), or results of operations (a “ Material Adverse Effect ”).
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.2             Corporate Power. The Company has all requisite corporate power to execute and deliver this Agreement, the Security Agreement, the Note and any other document provided for herein or by any of the foregoing (collectively, as the same may from to time be amended, modified, supplemented or restated, the “ Loan Documents ”) and to carry out and perform its obligations under the terms of the Loan Documents.  For the avoidance of doubt, “Loan Documents” shall not include the Distribution Agreement (as defined below).
 
3.3             Authorization. All corporate action on the part of the Company necessary for the authorization, execution, delivery and performance of the Loan Documents by the Company and the performance of the Company’s obligations thereunder has been taken or will be taken prior to the Initial Closing, and shall not have been rescinded. The Loan Documents, when executed and delivered by the Company, shall constitute valid and binding obligations of the Company enforceable in accordance with their terms, subject to laws of general application relating to equitable principles, bankruptcy, insolvency, the relief of debtors and, with respect to rights to indemnity, subject to federal and state securities laws. The issuance of the Note pursuant to the provisions of this Agreement will not give rise to any preemptive rights or rights of first refusal granted by the Company, and the Note will be issued in compliance with all applicable federal and state securities laws, and will be free of any liens or encumbrances, other than any liens or encumbrances created by or imposed upon the holders through no action of the Company.
 
3.4             Subsidiaries. The Company does not own or control, directly or indirectly, any interest in any corporation, partnership, limited liability company, association or other business entity. The Company is not a participant in any joint venture, partnership or other arrangement.
 
3.5             Capitalization. The number of shares and type of all authorized, issued and outstanding capital stock, options and other securities of the Company (whether or not presently convertible into or exercisable or exchangeable for shares of capital stock of the Company) has been set forth in the SEC Reports (as defined below) and has changed since the latest date covered by such SEC Reports only to reflect issuances pursuant to facilities disclosed in the SEC Reports, stock option exercises and grants and warrant exercises that have not, individually or in the aggregate, had a material effect on the issued and outstanding capital stock, options and other securities. All of the outstanding shares of capital stock of the Company are duly authorized, validly issued, fully paid and non-assessable, have been issued in compliance in all material respects with all applicable federal and state securities laws, and none of such outstanding shares was issued in violation of any preemptive rights or similar rights to subscribe for or purchase any capital stock of the Company. The rights, privileges and preferences of all of the Company’s capital stock are as stated in the Company’s certificate of incorporation or bylaws, a copy of which has been provided to counsel to the Purchaser. Except as set forth in the SEC Reports, there are no outstanding options, warrants, rights (including conversion or preemptive rights and rights of first refusal or similar rights) or agreements, orally or in writing, for the purchase or acquisition from the Company, or to the best knowledge of the Company, from any of its shareholders, of any capital stock of the Company. The Company is not a party or subject to any agreement or understanding and, to the knowledge of the Company, there is no agreement or understanding between any persons and/or entities that affects or relates to the voting or giving of written consents with respect to any security of the Company. Except as set forth in the SEC Reports, no agreement between the Company and any holder of any securities or rights to purchase securities of the Company provides for acceleration or other changes in the vesting provisions or other terms of such agreement or understanding as a result of: (i) termination of employment (whether actual or constructive); (ii) any merger, consolidated sale of units or assets, change in control or any other transaction(s) by the Company; or (iii) the occurrence of any other event or combination of events.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.6             No Conflicts. The execution, delivery and performance by the Company of the Loan Documents to which it is a party and the consummation by the Company of the transactions contemplated hereby or thereby (including, without limitation, the issuance of the Note) do not and will not (i) conflict with or violate any provisions of the Company’s certificate of incorporation or bylaws or otherwise result in a violation of the organizational documents of the Company, (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties or assets of the Company or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any Material Contract or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company is subject or decree (including federal and state securities laws and regulations and the rules and regulations, assuming the correctness of the representations and warranties made by the Purchaser, of any self regulatory organization to which the Company or its securities are subject), or by which any property or asset of the Company is bound or affected), except in the case of clause (iii) such as would not, individually or in the aggregate, have a Material Adverse Effect.
 
3.7             Governmental Consents. All consents, approvals, orders, or authorizations of, or registrations, qualifications, designations, declarations, or filings with, any governmental authority or other third party, required on the part of the Company in connection with the valid execution and delivery of the Loan Documents or the consummation of any other transaction contemplated hereby shall have been obtained and will be effective at the Initial Closing.
 
3.8             Regulatory Permits. The Company possesses all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct its business as currently conducted as described in the SEC Reports, including without limitation the Food and Drug Administration (the “ FDA ”), except where the failure to possess such permits, individually or in the aggregate, has not and would not have, individually or in the aggregate, a Material Adverse Effect (“ Material Permits ”), and (i) the Company has not received any notice of proceedings relating to the revocation or modification of any such Material Permits and (ii) the Company is unaware of any facts or circumstances that the Company would reasonably expect to give rise to the revocation or modification of any Material Permits.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.9             SEC Reports. The Company has filed all reports, schedules, forms, statements and other documents required to be filed by it under the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), including pursuant to Section 13(a) or 15(d) thereof, for twelve (12) months preceding the date hereof (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, being collectively referred to herein as the “ SEC Reports ”), on a timely basis or has received a valid extension of such time of filing and has filed any such SEC Reports prior to the expiration of any such extension. As of the date hereof, the Company is not aware of any event occurring on or prior to the Initial Closing (other than the transactions contemplated by the Loan Documents) that requires the filing of a Form 8-K after the Initial Closing. As of their respective filing dates, or to the extent corrected by a subsequent amendment, the SEC Reports complied in all material respects with the requirements of the Securities Act of 1933, as amended (the “ Securities Act ”), and the Exchange Act and the rules and regulations of the United States Securities and Exchange Commission (the “ Commission ”) promulgated thereunder, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.
 
3.10             Financial Statements. The financial statements of the Company included in the SEC Reports comply in all material respects with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing. Such financial statements have been prepared in accordance with GAAP applied on a consistent basis during the periods involved, except as may be otherwise specified in such financial statements or the notes thereto and except that unaudited financial statements may not contain all footnotes required by generally accepted accounting practices in the United States (“ GAAP ”), and fairly present in all material respects the financial position of the Company and its consolidated subsidiaries taken as a whole as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, year-end audit adjustments.
 
3.11             Material Contracts. Each of the Material Contracts to which the Company is a party or to which the property or assets of the Company is subject has been filed as an exhibit to the SEC Reports. The Material Contracts to which the Company is a party have been duly and validly authorized, executed and delivered by the Company and constitute the legal, valid and binding agreements of the Company, enforceable by and against the Company in accordance with their respective terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization or other similar laws relating to enforcement of creditors’ rights generally, and general equitable principles relating to the availability of remedies, except as rights to indemnity or contribution may be limited by federal or state securities laws. “ Material Contract ” means any contract of the Company that has been filed or was required to have been filed as an exhibit to the SEC Reports pursuant to Item 601(b)(4) or Item 601(b)(10) of Regulation S-K.
 
3.12             Internal Accounting Controls. The Company maintains a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset and liability accountability, (iii) access to assets or incurrence of liabilities is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets and liabilities is compared with the existing assets and liabilities at reasonable intervals and appropriate action is taken with respect to any differences.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.13             Compliance. The Company (i) is not in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company), nor has the Company received written notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other Material Contract (whether or not such default or violation has been waived), (ii) is not in violation of any order of any court, arbitrator or governmental body having jurisdiction over the Company or its properties or assets, or (iii) is not or has not been in violation of, or in receipt of notice that it is in violation of, any statute, rule or regulation of any governmental authority applicable to the Company, including without limitation, all applicable rules and regulations of the FDA, and all applicable laws, statutes, ordinances, rules or regulations (including, without limitation, the Federal Food, Drug and Cosmetic Act of 1938, as amended and similar foreign laws and regulations) enforced by the FDA or equivalent foreign authorities, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect.
 
3.14             Compliance with Other Instruments. The Company is not in violation of any term of its certificate of incorporation and bylaws, as amended to date, or, to the Company’s knowledge, of any term or provision of any material mortgage, indebtedness, indenture, contract, agreement, instrument, judgment, order or decree to which it is party or by which it is bound.
 
3.15             Litigation. There is no action, suit, inquiry, notice of violation, proceeding (including any partial proceeding such as a deposition) or investigation pending or, to the Company’s knowledge, threatened in writing (or otherwise overtly) against the Company or any of its respective properties or any officer, director or employee of the Company acting in his or her capacity as an officer, director or employee before or by any federal, state, county, local or foreign court, arbitrator, governmental or administrative agency, regulatory authority, stock market, stock exchange or trading facility which (i) adversely affects or challenges the legality, validity or enforceability of any of the Loan Documents, (ii) involves a claim of violation of or liability under any federal, state, local or foreign laws governing the Company’s operations, including without limiting the generality of the foregoing, laws regulating the protection of human health, including without limiting the generality of the foregoing, laws relating to the manufacture, processing, packaging, labeling, marketing, distribution, use, inspection, treatment, storage, disposal, transport or handling of the Company’s products, and regulated or hazardous substances, as well as all authorizations, codes, decrees, demands or demand letters, injunctions, judgments, licenses, notices or notice letters, orders, permits, plans or regulations issued, entered, promulgated or approved thereunder, all as may be in effect from time to time and all successors, replacements and expansions thereof, (iii) involves injury to or death of any person arising from or relating to any of the Company’s products, or (iv) would reasonably be expected to, if there were an unfavorable decision, individually or in the aggregate, have a Material Adverse Effect. The Commission has not issued any stop order or other order suspending the effectiveness of any registration statement filed by the Company under the Exchange Act or the Securities Act.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.16             Environmental Matters. To the Company’s knowledge, the Company (i) is not in violation of any statute, rule, regulation, decision or order of any governmental agency or body or any court, domestic or foreign, relating to the use, disposal or release of hazardous or toxic substances or relating to the protection or restoration of the environment or human exposure to hazardous or toxic substances (collectively, “ Environmental Laws ”), (ii) does not own or operate any real property contaminated with any substance that is in violation of any Environmental Laws, (iii) is not liable for any off-site disposal or contamination pursuant to any Environmental Laws, or (iv) is not subject to any claim relating to any Environmental Laws; which violation, contamination, liability or claim has had or would have, individually or in the aggregate, a Material Adverse Effect; and there is no pending or, to the Company’s Knowledge, threatened investigation that might lead to such a claim.
 
3.17             Employees and Labor. The Company is not bound by or subject to (and none of its assets or properties is bound by or subject to) any written or oral, express or implied, contract, commitment or arrangement with any labor union, and no labor union has requested or, to the knowledge of the Company, has sought to represent any of the employees, representatives or agents of the Company. There is no strike or other labor dispute involving the Company pending, or to the knowledge of the Company threatened, nor is the Company aware of any labor organization activity involving its employees. The employment of each officer and employee of the Company is terminable at the will of the Company. The Company has complied in all material respects with all applicable equal employment opportunity laws and with other laws related to employment. The Company is not aware that any officer or key employee of the Company intends to terminate his or her employment with the Company and the Company does not currently intend to terminate any such person. The Company does not have any Employee Benefit Plan as defined in the Employee Retirement Income Security Act of 1974, and the Company is not nor has it been obligated to contribute to any employee pension benefit plan that is or was a multi-employer plan within the meaning of Section 3(37) of such act.
 
3.18             Insurance. The Company is insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as the Company believes to be prudent in the businesses and locations in which the Company is engaged. The Company has not received any notice of cancellation of any such insurance, nor does the Company have any knowledge that it will be unable to renew its existing insurance coverage for the Company as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.
 
3.19             Tax Matters. The Company (i) has prepared and filed all foreign, federal and state income and all other tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations, except those being contested in good faith, with respect to which adequate reserves have been set aside on the books of the Company and (iii) has set aside on its books provisions reasonably adequate for the payment of all taxes for periods subsequent to the periods to which such returns, reports or declarations apply, except, in the case of clauses (i) and (ii) above, where the failure to so pay or file any such tax, assessment, charge or return would not have a Material Adverse Effect.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.20             Intellectual Property. The Company owns or possesses sufficient legal rights to all Proprietary Assets (as defined below) used by it in connection with the Company’s business, which represent all intellectual property rights necessary to the conduct of the Company’s business as now conducted and as presently contemplated to be conducted (collectively, the “ Company Proprietary Assets ”), without any conflict with, or infringement of, the rights of others. The transactions contemplated by the Loan Documents will have no adverse effect on the Company’s rights in and to the Company Proprietary Assets. There are no outstanding options, licenses or agreements of any kind relating to the Company Proprietary Assets, nor is the Company bound by or a party to any options, licenses or agreements of any kind with respect to Proprietary Assets of any other person or entity, with the exception of the Licenses set forth in Exhibit C, the Schedule of Exceptions (collectively referred to as the “ Existing License Agreements ”).
 
To its knowledge and belief, the Company is not infringing, misappropriating or making any unlawful use of and has not at any time infringed, misappropriated or made any unlawful use of, any Proprietary Assets of any other person, corporation or entity. The Company has not received any communications alleging that the Company has violated or, by conducting its business, would violate any of the Proprietary Assets of any other person or entity. To the Company’s knowledge, no other person is infringing, misappropriating or making any unlawful use of, and no Proprietary Asset owned or used by any other person infringes or conflicts with, any of the Company Proprietary Assets. The Company has not received any notice to the effect that any patents or registered trademarks, service marks or registered copyrights held by the Company are invalid or not subsisting. The Company is not aware that any of its employees is obligated under any contract (including licenses, covenants or commitments of any nature) or other agreement, or subject to any judgment, decree or order of any court or administrative agency, that would interfere with the use of such employee’s best efforts to promote the interest of the Company or that would conflict with the Company’s business. Neither the execution or delivery of this Agreement, nor the carrying on of the Company’s business by the employees of the Company, nor the conduct of the Company’s business as proposed, will, to the Company’s knowledge, conflict with or result in a breach of the terms, conditions, or provisions of, or constitute a default under, any contract, covenant or instrument under which any such employee is now obligated. The Company does not believe it is or will be necessary to use any inventions of any of its employees (or persons it currently intends to hire) made prior to their employment by the Company. The Company has taken all commercially reasonable steps to protect and preserve the confidentiality of all the Company Proprietary Assets not otherwise protected by patents, patent applications or copyright. The Company is not a party to any non-competition or other similar restrictive agreement or arrangement relating to any business or service anywhere in the world. As used in this Agreement, “ Proprietary Assets ” means any patent, patent application, invention disclosure, trademark (whether registered or unregistered), trademark application, trade name, fictitious business name, service mark (whether registered or unregistered), service mark application, domain name, copyright (whether registered or unregistered), copyright application, moral rights, maskwork, maskwork application, trade secret, know-how, customer list, franchise, system, computer software, computer program, source code, invention (whether patentable or not), design, algorithm, process blueprint, engineering drawing, product, technology, intellectual property right or intangible asset owned, possessed or controlled on a proprietary basis.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.21             Title to Assets. The Company does not own any real property. The Company has good and marketable title to all tangible personal property owned by it which is material to the business of the Company, in each case free and clear of all liens, encumbrances and defects except such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company. Any real property and facilities held under lease by the Company are held by it under valid, subsisting and enforceable leases with such exceptions as are not material and do not interfere with the use made and proposed to be made of such property and buildings by the Company.
 
3.22             Material Changes. Since the date of the latest financial statements included within the SEC Reports, except as specifically disclosed in the SEC Reports, (i) there have been no events, occurrences or developments that have had or would reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (ii) the Company has not incurred any material liabilities (contingent or otherwise) other than (A) trade payables, accrued expenses and other liabilities incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or to be disclosed in filings made with the Commission, (iii) the Company has not mortgaged, pledged, transferred a security interest in, or allowed a lien to be created, with respect to any of its material properties or assets, except for Permitted Liens (as defined in the Security Agreement), (iv) the Company has not sold, assigned or transferred any Company Proprietary Assets except in the ordinary course of business as it may exist from time to time, (v) the Company has not materially altered its method of accounting or the manner in which it keeps its accounting books and records, (vi) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock (other than in connection with repurchases of unvested stock issued to employees of the Company), (vii) the Company has not issued any equity securities to any officer, director or Affiliate, except Common Stock issued in the ordinary course as dividends pursuant to existing Company stock option or stock purchase plans or executive and director corporate arrangements disclosed in the SEC Reports and (viii) there has not been any material change or amendment to, or any waiver of any material right under, any Material Contract under which the Company or any of its assets is bound or subject. Except for the issuance of the Note contemplated by this Agreement, no event, liability or development has occurred or exists with respect to the Company or its business, properties, operations or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made that has not been publicly disclosed at least one trading day prior to the date that this representation is made.
 
3.23             Transactions With Affiliates and Employees. None of the officers or directors of the Company and, to the Company’s knowledge, none of the employees of the Company, is presently a party to any transaction with the Company or to a presently contemplated transaction (other than for services as employees, officers and directors) that would be required to be disclosed pursuant to Item 404 of Regulation S-K promulgated under the Securities Act, except as contemplated by the Loan Documents or set forth in the SEC Reports.
 
3.24             Full Disclosure. None of the Loan Documents, or the schedules and exhibits hereto and thereto, contain any untrue statement of a material fact nor, to the best of the Company’s knowledge, omit to state a material fact necessary in order to make the statements contained herein or therein not misleading.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
3.25             Sarbanes-Oxley; Disclosure Controls. To the Company’s knowledge, the Company is in compliance in all material respects with all of the provisions of the Sarbanes-Oxley Act of 2002 which are applicable to it, except where such noncompliance would not have, individually or in the aggregate, a Material Adverse Effect. The Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act).
 
 
4.
Representations and Warranties of the Purchaser
 
4.1             Organization; Authority. The Purchaser is an entity duly organized and validly existing under the laws of Japan with the requisite corporate or partnership power and authority to enter into and to consummate the transactions contemplated by the applicable Loan Documents and otherwise to carry out its obligations hereunder and thereunder. The execution, delivery and performance by the Purchaser of the transactions contemplated by this Agreement have been duly authorized by all necessary corporate action on the part of the Purchaser. Each of this Agreement and the Loan Documents has been duly executed by the Purchaser, and when delivered by the Purchaser in accordance with the terms hereof, will constitute the valid and legally binding obligation of the Purchaser, enforceable against it in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally the enforcement of, creditors’ rights and remedies or by other equitable principles of general application.
 
4.2             No Conflicts. The execution, delivery and performance by the Purchaser of this Agreement and the Loan Documents and the consummation by the Purchaser of the transactions contemplated hereby and thereby will not (i) result in a violation of the organizational documents of the Purchaser, (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which the Purchaser is a party, or (iii) result in a violation of any law, rule, regulation, order, judgment or decree applicable to the Purchaser, except in the case of clauses (ii) and (iii) above, for such conflicts, defaults, rights or violations which would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the ability of the Purchaser to perform its obligations hereunder.
 
 
5.
Events of Default; Remedies; Covenants
 
5.1             Events of Default. Each of the following shall constitute an event of default (each, an “ Event of Default ”) under this Agreement and the other Loan Documents:
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(a)            The Company fails to pay upon demand made by the Purchaser, at any time following the Maturity Date, any and all unpaid principal, accrued interest and all other amounts owing under any Loan Document;
 
(b)            Any representation or warranty made by the Company in any of the Loan Documents shall prove, when given, to be false or misleading in any material respect;
 
(c)            Except as set forth in Section 5.1(a) above, the Company breaches any covenant in, or fails to perform any obligation under, any Loan Document and has failed to cure such breach or failure within sixty (60) days after receipt of written notice of such breach or failure from the Purchaser;
 
(d)            (i) That certain Distribution Agreement by and between the Company and the Purchaser entered into as of the date of this Agreement (the “ Distribution Agreement ”) is cancelled by the Purchaser for cause pursuant to Section 13.1 of the Distribution Agreement or (ii) the Distribution Agreement terminates in accordance with Section 12.2 of the Distribution Agreement;
 
(e)            The Company files any petition or action for relief under any bankruptcy, reorganization, insolvency or moratorium law or any other law for the relief of, or relating to, debtors, now or hereafter in effect, or makes any general assignment for the benefit of creditors or takes any corporate action in furtherance of any of the foregoing;
 
(f)            An involuntary petition is filed against the Company (unless such petition is dismissed or discharged within forty-five (45) days) under any bankruptcy statute now or hereafter in effect, or a custodian, receiver, trustee, assignee for the benefit of creditors (or other similar official) is appointed to take possession, custody or control of any property of the Company;
 
(g)            Any declared default of the Company under any Indebtedness that gives the holder thereof the right to accelerate the principal and all accumulated interest amounts thereon, and the entire amount of such principal and interest amounts are in fact accelerated by the holder thereof. “ Indebtedness ” shall mean indebtedness for borrowed money evidenced by a promissory note or other similar agreement that provides for payment of interest based on a principal amount and includes the acceleration of payment of such principal amount upon certain events of default;
 
(h)            The Company’s shareholders and/or directors affirmatively vote to liquidate, dissolve, or wind up the Company or the Company otherwise ceases to carry on its ongoing business operations;
 
(i)            A judgment in the aggregate amount of $100,000 or more is rendered against the Company and is unsatisfied or unstayed for thirty (30) days;
 
(j)            If (i) a material portion of the Company’s assets is attached, seized, levied on, or comes into possession of a trustee or receiver and the attachment, seizure or levy is not removed in ten (10) days, (ii) the Company is enjoined, restrained, or prevented by a court order or other order of a governmental body from conducting its business, or (iii) notice of lien, levy, or assessment is filed against any of the Company’s assets by any court order or other order of any governmental body and it is not paid within thirty (30) days after the Company received notice thereof; or
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(k)            If, at any time, the Security Agreement shall be unenforceable or shall not be in full force and effect, or if, at any time, the Purchaser ceases to have a valid and perfected first priority security interest in any Collateral (as defined therein) purported to be covered thereby (to the extent a security interest in any Collateral can be perfected by the filing of a financing statement with the Delaware Department of State naming the Company as debtor and the Purchaser as secured party and sufficiently indicating the Collateral).
 
5.2             Remedies. Except as otherwise specifically set forth in the Note, upon the occurrence of any Event of Default, and while it is continuing, all unpaid principal on the Note, accrued and unpaid interest thereon and all other amounts owing under any of the Loan Documents shall, at the option the Purchaser, and, upon the occurrence of any Event of a Default pursuant to Section 5.1(e) or (f) above, automatically, be immediately due, payable and collectible by the Purchaser pursuant to applicable law. In the event of any Event of Default, the Company shall pay all reasonable attorneys’ fees and costs incurred by the Purchaser in enforcing and collecting the Note and the other Loan Documents. No right or remedy conferred upon or reserved to the Purchaser under this Agreement is intended to be exclusive of any other right or remedy, and every right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now and hereafter existing under applicable law.
 
5.3             Other Acceleration. In the event that the Company, or the surviving entity in the event of a merger or consolidation, notifies the Purchaser within ninety (90) days of a Change in Control that it has chosen to terminate the Distribution Agreement at any time on or after the first day of Contract Year 4 (as defined in the Distribution Agreement), upon such termination becoming effective, at the option of the Purchaser, all unpaid principal on the Note, accrued and unpaid interest thereon and all other amounts owing under any of the Loan Documents shall become immediately due, payable and collectible by the Purchaser pursuant to applicable law. In the event the Note is accelerated pursuant to this Section 5.3, the Company shall pay all reasonable attorneys’ fees and costs incurred by the Purchaser in enforcing and collecting the Note and the other Loan Documents. A “ Change in Control ” shall mean (i) any consolidation of the Company with or merger of the Company with or into another entity, or (ii) any sale, transfer or lease of all or substantially all the assets related to the Products (as defined in the Distribution Agreement), or (iii) any event in which any person or group of persons acting in concert acquires more than fifty percent (50%) of the voting stock of the Company.
 
5.4             Affirmative Covenants. The Company hereby covenants and agrees with the Purchaser as follows:
 
(a)            As promptly as possible, the Company shall give written notice to the Purchaser of:
 
 
13
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(i)            Any litigation or administrative or regulatory proceeding affecting the Company where the amount claimed against the Company or the granting of the relief requested would have a Material Adverse Effect.
 
(ii)            Any substantial dispute which may exist between the Company or any governmental or regulatory authority which would have a Material Adverse Effect.
 
(iii)            The occurrence of any Event of Default.
 
(iv)            The occurrence of a Change in Control.
 
(v)            Any change in the location of any of the Company’s places of business or Collateral at least ten (10) days in advance of such change, or of the establishment of any new, or the discontinuance of any existing, place of business.
 
(vi)            Any dispute or default by the Company or any other party under any joint venture, partnering, distribution, cross-licensing, strategic alliance, collaborative research or manufacturing, license or similar agreement which would reasonably be expected to have a Material Adverse Effect.
 
(vii)            The date upon which the Company obtains Additional Equity Financing, in accordance with and as described in Section 1.5(b), above.
 
(b)            As soon as available but no later than forty five (45) days after the end of each quarter, the Company’s unaudited balance sheet as of the end of such period, and the Company’s income statement for such period and for that portion of the Company’s financial reporting year ending with such period, prepared in accordance with GAAP (except that such statements may not contain all footnotes required by GAAP) and attested by a responsible financial officer of the Company as being complete and correct and fairly presenting the Company’s financial condition and the results of the Company’s operations, subject to normal recurring and year-end audit adjustments.
 
(c)            Permit employees or agents of the Purchaser at such reasonable times and upon reasonable notice as the Purchaser may request, at the Company’s expense, to inspect the Company’s properties, and to examine, and make copies and memoranda of the Company’s books, accounts and records.
 
(d)            Use commercially reasonable efforts to comply with all material laws, rules, regulations applicable to, and all orders and directives of any governmental or regulatory authority having jurisdiction over, the Company or the Company’s business, and with all material agreements to which the Company is a party.
 
(e)            Pay all of the Company’s Indebtedness within a reasonable time of when such Indebtedness becomes due; pay all taxes and other governmental or regulatory assessments before delinquency or before any penalty attaches thereto, except as may be contested in good faith by the appropriate procedures and for which the Company shall maintain appropriate reserves; and timely file all required tax returns or extensions therefor.
 
 
14
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(f)            Obtain and keep in force insurance in such amounts and types as is usual and customary in the type of business conducted by the Company.
 
(g)            Maintain and preserve the Company’s existence, present form of business, and all rights and privileges necessary or desirable in the normal course of its business; and keep all the Company’s property in good working order and condition, ordinary wear and tear excepted.
 
5.5             Negative Covenants. The Company hereby covenants and agrees with the Purchaser that it shall not, without the Purchaser’s prior written consent, take or authorize any of the following:
 
(a)            Pledge its remaining Proprietary Assets as collateral to any other creditor so long as this Agreement is valid and any amounts remain outstanding under the Note, except for Permitted Liens.
 
(b)            Except with contemporaneous notice to the Purchaser, the Company shall not sell, lease, transfer or otherwise dispose of any of its assets, except in the ordinary course of business, as it may exist from time to time and except for the Existing License Agreements. In the event that such a transfer also constitutes a Change in Control, the Company shall transfer to such successor entity this Agreement, the Note, and the Security Agreement to the same extent the Distribution Agreement is transferred to such successor entity.
 
(c)            Be indebted for borrowed money, the deferred purchase price of property, or leases which would be capitalized in accordance with GAAP; or become liable as a surety, guarantor, accommodation party or otherwise for or upon the obligation of any other Person, except:
 
(i)            Indebtedness incurred for the acquisition of supplies or inventory on normal trade credit.
 
(ii)            Indebtedness of the Company under the Note.
 
(iii)            Any additional Indebtedness so long as either (i) such Indebtedness is not secured by the Collateral, or (ii) if such Indebtedness is to be secured by the Collateral then the priority of any lien securing such Indebtedness and the rights of the holder thereof to enforce remedies against the Company’s interest in the Collateral following default have been made subordinate to the liens of the Purchaser under the Security Agreement pursuant to a written subordination agreement approved by the Purchaser in its reasonable discretion.
 
(iv)            Any Indebtedness existing as of the Effective Date, as set forth on Section 5.5(c) of the Schedule of Exceptions.
 
(v)            Indebtedness secured by Liens permitted by clause (c) of the definition of Permitted Liens.
 
 
15
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
6.
Conditions to Closing
 
6.1             Conditions to Purchaser’s Obligations at the Initial Closing. The obligation of the Purchaser to fund any Tranche of the Loan is subject to the fulfillment on or before the Initial Closing of each of the following conditions, which may be waived in writing by the Purchaser:
 
(a)             Representations and Warranties. The representations and warranties of the Company contained in Section 3 shall be true and correct in all material respects on and as of the Initial Closing with the same effect as though such representations and warranties had been made on and as of the date of the Initial Closing.
 
(b)             Performance. The Company shall have performed and complied with all agreements, obligations, and conditions contained in the Loan Documents that are required to be performed or complied with by it on or before the Initial Closing.
 
(c)             Qualifications. All authorizations, approvals, or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful issuance and sale of the Note shall be duly obtained and effective.
 
(d)             Other Agreements. The Company shall have entered into the Security Agreement, attached hereto as Exhibit B as of the Initial Closing and the Distribution Agreement as of the Effective Date.
 
(e)             Successful Deployment in a Clinical Case. Successful deployment, in the sole discretion of the Purchaser, of the Company’s [ * ] in a clinical case, currently scheduled in Germany for [ * ] , or at such other date or site as mutually agreed upon between the parties.
 
(f)             Proceedings and Documents. All corporate and other proceedings in connection with the transactions contemplated at each Closing and all documents incident thereto shall be reasonably satisfactory in form and substance to the Purchaser’s counsel, which shall have received all such counterpart original and certified copies of such documents as it may reasonably request.
 
6.2             Conditions to Purchaser’s Obligations at the Additional Closings. The obligation of the Purchaser to fund any Additional Tranche of the Loan is subject to the fulfillment on or before the relevant Additional Closing of each of the following conditions, which may be waived in writing by the Purchaser
 
(a)             Completion of Wet Lab . Satisfactory completion, in the sole discretion of the Purchaser, of a wet lab deploying the Company’s [ * ] , currently planned at the Company’s facilities for [ * ] , or at such other date as mutually agreed upon between the parties.
 
(b)             Representations and Warranties. The representations and warranties of the Company contained in Section 3 were true on and correct in all material respects as of the Initial Closing and the representations and warranties of the Company contained in Section 3 shall be true and correct in all material respects on and as of each Additional Closing with the same effect as though such representations and warranties had been made on and as of the date of such Additional Closing.
 
 
16
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(c)             Performance. The Company shall have performed and complied with all agreements, obligations, and conditions contained in the Loan Documents that are required to be performed or complied with by it on or before such Additional Closing.
 
(d)             Events of Default. No event shall have occurred and be continuing or would result from the consummation of the borrowing contemplated by such Additional Closing that would constitute an Event of Default.
 
(e)             Proceedings and Documents. All corporate and other proceedings in connection with the transactions contemplated at each Additional Closing and all documents incident thereto shall be reasonably satisfactory in form and substance to the Purchaser’s counsel, which shall have received all such counterpart original and certified copies of such documents as it may reasonably request.
 
(f)             Other Agreements. The Security Agreement, and the Distribution Agreement shall be in full force and effect, and the Company shall not be in breach or default of any material covenant, condition or other provision thereof beyond the applicable grace period, if any, specified therein, as of the date of each Additional Closing.
 
 
7.
Miscellaneous
 
7.1             Binding Agreement. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties. Nothing in this Agreement, expressed or implied, is intended to confer upon any third party any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.
 
7.2             Governing Law. This Agreement shall be governed by and construed under the laws of the State of New York, as applied to agreements among New York residents, made and to be performed entirely within the State of New York.
 
7.3             Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
7.4             Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.
 
7.5             Notices. All notices required or permitted hereunder shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (c) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. The address for such notices and communications shall be as follows;
 
 
17
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
If to the Company:
Cardica, Inc.
900 Saginaw Drive
Redwood City, California 94063
Telephone No.: (650) 364-9975
Facsimile No.: (650) 364-3134
Attention: Robert Y. Newell
 
With a copy to:
Cooley LLP
3175 Hanover Street
Palo Alto, California 94304
Telephone No.: (650) 843-5000
Facsimile No.: (650) 849-7400
Attention: Suzanne Sawochka Hooper, Esq.
 
If to the Purchaser:
Century Medical, Inc.
1-11-2 Osaki, Shinagawa-ku
Tokyo 141-8588, Japan
Telephone No.: +81-3-3491-1552
Facsimile No.: +81-3-3491-0577
Attention: Mr. Shunzo Saegusa
 
or such other address as may be designated in writing hereafter, in the same manner, by such Person.
 
With a copy to:
O’Melveny & Myers LLP
Meiji Yasuda Seimei Bldg., 11F
2-1-1 Marunouchi, Chiyoda-ku
Tokyo 100-0005, Japan
Facsimile No.: +81-3-5293-2780
Attention: Dale Araki, Esq.
 

 
7.6           Dispute Resolution; Waiver of Jury Trial.
 
(a)             Arbitration. In the event there arises a dispute between the parties as to the performance or interpretation of any of the provisions of this Agreement, or as to matters related to but not covered by this Agreement, then any such dispute shall be determined finally by final and binding arbitration in accordance with the International Arbitration Rules of the American Arbitration Association. The place of arbitration shall be San Francisco, California and the language of the arbitration shall be English. The arbitral tribunal shall consist of a single arbitrator. If the parties shall not have agreed upon an arbitrator within fifteen (15) days of the notice of arbitration, then the Administrator of the American Arbitration Association shall appoint one. The arbitrator may hold pre-hearing conferences or adopt other procedures. Discovery may be undertaken by either party. Any dispute with regard to the scope of necessity for any discovery shall be determined by the arbitrator in the arbitrator’s discretion. Each party will bear its own cost of presenting of defending its position in arbitration. The award of the arbitrator shall be final, binding and non-appealable, and judgment may be entered thereon in any court having jurisdiction thereof. Each of the parties intends that this dispute resolution process shall be the parties’ exclusive remedy for any dispute.
 
 
18
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(b)             Injunctive Relief. Notwithstanding the provisions of Section 7.6(a) above, either party may at any time seek from a court of competent jurisdiction any equitable, interim or provisional relief reasonably believed to be necessary to prevent a material diminution in the value of the Collateral or to otherwise avoid irreparable harm or injury.
 
(c)             Waiver of Jury Trial. Each party hereto hereby irrevocably waives all right to trial by jury in any proceeding (whether based on contract, tort or otherwise) arising out of or relating to this Agreement or any transaction or agreement contemplated hereby or the actions of any party hereto in the negotiation, administration, performance or enforcement hereof.
 
7.7             Amendment; Modification; Waiver. No amendment, modification or waiver of any provision of this Agreement or consent to departure therefrom shall be effective unless in writing and approved by the Company and the Purchaser.
 
7.8             Indemnification; Exculpation. The Company shall pay and protect, defend and indemnify the Purchaser and the Purchaser’s employees, officers, managers, members, affiliates, correspondents, agents and representatives (other than the Purchaser, collectively “ Agents ”) against, and hold the Purchaser and each such Agent harmless from, all claims, actions, proceedings, liabilities, damages, losses, expenses (including, without limitation, reasonable attorneys’ fees and costs) and other amounts reasonably incurred by the Purchaser and each such Agent, arising from (i) the matters contemplated by this Agreement or any other Loan Documents or (ii) any contention that the Company has failed to comply with any law, rule, regulation, order or directive applicable to the Company’s business; provided , however , that this indemnification shall not apply to any of the foregoing incurred solely as the result of the Purchaser’s or any Agent’s gross negligence or willful misconduct. This indemnification shall survive the payment and satisfaction of all of the Company’s obligations to the Purchaser pursuant to the Loan Documents.  For the avoidance of doubt, this Section 7.8 shall not apply to any claims, losses or expenses arising out of the Distribution Agreement.
 
7.9             Unenforceable Provisions. Any provision of any Loan Document executed by the Company which is prohibited or unenforceable in any jurisdiction, shall be so only as to such jurisdiction and only to the extent of such prohibition or unenforceability, but all the remaining provisions of any such Loan Document shall remain valid and enforceable.
 
7.10             Entire Agreement. This Agreement, the Exhibits hereto and the other Loan Documents constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof and no party shall be liable or bound to any other party in any manner by any representations, warranties, covenants and agreements except as specifically set forth herein and therein.
 
 
19
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

[ Signature page follows ]
 
 
 
20
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
In Witness Whereof, the parties have executed this Secured Note Purchase Agreement   as of the date first written above.
 

 
Company:
     
 
Cardica, Inc.
     
     
 
By:
/s/ Bernard Hausen
     
 
Name:
Bernard Hausen, MD
     
 
Title:
President & CEO
 
 
 
Purchaser:
     
 
Century Medical, Inc.
     
     
 
By:
/s/ Akira Hoshino
     
 
Name:
Akira Hoshino
     
 
Title:
President & CEO

 
Secured Note Purchase Agreement
Signature Page

[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

SCHEDULES AND EXHIBITS
 
Exhibit A:  Form of Secured Promissory Note
 
Exhibit B:  Form of Security Agreement
 
Exhibit C:  Schedule of Exceptions
 

 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
Exhibit A

Form of Secured Promissory Note

 
 
 

 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
Exhibit B

Form of Security Agreement
 
 
 

 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Exhibit C

Schedule of Exceptions

In connection with the Agreement of which this Exhibit forms a part, the Company hereby delivers this Schedule of Exceptions to the Company’s representations and warranties given in the Agreement.  This Schedule of Exceptions and the information and disclosures contained herein are intended only to qualify and limit the representations, warranties and covenants of the Company contained in the Agreement, and shall not be deemed to expand in any way the scope or effect of any of such representations, warranties or covenants.  The section numbers in this Schedule of Exceptions correspond to the section numbers in the Agreement; provided, however , that any information disclosed herein under any section number shall be deemed to be disclosed and incorporated in any other section of the Agreement where such disclosure would be appropriate and reasonably apparent.  Disclosure of any information or document herein is not a statement or admission that it is material or required to be disclosed herein.

Section 3.4

To the extent that the Existing License Agreements can be considered “other arrangements,” Cardica is a participant in those license agreements.

Section 3.5

After the date of the SEC Reports, the Company has issued an aggregate of 300,000 shares of its Common Stock to Aspire Capital Fund and an aggregate of 31,494 shares to McNicoll, Lewis & Vlak LLC (each pursuant to the arrangements disclosed in the SEC Reports).

Section 3.9

On or before September 7, 2011, the Company is required to file a Current Report on Form 8-K pertaining to executive compensation matters approved by the Board of Directors on August 31, 2011, including salary increases, fiscal year 2011 bonuses and the stock option grants referenced in the exception to Section 3.22 set forth below.

Section 3.20

The Company is a party to the following patent licenses:

An exclusive license to certain Company Proprietary Assets granted to Intuitive Surgical Operations, Inc., pursuant to that certain License Agreement dated August 16, 2010, in the field of robotics.

Exclusive licenses to certain Company Proprietary Assets granted to Cook Incorporated on December 9, 2005 and June 12, 2007, to proposed Cardica X-Port and PFO closure devices.

 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
An exclusive license to certain Company Proprietary Assets granted to CardioThoracic Systems, Inc., a wholly-owned subsidiary of Guidant Corporation (now MAQUET Cardiovascular), on December 4, 2003, solely to make, have made, use, sell, have sold, and import the product designated in that license as the Heartstring aorta cutter.

Section 3.22

After the date of the SEC Reports, the Company granted options to purchase shares of the Company’s Common Stock pursuant to its 2005 Equity Incentive Plan to the Company’s executive officers.

Section 3.24

The PAS-Port® anastomosis system and the C-Port ® anastomosis system have been cleared for sale in the United States by the U.S. Food and Drug Administration (FDA).

The products designated as the Microcutter Xpress 30, the Microcutter Xpress 45, and the FleXchange in Schedule 1 of the Distribution Agreement have not been cleared for sale in the United States by the FDA.  There is no guarantee and can be no guarantee that those products will be approved for sale in the United States by the FDA at any time in the future.  Additionally, the timing and scope of the Company’s planned clinical trial related to the Microcutter Xpress 30 is uncertain.

Section 5.5(c)

Indebtedness owing to Dell Financial Services, L.L.C. pursuant to that certain revolving credit Account # 6879450204011224874, dated July 16, 2008 (as more particularly described in that Financing Statement No. 20082535548 filed on July 23, 2008 with the Delaware Department of State naming the Company as debtor and Dell as secured party).
 
 
 
 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 10.38
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
SECURITY AGREEMENT
 
This Security Agreement   dated as of September 2, 2011 (“ Security Agreement ”), is made by and between Cardica, Inc. , a Delaware corporation (the “ Grantor ”), and Century Medical, Inc. , a Japan corporation, or its assigns (the “ Secured Party ”).
 
Recitals
 
A.            Pursuant to that certain Secured Note Purchase Agreement dated as of September 2, 2011 by and between Grantor and the Secured Party (as the same is amended and in effect from time to time, the “ Note Agreement ”), the Secured Party has agreed to make certain advances of money and to extend certain financial accommodation (the “ Loan ”) to Grantor as evidenced by that certain Secured Promissory Note dated as of the date hereof (as the same may from time to time be amended, modified, supplemented or restated, the “ Note ”), by and between Grantor and the Secured Party.
 
B.            The Secured Party is willing to make the Loan to Grantor, but only upon the condition, among others, that Grantor shall have executed and delivered to the Secured Party this Security Agreement.
 
Agreement
 
Now, Therefore , in order to induce the Secured Party to make the Loan and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, and intending to be legally bound, Grantor hereby represents, warrants, covenants and agrees as follows:
 
1.        Defined Terms . When used in this Security Agreement the following terms shall have the following meanings (such meanings being equally applicable to both the singular and plural forms of the terms defined). All capitalized terms used herein and not otherwise defined herein shall have the respective meanings given to them in the Note or the Note Agreement:
 
Bankruptcy Code ” means Title XI of the United States Code.
 
Collateral ” shall have the meaning assigned to such term in Section 2 of this Security Agreement.
 
Contracts ” means all contracts (including any customer, vendor, supplier, service or maintenance contract), leases, licenses, undertakings, purchase orders, permits, franchise agreements or other agreements (other than any right evidenced by Chattel Paper, Documents or Instruments), whether in written or electronic form, in or under which Grantor now holds or hereafter acquires any right, title or interest, including, without limitation, with respect to an Account, any agreement relating to the terms of payment or the terms of performance thereof.
 
Copyright License ” means any agreement, whether in written or electronic form, in which Grantor now holds or hereafter acquires any interest, granting any right in or to any
 
 
1

 
 
Copyright or Copyright registration (whether Grantor is the licensee or the licensor thereunder) including, without limitation, licenses pursuant to which Grantor has obtained the exclusive right to use a copyright owned by a third party.
 
Copyrights ” means all of the following now owned or hereafter acquired or created (as a work for hire for the benefit of Grantor) by Grantor or in which Grantor now holds or hereafter acquires or receives any right or interest, in whole or in part: (a) all copyrights, whether registered or unregistered, held pursuant to the laws of the United States, any State thereof or any other country; (b) registrations, applications, recordings and proceedings in the United States Copyright Office or in any similar office or agency of the United States, any State thereof or any other country; (c) any continuations, renewals or extensions thereof; (d) any registrations to be issued in any pending applications, and shall include any right or interest in and to work protectable by any of the foregoing which are presently or in the future owned, created or authorized (as a work for hire for the benefit of Grantor) or acquired by Grantor, in whole or in part; (e) prior versions of works covered by copyright and all works based upon, derived from or incorporating such works; (f) income, royalties, damages, claims and payments now and hereafter due and/or payable with respect to copyrights, including, without limitation, damages, claims and recoveries for past, present or future infringement; (g) rights to sue for past, present and future infringements of any copyright; and (h) any other rights corresponding to any of the foregoing rights throughout the world.
 
Event of Default ” means any “Event of Default” as defined in the Note Agreement.
 
Intellectual Property ” means any intellectual property, in any medium, of any kind or nature whatsoever, now or hereafter owned or acquired or received by Grantor or in which Grantor now holds or hereafter acquires or receives any right or interest, and shall include, in any event, any Copyright, Trademark, Patent, trade secret, customer list, internet domain name (including any right related to the registration thereof), proprietary or confidential information, mask work, source, object or other programming code, invention (whether or not patented or patentable), technical information, procedure, design, knowledge, know-how, software, data base, data, skill, expertise, recipe, experience, process, model, drawing, material or record.
 
License ” means any Copyright License, Patent License, Trademark License or other license of rights or interests, whether in-bound or out-bound, whether in written or electronic form, now or hereafter owned or acquired or received by Grantor or in which Grantor now holds or hereafter acquires or receives any right or interest, and shall include any renewals or extensions of any of the foregoing thereof.
 
Lien ” means any mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance.
 
Patent License ” means any agreement, whether in written or electronic form, in which Grantor now holds or hereafter acquires any interest, granting any right with respect to any invention on which a Patent is in existence (whether Grantor is the licensee or the licensor thereunder).
 
 
2
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
Patents ” means all of the following in which Grantor now holds or hereafter acquires any interest: (a) all letters patent of the United States or any other country, all registrations and recordings thereof and all applications for letters patent of the United States or any other country, including, without limitation, registrations, recordings and applications in the United States Patent and Trademark Office or in any similar office or agency of the United States, any State thereof or any other country; (b) all reissues, divisions, continuations, renewals, continuations-in-part or extensions thereof; (c) all petty patents, divisionals and patents of addition; (d) all patents to issue in any such applications; (e) income, royalties, damages, claims and payments now and hereafter due and/or payable with respect to patents, including, without limitation, damages, claims and recoveries for past, present or future infringement; and (f) rights to sue for past, present and future infringements of any patent.
 
Permitted Lien ” means: (a) any Liens existing on the date of this Security Agreement and set forth on Schedule A attached hereto; (b) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings; provided the same have no priority over any of Secured Party’s security interests; (c) Liens (i) upon or in any Equipment acquired or held by Grantor to secure the purchase price of such Equipment or indebtedness (including capital leases) incurred solely for the purpose of financing the acquisition of such Equipment or (ii) existing on such Equipment at the time of its acquisition, provided that the Lien is confined solely to the Equipment so acquired, improvements thereon and the Proceeds of such Equipment; (d) leases or subleases and licenses or sublicenses granted to others in the ordinary course of Grantor’s business if such do not interfere in any material respect with the business of Grantor; (e) any right, title or interest of a licensor under a license; (f) Liens arising from judgments, decrees or attachments not constituting an Event of Default; (g) easements, reservations, rights-of-way, restrictions, minor defects or irregularities in title and other similar Liens affecting real property not interfering in any material respect with the ordinary conduct of the business of Grantor; (h) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods; (i) Liens arising solely by virtue of any statutory or common law provision relating to banker’s liens, rights of setoff or similar rights and remedies as to deposit accounts or other funds maintained with a creditor depository institution; (j) Liens on equipment and other personal property (including proceeds thereof and accessions thereto) securing capital or operating lease obligations, including without limitation sale and lease-back transactions; (k) Liens in favor of a depository bank or a securities intermediary pursuant to such depository bank’s or securities intermediary’s customary customer account agreement; provided that any such Liens shall at no time secure any indebtedness or obligations other than customary fees and charges payable to such depository bank or securities intermediary; (l) statutory or common law Liens of landlords and carriers, warehousemen, mechanics, suppliers, materialmen, repairmen and other similar Liens, arising in the ordinary course of business and securing obligations that are not yet delinquent or are being contested in good faith by appropriate proceedings; (m) Liens incurred or deposits made to secure the performance of tenders, bids, leases, statutory or regulatory obligations, surety and appeal bonds, government contracts, performance and return-of-money bonds, and other obligations of like nature, in each case, in the ordinary course of business; (n) Liens incurred or deposits made in the ordinary course of business in connection with workers’ compensation, unemployment insurance and other types of social security; (o) pledges and deposits securing liability for reimbursement or indemnification obligations in respect of letters of credit or bank guarantees for the benefit of landlords; (p) Liens securing Indebtedness permitted under Section 5.5(c) of the Note Agreement; and (q) Liens incurred in connection with the extension, renewal or refinancing of indebtedness secured by Liens permitted under the preceding clauses, provided that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness being extended, renewed or refinanced does not increase.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
Secured Obligations ” means (a) the obligation of Grantor to repay the Secured Party all of the unpaid principal amount of, and accrued interest on (including any interest that accrues after the commencement of bankruptcy), the Loan or to perform any other obligation under the Note and (b) the obligation of Grantor to pay any fees, costs and expenses of the Secured Party under the Loan Documents or under Section 6(d) hereof and (c) all other indebtedness, liabilities and obligations of Grantor to the Secured Party, whether now existing or hereafter incurred, arising from or in connection with any Loan Document.
 
Security Agreement ” means this Security Agreement and all Schedules hereto, as the same may from time to time be amended, modified, supplemented or restated.
 
Trademark License ” means any agreement, whether in written or electronic form, in which Grantor now holds or hereafter acquires any interest, granting any right in and to any Trademark or Trademark registration (whether Grantor is the licensee or the licensor thereunder).
 
Trademarks ” means any of the following in which Grantor now holds or hereafter acquires any interest: (a) any trademarks, tradenames, corporate names, company names, business names, trade styles, service marks, logos, other source or business identifiers, prints and labels on which any of the foregoing have appeared or appear, designs and general intangibles of like nature, now existing or hereafter adopted or acquired, all registrations and recordings thereof and any applications in connection therewith, including, without limitation, registrations, recordings and applications in the United States Patent and Trademark Office or in any similar office or agency of the United States, any State thereof or any other country (collectively, the “ Marks ”); (b) any reissues, extensions or renewals thereof; (c) the goodwill of the business symbolized by or associated with the Marks; (d) income, royalties, damages, claims and payments now and hereafter due and/or payable with respect to the Marks, including, without limitation, damages, claims and recoveries for past, present or future infringement; and (e) rights to sue for past, present and future infringements of the Marks.
 
UCC ” means the Uniform Commercial Code as the same may from time to time be in effect in the State of New York and each reference in this Security Agreement to an Article thereof (denoted as a Division of the UCC as adopted and in effect in the State of New York) shall refer to that Article (or Division, as applicable) as from time to time in effect; provided, however, in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection or priority of the Secured Party’s security interest in any Collateral is governed by the Uniform Commercial Code as in effect in a jurisdiction other than the State of New York, the term “ UCC ” shall mean the Uniform Commercial Code (including the Articles thereof) as in effect at such time in such other jurisdiction for purposes of the provisions hereof relating to such attachment, perfection or priority and for purposes of definitions related to such provisions.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
In addition, the following terms shall be defined terms having the meaning set forth for such terms in the UCC: “Account” (including health-care-insurance receivables), “Account Debtor”, “Chattel Paper” (including tangible and electronic chattel paper), “Commercial Tort Claims”, “Commodity Account”, “Deposit Account”, “Documents”, “Equipment” (including all accessions and additions thereto), “Fixtures”, “General Intangible” (including payment intangibles and software), “Goods,” “Instrument”, “Inventory” (including all goods held for sale or lease or to be furnished under a contract of service, and including returns and repossessions), “Investment Property” (including securities and securities entitlements), “Letter-of-Credit Right” (whether or not the letter of credit is evidenced by a writing), “Payment Intangibles”, “Proceeds”, “Promissory Notes”, “Securities Account”, and “Supporting Obligations”. Each of the foregoing defined terms shall include all of such items now owned, or hereafter acquired, by Grantor.
 
2.       Grant of Security Interest .
 
(a)            As collateral security for the full, prompt, complete and final payment and performance when due (whether at stated maturity, by acceleration or otherwise) of all the Secured Obligations and in order to induce the Secured Party to cause the Loan to be made, Grantor hereby assigns, conveys, mortgages, pledges, hypothecates and transfers to the Secured Party, and hereby grants to the Secured Party, a first priority security interest in all of Grantor’s right, title and interest in, to and under the following, whether now owned or hereafter acquired and wherever located, (all of which being collectively referred to herein as the “ Collateral ”):
 
(i) Accounts; (ii) Chattel Paper; (iii) Commercial Tort Claims; (iv) Contracts (excluding Licenses); (v) Deposit Accounts; (vi) Documents; (vii) Equipment; (viii) Fixtures; (ix) Goods; (x) All Intellectual Property and Licenses of Grantor related to the Company’s PAS-Port™ product, including, without limitation, Payment Intangibles; (xi) Instruments, including, without limitation, Promissory Notes; (xii) Inventory; (xiii) Investment Property; (xiv) Letter-of Credit Rights; (xv) Supporting Obligations; (xvi) Commodity Accounts and Securities Accounts; (xvii) all property of Grantor held by the Secured Party, or any other party for whom the Secured Party is acting as agent hereunder, including, without limitation, all property of every-description now or hereafter in the possession or custody of or in transit to the Secured Party or such other party for any purpose, including, without limitation, safekeeping, collection or pledge, for the account of Grantor, or as to which Grantor may have any right or power; all other goods and personal property of Grantor, wherever located, whether tangible or intangible (but, with respect to intangible property, only to the extent otherwise granted pursuant to this Section 2), and whether now owned or hereafter acquired, existing, leased or consigned by or to Grantor; and (xviii) to the extent not otherwise included, all Proceeds of each of the foregoing and all accessions to, substitutions and replacements for and rents, profits and products of each of the foregoing.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(b)            Notwithstanding the foregoing provisions of this Section 2, the grant, assignment and transfer of a security interest as provided herein shall not extend to, and the term “Collateral” shall not include: (a) “intent-to-use” trademarks at all times prior to the first use thereof, whether by the actual use thereof in commerce, the recording of a statement of use with the United States Patent and Trademark Office or otherwise or (b) any Contract, Instrument or Chattel Paper in which Grantor has any right, title or interest if and to the extent such Contract, Instrument or Chattel Paper includes a provision containing a restriction on assignment such that the creation of a security interest in the right, title or interest of Grantor therein would be prohibited and would, in and of itself, cause or result in a default thereunder enabling another person party to such Contract, Instrument or Chattel Paper to enforce any remedy with respect thereto; provided that the foregoing exclusion shall not apply if (i) such prohibition has been waived or such other person has otherwise consented to the creation hereunder of a security interest in such Contract, Instrument or Chattel Paper or (ii) such prohibition would be rendered ineffective pursuant to Sections 9-406(d), 9-407(a) or 9-408(a) of the UCC, as applicable and as then in effect in any relevant jurisdiction, or any other applicable law (including the Bankruptcy Code) or principles of equity); provided further that immediately upon the ineffectiveness, lapse or termination of any such provision, the Collateral shall include, and Grantor shall be deemed to have granted a security interest in, all its rights, title and interests in and to such Contract, Instrument or Chattel Paper as if such provision had never been in effect; and provided further that the foregoing exclusion shall in no way be construed so as to limit, impair or otherwise affect the Secured Party’s unconditional continuing security interest in and to all rights, title and interests of Grantor in or to any payment obligations or other rights to receive monies due or to become due under any such Contract, Instrument or Chattel Paper and in any such monies and other proceeds of such Contract, Instrument or Chattel Paper.
 
(c)       If and to the extent Secured Party is granted a security interest in any of the Licensed IP (as such term is defined in the Intuitive License Agreement), Secured Party hereby recognizes the validity of the preexisting licenses and sublicenses granted to Intuitive under Section 2 of the Intuitive License Agreement and agrees that it takes such security interest subject to such preexisting licenses, sublicenses and the terms of the Intuitive License Agreement.
 
3.        Rights Of Secured Party; Collection Of Accounts .
 
(a)            Notwithstanding anything contained in this Security Agreement to the contrary, Grantor expressly agrees that it shall remain liable under each of its Contracts and each of its Licenses to observe and perform all the conditions and obligations to be observed and performed by it thereunder and that it shall perform all of its duties and obligations thereunder, all in accordance with and pursuant to the terms and provisions of each such Contract or License. The Secured Party shall not have any obligation or liability under any Contract or License by reason of or arising out of this Security Agreement or the granting to the Secured Party of a lien therein or the receipt by the Secured Party of any payment relating to any Contract or License pursuant hereto, nor shall the Secured Party be required or obligated in any manner to perform or fulfill any of the obligations of Grantor under or pursuant to any Contract or License, or to make any payment, or to make any inquiry as to the nature or the sufficiency of any payment received by it or the sufficiency of any performance by any party under any Contract or License, or to present or file any claim, or to take any action to collect or enforce any performance or the payment of any amounts which may have been assigned to it or to which it may be entitled at any time or times.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(b)            The Secured Party authorizes Grantor to collect its Accounts provided that such collection is performed in a prudent and businesslike manner, and Secured Party may, upon the occurrence and during the continuation of any Event of Default or acceleration pursuant to Section 5.3 of the Note Agreement (“ Other Acceleration ”), and without notice, limit or terminate said authority at any time. Upon the occurrence and during the continuance of any Event of Default or Other Acceleration, at the request of the Secured Party, Grantor shall deliver all original and other documents evidencing and relating to the performance of labor or service which created such Accounts, including, without limitation, all original orders, invoices and shipping receipts.
 
(c)            The Secured Party may at any time, upon the occurrence and during the continuance of any Event of Default or Other Acceleration, notify Account Debtors of Grantor, without notifying Grantor of its intention to do so, parties to the Contracts of Grantor, obligors in respect of Instruments of Grantor and obligors in respect of Chattel Paper of Grantor that the Accounts and the right, title and interest of Grantor in and under such Contracts, Instruments and Chattel Paper have been assigned to the Secured Party and that payments shall be made directly to the Secured Party. Upon the request of the Secured Party, Grantor shall so notify such Account Debtors, parties to such Contracts, obligors in respect of such Instruments and obligors in respect of such Chattel Paper. Upon the occurrence and during the continuance of any Event of Default or Other Acceleration, the Secured Party may, in its name or in the name of others, communicate with such Account Debtors, parties to such Contracts, obligors in respect of such Instruments and obligors in respect of such Chattel Paper to verify with such parties, to the Secured Party’s satisfaction, the existence, amount and terms of any such Accounts, Contracts, Instruments or Chattel Paper.
 
4.        Representations And Warranties . Grantor hereby represents and warrants to the Secured Party that:
 
(a)            Except for the security interest granted to the Secured Party under this Security Agreement and Permitted Liens, Grantor is the sole legal and equitable owner of each item of the Collateral in which it purports to grant a security interest hereunder having good and marketable title thereto, free and clear of any and all Liens.
 
(b)            No effective security agreement, financing statement, equivalent security or lien instrument or continuation statement covering all or any part of the Collateral exists, except such as may have been filed by Grantor in favor of the Secured Party pursuant to this Security Agreement and except for Permitted Liens.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(c)            Subject to Section 9-108(e)(1) (in the case of a description of a Commercial Tort Claim), this Security Agreement creates a legal, valid and first priority security interest on and in all of the Collateral in which Grantor now has rights and will create a legal and valid security interest in the Collateral in which Grantor later acquires rights.
 
(d)            Grantor’s taxpayer identification number is, and chief executive office, principal place of business, and the place where Grantor maintains its records concerning the Collateral are presently located at the address set forth on the signature page hereof. Grantor is a corporation duly organized under the laws of the State of Delaware and its exact legal name is as set forth on the signature page hereof. The tangible Collateral is presently located at such address and at such additional addresses set forth on Schedule B   attached hereto.
 
(e)            The name and address of each depository institution at which Grantor maintains any Deposit Account and the account number and account name of each such Deposit Account is listed on Schedule C   attached hereto. The name and address of each securities intermediary or commodity intermediary at which Grantor maintains any Securities Account or Commodity Account and the account number and account name is listed on Schedule C   attached hereto. Grantor agrees to amend Schedule C to reflect the opening of any additional Deposit Account, Securities Account or Commodity Account, or closing or changing the account name or number on any existing Deposit Account, Securities Account, or Commodity Account.
 
(f)            All Copyrights, Copyright Licenses, Patents, Patent Licenses, Trademarks and Trademark Licenses related to Grantor’s PAS-Port™ product now owned or held by Grantor are listed on Schedule D attached hereto, each of which, and any amendment of Schedule D hereafter, is deemed to be the confidential information of Grantor and which Secured Party will not disclose to any other person or entity except to the extent necessary to perfect Secured Party’s security interest in such property. Grantor shall amend Schedule D from time to time within forty-five (45) days after the end of each quarter to indicate the filing of any application for a Patent, Trademark or Copyright or the issuance of any Patent or registration of any Trademark or Copyright or to reflect any other additions or deletions from this list.
 
5.        Covenants . Unless the Secured Party otherwise consents, Grantor covenants and agrees with the Secured Party that from and after the date of this Security Agreement and until the Secured Obligations (other than inchoate indemnity obligations) have been performed and paid in full:
 
5.1             Disposition of Collateral. Except with contemporaneous notice to the Secured Party, Grantor shall not sell, lease, transfer or otherwise dispose of any of the Collateral, Intellectual Property or Licenses of the Company, except in the ordinary course of business, as it may exist from time to time, and except for the Existing License Agreements.
 
5.2             Change of Jurisdiction of Organization, Relocation of Business. Grantor shall not change its jurisdiction of organization or relocate its chief executive office, principal place of business or its records from such address(es) provided to the Secured Party pursuant to Section 4(d) above without at least seven (7) days’ prior notice to the Secured Party.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
5.3             Limitation on Liens on Collateral, Intellectual Property or Licenses. Grantor shall not, directly or indirectly, create, permit or suffer to exist, and shall defend the Collateral and its Intellectual Property and Licenses against and take such other action as is necessary to remove, any Lien on the Collateral or its Intellectual Property or Licenses, except (a) Permitted Liens and (b) the Lien granted to the Secured Party under this Security Agreement.
 
5.4             Taxes, Assessments, Etc. Grantor shall pay promptly when due all property and other taxes, assessments and government charges or levies imposed upon, and all claims (including claims for labor, materials and supplies) against, the Equipment, Fixtures or Inventory, except to the extent the validity or amount thereof is being contested in good faith and adequate reserves are being maintained in connection therewith.
 
5.5             Notification Regarding Changes in Intellectual Property or Licenses. Subject to Secured Party’s obligation to hold such information confidential as described in Section 4(f) above, Grantor shall advise the Secured Party in accordance with Section 4(f) above of any subsequent ownership right or interest of the Grantor in or to any Intellectual Property or License not specified on Schedule D hereto and shall permit the Secured Party to amend such Schedule, as necessary, to reflect any addition or deletion to such ownership rights.
 
5.6             Defense of Intellectual Property and Licenses. Grantor shall (i) protect, defend and maintain the validity and enforceability of all Intellectual Property and Licenses material to Grantor’s business, (ii) use its best efforts to detect infringements of all Intellectual Property material to Grantor’s business and promptly advise the Secured Party in writing of material infringements detected and (iii) not allow any Copyrights, Patents or Trademarks to be abandoned, forfeited or dedicated to the public without the written consent of the Secured Party, unless reasonable business practice would determine that any such abandonment is appropriate.
 
5.7           Further Assurances.
 
(a)            At any time and from time to time, upon the written request of the Secured Party, and at the sole expense of Grantor, Grantor shall promptly and duly execute and deliver any and all such further instruments and documents and take such further action as the Secured Party may reasonably deem necessary or desirable to obtain the full benefits of this Security Agreement, including, without limitation, (a) executing, delivering and causing to be filed any financing or continuation statements under the UCC with respect to the security interests granted hereby, (b) at the Secured Party’s reasonable request, filing or cooperating with the Secured Party in filing any forms or other documents required to be recorded with the United States Patent and Trademark Office or the United States Copyright Office, (c) at the Secured Party’s reasonable request, placing the interest of the Secured Party as lienholder on the certificate of title (or similar evidence of ownership) of any vehicle, watercraft or other Equipment constituting Collateral owned by Grantor which is covered by a certificate of title (or similar evidence of ownership), (d) at the Secured Party’s reasonable request, executing and delivering and using commercially reasonable efforts to cause the applicable depository institution, securities intermediary, commodity intermediary or issuer or nominated party under a letter of credit to execute and deliver a collateral control agreement with respect to any Deposit Account, Securities Account or Commodity Account or Letter-of-Credit Right in or to which Grantor has any right or interest and (e) at the Secured Party’s reasonable request, using commercially reasonable efforts to obtain acknowledgments from bailees having possession of any Collateral and waivers of liens from landlords and mortgagees of any location where any of the Collateral may from time to time be stored or located. Secured Party may at any time and from time to time file financing statements, continuation statements and amendments thereto that describe the Collateral as all assets of Grantor or words of similar effect.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(b)            Any such financing statements, continuation statements or amendments may be signed by Secured Party on behalf of Grantor and may be filed by Secured Party at any time in any jurisdiction. Grantor also hereby authorizes the Secured Party to file any such financing or continuation statement without the signature of Grantor. Grantor agrees to promptly reimburse Secured Party for all reasonable costs and expenses incurred in preparing and filing any such financing statement, continuation statement or amendment, including reasonable attorneys’ fees.
 
6.        Rights And Remedies Upon Default.   Beginning on the date which is one (1)   business day   after any Event of Default shall have occurred and while such Event of Default is continuing:
 
(a)            The Secured Party may exercise in addition to all other rights and remedies granted to it under this Security Agreement or any other Loan Document all rights and remedies of a secured party under the UCC. Without limiting the generality of the foregoing, Grantor expressly agrees that in any such event the Secured Party, without demand of performance or other demand, advertisement or notice of any kind (except the notice specified below of time and place of public or private sale) to or upon Grantor or any other person, may (i) reclaim, take possession, recover, store, maintain, finish, repair, prepare for sale or lease, shop, advertise for sale or lease and sell or lease (in the manner provided herein) the Collateral, and in connection with the liquidation of the Collateral and collection of the accounts receivable pledged as Collateral, use any Trademark, Copyright, or process used or owned by Grantor and (ii) forthwith collect, receive, appropriate and realize upon the Collateral, or any part thereof, and may forthwith sell, lease, assign, give an option or options to purchase or sell or otherwise dispose of and deliver said Collateral (or contract to do so), or any part thereof, in one or more parcels at public or private sale or sales, at any exchange or broker’s board or at the Secured Party’s offices or elsewhere at such prices as it may deem commercially reasonable, for cash or on credit or for future delivery without assumption of any credit risk. Grantor further agrees, at the Secured Party’s request, to assemble its Collateral and make it available to the Secured Party at places which the Secured Party shall reasonably select, whether at Grantor’s premises or elsewhere. The Secured Party shall apply the net proceeds of any such collection, recovery, receipt, appropriation, realization or sale as provided in Section 6(f), below, with Grantor remaining liable for any deficiency remaining unpaid after such application. Grantor agrees that the Secured Party need not give more than twenty (20) days’ notice of the time and place of any public sale or of the time after which a private sale may take place and that such notice is reasonable notification of such matters. Grantor shall remain liable for any deficiency if the proceeds of any sale or disposition of its Collateral are insufficient to pay all amounts to which Secured Party is entitled from Grantor, Grantor also being liable for the reasonable attorney costs of any attorneys employed by Secured Party to collect such deficiency.
 
 
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[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
(b)            As to any Collateral constituting certificated securities or uncertificated securities, if, at any time when the Secured Party shall determine to exercise its right to sell the whole or any part of such Collateral hereunder, such Collateral or the part thereof to be sold shall not, for any reason whatsoever, be effectively registered under Securities Act of 1933, as amended (as so amended the “ Act ”), the Secured Party may, in its discretion (subject only to applicable requirements of law), sell such Collateral or part thereof by private sale in such manner and under such circumstances as the Secured Party may deem necessary or advisable, but subject to the other requirements of this Section 6(b), and shall not be required to effect such registration or cause the same to be effected. Without limiting the generality of the foregoing, in any such event the Secured Party may, in its discretion, (i) in accordance with applicable securities laws, proceed to make such private sale notwithstanding that a registration statement for the purpose of registering such Collateral or part thereof could be or shall have been filed under the Act; (ii) approach and negotiate with a single possible purchaser to effect such sale; and (iii) restrict such sale to a purchaser who will represent and agree that such purchaser is purchasing for its own account, for investment, and not with a view to the distribution or sale of such Collateral or part thereof. In addition to a private sale as provided above in this Section 6(b), if any of such Collateral shall not be freely distributable to the public without registration under the Act at the time of any proposed sale hereunder, then the Secured Party shall not be required to effect such registration or cause the same to be effected but may, in its discretion (subject only to applicable requirements of law), require that any sale hereunder (including a sale at auction) be conducted subject to such restrictions as the Secured Party may, in its discretion, deem necessary or appropriate in order that such sale (notwithstanding any failure so to register) may be effected in compliance with the Bankruptcy Code and other laws affecting the enforcement of creditors’ rights and the Act and all applicable state securities laws.
 
(c)            Grantor agrees that in any sale of any of such Collateral, whether at a foreclosure sale or otherwise, Secured Party is hereby authorized to comply with any limitation or restriction in connection with such sale as it may be advised by counsel is necessary in order to avoid any violation of applicable law (including compliance with such procedures as may restrict the number of prospective bidders and purchasers, require that such prospective bidders and purchasers have certain qualifications and restrict such prospective bidders and purchasers to persons who will represent and agree that they are purchasing for their own account for investment and not with a view to the distribution or resale of such Collateral), or in order to obtain any required approval of the sale or of the purchaser by any governmental authority, and Grantor further agrees that such compliance shall not result in such sale being considered or deemed not to have been made in a commercially reasonable manner, nor shall Secured Party be liable nor accountable to Grantor for any discount allowed by the reason of the fact that such Collateral is sold in compliance with any such limitation or restriction.
 
(d)            Grantor also agrees to pay all fees, costs and expenses of the Secured Party, including, without limitation, reasonable attorneys’ fees, incurred in connection with the enforcement of any of its rights and remedies hereunder.
 
 
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(e)            Grantor hereby waives presentment, demand, protest or any notice (to the maximum extent permitted by applicable law) of any kind in connection with this Security Agreement or any Collateral.
 
(f)            The Proceeds of any sale, disposition or other realization upon all or any part of the Collateral shall be distributed by the Secured Party in the following order of priorities:
 
First , to the Secured Party in an amount sufficient to pay in full the reasonable costs of the Secured Party in connection with such sale, disposition or other realization, including all fees, costs, expenses, liabilities and advances incurred or made by the Secured Party in connection therewith, including, without limitation, reasonable attorneys’ fees;
 
Second , to the Secured Party in an amount equal to the then unpaid Secured Obligations; and
 
Finally , upon payment in full of the Secured Obligations, to Grantor or its representatives, in accordance with the UCC or as a court of competent jurisdiction may direct.
 
7.        Indemnity . Grantor agrees to defend, indemnify and hold harmless the Secured Party and their officers, employees, and agents (each an “ Indemnified Person ”) against (a) all obligations, demands, claims, and liabilities claimed or asserted by any other party in connection with the transactions contemplated by this Security Agreement and (b) all losses or expenses in any way suffered, incurred, or paid by the Secured Party as a result of or in any way arising out of, following or consequential to transactions between or among the Secured Party and Grantor, whether under this Security Agreement or otherwise (including without limitation, reasonable attorneys fees and expenses), except for losses arising from or out of any Indemnified Person’s gross negligence or willful misconduct.  For the avoidance of doubt, this Section 7 shall not apply to any claims, losses or expenses arising out of the Distribution Agreement.
 
8.        Limitation on Secured Party’s Duty in Respect of Collateral . Secured Party shall be deemed to have acted reasonably in the custody, preservation and disposition of any of the Collateral if it takes such action as Grantor requests in writing, but failure of Secured Party to comply with any such request shall not in itself be deemed a failure to act reasonably, and no failure of Secured Party to do any act not so requested shall be deemed a failure to act reasonably.
 
9.        Reinstatement . This Security Agreement shall remain in full force and effect and continue to be effective should any petition be filed by or against Grantor for liquidation or reorganization, should Grantor become insolvent or make an assignment for the benefit of creditors or should a receiver or trustee be appointed for all or any significant part of Grantor’s property and assets, and shall continue to be effective or be reinstated, as the case may be, if at any time payment and performance of the Secured Obligations, or any part thereof, is, pursuant to applicable law, rescinded or reduced in amount, or must otherwise be restored or returned by any obligee of the Secured Obligations, whether as a “voidable preference,” “fraudulent conveyance,” or otherwise, all as though such payment or performance had not been made. In the event that any payment, or any part thereof, is rescinded, reduced, restored or returned, the Secured Obligations shall be reinstated and deemed reduced only by such amount paid and not so rescinded, reduced, restored or returned.
 
 
12
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
10.        Miscellaneous.
 
10.1             Waivers; Modifications; Amendments. None of the terms or provisions of this Security Agreement may be waived, altered, modified or amended except with the written consent of the Grantor and the Secured Party.
 
10.2             Termination of this Security Agreement. Subject to Section 9 hereof, this Security Agreement shall terminate upon the payment and performance in full of the Secured Obligations (other than inchoate indemnity obligations) and Secured Party shall immediately thereafter execute and deliver to Grantor such documents as shall be reasonably necessary to reconvey to Grantor any interest Secured Party may have in the Collateral.
 
10.3             Successor and Assigns. This Security Agreement and all obligations of Grantor hereunder shall be binding upon the successors and assigns of Grantor, and shall, together with the rights and remedies of the Secured Party hereunder, inure to the benefit of the Secured Party, any future holder of any of the indebtedness and their respective successors and assigns. No sales of participations, other sales, assignments, transfers or other dispositions of any agreement governing or instrument evidencing the Secured Obligations or any portion thereof or interest therein shall in any manner affect the lien granted to the Secured Party hereunder.
 
10.4             Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.
 
10.5             Notices. All notices required or permitted hereunder shall be in writing and shall be given in the manner and to the addresses set forth in the Note Agreement.
 
10.6             Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
10.7             Governing Law. In all respects, including all matters of construction, validity and performance, this Security Agreement and the Secured Obligations arising hereunder shall be governed by, and construed and enforced in accordance with, the laws of the State of New York applicable to contracts made and performed in such state, without regard to the principles thereof regarding conflict of laws, except to the extent that the UCC provides for the application of the law of a different jurisdiction.
 
[ Signature page follows ]
 
 
13
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

In Witness Whereof , each of the parties hereto has caused this Security Agreement to be executed and delivered by its duly authorized officer on the date first set forth above.
 
Address Of Grantor
 
900 Saginaw Drive
Redwood City, CA  94063
 
 
 
 
Cardica, Inc. , as Grantor
 
By: /s/ Bernard Hausen                                                                 
Printed Name: Bernard Hausen, MD                                                                   
Title: President                                                                                
Taxpayer Identification Number of Grantor
 
94-3287832
Jurisdiction of Organization of Grantor
 
Delaware                                                                                         
 
 
 
 
Accepted And Acknowledged By:
 
Century Medical, Inc.
 
By: /s/ Akira Hoshino                                                                 
Printed Name: Akira Hoshino                                                                  
Title: President & CEO                                                                
   
 
 
 
[Signature page to Security Agreement]
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Schedule A
 
LIENS EXISTING ON THE DATE OF THIS SECURITY AGREEMENT
 
A Lien in favor of Dell Financial Services, L.L.C. (as more particularly described in that Financing Statement No. 20082535548 filed on July 23, 2008 with the Delaware Department of State naming Grantor as debtor and Dell as secured party).
 
 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
Schedule B
 
LOCATION OF COLLATERAL
 
Entity
Address
Cardica, Inc.
900 Saginaw Drive
Redwood City, CA  94063
   
   
   

 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
Schedule C
 
DEPOSIT ACCOUNTS, SECURITIES ACCOUNTS AND COMMODITY ACCOUNTS
 
(Including Grantor, Type of Account, Account Name, Account Number and Name of Institution/Intermediary)
 
Bank Account Information: [ * ]
Grantor: Cardica, Inc.

Type of Account: Checking Account

Account Name: Cardica, Inc.

Name of Institution: [ * ]

Account number: [ * ]

Routing number: [ * ]

SWIFT Code: [ * ]


Bank Account Information: [ * ]

Grantor: Cardica, Inc.

Type of Account: [ * ]

Account Name: Cardica, Inc.

Name of Institution: [ * ]

Account number: [ * ]

Routing number: [ * ]
 
 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
Schedule D
 
COPYRIGHTS, COPYRIGHT LICENSES, PATENTS, PATENT LICENSES, TRADEMARKS AND TRADEMARK LICENSES
 
Issued Patents Covering PAS-Port


 
Patent Number
Title
1
6,371,964
Trocar for Use in Deploying an Anastomosis Device and Method of Performing Anastomosis
2
6,402,764
Everter and Threadthrough System for Attaching Graft Vessel to Anastomosis Device
3
6,419,681
Implantable Medical Device Such as an Anastomosis Device
4
6,428,550
Sutureless Closure and Deployment System for Connecting Blood Vessels
5
6,461,320
Method and System for Attaching a Graft to a Blood Vessel
6
6,471,713
System for Deploying an Anastomosis Device and Method of performing anastomosis
7
6,537,288
Implantable Medical Device Such as an Anastomosis Device
8
6,652,541
Method of Sutureless Closure for Connecting Blood Vessels
9
6,666,832
Surgical Measurement Tool
10
6,673,088
Tissue Punch
11
6,719,769
Integrated Anastomosis Tool with Graft Vessel Attachment Device and Cutting Device
12
6,786,914
Sutureless Closure and Deployment System for Connecting Blood Vessels
13
6,821,286
System for Preparing a Graft Vessel for Anastomosis
14
6,893,449
Device for Cutting and Anastomosing Tissue
15
6,955,679
Everter and Threadthrough System for Attaching Graft Vessel to Anastomosis Device
16
6,962,595
Integrated Anastomosis System
17
7,004,949
Method and System for Attaching a Graft to a Blood Vessel
18
7,014,618
Surgical Measurement Tool
19
7,029,482
Integrated Anastomosis System
20
7,041,110
Method and System for Attaching a Graft to a Blood Vessel
 
 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 
21
7,048,751
Implantable Medical Device Such as an Anastomosis Device
22
7,172,608
Sutureless Closure and Deployment System for Connecting Blood Vessels
23
7,175,637
Sutureless Closure and Deployment System for Connecting Blood Vessels
24
7,223,274
Method of Performing Anastomosis
25
7,309,343
Method for Cutting tissue
26
7,335,216
Tool for Creating an Opening in Tissue
27
7,357,807
Integrated Anastomosis Tool with Graft Vessel Attachment Device and Cutting Device
28
7,427,261
System for Preparing a Graft Vessel for Anastomosis
29
7,455,677
Anastomosis Device Having a Deployable Section
30
7,468,066
Trocar for Use in Deploying an Anastomosis Device and Method of Performing Anastomosis
31
7,520,885
Functional Package for an Anastomosis Procedure
32
7,611,523
Method for Sutureless Connection of Vessels
33
8,012,164
Method and Apparatus for Creating an Opening in the Wall of a Tubular Vessel
34
DE69934319T2
Method and System for Attaching a Graft to a Blood Vessel
35
ES2277445
Method and System for Attaching a Graft to a Blood Vessel
36
68251BE/2007 (Italy)
Method and System for Attaching a Graft to a Blood Vessel
37
DE 100 84 618
Trocar for Use in Deploying an Anastomosis Device and Method of Performing Anastomosis
38
DE 100 84 620
Sutureless Closure and Deployment System for Connecting Blood Vessels
39
EP 1105069
Method and System for Attaching a Graft to a Blood Vessel

 
 
[ * ]   = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 10.39
 
THIS SECURED PROMISSORY NOTE HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”).  NO SALE OR DISPOSITION MAY BE EFFECTED EXCEPT IN COMPLIANCE WITH RULE 144 UNDER SAID ACT OR AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN APPLICABLE EXEMPTION THEREFROM.
 
SECURED PROMISSORY NOTE
 
No. SN-1
Up to U.S. $4,000,000
Redwood City, CA
_________, 2011
 
For value received, Cardica, Inc. ,   a Delaware corporation (“ Payor ”), hereby promises to pay to the order of Century Medical, Inc. , a Japan corporation, or its assigns (“ Holder ”), the principal sum of Four Million United States Dollars (U.S. $4,000,000) , or the aggregate unpaid principal amount of all advances made to Payor by Holder pursuant to the Note Agreement (as defined below), whichever is less , together with interest thereon, all as hereinafter provided and upon the following agreements, terms and conditions. Each advance hereunder shall bear interest from time to time, from the date of such advance until repaid, in the amount set forth in the Note Agreement.
 
1.             Payment; Security; Advances
 
(a)            This secured promissory note (this “ Note ”) is issued pursuant to the terms of that certain Secured Note Purchase Agreement by and between Payor and Holder dated as of September 2, 2011 (the “ Note Agreement ”). All capitalized terms used and not otherwise defined herein shall have the respective meanings given to them in the Note Agreement or the Security Agreement (as defined below), as applicable.
 
(b)            Payment of the full principal amount of this Note and accrued, but unpaid interest thereon, and all other fees and expenses due to Holder is secured by the Collateral identified and described as security therefor in that certain Security Agreement dated as of even date herewith and executed by Payor in favor of Holder (as the same may from time to time be amended, modified, supplemented or restated, the “ Security Agreement ”).
 
(c)            Payor hereby authorizes Holder or any authorized agent of Holder to endorse on the Schedule annexed to this Note (the “ Note Schedule ”) the principal amount of all advances made to Payor and evidenced hereby and all payments of principal amounts in respect of such advances, which endorsements shall, in the absence of manifest error, be conclusive as to the outstanding principal amount of all advances made hereunder; provided, however, that the failure to make such notation with respect to any advance or payment shall not limit or otherwise affect the obligations of Payor under this Note. Advances under this Note shall be made solely in accordance with the provisions of the Note Agreement.
 
(d)            All payments of principal and interest hereunder shall be in lawful money of the United States of America and shall be made to Holder. This Note shall mature and all principal and interest owing hereunder shall become due and payable in accordance with the provisions of the Note Agreement. The Note may be prepaid prior to the Maturity Date in accordance with the provisions of the Note Agreement.
 
 
1

 
 
(e)            Anything herein or in the Note Agreement to the contrary notwithstanding, if during any period for which interest is computed hereunder, the amount of interest computed on the basis provided for in the Note Agreement, together with all fees, charges and other payments which are treated as interest under applicable law, as provided for therein, herein or in any other document executed in connection herewith, would exceed the amount of such interest computed on the basis of the Highest Lawful Rate (as defined below), Payor shall not be obligated to pay, and the Holder shall not be entitled to charge, collect, receive, reserve or take, interest in excess of the Highest Lawful Rate. As used herein, “ Highest Lawful Rate ” means the maximum non-usurious rate of interest, as in effect from time to time, which may be charged, contracted for, reserved, received or collected by the Holder in connection with this Note under applicable law.
 
2.             Default; Remedies
 
(a)            Upon the occurrence and during the continuance of any Event of Default (as defined in the Note Agreement) or pursuant to Section 5.3 of the Note Agreement, all unpaid principal on this Note, accrued and unpaid interest thereon and all other amounts owing hereunder shall, at the option of Holder, and, upon the occurrence of any Event of a Default pursuant to Section 5.1(e) or (f) of the Note Agreement, automatically, be immediately due, payable and collectible by Holder pursuant to applicable law. Holder shall have all rights and may exercise all remedies available to it under law, successively or concurrently.
 
(b)            Upon the occurrence and during the continuance of any Event of Default or acceleration of this Note pursuant to Section 5.3 of the Note Agreement, Payor shall pay, on demand, all reasonable attorneys’ fees and court costs incurred by Holder in enforcing and collecting this Note.
 
3.             Waiver; Payment of Fees and Expenses . Payor waives presentment and demand for payment, notice of dishonor, protest and notice of protest of this Note. The right to plead any and all statutes of limitations as a defense to any demands hereunder is hereby waived to the full extent permitted by law. No delay by Holder shall constitute a waiver, election or acquiescence by it.
 
4.             Cumulative Remedies. Holder’s rights and remedies under this Note and the Security Agreement shall be cumulative. Holder shall have all other rights and remedies not inconsistent herewith as provided under the UCC, by law or in equity. No exercise by Holder of one right or remedy shall be deemed an election, and no waiver by Holder of any Event of Default shall be deemed a continuing waiver of such Event of Default or the waiver of any other Event of Default.
 
 
2

 
 
5.             Miscellaneous
 
(a)             Successors and Assigns; Assignment; Transfer. The terms and conditions of this Note shall inure to the benefit of and be binding upon the respective successors and assigns of the parties. Payor may not transfer or assign this Note or delegate any of its obligations hereunder without the written consent of Holder. Holder may transfer or assign this Note and its rights hereunder at any time without consent of Payor; provided, that the right to receive principal and/or interest payments on this Note may be assigned or transferred only in one of the following methods: (i) by surrender of this Note to Payor and (A) reissuance by Payor of this Note to the new Holder or (B) issuance by Payor of a new note to the new Holder; or (ii) by notification to Payor of the transfer and a change by Payor in Payor’s books identifying the new owner or an interest in principal or interest on this Note.
 
(b)             Governing Law. The terms of this Note shall be construed in accordance with the laws of the State of New York, as applied to contracts entered into by New York residents within the State of New York, and to be performed entirely within the State of New York.
 
(c)             Notices. Any notice required or permitted by this Note shall be delivered in accordance with, and governed by, the Note Agreement provisions regarding notices.
 
(d)             Titles and Subtitles. The titles and subtitles used in this Note are used for convenience only and are not to be considered in construing or interpreting the Note.
 
(e)             Amendment; Modification; Waiver. No term of this Note may be amended, modified or waived without the written consent of Payor and Holder.
 
(f)             Loss of Note. Upon receipt by Payor of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Note or any Note exchanged for it, and indemnity reasonably satisfactory to Payor (in case of loss, theft or destruction) or surrender and cancellation of such Note (in the case of mutilation), Payor will make and deliver in lieu of such Note a new Note of like tenor.
 
(g)             Counterparts. This Note may be executed in two or more counterparts, each of which shall be deemed and original, but all of which together shall constitute one and the same instrument.
 
[ Signature page follows ]
 
 
 
3

 
 
In Witness Whereof, the parties have executed this Secured Promissory Note   as of the date first written above.
 
 
     
Cardica, Inc.
 
         
     
By: /s/
 
         
     
Name:
 
         
     
Title:
 
 
 
 
Agreed to and Accepted:        
         
Century Medical, Inc.        
         
By: /s/
       
         
Name:
       
         
Title:
       

 
 
 
SIGNATURE PAGE                                                          
 
 
 

 


NOTE SCHEDULE


Advance No.
Date of Advance or Payment
Amount of Advance
1
_____, 2011
U.S. $_________
     
     
     
     
     
     
     
     
     


Exhibit 31.1
CERTIFICATION
 
I, Bernard A. Hausen, M.D., Ph.D., certify that;
 
1.    I have reviewed this quarterly report on Form 10-Q of Cardica, Inc.;
 
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 officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
 
(a)             All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
(b)             Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
       
Date: November 9, 2011
 
/s/ Bernard A. Hausen, M.D., Ph.D.
 
 
   
Bernard A. Hausen, M.D., Ph.D.
President, Chief Executive Officer, Chief Medical
Officer and Director
(Principal Executive Officer)
 
       
       
 
Exhibit 31.2
 
CERTIFICATION
 
I, Robert Y. Newell, certify that;
 
1.    I have reviewed this quarterly report on Form 10-Q of Cardica, Inc.;
 
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 officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
 
(a)             All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
(b)             Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
       
Date: November 9, 2011
 
/s/ Robert Y. Newell
 
 
   
Robert Y. Newell
Vice President, Finance, Chief Financial Officer and Secretary
(Principal Financial Officer)
 
       
       
 
Exhibit 32.1
CERTIFICATION

 
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350),   Bernard A. Hausen, M.D., Ph.D., Chief Executive Officer of Cardica, Inc. (the "Company"), and Robert Y. Newell, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
 
1.
The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2011, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
 
2.
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
In Witness Whereof , the undersigned have set their hands hereto as of the 9th day of November, 2011.
 

 
         
/s/ Bernard A. Hausen, M.D., Ph.D.
   
/s/ Robert Y. Newell
 
Bernard A. Hausen, M.D., Ph.D.
   
Robert Y. Newell
 
Chief Executive Officer  
   
Chief Financial Officer
 
 
 

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Cardica, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.