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 December 31, 2015

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 incorporation or organization)		(I.R.S. Employer 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 [ ]

Non-accelerated filer [ ] (Do not check if a smaller reporting company)

Smaller reporting company [x]

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 February 5, 2016, there were 89,018,550 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 DECEMBER 31, 2015

INDEX

  

PART I. FINANCIAL INFORMATION
Item 1.   Financial Statements
a. Condensed Consolidated Balance Sheets at December 31, 2015, and June 30, 2015	3
b. Condensed Consolidated Statements of Operations for the three and six months ended December 31, 2015 and 2014	4
c. Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended December 31, 2015 and 2014	5
d. Condensed Consolidated Statements of Cash Flows for the six months ended December 31, 2015 and 2014	6
e. Notes to Condensed Consolidated Financial Statements	7
Item 2.   Management's Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.   Quantitative and Qualitative Disclosures About Market Risk	24
Item 4.   Controls and Procedures	24
PART II. OTHER INFORMATION
Item 1A. Risk Factors	25
Item 6.    Exhibits	43
SIGNATURES	44

    

 

    

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

CARDICA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

(Unaudited)

 

 

See accompanying notes to the condensed consolidated financial statements.

    

 

   

CARDICA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

 

 

See accompanying notes to the condensed consolidated financial statements.

    

 

  

CARDICA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

(Unaudited)

 

 

See accompanying notes to the condensed consolidated financial statements.

 

 

  

CARDICA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

See accompanying notes to the condensed consolidated financial statements.

    

 

 

 CARDICA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2015

(Unaudited)

 

 

 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,” “estimate,” ”believe,” “potential,” or “continue” or variations 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.

 

The following discussion of our financial condition and results of operations should be read together with our financial statements and related notes included in Part I, Item 1 of this report, and with our financial statements and related notes, and Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended June 30, 2015, which was filed with the Securities and Exchange Commission on September 25, 2015.

 

 

 

Overview

 

We are commercializing and developing our MicroCutter XCHANGE® 30 based on our proprietary “staple-on-a-strip” technology for use by thoracic, pediatric, bariatric, colorectal and general surgeons. The MicroCutter XCHANGE® 30, which is currently commercially-available, is a cartridge based microcutter device with a 5 millimeter shaft diameter and a 30 millimeter staple line cleared for use in the United States for specific indications for use described below, and approved in Japan and in the European Union, or EU, for a broader range of indications for use. We previously had additional products in development, including the MicroCutter XCHANGE® 45, a cartridge based microcutter device with an 8 millimeter shaft and a 45 millimeter staple line, and the MicroCutter FLEXCHANGE™ 30, a cartridge based microcutter device with a flexible shaft to facilitate endoscopic procedures requiring cutting and stapling; however, we suspended development of these additional potential products to focus solely on development of the MicroCutter XCHANGE 30. We completed an assessment by an independent market research firm of the US market for the MicroCutter XCHANGE 30 which identified a potential market opportunity exceeding $250 million annually. In addition, we estimate that the commercially-available MicroCutter XCHANGE 30, along with our additional potential products, if developed, would be suited for use in approximately 1.4 million procedures annually in the United States, involving, we estimate, over four million staple cartridge deployments, three million of which we believe would be deployed in laparoscopic procedures.

 

In March 2012, we completed the design verification for and applied Conformité Européenne, or the CE Mark, to the MicroCutter XCHANGE 30 and, in December 2012, began a controlled commercial launch of the MicroCutter XCHANGE 30 in Europe. We received from the United States Food and Drug Administration, or FDA, 510(k) clearances for the MicroCutter XCHANGE 30 and blue cartridge in January 2014, and for the white cartridge in February 2014, for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix. The blue cartridge is for use in medium thickness tissue, and the white cartridge is for use in thin tissue. In March 2014, we made our first sale of the MicroCutter XCHANGE 30 in the United States, and subsequently temporarily suspended our controlled commercial launch in November 2014, as we shifted our focus to improved performance based on surgeon feedback. In April 2015, we resumed our controlled commercial launch primarily in Europe, of the MicroCutter XCHANGE 30 for thinner tissue usually requiring deployment of white cartridges. While we continue this controlled commercial launch, our goal is to complete product improvements on the MicroCutter XCHANGE 30 combo device that will accommodate thicker tissue ranges requiring deployment of both white and blue cartridges. To further expand the use of the MicroCutter XCHANGE 30, we submitted a 510(k) Premarket Notification to the FDA in April 2015, to expand the indications for use to include vascular structures, and recently received FDA 510(k) clearance to use the MicroCutter XCHANGE 30 surgical stapling device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures. This clearance complements the existing indications for use of the MicroCutter XCHANGE 30 in surgical procedures in the small and large intestine and in the appendix. We plan to initiate a controlled commercial launch to key opinion leaders throughout the United States, including those surgeons performing video-assisted thoracic surgery (VATS).

 

We are attempting to expand in the international market of our MicroCutter XCHANGE 30 with additional selected regulatory filings. We also submitted our MicroCutter XCHANGE 30 blue and white cartridges application to Health Canada for regulatory approval of our MicroCutter XCHANGE 30 and, if we receive approval, anticipate launching it in Canada. In addition, in August 2013, our exclusive distributor in Japan, Century Medical, Inc., or Century, filed for regulatory approval of our MicroCutter XCHANGE 30 cartridges with the Pharmaceuticals and Medical Devices Agency, or PMDA, in Japan and in April 2014, filed for the MicroCutter XCHANGE 30 stapler with TUV Rheinland Japan Ltd, a registered third-party agency in Japan and received approvals in late 2014 for both, to market in Japan. Also, in January 2015, Century submitted an application to PMDA, relating to a change in the material of the cartridge insert component within the MicroCutter XCHANGE 30 cartridges, changing the distal tip of the cartridge insert material from a Vectra Liquid Crystal Polymer, or LCP, to IXEF Polyarylamide, or IXEF, and received approval in August 2015 to market in Japan. We believe that the MicroCutter XCHANGE 30 is differentiated in the market compared to currently marketed staplers due to its significantly reduced size and ability to articulate up to 80 degrees.

 

Prior to 2009, our business focused on the design, manufacture and marketing of proprietary automated anastomotic systems used by cardiac surgeons to perform coronary bypass surgery. 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 coronary artery. As of December 31, 2015, more than 14,880 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 December 31, 2015, more than 42,700 PAS-Port systems had been sold in the United States, Europe and Japan.

 

Historically, we have generated revenues primarily from the sale of automated anastomotic systems; however, we started generating revenues from the commercial sales of the MicroCutter XCHANGE 30 in Europe in December 2012, and in the United States in March 2014, and through December 31, 2015, we have generated $1.7 million of net product revenues from the commercial sales of the MicroCutter XCHANGE 30. In November 2015, we issued a voluntary removal of the MicroCutter XCHANGE 30 blue cartridges from the market, as the MicroCutter XCHANGE 30 device sold primarily in Europe was labeled for use with the white cartridge only. The impact of the returned products from the voluntary removal was not significant.

 

 

 

For the six months ended December 31, 2015, we generated net revenue of $1.4 million, including $1.1 million from the sales of automated anastomotic systems, $0.3 million from commercial sales of the MicroCutter XCHANGE 30, $35,000 of royalty revenue, and incurred a net loss of $8.7 million.

 

Since our inception, we have incurred significant net losses, and we expect to continue to incur net losses for at least the next several years. We have not generated significant revenues from the MicroCutter XCHANGE 30. 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. Revenues 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 C-Port and PAS-Port systems or 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. During the three months ended March 31, 2015, we eliminated eight sales representatives, three of whom were related to selling our automated anastomotic systems and five were for microcutter products. We will continue to sell our automated anastomotic systems internationally through distributors and through independent sales representatives in the United States. We continue to sell our microcutter products only to a select number of key hospitals in the United States and through distributors in Europe before we broadly commercially re-launch our improved MicroCutter XCHANGE 30 combo device. As such, we do not anticipate that we will generate significantly higher products sales in the next few quarters.

 

As of December 31, 2015, we had approximately $18.5 million of cash, cash equivalents and short-term investments, and $4.0 million of debt principal outstanding. We believe that our existing cash, cash equivalents and short-term investments will be sufficient to meet our anticipated cash needs to enable us to conduct our business substantially as currently conducted for at least the next 12 months. We may be able to extend this time period to the extent that we decrease our planned expenditures, or raise additional capital. 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 on many factors, including the extent of our ongoing research and development programs and related costs, including costs related to the product development of the MicroCutter XCHANGE 30, 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 revenues, costs associated with our sales and marketing initiatives and manufacturing activities, costs and timing of obtaining and maintaining FDA, and other regulatory clearances or 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.

 

In order to satisfy our longer term liquidity requirements, 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 signed a distribution agreement, or the 2011 Distribution Agreement, with Century Medical, Inc., or Century with respect to distribution of our planned microcutter products in Japan.  Under the terms of a secured note purchase agreement (“the 2011 note agreement”), Century agreed to loan us an aggregate of up to $4.0 million, with principal due on September 30, 2016, under the agreement, subject to certain conditions, which principal due date was extended to September 30, 2018, effective July 1, 2014.  Under this facility, we received $2.0 million on September 30, 2011, and the remaining $2.0 million on December 27, 2011. The note bears 5% annual interest which is payable quarterly in arrears on the last business day of March, June, September and December of each year through September 30, 2018, the maturity date when the total $4.0 million of principal becomes due. 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 is responsible for securing regulatory approval from the Ministry of Health in Japan for the microcutter product line. Now that approvals of the MicroCutter XCHANGE 30 stapler and cartridge for marketing in Japan have been obtained, we are working with Century to determine their launch plan for the MicroCutter XCHANGE 30 in Japan, specifically whether they launch the commercially-available thin tissue version of the device, or whether they wait until the MicroCutter XCHANGE 30 combo device is available.

 

 

 

Proceeds from the note and granting the distribution rights were allocated to the note based on their aggregate fair value of $2.4 million at the dates of receipt. This fair value was determined by discounting cash flows using a discount rate of 18%, which we estimated was a market rate of borrowing that could be obtained by companies with credit risk similar to us. The remainder of the proceeds of $1.6 million was recorded as debt issuance discount and was allocated to the value of the distribution rights granted to Century under the 2011 Distribution Agreement and is included in deferred revenue. The deferred revenue will be recognized on a straight-line basis over the term of the 2011 Distribution Agreement, beginning upon the first sale by Century of microcutter products in Japan.

 

In addition, our distribution agreement with Century pertaining to the PAS-Port system, originally dated June 16, 2003, as amended, was last amended effective July 1, 2014. The last amendment, among other things, renewed the contract for another five years, and extended the expiration date to July 31, 2019. The note amendment was accounted for as the modification of the 2011 note agreement, as the value of the consideration provided by us in the form of additional distribution rights was estimated to be approximately equal to the reduction in the fair value of the note. Accordingly, we reduced the carrying value of the note of $3.1 million to its post-modification fair value of $2.6 million, and recorded the resulting incremental discount of $0.5 million as deferred revenue. We determined the fair value of the amended note using the discount rate of 18%, which we estimated as the market rate of borrowing as of the modification date that could be obtained by companies with credit risk similar to us. The incremental discount of $0.5 million will be amortized over the remaining term of the note using the effective interest rate method. The deferred revenue will be recognized over the term of the distribution agreement beginning upon the first sale by Century of the microcutter products in Japan.

 

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 eligible to receive 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, if any.  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.  Under the License Agreement, 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 shares of our 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. We have fully recognized such revenue, and as of December 31, 2015 and June 30, 2015, there was no deferred revenue.  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.

 

On December 31, 2015, we and Intuitive Surgical amended the license agreement which was initially signed in August 2010, to include, among other things, an agreement providing for a feasibility evaluation and potential development of a surgical stapling cartridge for use with Intuitive Surgical’s da Vinci Surgical Systems, effective December 30, 2015. Under the terms of the amendment, Intuitive Surgical paid $2.0 million to extend its rights to improvements in our stapling technology and certain patents until August 16, 2018, and to provide for a feasibility evaluation period of up to six months from December 31, 2015 to June 30, 2016.

 

The feasibility evaluation allows Intuitive Surgical to test and evaluate our MicroCutter XCHANGE technology. Upon completion of the evaluation, Intuitive Surgical will have the option to initiate a joint development program, for an 8-millimeters-in-diameter surgical stapling cartridge for use with the da Vinci Surgical System. Pursuant to such an agreement, we may receive further funding for development of the cartridge and tooling as well as a unit-based royalty on commercial sales. In addition, the amendment provides that each of the parties releases the other party from any claims they have or may have against the other party. We received the $2.0 million in January 2016, and as of December 31, 2015, we did not make delivery of our data to Intuitive Surgical, therefore, there was no impact to our consolidated financial statements.

 

 

 

Agreement with MLV

 

On August 3, 2011, we entered into the ATM Agreement with MLV, which expired on August 2, 2014, that provided for the sale of our common stock through MLV as our sales agent. We received net proceeds of $1.2 million from the sale of an aggregate of 884,756 shares of common stock through MLV prior to the expiration on August 2, 2014. During the six months ended December 31, 2014, we did not sell any shares of common stock through MLV.

 

Resignation of Chief Executive Officer

 

On October 5, 2015, we announced the appointment of Julian Nikolchev as our president, chief executive officer and a member of our board of directors, effective October 15, 2015. Mr. Nikolchev succeeded Bernard A. Hausen, M.D., Ph.D., who cofounded Cardica and served as president and chief executive officer since 2000. Dr. Hausen continued to serve as an employee to Cardica through December 31, 2015. Dr. Hausen is receiving, as severance benefits following the termination of his employment with Cardica, twelve months base salary and reimbursement of up to 18 months of COBRA premiums for his health care, and the vesting of all of his equity awards was accelerated.

 

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. 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 judgments 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, 2015, filed with the Securities and Exchange Commission on September 25, 2015.

 
 Results of Operations

 

Comparison of the three and six months ended December 31, 2015 and 2014

 

      Net Revenue. Total net revenue was $0.7 million and $1.4 million for the three and six months ended December 31, 2015, respectively, compared to $0.7 million and $1.7 million for the same periods in 2014, respectively. Product sales slightly increased by $44,000, or 7%, to $0.7 million for the three months ended December 31, 2015, compared to $0.6 million for the same period in 2014. The increase in product sales for the three months ended December 31, 2015, was due to both higher automated anastomotic systems and higher MicroCutter XCHANGE 30 sales. Product sales decreased by $0.3 million, or 16%, to $1.4 million for the six months ended December 31, 2015, compared to $1.7 million for the same period in 2014. The decrease in product sales for the six months ended December 31, 2015, was due to both lower automated anastomotic systems and lower MicroCutter XCHANGE 30 sales, the latter of which was a result of our temporarily suspending our controlled commercial launch of the MicroCutter XCHANGE 30 in November 2014, and the voluntary removal of our blue cartridges in November 2015. The impact of the returned products from the voluntary removal was not significant.

 

Royalty revenue was $17,000 and $35,000 for the three and six months ended December 31, 2015, respectively, compared to $18,000 and $35,000 for the same periods in 2014, respectively.

 

For the three months ended December 31, 2015 and 2014, sales of automated anastomosis systems to Century accounted for approximately 39% and 29%, respectively, of our total product sales, and for the six months ended December 31, 2015 and 2014, approximately 30% and 25% , respectively, of our total product sales. For the three months ended December 31, 2015 and 2014, sales of automated anastomosis systems to Herz-Und Diabeteszentrum in Germany accounted for approximately 11% and 9%, respectively, of our total product sales, and for the six months ended December 31, 2015 and 2014, approximately 11% and 7%, respectively, of our product sales.

 

We anticipate that product sales revenue will slightly increase in absolute terms in the next few quarters since we recently received FDA 510(k) clearance for the MicroCutter XCHANGE 30 with white cartridge for the expanded indications for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures, and we resumed our controlled commercial launch, primarily in Europe, of the MicroCutter XCHANGE 30 for thinner tissue usually requiring deployment of white cartridges.

 

      Cost of Product Sales. Cost of product sales consists primarily of material, labor and overhead costs. Cost of product sales decreased by $55,000, or 6%, to $0.9 million for the three months ended December 31, 2015, compared to $0.9 million for the same period in 2014. Cost of product sales decreased by $0.7 million, or 26%, to $1.9 million for the six months ended December 31, 2015, compared to $2.6 million for the same period in 2014. The decreases in cost of product sales for the three and six months ended December 31, 2015, was due to lower number of automated anastomotic systems and MicroCutter XCHANGE 30 units sold.

 

 

 

We anticipate that cost of product sales will slightly increase in absolute terms in the next few quarters, since we recently received FDA 510(k) clearance for the MicroCutter XCHANGE 30 with white cartridge for the expanded indications for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures, and we resumed our controlled commercial launch primarily in Europe, of the MicroCutter XCHANGE 30 for thinner tissue usually requiring deployment of white cartridges.

 

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 decreased by $0.2 million, or 12%, to $1.6 million for the three months ended December 31, 2015, compared to $1.8 million for the same period in 2014. The decrease was primarily attributable to a decrease in salaries and benefits expenses of $0.3 million due to lower staff level, and a decrease of $0.2 million in material purchases relating to the MicroCutter product line, partially offset by an increase of $0.1 professional outside services expenses and $0.2 million in clinical expenses due to the FDA submission for expanded vascular indications.

 

Research and development expense decreased by $0.3 million, or 9%, to $3.2 million for the six months ended December 31, 2015, compared to $3.5 million for the same period in 2014. The decrease was primarily attributable to a decrease in salaries and benefits of $0.6 million due to lower staff level, and a decrease of $0.2 million due to material purchases relating to the MicroCutter product line, partially offset by an increase of $0.4 million in clinical expenses due to the FDA submission for expanded vascular indications and an increase of $0.1 million in professional outside services.

 

We anticipate that research and development expenses will slightly increase in absolute terms in the next few quarters due to clinical trial, product testing and tooling expenses related to the improved MicroCutter XCHANGE 30.

 

Selling, General and Administrative Expense. Selling, general and administrative expenses decreased by $1.0 million, or 33%, to $2.2 million for the three months ended December 31, 2015, compared to $3.2 million for the same period in 2014. The decrease in selling, general and administrative expense was primarily attributable to a decrease in salaries and benefits of $0.3 million and travel expenses of $0.1 million due to lower staff level, a decrease in the microcutter demo and sample expenses of $0.3 million due to MicroCutter XCHANGE 30 hold, a decrease in professional outside service expenses of $0.2 million due to the resolution of the shareholder activist proxy contest for the 2014 annual meeting and lower non-cash stock compensation expenses of $0.1 million relating to market volatility and adjustments for terminated employees.

 

Selling, general and administrative expense decreased by $1.0 million, or 18%, to $4.8 million for the six months ended December 31, 2015, compared to $5.9 million for the same period in 2014. The decrease in selling, general and administrative expense was primarily attributable to a decrease in salaries and benefits of $0.3 million and travel expenses of $0.1 million due to lower staff level, a decrease in the microcutter demo and sample expenses of $0.6 million due to MicroCutter XCHANGE 30 hold, and lower non-cash stock compensation expenses of $0.2 million relating to market volatility and adjustments for terminated employees, partially offset by an increase of $0.2 million in professional outside services.

 

 We expect selling, general and administrative expense to increase slightly in absolute terms in the next few quarters due to the sales and marketing efforts for our recent FDA 510(k) clearance for the MicroCutter XCHANGE 30 with white cartridge for the expanded indications for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures .

 

Interest Expense. Interest expense for the three and six months ended December 31, 2015, did not change substantively compared to the same period in 2014. We expect interest expense to increase in future periods as the notes payable to Century are scheduled to mature on September 30, 2018, and the debt discount is accreted using the effective interest method.

 

Off-Balance Sheet Arrangements

 

      As of December 31, 2015, we did not have any off-balance sheet arrangements, including structured finance, special purpose or variable interest entities.

 

Liquidity and Capital Resources

 

As of December 31, 2015, our accumulated deficit was $198.4 million and we had cash, cash equivalents and short-term investments of $18.5 million, compared to cash, cash equivalents, and short-term investments of $21.2 million and $4.0 million in long-term investments at June 30, 2015. We currently invest some of our cash, cash equivalents and short-term investments in money market funds and corporate debt securities. Since inception, we have financed our operations primarily through private and public sales of convertible preferred stock, long-term note payable, public and private sales of common stock, warrants to purchase common stock, and license or collaboration agreements.

 

 

 

On September 2, 2011, we entered into a distribution agreement, or the Distribution Agreement, with Century Medical, Inc., or Century, with respect to distribution of our planned microcutter products in Japan.  Additionally, under the terms of a secured note purchase agreement, Century agreed to loan us an aggregate of up to $4.0 million, with principal due on September 30, 2016, subject to certain conditions, which principal due date was extended by two years to September 30, 2018, effective July 1, 2014. 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 is responsible for securing regulatory approval from the Ministry of Health in Japan for the microcutter product line. Now that approvals for the MicroCutter XCHANGE 30 stapler and cartridge have been obtained for marketing in Japan, we are working with Century to determine their launch plan for the MicroCutter XCHANGE 30 in Japan, specifically whether they launch the commercially-available thin tissue version of the device, or whether they wait until the MicroCutter XCHANGE 30 combo device is available.

 

We have drawn the full $4.0 million available to us under the secured note purchase agreement. The amended note bears 5% annual interest which is payable quarterly in arrears on the last business day of March, June, September and December of each year through September 30, 2018, the maturity date when the total $4.0 million of principal becomes due. Proceeds from the note and granting the distribution rights were allocated to the note based on their aggregate fair value of $2.4 million at the dates of receipt. This fair value was determined by discounting cash flows using a discount rate of 18%, which we estimated approximated a market rate of return on debt financing that could be obtained by companies with credit risk similar to us. The remainder of the proceeds of $1.6 million, and the additional $0.5 million due to the two years extension, were allocated to the value of the distribution rights granted to Century under the Distribution Agreement and is included in deferred revenue. The deferred revenue will be recognized on a straight-line basis over the term of the Distribution Agreement, beginning upon the first sale by Century of the microcutter products in Japan. In August 2013, Century filed for regulatory approval of our MicroCutter XCHANGE 30 cartridge with the Pharmaceuticals and Medical Devices Agency in Japan and in April 2014, filed for the MicroCutter XCHANGE 30 stapler with TUV Rheinland Japan Ltd, a registered third-party agency in Japan and received approvals in late 2014 for both, to market in Japan. Also, in January 2015, Century submitted an application to PMDA, relating to a change in the material of the cartridge insert component within the MicroCutter XCHANGE 30 cartridges, changing the distal tip of the cartridge insert material from a LCP to IXEF, and received approval in August 2015 to market in Japan.

 

Summary cash flow data is as follows (in thousands):

 

		Six months ended
		December 31,
		2015				2014
Net cash used in operating activities		$	(6,478	)		$	(8,465	)
Net cash provided by (used in) investing activities			4,595				(10,272	)
Net cash provided by (used in) financing activities			—				(65	)

 

      Our net use of cash in operating activities for the six months ended December 31, 2015, was primarily attributable to our net loss adjusted for non-cash items primarily due to the development of the microcutter product line and the improvements of the MicroCutter XCHANGE 30 and an increase in accounts receivable of $0.1 million due to higher product sales, offset by an increase in accrued compensation of $0.5 million relating to severance expenses, an increase in accounts payable and accrued liabilities of $0.3 million in part relating to clinical expenses for the expanded indications for use in vascular structures, and a decrease in inventories of $0.4 million due to lower sales production. Our net use of cash in operating activities for the six months ended December 31, 2014, was primarily attributable to our net loss adjusted for non-cash items primarily due to the development of the microcutter product line and commercialization efforts related to our MicroCutter XCHANGE 30, an increase in inventories of $0.3 million due to inventory management related to products shortage for MicroCutter XCHANGE 30, partially offset by a decrease in accounts receivable of $0.3 million mainly due to the temporary hold on the MicroCutter XCHANGE 30 sales.

 

      Net cash provided by investing activities for the six months ended December 31, 2015, was mainly due to the net proceeds from the sales of investments of $4.7 million, offset by capital equipment purchases of $0.1 million mainly related to our microcutter design changes. Net cash used in investing activities for the six months ended December 31, 2014, was mainly due to the net purchases of investments of $9.9 million and capital equipment purchases of $0.4 million mainly related to our microcutter design changes.

 

      Net cash used in financing activities for the six months ended December 31, 2014, was related to April 2014 offering issuance costs of $65,000.

 

 

 

We believe that our existing cash, cash equivalents and short-term investments will be sufficient to meet our anticipated cash needs to enable us to conduct our business substantially as currently conducted through at least the next 12 months. We may be able to extend this time period to the extent that we decrease our planned expenditures, or raise additional capital. 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, including the process for obtaining additional regulatory clearances and approvals for the commercial use of our microcutter products in the United States and internationally, and we could exhaust our available financial resources sooner than we currently expect.

 

In order to satisfy our longer term liquidity requirements, 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.

 

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 to which we are able to raise additional capital in any equity or debt transaction;
	●	market acceptance of our MicroCutter XCHANGE 30 in Europe and in the United States once we execute the broader commercial launch;
	●	market acceptance of our MicroCutter XCHANGE 30 cartridge and stapler in Japan once Century commercializes it;
	●	the extent of our ongoing enhancements of the MicroCutter XCHANGE 30, including alterations and post-commercialization improvements based on early adopter experience with this newly commercial product;
	●	the extent of our ongoing research and development programs and related costs, including costs related to the development of additional products and features in our planned 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 future products that we may commercialize;

	●	our level of revenues;

	●	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.

 

As part of our controlled commercial launch of the MicroCutter XCHANGE 30 in Europe and in the United States, we made our first sales in December 2012 and March 2014, respectively. We have agreements for the microcutter product line with four distributors in Europe. In addition, in August 2014, we established a subsidiary in Germany, Cardica, GmbH, to facilitate direct sale of the microcutter products. We intend to continue to make enhancements to the MicroCutter XCHANGE 30 before continuing our efforts to develop other products in our planned microcutter product line. We cannot predict when, if ever, we will generate significant commercial revenue from the sale of the MicroCutter XCHANGE 30 or any other products in our planned microcutter product line. Because we do not anticipate that we will generate sufficient product sales to achieve profitability for at least the next few years, if at all, we may 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 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 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 the 12 months, to ensure that we have sufficient capital to meet our obligations and continue on a path designed to preserve stockholder value.

 

 

 

Contractual Obligations

 

Our future contractual obligations at December 31, 2015, were as follows (in thousands):

 

Fiscal Year Ending June 30,		Operating lease obligations				Purchase commitments				Note payable, including interest				Total
2016 (Remaining six months)		$	489			$	478			$	100			$	1,067
2017 – 2018 (7/1/2016 – 6/30/2018)			2,033				—				400				2,433
2019 – 2020 (7/1/2018 – 6/30/2020)			173				—				4,050				4,223
Total		$	2,695			$	478			$	4,550			$	7,723

 

This compares to our future contractual obligations as of June 30, 2015, of $8.6 million.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

      During the six months ended December 31, 2015, 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, 2015, filed with the Securities and Exchange Commission on September 25, 2015.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Effectiveness of Disclosure Controls and Procedures

 

       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 December 31, 2015.

 

Changes in Internal Control over Financial Reporting

 

      There were no changes in our internal control over financial reporting during the quarter ended December 31, 2015, 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 internal control over financial reporting, including our disclosure controls and procedures, are designed to provide reasonable, not absolute, assurance that the objectives of our internal control over financial reporting, including 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 internal control over financial reporting, including our disclosure controls and procedures, were effective to provide reasonable assurance that the objectives of our internal control over financial reporting, including 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 currently known to us or that we currently believe are immaterial may also significantly impair our business operations. Although we have revised the text of some of the risk factors set forth below, the underlying risks have not changed materially from the risks described in our Annual Report on Form 10-K for the fiscal year ended June 30, 2015, other than the ones that we have marked with an asterisk (*).

 

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.

 

We have incurred annual net losses since our inception in October 1997.  As of December 31, 2015, our accumulated deficit was approximately $198.4 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, as well as increased sales of our commercially launched MicroCutter XCHANGE 30 in Europe and in the United States.

 

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

 

	●	achievement of broad acceptance for the MicroCutter XCHANGE 30 in Europe and in the United States, as well as any future products that we may commercialize;
	●	achievement of international and U.S. regulatory clearance or approval for additional products; and

●

successful sales, manufacturing, marketing and distribution of our products.

 

Historically, we have generated revenues primarily from the sale of automated anastomotic systems; however, we started generating revenues from the commercial sales of the MicroCutter XCHANGE 30 in Europe in December 2012, and in the United States in March 2014, and through December 31, 2015, we have generated $1.7 million of net product revenues from the commercial sales of the MicroCutter XCHANGE 30. Sales of our products, license and development and royalty activities generated revenues of only $1.4 million and $1.7 million for the six month periods ended December 31, 2015 and 2014, respectively. Sales of our products, license and development and royalty activities generated revenues of and $2.9 million, $3.6 million and $3.5 million for fiscal years 2015, 2014 and 2013, respectively. During the three months ended March 31, 2015, we eliminated eight sales representatives, three of whom were related to selling our automated anastomotic systems and five were for microcutter products. We will continue to sell our automated anastomotic systems internationally through distributors and through independent sales representatives in the United States. We continue to sell our microcutter products only to a select number of key hospitals and through members of Novation, a national health care services company that we recently signed an agreement with to sell in the United States and through distributors in Europe before we broadly commercially re-launch our improved MicroCutter XCHANGE 30 combo device. As such, we do not anticipate that we will generate significantly higher products sales in the next few quarters.

 

Our cost of product sales were 135% and 152% of our net product sales for the six month periods ended December 31, 2015 and 2014, respectively, and 145%, 136% and 117% of our net product sales for fiscal years 2015, 2014 and 2013, respectively. We expect slightly higher cost of product sales relative to product sales for the next few quarters. If, over the long term, we are unable to reduce our cost of producing goods and expenses relative to our net revenue, we will 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.

 

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

 

      An existing debt arrangement with our current distributor and lender Century under which, as of December 31, 2015, $4.0 million of principal is outstanding, as well as potential future arrangements with other lenders, allow or may allow these lenders to have priority over our stockholders to our assets, including our intellectual property should we be in default of our obligations to the lenders. The proceeds of any sale or liquidation of our assets under these circumstances would be applied first to any of our debt obligations.

 

 

 

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 trading volume of our stock;
	●	the extent to which we are able to raise additional capital in any equity or debt transaction;
	●	market acceptance of our MicroCutter XCHANGE 30 in Europe and the United States once we execute the broader commercial launch;
	●	market acceptance of our MicroCutter XCHANGE 30 cartridge and stapler in Japan once Century commercializes it;
	●	the extent of our ongoing enhancements of the MicroCutter XCHANGE 30, including alterations and post-commercialization improvements based on early adopter experience with this newly commercial product;
	●	the extent of our ongoing research and development programs and related costs, including costs related to the development of additional products and features in our planned 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 future products that we may commercialize;
	●	our level of revenues;
	●	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.

 

   Quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially.

 

Risks Related to Our Business

 

We have temporarily suspended our controlled commercial launch of our MicroCutter XCHANGE 30 combo device to focus on improving performance based on surgeon feedback, and if we are not able to improve performance then we may not be able to recommence commercial sales of our MicroCutter XCHANGE 30 combo device.

 

We have expended significant time, money and effort in the development of our microcutter product line and, in particular, our MicroCutter XCHANGE 30 combo device, a device that will accommodate thicker tissue ranges requiring deployment of both white and blue cartridges, which we commercially launched in Europe in December 2012, and in the United States in March 2014 in a controlled commercial launch. In November 2014, we shifted our focus to improved performance of the MicroCutter XCHANGE 30 combo device based on surgeon feedback, and temporarily suspended our controlled commercial launch. In November 2015, we voluntary removed our blue cartridges from the market. We expect that we will need to continue to make enhancements and improvements to the MicroCutter XCHANGE 30 combo device. If we are not successful in improving the performance of the MicroCutter XCHANGE 30 combo device to meet surgeon expectations and achieving market adoption of the MicroCutter XCHANGE 30 in Europe and the United States, we may never generate substantial revenue from this product line, and our business, financial condition and results of operations would be materially and adversely affected, and we may be forced to cease operations.

 

 

 

The current unit costs for our products are very high, and if we are not able to bring them down we will suffer from price competition and may not become profitable.

 

The current unit costs for our products, based on limited manufacturing volumes, are very high and for the MicroCutter XCHANGE 30 are in excess of revenues per unit. Our cost of product sales were 135% and 152% of our net product sales for the six month periods ended December 31, 2015 and 2014, respectively, and 145%, 136% and 117% of our net product sales for fiscal years 2015, 2014 and 2013, respectively. 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.

 

We are dependent upon the commercial success of our MicroCutter XCHANGE 30 in Europe and in the United States which, if not successful, could prevent us from successfully commercializing our other potential future microcutter products.

 

We have expended significant time, money and effort in the development of our microcutter product line and, in particular, our MicroCutter XCHANGE 30 combo device. If we are not successful in improving the performance of the MicroCutter XCHANGE 30 and achieving market adoption of the MicroCutter XCHANGE 30 combo device in Europe and the United States, we may never generate substantial revenue from this product line, and our business, financial condition and results of operations would be materially and adversely affected, and we may be forced to cease operations. We anticipate that our ability to increase our revenue significantly will depend on the continued adoption of the MicroCutter XCHANGE 30 in Europe, and adoption of the MicroCutter XCHANGE 30 in the United States, and our ability to expand our microcutter product line.

 

A number of factors will influence our ability to gain clinical adoption of the MicroCutter XCHANGE 30 and any future microcutter products:

 

●

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, now part of Medtronic, 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;

 

●

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;

 

●

if physicians are not able to use our microcutter products properly, or use them on tissue thicknesses for which they are not designed, adoption of our microcutter products may be negatively impacted;

 

●

any recalls may impact physicians’ and hospitals’ perception of our products;

 

●

we will need to demonstrate the cost-effectiveness of our products, including against branded, patent protected products, as well as any generic stapling products similar to currently commercially available products following expiration of patents on our competitors’ products;

 

●

our ability to reduce our costs of manufacturing the MicroCutter XCHANGE 30;

 

●

our ability to increase our sales force; and

 

●

our ability to address the need for improvements in response to feedback from physicians, if any.

 

We cannot predict when, if ever, we will generate significant commercial revenue from the sale of the MicroCutter XCHANGE 30 or any other potential future products or anticipated features in our microcutter product line. If we fail to achieve significant growth in market adoption of the MicroCutter XCHANGE 30, our ability to develop our other planned microcutter products, if at all, will be delayed, which would further harm our business.

 

 

 

We are dependent upon the success of our C-Port and PAS-Port systems to generate revenue in the near term, and sales of our C-Port and PAS-Port systems have not met the levels that we had anticipated and if we are unable to increase sales of our C-Port and PAS-Port systems, our business will be harmed.

 

We have expended significant time, money and effort in the development of our current commercial products used by cardiac surgeons to perform coronary bypass surgery, the C-Port and the PAS-Port systems. We commenced sales of our C-Port xA system in December 2006 (after introduction of our original C-Port system in January 2006) and our C-Port Flex A in April 2007. We commenced U.S. sales of our PAS-Port system in September 2008. To date, our anastomosis products have not gained, and we cannot assure you that our anastomosis 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 anastomosis 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. Further, if physicians have negative experiences with our anastomosis products in surgical procedures, whether due to the fault of our anastomosis products or the physician, the adoption of these products could be negatively impacted.

 

To date, we have generated revenues almost exclusively from the sale of automated anastomotic systems, and started generating minimal revenues from the commercial sales of the MicroCutter XCHANGE 30 in Europe in December 2012 and in the United States in March 2014, following our FDA clearances for the MicroCutter XCHANGE 30 with blue staple cartridge in January 2014, and for the white staple cartridge in February 2014. We will continue to sell our automated anastomotic systems internationally through distributors and sell our automated anastomotic systems through independent sales representatives in the United States. We continue to only sell our microcutter products to a select number of key hospitals and through members of Novation, a national health care services company that we recently signed an agreement with to sell in the United States and through distributors in Europe before we commercially re-launch our improved MicroCutter XCHANGE 30. 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.   

 

*The limitations on the indications for use for the MicroCutter XCHANGE 30 will limit our promotional activities, which could inhibit our success in commercializing the MicroCutter XCHANGE 30 and could expose us to potential off-label risks or adverse events, including fines, penalties, injunctions or product liability claims if our products are used off-label or we are determined to be promoting the use of our products for unapproved or “off-label” uses.

 

Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of the off-label use of our products. Healthcare providers may use our products off-label, as the FDA and foreign regulatory authorities do not restrict or regulate a physician’s choice of treatment within the practice of medicine. However, if the FDA or foreign regulatory authority determines that our promotional materials or training constitutes promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine and 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. Although our policy is to refrain from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and could result in substantial damage awards against us and harm our reputation.

 

We have limited clinical data regarding the safety and efficacy of the MicroCutter XCHANGE 30. 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 the MicroCutter XCHANGE 30, and any future microcutter products, 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 products 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.

 

 

 

If the FDA determines that our C-Port systems or PAS-Port systems do not perform as anticipated, or if the FDA identifies new concerns related to the safety and effectiveness of these products, we may be required to withdraw these products, which could harm our business.

 

As a condition of its U.S market clearance, the C-Port system is subject to a mandatory Post Market Surveillance order under 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.

 

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. 

 

We have limited experience as a company in the sale, marketing and distribution of our products. To commercialize the MicroCutter XCHANGE 30 in the United States, we will have to improve performance of the MicroCutter XCHANGE 30 combo device based on surgeon feedback and build a sales force. Century is responsible for marketing and commercialization of cardiac and microcutter products in Japan. To promote our current and future products in the United States, Canada and Europe, we must develop 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 or independent sales representatives for substantially all of our 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.

 

Our products require training to use, and if physicians are not willing to undergo that training, or if they undergo the training but do not use our products properly, or for other reasons, our products may not gain any significant degree of market acceptance and a lack of market acceptance would have a material adverse effect on our business.

 

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 use our products improperly due to unfamiliarity with the products, or may use the MicroCutter XCHANGE 30 on tissues with thicknesses greater than the specifications for the MicroCutter XCHANGE 30. If this were to happen, the MicroCutter XCHANGE 30 may not function as desired for the physicians and could be reported as a problem with the MicroCutter XCHANGE 30 rather than the physicians using it improperly, which could damage the reputation of the MicroCutter XCHANGE 30 and cause other physicians to consider the MicroCutter XCHANGE 30 to be not a safe product. Further, physicians may elect not to use our products for a number of other 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.

 

 

 

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

 

While we continue to improve performance of the MicroCutter XCHANGE 30 combo device based on surgeon feedback and make modifications and add features to our MicroCutter XCHANGE 30, we have suspended development of other potential products in our planned microcutter product line until the development and commercialization of the MicroCutter XCHANGE 30 have been completed. Significant additional research and development and financial resources will be required to continue the development of the other products in our planned product line into commercially viable products and to obtain necessary regulatory clearances 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 our other potential microcutter products. Further, even if we do successfully develop any of these microcutter products, we may not be successful in commercializing them for any number of reasons, including failure or delays in obtaining regulatory clearances, or if surgeons do not perceive the benefits of these products to be significantly greater than current established products. We may also face additional competition from branded, patent-protected products, as well as generic stapling products similar to currently commercially available products following expiration of patents on our competitors’ products, which could create greater price competition and decrease the revenue potential of our microcutter products. Our failure to successfully develop our other microcutter products and improvements to our MicroCutter XCHANGE 30 would have a material adverse effect on our business, growth prospects and ability to raise additional capital.

 

Healthcare reform measures could hinder or prevent the commercial success of our products.

 

The pricing and reimbursement environment may change in the future and become more challenging as a result of any of one several possible regulatory developments, including policies advanced by the United States government, new healthcare legislation or fiscal challenges faced by government health administration authorities. The U.S. government has shown significant interest in pursuing healthcare “reform” and reducing healthcare costs. For example, aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, were implemented starting in 2013. Any government-adopted reform measures that decrease the amount of reimbursement available from governmental and other third-party payers, and could potentially adversely affect our business.

 

Our PAS-Port and C-Port systems, our MicroCutter XCHANGE 30, and future products may face future development and regulatory difficulties and limitations on use.

 

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 and PAS-Port systems, may not obtain regulatory clearances 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).  

 

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.   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 clearance or 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 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 any 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.

 

 

 

The European Union, or 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 the two initial microcutter surgical cutting and stapling devices that we have developed, the MicroCutter XCHANGE 30 and the MicroCutter XPRESS 30. 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 to 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. 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, 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. 

 

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 submissions for and 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 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 federal, 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 International Standards Organization, or 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 System Regulation, or 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 the MicroCutter XCHANGE 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 the 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.

 

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.

 

 

 

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 clinical trials that we may conduct 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;
	●	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.

      

Clinical trials sometimes experience delays related to outcomes experienced during the course of the trials, which may result in a 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 upon which 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, any clinical trials that we may conduct 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.

 

 

  

Because two customers account for a substantial portion of our product sales, the loss of these significant customers would cause a substantial decline in our revenue.

 

We derive a substantial portion of our revenue from sales of automated anastomosis system to Century, our distributor in Japan, and to Herz-Und Diabeteszentrum in Germany. The loss of either of these customers would cause a decrease in revenue and, consequently, an increase in net loss. For the six months ended December 31, 2015 and 2014, sales of automated anastomosis system to Century accounted for approximately 30% and 25%, respectively, of our total product sales. For the six months ended December 31, 2015 and 2014, sales of automated anastomosis system to Herz-Und Diabeteszentrum accounted for approximately 11% and 7%, respectively, of our total product sales. We expect these customers will continue to account for a substantial portion of our sales in the near term. As a result, if we lose these customers, 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.

 

We may require substantial additional capital to continue operations as currently conducted and as proposed to be conducted.

 

As of December 31, 2015, we had approximately $18.5 million of cash, cash equivalents and short-term investments and $4.0 million of debt principal outstanding. We believe that our existing cash, cash equivalents, short-term and long-term investments will be sufficient to meet our anticipated cash needs to enable us to conduct our business substantially as currently conducted for at least the next 12 months. We may be able to extend this time period to the extent that we decrease our planned expenditures, or raise additional capital. We have based our estimate as to the sufficiency of our cash resources on assumptions that may prove to be wrong.

 

Because we do not anticipate that we will generate sufficient product sales to achieve profitability for the next several years, if at all, we may need to raise substantial additional capital to finance our operations in the future. 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. If additional funds are raised through the issuance of debt securities, these securities could have rights senior to those associated with our Series A preferred stock and 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. Failure to raise additional capital may result in our ceasing to be publicly traded or ceasing operations. 

 

 

 

If our competitors for our MicroCutter XCHANGE 30 have products that are marketed more effectively or are demonstrated to be safer or more effective than ours, our commercial opportunity for our MicroCutter XCHANGE 30 and any future microcutter products will be reduced or eliminated and our business will be harmed.

 

Although we have commercially launched the MicroCutter XCHANGE 30 in Europe and in the United States, we have generated minimal revenues from this launch through December 31, 2015. We only received the FDA 510(k) clearances for the MicroCutter XCHANGE 30 and blue staple cartridge in January 2014, and for the white staple cartridge in February 2014, for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in the small and large intestine, as well as the transection of the appendix. To further expand the use of the MicroCutter XCHANGE 30, we submitted a 510(k) Premarket Notification to the FDA in April 2015, to expand the indications for use to include vascular structures and recently received FDA 510(k) clearance for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures. The MicroCutter XCHANGE 30 competes, and the MicroCutter XCHANGE 45 and other planned improvements, features and 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 against laparoscopic stapling and sealing devices currently marketed around the world. We believe the principal competitive factors in the market for laparoscopic staplers include:

 

	●	reduced product size;
	●	ease of use;
	●	product quality and reliability;
	●	device cost-effectiveness;
	●	degree of articulation;
	●	surgeon relationships; and
	●	sales and marketing capabilities.

 

Two large competitors, Ethicon Endo-Surgery, part of Johnson & Johnson, and Covidien, now part of Medtronic, 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 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. A private company, JustRight Surgical, LLC, is developing smaller surgical instruments and has announced FDA 510(k) clearance for a 5 millimeter stapler that could be considered competitive with our stapling products, but is more limited in availability of staple sizes and articulation compared to the MicroCutter XCHANGE 30. Further, we may also face additional competition from generic surgical stapling products similar to currently commercially available products following expiration of patents on our competitors’ products.

 

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

 

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:

 

●

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 effect 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 non-competitive. 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.

 

      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 products for use in clinical studies and 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. Any shipment delays could harm perception of our products and have a material adverse impact on our results of operations.

 

*If we fail to retain key personnel, or to retain 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. We have had turnover in a number of senior executive positions, including our chief executive officer, our vice president of research and development, and our vice president of operations. Most recently, we hired a new chief operating officer who started on November 16, 2015, an executive officer on October 15, 2015, and a vice president of operations in May 2015. These transitions, along with the hiring of other new senior managers, may be disruptive to our business, and if we are unable to execute an orderly transition, our revenue, operating results and financial condition may be adversely impacted. Future changes to our executive and senior management teams, including new executive hires or departures, could cause further disruption to the business and have a negative impact on our operating performance, while these operational areas are in transition. Competition for qualified executive and other management personnel is intense, and we may not be successful in attracting or retaining such personnel. 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.

 

      As of December 31, 2015, we had 47 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.

 

      While we are not aware of any patents issued to third parties that contain subject matter materially related to our technology, there may be patents held by third parties of which we are not aware that contain subject matter materially related to our technology. We cannot assure you that 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.

 

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 non-competitive. Additionally, new, less invasive surgical procedures and medications could be developed that replace or reduce the importance of current procedures that use or could 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 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 are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, marketing expenditure tracking and disclosure (or “sunshine”) laws, health information privacy and security laws, and consumer protection laws. If we are unable to comply, or have not fully complied, with such laws, we could face criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

 

Our operations may be directly, or indirectly, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. These laws may impact, among other things, our current activities with physicians, including consulting arrangements, as well as proposed sales, marketing and educational activities. In addition, we may be subject to patient privacy regulation by the federal government and by the US states and foreign jurisdictions in which we conduct our business. The laws that may affect our ability to operate include, but are not limited to:

 

●

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which payment may be made under a federal health care program, such as the Medicare and Medicaid programs;

 

●

federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;

 

●

federal criminal statutes created under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;

 

 

 

●

HIPAA, as amended by the Health Information Technology and Clinical Health Act of 2009 (HITECH), and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;

 

●

state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

 

●

the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals);

 

●

federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.; and

 

●

state and federal marketing expenditure tracking and reporting laws, which generally require certain types of expenditures in the United States to be tracked and reported (compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities).

 

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, possible exclusion from Medicare, Medicaid and other government healthcare programs, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

 

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 MicroCutter XCHANGE 30, C-Port and PAS-Port systems and in Europe. 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 $10.0 million, 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.

 

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 any 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. 

 

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 financial results and industry in general, which could harm our business and the value of our stock.

 

Effective January 1, 2013, U.S. health care law reforms under the 2010 Affordable Care Act imposed 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. 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 materialize, then our business may be harmed and the value of our common stock could decline. We cannot assure you that the Affordable Care Act, as currently enacted or as amended in the future, will not adversely affect our business and financial results, and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

 

 

 

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

 

Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an "ownership change," generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation's ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income may be limited. If we undergo such an ownership change, the limitation may result in the expiration of our net operating losses and credits before we can use them, which could potentially result in increased future tax liability to us.  We may experience ownership changes in the future as a result of future offerings of our stock and other subsequent shifts in our stock ownership. As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards to offset United States federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us.

 

Risks Related to Our Common Stock

 

*Our common stock may be delisting from the NASDAQ Capital Market.

 

On December 8, 2015, we received a letter from the staff of The NASDAQ Stock Market LLC stating that we have not been able to regain compliance with the Nasdaq Listing Rule requiring that we maintain a closing bid price for our common stock of at least $1.00 per share, and that our common stock would be delisted on December 17, 2015, unless we requested an appeal of the staff’s determination to the Hearings Panel. We requested an appeal to the hearings Panel of the staff’s determination, which stayed the delisting of Cardica’s common stock pending the hearing panel’s decision. We are in the process of seeking to cure the deficiency by effecting a reverse stock split. If it appears to the NASDAQ staff that we will not be able to cure the deficiency, or if we do not meet the other listing standards, NASDAQ could provide notice that our common stock will become subject to delisting. We cannot guarantee that our stock price will meet the listing requirements and therefore our common stock may be subject to delisting.  If our common stock is delisted, this would, among other things, substantially impair our ability to raise additional funds and could result in a loss of institutional investor interest and fewer development opportunities for us.

 

The conversion of shares of Series A preferred stock into common stock, or the perception that such conversions may occur, could cause the market price of our common stock to decline. 

 

We currently have 191,474 shares of our Series A preferred stock outstanding. Each share of our Series A preferred stock is convertible into 100 shares of our common stock at any time at the option of the holder, subject to certain limitations. The conversion of substantial amounts of our Series A preferred stock would result in the issuance by us of a substantial number of additional shares of our common stock, which, subject to certain limitations, could be traded publicly. Such conversions, or the perception that such conversions may occur, could cause the market price of our common stock to decline.

 

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;
	●	our ability to maintain our listing on the NASDAQ Capital Market;
	●	perceptions that we may not be able to raise capital as needed, or that investors will be substantially diluted if we do raise capital;

 

●

market acceptance and adoption of our products;

 

●

regulatory clearance or approvals of or other regulatory developments with respect 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;

 

	●	developments in our industry; and
	●	actions by stockholder activists.

        

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.

  

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 41% of our outstanding common stock as of December 31, 2015. In addition, two stockholders collectively hold all of our Series A preferred stock and may convert those shares into 19,147,400 shares of our common stock and, if they were to convert all of the shares of our Series A preferred stock, our executive officers and directors and their affiliates, together with other stockholders that own 5% or more of our outstanding common stock, would beneficially own approximately 51% of our outstanding common stock. Accordingly, these stockholders have significant influence over the outcome of corporate actions requiring stockholder approval. 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 Commission 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 common 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 commercial launch 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.

 

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 stockholders of the opportunity to sell their shares to potential acquirers 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 Capital Market and the market for medical device companies in particular, have 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.

 

ITEM 6. EXHIBITS

 

See the Exhibit Index which follows the signature page of this Quarterly Report on Form 10-Q, which is incorporated here by reference.

 

 

 

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: February 10, 2016	/s/ Julian Nickolchev
	Julian Nickolchev
	President, Chief Executive Officer and Director,  (Principal Executive Officer)
Date: February 10, 2016	/s/ Robert Y. Newell
	Robert Y. Newell
	Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer)

 

 

   

INDEX TO EXHIBITS 

    

---

  

Incorporation by Reference

Exhibit Number

Exhibit Description

Form

File Number

Exhibit/ Appendix Reference

Filing Date

Filed Herewith

3.1

Amended and Restated Certificate of Incorporation of Cardica, Inc.

S-1

333-129497

3.2

01/13/2006

3.2

Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc.

10-Q

000-51772

3.3

11/15/2010

3.3

Certificate of Correction of Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc.

8-K

000-51772

3.2

11/16/2010

3.4

Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc.

8-K

000-51772

3.1

11/19/2012

3.5

Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc.

8-K

000-51772

3.1

11/15/2013

3.6

Certificate of Designations of Series A Preferred Stock.

S-1

333-194039

3.6

04/14/2014

3.7

Bylaws of the Registrant as currently in effect.

8-K

000-51772

3.2

08/19/2008

4.1

Specimen Common Stock certificate of the Registrant.

S-1

333-129497

3.5

02/01/2006

10.1

Employment Agreement, dated October 2, 2015, with Julian Nikolchev

10-Q

000-51772

10.1

11/12/2015

10.2

Cardica, Inc. Non-Employee Director Compensation.

X

10.3

Separation Agreement with Bernard Hausen, dated September 16, 2015

10-Q

000-51772

10.4

11/12/2015

10.4

Cardica, Inc, Inducement Plan

10-Q

000-51772

10.5

11/12/2015

10.5

Employment Agreement, dated October 28, 2015, with Thomas J. Palermo

X

10.6

Amendment to License Agreement and Potential Development Agreement, dated as of December 30, 2015, between Cardica, Inc. and Intuitive Surgical Operations, Inc.*

X

31.1

Certification required by Rule 13a-14(a) or Rule 15d-14(a).

X

31.2

Certification required by Rule 13a-14(a) or Rule 15d-14(a).

X

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).

X

101.INS

XBRL Instance Document

X

101.SCH

XBRL Taxonomy Extension Schema Document

X

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document

X

101.DEF

XBRL Taxonomy Extension Definition Linkbase

X

101.LAB

XBRL Taxonomy Extension Labels Linkbase Document

X

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document

X

* Confidential treatment has been requested for portions of this exhibit.

---

 

45 

Exhibit 10.2

 

NON-EMPLOYEE DIRECTOR COMPENSATION

  

Cash compensation for non-employee directors is as follows:

 

Position		Annual Retainer
All Members (Base)		$	25,000
Additional Retainers
Board Chairman (1)		$	20,000
Audit Committee Chairman		$	15,000
Compensation Committee Chairman		$	10,000
Audit Committee Member (other than Chairman)		$	5,000
Compensation Committee Member (other than Chairman)		$	5,000

 

(1)

Increased from $15,000 on March 11, 2015.

  

Equity compensation for non-employee directors is as follows:

 

Annual Grants. Each year, immediately following Cardica, Inc.’s Annual Meeting of Stockholders, each non-employee director will automatically be granted an option to purchase 150,000 shares of the Company’s common stock. Each such option will vest monthly over the ensuing year.

 

Initial Grants. Automatically upon becoming a director, any new non-employee director shall be granted an option to purchase 225,000 shares of Cardica, Inc.’s common stock, vesting monthly over three years.

 

Exhibit 10.5

 

 

 

October 28, 2015

 

 

Thomas J. Palermo

327 Ascente Commons

San Jose, CA 95125

 

 

Re:     Offer Letter and Employment Terms

 

Dear Tom:

 

We are excited that you are considering joining the Cardica team. We know your abilities and are confident that you will continue to flourish at and contribute to Cardica, Inc (the “Company”). On behalf of the Company, I am pleased to offer you the position of Chief Operating Officer. Your employment terms and other matters are described below.

 

As a Chief Operating Officer, your duties will include helping to translate our business priorities into operational tactics to achieve financial and strategic goals. You will have responsibility for and oversee Cardica’s research and development, operations/manufacturing and regulatory affairs. You will work at the Company’s Redwood City offices and report to me.

 

Your base salary rate of pay will be Twenty Five Thousand Eight Hundred Thirty Four dollars ($25,834.00) per month; less payroll deductions and all required withholdings, which will be paid semi-monthly. As a full-time, salaried, exempt employee you will be expected to work the Company’s normal business hours and additional hours as required by your job duties, and you will not be eligible for overtime pay.

 

You will be eligible to participate in the Company’s standard employee benefit plans in accordance with the terms and conditions of the plans and applicable policies which may be in effect from time to time and provided by the Company to its employees generally, including health insurance, life insurance/AD&D and long-term/short-term disability insurance, flexible spending account, employee assistance program, 401(k) plan, health club, paid time off, and holidays. Please note that the Company may, from time to time in its discretion, change your benefits, compensation, title, duties, reporting relationship and work location.

  

 

 

 

In addition to your base pay and benefits, your compensation includes the following components:

 

Annual Performance Bonus Plan: In the position of Chief Operating Officer, you are eligible to participate in Cardica’s annual performance-based Executive Bonus Plan, which runs concurrently with our fiscal year of July - June. The current target bonus for this position is up to 35% of your annual base salary. This bonus is based in part on the successful accomplishment of overall company objectives. The bonus amount will be subject to standard payroll deductions and all required withholdings, and will be paid at the end of the fiscal year.

 

Stock Options. Subject to approval by the Company’s Board of Directors (the “Board”), the Company will grant you an incentive stock option to purchase 1,630,400 shares of the Company’s common stock (the “Option”) pursuant to the Company’s 2016 Stock Incentive Plan (the “Plan”), at an exercise price equal to the fair market value of the common stock, as determined by the Board, at the time of grant. The Option will be subject to the following vesting schedule: 25% of the shares shall vest on the one year anniversary of your hire date, provided you are still employed by the Company as of such date; thereafter, 1/48 of the shares shall vest monthly until either (i) you cease to provide services to the Company for any reason, or (ii) the Option becomes fully vested. The Option will be governed in full by the terms and conditions of the Plan and your individual Option agreement.

 

As a condition of employment, you will be required to abide by Company rules and regulations, and to sign and comply with the Company’s Proprietary Information and Inventions Agreement attached hereto as Exhibit A (the “Employee Proprietary Agreement”). Further, you agree to devote all of your business time, energy, and skill to the affairs of the Company, and not to accept or engage in outside employment or business activities without the advance written consent of the Board of Directors. You may also be required to from time to time confirm in writing that you have read and understand certain policies, and the Company reserves the right to modify or alter its policies in its discretion.

 

Notwithstanding the foregoing, you are eligible to participate in Cardica’s “Change in Control Severance Benefit Plan”, attached as Exhibit B.

 

In your work for the Company, you will be expected not to use or disclose any confidential information or materials, including trade secrets, of any former employer or other third party to whom you have an obligation of confidentiality, and not to violate any lawful agreement that you may have with any third party. Rather, you will be expected to use only that information which is generally known and used by persons with training and experience comparable to your own, which is common knowledge in the industry or otherwise legally in the public domain, or which is otherwise provided or developed by the Company. By signing this letter, you represent that you are able to perform your job duties within these guidelines, and you are not in unauthorized possession of any confidential documents or other property of any former employer or other third party. In addition, you represent that you have disclosed to the Company in writing any agreement you may have with any third party (e.g., a former employer) which may limit your abilities to perform your duties to the Company, or which otherwise could create a conflict of interest with the Company.

 

 

  

 

 

Your employment relationship with the Company is at-will. Accordingly, you may terminate your employment with the Company at any time and for any reason whatsoever. Likewise, the Company may terminate your employment at any time, and with or without cause or advance notice. This at-will employment relationship cannot be changed except in writing signed by you and a duly authorized officer of the Company.

 

To ensure the timely and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company agree that any and all disputes, claims, or causes of action arising from or relating to the enforcement, breach, performance, negotiation, execution, or interpretation of this Agreement, your employment, or the termination of your employment, including but not limited to statutory claims, shall be resolved pursuant to the Federal Arbitration Act, 9 U.S.C. §1-16, and to the fullest extent permitted by law by final, binding and confidential arbitration, by a single arbitrator, in San Francisco, California, conducted by JAMS, Inc. (“JAMS”) under the then applicable JAMS rules (which can be found at the following web address: http://www.jamsadr.com/rulesclauses). By agreeing to this arbitration procedure, both you and the Company waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding. The Company acknowledges that you will have the right to be represented by legal counsel at any arbitration proceeding. The arbitrator shall: (a) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (b) issue a written arbitration decision, to include the arbitrator’s essential findings and conclusions and a statement of the award. The arbitrator shall be authorized to award any or all remedies that you or the Company would be entitled to seek in a court of law. The Company shall pay all JAMS’ arbitration fees in excess of the amount of court fees that would be required of you if the dispute were decided in a court of law. Nothing in this Agreement is intended to prevent either you or the Company from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration. Any awards or orders in such arbitrations may be entered and enforced as judgments in the federal and state courts of any competent jurisdiction.

 

This letter, together with Exhibit A & Exhibit B, forms the complete statement of your employment agreement with the Company. The employment terms in this letter supersede any other agreements or promises made to you by anyone, whether oral or written. Changes in your employment terms, other than those changes expressly reserved to the Company’s discretion in this letter, require a written modification signed by you and a duly authorized officer of the Company. This offer is subject to a background check clearance and satisfactory proof of your right to work in the United States, and as required by law, you must provide the necessary documentation within 72 hours after you begin working. You agree to assist as needed and to complete any documentation at the Company’s request to meet these conditions.

 

 

 

 

This letter agreement shall be construed and enforced in accordance with the laws of the State of California without regard to conflicts of law principles. This letter agreement may be executed in counterparts which shall be deemed to be part of one original, and facsimile and electronic image copies of signatures shall be equivalent to original signatures.

 

Please sign and date this letter and the attached Employee Proprietary Agreement, and return it to me by November 2 if you wish to accept this offer of employment at the Company under the terms of this letter. If you accept our offer, we would like you to start on November 16, 2015.

 

Everyone involved with the enterprise believes that the Company will thrive and grow in the years to come. We look forward to working with you in this unique growth opportunity and in having you join our team. If you have any questions regarding this offer, please call me or Bob Newell at (650) 331-7133

 

Regards,

 

/s/ Julian Nikolchev

 

Julian Nikolchev

President & CEO

 

Accepted:
/s/ Thomas J. Palermo
Thomas J. Palermo
November 2, 2015
Date Signed
November 16, 2015
Start Date

 

Attachments:

 

Exhibit A: Proprietary Information and Inventions Agreement

Exhibit B: Change of Control Severance Plan

 

 

 

 

CARDICA, INC.

 

EMPLOYEE PROPRIETARY INFORMATION AND INVENTIONS AGREEMENT

 

In consideration of my employment or continued employment by Cardica, Inc. (the “Company”), and the compensation now and hereafter paid to me, I hereby agree as follows:

 

1.     Nondisclosure.

 

1.1.     Recognition of the Company’s Rights; Nondisclosure. At all times during my employment and thereafter, I will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information (defined below), except as such disclosure, use or publication may be required in connection with my work for the Company. I hereby assign to the Company any rights I may have or acquire in such Proprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns.

 

1.2.     Proprietary Information. The term “Proprietary Information” shall mean any and all confidential and/or proprietary knowledge, data or information of the Company. By way of illustration but not limitation, “Proprietary Information” includes (a) information relating to products, processes, know how, designs, drawings, clinical data, test data, formulas, methods, samples, development or experimental work, improvements, discoveries (hereinafter collectively referred to as “Inventions”); (b) plans for research, new products, manufacturing, marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers; and (c) information regarding the skills and compensation of other employees of the Company. Notwithstanding the foregoing, it is understood that, at all such times, I am free to use information which is generally known in the trade or industry, which is not gained as a result of a breach of this Agreement, and my own skill, knowledge, know-how and experience to whatever extent and in whichever way I wish.

 

1.3.     Third Party Information. I understand, in addition, that the Company has received and in the future will receive from third parties confidential or proprietary information (“Third Party Information”) subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in connection with their work for the Company) or use, except in connection with my work for the Company, Third Party Information unless expressly authorized in writing by an officer of the Company.

 

1.4.     No Improper Use of Information of Prior Employers and Others. During my employment by the Company, I will not improperly use or disclose any confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation of confidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person.

 

2.	Assignment of Inventions.

 

2.1.     Proprietary Rights. The term “Proprietary Rights” shall mean all trade secret, patent, copyright, trademark, know-how, mask work and other intellectual property rights throughout the world.

 

2.2.     Prior Inventions. Except as set forth in that certain Technology Transfer Agreement between the Company and me dated _________________________, Inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with the Company are excluded from the scope of this Agreement. To preclude any possible uncertainty, I have set forth on Exhibit A-1 (Prior Inventions) attached hereto a complete list of all Inventions that I have, alone or jointly with others, conceived, developed or reduced to practice prior to the commencement of my employment with the Company, that I consider to be my property or the property of third parties and that I wish to have excluded from the scope of this Agreement (collectively referred to as “Prior Inventions”). If disclosure of any such Prior Inventions would cause me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit A-1 but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. A space is provided on Exhibit A-1 for such purpose. If no such disclosure is attached, I represent that there are no Prior Inventions. If, in the course of my employment with the Company, I incorporate a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, worldwide license (with rights to sublicense through multiple tiers of sublicensees) to make, have made, modify, use and sell such Prior Invention. Notwithstanding the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions (as defined below), product, process or machine without the Company’s prior written consent.

 

 

 

 

 

2.3.     Assignment of Inventions. Subject to Sections 2.4 and 2.6, I hereby assign and agree to assign in the future (when any such Inventions or Proprietary Rights are first reduced to practice or first fixed in a tangible medium, as applicable) to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company. Inventions assigned to the Company, or to a third party as directed by the Company pursuant to this Section 2, are hereinafter referred to as “Company Inventions”.

 

2.4.     Nonassignable Inventions. I recognize that, in the event of a specifically applicable state law, regulation, rule, or public policy (“Specific Inventions Law”), this Agreement will not require assignment of any invention which qualifies fully for protection under a Specific Inventions Law by virtue of the fact that any such invention was, for example, developed entirely on my own time without using the Company’s equipment, supplies, facilities, or trade secrets and neither related to the Company’s actual or anticipated business, research or development, nor resulted from work performed by me for the Company. In the absence of a Specific Invention Law, the preceding sentence will not apply.

 

2.5.     Obligation to Keep Company Informed. During the period of my employment and for six (6) months after termination of my employment with the Company, I will promptly disclose to the Company fully and in writing all Inventions authored, conceived or reduced to practice by me, either alone or jointly with others. In addition, I will promptly disclose to the Company all patent applications filed by me or on my behalf within a year after termination of employment. At the time of each such disclosure, I will advise the Company in writing of any Inventions that I believe fully qualify for protection under the provisions of a Specific Inventions law; and I will at that time provide to the Company in writing all evidence necessary to substantiate that belief. The Company will keep in confidence and will not use for any purpose or disclose to third parties without my consent any confidential information disclosed in writing to the Company pursuant to this Agreement relating to Inventions that qualify fully for protection under a Specific Inventions Law.

 

2.6.     Government or Third Party. I also agree to assign all my right, title and interest in and to any particular Company Invention to a third party, including without limitation the United States, as directed by the Company.

 

 

 

 

2.7.     Works for Hire. I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my employment and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C., Section 101).

 

2.8.     Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, United States and foreign Proprietary rights relating to Company Inventions in any and all countries. To that end, I will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute, verify and deliver assignments of such Proprietary Rights to the Company or its designee. My obligation to assist the Company with respect to Proprietary Rights relating to such Company Inventions in any and all countries shall continue beyond the termination of my employment, but the Company shall compensate me at a reasonable rate after my termination for the time actually spent by me at the Company’s request on such assistance.

 

2.9.     Execution of Documents. In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specified in the preceding paragraph, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney-in-fact, which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any and all claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned hereunder to the Company.

 

3.     Records. I agree to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may be required by the Company) of all Proprietary Information developed by me and all Inventions made by me during the period of my employment at the Company, which records shall be available to and remain the sole property of the Company at all times.

 

4.     Additional Activities. I agree that during the period of my employment by the Company, I will not, without the Company’s express written consent, engage in any employment or business activity which is competitive with the Company, or would otherwise conflict with my employment by the Company. I agree further that for the period of my employment with the Company and for one (1) year after the date of termination of my employment by the Company, I will not induce any employee of the Company to leave the employ of the Company.

 

5.     No Conflicting Obligation. I represent that my performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement to keep in confidence information acquired by me in confidence or in trust prior to my employment by the Company. I have not entered into, and I agree I will not enter into, any agreement either written or oral in conflict herewith.

 

6.     Return of Company Documents. When I leave the employ of the Company, I will deliver to the Company any and all drawings, notes, memoranda, specifications, devices, formulas, and documents, together with all copies thereof, and any other material containing or disclosing any Company Inventions, Third Party Information or Proprietary Information of the Company. I further agree that any property situated on the Company’s premises and owned by the Company, including disks and other storage media, filing cabinets or other work areas, is subject to inspection by Company personnel at any time with or without notice. Prior to leaving, I will cooperate with the Company in completing and signing the Company’s termination statement.

 

 

 

 

7.     Legal and Equitable Remedies. Because my services are personal and unique and because I may have access to and become acquainted with the Proprietary Information of the Company, the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief, without bond and without prejudice to any other rights and remedies that the Company may have for a breach of this Agreement.

 

8.     Notices. Any notices required or permitted hereunder shall be given to the appropriate party at the address specified below or at such other address as the party shall specify in writing. Such notice shall be deemed given upon: personal delivery to the appropriate address, by overnight courier upon written verification of receipt by telecopy or facsimile upon acknowledgement of receipt, or certified or registered mail, three (3) days after the date of mailing.

 

9.     Notification of New Employer. In the event that I leave the employ of the Company, I hereby consent to the notification of my new employer of my rights and obligations under this Agreement.

 

10.     General Provisions.

 

10.1.     Governing Law; Consent to Personal Jurisdiction. This Agreement will be governed by and construed according to the laws of the State of California, as such laws are applied to agreements entered into and to be performed entirely within California between California residents. I hereby expressly consent to the personal jurisdiction of the state and federal courts located in San Mateo County, California for any lawsuit filed there against me by the Company arising from or related to this Agreement.

 

10.2.     Severability. In case any one or more of the provisions contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein. If moreover, any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.

 

10.3.     Successors and Assigns. This Agreement will be binding upon my heirs, executors, administrators and other legal representatives and will be for the benefit of the Company, its successors and its assigns.

 

10.4.     Survival. The provisions of this Agreement shall survive the termination of my employment and the assignment of this Agreement by the Company to any successor in interest or other assignee.

 

10.5.     Employment. I agree and understand that nothing in this Agreement shall confer any right with respect to continuation of employment by the Company, nor shall it interfere in any way with my right or the Company’s right to terminate my employment at any time, with or without cause.

 

10.6.     Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by the Company of any right under this Agreement shall be construed as a waiver of any other right. The Company shall not be required to give notice to enforce strict adherence to all terms of this Agreement.

 

 

 

 

Entire Agreement. The obligations pursuant to Sections 1 and 2 of this Agreement shall apply to any time during which I was previously employed, or am in the future employed, by the Company as a consultant if no other agreement governs nondisclosure and assignment of inventions during such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter hereof and supersedes and merges all prior discussions between us. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my duties, salary or compensation will not affect the validity or scope of this Agreement.

 

 

  

This Agreement shall be effective as of the first day of my employment with the Company, namely: _____________________, 20XX.

 

I HAVE READ THIS AGREEMENT CAREFULLY AND UNDERSTAND ITS TERMS. I HAVE COMPLETELY FILLED OUT EXHIBIT A-1 TO THIS AGREEMENT.

 

 

Employee		Date

                                   

 

Address:

   

ACCEPTED AND AGREED TO:

 

CARDICA, INC., a Delaware Corporation

 

 

By
			Date

 

Address:

900 Saginaw Drive Redwood City, CA 94063

 

 

 

EXHIBIT A-1

  

TO:     CARDICA, INC.

 

FROM:     _______________________________ [employee name]

 

DATE:     ______________________, 20__

 

SUBJECT:     Prior Inventions

  

1.     Except as listed in Section 2 below, the following is a complete list of all inventions or improvements relevant to the subject matter of my employment by the Company that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:

  

 

2.     Due to a prior confidentiality agreement, I cannot complete the disclosure under Section 1 above with respect to inventions or improvements generally listed below, the proprietary rights and duty of confidentiality with respect to which I owed to the following party(ies)

 

	Invention or Improvement		Party(ies)		Relationship
1.
2.
3.

 

 

  

Exhibit B

  

Change in Control Severance Benefit Plan

 

Introduction.

 

The Cardica, Inc. Change in Control Severance Benefit Plan (the “Plan”) has been established effective February 11, 2009 (the “Effective Date”), and was amended April 2, 2013. The purpose of the Plan is to provide for severance benefits to certain eligible employees of Cardica, Inc. (the “Company”) whose employment with the Company is involuntarily terminated in connection with a change in the control of the Company. This Plan supersedes any previously established or maintained severance benefit agreement, plan, policy or practice applicable to any of the Company’s eligible employees in connection with a Qualifying Termination, whether formal or informal, written or unwritten. This Plan also supersedes any employment agreement between the Company and an Eligible Employee regarding such individual’s rights to severance benefits in connection with a Qualifying Termination. This Plan document also is the Summary Plan Description for the Plan.

 

Section 1.     Definitions.

 

For purposes of the Plan, certain terms are defined as follows:

 

(a)     “Base Salary” means the Eligible Employee’s annual rate of base pay (excluding incentive pay, premium pay, commissions, overtime, bonuses and other forms of variable compensation).

 

(b)     “Board” means the Company’s Board of Directors.

 

(c)     “Bonus Amount” means (1) the average annual incentive bonus paid to the Eligible Employee in the two most recent full bonus years or (2) if the Eligible Employee has not been employed by the Company during the entirety of the two most recent bonus years, the Eligible Employee’s target annual incentive bonus for the year of termination; provided, however, that if the Eligible Employee is a Vice President-level sales employee, then the Bonus Amount for that Eligible Employee is the greater of (1) the Vice President-level target annual incentive bonus percentage per the Company’s then most current bonus policy, multiplied by the Eligible Employee’s Base Salary, and (2) 100% of the Eligible Employee’s sales commissions earned in the trailing 12-month period.

 

(d)     “Cause” means any of the following events occurs (as determined in good faith by a majority of the members of the Board who are not the Eligible Employee in question):

 

the Eligible Employee’s conviction of, or a plea of nolo contendere with respect to, a felony involving moral turpitude;

 

willful and continued failure by the Eligible Employee to substantially perform the Eligible Employee’s assigned duties after written notice and a reasonable opportunity to cure (if capable of cure);

 

any (x) willful engagement in fraud or dishonesty in the Eligible Employee’s performance of duties to the Company or (y) willful misconduct or gross negligence independent of the Company, in each case under clause “y” of this Section 2(d)(3) that has a material adverse impact upon the operations, business, affairs, reputation or valuation of the Company; or

 

willful noncompliance by the Eligible Employee with any material written policy of the Company or any willful breach of any material written agreement between the Eligible Employee and the Company, in either case, which has a material adverse impact on the operations, business affairs, reputation or valuation of the Company.

 

 

 

“Change in Control” means the occurrence, in a single transaction or in a series of related transactions, of any one or more of the following events:

 

any Exchange Act Person becomes the owner, directly or indirectly, of securities of the Company representing more than thirty-five percent (35%) of the combined voting power of the Company’s then outstanding securities other than by virtue of a merger, consolidation or similar transaction. Notwithstanding the foregoing, a Change in Control shall not be deemed to occur (A) on account of the acquisition of securities of the Company by an investor, any affiliate thereof or any other Exchange Act Person from the Company in a transaction or series of related transactions the primary purpose of which is to obtain financing for the Company through the issuance of equity securities or (B) solely because the level of ownership held by any Exchange Act Person (the “Subject Person”) exceeds the designated percentage threshold of the outstanding voting securities as a result of a repurchase or other acquisition of voting securities by the Company reducing the number of shares outstanding, provided that if a Change in Control would occur (but for the operation of this sentence) as a result of the acquisition of voting securities by the Company, and after such share acquisition, the Subject Person becomes the owner of any additional voting securities that, assuming the repurchase or other acquisition had not occurred, increases the percentage of the then outstanding voting securities owned by the Subject Person over the designated percentage threshold, then a Change in Control shall be deemed to occur;

 

there is consummated a merger, consolidation or similar transaction involving (directly or indirectly) the Company and, immediately after the consummation of such merger, consolidation or similar transaction, the stockholders of the Company immediately prior thereto do not own, directly or indirectly, either (A) outstanding voting securities representing more than fifty percent (50%) of the combined outstanding voting power of the surviving Entity in such merger, consolidation or similar transaction or (B) more than fifty percent (50%) of the combined outstanding voting power of the parent of the surviving entity in such merger, consolidation or similar transaction, in each case in substantially the same proportions as their ownership of the outstanding voting securities of the Company immediately prior to such transaction;

 

the stockholders of the Company approve or the Board approves a plan of complete dissolution or liquidation of the Company, or a complete dissolution or liquidation of the Company shall otherwise occur;

 

there is consummated a sale, lease, exclusive license or other disposition of all or substantially all of the consolidated assets of the Company and its Subsidiaries, other than a sale, lease, license or other disposition of all or substantially all of the consolidated assets of the Company and its Subsidiaries to an Entity, more than fifty percent (50%) of the combined voting power of the voting securities of which are Owned by stockholders of the Company in substantially the same proportions as their Ownership of the outstanding voting securities of the Company immediately prior to such sale, lease, license or other disposition; or

 

such other transaction or series of transactions as may be determined by the Board in its discretion.

 

Notwithstanding the foregoing, the term Change in Control shall not include: (A) a sale of assets, merger or other transaction effected exclusively for the purpose of changing the domicile of the Company, (B) the sale of equity securities by the Company in a transaction consummated principal for capital raising purposes in which cash is received by the Company, or indebtedness of the Company converted or cancelled, or any combination thereof, in exchange for such equity securities, or (C) a merger, consolidation or similar transaction involving (directly or indirectly) the Company and, immediately after the consummation of such merger, consolidation or similar transaction, the stockholders of the Company immediately prior thereto own, directly or indirectly, either (A) outstanding voting securities representing more than fifty percent (50%) of the combined outstanding voting power of the surviving Entity in such merger, consolidation or similar transaction or (B) more than fifty percent (50%) of the combined outstanding voting power of the parent of the surviving entity in such merger, consolidation or similar transaction, in each case in substantially the same proportions as their ownership of the outstanding voting securities of the Company immediately prior to such transaction.

 

 

  

(e)     “Code” means the Internal Revenue Code of 1986, as amended.

 

(f)     “Director” means an Eligible Employee who is employed at the level of a director.

 

(g)     “Eligible Employee” means an employee of the Company serving at or above the level of Director (i) who is notified by the Company in a writing in substantially the form attached hereto as Exhibit A (the “Designation Form”) that he or she is eligible for participation in the Plan and (ii) who accepts such designation by signing and returning the Designation Form within the required period. The determination of whether an employee is an Eligible Employee shall be made by the Board, in its sole discretion, and such determination shall be binding and conclusive on all persons.

 

(h)     “Equity Awards” means all stock options, restricted stock awards, stock appreciation rights, stock unit awards, and other equity incentive awards covering the Company’s common stock that are held by an Eligible Employee and remain outstanding and unvested as of immediately prior to the Qualifying Termination.

 

(i)     “ERISA” means the Employee Retirement Income Security Act of 1974, as amended.

 

(j)     “Exchange Act Person” means any natural person, entity or “group” (within the meaning of Section 13(d) or 14(d) of the Exchange Act), except that “Exchange Act Person” shall not include (i) the Company or any subsidiary of the Company, (ii) any employee benefit plan of the Company or any subsidiary of the Company or any trustee or other fiduciary holding securities under an employee benefit plan of the Company or any Subsidiary of the Company, (iii) an underwriter temporarily holding securities pursuant to an offering of such securities, (iv) an entity owned, directly or indirectly, by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company; or (v) any natural person, entity or “group” (within the meaning of Section 13(d) or 14(d) of the Exchange Act) that, as of the Effective Date, is the owner, directly or indirectly, of securities of the Company representing more than fifty percent (50%) of the combined voting power of the Company’s then outstanding securities.

 

(k)     “Qualifying Termination” means an involuntary termination without Cause immediately prior to, on, or within eighteen (18) months after, the effective date of the Change in Control, or a Resignation for Good Reason on or within eighteen (18) months after the effective date of the Change in Control, in either case, provided such termination of employment is a “separation from service” for purposes of Treasury Regulation Section 1.409A-1(h).

 

(l)     “Resignation for Good Reason” means the Eligible Employee resigns from all positions (including membership on the Board) he or she then holds with the Company (or any successor thereto) if and only if:

 

(1)     one of the following actions has been taken:

 

(i)     there is a material adverse change in duties or responsibilities of Eligible Employee, including but not limited to demotion from current position; provided, however, that a change in job position (including, without limitation, a change in title) shall not be deemed a “material adverse change” unless Purchaser’s new duties or responsibilities are substantially reduced from the prior duties;

 

 

 

(ii)     there is a material reduction in the Eligible Employee’s annual base salary, except for a reduction of not more than 10% that is applicable to all Eligible Employees;

 

(iii)     the Eligible Employee is required to relocate his or her primary work location to a facility or location that would increase the Eligible Employee’s one way commute distance by more than fifty (50) miles from the Eligible Employee’s primary work location as of immediately prior to such change;

 

(iv)      the Company materially breaches its obligations under this Plan or any then-effective written employment agreement with the Eligible Employee; or

 

(v)     any acquirer, successor or assignee of the Company fails to assume and perform, in all material respects, the obligations of the Company hereunder; and

 

(2)     the Eligible Employee provides written notice to the Company’s Secretary within the 60-day period immediately following such action that the Eligible Employee believes one of the actions set forth in Section 2(m)(1) has been taken; and

 

(3)     such action (if possible to remedy) is not remedied by the Company within thirty (30) days following the Company’s receipt of such written notice; and

 

(4)     the Eligible Employee’s resignation is effective not later than sixty (60) days after the expiration of such thirty (30) day cure period.

 

(m)     “Sales Director Bonus Amount” means the greater of (1) the Eligible Employee’s target annual incentive bonus percentage per the Company’s then most current bonus policy, multiplied by the Eligible Employee’s Base Salary, multiplied by 0.33, and (2) 33% of the Eligible Employee’s sales commissions earned in the trailing 12-month period.

 

Eligibility For Benefits.

 

General Rules. Subject to the requirements of the Plan, the Company will provide the severance benefits described in Section 4 to Eligible Employees, provided that in order to be eligible to receive severance benefits under the Plan:

 

an Eligible Employee must remain on the job and satisfactorily provide services to the Company until the Qualifying Termination date.

 

an Eligible Employee must execute a general waiver and release in substantially the form attached hereto as Exhibit B, Exhibit C or Exhibit D, as appropriate, within the time frame set forth therein and such release must become effective in accordance with its terms. The Company, in its sole discretion, may modify the form of the required release to comply with applicable law and shall determine the form of the required release, which may be incorporated into a termination agreement or other agreement with the Eligible Employee.

 

an Eligible Employee must remain in compliance with his or her continuing obligations to the Company, including obligations under his or her Employee Proprietary Information and Inventions Agreement (such agreement, or any similar agreement, the “Inventions Agreement”).

 

 

 

in addition to any non-solicitation obligations owed by the Eligible Employee to the Company pursuant to the Inventions Agreement, an Eligible Employee must, for the period stated below after Qualifying Termination date, not induce any employee of the Company to leave the employ of the Company.

 

Eligible Employee’s Position/Level Immediately Prior to Qualifying Termination	Non-Solicitation Period
CEO	18 months
Vice President	12 months
Director	4 months

 

Exceptions to Benefit Entitlement. An employee, including an employee who otherwise is an Eligible Employee, will not receive benefits under the Plan (or will receive reduced benefits under the Plan) in the following circumstances, as determined by the Company in its sole discretion:

 

The employee’s employment terminates other than as a result of a Qualifying Termination (including, but not limited to, a termination for Cause prior to the effective date of a previously scheduled Qualifying Termination, a termination as a result of death or disability, a termination arising as a result of the employee failing to accept an offer of employment from the acquirer/successor entity on terms that do not give rise to a right to a Resignation for Good Reason, or the employee voluntarily terminates employment with the Company other than as a Resignation for Good Reason). Voluntary terminations include, but are not limited to, resignation, retirement, failure to return from a leave of absence on the scheduled date and/or termination in order to accept employment with another entity (including but not limited to any entity that is wholly or partly owned (directly or indirectly) by the Company or an affiliate of the Company).

 

The employee has not signed an enforceable Inventions Agreement covering the employee’s period of employment with the Company (and with any predecessor) and does not confirm in writing that he or she is and shall remain subject to the terms of that Inventions Agreement in accordance with its terms.

 

The employee has otherwise failed to comply with the terms of this Plan.

 

Section 2.     Type and Amount Of Benefits.

 

Cash Severance Benefits. An Eligible Employee who suffers a Qualifying Termination will receive the following cash severance benefits (the “Cash Severance”) subject to the terms of the Plan:

 

 

 

CEO and Vice Presidents. The Eligible Employee who is the CEO or a Vice President immediately prior to the event giving rise to the Qualifying Termination shall be entitled to Cash Severance equal to the product of (1) the sum of (i) the Eligible Employee’s Base Salary in effect immediately prior to the event giving rise to the Qualifying Termination and (ii) the Eligible Employee’s Bonus Amount (such sum, the “Cash Amount”) and (2) the “Multiple” set forth in the following table:

 

Eligible Employee’s Position/Level Immediately Prior to the Qualifying Termination Event	Multiple
CEO	1.5
Vice President	1.0

 

The Cash Severance will be paid in a lump sum on the first regular payroll pay date following the effective date of the general waiver and release, but in no event later than March 15 of the year following the year in which the Qualifying Termination occurs.

 

Directors. Each Eligible Employee who is a Director immediately prior to the event giving rise to the Qualifying Termination shall be entitled to receive Cash Severance equal to four (4) months of the Eligible Employee’s Base Salary in effect immediately prior to the event giving rise to the Qualifying Termination plus, in the case of a Director-level sales employee, the Sales Director Bonus Amount for that Eligible Employee. The Cash Severance will be paid in a lump sum on the first regular payroll pay date following the effective date of the general waiver and release, but in no event later than March 15 of the year following the year in which the Qualifying Termination occurs.

 

COBRA Continuation Coverage. If the Eligible Employee was enrolled in a group health (i.e., medical, dental, or vision) plan sponsored by the Company or an affiliate of the Company immediately prior to the Qualifying Termination, the Eligible Employee may be eligible to continue coverage under such group plan (or to convert to an individual policy) following termination under the Consolidated Omnibus Budget Reconciliation Act of 1985 (together with any state law of similar effect, “COBRA”). The Company (or its designated representative) will notify the Eligible Employee of any such right to continue such coverage at the time of termination. If an Eligible Employee makes a timely election to continue such coverage pursuant to COBRA, the Company shall pay the applicable premiums (or shall provide coverage under any self-funded plan) on behalf of the Eligible Employee for the Eligible Employee’s continued coverage under such plans, including coverage for the Eligible Employee’s eligible dependents, for up to that number of months set forth below following the Eligible Employee’s Qualifying Termination; provided, however, that no such premium payments shall be made (and no coverage shall be provided under any self-funded group health plan) following the date on which the Eligible Employee and his eligible dependents cease (or would cease) to be eligible for continued coverage under COBRA, including but not limited to the date on which the Eligible Employee becomes covered by another group health plan, whether through a subsequent employer or otherwise. The Eligible Employee is required to notify the Company immediately if the Eligible Employee becomes covered by another group health plan, whether through a subsequent employer or otherwise.

 

Eligible Employee’s Position/Level Immediately Prior to Qualifying Termination	Months of Company-Paid COBRA Coverage
CEO	18
Vice President	12
Director	4

 

No provision of this Plan will affect the continuation coverage rules under COBRA, except that the Company’s payment of applicable insurance premiums (or waiver of any cost of coverage under any self-funded group health plan) in accordance with the foregoing will be credited as payment by the Eligible Employee for purposes of the Eligible Employee’s payment required under COBRA (or the self-funded plan). Therefore, the period during which an Eligible Employee may elect to continue the Company’s health, dental, or vision plan coverage at his or her own expense under COBRA, the length of time during which COBRA coverage will be made available to the Eligible Employee, and all other rights and obligations of the Eligible Employee under COBRA (except the Company’s obligation to pay applicable insurance premiums in accordance with the foregoing) will be applied in the same manner that such rules would apply in the absence of this Plan. Upon the expiration of the period during which the Company pays an Eligible Employee’s insurance premiums in accordance with the foregoing, the Eligible Employee will be responsible for the entire payment of premiums for continued coverage thereafter. For purposes of this Section 4(b), any applicable insurance premiums that are paid by the Company shall not include any amounts payable by an Eligible Employee under an Internal Revenue Code Section 125 health care reimbursement plan, which amounts, if any, are the sole responsibility of the Eligible Employee.

 

 

 

Equity Vesting Acceleration. All Equity Awards held by the Eligible Employee as of immediately prior to the Qualifying Termination shall become fully vested and, as applicable, exercisable as of the date of the Qualifying Termination.

 

Additional Benefits. Notwithstanding the foregoing, the Company may, in its sole discretion, authorize benefits in an amount in addition to those benefits set forth in this Section 4 to an Eligible Employee. The provision of any such benefits to an Eligible Employee shall in no way obligate the Company to provide such benefits to any other Eligible Employee or to any other employee, even if similarly situated. Receipt of such additional benefits may be subject to a covenant of confidentiality and non-disclosure and to the execution of a release.

 

Certain Reductions.

 

The Company shall reduce an Eligible Employee’s severance benefits under this Plan, in whole or in part, by any other severance benefits, pay in lieu of notice, or other similar benefits payable to the Eligible Employee by the Company in connection with the Eligible Employee’s Qualifying Termination, including but not limited to any payments or benefits that are due pursuant to (i) any other severance plan, policy or practice, or any individually negotiated employment contract or agreement with the Company relating to severance benefits, in each case, as is in effect on the Eligible Employee’s termination date, (ii) any applicable legal requirement, including, without limitation, the Worker Adjustment and Retraining Notification Act or any state or local law of similar effect, or (iii) any Company policy or practice providing for the Eligible Employee to remain on the payroll without being in active service for a limited period of time after being given notice of the termination of the Eligible Employee’s employment. The benefits provided under this Plan are intended to satisfy, to the greatest extent possible, any and all statutory obligations that may arise out of an Eligible Employee’s termination of employment, and the Plan Administrator shall so construe and implement the terms of the Plan. In the Company’s sole discretion, such reductions may be applied on a retroactive basis, with severance benefits previously paid being recharacterized as payments pursuant to the Company’s statutory obligation.

 

If an Eligible Employee is indebted to the Company at his or her termination date, the Company reserves the right to offset any severance payments under the Plan by the amount of such indebtedness.

 

All payments under the Plan will be subject to applicable withholding for federal, state and local taxes.

 

If any payment or benefit (including payments and benefits pursuant to this Plan) that an Eligible Employee would receive in connection with a Change in Control from the Company or otherwise (“Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Code, and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Company shall cause to be determined, before any amounts of the Payment are paid to the Eligible Employee, which of the following two alternative forms of payment shall be paid to the Eligible Employee: (A) the payment in full of the entire amount of the Payment (a “Full Payment”), or (B) the payment of only a part of the Payment so that the Eligible Employee receives the largest payment possible without the imposition of the Excise Tax (such lesser amount, a “Reduced Payment”). The Company shall pay the Reduced Payment only if (x) payment of the Full Amount would result in the imposition of the Excise Tax, (y) payment of the Reduced Payment would not, and (z) in the case of Eligible Employees who are not Directors, the Reduced Payment is not less than the Full Payment minus an amount of cash not exceeding the product of (I) 0.5 and (II) the Cash Amount.

 

 

 

If the Full Payment is made and is subject to the Excise Tax, the Company shall pay, and the Eligible Employee shall be entitled to receive, an additional payment (a “Gross-Up Payment”) from the Company in an amount equal to (A) the Excise Tax on the Full Payment, (B) any interest or penalties imposed on the Eligible Employee with respect to the Excise Tax on the Full Payment, and (C) an additional amount sufficient to pay the Excise Tax and the federal and state income and employment taxes arising from the payments made by the Company to the Eligible Employee pursuant to (A), (B) and (C) – that is, a gross-up ad infinitim. Except as otherwise provided herein, the Eligible Employee shall not be entitled to any additional payments or other indemnity arrangements in connection with the Payment or the Gross-Up Payment.

 

For purposes of determining whether to make a Full Payment or a Reduced Payment, and for purposes of determining the amount of any Gross-Up Payment, the Eligible Employee shall be deemed to have: (A) paid federal income taxes at the highest marginal rate of federal income and employment taxation for the applicable calendar year, and (B) paid applicable state and local income taxes at the highest rate of taxation for the applicable calendar year, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state and local taxes.

 

If a Reduced Payment is made, the Payment shall be paid only to the extent permitted under the Reduced Payment alternative, and the Eligible Employee shall have no rights to any additional payments and/or benefits constituting the Payment. The reduction in the Payments shall occur from the Cash Severance.

 

The independent registered public accounting firm engaged by the Company for general audit purposes as of the day prior to the effective date of the Change in Control shall make all determinations required to be made under this Section 4(e)(4). If the independent registered public accounting firm so engaged by the Company is serving as accountant or auditor for the individual, entity or group effecting the Change in Control, the Company shall appoint a nationally recognized independent registered public accounting firm to make the determinations required hereunder. The Company shall bear all expenses with respect to the determinations by such independent registered public accounting firm required to be made hereunder. The firm engaged to make the determinations hereunder shall provide its calculations, together with detailed supporting documentation, to the Company and the Eligible Employee within thirty (30) calendar days after the date on which the Eligible Employee’s right to a Payment is triggered (if requested at that time by the Company or the Eligible Employee) or at such other time as reasonably requested by the Company or the Eligible Employee. If the independent registered public accounting firm determines that no Excise Tax is payable with respect to the Payment (either upon payment of the Full Payment or the Reduced Payment), it shall furnish the Company and the Eligible Employee with an opinion reasonably acceptable to the Eligible Employee that no Excise Tax will be imposed with respect to such Payment. If the firm determines that an Excise Tax is payable with respect to the Payment and that a Gross-Up Payment is due to the Eligible Employee, the Company shall pay the Gross-Up Payment not later than thirty (30) days after the date on which the Eligible Employee remits the Excise Tax to the appropriate taxing authorities. Any good faith determinations of the accounting firm made hereunder shall be final, binding and conclusive upon the Company and the Eligible Employee.

 

Other Employee Benefits.

 

All other payments and benefits (such as life insurance, disability coverage, and 401(k) plan coverage) terminate as of the Eligible Employee’s termination date or such earlier date as may be required under the applicable plan or policy (except to the extent that a conversion privilege (at the Eligible Employee’s expense) may be available thereunder).

 

 

 

Return of Company Property.

 

An Eligible Employee will not be entitled to any severance benefit under the Plan unless and until the Eligible Employee returns all Company Property. For this purpose, “Company Property” means all Company documents (and all copies thereof) and other Company property which the Eligible Employee had in his or her possession at any time, including, but not limited to, Company files, notes, drawings, records, plans, forecasts, reports, studies, analyses, proposals, agreements, financial information, research and development information, sales and marketing information, operational and personnel information, specifications, code, software, databases, computer-recorded information, tangible property and equipment (including, but not limited to, computers, facsimile machines, mobile telephones, servers), credit cards, entry cards, identification badges and keys; and any materials of any kind which contain or embody any proprietary or confidential information of the Company (and all reproductions thereof in whole or in part). In addition, the Eligible Employee must provide the Company with all logins, passwords, and similar information created by the Eligible Employee for the Company Property.

 

Section 3.     Section 409A.

 

Notwithstanding any payment schedule to the contrary contained herein, if the Company (or, if applicable, the successor entity thereto) determines that the payments and benefits provided under the Plan (the “Plan Payments”) constitute “deferred compensation” under Code Section 409A (together, with any state law of similar effect, “Section 409A”) and an Executive is a “specified employee” of the Company or any successor entity thereto, as such term is defined in Section 409A(a)(2)(B)(i) (a “Specified Employee”), then, solely to the extent necessary to avoid the incurrence of the adverse personal tax consequences under Section 409A, the timing of the Plan Payments shall be delayed as follows: on the earlier to occur of (i) the date that is six months and one day after the Eligible Employee’s “separation from service” (as defined under Section 409A) or (ii) the date of the Executive’s death (such earlier date, the “Delayed Initial Payment Date”), the Company (or the successor entity thereto, as applicable) shall (A) pay to the Eligible Employee a lump sum amount equal to the sum of the Plan Payments that the Eligible Employee would otherwise have received through the Delayed Initial Payment Date if the commencement of the payment of the Plan Payments had not been delayed pursuant to this Section 7 and (B) commence paying the balance of the Plan Payments in accordance with the applicable payment schedules set forth in Section 4 above. For the avoidance of doubt, it is intended that the Plan Payments satisfy, to the greatest extent possible, the exemptions from the application of Section 409A provided under Treasury Regulations 1.409A-1(b)(4), 1.409A-1(b)(5) and 1.409A-1(b)(9). Each payment under this Plan is intended to be a separate payment for purposes of Section 409A.

 

Reemployment.

 

In the event of an Eligible Employee’s reemployment by the Company during the period of time in respect of which severance benefits pursuant to Section 4 have been paid, the Company, in its sole and absolute discretion, may require such Eligible Employee to repay to the Company all or a portion of such severance benefits as a condition of reemployment.

 

Section 4.     Right To Interpret Plan; Amendment and Termination.

 

Exclusive Discretion. The Plan Administrator shall have the exclusive discretion and authority to establish rules, forms, and procedures for the administration of the Plan and to construe and interpret the Plan and to decide any and all questions of fact, interpretation, definition, computation or administration arising in connection with the operation of the Plan, including, but not limited to, the eligibility to participate in the Plan and amount of benefits paid under the Plan. The rules, interpretations, computations and other actions of the Plan Administrator shall be binding and conclusive on all persons.

 

 

 

Amendment or Termination. 

 

This Plan will have an initial term of two (2) years from the Effective Date, and will renew automatically for successive one (1) year terms thereafter unless notice of termination of the Plan is given by the Board to all Eligible Employees at least one hundred and eighty (180) days in advance of any such renewal date.

 

The Company reserves the right to amend this Plan or the benefits provided hereunder at any time; provided, however, that no such amendment shall affect the right to any unpaid benefit of any Eligible Employee whose Qualifying Termination date has occurred prior to the amendment of the Plan.

 

Any purported adverse amendment or termination of this Plan (and the exhibits and appendices hereto) within the time period beginning immediately prior to the effective date of the Change in Control and ending eighteen (18) months and one (1) day after the effective date of the Change in Control will not be effective as to any Eligible Employee who has not consented, in writing, to such amendment or termination.

 

Any action amending or terminating the Plan shall be in writing and executed by a member of the Board of Directors of the Company (or its duly authorized designee).

 

Section 5.     No Implied Employment Contract.

 

The Plan shall not be deemed (i) to give any employee or other person any right to be retained in the employ of the Company or (ii) to interfere with the right of the Company to discharge any employee or other person at any time, with or without cause, which right is hereby reserved.

 

Section 6.     Legal Construction.

 

This Plan is intended to be governed by and shall be construed in accordance with ERISA and, to the extent not preempted by ERISA, the laws of the State of California.

 

Section 7.     Claims, Inquiries And Appeals.

 

Applications for Benefits and Inquiries. Any application for benefits, inquiries about the Plan or inquiries about present or future rights under the Plan must be submitted to the Plan Administrator in writing by an applicant (or his or her authorized representative). The Plan Administrator is:

 

Cardica, Inc.

Attn: Secretary

900 Saginaw Drive

Redwood City, California 94063

 

Denial of Claims. In the event that any application for benefits is denied in whole or in part, the Plan Administrator must provide the applicant with written or electronic notice of the denial of the application, and of the applicant’s right to review the denial. Any electronic notice will comply with the regulations of the U.S. Department of Labor. The notice of denial will be set forth in a manner designed to be understood by the applicant and will include the following:

 

the specific reason or reasons for the denial;

 

references to the specific Plan provisions upon which the denial is based;

 

 

 

a description of any additional information or material that the Plan Administrator needs to complete the review and an explanation of why such information or material is necessary; and

 

an explanation of the Plan’s review procedures and the time limits applicable to such procedures, including a statement of the applicant’s right to bring a civil action under Section 502(a) of ERISA following a denial on review of the claim, as described in Section 12(d) below.

 

This notice of denial will be given to the applicant within ninety (90) days after the Plan Administrator receives the application, unless special circumstances require an extension of time, in which case, the Plan Administrator has up to an additional ninety (90) days for processing the application. If an extension of time for processing is required, written notice of the extension will be furnished to the applicant before the end of the initial ninety (90) day period.

 

This notice of extension will describe the special circumstances necessitating the additional time and the date by which the Plan Administrator is to render its decision on the application.

 

Request for a Review. Any person (or that person’s authorized representative) for whom an application for benefits is denied, in whole or in part, may appeal the denial by submitting a request for a review to the Plan Administrator within sixty (60) days after the application is denied. A request for a review shall be in writing and shall be addressed to:

 

Cardica, Inc.

Attn: Secretary

900 Saginaw Drive

Redwood City, California 94063

 

A request for review must set forth all of the grounds on which it is based, all facts in support of the request and any other matters that the applicant feels are pertinent. The applicant (or his or her representative) shall have the opportunity to submit (or the Plan Administrator may require the applicant to submit) written comments, documents, records, and other information relating to his or her claim. The applicant (or his or her representative) shall be provided, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant to his or her claim. The review shall take into account all comments, documents, records and other information submitted by the applicant (or his or her representative) relating to the claim, without regard to whether such information was submitted or considered in the initial benefit determination.

 

Decision on Review. The Plan Administrator will act on each request for review within sixty (60) days after receipt of the request, unless special circumstances require an extension of time (not to exceed an additional sixty (60) days), for processing the request for a review. If an extension for review is required, written notice of the extension will be furnished to the applicant within the initial sixty (60) day period. This notice of extension will describe the special circumstances necessitating the additional time and the date by which the Plan Administrator is to render its decision on the review. The Plan Administrator will give prompt, written or electronic notice of its decision to the applicant. Any electronic notice will comply with the regulations of the U.S. Department of Labor. In the event that the Plan Administrator confirms the denial of the application for benefits in whole or in part, the notice will set forth, in a manner calculated to be understood by the applicant, the following:

 

the specific reason or reasons for the denial;

 

references to the specific Plan provisions upon which the denial is based;

 

a statement that the applicant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant to his or her claim; and

 

 

 

a statement of the applicant’s right to bring a civil action under Section 502(a) of ERISA.

 

Rules and Procedures. The Plan Administrator will establish rules and procedures, consistent with the Plan and with ERISA, as necessary and appropriate in carrying out its responsibilities in reviewing benefit claims. The Plan Administrator may require an applicant who wishes to submit additional information in connection with an appeal from the denial of benefits to do so at the applicant’s own expense.

 

Exhaustion of Remedies. No legal action for benefits under the Plan may be brought until the applicant (i) has submitted a written application for benefits in accordance with the procedures described by Section 12(a) above, (ii) has been notified by the Plan Administrator that the application is denied, (iii) has filed a written request for a review of the application in accordance with the appeal procedure described in Section 12(c) above, and (iv) has been notified that the Plan Administrator has denied the appeal. Notwithstanding the foregoing, if the Plan Administrator does not respond to a Participant’s claim or appeal within the relevant time limits specified in this Section 12, the Participant may bring legal action for benefits under the Plan pursuant to Section 502(a) of ERISA.

 

Section 8.     Basis Of Payments To And From Plan.

 

The Plan shall be unfunded, and all benefits under the Plan shall be paid only from the general assets of the Company. An Eligible Employee’s right to receive payments under the Plan is no greater than that of the Company’s unsecured general creditors. Therefore, if the Company were to become insolvent, the Eligible Employee might not receive benefits under the Plan.

 

Section 9.     Other Plan Information.

 

Employer and Plan Identification Numbers. The Employer Identification Number assigned to the Company (which is the “Plan Sponsor” as that term is used in ERISA) by the Internal Revenue Service is 94-3287832. The Plan Number assigned to the Plan by the Plan Sponsor pursuant to the instructions of the Internal Revenue Service is 515.

 

Ending Date for Plan’s Fiscal Year. The date of the end of the fiscal year for the purpose of maintaining the Plan’s records is June 30. The Plan is a welfare benefit plan.

 

Agent for the Service of Legal Process. The agent for the service of legal process with respect to the Plan is:

 

Cardica, Inc.

Attn: Secretary

900 Saginaw Drive

Redwood City, California 94063

 

Plan Sponsor and Administrator. The “Plan Sponsor” and the “Plan Administrator” of the Plan is:

 

Cardica, Inc.

Attn: Secretary

900 Saginaw Drive

Redwood City, California 94063

 

The Plan Sponsor’s and Plan Administrator’s telephone number is (650) 364-9975. The Plan Administrator is the named fiduciary charged with the responsibility for administering the Plan.

 

 

 

Section 10.     Statement Of ERISA Rights.

 

Participants in this Plan are entitled to certain rights and protections under ERISA. If you are an Eligible Employee, you are considered a participant in the Plan and, under ERISA, you are entitled to:

 

Receive Information About Your Plan and Benefits

 

Examine, without charge, at the Plan Administrator’s office and at other specified locations, such as worksites, all documents governing the Plan and a copy of the latest annual report (Form 5500 Series), if applicable, filed by the Plan with the U.S. Department of Labor and available at the Public Disclosure Room of the Employee Benefits Security Administration;

 

Obtain, upon written request to the Plan Administrator, copies of documents governing the operation of the Plan and copies of the latest annual report (Form 5500 Series), if applicable, and an updated (as necessary) Summary Plan Description. The Administrator may make a reasonable charge for the copies; and

 

Receive a summary of the Plan’s annual financial report, if applicable. The Plan Administrator is required by law to furnish each participant with a copy of this summary annual report.

 

Prudent Actions by Plan Fiduciaries. In addition to creating rights for Plan participants, ERISA imposes duties upon the people who are responsible for the operation of the employee benefit plan. The people who operate the Plan, called “fiduciaries” of the Plan, have a duty to do so prudently and in the interest of you and other Plan participants and beneficiaries. No one, including your employer, your union or any other person, may fire you or otherwise discriminate against you in any way to prevent you from obtaining a Plan benefit or exercising your rights under ERISA.

 

Enforce Your Rights. If your claim for a Plan benefit is denied or ignored, in whole or in part, you have a right to know why this was done, to obtain copies of documents relating to the decision without charge, and to appeal any denial, all within certain time schedules.

 

Under ERISA, there are steps you can take to enforce the above rights. For instance, if you request a copy of Plan documents or the latest annual report from the Plan, if applicable, and do not receive them within 30 days, you may file suit in a Federal court. In such a case, the court may require the Plan Administrator to provide the materials and pay you up to $110 a day until you receive the materials, unless the materials were not sent because of reasons beyond the control of the Plan Administrator.

 

If you have completed the claims and appeals procedure described above and have a claim for benefits which is denied or ignored, in whole or in part, you may file suit in a state or Federal court.

 

If you are discriminated against for asserting your rights, you may seek assistance from the U.S. Department of Labor, or you may file suit in a Federal court. The court will decide who should pay court costs and legal fees. If you are successful, the court may order the person you have sued to pay these costs and fees. If you lose, the court may order you to pay these costs and fees, for example, if it finds your claim is frivolous.

 

Assistance with Your Questions. If you have any questions about the Plan, you should contact the Plan Administrator. If you have any questions about this statement or about your rights under ERISA, or if you need assistance in obtaining documents from the Plan Administrator, you should contact the nearest office of the Employee Benefits Security Administration, U.S. Department of Labor, listed in your telephone directory or the Division of Technical Assistance and Inquiries, Employee Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue N.W., Washington, D.C. 20210. You may also obtain certain publications about your rights and responsibilities under ERISA by calling the publications hotline of the Employee Benefits Security Administration or accessing its website at http://www.dol.gov/ebsa/.

 

 

 

Circular 230 Disclaimer.

 

THE FOLLOWING DISCLAIMER IS PROVIDED IN ACCORDANCE WITH THE INTERNAL REVENUE SERVICE’S CIRCULAR 230 (21 CFR PART 10). ANY ADVICE IN THIS PLAN IS NOT INTENDED OR WRITTEN TO BE USED, AND IT CANNOT BE USED BY YOU FOR THE PURPOSE OF AVOIDING ANY PENALTIES THAT MAY BE IMPOSED ON YOU. ANY ADVICE IN THIS PLAN WAS WRITTEN TO SUPPORT THE PROMOTION OR MARKETING OF PARTICIPATION IN THE COMPANY’S CHANGE IN CONTROL SEVERANCE PLAN. YOU SHOULD SEEK ADVICE BASED ON YOUR PARTICULAR CIRCUMSTANCES FROM AN INDEPENDENT TAX ADVISOR.

 

Section 11.     Execution.

 

To record the adoption of the Plan as set forth herein, effective as of February 11, 2009, Cardica, Inc. has caused its duly authorized officer to execute the same on February 11, 2009.

 

		Cardica, Inc.
	By:
	Title:

 

 

  

Exhibit A

 

DESIGNATION FORM

 

On ___________ ___, 2009, the Compensation Committee of the Board of Directors of Cardica, Inc. (the “Company”) designated you as an employee eligible for participation in the Company’s Change in Control Severance Benefit Plan (the “Plan”). In order to be eligible to receive payments and benefits under the Plan, you must sign and return this Designation Form to the Company within thirty (30) days of your receipt of this Designation Form and a copy of the Plan. By signing this Designation Form, you acknowledge that you have reviewed the Plan and you understand and agree to all of the terms and conditions thereof. You understand and agree that by accepting the designation as an Eligible Employee (as defined in the Plan), your rights under the Plan supersede and replace any rights you have to severance benefits under any other plan, policy or practice of the Company, or under any written or unwritten agreement with the Company with respect to a termination that constitutes a Qualifying Termination. You further understand that nothing in this Designation Form or the terms of the Plan modifies the at-will nature of your employment with the Company or the Company’s ability to terminate your participation in the Plan as provided in the Plan.

 

		Sincerely,
		[Name],
		[Title]

 

 

Acknowledged and Agreed:
[Name]
Date

 

 

 

Exhibit B

 

RELEASE AGREEMENT

 

I understand and agree completely to the terms set forth in the Cardica, Inc. Change in Control Severance Benefit Plan (the “Plan”).

 

I understand that this Release Agreement (“Release”), together with the Plan, constitutes the complete, final and exclusive embodiment of the entire agreement between Cardica, Inc. (the “Company”) and me with regard to the subject matter hereof. I am not relying on any promise or representation by the Company that is not expressly stated therein. Certain capitalized terms used in this Release are defined in the Plan.

 

I hereby acknowledge and reaffirm my continuing obligations under the Company’s Proprietary Information and Inventions Agreement that I signed in connection with my employment. In addition, I hereby represent that I have been paid all compensation owed and for all hours worked, have received all the leave and leave benefits and protections for which I am eligible, pursuant to the Family and Medical Leave Act or otherwise, and have not suffered any on-the-job injury for which I have not already filed a workers’ compensation claim.

 

Except as otherwise set forth in this Release, in exchange for the benefits I will receive pursuant to the Plan which I am not otherwise entitled to receive, and as required by the Plan, I hereby generally and completely release, acquit and forever discharge the Company and its parent, subsidiary, and affiliated entities, along with its and their predecessors and successors and their respective directors, officers, employees, shareholders, stockholders, partners, agents, attorneys, insurers, affiliates and assigns (collectively, the “Released Parties”), of and from any and all claims, liabilities and obligations, both known and unknown, that arise from or are in any way related to events, acts, conduct, or omissions occurring at any time prior to and including the date that I sign this Release (collectively, the “Released Claims”). The Released Claims include, but are not limited to: (a) all claims arising out of or in any way related to my employment with the Company, or the termination of that employment; (b) all claims related to my compensation or benefits from the Company, including salary, bonuses, commissions, other incentive compensation, vacation pay and the redemption thereof, expense reimbursements, severance payments, fringe benefits, stock, stock options, or any other ownership or equity interests in the Company; (c) all claims for breach of contract, wrongful termination, and breach of the implied covenant of good faith and fair dealing; (d) all tort claims, including but not limited to claims for fraud, defamation, emotional distress, and discharge in violation of public policy; and (e) all federal, state, and local statutory claims, including but not limited to claims for discrimination, harassment, retaliation, attorneys’ fees, or other claims arising under the federal Civil Rights Act of 1964 (as amended), the federal Americans with Disabilities Act of 1990 (as amended), the federal Age Discrimination in Employment Act of 1967 (as amended) (the “ADEA”), and the California Fair Employment and Housing Act (as amended). Notwithstanding the foregoing, the following are not included in the Released Claims (the “Excluded Claims”): (a) any rights or claims for indemnification I may have pursuant to any written indemnification agreement with the Company to which I am a party, the charter, bylaws, or under applicable law; (b) any rights which are not waivable as a matter of law; or (c) any claims for breach of the Plan arising after the date that I sign the Release. In addition, nothing in this Release prevents me from filing, cooperating with, or participating in any investigation or proceeding before the Equal Employment Opportunity Commission, the Department of Labor, the California Department of Fair Employment and Housing, or any other government agency, except that I hereby waive my right to any monetary benefits in connection with any such claim, charge, investigation or proceeding. I hereby represent and warrant that, other than the Excluded Claims, I am not aware of any claims I have or might have against any of the Released Parties that are not included in the Released Claims.

 

 

 

I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I may have under the ADEA, that the consideration given for the Release is in addition to anything of value to which I was already entitled, and that I have been advised by this writing, as required by the ADEA, that: (a) my release of claims does not apply to any rights or claims that arise after the date I sign this Release; (b) I should consult with an attorney prior to signing this Release (although I may choose voluntarily not to do so); (c) I have twenty-one (21) days to consider this Release (although I may choose voluntarily to sign it sooner); (d) I have seven (7) days following the date I sign this Release to revoke it by providing written notice of my revocation to the Company’s Chief Executive Officer; and (e) this Release will not be effective until the date upon which the revocation period has expired unexercised, which will be the eighth day after I sign this Release (the “Effective Date”).

 

I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: “A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor.” I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims, including but not limited to my release of unknown and unsuspected claims.

 

In addition to the above: (a) I agree not to disparage the Company or any of the other Released Parties in any manner likely to be harmful to its or their business, business reputations, or personal reputations; (b) I agree to return, no later than my employment termination date, all Company property, documents, information, and materials, including but not limited to any and all embodiments (e.g., notes, computer-recorded information) of the Company’s proprietary or confidential information (and all reproductions thereof, in whole or in part) in my possession or control; and (c) I will not voluntarily provide assistance, information or advice, directly or indirectly (including through agents or attorneys), to any person or entity in connection with any claim or cause of action of any kind brought against the Company or its officers, directors, or affiliated entities, nor induce or encourage any person or entity to bring such claims; provided that it shall not violate this covenant if I testify truthfully when required to do so by a valid subpoena or under similar compulsion of law.

 

I acknowledge that to become effective, I must sign and return this Release to the Company so that it is received not later than twenty-one (21) days following the date it is provided to me.

  

	EMPLOYEE
	Name:
	Date:

 

 

B-2

Exhibit 10.6

 

[*] = 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.

  

AMENDMENT TO LICENSE AGREEMENT AND POTENTIAL Development Agreement

 

This AMENDMENT TO LICENSE AGREEMENT AND POTENTIAL Development Agreement (the “Development Agreement”) is made and entered into as of December 30, 2015 (the “Effective Date”) by and between Cardica, Inc., a Delaware corporation having its principal place of business at 900 Saginaw Drive, Redwood City, CA 94063 (“Cardica”), and Intuitive Surgical Operations, Inc., a Delaware corporation having its principal place of business at 1266 Kifer Road, Sunnyvale, California 94086 (“IS Ops”) and Intuitive Surgical International, Ltd., a Cayman Islands company and an indirect and wholly-owned subsidiary of the Intuitive (“ISI”), collectively as “Intuitive”). Cardica and Intuitive are individually referred to as a “Party” or collectively as the “Parties”.

 

Whereas, Cardica is engaged in the design and manufacturing of proprietary stapling devices for surgical procedures;

 

Whereas, Intuitive designs, manufactures, and sells systems, instruments and accessories for robotic-assisted minimally invasive surgery;

 

Whereas, Cardica and Intuitive are parties to that certain License Agreement, dated August 16, 2010 (the “License Agreement”), under which Cardica granted to Intuitive an exclusive license in the Field of Use to intellectual property rights of Cardica;

 

Whereas, the License Agreement contemplates, inter alia, that the Parties will enter into a development agreement, pursuant to which Cardica and Intuitive will co-develop cutting and stapling devices and clip applier devices;

 

Whereas, the Parties now wish to enter into this Development Agreement to set forth the terms and conditions to evaluate the feasibility of such development work, to potentially engage in such development work, to amend certain terms and conditions of the License Agreement, and to provide a mutual release of past obligations under the License Agreement.

 

Now therefore, in consideration of the mutual promises and agreement set forth herein, and for other good and valuable considerations, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

1.	Definitions. Capitalized terms used but not defined herein shall have the meanings set forth in the License Agreement.

 

 

 

2.	Extension of Improvement Period under the License Agreement, Feasibility Evaluation and Mutual Release.

 

2.1     Extension of Improvement Period. The Parties agree to extend the “Improvement Period” in the License Agreement through August 16, 2018 and hereby amend the License Agreement accordingly as set forth in Section 8.1 below. As amended, the Improvement Period includes the entire time period between August 16, 2010 and August 16, 2018.

 

2.2     Feasibility Evaluation. Promptly after the Effective Date, the Parties shall initiate and collaborate on certain testing activities of Cardica’s MicroCutter XCHANGE®, in order for Intuitive to evaluate the feasibility of Cardica’s MicroCutter XCHANGE and decide whether to initiate a Joint Development Program (“Joint Development Program”) with Cardica to develop a new Reload and Stapler for use with Intuitive’s Surgical System, as further set forth in Section 3 (such testing and evaluation, the “Evaluation”). Such Evaluation shall be completed within the first six (6) months after the Effective Date unless the Parties otherwise agree in writing (the “Evaluation Period”). During the Evaluation Period, Cardica shall perform such testing as Intuitive shall reasonably request that is within the scope of the Evaluation and designed to evaluate whether Cardica’s MicroCutter XCHANGE will meet Intuitive’s specifications as specifically set forth in Exhibit A (the “Continuation Criteria”) and Cardica shall provide Intuitive with all data Intuitive shall reasonably request. Based on the result of such Evaluation, Intuitive shall decide whether it wishes to initiate the Joint Development Program by written notice to Cardica within sixty (60) days after the expiration of the Evaluation Period. If Intuitive notifies Cardica of its desire to initiate such Joint Development Program within sixty (60) days after the expiration of the Evaluation Period, then the Joint Development Program as set forth in Section 3 shall continue. If Intuitive notifies Cardica of its desire not to continue with such Joint Development Program, or if Intuitive does not provide Cardica with any notification of its intent within sixty (60) days after the expiration of the Evaluation Period, then the Joint Development Program as set forth in Section 3 herein shall not proceed. In the event that the Joint Development Program does not proceed because the Continuation Criteria have not been met by the end of the sixty (60) day period after the Evaluation Period, then the License Agreement shall continue as modified herein (e.g., Extension of the Improvement Period, the Mutual Release, etc.), but Section 7.3 shall not apply. In the event that testing during the Evaluation Period satisfies Intuitive that the MicroCutter XCHANGE is feasible, but Intuitive nevertheless elects not to proceed with the Joint Development Program, then the License Agreement shall continue as modified herein (e.g., Extension of the Improvement Period, the Mutual Release, etc.), and Section 7.3 shall apply.

 

2.3     Payment. In consideration of the extension of the Improvement Period and the feasibility Evaluation, Intuitive shall pay to Cardica a one-time, non-refundable and non-creditable payment in the amount of two million dollars (US$2,000,000) within ten (10) business days after the Effective Date.

 

2.4     Mutual Release In full consideration of and in exchange for the promises and consideration provided under this Article 2, each of Cardica and Intuitive hereby fully and unconditionally releases and forever discharges each other from any and all claims, causes of action, charges, complaints, demands, actions, and liabilities of any nature whatsoever, known or unknown, suspected or unsuspected, legal or equitable, that such Party may have against the other Party prior to and as of the Effective Date. It is further understood and agreed by the Parties that as a condition of this Development Agreement, Cardica and Intuitive hereby expressly waive and relinquish any and all claims, rights or benefits that they may have under California Civil Code Section 1542, which provides as follows:

 

 

 

“A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE WHICH IF KNOWN BY HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.”

 

In connection with such waiver and relinquishment, the Parties hereby acknowledge that they or their attorneys may hereafter discover claims or facts in addition to, or different from, those which they now know or believe to exist, but that they expressly agree to fully, finally and forever settle and release any and all claims, known or unknown, suspected or unsuspected, which exist or may exist on their behalf against Releasees at the time of execution of this Development Agreement. The Parties further acknowledge, understand and agree that this representation and commitment is essential to each Party and that this Development Agreement would not have been entered into were it not for this representation and commitment. For clarity, the License Agreement (as amended by this Development Agreement) remains in full force and effect, and nothing contained herein shall be construed to release, waive or discharge any Party from any of its future obligations under the License Agreement.

 

3.	Potential Joint Development Program.

 

3.1     Overview. Subject to the terms and conditions of this Development Agreement, and only upon election by Intuitive as described in Section 2.2, above, the Parties will conduct a Joint Development Program with the goal of developing and obtaining regulatory approval for an 8mm Reload using Cardica’s proprietary technology and the corresponding Stapler (such Reload, the “8mm Reload”, such Stapler, the “8mm Stapler” and collectively, the “8mm Products”) for use in the Field of Use with Intuitive’s da Vinci Xi robotic surgical system or any other of Intuitive’s robotic surgical systems (the “Intuitive Surgical System”). As between the Parties, Cardica shall be responsible for the design and development of the 8mm Reload according to the specifications provided by Intuitive (the “Specifications”), and Intuitive shall be responsible for: (a) developing the 8mm Stapler that deploys the 8mm Reload in the Intuitive Surgical System; and (b) obtaining regulatory approval of the 8mm Products for use with the Intuitive Surgical System, all as set forth in the Development Plan. Each Party shall conduct the activities assigned to it under the Development Plan in a professional manner and in compliance with all applicable laws and regulations.

 

3.2     Development Plan. Within ninety (90) days after Intuitive notifies Cardica of its desire to initiate the Joint Development Program under Article 2, the Parties will agree on a development plan (the “Development Plan”) that sets forth the timeline and details of all development work to be conducted by the Parties in order to obtain regulatory approval for the 8mm Products for use with the Intuitive Surgical System. Intuitive shall be responsible for development work on the 8mm Stapler, and Cardica shall be primarily responsible for development work on the staple cartridges. The Development Plan shall also include a budget for the development work on the staple cartridges to be conducted (the “Development Budget”). From time to time, the Parties may amend or update the Development Plan by mutual agreement.

 

 

 

3.3     Joint Development Team. In the event Intuitive elects to move forward under a Development Plan, the Parties shall establish a joint development team (the “Joint Development Team” or “JDT”) to oversee the Parties’ development work under this Development Agreement. The JDT shall consist of two (2) representatives from each Party, and each representative shall have knowledge and expertise in the development of similar products. The JDT shall coordinate the Parties’ development activities under the Development Plan, oversee the implementation of the Development Plan, and provide a forum for and facilitate communications between the Parties with respect to the development of the 8mm Products. The JDT shall not have any decision making authority and all decisions regarding the development of the 8mm Products shall be made by mutual agreement of the Parties. The JDT shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every quarter. The JDT meetings may be held in person or by audio or video teleconference. Each Party shall be responsible for all of its own expenses of participating in the JDT meetings.

 

3.4     Development Costs

 

a)     Intuitive shall be solely responsible for all costs and expenses incurred in conducting the development work related to the 8mm Stapler (including for any such work performed by Cardica, at Intuitive’s request).

 

b)     With regard to costs and expenses incurred in conducting the development work related to the 8mm Reload (“Reload Development Costs”), Intuitive shall contribute [*] of the Reload Development Costs during the first two and one half years after the Effective Date (the “Joint Development Period”), up to a maximum amount not to exceed [*] per year and [*] in total (collectively, the “Cap”). Within thirty (30) days after the end of each quarter in the Joint Development Period, each party shall provide the other with documentation setting forth Reload Development Costs incurred by them during the preceding quarter. Intuitive will then calculate each Party’s respective share of the Reload Development Costs and, in the event Cardica incurred more costs than its [*] share, Intuitive shall pay to Cardica the balance due, subject to the Cap, for that quarter within thirty (30) days after the receipt of documentation from Cardica setting forth its Reload Development Costs. In the event that Intuitive incurred more Reload Development Costs than its [*] share in a given quarter, then any amount incurred by Intuitive over and above its share shall be applied as credit to subsequent quarters. For avoidance of doubt, Intuitive shall not be credited for any Reload Development Costs for Reload Development Work that Cardica has not authorized. In the event of a dispute between the parties with regard to Development Costs incurred by either party, the parties shall proceed as set forth above with respect to the undisputed amount, and any disputed amounts shall be resolved pursuant to the Article 10 of the License Agreement (Dispute Resolution).

 

 

 

c)     Development Costs shall include parties’ internal (calculated at the FTE rate set forth below) and out of pocket costs and expenses incurred to conduct the development work under the Development Plan. For the purpose of this Development Agreement, (i) “FTE Rate” means the cost of an FTE performing development work under the Development Plan, which rate shall be calculated as (a) for an employee, [*] of that employee’s annual salary, up to a maximum of [*] per FTE per year, or (b) for a contractor, that contractor’s hourly rate of pay, up to a maximum of [*] per hour; and (ii) “FTE” means the equivalent of a full-time individual’s work, at [*] hours per year, for a twelve (12)-month period, performing development work under the Development Plan. For clarity, the Parties intend the FTE to be a unit of measurement used to calculate the amount of time dedicated to the performance of this Development Agreement. One FTE may constitute work performed by an individual whose time is dedicated solely to this Development Agreement or may be comprised of the efforts of several individuals, each of whom dedicates only part of his or her time to work under this Development Agreement.

 

3.5     Diligence. Each Party shall use Commercially Reasonable Efforts to conduct the development work assigned to such Party under the Development Plan. In particular, Intuitive shall use Commercially Reasonable Efforts to incorporate the 8mm Products into the Intuitive Surgical System and to obtain regulatory approval of the 8mm Products for use with the Intuitive Surgical System. Without limiting the foregoing, Intuitive shall maintain an active and ongoing development program for the 8mm Products, and for clarity, Intuitive shall not be deemed to be maintaining an active and ongoing development program for the 8 mm Product if Intuitive discontinues the development and/or commercialization activities with respect to the 8mm Product for an aggregate six (6) month period within any consecutive twelve (12) month period.

 

3.6     Records. Each Party shall keep complete and accurate records of the activities conducted by it under the Development Plan. The Parties shall share the progress of the development program regularly through the JPT meetings, and each Party shall, at the other Party’s reasonable request, provide the other Party access to such records in furtherance of the development program and/or to verify such Party’s compliance with this Agreement.

 

4.	Commercialization; Royalty.

 

4.1     Diligence. Intuitive shall use Commercially Reasonable Efforts to launch and commercialize the 8mm Products after regulatory approval has been obtained.

 

4.2     Royalty. Intuitive shall pay royalties to Cardica on the sale of the 8mm Products under the License Agreement, provided however that Section 4.2 of the License Agreement shall be amended as provided in Section 8.3 below.

 

5.	Special Tooling.

 

5.1     Tooling Costs. The Parties acknowledge that the development and manufacture of the 8mm Reloads require certain special tooling (“Tooling”) and Intuitive shall pay for the cost of such Tooling for three (3) sizes of 8mm Reload (white, blue and green) up to a total of [*]. Cardica shall provide a request for the planned purchase of such Tooling to Intuitive and Intuitive shall purchase such Tooling as soon as practicable but in no event later than thirty (30) days after receiving such request from Cardica. Intuitive shall retain title to the Tooling, which will be located in Cardica’s third party vendor, as agreed by Intuitive, until such time as [*], or as otherwise agreed to by the Parties, at which time Intuitive shall take possession of the Tooling.

 

 

 

5.2     Use; Maintenance. Cardica shall use the Tooling for the development and manufacture of the 8mm Reloads under this Development Agreement and for no other purpose absent the prior written consent of Intuitive. Intuitive shall be responsible for the maintenance and repair cost for the Tooling.

 

6.	Manufacture and Supply.

 

6.1     Initial Supply; Purchase Order. Cardica will manufacture and supply up to [*] 8mm Reloads to Intuitive for commercial use. Intuitive shall submit purchase order(s) for the 8mm Reloads to Cardica, specifying the quantity ordered and requested delivery date (no earlier than thirty (30) days after the date of the purchase order). All purchase orders are subject to reasonable acceptance by Cardica. The term and conditions of this Development Agreement shall be controlling over any conflicting terms and conditions stated in any purchase order or any other document submitted by a Party to the other Party with respect thereto (unless the Parties shall have mutually agreed to the contrary in writing with respect to a particular instance).

 

6.2     Delivery; Inspection. If Cardica accepts a purchase order, then Cardica shall manufacture and supply the 8mm Reloads in accordance with the purchase order. The delivery of the 8mm Reloads shall take place EXW at Cardica’s (or its third party manufacturer’s) facility (Incoterm 2010) and Intuitive shall contract and arrange for shipping and insurance from such facility. Intuitive shall promptly inspect the 8mm Reloads upon receipt and shall notify Cardica if any 8mm Reload does not conform to the applicable 8mm Reload specifications within thirty (30) days after receipt. If Cardica agrees that the 8mm Reload supplied is non-conforming product, then Cardica shall promptly replace such non-conforming product with conforming product at no additional cost to Intuitive.

 

6.3     Transfer Price; Payment. Intuitive shall pay for the 8mm Reloads supplied by Cardica at a transfer price of [*] per Reload. Cardica shall invoice Intuitive for the transfer price upon delivery and Intuitive shall pay the invoiced transfer price within thirty (30) days after the receipt of the invoice.

 

6.4     Manufacture by Intuitive; Technology Transfer. After Intuitive has purchased up to [*] 8mm Reloads from Cardica, Intuitive will manufacture and supply the 8mm Reloads itself (or through its own contract manufacturer). Upon Intuitive’s reasonable request, Cardica shall provide Intuitive (or its third party contract manufacturer) reasonable technical assistance to transfer the manufacturing process for the 8mm Reloads. Such technology transfer shall include reasonable access to Cardica’s technical personnel familiar with the manufacturing process. Intuitive shall be responsible for and shall reimburse Cardica for the cost and expenses incurred by Cardica for providing such technical assistance, including both internal personal cost (at the FTE Rate) and out-of-pocket costs, except that the first [*] hours of FTE time shall be provided at no cost to Intuitive.

 

 

 

7.	Term Termination.

 

7.1     Term. This Development Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to Section 7.2, shall remain in effect until the expiration of Intuitive’s royalty payment obligations under Section 4.2.

 

7.2     Termination. The Agreement may be terminated: (a) in the event testing during the Evaluation Period does not establish that Cardica’s MicroCutter XCHANGE will meet Intuitive’s specifications, (b) in the event testing during the Evaluation Period establishes that Cardica’s MicroCutter XCHANGE meets the Continuation Criteria, but Intuitive decides not to initiate the Joint Development Program or does not provide notification thereof to Cardica within sixty (60) days after the Evaluation Period; (c) upon written notification by either Party to the other Party for such other Party’s material breach of its obligations, representations and/or warranties in this Agreement, unless such other Party cures such breach within such thirty (30) day period; and/or (d) upon the termination of the License Agreement.

 

7.3     Effect of Early Termination. Upon any earlier termination (but not expiration) of this Development Agreement under Section 7.2(b) or a material breach by Intuitive under Section 7.2(c) (but not upon termination for a material breach by Cardica under Section 7.2(c), upon termination under Section 7.2(a) or upon termination under Section 7.2(d)):

 

a)     The licenses granted by Cardica to Intuitive under the License Agreement shall become non-exclusive, and the License Agreement shall be amended as set forth in Section 8.4.

 

b)     Cardica shall have the right to grant additional licenses under the Licensed IP. If Cardica grants any additional license to a third party for such third party to develop and commercialize any staple product covered by Licensed IP in the Field of Use and receives any Licensing Revenue, then [*] to the extent [*]. As used herein, “[*]” means [*].

 

7.4     Survival. Expiration or termination of this Development Agreement shall not affect any rights or obligations of either Party under this Development Agreement that have accrued before the date of expiration or termination. Except as expressly set forth herein, expiration or termination of this Development Agreement shall not affect the License Agreement, which shall continue in full force and effect (as amended by this Development Agreement). Without limiting the foregoing, the following provisions shall survive any expiration or termination of this Development Agreement: Sections 2.1, 2.4, 5, 7.4, 8.1, 8.2, 8.3, 8.4, and 9. In addition, the following provisions shall survive the earlier termination (but not the expiration) of this Development Agreement: Sections, 7.3 and 8.4.

 

8.	Amendment to Licensed Agreement.

 

8.1     Improvement Period. Section 1(j) of the License Agreement is hereby deleted and replaced in its entirety with the following:

 

“(j)     “Improvement Period” shall mean the period of time beginning on the Agreement Date and expiring on August 16, 2018.”

 

 

 

8.2     Improvement Period Patent Rights. Section 1(k) of the License Agreement is hereby deleted and replaced in its entirety with the following:

 

“(k)     “Improvement Period Patent Rights” shall mean: (a) any Patent Rights conceived or applied for by Cardica between August 16, 2010 and August 16, 2013; and (b) any Patent Rights conceived or applied for by Cardica in the Licensed Field between August 17, 2013 and August 16, 2018.”

 

8.3     Royalty. Section 4.2 of the License Agreement is hereby deleted and replaced in its entirety with the following:

 

“4.2.     8mm Products. Upon first commercial sale by Intuitive or an Affiliate or Sublicensee of an 8mm Reload, and for a period not to exceed [*] years from such first commercial sale, Intuitive or an Affiliate shall pay Cardica a royalty of [*] per 8mm Reload; provided however that, Intuitive shall have the right to deduct [*] of such royalty (i.e., [*] per 8mm Reload) until: the total development cost reimbursement paid by Intuitive to Cardica under Section 3.4 of that certain Development Agreement between the Parties dated December [__], 2015, minus the total deductions made by Intuitive under this Section 4.2 equals [*] of the total Cardica Development Costs incurred throughout the term of such Development Agreement. However, Intuitive is only obligated to pay Cardica any such royalty in a jurisdiction in which at least one valid granted patent owned or Controlled by Cardica has one or more claims that (i) include one or more novel features associated with such 8mm Reload and/or corresponding anvil, and (ii) would be infringed absent a license from Cardica by the use, sale, importation, or manufacture of any such 8mm Reload.”

 

8.4     Amendment upon Termination. In addition, upon earlier termination (but not expiration) of this Development Agreement under Section 7.2(b) or a material breach by Intuitive under Section 7.2(c) (but not upon termination for a material breach by Cardica under Section 7.2(c), upon termination under Section 7.2(a) or upon termination under Section 7.2(d)):

 

a)     The first sentence in Section 2.1(a) of the License Agreement shall be deleted and replaced with the following:

 

“Cardica hereby grants to Intuitive a worldwide, perpetual, irrevocable, non-exclusive, non-sublicenseable (except for any sublicense(s) granted by Intuitive prior to the effective date of such termination and to Intuitive Affiliates) license under the Licensed IP to practice such Licensed IP in the Field of Use, such non-exclusive license including but not limited to the right to make, have made, use, offer for sale, sell, market, import, export, distribute, and Commercialize, in any manner whatsoever, the Licensed IP in the Field of Use.”

 

b)     Sections 2.1(c), 2.1(d), 2.1(g), 2.2(b) and Section 2.3 are hereby deleted in their entirety.

 

c)     Section 5 of the License Agreement shall be deleted and replaced in its entirety with the following:

 

 

 

“5.     Enforcement and Defense of Licensed IP.

 

5.1.     Rights to Enforce. Cardica shall have the sole right but not the obligation to prosecute or seek to end at its own expense any Infringement of the Licensed IP.

 

5.2.     Defense of Licensed IP. If Intuitive receives notice by counterclaim, declaratory judgment action or otherwise, alleging the invalidity, unenforceability, non-infringement, misuse, or misappropriation with respect to any Licensed IP, it shall bring such fact to the attention of Cardica. Cardica shall have the sole right but not the obligation to defend such action at its own cost and expense, and Intuitive agrees to cooperate with Cardica in such defense.”

 

5.3.     Amount Recovered. Cardica shall retain any and all amounts recovered for the enforcement or defense of the Licensed IP.

 

d)     Section 6 of the License Agreement shall be deleted and replaced in its entirety with the following:

 

“6.     Prosecution of Patent Rights.

 

6.1     Prosecution and Maintenance of Patent Rights. As between the Parties, Cardica shall have the sole right, but not the obligation to prepare, file, prosecute and maintain any Licensed Patent Rights, at its own cost and expense.”

 

e)     Sections 9.1, 9.2 and 9.3 are hereby deleted in their entirety.

 

f)     The last sentence in Section 9.4 shall be deleted and replaced with the following:

 

“This paragraph shall not apply to any violation or infringement by a Party or its Affiliates of the Intellectual Property of the other Party or its Affiliates, or to any breach of Section 7.”

 

9.	Miscellaneous.

 

9.1     Confidentiality. All information disclosed by a Party to the other Party under this Development Agreement shall be deemed disclosed under the License Agreement and subject to the confidentiality obligations set forth therein.

 

9.2     Dispute Resolution. Any dispute or disagreement between the Parties under this Development Agreement shall be resolved in accordance with the dispute resolution mechanism set forth in the License Agreement.

 

9.3     Entire Agreement; Amendment. This Development Agreement, together with the License Agreement (as amended), constitute the entire agreement between the Parties with respect to the subject matter hereof and thereof, and supersede all prior agreements and understandings, whether written or oral, between the Parties, or any of the Parties, in connection with such subject matter. This Development Agreement may be amended, modified, or supplemented only by a written instrument executed by both Parties.

 

 

 

9.4     No Waiver. No waiver of any provision of this Development Agreement, or consent to any departure from the terms of this Development Agreement, shall be effective unless the same shall be in writing and signed by the Party waiving or consenting thereto. No failure on the part of any Party to exercise, and no delay in exercising, any right or remedy under this Development Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of any such right or remedy by such Party preclude any other or further exercise thereof or the exercise of any other right or remedy. The waiver by any Party to this Development Agreement of a breach of any provision of this Development Agreement shall not operate as a waiver of any subsequent breach. All rights and remedies under this Development Agreement are cumulative and are in addition to, and not exclusive of, any other rights and remedies provided by law.

 

9.5     Severability. If any provision of this Development Agreement is found invalid or unenforceable by an arbitrator or court of competent jurisdiction, such provision shall be enforced to the maximum extent permissible by law and the other provisions of this Development Agreement shall remain in full force and effect.

 

9.6     Relationship of the Parties. This Development Agreement shall not constitute either Party the agent or legal representative of the other Party for any purpose whatsoever, and neither Party shall hold itself out as an agent of the other Party. This Development Agreement creates no relationship of joint venturers, partners, associates, employment, or principal and agent between the Parties, and both Parties are acting as independent contractors. Neither Cardica nor Intuitive is granted in this Development Agreement any right or authority to, and shall not attempt to, assume or create any obligation or responsibility for or on behalf of the other. Neither Cardica nor Intuitive shall have any authority to bind the other to any contract, whether of employment or otherwise, and Cardica and Intuitive shall bear all of their respective expenses for their operations, including the compensation of their employees and the maintenance of their offices and service facilities. Cardica and Intuitive shall each be solely responsible for their own employees and salespeople and for their acts and the things done by them.

 

9.7     No Election of Remedies. Except as otherwise specifically provided in this Development Agreement, the rights and remedies accorded in this Development Agreement to Cardica and Intuitive are cumulative and in addition to those provided by law, and may be exercised separately, concurrently, or successively.

 

9.8     Costs and Expenses. Except as expressly stated otherwise in this Development Agreement, each Party shall bear its own costs and expenses of performance of this Development Agreement.

 

9.9     Force Majeure. No Party shall be liable for failure to perform any of its obligations under this Development Agreement when such failure is due to fire, flood, strikes, labor troubles or other industrial disturbances, legal restriction, riot, insurrection, or any other cause beyond the reasonable ability of the Party affected thereby to control, and without such Party’s fault or negligence (“Force Majeure”), provided that any Party claiming the existence of Force Majeure shall give notice to the other Party not more than seven (7) days after the commencement of the event of Force Majeure, and shall use prompt and diligent efforts to mitigate the effects of Force Majeure.

 

 

 

9.10     Notice. All notices, requests, demands, claims, and other communications under this Development Agreement shall be delivered in accordance with the requirements set forth in the License Agreement.

 

9.11     Benefits and Burdens; Assignments. This Development Agreement shall be binding upon and shall inure to the benefit of each of the Parties as well as their respective legal representatives, successors, and permitted assigns. This Development Agreement shall not be assignable or transferable, by operation of law or otherwise, by either Party without the other Party’s written consent, which consent shall not be unreasonably withheld, conditioned, or delayed, and with the exceptions that either Party or its permitted assignee(s) may assign this Development Agreement together with any permitted assignment of the License Agreement (i) in whole or in part to an Affiliate of the assigning Party so long as the assigning Party agrees in writing to remain liable for the Affiliate’s performance of its obligations under this Agreement; or (ii) in whole to a party who acquires all or substantially all of the assets of the assigning Party or of the assets of the business of the assigning Party to which this Agreement relates; or (iii) in whole to any successor to the assigning Party by merger or consolidations; provided in each case the assignee agrees in writing to assume the assigning Party’s obligations under this Agreement. Any attempt to assign or transfer this Development Agreement or any portion thereof in violation of this Section shall be void.

 

9.12     Interpretation. When a reference is made in this Development Agreement to Sections or Exhibits, such reference shall be to a Section of or Exhibit to this Development Agreement unless otherwise indicated. References to Sections include subsections, which are part of the related Section (e.g., a section numbered “Section 5.1(a)” would be part of “Section 5.1”, and references to “Section 5.1” would also refer to material contained in the subsection described as “Section 5.1(a)”). The recitals to this Development Agreement constitute an integral part of this Development Agreement. Headings contained in this Development Agreement are for convenience of reference only and shall not affect in any way the meaning or interpretation of this Development Agreement. The language used in this Development Agreement shall be deemed to be the language chosen by the Parties to this Development Agreement to express their mutual intent, and no rule of strict construction shall be applied against any Party (e.g., ambiguities, if any, in this Development Agreement shall not be construed by default against either Party simply because one or the other Party is deemed to have drafted the provision at issue). Whenever the context may require, any pronouns used in this Development Agreement shall include the corresponding masculine, feminine, or neuter forms, and the singular form of nouns and pronouns shall include the plural, and vice versa. Any reference to any federal, state, local, or foreign statute or law shall be deemed also to refer to all rules and regulations promulgated thereunder, unless the context requires otherwise. Whenever the words “include,” “includes” or “including” are used in this Development Agreement, they shall be deemed to be followed by the words “but not limited to”. No summary of this Development Agreement prepared by any Party shall affect the meaning or interpretation of this Development Agreement. All references to dollars in this Development Agreement shall be to United States Dollars.

 

 

 

9.13     Public Announcement. Neither Party or any of its Affiliates or Representatives shall issue any press release or make any public announcement or disclosure with respect to this Development Agreement or the transactions contemplated hereby, including the mutual release under the License Agreement, without the prior written consent of the other Party, which will not be unreasonably withheld or delayed, provided that in the event that a Party shall have previously approved the form of a press release or other public disclosure, the other Party shall be free to continue to disclose substantially the same information in additional public disclosures without having to obtain such Party’s consent thereto. Additionally, Intuitive acknowledges that as a public company, Cardica is required by law to file or disclose certain information with certain agencies or authorities. In connection herewith, Intuitive acknowledges that Cardica will be required to file this Development Agreement with the U.S. Securities and Exchange Commission (“SEC”) as a “material agreement” of Cardica, but Cardica shall do so with respect to this Development Agreement under a request for confidential treatment which shall be submitted to Intuitive for its approval (not to be unreasonably withheld or delayed) prior to submission. Once information is so disclosed or filed and is thereby made publicly available, Cardica shall be free to disclose substantially the same information in subsequent public filings or in public disclosures without having to first obtain Intuitive’s prior written approval.

 

9.14     Governing Law and Jurisdiction. This Development Agreement and any dispute arising from the performance or breach hereof shall be governed by, construed, and enforced in accordance with the laws of the State of California without regard to conflict of laws provisions.

 

9.15     Counterparts and Facsimile Signatures. This Development Agreement may be executed in two or more counterparts, all of which shall be considered one and the same agreement and shall become effective when two or more counterparts have been signed by each Party and delivered to the other Party, it being understood that all Parties need not sign the same counterpart. Facsimile execution and delivery of this Development Agreement by any of the Parties shall be legal, valid, and binding execution and delivery of such document for all purposes.

 

[signature page follows]

 

 

 

In Witness Whereof, the Parties have executed this Development Agreement in duplicate originals by their proper officers as of the Effective Date.

 

 

CARDICA, INC.			INTUITIVE SURGICAL OPERATIONS, INC.
By: /s/ Julian Nikolchev			By: /s/ Bob DeSantis
Name: Julian Nikolchev			Name: Bob DeSantis
Title: President and CEO			Title: Sr. VP Instrument Engineering

 

 

    

EXHIBIT A

CONTINUATION CRITERIA

  

[*]

 

 

[*] = 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 31.1

CERTIFICATION

 

 

I, Julian Nikolchev, certify that:

 

1.     I have reviewed this 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: February 10, 2016		/s/ Julian Nikolchev
		Julian Nikolchev
		President, Chief Executive Officer and Director
		(Principal Executive Officer)

 

Exhibit 31.2

 

CERTIFICATION

 

I, Robert Y. Newell, certify that:

 

1.     I have reviewed this 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: February 10, 2016		/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), Julian Nikolchev, 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 knowledge:

 

1.	The Company’s Quarterly Report on Form 10-Q for the period ended December 31, 2015, 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 10th day of February, 2016.

   

 

/s/ Julian Nikolchev			/s/ Robert Y. Newell
Julian Nikolchev			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.

v3.3.1.900

Document And Entity Information - shares	6 Months Ended
	Dec. 31, 2015	Feb. 05, 2016
Entity Registrant Name	CARDICA INC
Entity Central Index Key	0001178104
Trading Symbol	crdc
Current Fiscal Year End Date	--06-30
Entity Filer Category	Smaller Reporting Company
Entity Current Reporting Status	Yes
Entity Voluntary Filers	No
Entity Well-known Seasoned Issuer	No
Entity Common Stock, Shares Outstanding (in shares)		89,018,550
Document Type	10-Q
Document Period End Date	Dec. 31, 2015
Document Fiscal Year Focus	2016
Document Fiscal Period Focus	Q2
Amendment Flag	false

v3.3.1.900

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Dec. 31, 2015	Jun. 30, 2015
Current assets:
Cash and cash equivalents	$ 6,381	$ 8,264
Short-term investments	12,099	12,972
Accounts receivable, net	533	424
Inventories	1,018	1,391
Prepaid expenses and other current assets	221	310
Total current assets	20,252	23,361
Property and equipment, net	1,452	1,859
Long-term investments		3,970
Restricted cash	104	104
Total assets	21,808	29,294
Current liabilities:
Accounts payable	862	699
Accrued compensation	885	434
Other accrued liabilities	594	522
Current portion of deferred revenue	403	403
Total current liabilities	2,744	2,058
Deferred revenue, net of current portion	2,125	2,125
Notes Payable, Noncurrent	2,971	2,828
Other non-current liabilities	214	194
Total liabilities	$ 8,054	$ 7,205
Commitments and contingencies (Note 9)
Stockholders' equity:
Preferred stock, $0.001 par value: 5,000,000 shares authorized: 191,474 shares issued and outstanding at December 31, 2015, and June 30, 2015	$ 17,214	$ 17,214
Common stock, $0.001 par value: 125,000,000 shares authorized: 89,084,777 and 89,021,443 shares issued and 89,018,550 and 88,955,216 shares outstanding at December 31, 2015, and June 30, 2015, respectively	89	89
Additional paid-in capital	195,499	195,099
Treasury stock at cost (66,227 shares at December 31, 2015, and June 30, 2015)	(596)	(596)
Accumulated comprehensive loss	(14)	(8)
Accumulated deficit	(198,438)	(189,709)
Total stockholders' equity	13,754	22,089
Total liabilities and stockholders' equity	$ 21,808	$ 29,294

v3.3.1.900

Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares	Dec. 31, 2015	Jun. 30, 2015
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	191,474	191,474
Preferred stock, shares outstanding (in shares)	191,474	191,474
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	125,000,000	125,000,000
Common stock, shares issued (in shares)	89,084,777	89,021,443
Common stock, shares outstanding (in shares)	89,018,550	88,955,216
Treasury stock shares (in shares)	66,227	66,227

v3.3.1.900

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands	3 Months Ended		6 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2015	Dec. 31, 2014
Net revenue:
Product sales, net	$ 683,000	$ 639,000	$ 1,420,000	$ 1,690,000
Royalty revenue	17,000	18,000	35,000	35,000
Total net revenue	700,000	657,000	1,455,000	1,725,000
Operating costs and expenses:
Cost of product sales	889,000	944,000	1,912,000	2,577,000
Research and development	1,630,000	1,848,000	3,246,000	3,584,000
Selling, general and administrative	2,161,000	3,205,000	4,818,000	5,863,000
Total operating costs and expenses	4,680,000	5,997,000	9,976,000	12,024,000
Loss from operations	(3,980,000)	(5,340,000)	(8,521,000)	(10,299,000)
Interest income	14,000	13,000	27,000	26,000
Interest expense	(123,000)	(112,000)	(243,000)	(222,000)
Other income (expense), net	2,000	(3,000)	8,000	(12,000)
Net loss	$ (4,087,000)	$ (5,442,000)	$ (8,729,000)	$ (10,507,000)
Basic and diluted net loss per share (in dollars per share)	$ (0.05)	$ (0.06)	$ (0.10)	$ (0.12)
Shares used in computing basic and diluted net loss per share (in shares)	89,018	88,955	88,991	88,950

v3.3.1.900

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2015	Dec. 31, 2014
Net loss	$ (4,087)	$ (5,442)	$ (8,729)	$ (10,507)
Changes in market value of investments:
Change in unrealized loss on short-term investments, net of tax	(9)	(7)	(6)	(15)
Comprehensive loss	$ (4,096)	$ (5,449)	$ (8,735)	$ (10,522)

v3.3.1.900

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Operating activities:
Net loss	$ (8,729)	$ (10,507)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	543	743
Amortization of premiums on marketable securities	106	269
Stock-based compensation expense	400	627
Non-cash interest expense	143	121
Changes in operating assets and liabilities:
Accounts receivable, net	(109)	313
Prepaid expenses and other current assets	89	63
Inventories	373	(310)
Accounts payable and other accrued liabilities	255	628
Accrued compensation	451	(412)
Net cash used in operating activities	(6,478)	(8,465)
Investing activities:
Purchases of property and equipment	(136)	(385)
Proceeds from maturities of investments	13,658	13,279
Purchases of investments	(8,927)	(23,166)
Net cash provided by (cash used) in investing activities	4,595	(10,272)
Financing activities:
Net proceeds from issuances of common stock		(65)
Net increase (decrease) in cash and cash equivalents	(1,883)	(18,802)
Cash and cash equivalents at beginning of period	8,264	25,553
Cash and cash equivalents at end of period	6,381	6,751
Supplemental disclosure of cash flow information:
Interest paid	$ 100	100
Supplemental disclosure of non-cash information:
Incremental debt discount relating to note extension		$ 515

v3.3.1.900

Note 1 - Summary of Significant Accounting Policies	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Significant Accounting Policies [Text Block]	NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES   Organization         Cardica, Inc. (the “Company”) 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. The Company is commercializing and developing the MicroCutter XCHANGE® 30 based on its proprietary “staple-on-a-strip” technology intended for use by thoracic, pediatric, bariatric, colorectal and general surgeons. The MicroCutter XCHANGE® 30, which is currently commercially-available, is a cartridge based microcutter device with a 5 millimeter shaft diameter and a 30 millimeter staple line currently cleared for use in the United States for specified indications for use, and approved in Japan and in the European Union, or EU, for a broader range of specified indications for use. The Company previously had additional products in development, including the MicroCutter XCHANGE® 45, a cartridge based microcutter device with an 8 millimeter shaft and a 45 millimeter staple line, and the MicroCutter FLEXCHANGE™ 30, a cartridge based microcutter device with a flexible shaft to facilitate endoscopic procedures requiring cutting and stapling; however, the Company suspended development of these additional potential products to focus solely on development of the MicroCutter XCHANGE 30.   In March 2012, the Company completed the design verification for and applied Conformité Européenne, or the CE Mark, to the MicroCutter XCHANGE 30 and, in December 2012, began a controlled commercial launch of the MicroCutter XCHANGE 30 in Europe. The Company received from the United States Food and Drug Administration, or FDA, 510(k) clearances for the MicroCutter XCHANGE 30 and blue cartridge in January 2014, and for the white cartridge in February 2014, for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix. The blue cartridge is for use in medium thickness tissue, and the white cartridge is for use in thin tissue. In March 2014, the Company made its first sale of the MicroCutter XCHANGE 30 in the United States, and subsequently temporarily suspended its controlled commercial launch in November 2014, as the Company shifted its focus to improved performance based on surgeon feedback. In April 2015, the Company resumed its controlled commercial launch primarily in Europe, of the MicroCutter XCHANGE 30 for thinner tissue usually requiring deployment of white cartridges. While the Company continues this controlled commercial launch, the Company’s goal is to complete product improvements on the MicroCutter XCHANGE 30 combo device that will accommodate thicker tissue ranges requiring deployment of both white and blue cartridges. To further expand the use of the MicroCutter XCHANGE 30, the Company submitted a 510(k) Premarket Notification to the FDA in April 2015, to expand the indications for use to include vascular structures, and recently received FDA 510(k) clearance to use its MicroCutter XCHANGE ®  30 surgical stapling device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures. This clearance complements the existing indications for use of the MicroCutter XCHANGE 30 in surgical procedures in the small and large intestine and in the appendix.   The Company is attempting to expand in the international market of its MicroCutter XCHANGE 30 with additional selected regulatory filings. The Company also submitted the MicroCutter XCHANGE 30 blue and white cartridges application to Health Canada for regulatory approval of the MicroCutter XCHANGE 30 and, if the Company receives approval, anticipates launching it in Canada. In addition, in August 2013, the Company’s exclusive distributor in Japan, Century Medical, Inc., or Century, filed for regulatory approval of the MicroCutter XCHANGE 30 cartridges with the Pharmaceuticals and Medical Devices Agency, or PMDA, in Japan and in April 2014, filed for the MicroCutter XCHANGE 30 stapler with TUV Rheinland Japan Ltd, a registered third-party agency in Japan and received approvals in late 2014 for both, to market in Japan. Also, in January 2015, Century submitted an application to PMDA, relating to a change in the material of the cartridge insert component within the MicroCutter XCHANGE 30 cartridges, changing the distal tip of the cartridge insert material from a Vectra Liquid Crystal Polymer, or LCP, to IXEF Polyarylamide, or IXEF, and received approval in August 2015 to market in Japan.   Historically, the Company generated product revenues primarily from the sale of automated anastomotic systems; however, the Company started generating revenues from the commercial sales of the MicroCutter XCHANGE 30 in Europe in December 2012, and in the United States in March 2014, and through December 31, 2015, the Company generated $1.7 million of net product revenues from the commercial sales of the MicroCutter XCHANGE 30. In November 2015, the Company issued a voluntary removal of the MicroCutter XCHANGE 30 blue cartridges from the market, as the MicroCutter XCHANGE 30 device sold primarily in Europe was labeled for use with the white cartridge only. The impact of the returned products from the voluntary removal was not significant.     For the six months ended December 31, 2015, the Company generated net revenue of $1.4 million, including $1.1 million from the sale of automated anastomotic systems, $0.3 million from commercial sales of the MicroCutter XCHANGE 30 and $35,000 of royalty revenue.   Basis of Presentation and Principles of Consolidation   The accompanying unaudited condensed consolidated financial statements of the Company 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 consolidated financial statements have been prepared on the same basis as the annual financial statements which include the accounts of Cardica, Inc. and its wholly-owned subsidiary in Germany. All significant intercompany balances and transactions have been eliminated in consolidation. 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 consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended June 30, 2015, included in the Company’s Form 10-K filed with the Securities and Exchange Commission on September 25, 2015.   Recently Issued Accounting Standards   In November 2015, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2015-17, Income Taxes (Topic 740):  Balance Sheet Classification of Deferred Taxes . Under existing standards, deferred taxes for each tax-paying jurisdiction are presented as a net current asset or liability and net noncurrent asset or liability. The new guidance will require that all deferred tax assets and liabilities, along with related valuation allowances, be classified as noncurrent on the balance sheet. As a result, each tax-paying jurisdiction will now only have one net noncurrent deferred tax asset or liability. The new guidance does not change the existing requirement that prohibits offsetting deferred tax liabilities from one jurisdiction against deferred tax assets of another jurisdiction. ASU No. 2015-17 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016, which will be our fiscal year 2017 beginning July 1, 2016. The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated financial statements and related disclosures.   In July 2015, the FASB issued an accounting standard update which requires an entity measuring inventory other than last-in, first-out (LIFO) or the retail inventory method to measure inventory at the lower of cost and net realizable value. When evidence exists that the net realizable value of inventory is lower than its costs, the difference will be recognized as a loss in the statement of operations. The standard is effective for fiscal years beginning after December 15, 2016, and interim periods within fiscal years beginning after December 15, 2017. The Company will be evaluating the impact of the adoption of this standard on the Company’s consolidated financial statements and disclosures.   In April 2015, the FASB issued an accounting standard update which provides guidance on whether a cloud computing arrangement includes a software license to a customer of such an arrangement. If a cloud computing arrangement includes a software license, a customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses, otherwise the customer should account for the arrangement as a service contract. The standard is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015.  Early adoption is permitted. The standard can be applied prospectively to all arrangements entered into or materially modified after the effective date, or retrospectively. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements and disclosures.   In April 2015, the FASB issued an accounting standard update which requires an entity to present debt issuance costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. The standard is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015.  Early adoption is permitted. The standard will be applied retrospectively to each prior period presented.  The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated balance sheets.   In February 2015, the FASB issued an amendment to the accounting standard regarding the analysis that a reporting entity must perform to determine whether it should consolidate certain types of legal entities. All legal entities are subject to reevaluation under the revised consolidation model. The amendments in this update are effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015. The adoption of this update is not expected to have a material effect on the Company’s consolidated financial statements or disclosures.   In August 2014, the FASB issued an accounting standard update related to the disclosures around going concern. The new standard provides guidance around management’s responsibility to evaluate whether there are conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. The new standard is effective for the annual periods and interim periods within those annual periods beginning after December 15, 2016. Early application is permitted. The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated financial statements.   In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606): Revenue from Contracts with Customers , which guidance in this update will supersede the revenue recognition requirements in Topic 605, Revenue Recognition , and most industry-specific guidance when it becomes effective. ASU No. 2014-09 affects any entity that enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards. The core principal of ASU No. 2014-09 is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under current guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. ASU No. 2014-09 is effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period, which will be the Company’s fiscal year 2018 (beginning July 1, 2017), and entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. However, in July 2015, the FASB approved the deferral of the new standard's effective date by one year. The new standard will now be effective for annual reporting periods beginning after December 15, 2017, which will be our fiscal year 2019 (beginning July 1, 2018). The FASB will permit companies to adopt the new standard early, but not before the original effective date of December 15, 2016. The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated financial statements.   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. Significant estimates include the valuation of inventory, measurement of stock based compensation, valuation of financial instruments and revenue recognition. Actual results could materially 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 has 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 shipping documents and third-party proof of delivery to verify that title has 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’s sales to distributors do not include price protection.   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 they are earned and non-refundable upon receipt, 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 performance is rendered or 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. Further reduced demand may result in the need for additional 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.   Risks and Uncertainties   The Company depends upon a number of key suppliers, including single source suppliers, the loss of which would materially harm the Company’s business. Single source suppliers are relied upon for certain components and services used in manufacturing the Company’s products. The Company does not have long-term contracts with any of the suppliers; rather, purchase orders are submitted for each order. Because long-term contracts do not exist, none of the suppliers are required to provide the Company any guaranteed minimum quantities.   Foreign Currency Translation   The Company’s foreign operations are subject to exchange rate fluctuations and foreign currency costs. The functional currency of the German subsidiary is the United States dollar. Transactions and balances denominated in dollars are presented at their original amounts. Monetary assets and liabilities denominated in currencies other than the dollar are re-measured at the current exchange rate prevailing at the balance sheet date. All transaction gains or losses from the re-measurement of monetary assets and liabilities are included in the consolidated statements of operations within other income (expense).

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Note 2 - Stockholders' Equity	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Stockholders' Equity Note Disclosure [Text Block]	NOTE 2 - STOCKHOLDERS' EQUITY   Common Stock and Preferred Stock   In April 2014, the Company sold 37,375,000 shares of its common stock at $0.85 per share, and 191,474 shares of Series A Convertible Preferred Stock at $85 per share. The Series A convertible preferred stock is non-voting and is convertible into shares of common stock at a conversion rate of 100 shares of common stock for each share of Series A convertible preferred stock, provided that conversion will be prohibited if, as a result, the holder and their affiliates would own more than 9.98% of the total number of shares of the Company’s common stock then outstanding unless the holder gives the Company at least 61 days prior notice of an intent to convert into shares of common stock that would cause the holder to own more than 9.98% of the total number of shares of common stock then issued and outstanding. Net proceeds from the financing to the Company were approximately $44.6 million. For fiscal year ended June 30, 2014, the Company recorded a deemed dividend of $1.9 million related to beneficial conversion feature of series A convertible preferred stock. A one-time beneficial conversion charge was due to the difference between the common stock price and conversion price on the closing date of the Company’s public offering in April 2014.   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 provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company could 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 Company had received net proceeds of $1.2 million, from the sale of an aggregate of 884,756 shares of common stock through MLV prior to its expiration on August 2, 2014. During the six months ended December 31, 2014, the Company did not sell any shares of common stock through MLV.   Stock-Based Compensation   Stock-based compensation expense related to employee and director share-based compensation plans, including stock options and restricted stock units, or RSUs, pursuant to Accounting Standards Codification, or ASC, 718 “Compensation — Stock Compensation”. Stock-based compensation cost is measured on the grant date, based on the fair value-based measurement of the award and is recognized as an expense over the requisite service period which generally equals the vesting period of each grant. The Company recognizes compensation expense using the accelerated method and accounts for the non-employee share-based grants pursuant to ASC 505-50, Equity Based Payments to Non-Employees.   The Company selected the Black-Scholes option pricing model for determining the estimated fair value-based measurements of share-based awards. The use of the Black-Scholes model requires the use of assumptions including expected term, expected volatility, risk-free interest rate and expected dividends. The Company used the following assumptions in its fair value-based measurements:       Three months ended     Six months ended       December 31,     December 31,       2015     201 4     2015     201 4   Risk-free interest rate     1.33 %     0.21% - 1.59 %     0.71% - 1.50 %     0.21% - 1.65% % Dividend yield     —       —       —       —   Weighted-average expected term (in years)     4.98       4.90       4.24 - 4.98       4.83 - 4.90   Expected volatility     67.4 %     68.4 %     54.8% - 67.4 %     68.4% - 72.1 %   The Company estimates the expected life of options granted based on historical exercise and post-vest cancellation patterns, which the Company believes are representative of future behavior . The risk-free interest rate for the expected term of each option is based on a risk-free zero-coupon spot interest rate on the date of grant. The Company has never declared or paid any cash dividends and does not presently plan to pay cash dividends in the foreseeable future. The expected volatility is based on the Company’s historical stock price. The Company estimates forfeitures in calculating the expense related to stock-based compensation. The Company recorded stock-based compensation expenses under ASC 718 of $0.4 million and $0.6 million for the six months ended December 31, 2015 and 2014, respectively. The Company recorded stock-based compensation expenses under ASC 505-50 of $5,991 and $0 for the six months ended December 31, 2015 and 2014, respectively. In December 2014, the Company cancelled certain options granted to employees in excess of the stock plan limits, which resulted in the recognition of $0.2 million of unamortized expense recorded as stock-based compensation expenses. Total compensation expense related to unvested awards not yet recognized is approximately $1.0 million at December 31, 2015, and is expected to be recognized over a weighted average period of 3.3 years. For the three months ended December 31, 2015, the Company issued 4,891,169 options under its Inducement Plan to the Company’s new CEO at a grant price of $0.28 per share.         Included in the statement of operations are the following non-cash stock-based compensation expenses (in thousands):       Three months ended     Six months ended       December 31,     December 31,       2015     201 4     2015     201 4   Cost of product sales   $ 17     $ 21     $ 35     $ 51   Research and development     30       (10 )     72       53   Selling, general and administrative     218       303       293       523   Total   $ 265     $ 314     $ 400     $ 627

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Note 3 - Net Loss Per Share	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Earnings Per Share [Text Block]	NOTE 3 - NET LOSS PER SHARE   Basic net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding for the period, and without consideration of potential common shares.  Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period, plus 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 loss per share when their effect is dilutive.     In the years the preferred stock is outstanding, the two-class method is used to calculate basic and diluted earnings (loss) per common share since it is a participating security under ASC 260 Earnings per Share . The two-class method is an earnings allocation formula that determines earnings per share for each class of common stock and participating security according to dividends declared (or accumulated) and participation rights in undistributed earnings. Under the two-class method, basic earnings (loss) per common share is computed by dividing net earnings (loss) attributable to common share after allocation of earnings to participating securities by the weighted-average number of common shares outstanding during the year. Diluted earnings (loss) per common share is computed using the more dilutive of the two-class method or the if-converted method. In periods of net loss, no effect is given to participating securities since they do not contractually participate in the losses of the Company.   The following table sets forth the computation of basic and diluted net loss per share (in thousands, except per share data):       Three months ended     Six months ended       December 31,     December 31,       2015     2014     2015     2014   Numerator:                                 Net loss   $ (4,087 )   $ (5,442 )   $ (8,729 )   $ (10,507 ) Denominator:                                 Denominator for basic and diluted net loss per share     89,018       88,955       88,991       88,950   Basic and diluted net loss per share   $ (0.05 )   $ (0.06 )   $ (0.10 )   $ (0.12 )   The following table sets forth the outstanding securities not included in the diluted net loss per common share calculation as of December 31, 2015 and 2014, because their effect would be antidilutive (in thousands):       As of December 31,       2015     201 4   Options to purchase common stock     9,389       5,297   Unvested restricted stock awards     527       290   Shares reserved for issuance upon conversion of Series A Preferred     19,147       19,147   Total     29,063       24,734

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Note 4 - Fair Value Measurements	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Fair Value Disclosures [Text Block]	NOTE 4 - FAIR VALUE MEASUREMENTS         ASC 820, “Fair Value Measurements,”   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 on a recurring basis. All assets that are measured at fair value on a recurring basis 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 December 31 , 2015       Level 1     Level 2     Level 3     Total   Cash equivalents:                                 Money market funds   $ 5,165     $ —     $ —     $ 5,165   Corporate debt securities     —       744       —       744   Short-term investments:                                 Corporate debt securities     —       12,099       —       12,099                                     Total assets at fair value   $ 5,165     $ 12,843     $ —     $ 18,008         As of June 30, 2015       Level 1     Level 2     Level 3     Total   Cash equivalents:                                 Money market funds   $ 6,399     $ —     $ —     $ 6,399   Corporate debt securities     —       668       —       668   Short-term investments:                                 Corporate debt securities     —       12,972       —       12,972   Long-term investments:                                 Corporate debt securities     —       3,970       —       3,970                                     Total assets at fair value   $ 6,399     $ 17,610     $ —     $ 24,009       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 commercial papers are valued primarily using market prices comparable securities, bid/ask quotes, interest rate yields, and prepayment spreads and are included in Level 2.   Cash balances of $0.5 million at December 31, 2015, and $1.2 million at June 30, 2015, were not included in the fair value hierarchy disclosure. As of December 31, 2015, the Company’s material financial assets and liabilities were reported at their current carrying values which approximate fair value given the short-term nature of less than a year, except for its note payable. As of December 31, 2015, the Company’s note payable was reported at its current carrying value which approximates fair value based on Level 3 unobservable inputs involving discounted cash flows and the estimated market rate of borrowing that could be obtained by companies with credit risk similar to the Company’s credit risk. See “Note 8 - Note Payable ”.

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Note 5 - Available-for-Sale Securities	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block]	NOTE 5 – Available–for-Sale Securities   The Company held investments in marketable securities as of December 31, 2015, and June 30, 2015, with maturity dates of less than one year for short-term and greater than one year for long-term.   The Company’s investments consisted of the following (in thousands):       As of December 31, 2015       Amortized Cost     Gross Unrealized Gains     Gross Unrealized Losses     Fair Value   Available-for-sale securities:                                 Corporate debt securities – Short-term   $ 12,113     $ —     $ (14 )   $ 12,099                                     Total   $ 12,113     $ —     $ (14 )   $ 12,099           As of June 30, 201 5       Amortized Cost     Gross Unrealized Gains     Gross Unrealized Losses     Fair Value   Available-for-sale securities:                                 Corporate debt securities – Short-term   $ 12,978     $ —     $ (6 )   $ 12,972   Corporate debt securities – Long-term     3,972       —       (2 )     3,970                                     Total   $ 16,950     $ —     $ (8 )   $ 16,942

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Note 6 - Inventories	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Inventory Disclosure [Text Block]	NOTE 6 - INVENTORIES         Inventories consisted of the following (in thousands):       December 31, 201 5     June 30, 201 5   Raw materials   $ 714     $ 870   Work in progress     148       162   Finished goods     156       359   Total   $ 1,018     $ 1,391

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Note 7 - Distribution, License, Development and Commercialization Agreements	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Intangible Assets Disclosure [Text Block]	NOTE 7 – DISTRIBUTION, LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENTS   Century   On September 2, 2011, the Company signed a distribution agreement (the “2011 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 (“the 2011 note agreement”), Century agreed to loan the Company an aggregate of up to $4.0 million, with principal due in September 30, 2016, subject to certain conditions, which principal due date was extended by two years effective July 1, 2014. Under this facility, the Company received $2.0 million on September 30, 2011, and the remaining $2.0 million on December 27, 2011. The note bears 5% annual interest which is payable quarterly in arrears through September 30, 2018, the maturity date when the total $4.0 million of principal becomes due. In return for the loan commitment, the Company granted Century 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 is responsible for securing regulatory approval from the Ministry of Health in Japan for the microcutter product line. In August 2013, Century filed for regulatory approval of the MicroCutter XCHANGE 30 cartridges with the Pharmaceuticals and Medical Devices Agency and in April 2014, filed for the MicroCutter XCHANGE 30 stapler with TUV Rheinland Japan Ltd, a registered third-party agency in Japan and received approvals in late 2014 for both, to market in Japan. Also, in January 2015, Century submitted an application to PMDA, relating to a change in the material of the cartridge insert component within the MicroCutter XCHANGE 30 cartridges, changing the distal tip of the cartridge insert material from a LCP to IXEF, and received approval in August 2015 to market in Japan. Now that approvals for marketing in Japan have been obtained, the Company is working with Century to determine their launch plan for the MicroCutter XCHANGE 30 in Japan, specifically whether they launch the commercially-available thin tissue version of the device, or whether they wait until the MicroCutter XCHANGE 30 combo device is available.   Proceeds from the note and granting the distribution rights were allocated to the note based on its aggregate fair value of $2.4 million at the dates of receipt. This fair value was determined by discounting cash flows using a discount rate of 18%, which the Company estimated was a market rate of borrowing that could be obtained by companies with credit risk similar to the Company’s. The remainder of the proceeds of $1.6 million was recorded as debt issuance discount and was allocated to the value of the distribution rights granted to Century under the 2011 Distribution Agreement and is included in deferred revenue. The deferred revenue will be recognized over the term of the 2011 Distribution Agreement, beginning upon the first sale by Century of the microcutter products in Japan.   The Company’s distribution agreement with Century pertaining to the PAS-Port system, originally dated June 16, 2003, as amended, was last amended effective July 1, 2014. The last amendment, among other things, renewed the contract for another five years, and extended the expiration date to July 31, 2019. The note amendment was accounted for as the modification of the 2011 note agreement, as the value of the consideration provided by the Company in the form of additional distribution rights was estimated to be approximately equal to the reduction in the fair value of the note. Accordingly, the Company reduced the carrying value of the note of $3.1 million to its post-modification fair value of $2.6 million, and recorded the resulting incremental discount of $0.5 million as deferred revenue. The Company determined the fair value of the amended note using the discount rate of 18%, which the Company estimated as the market rate of borrowing as of the modification date that could be obtained by companies with credit risk similar to the Company’s. The incremental discount of $0.5 million will be amortized over the remaining term of the note using the effective interest rate method. The deferred revenue will be recognized over the term of the distribution agreement beginning upon the first sale by Century of the microcutter products in Japan.   As of December 31, 2015, and June 30, 2015, the balance of the loan was $3.0 million and $2.8 million net of debt issuance costs of $1.0 million and $1.2 million, respectively, and the distribution of the microcutter products had not begun for the respective periods.         For the six months ended December 31, 2015 and 2014, sales of automated anastomosis system to Century accounted for approximately 30% and 25%, of the Company’s total product sales. As of December 31, 2015, and June 30, 2015, Century accounted for approximately 39% and 47%, respectively, of the total accounts receivable balance.   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 eligible to receive single-digit royalties on sales by Intuitive Surgical, its affiliates or its sublicensees of specified products covered by the Company’s patent rights, if any. 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.   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 $3.0 million purchase of the Company’s common stock by Intuitive Surgical in connection with the License Agreement 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 was 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 was being recognized as revenue ratably over that three year period. The Company has fully recognized such revenue, and as of December 31, 2015, and June 30, 2015, there was no deferred revenue related to this arrangement.   On December 31, 2015, the Company and Intuitive Surgical amended the license agreement, which was initially signed in August 2010, to include, among other things, an agreement providing for a feasibility evaluation and potential development of a surgical stapling cartridge for use with Intuitive Surgical’s da Vinci Surgical Systems, effective December 30, 2015. Under the terms of the amendment, Intuitive Surgical paid $2.0 million to extend its rights to improvements in the Company’s stapling technology and certain patents until August 16, 2018, and to provide for a feasibility evaluation period of up to six months from December 31, 2015 to June 30, 2016.   The feasibility evaluation allows Intuitive Surgical to test and evaluate the Company’s MicroCutter XCHANGE technology. Upon completion of the evaluation, Intuitive Surgical will have the option to initiate a joint development program, for an 8-millimeters-in-diameter surgical stapling cartridge for use with the  da Vinci  Surgical System. Pursuant to such an agreement, the Company may receive further funding for development of the cartridge and tooling as well as a unit-based royalty on commercial sales. In addition, the amendment provides that each of the parties releases the other party from any claims they have or may have against the other party. The Company received the $2.0 million in January 2016, and as of December 31, 2015, the Company did not make delivery of its data to Intuitive Surgical, therefore, there was no impact to the Company’s consolidated financial statements.   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, to develop and commercialize a specialized device, which the Company refers to as the PFO Device, designed to close holes in the heart from genetic heart defects known as patent foramen ovales (“PFOs”). Under the agreement, Cook funded certain development activities and the Company and Cook jointly developed the PFO 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. The Company did not record any license and development revenue under this agreement for the six months ended December 31, 2015 or 2014.  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 $0.4 million under this agreement had been recorded as deferred revenue as of December 31, 2015, and June 30, 2015.  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.

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Note 8 - Note Payable	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Debt Disclosure [Text Block]	NOTE 8 – NOTE PAYABLE   In connection with the 2011 Distribution Agreement with Century (see Note 7, Distribution, License, Development and Commercialization Agreements), 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. The secured note purchase agreement was amended effective July 1, 2014, to extend the principal due date by two years. Under this facility, the Company received $2.0 million on September 30, 2011, and the remaining $2.0 million on December 27, 2011. The note bears 5% annual interest which is payable quarterly in arrears on the last business day of March, June, September and December of each year through September 30, 2018, the maturity date when the total $4.0 million of principal becomes due, and can be prepaid by the Company at any time without penalty. The debt issuance discount of approximately $2.1 million is reflected as a reduction in long-term debt and is being amortized as interest expense over the term of the note using the effective interest method. The note is secured by substantially all of the Company's assets, including the Company’s intellectual property related to the PAS-Port® Proximal Anastomosis System, but excluding all other intellectual property, until the note is repaid. There are no covenants associated with this debt.   As of December 31, 2015, and June 30, 2015, the balance of the loan was $3.0 million and $2.8 million net of debt issuance costs of $1.0 million and $1.2 million, respectively, and the distribution of the microcutter products had not begun for the respective periods.

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Note 9 - Commitments and Contingencies	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	NOTE 9 – COMMITMENTS AND CONTINGENCIES   Operating Lease   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 $0.1 million to be used in connection with the construction of alterations and refurbishment of improvements in the premises, which was used and reimbursed in November 2011, and January 2012. The leasehold improvement allowance was recorded as a reduction of rent expense on a straight-line basis over the term of the lease. On November 24, 2014, the Company entered into another amendment to its facility lease (the “Second Lease Amendment”), extended its lease by three years, from September 1, 2015, through August 31, 2018 (the “Second Extended Term”). In addition, under the Second Lease Amendment, the Company was granted an option to further extend the lease for a period of three years beyond August 31, 2018 (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 Second 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 $0.1 million was recorded as restricted cash in the condensed consolidated balance sheet as of December 31, 2015, and June 30, 2015, 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  December 31, 2015, including the Second Lease Amendment, are as follows (in thousands):   Fiscal year ending June 30,   Operating Leases   2016 (remaining six months)   $ 489   2017     1,001   2018     1,032   2019     173   Total minimum lease payments   $ 2,695     Legal Proceedings   From time to time, the Company is involved in claims and legal proceedings that arise in the ordinary course of business. Although there can be no assurance as to the ultimate disposition of these matters, the Company had determined, based upon the current information available, that the expected outcome of these matters, individually or in the aggregate, will not have a material adverse effect on our consolidated financial position, results of operations or cash flows.

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Note 10 - Subsequent Event	6 Months Ended
	Dec. 31, 2015
Notes to Financial Statements
Subsequent Events [Text Block]	NOTE 10 – S UBSEQUENT EVENT   At the Company’s annual meeting of stockholders held on January 29, 2016, the stockholders of the Company approved a reverse stock split of the Company’s common stock at a reverse stock split ratio of one-for-ten. Pending application to and approval from NASDAQ of the reverse stock split, the Company’s consolidated financial statements will be restated to reflect such reverse stock split.

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Significant Accounting Policies (Policies)	6 Months Ended
	Dec. 31, 2015
Accounting Policies [Abstract]
Organization [Policy Text Block]	Organization         Cardica, Inc. (the “Company”) 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. The Company is commercializing and developing the MicroCutter XCHANGE® 30 based on its proprietary “staple-on-a-strip” technology intended for use by thoracic, pediatric, bariatric, colorectal and general surgeons. The MicroCutter XCHANGE® 30, which is currently commercially-available, is a cartridge based microcutter device with a 5 millimeter shaft diameter and a 30 millimeter staple line currently cleared for use in the United States for specified indications for use, and approved in Japan and in the European Union, or EU, for a broader range of specified indications for use. The Company previously had additional products in development, including the MicroCutter XCHANGE® 45, a cartridge based microcutter device with an 8 millimeter shaft and a 45 millimeter staple line, and the MicroCutter FLEXCHANGE™ 30, a cartridge based microcutter device with a flexible shaft to facilitate endoscopic procedures requiring cutting and stapling; however, the Company suspended development of these additional potential products to focus solely on development of the MicroCutter XCHANGE 30.   In March 2012, the Company completed the design verification for and applied Conformité Européenne, or the CE Mark, to the MicroCutter XCHANGE 30 and, in December 2012, began a controlled commercial launch of the MicroCutter XCHANGE 30 in Europe. The Company received from the United States Food and Drug Administration, or FDA, 510(k) clearances for the MicroCutter XCHANGE 30 and blue cartridge in January 2014, and for the white cartridge in February 2014, for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix. The blue cartridge is for use in medium thickness tissue, and the white cartridge is for use in thin tissue. In March 2014, the Company made its first sale of the MicroCutter XCHANGE 30 in the United States, and subsequently temporarily suspended its controlled commercial launch in November 2014, as the Company shifted its focus to improved performance based on surgeon feedback. In April 2015, the Company resumed its controlled commercial launch primarily in Europe, of the MicroCutter XCHANGE 30 for thinner tissue usually requiring deployment of white cartridges. While the Company continues this controlled commercial launch, the Company’s goal is to complete product improvements on the MicroCutter XCHANGE 30 combo device that will accommodate thicker tissue ranges requiring deployment of both white and blue cartridges. To further expand the use of the MicroCutter XCHANGE 30, the Company submitted a 510(k) Premarket Notification to the FDA in April 2015, to expand the indications for use to include vascular structures, and recently received FDA 510(k) clearance to use its MicroCutter XCHANGE ®  30 surgical stapling device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures. This clearance complements the existing indications for use of the MicroCutter XCHANGE 30 in surgical procedures in the small and large intestine and in the appendix.   The Company is attempting to expand in the international market of its MicroCutter XCHANGE 30 with additional selected regulatory filings. The Company also submitted the MicroCutter XCHANGE 30 blue and white cartridges application to Health Canada for regulatory approval of the MicroCutter XCHANGE 30 and, if the Company receives approval, anticipates launching it in Canada. In addition, in August 2013, the Company’s exclusive distributor in Japan, Century Medical, Inc., or Century, filed for regulatory approval of the MicroCutter XCHANGE 30 cartridges with the Pharmaceuticals and Medical Devices Agency, or PMDA, in Japan and in April 2014, filed for the MicroCutter XCHANGE 30 stapler with TUV Rheinland Japan Ltd, a registered third-party agency in Japan and received approvals in late 2014 for both, to market in Japan. Also, in January 2015, Century submitted an application to PMDA, relating to a change in the material of the cartridge insert component within the MicroCutter XCHANGE 30 cartridges, changing the distal tip of the cartridge insert material from a Vectra Liquid Crystal Polymer, or LCP, to IXEF Polyarylamide, or IXEF, and received approval in August 2015 to market in Japan.   Historically, the Company generated product revenues primarily from the sale of automated anastomotic systems; however, the Company started generating revenues from the commercial sales of the MicroCutter XCHANGE 30 in Europe in December 2012, and in the United States in March 2014, and through December 31, 2015, the Company generated $1.7 million of net product revenues from the commercial sales of the MicroCutter XCHANGE 30. In November 2015, the Company issued a voluntary removal of the MicroCutter XCHANGE 30 blue cartridges from the market, as the MicroCutter XCHANGE 30 device sold primarily in Europe was labeled for use with the white cartridge only. The impact of the returned products from the voluntary removal was not significant.     For the six months ended December 31, 2015, the Company generated net revenue of $1.4 million, including $1.1 million from the sale of automated anastomotic systems, $0.3 million from commercial sales of the MicroCutter XCHANGE 30 and $35,000 of royalty revenue.
Basis of Presentation and Principles of Consolidation [Policy Text Block]	Basis of Presentation and Principles of Consolidation   The accompanying unaudited condensed consolidated financial statements of the Company 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 consolidated financial statements have been prepared on the same basis as the annual financial statements which include the accounts of Cardica, Inc. and its wholly-owned subsidiary in Germany. All significant intercompany balances and transactions have been eliminated in consolidation. 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 consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended June 30, 2015, included in the Company’s Form 10-K filed with the Securities and Exchange Commission on September 25, 2015.
New Accounting Pronouncements, Policy [Policy Text Block]	Recently Issued Accounting Standards   In November 2015, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2015-17, Income Taxes (Topic 740):  Balance Sheet Classification of Deferred Taxes . Under existing standards, deferred taxes for each tax-paying jurisdiction are presented as a net current asset or liability and net noncurrent asset or liability. The new guidance will require that all deferred tax assets and liabilities, along with related valuation allowances, be classified as noncurrent on the balance sheet. As a result, each tax-paying jurisdiction will now only have one net noncurrent deferred tax asset or liability. The new guidance does not change the existing requirement that prohibits offsetting deferred tax liabilities from one jurisdiction against deferred tax assets of another jurisdiction. ASU No. 2015-17 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016, which will be our fiscal year 2017 beginning July 1, 2016. The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated financial statements and related disclosures.   In July 2015, the FASB issued an accounting standard update which requires an entity measuring inventory other than last-in, first-out (LIFO) or the retail inventory method to measure inventory at the lower of cost and net realizable value. When evidence exists that the net realizable value of inventory is lower than its costs, the difference will be recognized as a loss in the statement of operations. The standard is effective for fiscal years beginning after December 15, 2016, and interim periods within fiscal years beginning after December 15, 2017. The Company will be evaluating the impact of the adoption of this standard on the Company’s consolidated financial statements and disclosures.   In April 2015, the FASB issued an accounting standard update which provides guidance on whether a cloud computing arrangement includes a software license to a customer of such an arrangement. If a cloud computing arrangement includes a software license, a customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses, otherwise the customer should account for the arrangement as a service contract. The standard is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015.  Early adoption is permitted. The standard can be applied prospectively to all arrangements entered into or materially modified after the effective date, or retrospectively. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements and disclosures.   In April 2015, the FASB issued an accounting standard update which requires an entity to present debt issuance costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. The standard is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015.  Early adoption is permitted. The standard will be applied retrospectively to each prior period presented.  The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated balance sheets.   In February 2015, the FASB issued an amendment to the accounting standard regarding the analysis that a reporting entity must perform to determine whether it should consolidate certain types of legal entities. All legal entities are subject to reevaluation under the revised consolidation model. The amendments in this update are effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015. The adoption of this update is not expected to have a material effect on the Company’s consolidated financial statements or disclosures.   In August 2014, the FASB issued an accounting standard update related to the disclosures around going concern. The new standard provides guidance around management’s responsibility to evaluate whether there are conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. The new standard is effective for the annual periods and interim periods within those annual periods beginning after December 15, 2016. Early application is permitted. The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated financial statements.   In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606): Revenue from Contracts with Customers , which guidance in this update will supersede the revenue recognition requirements in Topic 605, Revenue Recognition , and most industry-specific guidance when it becomes effective. ASU No. 2014-09 affects any entity that enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards. The core principal of ASU No. 2014-09 is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under current guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. ASU No. 2014-09 is effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period, which will be the Company’s fiscal year 2018 (beginning July 1, 2017), and entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. However, in July 2015, the FASB approved the deferral of the new standard's effective date by one year. The new standard will now be effective for annual reporting periods beginning after December 15, 2017, which will be our fiscal year 2019 (beginning July 1, 2018). The FASB will permit companies to adopt the new standard early, but not before the original effective date of December 15, 2016. The Company will be evaluating the impact of the adoption of this guidance on the Company’s consolidated financial statements.
Use of Estimates, Policy [Policy Text Block]	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. Significant estimates include the valuation of inventory, measurement of stock based compensation, valuation of financial instruments and revenue recognition. Actual results could materially differ from these estimates.
Revenue Recognition, Policy [Policy Text Block]	Revenue Recognition   The Company recognizes revenue when four basic criteria are met: (1) persuasive evidence of an arrangement exists; (2) title has 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 shipping documents and third-party proof of delivery to verify that title has 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’s sales to distributors do not include price protection.   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 they are earned and non-refundable upon receipt, 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 performance is rendered or the related development expenses, plus overhead costs for certain project activities, are incurred.
Inventory, Policy [Policy Text Block]	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. Further reduced demand may result in the need for additional 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.
Concentration Risk, Credit Risk, Policy [Policy Text Block]	Risks and Uncertainties   The Company depends upon a number of key suppliers, including single source suppliers, the loss of which would materially harm the Company’s business. Single source suppliers are relied upon for certain components and services used in manufacturing the Company’s products. The Company does not have long-term contracts with any of the suppliers; rather, purchase orders are submitted for each order. Because long-term contracts do not exist, none of the suppliers are required to provide the Company any guaranteed minimum quantities.
Foreign Currency Transactions and Translations Policy [Policy Text Block]	Foreign Currency Translation   The Company’s foreign operations are subject to exchange rate fluctuations and foreign currency costs. The functional currency of the German subsidiary is the United States dollar. Transactions and balances denominated in dollars are presented at their original amounts. Monetary assets and liabilities denominated in currencies other than the dollar are re-measured at the current exchange rate prevailing at the balance sheet date. All transaction gains or losses from the re-measurement of monetary assets and liabilities are included in the consolidated statements of operations within other income (expense).

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Note 2 - Stockholders' Equity (Tables)	6 Months Ended
	Dec. 31, 2015
Notes Tables
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]	Three months ended     Six months ended       December 31,     December 31,       2015     201 4     2015     201 4   Risk-free interest rate     1.33 %     0.21% - 1.59 %     0.71% - 1.50 %     0.21% - 1.65% % Dividend yield     —       —       —       —   Weighted-average expected term (in years)     4.98       4.90       4.24 - 4.98       4.83 - 4.90   Expected volatility     67.4 %     68.4 %     54.8% - 67.4 %     68.4% - 72.1 %
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block]	Three months ended     Six months ended       December 31,     December 31,       2015     201 4     2015     201 4   Cost of product sales   $ 17     $ 21     $ 35     $ 51   Research and development     30       (10 )     72       53   Selling, general and administrative     218       303       293       523   Total   $ 265     $ 314     $ 400     $ 627

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Note 3 - Net Loss Per Share (Tables)	6 Months Ended
	Dec. 31, 2015
Notes Tables
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]	Three months ended     Six months ended       December 31,     December 31,       2015     2014     2015     2014   Numerator:                                 Net loss   $ (4,087 )   $ (5,442 )   $ (8,729 )   $ (10,507 ) Denominator:                                 Denominator for basic and diluted net loss per share     89,018       88,955       88,991       88,950   Basic and diluted net loss per share   $ (0.05 )   $ (0.06 )   $ (0.10 )   $ (0.12 )
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]	As of December 31,       2015     201 4   Options to purchase common stock     9,389       5,297   Unvested restricted stock awards     527       290   Shares reserved for issuance upon conversion of Series A Preferred     19,147       19,147   Total     29,063       24,734

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Note 4 - Fair Value Measurements (Tables)	6 Months Ended
	Dec. 31, 2015
Notes Tables
Fair Value, Assets Measured on Recurring Basis [Table Text Block]	As of December 31 , 2015       Level 1     Level 2     Level 3     Total   Cash equivalents:                                 Money market funds   $ 5,165     $ —     $ —     $ 5,165   Corporate debt securities     —       744       —       744   Short-term investments:                                 Corporate debt securities     —       12,099       —       12,099                                     Total assets at fair value   $ 5,165     $ 12,843     $ —     $ 18,008       As of June 30, 2015       Level 1     Level 2     Level 3     Total   Cash equivalents:                                 Money market funds   $ 6,399     $ —     $ —     $ 6,399   Corporate debt securities     —       668       —       668   Short-term investments:                                 Corporate debt securities     —       12,972       —       12,972   Long-term investments:                                 Corporate debt securities     —       3,970       —       3,970                                     Total assets at fair value   $ 6,399     $ 17,610     $ —     $ 24,009

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Note 5 - Available-for-Sale Securities (Tables)	6 Months Ended
	Dec. 31, 2015
Notes Tables
Available-for-sale Securities [Table Text Block]	As of December 31, 2015       Amortized Cost     Gross Unrealized Gains     Gross Unrealized Losses     Fair Value   Available-for-sale securities:                                 Corporate debt securities – Short-term   $ 12,113     $ —     $ (14 )   $ 12,099                                     Total   $ 12,113     $ —     $ (14 )   $ 12,099       As of June 30, 201 5       Amortized Cost     Gross Unrealized Gains     Gross Unrealized Losses     Fair Value   Available-for-sale securities:                                 Corporate debt securities – Short-term   $ 12,978     $ —     $ (6 )   $ 12,972   Corporate debt securities – Long-term     3,972       —       (2 )     3,970                                     Total   $ 16,950     $ —     $ (8 )   $ 16,942

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Note 6 - Inventories (Tables)	6 Months Ended
	Dec. 31, 2015
Notes Tables
Schedule of Inventory, Current [Table Text Block]	December 31, 201 5     June 30, 201 5   Raw materials   $ 714     $ 870   Work in progress     148       162   Finished goods     156       359   Total   $ 1,018     $ 1,391

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Note 9 - Commitments and Contingencies (Tables)	6 Months Ended
	Dec. 31, 2015
Notes Tables
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block]	Fiscal year ending June 30,   Operating Leases   2016 (remaining six months)   $ 489   2017     1,001   2018     1,032   2019     173   Total minimum lease payments   $ 2,695

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Note 1 - Summary of Significant Accounting Policies (Details Textual) - USD ($)	3 Months Ended		6 Months Ended		37 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2015
MicroCutter XCHANGE 30 [Member]
Revenue, Net			$ 300,000		$ 1,700,000
Automated Anastomotic Systems [Member]
Revenue, Net			1,100,000
Revenue, Net	$ 700,000	$ 657,000	1,455,000	$ 1,725,000
Royalty Revenue	$ 17,000	$ 18,000	$ 35,000	$ 35,000

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Note 2 - Stockholders' Equity (Details Textual) - USD ($)	1 Months Ended		3 Months Ended	6 Months Ended		36 Months Ended
	Dec. 31, 2014	Apr. 30, 2014	Dec. 31, 2015	Dec. 31, 2015	Dec. 31, 2014	Aug. 02, 2014	Jun. 30, 2014	Aug. 03, 2011
MLV [Member] | Common Stock [Member]
Stock Issued During Period, Shares, New Issues						884,756
Proceeds from Issuance of Common Stock						$ 1,200,000
MLV [Member]
Aggregate Value of Shares Committed to be Purchased								$ 10,000,000
Common Stock [Member]
Stock Issued During Period, Shares, New Issues		37,375,000
Share Price		$ 0.85
Series A Preferred Stock [Member]
Stock Issued During Period, Shares, New Issues		191,474
Share Price		$ 85
Convertible Preferred Stock, Shares Issued upon Conversion		100
Common Stock Ownership Threshold, Preferred Stock Conversion		9.98%
Dividends Payable							$ 1,900,000
Non Employee Compensation [Member]
Allocated Share-based Compensation Expense				$ 5,991	$ 0
Employee Stock Option [Member] | Unamortized Expense Related to Share-based Awards Granted to Employees in Excess of Plan Limits [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures in Period	200,000
Inducement Plan [Member] | Chief Executive Officer [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross			4,891,169
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Grant Date Intrinsic Value			$ 0.28
Proceeds from Issuance or Sale of Equity		$ 44,600,000
Proceeds from Issuance of Common Stock					(65,000)
Allocated Share-based Compensation Expense				400,000	$ 600,000
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized			$ 1,000,000	$ 1,000,000
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition				3 years 109 days

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Note 2 - Stockholders' Equity - Black-Scholes Valuation Assumptions (Details)	3 Months Ended		6 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2015	Dec. 31, 2014
Maximum [Member]
Risk-free interest rate	1.33%	1.59%	1.50%	1.65%
Weighted-average expected term (in years)	4 years 357 days	4 years 328 days	4 years 357 days	4 years 328 days
Expected volatility	67.40%	68.40%	67.40%	72.10%
Minimum [Member]
Risk-free interest rate		0.21%	0.71%	0.21%
Weighted-average expected term (in years)			4 years 87 days	4 years 302 days
Expected volatility			54.80%	68.40%

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Note 2 - Stockholders' Equity - Non-Cash Stock-Based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2015	Dec. 31, 2014
Cost of Sales [Member]
Cost of product sales	$ 17	$ 21	$ 35	$ 51
Research and Development Expense [Member]
Cost of product sales	30	(10)	72	53
Selling, General and Administrative Expenses [Member]
Cost of product sales	218	303	293	523
Cost of product sales	$ 265	$ 314	$ 400	$ 627

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Note 3 - Net Loss Per Share - Computation of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		6 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2015	Dec. 31, 2014
Numerator:
Net loss	$ (4,087)	$ (5,442)	$ (8,729)	$ (10,507)
Denominator:
Denominator for basic and diluted net loss per share (in shares)	89,018	88,955	88,991	88,950
Basic and diluted net loss per share (in dollars per share)	$ (0.05)	$ (0.06)	$ (0.10)	$ (0.12)

v3.3.1.900

Note 3 - Net Loss Per Share - Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares shares in Thousands	6 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Equity Option [Member]
Options to purchase common stock (in shares)	9,389	5,297
Restricted Stock [Member]
Options to purchase common stock (in shares)	527	290
Common Stock Shares Reserved for Future Issuance [Member]
Options to purchase common stock (in shares)	19,147	19,147
Options to purchase common stock (in shares)	29,063	24,734

v3.3.1.900

Note 4 - Fair Value Measurements (Details Textual) - USD ($) $ in Millions	Dec. 31, 2015	Jun. 30, 2015
Cash	$ 0.5	$ 1.2

v3.3.1.900

Note 4 - Fair Value Measurements - Fair Value Measurements (Details) - USD ($) $ in Thousands	Dec. 31, 2015	Jun. 30, 2015
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member]
Cash equivalents	$ 5,165	$ 6,399
Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities with Maturity Less than 90 Days [Member]
Cash equivalents
Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities [Member]
Short-term investments
Long-term investments
Fair Value, Inputs, Level 1 [Member]
Total assets at fair value	$ 5,165	$ 6,399
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member]
Cash equivalents
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities with Maturity Less than 90 Days [Member]
Cash equivalents	$ 744	$ 668
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member]
Short-term investments	12,099	12,972
Long-term investments		3,970
Fair Value, Inputs, Level 2 [Member]
Total assets at fair value	$ 12,843	$ 17,610
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member]
Cash equivalents
Fair Value, Inputs, Level 3 [Member] | Corporate Debt Securities with Maturity Less than 90 Days [Member]
Cash equivalents
Fair Value, Inputs, Level 3 [Member] | Corporate Debt Securities [Member]
Short-term investments
Long-term investments
Fair Value, Inputs, Level 3 [Member]
Total assets at fair value
Money Market Funds [Member]
Cash equivalents	$ 5,165	$ 6,399
Corporate Debt Securities with Maturity Less than 90 Days [Member]
Cash equivalents	744	668
Corporate Debt Securities [Member]
Short-term investments	12,099	12,972
Long-term investments		3,970
Total assets at fair value	$ 18,008	$ 24,009

v3.3.1.900

Note 5 - Available-for-Sale Securities - Investments (Details) - USD ($) $ in Thousands	Dec. 31, 2015	Jun. 30, 2015
Corporate Debt Securities [Member]
Amortized Cost	$ 12,113	$ 12,978
Gross Unrealized Losses	(14)	(6)
Fair Value	12,099	12,972
Corporate Bond Securities [Member]
Amortized Cost		3,972
Gross Unrealized Losses		(2)
Fair Value		3,970
Amortized Cost	12,113	16,950
Gross Unrealized Losses	(14)	(8)
Fair Value	$ 12,099	$ 16,942

v3.3.1.900

Note 6 - Inventories - Inventories (Details) - USD ($) $ in Thousands	Dec. 31, 2015	Jun. 30, 2015
Raw materials	$ 714	$ 870
Work in progress	148	162
Finished goods	156	359
Total	$ 1,018	$ 1,391

v3.3.1.900

Note 7 - Distribution, License, Development and Commercialization Agreements (Details Textual) - USD ($)						1 Months Ended			2 Months Ended	6 Months Ended		12 Months Ended
	Dec. 31, 2015	Dec. 27, 2011	Sep. 30, 2011	Sep. 02, 2011	Aug. 16, 2010	Jan. 31, 2016	Sep. 30, 2011	Aug. 16, 2010	Aug. 16, 2010	Dec. 31, 2015	Dec. 31, 2014	Jun. 30, 2015	Jun. 30, 2014	Sep. 30, 2010
Cook Incorporated [Member]
Deferred Revenue, Current	$ 400,000									$ 400,000		$ 400,000
Licenses Revenue										0	$ 0
Intuitive Surgical [Member] | Subsequent Event [Member]
Proceeds from License Fees Received						$ 2,000,000
Intuitive Surgical [Member]
Deferred Revenue, Current	0									$ 0		$ 0
Licenses Revenue	$ 2,000,000							$ 9,000,000
Common Stock Premium									$ 1,000,000
Common Stock, Value, Issued					$ 3,000,000			$ 3,000,000	$ 3,000,000
Noncash or Part Noncash Divestiture, Amount of Consideration Received					$ 10,000,000
Deferred Revenue, Noncurrent														$ 1,000,000
Rights to Improvements in Stapling Technology and Certain Patents, Feasibility Evaluation Period	180 days
Century Medical [Member] | Product Concentration Risk [Member] | Sales Revenue, Net [Member]
Concentration Risk, Percentage										30.00%	25.00%
Century Medical [Member] | Product Concentration Risk [Member] | Accounts Receivable [Member]
Concentration Risk, Percentage										39.00%		47.00%
Century Medical [Member] | Notes Payable, Other Payables [Member]
Debt Instrument, Face Amount	$ 4,000,000			$ 4,000,000						$ 4,000,000
Debt Instrument, Interest Rate, Stated Percentage	5.00%			5.00%						5.00%
Fair Value Inputs, Discount Rate				18.00%
Debt Instrument, Unamortized Discount	$ 500,000			$ 1,600,000						$ 500,000
Deferred Revenue	500,000									500,000
Century Medical [Member]
Proceeds from Secured Notes Payable		$ 2,000,000	$ 2,000,000				$ 2,000,000
Notes Payable, Fair Value Disclosure	2,600,000			$ 2,400,000						2,600,000			$ 3,100,000
Debt Instrument, Unamortized Discount	2,100,000									2,100,000
Distribution Agreement Term of Extension											5 years
Notes Payable, Noncurrent	3,000,000									3,000,000		$ 2,800,000
Debt Issuance Cost										1,000,000		1,200,000
Deferred Revenue, Current	403,000									403,000		403,000
Notes Payable, Noncurrent	2,971,000									2,971,000		2,828,000
Common Stock, Value, Issued	89,000									89,000		89,000
Deferred Revenue, Noncurrent	$ 2,125,000									$ 2,125,000		$ 2,125,000

v3.3.1.900

Note 8 - Note Payable (Details Textual) - USD ($)			1 Months Ended	6 Months Ended	12 Months Ended
	Dec. 27, 2011	Sep. 30, 2011	Sep. 30, 2011	Dec. 31, 2015	Jun. 30, 2015	Sep. 02, 2011
Century Medical [Member] | Notes Payable, Other Payables [Member]
Debt Instrument, Face Amount				$ 4,000,000		$ 4,000,000
Debt Instrument, Interest Rate, Stated Percentage				5.00%		5.00%
Debt Instrument, Unamortized Discount				$ 500,000		$ 1,600,000
Century Medical [Member]
Proceeds from Secured Notes Payable	$ 2,000,000	$ 2,000,000	$ 2,000,000
Debt Instrument, Unamortized Discount				2,100,000
Notes Payable, Noncurrent				3,000,000	$ 2,800,000
Debt Issuance Cost				1,000,000	1,200,000
Notes Payable, Noncurrent				$ 2,971,000	$ 2,828,000

v3.3.1.900

Note 9 - Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands	Dec. 31, 2015	Jun. 30, 2015	Jun. 30, 2012
Restricted Cash, Letter of Credit [Member]
Restricted Cash and Cash Equivalents	$ 100	$ 100
Restricted Cash and Cash Equivalents	$ 104	$ 104
Leasehold Improvements, Gross			$ 100

v3.3.1.900

Note 9 - Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands	Dec. 31, 2015 USD ($)
2016 (remaining six months)	$ 489
2017	1,001
2018	1,032
2019	173
Total minimum lease payments	$ 2,695

v3.3.1.900

Note 10 - Subsequent Event (Details Textual)	Jan. 29, 2016
Reverse Stock Split [Member] | Subsequent Event [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	10