UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 June 30, 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: 000-22427
  HESKA CORPORATION
  (Exact name of registrant as specified in its charter)
Delaware 77-0192527
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer Identification Number)

 

3760 Rocky Mountain Avenue

Loveland, Colorado

 

 

80538

(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code:   (970) 493-7272
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 as defined in Rule 12b-2 of the Exchange Act.  See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.  (Check one):
Large accelerated filer [_] Accelerated filer [_]
Non-accelerated filer [_]   (Do not check if a small 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]

The number of shares of the Registrant's Public Common Stock outstanding at August 6, 2015

was 6,532,977.

 
       
 
 

TABLE OF CONTENTS

  Page
     
PART I - FINANCIAL INFORMATION
     
Item 1. Financial Statements:  
  Condensed Consolidated Balance Sheets (Unaudited) as of December 31, 2014 and
June 30, 2015
2
  Condensed Consolidated Statements of Income for the three months and six months ended June 30, 2014 and 2015 (Unaudited) 3
  Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three months and six months ended June 30, 2014 and 2015 4
  Condensed Consolidated Statements of Cash Flows (Unaudited) for the
three months and six months ended June 30, 2014 and 2015
5
  Notes to Condensed Consolidated Financial Statements (Unaudited) 6
     
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations

15
     
Item 3. Quantitative and Qualitative Disclosures About Market Risk 24
     
Item 4. Controls and Procedures 25
     
PART II -   OTHER INFORMATION
     
Item 1 . Legal Proceedings 25
     
Item 1A. Risk Factors 25
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 38
     
Item 3. Defaults Upon Senior Securities 38
     
Item 4. Mine Safety Disclosures 38
     
Item 5. Other Information 38
     
Item 6. Exhibits 39
     
Signatures 40
     
Exhibit Index   41
         

 

HESKA, SOLO STEP and VITALPATH are registered trademarks of Heska Corporation. TRI-HEART is a registered trademark of Intervet Inc., d/b/a Merck Animal Health, formerly known as Schering-Plough Animal Health Corporation ("Merck Animal Health"), which is a unit of Merck & Co., Inc. ("Merck"), in the United States and is a registered trademark of Heska Corporation in other countries. This Form 10-Q also refers to trademarks and trade names of other organizations.

- 1 -
 

HESKA CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands except shares and per share amounts)

 

     

 

December 31, 2014

 

(unaudited)

June 30,

2015

 
ASSETS
Current Assets:            
  Cash and cash equivalents $ 5,855   $ 6,647  
  Accounts receivable, net of allowance for doubtful accounts of
$216 and $256, respectively
 

 

11,919

   

 

11,368

 
  Due from – related parties   892     848  
  Inventories, net   12,658     16,836  
  Deferred tax asset, current   1,489     1,468  
  Other current assets   1,587     1,640  
    Total current assets   34,400     38,807  
Property and equipment, net   13,410     14,886  
Note receivable – related party   1,466     1,492  
Goodwill and other intangibles   21,205     21,132  
Deferred tax asset, net of current portion   25,721     24,954  
Other long-term assets   642     1,635  
    Total assets $ 96,844   $ 102,906  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:            
  Accounts payable $ 4,897   $ 6,147  
  Due to – related party   252     698  
  Accrued liabilities   5,130     5,520  
  Current portion of deferred revenue and other   4,584     4,506  
  Line of credit   48     1,373  
  Other short-term borrowings, including current portion of
long-term note payable
 

 

141

   

 

159

 
    Total current liabilities   15,052     18,403  
Long-term note payable, net of current portion   227     140  
Deferred revenue and other, net of current portion   12,754     12,062  
    Total liabilities   28,033     30,605  
                 
Commitments and contingencies            
                 
Non-Controlling Interest   15,679     15,705  
                 
Stockholders' equity:            
  Preferred stock, $.01 par value, 2,500,000 shares authorized;
none issued or outstanding
 

 

   

 

 
  Common stock, $.01 par value, 7,500,000 shares authorized,
none issued or outstanding
 

 

   

 

 
  Public common stock, $.01 par value, 7,500,000 shares authorized, 6,342,205 and 6,527,237 shares issued and outstanding, respectively  

 

63

   

 

65

 
  Additional paid-in capital   222,297     223,829  
  Accumulated other comprehensive income   283     452  
  Accumulated deficit   (169,511 )   (167,750 )
    Total stockholders' equity   53,132     56,596  
Total liability and stockholders' equity $ 96,844   $ 102,906  

See accompanying notes to condensed consolidated financial statements.

- 2 -
 

 

HESKA CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(in thousands, except per share amounts)

(unaudited)

 

 

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

  2014   2015   2014   2015
     
Revenue, net:    
Core companion animal health $ 17,486   $ 20,757   $ 34,852   $ 40,329  
Other vaccines, pharmaceuticals and products   5,430     3,153     8,857     6,475  
Total revenue, net   22,916     23,910     43,709     46,804  
                         
Cost of revenue   13,839     13,613     26,353     26,423  
                         
Gross profit   9,077     10,297     17,356     20,381  
                         
Operating expenses:                        
Selling and marketing   4,752     5,239     9,697     10,699  
Research and development   374     392     762     811  
General and administrative   3,034     2,837     6,081     6,021  
Total operating expenses   8,160     8,468     16,540     17,531  
Operating income   917     1,829     816     2,850  
Interest and other (income) expense, net   (7 )   37     9     174  
Income before income taxes   924     1,792     807     2,676  
Income tax expense:                        
Current tax expense   32     82     53     126  
Deferred tax expense   114     532     249     789  
Total income tax expense   146     614     302     915  
Net income   $ 778   $ 1,178   $ 505   $ 1,761  
Net income (loss) attributable to non-controlling interest   (291 )   (19 )   (756 )   (34 )
Net income attributable to Heska Corporation $ 1,069   $ 1,197   $ 1,261   $ 1,795  
                         
Basic net income per share attributable to Heska Corporation $ 0.18   $ 0.19   $ 0.21   $ 0.29  
Diluted net income per share attributable to Heska Corporation $ 0.17   $ 0.17   $ 0.20   $ 0.26  
                         

Weighted average outstanding shares used to compute basic net

income per share attributable to Heska Corporation

 

 

 

5,936

   

 

6,283

   

 

5,898

   

 

6,232

 
                         

Weighted average outstanding shares used to compute diluted net

income per share attributable to Heska Corporation

  6,384     7,075    

 

6,183

    6,980  
                             

 

 

  

 

 

 

 

See accompanying notes to condensed consolidated financial statements.

- 3 -
 

HESKA CORPORATION AND SUBSIDIARIES
CONDE NSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(in thousands)

(unaudited)

 

 

   

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 
    2014   2015   2014   2015  
                           
Net income $ 778   $ 1,178   $ 505   $ 1,761  
Other comprehensive income (expense):                        
  Minimum pension liability   8         (6 )    
  Foreign currency translation   43     87     70     163  
  Unrealized gain (loss) on available for sale investments   (2 )   6     (2 )   6  
Comprehensive income $ 827   $        1,271   $ 567   $ 1,930  
                         
Comprehensive income (loss) attributable to non-controlling interest $ (291 ) $ (19 ) $ (756 ) $ (34 )
Comprehensive income attributable to Heska Corporation $ 1,118   $ 1,290   $ 1,323   $ 1,964  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.

- 4 -
 

HESKA CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

(unaudited)

 

 

Six Months Ended

June 30,

  2014     2015
   
CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES:            
Net income $ 505   $ 1,761  

Adjustments to reconcile net income to cash provided by (used in) operating

activities:

           
Depreciation and amortization   1,617     2,074  
Deferred tax expense   249     789  
Stock-based compensation   586     879  
Unrealized (gain) loss on foreign currency translation   (5 )   44  
Changes in operating assets and liabilities:            
Accounts receivable   (585 )   552  
Inventories   (3,282 )   (6,670 )
Other current assets   394     (70 )
Accounts payable   1,523     1,696  
Accrued liabilities and other   33     458  
Other non-current assets   (207 )   (562 )
Deferred revenue and other   2,335     (1,233 )
Net cash provided by (used in) operating activities   3,163     (282 )
CASH FLOWS PROVIDED BY (USED IN) INVESTING ACTIVITIES:            
Purchase of property and equipment   (1,538 )   (936 )
       Proceeds from disposition of property and equipment   6      
Net cash provided by (used in) investing activities   (1,532 )   (936 )
CASH FLOWS PROVIDED BY (USED IN) FINANCING ACTIVITIES:            
Proceeds from issuance of common stock   902     680  
Proceeds from (repayments of) line of credit borrowings, net   (2,224 )   1,325  
Proceeds from (repayments of) other debt   (111 )   (69 )
Net cash provided by (used in) financing activities   (1,433 )   1,936  
EFFECT OF EXCHANGE RATE CHANGES ON CASH   50     74  
INCREASE (DECREASE)  IN CASH AND CASH EQUIVALENTS   248     792  
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD   6,016     5,855  
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 6,264   $ 6,647  

 

 

 

See accompanying notes to condensed consolidated financial statements.

- 5 -
 

HESKA CORPORATION AND SUBSIDIARIES


 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2015

(UNAUDITED)

 

 

1.        ORGANIZATION AND BUSINESS

Heska Corporation ("Heska" or the "Company") develops, manufactures, markets, sells and supports veterinary products. Heska's core focus is on the canine and feline companion animal health markets.

 

2.      SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

 



The accompanying unaudited condensed consolidated financial statements are the responsibility of the Company's management and have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the instructions to Form 10-Q and rules and regulations of the Securities and Exchange Commission (the "SEC"). The condensed consolidated balance sheet as of June 30, 2015, the condensed consolidated statements of income for the three months and six months ended June 30, 2014 and 2015, the condensed consolidated statements of comprehensive income for the three months and six months ended June 30, 2014 and 2015 and the condensed consolidated statements of cash flows for the six months ended June 30, 2014 and 2015 are unaudited, but include, in the opinion of management, all adjustments (consisting of normal recurring adjustments) which the Company considers necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented. All material intercompany transactions and balances have been eliminated in consolidation. Although the Company believes that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote disclosures normally included in complete financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to the rules and regulations of the SEC.

 

Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying financial statements and related disclosures have been prepared with the presumption that users of the interim financial information have read or have access to the audited financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2014, included in the Company's Annual Report on Form 10-K filed with the SEC on March 25, 2015.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenue and expense during the reported period. Actual results could differ from those estimates. Significant estimates are required when establishing the allowance for doubtful accounts and the provision for excess/obsolete inventory, in determining the period over which the Company's obligations are fulfilled under agreements to license product rights and/or technology rights, in determining the need for, and the amount of, a valuation allowance on certain deferred tax assets and in determining the need for, and the amount of, an accrued liability for future payments related to minimum purchase obligations the Company may make in order to maintain certain product rights.

   

 

- 6 -
 

 

Inventories

 

Inventories are stated at the lower of cost or market using the first-in, first-out method. Inventory manufactured by the Company includes the cost of material, labor and overhead. If the cost of inventories exceeds estimated fair value, provisions are made to reduce the carrying value to estimated fair value.

 

Inventories, net consist of the following (in thousands):

 

   

December 31,

2014

 

June 30,

2015

 
           
  Raw materials $ 6,298   $ 8,405  
  Work in process   2,966     4,152  
  Finished goods   4,949     5,744  
  Allowance for excess or obsolete inventory   (1,555 )   (1,465 )
    $ 12,658   $ 16,836  

 

Property and Equipment

The Company has utilized marketing programs whereby its instruments in inventory may be placed in a customer's location on a rental basis. The cost of these instruments is transferred to machinery and equipment or other long-term assets and depreciated or amortized, typically over a five to seven year period depending on the circumstance under which the instrument is placed with the customer. For the six months ended June 30, 2014 and the six months ended June 30, 2015, total costs transferred from inventory, including related to instrument rentals, were approximately $2.3 million and $2.5 million, respectively.

The Company has sold certain customer rental contracts and underlying assets to a third party under the agreement that once the customer has met the customer obligations under the contract, ownership of the assets underlying the contract would be returned to the Company. The Company enters a debit to cash and a corresponding credit to deferred revenue at the time of these sales. These sales provided $874 thousand and $59 thousand of cash which was reported in the "deferred revenue and other" line item of the Company's consolidated statements of cash flows as of June 30, 2014 and June 30, 2015, respectively, all related to the Company's 54.6%-owned subsidiary, Heska Imaging US, LLC. As the Company anticipates it will regain ownership of the assets underlying these sales, it reports these assets as part of property and equipment and depreciates these assets per its depreciation policies. The Company had $3.0 million of net property and equipment and $2.7 million of net property and equipment related to these transactions as of December 31, 2014 and June 30, 2015, respectively, all related to the Company's 54.6%-owned subsidiary, Heska Imaging US, LLC.

 

Capitalized Software

 

The Company capitalizes third-party software costs, where appropriate, and reports such capitalized costs, net of accumulated amortization, on the "property and equipment" line of its consolidated balance sheets. The Company had $587 thousand and $515 thousand of such capitalized costs, net of accumulated amortization, on the "property and equipment" line of its consolidated balance sheets as of December 31, 2014 and June 30, 2015, respectively. Capitalized software costs in a given year are reported on the "purchases of property and equipment" line item of the Company's consolidated statements of cash flows. The Company had $31 thousand and $44 thousand of capitalized software costs reported on the "purchases of property and equipment" line item of its consolidated statements of cash flows for the six months ended June 30, 2014 and June 30, 2015, respectively.

 

Cash Interest

 

Cash paid for interest for the six months ended June 30, 2014 and June 30, 2015 was $44 thousand and $40 thousand, respectively.

 

- 7 -
 

Basic and Diluted Net Income (Loss) Per Share

 

Basic net income (loss) per common share is computed using the weighted average number of common shares outstanding during the period. The weighted average number of common shares outstanding used to calculate basic net income per common share for the three and six months ended June 30, 2015 excluded unvested shares of restricted common stock, which totaled 209,177 shares at June 30, 2015. Diluted net income (loss) per share is computed using the sum of the weighted average number of shares of common stock outstanding, and, if not anti-dilutive, the effect of outstanding common stock equivalents (such as stock options and warrants) determined using the treasury stock method.

 

For the three and six months ended June 30, 2014 and June 30, 2015, the Company reported net income attributable to Heska Corporation and therefore, unvested shares of restricted common stock and other dilutive common stock equivalent securities, as computed using the treasury method (but excluding options to purchase fractional shares resulting from the Company's December 2010 1-for-10 reverse stock split), were added to basic weighted average shares outstanding for the period to derive the weighted average shares for the diluted earnings per share calculation. Common stock equivalent securities, other than options to purchase fractional shares, that were anti-dilutive for the three and six months ended June 30, 2014, and therefore excluded, were outstanding options to purchase 288,763 and 430,109 shares of common stock, respectively. Common stock equivalent securities, other than options to purchase fractional shares, that were anti-dilutive for the three and six months ended June 30, 2015, and therefore excluded, were outstanding options to purchase 26,500 and 27,700 shares of common stock, respectively. These securities are anti-dilutive primarily due to exercise prices greater than the average trading price of the Company's common stock during the three and six months ended June 30, 2014 and June 30, 2015.

 

3.        NON-CONTROLLING INTEREST AND RELATED PARTY ITEMS

 

On February 24, 2013, the Company acquired a 54.6% interest in Cuattro Veterinary USA, LLC, an entity which was subsequently renamed Heska Imaging US, LLC ("Heska Imaging"). The remaining minority position (45.4%) in Heska Imaging is subject to purchase by Heska under performance-based puts and calls following calendar year 2015, 2016 and 2017. Should Heska undergo a change in control, as defined, prior to the end of 2017, Heska Imaging minority unit holders will be entitled to sell their Heska Imaging units to Heska at the highest call value they could have otherwise obtained if Heska Imaging meets certain minimum performance criteria.

 

Heska Imaging markets, sells and supports digital radiography and ultrasound products along with embedded software and support, data hosting and other services.

 

Shawna M. Wilson, Clint Roth, DVM, Steven M. Asakowicz, Rodney A. Lippincott, Kevin S. Wilson and Cuattro, LLC own approximately 29.75%, 8.39%, 4.09%, 3.07%, 0.05% and 0.05% of Heska Imaging, respectively. Kevin S. Wilson is the Chief Executive Officer and President of the Company, a member of the Company's Board of Directors and the spouse of Shawna M. Wilson. Steven M. Asakowicz serves as Executive Vice President, Companion Animal Health Sales for the Company. Rodney A. Lippincott serves as Executive Vice President, Companion Animal Health Sales for the Company. Mr. Wilson, Mrs. Wilson and trusts for their children and family own a 100% interest in Cuattro, LLC. Cuattro, LLC owns a 100% interest in Cuattro Software, LLC and a majority interest in Cuattro Veterinary, LLC. Mr. Wilson, Mrs. Wilson and trusts for their children and family own a majority interest in Cuattro Medical, LLC.

 

Since January 1, 2015, Cuattro, LLC charged Heska Imaging $3.9 million, primarily related to digital imaging products, for which there is an underlying supply contract with minimum purchase obligations, software and services as well as other operating expenses; Heska Corporation charged Heska Imaging $2.2 million, primarily related to sales expenses; Heska Corporation charged Cuattro, LLC $79 thousand, primarily related to facility usage and other services.

 

- 8 -
 

 

At June 30, 2015, Heska Imaging has a $1.5 million note receivable, including accrued interest, from Cuattro Veterinary, LLC, which is due on March 15, 2016 and which is listed as "Note receivable – related party" on the Company's consolidated balance sheets; Heska Imaging had accounts receivable from Cuattro Software, LLC of $832 thousand, which is included in "Due from – related parties" on the Company's consolidated balance sheets; Heska Corporation had net accounts receivable from Cuattro, LLC of $16 thousand which is included in "Due from – related parties" on the Company's consolidated balance sheets; Heska Imaging had net accounts payable to Cuattro, LLC of $698 thousand which is included in "Due to – related party" on the Company's consolidated balance sheets; Heska Corporation had accounts receivable from Heska Imaging of $5.7 million, including accrued interest, which eliminated in consolidation of the Company's financial statements; all monies owed accrue interest at the same rate Heska Corporation pays under its credit and security agreement with Wells Fargo Bank, National Association ("Wells Fargo") once past due with the exception of the note receivable, which accrues at this rate to its maturity date.

 

The aggregate position in Heska Imaging of the unit holders who hold the 45.4% of Heska Imaging that Heska Corporation does not own (the "Put Value") is being accreted to its estimated redemption value in accordance with Heska Imaging's Amended and Restated Operating Agreement (the "Operating Agreement"). Since the Operating Agreement contains certain put rights that are out of the control of the Company, authoritative guidance requires the non-controlling interest, which includes the estimated values of such put rights, to be displayed outside of the equity section of the consolidated balance sheets. The adjustment to increase or decrease the Put Value to its expected redemption value and to estimate any distributions required under Heska Imaging's Operating Agreement to the unit holders who hold the 45.4% of Heska Imaging that Heska Corporation does not own (the "Imaging Minority") each reporting period is recorded to stockholders' equity in accordance with United States Generally Accepted Accounting Principles.

 

The following is a reconciliation of the non-controlling interest balance (in thousands):

 

  Beginning at December 31, 2014 $ 15,679
    Accretion of Put Value   26
  Balance at June 30, 2015 $ 15,705
         

 

 

4.        CAPITAL STOCK

 

Stock Option Plans

 

The fair value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model, with the following weighted average assumptions for options granted in the three and six months ended June 30, 2014 and 2015.

 

   

Three Months Ended

June 30

 

Six Months Ended

June 30

    2014   2015   2014   2015
                 
  Risk-free interest rate 1.10%   1.17%   1.07%   1.16%
  Expected lives 3.3 years   3.4 years   3.3 years   3.4 years
  Expected volatility 45%   43%   45%   43%
  Expected dividend yield 0%   0%   0%   0%

 

- 9 -
 

 

 

A summary of the Company's stock option plans, excluding options to purchase fractional shares resulting from the Company's December 2010 1-for-10 reverse stock split is as follows:

 

     

Year Ended

December 31, 2014

Six Months Ended

June 30, 2015

     

 

 

 

Options

Weighted

Average

Exercise

Price

 

 

 

Options

Weighted

Average

Exercise

Price

  Outstanding at beginning of period   1,321,232   $ 10.386     1,074,251   $ 10.111  
    Granted at market   134,800   $ 16.398     29,046   $ 27.650  
    Cancelled   (218,926 ) $ 17.786     (27,585 ) $ 10.067  
    Exercised   (162,855 ) $ 7.234     (128,721 ) $ 8.816  
  Outstanding at end of period   1,074,251   $ 10.110     946,991   $ 10.826  
  Exercisable at end of period   729,175   $ 9.800     680,767   $ 10.688  

 

The estimated fair value of stock options granted during the six months ended June 30, 2014 and 2015 was computed to be approximately $114 thousand and $258 thousand, respectively. The amount is amortized ratably over the vesting period of the options. The per share weighted average estimated fair value of options granted during the six months ended June 30, 2014 and 2015 was computed to be approximately $3.66 and $8.88, respectively. The total intrinsic value of options exercised during the six months ended June 30, 2014 and 2015 was approximately $440 thousand and $1.9 million, respectively. The cash proceeds from options exercised during the six months ended June 30, 2014 and 2015 were approximately $789 thousand and $715 thousand, respectively.

 

The following table summarizes information about stock options outstanding and exercisable at June 30, 2015, excluding outstanding options to purchase an aggregate of 8.6 fractional shares resulting from the Company's December 2010 1-for-10 reverse stock split with a weighted average remaining contractual life of 1.1 years, a weighted average exercise price of $15.27 and exercise prices ranging from $9.50 to $22.50. The Company intends to issue whole shares only from option exercises.

 

    Options Outstanding Options Exercisable  
  Exercise Prices Number of
Options
Outstanding
at
June 30,
2015
Weighted
Average
Remaining
Contractual
Life in Years
Weighted
Average
Exercise
Price
Number of
Options
Exercisable
at
June 30,
2015
Weighted
Average
Exercise
Price
 
  $  4.40 - $  6.90   226,753     5.40   $ 5.597     213,505   $ 5.529  
  $  6.91 - $  8.34   209,299     8.32   $ 7.476     93,264   $ 7.585  
  $  8.35 - $12.40   176,019     7.18   $ 9.445     127,538   $ 9.735  
  $12.41 -$17.17   147,561     1.10   $ 13.752     143,487   $ 13.718  
  $17.18 - $28.55   187,359     7.08   $ 19.890     102,973   $ 21.151  
  $  4.40 - $28.55   946,991     6.04   $ 10.826     680,767   $ 10.688  
                                       

 

As of June 30, 2015, there was approximately $1.1 million of total unrecognized compensation cost related to outstanding stock options. That cost is expected to be recognized over a weighted average period of 1.8 years, with approximately $324 thousand to be recognized in the six months ending December 31, 2015 and all the cost to be recognized as of May 2019, assuming all options vest according to the vesting schedules in place at June 30, 2015. As of June 30, 2015, the aggregate intrinsic value of outstanding options was approximately $17.9 million and the aggregate intrinsic value of exercisable options was approximately $12.9 million.

 

- 10 -
 

 

Employee Stock Purchase Plan (the "ESPP")

 

On May 5, 2015, the Company's shareholders approved the amendment and restatement of the ESPP, including a 75,000 share increase to 450,000 total shares authorized under the ESPP as well as the following changes as compared to the ESPP prior to the amendment and restatement. Beginning April 1, 2015, employees may elect to withhold a positive fixed amount from each compensation payment in addition to the previous approach of withholding a whole percentage of such compensation payment, with all withholding for a given employee subject to a maximum monthly amount of $2,500 following the amendment and restatement as opposed to a $25,000 maximum annual amount prior to the amendment and restatement. For offering periods beginning on or after April 1, 2015, the purchase price of stock on March 31, June 30, September 30 and December 31 is to be the lesser of (1) 85% of the fair market value at the time of purchase and (2) the greater of (i) 85% of the fair market value at the beginning of the applicable offering period, (ii) the fair market value at the beginning of the applicable offering period less 1 cent and (iii) 65% of the fair market value at the time of purchase. In addition, participating employees may elect to purchase shares under the ESPP at the beginning of an applicable offering period for a purchase price of stock equal to the greater of (1) 85% of the fair market value at the beginning of the applicable offering period and (2) the fair market value at the beginning of the applicable offering period less 1 cent or at 5 pm on a day other than March 31, June 30, September 30 and December 31 during the applicable offering period for a purchase price of stock equal to the greater of (1) 85% of the fair market value at the time of purchase and (2) the fair market value at the time of purchase less 1 cent.

 

In the six months ended June 30, 2014, the Company issued 16,069 shares under the ESPP. In the six months ended June 30, 2015, the Company issued 6,043 shares under the ESPP.

 

For the three and six months ending June 30 of the following years, the Company estimated the fair values of stock purchase rights granted under the ESPP using the Black-Scholes pricing model and the following weighted average assumptions:

 

   

Three Months Ended

June 30

 

Six Months Ended

June 30

    2014   2015   2014   2015
                 
  Risk-free interest rate 0.23%   0.24%   0.23%   0.24%
  Expected lives 1.3 years   1.2 years   1.3 years   1.2 years
  Expected volatility 35%   36%   34%   35%
  Expected dividend yield 0%   0%   0%   0%

 

For the six months ended June 30, 2014, the weighted-average fair value of the purchase rights granted was $2.26 per share, respectively. For the six months ended June 30, 2015, the weighted-average fair value of the purchase rights granted $5.67 per share, respectively.

 

Restricted Stock Vesting and Issuance

 

In the six months ended June 30, 2015, Mr. Wilson vested 39,000 shares, which were shares originally issued on May 6, 2014 following a vote of approval by the Company's stockholders pursuant to an employment agreement between Mr. Wilson and the Company effective as of March 26, 2014 (the "Wilson Employment Agreement"), upon the Company's achievement of certain stock price targets as defined and further described in the Wilson Employment Agreement.

 

- 11 -
 

 

On March 17, 2015, the Company issued unvested shares to certain Executive Officers related to performance-based restricted stock grants (the "Performance Grants") and performance-based restricted stock grants related to the Company's 2015 Management Incentive Plan (the "MIP Grants"). The Performance Grants are to cliff vest three years following issuance, subject to the Company's achieving $7 million in Operating Cash Flow, as defined in the underlying restricted stock grant agreement, in at least one of 2015, 2016 or 2017, and other vesting provisions in the underlying restricted stock grant agreement. The MIP Grants are to vest on the date MIP Payouts are to be made under the 2015 Management Incentive Plan and are subject to the Company's achievement of certain financial goals and other vesting provisions in the underlying restricted stock grant agreement. The Company issued 52,956 shares under Performance Grants and 24,649 shares under MIP Grants on March 17, 2015.

 

Restrictions on the transfer of Company stock

 

The Company's Restated Certificate of Incorporation, as amended (the "Certificate of Incorporation"), places restrictions (the "Transfer Restrictions") on the transfer of the Company's stock that could adversely effect the Company's ability to utilize its domestic Federal Net Operating Loss Position. In particular, the Transfer Restrictions prevent the transfer of shares without the approval of the Company's Board of Directors if, as a consequence of such transfer, an individual, entity or groups of individuals or entities would become a 5-percent holder under Section 382 of the Internal Revenue Code of 1986, as amended, and the related Treasury regulations, and also prevents any existing 5-percent holder from increasing his or her ownership position in the Company without the approval of the Company's Board of Directors. Any transfer of shares in violation of the Transfer Restrictions (a "Transfer Violation") shall be void ab initio under the Certificate of Incorporation, and the Company's Board of Directors has procedures under the Certificate of Incorporation to remedy a Transfer Violation including requiring the shares causing such Transfer Violation to be sold and any profit resulting from such sale to be transferred to a charitable entity chosen by the Company's Board of Directors in specified circumstances.

 

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5.        SEGMENT REPORTING

 

The Company is comprised of two reportable segments, Core Companion Animal Health ("CCA") and Other Vaccines, Pharmaceuticals and Products ("OVP"). The Core Companion Animal Health segment includes diagnostic instruments and supplies, as well as single use diagnostic and other tests and pharmaceuticals. The CCA segment also includes digital radiography and ultrasound products along with embedded software and support, data hosting and other services from Heska Imaging. These products are sold directly by the Company as well as through independent third-party distributors and through other distribution relationships. CCA segment products manufactured at the Des Moines, Iowa production facility included in the OVP segment's assets are transferred at cost and are not recorded as revenue for the OVP segment. The Other Vaccines, Pharmaceuticals and Products segment includes private label vaccine and pharmaceutical production, primarily for cattle, but also for other animals including small mammals. All OVP products are sold by third parties under third-party labels.

 

Summarized financial information concerning the Company's reportable segments is shown in the following table (in thousands):

- 13 -
 

 

 

     

 

Core

Companion

Animal Health

 

 

Other Vaccines,

Pharmaceuticals

and Products

 

 

 

 

Total

 

Six Months Ended

June 30, 2014:

 
    Total revenue $ 34,852   $ 8,857     $ 43,709  
    Operating income (loss)   (265 )   1,081       816  
    Interest expense   74     28       102  
    Total assets   81,903     15,214       97,117  
    Net assets   39,968     11,715       51,683  
    Capital expenditures   1,334     204       1,538  
    Depreciation and amortization   1,231     386       1,617  
       
 

Six Months Ended

June 30, 2015:

 
    Total revenue $ 40,329   $ 6,475     $ 46,804  
    Operating income   2,071     779       2,850  
    Interest expense   80     23       103  
    Total assets   88,254     14,652       102,906  
    Net assets   43,989     12,607       56,596  
    Capital expenditures   449     487       936  
    Depreciation and amortization   1,724     350       2,074  
                             

 

     

 

Core

Companion

Animal Health

 

 

Other Vaccines,

Pharmaceuticals

and Products

 

 

 

 

Total

 

Three Months Ended

June 30, 2014:

 
    Total revenue $ 17,486   $ 5,430     $ 22,916  
    Operating income   43     874       917  
    Interest expense   37     15       52  
    Total assets   81,903     15,214       97,117  
    Net assets   39,968     11,715       51,683  
    Capital expenditures   123     98       221  
    Depreciation and amortization   688     200       888  
       
 

Three Months Ended

June 30, 2015:

 
    Total revenue $ 20,757   $ 3,153     $ 23,910  
    Operating income   1,536     293       1,829  
    Interest expense   40     11       51  
    Total assets   88,254     14,652       102,906  
    Net assets   43,989     12,607       56,596  
    Capital expenditures   142     189       331  
    Depreciation and amortization   894     174       1,068  
                             

  

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Item 2.


MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 



The following discussion and analysis of our financial condition and results of operations should be read in conjunction with "Selected Consolidated Financial Data" and the Unaudited Condensed Consolidated Financial Statements and related Notes included in Part I Item 1 of this Form 10-Q.

This discussion contains forward-looking statements that involve risks and uncertainties. Such statements, which include statements concerning future revenue sources and concentration, gross profit margins, selling and marketing expenses, general and administrative expenses, research and development expenses, capital resources, capital expenditures and additional financings or borrowings, are subject to risks and uncertainties, including, but not limited to, those discussed below and elsewhere in this Form 10-Q, particularly in Part II Item 1A. "Risk Factors," that could cause actual results to differ materially from those projected. The forward-looking statements set forth in this Form 10-Q are as of the close of business on August 6, 2015 and we do not intend to update this forward-looking information.

Overview

We develop, manufacture, market, sell and support veterinary products. Our business is comprised of two reportable segments, Core Companion Animal Health ("CCA"), which represented 84% of our revenue for the twelve months ended June 30, 2015 (which we define as "LTM") and Other Vaccines, Pharmaceuticals and Products ("OVP"), which represented 16% of LTM revenue.

 

The CCA segment includes, primarily for canine and feline use, blood testing instruments and supplies, digital imaging products, software and services, and single use products and services such as heartworm diagnostic tests, heartworm preventive products, allergy immunotherapy products and allergy testing.

 

Blood testing and other non-imaging instruments and supplies represented approximately 39% of our LTM revenue. Many products in this area involve placing an instrument in the field and generating future revenue from consumables, including items such as supplies and service, as that instrument is used. Approximately 32% of our LTM revenue resulted from the sale of such consumables to an installed base of instruments and approximately 7% of our LTM revenue was from hardware revenue. A loss of or disruption in supply of consumables we are selling to an installed base of instruments could substantially harm our business. All of our blood testing and other non-imaging instruments and supplies are supplied by third parties, who typically own the product rights and supply the product to us under marketing and/or distribution agreements. In many cases, we have collaborated with a third party to adapt a human instrument for veterinary use. Major products in this area include our chemistry instruments, our hematology instruments and our blood gas instruments and their affiliated operating consumables. Revenue from products in these three areas, including revenues from consumables, represented approximately 35% of our LTM revenue.

 

Imaging hardware, software and services represented approximately 18% of LTM revenue. Digital radiography is the largest product offering in this area, which also includes ultrasound instruments. Digital radiography solutions typically consist of a combination of hardware and software placed with a customer, often combined with an ongoing service and support contract. It has been our experience that most of the economic benefit is generated at the time of sale in this area, in contrast to the blood testing category discussed above where ongoing consumable revenue is often a larger component of economic value.

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Other CCA revenue, including single use diagnostic and other tests, pharmaceuticals and biologicals as well as research and development, licensing and royalty revenue, represented approximately 27% of our LTM revenue. Since items in this area are often single use by their nature, our typical aim is to build customer satisfaction and loyalty for each product, generate repeat annual sales from existing customers and expand our customer base in the future. Products in this area are both supplied by third parties and provided by us. Major products and services in this area include our heartworm preventives, our heartworm diagnostic tests, our allergy immunotherapy, our allergy testing and our allergy test kits. Combined revenue from heartworm-related products and allergy-related products represented 25% of our LTM revenue.

 

We consider the CCA segment to be our core business and devote most of our management time and other resources to improving the prospects for this segment. Maintaining a continuing, reliable and economic supply of products we currently obtain from third parties is critical to our success in this area. Virtually all of our sales and marketing expenses occur in the CCA segment. The majority of our research and development spending is dedicated to this segment as well.

 

All our CCA products are ultimately sold primarily to or through veterinarians. In many cases, veterinarians will mark up their costs to the end user. The acceptance of our products by veterinarians is critical to our success. CCA products are sold directly to end users by us as well as through distribution relationships, such as our corporate agreement with Merck Animal Health, the sale of kits to conduct blood testing to third-party veterinary diagnostic laboratories and independent third-party distributors. Revenue from direct sales and distribution relationships represented approximately 72% and 28%, respectively, of CCA LTM revenue.

 

We intend to sustain profitability over the long term through a combination of revenue growth, gross margin improvement and expense control. Accordingly, we closely monitor revenue growth trends in our CCA segment. LTM revenue in this segment increased 12% as compared to revenue in this segment for the twelve months ended June 30, 2014.

 

The OVP segment includes our 168,000 square foot USDA- and FDA-licensed production facility in Des Moines, Iowa. We view this facility as an asset which could allow us to control our cost of goods on any pharmaceuticals and vaccines that we may commercialize in the future. We have increased integration of this facility with our operations elsewhere. For example, virtually all our U.S. inventory, excluding Heska Imaging, is now stored at this facility and related fulfillment logistics are managed there. CCA segment products manufactured at this facility are transferred at cost and are not recorded as revenue for our OVP segment. We view OVP reported revenue as revenue primarily to cover the overhead costs of the facility and to generate incremental cash flow to fund our CCA segment.

 

Our OVP segment includes private label vaccine and pharmaceutical production, primarily for cattle but also for other animals such as small mammals. All OVP products are sold by third parties under third-party labels.

Historically, a significant portion of our OVP segment's revenue has been generated from the sale of certain bovine vaccines, which have been sold primarily under the Titanium® and MasterGuard® brands. We have a supply agreement with Eli Lilly and Company ("Eli Lilly") and its Affiliates operating through its Elanco Animal Health division ("Elanco") for the production of these vaccines. Our OVP segment also produces vaccines and pharmaceuticals for other third parties.

 

- 16 -
 

 

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations is based upon the consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of revenue and expense during the periods. These estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances. We have identified those critical accounting policies used in reporting our financial position and results of operations based upon a consideration of those accounting policies that involve the most complex or subjective decisions or assessment. We consider the following to be our critical policies.

 

Revenue Recognition

 

We generate our revenue through the sale and rental of products, as well as through licensing of technology product rights, royalties and sponsored research and development. Our policy is to recognize revenue when the applicable revenue recognition criteria have been met, which generally include the following:

 

· Persuasive evidence of an arrangement exists;
· Delivery has occurred or services rendered;
· Price is fixed or determinable; and
· Collectability is reasonably assured.

 

Revenue from the sale of products is recognized after both the goods are shipped to the customer and acceptance has been received, if required, with an appropriate provision for estimated returns and allowances. We do not permit general returns of products sold. Certain of our products have expiration dates. Our policy is to exchange certain outdated, expired product with the same product. We record an accrual for the estimated cost of replacing the expired product expected to be returned in the future, based on our historical experience, adjusted for any known factors that reasonably could be expected to change historical patterns, such as regulatory actions which allow us to extend the shelf lives of our products. Revenue from both direct sales to veterinarians and sales to independent third-party distributors are generally recognized when goods are shipped. Our products are shipped complete and ready to use by the customer. The terms of the customer arrangements generally pass title and risk of ownership to the customer at the time of shipment. Certain customer arrangements provide for acceptance provisions. Revenue for these arrangements is not recognized until the acceptance has been received or the acceptance period has lapsed. We reduce our revenue by the estimated cost of any rebates, allowances or similar programs, which are used as promotional programs.

 

Recording revenue from the sale of products involves the use of estimates and management judgment. We must make a determination at the time of sale whether the customer has the ability to make payments in accordance with arrangements. While we do utilize past payment history, and, to the extent available for new customers, public credit information in making our assessment, the determination of whether collectability is reasonably assured is ultimately a judgment decision that must be made by management. We must also make estimates regarding our future obligation relating to returns, rebates, allowances and similar other programs.

 

License revenue under arrangements to sell or license product rights or technology rights is recognized as obligations under the agreement are satisfied, which generally occurs over a period of time. Generally, licensing revenue is deferred and recognized over the estimated life of the related agreements, products, patents or technology. Nonrefundable licensing fees, marketing rights and milestone payments received under contractual arrangements are deferred and recognized over the remaining contractual term using the straight-line method.

- 17 -
 

 

Recording revenue from license arrangements involves the use of estimates. The primary estimate made by management is determining the useful life of the related agreement, product, patent or technology. We evaluate all of our licensing arrangements by estimating the useful life of either the product or the technology, the length of the agreement or the legal patent life and defer the revenue for recognition over the appropriate period.

 

We may enter into arrangements that include multiple elements. Such arrangements may include the licensing of technology and manufacturing of product or an agreement allowing for usage of an instrument and a given level of consumables for one monthly payment. In these situations we must determine whether the various elements meet the criteria to be accounted for as separate elements. If the elements cannot be separated, revenue is recognized once revenue recognition criteria for the entire arrangement have been met or over the period that the Company's obligations to the customer are fulfilled, as appropriate. If the elements are determined to be separable, the revenue is allocated to the separate elements based on relative fair value and recognized separately for each element when the applicable revenue recognition criteria have been met. In accounting for these multiple element arrangements, we must make determinations about whether elements can be accounted for separately and make estimates regarding their relative fair values.

 

Allowance for Doubtful Accounts

 

We maintain an allowance for doubtful accounts receivable based on client-specific allowances, as well as a general allowance. Specific allowances are maintained for clients which are determined to have a high degree of collectability risk based on such factors, among others, as: (i) the aging of the accounts receivable balance; (ii) the client's past payment history; (iii) a deterioration in the client's financial condition, evidenced by weak financial condition and/or continued poor operating results, reduced credit ratings, and/or a bankruptcy filing. In addition to the specific allowance, the Company maintains a general allowance for credit risk in its accounts receivable which is not covered by a specific allowance. The general allowance is established based on such factors, among others, as: (i) the total balance of the outstanding accounts receivable, including considerations of the aging categories of those accounts receivable; (ii) past history of uncollectable accounts receivable write-offs; and (iii) the overall creditworthiness of the client base. A considerable amount of judgment is required in assessing the realizability of accounts receivable. Should any of the factors considered in determining the adequacy of the overall allowance change, an adjustment to the provision for doubtful accounts receivable may be necessary.

 

Inventories

 

Inventories are stated at the lower of cost or market, cost being determined on the first-in, first-out method. Inventories are written down if the estimated net realizable value of an inventory item is less than its recorded value. We review the carrying cost of our inventories by product each quarter to determine the adequacy of our reserves for excess/obsolescence inventory. In accounting for inventories we must make estimates regarding the estimated net realizable value of our inventory. This estimate is based, in part, on our forecasts of future sales and shelf life of product.

 

Deferred Tax Assets – Valuation Allowance

 

Our deferred tax assets, such as a domestic Net Operating Loss ("NOL"), are reduced by an offsetting valuation allowance based on judgmental assessment of available evidence if we are unable to conclude that it is more likely than not that some or all of the related deferred tax assets will be realized. If we are able to conclude it is more likely than not that we will realize a future benefit from a deferred tax asset, we will reduce the related valuation allowance by an amount equal to the estimated quantity of income taxes we would pay in cash if we were not to utilize the deferred tax asset in the future. The first time this occurs in a given jurisdiction, it will result in a net deferred tax asset on our consolidated balance sheets and an income tax benefit of equal magnitude in our

- 18 -
 

statement of operations in the period we make the determination. In future periods, we will then recognize as income tax expense the estimated quantity of income taxes we would have paid in cash had we not utilized the related deferred tax asset. The corresponding journal entry will be a reduction of our deferred tax asset. If there is a change regarding our tax position in the future, we will make a corresponding adjustment to the related valuation allowance.

 

Results of Operations

 

Revenue

 

Total revenue was $46.8 million for the six months ended June 30, 2015, an increase of 7% as compared to $43.7 million in the corresponding period in 2014. Total revenue was $23.9 million for the three months ended June 30, 2015, a 4% increase from $22.9 million in the corresponding period in 2014.

 

Revenue from our CCA segment was $40.3 million, including $8.6 million recognized from Heska Imaging, for the six months ended June 30, 2015, an increase of 16% as compared to $34.9 million, including $5.3 million recognized from Heska Imaging, for the corresponding period in 2014. Revenue from our CCA segment was $20.8 million, including $4.4 million recognized from Heska Imaging, for the three months ended June 30, 2015, an increase of 19% as compared to $17.5 million, including $3.2 million recognized from Heska Imaging, for the corresponding period in 2014. In both cases, increased revenue from Heska Imaging, our instrument consumables, our chemistry instruments and our hematology instruments, somewhat offset by lower revenue from our canine heartworm preventive, were key factors in the increase.

 

Revenue from our OVP segment was $6.5 million for the six months ended June 30, 2015, a decrease of 27% as compared to $8.9 million in the corresponding period in 2014. Revenue from our OVP segment was $3.2 million for the three months ended June 30, 2015, a decrease of 42% as compared to $5.4 million in the corresponding period in 2014. Lower revenue from our vaccine supply agreement with Elanco was a factor in the change in both cases.

 

Cost of Revenue

Cost of revenue totaled $26.4 million for the six months ended June 30, 2015, a slight increase compared to the corresponding period in 2014. Gross profit was $20.4 million, including $3.2 million recognized from Heska Imaging, for the six months ended June 30, 2015 a 17% increase as compared to $17.4 million, including $1.2 million recognized from Heska Imaging, in the prior year period. Gross Margin, i.e. gross profit divided by total revenue, increased to 43.5% for the six months ended June 30, 2015 from 39.7% in the prior year period. Improved Gross Margin due to product mix and a lower relative contribution of revenue from our OVP segment, which tends to operate at lower Gross Margin than our consolidated Gross Margin, as well as improved Gross Margin from Heska Imaging, somewhat offset by lower Gross Margin in the rest of our CCA segment due to product mix, were key factors in the improvement.

 

Cost of revenue totaled $13.6 million for the three months ended June 30, 2015, a decrease of 2% as compared to $13.8 million for the corresponding period in 2014. Gross profit was $10.3 million, including $1.7 million recognized from Heska Imaging, for the three months ended June 30, 2015, a 13% increase as compared to $9.1 million, including $882 thousand recognized from Heska Imaging, in the prior year period. Gross Margin increased to 43.1% for the three months ended June 30, 2015 from 39.6% in the prior year period. A lower relative contribution of revenue from our OVP segment, which tends to operate at lower Gross Margin than our consolidated Gross Margin, improved Gross Margin from Heska Imaging and improved Gross Margin in the rest of our CCA segment due to product mix, were key factors in the improvement.

 

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Operating Expenses

 

Total operating expenses were $17.5 million, including $3.2 million recognized from Heska Imaging, in the six months ended June 30, 2015, an increase of 6% from $16.5 million, including $2.8 million recognized from Heska Imaging, in the prior year period. Total operating expenses were $8.5 million, including $1.6 million recognized from Heska Imaging, in the three months ended June 30, 2015, an increase of 4% from $8.2 million, including $1.5 million recognized from Heska Imaging, in the prior year period.

 

Selling and marketing expenses were $10.7 million in the six months ended June 30, 2015, as compared to $9.7 million in the six months ended June 30, 2014, a year-over-year increase of 10%. Selling and marketing expenses were $5.2 million, in the three months ended June 30, 2015, an increase of 10% as compared to $4.8 million in the three months ended June 30, 2014. Increased commissions and distributor incentives were key factors in the change in both cases.

 

Research and development expenses were $811 thousand in the six months ended June 30, 2015, a 6% increase as compared to $762 thousand in the corresponding period in 2014. Research and development expenses were $392 thousand in the three months ended June 30, 2015, a 5% increase as compared to $374 thousand in the corresponding period in 2014. Increased research and development expenses related to Heska Imaging was a key factor in the change in both cases.

 

General and administrative expenses were $6.0 million in the six months ended June 30, 2015, a 1% decrease from $6.1 million in the prior year period. A decrease in severance expenses was a factor in the change. General and administrative expenses were $2.8 million in the three months ended June 30, 2015, a decrease of 7% from $3.0 million in the prior year period. Lower outside consulting fees related to our information technology systems was a factor in the improvement.

 

Interest and Other (Income) Expense, Net

 

In the six months ended June 30, 2015, this line item was an $174 thousand expense as opposed to a $9 thousand expense in the prior year period. In the three months ended June 30, 2015, this line item was a $37 thousand expense as opposed to $7 thousand in income in the prior year period. In both cases, the largest factor in the change related to larger currency losses in the 2015 period, primarily related to our Swiss operating subsidiary, which uses the Swiss Franc as its functional currency. In the six months ended June 30, we recognized $171 thousand in net currency losses in the 2015 period as opposed to $6 thousand in net currency losses in the 2014 period. In the three months ended June 30, we recognized $28 thousand in net currency losses in the 2015 period as opposed to $1 thousand in net currency gains in the 2014 period.

 

Income Tax Expense

 

We recognized $915 thousand net income tax expense in the six months ended June 30, 2015, as compared to $302 thousand in the prior year period. We recognized $614 thousand net income tax expense in the three months ended June 30, 2015, as compared to $146 thousand in the prior year period.

 

Current tax expense was $126 thousand in the six months ended June 30, 2015, an increase of $73 thousand as compared to $53 thousand in the prior year period. Current tax expense was $82 thousand in the three months ended June 30, 2015, an increase of $50 thousand as compared to $32 thousand in the prior year period.

 

For the six months ended June 30, 2015, deferred tax expense was $789 thousand, a $540 thousand change from $249 thousand in deferred tax expense in the prior year period. For the three months ended June 30, 2015, deferred tax expense was $532 thousand, a $418 thousand change from $114 thousand in deferred tax expense in the prior year period.

 

Greater income before income taxes was a key factor in the increase in both current tax expense and deferred tax expense.

- 20 -
 

 

Net Income

 

Net income was $1.8 million in the six months ended June 30, 2015, an increase of approximately $1.3 million compared to $505 thousand in the prior year period. Net income was $1.2 million in the three months ended June 30, 2015, an increase of approximately $400 thousand compared to $778 thousand in the prior year period. Greater revenue and higher Gross Margin, somewhat offset by increased operating expenses, were key factors in the change.

 

Net Income attributable to Heska Corporation

 

Net income attributable to Heska Corporation was $1.8 million in the six months ended June 30, 2015, an increase of approximately $534 thousand compared to $1.3 million net income in the prior year period. Net income attributable to Heska Corporation was $1.2 million in the three months ended June 30, 2015, an increase of approximately $128 thousand compared to $1.1 million net income in the prior year period. The difference between this line item and "Net Income (Loss)" above is the net income or loss attributable to the minority interest in Heska Imaging, which was a net loss of $34 thousand in the six months ended June 30, 2015 and a net loss of $19 thousand in the three months ended June 30, 2015 compared to a net loss of $756 thousand in the six months ended June 30, 2014 and a net loss of $291 thousand in the three months ended June 30, 2014, respectively. Greater revenue and higher Gross Margin, somewhat offset by increased operating expenses, were key factors in the change in net income attributable to Heska Corporation.

 

Liquidity and Capital Resources

 

We have incurred net cumulative negative cash flow from operations since our inception in 1988. For the six months ended June 30, 2015, we had net income of $1.8 million. During the six months ended June 30, 2015, our operations used cash of approximately $282 thousand. At June 30, 2015, we had $6.6 million of cash and cash equivalents, $20.4 million of working capital, and $1.4 million of outstanding borrowings under our revolving line of credit, discussed below.

 

Net cash used by operating activities was approximately $282 thousand for the six months ended June 30, 2015 as compared to $3.2 million of cash provided by operating activities in the six months ended June 30, 2014, a change of approximately $3.4 million. Key factors in the change were $3.4 million greater cash used in inventory purchases in the 2015 period and a $3.0 million milestone payment received in the 2014 period but not the 2015 period, somewhat offset by $1.8 million in greater cash provided by net income and deferred tax expense and $1.1 million more cash provided by accounts receivable in the 2015 period related to payment timing.

 

Net cash flows used in investing activities were $936 thousand in the six months ended June 30, 2015, a decrease of approximately $596 thousand as compared to $1.5 million used during the six months ended June 30, 2014. This line item primarily relates to the purchase of property and equipment and a key factor in the decline was lower purchases of demonstration and loaner equipment by Heska Imaging in the 2015 period as compared to the 2014 period.  

 

Net cash flows provided in financing activities were $1.9 million during the six months ended June 30, 2015, a $3.4 million change as compared to $1.4 million used by financing activities in the six months ended June 30, 2014. The largest factor in the change related to our line of credit, where we borrowed $1.3 million in the 2015 period and repaid $2.2 million in the 2014 period.

 

At June 30, 2015, Heska Corporation had accounts receivable from Heska Imaging of $5.7 million, including accrued interest, which eliminates upon consolidation of our financial statements. These monies accrue interest at the same interest rate as Heska Corporation pays under its asset-based revolving line of credit with Wells Fargo once past due.

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At June 30, 2015, we, including the consolidated balance sheets of our subsidiaries, had an account receivable from Cuattro Software, LLC of $832 thousand, net accounts receivable from Cuattro, LLC of $16 thousand and net accounts payable to Cuattro, LLC of $698 thousand. These items are included on our consolidated balance sheets in "Due from – related parties" and "Due to – related parties" as Kevin S. Wilson, our Chief Executive Officer and President, Mrs. Wilson and trusts for their children and family hold a 100% interest in Cuattro, LLC and Cuattro, LLC owns a 100% interest in Cuattro Software, LLC. All monies owed are to accrue interest at the same interest rate the Company pays under its credit and security agreement with Wells Fargo once past due.

 

At June 30, 2015, we had a $1.5 million note receivable, including accrued interest, from Cuattro Veterinary, LLC. The note is to pay interest at the same interest rate as Heska Corporation pays under its asset-based revolving line of credit with Wells Fargo and is due on March 15, 2016. Cuattro Veterinary, LLC sells the same digital radiography solutions outside the United States that Heska Imaging sells in the United States. The note is listed on our balance sheet as a "Note receivable – related party" as Cuattro, LLC holds a majority interest in Cuattro Veterinary, LLC. This note was held by Heska Imaging at the time of our acquisition of Heska Imaging (the "Acquisition") on February 24, 2013.

 

At June 30, 2015, we had a $15.0 million asset-based revolving line of credit with Wells Fargo which had a maturity date of December 31, 2015 as part of our credit and security agreement with Wells Fargo. At June 30, 2015, we had $1.4 million in outstanding borrowings under this line of credit. Our ability to borrow under this facility varies based upon available cash, eligible accounts receivable and eligible inventory. On June 30, 2015, interest on borrowings due was to be charged at a stated rate of three month LIBOR plus 2.75% and payable monthly. The stated rate declined to three month LIBOR plus 2.75% as of April 1, 2015 based on the terms of the credit and security agreement and our 2014 financial performance. We are required to comply with various financial and non-financial covenants, and we have made various representations and warranties under our agreement with Wells Fargo. A key financial covenant is based on a fixed charge coverage ratio under this agreement. Failure to comply with any of the covenants, representations or warranties could result in our being in default on the loan and could cause all outstanding amounts payable to Wells Fargo to become immediately due and payable or impact our ability to borrow under the agreement. We were in compliance with all financial covenants as of June 30, 2015. At June 30, 2015, our available borrowing capacity based upon eligible accounts receivable and eligible inventory under our revolving line of credit was approximately $8.2 million.

 

At June 30, 2015, we had other borrowings outstanding totaling $299 thousand, all of which were obligations of a Heska Imaging loan from De Lage Landen Financial Services, Inc. ("DLL"). The note bears an interest rate of 6% and is due in equal monthly payments, including principal and interest, of $13 thousand through June 2017. The note may be prepaid prior to maturity, but is subject to a surcharge in such a circumstance. $159 thousand of principal associated with this note is listed as short term on our balance sheet as it is due within a year.

 

At June 30, 2015, our consolidated balance sheets included $15.7 million in non-controlling interest. This represents the value of the aggregate position in Heska Imaging of the Imaging Minority. We evaluate the value of this position every reporting period and make adjustments using a weighted average based on various potential outcomes and our estimate of the likelihood of such outcomes. For the six months ended June 30, 2015, this resulted in approximately $26 thousand in net accretion which was recorded as a credit to this line item, with the corresponding debit to directly reduce additional paid-in-capital as we have an accumulated deficit.

Our financial plan for 2015 indicates that our available cash and cash equivalents, together with cash from operations and borrowings expected to be available under our revolving line of credit, will be sufficient to fund our operations through 2015 and into 2016. However, our actual results may differ from this plan, and we may be required to consider alternative strategies. We may be required to raise additional capital in the future. If necessary, we expect to raise these additional funds through the increased sale of customer leases, the sale of equity securities or the issuance of new term debt secured by the same assets as the term loans which were fully repaid in 2010. There is no guarantee that additional capital will be available from these sources on acceptable terms, if at all, and certain of these sources may require approval by existing lenders.

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Under the Operating Agreement, should Heska Imaging meet certain performance criteria, the Imaging Minority has been granted a put option to sell us some or all of the Imaging Minority's remaining 45.4% position in Heska Imaging following the audit of our financial statements in 2015, 2016 and 2017. Furthermore, should Heska Imaging meet certain performance criteria, and the Imaging Minority fail to exercise an applicable put to sell us all of the Imaging Minority's position in Heska Imaging following the audit of our financial statements in 2015, 2016 and 2017, we would have a call option to purchase all, but not less than all, of the Imaging Minority's position in Heska Imaging. While we intend to meet any related cash payment obligations with funds provided by our ongoing operations and assets, likely supplemented by debt financing and potentially with equity financing, there can be no assurance our results will unfold according to our expectations. These potential cash payment obligations are an important consideration for us in our cash management decisions.

We believe it is likely that Heska Imaging will meet the required performance criteria for its 2015 lowest strike put, but not its 2015 highest strike put, in 2015. In this case, the Imaging Minority would be granted a put following our 2015 audit which could require us to deliver up to $13.6 million, as well as 25% of Heska Imaging's cash, to purchase the 45.4% of Heska Imaging we do not own. In such a case, while we have the right to deliver up to 55% of the consideration in our Public Common Stock under certain circumstances, such stock is to be valued based on 90% of market value (the "Delivery Stock Value") and is limited to approximately 650 thousand shares in any case. If the Delivery Stock Value per share is less than the market value per share of our Public Common Stock at the time of the Acquisition, we do not have the right to deliver any Public Common Stock as consideration. Assuming we deliver the full 55% of the consideration in our Public Common Stock, we could still have an obligation to pay as much as approximately $6.1 million in cash as well as 25% of Heska Imaging's cash to the Imaging Minority in this circumstance.

We would consider acquisitions if we felt they were consistent with our strategic direction. We paid $1.6 million in dividends in 2012, and while we may consider paying dividends again in the long term, we do not anticipate the payment of any further dividends for the foreseeable future. We conducted an odd lot tender offer in 2012 which could have led to the repurchase of approximately $400 thousand of our stock if all eligible holders had chosen to participate, and while we may consider stock repurchase alternatives in an opportunistic manner or in the long term, we do not anticipate the implementation of any stock repurchase programs for the foreseeable future.

 

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Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

Market risk represents the risk of loss that may impact the financial position, results of operations or cash flows due to adverse changes in financial and commodity market prices and rates. We are exposed to market risk in the areas of changes in United States and foreign interest rates and changes in foreign currency exchange rates as measured against the United States dollar and against other foreign currencies. These exposures are directly related to our normal operating and funding activities.

Interest Rate Risk

 

At June 30, 2015, there was $1.4 million in debt outstanding on our line of credit with Wells Fargo. We also had approximately $6.6 million of cash and cash equivalents at June 30, 2015, the majority of which was invested in liquid accounts. We had no interest rate hedge transactions in place on June 30, 2015. We completed an interest rate risk sensitivity analysis based on the above and an assumed one percentage point increase/decrease in interest rates. If market rates increase/decrease by one percentage point and such changes were reflected in all our investments, we would experience a decrease/increase in annual net interest expense of approximately $53 thousand based on our outstanding balances as of June 30, 2015.

 

Foreign Currency Risk

Our investment in foreign assets consists primarily of our investment in our Swiss subsidiary. Foreign currency risk may impact our results of operations. In cases where we purchase inventory in one currency and sell corresponding products in another, our gross margin percentage is typically at risk based on foreign currency exchange rates. In addition, in cases where we may be generating operating income in foreign currencies, the magnitude of such operating income when translated into U.S. Dollars will be at risk based on foreign currency exchange rates. Our agreements with suppliers and customers vary significantly in regard to the existence and extent of currency adjustment and other currency risk sharing provisions. We had no foreign currency hedge transactions in place on June 30, 2015.

We have a wholly-owned subsidiary in Switzerland which uses the Swiss Franc as its functional currency. We purchase inventory with exposure to foreign currencies, primarily Euros and Chinese Yuan, and sell corresponding products in U.S. Dollars. We also sell products in foreign currencies, primarily Euros and Japanese Yen, where our inventory costs are largely in U.S. Dollars. Based on our results of operations for the twelve months ending June 30, 2015, currency holdings and currency-related prepaid accounts, accounts receivable and accounts payable (all of which, including currency holdings, we will refer to as "Currency Accounts") as of June 30, 2015 and the functional currency of the accounting entity where such Currency Accounts are held, the expected impact on our consolidated statements of operations, if foreign currency exchange rates were to strengthen/weaken by 25% against the Dollar, would be a resulting gain/loss in operating income of approximately $170 thousand and a currency loss/gain of $31 thousand, if all other currencies were to strengthen/weaken by 25% against the Swiss Franc, would be a resulting loss/gain in operating income of approximately $76 thousand and a currency gain/loss of $389 thousand, and if all other currencies were to strengthen/weaken by 25% against the Euro, would be a resulting loss/gain in operating income of approximately $280 thousand and a currency loss/gain of $350 thousand.

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 Item 4.

CONTROLS AND PROCEDURES

 

(a) Evaluation of Disclosure Controls and Procedures . Our management, with the participation of our chief executive officer and our chief financial officer, evaluated the effectiveness of our disclosure controls and procedures, as defined by Rule 13a-15 of the Exchange Act, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our chief executive officer and our chief financial officer have concluded that our disclosure controls and procedures are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure.

 

(b) Changes in Internal Control over Financial Reporting . There was no change in our internal control over financial reporting that occurred during our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

Item 1.    Legal Proceedings

 

From time to time, we may be involved in litigation relating to claims arising out of our operations. On March 12, 2015, a complaint was filed against us by Shaun Fauley in the United States District Court Northern District of Illinois alleging our transmittal of unauthorized faxes in violation of the federal Telephone Consumer Protection Act of 1991, as amended by the Junk Fax Prevention Act of 2005, as a class action seeking stated damages of the greater of actual monetary loss or five hundred dollars per violation. We intend to defend the Company vigorously in this matter. As of June 30, 2015 we were not a party to any other legal proceedings that are expected, individually or in the aggregate, to have a material adverse effect on our business, financial condition or operating results.

 

Item 1A.  Risk Factors

 

Our future operating results may vary substantially from period to period due to a number of factors, many of which are beyond our control. The following discussion highlights some of these factors and the possible impact of these factors on future results of operations. The risks and uncertainties described below are not the only ones we face. Additional risks or uncertainties not presently known to us or that we deem to be currently immaterial also may impair our business operations. If any of the following factors actually occur, our business, financial condition or results of operations could be harmed. In that case, the price of our Public Common Stock could decline and you could experience losses on your investment.

 

Our February 2013 acquisition of a 54.6% majority interest in Cuattro Veterinary USA, LLC, which has been renamed Heska Imaging US, LLC, could be detrimental to the interests of our shareholders due to related puts, calls or other provisions, or for other reasons.

 

Under the Amended and Restated Operating Agreement of Heska Imaging (the "Operating Agreement"), should Heska Imaging meet certain performance criteria, the Imaging Minority has been granted a put option to sell us some or all of the Imaging Minority's position in Heska Imaging following the audit of our financial statements for 2015, 2016 and 2017. Based on Heska Imaging's current ownership position, this put option could require us to deliver either up to $17.0 million following calendar year 2015, $17.0 million following calendar year 2016 or $36.9 million following calendar year 2017 - as well as 25% of Heska Imaging's cash (any applicable payment in aggregate to be defined as the "Put Payment") to acquire the outstanding minority interest in Heska Imaging. While we have the right to deliver up to 55% of the consideration in our Public Common Stock under certain circumstances, such stock is to be valued based on 90% of market value (the "Delivery Stock Value") and is limited to approximately 650 thousand shares in any case. If the Delivery Stock Value per share

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is less than the market value per share of our Public Common Stock at the time of the Acquisition, we do not have the right to deliver any Public Common Stock as consideration. Cash required under any Put Payment could put a significant strain on our financial position or require us to raise additional capital. There is no guarantee that additional capital will be available in such a circumstance on reasonable terms, if at all. We may be unable to obtain debt financing, the public markets may be unreceptive to equity financing and we may not be able to obtain financing from other alternative sources, such as private equity. Any debt financing, if available, may include restrictive covenants and high interest rates and any equity financing would likely be dilutive to stockholders in this scenario. If additional funds are required and are not available, it would likely have a material adverse effect on our business, financial condition and our ability to continue as a going concern.

 

Under the Operating Agreement, should Heska Imaging meet certain performance criteria, and the Imaging Minority fail to exercise an applicable put to sell us all of the Imaging Minority's position in Heska Imaging following the audit of our financial statements for 2015, 2016 and 2017, we would have a call option to purchase all, but not less than all, of the Imaging Minority's position in Heska Imaging. Based on Heska Imaging's current ownership position, exercising this call option could require us to deliver up to $19.6 million following calendar year 2015, $19.6 million following calendar year 2016 or $42.4 million following calendar year 2017 - as well as 25% of Heska Imaging's cash (any applicable payment in aggregate to be defined as the "Call Payment") to acquire the outstanding minority interest in Heska Imaging. While we have the right to deliver up to 55% of the consideration in our Public Common Stock under certain circumstances, such stock is to be valued based on 90% of market value (the "Delivery Stock Value") and is limited to approximately 650 thousand shares in any case. If the Delivery Stock Value per share is less than the market value per share of our Public Common Stock at the time of the Acquisition, we do not have the right to deliver any Public Common Stock as consideration. If we believe it is desirable to exercise any one of these calls, cash required under the Call Payment could put a significant strain on our financial position or require us to raise additional capital. There is no guarantee that additional capital will be available in such a circumstance on reasonable terms, if at all. If we believe it is desirable to exercise any such call, determine we are unable to economically finance the Call Payment and do not exercise the call as a result, we could be subject to a more expensive Put Payment less than a year in the future. In this circumstance, unless there is a significant change in our financial position or market conditions, such a Put Payment could have a material adverse effect on our business, financial condition and our ability to continue as a going concern.

 

Under and as defined in the Operating Agreement, should we undergo a change in control prior to the end of 2017, the Imaging Minority will be entitled to sell their Heska Imaging units to us for cash at the highest call value they otherwise could have obtained (the "Change in Control Payment"). This will be $42.4 million until at least the end of 2015 and could be as high as $42.4 million beyond 2015 if Heska Imaging meets certain minimum performance criteria. The Change in Control Payment may materially decrease the interest of third parties in acquiring the Company or a majority of the Company's shares, which could otherwise have occurred at a significant premium to the Company's then current market price for the benefit of some or all of our shareholders. This could make some investors less likely to buy and hold our stock.

 

Under the terms of the Operating Agreement, Heska Imaging will be managed by a three-person board of managers, two of which are to be appointed by Heska Corporation and one of which is to be appointed by Kevin   S. Wilson, a founder of Heska Imaging who has also been Heska Corporation's Chief Executive Officer and President since March 31, 2014. The current board of managers consists of Robert B. Grieve, Ph.D., Heska Corporation's Executive Chair, Mr. Wilson and Jason A. Napolitano, Heska Corporation's Executive Vice President, Chief Financial Officer and Secretary. Until the earlier of (1) our acquiring 100% of the units of Heska Imaging pursuant to the puts and/or calls discussed above or (2) the sixth anniversary of the Acquisition, Heska Imaging may only take the following actions, among others, by unanimous consent of the board of managers: (i) issue securities, (ii) incur, guarantee, prepay, refinance, renew, modify or extend debt, (iii) enter into material contracts, (iv) hire or terminate an officer or amend the terms of their employment, (v) make a distribution other than a tax or liquidation distribution, (vi) enter into a material acquisition or disposition arrangement or a merger, (vii) lease or acquire an interest in real property, (viii) convert or reorganize Heska Imaging, or (ix) amend its certificate of formation or the Heska Imaging Agreement. This unanimous consent provision may hinder our ability to optimize the value of its investment in Heska Imaging in certain circumstances.

 

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Mr. Wilson's employment agreement with us acknowledges that Mr. Wilson has business interests in Cuattro, LLC, Cuattro Software, LLC, Cuattro Medical, LLC and Cuattro Veterinary, LLC which may require a portion of his time, resources and attention in his working hours. If Mr. Wilson is distracted by these or other business interests, he may not contribute as much as he otherwise would have to enhancing our business, to the detriment of our shareholder value. Mr. Wilson is the spouse of Shawna M. Wilson ("Mrs. Wilson"). Mr. Wilson, Mrs. Wilson and trusts for their children and family own a majority interest in Cuattro Medical, LLC. In addition, including shares held by Mrs. Wilson and by trusts for the benefit of Mr. and Mrs. Wilson's children and family, Mr. Wilson also owns a 100% interest in Cuattro, LLC, the largest supplier to Heska Imaging. Cuattro, LLC owns a 100% interest in Cuattro Software, LLC and a majority interest in Cuattro Veterinary, LLC. While the terms of both the Amended and Restated Master License Agreement and the Supply Agreement between Heska Imaging and Cuattro, LLC were negotiated at arm's length as part of the Acquisition, Mr. Wilson has an interest in these agreements and any time and resources devoted to monitoring and overseeing this relationship may prevent us from deploying such time and resources on more productive matters.

 

Since January 1, 2015, Cuattro, LLC charged Heska Imaging $3.9 million, primarily related to digital imaging products, for which there is an underlying supply contract with minimum purchase obligations, software and services as well as other operating expenses provided for under a license agreement and a supply agreement, respectively; Heska Corporation charged Heska Imaging $2.2 million, primarily related to sales and other administrative expenses; Heska Corporation net charged Cuattro, LLC $79 thousand, primarily related to facility usage and other services.

 

At June 30, 2015, Heska Imaging had a $1.5 million note receivable, including accrued interest, from Cuattro Veterinary, LLC, which is due on March 15, 2016; Heska Imaging had accounts receivable from Cuattro Software, LLC of $832 thousand, including accrued interest; Heska Corporation had accounts receivable from Heska Imaging of $5.7 million, including accrued interest; Heska Corporation had net accounts receivable from Cuattro, LLC of $16 thousand; Heska Imaging had net accounts payable to Cuattro, LLC of $698 thousand. All monies owed accrue interest at the same interest rate Heska Corporation pays under its credit and security agreement with Wells Fargo once past due with the exception of the note receivable, which accrues at this rate to its maturity date.

 

Mrs. Wilson, Clint Roth, DVM, Mr. Asakowicz, Mr. Lippincott, Mr. Wilson and Cuattro, LLC own approximately 29.75%, 8.39%, 4.09%, 3.07%, 0.05% and 0.05% of Heska Imaging, respectively, each are a member of Heska Imaging, and each have an interest in the puts and calls discussed above. If Mr. Wilson, Mr. Asakowicz or Mr. Lippincott is distracted by these holdings or interests, they may not contribute as much as they otherwise would have to enhancing our business, to the detriment of our shareholder value. While the Operating Agreement was negotiated at arm's length as part of the Acquisition, and requires that none of the members shall cause Heska Imaging to operate its business in any manner other than the ordinary course of business, any time and resources devoted to monitoring and overseeing this relationship may prevent us from deploying such time and resources on more productive matters.

 

In addition, like any acquisition, if Heska Imaging significantly underperforms our financial expectations, it may serve to diminish rather than enhance shareholder value. Heska Imaging generated an operating loss of approximately $2.1 million in the year ended December 31, 2014.

 

If the third parties who have substantial marketing rights for certain of our historical products, existing products or future products under development are not successful in marketing those products, then our sales and financial position may suffer.

 

Our agreements with our corporate marketing partners may contain no or small minimum purchase requirements in order for them to maintain their exclusive marketing rights. We are party to an agreement with Merck Animal Health, which grants Merck Animal Health exclusive distribution and marketing rights for our canine heartworm preventive product, TRI-HEART Plus Chewable Tablets, ultimately sold to or through veterinarians in the United States and Canada. Historically, a significant portion of our OVP segment's revenue has been generated from the sale of certain bovine vaccines, which have been sold primarily under the Titanium® and MasterGuard® brands. We have a supply agreement with Eli Lilly and its Affiliates operating

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through Elanco for the production of these vaccines. Novartis Agro K.K., Tokyo ("Novartis Japan") markets and distributes our SOLO STEP CH heartworm test in Japan under an exclusive arrangement. One or more of these marketing partners may not devote sufficient resources to marketing our products and our sales and financial position could suffer significantly as a result. Revenue from Merck entities, including Merck Animal Health, represented 9% of our LTM revenue. Revenue from Eli Lilly entities, including Elanco and pro forma for an acquisition made by Eli Lilly in the LTM period, represented 12% of our LTM revenue. If Merck Animal Health personnel fail to market, sell and support our heartworm preventive sufficiently or if Elanco personnel fail to market, sell and support the bovine vaccines we produce and sell to Elanco sufficiently, our sales could decline significantly. Furthermore, there may be nothing to prevent these partners from pursuing alternative technologies, products or supply arrangements, including as part of mergers, acquisitions or divestitures. For example, we believe a unit of Merck has obtained FDA approval for a canine heartworm preventive product with additional claims compared with our TRI-HEART Plus Chewable Tablets, which we believe is not currently being marketed actively. Should Merck decide to emphasize sales and marketing efforts of this product rather than our TRI-HEART Plus Chewable Tablets or cancel our agreement regarding canine heartworm preventive distribution and marketing, our sales could decline significantly. In another example, if Elanco were to emphasize sales and marketing efforts for bovine vaccines other than those we produce or cancel our supply agreement and produce the vaccines we supply to them by themselves, our sales could decline significantly. In the future, third-party marketing assistance may not be available on reasonable terms, if at all. If any of these events occur, we may not be able to maintain our current market share or commercialize certain of our products and our sales will decline accordingly.

 

We may face costly legal disputes, including related to our intellectual property or technology or that of our suppliers or collaborators.

 

We may face legal disputes related to our business. For example, on March 12, 2015, a complaint was filed against us by Shaun Fauley in the United States District Court Northern District of Illinois alleging our transmittal of unauthorized faxes in violation of the federal Telephone Consumer Protection Act of 1991, as amended by the Junk Fax Prevention Act of 2005, as a class action seeking stated damages of the greater of actual monetary loss or five hundred dollars per violation. Even if meritless, these disputes may require significant expenditures on our part and could entail a significant distraction to members of our management team or other key employees. We may have to use legal means to collect payment for goods shipped to third parties. A legal dispute leading to an unfavorable ruling or settlement could have significant material adverse consequences on our business.

 

We may become subject to patent infringement claims and litigation in the United States or other countries or interference proceedings conducted in the United States Patent and Trademark Office, or USPTO, to determine the priority of inventions. The defense and prosecution of intellectual property suits, USPTO interference proceedings and related legal and administrative proceedings are likely to be costly, time-consuming and distracting. As is typical in our industry, from time to time we and our collaborators and suppliers have received, and may in the future receive, notices from third parties claiming infringement and invitations to take licenses under third-party patents. Any legal action against us or our collaborators or suppliers may require us or our collaborators or suppliers to obtain one or more licenses in order to market or manufacture effected products or services. However, we or our collaborators or suppliers may not be able to obtain licenses for technology patented by others on commercially reasonable terms, or at all, may not be able to develop alternative approaches if unable to obtain licenses or current and future licenses may not be adequate, any of which could substantially harm our business.

 

We may also need to pursue litigation to enforce any patents issued to us or our collaborative partners, to protect trade secrets or know-how owned by us or our collaborative partners, or to determine the enforceability, scope and validity of the proprietary rights of others. Any litigation or interference proceedings will likely result in substantial expense to us and significant diversion of the efforts of our technical and management personnel. Any adverse determination in litigation or interference proceedings could subject us to significant liabilities to third parties. Further, as a result of litigation or other proceedings, we may be required to seek licenses from third parties which may not be available on commercially reasonable terms, if at all.

 

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The loss of significant customers who, for example, are historically large purchasers or who are considered leaders in their field could damage our business and financial results.

 

Revenue from Merck entities, including Merck Animal Health, represented approximately 11% of our consolidated revenue for the six months ended June 30, 2015, as well as 16% and 13% for the six months and three months ended June 30, 2014, respectively. Revenue from Butler Animal Health Supply, LLC d/b/a Henry Schein Animal Health ("Henry Schein") represented approximately 11% of our consolidated revenue for the three months ended June 30, 2014. Eli Lilly entities, including Elanco, represented approximately 11% and 16% of our consolidated revenue for the six months and three months ended June 30, 2014, respectively. No other single customer accounted for more than 10% of our consolidated revenue for the six months and three months ending June 30, 2015 or the six months and three months ending June 30, 2014. Merck entities accounted for approximately 15% of our consolidated accounts receivable at June 30, 2015. Eli Lilly entities, including Elanco, accounted for approximately 10% of our consolidated accounts receivable at June 30, 2015 and 27% of our consolidated accounts receivable at June 30, 2014. No other single customer accounted for more than 10% of our consolidated accounts receivable at June 30, 2015 or June 30, 2014.

 

The loss of significant customers who, for example, are historically large purchasers or who are considered leaders in their field could damage our business, including via reputational damage, and financial results.

 

Obtaining and maintaining regulatory approvals in order to market our products may be costly and delay the marketing and sales of our products. Failure to meet all regulatory requirements could cause significant losses from affected inventory and the loss of market share.

 

Many of the products we develop, market or manufacture may subject us to extensive regulation by one or more of the USDA, the FDA, the EPA and foreign and other regulatory authorities. These regulations govern, among other things, the development, testing, manufacturing, labeling, storage, pre-market approval, advertising, promotion and sale of some of our products. Satisfaction of these requirements can take several years and time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the product. The decision by a regulatory authority to regulate a currently non-regulated product or product area could significantly impact our revenue and have a corresponding adverse impact on our financial performance and position while we attempt to comply with the new regulation, if such compliance is possible at all.

 

The effect of government regulation may be to delay or to prevent marketing of our products for a considerable period of time and to impose costly procedures upon our activities. We may not be able to estimate the time to obtain required regulatory approvals accurately and such approvals may require significantly more time than we anticipate. We have experienced in the past, and may experience in the future, difficulties that could delay or prevent us from obtaining the regulatory approval or license necessary to introduce or market our products. Such delays in approval may cause us to forego a significant portion of a new product's sales in its first year due to seasonality and advanced booking periods associated with certain products. Regulatory approval of our products may also impose limitations on the indicated or intended uses for which our products may be marketed.

 

Difficulties in making established products to all regulatory specifications may lead to significant losses related to affected inventory as well as market share. Among the conditions for certain regulatory approvals is the requirement that our facilities and/or the facilities of our third-party manufacturers conform to current Good Manufacturing Practices and other requirements. If any regulatory authority determines that our manufacturing facilities or those of our third-party manufacturers do not conform to appropriate manufacturing requirements, we or the manufacturers of our products may be subject to sanctions, including, but not limited to, warning letters, manufacturing suspensions, product recalls or seizures, injunctions, refusal to permit products to be imported into or exported out of the United States, refusals of regulatory authorities to grant approval or to allow us to enter into government supply contracts, withdrawals of previously approved marketing applications, civil fines and criminal prosecutions. Furthermore, third parties may perceive procedures required to obtain regulatory approval objectionable and may attempt to disrupt or otherwise damage our business as a result. In addition, certain of our agreements may require us to pay penalties if we are unable to supply products, including for failure to maintain regulatory approvals.

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Any of these events, alone or in unison, could damage our business.

 

We may be unable to market and sell our products successfully.

 

We may not develop and maintain marketing and/or sales capabilities successfully, and we may not be able to make arrangements with third parties to perform these activities on satisfactory terms. If our marketing and sales strategy is unsuccessful, our ability to sell our products will be negatively impacted and our revenues will decrease. This could result in the loss of distribution rights for products or failure to gain access to new products and could cause damage to our reputation and adversely affect our business and future prospects.

 

The market for companion animal healthcare products is highly fragmented. Because our CCA proprietary products are generally available only to veterinarians or by prescription and our medical instruments require technical training to operate, we ultimately sell all our CCA products primarily to or through veterinarians. The acceptance of our products by veterinarians is critical to our success. Changes in our ability to obtain or maintain such acceptance or changes in veterinary medical practice could significantly decrease our anticipated sales. As the vast majority of cash flow to veterinarians ultimately is funded by pet owners without private insurance or government support, our business may be more susceptible to severe economic downturns than other health care businesses which rely less on individual consumers.

 

We recently have entered into agreements with independent third party distributors, including Henry Schein, which we expect to market and sell our products to a greater degree than in the recent past. Our agreement with Henry Schein prohibits us from selling our chemistry blood testing products and our hematology blood testing products to an independent third party distributor other than Henry Schein. Independent third-party distributors may be effective in increasing sales of our products to veterinarians, although we would expect a corresponding lower gross margin as such distributors typically buy products from us at a discount to end user prices.  It is possible new or existing independent third-party distributors could cannibalize our direct sales efforts and lower our total gross margin.  For us to be effective when working with an independent third-party distributor, the distributor must agree to market and/or sell our products and we must provide proper economic incentives to the distributor as well as contend effectively for the time, energy and focus of the employees of such distributor given other products the distributor may be carrying, potentially including those of our competitors.  If we fail to be effective with new or existing independent third-party distributors, our financial performance may suffer.

 

We rely substantially on third-party suppliers. The loss of products or delays in product availability from one or more third-party suppliers could substantially harm our business.

 

To be successful, we must contract for the supply of, or manufacture ourselves, current and future products of appropriate quantity, quality and cost. Such products must be available on a timely basis and be in compliance with any regulatory requirements. Similarly, we must provide ourselves, or contract for the supply of certain services. Such services must be provided in a timely and appropriate manner. Failure to do any of the above could substantially harm our business.

 

We rely on third-party suppliers to manufacture those products we do not manufacture ourselves and to provide services we do not provide ourselves. Proprietary products provided by these suppliers represent a majority of our revenue. We currently rely on these suppliers for our blood testing instruments and consumable supplies for these instruments, for our imaging products and related software and services, for key components of our point-of-care diagnostic tests as well as for the manufacture of other products.

 

The loss of access to products from one or more suppliers could have a significant, negative impact on our business. Major suppliers who sell us proprietary products who are responsible for more than 5% of our 2015 revenue for the twelve months ended June 30, 2015 are Boule Medical AB, Cuattro, LLC, and FUJIFILM Corporation. None of these suppliers sold us products which were responsible for more than 25% of our 2015 revenue, although products purchased from one of these suppliers was responsible for more than 20% of our 2015 revenue and products purchased from another was responsible for more than 10% of our 2015 revenue. We

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often purchase products from our suppliers under agreements that are of limited duration or potentially can be terminated on an annual basis. In the case of our blood testing instruments and our digital radiography solutions we are typically entitled to non-exclusive access to consumable supplies, or ongoing non-exclusive access to products and services to meet the needs of an existing customer base, respectively, for a defined period upon expiration of exclusive rights, which could subject us to competitive pressures in the period of non-exclusive access. Although we believe we will be able to maintain supply of our major product and service offerings in the near future, there can be no assurance that our suppliers will meet their obligations under any agreements we may have in place with them or that we will be able to compel them to do so. Risks of relying on suppliers include:

· Inability to meet minimum obligations. Current agreements, or agreements we may negotiate in the future, may commit us to certain minimum purchase or other spending obligations. It is possible we will not be able to create the market demand to meet such obligations, which could create a drain on our financial resources and liquidity. Some such agreements may require minimum purchases and/or sales to maintain product rights and we may be significantly harmed if we are unable to meet such requirements and lose product rights.
· Loss of exclusivity. In the case of our blood testing instruments, if we are entitled to non-exclusive access to consumable supplies for a defined period upon expiration of exclusive rights, we may face increased competition from a third party with similar non-exclusive access or our former supplier, which could cause us to lose customers and/or significantly decrease our margins and could significantly affect our financial results. In addition, current agreements, or agreements we may negotiate in the future, with suppliers may require us to meet minimum annual sales levels to maintain our position as the exclusive distributor of these products. We may not meet these minimum sales levels and maintain exclusivity over the distribution and sale of these products. If we are not the exclusive distributor of these products, competition may increase significantly, reducing our revenues and/or decreasing our margins.
· Changes in economics. An underlying change in the economics with a supplier, such as a large price increase or new requirement of large minimum purchase amounts, could have a significant, adverse effect on our business, particularly if we are unable to identify and implement an alternative source of supply in a timely manner.
· The loss of product rights upon expiration or termination of an existing agreement. Unless we are able to find an alternate supply of a similar product, we would not be able to continue to offer our customers the same breadth of products and our sales and operating results would likely suffer. In the case of an instrument supplier, we could also potentially suffer the loss of sales of consumable supplies, which would be significant in cases where we have built a significant installed base, further harming our sales prospects and opportunities. Even if we were able to find an alternate supply for a product to which we lost rights, we would likely face increased competition from the product whose rights we lost being marketed by a third party or the former supplier and it may take us additional time and expense to gain the necessary approvals and launch an alternative product.
· High switching costs. In our blood testing instrument products we could face significant competition and lose all or some of the consumable revenues from the installed base of those instruments if we were to switch to a competitive instrument. If we need to change to other commercial manufacturing contractors for certain of our regulated products, additional regulatory licenses or approvals generally must be obtained for these contractors prior to our use. This would require new testing and compliance inspections prior to sale, thus resulting in potential delays. Any new manufacturer would have to be educated in, or develop, substantially equivalent processes necessary for the production of our products. We likely would have to train our sales force, distribution network employees and customer support organization on the new product and spend significant funds marketing the new product to our customer base.
· The involuntary or voluntary discontinuation of a product line. Unless we are able to find an alternate supply of a similar product in this or similar circumstances with any product, we would not be able to continue to offer our customers the same breadth of products and our sales would likely suffer. Even if we are able to identify an alternate supply, it may take us additional time and
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expense to gain the necessary approvals and launch an alternative product, especially if the product is discontinued unexpectedly.

· Inconsistent or inadequate quality control. We may not be able to control or adequately monitor the quality of products we receive from our suppliers. Poor quality items could damage our reputation with our customers.
· Limited capacity or ability to scale capacity. If market demand for our products increases suddenly, our current suppliers might not be able to fulfill our commercial needs, which would require us to seek new manufacturing arrangements and may result in substantial delays in meeting market demand. If we consistently generate more demand for a product than a given supplier is capable of handling, it could lead to large backorders and potentially lost sales to competitive products that are readily available. This could require us to seek or fund new sources of supply, which may be difficult to find or may require terms that are less advantageous if available at all.
· Regulatory risk. Our manufacturing facility and those of some of our third-party suppliers are subject to ongoing periodic unannounced inspection by regulatory authorities, including the FDA, USDA and other federal, state and foreign agencies for compliance with strictly enforced Good Manufacturing Practices, regulations and similar foreign standards. We do not have control over our suppliers' compliance with these regulations and standards. Regulatory violations could potentially lead to interruptions in supply that could cause us to lose sales to readily available competitive products.
· Developmental delays. We may experience delays in the scale-up quantities needed for product development that could delay regulatory submissions and commercialization of our products in development, causing us to miss key opportunities.
· Limited intellectual property rights. We typically do not have intellectual property rights, or may have to share intellectual property rights, to the products supplied by third parties and any improvements to the manufacturing processes or new manufacturing processes for these products.

 

Potential problems with suppliers such as those discussed above could substantially decrease sales, lead to higher costs and/or damage our reputation with our customers due to factors such as poor quality goods or delays in order fulfillment, resulting in our being unable to sell our products effectively and substantially harming our business.

 

We operate in a highly competitive industry, which could render our products obsolete or substantially limit the volume of products that we sell. This would limit our ability to compete and maintain sustained profitability.

 

The market in which we compete is intensely competitive. Our competitors include independent animal health companies and major pharmaceutical companies that have animal health divisions. We also compete with independent, third-party distributors, including distributors who sell products under their own private labels. In the point-of-care diagnostic testing market, our major competitors include IDEXX Laboratories, Inc., Abaxis, Inc. ("Abaxis"), and Synbiotics Corporation, a unit of Zoetis Inc. ("Zoetis"). The products manufactured by our OVP segment for sale by third parties compete with similar products offered by a number of other companies, some of which have substantially greater financial, technical, research and other resources than us and may have more established marketing, sales, distribution and service organizations than those of our OVP segment's customers. Competitors may have facilities with similar capabilities to our OVP segment, which they may operate and sell at a lower unit price to customers than our OVP segment does, which could cause us to lose customers. Companies with a significant presence in the companion animal health market, such as Bayer AG, CEVA Santé Animale, Eli Lilly, Merck, Sanofi, Vétoquinol S.A., Virbac S.A. and Zoetis may be marketing or developing products that compete with our products or would compete with them if developed. These and other competitors and potential competitors may have substantially greater financial, technical, research and other resources and larger, more established marketing, sales and service organizations than we do. Our competitors may offer broader product lines and have greater name recognition than we do. For example, if Zoetis devotes its significant commercial and financial resources to growing Synbiotics' market share, our sales could suffer significantly. Our competitors may also develop or market technologies or products that are more effective or

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commercially attractive than our current or future products or that would render our technologies and products obsolete. Further, additional competition could come from new entrants to the animal health care market. Moreover, we may not have the financial resources, technical expertise or marketing, sales or support capabilities to compete successfully. One of our competitors, Abaxis, recently announced agreements with units of VCA Inc. ("VCA") for the long-term supply of blood chemistry testing products to VCA-owned veterinary clinics and for the co-marketing of Abaxis' blood chemistry testing products with VCA's veterinary diagnostic laboratory offering, which may serve to intensify competition and lower our margins as well as limit our prospects to sell blood chemistry testing products to VCA-owned veterinary clinics.

 

If we fail to compete successfully, our ability to achieve sustained profitability will be limited and sustained profitability, or profitability at all, may not be possible .

 

Our future revenues depend on successful product development, commercialization and/or market acceptance, any of which can be slower than we expect or may not occur.

 

The product development and regulatory approval process for many of our potential products is extensive and may take substantially longer than we anticipate. Research projects may fail. New products that we may be developing for the veterinary marketplace may not perform consistently within our expectations. Because we have limited resources to devote to product development and commercialization, any delay in the development of one product or reallocation of resources to product development efforts that prove unsuccessful may delay or jeopardize the development of other product candidates. If we fail to successfully develop new products and bring them to market in a timely manner, our ability to generate additional revenue will decrease.

 

Even if we are successful in the development of a product or obtain rights to a product from a third-party supplier, we may experience delays or shortfalls in commercialization and/or market acceptance of the product. For example, veterinarians may be slow to adopt a product, a product may not achieve the anticipated technical performance in field use or there may be delays in producing large volumes of a product. The former is particularly likely where there is no comparable product available or historical precedent for such a product. The ultimate adoption of a new product by veterinarians, the rate of such adoption and the extent veterinarians choose to integrate such a product into their practice are all important factors in the economic success of one of our new products and are factors that we do not control to a large extent. If our products do not achieve a significant level of market acceptance, demand for our products will not develop as expected and our revenues will be lower than we anticipate. For example, our VitalPath Blood Gas and Electrolyte Analyzer generated significantly less revenue than we anticipated following its launch in May 2010 as placements of this product with customers did not occur as we expected.

 

We have historically not consistently generated positive cash flow from operations, may need additional capital and any required capital may not be available on reasonable terms or at all.

 

We may be required to raise additional capital in the future. If necessary, we expect to raise these additional funds by borrowing under our revolving line of credit, the increased sale of customer leases, the sale of equity securities or the issuance of new term debt secured by the same assets as the term loans which we fully repaid in 2010. There is no guarantee that additional capital will be available from these sources on reasonable terms, if at all, and certain of these sources may require approval by existing lenders. Funds we expect to be available under our existing revolving line of credit may not be available and other lenders could refuse to provide us with additional debt financing. Financial institutions and other potentially interested parties may not be interested in purchasing our customer leases on economic terms, or at all. The public markets may be unreceptive to equity financings and we may not be able to obtain additional private equity or debt financing. Any equity financing would likely be dilutive to stockholders and additional debt financing, if available, may include restrictive covenants and increased interest rates that would limit our currently planned operations and strategies. Furthermore, even if additional capital is available, it may not be of the magnitude required to meet our needs under these or other scenarios. If additional funds are required and are not available, it would likely have a material adverse effect on our business, financial condition and our ability to continue as a going concern.

 

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We depend on key personnel for our future success. If we lose our key personnel or are unable to attract and retain additional personnel, we may be unable to achieve our goals.

 

Our future success is substantially dependent on the efforts of our senior management and other key personnel, including our Chief Executive Officer, Kevin Wilson. The loss of the services of members of our senior management or other key personnel may significantly delay or prevent the achievement of our business objectives. Although we have an employment agreement with many of these individuals, all are at-will employees, which means that either the employee or Heska may terminate employment at any time without prior notice. If we lose the services of, or fail to recruit, key personnel, the growth of our business could be substantially impaired. We do not maintain key person life insurance for any of our senior management or key personnel.

 

Our stock price has historically experienced high volatility, and could do so in the future, including experiencing a material price decline resulting from a large sale in a short period of time. In addition, our Public Common Stock has certain transfer restrictions which could reduce trading liquidity from what it otherwise would have been and have other undesired effects.

 

Should a relatively large shareholder decide to sell a large number of shares in a short period of time, it could lead to an excess supply of our shares available for sale and correspondingly result in a significant decline in our stock price.

 

The securities markets have experienced significant price and volume fluctuations and the market prices of securities of many microcap and small cap companies have in the past been, and can in the future be expected to be, especially volatile. During the twelve months ended June 30, 2015, our closing stock price has ranged from a low of $10.81 to a high of $32.32. Fluctuations in the trading price or liquidity of our Public Common Stock may adversely affect our ability to raise capital through future equity financings. Factors that may have a significant impact on the market price and marketability of our Public Common Stock include:

 

· stock sales by large stockholders or by insiders;
· changes in the outlook for our business;
· our quarterly operating results, including as compared to expected revenue or earnings and in comparison to historical results;
· termination, cancellation or expiration of our third-party supplier relationships;
· announcements of technological innovations or new products by our competitors or by us;
· litigation;
· regulatory developments, including delays in product introductions;
· developments or disputes concerning patents or proprietary rights;
· availability of our revolving line of credit and compliance with debt covenants;
· releases of reports by securities analysts;
· economic and other external factors; and
· general market conditions.

 

In the past, following periods of volatility in the market price of a company's securities, securities class action litigation has often been instituted. If a securities class action suit is filed against us, it is likely we would incur substantial legal fees and our management's attention and resources would be diverted from operating our business in order to respond to the litigation.

 

On May 4, 2010, our shareholders approved an amendment (the "Amendment") to our Restated Certificate of Incorporation. The Amendment places restrictions on the transfer of our stock that could adversely affect our ability to use our domestic Federal Net Operating Loss carryforward ("NOL"). In particular, the Amendment prevents the transfer of shares without the approval of our Board of Directors if, as a consequence, an individual, entity or groups of individuals or entities would become a 5-percent holder under Section 382 of the Internal Revenue Code of 1986, as amended, and the related Treasury regulations, and also prevents any existing 5-percent holder from increasing his or her ownership position in the Company without the approval of our Board of Directors. Any transfer of shares in violation of the Amendment (a "Transfer Violation") shall be void ab

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initio under the our Restated Certificate of Incorporation, as amended (our "Certificate of Incorporation") and our Board of Directors has procedures under our Certificate of Incorporation to remedy a Transfer Violation including requiring the shares causing such Transfer Violation to be sold and any profit resulting from such sale to be transferred to a charitable entity chosen by the Company's Board of Directors in specified circumstances. The Amendment could have an adverse impact on the value and trading liquidity of our stock if certain buyers who would otherwise have bid on or purchased our stock, including buyers who may not be comfortable owning stock with transfer restrictions, do not bid on or purchase our stock as a result of the Amendment. In addition, because some corporate takeovers occur through the acquirer's purchase, in the public market or otherwise, of sufficient shares to give it control of a company, any provision that restricts the transfer of shares can have the effect of preventing a takeover. The Amendment could discourage or otherwise prevent accumulations of substantial blocks of shares in which our stockholders might receive a substantial premium above market value and might tend to insulate management and the Board of Directors against the possibility of removal to a greater degree than had the Amendment not passed.

 

We often depend on third parties for products we intend to introduce in the future. If our current relationships and collaborations are not successful, we may not be able to introduce the products we intend to introduce in the future.

 

We are often dependent on third parties and collaborative partners to successfully and timely perform research and development activities to successfully develop new products. For example, we jointly developed point-of-care diagnostic products with Quidel Corporation. In other cases, we have discussed Heska marketing in the veterinary market an instrument being developed by a third party for use in the human health care market. In the future, one or more of these third parties or collaborative partners may not complete research and development activities in a timely fashion, or at all. Even if these third parties are successful in their research and development activities, we may not be able to come to an economic agreement with them. If these third parties or collaborative partners fail to complete research and development activities, fail to complete them in a timely fashion, or if we are unable to negotiate economic agreements with such third parties or collaborative partners, our ability to introduce new products will be impacted negatively and our revenues may decline. For example, we have experienced significant delays compared to our expectations in our development of products in collaboration with Rapid Diagnostek, Inc.

 

Interpretation of existing legislation, regulations and rules, including financial accounting standards, or implementation of future legislation, regulations and rules could cause our costs to increase or could harm us in other ways.

 

We prepare our financial statements in conformance with United States generally accepted accounting principles, or GAAP. These accounting principles are established by and are subject to interpretation by the SEC, the Financial Accounting Standards Board ("FASB") and others who interpret and create accounting policies. A change in those policies can have a significant effect on our reported results and may affect our reporting of transactions completed before a change is made effective. Such changes may adversely affect our reported financial results, the way we conduct our business or have a negative impact on us if we fail to track such changes. For example, we have found FASB's recent decision to codify the accounting standards has made it more difficult to research complex accounting matters, increasing the risk we will fail to account consistent with FASB rules in the future.

 

If our regulators and/or auditors adopt or interpret more stringent standards than we anticipate, we could experience unanticipated changes in our reported financial statements, including but not limited to restatements, which could adversely affect our business due to litigation and investor confidence in our financial statements. In addition, changes in the underlying circumstances to which we apply given accounting standards and principles may affect our results of operations and have a negative impact on us. For example, we review goodwill recognized on our consolidated balance sheets at least annually and if we were to conclude there was an impairment of goodwill, we would reduce the corresponding goodwill to its estimated fair value and recognize a corresponding expense in our statement of operations. This impairment and corresponding expense could be as large as the total amount of goodwill recognized on our consolidated balance sheets, which was $21.0 million at

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June 30, 2015. There can be no assurance that future goodwill impairments will not occur if projected financial results are not met, or otherwise.

 

The Sarbanes-Oxley Act of 2002 ("Sarbanes-Oxley") has increased our required administrative actions and expenses as a public company since its enactment. The general and administrative costs of complying with Sarbanes-Oxley will depend on how it is interpreted over time. Of particular concern are the level of standards for internal control evaluation and reporting adopted under Section 404 of Sarbanes-Oxley. If our regulators and/or auditors adopt or interpret more stringent standards than we anticipate, we and/or our auditors may be unable to conclude that our internal controls over financial reporting are designed and operating effectively, which could adversely affect investor confidence in our financial statements and cause our stock price to decline. Even if we and our auditors are able to conclude that our internal controls over financial reporting are designed and operating effectively in such a circumstance, our general and administrative costs are likely to increase. For the first time since the audit for the year ended December 31, 2008, we will be required to have our independent registered public accountant conduct an audit of our internal controls as on June 30, 2015 our stock market value was above a certain level prescribed by regulation. This is expected to increase our general and administrative costs in 2015 from what they otherwise would have been, at a minimum.

 

Similarly, we are required to comply with the SEC's mandate to provide interactive data using the eXtensible Business Reporting Language as an exhibit to certain SEC filings. Compliance with this mandate has required a significant time investment, which has and may in the future preclude some of our employees from spending time on more productive matters. In addition, actions by other entities, such as enhanced rules to maintain our listing on the Nasdaq Capital Market, could also increase our general and administrative costs or have other adverse effects on us, as could further legislative, regulatory or rule-making action or more stringent interpretations of existing legislation, regulations and rules.

 

Our Public Common Stock is listed on the Nasdaq Capital Market and we may not be able to maintain that listing, which may make it more difficult for you to sell your shares. In addition, we have less than 300 record holders, which would allow us to terminate voluntarily the registration of our common stock with the SEC and after which we would no longer be eligible to maintain the listing of our Public Common Stock on the Nasdaq Capital Market.

 

Our Public Common Stock is listed on the Nasdaq Capital Market. The Nasdaq has several quantitative and qualitative requirements companies must comply with to maintain this listing, including a $1.00 minimum bid price. We completed a 1-for-10 reverse stock split effective December 30, 2010 in order to resolve an ongoing minimum bid price deficiency. While we believe we are currently in compliance with all Nasdaq requirements, there can be no assurance we will continue to meet Nasdaq listing requirements including the minimum bid price, that Nasdaq will interpret these requirements in the same manner we do if we believe we meet the requirements, or that Nasdaq will not change such requirements or add new requirements to include requirements we do not meet in the future. If we are delisted from the Nasdaq Capital Market, our Public Common Stock may be considered a penny stock under the regulations of the SEC and would therefore be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities. The additional burdens imposed upon broker-dealers may discourage broker-dealers from effecting transactions in our Public Common Stock, which could severely limit market liquidity of the Public Common Stock and any stockholder's ability to sell our securities in the secondary market. This lack of liquidity would also likely make it more difficult for us to raise capital in the future.

 

We have less than 300 record holders as of our latest information, a fact which would make us eligible to terminate voluntarily the registration of our common stock with the SEC and therefore suspend our reporting obligations with the SEC under the Exchange Act and become a non-reporting company. If we were to cease reporting with the SEC, we would no longer be eligible to maintain the listing of our common stock on the Nasdaq Capital Market, which we would expect to materially adversely affect the liquidity and market price for our common stock.

 

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We may not be able to continue to achieve sustained profitability or increase profitability on a quarterly or annual basis.

 

Prior to 2005, we incurred net losses on an annual basis since our inception in 1988 and, as of June 30, 2015, we had an accumulated deficit of $166.1 million. We have achieved only five quarters with income before income taxes greater than $1.5 million. Accordingly, relatively small differences in our performance metrics may cause us to generate an operating or net loss in future periods. Our ability to continue to be profitable in future periods will depend, in part, on our ability to increase sales in our CCA segment, including maintaining and growing our installed base of instruments and related consumables, to maintain or increase gross margins and to limit the increase in our operating expenses to a reasonable level as well as avoid or effectively manage any unanticipated issues. We may not be able to generate, sustain or increase profitability on a quarterly or annual basis. If we cannot achieve or sustain profitability for an extended period, we may not be able to fund our expected cash needs, including the repayment of debt as it comes due, or continue our operations.

 

Many of our expenses are fixed and if factors beyond our control cause our revenue to fluctuate, this fluctuation could cause greater than expected losses, cash flow and liquidity shortfalls.

 

We believe that our future operating results will fluctuate on a quarterly basis due to a variety of factors which are generally beyond our control, including:

 

· supply of products from third-party suppliers or termination, cancelation or expiration of such relationships;
· competition and pricing pressures from competitive products;
· the introduction of new products or services by our competitors or by us;
· large customers failing to purchase at historical levels;
· fundamental shifts in market demand;
· manufacturing delays;
· shipment problems;
· information technology problems, which may prevent us from conducting our business effectively, or at all, and may also raise our costs;
· regulatory and other delays in product development;
· product recalls or other issues which may raise our costs;
· changes in our reputation and/or market acceptance of our current or new products; and
· changes in the mix of products sold.

 

We have high operating expenses, including those related to personnel. Many of these expenses are fixed in the short term and may increase over the course of the coming year. If any of the factors listed above cause our revenues to decline, our operating results could be substantially harmed.

 

If we are unable to maintain various financial and other covenants required by our credit facility agreement we will be unable to borrow any funds under the agreement and fund our operations.

 

Under our credit and security agreement with Wells Fargo, we are required to comply with various covenants, both financial and non-financial, in order to borrow under the agreement.  The availability of borrowings under this agreement is expected to be important to continue to fund our operations.  Beginning January 1, 2015 a key financial covenant is based on a fixed charge coverage ratio, as defined in the credit and security agreement with Wells Fargo. Although we believe we will be able to maintain compliance with all these covenants and any covenants we may negotiate in the future, there can be no assurance thereof.  We have not always been able to maintain compliance with all covenants under our credit and security agreement with Wells Fargo.  Although Wells Fargo has granted us a waiver of non-compliance in each case, there can be no assurance we will be able to obtain similar waivers or other modifications if needed in the future on economic terms, if at all. Failure to comply with any of the covenants, representations or warranties, or failure to modify them to allow future compliance, could result in our being in default and could cause all outstanding borrowings under our credit and security agreement to become immediately due and payable, or impact our ability to borrow under the agreement.  In addition, Wells Fargo has discretion in setting the advance rates which we may borrow against

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eligible assets. We may need to rely on available borrowings under the credit and security agreement to fund our operations in the future.  If we are unable to borrow funds under this agreement, we will need to raise additional capital from other sources to continue our operations, which capital may not be available on acceptable terms, or at all.

 

We may face product returns and product liability litigation in excess of, or not covered by, our insurance coverage or indemnities and/or warranties from our suppliers. If we become subject to product liability claims resulting from defects in our products, we may fail to achieve market acceptance of our products and our sales could substantially decline.

 

The testing, manufacturing and marketing of our current products as well as those currently under development entail an inherent risk of product liability claims and associated adverse publicity. Following the introduction of a product, adverse side effects may be discovered. Adverse publicity regarding such effects could affect sales of our other products for an indeterminate time period. To date, we have not experienced any material product liability claims, but any claim arising in the future could substantially harm our business. Potential product liability claims may exceed the amount of our insurance coverage or may be excluded from coverage under the terms of the policy. We may not be able to continue to obtain adequate insurance at a reasonable cost, if at all. In the event that we are held liable for a claim against which we are not indemnified or for damages exceeding the $10 million limit of our insurance coverage or which results in significant adverse publicity against us, we may lose revenue, be required to make substantial payments which could exceed our financial capacity and/or lose or fail to achieve market acceptance.

 

We may be held liable for the release of hazardous materials, which could result in extensive remediation costs or otherwise harm our business.

 

Certain of our products and development programs produced at our Des Moines, Iowa facility involve the controlled use of hazardous and bio hazardous materials, including chemicals and infectious disease agents. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by applicable local, state and federal regulations, we cannot eliminate the risk of accidental contamination or injury from these materials. In the event of such an accident, we could be held liable for any fines, penalties, remediation costs or other damages that result. Our liability for the release of hazardous materials could exceed our resources, which could lead to a shutdown of our operations, significant remediation costs and potential legal liability. In addition, we may incur substantial costs to comply with environmental regulations if we choose to expand our manufacturing capacity.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

None.

 

Item 5. Other Information

 

None.

 

 

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Item 6. Exhibits

 

(a) Exhibits

   

  Number Description
10.1* Master Supply Agreement between Diamond Animal Health, Inc. and Eli Lilly and Company and its Affiliates, operating through its Elanco Animal Health division, effective as of October 1, 2014.
10.2* Supplemental Agreement between Diamond Animal Health, Inc. and Eli Lilly and Company and its Affiliates, operating through its Elanco Animal Health division, effective as of October 1, 2014.
31.1 Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended.
31.2 Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended .
32.1** Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS XBRL Instance Document.
101.SCH XBRL Taxonomy Extension Schema Document.
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF XBRL Taxonomy Extension Definition Linkbase Document.
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document.
101.LAB XBRL Taxonomy Extension Label Linkbase Document.

 

* Confidential portions of this amendment have been omitted pursuant to a request for confidential treatment filed separately with the Securities and Exchange Commission.
** Furnished with this report

 

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HESKA CORPORATION

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.

 

HESKA CORPORATION

Date: August 7, 2015 By: /s/ Kevin S. Wilson
      KEVIN S. WILSON
      Chief Executive Officer and President
(on behalf of the Registrant and as the Registrant's Principal Executive Officer)
       
Date: August 7, 2015 By: /s/ Jason A. Napolitano
      JASON A. NAPOLITANO
      Executive Vice President and Chief Financial Officer
(on behalf of the Registrant and as the Registrant's Principal Financial Officer)

 

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Exhibit Index

  Number Description
10.1* Master Supply Agreement between Diamond Animal Health, Inc. and Eli Lilly and Company and its Affiliates, operating through its Elanco Animal Health division, effective as of October 1, 2014.
10.2* Supplemental Agreement between Diamond Animal Health, Inc. and Eli Lilly and Company and its Affiliates, operating through its Elanco Animal Health division, effective as of October 1, 2014.
31.1 Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended.
31.2 Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended .
32.1** Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS XBRL Instance Document.
101.SCH XBRL Taxonomy Extension Schema Document.
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF XBRL Taxonomy Extension Definition Linkbase Document.
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document.
101.LAB XBRL Taxonomy Extension Label Linkbase Document.

 

* Confidential portions of this amendment have been omitted pursuant to a request for confidential treatment filed separately with the Securities and Exchange Commission.
** Furnished with this report

 

 

 

 

 

 

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Exhibit 10.1

 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

Master Supply Agreement

Introduction and Scope

Section  1         Parties; Defined Terms
1.1 This is an agreement between Eli Lilly and Company, an Indiana Corporation, and its Affiliates, operating through its Elanco Animal Health division ("Elanco or "Lilly") and Diamond Animal Health, Inc., an Iowa Corporation, and its Affiliates ("Diamond").
1.2 This Agreement terminates, supersedes and replaces the Bovine Vaccine Distribution Agreement between Diamond Animal Health, Inc. and Agri Laboratories, Ltd., effective February 13, 1998 and its amendments, which were assigned to Eli Lilly and Company.
1.3 Other capitalized terms are defined in Exhibit A Definitions with some others defined in various other locations.
Section  2         Background
2.1 Elanco is a global research-based corporation that develops, manufactures and sells animal health products.
2.2 Diamond is a manufacturer and service provider which is knowledgeable and experienced in development and manufacturing of various animal health vaccine products.
2.3 Elanco and Diamond wish to enter into this Master Agreement in order to facilitate Elanco's engagement of Diamond to supply certain products to Elanco from time to time.
2.4 The Parties conduct business around the globe in their own names or through their respective Affiliates. Affiliates of Elanco or Diamond may opt into the terms of this Agreement or create an independent local agreement incorporating such terms between an Elanco Affiliate and Diamond or between an Elanco Affiliate and a Diamond Affiliate. Parties may opt-in through the use of an opt-in or similar agreement (also known as a Localization Agreement) or through a Supplemental Agreement signed by the respective Parties. This opt-in or Localization Agreement (see Exhibit E Example Localization Agreement) shall be modified to comply with local law or practice.
Section  3         Scope of Agreement
3.1 This Master Agreement covers projects in which Diamond furnishes Elanco products as specified in the respective Supplemental Agreements.
3.2 As soon as practicable after the execution of this Agreement, and in connection with the creation of any Supplemental Agreements, as applicable, the Parties shall enter into good faith negotiations pertaining to appropriate Quality Agreement(s) ("Quality Agreement") and / or applicable Manufacturing Responsibilities Document(s) ("MRD"). The obligations set forth in the MRD(s) and the Quality Agreement(s), and
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3.3 any amendments thereto, once executed and delivered, shall become part of, and be incorporated into, this Agreement and the relevant Supplemental Agreement.
3.4 If the terms of the Quality Agreement are inconsistent with the terms of this Agreement, the Quality Agreement controls unless:
3.4.1 This Agreement expressly allows this Agreement to supersede the inconsistent term; or
3.4.2 This Agreement clearly expresses the Parties' intent to do so.
3.5 From time to time during the term of the Master Agreement, Diamond and Elanco may enter into Supplemental Agreements consistent with the Supplemental Agreement definition in Exhibit A Definitions for contract manufacturing or packaging of animal health related products.
3.6 The term of this Master Agreement is from October 1, 2014 through June 16, 2023 unless it is terminated earlier. Nonetheless, if any Supplemental Agreements are in effect on the day the Master Agreement would otherwise expire, the Master Agreement remains in effect solely for the purpose of those Supplemental Agreements (and not for the purpose of executing new Supplemental Agreements) until their expiration or termination.
3.7 If no expiration date is specified, the Supplemental Agreement expires upon the one (1) year anniversary of the effective date of the Supplemental Agreement and shall thereafter renew for successive one (1) year terms unless either Party provides written notice to the other Party of its intention not to renew no less than sixty(60) days prior to expiration of the then current term. Any individual Supplemental Agreement may be terminated independently of the rest of the Agreement, with any provision of the Agreement relevant to termination applying only to that Supplemental Agreement. Termination of the Master Agreement terminates all Supplemental Agreements.
3.8 If a Supplemental Agreement conflicts with the Master Agreement, unless expressly stated in the Supplemental Agreement, the Master Agreement controls over the conflicting provision of the Supplemental Agreement.
3.9 Except to the extent set forth in a Supplemental Agreement, Diamond has no obligation to provide Elanco, and Elanco has no obligation to purchase from Diamond, any Services or Deliverables. Neither Party makes any commitment regarding the number of Supplemental Agreements that will be established or the quantity or value of Services or Deliverables that will be requested, purchased, or provided under this Master Agreement.

Diamond's Rights and Obligations

Section  4         Diamond's General Obligations
4.1 Diamond will furnish Elanco all Deliverables in accordance with the Product Specifications and will provide everything it needs to furnish such Deliverables except for those responsibilities the Agreement expressly assigns to Elanco.
4.2 Diamond will perform all other obligations the Agreement requires it to perform.
4.3 Upon expiration or notice of termination of this Agreement and if requested by Elanco:
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4.3.1 Diamond shall provide all reasonable support to Elanco in the prompt licensure of the Products at an Elanco manufacturing facility or at another manufacturing facility designated by Elanco (as applicable). For the avoidance of doubt, Diamond shall retain its Registrations for Products during and after the term of this Agreement. Such support by Diamond shall include, but not be limited to, providing Elanco with the following: (i) all related materials, including but not limited to seeds, cell stocks, reference materials and critical testing reagents; (ii) all Registrations for Products; (iii) collaboration in transferring these Registrations to the designated site; (iv) all correspondence with Regulatory Agencies related to Products; (v) all reports related to the Products; and (vi) all manufacturing and quality control testing documentation that supports the manufacturing and testing of the biological products and it's components.
4.3.2 Elanco shall reimburse Diamond for all reasonable out of pocket expenses incurred by Diamond and for reasonable labor efforts pertaining to the performance of such support set forth in Section 4.3.1;
4.3.3 Except as set forth below, Diamond will also, at its sole expense : (i) promptly effect the removal of Elanco's Confidential Information from its systems and files and those of its Subcontractors; (ii) deliver to Elanco any of Elanco's Property in Diamond's possession or control; and (iii) promptly deliver to Elanco any Records of Elanco's Confidential Information in Diamond's possession or control that are not Elanco's Property. As an alternative to delivery of Elanco's Property or Records of Elanco's Confidential Information to Elanco, Elanco may direct Diamond to destroy them or deliver them to another destination of Elanco's choosing. Elanco's exercise of this alternative must be in writing. Notwithstanding the foregoing, Diamond shall have no obligations under this Section 4.3.3(i) with respect to Confidential Information or Property of Elanco to the extent such Confidential Information or Property (a) must be retained by Diamond pursuant to Regulatory Agencies or Diamond's standard operating procedures, (b) is maintained on backup systems or disaster recovery systems that are not readily obtainable; provided such Confidential Information or Property remains subject to the confidentiality obligations hereunder.
4.3.4 Despite anything to the contrary in this Agreement, Diamond may make and retain one (1) Record of Elanco's Confidential Information solely for its legal archives.
4.4 Diamond has communicated all necessary terms and obligations to Subcontractors, if any, who will be performing work under this Agreement so that the Subcontractor may appropriately carry out its obligations under the terms of this Agreement.
4.5 Diamond is responsible for the development of, and compliance with, procedures necessary to ensure the health and safety of its employees and representatives.
Section  5         Manufacture and Supply of Product

5.1               Diamond will manufacture Product at Diamond's USDA-CVB approved facility in Des Moines, IA in accordance with the Product Specifications, the MRD, the Quality Agreement and Applicable Law.

5.2               Diamond will deliver product on the delivery dates specified by Elanco in accordance with the applicable Supplemental Agreement.

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5.3               Diamond will comply with any exposure guidelines set forth in any material safety data sheets provided by Diamond for the Product. Diamond will promptly inform Elanco of any adverse environmental, health or safety events that have a material adverse effect on the manufacture of the Product.

5.4               Diamond will not, without Elanco's prior written consent: (i) make any changes to the Product Specifications (including the standard operating procedures incorporated into the processes or Product Specifications), except to the extent such changes are required by a Regulatory Agency; or (ii) manufacture the Product in any facility other than the manufacturing facility specified in Section 5.1.

5.5               Elanco reserves the right to reject Product, within thirty (30) days after delivery, that does not conform to the Product Specifications. Unless required to return the Product to Diamond by a Governmental Authority or unless the Parties agree otherwise, Elanco shall retain the non-conforming Products and Diamond shall have the right to inspect such Products to confirm whether non-conformity actually exists. In the event of any rejection of Product: (i) Elanco shall notify Diamond in writing detailing the non-conformance within thirty (30) days of delivery of the applicable shipment of Product; (ii) the Parties shall promptly endeavor to agree whether or not the delivery in question complies with the Specifications and if the Parties cannot so agree then the matter shall be submitted to a mutually agreed upon third party for determination, the expense for which shall be borne by the party against whom the finding is adverse; and (iii) if it is determined by both Parties that the Product is non-conforming, Diamond shall, upon confirmation of such determination, either (x) replace within a time reasonably satisfactory to Elanco such non-conforming Product to the applicable Specifications at no additional cost to Elanco, or (y) if Diamond, using reasonable commercial efforts, cannot replace such non-conforming Product in accordance with (x), then credit or refund Elanco such monies paid by Elanco to Diamond for the production and shipping of such non-conforming Product at Diamond's sole discretion. The Parties shall use all reasonable endeavors to resolve any dispute that may arise pursuant to this Section within thirty (30) days of notification to Diamond pursuant to this Section. Unless otherwise agreed upon or required under Applicable Law, if the Parties mutually agree that the Product is nonconforming then the non-conforming Product shall become the property of and be returned to Diamond at Diamond's expense. Diamond shall dispose of such Product at its own expense according to all appropriate regulations, including in the case of hazardous waste.

5.6               Diamond will not Reprocess lots of Product without approval by Elanco (which will not be unreasonably withheld) and the applicable Governmental Authority (if required), such as the USDA-CVB.

5.7               Diamond will establish and maintain a stability study program for Products in accordance with Applicable Law.

5.8               Diamond has developed and documented contingency plans to help ensure continuous supply of Product to Elanco. Such contingency plan includes, without limitation, Diamond's plans for the maintenance of adequate raw materials to help meet demand, equipment preventative maintenance plans, and inventory safety stock to cover line down situations.

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Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

Section  6    Process Improvement Initiatives        

6.1               Diamond will use commercially reasonable efforts to search for opportunities for cost reductions in the manufacture and supply of Product, including, without limitation, process enhancements and the selection of alternative raw materials. Diamond will present commercially reasonable opportunities, if any, for cost reductions to the Steering Committee. If elected by the Steering Committee, [***]. Ownership of any such process improvement initiatives, and any intellectual property right therein, shall be determined pursuant to Section 24.

Section  7         Allocation of Supply

7.1               In addition to whatever remedies are available to Elanco at law, in equity or under this Agreement, if for any reason Diamond's supply of Product at any time, including during a Force Majeure condition, is insufficient to meet its obligation to Elanco under this Agreement and to other customers under other agreements, purchase orders or arrangements, Diamond will allocate the available resources with respect to the supply of such Product to Elanco and its other customers on a pro rata basis, with Elanco's pro rate share being based upon the binding purchase orders provided by Elanco to Diamond. Diamond may start-up its facility to manufacture products for other customers, provided Elanco receives its pro rata share of Product in a timely manner.

Section  8         Manufacturing Reporting

8.1               Upon written request, each Party will, on a timely basis, provide the other Party with all information reasonably necessary for such other Party to comply with its regulatory requirements, including, without limitation, stability data, any changes to the master batch record or production or quality control procedures referenced in the master batch record and the detailed reason for such change.

Section  9         Diamond's Representations and Warranties
9.1 Diamond represents and warrants that:
9.1.1 Neither Diamond nor any other Person who furnishes Services or Deliverables for Elanco or satisfies any other obligation of Diamond under the Agreement is prohibited from doing so by any legal obligation or restriction, including any Applicable Law or contractual commitment.
9.1.2 Diamond's performance under this Agreement complies with all Applicable Law and with any relevant description or specification in the Agreement, including the Project Specifications, the MRD, and the Quality Agreement.
9.1.3 Diamond has obtained all permits, licenses and other authorizations, which are required under Applicable Law to manufacture the Product. Diamond is in compliance, and during the term of this Agreement will take all actions necessary to comply, with all terms and conditions of any and all required permits, licenses and authorizations applicable to the manufacture and supply of Product.
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9.1.4 All Product supplied by Diamond under this Agreement conforms to the Product Specifications.
9.1.5 All Products are free from material defects in material and workmanship.
9.1.6 The Products are free from all liens, Claims and encumbrances.
9.1.7 Diamond has the right to make any grants of Intellectual Property Rights to the Work Product or Deliverables that it makes or is required to make under the Agreement.
9.1.8 That portion of the Deliverables developed by Diamond (excluding that portion of the Deliverables developed or otherwise provided by Elanco) do not infringe any Intellectual Property Rights of any other Person, and any use thereof by Elanco consistent with this Agreement does not infringe such rights.
9.1.9 Diamond shall not subcontract any performance of this Agreement to any Party that is on the Specialty Designated Nationals and Blocked Persons List available at http://www.ustreas.gov/offices/enforcement/ofac/ maintained by the U.S. Treasury Department's Office of Foreign Assets Control or to any Party who is located in or has its principal place of business in a country subject to economic sanctions maintained by the U.S. Treasury Department's Office of Foreign Asset.
Section  10     Disclaimer of Warranties; Remedies
10.1 EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, ANY AND ALL WARRANTIES CONCERNING PRODUCTS, SERVICES, DELIVERABLES OR OTHER MATTERS PROVIDED BY DIAMOND OR ELANCO PURSUANT TO THIS AGREEMENT, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY, TITLE, NON-INFRINGEMENT, CONDITION, FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE ARE EXPRESSLY DISCLAIMED AND EXCLUDED.
10.2 THE REMEDIES DESCRIBED IN SECTIONS 5.5, 12 AND 30 ARE EXCLUSIVE AND IN LIEU OF ANY OTHER REMEDY ELANCO WOULD OTHERWISE HAVE AGAINST DIAMOND WITH RESPECT TO DEFECTIVE PRODUCTS OR ANY BREACH OF DIAMOND'S WARRANTY UNDER SECTION 9.1.4 OR 9.1.5 OF THIS AGREEMENT; PROVIDED, THAT THIS SECTION SHALL NOT LIMIT DIAMOND'S INDEMNITY OBLIGATION SET FORTH IN SECTION 31 WITH RESPECT TO THIRD-PARTY CLAIMS.
Section  11     Regulatory Inspections
11.1 Both Diamond and Elanco must notify the other company contacts within two (2) business days, and in writing within five (5) business days, of any regulatory agency inspections, inquiry or notifications of an official nature provided by a Governmental Authority, or regulatory actions related to the Product(s) or the facility in which the Product(s) is manufactured, packaged, stored or tested.
11.2 The inspected party (Diamond or Elanco) shall provide to the other party (in writing within five (5) business days of receipt) any observation issued, of an official nature, with the Governmental Authority that affects the supply of Product under this Agreement.  The informed party shall have the opportunity to consult with the other
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Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

company on any response to the Governmental Authority; however the inspected party shall have final say in the response.

Section  12     Recalls
12.1 If Diamond determines there is a defect, impurity, contamination or non-conformity in Product previously delivered pursuant to this Agreement, or for any other reason decides to recall Product, Diamond will promptly notify Elanco[***].
12.2 In the event that Elanco or Diamond is required by any Governmental Authority , or voluntarily decides (based upon mutual written agreement between the Parties), to recall a Product because of a defect in the Product due to any Fault of Diamond, Diamond will, in addition to the other remedies set forth in this Agreement, reimburse Elanco for:
[***]
[***]
12.3 Unless required by any Governmental Authority, neither Party will affect a recall of a Product unless mutually agreed in writing by the Parties, such agreement not to be unreasonably withheld or delayed by either Party if either Party provides notice to the other that it believes a recall is appropriate.
Section  13        Delivery Terms and Risk of Loss
13.1 Delivery Terms . The Parties agree that any materials shipped in conjunction with Diamond's performance of its obligations under this Agreement, and to be delivered to Elanco or Elanco's designee, will be delivered FCA Diamond's Des Moines, IA facility (Incoterms® 2010).
13.2 Risk of Loss . With respect to materials or Deliverables manufactured or shipped under this Agreement, Diamond (or its agent) shall retain title until delivered to the common carrier, and will retain risk of loss or other damage until delivered to the common carrier, consistent with the delivery terms in the preceding Subsection.
Section  14     Exports
14.1 Notwithstanding any other provision of the Agreement, Diamond will not export, re-export, or transfer any goods, technology, or software, or cause the export, re-export, or transfer of any goods, technology, or software, with Elanco listed as the principal party in interest or exporter, or otherwise in Elanco's name, without the valid, written authorization of Elanco's Export Planning and Compliance organization. In no event will Diamond export, re-export, or transfer any such good, technology, or software if doing so would cause Elanco, Diamond, or any other Person to violate the Export Administration Regulations (15 C.F.R. Part 730 et seq.), the U.S. Foreign Trade Regulations (15 C.F.R. Part 30), the U.S. Foreign Trade Regulations (15 C.F.R. Part 30), any trade or economic sanctions regulations (including those administered by the U.S. Treasury Department's Office of Foreign Assets Control (31 C.F.R. Ch.V) or any other Applicable Law. Elanco reserves the right to revoke any such export authorization at any time and for any reason.
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14.2 Export Clearance Documentation . If Diamond is authorized by Elanco to file export clearance documentation (such as Electronic Export Information in the United States) with any governmental authority on Elanco's behalf, Diamond shall: (i) accurately prepare and timely file such export clearance documentation as required by Applicable Law based on information provided by Elanco or by other parties involved in the transaction; (ii) retain such export clearance filings, whether electronically or otherwise, and documentation to support the information provided in the filing of such clearance documents for a period of at least five (5) years from the date of export; and (iii) upon request, provide Elanco in a mutually agreed format a copy of export clearance documents filed, electronically or otherwise, by Diamond on behalf of Elanco. In the event that Diamond is uncertain of or is missing specific information required for the filing of export clearance documentation, or has questions about any other legal or factual issue related to an export, Diamond shall promptly inquire of Elanco concerning such uncertainty, missing information, or question.
Section  15     [Intentionally omitted.]
Section  16     Diamond's Invoices
16.1 Timing . Diamond will submit invoices as follows:
16.1.1 Product invoices will be submitted upon shipment;
16.1.2 Invoices for any other reason per the appropriate Supplemental Agreement.
16.2 Form and Supplemental Information . Each invoice must be submitted via Lilly's web invoicing system and must comply with Lilly's standard forms and procedures (as changed from time to time) and published on the internet at http://supplierportal.lilly.com and with any specific requirements in this Agreement. Each invoice will be accompanied by any information required by the Agreement or that Elanco may reasonably request, including detailed information for any amounts of Taxes Diamond is collecting from Elanco. Elanco shall provide no less than ninety (90) days prior written notice to Diamond of any substantive changes to Lilly's web invoicing system or Lilly's standard forms and procedures. In the event that any such changes cause a material increase to labor costs associated with performance hereunder, Diamond may adjust the Compensation as set forth in the Supplemental Agreement.
16.3 Currency . Invoices must be presented in United States Dollars.
Section  17     Supplier Sustainability

17.1           Upon written request by Elanco, Diamond will complete (i) an initial Health Safety and Environmental ("HSE") survey and (ii) an updated survey every two (2) years thereafter for the term of the Agreement. Diamond agrees to meet annually with Elanco to review HSE performance. Diamond agrees to provide timely notification to Elanco of an HSE event that impacts Elanco materials, including, but not limited to fires, explosions or fatalities.

Section  18     [Intentionally omitted.]
Section  19     [Intentionally omitted.]
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Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

Elanco's Rights and Obligations

Section  20     Elanco's General Obligations
20.1 Elanco will pay Diamond the Compensation according to the terms of this Agreement.
20.2 Elanco will perform any obligations expressly assigned to it in the Project Specifications, Supplemental Agreement or elsewhere in the Agreement.
Section  21     Payment
21.1 Payment Terms . Elanco shall pay all invoices within [***] days (Elanco will receive a [***] discount if paid within [***] days ) after Elanco's Accounts Payable Department receives an invoice that complies with the requirements of this Agreement, except that Elanco may withhold payment of any amount that it may reasonably dispute in good faith until such dispute is resolved; provided that (i) any amounts not in dispute are paid in accordance with the terms hereof, (ii) Elanco provides Diamond notice of any dispute within thirty (30) days after Elanco's Accounts Payable Department receives such invoice, and (iii) Elanco diligently attempts to resolve such dispute within sixty (60) days after Diamond's receipt of notice thereof. Diamond must provide banking instructions to allow payments to be made electronically.
21.2 Currency . Payment will be made in United States Dollars.
21.3 Compensation . The Compensation is Diamond's entire recompense for full performance of all of Diamond's obligations under this Agreement, with no other amounts owed to Diamond by Elanco for labor, materials, expenses, time of staff, overhead, profit, taxes, insurance, or other costs of furnishing or use by Elanco of the Deliverables.
21.4 Interest on Late Payments . If either Party fails to pay any payment due under this Agreement on or before the date such payment is due, as provided in this Agreement, such late payment shall bear interest, to the extent permitted by applicable law, at the prime rate as of the date of U.S. Mail postmark of the relevant payment if sent by U.S. Mail, or otherwise on the date of receipt of payment, as published in The Wall Street Journal and found on the wsj.com website at the following link or its successor site: (http://interactive5.wsj.com/edition/resources/documents/mktindex.htm?rates.htm), plus [***], as calculated on the number of days the relevant payment is delinquent from and including the date payment is due through and including the date upon which the owed Party has collected immediately available funds in its own account.
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  Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

Section  22   Changes to Product Specification    

22.1           Elanco, at its option from time to time, may request a change in the Product Specifications by notifying Diamond in writing. As soon as reasonably practical, but in any event within thirty (30) days, after the change request is received by Diamond, Diamond will notify Elanco of any adjustments necessary to accommodate the changed Product Specifications, including without limitation, adjustments to the Compensation. To the extent mutually agreed in writing between the parties, the revised Product Specifications will become applicable as of the date mutually agreed to by Elanco and Diamond, and all references thereafter to the "Product Specifications" will refer to the Product Specifications as modified. The new Product Specifications will be attached to the applicable Quality Agreement.

Section   23     Elanco's Representations and Warranties

23.1           Elanco represents and warrants that:

23.1.1 Neither Elanco nor any other Person who performs any obligation of Elanco under the Agreement is prohibited from doing so by any: (i) Applicable Law; (ii) Covenant not to compete; (iii) Contract to deal exclusively with another Person; or (iv) Other legal or professional obligation or restriction.
23.1.2 The performance of Elanco's responsibilities under the Agreement and Elanco's use of the Services and Deliverables comply with all Applicable Law.
23.1.3 Elanco has obtained all permits, licenses and other authorizations, which are required under Applicable Law to commercialize, sell or otherwise distribute the Product. Elanco is in compliance, and during the term of this Agreement will take all actions necessary to comply, with all terms and conditions of any and all required permits, licenses and authorizations applicable to the manufacture and supply of Product.

 

Information and Property Rights

Section  24     Rights to Intellectual Property and Deliverables

24.1           [***].   Any Know-How that results from performance under this Agreement shall be owned as follows:  (a) by Diamond, [***]; and (b) by Elanco, [***].    Each party hereby assigns any right, title and interest it may have in connection with the Know-How that results from performance under this Agreement so as to be consistent with the ownership of such Know-How set forth in this Section 24.1.  Each Party agrees to execute and deliver such documents, instruments and assignments as shall be necessary or advisable to confirm the allocation of Know-How rights set forth above in this Section 24.1.

 

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Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

24.2           Notwithstanding the ownership by [***] of Know-How relating to the [***].

Section 25     [Intentionally omitted.]
Section  26     Each Party's Possession of the Other's Property

26.1           As used in this Section, "property" means property of any form other than real property, including Records and Intellectual Property. In the course of their relationship under this Agreement, each Party may have the other Party's property in its possession. Each Party will retain the other Party's property and will exercise appropriate care toward it to protect against damage, destruction, loss, unauthorized use, or unauthorized disclosure, but in no event will such Party exercise a lower degree of care in safeguarding the other Party's property than such Party uses in safeguarding its own property of a similar nature.

26.2           Each Party will neither encumber the other Party's property nor use it for any purpose other than the performance of its obligations under this Agreement.

26.3           Each Party will promptly notify the other Party of any loss or damage to such other Party's property in its possession.

26.4 Each Party will neither dispose of the other Party's property nor transfer possession of it to anyone else except in accordance with this Agreement. Each Party will follow the other Party's reasonable written instructions for disposition of any of such other Party's property (including any Records that are such other Party's property) in such Party's possession. Such disposition may include destruction, delivery to such other Party, or delivery to another destination of such other Party's choosing. For the purpose of Electronic Records, "delivery" includes an electronic transmission of the Record or the delivery of the Record stored on an appropriate physical medium; and "destruction" includes the destruction of the physical medium on which a Record is stored or the complete and permanent removal of a Record from its storage medium.
26.5 If such other Party does not furnish written instructions for the disposition of its property within a reasonable period of time after expiration or termination of the Agreement, each Party will deliver to such other Party all of such other Party's property in its possession and will destroy any residual Electronic Records that are such other Party's property.
26.6 Despite anything to the contrary in this Agreement, Diamond may make and retain one (1) Record of any written Deliverables solely for its legal archives.
Section  27     Confidential Information
27.1 The Parties anticipate that each Party (the "Receiving Party") has already or may acquire or have access to Confidential Information of the other Party (the "Disclosing Party"), including but not limited to the following types: research and development plans and results; new compounds and processes; evaluation procedures (including
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clinical and field testing); product formulations; manufacturing methods; applications to government authorities; pricing or cost; sales, marketing, and advertising studies and plans; customer lists; computer information and software; special techniques unique to the Disclosing Party's business; information subject to a right of privacy; and information the Disclosing Party maintains under a system of protection against unauthorized access.

27.2 The Receiving Party will neither:
27.2.1 Disclose the Disclosing Party's Confidential Information except as authorized below or by the Disclosing Party in writing; nor
27.2.2 Use the Disclosing Party's Confidential Information for any purpose other than the purpose of this Agreement.
27.3 The Receiving Party may disclose the Disclosing Party's Confidential Information:
27.3.1 To its Representatives and to its Affiliates, Subcontractors, and their respective Representatives who need to know the information for the purpose of this Agreement and who have contractual obligations that prohibit any disclosure and use of the Disclosing Party's Confidential Information prohibited by this Agreement. The Receiving party is responsible to the Disclosing Party for any unauthorized disclosure or use of the Disclosing Party's Confidential Information by the Receiving Party's Representatives.
27.3.2 To the extent compelled by Applicable Law, the Receiving Party will give the Disclosing Party reasonable advance notice of the disclosure.
27.3.3 In communications to its attorneys or accountants who have a professional obligation to maintain such information in confidence. The Receiving Party is responsible to the Disclosing Party for disclosure or use by any such persons of the Disclosing Party's Confidential Information not authorized by the Disclosing Party.

27.4           Promptly upon termination or expiration of this Agreement, upon request by the Disclosing Party, the Receiving Party will destroy all Records of the Disclosing Party's Confidential Information in the Receiving Party's possession or control that are not the Disclosing Party's property. (Records that are the Disclosing Party's property are addressed in Section 26.) For the purpose of Electronic Records, "destroy" includes destroying the physical medium on which a Record is stored or completely and permanently removing a Record from its storage medium.

27.5 Despite anything to the contrary in this Agreement, the Receiving Party may make and retain one (1) Record of the Disclosing Party's Confidential Information solely for its legal archives subject to continuing obligations of confidentiality and non-use consistent herewith.
27.6 The prohibitions on disclosure and use of the Disclosing Party's Confidential Information survive for ten (10) years after expiration or termination of this Agreement or after the Receiving Party returns or destroys all Records of the relevant Confidential Information in its possession or control, whichever is later. The foregoing notwithstanding, the restrictions on prohibition or use of the Disclosing Party's Trade Secrets survive for as long as the information satisfies the definition of Trade Secret, provided that the Disclosing Party informs the Receiving Party in writing at the time of disclosure that the information constitutes a Trade Secret.
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Section  28   Records and Audits     

28.1 Records That Must Be Created and Maintained . At its own expense, Diamond will create and maintain all Records: (i) required by this Agreement and Applicable Law that relate to this Agreement and to Diamond's performance under this Agreement; (ii) sufficient to demonstrate that any and all amounts invoiced to Elanco under this Agreement are accurate and proper in both kind and amount; (iii) sufficient to demonstrate the accuracy of any representations or reports submitted to Elanco under this Agreement; and (iv) sufficient to enable Elanco to comply with Applicable Laws and other legal obligations, to the extent that Diamond has or reasonably should have knowledge of those Applicable Laws.
28.2 Record Retention Periods . Diamond will maintain all of the Records listed above for the longest of the following retention periods that applies: (i) any period prescribed by Applicable Law or stated expressly in this Agreement; (ii) for Records related to invoices, for three (3) years after payment of the invoice by Elanco; (iii) for Records related to reports submitted to Elanco, for three (3) years after the report is submitted; and (iv) for all Records not addressed by one of the above, in accordance with Diamond's standard operating procedures.
28.3 Access to Records . Diamond will allow Elanco to inspect (and, upon request, Diamond will furnish copies of) Records Diamond is required to create or maintain under this Agreement for the purposes of evaluating and verifying: (i) compliance with the requirements of this Agreement; (ii) compliance with Applicable Law related to this Agreement or to Diamond's performance under this Agreement; (iii) the accuracy and propriety of any invoice submitted to Elanco; (iv) compliance with any health, safety and environmental standards set forth in Section 17.1; and (v) the accuracy of any representations or reports submitted to Elanco. Elanco will reimburse that portion of Diamond's time and expense that exceed $1,000 incurred in providing copies of Records to Elanco.
28.4 Access to Facilities . At reasonable times, with reasonable advance notice, upon a mutually agreed upon schedule and subject to compliance with all applicable confidentiality provisions herein, Elanco may enter and inspect any premises where Records are maintained or Services are performed as Elanco deems reasonably necessary to accomplish the evaluations and verifications described in the preceding Section, Access to Records. Diamond will cooperate with Elanco to facilitate the evaluation and inspection, and provide reasonable assistance to Elanco, all at Elanco's expense. Elanco will reasonably cooperate with Diamond to mitigate disruption to Diamond's operations. In the event that Records are maintained, or Elanco's property is kept at premises that Diamond does not control, Diamond will use commercially reasonable efforts to secure rights of entry to such premises.
28.5 Elanco Employees and Designees . Elanco, its employees, or designees may exercise Elanco's rights of entrance and inspection under this Section. Employees and designees shall be held to the same standards of confidentiality provided in this Agreement through the independent contractual obligations he/she has with Elanco. Examples of Persons that Elanco may designate include Elanco's independent auditors and representatives of Government Authorities having jurisdiction over Elanco or its activities related to this Agreement.
28.6 Records Subject to Other Provisions of this Agreement . Some Records required by this Section may also fall within the definition of Deliverables or Diamond Technology.
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Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

Diamond's obligations under this Section do not diminish Diamond's other obligations toward, or Elanco's property rights to, such Records. Diamond's obligations to maintain Records under this Section are extinguished to the extent that Diamond properly satisfies another obligation in this Agreement to deliver or to dispose of such Records.

28.7 Audit Expenses . Elanco will pay its own expenses for any inspection of the Records on Diamond's premises. However, if in any audit, Elanco determines that material issues exist that result, resulted or will result in an overcharge of [***] or more of the invoiced amount for the audited period, Diamond will, within sixty (60) days, reimburse Elanco for its out-of-pocket costs incurred in conducting the audit, in addition to any remedies that Elanco may have for the overcharge (such as a refund). This Section is intended as a fair allocation of audit expenses, not as damages or a penalty.
Section  29     Nondisclosure, Publicity, and Use of Name or Trademarks
29.1 Diamond will not disclose any information about the terms and conditions of this Agreement, excluding information contained on Product packaging and shipping documents and except as required by Applicable Law, without Elanco's consent.
29.2 Neither Party will use the name of the other Party or their Affiliates' employee, or product or service in any press release, advertising or materials distributed to prospective or existing customers, annual reports or any other public disclosure, except with the other Party's prior written authorization or as required by Applicable Law. To the extent allowed by Applicable Law, each Party will provide copies of any proposed disclosure for prior review and comment by the other Party's external corporate communications (public relations) department no less than ten (10) days prior to disclosure. Under no circumstances will either Party use the other Party's logo or other trademark in any such materials or disclosures.
29.3 In no event will either Party use the other Party's name, logo, or other trademarks on any business cards, letterhead, or similar materials.
29.4 Each Party may, in its sole discretion, revoke any authorization or consent given under this Section.

Risk Allocation

Section  30     Termination, Breach and Remedies
30.1 The naming of a specific remedy does not preclude any other remedy unless the Agreement clearly states that the specified remedy is the sole or exclusive remedy.
30.2 Elanco shall be able to terminate this Agreement without cause on or after June 17, 2018 provided that 1) Elanco provides no less than three (3) years prior Notice to Diamond of its intent to terminate this Agreement, and 2) pays to Diamond on or before the effective date of termination, an early termination fee equal to [***].
30.3 Termination for Breach . Either Party may terminate this Agreement or any Supplemental Agreement hereunder for material breach by written notice to the breaching Party (with a copy to the breaching Party's legal counsel). Termination will be effective ninety (90) days after receipt of the notice unless the breach is cured before that effective date.
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30.4           Termination related to Anti-Bribery Commitments . Diamond agrees that breach of the Anti-Bribery Laws pursuant to Section 34.1.1 of this Agreement shall be considered a material breach of the Agreement and that Elanco may immediately seek all remedies available under law and equity including termination of this Agreement if it believes, in good faith, that such a breach by Diamond has occurred.

30.5           Termination for Insolvency . Either Party may elect to immediately terminate this Agreement in the event of a commencement by the other Party of a voluntary case under any applicable bankruptcy, insolvency or other similar law now or hereafter in effect; or the entry of a decree or order for relief in respect of such other Party in a case under any such law or appointing a receiver, liquidator, assignee, custodian, trustee, sequestrator (or other similar official) of such other Party, or for any substantial part of the property of such other Party, or ordering the wind-up or liquidation of the affairs of such other Party; or the filing and pendency for thirty (30) days without dismissal of a petition initiating an involuntary case under any such bankruptcy, insolvency or similar law; or the making by such other Party of any general assignment for the benefit of creditors; or the failure of such other Party generally to pay its debts as such debts become due; or the taking of action by Diamond in furtherance of any of the foregoing.

30.6 In the event that Diamond, at any time during the term of this Agreement, determines that it will be unable to supply Elanco with the full quantity of Product ordered by Elanco in a binding purchase order, in a timely manner, Diamond shall notify Elanco thereof as soon as reasonably practicable following Diamond's determination of such inability or anticipated inability, but in any event, no later than two (2) business days following Diamond's determination. Such notification shall include the reasons and the expected duration of Diamond's inability or anticipated inability to supply Product. Promptly thereafter, but in no event more than five (5) business days after such notification, the Parties shall discuss the matters set forth in such notification. If Diamond fails to delivery ninety percent (90%) of the full quantity of a given Product specified in a purchase order within sixty (60) days after the required delivery date specified therein (other than by reason of a Force Majeure event or Confirmatory Testing), Elanco, at its option, may cancel all or any portion of such purchase order, in which event Elanco shall have no liability with respect to the portion of such purchase order so canceled. The quantities so canceled will reduce the quantities of Product (if any) Elanco is required to purchase from Diamond.
30.7 Each Party acknowledges that monetary damages are inadequate to protect the other Party from a breach or threatened breach of each Party's duty to protect the other Party's Confidential Information and that any such breach will cause irreparable harm to such other Party. Accordingly, such other Party may seek an injunction restraining any breach or threatened breach without having to prove the inadequacy of monetary damages or irreparable harm.
Section  31     Indemnification
31.1 Each Party will indemnify and defend the other Party and its Affiliates against any and all Losses incurred pursuant to third party Claims to the extent arising from:
31.1.1 Any Fault of such Party or its Affiliates.
31.1.2 Any Fault incident to this Agreement on the part of such Party's Representatives, or its Affiliates' Representatives, or its Subcontractors, or its Subcontractor's Representatives.
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31.2 Notwithstanding the foregoing, Losses incurred by a Party as a result of third party claims shall not be deemed consequential, indirect or incidental damages for purposes of this Section 31.
31.3 Diamond will indemnify and defend Elanco and its Affiliates against any and all Losses incurred pursuant to third party Claims to the extent arising from:
31.3.1 Any Claim that the Services or Deliverables, or Elanco's use thereof, infringes the Intellectual Property Rights of another Person.

 

31.4 Elanco will indemnify and defend Diamond and its Affiliates against any and all Losses incurred pursuant to third party Claims to the extent arising from:
31.4.1 Any Claim that the Elanco Technology, or Diamond's use thereof, infringes the Intellectual Property Rights of another Person.

 

31.5 Procedures for Indemnification
31.5.1 If an indemnitee becomes aware of a third-party Claim that (if successful) will result in a Loss to be indemnified under this Section, the indemnitee will promptly notify the indemnitor in writing (with a copy of the notice to the indemnitor's legal counsel). Failure or delay in giving such notice will not affect the right to be indemnified except to the extent that it prejudices the defense of the Claim. If the indemnitor acknowledges that the Claim (if successful) will result in Loss within its obligation to indemnify under this Section, it may assume the defense within fifteen (15) days after receiving the notice of the Claim. In the meantime, the indemnitee may take any action that it deems appropriate to protect its interests or those of the indemnitor, provided it is not prejudicial to the indemnitor.
31.5.2 If the indemnitor acknowledges its obligation to indemnify and assumes the defense, it will have both the duty to defend and the right to control the defense. The indemnitor will conduct the defense in a prudent manner and will keep the indemnitee reasonably informed as to the status of the defense. The indemnitee will cooperate with the defense and may retain separate counsel at its own expense to participate in, but not control, the defense. Neither party may settle a Claim without the consent of the other, and that consent may not be unreasonably withheld or delayed.
31.5.3 If the indemnitor does not timely assume the defense, the indemnitee will have the right (but no duty) to defend or settle the Claim at the risk of the indemnitor. The indemnitor will reimburse the indemnitee for its expenses (including reasonable attorney's fees) of defending or settling the Claim.
Section  32     Exclusion of Certain Damages
32.1 Neither Party (nor any of its Affiliates) is required to pay, or to indemnify any Person for, consequential, indirect, incidental, punitive, or special damages, including loss of revenues and lost profits, arising from or relating to:
32.1.1 Any breach of any provision of this Agreement, except any provision relating to Confidential Information or Intellectual Property Rights, or
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32.1.2 Any negligence in its performance under this Agreement, except gross negligence or intentional misconduct.
32.2 THESE LIMITATIONS SHALL APPLY EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

 

Section  33     Insurance
33.1 Diamond will satisfy the requirements of Exhibit D Insurance.
Section  34     Disaster Recovery and Business Continuity Plan
34.1 At all times during the course of this Agreement, Diamond will maintain and adequately support a disaster recovery and business continuity program ("Disaster Recovery and Business Continuity Program") that is intended to help ensure the continuous operation and, in the event of an interruption, the recovery of all material business functions reasonably needed to meet Diamond's obligations under this Agreement. The Disaster Recovery and Business Continuity Program will include at a minimum a detailed disaster recovery plan, which describes the management methodology, management team, emergency contact persons, and specific plans for potential risks that may disrupt Diamond's operations. Upon demand, Diamond will provide a copy and overview of the plan to Elanco.

General Terms and Conditions

Section  35     Compliance with Law

35.1           In the performance of its Services and obligations under this Agreement, Diamond shall comply with all Applicable Laws, including, but not limited to:

35.1.1 Anti-Bribery Laws. In carrying out their responsibilities under this Agreement, the Parties shall comply with all applicable anti-bribery laws in the countries where the Parties have their principal places of business and where they conduct activities under this Agreement. Additionally, the Parties understand and agree to comply with the U.S. Foreign Corrupt Practices Act, as revised, which generally prohibits the offer, promise, payment or giving of anything of value either directly or indirectly to any government official for the purpose of obtaining or retaining business or any improper advantage. For purposes of this section, "government official" means any official, officer, representative, or employee of, including any doctor employed by, any non-U.S. government department, agency or instrumentality (including any government-owned or controlled commercial enterprise), or any official of a public international organization or political party or candidate for political office. Additionally, Elanco represents that neither it nor any of its owners, directors, employees, agents, consultants (A) is a government official, or will directly or indirectly (B) offer to pay, promise to pay or give anything of value to any government official for purposes of (i) influencing any act or decision of such government official in his official capacity; (ii) inducing such government official to do or omit to do any act in violation of the lawful duty of such official; (iii) securing any improper
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advantage; or (iv) inducing such government official to use his influence with the government or instrumentality thereof to affect or influence any act or decision of the government or such instrumentality with respect to any activities undertaken relating to this Agreement. Additionally, the Parties will make reasonable efforts to comply with requests for information, including answering questionnaires and narrowly tailored audit inquiries, to enable the other Party to ensure compliance with applicable anti-bribery laws.

35.2           Notwithstanding anything in this Agreement, the parties expressly agree that the provisions of the Uniform Computer Information Transaction Act and the United Nations convention on Contracts for the International Sale of Goods (including any provision of any state law adopting exactly, or in modified form, such laws) shall not apply to this Agreement, Supplemental Agreement, Purchase Order, Work Product, Deliverables, software services, or products provided hereunder and that both parties waive any and all rights arising from such laws.

35.3 The Parties acknowledge that each maintains its own financial authorization policies on ensuring requisite corporate authority has been given for specific transactions. The Parties therefore agree that any communications between the employees of the Parties that may impact previously agreed upon financial, economic or legal expectations under this Agreement must be approved by the authorized individuals of both Parties. The Parties further agree to periodically meet and/or enter into discussions to identify authorized individuals as well as take any corrective actions necessary for any past discrepancies in order to meet appropriate financial expectations for potential future transactions.
Section  36     Taxes

36.1           Payment of Taxes . Each Party will be responsible for its own taxes, including Property Taxes on property it owns or leases, Income Taxes on its business and, any other Taxes incurred by such Party in connection with its business and with performing its obligations hereunder. Elanco will be responsible for any Transaction Taxes properly collectible from Elanco under Applicable Law. Diamond will be responsible for payment of any Transaction Taxes that are, under Applicable Law, properly borne by Diamond. The calculation of Taxes shall not include, and Elanco shall not pay, any Taxes that are related to intra-corporate transfers or intermediate supplies of the Services between Diamond and its Affiliates or between Diamond's Affiliates and related entities.

36.2           Recoverable Taxes . Each Party shall make all reasonable efforts to recover any and all VAT (or similar taxes) incurred by it in performing its obligations under this Agreement. Each Party will pay all unrecoverable VAT (or similar taxes) unless otherwise agreed in the applicable Supplemental Agreement. If any Governmental Authority refunds any Transaction Tax to either Party which the other Party or its Affiliates originally paid to such Party in accordance with the Section above, or such Party otherwise becomes aware that any such Transaction Tax was incorrectly and/or erroneously collected from such other Party or its Affiliates, or such Party otherwise receives an economic benefit (such as an audit offset) as the result of incorrectly and/or erroneously receiving such collected Transaction Taxes from such other Party, then such Party shall promptly remit to such other Party the amount of refund or tax erroneously or incorrectly collected.

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36.3           Withholding Taxes . If any payments made by the Parties under this Agreement become subject to withholding taxes under Applicable Laws of any state, federal, provincial or foreign government, each Party shall be authorized to withhold such Taxes as are required under Applicable Law, pay such Taxes to the appropriate Government Authority, and remit the balance due to the other Party net of such Taxes. The Party paying the taxes to the Government Authority shall secure and promptly deliver to the other Party an official receipt for Taxes paid.

36.4           Taxes Due to Relocation of Services . Any Transactional Taxes assessed on the provision of the Services for a particular site resulting from Diamond's relocating or rerouting the delivery of Services or Deliverables for Diamond's convenience to, from or through a location other than the Diamond's location used to provide the Services as of the Effective Date of the Agreement shall be borne by Diamond.

36.5           Tax Documents and Information . The Parties agree to fully cooperate with each other to enable each Party to more accurately determine its own Tax liability and to minimize such liability to the extent legally permissible and administratively reasonable. Each Party shall provide and make available to the other Party any exemption certificates, resale certificates, information regarding out of state or out of country sales or use of equipment, materials or services, and any other information reasonably requested by the other Party to support the provisions of this Section, including the appropriate organization of invoice formats and supporting documents to allow maximization of reclamation of VAT and other Transaction Taxes paid by either Party.

36.6           Tax Filings and Audits or Proceedings . Each Party represents, warrants, and covenants that it will file appropriate tax returns and pay applicable Taxes owed and arising from or related to the provision of the Services and Deliverables in applicable jurisdictions.

Section  37     Independent Contractor

37.1           In performing its obligations under this Agreement, Diamond acts solely as an independent contractor. This Agreement does not create a partnership, joint venture, or any similar relationship between Elanco and Diamond. Neither Diamond nor Elanco has any authority:

37.1.1 To bind, incur any liability on behalf of, or otherwise commit the other; or
37.1.2 To act in any other manner as agent or representative of the other.
37.2 Neither Diamond, its Affiliates, its Subcontractors, nor any of their Representatives are employees of Elanco for any purpose. Elanco will not withhold any taxes, pay any Social Security taxes, pay unemployment compensation, furnish worker's compensation insurance, or provide any employment benefits for Diamond, its Affiliates, its Subcontractors or any of their Representatives.
Section  38     Delegation and Assignment
38.1 Neither Party may assign its rights or delegate its obligations under the Agreement except that:
38.1.1 Property rights acquired under the Agreement may be freely assigned unless the Agreement expressly prohibits the assignment.
38.1.2 Accounts receivable may be assigned in accordance with Applicable Law.
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38.1.3 Diamond may engage one or more Subcontractors to perform its obligations under the Agreement; however, Diamond will remain fully responsible to Elanco for the performance of all obligations delegated to the Subcontractor; provided, however any Subcontractor engaged by Diamond to perform a significant portion of the Product manufacturing process will require the prior written consent of Elanco which will not be unreasonably withheld, conditioned or delayed.
38.1.4 Either Party may assign any or all of its rights or delegate any or all of its obligations under the Agreement to any of its Affiliates.

 

38.1.5 Either Party may assign its rights and delegate its obligations hereunder, on condition that the assignee accepts all remaining obligations under the Agreement, without prior written consent of the other Parties to any successor entity by way of merger, consolidation, or reorganization or to a purchaser of all or substantially all of the assets of the assignor to which this Agreement relates.
Section  39     Severability
39.1 If a provision of this Agreement is held to be unenforceable, the other provisions will remain in effect. If possible, the offending provision will be modified to the slightest degree necessary to make it enforceable, remaining as close as possible to the Parties' original intent for the provision. If not possible, the offending provision will be struck.
Section  40     Contract Interpretation
40.1 The meaning of a provision of this Agreement will be considered in context with other provisions of the Agreement.
40.2 The following principles apply to the construction of this Agreement unless the construction is plainly contrary to the intent of the Parties:
40.2.1 "Including" means "including but not limited to."
40.2.2 Language that has a generally prevailing meaning is given that meaning unless the Agreement expressly assigns a different one.
40.2.3 Technical terms used in the technical field of the subject of the Agreement are given their technical meaning.
40.2.4 Singular words may be treated as plural and plural words may be treated as singular.
40.2.5 The masculine gender may be treated as feminine, and the feminine gender may be treated as masculine.
40.2.6 In computing any period of time under this Agreement, the day of the act, event, or default from which the designated period of time begins to run is not included. If the Agreement specifies that a period is to run for a certain number of business days, only business days are included in the count, and the period may not end on any other day.
Section  41     Choice of Law
41.1 This Agreement shall be governed by and construed in accordance with the Laws of the State of New York, excluding its rules on conflict of law.
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Section  42  Survival    

42.1 The expiration or termination of this Agreement will not extinguish the rights of either Party that accrue prior to expiration or termination or any obligations that extend beyond termination or expiration either by their inherent nature or by their express terms.
Section  43     No Waiver
43.1 No provision of this Agreement is waived unless the waiver is in writing and signed by the Party granting the waiver.
43.2 No delay in exercising any right, power or privilege under this Agreement will operate to waive completely or partially any present or future exercise of that right, power or privilege.
Section  44     Notice
44.1 Unless specifically directed otherwise in the Agreement, whenever written notice is required by this Agreement, it must be delivered to address indicated below by:
44.1.1 Certified mail, postage pre-paid, return receipt requested;
44.1.2 Hand delivery;
44.1.3 Commercial overnight delivery service such as Federal Express or United Parcel Service;
44.1.4 or
44.1.5 Electronic mail (and promptly confirmed pursuant to Sections 44.1.2 or 44.1.3).
44.2 Either Party may change its address for notices by written notice to the other.
44.3 Notice is effective when received. If delivery of any written notice under this Agreement cannot be made despite the exercise of diligent efforts, the requirement to give notice is excused.
Address for Notices to Elanco:


Elanco Animal Health
2500 Innovation Way
Greenfield, IN 46140
Attention: Procurement

Address for Notices to Lilly's Legal Counsel (if required):

Eli Lilly and Company

Lilly Corporate Center

Indianapolis, IN 46285

Attn: General Counsel

 

 

 

 

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Address for Notices to Diamond:


Diamond Animal Health, Inc.
2538 S.E. 43 rd Street

Des Moines, IA 50317

Attn: President

 

 

Address for Notices to Diamond's Legal Counsel (if required):

William M. Hardin

Osborn Maledon, P.A.

2929 N. Central Avenue,

Suite 2100

Phoenix, AZ 85012

 

 

     
Section  45     Integration and Amendments
45.1 This Agreement, its exhibits and attachments are the final, complete and exclusive expression of all the statements, promises, terms and conditions within its scope and supersedes any prior written or oral agreements within its scope. In making the Agreement, neither Party relies on any promise or statement made by the other Party, other than those contained in the Agreement, its exhibits or attachments.

45.2           No amendment to this Agreement will be binding on either Party unless it is in writing and signed by each Party or executed in another manner expressly provided by this Agreement. Such an amendment does not require the consent or agreement of any third party, even if the third party is beneficiary of this Agreement.

45.3 In the event of a conflict between the provisions of the exhibits or the attachments to this Agreement and the provisions of this Agreement itself, the conflicting provision(s) of the Agreement shall control over the language in the exhibit or attachments, unless otherwise agreed by the Parties.
   
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Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

 

Section  46  Signatures    

46.1 This Agreement is legally binding when, but not until, each Party has received from the other a counterpart of the Agreement signed by an authorized Representative. The Parties' representatives may sign separate, identical counterparts of this document; taken together, they constitute one agreement. A signed counterpart may be delivered by any reasonable means, including facsimile or other Electronic transmission.

 

 

  ELI LILLY AND COMPANY
  By: [***]
  Name: [***]
  Title: [***]
  Date: 2015.01.14 09:09 -05'00'
     
  DIAMOND ANIMAL HEALTH, INC.
  By: /s/ Michael J. McGinley
  Name: Michael J. McGinley
  Title: Vice President - Diamond
  Date: 15 Jan 2015

 

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Exhibit A  Definitions

A.1 Capitalized Terms
A.1.1 "Affiliate" of a Party means any entity that controls, is controlled by, or is under common control with that Party. One entity is deemed to control the other if and only if it directly or indirectly:
A.1.1.1 Owns more than fifty percent (50%) of the equity in the other; or
A.1.1.2 Controls more than fifty percent (50%) of the voting rights of the other.
A.1.2 "Agreement" includes the Master Agreement and any Supplemental Agreements.
A.1.3 "Applicable Law" means any statute, law, treaty, rule, code, ordinance, regulation, permit, interpretation, certificate, judgment, decree, injunction, writ, order, subpoena, or like action of a Governmental Authority that applies, as the context requires to: (i) the Agreement; (ii) the performance of obligations or other activities related to the Agreement; and (iii) a Party or a Party's Affiliates (if any).
A.1.4 "Biological Assets" shall have the meaning as defined in the APA.
A.1.5 "Cattle Vaccine Products" shall have the meaning as defined in the APA.
A.1.6 "Claim" includes claims, demands, lawsuits, administrative proceedings or similar actions.
A.1.7 "Compensation" means: (i) the amount of compensation set forth in any Supplemental Agreements; plus (ii) to the extent another term of the Agreement expressly requires Elanco to bear (or to reimburse Diamond for) a particular cost of Diamond's performance of an obligation under the Agreement, an amount equal to Diamond's actual cost to perform that obligation.
A.1.8 "Confidential Information" means information deemed confidential or proprietary by a Party to the Agreement (the "disclosing Party"), including information deemed confidential or proprietary by virtue of the disclosing Party's obligations to another Person, that may be disclosed to, acquired by or on behalf of, the other Party (the "acquiring Party"). The status of information as Confidential Information is not affected by the means of acquisition or disclosure. For example, Confidential Information may be acquired by written, oral, or electronic communication; directly from the disclosing Party's Representative or independent contractor, or indirectly through one or more intermediaries; or by visual observation. Similarly, acquisition or disclosure of information may be either intentional or inadvertent without affecting its status as Confidential Information. Notwithstanding anything to the contrary in this Agreement, Confidential Information does not include any information that:
A.1.8.1 Is generally known to the public or becomes generally known to the public by means other than a breach by the acquiring Party of a contractual, legal, or fiduciary duty of confidentiality owed to the disclosing Party, its Affiliates, its Subcontractors (if applicable), or any of their Representatives;
A.1.8.2 The acquiring Party lawfully possessed before acquiring it as a result of this Agreement;
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A.1.8.3 Is or becomes available to the acquiring Party on a nonconfidential basis from a third person that is not bound by any contractual, legal, or fiduciary duty of confidentiality to the disclosing Party, to its Affiliates, or to the Representatives of the disclosing Party or its Affiliates; or
A.1.8.4 Is developed entirely by Representatives of the acquiring Party without use of or reference to the disclosing Party's Confidential Information.
A.1.9 "Confirmatory Testing" means the selection of a biological product for inspection and testing by a Regulatory Agency for purity, safety, potency or efficacy, including but not limited to testing pursuant to 9 C.F.R. Part 113.6.
A.1.10 "Control" means, with respect to any material, information, or intellectual property right, that a Party owns or has a license to such material, information, or intellectual property right and has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to such material, information, or intellectual property right on the terms and conditions set forth herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be first required hereunder to grant to the other Party such access, license, or sublicense.
A.1.11 "Deliverables" means any materials, articles, substances, models, samples, software, data, records, reports, notices, documents, photographs, video recordings, audio recordings, drawings, designs, specifications, information and the like (whether physical, Electronic, magnetic or other form) that Diamond is specifically obligated to furnish Elanco or that are identified as Deliverables in this Agreement.
A.1.12 "Diamond Pre-Existing Know-How" means all Know How (excluding any published Diamond Patent Rights) that is Controlled as of the Effective Date or is developed outside the scope of this Agreement by Diamond and/or its Affiliates and is reasonably necessary or useful for the manufacture of the Product(s). For clarity, the use of "Affiliate" in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party's acquisition of Diamond except as provided in Section 38.
A.1.13 "Diamond Developed Know-How" means all Know How (excluding any published Diamond Patent Rights) that is Controlled during the term of this Agreement by Diamond and/or its Affiliates, is reasonably necessary or useful for the manufacture of the Product(s) and is made by or on behalf of Diamond or its Affiliate in the course of performing Diamond's obligations or exercising Diamond's rights under this Agreement. For clarity, the use of "Affiliate" in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party's acquisition of Diamond except as provided in Section 38.
A.1.14 "Diamond Patent Rights" means the Diamond Pre-Existing Patent Rights and the Diamond Developed Patent Rights.
A.1.15 "Diamond Pre-Existing Patent Rights" means all patents and patent applications that are Controlled as of the Effective Date or are developed outside the scope of this Agreement by Diamond and/or its Affiliates and are necessary or useful for the manufacture of the Product, including: (i) all substitutions, divisions, continuations, continuations-in-part thereof and requests for continued examination of any of the foregoing, (ii) all patents issued from any of the foregoing patent applications, (iii) all reissues, renewals, registrations, confirmations, re-examinations, extensions, and supplementary protection certificates of any of the foregoing, and (iv) all foreign equivalents of any of the foregoing. For clarity, the use of "Affiliate" in subclause (a) of this definition shall
Page 25
 

exclude any Third Party that becomes an Affiliate due to such Third Party's acquisition of Diamond except as provided in Section 38.

A.1.16 "Diamond Developed Patent Rights" means all patents and patent applications that are Controlled during the term of this Agreement by Diamond and/or its Affiliates, are necessary or useful for the manufacture of the Product and are made by or on behalf of Diamond or its Affiliate in the course of performing Diamond's obligations or exercising Diamond's rights under this Agreement, including: (i) all substitutions, divisions, continuations, continuations-in-part thereof and requests for continued examination of any of the foregoing, (ii) all patents issued from any of the foregoing patent applications, (iii) all reissues, renewals, registrations, confirmations, re-examinations, extensions, and supplementary protection certificates of any of the foregoing, and (iv) all foreign equivalents of any of the foregoing. For clarity, the use of "Affiliate" in subclause (a) of this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party's acquisition of Diamond except as provided in Section 38.
A.1.17 "Diamond Pre-Existing Technology" means the Diamond Pre-Existing Patent Rights and Diamond Pre-Existing Know-How.
A.1.18 "Diamond Developed Technology" means the Diamond Developed Patent Rights and Diamond Developed Know-How.
A.1.19 "Diamond Technology" means the Diamond Pre-Existing Technology and the Diamond Developed Technology.
A.1.20 "Elanco Know-How" shall mean all Know-How (excluding any published Elanco Patent Rights) that is (a) Controlled as of the Effective Date or thereafter during the term of this Agreement by Elanco or its Affiliate and is reasonably necessary or useful for the research, development, use, importation or sale of the Elanco Biological Asset(s) as defined in the Asset Purchase and License Agreement between Diamond and Elanco effective June 17, 2013 ("APA") or Product(s) in the Field, including any such Know-How made by or on behalf of Elanco or its Affiliates or sublicensees in the course of performing Elanco's obligations or exercising Elanco's rights under this Agreement. For clarity, the use of "Affiliate" in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party's acquisition of Elanco except as provided in Section 38.
A.1.21 "Elanco Patent Rights" means all patents and patent applications that:
a) are Controlled as of the Effective Date or thereafter during the term of this Agreement by Elanco and/or its Affiliates and are necessary or useful for the research, development, importation, offer for sale or sale in the Field of the Elanco Biological Asset(s) or Product, including: (i) all substitutions, divisions, continuations, continuations-in-part thereof and requests for continued examination of any of the foregoing, (ii) all patents issued from any of the foregoing patent applications, (iii) all reissues, renewals, registrations, confirmations, re-examinations, extensions, and supplementary protection certificates of any of the foregoing, and (iv) all foreign equivalents of any of the foregoing; or
b) without limiting subclause (a) and for the avoidance of doubt, claim inventions that are conceived or reduced to practice (whether solely or jointly) by or on behalf of Elanco or its Affiliates, in each case pursuant to performing Elanco's obligations or exercising Elanco's rights under this Agreement.
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For clarity, the use of "Affiliate" in subclause (a) of this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party's acquisition of Elanco except as provided in Section 11.6.

A.1.22 "Elanco Technology" means the Elanco Patent Rights and Elanco Know-How.
A.1.23 "Electronic" relates to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities.
A.1.24 "Fault" means any act or omission of gross negligence; or willful, wanton, or intentional misconduct.
A.1.25 "Field" shall have the meaning as defined in the APA."Governmental Authority" means: (i) any national, federal, state, or local government entity, authority, agency, instrumentality, court, tribunal, regulatory commission or other body, either foreign or domestic, whether legislative, judicial, administrative or executive; and (ii) any arbitrator to whom a dispute has been presented under government rule or by agreement of the Parties with an interest in such dispute.
A.1.26 "Force Majeure" means any extraordinary, unexpected and unavoidable event, including, without limitation, acts of God, floods, fires, riots, terrorism, war, accidents, labor disturbances, breakdown of plant or equipment, lack or failure of transportation facilities, unavailability of equipment, sources of supply or labor, raw materials, power or supplies, infectious diseases of animals, or by the reason of any law, order, proclamation, regulation, ordinance, demand or requirement of the relevant government or any sub-division, authority or representative thereof (provided that in all such cases the Party claiming relief on account of such event can demonstrate that such event was extraordinary, unexpected and unavoidable by the exercise of reasonable care).
A.1.27 "Intellectual Property" means all inventions, original expressions of ideas embodied in a tangible form, copyrights, trademarks, trade secrets, information, know-how, and the like that are afforded (or may be afforded upon action by a Governmental Authority, such as the United States Patent Office) Intellectual Property Rights.
A.1.28 "Intellectual Property Rights" means the property rights or quasi-property rights afforded by patents, copyrights, trademarks, or trade secrets; publicity rights; privacy rights; and moral rights (such as the rights of attribution and integrity).
A.1.29 "Know-How" shall mean any and all formulae, processes, trade secrets, technologies, know-how, inventions, improvements, discoveries and claims (including confidential data and Confidential Information), whether patentable or unpatentable, including, without limitation, synthesis, preparation, recovery and purification processes and techniques, control methods and assays, chemical data, toxicological and pharmacological data and techniques, clinical data, medical uses, product forms and product formulations and specifications.
A.1.30 "Loss" includes losses, damages, costs, or expenses (including interest, penalties, reasonable attorney or accounting fees, and expert witness fees) recoverable at law or in equity, whether sounding in contract, tort, strict liability or other theory.
A.1.31 "Master Agreement" means the body of the document this exhibit is attached to and all of its exhibits, excluding any Supplemental Agreements.
A.1.32 "Person" includes an individual or a partnership, corporation, association, limited liability company or other form of organization.
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A.1.33 "Product" shall have the meaning as defined in the APA.
A.1.34 "Product Specifications" means the specifications of the Products as defined by the USDA.
A.1.35 "Pro Forma Invoice" means an invoice that will not be processed for payment by Elanco's accounts payable department, but rather is used for customs entry only and contains "value for customs purposes only". A Pro Forma Invoice should not contain payment terms, or a payment date.
A.1.36 "Project" means the collection of all the Services and Deliverables Diamond is required to furnish under a particular Supplemental Agreement.
A.1.37 "Proposal" means a proposed Supplemental Agreement.
A.1.38 "Record" means information of any type (including text, data, code, images, and sound) that is either:
A.1.38.1 Recorded on paper or other tangible medium; or
A.1.38.2 Recorded on an Electronic medium and retrievable in a perceivable form.
A.1.39 "Registration" means a marketing authorization, product license or permit issued for a given Product or by a Regulatory Agency.
A.1.40 "Regulatory Agency" means, any governmental authority that regulates Products, including but not limited to U.S. Department of Agriculture (USDA) Center for Veterinary Biologics; or any counterparts thereof in jurisdictions outside of the USA.
A.1.41 "Representative" means an employee, officer, director, or agent.
A.1.42 "Reprocess" means making any modifications after all the ingredients that make up the serial have been combined according to the procedures indicated in Diamond's outline of production and the product is in its final form and composition.
A.1.43 "Services" means the particular services that Diamond is obligated to furnish Elanco or that are identified as Services in the Agreement.
A.1.44 "Subcontractor" means any Person that performs any of the obligations of Diamond under this Agreement, whether in privity to Diamond or in privity to another Subcontractor.
A.1.45 "Tax" or "Taxes" means all taxes, levies, or other like assessments, charges, fees, including, without limitation, income, gross receipts, excise, ad valorem, property, goods and services, value added ("VAT"), import, export, sales, use, license, payroll, franchise and privilege taxes or other taxes, fees, duties, charges, levies, or assessments of any kind whatsoever (whether payable directly or by withholding), together with any interest and any penalties, additions to tax or additional amounts, imposed by state, federal, provincial or foreign government or any subdivision or agency thereof. "Income Tax" means all Taxes (including franchise and privilege taxes) based upon or measured by income or gross receipts over a period of time, including withholding Taxes imposed in lieu of Income Taxes. "Transaction Tax" means all services, VAT, sales, use, transaction-based gross receipts, COFINS, ISS, PIS, China Business Tax and other similar Taxes arising in connection with Diamond's charges to Elanco under this Agreement or a particular transfer of property, goods or services. "Property Tax" means real and personal property ad valorem Taxes and any other Taxes imposed on a periodic basis and measured by the level of any item. "Import or Export Tax" means any import, export, withholding and
Page 28
 

similar Taxes related to the importation or exportation of any goods or services, Deliverables or Work Product performed under this Agreement.

A.1.46 "Technology" shall have the meaning as defined in the APA.
A.1.47 "Third Party" means any entity, including any natural person, other than Diamond or Elanco and their respective Affiliates.
A.1.48 "Trade Secret" means any information that satisfies the definition of "trade secret" established in either: (i) the Economic Espionage Act of 1996, 18 U.S.C. §§ 1831-1839, § 1839(3); or (ii) the Indiana Uniform Trade Secrets Act, Ind. Code § 24-2-3.
A.1.49 "Vendor" means Supplier for purposes of the Vendor Privacy and Security Standard.
A.1.50 "Supplemental Agreement" is a contractual commitment meeting the requirements for a Supplemental Agreement set forth in this Agreement, executed by both Elanco and Diamond, that engages Diamond to furnish Elanco specified Deliverables.
Page 29
 

Exhibit B  Example Supplemental Agreement

This exhibit shows an example the form that will be used to write Supplemental Agreements under this Master Agreement. Instructions for completing the form are shown in italics.

 

B.1 Parties and Master Agreement
B.1.1 Eli Lilly and Company is an Indiana, US Company, operating through its Elanco Animal Health division ("Elanco").
B.1.2 Diamond Animal Health, Inc.is an Iowa, US Corporation ("Diamond").
B.1.3 This Supplemental Agreement is subject to the Master Agreement between the Parties effective ________.
B.1.4 Capitalized words that appear in this Supplemental Agreement are defined in the Master Agreement.
B.2 Project / product Information

Fill in the blanks.

B.2.1 [ Insert detailed description of all Services and Products including milestones and deadlines, including the start date and the projected end date.]

Diamond will manufacture and supply Product which meets the Product Specifications attached to this Supplemental Agreement as Appendix B: Product Specifications . Diamond will manufacture Product for Elanco at its facility(ies) in [ insert identifying information about facility ].

Diamond will manufacture and supply Product to Elanco as described in this Supplemental Agreement, the MRD, the Quality Agreement and the Master Agreement.

Elanco supplied materials: (insert specific items)

Diamond supplied materials : (insert specific items)

B.2.2 [ Parties' responsibilities ]
B.3 Orders
B.4 Inventory Control
B.5 Yield
B.6 Product Approval
B.7 Shipping
B.8 Deliverables

[Insert detailed specifications of all Deliverables, including timelines for Delivery.]

B.9 Compensation

Diamond's entire Compensation for complete performance of this Project is set forth in this section. See the Master Agreement for additional explanation.

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B.10 Signatures
B.10.1 This Supplemental Agreement is legally binding when, and not until, each Party has executed it in a manner allowed by the Master Agreement.

 

ELI LILLY AND COMPANY DIAMOND ANIMAL HEALTH, INC.

 

By: (Example only. Not intended to be signed.)

 

Printed Name: ___________________________

 

Title: ___________________________________

 

Date: __________________________________

 

By: (Example only. Not intended to be signed.)

 

Printed Name: ___________________________

 

Title: ___________________________________

 

Date: __________________________________

Page 31
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

Exhibit C  Insurance

C.1 Required Policies
C.1.1 Diamond will maintain, or will cause its Affiliates and Subcontractors to maintain, all insurance policies described in Table C-1 (below) covering all activities related to this Agreement on the part of Diamond, its Affiliates, its Subcontractors, their respective Representatives.
C.1.2 Diamond will maintain umbrella liability insurance of no less than $[***] following form with the policies required by Table D-1.
C.1.3 Each policy other than workers' compensation policies will name Elanco as an additional insured.
C.1.4 Diamond shall be responsible for payment of all deductibles or retentions.
C.2 Certificates of Insurance
C.2.1 Diamond will cause the underwriter of each policy to furnish Elanco a certificate of insurance for each insurance policy required by this exhibit. The certificate will contain the insurer's assurance that it will endeavor to notify Elanco at least thirty (30) days in advance of canceling the policy. Such certificates must be furnished to Elanco before Diamond begins performance under this Agreement and again upon renewal or replacement of any policy required by this exhibit.
Page 32
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

Table D-1

[***] [***] [***]

 

Page 33
 

Exhibit D  Example Localization Agreement

D.1.1 [Lilly Affiliate] is an Affiliate of Eli Lilly and Company.
D.1.2 [Diamond Affiliate] is an Affiliate of Diamond.
D.1.3 This Supplemental Agreement/Localization Agreement forms an independent agreement between [Lilly Affiliate] and [Diamond Affiliate] incorporating the terms and conditions of the [Name of Master Agreement] between Eli Lilly and Company and Diamond. Any references to Lilly or Diamond in the [Name of Master Agreement] shall be deemed to refer to [Lilly Affiliate] or Diamond Affiliate respectively. All rights and obligations of Lilly in the [Name of Master Agreement] shall apply to Lilly Affiliate and all rights and obligations of Diamond shall apply to Diamond Affiliate. The parties agree that this agreement shall terminate at the same time as termination or expiration of the [Name of Master Agreement] between Eli Lilly and Company and Diamond.

 

[ Insert any additional applicable local laws or requirements that are not covered or needs to be different from the master agreement ]

 

[ Insert Signature Blocks ]

 

 

 

 

 

 

 

 

 

 

 

Page 34

Exhibit 10.2

 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

Supplemental Agreement

 

A.1 Parties and Other Agreements
A.1.1 Eli Lilly and Company, an Indiana Corporation, and its Affiliates, operating through its Elanco Animal Health division ("Elanco or "Lilly").
A.1.2 Diamond Animal Health, Inc., an Iowa Corporation, and its Affiliates ("Diamond").
A.1.3 This Supplemental Agreement is subject to the Master Supply Agreement ("MSA") between the Parties effective October 1, 2014.
A.1.4 Capitalized words that appear in this Supplemental Agreement are defined in the Asset Purchase and License Agreement between the Parties, Effective June 17, 2013 (the "APA"), or in the MSA.
A.2 Term
A.2.1 The term of this Supplemental Agreement is from October 1, 2014 through June 16, 2023, unless cancelled or terminated earlier by either Party subject to the terms of this Supplemental Agreement and the MSA.
A.2.2 Elanco shall be able to terminate this Agreement without cause on or after June 17, 2018 provided that 1) Elanco provides no less than three (3) years prior written notice to Diamond of its intent to terminate this Agreement, and 2) pays to Diamond on or before the effective date of termination, an early termination fee equal to [***].
A.3 Project /Product Information
A.3.1 The scope of this Supplemental Agreement is for the supply of the vaccines listed in Exhibit A.
A.3.2 Diamond will manufacture Product for Elanco at its facility in Des Moines, IA.
A.3.3 Diamond will manufacture and supply Product to Elanco as described in this Supplemental Agreement and the MSA.
A.3.4 Upon [***]
 
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

[***].

A.3.5 The Parties acknowledge that during the term of this Agreement, Diamond will have the obligation to make Product for Elanco and/or Defined Third Parties, and that such obligation will entail consumption of a portion of certain Purchased Assets. To the extent that such obligation to make Defined Product(s) pertain to supply by Diamond to Defined Third Parties, such supply should be sourced from the assets contained in the Diamond Subset. Conversely, to the extent that such obligation to make Products pertains to the supply by Diamond to Elanco, such supply should be sourced from the assets contained in the Elanco Subset.
A.4 Minimum Purchases
A.4.1 Elanco will purchase during each calendar year of the term of this Supplemental Agreement, as a minimum, Product with an aggregate price purchased from Diamond during such calendar year (based upon delivered Product and open purchase orders meeting agreed Product lead times to delivery) (the "Actual Annual Purchases") equal to the minimum annual purchase set forth on Exhibit A.
A.4.2 For a given calendar year, and unless otherwise agreed by the Parties in writing, for any shortfall of Actual Annual Purchases relative to the Minimum Annual Purchases for such calendar year, Elanco shall purchase additional Products to cover the shortfall (provided Elanco takes delivery on or before December 31 of that year) or shall pay Diamond for any shortfall from such Minimum Annual Purchases requirement within sixty (60) days following the end of such calendar year.
A.5 Investment Needs
A.5.1 The Parties acknowledge that investments in capital improvement, maintenance and repair in Diamond's manufacturing facility (the "Manufacturing Facility") will be required during the term of this Agreement to: 1) provide for compliance with regulatory requirements from Regulatory Agencies in the Territory are met and maintained throughout the term of this Agreement and 2) provide that facilities and equipment are maintained in good working order to assure reliability of supply. Diamond shall be responsible for any and all investments required to meet or maintain compliance with such regulatory requirements in the United States or any other country for which Diamond manufactures as of the Effective Date of the APA and to maintain, refurbish and/or replace equipment and facilities, as Diamond reasonably determines are necessary, to provide for reliability of supply after the Effective Date of the APA; provided, however, Elanco shall be responsible for: i) any and all investments required to meet or maintain compliance with such regulatory requirements for any country other than those countries for which Diamond manufactures as of the Effective Date of the APA, ii) any product-specific investment required to commercialize a new product and iii) all investments specifically requested by Elanco that are not otherwise required by an applicable Regulatory Agency or reasonably determined by Diamond to be needed to provide for on-going, reliable supply of Product.
 
 
     
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

A.6 Compensation
A.6.1 Diamond may change purchase prices for each Product to be delivered in each subsequent calendar year by written notice to Elanco if the notice is delivered to Elanco at least ninety (90) days before the end of the preceding calendar year, taking into account factors including, but not limited to, cost changes, volume changes and plant utilization; provided that, such increase for any calendar year, plus any increase in the preceding calendar year resulting from the immediately following sentence shall not exceed [***] of the purchase price in effect at the beginning of the preceding calendar year. In addition, Diamond shall have the right, but not the obligation, to increase or decrease purchase prices by notice to Elanco in writing during any calendar year by an amount equal to (i) any cost increases or decreases for raw materials and packaging components for each Product to the extent such cost increase or decreases, individually or in the aggregate, would cause total finished cost of goods of such Product to increase or decrease by more than [***]; and (ii) any cost increases or decreases charged by [***] for [***].
A.6.2 Notwithstanding Section A.6.1, the purchase prices charged to Elanco by Diamond for the Products to be distributed in the United States will not be higher than the prices charged to any Defined Third Party in the United States purchasing identical Products with identical quality controls and safety requirements.
A.6.3 Elanco shall purchase Product from Diamond at the prices set forth on Exhibit A.
A.7 Registration
A.7.1 The Parties agree that Elanco shall have the responsibility for, and shall pay all Product Registration Costs associated with securing all appropriate regulatory licenses and approvals required for marketing the Products. Elanco may, with Diamond's consent, engage Diamond to perform any activities connected with obtaining such licenses and approvals and shall pay all Product Registration Costs associated with Diamond's services, excluding costs related to the facility licenses owned by Diamond, facility inspection relating to facility licenses owned by Diamond including but not limited to USDA/APHIS/CVB, international licenses and inspections and their maintenance, all to the extent such licenses are owned by Diamond. Diamond shall be responsible, at Elanco's cost, for all dossier submissions to all regulatory authorities necessary to obtain registration of the Products in such jurisdictions. License submissions outside of the USA and Canada will be made by Elanco in these countries. The Parties shall agree upon a written work plan prior to commencement of any such services. Such work plan shall specify how Product Registration Costs will be calculated (e.g., hourly) and when they will be paid. Any estimate of Product Registration Costs shall be a non-binding estimate only. For the purposes of this Agreement, "Product Registration Costs" shall mean all direct costs and expenses associated with achieving regulatory licensure of a Product, including clinical trial costs, assay development and validation, development of seed stocks, production processes scale-up, formulation development, production of pre-licensing serials, conduct of field safety trials, preparation of reports, preparation of regulatory submissions, application fees and other costs and expenses reasonably incidental thereto. As between the parties, additional costs and expenses shall include labor and service charges at Diamond's standard hourly rates, direct cost of required materials provided by Diamond, and out-of-pocket and third-party expenditures.
A.7.2 Diamond shall be responsible for securing all appropriate regulatory licenses and approvals required for manufacturing the Products for sale in the United States and Canada. Except as provided in Section A.7.1 above, Elanco shall pay all Manufacturer
 
 

Registration Costs set forth in this Supplemental Agreement, as may be amended by the Parties. The Parties shall agree upon a written work plan prior to commencement of any registration activities. Such work plan shall specify how Manufacturer Registration Costs will be calculated (e.g., hourly) and when they will be paid. Any estimate of Manufacturer Registration Costs shall be non-binding estimate only. For the purposes of this Agreement, "Manufacturer Registration Costs" shall mean all direct costs and expenses associated with achieving regulatory licensure of Diamond to manufacture any Product, including costs of animal studies, production process, validation costs, stability studies, production of pre-licensing serials, application fees and other costs and expenses reasonably incidental thereto. As between the parties, additional costs and expenses shall include labor and service charges at Diamond's standard hourly rates, direct cost of required materials provided by Diamond, and out-of-pocket and third-party expenditures.

A.7.3 Each party grants to the other party the right to participate in discussions with the USDA/APHIS/CVB, USDA/APHIS/NIES, CFIA/CFBD and all other applicable Regulatory Agencies relating to any United States and Canada registration filings made pursuant to this Section A.7. Should a party receive a written communication from a Regulatory Agency relating to any such registration filing it will, within two (2) business days, and in writing within five (5) business days, provide a copy of such communication to the other party and, subject to any mandatory response time designated by the Regulatory Agency, allow the other party to provide its suggested response to that communication and in good faith consider inclusion of such suggested response it its reply to the Regulatory Agency. In relation to non-United States (excluding Canada) registration filings made by Elanco, Elanco will provide Diamond with copies of any communication from a Regulatory Agency relating to the Diamond manufacturing facility where Elanco products will be manufactured and the foregoing provisions of this Subsection A.7.3 shall apply to the response to such Regulatory Agency communication.
A.8 Forecasts, Order Procedures and Shipment
A.8.1 Except to the extent that the Parties otherwise agree in writing with regard to a particular shipment, Elanco shall submit to Diamond a firm written purchase order or orders specifying the types, quantities and delivery dates of Products that it desires to purchase within at least the lead time and in the Standard Lot Sizes specified on Exhibit A prior to the requested delivery date(s). Diamond will review each purchase order within five (5) business days of receipt and either issue its confirmation or its proposed modified delivery date(s) to accommodate Diamond's scheduling requirements. Diamond will use reasonable commercial efforts to accommodate and to minimize modifications to the delivery dates requested by Elanco. Each purchase order shall be binding on Elanco upon written confirmation by Diamond or, if Diamond has made a proposal for modifications to delivery dates, upon Elanco's written acceptance of such modifications; provided that no material modification will become effective after confirmation without the written approval of both parties. Revisions to labeling or packaging configurations may be made by Elanco not less than ninety (90) days prior to the specified delivery date (subject to approval by Regulatory Agencies) unless otherwise agreed by Diamond, provided that the Purchase Price(s) shall be adjusted for any such changes and Diamond will promptly notify Elanco thereof. In the event Elanco does not agree to the adjustment in Purchase Price for changed configurations, then the original configuration may be used. Diamond agrees that with respect to Products covered by a purchase order confirmed by it in writing, the Products shall be available for shipment on the specified delivery dates, except to the extent it is prevented from doing so due to conditions beyond its control. The applicable delivery schedules shall be suspended during any period that
 
 

Products have been selected for testing by a Governmental Authority which testing would affect or prevent manufacture or delivery.

A.8.2 Elanco will order Products in standard batch sizes as shown on Exhibit A. If specified order amounts for Elanco would result in a batch which is ten percent (10%) or more below the applicable standard batch size, Diamond will so notify Elanco and at Elanco's option (i) the Parties will mutually agree to an increased Purchase Price for such Products; or (ii) Elanco may submit a revised purchase order for a quantity of Products within the permitted parameters. The Purchase Price shall remain applicable for amounts resulting in a batch up to ten percent (10%) more or less than the applicable standard batch size, and Elanco shall be required to accept any such entire batch.
A.8.3 Within fifteen (15) days after the issuance of the Product License by the CVB, Elanco will furnish Diamond a written forecast of the quantities and types of Products that Elanco anticipates it will order from Diamond during the First Contract Year. Thereafter, within fifteen (15) days after the first day of each month during the term of this Agreement, Elanco will also furnish to Diamond revised written estimates of the quantities it anticipates it will order during each month of the succeeding Contract Year. Such forecasts are not binding commitments, but are for the purpose of enabling Diamond to more effectively schedule the use of its facilities. Diamond shall use commercially reasonable efforts to have capacity and availability of the facilities for the manufacture of the Product notwithstanding any forecasts.
A.8.4 Diamond agrees to store the Products under conditions required to maintain the quality and stability of the Product at no cost to Elanco as required by Elanco for a period of not to exceed forty-five (45) days from the date Diamond notifies Elanco the Products are ready for shipment. With respect to Products that are not picked up by the common carrier designated by Elanco's shipping instructions within forty-five (45) days from the date Diamond notifies Elanco the Products are ready for shipment, Diamond shall charge a warehousing fee of two percent (2%) of the invoice amount per month or portion thereof until such Products are shipped.
A.9 Labeling; Trademarks
A.9.1 Diamond shall affix labeling to the Products as required, such labeling to bear one or more Elanco trademarks, as specified by Elanco. Nothing contained herein shall give Diamond any right to use any Elanco trademark except on Products for Elanco and Diamond shall not obtain any right, title or interest in any Elanco trademark by virtue of this Agreement. Elanco shall not use, nor shall Elanco obtain any right, title or interest in any Diamond trademark. Elanco shall cause all Product labeling to contain only such claims as are permitted under applicable licenses for such Product and otherwise comply with Applicable Law. Elanco shall be responsible for the costs of developing and changing packaging for the Products, including costs of obsolete labeling and packaging due to changes requested by Elanco or required by Governmental Authorities. Elanco agrees to provide label specifications compatible with Diamond's equipment, as specified by Diamond. Additional details to be set forth on Exhibit A. In the event that Diamond purchases labeling or packaging materials for use with the Products, Diamond shall purchase an amount reasonably required for the amount of Products manufactured; provided the Parties agree that a six (6) month supply of labeling and packaging materials is reasonable, and Elanco shall be required to bear the full cost of such reasonable supply even if this Agreement is terminated, unless otherwise agreed upon by the Parties.
 
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment .

 

A.10 Signatures
A.10.1 This Supplemental Agreement is legally binding when, and not until, each Party has executed it in a manner allowed by the MSA.

 

ELI LILLY AND COMPANY DIAMOND ANIMAL HEALTH, INC.

 

By: [***] _________________________________

 

Printed Name: [***] ________________________

 

Title: [***] _______________________________

 

Date: 2015.01.14 09:09:58 -05'00' _____________

 

By: /s/ Michael J. McGinley

 

Printed Name: Michael J. McGinley ___________

 

Title: Vice President - Diamond ______________

 

Date: 15 Jan 2015 _________________________

   

 

 
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

Exhibit A 

 Minimum Annual Purchases

For the purposes of Section A.5.1 of this Supplemental Agreement, the Minimum Annual Purchases shall mean [***].

 

Lead Time for Product Orders

Unless otherwise agreed to in writing by Diamond and Elanco on a specific order, the minimum lead time between confirmation of an order by Diamond and the shipping date for such order is [***].

 

Minimum Dating Requirements

Unless otherwise agreed to in writing by Diamond and Elanco on a specific order, the minimum shelf life for Product purchased under this Supplemental Agreement as of the shipping date for such Product shall be [***].

 
 

 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

Standard Serial Sizes

Unless otherwise agreed to in writing by Diamond and Elanco on a specific order, the standard serial size for Product under this Supplemental Agreement is as follows (the "Standard Serial Sizes"):

Product Type Dose Size Minimum Serial Size
Bovine Modified Live Viruses (Titanium) [***] [***]
Bovine Modified Live Viruses (Titanium) [***] [***]
Bovine Modified Live Viruses + Leptospira Pomona [***] [***]
Titanium 3 LP (DAH Item No. [***]) [***] [***]
Modified Live/Killed Virus/Lepto 5 Combination (Masterguard 10) [***] [***]
Modified Live/Killed Virus/Lepto 5 Combination (Masterguard 10) [***] [***]
Modified Live/Killed Virus Combination (Masterguard 5) [***] [***]
Modified Live/Killed Virus/Lepto 5 Combination (Masterguard 5) [***] [***]
Masterguard Preg 5-South Africa (DAH Item No. [***] [***] [***]
Masterguard Preg 5-South Africa (DAH Item No. [***] [***] [***]
Feline Ultranasal FVRC and FVRCP [***] [***]

 

For orders below the Standard Serial Size requested by Elanco, the additional cost per split serial is as follows:

[***]

 

To the extent the serial sizes received by Diamond from [***] do not align with the Standard Serial Sizes set forth above, either (a) Elanco shall permit Diamond's manufacture and delivery of Product in a serial size smaller than the applicable Standard Serial Size, or (b) Elanco shall pay Diamond for (i) Diamond's cost of any such [***] (set forth in footnote (4) to the Pricing Schedule) that remains after manufacturing of a Product that includes such [***] and that can't otherwise be used in the manufacture of other Product that includes such [***] , taking into account dating requirements (the "Unused [***] , and (ii) Diamond's cost of destruction of such Unused [***] .

 

Additional Terms and Conditions

Elanco acknowledges and agrees that Diamond shall not be in breach of this Supplemental Agreement, responsible, or otherwise liable for failure to supply any Product to the extent such

 
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment .

failure is the result of [***] , whether as a result of failure to obtain sufficient quantities thereof, failure of viricidal testing thereof, receipt of [***] with insufficient minimum shelf life, or otherwise. Further, upon failure of viricidal testing of any [***] , Elanco shall reimburse Diamond for Diamond's costs incurred for such testing.

Elanco acknowledges and agrees that any [***] that are not used pursuant to a firm written purchase order for Product within six (6) month from the date Diamond receives such [***] , Diamond shall charge, and Elanco shall pay, a warehousing fee equal to [***] of the invoice amount of such [***] per month (for each full or partial month) that exceeds such six (6) month period. Diamond shall invoice Elanco on the first day of the first month after expiration of such six (6) month period and each monthly anniversary thereafter until used pursuant to a firm written purchase order for Product or otherwise destroyed.

Elanco may request Diamond to destroy [***] which is deemed unacceptable for rework, re-sort, or remanufacture. Diamond agrees to destroy such Product, and provide Elanco with proof of destruction. Upon any destruction of [***] upon Elanco's request or for any reason other than Diamond's Fault, Elanco shall reimburse Diamond for the cost of such [***] upon invoice therefor.

For the avoidance of doubt, Diamond's failure to supply any Product resulting from [***] , whether as a result of failure to obtain sufficient quantities thereof, failure of viricidal testing thereof, receipt of [***] with insufficient minimum shelf life, or otherwise, shall in no way reduce, count toward or otherwise minimize Elanco's minimum purchase requirements set forth in Section A.4 of this Supplemental Agreement.

 
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.  

 

Pricing Schedule

      Pricing at Annual Additional doses (in millions) (3) ;
DAH Item Number  Elanco Material
Number
Elanco Purchase Order Product Name   Country Base Price (1)  5.2 (2)   10.2 (2) 15.0 (2) 20.0 (2)  
[***]   [***]   [***]   [***]   [***]   [***]   [***]   [***]   [***]  

 

 
 

 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

      Pricing at Annual Additional doses (in millions) (3) ;
DAH Item Number  Elanco Material
Number
Elanco Purchase Order Product Name   Country Base Price (1)  5.2 (2)   10.2 (2) 15.0 (2) 20.0 (2)  
 [***]  [***] [***]   [***]   [***]   [***]   [***]   [***]   [***]  

 

 

 
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

(1) Base Price based on [***] doses of Product purchased by Elanco under this Supplemental Agreement per calendar, plus the [***].
(2) The price adjustment trigger for any given calendar year during the term of this Supplemental Agreement is equal to the number set forth in the chart above (in millions), plus [***].
(3) Once the number of doses of Product purchased by Elanco under this Supplemental Agreement [***].
(4) The price associated with DAH Item Numbers [***] include the purchase of [***]. The Parties acknowledge and agree that the amounts set forth below for the [***] included in the Combination Products do not count toward the Actual Annual Purchases required by this Supplemental Agreement. Further, the amounts set forth below are subject to change by Diamond pursuant to Section A.6.1.

 

  PRICING FOR [***]
DAH Number Diamond Purchase Order Product Name

Additional

Price

DAH Item

Number

 
[***] [***] [***] [***]  
[***] [***] [***] [***]  
           

 

 
 

Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act. Omitted information, marked "[***]" in this exhibit, has been filed with the Securities and Exchange Commission together with such request for confidential treatment.

 

(5) The following individual products must only be sold as a combination of the two DAH Item Numbers listed. The prices provided above are only valid in the listed combination and cannot be combined or used in any other way:

[***] [***]

 

(6) The bulk product pricing for DAH Item Numbers [***] are valid only if the labeled Product is shipped in a [***] as defined for each Product. Elanco agrees to obtain prior written approval from DAH for the intended use of each such Product (including the number of doses) prior to the initial bid. Diamond agrees to provide written approval or rejection thereof to Elanco with ten (10) days of receipt of each request. Such Product can only be sold [***].
(7) The products with DAH Item Numbers [***] do not count toward the Minimum Annual Purchases required hereunder.

 

By way of example, during a calendar year of this Supplemental Agreement, if the pro-rated portion of the aggregate doses purchased by a Defined Third Party in the twelve (12) month period immediately preceding the termination of a Segment pursuant to Section 2.3 of the APA after the Effective Date of this Agreement equals [***].

 

 

 

Exhibit 31.1

 

 

CERTIFICATION

 

I, Kevin S. Wilson, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Heska Corporation;
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 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 controls 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; and
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 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.

 

 

Dated: August 7, 2015 /s/ Kevin S. Wilson
  KEVIN S. WILSON
  Chief Executive Officer and President
  (Principal Executive Officer)

 

 

 

 

 

Exhibit 31.2

 

CERTIFICATION

 

I, Jason A. Napolitano, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Heska Corporation;
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 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 controls 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; and
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 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.

 

 

Dated: August 7, 2015 /s/ Jason A. Napolitano
  JASON A. NAPOLITANO
  Executive Vice President and Chief Financial Officer
  (Principal Financial Officer and Principal Accounting Officer)

 

 

 

 

 

 

 

 

Exhibit 32.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER

PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Kevin S. Wilson, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Heska Corporation on Form 10-Q for the quarter ended June 30, 2015 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Form 10-Q fairly presents in all material respects the financial condition and results of operations of Heska Corporation.

 

Dated: August 7, 2015 By: /s/ Kevin S. Wilson
  Name: KEVIN S. WILSON
  Title: Chief Executive Officer and
    President

 

I, Jason A. Napolitano, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Heska Corporation on Form 10-Q for the quarter ended June 30, 2015 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Form 10-Q fairly presents in all material respects the financial condition and results of operations of Heska Corporation.

 

Dated: August 7, 2015 By: /s/ Jason A. Napolitano
  Name: JASON A. NAPOLITANO
  Title: Executive Vice President and
    Chief Financial Officer

 

A signed original of this written statement required by Section 906 has been provided to Heska Corporation and will be retained by Heska Corporation and furnished to the Securities and Exchange Commission or its staff upon request.