UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

[ X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: March 31, 2016

 

[  ] 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: 000-51030

 

TearLab Corporation

(Exact name of registrant as specified in its charter)

 

Delaware   59 343 4771
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)

 

9980 Huennekens Street., Suite 100, San Diego, CA 92121

(Address of principal executive offices)

 

(858) 455-6006

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) 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 registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

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

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):

Yes [  ] No [X]

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 34,214,447 as of May 2, 2016.

 

 

 

 
 

 

PART I. FINANCIAL INFORMATION  
     
Item 1. Financial Statements (Unaudited)  4
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations  20
Item 3. Quantitative and Qualitative Disclosures about Market Risk  27
Item 4. Controls and Procedures  28
     
     
PART II. OTHER INFORMATION  
     
Item 1. Legal Proceedings  28
Item 1A. Risk Factors  29
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds  41
Item 3. Defaults Upon Senior Securities  41
Item 4. Mine Safety Disclosures  41
Item 5. Other Information  41
Item 6. Exhibits  43

 

2  
 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements relating to future events and our future performance within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “pursue,” “potential” and similar expressions intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to future events, future results, and future economic conditions in general and statements about:

 

The adequacy of our funding and our forecast of the period of time through which our financial resources will be adequate to support our operations;
   
Our future strategy, structure, and business prospects;
   
Our ability to obtain additional financing for working capital on acceptable terms and in a timely manner;
   
The planned commercialization of our current product;
   
Our ability to meet the financial covenants under our credit facilities;
   

Our anticipated use of cash, cash needs and ability to raise capital;

   

The size and growth of the existing and potential markets for our product and technology;

   
The effect of our strategy to streamline our organization and lower our costs;
   
The adequacy of current, and the development of new distributor, reseller, and supplier relationships, and our efforts to expand relationships with distributors and resellers in additional countries;
   
Our anticipated expansion of United States and international sales and operations;
   
Our ability to obtain and protect our intellectual property and proprietary rights;
   
The results of our clinical trials;
   
Our plan to continue to develop and execute our conference and podium strategy to ensure visibility and evidence-based positioning of the TearLab® Osmolarity System among eye care professionals;
   
Our ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in medical technology, who are in short supply;
   
Our beliefs about our employee relations; and
   
Our efforts to assist our customers in obtaining their CLIA waiver or providing them with support from certified professionals.

 

These statements involve known and unknown risks, uncertainties and other factors, including the risks described in Part II, Item 1A. of this Quarterly Report on Form 10-Q, which may cause our actual results, performance or achievements to be materially different from any future results, performances, time frames or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. Information regarding market and industry statistics contained in this Quarterly Report on Form 10-Q is included based on information available to us that we believe is accurate. It is generally based on academic and other publications that are not produced for purposes of securities offerings or economic analysis. We have not reviewed or included data from all sources and cannot assure you of the accuracy of the market and industry data we have included.

 

Unless the context indicates or requires otherwise, in this Quarterly Report on Form 10-Q, references to the “Company” shall mean TearLab Corporation or TearLab Corp. and its subsidiaries. References to “$” or “dollars” shall mean U.S. dollars unless otherwise indicated.

 

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TearLab Corporation

 

PART I. FINANCIAL INFORMATION
   
ITEM 1. FINANCIAL STATEMENTS (Unaudited)

 

4  
 

 

TearLab Corporation

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(expressed in thousands of U.S. dollars except number of shares )

( Unaudited )

 

    March 31, 2016     December 31, 2015  
    (Unaudited)        
ASSETS                
Current assets                
Cash   $ 7,200     $ 13,838  
Accounts receivable, net     3,026       3,021  
Inventory     3,642       3,972  
Prepaid expenses and other current assets     1,265       790  
Total current assets     15,133       21,621  
                 
Fixed assets, net     5,220       5,352  
Intangible assets, net     885       1,197  
Other non-current assets     213       181  
Total assets   $ 21,451     $ 28,351  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities                
Accounts payable   $ 3,013     $ 2,292  
Accrued liabilities     3,578       5,047  
Deferred Rent     111       114  
Obligations under warrants     2       29  
Total current liabilities     6,704       7,482  
                 
Long-term debt     25,195       24,859  
                 
Total liabilities     31,899       32,341  
                 
Exchange right     -       250  
Commitments and contingencies (Note 10)                
                 
Stockholders’ deficit                
Capital stock                
Preferred Stock, $0.001 par value, authorized 10,000,000, none outstanding            
Common stock, $0.001 par value, 65,000,000 authorized, 34,214,447 and 33,760,904 issued and outstanding at March 31, 2016 and December 31, 2015, respectively     34       34  
Additional paid-in capital     489,561       488,514  
Accumulated deficit     (500,043 )     (492,788 )
Total stockholders’ deficit     (10,448 )     (4,240 )
Total liabilities and stockholders’ deficit   $ 21,451     $ 28,351  

 

See accompanying notes to interim condensed consolidated financial statements

 

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TearLab Corporation

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(expressed in thousands of U.S. dollars except shares and per share amounts)

(Unaudited)

 

    March 31,  
    2016     2015  
             
Revenue                
Product sales   $ 5,502     $ 4,092  
Reader equipment rentals     1,265       1,316  
Total revenue     6,767       5,408  
Cost of goods sold                
Cost of goods sold (excluding amortization of intangible assets)     2,540       2,387  
Cost of goods sold - reader equipment depreciation     554       392  
Gross profit     3,673       2,629  
Operating expenses                
Sales and marketing     4,636       5,278  
Clinical, regulatory and research & development     1,138       1,404  
General and administrative     3,931       3,637  
Amortization of intangible assets     304       381  
Total operating expenses     10,009       10,700  
Loss from operations     (6,336 )     (8,071 )
Other income (expense)                
Interest income (expense)     (883 )     (155 )
Changes in fair value of warrant obligations     27       113  
Other, net     (62 )     (55 )
Total other income (expense)     (918 )     (97 )
Net loss and comprehensive loss   $ (7,254 )   $ (8,168 )
Weighted average shares outstanding - basic     33,825,669       33,647,720  
Net loss per share – basic   $ (0.21 )   $ (0.24 )
Weighted average shares outstanding - diluted     33,825,669       33,692,507  
Net loss per share – diluted   $ (0.21 )   $ (0.25 )

 

See accompanying notes to interim condensed consolidated financial statements

 

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TearLab Corporation

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(expressed in thousands of U.S. dollars)

(Unaudited)

 

    Three months ended  
    March 31,  
    2016     2015  
             
OPERATING ACTIVITIES                
Net loss for the period   $ (7,254 )   $ (8,168 )
Adjustments to reconcile net loss to cash used in operating activities:                
Stock-based compensation     714       1,061  
Depreciation of fixed assets     620       414  
Amortization of intangible assets     315       389  
Changes in fair value of warrant obligations     (27 )     (113 )
Amortization of deferred financing charges     43       15  
Interest accrued     -       51  
Net change in working capital and non-current asset balances related to operations     (549 )     (683 )
Cash used in operating activities     (6,138 )     (7,034 )
                 
INVESTING ACTIVITIES                
Additions to fixed assets, net of proceeds     (500 )     (581 )
Cash used in investing activities     (500 )     (581 )
                 
FINANCING ACTIVITIES                
Proceeds from the issuance of term loan     -       14,554  
Proceeds from the exercise of options     -       38  
Cash provided by financing activities     -       14,592  
                 
Increase (decrease) in cash and cash equivalents during the period     (6,638 )     6,977  
Cash, beginning of period     13,838       16,338  
Cash, end of period   $ 7,200     $ 23,315  

 

See accompanying notes to interim consolidated financial statements

 

7  
 

 

TearLab Corporation

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(expressed in thousands of U.S. dollars except as otherwise stated)

(Unaudited)

 

1. BASIS OF PRESENTATION

 

Nature of Operations

 

TearLab Corporation (formerly OccuLogix, Inc.) (“TearLab” or the “Company”), a Delaware corporation, is an ophthalmic device company that is commercializing a proprietary in vitro diagnostic tear testing platform, the TearLab® test for dry eye disease, or DED, which enables eye care practitioners to test for highly sensitive and specific biomarkers using nanoliters of tear film at the point-of-care.

 

The accompanying condensed consolidated financial statements include the accounts of the Company, all of its wholly owned subsidiaries, and all of OcuHub, LLC, a majority owned subsidiary. Intercompany accounts and transactions have been eliminated on consolidation.

 

Liquidity and Going Concern

 

The accompanying condensed consolidated financial statements have been prepared on the going concern basis, which assumes that the Company will continue to operate as a going concern and which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. However, the Company has sustained substantial losses of $7,254 for the three months ended March 31, 2016 and $33,229 for the year ended December 31, 2015. The Company’s working capital surplus at March 31, 2016 is $8,429 which represents a $5,710 decrease from its working capital at December 31, 2015. As a result of the Company’s history of losses and financial condition, there is substantial doubt about the ability of the Company to continue as a going concern. On May 9, 2016, the Company issued 23,000,000 shares of stock at $0.75 per share to raise additional funds for general corporate purposes. The Company’s existing cash of $7,200 at March 31, 2016, combined with funds received from the equity raise and anticipated cash flows provided by the sales of its products may not be sufficient to cover its cash requirements through the next twelve months if management is unsuccessful in decreasing the cash consumed by operating activities. Based on the Company’s current rate of cash consumption management estimates cash will go below $5,000 within the next twelve months, violating a debt covenant, and the Company will need additional capital or a waiver to remain compliant. These matters, among others, raise substantial doubt about the Company’s ability to continue as a going concern.

 

A successful transition to attaining profitable operations is dependent upon obtaining sufficient financing to fund the Company’s planned expenses and achieving a level of revenues adequate to support the Company’s cost structure. If events or circumstances occur that impact the Company’s access to funding, it may be required to reduce operating expenses and reduce the planned levels of inventory and capital expenditures which could have an adverse impact on its ability to achieve its intended business objectives. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

2. SIGNIFICANT ACCOUNTING POLICIES

 

The consolidated balance sheet at December 31, 2015 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States (“U.S. GAAP”) for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared using significant accounting policies that are consistent with the policies used in preparing the Company’s audited consolidated financial statements for the year ended December 31, 2015. The audited financial statements for the year ended December 31, 2015, filed with the SEC with our annual report on Form 10-K on March 9, 2016 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. Management believes that all adjustments necessary for the fair presentation of results, consisting of normally recurring items, have been included in the unaudited condensed consolidated financial statements for the interim periods presented.

 

8  
 

 

TearLab Corporation

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. The principal areas of judgment relate to revenue and inventory reserves, allowance for doubtful accounts, impairment of long-lived and intangible assets, and the fair value of stock options and warrants.

 

Revenue recognition

 

Revenue is recognized when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is fixed or determinable; and (iv) collectibility is reasonably assured. The Company’s timing of revenue recognition is impacted by factors such as passage of title, payments and customer acceptance. Amounts received in excess of revenue recognizable are deferred.

 

The Company sells its proprietary TearLab® Osmolarity System and related test cards to external customers, who are primarily eye care professionals, for use in osmolarity testing procedures. Revenue is primarily derived from the sale of disposable test cards. Products are generally shipped from a distribution and warehousing facility located in San Diego, California. The Company’s sales are currently direct to customers in the United States and Canada and to distributors in South America, Europe, Asia and Australia.

 

Purchase commitments for Use Agreements and Flex Agreements are expressed in the agreement for a specified period of time (generally one to three years). The purchase commitment for Masters Agreements is implied for large physician practices with an expectation of purchasing certain levels of test cards. The Company recovers the cost of providing the reader equipment in the amount charged for disposable test cards. These agreements are treated as operating leases as collectability of the minimum lease payments is not reasonably predictable at the outset of the arrangement. Accordingly, revenue is recognized over the defined contract term as disposable test cards are shipped. Revenue under such agreements is allocated between the lease of the reader equipment and the sale of the disposables based upon each component’s relative fair value. When reader equipment is placed with a customer at no separate cost, the Company retains title to the equipment and it remains capitalized on the Company’s Consolidated Balance Sheet as equipment classified within fixed assets, net. The equipment is depreciated on a straight-line basis once shipped to a customer location over its estimated useful life and depreciation expense is included in cost of goods sold within the Consolidated Statements of Operations and Comprehensive Loss.

 

Revenue recognition for Purchase Agreements with multiple deliverables is based on the individual units of accounting determined to exist in the contract. A delivered item is considered a separate unit of accounting when the delivered item has value to the customer on a stand-alone basis. Items are considered to have stand-alone value when they are sold separately by any vendor or when the customer could resell the item on a stand-alone basis. Considering that test cards are essential to the operation of a TearLab reader, there is no alternative vendor for the test cards and no indication that a secondary market for the TearLab readers is established, the deliverables under the contracts do not meet criteria for separation under the multiple-element arrangements guidance. Consideration is allocated at the inception of the contract to all deliverables based on their relative selling price, as determined by the selling price of similar individual items on a stand-alone basis. The Company recognizes revenue for each of the elements only when it determines that all applicable recognition criteria have been met.

 

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TearLab Corporation

 

Although the Company typically has a no return policy for its products, the Company has established a reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenues at the time of shipment based on historical experience. The reserve of $16 and $67 as of March 31, 2016 and December 31, 2015, respectively, has reduced revenue and is included in accounts receivable.

 

Warrant liabilities

 

The Company issued several rounds of warrants related to various debt and equity transactions which occurred in 2011. The Company determined that these warrants do not meet the criteria for classification as equity and, accordingly, classified the warrants as current liabilities. The warrant liabilities are subject to remeasurement at each balance sheet date, with any change in fair value recognized as a component of other income (expense), net in the Statements of Operations and Comprehensive Loss. Warrants are also remeasured at fair value immediately prior to being exercised, and the resulting fair value is reclassified into additional paid-in capital, net of any applicable exercise proceeds. The Company estimated the fair value of these warrants at the respective balance sheet dates using the Black-Scholes Merton option-pricing model, based on the estimated market value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrant, risk-free interest rates and expected dividends on and expected volatility of the price of the underlying common stock.

 

Recent accounting pronouncements

 

In March 2016, the Financial Accountings Standards Board (the “FASB”) issued Accounting Standards Update No. 2016-09, Improvement to Employee Share-Based Payment Accounting (“ASU 2016-09”), which involves several aspects of accounting for share-based payment transactions, including income tax consequences, classification of awards as liabilities or equity, and classifications on the statement of cash flows. ASU 2016-09 is effective for fiscal and interim periods beginning after December 15, 2016. The Company is currently evaluating the impact the adoption of the new standard will have on its financial statements.

 

In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 establishes a right-of-use model that requires a lessee to record an asset and liability on the balance sheet for all leases with terms longer than twelve months. ASU 2016-02 is effective for fiscal years and interim periods beginning after December 15, 2018. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact of the new standard on its financial statements.

 

In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. Early application is not permitted. On April 1, 2015, the FASB voted to propose a deferral of the effective date of the standard by one year which would result in the new standard being effective for the Company at the beginning of its first quarter of fiscal year 2018. The Company has not yet completed its assessment of the impact of the new standard, including possible transition alternatives, on the Company’s financial statements.

 

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TearLab Corporation

 

3. BALANCE SHEET DETAILS

 

Accounts receivable

 

    March 31, 2016     December 31, 2015  
             
Trade receivables   $ 3,689     $ 3,610  
                 
Allowance for doubtful accounts     (663 )     (589 )
    $ 3,026     $ 3,021  

 

Inventory

 

Inventory is recorded at the lower of cost or market and consists of finished goods. Inventory is accounted for on a first-in, first-out basis.

 

    March 31, 2016     December 31, 2015  
             
Finished goods   $ 3,673     $ 4,002  
Inventory reserves     (31 )     (30 )
    $ 3,642     $ 3,972  

 

The Company evaluates inventory for estimated excess quantities and obsolescence, based on expected future sales levels and projections of future demand, and establishes inventory reserves for obsolete and excess inventories. In addition, the Company assesses the impact of changing technology and market conditions. The Company has entered into a long term purchase commitment to buy the test cards from MiniFAB (Note 10). The purchase commitment contains required minimum annual purchases and a total purchase commitment under the manufacturing agreement. As part of its analysis of excess or obsolete inventories, the Company considers future annual minimum purchases, estimated future usage and the expiry dating of the cards to determine if any inventory reserve is needed.

 

Prepaid expenses and other current assets

 

    March 31, 2016     December 31, 2015  
Prepaid trade shows   $ 280     $ 246  
Prepaid insurance     347       87  
Manufacturing deposits     337       154  
Subscriptions     104       128  
Other fees and services     174       146  
Other current assets     23       29  
    $ 1,265     $ 790  

 

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TearLab Corporation

 

Fixed assets

 

    March 31, 2016     December 31, 2015  
Capitalized TearLab equipment   $ 8,752     $ 8,349  
Leasehold improvements     61       61  
Computer equipment and software     1,023       1,023  
Furniture and office equipment     281       278  
Medical equipment     500       431  
    $ 10,617     $ 10,142  
Less accumulated depreciation     (5,397 )     (4,790 )
    $ 5,220     $ 5,352  

 

Depreciation expense was $619 and $414 during the three months ended March 31, 2016 and 2015, respectively.

 

Accrued liabilities

 

    March 31, 2016     December 31, 2015  
Due to professionals   $ 560     $ 256  
Due to employes and directors     1,770       2,130  
Sales and use tax liabilities     186       231  
Royalty liability     407       753  
Warranty     126       94  
Other     529       1,583  
    $ 3,578     $ 5,047  

 

4. INTANGIBLE ASSETS

 

The Company’s intangible assets consist primarily of the value of TearLab® Technology acquired in the acquisition of TearLab Research and the value of the OcuHub platform technology acquired in the acquisition of the OcuHub business unit from AOAExcel. The TearLab Technology consists of a disposable lab card and card reader, supported by an array of patents and patent applications that are either held or in-licensed by the Company. The TearLab Technology is being amortized using the straight-line method over an estimated useful life of 10 years. The OcuHub platform technology was fully-impaired as of December 31, 2015, with the impairment charge taken in December 2015. Amortization expense for the three months ended March 31, 2016 and 2015 was $315 and $389, respectively.

 

On April 8, 2016, OcuHub Holdings, Inc., a wholly-owned subsidiary of the Company, completed the sale of 10,167.5 units of OcuHub to an executive of OcuHub and an unrelated third party. After the sale, OcuHub Holdings, Inc. owns 10.5% of OcuHub on a fully-diluted basis. The sale of OcuHub does not represent a significant strategic shift for the Company.

 

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TearLab Corporation

 

Intangible assets subject to amortization consist of the following:

    Remaining               Net Book  
    Useful Life     Gross Value     Accumulated     Value at  
    (Years)     at March 31, 2016     Amortization     March 31, 2016  
                         
TearLab® technology     1     $ 12,172     $ (11,409 )   $ 763  
Patents and trademarks     2       271       (217 )     54  
Prescriber list     2       90       (22 )     68  
Total           $ 12,533     $ (11,648 )   $ 885  

 

              Net Book  
    Gross Value at     Accumulated     Value at  
    December 31, 2015     Amortization     December 31, 2015  
                   
TearLab® technology   $ 12,172     $ (11,106 )   $ 1,066  
Patents and trademarks     268       (216 )     52  
Prescriber list     90       (11 )     79  
Total   $ 12,530     $ (11,333 )   $ 1,197  

 

The estimated amortization expense for the intangible assets for the remainder of 2016 and thereafter is as follows:

 

    Amortization  
    of intangible  
    assets  
       
Remainder of 2016   $ 826  
2017     59  
    $ 885  

 

5. TERM LOAN

 

On March 4, 2015, the Company executed a term loan agreement with CRG LP and certain of its affiliate funds (“CRG”) as lenders providing the Company with access of up to $35,000 under the arrangement. The Company received $15,000 in gross proceeds under the arrangement on March 4, 2015, and an additional $10,000 on October 6, 2015. A third tranche of $10,000 is available to the Company if the Company achieves at least $38,000 in trailing twelve-month revenue prior to June 30, 2016 and satisfies other borrowing conditions. The Term Loan Agreement matures on December 31, 2020 and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. While interest on the loan is accrued at 13% per annum, the Company may elect to make interest-only payments at 8.5% per annum. The unpaid interest of 4.5% is added to the principal of the loan and is subject to additional accrued interest (“PIK interest”). The accrued interest can be deferred and paid together with the principal in the fifth and sixth years.

 

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TearLab Corporation

 

As part of the amended Term Loan Agreement, and funding of the second tranche, CRG received 350,000 warrants dated as of October 6, 2015 to purchase common shares of the Company at a price of $5.00 per share (the “CRG Warrants”). The CRG Warrants have a five-year life. The CRG Warrants are classified as equity on the Consolidated Balance Sheet as of December 31, 2015 and March 31, 2016. The CRG Warrants were valued at their issuance date using the Black-Scholes Merton model. The related reduction of the long-term debt will be amortized over the life of the debt (Note 7).

 

The Company incurred financing and legal fees associated with the debt of $606, which were recorded as a direct discount to the debt and is being amortized using the effective interest method. The Company presents the debt issuance costs related to the recognized debt liability on the Consolidated Balance Sheet as a reduction of the liability.

 

The following is a summary of the Term Loan Agreement as of March 31, 2016 and related maturities of outstanding principle:

 

Prinicple balance outstanding   $ 25,000  
PIK interest     974  
less discount on term loan:        
deferred financing fees, net     (508 )
fair value of detachable warrants, net     (271 )
Total term loan   $ 25,195  

 

Principal due for each of the next 5 years and in the aggregate thereafter:

 

Remaining 2016   $ -  
2017     -  
2018     -  
2019     12,987  
2020     12,987  
Total principal due     25,974  
Less: discount on term loan     (779 )
Total term loan   $ 25,195  

 

The Term Loan Agreement provides for prepayment fees of 5% of the outstanding balance of the loan if the loan is repaid prior to March 31, 2016. The prepayment fee is reduced 1% per year for each subsequent year until maturity.

 

The loan is collateralized by all assets of the Company. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants agreed to by the Company. Among them, the Company must attain minimum certain annual revenue and minimum cash threshold levels. On April 7, 2016, the Company amended the Term Loan Agreement to change the required minimum revenue levels. The amended minimum revenue is $27,000 for 2016, $31,000 for 2017, $36,000 for 2018, $45,000 for 2019 and $55,000 for 2020. The amendment also reduced the exercise price of the CRG Warrants from $5.00 per share to $1.50 per share.

 

If the Company does not have annual revenue greater or equal to the annual revenue covenant in a calendar year, the Company will have the right to cure within 90 days of the end of the respective calendar year by raising subordinated debt or equity equal to twice the difference between the annual revenue and the revenue covenant, with the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement. In the event of a default, the Company may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in the Company’s assets.

 

14  
 

 

TearLab Corporation

 

Borrowings under the term loan are subject to non-occurrence of a material adverse change in our business or operations (financial or otherwise), or a material impairment of the prospect of repayment of obligations.

 

At March 31, 2016, the Company was in compliance with all of the covenants.

 

6. FAIR VALUE MEASUREMENTS

 

The Company measures certain assets and liabilities in accordance with authoritative guidance which requires fair value measurements be classified and disclosed in one of the following three categories:

 

  ●  Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities.
     
    Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.
     
  Level 3: Unobservable inputs are used when little or no market data is available.

 

Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy. The Company did not have any assets or liabilities in Level 1 and Level 2 and no transfers to or from Level 3 of the fair value measurement hierarchy during the three months ended March 31, 2016.

 

At March 31, 2016, the Company had a liability for warrants to purchase 219,604 shares of common stock at an exercise price of $1.86 per share valued at $2 (Note 7). The warrant liability is classified as a Level 3 fair value measurement.

 

The following table provides a reconciliation for the warrant liability measured at fair value using significant unobservable inputs (Level 3) for the three months ended March 31, 2016 (in thousands):

 

    Fair Value Measurements  
    Using Significant  
    Unobservable Inputs (Level 3)  
Balance of warrant liability at January 1, 2016   $ 29  
Warrant exercises     -  
Change in fair value of warrant liability included in other (income) / expense     (27 )
Balance of warrant liability at March 31, 2016   $ 2  

 

15  
 

 

TearLab Corporation

 

7. STOCKHOLDERS’ EQUITY

 

(a) Authorized share capital

 

The total number of authorized shares of common stock of the Company is 65,000,000. Each share of common stock has a par value of $0.001 per share. The total number of authorized shares of preferred stock of the Company is 10,000,000. Each share of preferred stock has a par value of $0.001 per share.

 

(b) Stock Incentive Plan

 

The Company has a stock incentive plan, the 2002 Stock Incentive Plan (the “Stock Incentive Plan”), under which up to 6,200,000 options are available for grant to employees, directors and consultants. Options granted under the Stock Incentive Plan may be either incentive stock options or non-statutory stock options. Under the terms of the Stock Incentive Plan, the exercise price per share for an incentive stock option shall not be less than the fair market value of a share of stock on the effective date of grant and the exercise price per share for non-statutory stock options shall not be less than 85% of the fair market value of a share of stock on the date of grant. No option granted to a holder of more than 10% of the Company’s common stock shall have an exercise price per share less than 110% of the fair market value of a share of stock on the effective date of grant.

 

Options granted are typically service-based options. Generally, options expire 10 years after the date of grant. No incentive stock options granted to a 10% owner optionee shall be exercisable after the expiration of five years after the effective date of grant of such option, no option has been granted to a prospective employee, prospective consultant or prospective director prior to the date on which such person commences service, and with the exception of an option granted to an officer, director or consultant, no incentive option shall become exercisable at a rate less than 20% per annum over a period of five years from the effective date of grant of such option unless otherwise approved by the Board.

 

The Company accounts for stock-based compensation under the authoritative guidance which requires that share-based payment transactions with employees be recognized in the financial statements based on their fair value and recognized as compensation expense over the vesting period. The amount of expense recognized during the period is affected by subjective assumptions, including: estimates of the Company’s future volatility, the expected term for its stock options, option exercise behavior, the number of options expected to ultimately vest, and the timing of vesting for the Company’s share-based awards.

 

The following table sets forth the total stock-based compensation expense resulting from stock options and the employee stock purchase plan included in the Company’s condensed consolidated statements of operations and comprehensive loss (in thousands):

 

    Three months ended  
    March 31,  
    2016     2015  
             
Sales and marketing   $ 136     $ 504  
Clinical, regulatory and research and development     83       99  
General and administrative     495       458  
Stock-based compensation expense before income taxes   $ 714     $ 1,061  

 

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TearLab Corporation

 

(c) Employee Stock Purchase Plan

 

In July 2014, the Company’s Board of Directors adopted the 2014 Employee Stock Purchase Plan (the “ESPP”) which was approved by the Company’s stockholders in June 2014 at the Company’s Annual Meeting of Stockholders. A total of 671,500 shares of the Company’s common stock are reserved for issuance under the plan, which permits eligible employees to purchase common stock at a discount through payroll deductions.

 

The price at which stock is purchased under the ESPP is equal to 90% of the fair market value of the common stock on the first or the last day of the offering period, whichever is lower. Generally, each offering under the ESPP will be for a period of six months as determined by the Company’s Board of Directors. Employees may invest up to 20% of their gross compensation through payroll deductions. In no event may an employee invest more than $25 worth of stock in the plan during each calendar year or more than 5,000 shares per offering period. During the three months ended March 31, 2016 and 2015, the Company recorded $3 and $19 of expense, respectively, under the ESPP. During the three months ended March 31, 2016, the Company issued 67,743 shares of common stock under the ESPP.

 

(d) Warrants

 

On June 13, 2011, the Company issued 1,629,539 shares of its common stock as well as warrants (‘‘Financing Warrants’’) to purchase 109,375 shares of its common stock in consideration of conversion and retirement of the Company’s outstanding July and August 2009 debt obligations. The exercise price of the Financing Warrants is $1.60 per common share representing the price per share equal to the closing bid price per share of the Company’s common stock on the NASDAQ stock market on July 15, 2009. No Financing Warrants were exercised during the three months ended March 31, 2016 or 2015.

 

On June 30, 2011, the Company closed a private placement financing in which 3,846,154 shares of common stock and warrants (‘‘2011 Warrants’’) to purchase 3,846,154 shares of common stock for gross proceeds of approximately $7,000. The exercise price of the warrants is $1.86 per share. The warrants are exercisable until June 30, 2016. The Company estimated the fair value of the warrants at the date of issuance using the Black-Scholes Merton option pricing model with a 101% volatility, 5.0 years expected life and a risk-free interest rate of 1.76%. The 2011 Warrants are recorded as a liability on the Company’s balance sheet and remeasured each period using the Black-Scholes Merton option-pricing model. There were no exercises of 2011 Warrants during the three months ended March 31, 2016 or 2015. There were 219,604 of the 2011 Warrants outstanding as of March 31, 2016 and December 31, 2015 with a value of $2 and $29, respectively. Changes in the fair value of the 2011 Warrants outstanding were presented as Changes in fair value of warrant obligations in the Consolidated Statements of Operations and Comprehensive Loss.

 

The estimated fair value of the 2011 Warrants at March 31, 2016 was determined using the Black-Scholes option-pricing model with the following assumptions:

 

Volatility     122 %        
Expected life of Warrants     0.25       years  
Risk-free interest rate     0.21 %        
Dividend yield     0 %        

 

In October 2015, as part of the second amendment to the Term Loan Agreement and funding of the $10,000 tranche, CRG received warrants to purchase 350,000 common shares in the Company at a price of $5.00 per share (the “CRG Warrants”). The CRG Warrants are exercisable any time prior to October 6, 2020. The CRG Warrants are classified as equity on the Consolidated Balance Sheets as of December 31, 2015 and March 31, 2016. The CRG Warrants were valued at issuance using the Black-Scholes Merton model assuming volatility of 73%, an expected life of 5.0 years, a risk-free interest rate of 1.71%, and 0% dividend yield. No CRG Warrants were exercised during the three months ended March 31, 2016. On April 8, 2016, the Company amended its Term Loan Agreement. As part of the amendment, the term of the CRG Warrants were changed to allow the holder to purchase 350,000 common shares in the Company at a price of $1.50 per share.

 

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TearLab Corporation

 

(e) Exchange Right

 

In August 2014, the Company sold membership units in OcuHub LLC, a Delaware limited liability company and a wholly owned subsidiary of TearLab Corporation in exchange for 2% ownership of OcuHub LLC. In connection with the sale of the membership units, the new members received an exchange right allowing the units to be exchanged upon written notice and during a specified exchange window for shares in the Company’s common stock. On March 31, 2016, the members exchanged the ownership interest in OcuHub LLC for 385,800 shares of the Company’s common stock.

 

8. NET INCOME ( LOSS) PER SHARE

 

Basic income (loss) per share is calculated by dividing net income (loss) by the weighted average number of common shares and vested restricted stock units outstanding. Diluted income (loss) per share is computed by dividing net income (loss), less any dilutive amounts recorded during the period for the change in fair value of warrant liabilities, by the weighted average number of common shares and vested restricted stock units outstanding and the weighted average number of dilutive common stock equivalents, from stock options, warrants, and non-vested restricted stock units. Common stock equivalents are only included in the diluted earnings per share calculation when their effect is dilutive. Diluted loss per share for the three months ended March 31, 2015 includes the dilutive impact of the gain recorded from the Company’s June 30, 2011 warrants.

 

The following securities were not included in the calculation of diluted earnings per share because their effects were anti-dilutive:

 

    Three Months Ended  
(in thousands of shares)   March 31,  
    2016     2015  
Stock options     6,376       6,400  
Warrants     644       74  
ESPP shares     76       -  
                 
Total     7,096       6,474  

 

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TearLab Corporation

 

9. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

The net change in working capital and non-current asset balances related to operations consists of the following:

 

    Three months ended  
    March 31,  
    2016     2015  
Accounts receivable, net   $ (5 )   $ 160  
Inventory     338       (189 )
Prepaid expenses and other assets     (475 )     (96 )
Other non-current assets     (32 )     (40 )
Accounts payable     721       272  
Accrued liabilities     (1,385 )     (769 )
Deferred interest     292       -  
Deferred rent/revenue     (3 )     (21 )
    $ (549 )   $ (683 )

 

10. COMMITMENTS AND CONTINGENCIES

 

On March 7, 2016, the Company, through its subsidiary, TearLab Research, Inc., entered into a supply and development agreement (“Supply Agreement”) with MiniFAB (Aust) Pty Ltd (“MiniFAB”). The agreement is an exclusive supply agreement through June 2021, which will provide 16% savings on the purchase and delivery of individual osmolarity test cards following a transition period to account for ending inventory at December 31, 2015 and other elements of the prior agreement. The savings consist of lower prices for the purchase of the test cards and for freight costs to ship the cards to the Company’s distribution facility. The lower purchase price will remain in place until the earlier of, the Company reaches an annual volume of 4.5 million test cards or March 31, 2018. The savings from freight costs will remain in place throughout the agreement. The Supply Agreement requires, in any given 6 calendar months, the Company must place aggregate purchase orders equal to at least 50% of the orders forecasted for that 6 month period at its onset. The Supply Agreement can be extended by either party for a term of five years with the option for the Company to buyout the exclusive supply provision during any extended term. This Supply Agreement replaces the July 2011 agreement between MiniFAB and the Company.

 

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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 our condensed consolidated financial statements and related notes, included in Item 1 of this Report. Unless otherwise specified, all dollar amounts are U.S. dollars.

 

Overview

 

We are an in-vitro diagnostic company based in San Diego, California. We have commercialized a proprietary tear testing platform, the TearLab® Osmolarity System that enables eye care practitioners to test for highly sensitive and specific biomarkers using nanoliters of tear film at the point-of-care. Our first product measures tear film osmolarity for the diagnosis of Dry Eye Disease (“DED”). Our results are included in our financial statements, which are included under Item 8 to this Annual Report on Form 10-K.

 

TearLab Research, Inc.

 

TearLab Research, Inc. (“TearLab Research”), our wholly-owned subsidiary, develops technologies to enable eye care practitioners to test a wide range of biomarkers (chemistries, metabolites, genes and proteins) at the point-of-care. Commercializing that tear testing platform is now the focus of our business.

 

Our product, the TearLab® Osmolarity System, enables the rapid measurement of tear osmolarity in the doctor’s office. Osmolarity is a quantitative and highly specific biomarker that has been shown to assist in the diagnosis and disease management of DED. Based on the Beaver Dam Offspring Study (2005-2008), prevalence of DED was 14.5% across an adult population aged 21-84, impacting 17.9% of women and 10.5% of men in the study.The innovation of the TearLab® Osmolarity System is its ability to precisely and rapidly measure osmolarity in nanoliter volumes of tear samples, using a highly efficient and novel tear collection system at the point of care. Historically, eye care researchers have relied on expensive instruments to perform tear biomarker analysis. In addition to their cost, these conventional systems are slow, highly variable in their measurement readings, and not categorized as waived by the United States Food and Drug Administration (the “FDA”), under regulations promulgated under the Clinical Laboratory Improvement Amendments, (“CLIA”).

 

The TearLab® Osmolarity System consists of the following three components: (1) the TearLab disposable, which is a single-use microfluidic microchip; (2) the TearLab Pen, which is a hand-held device that interfaces with the TearLab disposable; and (3) the TearLab Reader, which is a small desktop unit that allows for the docking of the TearLab Pen and provides a quantitative reading for the operator.

 

In October 2008, the TearLab® Osmolarity System received CE mark approval, clearing the way for sales in the European Union and all countries recognizing the CE mark. While our current focus is on developing our business in the United States, we do have agreements with numerous distributors for distribution of the TearLab® Osmolarity System in South America, Europe, Asia and Australia.

 

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RESULTS OF OPERATIONS

 

Revenue, Cost of Sales and Gross Margin

 

(in thousands)   Three Months Ended March 31,        
    2016     2015     Change  
                         
TearLab revenue   $ 6,767     $ 5,408     $ 1,359  
TearLab – cost of sales     3,094       2,779       315  
TearLab gross profit     3,673       2,629       1,044  
Gross profit percentage     54 %     49 %        

 

Revenue

 

TearLab revenue consists of sales of the TearLab® Osmolarity System, which is a hand-held tear film test for the measurement of tear osmolarity, a quantitative and highly specific biomarker that has shown to correlate with dry eye disease (“DED”).

 

The TearLab Osmolarity System consists of the following three components: (1) the TearLab disposable, which is a single-use microfluidic lab test card; (2) the TearLab pen, which is a hand-held device that interfaces with the TearLab disposable; and (3) the TearLab reader, which is a small desktop unit that allows for the docking of the TearLab disposable and the TearLab pen and provides a quantitative reading for the operator.

 

TearLab revenue increased by $1.4 million or 25% for the three months ended March 31, 2016 compared to the three months ended March 31, 2015. The increase is attributable to an increase in test card sales of $1.1 million and an increase of $257,000 in reader sales, when compared to the three months ended March 31, 2015.

 

Cost of Sales

 

TearLab cost of sales includes costs of goods sold, warranty, and royalty costs. Our cost of goods sold consists primarily of costs for the manufacture of the TearLab Osmolarity System, including the costs we incur for the purchase of component parts from our suppliers, applicable freight and shipping costs, fees related to warehousing and logistics inventory management.

 

TearLab costs of sales for the three months ended March 31, 2016 increased $315,000, or 11%, compared to the three months ended March 31, 2015. The increased costs associated with higher sales volumes were offset, in part, by cost savings on our gross margin.

 

Gross Profit

 

TearLab gross profit for the three months ended March 31, 2016 increased by $1.0 million or 40% compared to the three months ended March 31, 2015. The increase is due to a combination of higher sales volume and improved gross margin. The gross margin percentage of revenue for the three months ended March 31, 2016 was 54% as compared to 49% for the three months ended March 31, 2015. Gross margin improvement for the three months ended March 31, 2016 was due primarily to the conversion and addition of our more productive Flex accounts. Also, beginning January 1, 2016, gross margin benefited from a two year moratorium on the 2.3% medical device excise tax on sales in the United States.

 

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Operating Expenses

 

    Three Months Ended        
(in thousands)   March 31,        
    2016     2015     Change  
                   
Sales and marketing   $ 4,636     $ 5,278     $ (642 )
Clinical, regulatory and research and development     1,138       1,404       (266 )
General and administrative     3,931       3,637       294  
Amortization of intangible assets     304       381       (77 )
Operating expenses   $ 10,009     $ 10,700     $ (691 )

 

Sales and Marketing Expense

 

Sales and marketing expenses decreased by $642,000 or 12% in the three months ended March 31, 2016, as compared with the comparable period in fiscal 2015. The reduction in sales and marketing expenses is attributable to cost savings from our February 2016 organizational restructuring and reduced marketing spend in the three months ended March 31, 2016, offset in part by $175,000 of restructuring related expenses.

 

The cornerstone of our sales and marketing strategy to date has been to increase awareness of our products among eye care professionals and, in particular, the key opinion leaders in the eye care professions. We assist key opinion leaders in performing clinical trials to generate increased data to provide an increased understanding in the use of the TearLab Osmolarity System for diagnostic, treatment and monitoring of patients. Presently we are primarily focused on increasing sales in North America and we continue to develop and execute our conference and podium strategy to ensure visibility and evidence-based positioning of the TearLab® Osmolarity System among eye care professionals.

 

Clinical, Regulatory and Research and Development Expenses

 

Total clinical, regulatory and research and development expenses decreased $266,000 or 19% in the three months ended March 31, 2016 as compared with the three months ended March 31, 2015. The expense decrease in comparing the three months ended March 31, 2016 with the corresponding period in the prior year was almost entirely due to a decrease in external product development costs of $242,000 related to the timing of the next generation of diagnostic products.

 

General and Administrative Expenses

 

Total general and administrative expenses increased $294,000 or 8% in the three months ended March 31, 2016 as compared with the three months ended March 31, 2015. The increase when compared to the prior fiscal period was driven by higher legal and other professional services costs associated with our shelf offering withdrawn from the market in February of 2016.

 

22  
 

 

Amortization of Intangible Assets

 

Amortization expense of intangible assets for the three months ended March 31, 2016 was $304,000, as compared to the $381,000 in the prior year fiscal period, with the decrease of $77,000 resulted from the amortization of certain OcuHub related intangibles in the prior year fiscal period. The OcuHub intangibles were fully impaired in the fourth quarter of 2015, so no corresponding amortization expense was incurred in 2016.

 

Other Income (Expense)

 

(in thousands)   Three Months Ended
March 31,
       
    2016     2015     Change  
                   
Interest income (expense)   $ (883 )   $ (155 )   $ (728 )
Changes in fair value of warrant obligations     27       113       (86 )
Other (net )     (62 )     (55 )     (7 )
Other income   $ (918 )   $ (97 )   $ (821 )

 

Interest Income (Expense)

 

Interest expense for the three months ended March 31, 2016 and 2015 was from the interest for the CRG term loan. For the three months ended March 31, 2016, we paid $552,000 of interest and deferred $292,000 into the balance of long-term debt. For the three months ended March 31, 2015, we paid $95,000 and deferred $51,000. Interest expense increased for the three months ended March 31, 2016 on larger average balances of long-term debt outstanding during the period.

 

Changes in Fair Value of Warrants Obligations

 

The Company records outstanding warrants considered liabilities at fair value at the end of each reporting period, resulting in an adjustment to the warrant obligations, with any gain or loss recorded in earnings for the applicable period. The Company recorded income related to a decrease in the fair value of warrant obligations of $27,000 and $113,000 for the three months ended March 31, 2016 and 2015, respectively.

 

Other (net)

 

Other income (loss) for the three months ended March 31, 2016 and 2015 consists primarily of foreign exchange transaction gains and losses, based on fluctuations of the Company’s foreign denominated currencies.

 

Liquidity and Capital Resources

 

(in thousands)   March 31, 2016     December 31, 2015     Change  
Cash and cash equivalents   $ 7,200     $ 13,838     $ (6,638 )
Percentage of total assets     33.6 %     48.8 %        
                         
Working capital   $ 8,429     $ 14,139     $ (5,710 )

 

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Financial Condition

 

On May 9, 2016, the Company issued 23,000,000 shares of stock at $0.75 per share to raise additional funds for general corporate purposes. The Company may be able to raise either additional debt financing or additional equity financing. The CRG Term Loan Agreement provides for an increase in the term loan of up to $10.0 million, provided we achieve trailing twelve-month revenue of at least $38.0 million prior to June 30, 2016. The Company can make no assurances that it will be able to raise the required additional capital, either through debt or equity financing, on acceptable terms or at all. Unless we succeed in decreasing the cash consumed by operating activities , we anticipate that we will be below our required minimum cash balance under our debt agreement within the next twelve months. As a result of the Company’s historical losses and financial condition, there is substantial doubt about the Company’s ability to continue as a going concern.

 

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties. Actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:

 

  whether government and third-party payers agree to reimburse the TearLab ® Osmolarity System;
     
  whether eye care professionals engage in the process of obtaining their CLIA waiver certification;
     
  the costs and timing of building the infrastructure to market and sell the TearLab® Osmolarity System;
     
  the cost and results of continuing development of the TearLab ® Osmolarity System;
     
  the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
     
  the effect of competing technological and market developments; and
     
  Our purchases of test cards are in Australian dollars and fluctuations in the exchange rate between the U.S. dollar and Australian dollar may be material. For example, in 2015 we purchased Australian dollars to pay to our Australian supplier and the exchange rate between the U.S. and Australian dollar fluctuated from $0.82 USD to $0.69 USD per $1.00 AUD.

 

At the present time, our only product is the TearLab Osmolarity System, and although we have received 510(k) approval from the FDA and a CLIA waiver approval from the FDA, at this time we do not know when we can expect to begin to generate significant revenues from the TearLab Osmolarity System in the United States.

 

Further, a successful transition to attaining profitable operations is dependent upon obtaining sufficient financing to fund the Company’s planned expenses and achieving a level of revenue adequate to support the Company’s cost structure. If events or circumstances occur such that we do not meet our plans to fund the business, we may be required to reduce operating expenses and reduce the planned levels of inventory and fixed assets in 2016 which could have an adverse impact on our ability to achieve our intended business objectives.

 

24  
 

 

Indebtedness

 

On March 4, 2015, we executed the Term Loan Agreement with CRG as lenders providing us with access of up to $35.0 million under the Term Loan Agreement. We entered into a second amendment to the Term Loan Agreement with CRG on August 6, 2015. We received $15.0 million in gross proceeds under the Term Loan Agreement on March 4, 2015, and an additional $10.0 million on October 6, 2015. A third tranche of $10.0 million is available to us if we achieve at least $38.0 million in trailing twelve-month revenue prior to June 30, 2016, and satisfy other borrowing conditions. As part of the second amendment to the Term Loan Agreement and funding of the $10.0 million tranche, CRG received warrants to purchase 350,000 common shares in the Company at a price of $5.00 per share. The warrants have a life of five years. The Term Loan Agreement has a term of six years and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. At our option, during the first four years a portion of the interest payments may be deferred and paid together with the principal in the fifth and sixth years.

 

On April 7, 2016, we further amended the Term Loan Agreement (the “Fourth Amendment”). The Fourth Amendment changes the required minimum revenue levels under the Term Loan Agreement to $27.0 million, $31.0 million, $36.0 million, $45.0 million and $55.0 million for the calendar years 2016, 2017, 2018, 2019 and 2020, respectively. In addition, the Fourth Amendment releases the guaranty and other obligations given by OcuHub LLC under the Term Loan Agreement. The Fourth Amendment also reduced the exercise price of the warrants to purchase 350,000 common shares in the Company issued to CRG from $5.00 per share to $1.50 per share.

 

The Term Loan Agreement is collateralized by all our assets. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants. Among them, we must attain minimum certain annual revenue and minimum cash threshold levels. The minimum cash balance required is $5.0 million, subject to certain conditions.

 

If we do not have annual revenue greater or equal to the annual revenue covenant in a calendar year, we will have the right to cure by raising subordinated debt or equity equal to twice the difference between the annual revenue and the revenue covenant, with the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement. In the event we do not achieve the minimum revenue threshold and cannot cure as described above, we may be in default of the Term Loan Agreement. In the event of a default, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

Ongoing Sources and Uses of Cash

 

We anticipate that our cash and cash equivalents and cash generated from increased revenues and the senior term loan agreement will be sufficient to sustain our operations into the second quarter of 2016. We continually evaluate various financing possibilities but we typically expect our primary sources of cash will be related to the collection of accounts receivable and, to a lesser degree, interest income on our cash balances. Our accounts receivable collections will be impacted by our ability to grow our point-of-care revenue.

 

We expect our primary uses of cash will be to fund our operating expenses and pursuing and maintaining our patents and trademarks. In addition, dependent on available funds, we expect to expend cash to improve production capability of the TearLab test, to further improve the performance of the TearLab test, and to pursue additional applications for the lab-on-a-chip technology.

 

Changes in Cash Flows

 

Cash Used in Operating Activities

 

Net cash used to fund our operating activities during the three months ended March 31, 2016 was $6.1 million. Net cash used in operating activities during the three month period was less than our net loss of $7.3 million primarily due to the amortization of intangible assets, depreciation of fixed assets, stock-based compensation and changes in the fair value of warrant obligations. In aggregate, these non-cash items totaled $1.7 million.

 

25  
 

 

The net change in working capital and non-current asset balances related to operations for the three months ended March 31, 2016 and 2015 consists of the following:

 

    Three months ended  
    March 31,  
    2016     2015  
Accounts receivable, net   $ (5 )   $ 160  
Inventory     338       (189 )
Prepaid expenses and other assets     (475 )     (96 )
Other non-current assets     (32 )     (40 )
Accounts payable     721       272  
Accrued liabilities     (1,385 )     (769 )
Deferred interest     292       -  
Deferred rent/revenue     (3 )     (21 )
    $ (549 )   $ (683 )

 

Explanations of the more significant net changes in working capital and non-current asset balances are as follows:

 

  Inventory decreased in the three months ended March 31, 2016 because of a combination of reduced levels of test card inventory on hand and more favorable pricing for the inventory on hand.
     
  Prepaid expenses increased in the three months ended March 31, 2016 due to the timing of some of our second quarter conferences and the annual renewal cycle of our insurance policies.
     
  Accounts payable and accrued liabilities had a net decrease during the three months ended March 31, 2016 because of the timing of invoices received late in the period for professional services rendered. The change included invoices that were unbilled at December 31, 2015 for development associated with the next generation diagnostic products and invoiced during the first quarter of 2016 which resulted in an accounts payable increase and a corresponding decrease in accrued liabilities during the three months ended March 31, 2016.
     
  Deferred interest in the three months ended March 31, 2016 relates to the Company electing the option to defer 4.5 percent of the interest on the Term loan Agreement and pay together with the principal in the fifth and sixth year of the Term Loan Agreement.

 

Cash Used in Investing Activities

 

Net cash used in investing activities for the three months ended March 31, 2016 and 2015 was $500,000 and $581,000, respectively, to acquire fixed assets, primarily TearLab Osmolarity systems.

 

Cash Provided by Financing Activities

 

There was no net cash provided by or used in financing activities during the three months ended March 31, 2016. For the three months ended March 31, 2015, net cash provided by financing activities consisted primarily of proceeds from the term loan.

 

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Off-Balance-Sheet Arrangements

 

As of March 31, 2016, we did not have any material off-balance-sheet arrangements as defined in Item 303(1)(4)(ii) of SEC Regulation S-K.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements which are prepared in accordance with accounting principles that are generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. We continually evaluate our estimates and judgments, the most critical of which are those related to revenue recognition and inventory valuation. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known.

 

There were no significant changes during the three months ended March 31, 2016 to the items that we disclosed as our critical accounting policies and estimates in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. For further clarification with regards to the Company’s specific policies for revenue recognition, see Note 2 of the Notes to the Unaudited Condensed Consolidated Financial Statements for the three months ended March 31, 2016 included in Item 1.

 

Recent Accounting Pronouncements

 

For information on the recent accounting pronouncements impacting our business, see Note 2 of the Notes to the unaudited Condensed Consolidated Financial Statements for the three months ended March 31, 2016 included in Item 1.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Currency Fluctuations and Exchange Risk

 

Our sales are denominated primarily in U.S. dollars with minimal sales in euros and pound sterling. Most of our expenses are denominated in U.S. dollars, however, purchases of test cards are in Australian dollars and a minor portion of our other expenses are in Canadian dollars, Australian dollars and pounds sterling. We cannot predict any future trends in the exchange rate of the Canadian dollar, Australian dollar, euro or pound sterling against the U.S. dollar. Any strengthening of the Canadian dollar, Australian dollar, euro or pound sterling in relation to the U.S. dollar would increase the U.S. dollar cost of our operations, and affect our U.S. dollar measured results of operations. We maintain bank accounts in Canadian dollars, Australian dollars, euros and pounds sterling to meet short term operating requirements. We do not engage in any hedging or other transactions intended to manage these risks. In the future, we may undertake hedging or other similar transactions or invest in market risk sensitive instruments if we determine that is advisable to offset these risks.

 

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Interest Rate Risk

 

Our interest payments to CRG are based on a fixed contractual interest rate of 13%. A decrease in market interest rates would increase the fair value of our long-term debt.

 

ITEM 4. CONTROLS AND PROCEDURES.

 

(a) Disclosure Controls and Procedures.

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to the our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be considered relative to their costs. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)). Based on that evaluation, our chief executive officer and chief financial officer concluded that, as at March 31, 2015 our disclosure controls and procedures were effective at the reasonable assurance level.

 

(b) Changes in Internal Control over Financial Reporting.

 

During the first quarter of 2016, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

We are not aware of any material litigation involving us that is outstanding, threatened or pending.

 

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ITEM 1A. RISK FACTORS.

 

Risks Relating to Our Financial Condition

 

We have limited working capital and a history of losses that raise substantial doubts as to whether we will be able to continue as a going concern.

 

We have prepared our consolidated financial statements on the basis that we would continue as a going concern. However, we have incurred losses in each year since our inception. Our net working capital balance at March 31, 2016 was $8.4 million which represents a $5.7 million decrease in the balance from our working capital of $14.1 million at December 31, 2015. We do not currently have any available borrowing under our term loan or credit facility.

 

Although current levels of cash flows are negative, management believes the Company’s existing cash as of March 31, 2016 will be sufficient to cover its operating and other cash demands through the second quarter of 2016.

 

Our consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary if we were not able to continue as a going concern. If we are unable to generate positive cash flows from operations, we would need to undertake a review of potential business alternatives, which may include, but are not limited to, a merger or sale of the company or ceasing operations and winding down the business.

 

We have incurred losses since inception and anticipate that we will incur continued losses for the foreseeable future.

 

We have incurred losses in each year since our inception. As of March 31, 2016, we had an accumulated deficit of $500.0 million. Our losses have resulted primarily from expenses incurred in research and development of our product candidates from the former retina and glaucoma business divisions. We do not know when or if we will successfully commercialize the TearLab® Osmolarity System in the United States or in international markets. As a result, and because of the numerous risks and uncertainties facing us, it is difficult to provide the extent of any future losses or the time required to achieve profitability, if at all. Any failure to become and remain profitable would require us to undertake a review of the potential business alternatives discussed above.

 

We will need to raise additional capital in the near future. Such capital may not be available to us on reasonable terms, if at all, when or as we require additional funding. If we issue additional shares of our common stock or other securities that may be convertible into, or exercisable or exchangeable for, our common stock, our existing stockholders, would experience further dilution.

 

We expect that we will seek to raise additional capital from time to time in the future. Such financings may involve the issuance of debt, equity and/or securities convertible into or exercisable or exchangeable for our equity securities. These financings may not be available to us on reasonable terms or at all when and as we require funding. Any failure to obtain additional working capital when required would have a material adverse effect on our business and financial condition, our ability to continue as a going concern and would be expected to result in a decline in our stock price. If we consummate such financings, the terms of such financings may adversely affect the interests of our existing stockholders. Any issuances of our common stock, preferred stock, or securities such as warrants or notes that are convertible into, exercisable or exchangeable for, our capital stock, would have a dilutive effect on the voting and economic interest of our existing stockholders.

 

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We may not be able to generate sufficient cash to service our indebtedness, which currently consists of our credit facility with CRG. We may not be able to satisfy our minimum revenue and cash covenants, as required by the CRG term loan. If our annual sales revenue levels do not meet or exceed the levels required by the CRG covenants, we will be required to raise additional equity or subordinated debt, with the proceeds paid to reduce the outstanding principal of the CRG term loan. This financing could dilute existing shareholders and impact the value of their investment.

 

On March 4, 2015, we executed a term loan agreement with CRG as lenders (the “Term Loan Agreement”) providing us with access of up to $35.0 million under the Term Loan Agreement. We entered into an amendment of the Term Loan Agreement with CRG on August 6, 2015. We received $25.0 million in gross proceeds during 2015. A third tranche of $10.0 million is available to us only if we achieve at least $38.0 million in twelve-month sales revenue prior to June 30, 2016, and satisfy other borrowing conditions, and we may not be able to achieve these conditions. We can make no assurance that we will be able to raise either additional debt financing or additional equity capital. There can be no assurances that there will be adequate financing available to us on acceptable terms or at all.

 

Our ability to make scheduled payments or to refinance our debt obligations depends on numerous factors, including the amount of our cash reserves and our actual and projected financial and operating performance. These amounts and our performance are subject to certain financial and business factors, as well as prevailing economic and competitive conditions, some of which may be beyond our control. We cannot assure you that we will maintain a level of cash reserves or cash flows from operating activities sufficient to permit us to pay the principal, premium, if any, and interest on our existing or future indebtedness. If our cash flows and capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital or restructure or refinance our indebtedness. We cannot assure you that we would be able to take any of these actions, or that these actions would permit us to meet our scheduled debt service obligations. In addition, in the event of our breach of the Term Loan Agreement with CRG, we may not be allowed to draw additional amounts under the agreement, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

The CRG loan is collateralized by all our assets. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants agreed to by the Company. Among them, we must attain minimum annual revenue and minimum cash threshold levels. The minimum annual revenue threshold levels required by the Term Loan are $27.0 million, $31.0 million, $36.0 million, $45.0 million and $55.0 million for calendar years 2016, 2017, 2018, 2019 and 2020, respectively. The minimum cash balance required is $5.0 million, subject to certain conditions.

 

If we do not have annual revenue greater or equal to the annual revenue covenant in a calendar year, we will have the right to cure by raising subordinated debt or equity equal to twice the difference between the annual revenue and the revenue covenant, with the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement. We cannot assure you that we will be able to achieve the annual revenue thresholds and the daily cash threshold. We cannot assure you that we would be able to raise the financing described above, if required. In addition, in the event of our breach of the Term Loan Agreement with CRG, we may not be allowed to draw additional amounts under the Term Loan Agreement, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

Borrowings under the Term Loan Agreement are subject to certain conditions, including the non-occurrence of a material adverse change in our business or operations (financial or otherwise), or a material impairment of the prospect of repayment of obligations.

 

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Our existing Term Loan Agreement contains restrictive and financial covenants that may limit our operating flexibility.

 

Our existing Term Loan Agreement with CRG contains certain restrictive covenants that limit our ability to incur additional indebtedness and liens, merge with other companies or consummate certain changes of control, acquire other companies, engage in new lines of business, make certain investments, pay dividends, transfer or dispose of assets, amend certain material agreements or enter into various specified transactions. We therefore may not be able to engage in any of the foregoing transactions unless we obtain the consent of the lender or terminate the Term Loan Agreement. There is no guarantee that we will be able to generate sufficient cash flow or sales to meet the financial covenants or pay the principal and interest under the agreement. Furthermore, there is no guarantee that future working capital, borrowings or equity financing will be available to repay or refinance the amounts outstanding under the Term Loan Agreement.

 

Our financial results may vary significantly from year-to-year [and quarter-to-quarter] due to a number of factors, which may lead to volatility in the trading price of our common stock.

 

Our annual and quarterly revenue and results of operations have varied in the past and may continue to vary significantly from year-to-year and quarter-to-quarter. The variability in our annual and quarterly results of operations may lead to volatility in our stock price as research analysts and investors respond to these annual fluctuations. These fluctuations are due to numerous factors that are difficult to forecast, including:

 

  fluctuations in demand for our products;
     
  changes in customer budget cycles and capital spending;
     
  seasonal variations in customer operations that could occur during holiday or summer vacation periods;
     
  tendencies among some customers to defer purchase decisions until the end of the quarter;
     
  the large unit value of our systems;
     
  changes in our pricing and sales policies or the pricing and sales policies of our competitors;
     
  our ability to design, manufacture and deliver products to our customers in a timely and cost effective manner;
     
  quality control or yield problems in our manufacturing operations;
     
  our ability to timely obtain adequate quantities of the components used in our products;
     
  new product introductions or enhancements by us and our competitors;
     
  unanticipated increases in costs or expenses;
     
  our complex, variable and, at times, lengthy sales cycle;
     
  global economic conditions; and
     
  fluctuations in foreign currency exchange rates.

 

In addition, we may experience seasonal variations in our customer operations such as could occur during holiday vacation periods. For example, one of our principal target markets consists of private ophthalmic and optometric practices, and our operating results in the quarter ending September 30 of each fiscal year could be adversely affected by summer vacation periods. The foregoing factors, as well as other factors, could materially and adversely affect our quarterly and annual results of operations. In addition, a significant amount of our operating expenses are relatively fixed due to our manufacturing, research and development, and sales and general administrative efforts. Any failure to adjust spending quickly enough to compensate for a revenue shortfall could magnify the adverse impact of such revenue shortfall on our results of operations. We expect that our sales will continue to fluctuate on a quarterly basis and our financial results for some periods may differ from those projected by securities analysts, which could significantly decrease the price of our common stock.

 

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Risks Related to Our Business

 

Our near-term success is highly dependent on the success of the TearLab® Osmolarity System, and we cannot be certain that it will be successfully commercialized in the United States.

 

The TearLab® Osmolarity System is currently our only product. Our product is currently sold outside of the United States pursuant to CE mark approval; in Canada pursuant to a Health Canada Medical Device License; and in the United States as a result of having received 510(k) approval from the FDA to market the TearLab® Osmolarity System to those reference and physician operated laboratories with CLIA waiver certifications. Even though the TearLab® Osmolarity System has received all regulatory approvals in the United States, it may never be successfully commercialized. If the TearLab® Osmolarity System is not as successfully commercialized as expected, we may not be able to generate revenue, become profitable or continue our operations. Any failure of the TearLab® Osmolarity System to be successfully commercialized in the United States would have a material adverse effect on our business, operating results, financial condition and cash flows and could result in a substantial decline in the price of our common stock.

 

Our near-term success is highly dependent on increasing sales of the TearLab® Osmolarity System outside the United States, and we cannot be certain that we will successfully increase such sales.

 

Our product is currently sold outside of the United States pursuant to CE mark approval and Health Canada Approval in Canada. Our near-term success is highly dependent on increasing our international sales. We may also be required to register our product with health departments in our foreign market countries. A failure to successfully register in such markets would negatively affect our sales in any such markets. In addition, import taxes are levied on our product in certain foreign markets. Other countries may adopt taxation codes on imported products. Increases in such taxes or other restrictions on our product could negatively affect our ability to import, distribute and price our product.

 

We have outstanding liabilities, which could adversely affect our ability to adjust our business to respond to competitive pressures and to obtain sufficient funds to satisfy our future research and development needs, and to defend our intellectual property.

 

As of March 31, 2016, our total liabilities were $31.9 million including $25.2 million of long-term obligations under our Term Loan Agreement. Our significant liability service requirements could adversely affect our ability to operate our business and may limit our ability to take advantage of potential business opportunities. For example, our liabilities present the following risks:

 

  our liabilities increase our vulnerability to economic downturns and adverse competitive and industry conditions and could place us at a competitive disadvantage compared to those of our competitors that are less leveraged;
     
  our liabilities could limit our flexibility in planning for, or reacting to, changes in our business and our industry and could limit our ability to pursue other business opportunities, borrow money for operations or capital in the future and implement our business strategies; and
     
  our liabilities may restrict us from raising additional funds on satisfactory terms to fund working capital, capital expenditures, product development efforts, strategic acquisitions, investments and alliances, and other general corporate requirements.

 

If we are at any time unable to generate sufficient cash flow to service our liabilities when payment is due, we may be required to attempt to renegotiate the terms of the instruments relating to the liabilities, seek to refinance all or a portion of the liabilities or obtain financing. There can be no assurance that we will be able to successfully renegotiate such terms, that any such refinancing would be possible or that any additional financing could be obtained on terms that are favorable or acceptable to us.

 

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We may not be able to raise the capital necessary to fund our operations.

 

Since inception, we have funded our operations through debt and equity financings, including the exercise of warrants and options in 2013, the underwritten public offering in July 2013, as well as the Term Loan Agreement in March 2015. However, our prospects for obtaining additional financing are uncertain. Additional capital may not be available on terms favorable to us, or at all. If financing is available, it may not be sufficient for us to continue as a going concern and it may be on terms that adversely affect the interest of our existing stockholders. In addition, future financings could result in significant dilution of existing stockholders and adversely affect the economic interests of existing stockholders.

 

We will face challenges in bringing the TearLab® Osmolarity System to market in the United States and may not succeed in executing our business plan.

 

There are numerous risks and uncertainties inherent in the development of new medical technologies. In addition to our requirement for additional capital, our ability to bring the TearLab® Osmolarity System to market in the United States and to execute our business plan successfully is subject to the following risks, among others:

 

  Our clinical trials may not succeed. Clinical testing is expensive and can take longer than originally anticipated. The outcomes of clinical trials are uncertain, and failure can occur at any stage of the testing. We could encounter unexpected problems, which could result in a delay in efforts to complete clinical trials supporting our commercialization efforts.
     
  The TearLab® Osmolarity System is rated under a CLIA waiver certification which requires our customers to be certified under the CLIA waiver requirements to be reimbursed under Medicare, including certain parallel state requirements. If our customers are unwilling or unable to comply with such requirements, it could have an adverse effect on their acceptance of and on our ability to market the TearLab® Osmolarity System in the United States.
     
  Our suppliers and we will be subject to numerous FDA requirements covering the design, testing, manufacturing, quality control, labeling, advertising, promotion and export of the TearLab® Osmolarity System and other matters. If our suppliers or we fail to comply with these regulatory requirements, the TearLab® Osmolarity System could be subject to restrictions or withdrawals from the market and we could become subject to penalties.
     
  Even though we successfully obtained the sought-after FDA approvals, we may be unable to commercialize the TearLab® Osmolarity System successfully in the United States. Successful commercialization will depend on a number of factors, including, among other things, achieving widespread acceptance of the TearLab® Osmolarity System among physicians, establishing adequate sales and marketing capabilities, addressing competition effectively, the ability to obtain and enforce patents to protect proprietary rights from use by would-be competitors, key personnel retention and ensuring sufficient manufacturing capacity and inventory to support commercialization plans.

 

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Our business is subject to health care industry cost-containment measures that could result in reduced sales of our TearLab® Osmolarity System.

 

Most of our customers rely on third-party payers, including government programs and private health insurance plans, to reimburse some or all of the cost of the procedures which use our TearLab® Osmolarity System. The continuing efforts of governmental authorities, insurance companies, and other health care payers to contain or reduce these costs could lead to patients being unable to obtain approval for payment from these third-party payers. If patients cannot obtain third-party payer payment approval, the use of our TearLab® Osmolarity System may decline significantly and our customers may reduce or eliminate the use of our system. The cost-containment measures that health care providers are instituting, both in the U.S. and internationally, could harm our ability to operate profitably. For example, managed care organizations have successfully negotiated volume discounts for pharmaceuticals. While this type of discount pricing does not currently exist for the medical systems we supply, if managed care or other organizations were able to affect discount pricing for such systems, it could result in lower prices to our customers from their customers and, in turn, reduce the amounts we can charge our customers for our products.

 

If we are subject to regulatory enforcement action as a result of our failure to comply with regulatory requirements, our commercial operations would be harmed.

 

While we received the 510(k) clearance and CLIA waiver that we were seeking, we will be subject to significant ongoing regulatory requirements, and if we fail to comply with these requirements, we could be subject to enforcement action by the FDA or state agencies, including:

 

  adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties;
     
  repair, replacement, refunds, recall or seizure of our product;
     `
  operating restrictions or partial suspension or total shutdown of production
     
  delay or refusal of our requests for 510(k) clearance or premarket approval of new products or of new intended uses or modifications to our existing product;
     
  refusal to grant export approval for our products;
     
  withdrawing 510(k) clearances or premarket approvals that have already been granted; and
     
  criminal prosecution.

 

If the government initiated any of these enforcement actions, our business could be harmed.

 

We are required to demonstrate and maintain compliance with the FDA’s Quality System Regulation, or the QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of our products. The FDA must determine that the facilities which manufacture and assemble our products that are intended for sale in the United States, as well as the manufacturing controls and specifications for these products, are compliant with applicable regulatory requirements, including the QSR. The FDA enforces the QSR through periodic unannounced inspections. The FDA has not yet inspected our facilities, and we cannot assure you that we will pass any future FDA inspection. Our failure, or the failure of our suppliers, to take satisfactory corrective action in response to an adverse QSR inspection could result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations, a recall of our product, civil or criminal penalties or other sanctions, which would significantly harm our available inventory and sales and cause our business to suffer.

 

If we are unable to fully comply with federal and state “fraud and abuse laws,” we could face substantial penalties, which may adversely affect our business, financial condition and results of operations.

 

We are subject to various laws pertaining to health care fraud and abuse, including the U.S. Anti- Kickback Statute, physician self-referral laws (the “Stark Law”), the U.S. False Claims Act, the U.S. False Statements Statute, the Physician Payment Sunshine Act, and state law equivalents to these U.S. federal laws, which may not be limited to government-reimbursed items and may not contain identical exceptions. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal and state health care programs, including Medicare and Medicaid, and the curtailment or restructuring of operations. Any action against us for violation of these laws could have a significant impact on our business. In addition, we are subject to the U.S. Foreign Corrupt Practices Act. Any action against us for violation by us or our agents or distributors of this act could have a significant impact on our business.

 

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If we fail to comply with contractual obligations and applicable laws and regulations governing the handling of patient identifiable medical information, we could suffer material losses or be adversely affected by exposure to material penalties and liabilities.

 

Many, if not all of our customers, are covered entities under the Health Insurance Portability and Accountability Act of August 1996 or HIPAA. As part of the operation of our business, we provide reimbursement assistance to certain of our customers and as a result we act in the capacity of a business associate with respect to any patient-identifiable medical information, or PHI, we receive in connection with these services. We and our customers must comply with a variety of requirements related to the handling of patient information, including laws and regulations protecting the privacy, confidentiality and security of PHI. The provisions of HIPAA require our customers to have business associate agreements with us under which we are required to appropriately safeguard the PHI we create or receive on their behalf. Further, we and our customers are required to comply with HIPAA security regulations that require us and them to implement certain administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of electronic PHI, or EPHI. We are required by regulation and contract to protect the security of EPHI that we create, receive, maintain or transmit for our customers consistent with these regulations. To comply with our regulatory and contractual obligations, we may have to reorganize processes and invest in new technologies. We also are required to train personnel regarding HIPAA requirements. If we, or any of our employees or consultants, are unable to maintain the privacy, confidentiality and security of the PHI that is entrusted to us, we and/or our customers could be subject to civil and criminal fines and sanctions and we could be found to have breached our contracts with our customers. Under the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and recent omnibus revisions to the HIPAA regulations, we are directly subject to HIPAA’s criminal and civil penalties for breaches of our privacy and security obligations and are required to comply with security breach notification requirements. The direct applicability of the HIPAA privacy and security provisions and compliance with the notification requirements requires us to incur additional costs and may restrict our business operations.

 

Our patents may not be valid, and we may not obtain and enforce patents to protect our proprietary rights from use by would-be competitors. Companies with other patents could require us to stop using or pay to use required technology.

 

Our owned and licensed patents may not be valid, and we may not obtain and enforce patents to maintain trade secret protection for our technology. The extent to which we are unable to do so could materially harm our business.

 

We have applied for, and intend to continue to apply for, patents relating to the TearLab® Osmolarity System and related technology and processes. Such applications may not result in the issuance of any patents, and any patents now held or that may be issued may not provide adequate protection from competition. Furthermore, it is possible that patents issued or licensed to us may be challenged successfully. In that event, if we have a preferred competitive position because of any such patents, any preferred position would be lost. If we are unable to secure or to continue to maintain a preferred position, the TearLab® Osmolarity System could become subject to competition from the sale of generic products.

 

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Patents issued or licensed to us may be infringed by the products or processes of others. The cost of enforcing patent rights against infringers, if such enforcement is required, could be significant and the time demands could interfere with our normal operations. There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical, biotechnology and medical technology industries. We could become a party to patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved in our favor, could be substantial. Some of our would-be competitors may sustain the costs of such litigation more effectively than we can because of their greater financial resources. Litigation also may absorb significant management time.

 

Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our future scientific and commercial success. Although we attempt, and will continue to attempt, to protect our proprietary information through reliance on trade secret laws and the use of confidentiality agreements with corporate partners, collaborators, employees and consultants and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access to, the same or similar information.

 

Certain of our patent rights are licensed to us by third parties. If we fail to comply with the terms of these license agreements, our rights to those patents may be terminated, and we will be unable to conduct our business.

 

It is possible that a court may find us to be infringing upon validly issued patents of third parties. In that event, in addition to the cost of defending the underlying suit for infringement, we may have to pay license fees and/or damages and may be enjoined from conducting certain activities. Obtaining licenses under third-party patents can be costly, and such licenses may not be available at all.

 

We may face future product liability claims.

 

The testing, manufacturing, marketing and sale of therapeutic and diagnostic products entail significant inherent risks of allegations of product liability. Our past use of the RHEO System and the components of the SOLX Glaucoma System in clinical trials and the commercial sale of those products may have exposed us to potential liability claims. Our use of the TearLab® Osmolarity System and its commercial sale could also expose us to liability claims. All of such claims might be made directly by patients, health care providers or others selling the products. We carry clinical trials and product liability insurance to cover certain claims that could arise, or that could have arisen, during our clinical trials or during the commercial use of our products. We currently maintain clinical trials and product liability insurance with aggregate annual coverage limits of $2.0 million. Such coverage, and any coverage obtained in the future, may be inadequate to protect us in the event of successful product liability claims, and we may not increase the amount of such insurance coverage or even renew it. A successful product liability claim could materially harm our business. In addition, substantial, complex or extended litigation could result in the incurrence of large expenditures and the diversion of significant resources.

 

If we do not introduce new commercially successful products in a timely manner, our products may become obsolete over time, customers may not buy our products and our revenue and profitability may decline.

 

Demand for our products may change in ways we may not anticipate because of:

 

  evolving customer needs;
     
  the introduction of new products and technologies; and
     
  evolving industry standards.

 

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Without the timely introduction of new commercially successful products and enhancements, our products may become obsolete over time, in which case our sales and operating results would suffer. The success of our new product offerings will depend on several factors, including our ability to:

 

  properly identify and anticipate customer needs;
     
  commercialize new products in a cost-effective and timely manner;
     
  manufacture and deliver products in sufficient volumes on time;
     
  obtain and maintain regulatory approval for such new products;
     
  differentiate our offerings from competitors’ offerings;
     
  achieve positive clinical outcomes; and
     
  provide adequate medical and/or consumer education relating to new products.

 

Moreover, innovations generally will require a substantial investment in research and development before we can determine the commercial viability of these innovations and we may not have the financial resources necessary to fund these innovations. In addition, even if we successfully develop enhancements or new generations of our products, these enhancements or new generations of products may not produce revenue in excess of the costs of development and they may be quickly rendered obsolete by changing customer preferences or the introduction by our competitors of products embodying new technologies or features.

 

We rely on a limited number of suppliers of each of the key components of the TearLab® Osmolarity System and are vulnerable to fluctuations in the availability and price of our suppliers products and services.

 

We purchase each of the key components of the TearLab ® Osmolarity System from a limited number of third-party suppliers. Our suppliers may not provide the components or other products needed by us in the quantities requested, in a timely manner or at a price we are willing to pay. In the event we were unable to renew our agreements with our suppliers or they were to become unable or unwilling to continue to provide important components in the required volumes and quality levels or in a timely manner, or if regulations affecting the components were to change, we would be required to identify and obtain acceptable replacement supply sources. We may not be able to obtain alternative suppliers or vendors on a timely basis, or at all, which could disrupt or delay, or halt altogether, our ability to manufacture or deliver the TearLab® Osmolarity System. If any of these events should occur, our business, financial condition, cash flows and results of operations could be materially adversely affected.

 

We face intense competition, and our failure to compete effectively could have a material adverse effect on our results of operations.

 

We face intense competition in the markets for ophthalmic products and these markets are subject to rapid and significant technological change. Although we have no direct competitors, we have numerous potential competitors in the United States and abroad. We face potential competition from industry participants marketing conventional technologies for the measurement of osmolarity and other in-lab testing technologies, and commercially available methods, such as the Schirmer Test and ocular surface staining. Many of our potential competitors have substantially more resources and a greater marketing scale than we do. If we are unable to develop and produce or market our products to effectively compete against our competitors, our operating results will materially suffer.

 

37  
 

 

If we lose key personnel, or we do not attract and retain highly qualified personnel on a cost-effective basis, it would be more difficult for us to manage our existing business operations and to identify and pursue new growth opportunities.

 

Our success depends, in large part, upon our ability to attract and retain highly qualified scientific, clinical, manufacturing and management personnel. In addition, any difficulties in retaining key personnel or managing this growth could disrupt our operations. Future growth will require us to continue to implement and improve our managerial, operational and financial systems, and to continue to recruit, train and retain, additional qualified personnel, which may impose a strain on our administrative and operational infrastructure. The competition for qualified personnel in the medical technology field is intense. We are highly dependent on our continued ability to attract, motivate and retain highly qualified management, clinical and scientific personnel.

 

Due to our limited resources, we may not effectively recruit, train and retain additional qualified personnel. If we do not retain key personnel or manage our growth effectively, we may not implement our business plan effectively.

 

Furthermore, we have not entered into non-competition agreements with our key employees. In addition, we do not maintain “key person” life insurance on any of our officers, employees or consultants. The loss of the services of existing personnel, the failure to recruit additional key scientific, technical and managerial personnel in a timely manner, and the loss of our employees to our competitors would harm our research and development programs and our business.

 

If we fail to establish and maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired, which would adversely affect our consolidated operating results, our ability to operate our business and our stock price.

 

Ensuring that we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently. Failure on our part to maintain effective internal financial and accounting controls would cause our financial reporting to be unreliable, could have a material adverse effect on our business, operating results, financial condition and cash flows, and could cause the trading price of our common stock to fall dramatically.

 

Maintaining proper and effective internal controls will require substantial management time and attention and may result in our incurring substantial incremental expenses, including with respect to increasing the breadth and depth of our finance organization to ensure that we have personnel with the appropriate qualifications and training in certain key accounting roles and adherence to certain control disciplines within the accounting and reporting function. Any failure in internal controls or any errors or delays in our financial reporting would have a material adverse effect on our business and results of operations and could have a substantial adverse impact on the trading price of our common stock.

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our management does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Our management has identified control deficiencies in the past and may identify additional deficiencies in the future.

 

We cannot be certain that the actions we are taking to improve our internal controls over financial reporting will be sufficient or that any changes in processes and procedures can be completed in a timely manner. In future periods, if the process required by Section 404 of the Sarbanes-Oxley Act of 2002 reveals material weaknesses or significant deficiencies, the correction of any such material weaknesses or significant deficiencies could require additional remedial measures which could be costly and time-consuming. In addition, we may be unable to produce accurate financial statements on a timely basis. Any of the foregoing could cause investors to lose confidence in the reliability of our consolidated financial statements, which could cause the market price of our common stock to decline and make it more difficult for us to finance our operations and growth.

 

38  
 

 

Risks Related to Our Common Stock

 

The trading price of our common stock may be volatile.

 

The market prices for, and the trading volumes of, securities of medical device companies, such as ours, have been historically volatile. The market has experienced, from time to time, significant price and volume fluctuations unrelated to the operating performance of particular companies. The market price of our common shares may fluctuate significantly due to a variety of factors, including:

 

  the results of pre-clinical testing and clinical trials by us, our collaborators and/or our competitors;
     
  technological innovations or new diagnostic products;
     
  governmental regulations;
     
  developments in patent or other proprietary rights;
     
  litigation;
     
  public concern regarding the safety of products developed by us or others;
     
  comments by securities analysts;
     
  the issuance of additional shares to obtain financing or for acquisitions;
     
  general market conditions in our industry or in the economy as a whole; and
     
  political instability, natural disasters, war and/or events of terrorism.

 

In addition, the stock market in general has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of individual companies. Broad market and industry factors may seriously affect the market price of our stock, regardless of actual operating performance. In the past, securities class action litigation often follows periods of volatility in the overall market and market price of a particular company’s securities. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.

 

Because we do not expect to pay dividends on our common stock, stockholders will benefit from an investment in our common stock only if it appreciates in value.

 

We have never paid cash dividends on our common stock and have no present intention to pay any dividends in the future. We are not profitable and may not earn sufficient revenue to meet all operating cash needs. As a result, we intend to use all available cash and liquid assets in the development of our business. Any future determination about the payment of dividends will be made at the discretion of our board of directors and will depend upon our earnings, if any, our capital requirements, our operating and financial conditions and on such other factors as our board of directors may deem relevant. As a result, the success of an investment in our common stock will depend upon any future appreciation in its value. There is no guarantee that our common stock will appreciate in value or even maintain the price at which stockholders have purchased their shares.

 

39  
 

 

Warrant holders will not be entitled to any of the rights of common stockholders, but will be subject to all changes made with respect thereto.

 

If you hold warrants, you will not be entitled to any rights with respect to our common stock (including, without limitation, voting rights and rights to receive any dividends or other distributions on our common stock), but you will be subject to all changes affecting our common stock. You will have rights with respect to our common stock only if you receive our common stock upon exercise of the warrants and only as of the date when you become a record owner of the shares of our common stock upon such exercise. For example, if a proposed amendment to our charter or bylaws requires stockholder approval and the record date for determining the stockholders of record entitled to vote on the amendment occurs prior to the date that you are deemed to be the owner of the shares of our common stock due upon exercise of your warrants, you will not be entitled to vote on the amendment; although, you will nevertheless be subject to any changes in the powers, preferences or special rights of our common stock.

 

We can issue shares of preferred stock that may adversely affect the rights of holders of our common stock.

 

Our certificate of incorporation authorizes us to issue up to 10.0 million shares of preferred stock with designations, rights, and preferences determined from time to time by our board of directors. Accordingly, our board of directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, conversion, voting or other rights superior to those of holders of our common stock. For example, an issuance of shares of preferred stock could:

 

  adversely affect the voting power of the holders of our common stock;
     
  make it more difficult for a third party to gain control of us;
     
  discourage bids for our common stock at a premium;
     
  limit or eliminate any payments that the holders of our common stock could expect to receive upon our liquidation; or
     
  otherwise adversely affect the market price or our common stock.

 

Our common stock may be delisted from The NASDAQ Capital Market if we cannot maintain compliance with NASDAQ’s continued listing requirements.

 

In order to maintain our listing on NASDAQ, we are required to maintain a stockholders’ equity and minimum bid price requirement. In particular, we are required to (i) maintain a minimum bid price of $1.00, and we have traded below that threshold since February 2, 2016, and (ii) maintain a minimum stockholders’ equity of $2.5 million or meet alternative market capitalization or income from continuing operations tests. On March 16, 2016, we received notices from NASDAQ stating (i) that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 for 30 consecutive business days; and (ii) that we were not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Rule”) because the Company did not have a minimum stockholders’ equity, as of December 31, 2015, of $2.5 million and the Company also did not meet the alternative market capitalization and income from continuing operations tests. The Notices have no immediate effect on the NASDAQ listing or trading of the Company’s common stock.

 

We have a compliance period for the Minimum Bid Price Rule of 180 calendar days, or until September 12, 2016, in which to regain compliance, pursuant to NASDAQ Marketplace Rule 5810(c)(3)(A). If, at any time before that date the bid price of our common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, NASDAQ will notify us that we have achieved compliance with the Rule. We submitted a plan for compliance with the Stockholders’ Equity Rule on May 2, 2016. If the plan is acceptable, NASDAQ will grant us an extension until August 31, 2016 to evidence compliance. If NASDAQ does not accept our plan, we will have the opportunity to appeal that decision to a NASDAQ Hearings Panel.

 

40  
 

 

If we do not regain compliance with the Minimum Bid Price Rule and the Stockholders’ Equity Rule, then NASDAQ will notify us that our common stock will be delisted from the Nasdaq Capital Market, unless we request a hearing before a Nasdaq Hearings Panel. If we fail to regain compliance with the applicable requirements, our stock may be delisted. Delisting from The NASDAQ Capital Market could make trading our common stock more difficult for investors, potentially leading to declines in our share price and liquidity. Without a NASDAQ Capital Market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our stock, the sale or purchase of our stock would likely be made more difficult and the trading volume and liquidity of our stock could decline. Delisting from The NASDAQ Capital Market could also result in negative publicity and could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our stockholders to sell our common stock in the secondary market. If our common stock is delisted by NASDAQ, our common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock. We cannot assure you that our common stock, if delisted from The NASDAQ Capital Market, will be listed on another national securities exchange or quoted on an over-the counter quotation system.

 

If we are delisted from The NASDAQ Capital Market, your ability to sell your shares of our common stock would also be limited by the penny stock restrictions, which could further limit the marketability of your shares.

 

If our common stock is delisted, it would come within the definition of “penny stock” as defined in the Securities Exchange Act of 1934, or the Exchange Act, and would be covered by Rule 15g-9 of the Exchange Act. That Rule imposes additional sales practice requirements on broker-dealers who sell securities to persons other than established customers and accredited investors. For transactions covered by Rule 15g-9, the broker-dealer must make a special suitability determination for the purchaser and receive the purchaser’s written agreement to the transaction prior to the sale. Consequently, Rule 15g-9, if it were to become applicable, would affect the ability or willingness of broker-dealers to sell our securities, and accordingly would affect the ability of stockholders to sell their securities in the public market. These additional procedures could also limit our ability to raise additional capital in the future.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION.

 

None.

 

41  
 

 

ITEM 6. EXHIBITS (WSGR to update – need to include new MiniFAB agreement and CRG Amendment No. 4)

 

Exhibit Number   Exhibit Description   Incorporated by Reference
         
4.1   Form of warrant issued to certain affiliated funds of CRG LP (formerly known as Capital Royalty) pursuant to the terms of the Term Loan Agreement, dated as of March 4, 2015, as amended by the Omnibus Amendment Agreement, dated as of April 2, 2015, Amendment 2, dated August 6, 2015, Amendment 3, dated December 31, 2015, and Amendment 4, dated April 7, 2016, by and among TearLab Corporation, certain of its subsidiaries from time to time party thereto as guarantors and CRG LP (formerly known as Capital Royalty) and certain of its affiliate funds, as lenders, dated as of April 7, 2016.    
         
10.1#   Manufacturing, Supply and Development Agreement between MiniFAB (Aust) Pty Ltd and TearLab Research, Inc., dated March 7, 2016.    
         
10.2   Amendment to Term Loan Agreement, dated as of March 4, 2015, as amended by the Omnibus Amendment Agreement, dated as of April 2, 2015, Amendment 2, dated August 6, 2015, and Amendment 3, dated December 31, 2015, by and among the Registrant, certain of its subsidiaries from time to time party thereto as guarantors and CRG LP (formerly known as Capital Royalty) and certain of its affiliate funds, as lenders, dated as of April 7, 2016.    
         
31.1   CEO’s Certification required by Rule 13A-14(a) of the Securities Exchange Act of 1934.    
         
31.2   CFO’s Certification required by Rule 13A-14(a) of the Securities Exchange Act of 1934.    
         
32.1+   CEO’s Certification of periodic financial reports pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, U.S.C. Section 1350.    
         
32.2+   CFO’s Certification of periodic financial reports pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, U.S.C. Section 1350.    
         
101.INS*   XBRL Instance    
         
101.SCH*   XBRL Taxonomy Schema    
         
101.CAL*   XBRL Taxonomy Extension Calculation    
         
101.DEF*   XBRL Taxonomy Extension Definition    
         
101.LAB*   XBRL Taxonomy Extension Labels    
         
101.PRE*   XBRL Taxonomy Extension Presentation    

   

# Portions of this exhibit have been omitted pursuant to a request for confidential treatment and the non-public information has been filed separately with the Securities and Exchange Commission.

 

*XBRL information is furnished and not filed or a part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of section.

 

+In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished pursuant to this item will not be deemed “filed” for purposes of Section 18 of the Exchange Act (15 U.S.C. 78r), or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.

 

42  
 

 

SIGNATURE

 

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.

 

    TearLab Corp.
    (Registrant)
     
Date: May 9, 2016 /s/ Joseph Jensen
    Joseph Jensen
    Chief Executive Officer

 

43  
 

  

 

THIS WARRANT AND THE UNDERLYING SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ ACT ”), OR UNDER THE SECURITIES LAWS OF ANY STATE. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE, TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. This warrant must be surrendered to the coMPANY or its transfer agent as a condition precedent to the sale, transfer, pledge or hypothecation of any interest in any of the securities represented hereby.

 

WARRANT TO PURCHASE SHARES OF COMMON STOCK

of

TEARLAB CORPORATION

 

Dated as of April 7, 2016

Void after the date specified in Section 8

 

 

Warrant to Purchase

[  ] Shares of

Common Stock

(subject to adjustment)

 

THIS CERTIFIES THAT, for value received, [  ], or its registered assigns (the “ Holder ”), is entitled, subject to the provisions and upon the terms and conditions set forth herein, to purchase from Tearlab Corporation, a Delaware corporation (the “ Company ”), shares of the Company’s common stock, $0.001 par value per share (the “ Shares ”), in the amounts, at such times and at the price per share set forth in Section 1. The term “ Warrant ” as used herein shall include this Warrant and any warrants delivered in substitution or exchange therefor as provided herein. This Warrant is issued in connection with the transactions described in the Term Loan Agreement, dated as of March 4, 2015, by and between the Company, the Subsidiary Guarantors party thereto, and Capital Royalty Partners II L.P., Capital Royalty Partners II – Parallel Fund “A” L.P. and Parallel Investment Opportunities Partners II L.P., as amended.

 

The following is a statement of the rights of the Holder and the conditions to which this Warrant is subject, and to which Holder, by acceptance of this Warrant, agrees:

 

1. Number and Price of Shares; Exercise Period.

 

(a) Number of Shares. Subject to any previous exercise of the Warrant, the Holder shall have the right to purchase up to [  ] Shares, as may be adjusted pursuant hereto prior to (or in connection with) the expiration of this Warrant as provided in Section 8.

 

(b) Exercise Price. The exercise price per Share shall be equal to $1.50, subject to adjustment pursuant hereto (the “ Exercise Price ”).

 

   
 

 

(c) Exercise Period. This Warrant shall be exercisable, in whole or in part, prior to (or in connection with) the expiration of this Warrant as set forth in Section 8.

 

2. Exercise of the Warrant.

 

(a) Exercise. The purchase rights represented by this Warrant may be exercised at the election of the Holder, in whole or in part, in accordance with Section 1, by:

 

(i) the tender to the Company at its principal office (or such other office or agency as the Company may designate) of a notice of exercise in the form of Exhibit A (the “ Notice of Exercise ”), duly completed and executed by or on behalf of the Holder, together with the surrender of this Warrant; and

 

(ii) the payment to the Company of an amount equal to (x) the Exercise Price multiplied by (y) the number of Shares being purchased, by wire transfer or certified, cashier’s or other check acceptable to the Company and payable to the order of the Company.

 

(b) Net Issue Exercise. In lieu of exercising this Warrant pursuant to Section 2(a)(ii), if the fair market value of one Share is greater than the Exercise Price (at the date of calculation as set forth below), the Holder may elect to receive a number of Shares equal to the value of this Warrant (or of any portion of this Warrant being canceled) by surrender of this Warrant at the principal office of the Company (or such other office or agency as the Company may designate) together with a properly completed and executed Notice of Exercise reflecting such election, in which event the Company shall issue to the Holder that number of Shares computed using the following formula:

 

X = Y (A – B)
    A

 

Where:

 

  X = The number of Shares to be issued to the Holder
       
  Y = The number of Shares purchasable under this Warrant or, if only a portion of the Warrant is being exercised, the portion of the Warrant being canceled (at the date of such calculation)
       
  A = The fair market value of one Share (at the date of such calculation)
       
  B = The Exercise Price (as adjusted to the date of such calculation)

 

For purposes of the calculation above, the fair market value of one Share shall be determined by the Board of Directors of the Company, acting in good faith; provided, however, that where a public market exists for the Company’s common stock at the time of such exercise, the fair market value per Share shall be the average of the closing bid prices of the common stock or the closing price quoted on the national securities exchange on which the common stock is listed as published in the Wall Street Journal , as applicable, for the ten (10) trading day period ending five (5) trading days prior to the date of determination of fair market value.

 

  - 2 -  
 

 

(c) Stock Certificates. The rights under this Warrant shall be deemed to have been exercised and the Shares issuable upon such exercise shall be deemed to have been issued immediately prior to the close of business on the date this Warrant is exercised in accordance with its terms, and the person entitled to receive the Shares issuable upon such exercise shall be treated for all purposes as the holder of record of such Shares as of the close of business on such date. As promptly as reasonably practicable on or after such date, the Company shall issue and deliver to the person or persons entitled to receive the same a certificate or certificates for that number of shares issuable upon such exercise. In the event that the rights under this Warrant are exercised in part and have not expired, the Company shall execute and deliver a new Warrant reflecting the number of Shares that remain subject to this Warrant.

 

(d) No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of the rights under this Warrant. In lieu of such fractional share to which the Holder would otherwise be entitled, the Company shall make a cash payment equal to the Exercise Price multiplied by such fraction.

 

(e) Conditional Exercise. The Holder may exercise this Warrant conditioned upon (and effective immediately prior to) consummation of any transaction that would cause the expiration of this Warrant pursuant to Section 8 by so indicating in the notice of exercise.

 

(f) Reservation of Stock. The Company agrees during the term the rights under this Warrant are exercisable to reserve and keep available from its authorized and unissued shares of common stock of the Company for the purpose of effecting the exercise of this Warrant such number of shares as shall from time to time be sufficient to effect the exercise of the rights under this Warrant; and if at any time the number of authorized but unissued shares of common stock shall not be sufficient for purposes of the exercise of this Warrant in accordance with its terms, without limitation of such other remedies as may be available to the Holder, the Company will use all reasonable efforts to take such corporate action as may be necessary to increase its authorized and unissued shares of common stock of the Company to a number of shares as shall be sufficient for such purposes. The Company represents and warrants that all shares that may be issued upon the exercise of this Warrant will, when issued in accordance with the terms hereof, be validly issued, fully paid and nonassessable.

 

3. Replacement of the Warrant. Subject to the receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and substance to the Company or, in the case of mutilation, on surrender and cancellation of this Warrant, the Company at the expense of the Holder shall execute and deliver, in lieu of this Warrant, a new warrant of like tenor and amount.

 

4. Transfer of the Warrant.

 

(a) Warrant Register. The Company shall maintain a register (the “ Warrant Register ”) containing the name and address of the Holder or Holders. Until this Warrant is transferred on the Warrant Register in accordance herewith, the Company may treat the Holder as shown on the Warrant Register as the absolute owner of this Warrant for all purposes, notwithstanding any notice to the contrary. Any Holder of this Warrant (or of any portion of this Warrant) may change its address as shown on the Warrant Register by written notice to the Company requesting a change.

 

(b) Warrant Agent. The Company may appoint an agent for the purpose of maintaining the Warrant Register referred to in Section 4(a), issuing the Shares or other securities then issuable upon the exercise of the rights under this Warrant, exchanging this Warrant, replacing this Warrant or conducting related activities.

 

  - 3 -  
 

 

(c) Transferability of the Warrant. Subject to the provisions of this Warrant with respect to compliance with the Securities Act of 1933, as amended (the “ Securities Act ”) and limitations on assignments and transfers, including without limitation compliance with the restrictions on transfer set forth in Section 5, title to this Warrant may be transferred by endorsement (by the transferor and the transferee executing the assignment form attached as Exhibit B (the “ Assignment Form ”)) and delivery in the same manner as a negotiable instrument transferable by endorsement and delivery.

 

(d) Exchange of the Warrant upon a Transfer. On surrender of this Warrant (and a properly endorsed Assignment Form) for exchange, subject to the provisions of this Warrant with respect to compliance with the Securities Act and limitations on assignments and transfers, the Company shall issue to or on the order of the Holder a new warrant or warrants of like tenor, in the name of the Holder or as the Holder (on payment by the Holder of any applicable transfer taxes) may direct, for the number of shares issuable upon exercise hereof, and the Company shall register any such transfer upon the Warrant Register. This Warrant (and the securities issuable upon exercise of the rights under this Warrant) must be surrendered to the Company or its warrant or transfer agent, as applicable, as a condition precedent to the sale, pledge, hypothecation or other transfer of any interest in any of the securities represented hereby.

 

(e) Taxes. In no event shall the Company be required to pay any tax which may be payable in respect of any transfer involved in the issue and delivery of any certificate in a name other than that of the Holder, and the Company shall not be required to issue or deliver any such certificate unless and until the person or persons requesting the issue thereof shall have paid to the Company the amount of such tax or shall have established to the satisfaction of the Company that such tax has been paid or is not payable.

 

5. Restrictions on Transfer of the Warrant and Shares; Compliance with Securities Laws. By acceptance of this Warrant, the Holder agrees to comply with the following:

 

(a) Restrictions on Transfers. Subject to Section 5(b), this Warrant may not be transferred or assigned in whole or in part without the Company’s prior written consent (which shall not be unreasonably withheld), and any attempt by Holder to transfer or assign any rights, duties or obligations that arise under this Warrant without such permission shall be void. Any transfer of this Warrant or the Shares (the “ Securities ”) must be in compliance with all applicable federal and state securities laws. The Holder agrees not to make any sale, assignment, transfer, pledge or other disposition of all or any portion of the Securities, or any beneficial interest therein, unless and until the transferee thereof has agreed in writing for the benefit of the Company to take and hold such Securities subject to, and to be bound by, the terms and conditions set forth in this Warrant to the same extent as if the transferee were the original Holder hereunder, and

 

(i) there is then in effect a registration statement under the Securities Act covering such proposed disposition and such disposition is made in accordance with such registration statement, or

 

(ii) (A) such Holder shall have given prior written notice to the Company of such Holder’s intention to make such disposition and shall have furnished the Company with a detailed description of the manner and circumstances of the proposed disposition, (B) the transferee shall have confirmed to the satisfaction of the Company in writing, substantially in the form of Exhibit A-1, that the Securities are being acquired (i) solely for the transferee’s own account and not as a nominee for any other party, (ii) for investment and (iii) not with a view toward distribution or resale, and shall have confirmed such other matters related thereto as may be reasonably requested by the Company, and (C) if requested by the Company, such Holder shall have furnished the Company, at the Holder’s expense, with (i) evidence reasonably satisfactory to the Company that such disposition will not require registration of such Securities under the Securities Act or (ii) a “no action” letter from the Securities and Exchange Commission to the effect that the transfer of such Securities without registration will not result in a recommendation by the staff of the Securities and Exchange Commission that action be taken with respect thereto, whereupon such Holder shall be entitled to transfer such Securities in accordance with the terms of the notice delivered by the Holder to the Company.

 

  - 4 -  
 

 

(b) Permitted Transfers. Permitted transfers with respect to Section 5(a) include (i) a transfer not involving a change in beneficial ownership, or (ii) transactions involving the distribution without consideration of Securities by any Holder to (x) a parent, subsidiary or other affiliate of a Holder that is a corporation, (y) any of the Holder’s partners, members or other equity owners, or retired partners or members, or to the estate of any of its partners, members or other equity owners or retired partners or members, or (z) a venture capital fund that is controlled by or under common control with one or more general partners or managing members of, or shares the same management company with, the Holder; provided , however, that the Holder may not effect a transfer under this Section 5(b) to any entity reasonably determined by the Company to be a competitor of the Company and that, in each case, the Holder shall give written notice to the Company of the Holder’s intention to effect such disposition and shall have furnished the Company with a detailed description of the manner and circumstances of the proposed disposition.

 

(c) Investment Representation Statement. Unless the rights under this Warrant are exercised pursuant to an effective registration statement under the Securities Act that includes the Shares with respect to which the Warrant was exercised, it shall be a condition to any exercise of the rights under this Warrant that the Holder shall have confirmed to the satisfaction of the Company in writing, substantially in the form of Exhibit A-1, that the Shares so purchased are being acquired solely for the Holder’s own account and not as a nominee for any other party, for investment and not with a view toward distribution or resale and that the Holder shall have confirmed such other matters related thereto as may be reasonably requested by the Company.

 

(d) Securities Law Legend. The Securities shall (unless otherwise permitted by the provisions of this Warrant) be stamped or imprinted with a legend substantially similar to the following (in addition to any legend required by state securities laws):

 

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF CERTAIN STATES. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. This certificate must be surrendered to the coMPANY or its transfer agent as a condition precedent to the sale, TRANSFER, pledge OR hypothecation of any interest in any of the securities represented hereby.

 

  - 5 -  
 

 

(e) Instructions Regarding Transfer Restrictions. The Holder consents to the Company making a notation on its records and giving instructions to any transfer agent in order to implement the restrictions on transfer established in this Section 5.

 

(f) Removal of Legend. The legend referring to federal and state securities laws identified in Section 5(d) stamped on a certificate evidencing the Shares and the stock transfer instructions and record notations with respect to such securities shall be removed and the Company shall issue a certificate without such legend to the holder of such securities if (i) such securities are registered under the Securities Act, or (ii) such holder provides the Company with an opinion of counsel reasonably acceptable to the Company to the effect that a sale or transfer of such securities may be made without registration or qualification.

 

(g) Compliance with Securities Laws . The Holder is aware of the restrictions imposed by the United States securities laws on the purchase or sale of securities by any person who has received material, non-public information from the issuer of such securities and on the communication of such information to any other person when it is reasonably foreseeable that such other person is likely to purchase or sell such securities in reliance upon such information.

 

(h) No Transfers to Bad Actors; Notice of Bad Actor Status . The Holder agrees not to sell, assign, transfer, pledge or otherwise dispose of any securities of the Company, or any beneficial interest therein, to any person (other than the Company) unless and until the proposed transferee confirms to the reasonable satisfaction of the Company that neither the proposed transferee nor any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members nor any person that would be deemed a beneficial owner of those securities (in accordance with Rule 506(d) of the Securities Act) is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act, except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the transfer, in writing in reasonable detail to the Company. The Holder will promptly notify the Company in writing if the Holder or, to the Holder’s knowledge, any person specified in Rule 506(d)(1) under the Securities Act becomes subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act.

 

6. Adjustments. Subject to the expiration of this Warrant pursuant to Section 8, the number and kind of shares purchasable hereunder and the Exercise Price therefor are subject to adjustment from time to time, as follows:

 

(a) Merger or Reorganization. If at any time there shall be any reorganization, recapitalization, merger or consolidation (a “ Reorganization ”) involving the Company (other than as otherwise provided for herein or as would cause the expiration of this Warrant under Section 8) in which shares of the Company’s stock are converted into or exchanged for securities, cash or other property, then, as a part of such Reorganization, lawful provision shall be made so that the Holder shall thereafter be entitled to receive upon exercise of this Warrant, the kind and amount of securities, cash or other property of the successor corporation resulting from such Reorganization, equivalent in value to that which a holder of the Shares deliverable upon exercise of this Warrant would have been entitled in such Reorganization if the right to purchase the Shares hereunder had been exercised immediately prior to such Reorganization. In any such case, appropriate adjustment (as determined in good faith by the Board of Directors of the successor corporation, subject to the rules of TSX) shall be made in the application of the provisions of this Warrant with respect to the rights and interests of the Holder after such Reorganization to the end that the provisions of this Warrant shall be applicable after the event, as near as reasonably may be, in relation to any shares or other securities deliverable after that event upon the exercise of this Warrant.

 

  - 6 -  
 

 

(b) Reclassification of Shares. If the securities issuable upon exercise of this Warrant are changed into the same or a different number of securities of any other class or classes by reclassification, capital reorganization or otherwise (other than as otherwise provided for herein) (a “ Reclassification ”), then, in any such event, in lieu of the number of Shares which the Holder would otherwise have been entitled to receive, the Holder shall have the right thereafter to exercise this Warrant for a number of shares of such other class or classes of stock that a holder of the number of securities deliverable upon exercise of this Warrant immediately before that change would have been entitled to receive in such Reclassification, all subject to further adjustment as provided herein with respect to such other shares.

 

(c) Subdivisions and Combinations. In the event that the outstanding shares of common stock are subdivided (by stock split, by payment of a stock dividend or otherwise) into a greater number of shares of such securities, the number of Shares issuable upon exercise of the rights under this Warrant immediately prior to such subdivision shall, concurrently with the effectiveness of such subdivision, be proportionately increased, and the Exercise Price shall be proportionately decreased, and in the event that the outstanding shares of common stock are combined (by reclassification or otherwise) into a lesser number of shares of such securities, the number of Shares issuable upon exercise of the rights under this Warrant immediately prior to such combination shall, concurrently with the effectiveness of such combination, be proportionately decreased, and the Exercise Price shall be proportionately increased.

 

(d) Notice of Adjustments. Upon any adjustment in accordance with this Section 6(d), the Company shall give notice thereof to the Holder, which notice shall state the event giving rise to the adjustment, the Exercise Price as adjusted and the number of securities or other property purchasable upon the exercise of the rights under this Warrant, setting forth in reasonable detail the method of calculation of each. The Company shall, upon the written request of any Holder, furnish or cause to be furnished to such Holder a certificate setting forth (i) such adjustments, (ii) the Exercise Price at the time in effect and (iii) the number of securities and the amount, if any, of other property that at the time would be received upon exercise of this Warrant.

 

7. Notification of Certain Events. Prior to the expiration of this Warrant pursuant to Section 8, in the event that the Company shall authorize:

 

(a) the issuance of any dividend or other distribution on the capital stock of the Company (other than (i) dividends or distributions otherwise provided for in Section 6(d), (ii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries upon termination of their employment or services pursuant to agreements providing for the right of said repurchase; (iii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries pursuant to rights of first refusal or first offer contained in agreements providing for such rights; or (iv) repurchases of capital stock of the Company in connection with the settlement of disputes with any stockholder ), whether in cash, property, stock or other securities;

 

(b) the voluntary liquidation, dissolution or winding up of the Company; or

 

(c) any transaction resulting in the expiration of this Warrant pursuant to Section 8(b);

 

the Company shall send to the Holder of this Warrant at least ten (10) calendar days prior written notice of the date on which a record shall be taken for any such dividend or distribution specified in clause (a) or the expected effective date of any such other event specified in clause (b) or (c), as applicable. The notice provisions set forth in this section may be shortened or waived prospectively or retrospectively by the consent of the Holder of this Warrant.

 

  - 7 -  
 

 

8. Expiration of the Warrant. This Warrant shall expire and shall no longer be exercisable as of the earlier of:

 

(a) 5:00 p.m., Pacific time, on April 7, 2021; or

 

(b) (i) the acquisition of the Company by another entity by means of any transaction or series of related transactions to which the Company is a party (including, without limitation, any stock acquisition, reorganization, merger or consolidation, but excluding any sale of stock for capital raising purposes and any transaction effected primarily for purposes of changing the Company’s jurisdiction of incorporation) other than a transaction or series of related transactions in which the holders of the voting securities of the Company outstanding immediately prior to such transaction or series of related transactions retain, immediately after such transaction or series of transactions, as a result of shares in the Company held by such holders prior to such transaction or series of transactions, at least a majority of the total voting power represented by the outstanding voting securities of the Company or such other surviving or resulting entity (or if the Company or such other surviving or resulting entity is a wholly-owned subsidiary immediately following such acquisition, its parent), or (ii) a sale, lease or other disposition of all or substantially all of the assets of the Company and its subsidiaries taken as a whole by means of any transaction or series of related transactions, except where such sale, lease or other disposition is to a wholly-owned subsidiary of the Company.

 

9. No Rights as a Stockholder. Nothing contained herein shall entitle the Holder to any rights as a stockholder of the Company or to be deemed the holder of any securities that may at any time be issuable on the exercise of the rights hereunder for any purpose nor shall anything contained herein be construed to confer upon the Holder, as such, any right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof, or to give or withhold consent to any corporate action (whether upon any recapitalization, issuance of stock, reclassification of stock, change of par value or change of stock to no par value, consolidation, merger, conveyance or otherwise) or to receive notice of meetings, or to receive dividends or subscription rights or any other rights of a stockholder of the Company until the rights under the Warrant shall have been exercised and the Shares purchasable upon exercise of the rights hereunder shall have become deliverable as provided herein.

 

10. Representations and Warranties of the Holder. By acceptance of this Warrant, the Holder represents and warrants to the Company as follows:

 

(a) No Registration. The Holder understands that the Securities have not been, and will not be, registered under the Securities Act by reason of a specific exemption from the registration provisions of the Securities Act, the availability of which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Holder’s representations as expressed herein or otherwise made pursuant hereto.

 

(b) Investment Intent. The Holder is acquiring the Securities for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, any distribution thereof. The Holder has no present intention of selling, granting any participation in, or otherwise distributing the Securities, nor does it have any contract, undertaking, agreement or arrangement for the same.

 

(c) Investment Experience. The Holder has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company, and has such knowledge and experience in financial or business matters so that it is capable of evaluating the merits and risks of its investment in the Company and protecting its own interests.

 

  - 8 -  
 

 

(d) Speculative Nature of Investment. The Holder understands and acknowledges that its investment in the Company is highly speculative and involves substantial risks. The Holder can bear the economic risk of its investment and is able, without impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.

 

(e) Access to Data. The Holder has had an opportunity to ask questions of officers of the Company, which questions were answered to its satisfaction. The Holder believes that it has received all the information that it considers necessary or appropriate for deciding whether to acquire the Securities. The Holder understands that any such discussions, as well as any information issued by the Company, were intended to describe certain aspects of the Company’s business and prospects, but were not necessarily a thorough or exhaustive description. The Holder acknowledges that any business plans prepared by the Company have been, and continue to be, subject to change and that any projections included in such business plans or otherwise are necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying the projections will not materialize or will vary significantly from actual results.

 

(f) Accredited Investor. The Holder is an “accredited investor” within the meaning of Regulation D, Rule 501(a), promulgated by the Securities and Exchange Commission and agrees to submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Holder has furnished or made available any and all information requested by the Company or otherwise necessary to satisfy any applicable verification requirements as to “accredited investor” status. Any such information is true, correct, timely and complete.

 

(g) Residency. The residency of the Holder (or, in the case of a partnership or corporation, such entity’s principal place of business) is correctly set forth on the signature page hereto.

 

(h) Restrictions on Resales. The Holder acknowledges that the Securities must be held indefinitely unless subsequently registered under the Securities Act or an exemption from such registration is available. The Holder is aware of the provisions of Rule 144 promulgated under the Securities Act, which permit resale of shares purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the availability of certain current public information about the Company; the resale occurring not less than a specified period after a party has purchased and paid for the security to be sold; the number of shares being sold during any three-month period not exceeding specified limitations; the sale being effected through a “broker’s transaction,” a transaction directly with a “market maker” or a “riskless principal transaction” (as those terms are defined in the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder); and the filing of a Form 144 notice, if applicable. The Holder acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time the Holder wishes to sell the Securities and that, in such event, the Holder may be precluded from selling the Securities under Rule 144 even if the other applicable requirements of Rule 144 have been satisfied. The Holder acknowledges that, in the event the applicable requirements of Rule 144 are not met, registration under the Securities Act or an exemption from registration will be required for any disposition of the Securities. The Holder understands that, although Rule 144 is not exclusive, the Securities and Exchange Commission has expressed its opinion that persons proposing to sell restricted securities received in a private offering other than in a registered offering or pursuant to Rule 144 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales and that such persons and the brokers who participate in the transactions do so at their own risk.

 

  - 9 -  
 

 

(i) Brokers and Finders. The Holder has not engaged any brokers, finders or agents in connection with the Securities, and the Company has not incurred nor will incur, directly or indirectly, as a result of any action taken by the Holder, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Securities.

 

(j) Legal Counsel. The Holder has had the opportunity to review this Warrant, the exhibits and schedules attached hereto and the transactions contemplated by this Warrant with its own legal counsel. The Holder is not relying on any statements or representations of the Company or its agents for legal advice with respect to this investment or the transactions contemplated by this Warrant.

 

(k) Tax Advisors. The Holder has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by this Warrant. With respect to such matters, the Holder relies solely on any such advisors and not on any statements or representations of the Company or any of its agents, written or oral. The Holder understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment and the transactions contemplated by this Warrant.

 

(l) Authorization . The Holder has full legal capacity, power and authority to execute and deliver this Warrant and to perform its obligations hereunder. This Warrant constitutes the valid and binding obligations of the Holder, enforceable in accordance with its terms, except as limited by bankruptcy, insolvency or other laws of general application relating to or affecting the enforcement of creditors’ rights generally and general principles of equity.

 

(m) No “Bad Actor” Disqualification. Neither (i) the Holder, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of any of the Company’s voting equity securities (in accordance with Rule 506(d) of the Securities Act) held by the Holder is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act, except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the acceptance of this Warrant, in writing in reasonable detail to the Company.

 

11. Miscellaneous.

 

(a) Amendments. Except as expressly provided herein, neither this Warrant nor any term hereof may be amended, waived, discharged or terminated other than by a written instrument referencing this Warrant and signed by the Company and the Holder of this Warrant.

 

(b) Waivers. No waiver of any single breach or default shall be deemed a waiver of any other breach or default theretofore or thereafter occurring.

 

(c) Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered or certified mail, postage prepaid, sent by facsimile or electronic mail (if to the Holder) or otherwise delivered by hand, messenger or courier service addressed:

 

(i) if to the Holder, to the Holder at the Holder’s address, facsimile number or electronic mail address as shown in the Company’s records, as may be updated in accordance with the provisions hereof, or until any such Holder so furnishes an address, facsimile number or electronic mail address to the Company, then to and at the address, facsimile number or electronic mail address of the last holder of this Warrant for which the Company has contact information in its records; or

 

  - 10 -  
 

 

(ii) if to the Company, to the attention of the Chief Executive Officer or Chief Financial Officer of the Company at the Company’s address as shown on the signature page hereto, or at such other current address as the Company shall have furnished to the Holder.

 

Each such notice or other communication shall for all purposes of this Warrant be treated as effective or having been given (i) if delivered by hand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), or (ii) if sent via mail, at the earlier of its receipt or five days after the same has been deposited in a regularly-maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via facsimile, upon confirmation of facsimile transfer or, if sent via electronic mail, upon confirmation of delivery when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s next business day. In the event of any conflict between the Company’s books and records and this Warrant or any notice delivered hereunder, the Company’s books and records will control absent fraud or error.

 

(d) Governing Law. This Warrant and all actions arising out of or in connection with this Warrant shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to the conflicts of law provisions of the State of Delaware, or of any other state.

 

(e) Jurisdiction and Venue. Each of the Holder and the Company irrevocably consents to the exclusive jurisdiction and venue of any court within San Diego County, State of California, in connection with any matter based upon or arising out of this Warrant or the matters contemplated herein, and agrees that process may be served upon them in any manner authorized by the laws of the State of California for such persons.

 

(f) Titles and Subtitles. The titles and subtitles used in this Warrant are used for convenience only and are not to be considered in construing or interpreting this Warrant. All references in this Warrant to sections, paragraphs and exhibits shall, unless otherwise provided, refer to sections and paragraphs hereof and exhibits attached hereto.

 

(g) Severability. If any provision of this Warrant becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, portions of such provision, or such provision in its entirety, to the extent necessary, shall be severed from this Warrant, and such illegal, unenforceable or void provision shall be replaced with a valid and enforceable provision that will achieve, to the extent possible, the same economic, business and other purposes of the illegal, unenforceable or void provision. The balance of this Warrant shall be enforceable in accordance with its terms.

 

(h) Waiver of Jury Trial. Each of the Holder and the Company waives, to the fullest extent permitted by law, any and all right to trial by jury in any legal proceeding (whether based on contract, tort or otherwise) arising out of or related to this Warrant.

 

(i) California Corporate Securities Law. THE SALE OF THE SECURITIES THAT ARE THE SUBJECT OF THIS WARRANT HAS NOT BEEN QUALIFIED WITH THE COMMISSIONER OF CORPORATIONS OF THE STATE OF CALIFORNIA AND THE ISSUANCE OF SUCH SECURITIES OR THE PAYMENT OR RECEIPT OF ANY PART OF THE CONSIDERATION THEREFOR PRIOR TO SUCH QUALIFICATION IS UNLAWFUL, UNLESS THE SALE OF SECURITIES IS EXEMPT FROM QUALIFICATION BY SECTION 25100, 25102, OR 25105 OF THE CALIFORNIA CORPORATIONS CODE. THE RIGHTS OF ALL PARTIES TO THIS WARRANT ARE EXPRESSLY CONDITIONED UPON THE QUALIFICATION BEING OBTAINED, UNLESS THE SALE IS SO EXEMPT.

 

  - 11 -  
 

 

(j) Saturdays, Sundays and Holidays. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall be a Saturday, Sunday or U.S. federal holiday, then such action may be taken or such right may be exercised on the next succeeding day that is not a Saturday, Sunday or U.S. federal holiday.

 

(k) Rights and Obligations Survive Exercise of the Warrant. Except as otherwise provided herein, the rights and obligations of the Company and the Holder under this Warrant shall survive exercise of this Warrant.

 

(l) Entire Agreement. Except as expressly set forth herein, this Warrant (including the exhibits attached hereto) constitutes the entire agreement and understanding of the Company and the Holder with respect to the subject matter hereof and supersede all prior agreements and understandings relating to the subject matter hereof.

 

( signature page follows )

 

  - 12 -  
 

 

The Company and the Holder sign this Warrant as of the date stated on the first page.

 

  TEARLAB CORPORATION
     
  By:                
  Name:  
  Title:  
     
  Address:  
     
  9980 Huennekens St
  San Diego, CA 92121

 

AGREED AND ACKNOWLEDGED,  
     
By:                         
Name:    
Title:    

 

Address:

 

( Signature page to the Notice of Exercise )

 

   
 

 

EXHIBIT A

 

NOTICE OF EXERCISE

 

TO: TEARLAB CORPORATION (the “ Company ”)
   
Attention: CHIEF EXECUTIVE OFFICER

 

(1) Exercise. The undersigned elects to purchase the following pursuant to the terms of the attached warrant:

 

Number of shares: __________________________________________________________________________

 

Type of security: ___________________________________________________________________________

 

(2) Method of Exercise. The undersigned elects to exercise the attached warrant pursuant to:

 

  [  ] A cash payment, and tenders herewith payment of the purchase price for such shares in full, together with all applicable transfer taxes, if any.
     
  [  ] The net issue exercise provisions of Section 2(b) of the attached warrant.

 

(3) Conditional Exercise. Is this a conditional exercise pursuant to Section 2(e):

 

  [  ] Yes   [  ] No

 

  If “Yes,” indicate the applicable condition:
   
   

 

(4) Stock Certificate. Please issue a certificate or certificates representing the shares in the name of:

 

  [  ] The undersigned  
       
  [  ] Other—Name:  
       
    Address:  
       
       

 

(5) Unexercised Portion of the Warrant. Please issue a new warrant for the unexercised portion of the attached warrant in the name of:

 

  [  ] The undersigned  
       
  [  ] Other—Name:  
       
    Address:  
       
       
       
  [  ] Not applicable  

 

  A -1  
 

 

(6) Tax Advisors. The undersigned has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by this warrant. With respect to such matters, the undersigned relies solely on any such advisors and not on any statements or representations of the Company or any of its agents, written or oral. The undersigned understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment and the transactions contemplated by this warrant.
   
(7) Investment Intent. The undersigned represents and warrants that the aforesaid shares are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that the undersigned has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties of the undersigned set forth in Section 10 of the attached warrant are true and correct as of the date hereof.
   
(8) Investment Representation Statement. The undersigned has executed, and delivers herewith, an Investment Representation Statement in a form substantially similar to the form attached to the warrant as Exhibit A-1.
   
(9) Consent to Receipt of Electronic Notice. Subject to the limitations set forth in Delaware General Corporation Law §232(e), the undersigned consents to the delivery of any notice to stockholders given by the Company under the Delaware General Corporation Law or the Company’s certificate of incorporation or bylaws by (i) facsimile telecommunication to the facsimile number provided below (or to any other facsimile number for the undersigned in the Company’s records), (ii) electronic mail to the electronic mail address provided below (or to any other electronic mail address for the undersigned in the Company’s records), (iii) posting on an electronic network together with separate notice to the undersigned of such specific posting or (iv) any other form of electronic transmission (as defined in the Delaware General Corporation Law) directed to the undersigned. This consent may be revoked by the undersigned by written notice to the Company and may be deemed revoked in the circumstances specified in Delaware General Corporation Law §232.

 

   
  ( Print name of the warrant holder )
   
   
  ( Signature )
   
   
  ( Name and title of signatory, if applicable )
   
   
  ( Date )
   
   
  ( Fax number )
   
   
  ( Email address )

 

(Signature page to the Notice of Exercise)

 

  A-2  
 

 

EXHIBIT A-l

 

INVESTMENT REPRESENTATION STATEMENT

 

INVESTOR:  
   
COMPANY: TEARLAB CORPORATION
   
SECURITIES: THE WARRANT ISSUED ON April 7, 2016 (THE “ WARRANT ”) AND THE SECURITIES ISSUED OR ISSUABLE UPON EXERCISE THEREOF

 

DATE:

 

In connection with the purchase or acquisition of the above-listed Securities, the undersigned Investor represents and warrants to, and agrees with, the Company as follows:

 

1. No Registration. The Investor understands that the Securities have not been, and will not be, registered under the Securities Act of 1933, as amended (the “ Securities Act ”), by reason of a specific exemption from the registration provisions of the Securities Act, the availability of which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Investor’s representations as expressed herein or otherwise made pursuant hereto.

 

2. Investment Intent. The Investor is acquiring the Securities for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, any distribution thereof. The Investor has no present intention of selling, granting any participation in, or otherwise distributing the Securities, nor does it have any contract, undertaking, agreement or arrangement for the same.

 

3. Investment Experience. The Investor has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company, and has such knowledge and experience in financial or business matters so that it is capable of evaluating the merits and risks of its investment in the Company and protecting its own interests.

 

4. Speculative Nature of Investment. The Investor understands and acknowledges that its investment in the Company is highly speculative and involves substantial risks. The Investor can bear the economic risk of its investment and is able, without impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.

 

5. Access to Data. The Investor has had an opportunity to ask questions of officers of the Company, which questions were answered to its satisfaction. The Investor believes that it has received all the information that it considers necessary or appropriate for deciding whether to acquire the Securities. The Investor understands that any such discussions, as well as any information issued by the Company, were intended to describe certain aspects of the Company’s business and prospects, but were not necessarily a thorough or exhaustive description. The Investor acknowledges that any business plans prepared by the Company have been, and continue to be, subject to change and that any projections included in such business plans or otherwise are necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying the projections will not materialize or will vary significantly from actual results.

 

A-1- 1
 

 

6. Accredited Investor. The Investor is an “accredited investor” within the meaning of Regulation D, Rule 501(a), promulgated by the Securities and Exchange Commission and agrees to submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Investor has furnished or made available any and all information requested by the Company or otherwise necessary to satisfy any applicable verification requirements as to “accredited investor” status. Any such information is true, correct, timely and complete.

 

7. Residency. The residency of the Investor (or, in the case of a partnership or corporation, such entity’s principal place of business) is correctly set forth on the signature page hereto.

 

8. Restrictions on Resales. The Investor acknowledges that the Securities must be held indefinitely unless subsequently registered under the Securities Act or an exemption from such registration is available. The Investor is aware of the provisions of Rule 144 promulgated under the Securities Act, which permit resale of shares purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the availability of certain current public information about the Company; the resale occurring not less than a specified period after a party has purchased and paid for the security to be sold; the number of shares being sold during any three-month period not exceeding specified limitations; the sale being effected through a “broker’s transaction,” a transaction directly with a “market maker” or a “riskless principal transaction” (as those terms are defined in the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder); and the filing of a Form 144 notice, if applicable. The Investor acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time the Investor wishes to sell the Securities and that, in such event, the Investor may be precluded from selling the Securities under Rule 144 even if the other applicable requirements of Rule 144 have been satisfied. The Investor understands and acknowledges that, in the event the applicable requirements of Rule 144 are not met, registration under the Securities Act or an exemption from registration will be required for any disposition of the Securities. The Investor understands that, although Rule 144 is not exclusive, the Securities and Exchange Commission has expressed its opinion that persons proposing to sell restricted securities received in a private offering other than in a registered offering or pursuant to Rule 144 will have a substantial burden of proof in establishing that an exemption from registration is available for those offers or sales and that those persons and the brokers who participate in the transactions do so at their own risk.

 

9. Brokers and Finders. The Investor has not engaged any brokers, finders or agents in connection with the Securities, and the Company has not incurred nor will incur, directly or indirectly, as a result of any action taken by the Investor, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Securities.

 

10. Legal Counsel. The Investor has had the opportunity to review the Warrant, the exhibits and schedules attached thereto and the transactions contemplated by the Warrant with its own legal counsel. The Investor is not relying on any statements or representations of the Company or its agents for legal advice with respect to this investment or the transactions contemplated by the Warrant.

 

11. Tax Advisors. The Investor has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by the Warrant. With respect to such matters, the Investor relies solely on such advisors and not on any statements or representations of the Company or any of its agents, written or oral. The Investor understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment or the transactions contemplated by the Warrant.

 

A-1- 2
 

 

12. No “Bad Actor” Disqualification. Neither (i) the Investor, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of any of the Company’s voting equity securities (in accordance with Rule 506(d) of the Securities Act) held by the Investor is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act, except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the purchase or acquisition of the Securities, in writing in reasonable detail to the Company.

 

( signature page follows )

 

A-1- 3
 

 

The Investor is signing this Investment Representation Statement on the date first written above.

 

  INVESTOR
   
   
  ( Print name of the investor )
   
   
  ( Signature )
   
   
  ( Name and title of signatory, if applicable )
   
   
  ( Street address )
   
   
  ( City, state and ZIP )

 

A-1- 4
 

 

EXHIBIT B

 

ASSIGNMENT FORM

 

ASSIGNOR: _________________________
   
COMPANY: TEARLAB CORPORATION
   
WARRANT: THE WARRANT TO PURCHASE SHARES OF COMMON STOCK ISSUED ON April 7, 2016 (THE “ WARRANT ”)

 

DATE: _________________________

 

(1) Assignment. The undersigned registered holder of the Warrant (“ Assignor ”) assigns and transfers to the assignee named below (“ Assignee ”) all of the rights of Assignor under the Warrant, with respect to the number of shares set forth below:

 

  Name of Assignee:  
     
  Address of Assignee:  
     
     
     
  Number of Shares Assigned:  

 

and does irrevocably constitute and appoint ______________________ as attorney to make such transfer on the books of TearLab Corporation, maintained for the purpose, with full power of substitution in the premises.

 

(2) Obligations of Assignee. Assignee agrees to take and hold the Warrant and any shares of stock to be issued upon exercise of the rights thereunder (the “ Securities ”) subject to, and to be bound by, the terms and conditions set forth in the Warrant to the same extent as if Assignee were the original holder thereof.
   
(3) Investment Intent. Assignee represents and warrants that the Securities are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that Assignee has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties set forth in Section 10 of the Warrant are true and correct as to Assignee as of the date hereof.
   
(4) Investment Representation Statement. Assignee has executed, and delivers herewith, an Investment Representation Statement in a form substantially similar to the form attached to the Warrant as Exhibit A-1.
   
(5) No “Bad Actor” Disqualification. Neither (i) Assignee, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of any of the Company’s securities held or to be held by Assignee is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act of 1933, as amended (the “ Securities Act ”), except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the transfer of the Securities, in writing in reasonable detail to the Company.

 

  - 1 -  
 

 

Assignor and Assignee are signing this Assignment Form on the date first set forth above.

 

ASSIGNOR   ASSIGNEE
     
     
( Print name of Assignor )   ( Print name of Assignee )
     
     
( Signature of Assignor )   ( Signature of Assignee )
     
     
( Print name of signatory, if applicable )   ( Print name of signatory, if applicable )
     
     
( Print title of signatory, if applicable )   ( Print title of signatory, if applicable )
     
Address:   Address:
     
     
     
     

 

  - 2 -  
 

 

 

CONFIDENTIAL TREATMENT REQUESTED

 

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.

 

Dated

 

Manufacturing, Supply and

Development Agreement

 

Parties

 

MiniFAB (Ault) Pty Ltd

ACN 100 768 474

 

TearLab Research, Inc.

 

Contact

 

Bernard O’Shea

Norton Rose Fulbright Australia

Level 15, RACV Tower, 485 Bourke Street, Melbourne, Victoria 3000

Tel: +61 (0)3 8686 6573

www.nortonrosefulbright.com

Our ref: 2626784

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

   
     

 

Contents

 

1. Definitions and interpretation   1
2. Establishment of New Location   8
3. Manufacture of Product   9
4. Forecasting and ordering   11
5. Delivery   15
6. Price   17
7. Disaster Recovery Planning   17
8. Development of New Products   18
9. Intellectual Property   24
10. Obligations of MiniFAB   28
11. Meeting   29
12. Amendments to Specifications   29
13. Registrations, safety and Product liability   31
14. Insurance   32
15. Warranties   32
16. Sub-Contractors   33
17. Term, breach and termination   33
18. Liability and Indemnity   37
19. Confidentiality   39
20. Disputes   41
21. Force Majeure   43
22. Notices   43
23. General   44
Schedule 1 - Pricing Schedule   47
Schedule 2 Base Card   48
Schedule 3 Finished Product   49
Schedule 4 Deed Poll of Accession   50
Annexure A Requirement Definitions of Product   51
Annexure B Specifications for Product   52

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

   
     

 

Agreement dated March 2016

 

Parties MiniFAB (Aust) Pty Ltd ACN 100 768 474
  of 9 The Centreway, Mount Waverley, Victoria 3149,
  Australia
  ( MiniFAB )
   
  TearLab Research, Inc.
  of 9980 Huennekens St, Suite 100, San Diego, CA 92121, U.S.A.
  ( TearLab )

 

Introduction

 

A. MiniFAB and TearLab entered into a manufacturing and development agreement on 19 July 2011 which was subsequently varied by a deed executed in or about May 2013 (the agreement as amended being the Original Agreement ).
   
B. The parties have agreed to replace the Original Agreement with this Agreement to provide for:

 

  (1) the manufacture and supply of certain products, being initially the first product developed under the Original Agreement;
     
  (2) the terms and conditions governing the development of future products or variations to existing products;
     
  (3) the future alteration of the supply arrangements to provide for manufacture and supply of the relevant products through a MiniFAB owned and controlled entity based in the United States; and
     
  (4) the transition period of pricing mechanisms in the old agreement to the new agreement.

 

It is agreed

 

1. Definitions and interpretation
   
1.1 Definitions
   
  In this Agreement:

 

  (1) Affiliate means with respect to any person, any other person controlling, controlled by or under direct or indirect common control with such person. A person will be deemed to control a corporation (or other entity) if such person possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation (or other entity), whether through the ownership of voting securities, by contract or otherwise.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 1 -  
     

 

  (2) Agreement means this document, including any schedule or annexure to it;
     
  (3) Base Card means the Osmolarity Test Card as further described In Schedule 2:
     
  (4) Business Day means a day that is not a Saturday, Sunday or any other day which is a public holiday or a bank holiday in Melbourne, Australia or California, United States;
     
  (5) cGMP means current Good Manufacturing Practices, as established by the FDA;
     
  (6) Commencement Date of Original Agreement means January 1, 2010;
     
  (7) Commercially Reasonable Efforts means the exercise of such efforts and commitment of such resources by MiniFAB as would be expended on, or committed by MiniFAB for, a comparable development or manufacturing program of a similar scope and at a similar stage in development or product lifecycle, comparable profit margin and potential, competitive landscape, and risk profile, in each case with due regard to the nature of efforts and cost required for such development or manufacturing and taking into account payments made by TearLab, or obligated to be made by TearLab, under this Agreement;
     
  (8) Confidential Information of a party means any Information (and all of its tangible and intangible embodiments of any kind whatsoever) provided by that party or its Representatives to the other party or its Representatives whether provided orally or in any form and is marked, identified as or otherwise acknowledged to be confidential at the time of disclosure to the other party; provided, however, that information, data and results generated by MiniFAB under the Original Agreement or the Original Development Agreement, or in the course of performing activities under this Agreement, that relate to TearLab’s technology or to the development of Product or prototypes thereof shall be deemed the Confidential Information of TearLab;
     
  (9) Dedicated Improvements has the meaning given in clause 9.3;
     
  (10) Deed Poll of Accession means a deed in the form of Schedule 4;
     
  (11) Default Rate means [***];
     
  (12) Delivery Point means the TearLab’s nominated warehouse in California, or such other place as may be agreed from time to time;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 2 -  
     

 

  (13) Effective Date means the date of execution of this Agreement by the last party signing it;
     
  (14) End Date means 30 June 2021:
     
  (15) FDA means the United States Food and Drug Administration;
     
  (16) Final Assembly Changeover Date means the operative date specified by MiniFAB under and in accordance with clause 2.2(3);
     
  (17) Force Majeure means any cause which is not within the reasonable control of the party affected by it including, acts of God, war declared or undeclared, civil disturbance, acts or omissions of government or other competent authority, fire, lightning, explosion or flood, but excludes any cause due to lack of demand or market success for the Products;
     
  (18) Governmental Agency means any court, administrative agency or commission or other governmental agency, body or instrumentality, domestic or foreign;
     
  (19) Information means any information or know-how pertaining to, or in the possession or control of, a party including, information concerning its business, systems, technology and affairs, such as:

 

  (a) financial, technological, strategic or business information, concepts, plans, strategies, directions or systems;
     
  (b) research, development, operational, legal, marketing or accounting information, concepts, plans, strategies, directions or systems;
     
  (c) technology, source and object codes for computer software, Intellectual Property rights and technical and historical information relating thereto;
     
  (d) customer and supplier information; and
     
  (e) information relating to the Product.

 

  (20) Insolvency Event in the context of:

 

  (a) MiniFAB means:

 

  (i) a receiver, receiver and manager, official manager, trustee, administrator, other controller (as defined in the Corporations Act 2001 (Cth)) or similar official is appointed, or steps are taken for such appointment, over any of the equipment or undertaking of MiniFAB:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 3 -  
     

 

  (ii) MiniFAB is or becomes unable to pay its debts when they are due or is or becomes unable to pay its debts within the meaning of the Corporations Act 2001 (Cth) or is presumed to be insolvent under the Corporations Act 2001 (Cth);
     
  (iii) MiniFAB ceases to carry on business; or
     
  (iv) an application or order is made for the liquidation of MiniFAB or a resolution is passed or any steps are taken to liquidate or pass a resolution for the liquidation of MiniFAB otherwise than for the purpose of an amalgamation or reconstruction; and

 

  (b) TearLab or NewFAB means:

 

  (i) a receiver, receiver and manager, controller, managing controller, administrator, official manager, trustee or provisional or official liquidator is appointed over the assets or undertaking of TearLab or NewFAB;
     
  (ii) TearLab or NewFAB:

 

  (A)     suspends payments of its debts generally;
   
  (B)     enters into or resolves to enter into any arrangement, composition or compromise with, or assignment for the benefit of, its creditors or any class of them;
   
  (C)     files a petition in Chapter 7 bankruptcy under the U.S. Bankruptcy Code; or
   
  (D)     ceases to carry on business; or

 

  (iii) an order is made or resolution passed for the winding up or dissolution of TearLab or NewFAB other than for the purposes of solvent reconstruction or amalgamation; or
     
  (iv) in the case of TearLab, if TearLab Corporation suffers an ‘Event of Default’ under clause 11.01(1) of the ‘Term Loan Agreement’ (dated March 4, 2015 between TearLab Corporation, as borrower, and Capital Royalty Partners II L.P. and others (CRG), as lenders) and that default is not waived by the lenders.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 4 -  
     

 

  (21) Intellectual Property means any copyright, design (whether registered or unregistered), trademark (whether registered or unregistered), patent or patent application or invention, circuit layout, know-how, confidential information (whether such information is in writing or recorded in any other form) and other proprietary or personal rights arising from intellectual activity in the business, industrial, scientific or artistic fields;
     
  (22) Loss means any loss, damage, cost, interest, expense, fee, penalty, fine, forfeiture, assessment, demand, liability or damages incurred by a person to the extent resulting from any action, suit, claim, proceeding or cause of action brought against such party by a third party.
     
  (23) Manufacture means all the activities required to produce Product which complies with the Specifications including the manufacture, packaging, labelling, storage, handling and shipment of the Product;
     
  (24) MiniFAB Facility means the facility at 1 Dalmore Drive, Caribbean Business Park, Scoresby, Victoria, Australia;
     
  (25) Monthly Manufacturing Limit means initially 417,000 units of Product per month as varied in accordance with clause 4.2;
     
  (26) New Location means the new location for final assembly of the Product to be established in the United States, as advised under clause 2.1;
     
  (27) NewFAB means the new Affiliate of MiniFAB to be established in the United States;
     
  (28) Original Development Agreement means the development agreement for a tear collection interface device comprised of Terms of Business and the Project Proposal for Project Tear-Sense (Stage 0), each dated 17 November 2006 between MiniFAB and TearLab;
     
  (29) Quarter means each period of 3 months beginning 1 January. 1 April, 1 July and 1 October;
     
  (30) Price means the price payable by TearLab to MiniFAB for the supply of the Product, inclusive of all packaging, labelling, freight, insurance and all other shipping and handling charges, as set out in the Pricing Schedule;
     
  (31) Pricing Schedule means the Pricing Schedule set out in Schedule 1;
     
  (32) Product means the Base Card, together with the capsule and applicable packaging, all as further described in Schedule 2 and Schedule 3;
     
  (33) Provider means MiniFAB in respect of the Base Cards and the Supplier in respect of the further steps required to Manufacture Product;
     
  (34) Purchase Order means an order for Product as provided for in clause 4.1(1)(a);

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 5 -  
     

 

  (35) Registrations means all registrations or approvals required from the relevant Regulatory Authority or Authorities for the export, import, storage, promotion, supply, sale or other distribution in the Product;
     
  (36) Regulatory Authority means any Governmental Agency having responsibility for the regulation of, oversight of or whose approval is required for the manufacture, marketing, sale or supply of the Product or the facilities in which they are manufactured, processed or stored;
     
  (37) Regulatory Requirements means, collectively:

 

  (a) all laws and regulations and any and all other requirements of the FDA or any other Regulatory Authority that are mandatory to the manufacture, packaging, labelling, storage, handling and shipment of the Product by MiniFAB or NewFAB and, subject to clause 10.3, includes cGMP; and
     
  (b) all standards set by the International Organization for Standardization (ISO) that are mandatory to the manufacture, packaging, labelling, storage, handling and shipment of the Product by MiniFAB or NewFAB, including ISO 13485:2003 (Medical Devices Quality Management System), ISO 10993-1 (Biocompatibility), ISO 10993-5 (Biocompatibility: Cytotoxicity), and ISO 10993-10 (Biocompatibility: Sensitization and Irritation),
     
    but excludes any law, regulation, requirement or standards that apply to the design, trials, marketing, sales or supply of the Product (and which do not also apply to the manufacture of the Product and/or to MiniFAB or NewFAB’s supply to TearLab hereunder);

 

  (38) Representative of a party means the employees, directors, agents or advisors of that party;
     
  (39) Requirement Definitions or PRD means the written documentation guiding MiniFAB’s development of the Product, including detailed requirement definitions for the Product, as agreed by the parties. The Requirement Definitions may be modified from time to time by mutual agreement of TearLab and MiniFAB in the course of ongoing development work for such Product, and MiniFAB agrees to use Commercially Reasonable Efforts to accommodate changes to the Requirement Definitions as TearLab may from time to time request;
     
  (40) Specifications means, with respect to the Product, the definitive written documentation guiding the manufacture, packaging, labelling, storage and handling of such product, prepared and agreed in accordance with clause 3,1 , and as modified from time to time by mutual agreement of TearLab and MiniFAB in accordance with clause 12;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 6 -  
     

 

  (41) Supplier means MiniFAB prior to the Final Assembly Changeover Date and NewFAB thereafter;
     
  (42) TearLab IP has the meaning given in clause 9.2;
     
  (43) Technical Agreement means the technical agreement entered into between MiniFAB or New FAB and TearLab with respect to the Product, as may be amended or replaced from time to time, which specifies their respective responsibilities for quality control and quality assurance and related activities and qualifications with respect to the Product;
     
  (44) Term means the term of this Agreement, including any extended term under clause 17.1; and
     
  (45) Transition Payments means the payments described as such and set out in the Pricing Schedule.
     
  (46) Volume Threshold means the sales by TearLab of the Product to end user customers exceed 1.075 million units over a period of 3 consecutive 3 month periods, that is months: 1, 2 and 3; 2, 3 and 4: and 3, 4 and 5.

 

1.2 Interpretation

 

  (1) Reference to:

 

  (a) one gender includes the others;
     
  (b) a person includes a body corporate;
     
  (c) a party includes the party’s executors, administrators, successors and permitted assigns;
     
  (d) a statute, regulation, code or other law or a provision of any of them includes:

 

  (i) any amendment or replacement of it; and
     
  (ii) another regulation or other statutory instrument made under it, or made under it as amended or replaced; and

 

  (e) dollars means US dollars unless otherwise stated.

 

  (2) “Including” and similar expressions are not words of limitation.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 7 -  
     

 

  (3) Where a capitalized word or expression is given a particular meaning, other parts of speech and grammatical forms of that capitalized word or expression have a corresponding meaning.
     
  (4) Headings and any table of contents or index are for convenience only and do not form part of this Agreement or affect its interpretation.
     
  (5) A provision of this Agreement must not be construed to the disadvantage of a party merely because that party was responsible for the preparation of the Agreement or the inclusion of the provision in the Agreement.
     
  (6) If an act must be done on a specified day which is not a Business Day, it must be done instead on the next Business Day.

 

2. Establishment of New Location
   
2.1 MiniFAB to establish New Location
   
  From the date this Agreement is signed, MiniFAB will work to establish a facility on the United States of America mainland (New Location) where NewFAB will undertake the final assembly of the Product.
   
2.2 Commencement of US final assembly

 

  (1) Not more than 6 months after the Volume Threshold is reached (or earlier if MiniFAB determines), provided there is at least 2 years remaining on the Term, MiniFAB and TearLab will meet in good faith to determine whether the projected manufacturing volume requirements for the remainder of the Term warrant investment in the New Location.
     
  (2) If the parties determine that a New Location is warranted, then MiniFAB must provide TearLab with written notice of the date on which the New Location will become operative for final assembly of the Product, which date shall be no later than 18 months after the date in which determination is made (Readiness Notice). The Readiness Notice will provide at least 3 months’ notice of the date that final assembly at the New Location will commence from. The Readiness Notice is to be accompanied by an executed Deed Poll of Accession, and if required provide details of NewFAB.
     
  (3) Upon receipt of the Readiness Notice TearLab may enter and inspect the New Location with a view to satisfying itself the New Location is reasonably suitable for the conduct of final assembly of the Product in accordance with this Agreement. If TearLab considers there are any deficiencies it will notify MiniFAB, and either the deficiencies must be rectified or otherwise resolved. If acceptance of the New Location for final assembly cannot be agreed between MiniFAB and TearLab within 2 months of the Readiness Notice, then the matter will be dealt with in accordance with clause 20. After acceptance and at least 2 weeks prior to the New Location becoming operative for final assembly of the Product, MiniFAB will provide TearLab with a further written notice specifying the operative date.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 8 -  
     

 

2.3 Accession of NewFAB

 

  At the appropriate time as provided for by clause 2.2 MiniFAB must deliver to TearLab an executed Deed Poll of Accession. Thereafter, as and from the Final Assembly Changeover Date, NewFAB will be bound to perform and discharge those obligations placed upon it as a Supplier under this Agreement.

 

2.4 Other markets - other locations

 

  (1) When TearLab sales to its customers of Product in agreed target markets other than the United States (Other Market Sales) reach levels to be agreed, MiniFAB will establish additional facilities to service those target markets in which the Product will undergo assembly and packaging ready for shipment to customers in those markets.
     
  (2) When Other Market Sales reach significant levels, but short of the levels referred to in clause 2.4(1), MiniFAB and TearLab will discuss whether other market distribution services might be warranted and could be established and priced on mutually beneficial basis.

 

2.5 Discuss warehousing

 

  Within 2 months after receipt of the Readiness Notice under clause 2,2, TearLab will initiate discussions with MiniFAB in relation to the possibility of warehousing and logistics services being delivered to TearLab by MiniFAB.

 

3. Manufacture of Product
   
3.1 Development of Specifications

 

  The Specifications may be modified or amended by mutual written agreement of the Parties. In the event that TearLab requests changes to the Specifications MiniFAB agrees to use Commercially Reasonable Efforts to accommodate such requested changes.

 

3.2 Product compliance

 

  MiniFAB shall set up the manufacturing process, manufacture the Product, and assemble and package the Product, all in accordance with the Specifications and all Regulatory Requirements. MiniFAB shall label the Product with such labels, tradenames, and trademarks as directed by TearLab.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 9 -  
     

 

3.3 Supply and Purchase Obligations

 

  (1) MiniFAB shall manufacture the Product exclusively for TearLab; and MiniFAB shall sell the Product exclusively to TearLab or its designee; and unless the Parties otherwise agree MiniFAB shall not otherwise manufacture, sell, or distribute the Product to any third party.
     
  (2) TearLab must exclusively order the Product from MiniFAB unless there are Exceptional Circumstances or clause 3.3(5) applies . For the purposes of this Agreement, Exceptional Circumstances mean:

 

  (a) an inability by MiniFAB to provide the Product for 60 days; or
     
  (b) a 3 month period in which each delivery of Product has at least 10% of the Product failing to meet the Supply Requirements, and MiniFAB being unable to supply conforming replacement Product such that MiniFAB would have to exceed the Monthly Manufacturing Limit in the following two months in order to ensure that it was able to supply the forecast requirements of Product in those two months.

 

    In the case that there are Exceptional Circumstances, MiniFAB may notify TearLab when the Exceptional Circumstances have been overcome and TearLab will be required, from 60 days after such notification, to be supplied exclusively with Product from MiniFAB; provided that TearLab shall have the right to fully honor any supply commitments incurred by TearLab resulting from the Exceptional Circumstances, to the extent that such commitment are not inconsistent with this Agreement.

 

  (3) MiniFAB hereby acknowledges that TearLab needs to obtain a reliable supply of the Product that meet certain quality, quantity and timing requirements, and agrees to comply with the following Supply Requirements :

 

  (a) ensure that each batch of Product is in full compliance with the Specifications (allowing for any failure rates specified in the Specifications); and
     
  (b) ensure that it does not for 3 successive months deliver to TearLab less than 95% of quantity of Product ordered by TearLab for delivery in those months in accordance with this agreement, after taking account of replacement Product.

 

  (4) If MiniFAB fails to comply with the Supply Requirements then:

 

  (a) MiniFAB must provide TearLab with the reasons for the non-compliance;
     
  (b) the parties must meet and discuss the reasons given by MiniFAB;
     
  (c) the parties must, acting reasonably, negotiate a mutually agreed remedy plan to address the reasons for the non-compliance; and
     
  (d) MiniFAB must implement the agreed remedy plan.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 10 -  
     

 

  (5) If MiniFAB:

 

  (a) gives notice to TearLab of Exceptional Circumstances or TearLab reasonably determines that the Exceptional Circumstances have occurred; or
     
  (b) fails to meet Supply Requirements more than 3 times in any 18 month period and is unable to satisfy TearLab (acting reasonably) that it will be able to maintain a reliable supply of the Product that meet the quality, quantity and timing requirements, then TearLab may order the Product from an alternative supplier.

 

  (6) MiniFAB acknowledges and agrees that in consideration for Customer’s agreement to purchase the Product exclusively from MiniFAB, TearLab shall be entitled to all remedies (which remedies shall be cumulative) available under this Agreement and under applicable law, including without limitation the reasonable cover remedy, subject to TearLab duty to reasonably mitigate the damages.

 

4. Forecasting and ordering
   
4.1 Basic Forecast

 

  (1) 15 Business Days before the 1 st day of each calendar month, TearLab must submit to the Supplier a forecast of the quantity of the Product that TearLab expects to take delivery of in each of the next 12 months. This will be on the basis that:

 

  (a) Month 1 — will be a firm order for Product (Purchase Order), which the Supplier must accept and comply with, provided it is no more than 120% of the quantity specified in Month 2 of the prior forecast, does not breach the Upper Limit Rule below and is no more than the Monthly Manufacturing Limit;
     
  (b) Months 2 and 3 are constrained forecasts and cannot be more than 120% of the quantity specified in Months 3 and 4 respectively of the prior forecast;
     
  (c) Months 4 through 12 are best efforts forecasts by TearLab but are not binding in any way; and
     
  (d) The total of months 1 through to 6 multiplied by 1.2 represents an aggregate upper limit on the total orders for Product that the Supplier can be required to manufacture and deliver in that 6 month period (the Upper Limit Rule).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 11 -  
     

 

  (2) A Purchase Order constitutes an irrevocable offer in respect of the relevant month made by TearLab to the Supplier for the Product for the delivery of the Product to the Delivery Point all in accordance with the terms and conditions of this Agreement. Once received by the Supplier, the Purchase Order is firm and may not be cancelled or modified without the Supplier’s prior written consent.
     
  (3) Subject to clauses 4.1(4) and 4.2, the Supplier must accept a Purchase Order if the quantity of the Product the subject of the Purchase Order is no more than 120% of the most recent forecast for that month, it does not breach the Upper Limit Rule and is no more than the Monthly Manufacturing Limit (Complying Order). In addition, the Supplier agrees to use Commercially Reasonable Efforts to accept and satisfy an order which is not a Complying Order. In the event that TearLab places an order which is not a Complying Order, the Supplier shall:

 

  (a) accept the Purchase Order with respect to quantities that would mean the order is a Complying Order; and
     
  (b) notify TearLab in writing of those quantities (if any) exceeding such quantity as the Supplier is prepared to deliver, which together with the quantities accepted under clause 4.1(3)(a) will be taken to comprise the Purchase Order.

 

  (4) If the Supplier believes, on reasonable grounds, that a Purchase Order is materially incorrect or, to the extent a Purchase Order is not a Complying Order, the Supplier is not capable of satisfying the Purchase Order to the extent of such excess, the Supplier must notify TearLab as soon as possible. If the Supplier does not reject a Purchase Order to the extent of such excess within 5 Business Days of receipt of the Purchase Order, then the Supplier is deemed to have accepted the Purchase Order in full. Any rejection by the Supplier of a Purchase Order that is not provided for in this clause 4.1(4) is deemed to be a material breach of this Agreement for the purposes of clause 17.2(1).

 

4.2 Capacity increase

 

  (1) When the Volume Threshold is reached, provided that there is at least two years remaining in the Term, upon request by TearLab MiniFAB and TearLab will meet in good faith to determine whether the projected manufacturing volume requirements for the remainder of the Term warrant investment in an increase in its annual production capacity of Product to 10 million units (or some other capacity increase that is economically viable).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 12 -  
     

 

  (2) If the parties determine that an increase in its annual production capacity is warranted (including TearLab being satisfied that the capital expenditure is proportionate to the economic value likely to be derived), then MiniFAB will initiate an increase in its annual production capacity of Product to 10 million units per annum (or such other capacity increase as is agreed). MiniFAB will use Commercially Reasonable Efforts to have such increased capacity online within 12 months of such event occurring. When such increased capacity is on-line MiniFAB will advise TearLab and advise the new Monthly Manufacturing Limit.
     
  (3) When MiniFAB advises TearLab of the new Monthly Manufacturing Limit under clause 4.2(1), the increased capacity will be deemed to be a Requested Capacity Increase of 5 million Product units per annum for the purposes of clauses 4.3(2), 4.3(3) and 4.3(4).

 

4.3 Manufacturing Limit

 

  (1) TearLab may, at any time initiate discussions to determine whether the projected manufacturing volume requirements for the remainder of the Term warrant investment in an increase in MiniFAB’s annual production capacity (noting that on the basis of current manufacturing technology, economical increases will be in steps of 5 million Product units per annum). if the parties determine that an increase in annual production capacity is warranted, then TearLab may request that the production capacity be increased (Requested Capacity Increase).
     
  (2) If new facilities are required to meet the Requested Capacity Increase, there will be an 18 month lead time for the Requested Capacity Increase to come on-line, Otherwise, there will be a 12 month lead time for the Requested Capacity Increase to come on-line. Once the Requested Capacity Increase comes on-line MiniFAB will advise TearLab of the new Monthly Manufacturing Limit.
     
  (3) If MiniFAB agrees to meet a Requested Capacity Increase, TearLab must provide Purchase Orders in the 3 years after the Requested Capacity Increase comes online (or such shorter period which ends at the end of the Term) which require at least 80% of the Requested Capacity Increase to be utilised over the 3 years (or such shorter period which ends at the end of the Term) (the AP Period). Such calculation is to be done on the basis that the full capacity of the pre-existing production capacity is utilised, before the added capacity is used, even if the added capacity was actually utilised to produce the relevant Products.
     
  (4) If TearLab fails to provide Purchase Orders which meet the requirements of clause 4.3(3), TearLab will reimburse the Supplier for the un-recouped proportion of the capital expense of undertaking the Requested Capacity Increase as determined in accordance with the following formula. Once evidence of the capital expense is provided, TearLab will pay such compensation within 30 days.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 13 -  
     

 

  CP = RCIxAPx0.8 — PO xCE  
  RCIxAP  

 

  Where:
   
  CP is the compensation payable to MiniFAB, but may not be less than zero. RCI is the Requested Capacity Increase per annum.
   
  AP is the period in years for which the increased capacity is on-line during the Term expressed in years, capped at a maximum of 3.
   
  PO is the total number of units of Product supplied during the AP Period after deducting the capacity available during the AP Period before the Requested Capacity Increase.
   
  CE is the capital expense of undertaking the Requested Capacity Increase. The Supplier will be required to provide evidence of this amount.

 

4.4 Management of stock levels of Product

 

  (1) TearLab will use all reasonable endeavours to order sufficient quantities of Product to ensure that, subject to the Supplier performing its obligations under this Agreement, TearLab maintains on hand in the United States a sufficient stock of Product which has been delivered by the Supplier to satisfy three months expected demand (Target Stock).
     
  (2) The relevant stock may be warehoused in whole or in part by the Supplier, subject to the parties agreeing commercial terms for that additional service.

 

4.5 Minimum Order Requirement

 

  In any given period of 6 calendar months, TearLab must place in those 6 months aggregate Purchase Orders equal to 50% of the aggregate of the forecast orders for Product provided in the respect of the first month of that period (the Minimum Orders). If TearLab fails to do so, then it must pay to MiniFAB an amount equal to the Price (as set out in the Pricing Schedule) multiplied by the difference between the Minimum Orders and the actual aggregate Purchase Orders. Unless otherwise agreed, such amount, if any, will be calculated and invoiced by MiniFAB within 60 days of the end of the relevant 6 month period, and be payable by TearLab within 40 days of invoice. Where any such sum is paid, it will be deemed to be equivalent to a Purchase Order of the relevant number of Products in the month in which it is paid, and be taken into account in any further calculation under this clause in respect of that month.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 14 -  
     

 

5. Delivery
   
5.1 Product

 

  MiniFAB will manufacture the Product ordered in respect of a month and deliver it CIP (Incoterms 2010) for no delivery charge to the Delivery Point by the end of the relevant month. In the event that any two or more consecutive monthly orders by TearLab in accordance with clause 4 are delivered more than forty-five (45) day after the end of the month to which they relate (unless some later date has been agreed), then TearLab shall be entitled to a ten percent (10%) discount on the Price of the Products which were not delivered at the end of that 45 day period. Provided that the Products are delivered within 90 days after the end of the relevant month, then the discount set out above is the sole and exclusive remedy of TearLab for any loss, damage or liability suffered or incurred by TearLab in connection with the delay. To avoid doubt, delivery occurs when the Products are available for inspection at the Delivery Point.

 

5.2 Inspection and Nonconforming Product

 

  (1) TearLab has the right to enter the MiniFAB Facility and inspect the Product within 14 days after delivery (or such longer time as provided in the Technical Agreement) and must accept the Product if they meet the Specifications. The Product will be deemed accepted if TearLab does not inspect the Product within such 14 day period. If TearLab fails to object in writing within the applicable period, then TearLab must accept the delivered Product. TearLab may reject the delivered Product only if the Product fail to meet the Specifications. If TearLab rejects the delivered Product, TearLab must provide MiniFAB in writing the reasons for the rejection and the reasonably available evidence to substantiate those reasons.
     
  (2) If TearLab rejects any Product, then MiniFAB shall promptly supply conforming replacement Product as soon as possible, whether or not MiniFAB agrees that TearLab properly rejected such Product. MiniFAB agrees to notify TearLab in writing if such replacement Product cannot be despatched from the MiniFAB Facility within five (5) Business Days.
     
  (3) If TearLab properly rejected the original Product, then:

 

  (a) TearLab’s payment for the rejected Product shall be deemed payment for the replacement Product; and
     
  (b) If it takes MiniFAB more than 1 month after the original required delivery date to deliver the replacement Product, then TearLab shall be entitled to a ten percent (10%) discount on the Price of the rejected Product, and provided the replacement Product are delivered within 2 months of the original required delivery date then that discount is the sole and exclusive remedy of TearLab for any loss, damage or liability suffered or incurred by TearLab in connection with the rejected Product.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 15 -  
     

 

  (4) If TearLab was not entitled to reject the original Product in accordance with clause 5.2(1) then TearLab shall pay for both the rejected Product and the replacement Product.
     
  (5) If the parties disagree whether TearLab properly rejected the original Product, then the parties shall refer such matter to a mutually acceptable, independent testing laboratory (the Testing Lab) to determine whether such Product were properly rejected. The fees and costs of the Testing Lab shall be borne by TearLab if the Testing Lab determines that the Product were improperly rejected and by MiniFAB if the Testing Lab determines that the Product were properly rejected. If the Testing Lab is unable to determine whether the rejected Product met the Specifications, then either party may submit the matter to the dispute resolution process in clause 20.
     
  (6) TearLab may withhold payment for any rejected Product (and only the rejected Product) until:

 

  (a) MiniFAB delivers conforming Product, or
     
  (b) the Testing Lab or dispute resolution process determines that the Product rejected by TearLab met the Specifications.

 

5.3 Risk and title

 

  (1) Risk in the Product will remain with the Supplier until the Product is provided at the Delivery Point.
     
  (2) Property in the Product supplied by the Supplier to TearLab under this Agreement does not pass to TearLab until the money owing for the Product has been paid in full. If TearLab in the meantime takes custody of the Product, TearLab retains them as bailee of the Supplier. Once title to Products passes to TearLab, the Supplier retains a lien on them in respect of other monies payable to it by TearLab.

 

5.4 Quality Control

 

  MiniFAB shall conduct all quality control testing of the Product supplied under this Agreement prior to delivery in accordance with the relevant Technical Agreement and applicable Laws. MiniFAB shall, and shall cause its subcontractors to, retain records and samples of Product relating to such testing, and samples (identified by batch number) of the Product supplied to TearLab, in each case in conditions and for times as required by applicable Law (collectively, Delivery Samples ), and shall provide TearLab with reasonable access to the Delivery Samples for testing and other purposes on TearLab’s request. If TearLab conducts quality control testing of Product after their delivery to TearLab, TearLab must use the same analytical methodology as used by MiniFAB. Upon written request from TearLab, MiniFAB shall provide a reasonably detailed description of the analytical methodology used by MiniFAB for quality control testing of the Product.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 16 -  
     

 

6. Price
   
6.1 Pricing Schedule
   
  The Price for the Product is set out in the Pricing Schedule.
   
6.2 Provisions of the Pricing Schedule
   
  To the extent the Pricing Schedule contains any provisions inconsistent with the body of this Agreement the provisions of the Pricing Schedule apply.
   
6.3 Invoicing
   
  MiniFAB will invoice TearLab the Price for Product after shipment to the Delivery Point.
   
6.4 Payment
   
  TearLab must pay all undisputed invoices within 40 days after date of the invoice.
   
6.5 Interest
   
  If TearLab fails to pay an amount on the due date for any undisputed payment, TearLab must additionally pay interest at the Default Rate on the amount outstanding. Interest will be calculated and payable monthly, computed on the last day of each month on the maximum outstanding during that month, from the due date until all amounts are paid in full. MiniFAB may apply any payments received from TearLab against the interest on outstanding amounts first.
   
6.6 Transition Payments
   
  In addition to the Price for the Product TearLab must pay the Transition Payments to MiniFAB on the dates set out in the Pricing Schedule,

 

7. Disaster Recovery Planning
   
7.1 Duplicate final assembly Cell
   
  Once the Volume Threshold is reached, provided there is at least 2 years remaining on the Term, MiniFAB and TearLab will meet in good faith to determine whether the projected manufacturing volume requirements for the remainder of the Term warrant investment in a duplicate final assembly and packaging cell at an alternative and separate secured location within the MiniFAB Facility or New Location.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 17 -  
     

 

7.2 Base Card stock

 

  (1) MiniFAB will manufacture and hold a supply of Base Cards, to enable MiniFAB to re-establish its Manufacturing capacity within a reasonable period following a disaster event. The supply will be as agreed, but will not be less than 3 months’
     
  (2) After the Final Assembly Changeover Date, 2 months’ supply of the Base Card stock held under clause 7.2(1) will be held in the New Location.

 

8. Development of New Products
   
8.1 R&D Services

 

  (1) R&D Services for New Products include:

 

  (a) project management services relating to the development of the New Product;
     
  (b) assisting TearLab in the development, validation and finalisation of the Requirement Definitions for the New Product;
     
  (c) assisting TearLab in the development, validation and finalisation of the Specifications for the New Product;
     
  (d) using Commercially Reasonable Efforts to develop processes, methodology and technology to manufacture the New Product;
     
  (e) using Commercially Reasonable Efforts to evaluate and recommend appropriate technology necessary to manufacture the New Product;
     
  (f) using Commercially Reasonable Efforts to develop and construct plant and equipment necessary to manufacture the New Product; and
     
  (g) such other services as specified in a Development Order.

 

  (2) R&D Services exclude.

 

  (a) the initial formulation of and research on the Requirement Definitions for the New Product;
     
  (b) carrying out experiments, clinical tests or other validation methodologies in relation to the New Product;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 18 -  
     

 

  (c) preparations or filings relating to obtaining Registration for the New Product;
     
  (d) sales, distribution, marketing or public release of the New Product;
     
  (e) patent review; and
     
  (f) legal or other professional advisory services.

 

8.2 Request for development

 

  (1) TearLab may, from time to time, request MiniFAB in writing to provide R&D Services to develop a New Product ( Development Request ).
     
  (2) Subject to clause 8.2(4), if and when TearLab elects, in its discretion, to develop a Second Product, TearLab agrees that it will provide an opportunity for MiniFAB to provide the R&D Services with respect to the Second Product, as follows:

 

  (a) TearLab shall provide a written Development Request for the Second Product pursuant to clauses 8.2(1) and 8.2(3);
     
  (b) the parties shall discuss in good faith the anticipated activities under the Development Request and capabilities required to perform such activities;
     
  (c) if MiniFAB does not wish to undertake to perform the applicable R&D Services for the Second Product, MiniFAB agrees to promptly notify TearLab in writing;
     
  (d) if MiniFAB wishes to perform the applicable R&D Activities for the Second Product, MiniFAB shall propose the financial terms under which it is willing to undertake the R&D Services specified in the Development Request; and
     
  (e) if MiniFAB has appropriate capability to perform such R&D Activities for the Second Product as set forth in the Development Request, and offers to perform such activities on financial terms that are at least as favorable to TearLab as other bids for conducting such R&D Services TearLab receives from third parties with capability of performing such R&D Services, then TearLab shall engage MiniFAB for the conduct of such R&D Services for the Second Product. In such event, the parties shall prepare and sign a mutually agreed written Development Order, which shall set forth the activities to be conducted, timelines, deliverables, financial terms, and other mutually agreed terms and conditions regarding such R&D Services. Such Development Order shall be consistent with the intellectual property provisions and other applicable terms and conditions of this Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 19 -  
     

 

    Subject to the foregoing and clause 8.2(5), TearLab may engage any other person to provide R&D Services and TearLab shall have no obligation to engage MiniFAB to perform any R&D Services. For clarity, TearLab shall not be obligated to engage MiniFAB to perform R&D Services for any New Product other than the Second Product.

 

  (3) A Development Request must include:

 

  (a) a detailed description of the New Product;
     
  (b) draft Requirement Definitions for the New Product; and
     
  (c) a draft project plan including a proposed timetable.

 

  (4) MiniFAB will consider a Development Request and notify TearLab in writing whether or not MiniFAB accepts the Development Request within 20 Business Days of receipt of the request. If MiniFAB fails to respond within that time period, then it is deemed to have rejected the Development Request. To avoid doubt, MiniFAB is not required to provide any reason for rejecting a Development Request. It is understood that the Development Request is intended as an opportunity for the parties to negotiate terms and conditions on which MiniFAB may conduct the applicable R&D Services for TearLab. Accordingly, (i) MiniFAB shall not be obligated to accept any Development Request, and (ii) except as expressly set forth in clause 8.2(2)(e) with respect to the Second Product, TearLab shall not be obligated to engage MiniFAB to conduct R&D Services. Without limiting the foregoing, if MiniFAB rejects (or is deemed to have rejected) the Development Request for the Second Product, then despite clause 8.2(2), TearLab may engage another service provider to provide R&D Services in respect of that Development Request. TearLab shall have no obligation to offer to MiniFAB any further opportunity, or to engage MiniFAB, to perform any R&D Services except as expressly set forth under clause 8.2(2).
     
  (5) Without limiting anything else in this clause 8, if TearLab wishes to develop any New Product that is relevant to MiniFAB’s technology, it must provide MiniFAB with the opportunity to submit a proposal for the performance of the work by providing a Development Request. TearLab may also tender the development work in respect of the New Product to any other person, but it must give MiniFAB a final opportunity to quote on the work before offering the job to someone else.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 20 -  
     

 

8.3 Development Order

 

  (1) If MiniFAB accepts a Development Request, then:

 

  (a) MiniFAB will provide TearLab with a revised draft project plan including proposed milestones and payment milestones; and
     
  (b) the parties must meet within 20 Business Days of the acceptance to meet and discuss the Development Request with the intent to finalise a Development Order.

 

  (2) The parties will act reasonably in negotiating the terms of the Development Order.
     
  (3) To avoid doubt, neither party is bound by a Development Request, a Development Order or any obligations to develop a New Product until the relevant Development Order is signed by both parties.

 

8.4 Provision of R&D Services

 

  (1) MiniFAB will provide the R&D Services in accordance with the relevant Development Order in a diligent and ethical manner, with due care and skill and to a high professional standard, in accordance with this Agreement, and all applicable Regulatory Requirements.
     
  (2) MiniFAB will use Commercially Reasonable Efforts to meet any milestones agreed in the relevant Development Order. Each Development Order may specify the agreed-upon remedies that shall apply for any failure by MiniFAB to meet such milestones, or otherwise fail to perform the R&D Services in accordance with clause 8.4(1).

 

8.5 Responsibilities of each party

 

  (1) MiniFAB is responsible for and will bear the costs and expenses associated with:

 

  (a) the provision of the R&D Services in accordance with the relevant Development Order ( Development Expenses ); and
     
  (b) the construction and acquisition of any plant and equipment and other related capital expenditures relating to the R&D Services.

 

  (2) TearLab will develop, validate and finalise the Requirement Definitions and the Specifications of the New Product in consultation with MiniFAB. MiniFAB will assist TearLab in accordance with the R&D Services.
     
  (3) TearLab is solely responsible for and will bear all costs and expenses associated with all activities relating to the research and development of the New Product that are not expressly included as part of R&D Services or that are expressly excluded from the R&D Services.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 21 -  
     

 

8.6 Ownership of Requirement Definitions and Specifications
   
  The Requirement Definitions and the Specifications of any Product and all Intellectual Property rights relating to any Product, the Requirement Definitions and the Specifications therefor are and will remain to be owned solely by TearLab. MiniFAB hereby assigns all Intellectual Property subsisting in the foregoing to TearLab.
   
8.7 Payment for R&D Services
   
  TearLab will pay MiniFAB for the provision of the R&D Services in accordance with payment milestones specified in the relevant Development Order.
   
8.8 Other matters relating to Development Order
   
  Prior to the Successful Completion of a New Product, the parties will meet and negotiate (acting reasonably) the following items relating to the New Product:

 

  (1) the Pricing Schedule for the New Product;
     
  (2) the Manufacturing and Ordering Schedule (including the Annual Production Capacity) for the New Product, if any; and
     
  (3) if the New Product is a replacement or successor of an existing Product, variations to the Manufacturing and Ordering Schedule of the existing product (including the Annual Production Capacity and Expected Limit) for that existing Product.

 

8.9 Prototype Acceptance Testing

 

  (1) If required under the relevant Development Order, the parties will conduct acceptance testing of the New Product in accordance with this clause 8.9.
     
  (2) Promptly upon completion of the development of the New Product, MiniFAB shall manufacture and supply to TearLab a reasonable number of prototype units for the purposes of TearLab’s testing and evaluation, together with such documentation (including without limitation the QA test report), materials and equipment reasonably necessary for TearLab to perform testing and evaluation of the prototype. It is understood that the mutually agreed Development Order may provide for the supply and testing of multiple sets of prototype units for the New Product at different stages of development (such as, for example, alpha prototypes and beta prototypes).
     
  (3) TearLab may reject the prototype of the New Product only if it does not conform to the Requirement Definitions. TearLab must accept the prototype of the New Product if it conforms to the Requirement Definitions.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 22 -  
     

 

  (4) If TearLab rejects the prototype then TearLab must notify MiniFAB of the reasons for such rejection and MiniFAB will have thirty (30) days to cure such defect or non-conformance or dispute TearLab’s rejection pursuant to the dispute resolution process under clause 19. TearLab may require MiniFAB to resubmit revised prototype units to TearLab for testing and evaluation until the prototype fully conforms to the Requirement Definitions of the Product.
     
  (5) Upon TearLab’s acceptance of the New Product (“Acceptance”), TearLab shall promptly inform MiniFAB in writing.

 

8.10 Successful Completion
   
  Successful Completion in relation to a New Product means:

 

  (1) if the relevant Development Order provides a definition - the meaning ascribed to that term in the Development Order; or
     
  (2) the Acceptance of a New Product by TearLab, as such term is defined in clause 8.9.

 

8.11 Discontinuance — Unable to finalise Requirement Definitions
   
  If the parties are unable to finalise the Requirement Definitions for the New Products by the deadline specified in the relevant Development Order (or after a reasonable time if no such deadline is specified), then either party may discontinue the relevant Development Order by notifying the other party in writing, in which case TearLab will be solely responsible for all Development Expenses incurred up to that point in time and any other unavoidable costs reasonably incurred by MiniFAB in connection with the discontinuance.
   
8.12 Discontinuance — TearLab
   
  TearLab may discontinue the development of any New Product at any time upon written notice, in which case MiniFAB will invoice, and TearLab must pay, all outstanding amounts that are payable in accordance with the payment milestones specified in the Development Order for the R&D Services actually rendered by MiniFAB prior to the termination of the relevant Development Order. It is understood and agreed that any R&D Services with respect to the Second Product and any other New Product will be undertaken in reasonable stages in order to provide TearLab an opportunity to evaluate the results of the R&D Services in each such stage and to determine whether TearLab, in its discretion, wishes to cease development of the Second Product or other New Product. In the event that TearLab unilaterally discontinues development of the Second Product and terminates the corresponding R&D Services (other than as a result of MiniFAB’s inability or unwillingness to conduct such R&D Services, or as set forth in clause 17.2) prior to MiniFAB’s shipment of beta prototypes, then TearLab agrees that it will provide an opportunity for MiniFAB to provide the R&D Services with respect to development of its next subsequent New Product (excluding any New Products then already under contract for development by third parties) as set forth in clause 8.2(2), subject to the terms of clause 8.2(4).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 23 -  
     

 

8.13 Definitions used in this clause

 

  (1) New Products means any test cards developed pursuant to this Agreement and any other goods that the parties agree are New Products. For the avoidance of doubt, New Products do not include the first Product;
     
  (2) Second Product means the first New Product developed pursuant to this Agreement, which the parties intend to be a test cards similar to the first Product, provided that such product would be designed to measure either (i) a marker other than osmolarity, or (ii) both osmolarity and one other additional marker:

 

9. Intellectual Property
   
9.1 Ownership of Requirement Definitions and Specifications
   
  The Requirement Definitions and the Specifications of the Product and all Intellectual Property rights relating to the Product, the Requirement Definitions and the Specifications are and will remain owned solely by TearLab.
   
9.2 TearLab Background IP
   
  TearLab shall retain ownership of any pre-existing Intellectual Property rights in materials and information provided by TearLab to the Provider for use by the Provider for the purposes of undertaking activities under this Agreement.
   
9.3 MiniFAB Background IP

 

  (1) MiniFAB shall retain ownership of any pre-existing Intellectual Property rights in materials, information, tools and methodologies provided by MiniFAB for the purposes of undertaking activities under this Agreement, and any improvements to them (except to the extent that those improvements relate solely to the Product (Dedicated Improvements)) (collectively, “MiniFAB Background IP”) and MiniFAB hereby grants TearLab a worldwide, non-exclusive, royalty-free license (with the right to grant and authorize sublicenses) to make, have made, use, offer for sale, sell and otherwise exploit MiniFAB Background IP as may be required to make, have made, use, offer for sale, sell and otherwise exploit the Product or incorporated into processes or procedures for manufacturing or testing the Product.
     
  (2) All MiniFAB Background IP shall be treated by TearLab and its sublicensees and their third party manufacturers as Confidential Information of MiniFAB; provided, however, that

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 24 -  
     

 

  (a) TearLab may disclose the MiniFAB Background IP to actual and potential investors, sublicensees, advisors and/or contract manufacturers of Base Cards or finished Products, in each case under reasonable and customary terms of confidentiality; and
     
  (b) TearLab and its sublicensees and contract manufacturers may disclose such information as is reasonably necessary in seeking regulatory approvals in connection with the manufacture, clinical development, use or commercialization of Product.

 

9.4 Limited licences

 

  (1) Subject to the terms and conditions of this Agreement, TearLab grants a non-exclusive licence (TearLab Licence) in respect of any Intellectual Property, know-how and technical information owned (or licensed with the right to sublicense) by TearLab relating to the Manufacture of the Base Cards or final assembly of the finished Product (TearLab IP) to:

 

  (a) MiniFAB to perform MiniFAB’s obligations under this Agreement, which licence may not be sublicensed (except lo the extent necessary to allow MiniFAB to subcontract as permitted under clause 16), is royalty free and continues only during the Term:
     
  (b) NewFAB to perform NewFAB’s obligations under this Agreement, which licence may not be sublicensed (except to the extent necessary to allow MiniFAB to subcontract as permitted under clause 16), is royalty free and continues only during the Term; and
     
  (c) MiniFAB to reproduce, use and modify the TearLab IP solely for the purposes of manufacturing, marketing, distributing and selling the Product in accordance with clause 17.5, which licence may be sublicensed, is royalty bearing in accordance with clause 17.5(2)(e), and continues for the term provided in clause 17.5(2)(b), and is irrevocable.

 

  (2) Under the licences granted in clauses 9.4(1)(a) and 9.4(1)(b) MiniFAB and NewFAB may only use the TearLab IP to the extent necessary or desirable to perform their obligations under this Agreement.

 

9.5 Provision of TearLab IP materials
   
  TearLab will provide or otherwise make available all information and materials relating to the TearLab IP known to or possessed by TearLab that are reasonably necessary to enable MiniFAB and NewFAB to perform their obligations under this Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 25 -  
     

 

9.6 Ownership of TearLab IP and Improvements to TearLab IP

 

  (1) All TearLab IP, together with all improvements to TearLab IP, including any modifications and developments made thereto by MiniFAB or NewFAB, and any Dedicated Improvements (collectively, TearLab Improvements), shall be the sole property of TearLab. MiniFAB and NewFAB hereby assign to TearLab their entire right, title and interest in TearLab Improvements. TearLab Improvements will be included in TearLab IP and covered by the TearLab Licence.
     
  (2) All TearLab IP shall be treated by MiniFAB and NewFAB as Confidential Information of TearLab.
     
  (3) MiniFAB and NewFAB shall promptly disclose to TearLab all TearLab Improvements, and provide TearLab with copies of all information available to MiniFAB and NewFAB regarding TearLab Improvements.
     
  (4) To the extent any of the rights that the parties intend to be assigned by MiniFAB or NewFAB to TearLab (as set forth in clause 9.1 and this clause 9.6) cannot be assigned by MiniFAB or NewFAB to TearLab, MiniFAB or NewFAB (as relevant) hereby grant to TearLab an exclusive, royalty-free, transferable, irrevocable, worldwide license (with rights to sublicense through multiple tiers of sub-licensees) to practice such non-assignable rights, title and interest. To the extent any of such rights can be neither assigned nor licensed by MiniFAB or NewFAB to TearLab, MiniFAB and NewFAB hereby irrevocably waive and agree never to assert such non-assignable and non-licensable rights, title and interest against TearLab or any of TearLab’s licensees or successors in interest to such non-assignable and non-licensable rights.

 

9.7 IP Warranties and indemnity

 

  (1) TearLab warrants that TearLab has the right and authority to grant the TearLab Licence.
     
  (2) TearLab shall indemnify and at all times holds harmless MiniFAB and NewFAB against any Losses resulting from a third person’s claim against MiniFAB or NewFAB alleging that the use of TearLab IP by MiniFAB or NewFAB constitutes an infringement of any Intellectual Property of that third person; provided, however, that TearLab shall not be obligated to indemnify MiniFAB or NewFAB, and MiniFAB and NewFAB shall indemnify and at all times hold harmless TearLab against any such Losses (i.e., Losses arising from third party claims of infringement), to the extent the alleged infringement results from any modifications and developments made to TearLab IP by MiniFAB or NewFAB other than in accordance with instructions contained in any Specifications.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 26 -  
     

 

9.8 Assurance of TearLab Licence
   
  MiniFAB acknowledges that certain parts of the TearLab IP may incorporate or exploit Intellectual Property that is licensed from University of California, San Diego (UCSD IP). If MiniFAB’s rights under clause 17.5 take effect, TearLab will (providing MiniFAB remains within the licensure requirements):

 

  (1) provide MiniFAB with all information and materials relating to the UCSD IP, including explanations on which parts of the TearLab IP incorporate or exploit the UCSD IP;
     
  (2) use its best endeavours to procure a sub-licensable licence direct to MiniFAB to allow MiniFAB reproduce, use and modify the UCSD IP solely for the purposes of manufacturing, marketing, distributing and selling the Product in accordance with clause 17.5, which licence is only to take effect from the date as provided in clause 17.5; and
     
  (3) facilitate, and provide all reasonable assistance to MiniFAB in relation to, any negotiations for a direct licence between MiniFAB and the University of California, San Diego in respect of the UCSD IP.

 

9.9 Infringement and protection of TearLab IP
   
  TearLab is solely responsible for the protection, defence and maintenance of the TearLab IP. However, MiniFAB and NewFAB will promptly notify TearLab if they are aware of any infringement of the TearLab IP by any third person.
   
9.10 Base Card Moulds

 

  (1) Notwithstanding the previous provisions of this clause 9, all injection moulds directed to the Base Cards that are paid for directly by TearLab and invoiced as a separate item will belong to TearLab, otherwise they will be owned by MiniFAB.
     
  (2) All rights in and to such injection moulds, shall be owned by MiniFAB and are not part of TearLab IP. MiniFAB will cooperate with TearLab in good faith to assist TearLab in such manner as TearLab may reasonably request if such moulds are required to be duplicated,
     
  (3) In the event that this Agreement is terminated for any reason, MiniFAB will still provide reasonable assistance to TearLab under clause 9.10(2) on reasonable commercial terms as agreed between MiniFAB and TearLab.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 27 -  
     

 

10. Obligations of MiniFAB
   
10.1 Cooperation with TearLab
   
  MiniFAB will (a) provide TearLab with analytical and manufacturing documentation, internal progress reports, regulatory compliance files and quality assurance files, and other relevant information as requested by TearLab regarding quality control for the Product supplied under this Agreement, (b) reasonably cooperate with TearLab in responding to all requests for information from customers and the relevant Regulatory Authorities having jurisdiction to make such requests, and (c) on a quarterly basis, prepare and submit to TearLab a production capacity development plan addressing MiniFAB’s efforts to increase production capacity to meet TearLab’s forecasts, and participate in a review thereof with TearLab. TearLab must bear any reasonable pre-approved out-of-pocket costs incurred by MiniFAB pursuant to this clause 10.1. If TearLab refuses to pre-approve any such reasonable costs described in the preceding sentence on request by MiniFAB, then MiniFAB is released from its obligations under this clause 1001 in respect of the obligations that are subject of, and to the extent subject of, those costs that TearLab refused to pre-approve.
   
10.2 Regulatory licences
   
  MiniFAB and at the appropriate time NewFAB must at its own cost obtain and comply with all necessary licences, consents, permits and regulations which may from time to time be required by the relevant Regulatory Authorities to carry out their obligations under this Agreement. Where necessary, TearLab is responsible for obtaining all Registrations and approvals for the export of the Products from Australia or supply of the Products anywhere in the world.
   
10.3 Regulatory approvals and exemptions
   
  As between the parties, TearLab shall be responsible, in its discretion, for activities in seeking Registrations and other regulatory approvals from applicable Regulatory Authorities with respect to the Product (including any CLIA waiver from the FDA in respect of the FDA 510(k) application for the TearLab system which uses the Product developed under the Original Agreement).
   
10.4 Lot records
   
  Without limiting the generality of clause 10.1, on a monthly basis, MiniFAB must retain and furnish to TearLab for analysis by TearLab’s Quality Department:

 

  (1) samples of each lot of Product supplied under this Agreement; and
     
  (2) quality control records,

 

    to the extent required by the Specifications and all applicable Regulatory Requirements.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 28 -  
     

 

10.5 Facility Audits
   
  TearLab shall have the right, during normal business hours and upon reasonable notice, to audit the Provider’s facility (or any one of such facilities) at which the Products are manufactured for compliance with the Specifications, the Regulatory Requirements, and the terms and conditions of this Agreement. MiniFAB shall give TearLab prior written notice (whenever reasonably feasible) of any Governmental Agency inspection of any facility, and shall permit a representative of TearLab to be present at such inspection. MiniFAB shall promptly provide to TearLab copies of all notices, correspondence and other materials delivered to or received from the Governmental Agency regarding such facility or the Products.

 

11. Meeting
   
11.1 During the Term, MiniFAB and TearLab will endeavour to meet at least every 6 months to discuss and review the state of the relationship between them. Each of them must ensure that at least one of its senior representatives attend each meeting. Any such meeting may be teleconferenced.
   
11.2 MiniFAB and TearLab will alternate to organise the meeting. The person responsible for organising the meeting must prepare a formal agenda prior to the meeting and organise formal minutes to be taken and distributed to ail attendees after the meeting takes place. Each party may provide its suggest agenda items. The compulsory topics for the agenda are as follows:

 

  (1) review of previous minutes; and
     
  (2) progress of any development and registration.

 

11.3 The parties acknowledge that the Pricing Schedule is based on various assumptions relating to demands, pricing and profitability of the Product. If either MiniFAB or TearLab reasonably considers that these assumptions are not valid, then they will, on request from the other party, discuss the impact of these invalid assumptions on the Pricing Schedule. The parties may (but are not obliged to) agree to amend the Pricing Schedule in accordance with the process set out in clause 23.4, inclusive of the minimum order amount.

 

12. Amendments to Specifications
   
12.1 Compliance with Regulatory Requirements
   
  In the event that TearLab or MiniFAB becomes aware of any changes or any pending changes in any applicable Regulatory Requirements which could affect the manufacture of the Product, TearLab or MiniFAB, as applicable must promptly notify the other in writing of any such change or proposed change and the Specifications of the Product must then, if necessary be amended by mutual written agreement of the MiniFAB and TearLab. Such change will become effective and binding on the Provider from a date agreed by MiniFAB and TearLab. Costs and expenses reasonably incurred by the Provider to implement the amendments to the Specifications required under this clause 12.1 may be reflected in the Price of Product as set forth in clause 12.3.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 29 -  
     

 

12.2 Voluntary changes
   
  Either MiniFAB or TearLab may suggest changes in the Specifications by notifying the other in writing in reasonable detail of such suggested changes. MiniFAB and TearLab must negotiate in good faith with a view to agreeing to the suggested changes and who will bear the cost of the same. If they agree in writing upon the suggested changes, including the lead-time for implementing such changes, the relevant Specifications must be amended accordingly, and any such change will become effective and binding on the Provider from a date agreed by them. Notwithstanding the foregoing, TearLab shall not be obligated to agree to any change to Specifications proposed by MiniFAB,
   
12.3 Cost of amendments to Specifications or changes in Regulatory Requirements
   
  Unless otherwise agreed by the parties, it is understood that the Price of the Product will be adjusted up or down by an amount equal to the increase or decrease in the Provider’s costs (as determined by the parties’ mutually agreed cost model, which shall not include amounts allocable to other products or to facilities or equipment not utilized for Product) as a result of changes in Regulatory Requirements and/or changes in the Specifications. Subject to clauses 12.1 and 12.2, TearLab is responsible for all pre-approved reasonable out-of-pocket costs and expenses incurred by the Provider to implement any changes to the Specifications under this clause 12. It is understood and agreed that if TearLab pays for the purchase of capital equipment under this clause 12.3, then (i) TearLab shall be the owner of such equipment, (ii) such equipment shall not be used in the manufacture or testing of any products other than the Product, and (iii) and the parties shall reasonably cooperate to execute and file such documents as are reasonably required to evidence and protect TearLab’s ownership interest in such equipment. In the event MiniFAB proposes an upward adjustment in the Price of Product under this clause 12.3, TearLab shall have the right, at its sole cost, to designate an independent accounting firm reasonably acceptable to MiniFAB to audit MiniFAB’s books and records to verify the amount of the cost increase claimed by MiniFAB to determine the rights of the parties as described above in this clause 12.3.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 30 -  
     

 

13. Registrations, safety and Product liability
   
13.1 Registrations of Products
   
  TearLab is responsible for the sales, marketing and distribution of the Product, and is also responsible for:

 

  (1) obtaining all necessary Registrations for the Product; and
     
  (2) maintaining records of all sales of Product sufficient to adequately administer a recall, market withdrawal or correction for such period as is required under applicable regulations.

 

  MiniFAB agrees to maintain all applicable records relating to the Manufacture of Product supplied hereunder for a period of 5 years after they are supplied hereunder, as more particularly set forth in the relevant Technical Agreement. Thereafter, MiniFAB shall notify TearLab in writing before destroying any such records and, if requested by TearLab, agrees to transfer all such records to TearLab or its designee at TearLab’s expense.
   
13.2 Adverse events
   
  TearLab must promptly disclose to MiniFAB during the Term any information it acquires which relates to the safety of the Product, including, inter alia, all side effects, injury, toxicity or sensitivity reactions including unexpected or increased incidence and severity thereof. All such information will be treated as Confidential Information of TearLab.
   
13.3 Notification of defects
   
  In the event the Provider becomes aware of any defect in the Product it will immediately notify TearLab in writing and provide it with a full disclosure of the defect or non-compliance.
   
13.4 Recalls

 

  (1) The parties each must notify the other promptly and in writing if any Product is requested or required to be the subject of a recall, market withdrawal or correction (Recall).
     
  (2) TearLab is solely responsible for the handling and disposition of any Recall and will assume all regulatory responsibility for such matters, including responsibility for all communications with the relevant Governmental Agencies. MiniFAB shall diligently cooperate with TearLab in the administration of any recall.
     
  (3) If a Recall is necessary because the Product does not comply with the relevant Requirements, and that non-compliance is caused by the fault of the Provider then the Provider will bear the reasonable cost of the Recall. In all other cases TearLab is solely responsible for the cost of the Recall.
     
  (4) For the purposes of clause 13.4(3), ‘reasonable cost’ means those costs incurred as a direct result of the non-compliance, and which costs are to be reduced to the extent that TearLab contributed to or failed to reasonably mitigate such costs.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 31 -  
     

 

14. Insurance
   
14.1 Required Insurance from MiniFAB
   
  MiniFAB must take out and maintain during the Term in respect of both itself and NewFAB:

 

  (1) all insurances required by law, including workers compensation insurance in accordance with relevant law; and
     
  (2) public liability insurance for an amount of not less than A$2 Million per claim and in the aggregate.

 

14.2 Required Insurance from TearLab
   
  TearLab must take out and maintain during the Term:

 

  (1) all insurances required by law, including workers compensation insurance in accordance with relevant law; and
     
  (2) product liability insurance for an amount of not less than US$2 Million per claim in the aggregate.

 

14.3 Evidence of insurance
   
  Each party must, if reasonably requested by the other party, provide the other party with evidence that the each insurance required to be taken out by the party pursuant to this clause 14 exists and is current.

 

15. Warranties
   
15.1 Product warranties
   
  Each of MiniFAB and NewFAB warrant that

 

  (1) the Product Manufactured under this Agreement will comply with the Specifications and shall be free from defects in material and workmanship;
     
  (2) the facilities for Manufacture of the Product shall be maintained and operated in compliance with all applicable Regulatory Requirements; and
     
  (3) all Product shall be Manufactured in compliance with the Specifications.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 32 -  
     

 

16. Sub-Contractors

 

  (1) Except with respect to laser ablation and etching and injection moulding activities, which activities shall be conducted at MiniFAB’s Facility unless otherwise agreed by the parties, the Provider may engage sub-contractors to perform the Provider’s obligations under this Agreement upon express prior written consent of TearLab, which consent shall not be unreasonably withheld.
     
  (2) Without limitation, it is agreed that if TearLab is not comfortable that a proposed sub-contractor has the requisite capabilities and that such proposed sub-contractor will protect TearLab’s Intellectual Property rights and that such proposed subcontractor will comply with the terms and conditions set forth in this Agreement (including assignment of intellectual property), or if such proposed sub-contractor is involved in the manufacture, development or commercialization of products competing with the Product, then it shall be reasonable for TearLab to withhold approval of such proposed sub-contractor.
     
  (3) The appointment of sub-contractors shall not affect or diminish the Provider’s responsibilities and obligations under this Agreement, and the Provider shall ensure the compliance of each such subcontractor with the confidentiality obligations and other obligations of the Provider set forth in this Agreement.

 

17. Term, breach and termination
   
17.1 Term

 

  (1) This Agreement commences on the Effective Date and continues for an initial period ending on the End Date.
     
  (2) Either party will have the right to extend this Agreement for an additional term of five (5) years, which right is to be exercised by notice in writing to the other party at least 6 months before the End Date, provided that if there has been a significant movement in the cost of raw materials so as to render the continuation of the Agreement untenable in the reasonable opinion of MiniFAB, then MiniFAB will give notice of that fact to TearLab and the parties will negotiate in good faith to amend the terms to the extent necessary to achieve a sustainable agreement.
     
  (3) If this Agreement is extended under clause 17.1(2) then after the renewal date TearLab will have the option to purchase MiniFAB’s rights to exclusivity under this Agreement for $1,500,000. The option may be exercised by giving six (6) months’ notice to MiniFAB.
     
  (4) If this Agreement is extended under clause 17.1(2) then at the end of that further term this Agreement shall automatically renew for an additional term of five (5) years, unless either party provides the other party with a written notice of non-renewal at least 6 months prior to the end of the then current term.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 33 -  
     

 

17.2 Termination for cause - MiniFAB

 

  (1) TearLab commits a material breach of this Agreement and fails to correct the breach within 60 days after written notice to do so;
     
  (2) TearLab fails to carry out any material provision of this Agreement and the failure is not capable of remedy; or
     
  (3) an Insolvency Event occurs in relation to TearLab.

 

17.3 Termination for cause - TearLab
   
  Notwithstanding clause 17.1, TearLab may terminate this Agreement effective immediately upon the giving of written notice to MiniFAB ( Defaulting Party ) if:

 

  (1) MiniFAB or NewFAB commits a material breach of this Agreement and fails to correct the breach within 60 days after written notice to do so;
     
  (2) MiniFAB or NewFAB fails to carry out any material provision of this Agreement and the failure is not capable of remedy; or
     
  (3) an Insolvency Event occurs in relation to the MiniFAB or NewFAB.

 

17.4 Effect of termination

 

  (1) Upon termination or expiry of this Agreement for any reason other than due to an Insolvency Event in relation to TearLab or breach by TearLab:

 

  (a) the Supplier will complete the delivery of all outstanding Purchase Orders;
     
  (b) TearLab will be bound to purchase and MiniFAB will be bound to manufacture into Product, sell and supply, the whole of its stock of cards held by it. This is subject to an upper limit equal to the then outstanding limit on total orders created by the Upper Limit Rule, with TearLab having an option to purchase any excess quantity that may be available.

 

  The Supplier will invoice and TearLab will pay for the Product in accordance with the usual terms of this Agreement.

 

  (2) Upon termination or expiry of this Agreement for any reason:

 

  (a) TearLab must pay all outstanding undisputed invoices for all completed Purchase Orders; and
     
  (b) each party must immediately return the Confidential Information of the other party to the other party.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 34 -  
     

 

  (3) In the event of any termination of this Agreement other than a termination for cause by MiniFAB under clause 17.2, TearLab shall have the right to require MiniFAB:

 

  (a) to provide all reasonable assistance as requested by TearLab, including transfer of technology, materials, information and documentation, to enable TearLab to manufacture the Product internally or to secure the production and supply of the Product by a third party contractor (whether or not all or part of such technology, materials, information and documentation falls within the MiniFAB Background IP owned by MiniFAB); and
     
  (b) to provide TearLab with the consultancy services of all key engineering personnel of MiniFAB to effect or support such transfer of technology and/or the license to MiniFAB Background IP.

 

    TearLab shall pay MiniFAB for the time spent by MiniFAB’s key personnel in conducting such technology transfer activities as may be requested by TearLab, at MiniFAB’s reasonable and customary rates for similar consultancy, and shall reimburse MiniFAB’s out-of-pocket expenses incurred in conducting such technology transfer.

 

  (4) Except as provided in clause 17.5, termination is without prejudice to the rights of either party for any prior breach.

 

17.5 Continuing right to manufacture

 

  (1) The parties acknowledge that if this Agreement is terminated by MiniFAB prior to the End Date as a result of TearLab being the subject of an Insolvency Event or breach by TearLab or TearLab’s inability to supply the market, such premature termination deprives MiniFAB of the opportunity to earn an appropriate return on its investment in the Products and its expected return from the full expected performance of this Agreement through its expected term. Accordingly, this clause provides certain rights to MiniFAB under these scenarios. Both parties recognize that a significant portion of TearLab’s ability to market and sell its products is subject to a license and royalty agreement with the University of California at San Diego (UCSD). Both parties also acknowledge that no rights conferred in this Agreement can conflict or go beyond the rights granted to TearLab under its current agreement with UCSD and as amended.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 35 -  
     

 

  (2) In recognition of the above, it is agreed that if TearLab ceases to trade or otherwise ceases to supply the Product to the market for a period of at least 60 days for reasons other than (1) lack of supply of product, or (2) a regulatory recall or action which prohibits supply into the market, and no new party acquires the assets to allow it to supply the Product to the market, then MiniFAB will have the right to make and supply the Product to the existing users in the global market, and the following provisions will apply from the termination of this Agreement:

 

  (a) MiniFAB’s obligation under clause 3.3(1) to manufacture the Product exclusively for TearLab and to sell the Product exclusively to TearLab or its designee, and not otherwise to manufacture, sell, warehouse or distribute the Product to any third party shall terminate;
     
  (b) TearLab irrevocably appoints MiniFAB as its worldwide, non-exclusive distributor to market, distribute and sell the Base Cards and/or finished Product, for the period through to 5 years after the End Date commencing from the effective date of termination of this Agreement;
     
  (c) Unless otherwise agreed by MiniFAB, TearLab must maintain the regulatory approvals for the Product, and MiniFAB will reimburse TearLab for the costs and expenses reasonably incurred by TearLab in maintaining the regulatory approvals;
     
  (d) MiniFAB will manufacture the Product on behalf of TearLab in accordance with the Regulatory Requirements, and may market, distribute and sell the Product anywhere in the world, subject to regulatory approvals; and
     
  (e) MiniFAB will pay TearLab a royalty in respect of the ongoing use of the TearLab IP and reliance on the regulatory approvals for the Product equal to 5% of the price received by MiniFAB for the Product, net of any tax (excluding income tax), excise or other governmental charge upon or in relation to the sale of the Product (less any amounts payable to UCSD under the licence contemplated in clause 9.8(2)), plus an amount equivalent to any amount payable by TearLab to UCSD in respect of the sales of the Product by MiniFAB, such royalty to be calculated and paid on a monthly in arrears basis.

 

17.6 Survival
   
  All clauses that by their nature survive expiration or termination of this Agreement will remain in force. For the avoidance of doubt, clauses 1, 1.1, 9.1, 9.6, 9.7(2), 9.8, 13.1, 13.4, 15, 9.2, 17, 18, 19, 20, 22 and 23 survive termination.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 36 -  
     

 

18. Liability and Indemnity
   
18.1 Indemnity by TearLab
   
  TearLab shall indemnify MiniFAB and NewFAB and their Representatives against ail Losses incurred by any of them as result of claims by third persons against any of them arising directly or indirectly as a result of:

 

  (1) any grossly negligent, unlawful, fraudulent or wilful misconduct committed by TearLab or its Representatives in the performance of this Agreement;
     
  (2) the marketing, promotion, sale or supply of the Product by TearLab; or
     
  (3) TearLab’s failure to obtain, maintain or comply in any respect with any Registrations,

 

  except, in each case, to the extent Losses result from any event described in clause 18.2.
   
18.2 Indemnity by MiniFAB
   
  MiniFAB shall indemnify TearLab and its Representatives against all Losses incurred by them as a result of claims by third persons against TearLab arising directly or indirectly, to the extent resulting from:

 

  (1) any grossly negligent, unlawful, fraudulent or wilful misconduct committed by the MiniFAB or NewFAB or their Representatives in the performance of this Agreement;
     
  (2) any manufacturing defect in any Product supplied to TearLab, or any failure of any Product to conform to the Specifications; or
     
  (3) the failure to obtain and maintain all necessary governmental permits for the development and manufacture of Product hereunder,

 

  except, in each case, to the extent Losses result from any event described in clause 18.1.
   
18.3 General provisions applicable to indemnities

 

  (1) A party (the “Indemnitee”) that intends to claim indemnification under this clause 18 shall promptly notify the other party (the “Indemnitor”) of any claim, demand, action or other proceeding for which the Indemnitee intends to claim such indemnification.
     
  (2) The Indemnitor shall have the right to assume and control the defense thereof with counsel selected by the Indemnitor; provided, however, that the Indemnitee shall have the right to retain its own counsel to participate in the defense, subject to Indemnitor’s right to control the defense.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 37 -  
     

 

  (3) The indemnity obligations under this clause 18 shall not apply to amounts paid in settlement of any Loss if such settlement is effected without the prior express written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed.
     
  (4) The failure to deliver notice to the Indemnitor within a reasonable time after notice of any relevant claim, or the commencement of any such action or other proceeding shall not relieve such Indemnitor of all liability to the Indemnitee under this clause 18 with respect thereto, but if such failure is prejudicial to the Indemnitor’s ability to defend such claim, and if such prejudice results in Losses that otherwise would likely have been avoided or reduced if timely notice had been given, then the Indemnitor shall be relieved of said part of the Losses.
     
  (5) The Indemnitor may not settle or otherwise consent to an adverse judgment in any such claim, that diminishes the rights or interests of the Indemnitee without the prior express written consent of the Indemnitee, which consent shall not be unreasonably withheld or delayed (it being understood that no consent by the Indemnitee is required for the Indemnitor to obtain a full release of all claims by a third person against an Indemnitee in exchange solely for the payment of a settlement amount by Indemnitor).
     
  (6) The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any claim covered by this clause 18.
     
  (7) The indemnities contained in this clause 18 do not negate the obligation of the party having the benefit of such indemnity to mitigate its Losses: and are continuing obligations on each party, separate and independent of any other obligation.

 

18.4 No consequential damages
   
  Except for any liability under clause 19 or the indemnity provided under clauses 18.1 or 18.2, to the extent permitted by law, neither party will be liable to the other party in any circumstances for any special, incidental, punitive, exemplary, consequential or any other indirect loss or damage, or in any event for any loss of revenue, loss of production, loss of profit or loss of data.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 38 -  
     

 

19. Confidentiality
   
19.1 Prohibited acts
   
  Neither party may, without the other party’s prior written consent, copy or disclose or cause to be copied or disclosed any Confidential Information of the other party other than to the extent that such Confidential Information must be disclosed:

 

  (1) to the party’s sub-contractors, employees, legal advisers, auditors, investors or other consultants in order for this Agreement to be performed, provided that the recipients of the information undertake in writing to the party to keep that information strictly confidential; or
     
  (2) to Regulatory Authorities as required to obtain or maintain any regulatory approvals.

 

19.2 Permitted uses
   
  Each party may only make use of Confidential Information of the other party to the extent necessary to enable the party to perform its obligations or exercise its rights under this Agreement.
   
19.3 Excluded Information
   
  For the purposes of this clause, Confidential Information does not include any information which the receiving party can establish:

 

  (1) was in the public domain when it was disclosed to the receiving party;
     
  (2) becomes, after being disclosed to the receiving party, part of the public domain, except through disclosure contrary to this Agreement;
     
  (3) was already in the receiving party’s possession when it was disclosed to the receiving party and was not otherwise acquired from the other party directly or indirectly; or
     
  (4) was lawfully disclosed to the receiving party by a third party having the unrestricted legal right to disclose that information without requiring the maintenance of confidentiality.

 

  Prior to making a disclosure of information which the receiving party alleges is no longer or never was Confidential Information by virtue of falling within one of the above exceptions, the receiving party must give to the other party 10 Business Days’ notice of the proposed disclosure and the reasons for the exception applying,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 39 -  
     

 

19.4 Compulsory disclosures
   
  The obligations of confidentiality in this clause do not apply to a receiving party where the receiving party is required under the lawful compulsion of any court, tribunal, authority or regulatory body to disclose any Confidential Information of the other party. Provided that before a party discloses any Confidential Information pursuant to the foregoing it must provide the other party with reasonable notice to enable it to seek a protective court order or other remedy in respect of the Confidential Information, and it must provide the other party with all assistance and co-operation which the other party considers necessary to obtain such protective court order or other remedy.
   
19.5 Protection of information
   
  Each party must notify the other party in writing immediately upon the discovery of arty apparent unauthorised use or disclosure of any Confidential Information and take all reasonable steps to enforce the confidentiality obligations imposed or required to be imposed by this clause 19 including diligently prosecuting at its cost any breach or threatened breach of any such confidentiality obligations by any person to whom it has disclosed or allowed access to the Confidential Information or at the other party’s option making all reasonable efforts to assist the other party to help regain possession of the Confidential Information and prevent any further unauthorised disclosure or use.
   
19.6 Confidentiality of agreement
   
  The parties must maintain absolute confidentiality concerning the existence and subject matter of this Agreement and no public announcement or communication relating to the negotiations of the parties or the existence, subject matter or terms of this Agreement may be made or authorised by a party without the prior written approval of the other party except that the following disclosures may be made in relation to this Agreement:

 

  (1) by either party to its sub-contractors, employees, auditors, consultants, professional advisers, bankers, financial advisers, financiers, investors and potential investors upon those persons undertaking to keep confidential any information so disclosed; or
     
  (2) to comply with any applicable law or requirement of any Governmental Agency or of any public stock exchange on which shares of the disclosing party are listed.

 

19.7 Return of Confidential information
   
  Each party agrees that on termination or expiration of this Agreement it will deliver to that other party any and all materials containing or embodying that other party’s Confidential Information and any copies thereof; provided that each party shall be entitled to retain one (1) copy of the other party’s Confidential Information, to be kept at such party’s legal files for use solely for the purpose of ensuring continued compliance with the terms of this Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 40 -  
     

 

20. Disputes
   
20.1 Attempt to Settle
   
  If a dispute arises between the parties in connection with this Agreement then the parties must use all reasonable endeavours acting in good faith to settle the dispute as soon as practicable.
   
20.2 Limitations on Court Proceedings
   
  A party must not commence court proceedings in relation to a dispute arising in connection with this Agreement until it has exhausted the procedures in this clause 20, unless the party seeks urgent interlocutory relief.
   
20.3 Disputes relating to Products
   
  If the dispute relates to whether or not a particular Product meets the relevant Specifications and the Regulatory Requirements, then the parties must submit the dispute to an independent laboratory, which will act as an expert in determining whether or not the Product meets the relevant Specifications and the Regulatory Requirements; provided, however, that if it is not technically feasible to make such independent laboratory determination in connection with a particular dispute (e.g., if insufficient number of samples of a relevant lot of Product is available), then such dispute shall be determined by arbitration under clause 20.5.
   
20.4 Other disputes
   
  If a dispute does not relate to whether or not a particular Product meets the relevant Specifications and the Regulatory Requirements and the parties are unable in good faith to settle the dispute within 20 Business Days after the dispute arose, then either party may submit the matter to arbitration under clause 20.5.
   
20.5 Arbitration

 

  (1) If any dispute arises under, or in connection with, this Agreement and/or in connection with any breach or alleged breach of this Agreement, and such matter is not resolved pursuant to clause 20.1 or 20.3 or by other agreement of the parties, such matter shall be finally resolved through binding arbitration as set forth in this clause 20.5. Either party may initiate arbitration of such a matter, and the party initiating arbitration of such dispute must give to the other party or parties to the dispute notice specifying the dispute and requiring its resolution under this clause 20.5 (Notice of Dispute). Such Notice of Dispute shall be given in accordance with the arbitration rules specified under this clause 20.5.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 41 -  
     

 

  (2) Each such dispute is by this clause 20.5 referred to binding arbitration for final resolution. The arbitration must be conducted in:

 

  (a) Melbourne, Australia if the Notice of Dispute is given by TearLab; and
     
  (b) San Diego California, USA, if the Notice of Dispute is given by MiniFAB.

 

  (3) If the parties have not agreed upon the arbitrator within 7 days after the Notice of Dispute is given, the arbitrator will be appointed in accordance with the then-current rules of the International Centre for Dispute Resolution.
     
  (4) The arbitrator must not be a present or former member, officer, employee or agent of a party to the dispute or a person who has acted as a mediator or advised any party in connection with the dispute.
     
  (5) The arbitration shall be conducted in accordance with the then-current rules of the International Centre for Dispute Resolution by one (1) arbitrator appointed in accordance with such rules. The arbitrator shall determine what discovery will be permitted, consistent with the goal of limiting the cost and time which the parties must expend for discovery; provided the arbitrator shall permit such discovery as the arbitrator deems necessary to permit an equitable resolution of the dispute. The arbitrator shall not order or require discovery against either party of a type or scope that is not permitted against the other party. The costs of the arbitration, including administrative and arbitrators’ fees, shall be shared equally by the parties, and each party shall bear its own costs and attorneys’ and witness’ fees incurred in connection with the arbitration. Any arbitration subject to this Article shall be completed within one (1) year from the filing of notice of a request for such arbitration. No punitive damages may be granted by the arbitrator. The arbitration proceedings and the decision shall not be made public without the joint consent of the parties, and each party shall maintain the confidentiality of such proceedings and decision unless otherwise permitted by the other party, except to the extent (and solely to the extent) either party is required to disclose such information by applicable securities or other laws. The parties agree that the decision shall be the sole, exclusive and binding remedy between them regarding any and all disputes, controversies, claims and counterclaims presented to the arbitrator. Any award may be entered in a court of competent jurisdiction for a judicial recognition of the decision and applicable orders of enforcement, and either party may apply to any court of competent jurisdiction for appropriate temporary injunctive relief pending resolution of any arbitration proceeding. The arbitrator shall provide a written arbitration award setting forth the arbitrator’s findings on material questions of law and of fact, including references to the evidence on which the findings of fact were based. Each party may be represented by a qualified legal practitioner or other representative.
     
  (6) This clause 20.5 applies even where the Agreement is otherwise void or voidable.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 42 -  
     

 

20.6 Continuing Obligations
   
  Except as specifically provided in this Agreement, the parties must continue to perform their obligations under this Agreement despite the existence of a dispute or any steps being taken under this clause 20.

 

21. Force Majeure
   
21.1 Party not liable
   
  Where a party is required under this Agreement to perform an obligation or do any act or thing by a designated time or date (Obligation), the party is not liable for any delay in performing or for failure to perform an Obligation where the delay or failure arises from Force Majeure and that party has complied with this clause.
   
21.2 Notice of Force Majeure
   
  A party who claims Force Majeure must

 

  (1) give the other party prompt notice of the Force Majeure with reasonably full particulars and an estimate of the extent and duration of its delay in performance, or inability to perform; and

 

21.3 Termination in case of Force Majeure
   
  If the delay continues beyond 30 days after the notice given under clause 21.2, the parties must meet to discuss in good faith a mutually satisfactory resolution of the problem and, if unable to achieve such a resolution within a further 60 days, either party may elect to terminate this Agreement by 30 days’ prior written notice to the other.

 

22. Notices
   
22.1 A notice or other communication connected with this Agreement (Notice) has no legal effect unless it is in writing.
   
22.2 In addition to any other method of service provided by law, the Notice may be:

 

  (1) sent by prepaid post to the address of the addressee set out in this Agreement or subsequently notified;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 43 -  
     

 

  (2) sent by facsimile to the facsimile number of the addressee;
     
  (3) sent via email to the email address of the addressee; or
     
  (4) delivered at the address of the addressee set out in this Agreement or subsequently notified.

 

22.3 If the Notice is sent or delivered in a manner provided by clause 22.2, it must be treated as given to and received by the party to which it is addressed:

 

  (1) if sent by facsimile or email, on the next Business Day at the place of receipt, unless a transmission failure notice is received by the sender; or
     
  (2) if sent by post or otherwise, upon receipt by the addressee.

 

22.4 Despite clause 22.3(1):

 

  (1) a facsimile is not treated as given or received unless at the end of the transmission the sender’s facsimile machine issues a report confirming the transmission of the number of pages in the Notice;
     
  (2) a facsimile is not treated as given or received if it is not received in full and in legible form and the addressee notifies the sender of that fact by the close of the Business Day on which it would otherwise be treated as given and received.

 

23. General
   
23.1 Communication
   
  Each party will on an ongoing basis by fully responsive to requests from the other for approvals or the provision of information relevant to the first party’s activities under the Agreement.
   
23.2 Further assurance
   
  Each party must promptly at its own cost do all things (including executing and if necessary delivering all documents) necessary or desirable to give full effect to this Agreement, to the extent commercially reasonable to do so.
   
23.3 Entire understanding
   
  This Agreement is the entire agreement and understanding between the parties on everything connected with the subject matter of this Agreement and supersedes any prior agreement or understanding on anything connected with that subject matter on the going-forward basis from the Effective Date.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 44 -  
     

 

23.4 Variation
   
  An amendment or variation to this Agreement is not effective unless it is in writing and signed by the parties.
   
23.5 Assignment within corporate structure
   
  Neither party may assign its right or obligations under this Agreement without the consent of the other party, except where the assignee is related body corporate to the assignor. In this clause, where a body corporate is: (a) a holding company of another body corporate; or (b) a subsidiary of another body corporate; or (c) a subsidiary of a holding company of another body corporate; the first-mentioned body and the other body are related to each other.
   
23.6 No assignment of bare IP
   
  TearLab may not assign the benefit of any Intellectual Property rights granted by MiniFAB or NewFAB under this Agreement independent of the obligations of this Agreement without the written consent of MiniFAB, which may be given on such terms as it reasonably considers necessary to protect its right under this Agreement.
   
23.7 Waiver
   
  A party’s failure or delay to exercise a power or right does not operate as a waiver of that power or right. The exercise of a power or right does not preclude either its exercise in the future or the exercise of any other power or right. A waiver is not effective unless it is in writing. Waiver of a power or right is effective only in respect of the specific instance to which it relates and for the specific purpose for which it is given.
   
23.8 Costs and outlays
   
  Each party must pay its own costs and outlays connected with the negotiation, preparation and execution of this Agreement.
   
23.9 Governing law and jurisdiction
   
  This Agreement shall be governed and construed in accordance with the laws of England, United Kingdom
   
23.10 Affiliates Actions
   
  Each party will ensure that none of its affiliates takes any action which is inconsistent with that Party’s obligations under this Agreement, or which if it was done or not done under this Agreement by that party would amount to a breach of this Agreement by that party.

 

[Signature page follows]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 45 -  
     

 

Executed as an agreement.    
     
Executed by MINIFAB (AUST) PTY LTD    
in accordance with section 127 of the    
Corporations Act 2001:    
     
/s/ Michael Wilkinson   /s/ Erol Harvey
Director/company secretary   Director
     
Michael Wilkinson   Erol Harvey
Name of director/company secretary   Name of director
(BLOCK LETTERS)   (BLOCK LETTERS)
     
Signed for and on behalf of TearLab    
Research, Inc. by its authorized    
representative in the presence of:    
     
/s/ Wes Brazell   /s/ Seph Jensen
Signature of witness   Signature of authorised representative
     
Wes Brazell   Seph Jensen
Name of witness   Name of authorised representative
(BLOCK LETTERS)   (BLOCK LETTERS)
     
940 S. Kimball, Southlake, TX, USA    
Address of witness    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 46 -  
     

 

Schedule 1 - Pricing Schedule

 

2. Price

 

Both parties acknowledge the need for a pricing transition structure to address the pricing mechanisms under the Original Agreement as well as the existing inventory as of the date of the Agreement. The Initial TCI Card Volume and the Transition Payments noted below represent complete disposition of any pricing adjustments from the Original Agreement. In addition, the Initial TCI Card Volume up to [***] units are for the first units of product purchased in the aggregate without regard to year. After an aggregate of [***] products are purchased, the price of all units will revert to $[***] per unit until the Final Tier Trigger is reached.

 

The Price for each Product is as set out in the tables below.

 

Initial TCI Card Volume *   TCI Card Price USD
[***]   [***]
     
[***]   [***]
     
[***]   [***]
     
[***]   [***]

 

* The ‘Final Tier Trigger’ is reached on the earlier of:

 

  (1) the date when the annual card volume in any twelve (12) month period exceeds 4,500,000 cards; or
     
  (2) March 31, 2018

 

All sales of cards from MiniFAB to TearLab made after the date on which the Final Tier Trigger occurs will be based on the Final Tier pricing set out in the table below.

 

Final Tier TCI Card Volume **   TCI Card Price USD
[***]   [***]
     
[***]   [***]
     
[***]   [***]
     
[***]   [***]

 

** TCI Card Price per Product will be determined at the end of each month, by reference to the relevant Final Tier TCI Card Volume to be applicable to orders placed in the following month based on the total number of Products ordered in the rolling twelve (12) month period ending on the last day of the expiring month.

 

The Transition Payments to be made by TearLab to MiniFab are set out in the table below.

 

Transition Payment Timing   Amount USD
[***]   [***]
     
[***]   [***]
     
[***]   [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 47 -  
     

 

Schedule 2

Base Card

 

Name

 

Osmolarity Tear Collection Interface Base Chip (Base TCI cards)

 

Description

 

A Base Test Card for collecting tear fluid and measuring osmolarity, as more particularly described in the applicable Requirements Definitions and Specifications.

 

Osmolarity Base Test Chip means the tear collection device, without capsule and packaging, developed by MiniFAB and TearLab to measure osmolarity. The osmolarity test card (TCI card interface) is described in PRD0001 (A copy of which is annexed to this Agreement).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 48 -  
     

 

Schedule 3

Finished Product

 

Name

 

Osmolarity Test Cards (TCI cards)

 

Description

 

A Test Card for measuring osmolarity, as more particularly described in the applicable Requirements Definitions and Specifications.

 

Osmolarity Test Card means the tear collection device developed by MiniFAB and TearLab to measure osmolarity. The osmolarity test card (TCI card interface) is described in PRD0001 (A copy of which is annexed to this Agreement).

 

All price and cost information is based on a tested and packaged osmolarity test card, packaged and configured as mutually agreed.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 49 -  
     

 

Schedule 4

Deed Poll of Accession

 

Deed Poll dated

 

Name

 

Address

 

(Acceding Party)

 

Introduction

 

This deed poll is supplemental to the Manufacturing and Supply Agreement between MiniFAB (Aust) Pty Ltd and TearLab Research, Inc. (TearLab) dated on or about [date] (Manufacturing and Supply Agreement).

 

Operative part

 

1. The Acceding Party confirms that it has been supplied with a copy of the Manufacturing and Supply Agreement and covenants with all present parties to the Manufacturing and Supply Agreement (whether original or by accession) (“Parties’’) to observe, perform and be bound by the Manufacturing and Supply Agreement so that the Acceding Party is deemed, from the date on which a copy of this deed poll is delivered to TearLab, to be a party to the Manufacturing and Supply Agreement.
   
2 This deed poll is governed in accordance with the laws of England, United Kingdom.
   
3. The Acceding Party’s address details for services of notices under the Manufacturing and Supply Agreement are:

 

 

Name: #Company name#’
Attention: #name#
Address: #address#
Facsimile no: #fax number#
Electronic mail address: #email address#

 

Executed as a deed poll.

 

[Insert appropriate execution clause]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 50 -  
     

 

Annexure A

Requirement Definitions of Product

 

[#To be inserted]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 51 -  
     

 

Annexure B

Specifications for Product

 

[# To be inserted]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 52 -  
     

 

Annexure C

Manufacturing Plan Version 1.1

 

[#To be inserted]

 

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

  - 53 -  
     

 

AMENDMENT 4 TO TERM LOAN AGREEMENT

 

THIS AMENDMENT 4, dated as of April 7, 2016 (this “ Amendment ”) is made among TearLab Corporation, a Delaware corporation (“ Borrower ”), the subsidiary guarantors listed on the signature pages hereof under the heading “SUBSIDIARY GUARANTORS” (each a “ Subsidiary Guarantor ” and, collectively, the “ Subsidiary Guarantors ”) and the lenders listed on the signature pages hereof under the heading “LENDERS” (each a “ Lender ” and, collectively, the “ Lenders ”), with respect to the Loan Agreement referred to below.

 

RECITALS

 

WHEREAS, the Borrower and the Lenders are parties to a Term Loan Agreement, dated as of March 4, 2015, as amended by the Omnibus Amendment Agreement, dated as of April 2, 2015, by Amendment 2, dated as of August 6, 2015, and by Amendment 3, dated as of December 31, 2015 (the “ Loan Agreement ”), with the Subsidiary Guarantors from time to time party thereto.

 

WHEREAS, the Borrower has informed the Lenders that its Subsidiary, OcuHub Holdings, Inc. (“ OcuHub Holdings ”) has sold 9,082 membership units (the “ OcuHub Units ”) of its subsidiary, OcuHub LLC, pursuant to that certain Unit Purchase Agreement dated as of April 7, 2016, such OcuHub Units representing the majority of OcuHub LLC membership units previously owned by OcuHub Holdings.

 

WHEREAS, OcuHub LLC is a Subsidiary Guarantor under the Loan Agreement.

 

WHEREAS, the Borrower has requested, and Lenders have agreed, to terminate the guarantee provided by OcuHub LLC under the Loan Agreement (the “ OcuHub Guarantee ”).

 

WHEREAS, the parties hereto desire, on the terms and subject to the conditions set forth herein, to amend the Loan Agreement, terminate the OcuHub Guarantee and release OcuHub LLC of its Obligations under the Loan Agreement and each other Loan Document to which it is a party.

 

NOW, THEREFORE, in consideration of the mutual agreements, provisions and covenants contained herein, the parties agree as follows:

 

SECTION 1. Definitions; Interpretation .

 

(a) Terms Defined in Loan Agreement . All capitalized terms used in this Amendment (including in the recitals hereof) and not otherwise defined herein shall have the meanings assigned to them in the Loan Agreement.

 

(b) Interpretation . The rules of interpretation set forth in Section 1.03 of the Loan Agreement shall be applicable to this Amendment and are incorporated herein by this reference.

 

     
 

 

SECTION 2. Amendment . Subject to Section 4 , the Loan Agreement is hereby amended as follows:

 

(a) All references in the Loan Agreement to “Permitted Priority Debt” are hereby deleted.

 

(b) Section 1.01 of the Loan Agreement is amended by deleting the definition of “Permitted Priority Debt”.

 

(c) Section 6.02(g) of the Loan Agreement is amended by replacing the “$5.00” at the end of such section with “$1.50”.

 

(d) Section 9.01(c) of the Loan Agreement is amended and restated in its entirety as follows:

 

“(c) [Reserved];”

 

(e) Section 9.02(c) of the Loan Agreement is amended and restated in its entirety as follows:

 

“(c) [Reserved];”

 

(f) Section 10.01 of the Loan Agreement is amended and restated in its entirety as follows:

 

“Borrower shall maintain at all times Liquidity in an amount in excess of $5,000,000.”

 

(g) Sections 10.02(b)-(f) of the Loan Agreement are amended and restated in their entirety as follows:

 

(b) during the twelve month period beginning on January 1, 2016, of at least $27,000,000;

 

(c) during the twelve month period beginning on January 1, 2017, of at least $31,000,000;

 

(d) during the twelve month period beginning on January 1, 2018, of at least $36,000,000;

 

(e) during the twelve month period beginning on January 1, 2019, of at least $45,000,000;

 

(f) during the twelve month period beginning on January 1, 2020, of at least $55,000,000.”

 

(h) Annex B to the Form of Compliance Certificate attached to the Loan Agreement as Exhibit E is replaced in its entirety with Exhibit A attached hereto.

 

  2  
 

 

SECTION 3. Termination of Guarantee. Subject to Section 4 , the Lenders here agree that:

 

(a) The OcuHub Guarantee is hereby irrevocably, absolutely and unconditionally terminated and discharged (except any provisions thereof that expressly survive termination thereof) without any further action.

 

(b) OcuHub LLC is hereby irrevocably, absolutely and unconditionally released from any and all Obligations under the Loan Agreement and each other Loan Document to which it is a party.

 

SECTION 4. Conditions of Effectiveness . The effectiveness of Sections 2 and 3 shall be subject to the following conditions precedent:

 

(a) The Borrower shall have paid or reimbursed Lenders for Lenders’ reasonable out of pocket costs and expenses incurred in connection with this Amendment, including Lenders’ reasonable and documented out of pocket legal fees and costs, pursuant to Section 12.03(a)(i)(z) of the Loan Agreement.

 

(b) The representations and warranties in Section 5 shall be true in all material respects on the date hereof and on the first date on which the condition set forth in Section 4(a) shall have been satisfied.

 

SECTION 5. Representations and Warranties; Reaffirmation .

 

(a) The Borrower hereby represents and warrants to each Lender as follows:

 

(i) The Borrower has full power, authority and legal right to make and perform this Amendment. This Amendment is within the Borrower’s corporate powers and has been duly authorized by all necessary corporate and, if required, by all necessary shareholder action. This Amendment has been duly executed and delivered by the Borrower and constitutes a legal, valid and binding obligation of the Borrower, enforceable against the Borrower in accordance with its terms, except as such enforceability may be limited by (a) bankruptcy, insolvency, reorganization, moratorium or similar laws of general applicability affecting the enforcement of creditors’ rights and (b) the application of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law). This Amendment (x) does not require any consent or approval of, registration or filing with, or any other action by, any Governmental Authority or any third party, except for such as have been obtained or made and are in full force and effect, (y) will not violate any applicable law or regulation or the charter, bylaws or other organizational documents of the Borrower and its Subsidiaries or any order of any Governmental Authority, other than any such violations that, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect, (z) will not violate or result in an event of default under any material indenture, agreement or other instrument binding upon the Borrower and its Subsidiaries or assets, or give rise to a right thereunder to require any payment to be made by any such Person.

 

(ii) No Default has occurred or is continuing or will result after giving effect to this Amendment.

 

  3  
 

 

(iii) The representations and warranties made by or with respect to the Borrower in Section 7 of the Loan Agreement are true in all material respects (taking into account any changes made to schedules updated in accordance with Section 7.21 of the Loan Agreement or attached hereto), except that such representations and warranties that refer to a specific earlier date were true in all material respects on such earlier date.

 

(iv) There has been no Material Adverse Effect since the date of the Loan Agreement.

 

(b) The Borrower hereby ratifies, confirms, reaffirms, and acknowledges its obligations under the Loan Documents to which it is a party and agrees that the Loan Documents remain in full force and effect, undiminished by this Amendment, except as expressly provided herein. By executing this Amendment, the Borrower acknowledges that it has read, consulted with its attorneys regarding, and understands, this Amendment.

 

SECTION 6. Governing Law; Submission to Jurisdiction; Waiver of Jury Trial .

 

(a) Governing Law . This Amendment and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance with, the law of the State of New York, without regard to principles of conflicts of laws that would result in the application of the laws of any other jurisdiction; provided that Section 5-1401 of the New York General Obligations Law shall apply.

 

(b) Submission to Jurisdiction . The Borrower agrees that any suit, action or proceeding with respect to this Amendment or any other Loan Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in Houston, Texas or in the courts of its own corporate domicile and irrevocably submits to the non-exclusive jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment. This Section 6 is for the benefit of the Lenders only and, as a result, no Lender shall be prevented from taking proceedings in any other courts with jurisdiction. To the extent allowed by applicable Laws, the Lenders may take concurrent proceedings in any number of jurisdictions.

 

(c) Waiver of Jury Trial . The Borrower and each Lender hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any suit, action or proceeding arising out of or relating to this Amendment, the other Loan Documents or the transactions contemplated hereby or thereby .

 

SECTION 7. Miscellaneous .

 

(a) No Waiver . Nothing contained herein shall be deemed to constitute a waiver of compliance with any term or condition contained in the Loan Agreement or any of the other Loan Documents or constitute a course of conduct or dealing among the parties. Except as expressly stated herein, the Lenders reserve all rights, privileges and remedies under the Loan Documents. Except as amended hereby, the Loan Agreement and other Loan Documents remain unmodified and in full force and effect. All references in the Loan Documents to the Loan Agreement shall be deemed to be references to the Loan Agreement as amended hereby.

 

  4  
 

 

(b) Severability . In case any provision of or obligation under this Amendment shall be invalid, illegal or unenforceable in any jurisdiction, the validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.

 

(c) Headings . Headings and captions used in this Amendment (including the Exhibits, Schedules and Annexes hereto, if any) are included for convenience of reference only and shall not be given any substantive effect.

 

(d) Integration . This Amendment constitutes a Loan Document and, together with the other Loan Documents, incorporates all negotiations of the parties hereto with respect to the subject matter hereof and is the final expression and agreement of the parties hereto with respect to the subject matter hereof.

 

(e) Counterparts . This Amendment may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument and any of the parties hereto may execute this Amendment by signing any such counterpart.

 

(f) Controlling Provisions . In the event of any inconsistencies between the provisions of this Amendment and the provisions of any other Loan Document, the provisions of this Amendment shall govern and prevail. Except as expressly modified by this Amendment, the Loan Documents shall not be modified and shall remain in full force and effect.

 

[Remainder of page intentionally left blank]

 

  5  
 

 

IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment, as of the date first above written.

 

  BORROWER:
     
  TEARLAB CORPORATION
     
  By: /s/ Wes Brazell
  Name: Wes Brazell
  Title: Chief Financial Officer
     
  SUBSIDIARY GUARANTORS:
     
  TEARLAB RESEARCH, INC.
     
  By : /s/ Wes Brazell
  Name: Wes Brazell
  Title: Chief Financial Officer
     
  OCUHUB HOLDINGS, INC.
     
  By: /s/ Wes Brazell
  Name: Wes Brazell
  Title: Chief Financial Officer
     
  OCCULOGIX CANADA CORP.
     
  By: /s/ Wes Brazell
  Name: Wes Brazell
  Title: Chief Financial Officer

 

[ Signature page 1 to Fourth Amendment to Term Loan Agreement ]

 

     
 

 

  Agreed and acknowledged with respect to Section 3 only:
     
  OCUHUB LLC
     
  By: /s/ Seph Jensen
  Name: Seph Jensen
  Title: CEO

 

[ Signature page 2 to Fourth Amendment to Term Loan Agreement ]

 

     
 

 

LENDERS:

 

CAPITAL ROYALTY PARTNERS II L.P.

      By CAPITAL ROYALTY PARTNERS II GP

     L.P., its General Partner

               By CAPITAL ROYALTY PARTNERS II

               GP LLC, its General Partner

 

By: /s/ Nathan Hukill  
Name: Nathan Hukill  
Title: Authorized Signatory  

 

PARALLEL INVESTMENT OPPORTUNITIES
PARTNERS II L.P.

     By PARALLEL INVESTMENT
     OPPORTUNITIES PARTNERS II GP L.P., its
      General Partner

               By PARALLEL INVESTMENT
              OPPORTUNITIES PARTNERS II GP LLC,

               its General Partner

 

By : /s/ Nathan Hukill  
Name: Nathan Hukill  
Title: Authorized Signatory  

 

CRG Issuer 2015-1  
By CRG Servicing LLC , as Administrator  
     
By: /s/ Nathan Hukill  
Name: Nathan Hukill  
Title President  

 

[ Signature page 3 to Fourth Amendment to Term Loan Agreement ]

 

     
 

 

Exhibit A

 

(See attached)

 

     
 

 

Annex B to Compliance Certificate

 

CALCULATIONS OF FINANCIAL COVENANT COMPLIANCE

 

I.   Section 10.01: Minimum Liquidity    
         
A.   Amount of unencumbered cash and Permitted Cash Equivalent Investments (which for greater certainty shall not include any undrawn credit lines), in each case, to the extent held in an account over which the Lenders have a first priority perfected security interest, subject to Permitted Priority Liens:   $__________
         
    Is Line IA equal to or greater than $5,000,000?:   Yes: In compliance;
No: Not in compliance
         
II.   Section 10.02(a)-(f): Minimum Revenue—Subsequent Periods    
         
A.   Revenues during the twelve month period beginning on January 1, 2015   $__________
         
    [Is line II.A equal to or greater than $25,000,000?   Yes: In compliance;
No: Not in compliance] 1
         
B.   Revenues during the twelve month period beginning on January 1, 2016   $__________
         
    [Is line II.B equal to or greater than $27,000,000?   Yes: In compliance;
No: Not in compliance] 2
         
C.   Revenues during the twelve month period beginning on January 1, 2017   $__________
         
    [Is line II.C equal to or greater than $31,000,000?   Yes: In compliance;
No: Not in compliance] 3
         
D.   Revenues during the twelve month period beginning on January 1, 2018   $__________
         
    [Is line II.D equal to or greater than $36,000,000?   Yes: In compliance;
No: Not in compliance] 4
         
E.   Revenues during the twelve month period beginning on January 1, 2019   $__________
         
    [Is line II.E equal to or greater than $45,000,000?   Yes: In compliance;
No: Not in compliance] 5
         
F.   Revenues during the twelve month period beginning on January 1, 2020    
         
    [Is line II.F equal to or greater than $55,000,000?   Yes: In compliance;
No: Not in compliance] 6

 

 

 

1 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2015 pursuant to Section 8.01(b) of the Loan Agreement.

2 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2016 pursuant to Section 8.01(b) of the Loan Agreement.

3 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2017 pursuant to Section 8.01(b) of the Loan Agreement.

4 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2018 pursuant to Section 8.01(b) of the Loan Agreement.

5 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2019 pursuant to Section 8.01(b) of the Loan Agreement.

6 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2020 pursuant to Section 8.01(b) of the Loan Agreement.

 

     
 

 

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO RULE 13A-14 OR 15D-14 OF THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Joseph Jensen, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of TearLab 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 control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
   
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under the Company’s 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 the Company’s supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
   
c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report the Company’s 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 the Company’s most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of Registrant’s board of directors (or persons performing the equivalent function):
   
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:  May 9, 2016

 

  /s/ Joseph Jensen
  Joseph Jensen
  Chief Executive Officer

 

 
 

 

 

Exhibit 31.2

 

CERTIFICATION PURSUANT TO RULE 13A-14 OR 15D-14 OF THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Wes Brazell, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of TearLab 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 control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
   
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under the Company’s 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 the Company’s supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
   
c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report the Company’s 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 the Company’s most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of Registrant’s board of directors (or persons performing the equivalent function):
   
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: May 9, 2016

 

  /s/ Wes Brazell
  Wes Brazell
  Chief Financial Officer

 

 
 

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of TearLab Corporation (the “Company”) for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joseph Jensen, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

  By: /s/ Joseph Jensen
    Joseph Jensen
    Chief Executive Officer

 

Dated: May 9, 2016

 

 
 

 

Exhibit 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of TearLab Corporation (the “Company”) for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Wes Brazell, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

  By:  /s/ Wes Brazell
    Wes Brazell
    Chief Financial Officer

 

Dated: May 9, 2016