UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q


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

For the quarterly period ended June 30, 2016

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

Commission File Number: 001-36242

ADAMIS PHARMACEUTICALS CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware   82-0429727

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification Number)

11682 El Camino Real, Suite 300, San Diego, CA 92130

(Address of principal executive offices, including zip code)

(858) 997-2400

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Sections 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  ☒    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  ☒    No  ☐

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

Large accelerated filer   Accelerated filer
         
Non-accelerated filer   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  ☒

The number of shares outstanding of the issuer’s common stock, par value $0.0001 per share, as of August 15, 2016, was 20,886,829.

 
 

 

ADAMIS PHARMACEUTICALS, INC.

CONTENTS OF QUARTERLY REPORT ON FORM 10-Q

 

      Page
PART I FINANCIAL INFORMATION    
       
Item 1. Financial Statements:    
       
  Condensed Consolidated Balance Sheets   3
       
  Condensed Consolidated Statements of Operations   4
       
  Condensed Consolidated Statements of Cash Flows   5–6
       
  Notes to Condensed Consolidated Financial Statements   7
       
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   4
       
Item 3. Quantitative and Qualitative Disclosure of Market Risk   34
       
Item 4. Controls and Procedures   34
       
PART II OTHER INFORMATION    
       
Item 1. Legal Proceedings   35
       
Item 1A. Risk Factors   35
       
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   35
       
Item 3. Defaults Upon Senior Securities   36
       
Item 4. Mine Safety Disclosures   36
       
Item 5. Other Information   36
       
Item 6. Exhibits   37
       
Signatures   38

 

     
 

ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

    June 30, 2016        
    (Unaudited)     December 31, 2015  
ASSETS                
CURRENT ASSETS                
Cash   $ 417,076     $ 4,080,648  
Accounts Receivable, net     744,703        
Inventories, net     1,226,097        
Prepaid Expenses and Other Current Assets     170,823       70,985  
      2,558,699       4,151,633  
LONG TERM ASSETS                
Security Deposits     85,000       85,000  
Intangible Assets, net     19,371,395       7,766,960  
Goodwill     2,225,101        
Building and Equipment, net     5,125,395       58,260  
Total Assets   $ 29,365,590     $ 12,061,853  
LIABILITIES AND STOCKHOLDERS’ EQUITY                
CURRENT LIABILITIES                
Accounts Payable   $ 4,174,197     $ 497,794  
Accrued Other Expenses     1,967,605       214,036  
Accrued Bonuses     470,220       478,274  
Bank Loans - Line of Credit     4,115,792        
Bank Loans - Building and Equipment     3,606,766        
Warrants, at fair value           1,174,312  
Warrant Derivative Liabilities, at fair value           383,404  
Total Liabilities     14,334,580       2,747,820  
                 
COMMITMENTS AND CONTINGENCIES                
STOCKHOLDERS’ EQUITY                
Preferred Stock - Par Value $.0001; 10,000,000 Shares Authorized; Series A Convertible, Zero and 1,009,021 Issued and Outstanding at June 30, 2016 and December 31, 2015, Respectively           101  

Common Stock - Par Value $.0001; 100,000,000 Shares Authorized; 17,621,114 and  13,739,199 Issued, 17,313,574 and 13,431,659 Outstanding at June 30, 2016 and December 31, 2015, Respectively

    1,762       1,374  
Additional Paid-in Capital     96,178,713       78,339,143  
Accumulated Deficit     (81,144,236 )     (69,021,356 )
Treasury Stock - 307,540 Shares, at cost     (5,229 )     (5,229 )
Total Stockholders’ Equity     15,031,010       9,314,033  
    $ 29,365,590     $ 12,061,853  

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements 

  3  
 

 

ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES  

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    Three Months Ended     Six Months Ended  
    June 30, 2016     June 30, 2015     June 30, 2016     June 30, 2015  
    (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  
REVENUE, net   $ 1,928,103     $     $ 1,928,103     $  
COST OF GOODS SOLD   1,346,030         1,346,030        
                  Gross Profit     582,073             582,073        
                                 
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES     4,583,097       2,261,831       7,199,481       5,055,377  
RESEARCH AND DEVELOPMENT     3,429,899       1,269,590       6,830,719       2,624,913  
Loss from Operations     (7,430,923 )     (3,531,421 )     (13,448,127 )     (7,680,290 )
OTHER INCOME (EXPENSE)                                
Interest Expense     (72,391         (72,391    
Interest Income     167             167        
Change in Fair Value of Warrants     1,432,052     (92,026     1,049,330       1,000,032  
Change in Fair Value of Warrant Derivative Liabilities     356,706     (21,454 )     348,141     (106,349 )
Total Other Income (Expense)     1,716,534     (113,480 )     1,325,247       893,683  
Net (Loss)   $ (5,714,389 )   $ (3,644,901 )   $ (12,122,880 )   $ (6,786,607 )
Basic and Diluted (Loss) Per Share:                                
                                 
Basic (Loss) Per Share   $ (0.37 )   $ (0.27 )   $ (0.84 )   $ (0.52 )
                                 
Basic Weighted Average Shares Outstanding     15,373,510       13,415,920       14,408,971       13,123,646  
                                 
Diluted (Loss) Per Share   $ (0.37 )   $ (0.27 )   $ (0.84 )   $ (0.58 )
                                 
Diluted Weighted Average Shares Outstanding     15,373,510       13,415,920       14,408,971       13,324,730  

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements 

  4  
 

 

ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    Six Months Ended June 30,  
    2016     2015  
    (Unaudited)     (Unaudited)  
CASH FLOWS FROM OPERATING ACTIVITIES                
Net (Loss)   $ (12,122,880 )   $ (6,786,607 )
Adjustments to Reconcile Net (Loss) to Net                
Cash (Used in) Operating Activities:                
Stock Based Compensation     2,269,633       1,236,487  
Stock Issued in Exchanged for Services     59,087       25,002  
Provision for Bad Debts     15,563      
Change in Fair Value of Warrants     (1,049,330 )     (1,000,032 )
Change in Fair Value of Warrant Derivative Liabilities     (348,141     106,349  
Depreciation and Amortization Expense     966,618       495,145  
Change in Assets and Liabilities:                
(Increase) Decrease in, net of impact of USC acquisition:                
      Accounts Receivable - Trade     (296,606 )      —  
      Inventories     (282,139 )      —  
Prepaid Expenses and Other Current Assets     (36,464     133,300
Increase (Decrease) in:                
Accounts Payable     316,665     (289,002 )
Accrued Other Expenses and Bonuses     (626,137     118,499
Net Cash (Used in) Operating Activities     (11,134,131 )     (5,960,859 )
CASH FLOWS FROM INVESTING ACTIVITIES                
        Purchase of Equipment     (16,832 )      
        Cash from Acquisition of USC     381,883        
        Cash Payment to Former Shareholders of USC     (32 )      
                        Net Cash Provided in Investing Activities     365,019      
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from Issuance of Preferred Stock, net of issuance cost     4,927,760        
Proceeds from Issuance of Common Stock, net of issuance cost           10,565,972  
Proceeds from Bank loan - Line of Credit     2,000,000        
Proceeds from Exercise of Warrants     177,780       75,589
Net Cash Provided by Financing Activities     7,105,540       10,641,561  
Increase (Decrease) in Cash     (3,663,572     4,680,702
Cash:                
Beginning     4,080,648       3,774,665  
Ending   $ 417,076     $ 8,455,367  

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements

  5  
 

 

ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 

    Six Months Ended June 30,  
    2016     2015  
    (Unaudited)     (Unaudited)  
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION                
Cash Paid for Income Taxes   $ 2,400     $ 46,053  

SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING AND   INVESTING ACTIVITIES

               
Release of Warrants Liability Upon Exercise   $ 160,245     $ 230,332  

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements 

  6  
 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1: Basis of Presentation

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Articles 8 and 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements reflect all adjustments (including normal recurring adjustments and the elimination of intercompany accounts) considered necessary for a fair statement of all periods presented. The results of Adamis Pharmaceuticals Corporation’s operations for any interim periods are not necessarily indicative of the results of operations for any other interim period or for a full fiscal year. These unaudited interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.

In January 2016, two wholly owned subsidiaries of Adamis Corporation, Adamis Viral Therapies, Inc., or Adamis Viral, and Adamis Laboratories, Inc., or Adamis Labs, effected a short-form merger, pursuant to which Adamis Viral and Adamis Labs merged with and into Adamis Corporation, with Adamis Corporation as the surviving corporation. 

 On April 11, 2016, Adamis Pharmaceuticals Corporation (the "Company" or "Adamis") completed its acquisition of U.S. Compounding, Inc., an Arkansas corporation ("USC"), pursuant to the terms of the Agreement and Plan of Merger dated March 28, 2016 (the "Merger Agreement") and entered into by and among the Company, USC and Ursula MergerSub Corp., an Arkansas corporation and a wholly owned subsidiary of the Company ("MergerSub"). Pursuant to the terms of the Merger Agreement, MergerSub merged with and into USC (the "Merger"), with USC surviving as a wholly owned subsidiary of the Company.

Segment Information

The Company is engaged primarily in the discovery, development and sales of pharmaceutical, biotechnology and other drug products. Accordingly, the Company has determined that it operates in one operating segment.

Overview of U.S. Compounding, Inc.

             USC, which is registered as a drug compounding outsourcing facility under Section 503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug Quality and Security Act, provides prescription compounded medications, including compounded sterile preparations and non-sterile compounds to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.  USC’s product offerings broadly include, among others, corticosteroids, hormone replacement therapies, hospital outsourcing products, injectables, urological preparations, ophthalmic preparations, topical compounds for pain and men’s and women’s health products.  USC’s compounded formulations in many circumstances are offered as therapeutic alternatives to drugs approved by the U.S. Food and Drug Administration, or the FDA.  USC also provides certain veterinary pharmaceutical products for animals.

  7  
 

 

Revenue Recognition.

The Company recognize revenues when all of the following criteria have been met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred; (3) the selling price is fixed and determinable; and (4) collectability is reasonably assured. Revenues from our USC subsidiary consist of sales of compounded drugs for humans and animals, including sterile injectable and non-sterile integrative therapies. Sales discounts and rebates are sometimes offered to customers if specified criteria are met. Additionally, sales are generally made with a limited right of return under certain conditions. Revenues are recorded net of provisions for sales discounts and returns, which are established at the time of sale.  

Accounts Receivable

 Accounts receivable are reported at the amount management expects to collect on outstanding balances. Management provides for probable uncollectible amounts through a charge to earnings and credit to allowance for doubtful accounts. Uncollectible amounts are based on USC's history of past write-offs and collections and current credit conditions. Provision for bad debt totaled $15,563 for the period ended June 30, 2016.

  Inventories

Inventories are valued at the lower of cost or market. The cost of inventories are determined using the first-in, first-out (“FIFO”) method. Inventories consist of compounding formulation raw materials, currently marketed products, and device supplies. A reserve for obsolescence is recorded monthly based on a review of inventory for obsolescence. Reserve for obsolescence was $20,253 as of June 30, 2016.

Acquisitions and Intangibles

 

The Company has engaged in business combination activity. The accounting for business combinations requires management to make judgments and estimates of the fair value of assets acquired, including the identification and valuation of intangible assets, as well as liabilities assumed. Such judgments and estimates directly impact the amount of goodwill recognized in connection with each acquisition, as goodwill represents the excess of the purchase price of an acquired business over the fair value of its net tangible and identifiable intangible assets.

 

Goodwill and Other Long-Lived Assets

 

Goodwill, which has an indefinite useful life, represents the excess of cost over fair value of net assets acquired. Goodwill is reviewed for impairment at least annually during the fourth quarter, or more frequently if events occur indicating the potential for impairment. During its goodwill impairment review, the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions, industry and market considerations, and the overall financial performance of the Company. If, after assessing the totality of these qualitative factors, the Company determines that it is not more likely than not that the fair value of its reporting unit is less than its carrying amount, then no additional assessment is deemed necessary. Otherwise, the Company proceeds to perform the two-step test for goodwill impairment. The first step involves comparing the estimated fair value of the reporting unit with its carrying value, including goodwill. If the carrying amount of the reporting unit exceeds its fair value, the Company performs the second step of the goodwill impairment test to determine the amount of loss, which involves comparing the implied fair value of the goodwill to the carrying value of the goodwill. The Company may also elect to bypass the qualitative assessment in a period and elect to proceed to perform the first step of the goodwill impairment test.

 

The Company evaluates its long-lived assets with definite lives, such as property and equipment, acquired technology, customer relationships, patent and license rights, for impairment by considering competition by products prescribed for the same indication, the likelihood and estimated future entry of non-generic and generic competition with the same or similar indication and other related factors. The factors that drive the estimate of the life are often uncertain and are reviewed on a periodic basis or when events occur that warrant review. Recoverability is measured by comparison of the assets' book value to future net undiscounted cash flows that the assets are expected to generate.

  Claims Liabilities

             USC is self-insured up to certain limits for health insurance. Provisions are made for both the estimated liabilities for known claims as incurred and estimates for those incurred but not reported. As of June 30, 2016, the Company was self-insured for up to the first $40,000 of claims per covered person with an aggregate deductible of $626,445. The estimated IBNR (Incurred But Not Reported) provided by the plan administrator was $77,818 at June 30, 2016.

 

Deferred Income Taxes

             Deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the tax basis of such assets and liabilities. The Company maintains a valuation allowance against its deferred tax assets due to the uncertainty regarding the future realization of such assets, which is based on historical taxable income, projected future taxable income and the expected timing of the reversals of existing temporary differences. Until such time as the Company can demonstrate that it will no longer incur losses, or if the Company is unable to generate sufficient future taxable income, it could be required to maintain the valuation allowance against its deferred tax assets. 

Liquidity and Capital Resources

Our cash was $417,076 and $4,080,648 at June 30, 2016 and December 31, 2015, respectively.

We prepared the condensed consolidated financial statements assuming that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. In preparing these condensed consolidated financial statements, consideration was given to the Company’s future business as described below, which may preclude the Company from realizing the value of certain assets.

The Company has significant operating cash flow deficiencies. Additionally, the Company will need significant funding for future operations and the expenditures that will be required to conduct the clinical and regulatory work to develop the Company’s product candidates and to support the Company’s other operations. Management’s plans include attempting to secure additional required funding through equity or debt financings, sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions, in order to satisfy existing obligations, liabilities and future working capital needs, to build working capital reserves and to fund the Company’s research and development projects and other ongoing activities. There is no assurance that the Company will be successful in obtaining the necessary funding to meet its business objectives.

Basic and Diluted (Loss) per Share

The Company computes basic loss per share by dividing the loss attributable to holders of common stock for the period by the weighted average number of shares of common stock outstanding during the period. The diluted loss per share calculation is based on the treasury stock method and gives effect to dilutive options, warrants, convertible notes, convertible preferred stock and other potential dilutive common stock. Except as noted below, the effect of common stock equivalents was anti-dilutive and was excluded from the calculation of weighted average shares outstanding. Potential dilutive securities, which are not included in dilutive weighted average shares for the six months ended June 30, 2016 and June 30, 2015 consist of outstanding equity classified warrants (3,914,299 and 1,730,868, respectively), outstanding options (4,516,019 and 2,173,485, respectively), outstanding restricted stock units (355,590 and 5,590, respectively), and convertible preferred stock  (zero and 1,009,021 respectively). 

  8  
 

 

The calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of liability classified equity securities and the presumed exercise of such securities are dilutive to loss per share for the period, an adjustment to net loss used in the calculation is required to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. Accordingly, the Company considered the impact of the warrants from the June 2013 private placement (see Note 7) on the calculation of the diluted earnings per share.

   

For the Three
Months Ended
June 30, 2016

   

For the Three
Months Ended
June 30, 2015

   

For the Six
Months Ended
June 30, 2016

   

For the Six
Months Ended
June 30, 2015

 
Loss per Share - Basic                                
Numerator for basic loss per share   $ (5,714,389 )   $ (3,644,901 )   $ (12,122,880 )   $ (6,786,607 )
Denominator for basic loss per share     15,373,510       13,415,920       14,408,971       13,123,646  
Loss per common share - basic   $ (0.37 )   $ (0.27 )   $ (0.84 )   $ (0.52 )
                                 
Loss per Share - Diluted                                
Numerator for basic loss per share   $ (5,714,389 )   $ (3,644,901 )   $ (12,122,880 )   $ (6,786,607 )
Adjust: Change in Fair Value of Warrant Liability               (1,000,032 )
Adjust: Change in Fair Value Warrant Derivative Liability                       106,349  
Numerator for dilutive loss per share   $ (5,714,389 )   $ (3,644,901 )   $ (12,122,880 )   $ (7,680,290 )
                                 
Denominator for diluted loss per share     15,373,510       13,415,920       14,408,971       13,123,646  
Plus: Incremental shares underlying “in the money” warrants outstanding                       201,084  
Denominator for dilutive loss per share     15,373,510       13,415,920       14,408,971       13,324,730  
Loss per common share - diluted   $ (0.37 )   $ (0.27 )   $ (0.84 )   $ (0.58 )

Recent Accounting Pronouncements

In July 2015, the FASB issued ASU 2015-11 Simplifying the Measurement of Inventory which requires entities to measure most inventory “at the lower of cost and net realizable value (“NRV”),” thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is “measured at the lower of cost and net realizable value,” which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.” The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. Early application is permitted. The Company is evaluating the impact of adoption of this guidance on its financial position and results of operations.

In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients. ASU No. 2016-12 is a response to concerns brought up by the Joint Transaction Resource Group for Revenue Recognition (TRG). The Update is intended to improve Topic 606 (Revenue from Contracts with Customers) by reducing the potential for diversity in practice and application, and the complexity of application. The effective date for ASU No. 2016-12 defers the effective date for Update 2014-09 (Fiscal periods beginning after December 15, 2017) by one year, which will be fiscal 2018 for us. We do not expect adoption of ASU No. 2016-12 to have a significant impact on our financial statements.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses. ASU No. 2016-13 is intended to provide users of financial statements with more decision-useful information about credit losses on financial instruments that are expected, but do not yet meet the “probable” threshold. This Update replaces the incurred loss impairment methodology with a methodology that reflects expected credit losses. The effective date that applies to SEC filers for ASU No. 2016-13 is for fiscal years beginning after December 15, 2019. We have not yet evaluated the impact of ASU No. 2016-13 on our financial statements.

 

  9  
 

 

Note 2: Acquisition of U.S. Compounding

            On April 12, 2016, the Company filed a report on Form 8-K announcing the completion of its acquisition of U.S. Compounding, Inc., an Arkansas corporation ("USC"), pursuant to the terms of the Agreement and Plan of Merger, dated March 28, 2016 (the "Merger Agreement"), with USC and Ursula MergerSub Corp., an Arkansas corporation and a wholly owned subsidiary of the Company ("Merger Sub"). Pursuant to the terms of the Merger Agreement, Merger Sub merged with and into USC (the "Merger"), with USC surviving as a wholly owned subsidiary of  the Company. Pursuant to the Merger and the Merger Agreement, all of the outstanding shares of common stock of USC were converted into the right to receive a total of approximately 1,618,539 shares of Adamis common stock; and as described further below, in connection with the Merger and the transactions contemplated by the Merger Agreement, the Company assumed approximately $5,722,000 principal amount of debt obligations and related loan agreements of USC and certain related entities.

 

The merger is accounted for as an acquisition of USC under the purchase method of accounting in accordance with FASB Accounting Standard Codification Subtopic 805—Business Combinations. The assets and liabilities of USC will be reflected at fair value on the balance sheet of the Company. The fair value of the assets and liabilities reflected in the financial statements and notes appearing in this Report on Form 10-Q was based on the estimated value of USC as of April 11, 2016 (the date on which the Company acquired USC). A final determination of the purchase accounting adjustments, including the allocation of fair value to the USC assets and liabilities, has not been made. Actual adjustments and allocations will be based on the final purchase price and analyses of fair values of identifiable tangible and intangible assets, and estimates of the useful lives of tangible and intangible assets, which will be completed after the Company completes its valuation and assessment process, which the Company believes will be finalized not later than one year from the acquisition date. Accordingly, the purchase accounting adjustments made in connection with the development of the financial statements are preliminary. Differences between the preliminary and final purchase price allocations could have a material impact on the accompanying unaudited financial statements for the period ended June 30, 2016 and the Company's future results of operations and financial position. The Company's unaudited financial statements as of June 30, 2016 do not include any adjustments to income tax benefit/provision related to the Merger.  

 

Total estimated purchase price is summarized as follows: 

 

Stock to Seller at Close

 

$

3,598,884

 

Stock to Escrow

 

 

1,899,000

 

Incentive Stock to Seller

 

 

4,747,500

 

Plus: Assumed Liabilities

 

 

5,722,558

 

Total Estimated Purchase Price

 

$

15,967,942

 

 

The purchase price has been preliminarily allocated based on the estimated fair value of assets acquired and liabilities assumed:

 

Assets Acquired:

 

 

 

 

Cash

 

$

381,883

 

Accounts Receivable and Prepaid Expenses

 

 

527,034

 

Inventory

 

 

943,958

 

Property, Plant & Equipment

 

 

5,202,356

 

Intangible Assets

 

 

12,419,000

 

Goodwill

 

 

2,225,101

 

Total assets

 

 

21,699,332

 

 

 

 

 

 

Liabilities Assumed:

 

 

 

 

Accounts Payable and Accrued Expenses

 

 

5,731,390

 

Total Liabilities

 

 

5,731,390

 

 

 

 

 

 

Total Estimated Purchase Price

 

$

15,967,942

 

 

 

  10  
 

 

              

Note 3: Inventories

 

           As of June 30, 2016, the inventories of the Company, which consisted of inventories of the Company's wholly o wned subsidiary USC, consisted of the following:

 

Finished Goods   $ 538,127  
Raw Material     509,320  
Devices     178,650  
    $ 1,226,097  

 

Note 4: Fixed Assets

 

Fixed Assets at June 30, 2016 is summarized in the table below:

Fixed Asset Description   Costs/FMV   Accumulated Depreciation   Net Book Value
Adamis:            
Equipment   $ 97,100     $ (48,550 )   $ 48,550  
                         
USC:                        
Land     460,000           460,000  
Building     3,040,000       (21,213 )     3,018,787  
Machinery & Equipment     1,296,126       (107,108 )     1,189,018  
Furnitures & Fixtures     129,630       (7,577 )     122,053  
Automobile     9,395       (844 )     8,551  
Leasehold Improvements     284,037       (5,601 )     278,436  
     $ 5,316,288     (190,893 )   5,125,395  

For the three months ended and six months ended June 30, 2016, depreciation and amortization expense was $147,199 and $152,053, respectively. 

11
 

Note 5: Intangible Assets and Goodwill

 

The Company's intangible assets at June 30, 2016, consisted of the following: 

  Amortization Periods
(in years)
  Cost   Accumulated Amortization   Net Carrying Value
Adamis:                            
Taper DPI Intellectual Property   5 years   $ 9,708,700     $ (2,427,175   $ 7,281,525  
USC:                            
Trade Name and Brand   Indefinite     1,245,000             1,245,000  
Non-competition Agreement   3 years     1,639,000       (119,890     1,519,110  
Customer Relationships   10 years     5,572,000        (122,274     5,449,726  
FDA 503B Registration and Compliance   10 years     3,963,000       (86,966     3,876,034  
        $ 22,127,700     (2,756,305   $ 19,371,395  
                             

 

Amortization expense for intangible assets for the period ended June 30, 2016, was as follows:

   

For the Three

Months Ended

June 30, 2016

     

For the Six

Months Ended

June 30, 2016

 
Adamis:                
Taper DPI Intellectual Property   242,718     485,435  
USC:                
Non-competition Agreement     119,890       119,890  
Customer Relationships     122,274       122,274  
FDA 503B Registration and Compliance     86,966       86,966  
    571,848     $   814,565  

 

Estimated future amortization expense for the Company's intangible assets at June 30, 2016, is as follows: 

Remainder of 2016 1,235,352  
2017   2,470,703  
2018   2,470,703  
2019   2,077,647  
2020   1,924,370  
Thereafter   7,947,620  
   $ 18,126,395  
       

 

  12  
 

Goodwill recorded at the acquisition of USC was approximately $2,225,000. Goodwill is calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from other assets acquired that could not be individually identified and separately recognized. Goodwill is not amortized and is not deductible for income tax purposes. As indicated in Note 2 above, with respect to the Company’s acquisition of USC in April 2016, a final allocation of fair value to the USC assets and liabilities, including intangible assets and goodwill, has not been made. As a result, the amount of intangible assets, amortization expense and goodwill are subject to change, and differences between the preliminary and final purchase price allocations could have a material impact on the determination of such amounts.

Note 6: Sale of Preferred Stock

August 2014 Series A Preferred Stock             

On August 19, 2014, the Company completed a private placement transaction with a small number of sophisticated investors pursuant to which the Company issued 1,418,439 shares of Series A Convertible Preferred Stock and warrants to purchase up to 1,418,439 shares of common stock. The shares of Series A Preferred and warrants were sold in units, with each unit consisting of one share and one warrant, at a purchase price of $3.525 per unit. The Series A Preferred is convertible into shares of common stock at an initial conversion rate of 1-for-1 (subject to stock splits, reverse stock splits and similar events) at any time at the discretion of the investor. The exercise price of the warrants is $3.40 per share, and the warrants are exercisable for five years. If the Company grants, issues or sells any Common Stock equivalents pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then a holder of Series A Preferred or warrants will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the holder could have acquired if the holder had held the number of shares of Common Stock acquirable upon conversion of the Series A Preferred or exercise of the warrants (without regard to any limitations on conversion). If the Company declares or makes any dividend or other distribution of its assets (or rights to acquire its assets) to holders of Common Stock, then a holder of Series A Preferred or warrants is entitled to participate in such distribution to the same extent as if the holder had held the number of shares of Common Stock acquirable upon complete conversion of the Series A Preferred or exercise of the warrants (without regard to any limitations on conversion). In accordance with the transaction agreements, the Company filed a registration statement with the SEC, which has been declared effective, to register the resale from time to time of shares of common stock underlying the Series A Preferred and the warrants.

The warrants include call provisions giving the Company the option, subject to various conditions, to call the exercise of any or all of the 2014 warrants, by giving a call notice to the warrant holders.  We may give a call notice only within (i) if a holder and its affiliates beneficially own 2% or less of our outstanding common stock, then 10 trading days after any 20‑consecutive trading day period during which the daily volume weighted average price of the common stock (the "VWAP") is not less than 250% of the exercise price for the 2014 warrants in effect for 10 out of such 20-consecutive trading day period, and (ii) if holder and its affiliates beneficially own more than 2% of the outstanding common stock, five trading days after any 30-consecutive trading day period during which the VWAP of the common stock is not less than 250% of the exercise price then in effect for 25 out of such 30-consecutive trading day period.  The exercise price of the 2014 warrants is $3.40 per share, and accordingly 250% of such exercise price is $8.50 per share. During a “call period” of 30 trading days following the date on which the call notice is deemed given and effective (with the call period being extended for one trading day for each trading day during the call period during which the VWAP is less than 225% of the exercise price then in effect during the call period), a holder may exercise the 2014 warrant and purchase the called warrant shares.  Subject to the foregoing and to the other provisions of the 2014 warrants, if the holder fails to timely exercise the called 2014 warrant, the Company may cancel the unexercised called warrant (or portion thereof that was called).  

As of June 30, 2016, the investors have converted 1,418,439 shares of Series A Preferred into an equal number of shares of common stock, with zero Series A Preferred Shares remaining outstanding.

  13  
 

January 2016 Series A-1 Preferred Stock

On January 26, 2016, the Company completed a private placement transaction with a small number of accredited investors pursuant to which the Company issued 1,183,432 shares of Series A-1 Convertible Preferred Stock ("Series A-1 Preferred") and warrants to purchase up to 1,183,432 shares of common stock or Series A-1 Preferred. The shares of Series A-1 Preferred and warrants were sold in units, with each unit consisting of one share and one warrant, at a purchase price of $4.225 per unit. The Series A-1 Preferred is convertible into shares of common stock at an initial conversion rate of 1-for-1 (subject to stock splits, reverse stock splits and similar events) at any time at the discretion of the investor. The exercise price of the warrants is $4.10 per share, and the warrants are exercisable at any time over the five year term of the warrants. If the Company grants, issues or sells any Common Stock equivalents pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then a holder of Series A-1 Preferred or warrants will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the holder could have acquired if the holder had held the number of shares of Common Stock acquirable upon conversion of the Series A-1 Preferred or exercise of the warrants (without regard to any limitations on conversion). If the Company declares or makes any dividend or other distribution of its assets (or rights to acquire its assets) to holders of Common Stock, then a holder of Series A-1 Preferred or warrants is entitled to participate in such distribution to the same extent as if the holder had held the number of shares of Common Stock acquirable upon complete conversion of the Series A-1 Preferred or exercise of the warrants (without regard to any limitations on conversion). Gross proceeds to the Company were approximately $5,000,000 excluding transactions costs, fees and expenses. In accordance with the transaction agreements, the Company filed a registration statement with the SEC, which has been declared effective, to register the resale from time to time of shares of common stock underlying the Series A-1 Preferred and the warrants.   The 2016 warrants include call provisions that are generally similar to the 2014 warrants.  The exercise price of the 2016 warrants is $4.10 per share, and accordingly 250% of such exercise price is $10.25 per share.  

As of June 30, 2016, the investors have converted 1,183,432 shares of Series A-1 Preferred into an equal number of shares of common stock, with zero Series A-1 Preferred Shares remaining outstanding.

Note 7: Debt

Ben Franklin Note

Biosyn, Inc.,  a wholly owned subsidiary of the Company, issued a note payable to Ben Franklin Technology Center of Southeastern Pennsylvania (“Ben Franklin Note”) in October 1992, in connection with funding the development of Savvy, a compound then under development to prevent the transmission of HIV/AIDS.

The Ben Franklin Note was recorded at its estimated fair value of $205,000 and was assumed by the Company as an obligation in connection with its acquisition of Biosyn in 2004. The repayment terms of the non-interest bearing obligation include the remittance of an annual fixed percentage of 3.0% applied to future revenues of Biosyn, if any, until the principal balance of $777,902 (face amount) is satisfied. Under the terms of the obligation, revenues are defined to exclude the value of unrestricted research and development funding received by Biosyn from nonprofit sources. Absent a material breach of contract or other event of default, there is no obligation to repay the amounts in the absence of future Biosyn revenues. The Company accreted the discount of $572,902 against earnings using the interest rate method (approximately 46%) over the discount period of five years, which was estimated in connection with the Ben Franklin Note’s valuation at the time of the acquisition.

14 
 

 

Accounting principles generally accepted in the United States emphasize market-based measurement through the use of valuation techniques that maximize the use of observable or market-based inputs. The Ben Franklin Note’s peculiar repayment terms outlined above affects its comparability with main stream market issues and also affects its transferability. The value of the Ben Franklin Note would also be impacted by the ability to estimate Biosyn’s expected future revenues which in turn hinge largely upon future efforts to commercialize the product candidate, the results of which efforts are not known by the Company. Given the above factors and therefore the lack of market comparability, the Ben Franklin Note would be valued based on Level 3 inputs (see Note 8). As such, management has determined that the Ben Franklin Note will have no future cash flows, as we do not believe the product will create a revenue stream in the future. As a result, the Note had no fair market value at the time of the merger in April 2009 between the Company (which was then named Cellegy Pharmaceuticals, Inc.) and the corporation then-named Adamis Pharmaceuticals Corporation.

Secured Convertible Promissory Notes

On June 26, 2013, the Company completed the closing of a private placement financing transaction (the “Transaction”) with a small number of accredited institutional investors. Pursuant to a Subscription Agreement (the “Purchase Agreement”) and other transaction documents, we issued Secured Convertible Promissory Notes (“Secured Notes”) and common stock purchase warrants (“Warrants”) to purchase up to 764,960 shares of common stock (“Warrant Shares”), and received gross cash proceeds of $5,300,000, of which $286,349 was used to pay for transaction costs, fees and expenses. The Secured Notes had an aggregate principal amount of $6,502,158. The Secured Notes are no longer outstanding. The exercise price of the Warrants is subject to anti-dilution provisions providing that, with the exception of certain excluded categories of issuances and transactions, if we issue any shares of common stock or securities convertible into or exercisable for common stock, or if common stock equivalents are repriced, at an effective price per share less than the exercise price, without the consent of a majority in interest of the investors, the exercise price will be adjusted downward to equal the per share price of the securities issued or deemed issued in such transaction.

The Warrants are exercisable for a period of five years from the date of issuance. The exercise price of the Warrants was initially $12.155 per share (and was subsequently reduced to $3.40 per share), which was 110% of the closing price of the common stock on the day before the closing. The Warrants provide for proportional adjustment of the number and kind of securities purchasable upon exercise of the Warrants and the per share exercise price upon the occurrence of certain specified events, and include price anti-dilution provisions which provide for an adjustment to the per share exercise price of the Warrants and, in certain instances, the number of shares issuable upon exercise of the Warrants, if the Company issues common stock or common stock equivalents at effective per share prices lower than the exercise price of the Warrants. As described in the paragraph below the warrants were called pursuant to the Trigger Condition and are cancelled. 

 On May 31, 2016, the Company gave a Call Notice to all outstanding warrant holders to exercise the warrants. A Call Notice may be given only within 10 trading days after any 20-consecutive trading day period during which the volume weighted average price (“VWAP”) of the Company’s common stock is not less than 250% of the exercise price for the Warrants in effect for 10 out of such 20-consecutive trading day period. A holder must exercise the Warrant and purchase the called Warrant Shares within 14 trading days after the Call Date, or the Warrant will be cancelled with respect to the unexercised portion of the Warrant that was subject to the Call Notice. After the expiration of the applicable period, in June 2016 the holders of unexercised warrants were informed that the unexercised warrants subject to the Call Notice were canceled.  

  15  
 

 

Provided (i) there is an effective registration statement that covers resale of all of the Warrant Shares, or (ii) all of the Warrant Shares may be sold pursuant to Rule 144 upon cashless exercise without restrictions including without volume limitations or manner of sale requirements, each such event referred to as a Trigger Condition, the Company has the option to “call” the exercise of any or all of the Warrants, referred to as a Warrant Call, from time to time by giving a Call Notice to the holders, provided that the other conditions on the Company’s option to exercise a Warrant Call have been satisfied. The Company’s right to exercise a Warrant Call commences five trading days after either of the Trigger Conditions has been in effect continuously for 15 trading days. A holder has the right to cancel the Warrant Call up until the date that the called Warrant Shares are actually delivered to the holder, such date referred to as the Warrant Call Delivery Date, if the Trigger Condition relied upon for the Warrant Call ceases to apply. A Call Notice may not be given within 30 days of the expiration of the term of the Warrants. In addition, a Call Notice may be given not sooner than 15 trading days after the Warrant Call Delivery Date of the immediately preceding Call Notice.

 The Warrants with the embedded call option at issuance were valued using the Binomial Option Pricing Model (“BOPM”). The estimated fair value of a single Warrant, including the call option, was $2.329 per share and the estimated value of the Warrant anti-dilution reset feature was $1.2002 per share. As a result, the Company recorded liabilities for the warrant and warrant down-round protection derivative totaling $2,398,280. The warrant and warrant derivative liabilities at June 30, 2016 were zero with the cancellation of  the June 2013 warrants, see Note 8.

Working Capital Line of Credit

On March 28, 2016, the Company entered into a loan and security agreement with Bear State Bank, N.A. (the “Lender” or the “Bank”), pursuant to which the Company may borrow up to an aggregate of $2,000,000 to provide working capital to USC, subject to the terms and conditions of the loan agreement.  Interest on amounts borrowed under the Company's loan agreement with the Bank accrues at a rate equal to the prime interest rate, as defined in the agreement. Interest payments are required to be made quarterly.  The entire outstanding principal balance, and all accrued and unpaid interest and all other sums payable pursuant to the loan documents, are due and payable on March 1, 2017, or sooner upon the occurrence of certain events as provided in the loan agreement and related documents.  The Company's obligations under the loan agreement are secured by certain collateral, including without limitation its interest in amounts that it has loaned to USC, and a warrant that the Company issued to the Bank to purchase up to 1,000,000 shares of the Company's common stock at an exercise price equal to par value per share, exercisable only if the Company is in default under the loan agreement or related loan documents. As of June 30, 2016, the loan balance on the line of credit was $2,000,000 and accrued interest expense related to the loan was approximately $11,000.

16
 

Loans Assumed from Acquisition of USC:

           Building Loan

            In connection with the closing of the Merger, the Company acquired from 4 HIMS, of which Eddie Glover, the chief executive officer of USC, and certain other former stockholders of USC are members, the 4 HIMS Property, in consideration of the Company being added as an additional “borrower” and assuming the obligations under the 4 HIMS Loan Agreement, the 4 HIMS Note and the other 4 HIMS Loan Documents. As of June 30, 2016, the outstanding principal balance owed on the note was approximately $2,454,000. The loan currently bears an interest of 3.75% per year with total interest payable of approximately $37,000.

           Equipment Loan, Tribute

                In connection with the Merger, Tribute Labs, LLC, a Nevada limited liability company and former related party of USC (“Tribute” or “Borrower”) assigned to Adamis all of its rights under the Tribute Loan Agreement and other Tribute Loan Documents, Adamis agreed to become an additional co-borrower and to assume Borrower’s obligations under the Tribute Loan Documents, in consideration of the transfer to USC of laboratory equipment owned by Tribute and used to perform testing services for USC’s products, and Lender consented to such assignment. As of June 30, 2016, the outstanding unpaid principal balance under the  Loan Agreement was  approximately $518,000. The loan currently bears an interest of 4.75% per year with total interest payable of approximately $19,000.

           USC Working Capital Loan 

                  In connection with the Merger, Adamis agreed to be added as a Borrower and to assume the obligations as a Borrower under the USC Working Capital Loan Agreement and the USC Working Capital Loan Documents.

                Under the USC Working Capital Loan Agreement, Lender agreed to loan funds to USC, as the “Borrower,” up to an aggregate principal amount of $2,500,000, and evidenced by the USC Working Capital Note. Borrowings are limited to 80% of qualified trade accounts receivables and 50% of qualified inventories per the borrowing base agreement and are collateralized with trade accounts receivables and inventory. As of June 30, 2016, the outstanding unpaid principal balance under the USC Working Capital Note was approximately $2,116,000. The note currently accrues interest at 3.25% per year with total interest payable of $43,000.

           USC Equipment Loan 

                 In connection with the Merger, Adamis agreed to become a Borrower and to assume the obligations as a Borrower under the USC Equipment Loan Agreement and the USC Equipment Loan Documents. Under the USC Equipment Loan Agreement, Lender agreed to loan funds to USC, as the “Borrower,” up to an aggregate principal amount of $700,000, with amounts loaned evidenced by the Commercial Line of Credit Agreement and Note (the “USC Equipment Note”). The loan is collateralized by USC's property and equipment. As of June 30, 2016, the outstanding unpaid principal balance under the USC Equipment Note was approximately $635,000. The note currently accrues interest at 3.25% per year with total interest payable of $13,000.

 

  17  
 
 

Loan Amendment, Forbearance and Assumption Agreement

                  In connection with the closing of the transactions contemplated by the Merger Agreement, Lender, Adamis, USC, 4 HIMS and Tribute (USC, 4 HIMS and Tribute sometimes referred to as the “Initial Loan Parties” and together with Adamis, collectively the “Loan Parties”), and certain individual guarantors, including without limitation Eddie Glover and Kristen Riddle (sometimes referred to as the “Individual Guarantors”), entered into the Loan Amendment Agreement.

                 Pursuant to the Loan Amendment Agreement, Adamis agreed that effective as of the Merger Closing, the Existing Loan Documents will be deemed to be amended to add Adamis as a co-borrower under each of the Existing Loans with respect to periods after the Merger Closing, and Adamis agreed to assume responsibility as borrower for all obligations, duties and liabilities after the Merger Closing under the Existing Loan Documents, jointly and severally with the current borrower or borrowers under each of the Existing Loans. The parties agreed that each of the Initial Loan Parties will remain, as applicable, a co-borrower under each of the Existing Loan Documents and that such party’s rights and obligations will not be affected.

                 In addition, in the Loan Amendment Agreement the Company and the Bank agreed to discuss in good faith mutually agreeable amendments or modifications to the Existing Loan Documents in light of the changes in circumstances resulting from the Merger and the transfer of the real property and equipment discussed above to Adamis and USC.

                  In the Loan Amendment Agreement, the Initial Loan Parties acknowledged that the Existing Loans are currently in default with respect to certain nonmonetary covenants contained in the Existing Loan Documents. The Bank agreed that all obligations of the Bank to forbear from pursuing its available remedies to collect the obligations evidenced and secured by the Existing Loan Documents shall conditionally exist until October 31, 2016 (the "Forbearance Period"). During the Forbearance Period, and subject to the terms of the Loan Amendment Agreement and the compliance by the Loan Parties with their obligations under the Loan Amendment Agreement, the Bank agreed that it would not pursue available remedies existing as a result of the Loan Parties’ failure to comply with the nonmonetary covenants of the Loan Parties as set forth in the Existing Loan Documents. Upon the expiration of the Forbearance Period, all monetary and nonmonetary obligations of the Loan Parties as set forth in the Existing Loan Documents will be fully reinstated.

 The Loan Parties agreed during the Forbearance Period to (i) continue to make all regularly scheduled payments of principal and interest due as set forth in the Existing Loan Documents, and (ii) except to the extent modified in the Loan Amendment Agreement, comply with all covenants of the Loan Parties set forth in the Existing Loan Documents. In the Loan Amendment Agreement, each Initial Loan Party reaffirmed its obligations under the Existing Loans and made certain other representations, warranties and agreements regarding the Existing Loans, and the Bank acknowledged that the applicable Borrower was current in its interest payments or other obligations under the applicable Loan Documents that are due and payable before the date of the Loan Amendment Agreement. The parties also agreed that the real and personal property securing each of the Existing Loans will also secure each of the other Existing Loans, as well as the Adamis New Working Capital Line of $2.0 million.

 

18
 

 

                  Upon termination of the Forbearance Period by expiration of time or resulting from any noncompliance of the Loan Parties with the conditions set forth in the Loan Amendment Agreement, including the nonperformance of any of the conditions or covenants, or if any of the warranties and representations set forth in the Loan Amendment Agreement prove to be incorrect: (i) all obligations of the Loan Parties pursuant to the Existing Loan Documents and the Existing Loans will be fully reinstated; (ii) the Bank will have all rights and remedies provided the Bank pursuant to the Existing Loan Documents; and (iii) the Bank will be entitled, to the maximum extent most beneficial to the Bank, to all rights and remedies allowed by any applicable law.

                  Except as expressly set forth in the Loan Amendment Agreement, the terms and provisions set forth in the Existing Loan Documents were not modified and remain in full force and effect. Subject to the satisfaction of all conditions precedent set forth in the Loan Amendment Agreement, the Bank consented to the transfer of the real and personal property by 4 HIMS and Tribute to Adamis and the foregoing acceptance and assumptions by Adamis. The Loan Amendment Agreement provide for a number of conditions precedent to Bank’s obligations under the agreement, including without limitation: (i) satisfactory title insurance and other insurance regarding the 4 HIMS Property; (ii) satisfactory lien searches and UCC-1 financing statements; (iii) any other document and agreements required by the Bank; (iv) accuracy of the representations and warranties set forth in the Loan Amendment Agreement; and (v) certain other customary conditions. The Loan Amendment Agreement reflects the terms of an earlier letter agreement entered into between Lender and Adamis in connection with the execution of the Merger Agreement, in which Adamis agreed that effective upon the closing of the Merger it would assume the obligations under the Existing Loans, and Lender agreed during the forbearance period specified therein to forbear from exercise of its rights and remedies in connection with instances of default or noncompliance under the Existing Loans. The agreement provides that upon expiration of the forbearance period, Lender will commence testing for compliance with the financial covenants contained in the Loan Documents, and full compliance with such financial covenants must be attained by December 31, 2016. The agreement is conditioned on the parties’ execution of a subsequent loan amendment agreement, which is reflected in the Loan Amendment Agreement.

                   In August 2016, the Company received a commitment letter from the Bank describing a proposal to modify, consolidate and replace certain of the Existing Loan Documents with a new loan agreement, and the Company expects to engage in discussions with the Bank concerning modifications to the other Existing Loan Documents or entering into new loan agreements to replace and supersede the other Existing Loan Documents. 

 

Note 8: Derivative Liabilities and Fair Value Measurements

Accounting Standards Codification (“ASC”) 815 - Derivatives and Hedging provides guidance to determine what types of instruments, or embedded features in an instrument, are considered derivatives. This guidance can affect the accounting for convertible instruments that contain provisions to protect holders from a decline in the stock price, referred to as anti-dilution or down-round protection. Down-round provisions reduce the exercise price of a convertible instrument if a company either issues equity shares for a price that is lower than the exercise price of those instruments, or issues new convertible instruments that have a lower exercise price. The Company has determined that the warrant liability and down-round provision related to the warrants that were issued in connection with the Secured Notes should be treated as derivatives. The Company is required to report derivatives at fair value and record the fluctuations in fair value in current operations.

The Company recognizes the derivative liabilities at their respective fair values at inception and on each reporting date. The Company values its financial assets and liabilities on a recurring basis and certain nonfinancial assets and nonfinancial liabilities on a nonrecurring basis based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, a fair value hierarchy that prioritizes observable and unobservable inputs is used to measure fair value into three broad levels, which are described below: 

Level 1:

Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

   
Level 2: Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in inactive markets; or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data.
   
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
  19  
 

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.

The Company recognizes derivative liabilities at their respective fair values at inception and on each reporting date. The Company utilized the BOPM to develop its assumptions for determining the fair value of the Warrants and related anti-dilution features.

The number of liability classified Warrants outstanding as of June 30, 2016 and December 31, 2015 were zero and 575,164, respectively. As shown in the table below, after the cancellation of the Warrants with call options the carrying value at June 30, 2015 was $0 and the carrying value of the down-round protection derivative for the same date was $0.

During the six months ended June 30, 2016, a total of 52,288 warrants were exercised, reducing the fair value of warrants and derivative liabilities and increasing Additional Paid in Capital by $160,245. The cancellation of 522,876 Warrants in June 2016 resulted to the reversal of liability and expense totaling $1,788,758.

The table below provides a reconciliation of beginning and ending balances for the liabilities measured at fair value using significant unobservable inputs (Level 3): 

            Warrant          
    Warrants     Derivative     Total  
Balance: December 31, 2015   $ (1,174,312 )   $ (383,404 )   $ (1,557,716 )
Release of Warrant Liability Upon Exercise     53,379       17,428       70,807  
Net Change in Fair Value     (382,722     (8,565 )     (391,287  
Balance: March 31, 2016     (1,503,655 )     (374,541 )     (1,878,196 )
Release of Warrant Liability Upon Exercise     71,603       17,835       89,438  
Change in Fair Value      1,432,052     356,706     1,788,758
Balance: June 30, 2016   $   $   $

 

The derivative liabilities are considered Level 3 liabilities on the fair value hierarchy as the determination of fair values includes various assumptions about future activities and stock price and historical volatility inputs.

The following table describes the valuation techniques used to calculate fair values for liabilities in Level 3. There were no changes in the valuation techniques during the six months ended June 30, 2016 from December 31, 2015. 

    Fair Value at     Fair Value at     Valuation   Unobservable        
    6/30/2016     12/31/2015     Technique   Input   Range  

Warrant Derivative and

Warrant Down-round

Protection Derivative

(combined)

  $     $ 1,557,716    

Binomial

Option Pricing

Model

 

Probability of

common stock

issuance at

prices less than exercise prices stated in agreements

    — & 50 %
                                 
                       

Probability of

reset provision

being waived

    —  & 5 %

 

  

  20  
 

 

Significant unobservable inputs for the derivative liabilities include (1) the estimated probability of the occurrence of a down-round financing during the term over which the related warrants are exercisable, (2) the estimated magnitude of the down-round and (3) the probability of the reset provision being waived. These estimates which are unobservable in the market were utilized to value the anti-dilution features of the warrants as of December 31, 2015.

Note 9: License Agreement

              On May 9, 2016, the Company entered into a Development, License and Commercialization Agreement (the “Agreement”) with Allergan plc’s wholly owned subsidiary, Watson Laboratories, Inc. (“Licensee”), regarding the Company’s Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis. Under the terms of the Agreement, the Company granted Licensee exclusive commercial rights to market and sell the PFS product in the United States and related territories. Licensee agreed to pay the Company an upfront payment and agreed to make additional potential regulatory, performance and sales based milestone payments. If the FDA does not approve the Company's New Drug Application ("NDA") relating to the PFS product within the time period specified in the Agreement, Licensee has the right, but not the obligation, to terminate the Agreement, and if Licensee elects to terminate the Agreement then the upfront payment previously paid to the Company will be refunded.  

               On July 21, 2016, the Company received a notice from Licensee exercising its right to terminate the Agreement; in the absence of termination of the Agreement before expiration of the time period specified in the Agreement, any milestone or other payments would not be refundable. No upfront fee or payment was made, and as a result the Company is not obligated to refund any amounts to Licensee as a result of the termination.


Note 10: Common Stock

On April 11, 2016, the Company completed its acquisition of U.S. Compounding, Inc. Pursuant to the merger agreement, the Company issued a total of 1,618,539 shares of Adamis common stock to the former shareholders of USC. 

On April 15, 2016,  the Company issued common stock upon exercise of an investor warrant. The warrant holder exercised for cash at an exercise price of $3.40 per share. The Company received a total of approximately $89,000 and the warrant holder received 26,144 shares of common stock.

On May 26, 2016, the Company issued a total of 10,708 shares of common stock upon exercise of options granted under the Company's 2009 Equity Incentive Plan. The option holders utilized a cashless net exercise (based on a common stock price of $8.51 per share on the date of exercise) of a total of 29,712 stock options with an exercise price ranging from $4.10 to $6.53.

On June 2, 2016, the Company awarded a total of 6,669 shares of common stock to two employees of U.S. Compounding, Inc. to settle unpaid compensation of approximately $59,000. 

In June 2016, 1,009,021 and 1,183,432 of Series A Convertible Preferred and Series A-1 Convertible Preferred, respectively, were converted into shares of common stock on a 1:1 ratio. 

 

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Note 11: Stock Option Plans, Shares Reserved and Warrants

The Company has a 2009 Equity Incentive Plan (the “2009 Plan”). The 2009 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights, performance stock awards, and other forms of equity compensation (collectively “stock awards”). In addition, the 2009 Plan provides for the grant of performance cash awards. The initial aggregate number of shares of common stock that may be issued initially pursuant to stock awards under the 2009 Plan was 411,765 shares. The number of shares of common stock reserved for issuance automatically increase on January 1 of each calendar year, from January 1, 2010 through and including January 1, 2019, by the lesser of (a) 5.0% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year or (b) a lesser number of shares of common stock determined by the Company’s board of directors before the start of a calendar year for which an increase applies. On May 25, 2016, pursuant to the approval of the Company's stockholders, the number of shares reserved for issuance increased by 4,500,000, an aggregate of 8,566,800 shares (including shares issued pursuant to exercise of previous awards under the 2009 Plan and shares subject to outstanding awards under the 2009 Plan) at June 30, 2016.

On May 25, 2016, the Company issued options to purchase 1,290,000 shares of common stock to the officers and employees of USC and the board of directors of the Company under the 2009 Plan with an exercise price of $8.46 per share. The options will vest over a period of three years. These options were valued using the Black-Scholes option pricing model, the expected volatility was approximately 59%, the term was six years, the dividend rate was 0.0 % and the risk-free interest rate was approximately 1.69%, which resulted in a calculated fair value of $6,063,000.

On May 25, 2016, the Company issued options to purchase 155,000 shares of common stock to consultants of the Company with an exercise price of $8.46 per share. The options were exercisable in full as of the date of grant. These options were valued using the Black-Scholes option pricing model, the expected volatility was approximately 56%, the term was five years, the dividend rate was 0.0 % and the risk-free interest rate was approximately 1.40%, which resulted in a calculated fair value of $643,250.

On May 25, 2016, the Company awarded Restricted Stock Units ("RSUs") covering 350,000 shares of common stock to the non-employee directors of the Company under the 2009 Plan; as of the date of grant, the market price of the common stock was $8.46 per share. These RSUs vest on the seventh anniversary from grant date, or earlier upon the occurrence of certain events including a change of control of the Company. The calculated fair value of the RSUs was $2,961,000.

The following summarizes the stock option activity for the six months ended June 30, 2016 below:

          Weighted     Weighted  
      Stock     Average     Average  
      Option      Exercise     Remaining  
      Shares     Price     Contract Life  
  Balance as of December 31, 2015     2,112,800     $ 5.60     8.05 years  
                         
  Options Granted     2,490,697       6.65     9.46 years  
  Options Exercised     (46,379 )     5.07      —  
  Options Cancelled     (41,099     4.93        —   
                         
  Balance as of June 30, 2016     4,516,019     $ 6.19     8.75 years  
                         
  Exercisable at June 30, 2016     1,748,933     $ 5.77     7.26 years  

 

The aggregate intrinsic value (the difference between the Company’s closing stock price on the last trading day of the period and the exercise price, multiplied by the number of in-the-money options) of the 4,516,019 and 2,112,800 stock options outstanding at June 30, 2016 and December 31, 2015 was approximately $0 and approximately $916,000, respectively. The aggregate intrinsic value of 1,748,933 and 1,173,443 stock options exercisable at June 30, 2016 and December 31, 2015 was approximately $0 and $681,000, respectively.

The following summarizes warrants outstanding at June 30, 2016:  

    Warrant     Exercise Price     Date   Expiration
    Shares     Per Share     Issued   Date
Old Adamis Warrants     58,824     $ 8.50     November 15, 2007   November 15, 2017
2013 Private Placement     22,057     $12.16     June 26, 2013   June 26, 2018
Consultant Warrants     17,647     $ 3.74     July 11, 2011   July 11, 2016
Underwriter Warrants     186,000     $ 7.44     December 12, 2013   December 12, 2018
Underwriter Warrants     27,900     $ 7.44     January 16, 2014   January 16, 2019
Preferred Stock Series A Warrants     1,418,439     $ 3.40     August 19, 2014   August 19, 2019
Preferred Stock Series A-1 Warrants     1,183,432     $ 4.10     January 26, 2016   January 26, 2021
Bear State Bank, Collateral to Line of Credit     1,000,000  *   $ 0.0001     March 28, 2016    
Total Warrants     3,914,299                  

 

*Exercisable upon default of Line of Credit at Bear State Bank, please see Note 7.

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At June 30, 2016, the Company has reserved shares of common stock for issuance upon exercise of outstanding options and warrants, convertible preferred stock shares, and options and other awards that may be granted in the future under the 2009 Equity Incentive Plan, as follows:

Warrants     3,914,299  
Convertible Preferred Stock      
2009 Equity Incentive Plan     8,566,800  
Total Shares Reserved     12,481,099  

Note 12: Subsequent Events

On July 11, 2016, the Company completed a private placement financing transaction. Pursuant to a Purchase Agreement and a registration rights agreement, we issued 1,724,137 shares of a new series of preferred stock, Series A-2 Convertible Preferred Stock (the “Series A-2 Preferred”), and warrants (“Warrants”) to purchase up to 1,724,137 shares of the Company’s Common Stock or Series A-2 Preferred (“Warrant Shares”), and received gross cash proceeds of approximately $5,000,000, excluding transactions costs, fees and expenses. The shares of Series A-2 Preferred and Warrants were sold in units, with each unit consisting of one share and one Warrant, at a purchase price of $2.90 per unit. The Series A-2 Preferred is convertible into shares of the Company’s Common Stock (the “conversion shares”), at an initial conversion rate of 1-for-1, at any time at the discretion of the investor. The exercise price of the Warrants is $2.90 per share, and the Warrants are exercisable for five years. The purchasers included a small number of institutional investors. The rights, preferences, privileges, and restrictions applicable to the Series A-2 Preferred are generally similar to those of the Company’s Series A-1 Convertible Preferred Stock, which the Company issued to a small number of institutional investors in a January 2016 private placement transaction.

On July 11, 2016, warrants issued to consultants to purchase 17,647 shares of common stock at $3.74 per share expired. 

 As disclosed in Note 9 above, on July 21, 2016, Watson Laboratories, Inc. terminated the Development, License and Commercialization Agreement with the Company.  

 On  August 3, 2016, the Company completed a registered direct offering of 3,573,255 shares of common stock and warrants to purchase 3,573,255 shares of common stock under its existing shelf registration statements. The shares and warrants were sold in units, each unit consisting of (i) one share of common stock and (ii) one warrant to purchase one share of common stock at an exercise price of $2.98 per share, at a purchase price of $3.095 per unit.  The warrants will expire five years from the date on which they become exercisable.  Gross proceeds from the offering, after deducting placement agent fees, were approximately $10.3 million, excluding any future proceeds from the potential exercise of the warrants and before deducting other estimated offering expenses payable by the Company. 

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ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Information Relating to Forward-Looking Statements

This Quarterly Report on Form 10-Q includes “forward-looking” statements. These forward-looking statements are not historical facts, but are based on current expectations, estimates and projections about our industry, our beliefs and our assumptions. These forward-looking statements include statements about our strategies, objectives and our future achievement. To the extent statements in this Quarterly Report involve, without limitation, our expectations for growth, estimates of future revenue, our sources and uses of cash, our liquidity needs, our current or planned clinical trials or research and development activities, product development timelines, our future products, regulatory matters, expense, profits, cash flow balance sheet items or any other guidance on future periods, these statements are forward-looking statements. These statements are often, but not always, made through the use of word or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and “would.” These forward-looking statements are not guarantees of future performance and concern matters that could subsequently differ materially from those described in the forward-looking statements. Actual events or results may differ materially from those discussed in this Quarterly Report on Form 10-Q. Except as may be required by applicable law, we undertake no obligation to update any forward-looking statements or to reflect events or circumstances arising after the date of this Report. Important factors that could cause actual results to differ materially from those in these forward-looking statements are in the section entitled “Risk Factors” in the most recent Annual Report on Form 10- K, filed with the Securities and Exchange Commission, and the other risks and uncertainties described elsewhere in this report as well as other risks identified from time to time in our filings with the Securities and Exchange Commission, press releases and other communications. In addition, the statements contained throughout this Quarterly Report concerning future events or developments or our future activities, including concerning, among other matters, current or planned clinical trials, anticipated research and development activities, anticipated dates for commencement of clinical trials, anticipated completion dates of clinical trials, anticipated meetings with the FDA or other regulatory authorities concerning our product candidates, anticipated dates for submissions to obtain required regulatory marketing approvals, anticipated dates for commercial introduction of products, and other statements concerning our future operations and activities, are forward-looking statements that in each instance assume that we are able to obtain sufficient funding in the near term and thereafter to support such activities and continue our operations and planned activities in a timely manner. There can be no assurance that this will be the case. Also, such statements assume that there are no significant unexpected developments or events that delay or prevent such activities from occurring. Failure to timely obtain sufficient funding, or unexpected developments or events, could delay the occurrence of such events or prevent the events described in any such statements from occurring.

Unless the context otherwise requires, the terms “we,” “our,” and “the Company” refer to Adamis Pharmaceuticals Corporation, a Delaware corporation, and its subsidiaries.

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General

Company Overview

We are an emerging pharmaceutical company focused on combining specialty pharmaceuticals and biotechnology to provide innovative medicines for patients and physicians. We are currently primarily focused on our specialty pharmaceutical products. We are currently developing several products in the allergy and respiratory markets, including our Epinephrine PFS product, for the emergency treatment of acute allergic reactions, including anaphylaxis, and a dry powder inhaler technology. Our goal is to create low cost therapeutic alternatives to existing treatments. Consistent across all specialty pharmaceuticals product lines, we intend to submit Section 505(b)(2) New Drug Applications, or NDAs, or Section 505(j) Abbreviated New Drug Applications or ANDAs, to the U.S. Food and Drug Administration, or FDA, whenever possible, in order to potentially reduce the time to market and to save on costs, compared to those associated with Section 505(b)(1) NDAs for new drug products. We also have a number of biotechnology product candidates and technologies, including therapeutic vaccine and cancer product candidates and technologies intended to treat patients with unmet medical needs in the global cancer market. To achieve our goals and support our overall strategy, we will need to raise a substantial amount of funding and make significant investments in equipment, new product development and working capital. 

             Our USC subsidiary, which is registered as a drug compounding outsourcing facility under Section 503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug Quality and Security Act, provides prescription compounded medications, including compounded sterile preparations, and non-sterile compounds to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.  USC’s product offerings broadly include, among others, corticosteroids, hormone replacement therapies, hospital outsourcing products, injectables, urological preparations, ophthalmic preparations, topical compounds for pain and men’s and women’s health products.  USC’s compounded formulations in many circumstances are offered as therapeutic alternatives to drugs approved by the U.S. Food and Drug Administration, or the FDA.  USC prepares and provides a broad range of customized stock keeping units to meet the individual requirements of customers located throughout most of the United States. USC also provides certain veterinary pharmaceutical products for animals.

Segment Information

The Company is engaged primarily in the discovery, development and sales of pharmaceutical, biotechnology and other drug products. Accordingly, the Company has determined that it operates in one operating segment.

            

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Recent Developments

Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe

On May 28, 2014, we submitted a Section 505(b)(2) NDA application to the FDA for approval for sale of our Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe, or the Epinephrine PFS product. The Epinephrine PFS product delivers a premeasured dose of epinephrine for the emergency treatment of acute allergic reactions, including anaphylaxis.  We received a complete response letter (“CRL”) from the FDA on March 27, 2015.  A CRL is issued by the FDA’s Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.  We resubmitted the NDA on December 4, 2015.

On June 6, 2016, we issued a press release announcing that we received a second Complete Response Letter from the FDA regarding our NDA for the Epinephrine PFS product.  The CRL indicated that the FDA determined that it could not approve the NDA in its present form. The agency indicated that in order to support approval of the product, the Company must expand its human factors study (patient usability) and reliability study (product stress testing), with new studies, with protocols to be reviewed by the FDA before commencement of the studies. The CRL indicated that the new human factors study would need to provide additional, adequate and satisfactory data and information concerning, among other things, use of the product in different use environments and by different kinds of users and user groups. The CRL included comments on certain other aspects of the product and the materials and data submitted as part of the NDA. The CRL indicated that the agency had reserved comment, if any, on the proposed labeling for the product until the application was otherwise adequate. The FDA indicated that the NDA will remain open until the issues identified in the CRL are resolved.

The Company is continuing to review the CRL and actions that may be responsive to the items raised in the CRL, and the Company plans to request a meeting with the FDA to discuss the CRL.  Subsequent to the meeting with the FDA the Company plans to prepare and submit a response to the FDA that addresses the items raised in the CRL. Under the FDA’s procedures concerning target response times, the Company believes that the FDA should respond to the Company’s additional submission within six months after the Company’s responsive submission, though that target deadline may be extended if FDA requests additional data, information, materials or clarification or for other reasons, such as difficulties scheduling an advisory committee meeting, FDA workload issues, or other reasons.  The Company remains committed to attempting to obtain FDA approval of the NDA for the Epinephrine PFS product and commercializing the product, and remains hopeful that the issues and questions raised by the FDA in the CRL will be satisfactorily addressed and the product ultimately approved for marketing.  However, the Company cannot provide any assurances concerning if or when the NDA will be approved, the timing or outcome of any meeting with the FDA concerning our NDA, what actions will be required in order to satisfy the FDA’s issues and questions, and whether the Epinephrine PFS product will ultimately be  commercialized.  In addition, the Company will be required to devote additional cash resources, which could be significant, in order to respond to the issues raised by the FDA in the CRL and any follow-up requests and to design and manufacture the Epinephrine PFS product in a manner that is satisfactory to the FDA. 

APC-1000

The Company is continuing development of the APC-1000 product candidate, a steroid hydrofluoroalkane, or HFA, metered dose inhaler product for asthma.  Following discussions with the FDA and additional consideration of the development pathway for the product, the Company has decided to conduct additional development work for APC-1000.  As a result, the Company intends, depending on the outcome of several factors including results of the additional development work and obtaining additional funding that will be required to commence a trial, to submit an IND for APC-1000 during the first half of 2017, although there can be no assurances concerning the timing of any such filing or the commencement of a clinical trial relating to APC-1000 after submission of such an IND.  

 

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Going Concern and Management Plan

Our independent registered public accounting firm has included a “going concern” explanatory paragraph in its report on our consolidated financial statements for the years ended December 31, 2016 and 2015 indicating that we have sustained substantial losses from continuing operations and have used, rather than provided, cash in its continuing operations, and incurred recurring losses from operations and have limited working capital to pursue our business alternatives, and that these factors raise substantial doubt about our ability to continue as a going concern. As of June 30, 2016, we had cash of approximately $417,000, an accumulated deficit of approximately $81.1 million, and liabilities of approximately $14.3 million. Even with the proceeds from our July 2016 private placement financing transaction and our recent registered direct offering of shares of common stock and warrants, we will need significant funding to continue operations, satisfy our obligations and fund the future expenditures that will be required to conduct the clinical and regulatory work to develop our product candidates and to support our other activities. Such additional funding may not be available, may not be available on reasonable terms, and could result in significant additional dilution to our stockholders. If we do not obtain required additional equity or debt funding, our cash resources will be depleted and we could be required to materially reduce or suspend operations, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained.  

The above conditions raise substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements included elsewhere herein for the three months and six months ended June 30, 2016, were prepared under the assumption that we would continue our operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. In preparing these condensed consolidated financial statements, consideration was given to our future business as described elsewhere herein, which may preclude us from realizing the value of certain assets. Our unaudited condensed consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business. Without additional funds from debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or from a business combination or a similar transaction, after expenditure of our existing cash resources we would exhaust our resources and would be unable to continue operations.

Our management intends to attempt to secure additional required funding through equity or debt financings, sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions. However, there can be no assurance that we will be able to obtain any required additional funding. If we are unsuccessful in securing funding from any of these sources, we will defer, reduce or eliminate certain planned expenditures and delay development or commercialization of some or all of our products. If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us. 

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Results of Operations

Six Months Ended June 30, 2016 and 2015

Revenues

Revenues were approximately $1,928,000 and $0 for the six months ended June 30, 2016 and 2015, respectively. The revenues for the six-month period ended June 30, 2016, consist of and reflect our acquisition of USC effective April 11, 2016, but do not include revenues of USC before the closing date of the acquisition. Revenues for the six-month period were adversely affected by the suspension of production of USC’s sterile compounded formulations, product recall and remediation efforts in the third and fourth quarters of 2015 and the first quarter of 2016.  USC resumed production and sales of compounded sterile formulations in March and April 2016.  The suspension of production and sales of compounded sterile formulations adversely affected USC’s relationships with certain of its customers and with certain of USC’s independent contractors and sales representatives, and is expected to continue to adversely affect sales of compounded sterile compounded formulations.  

Cost of Sales.

Cost of sales were approximately $1,346,000 and $0 for the six months ended June 30, 2016 and 2015, respectively. Our cost of sales includes direct and indirect costs to manufacture formulations and sell products, including active pharmaceutical ingredients, personnel costs, packaging, storage, shipping and handling costs, the write-off of obsolete inventory and other related expenses.

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Research and Development Expenses . Our research and development costs are expensed as incurred. Non-refundable advance payments for goods and services to be used in future research and development activities are recorded as an asset and are expensed when the research and development activities are performed. Research and development costs were approximately $6,831,000 and $2,625,000 for the six months ended June 30, 2016 and 2015, respectively. The increase in research and development expenses was primarily due to the additional expense in product development, consisting mostly of expenditures related to clinical trials, product testing and product validation of approximately $3,652,000 relating to our Epinephrine PFS product candidate, APC-2000 and APC-5000 product candidates and somewhat offset by a reduction on development costs of our APC 1000 and APC 3000 product candidates. Compensation expense, which includes salaries, stock options, employee benefits and bonus accrual, increased by approximately $542,000 for the first half of 2016 compared to the comparable period of the prior year because of salary increase, new hires, additional stock option grants and monthly accrual of bonus.  

Selling, General and Administrative Expenses . Selling, general and administrative expenses consist primarily of depreciation and amortization, legal fees, accounting and audit fees, professional/consulting fees and employee compensation. Selling, general and administrative expenses for the six months ended June 30, 2016 and 2015 were approximately $7,199,000 and $5,055,000, respectively. The increase was primarily due to expenses of approximately $2,004,000 relating to our USC subsidiary which we acquired in April 2016. Expenses related to the commercialization activities of Epinephrine PFS product candidate decreased by approximately $617,000 for the first six months of the year compared to the comparable period of 2015. Compensation expense for selling, general and administrative employees increased by approximately $480,000 for the six months ended June 30, 2016 compared to the comparable period of the prior year, primarily due to salary increases, additional stock options granted and monthly accrual of bonus. Other increases in expenditures for the six months ended June 30, 2016 compared to the six months ended June 30, 2015 included increase in board of directors' fees of approximately $24,000 and insurance costs of approximately $60,000, and expenses of approximately $257,000 incurred in connection with the acquisition of U.S. Compounding, Inc. Legal expenses decreased by approximately $64,000 during the six month period ended June 30, 2016 compared to the comparable period of 2015 primarily due to FDA related matters, patents and commercialization related contracts. 

Other Income (Expense) . Other income for the six month period ended June 30, 2016 and 2015 was approximately $1,325,000 and approximately $894,000, respectively. Other Income (Expense) consists primarily of a change in fair value of warrants, change in fair value of derivative liabilities, and interest expense. The net change in fair value of warrants and derivatives resulted in an income of approximately $1,397,000 for the six months ended June 30, 2016, compared to income of approximately $894,000 for the six months ended June 30, 2015. The cancellation of the liability classified warrants resulted in the recognition of the recorded liability to income. Debt related expense (Interest Expense) for the six month periods ended June 30, 2016 and 2015 was approximately $72,000 and $0, respectively. The increase in debt related expenses for the six month period ended June 30, 2016, in comparison to the same period for fiscal 2015 was due to the working capital loan of $2.0 million and other bank liabilities assumed in relation to the acquisition of USC in April 2016. 

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Three Months Ended June 30, 2016 and 2015

Revenues

Revenues were approximately $1,928,000 and $0 for the three months ended June 30, 2016 and 2015, respectively. The revenues for the three-month period ended June 30, 2016, consist of and reflect our acquisition of USC effective April 11, 2016, but do not include revenues of USC before the closing date of the acquisition. Revenues for the three-month period were adversely affected by the suspension of USC’s sterile compounded formulations, product recall and remediation efforts in the third and fourth quarters of 2015 and the first quarter of 2016.  USC resumed production and sales of compounded sterile formulations in March and April 2016.    The suspension of production and sales of compounded sterile formulations adversely affected USC’s relationships with certain of its customers and with certain of USC’s independent contractors and sales representatives, and is expected to continue to adversely affect sales of compounded sterile compounded formulations.  

Cost of Sales.

Cost of sales were approximately $1,346,000 and $0 for the three months ended June 30, 2016 and 2015, respectively. Our cost of sales includes direct and indirect costs to manufacture formulations and sell products, including active pharmaceutical ingredients, personnel costs, packaging, storage, shipping and handling costs, the write-off of obsolete inventory and other related expenses.

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Research and Development Expenses . Our research and development costs are expensed as incurred. Non-refundable advance payments for goods and services to be used in future research and development activities are recorded as an asset and are expensed when the research and development activities are performed. Research and development costs were approximately $3,430,000 and $1,270,000 for the three months ended June 30, 2016 and 2015, respectively. The increase in research and development expenses was primarily due to additional expense in product development, consisting mostly of expenditures related to product testing and product validation of approximately $1,674,000. Compensation expense, which includes salaries, stock options, employee benefits and bonus accrual, increased by approximately $478,000 for the three month period ended June 30, 2016 compared to the comparable period of the prior year, primarily due to salary increases, additional stock options granted and monthly accrual of bonus. 

Selling, General and Administrative Expenses . Selling, general and administrative expenses consist primarily of depreciation and amortization, legal fees, accounting and audit fees, professional/consulting fees and employee compensation. Selling, general and administrative expenses for the three months ended June 30, 2016 and 2015 were approximately $4,583,000 and $2,262,000, respectively. The increase was primarily due to our USC subsidiary that we acquired during the second quarter of 2016, of approximately $2,004,000. Expenses related to the commercialization activities related to Epinephrine PFS product decreased by approximately $19,000. Compensation expense for selling, general and administrative employees increased by approximately $136,000 for the three months ended June 30, 2016 compared to the comparable period of the prior year, primarily due to salary increases, new hires, additional stock options granted and monthly accrual of bonus. Other increases in expenditures for the three months ended June 30, 2016 compared to the comparable quarter in 2015 included increase in insurance costs of approximately $54,000, USC acquisition related expenses of approximately $62,000 and increase of approximately $84,000 in other expenses in relation to SEC and proxy expenses, franchise tax, board of directors’ fees, patent cost and upgrade of telephones, file sharing service and data server. 

Other Income (Expense) . Other income (expense) for the three month period ended June 30, 2016 and 2015 was approximately $1,717,000 and approximately ($113,000), respectively. Other Income (Expense) consists primarily of a change in fair value of warrants, change in fair value of derivative liabilities and interest expense. The net change in fair value of warrants and derivatives resulted in an income of approximately $1,789,000 for the three months ended June 30, 2016, compared to expense of approximately $113,000 for the three months ended June 30, 2015. The cancellation of the liability classified warrants resulted in the recognition of the recorded liability to income.  Interest expense for the three months ended June 30, 2016 and 2015 was approximately $72,000 and $0, respectively. The increase in debt related expenses for the three month period ended June 30, 2016, in comparison to the same period for fiscal 2015 was due to the working capital loan of $2.0 million and other bank liabilities assumed in relation to the acquisition of USC in April 2016. 

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Liquidity and Capital Resources

We have incurred net losses of approximately $12.1 million and $6.8 million for the six months ended June 30, 2016 and 2015, respectively. Since inception, and through June 30, 2016, we have an accumulated deficit of approximately $81.1 million. Since inception and through June 30, 2016 we have financed our operations principally through debt financing, through private issuances of common stock and preferred stock, and through underwritten public offerings of common stock. Since inception and through June 30, 2016, we have raised a total of approximately $79.0 million in debt and equity financing transactions, consisting of approximately $17.8 million in debt financing and approximately $61.2 million in equity financing transactions. We expect to finance future cash needs primarily through proceeds from equity or debt financings, loans, sales of assets, out-licensing transactions, and/or collaborative agreements with corporate partners. We have used the net proceeds from debt and equity financings for general corporate purposes, which have included funding for research and development, selling, general and administrative expenses, working capital, reducing indebtedness, pursuing and completing licenses, acquisitions or investments in other businesses, products or technologies, and for capital expenditures.

Total assets were approximately $29.4 million and $12.1 million as of June 30, 2016 and December 31, 2015, respectively.  Current liabilities exceed current assets by approximately $11.8 million at June 30, 2016.

Net cash used in operating activities for the six months ended June 30, 2016 and 2015, was approximately $11.1 million and $6.0 million, respectively. Net cash used in operating activities increased due to additional research and development costs, and increases in SG&A expenses.

Net cash provided by investing activities was approximately $365,000 and $0 for six months ended June 30, 2016 and 2015, respectively. The net cash provided by investing activities increased due to the cash received from the acquisition of USC. 

Net cash provided by financing activities was approximately $7.1 million and $10.6 million for the six months ended June 30, 2016 and 2015, respectively. Net cash flows provided by financing activities decreased due to the issuance of common stock in January 2015 that generated net proceeds of approximately $10.6 million whereas, in 2016, capital raised from issuance of preferred stock and warrant conversion totaled $5.1 million and proceeds of bank loan amounted to $2 million. 

As noted above under the heading “Going Concern and Management Plan,” through June 30, 2016, Adamis had incurred substantial losses. The availability of any required additional funding cannot be assured. If we do not obtain additional equity or debt funding in the near future, our cash resources will be depleted and we will be required to materially reduce or suspend operations. Even if are successful in obtaining additional funding to permit us to continue operations at the levels that we desire, substantial time will pass before we obtain regulatory marketing approval for any products and begin to realize revenues from product sales, and during this period Adamis will require additional funds. No assurance can be given as to the timing or ultimate success of obtaining future funding. As noted under the heading Recent Developments, the Company will be required to devote additional cash resources, which could be significant, in order to respond to the issues and questions raised by the FDA in the CRL regarding our Epinephrine PFS product and to continue development of our other product candidates including APC-1000 and APC-5000, and to support our other operations and activities.

32
 

 

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosure of contingent assets and liabilities. We evaluate our estimates on an ongoing basis. We base our estimates on historical experience and on other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

The Company’s critical accounting policies and estimates previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2015 have not significantly changed except for the following policies that have been adopted during the six months ended June 30, 2016.

Revenue Recognition

The Company recognize revenues when all of the following criteria have been met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred; (3) the selling price is fixed and determinable; and (4) collectability is reasonably assured. Revenues from our USC subsidiary consist of sales of compounded drugs for humans and animals, including sterile injectable and non-sterile integrative therapies. Sales discounts and rebates are sometimes offered to customers if specified criteria are met. Additionally, sales are generally made with a limited right of return under certain conditions. Revenues are recorded net of provisions for sales discounts and returns, which are established at the time of sale.  

Accounts Receivable

 Accounts receivable are reported at the amount management expects to collect on outstanding balances. Management provides for probable uncollectible amounts through a charge to earnings and credit to allowance for doubtful accounts. Uncollectible amounts are based on USC's history of past write-offs and collections and current credit conditions. Provision for bad debt totaled $15,563 for the period ended June 30, 2016.

  Inventories

Inventories are valued at the lower of cost or market. The cost of inventories are determined using the first-in, first-out (“FIFO”) method. Inventories consist of compounding formulation raw materials, currently marketed products, and device supplies. A reserve for obsolescence is recorded monthly based on a review of inventory for obsolescence. Reserve for obsolescence was $20,253 as of June 30, 2016. 

Acquisitions and Intangibles

 

The Company has engaged in business combination activity. The accounting for business combinations requires management to make judgments and estimates of the fair value of assets acquired, including the identification and valuation of intangible assets, as well as liabilities assumed. Such judgments and estimates directly impact the amount of goodwill recognized in connection with each acquisition, as goodwill presents the excess of the purchase price of an acquired business over the fair value of its net tangible and identifiable intangible assets.

 

Goodwill and Other Long-Lived Assets

 

Goodwill, which has an indefinite useful life, represents the excess of cost over fair value of net assets acquired. Goodwill is reviewed for impairment at least annually during the fourth quarter, or more frequently if events occur indicating the potential for impairment. During its goodwill impairment review, the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions, industry and market considerations, and the overall financial performance of the Company. If, after assessing the totality of these qualitative factors, the Company determines that it is not more likely than not that the fair value of its reporting unit is less than its carrying amount, then no additional assessment is deemed necessary. Otherwise, the Company proceeds to perform the two-step test for goodwill impairment. The first step involves comparing the estimated fair value of the reporting unit with its carrying value, including goodwill. If the carrying amount of the reporting unit exceeds its fair value, the Company performs the second step of the goodwill impairment test to determine the amount of loss, which involves comparing the implied fair value of the goodwill to the carrying value of the goodwill. The Company may also elect to bypass the qualitative assessment in a period and elect to proceed to perform the first step of the goodwill impairment test.

 

The Company evaluates its long-lived assets with definite lives, such as property and equipment, acquired technology, customer relationships, patent and license rights, for impairment by considering competition by products prescribed for the same indication, the likelihood and estimated future entry of non-generic and generic competition with the same or similar indication and other related factors. The factors that drive the estimate of the life are often uncertain and are reviewed on a periodic basis or when events occur that warrant review. Recoverability is measured by comparison of the assets' book value to future net undiscounted cash flows that the assets are expected to generate.

 

  Claims Liabilities

             USC is self-insured up to certain limits for health insurance. Provisions are made for both the estimated liabilities for known claims as incurred and estimates for those incurred but not reported. As of June 30, 2016, the Company was self-insured for up to the first $40,000 of claims per covered person with an aggregate deductible of $626,445. The estimated IBNR (Incurred But Not Reported) provided by the plan administrator was $77,818 at June 30, 2016.

 

Deferred Income Taxes

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. We maintain a valuation allowance against the deferred tax asset due to uncertainty regarding the future realization based on historical taxable income, projected future taxable income and the expected timing of the reversals of existing temporary differences. Until such time as we can demonstrate that we will no longer incur losses, or if we are unable to generate sufficient future taxable income, we could be required to maintain the valuation allowance against our deferred tax assets.

  33  
 

 

Recent Accounting Pronouncements

In July 2015, the FASB issued ASU 2015-11 Simplifying the Measurement of Inventory which requires entities to measure most inventory “at the lower of cost and net realizable value (“NRV”),” thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is “measured at the lower of cost and net realizable value,” which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.” The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. Early application is permitted. We have not yet evaluated the impact of ASU No. 2015-11 on our financial statements.

In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients. ASU No. 2016-12 is a response to concerns brought up by the Joint Transaction Resource Group for Revenue Recognition (TRG). The Update is intended to improve Topic 606 (Revenue from Contracts with Customers) by reducing the potential for diversity in practice and application, and the complexity of application. The effective date for ASU No. 2016-12 defers the effective date for Update 2014-09 (Fiscal periods beginning after December 15, 2017) by one year, which will be fiscal 2018 for us. We do not expect adoption of ASU No. 2016-12 to have a significant impact on our financial statements.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses. ASU No. 2016-13 is intended to provide users of financial statements with more decision-useful information about credit losses on financial instruments that are expected, but do not yet meet the “probable” threshold. This Update replaces the incurred loss impairment methodology with a methodology that reflects expected credit losses. The effective date that applies to SEC filers for ASU No. 2016-13 is for fiscal years beginning after December 15, 2019. We have not yet evaluated the impact of ASU No. 2016-13 on our financial statements. 

Off Balance Sheet Arrangements

At June 30, 2016, Adamis did not have any off balance sheet arrangements. 

ITEM 3. Quantitative and Qualitative Disclosure of Market Risk

Not required. 

ITEM 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports, filed under the Securities Exchange Act of 1934, is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance and not absolute assurance of achieving their objectives.  In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

As required by the SEC Rule 13a-15(b), 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 of the end of the period covered by this report. Based on the foregoing, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.  

 

Changes in Internal Controls

Except as described in this paragraph, there has been no change during the three months ended June 30, 2016 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. In connection with our acquisition of U.S. Compounding, Inc. (“USC”) in April 2016, we began implementing the Company’s standards and procedures at USC, including controls over accounting systems, financial reporting, and the preparation of financial statements in accordance with U.S. GAAP. We are continuing to integrate the acquired operations of USC into our overall internal control over financial reporting process.

  34  
 

 

PART II OTHER INFORMATION

ITEM 1. Legal Proceedings

Information regarding certain legal proceedings to which the Company is or may become a party can be found in the description of legal proceedings contained in the Company’s most recent Annual Report on Form 10-K for the nine-month period ended December 31, 2015, and is incorporated herein by reference. There have not been any material developments with respect to any such proceedings during the quarter to which this Report on Form 10-Q relates.

Item 1A. Risk Factors

As a smaller reporting company, Adamis is not required under the rules of the Securities and Exchange Commission, or SEC, to provide information under this Item. Risks and uncertainties relating to the amount of cash and cash equivalents at June 30, 2016, and uncertainties concerning the need for additional funding, are discussed above under the headings, “Going Concern and Management Plan” and “Liquidity and Capital Resources” in the Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this Form 10-Q, and are incorporated herein by this reference. Other material risks and uncertainties associated with Adamis’ business have been previously disclosed in our most recent transition report on Form 10-K filed with the Securities and Exchange Commission, included under the heading “Risk Factors,” and in our Report on Form 8-K filed with the Commission on July 28, 2016, including under the heading “Risk Factors,” and those disclosures are incorporated herein by reference.

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

Except as described below, information required by this Item regarding sales of equity securities during the quarter ended June 30, 2016, without registration under the Securities Act of 1933, as amended, has been previously included in Current Reports on Form 8-K filed by the Company. 

On March 25, 2016, the Company issued an option to a consultant to purchase 55,000 shares of common stock, with an exercise price of $8.46 per share, representing the fair market value of the common stock on the date of grant.  The option was exercisable in full as of the date of grant.  The securities were issued in a private placement transaction in reliance on Section 4(2) of the Securities Act of 1933, as amended. The optionee represented that the securities were being acquired for investment purposes, for the person’s or entity’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and that the optionee was an accredited investor as defined in Regulation D promulgated under the Securities Act.

During April 2016, the Company issued 26,144 shares of common stock upon exercise of a warrant granted in June 2013 in connection with a private placement transaction.  The warrant holder exercised the warrant for cash at an exercise price of $3.40 per share, and the Company received cash of approximately $89,000. The warrant, and the shares issued upon exercise of the warrant, were issued in a private placement transaction to the warrant holder and a limited number of other shareholders in reliance on Section 4(2) of the Securities Act of 1933, as amended, and/or Regulation D promulgated under the Securities Act. Each person or entity to whom securities were issued represented that the securities were being acquired for investment purposes, for the person’s or entity’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and that such person was an accredited investor as defined in Regulation D.

 

35
 

 

ITEM 3. Defaults Upon Senior Securities

As we have previously disclosed in our SEC filings and as disclosed elsewhere in this Report on Form 10-Q, in connection with our acquisition of USC and the transactions contemplated by the Merger Agreement relating to the USC transaction, we assumed approximately $5,722,500 principal amount of debt obligations under certain loan agreements and related agreements and documents of USC and certain related entities (the “Existing Loan Documents”), and agreed to become an additional co-borrower under such Existing Loan Documents.  The lender under the Existing Loan Documents was Bear State Bank, N.A. (the “Bank”).  The borrowers under these Existing Loan Documents, which include USC and us, among other parties, are required to make current periodic interest payments under the Existing Loan Documents in an amount of approximately $18,000 per month.  There have not been any material defaults in scheduled payments of principal or interest under the Existing Loan Documents.  However, as previously disclosed, USC and the other borrower entities under the Existing Loan Documents were, at the time of our acquisition of USC, in default of certain covenants in the Existing Loan Documents, including without limitation those that requires maintenance of certain financial ratios relating to maintaining at least a certain Fixed Charge Coverage ratio and to the eligible Borrowing Base (based on eligible accounts receivable, inventory and real property), as defined in the Existing Loan Documents.  

In connection with the closing of the USC Merger, we entered into a Loan Amendment, Forbearance and Assumption Agreement (the “Loan Amendment Agreement”) with the Bank and certain other parties.  Pursuant to the Loan Amendment Agreement, we were added as a “Borrower” under the Existing Loan Documents described above and assumed all of the rights, duties, liabilities and obligations as a Borrower and a party under the Existing Loan Documents. 

In addition, in recognition of the fact that the loans made by the Bank under the Existing Loan Documents were in default with respect to certain nonmonetary covenants in the Existing Loan Documents, the Bank agreed that until October 31, 2016, and subject to compliance with the other provisions of the Loan Amendment Agreement, it would not pursue available remedies as a result of such noncompliance or demand payment under the promissory notes included in the Existing Loan Documents.  In addition, in the Loan Amendment Agreement the Company and the Bank agreed to discuss in good faith mutually agreeable amendments or modifications to the Existing Loan Documents in light of the changes in circumstances resulting from the Merger. In August 2016, the Company received a commitment letter from the Bank describing a proposal to modify, consolidate and replace certain of the Existing Loan Documents with a new loan agreement, and the Company expects to engage in discussions with the Bank concerning modifications to the other Existing Loan Documents or entering into new loan agreements to replace and supersede the other Existing Loan Documents. 

 

ITEM 4. Mine Safety Disclosures

Removed and Reserved. 

ITEM 5. Other Information

None. 

  36  
 

 

ITEM 6. Exhibits

The following exhibits are attached hereto or incorporated herein by reference.

 

10.1   Business Loan Agreement dated July 14, 2014, between First Federal Bank and U.S. Compounding, Inc., and related loan documents.  
     
10.2   Business Loan Agreement dated July 14, 2014, between First Federal Bank and U.S. Compounding, Inc., and related loan documents.
     
10.3   Business Loan Agreement between 4 HIMS, LLC and First Federal Bank dated August 8, 2014, and related loan documents.
     
10.4   Business Loan Agreement between Tribute Labs, LLC and First Federal Bank dated March 21, 2014, and related loan documents.  
     
10.5   Loan Amendment, Forbearance and Assumption Agreement, between the Company and Bear State Bank, N.A.
     
10.6   Development, License and Commercialization Agreement dated as of May [10], 2016, between the Company and Watson Laboratories, Inc. (1)
     
31.1   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
31.2   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
32.1   Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
32.2   Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
101.INS   XBRL Instance Document
     
101.SCH   XBRL Taxonomy Extension Schema Document
     
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document
     
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document
     
101.LAB   XBRL Taxonomy Extension Label Linkbase Document
     
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document

 

 (1) Confidential treatment has been requested for portions of this exhibit.

  37  
 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

  ADAMIS PHARMACEUTICALS, INC.
     
Date: August 15, 2016 By: /s/ Dennis J. Carlo
    Dennis J. Carlo
    Chief Executive Officer
     
Date: August 15, 2016 By: /s/ Robert O. Hopkins
    Robert O. Hopkins
    Vice President, Finance and Chief Financial Officer

 

  38  

 

Adamis Pharmaceuticals Corporation 10-Q

Exhibit 10.1

 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 

 

 
 

 

 

Adamis Pharmaceuticals Corporation 10-Q

Exhibit 10.2

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 

 
 

 

 

Adamis Pharmaceuticals 10-Q

Exhibit 10.3

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 

 

 

Adamis Pharmaceuticals 10-Q

Exhibit 10.4

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

 

 

 

Adamis Pharmaceuticals Corporation 10-Q

 

Exhibit 10.5

 

 

LOAN AMENDMENT, FORBEARANCE AND ASSUMPTION AGREEMENT

THIS LOAN AMENDMENT, FORBEARANCE AND ASSUMPTION AGREEMENT (this “ Agreement ”) is made and entered into as of April _____, 2016 (the “ Agreement Date ”), by and among 4 HIMS, LLC , an Arkansas limited liability company (“ 4 HIMS ”), Tribute Labs, LLC , a Nevada limited liability company (“ Tribute ”), US Compounding, Inc ., an Arkansas corporation (“ USC ”) (4 HIMS, Tribute and USC are collectively hereinafter referred to as the “ Initial Loan Parties ”); EDDIE GLOVER , an individual, and WILLIAM L. SPARKS , an individual; and KRISTEN RIDDLE , an individual (collectively, the “ Individual Guarantors ”); Adamis Pharmaceuticals Corporation , a Delaware corporation (“ Adamis ”); and Bear State Bank, INC. , a national banking association (“ Bank ”).

BACKGROUND

A.

Pursuant to that certain Business Loan Agreement (as modified, amended or supplemented, the “ 4 HIMS Loan Agreement ”) dated as of August 8, 2014, entered into by and between 4 HIMS, as borrower, and Bank, as lender, Bank agreed to make a loan, Loan No. 5500000152 (the “ 4 HIMS Loan ”) to 4 HIMS in the initial principal amount of up to Two Million Five Hundred Eight-Six Thousand Eight Hundred Ninety-Two and 09/100 Dollars ($2,586,892.09). The 4 HIMS Loan is evidenced by that certain Commercial Promissory Note (as modified, amended or supplemented, the “ 4 HIMS Note ”) dated as of August 8, 2014, executed by 4 HIMS in favor of Bank. The 4 HIMS Note is secured by, among other things, that certain Commercial Real Estate Mortgage (as modified, amended or supplemented, the “ 4 HIMS Mortgage ”) dated as of August 8, 2014, executed by 4 HIMS in favor of Bank and recorded in the Official Records of Faulkner County as Doc #2014-11418, encumbering certain real property more particularly described in the 4 HIMS Mortgage. In connection with the 4 HIMS Loan, 4 HIMS also entered into certain other agreements and instruments, (the 4 HIMS Loan Agreement, the 4 HIMS Note, the 4 HIMS Mortgage and all other documents executed in connection with the 4 HIMS Loan, all as previously modified, amended or supplemented, collectively referred herein as the “ 4 HIMS Loan Documents ”). The Eddie Glover and William L. Sparks (collectively the “ 4 HIMS Individual Guarantors” ) and USC guaranteed repayment of the 4 HIMS Loan pursuant to those certain documents each titled Guaranty of Specific Transaction (such guarantees by the 4 HIMS Individual Guarantors and USC, as may be modified, amended or supplemented, referred to as the “ 4 HIMS Guarantees ”) dated as of August 8, 2014, entered into by each of them for the benefit of Bank.

B.

Pursuant to that certain Business Loan Agreement (as modified, amended or supplemented, the “ Tribute Loan Agreement ”) dated as of ____________, 20__, entered into by and between Tribute, as borrower, and Bank, as lender, Bank agreed to make a loan, Loan No. 55000024132 (the “ Tribute Loan ”) to Tribute in the initial principal amount of ___________________________ and __/100 Dollars ($___________). The Tribute Loan is evidenced by that certain Commercial Promissory Note (as modified, amended or supplemented, the “ Tribute Note ”) dated as of ___________, 20___, executed by Tribute in favor of Bank. The Tribute Note is secured by, among other things, [___________________] encumbering certain personal property of Tribute. In connection with the Tribute Loan, Tribute also entered into certain other agreements and instruments, (the Tribute Loan Agreement, the Tribute Note and all other documents executed in connection with the Tribute Loan, all as previously modified, amended or supplemented, collectively referred herein as the “ Tribute Loan Documents ”). [Eddie Glover, Kristen Riddle and other individuals (“ Tribute Individual Guarantors” ) guaranteed repayment of the Tribute Loan pursuant to those certain documents titled Guaranty of Specific Transaction (such guarantees by the Tribute Individual Guarantors, as may be modified, amended or supplemented, referred to as the “ Guarantees ”) dated as of _______________, 20___, entered into by each of them for the benefit of Bank.]

C.

The Bank has made the following loans to USC (collectively, the “ USC Loans ”)

(a)

that certain loan, Loan No. 55000028497, evidenced by that Business Loan Agreement (as modified, amended or supplemented, the “ USC Working Capital Loan Agreement ”) dated as of July 14, 2014, entered into by and between USC, as borrower, and Bank, as lender (the “ USC Working Capital Loan ”) to USC in the initial principal amount of Two Million Five Hundred Thousand and No/100 Dollars ($2,500,000.00). The USC Working Capital Loan is evidenced by that certain Commercial Line of Credit Agreement and Note (as modified, amended or supplemented, the “ USC Working Capital Note ”) dated as of July 14, 2014, executed by USC in favor of Bank. The USC Working Capital Loan is secured by, among other things: (i) a first priority security interest in the accounts receivable and inventory of USC, pursuant to that certain Commercial Security Agreement between USC and the Bank (the “ USC Working Capital Security Agreement ”); and (ii) that certain Commercial Real Estate Mortgage (as modified, amended or supplemented, the “ Glover Mortgage ”) dated as of December 19, 2014, executed by the Eddie Glover Revocable Trust in favor of Bank and recorded in the Official Records of Faulkner County as Doc #2014-18380, encumbering certain real property more particularly described in the Glover Mortgage (the “ Glover Property ”) (the collateral referenced in the USC Working Capital Security Agreement, the Glover Property and any other real or personal property, if any, securing the USC Working Capital Loan collectively referred to herein as the “ USC Working Capital Property ”). In connection with the USC Working Capital Loan, USC also entered into certain other agreements and instruments (the USC Working Capital Loan Agreement, the USC Working Capital Note and all other documents executed in connection with the USC Working Capital Loan, all as previously modified, amended or supplemented, collectively referred herein as the “ USC Working Capital Loan Documents ”). Individual Guarantors Eddie Glover and Kristen Riddle (“ USC Individual Guarantors ”) guaranteed repayment of the USC Working Capital Loan pursuant to those certain documents titled Guaranty of Specific Transaction (such guarantees by such USC Individual Guarantors, as may be modified, amended or supplemented, referred to as the “ USC Working Capital Guarantees ”) dated as of July 14, 2014, entered into by each of them for the benefit of Bank.

 

 
 

 

(b)

that certain loan, Loan No. 55000028406, evidenced by that Business Loan Agreement (as modified, amended or supplemented, the “ USC Equipment Loan Agreement ”) dated as of July 14, 2014, entered into by and between USC, as borrower, and Bank, as lender (the “ USC Equipment Loan ”) to USC in the initial principal amount of One Million and No/100 Dollars ($1,000,000.00). The USC Equipment Loan is evidenced by that certain Commercial Line of Credit Renewal Agreement and Note (as modified, amended or supplemented, the “ USC Equipment Note ”) dated as of July 14, 2014, executed by USC in favor of Bank. The USC Equipment Loan is secured by, among other things, a first priority security interest in all equipment of USC, pursuant to that certain Commercial Security Agreement between USC and the Bank (the “ USC Equipment Security Agreement ”) (the collateral referenced in the USC Equipment Security Agreement and any other real or personal property, if any, securing the USC Equipment Loan collectively referred to herein as the USC Equipment Property ”). In connection with the USC Equipment Loan, USC also entered into certain other agreements and instruments, (the USC Equipment Loan Agreement, the USC Equipment Note and all other documents executed in connection with the USC Equipment Loan, all as previously modified, amended or supplemented, collectively referred herein as the “ USC Equipment Loan Documents ”). USC Individual Guarantors guaranteed repayment of the USC Working Capital Loan pursuant to those certain documents titled Guaranty of Specific Transaction (such guarantees by such USC Individual Guarantors, as may be modified, amended or supplemented, referred to as the “ USC Equipment Guarantees ”) dated as of July 14, 2014, entered into by each of them for the benefit of Bank. For purposes of this Agreement, the USC Working Capital Loan Documents and the USC Equipment Loan Documents are collectively hereinafter referred to as the “ USC Loan Documents .” For purposes of this Agreement, the USC Working Capital Property and the USC Equipment Property are collectively hereinafter referred to as the “ USC Property .”

D.

For purposes of this Agreement, the 4 HIMS Loan, the Tribute Loan and the USC Loans are collectively hereinafter referred to as the “ Existing Loans ” and the 4 HIMS Loan Documents, the Tribute Loan Documents and the USC Loan Documents are collectively hereinafter referred to as the “ Existing Loan Documents .”

E.

Adamis has agreed to enter into a merger transaction with USC (the “ Merger ”), pursuant to that certain Agreement and Plan of Merger dated as of March 28, 2016 (the “ Merger Agreement ”). USC’s principal offices are currently located on the 4 HIMS Property.

(a)

In connection with the Merger and effective as of the closing of the transactions contemplated by the Merger Agreement, Adamis will acquire from 4HIMS the entire fee simple interest in and to the real property and tangible assets that 4HIMS has agreed to sell and transfer to Adamis (the “ 4 HIMS Property ”) pursuant to that certain Purchase and Sale Agreement dated as of March 28, 2016, and entered into by and between Adamis and 4 HIMS for consideration consisting only of the assumption of the 4 HIMS Loan by Adamis.

(b)

Also in connection with the Merger and effective as of the closing of the transactions contemplated by the Merger Agreement, USC will acquire the certain equipment and assets of Tribute (collectively, the “ Tribute Property ”) pursuant to that certain Asset Purchase Agreement dated March 28, 2016, entered into by and between Tribute and USC for consideration consisting only of the assumption of the Tribute Loan by USC.

F.

Also in connection with the Merger, Adamis has requested, and the Bank has agreed, to extend to Adamis a credit facility in the amount of Two Million and No/100 United States Dollars ($2,000,000.00)(the “ Adamis New Loan ”), pursuant to a Negotiable Term Promissory Note dated March 28, 2016, in the amount of Two Million and No/100 United States Dollars ($2,000,000.00) and such other agreements and instruments to evidence and secure the Adamis New Loan (all documents executed in connection with the Adamis New Loan, all as may be modified, amended or supplemented, collectively referred herein as the “ Adamis New Loan Documents ”). The Existing Loans and the Adamis New Loan may be collectively referred to herein as the “ Loans .” Adamis and the Initial Loan Parties may be collectively referred to herein as the “ Loan Parties .” The Adamis New Loan Documents and the Existing Loan Documents may be collectively referred to herein as the “ Loan Documents .” In connection the Merger, the Bank has requested that the Loan Parties enter into this Agreement to evidence the following: 

2  
 

 

(a)

The addition of Adamis as a borrower to the Existing Loan Documents, whereby Adamis shall have, effective as of the Merger Closing, all rights, duties, liabilities and obligations under the Existing Loan Documents, and the acceptance and assumption of such rights, duties, liabilities and obligations by Adamis; and the addition of USC as a borrower to the Tribute Loan Documents, whereby USC shall have, effective as of the Agreement Date, all rights, duties, liabilities and obligations under the Tribute Loan Documents, and the acceptance and assumption of such rights, duties, liabilities and obligations by USC.

(b)

The continuation, except as noted below, of each of the Initial Loan Parties’ rights, duties, liabilities and obligations under the Existing Loan Documents as a co-borrower, notwithstanding the acceptance and assumption of such rights, duties, liabilities and obligation by Adamis;

(c)

The removal of Eddie Glover and William L. Sparks as 4 HIMS Individual Guarantors under the 4 HIMS Loan Documents and release of the Glover Mortgage in connection with the USC Working Capital Loan;

(d)

The cross-collateralization of the Loans; and

(e)

The temporary forbearance of certain obligations pursuant to the Existing Loans.

AGREEMENT

NOW, THEREFORE, in consideration of the mutual benefits accruing to the parties hereto and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

1.

Reaffirmation of Loans .

1.1

4 HIMS Loan .

(a)

4 HIMS represents and warrants that as of the Agreement Date, the outstanding principal balance of the 4 HIMS Note is Two Million Four Hundred Fifty Three Eight Hundred Seventy Six and 12/100 United States Dollars ($2,453,876.12), and payments under the 4 HIMS Note are current through April 1, 2016, and the Bank acknowledges and agrees that to its knowledge such amounts represent the outstanding principal balance of the 4 HIMS Note. The Bank acknowledges and agrees that 4 HIMS is current in its interest payments or other obligations under the 4 HIMS Loan Documents that are due and payable before the Agreement Date. 

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(b)

4 HIMS unconditionally and irrevocably agrees to and acknowledges the unqualified and unconditional obligation for the 4 HIMS Loans, without defense, affirmative defense, counterclaim, right of setoff, or other impediment to collection, the same, if existing, being expressly released and waived by 4 HIMS in consideration for the Bank entering into this Agreement. 4 HIMS hereby ratifies, affirms, reaffirms, acknowledges, confirms, and agrees the any 4 HIMS Loan Documents to which it is a party represent the valid, enforceable, and binding obligations of 4 HIMS.

1.2

Tribute Loan .

(a)

Tribute represents and warrants that as of the Agreement Date, the outstanding principal balance of the Tribute Loan is Five Hundred Eighteen Thousand Two Hundred Thirty Three and 24/100 United States Dollars ($518,233.24), and payments under the Tribute Note are current through April 1, 2016, and the Bank acknowledges and agrees that to its knowledge such amounts represent the outstanding principal balance of the Tribute Note. The Bank acknowledges and agrees that Tribute is current in its interest payments or other obligations under the Tribute Loan Documents that are due and payable before the Agreement Date.

(b)

Tribute unconditionally and irrevocably agrees to and acknowledges the unqualified and unconditional obligation for the Tribute Loan, without defense, affirmative defense, counterclaim, right of setoff, or other impediment to collection, the same, if existing, being expressly released and waived by Tribute in consideration for the Bank entering into this Agreement. Tribute hereby ratifies, affirms, reaffirms, acknowledges, confirms, and agrees the any Tribute Loan Documents to which it is a party represent the valid, enforceable, and binding obligations of Tribute.

1.3

USC Loans .

(a)

USC represents and warrants that as of the Agreement Date, the outstanding principal balance of the USC Working Capital Note is Two Million One Hundred Fifteen Thousand Seven Hundred Ninety One and 86/100 United States Dollars ($2,115,791.86), and payments under the USC Working Capital Note are current through April 1, 2016, and the Bank acknowledges and agrees that to its knowledge such amounts represent the outstanding principal balance of the USC Working Capital Note. The Bank acknowledges and agrees that USC is current in its interest payments or other obligations under the USC Working Capital Loan Documents that are due and payable before the Agreement Date.

 

(b)

USC represents and warrants that as of the Agreement Date, the outstanding principal balance of the USC Equipment Note is Six Hundred Thirty Four Thousand Six Hundred Fifty Seven and 09/100 United States Dollars ($634,657.09), and payments under the USC Equipment Note are current through April 1, 2016, and the Bank acknowledges and agrees that to its knowledge such amounts represent the outstanding principal balance of the USC Equipment Note. The Bank acknowledges and agrees that USC is current in its interest payments or other obligations under the USC Equipment Loan Documents that are due and payable before the Agreement Date.

 

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(c)

USC unconditionally and irrevocably agrees to and acknowledges the unqualified and unconditional obligation for the USC Loans, without defense, affirmative defense, counterclaim, right of setoff, or other impediment to collection, the same, if existing, being expressly released and waived by USC in consideration for the Bank entering into this Agreement. USC hereby ratifies, affirms, reaffirms, acknowledges, confirms, and agrees the any USC Loan Documents to which it is a party represent the valid, enforceable, and binding obligations of USC.

1.4

Release . The Initial Loan Parties and Individual Guarantors unconditionally, irrevocably, jointly and severally release the Bank, its respective past, present or future affiliates, subsidiaries, holding company, owners, officers, directors, shareholders, employees, a.gents, independent contractors, attorneys, or other persons or entities employed or engaged by or affiliated with the Bank, in addition to any purchaser of all or a portion of any of the Existing Loans and current or future owners of participation in the Existing Loans (collectively, the “ Released Parties ”) (whether signatory hereto or not, and if not a party to this Agreement, being an intended (and not incidental) third party beneficiary hereof) from any causes of action, judgments, executions, suits, debts, claims, demands, liabilities, obligations, damages, and expenses of any and every kind or nature, whether heretofore or hereafter arising, for or because of any matter or thing done, omitted, or suffered to be done by any of the Released Parties prior to and including the date of execution hereof, and in any way directly or indirectly arising out of or in any way connected to this Agreement and the Existing Loan Documents. The provisions of this Section 1 (including subsections 1.1 – 1.4 hereof) and the remainder of this Agreement shall inure to the Bank and also run in favor of and inure to the maximum extent permitted by law to intended (and not incidental) third-party beneficiaries, which the Initial Loan Parties and Individual Guarantors agree shall include, without limitation, the Released Parties.

2.

Addition of Adamis as Co-Borrower under the Existing Loan Documents . Effective as of the Merger Closing, without the necessity of further documentation by the parties hereto, the Existing Loan Documents shall be deemed to be amended to add Adamis as a co-borrower under each of the Existing Loans, with the intention that, pursuant to such amendment, Adamis shall assume responsibility as borrower for all obligations, duties and liabilities under the Existing Loan Documents, jointly and severally with the current borrower or borrowers under each of the Existing Loans. Notwithstanding the foregoing, the parties expressly agree each of the Initial Loan Parties shall remain, as applicable, a co-borrower under the each of the Existing Loan Documents as set forth immediately prior to execution of this Agreement, and accordingly: (a) each of the Initial Loan Parties’ rights under the Existing Loan Documents shall not be affected, nor shall they be relieved of their obligations, duties and liabilities thereunder, and (b) each of the Initial Loan Parties shall continue to be bound by all of the terms, provisions and conditions contained in the Existing Loan Documents.

3.

Assumption

(a)

By Adamis . Effective as of the Agreement Date, Adamis hereby accepts the foregoing assumption of rights, obligations, duties and liabilities and assumes and agrees to pay and to perform, jointly and severally with each of the Initial Loan Parties (as applicable) all of the obligations, duties and liabilities as an original borrower under the Existing Loan Documents, whether accruing on or after the date hereof, and further agrees that Adamis shall hereafter be bound by all of the terms, provisions and conditions contained in the Existing Loan Documents. Notwithstanding the foregoing assumption by Adamis, except for the 4HIMS Property, each respective security agreement or security interest issued in connection with the Existing Loans will apply only to the assets of the entity named therein. 

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(b)

By USC . Effective as of the Agreement Date, USC hereby accepts the foregoing assumption of rights, obligations, duties and liabilities and assumes and agrees to pay and to perform, jointly and severally with each of the Initial Loan Parties (as applicable) all of the obligations, duties and liabilities as an original borrower under the Tribute Loan Documents, whether accruing on or after the date hereof, and further agrees that USC shall hereafter be bound by all of the terms, provisions and conditions contained in the Tribute Loan Documents.

4.

Forbearance .

4.1

Period . The Initial Loan Parties acknowledge that the Existing Loans are currently in default with respect to certain nonmonetary covenants contained in the Existing Loan Documents. All obligations of the Bank to forbear from pursuing its available remedies to collect the obligations evidenced and secured by the Existing Loan Documents shall conditionally exist until October 31, 2016 (the “ Forbearance Period ”). During the Forbearance Period, the Loan Parties shall be entitled to the benefits of subsection 4.3. Upon the expiration of the Forbearance Period, all monetary and nonmonetary obligations of the Loan Parties as set forth in the Existing Loan Documents shall be fully and completely reinstated.

4.2

Conditions to Obtain and Maintain the Forbearance Period . Notwithstanding the provisions of subsection 4.1, during the Forbearance Period the Loan Parties shall (i) continue to make all regularly scheduled payments of principal and interest due as set forth in the Existing Loan Documents; (ii) except to the extent modified herein, fully, completely and continuously comply with all covenants of the Loan Parties set forth in the Existing Loan Documents; and (iii) completely and continuously comply with any the provisions of this Agreement.  

4.3

Forbearance from Exercise of Remedies . Subject to the terms and provisions contained herein, the Bank will not pursue available remedies existing as a result of the Loan Parties’ failure to comply with the nonmonetary covenants of the Loan Parties as set forth in the Existing Loan Documents, including, but not limited to, with respect to the (A) 4 HIMS Loan Agreement, the sections of such agreement and provisions entitled or related to (i) Business Existence and Operations, (ii) Fixed Charge Coverage Ratio, (iii) No Borrowings or Guarantees and (iv) Other Information covenants; (B) Tribute Loan Agreement, the sections of such agreement and provisions entitled or related to (i) Borrower Performance Covenant and (ii) Other Information covenants; and (C) USC Working Capital Loan and USC Equipment Loan Agreements, the sections of such agreement and provisions entitled or related to (i) Fixed Charge Coverage Ratio, (ii) Funded Debt to EBITDA Ratio, (iii) No Borrowings or Guarantees, (iv) Other Information Covenants, (v) Quarterly Trend Analysis, and (vi) Owner Buyout Note covenants. 

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In addition, subject to the terms and provisions contained herein, during the Forbearance Period, the Bank will not exercise its rights to “demand’ payment under the “Promise to Pay” clause of the 4 HIMS Note, Tribute Note, USC Working Capital Note, and USC Equipment Note.  

4.4

Termination of Forbearance Period . Upon termination of the Forbearance Period by expiration of time or resulting from any noncompliance of the Loan Parties with the conditions set forth in subsection 4.2, including the nonperformance of any of the conditions or covenants, or if any of the warranties and representations set forth in this Agreement prove to be incorrect, the parties agree that: (i) all obligations of the Loan Parties pursuant to the Existing Loan Documents and the Existing Loans shall be fully reinstated; (ii) the Bank shall have all rights and remedies provided the Bank pursuant to the Existing Loan Documents; and (iii) the Bank shall be entitled, to the maximum extent most beneficial to the Bank, to all rights and remedies allowed by any applicable law. 

4.5

No Impairment; Forbearance Not a Waiver . Except as expressly set forth in this Agreement, the terms and provisions set forth in the Existing Loan Documents, all of which are incorporated herein, are unmodified and shall remain in full force and effect, the Loan Parties hereby ratifying and confirming such terms and provisions and this Agreement shall not be deemed to or shall in any manner prejudice or impair, or act as a release or relinquishment of, any of the Existing Loan Documents or any rights of the Bank under the Existing Loan Documents, or any lien, security interest or assignment granted to or held by the Bank in connection with the Existing Loans. The execution of this Agreement by the Bank does not constitute a waiver, limitation, or modification of any of the Bank’s rights or remedies under the Loan Documents or applicable law, all of which Bank hereby expressly reserves, nor shall the same constitute a waiver of any default which may have heretofore occurred or which may hereafter occur with respect to the Loan Documents. No omission or failure by the Bank to exercise, and no delay in exercising, any right or remedy hereunder or under the Loan Documents executed in connection herewith shall operate as a waiver of any right or remedy, which the Bank may have hereunder or under any applicable law. All rights and remedies shall be cumulative and may be exercised concurrently or consecutively. No single or partial exercise by the Bank of any right or remedy shall preclude the concurrent or subsequent exercise of any right or remedy.

 

5.

Cross-Collateralization . The Loan Parties and the Bank hereby acknowledge and agree that the real and personal property securing each of the Existing Loans shall also secure each of the other Existing Loans, as well as the Adamis New Loan, and also any and all extensions, renewals, modifications, replacements, substitutions or rearrangements of or for the Existing Loans or the Adamis New Loan, whether now existing or hereafter arising, and whether or not represented by any note or notes, or any guaranty, endorsement or contract of suretyship, or secured by any other security.

 

6.

Consent by Bank . Subject to the satisfaction of all conditions precedent set forth in Section 7 hereof, the Bank hereby expressly consents to the transfer of the 4HIMS Property and Tribute Property and the foregoing acceptance and assumption; provided, however , that such consent shall not constitute (a) a waiver of any right of Bank under the Loan Documents to require its consent to any further assignment or delegation or to any transfer or conveyance of any real or personal property for which consent is required under the terms of the Loan Documents, and/or (b) an agreement by the Bank to consent to any such further assignment or delegation or any such transfer or conveyance for which consent is required under the terms of the Loan Documents. Upon the acquisition of the 4 HIMS Property by Adamis, Bank consents to the termination of that certain lease between 4 HIMS and USC. 

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7.

Conditions Precedent . The following are conditions precedent to Bank’s entering into this Agreement:

7.1

Title Commitment . The irrevocable commitment of Conway Title Services & Escrow, Inc. (“ Title Company ”) to issue CLTA 110.5, CLTA 104.8 and CLTA 111.4 (or equivalent) endorsements to Title Company’s Title Policy No . 72307-44557291, dated December 23, 2014, and Title Policy No. LX 992447, dated August 8, 2014 (“ Existing Title Policy ”), in each case in form and substance acceptable to Bank and without deletions or exceptions other than as expressly approved by Bank in writing, or the irrevocable commitment of a title company approved by Bank to issue a new policy identical to Existing Title Policy and including such title matters arising after the date of the existing title policy which are reasonably acceptable to Bank, insuring Bank that the priority and validity of all current mortgages provided by the Initial Loan Parties have not been and will not be impaired by this Agreement, the conveyance of the 4 HIMS Property, or the transactions contemplated hereby.

7.2

UCC Filings . Lien searches evidencing that the Bank is the sole lienholder with respect to any property securing the Loans, which may be secured by UCC-1 Financing Statement.

7.3

Certain Documentation . Receipt and approval by Bank of: (a) the executed original of this Agreement; and (b) any other documents and agreements which are required to effectuate the transactions contemplated by this Agreement, determined in the Bank’s sole and absolute discretion, in form and content acceptable to Bank.

7.4

Recordation of Certain Documents . Recordation in the Official Records of such documents and agreements, if any, required pursuant to this Agreement or which Bank has requested to be recorded or filed.

7.5

Organizational Documents . Delivery to Bank of the organizational documents and evidence of good standing of each of the Loan Parties, together with such resolutions or certificates as Bank may require, in form and content acceptable to Bank, authorizing the assumption and amendment of the Loans and executed by the appropriate persons and/or entities on behalf of each of the Loan Parties.

7.6

Accuracy of Representations and Warranties . The representations and warranties contained herein are true and correct.

7.7

Insurance . Receipt by Bank of certificates of insurance evidencing Adamis’ casualty insurance policy and comprehensive liability insurance policy with respect to the 4 HIMS Property, each in form and amount satisfactory to Bank. 

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7.8

Opinion of Counsel . Bank shall have received such opinions of counsel as may be required by Bank’s counsel or the Loan Documents, addressed to Bank with respect to the enforceability, due execution and compliance of this Agreement, the transfer of the 4HIMS and Tribute Property, and the transactions referenced herein.

8.

Representations, Warranties and Covenants of Initial Loan Parties . To induce Bank to enter into this Agreement, 4 HIMS, Tribute and USC, jointly and severally, hereby represent and warrant to, and covenants with, Bank and Adamis as follows:

8.1.

Status of Title to 4 HIMS Property . 4 HIMS lawfully possesses and will hold fee simple title in and to the 4 HIMS Property until the transfer to Adamis, and the 4 HIMS Mortgage is a first and prior lien on the 4 HIMS Property.

8.2.

Status of Title to Tribute Property . Tribute lawfully possesses and will hold fee simple title in and to the Tribute Property until the transfer to USC, and the liens and security interests in the Tribute Property are first priority liens or security interests on the Tribute Property.

8.3.

Status of Title to USC Property . USC lawfully possesses and will hold fee simple title in and to the USC Property, and the liens and security interests in the USC Property are first priority liens or security interests on the USC Property.

8.4.

Legal Status; Authority; Enforceability--Initial Loan Parties . 4 HIMS is an Arkansas limited liability company validly existing and in good standing under the laws of the State of Arkansas. Tribute is a Nevada limited liability company validly existing and in good standing under the laws of the State of Arkansas. USC is an Arkansas corporation validly existing and in good standing under the laws of the State of Arkansas. Each of the Initial Loan Parties has all requisite power and authority to enter into this Agreement and to make the assignments and delegations provided for herein. Upon execution and delivery hereof, this Agreement shall constitute the legal, valid and binding obligations of each of the Initial Loan Parties, enforceable against each of the Initial Loan Parties in accordance with its terms.

9.

Representations and Warranties of Adamis . To induce Bank to enter into this Agreement, Adamis hereby represents and warrants to Bank as follows:

9.1.

Legal Status; Authority; Enforceability--Adamis . Adamis is a Delaware corporation validly existing and in good standing under the laws of the State of Delaware and the State of Arkansas. Adamis has all requisite corporate power and authority to enter into this Agreement and to perform its obligations hereunder. Upon the Agreement Date, the Loan Documents to which Adamis shall have become a party as a result hereof shall constitute the legal, valid and binding obligations of Adamis, enforceable against Adamis in accordance with their respective terms.

9.2.

Reports . All reports, documents, instruments and information delivered to Bank by Adamis or on behalf of Adamis in connection with Adamis’ assumption of liability under the Loans: (a) are correct and sufficiently complete to give Bank accurate knowledge of their subject matter; and (b) do not contain any misrepresentation of a material fact or omission of a material fact which omission makes the provided information misleading. 

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9.3.

Embargoed Person . None of the funds or other assets of Adamis constitute property of, or are beneficially owned, directly or indirectly, by any person, entity or government subject to trade restrictions under U.S. law, including but not limited to, the USA PATRIOT Act (including the anti-terrorism provisions thereof), the International Economic Powers Act, 50 U.S.C. §§ 1701, et . seq ., the Trading with the Enemy Act, 50 U.S.C. App. 1 et . seq ., and any Executive Orders or regulations promulgated thereunder, including those related to Specially Designated Nationals and Specially Designated Global Terrorists (“ Embargoed Person ”). No Embargoed Person has any interest of any nature whatsoever in Adamis.

10.

General Provisions .

10.1.

Non-Control . In no event shall the rights of the Bank pursuant to this Agreement or the Loan Documents be deemed to imply the Bank is in control of the business, management or properties of the Loan Parties or has power over the daily management functions and operating decisions made by the Loan Parties. The Loan Parties warrant and represent to the Bank that no misconduct or other improper action by the Bank has taken place prior to the date hereof which could give rise to an affirmative defense or separate cause of action on the part of the Loan Parties. However, should the Loan Parties or the Individual Guarantors (or any of them) have any perception or reason (without requirement of validation) to believe or assert the Bank has not acted in good faith regarding the Loans or should such defense or cause of action exist as of the date hereof, in consideration for Ten Dollars ($10.00), the provisions of this Agreement and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Loan Parties and Individual Guarantors (including all members, managers, employees, agents and independent contractors hereby jointly, severally, unconditionally and irrevocably release, discharge and agree to hold the Released Parties harmless from any claims, or possibility of a claim arising as a result thereof, whether known or unknown.

10.2.

References in Existing Loan Documents . As of the Agreement Date, as used in the Existing Loan Documents, except for this Agreement and, except as the context may otherwise require, all references in such Existing Loan Documents to Borrower (whether denominated therein as “Borrower” or “Trustor,” or otherwise) shall thereafter refer to and mean Adamis and each Initial Loan Party set forth in each of the Existing Loan Documents, jointly and severally.

10.3.

Continuing Force and Effect . Except as modified hereby, all of the terms and provisions of the Loan Documents will remain in full force and effect.

10.4.

Successors and Assigns . This Agreement shall be binding upon and inure to the benefit of the parties hereto as well as their respective heirs, executors, administrators, successors and permitted assigns.

10.5.

Governing Jurisdiction . This Agreement shall be governed by and construed in accordance with the laws of the State of Arkansas, without reference to conflicts of laws principles. 

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10.6.

Entire Agreement . This Agreement constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, superseding all prior written or oral understandings or communications. This Agreement may not be amended or modified, except by a written agreement signed by the applicable Loan Parties (with such applicability determined under each of the Loan Documents) and Bank.

10.7.

Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute but one and the same document.

10.8.

Amendments and Modifications By Bank and Adamis . The Bank and Adamis will in good faith discuss mutually agreeable amendments or modifications to the Existing Loan Documents in light of the changes in circumstances resulting from the Merger and the transfer of the 4 HIMS Property and the Tribute Property to Adamis and USC, respectively.

10.9.

Confirmation By 4 HIMS, Tribute, USC and Adamis . 4 HIMS and Adamis acknowledge that they are parties to a Purchase and Sale Agreement dated as of March 28, 2016, entered into by and between Adamis and 4 HIMS relating to the transfer of the 4 HIMS Property and the assignment to Adamis of obligations under the 4 HIMS Loan Documents under an Assignment, Assumption and Consent Agreement dated as of March 28, 2016 (together, the “4 HIMS Assignment Agreements”); and Tribute and USC acknowledge that they are parties to an Asset Purchase Agreement dated as of March 28, 2016, entered into by and between Tribute and USC relating to the transfer of the Tribute Property and the assignment to USC of the obligations under the Tribute Loan Documents under an Assignment and Assumption Agreement made and entered into as of March 28, 2016 (together, the “Tribute Assignment Agreements”). 4 HIMS, Tribute and USC agree that the addition of Adamis as a Borrower under the 4 HIMS Loan Agreement and the Tribute Loan Agreement as provided in this Agreement, and the assumption by Adamis of obligations there under as a Borrower, shall be governed by the provisions of this Agreement rather than by any different or conflicting provisions in the 4 HIMS Assignment Agreements or the Tribute Assignment Agreements, all of which different or conflicting provisions shall be deemed superseded by the provisions of this Agreement. 

10.10.

Release of Glover Mortgage . Notwithstanding any provision of this Agreement to the foregoing, the parties hereto agree that contemporaneously with consummation of this Agreement, the Bank hereby agrees to fully and unconditionally release the lien evidenced by the Glover Mortgage against the Glover Property.

10.11.

Release of 4 HIMS Individual Guarantors . Notwithstanding any provision of this Agreement to the foregoing, the parties hereto agree that contemporaneously with consummation of this Agreement, the Bank hereby agrees to fully and unconditionally release Eddie Glover and William L. Sparks as 4 HIMS Individual Guarantors under the 4 HIMS Loan Documents. 

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the Agreement Date.

 

      INITIAL LOAN PARTIES :
       
      4 HIMS, LLC ,
      an Arkansas limited liability company
       
       
  By:   /s/ Eddie Glover
      [Signature]
       
      Eddie Glover
      [Print Name]
       
      Partner
      [Title]
       
       
      TRIBUTE LABS, LLC ,
      a Nevada limited liability company
       
       
  By:   /s/Eddie Glover
      [Signature]
       
      Eddie Glover
       [Print Name]
       
      Partner
      [Title]
       
       
      US COMPOUNDING, INC. ,
      an Arkansas corporation
       
       
  By:   /s/ Eddie Glover
      [Signature]
       
      Eddie Glover
      [Print Name]
       
      CEO
      [Title]

 

 

[INDIVIDUAL GUARANTORS SIGNATURE PAGE FOLLOWS]

 

12  
 

 

      INDIVIDUAL GUARANTORS :
       
       
      /s/ Eddie Glover
      Eddie Glover , an individual
       
       
      /s/ William L. Sparks
      William L. Sparks , an individual
       
       
      /s/ Kristen Riddle
      KRISTEN RIDDLE , an individual

 

 

[ADAMIS SIGNATURE PAGE FOLLOWS]

 

13  
 

 

      Adamis :
       
      Adamis Pharmaceuticals Corporation ,
      a Delaware corporation
       
       
  By: /s/ Robert O. Hopkins
      [Signature]
       
      Robert O. Hopkins
      [Print Name]
       
      Chief Financial Officer
      [Title]

 

 

[BANK SIGNATURE PAGE FOLLOWS]

 

14  
 

 

 

      Bank :
       
      BEAR STATE BANK, INC ,
      a national banking association
       
       
  By : /s/ Steve Moore
      [Signature]
       
      Steve Moore
      [Print Name]
       
      Executive Vice President
      [Title]

 

 

15  

 

Adamis Pharmaceuticals Corporation 10-Q

 

Exhibit 10.6

 

Execution copy

 

[*Designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission]

 

DEVELOPMENT, LICENSE AND COMMERCIALIZATION AGREEMENT

 

THIS DEVELOPMENT, LICENSE AND COMMERCIALIZATION AGREEMENT (this “ Agreement ”) is made and entered into on May 9, 2016 (the “ Effective Date ”), by and between Watson Laboratories, Inc., a Nevada corporation (“ Watson ”), on the one hand, and Adamis Pharmaceuticals Corporation, a company incorporated under the laws of Delaware (“ Adamis ”), on the other hand. Watson and Adamis shall each sometimes be referred to herein as a “ Party ” and collectively as the “ Parties .”

 

RECITALS

 

1.          Watson is engaged in the development, manufacture, promotion, sale and distribution of pharmaceutical products throughout the world.

 

2.          Adamis is engaged in research and development of pharmaceutical products and had developed a pre-filled single dose syringe for the delivery of epinephrine solution.

 

3.          Watson desires to obtain, and Adamis is willing to provide Watson, with the exclusive right to use and sell the Product (as defined below) in the Territory on the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth, the receipt and sufficiency of which is hereby acknowledged by the Parties, the Parties hereby agree as follows:

 

ARTICLE 1
DEFINITIONS

 

As used herein, the following terms shall have the following meanings.

 

[*] Product ” means a PFS designed to deliver [*] Epinephrine Injection USP for subcutaneous or intramuscular injection.

 

0.3mg Product ” means a PFS designed to deliver 0.3mg Epinephrine Injection USP, which contains approximately [*] epinephrine solution for subcutaneous or intramuscular injection.

 

AAA ” has the meaning set forth in Section 12.2(a).

 

Adamis ” has the meaning set forth in the Caption.

 

Adamis Indemnitee ” has the meaning set forth in Section 10.1.

 

 

 

 

Affiliate ” means, with respect to a Person, any Person that directly or indirectly controls, is controlled by or is under common control with such Person. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means (a) ownership of fifty percent (50%) or more of the voting and equity rights of such Person, or (b) the power to direct the management of such Person. Notwithstanding the foregoing, for purposes of this Agreement, a Wholesaler Affiliate shall not constitute an Affiliate of Watson.

 

Agreement ” has the meaning set forth in the Caption.

 

Applicable Law means any and all laws, statutes, ordinances, rules, regulations, permits, orders, decrees, judgments, directives or guidelines of any kind whatsoever that may apply to the development, manufacturing, marketing or sale of a Product or the performance of either Party’s obligations under this Agreement, including laws, regulations and guidelines governing the import, export, development, manufacturing, marketing, distribution and sale of a Product, to the extent applicable and relevant, and including all current Good Manufacturing Practices or guidelines promulgated by the FDA or other Governmental Authorities and including trade association guidelines, where applicable, as well as U.S. import and export control laws and the U.S. Foreign Corrupt Practices Act.

 

Approval Deadline ” has the meaning set forth in Exhibit A .

 

Back-up Facility ” has the meaning set forth in Section 4.3(a).

 

Bankruptcy Code ” has the meaning set forth in Section 11.3.

 

Bankruptcy Laws ” has the meaning set forth in Section 11.3.

 

Calendar Quarter means each consecutive three-month period beginning on January 1, April 1, July 1 or October 1 of any given year.

 

Calendar Year means each consecutive beginning on January 1 and ending on December 31 of any given year.

 

Catalent ” means Catalent Belgium, S.A. and any successor thereto.

 

Commercial Supply ” has the meaning set forth in Section 4.1(a).

 

Commercial Supply Price ” means, unless otherwise agreed by the Parties in writing:

 

(i)  to the extent that manufacturing (which for all purposes of this Agreement includes packaging and/or labelling activities) of the Product for the Territory is performed by a Contract Manufacturer, the amount owing or made to any Contract Manufacturer for the acquisition of the Product, including, without limitation, [*];

 

(ii)  to the extent that a Party or its Affiliate performs all or any part of the manufacturing or supply of the Product, the Cost of Manufacture of the Product, plus a margin of [*] percent ([*]%), provided however, this amount shall not exceed the [*] (i.e., [*]) [*]; and

 

2  

 

 

(iii) notwithstanding (i) and (ii) above, if a Party determines to qualify a Back-up Facility pursuant to Section 4.2(a) and the Parties do not agree in writing on their relative payment responsibility for such qualification, such Party shall bear [*].

 

For the avoidance of doubt, if a Party or its Affiliate performs only a part of the manufacturing required for the Product, the [*] payable pursuant to (ii) or (iii) above shall only apply to [*].

 

Commercially Reasonable Efforts ” means, with respect to a Party, such efforts and resources which are consistent with those efforts and resources that would be used by a similarly situated company to perform any activity for any product at a comparable stage of development or commercialization, taking into consideration such product’s commercial potential, stage of development and life cycle, medical/scientific viability, technical and regulatory profile, intellectual property protection and risks, competitiveness in the marketplace, profitability (but without consideration of the sharing of Net Profits pursuant to this Agreement) and other relevant factors.

 

Competing Product means any other PFS epinephrine solution product.

 

Confidential Information means, with respect to a Party, all information of any kind whatsoever (including, without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies, techniques and all non-public intellectual property rights, as hereinafter defined), and all tangible and intangible embodiments thereof of any kind whatsoever (including, without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), which is disclosed or made available to the other Party regardless of whether such information is marked, identified as or otherwise acknowledged to be confidential at the time of disclosure to the other Party. All information shall be deemed confidential unless agreed otherwise. Notwithstanding the foregoing, Confidential Information of a Party shall not include information which the other Party can establish by written documentation or similar evidence (a) to have been publicly known prior to disclosure of such information by the disclosing Party to the other Party, (b) to have become publicly known, without breach of this Agreement or violation of Applicable Laws on the part of the other Party or its Affiliates or any employee, contractor or agent acting on their behalf, subsequent to disclosure of such information by the disclosing Party to the other Party, (c) to have been received by the other Party at any time without obligation of confidentiality from a source, other than the disclosing Party, rightfully having possession of and the right to disclose such information, (d) to have been otherwise known by the other Party prior to disclosure of such information by the disclosing Party to the other Party, or (e) to have been independently developed by employees or agents of the other Party without the use of or reliance upon any information disclosed by the disclosing Party to the other Party.

 

Contract Manufacturer ” means Catalent, [*], or any other Third Party that is engaged by either Party to manufacture and/or package the Product.

 

Cost of Manufacture ” means the [*].

 

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Development Plan means the development plan and responsibility matrix attached hereto as Exhibit B , relating to the development of and regulatory submission for the [*] Product, as well as the marketing materials for the Product, as modified by the Parties from time to time upon written agreement.

 

Development Services ” means those services set forth in the Development Plan to be performed by the Party identified in the Development Plan.

 

Direct Cost ” means the cost of [*].

 

Dispute ” has the meaning set forth in Section 12.1.

 

Effective Date ” has the meaning set forth in the Caption.

 

[*] means either or both (i) [*], and (ii) [*].

 

FDA ” means the United States Food and Drug Administration or its successor agency.

 

FDCA ” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended.

 

Governmental Authority ” means any transnational, domestic or foreign federal, provincial, state or local governmental, regulatory or administrative authority (including, without limitation, any Regulatory Authority), department, bureau, court, agency or official, including, without limitation, any political subdivision thereof.

 

Indemnified Party ” has the meaning set forth in Section 10.3.

 

Indemnifying Party ” has the meaning set forth in Section 10.3.

 

Initial Marketing and Regulatory Activities ” means all activities customarily undertaken by a pharmaceutical company to create and implement its marketing plans and strategies to encourage the FDA approved use of a prescription pharmaceutical product, including the preparation of training and promotional materials (materials intended for training purposes and/or for distribution or dissemination to sales representatives, medical professionals and other Third Parties, briefing documents, information about Watson, strategy and tactical plans to promote the Product, as well as advertising), and any regulatory or legal activities related thereto, including review and approval by a promotional review committee comprised of medical, legal and/or regulatory personnel required.

 

Initial Term ” has the meaning set forth in Section 11.1.

 

Know-How ” means any confidential and proprietary ideas, concepts, discoveries, inventions, developments, improvements, know-how, trade secrets, designs, devices, process conditions, algorithms, notation systems, works of authorship, technology, formulas, techniques, methods, procedures, protocols, data, specifications, conclusions, skill, experience, test data and results (including, without limitation, pharmacological, toxicological, manufacturing, and clinical test data and results), analytical and quality control data, results or descriptions, in each case whether patentable or otherwise. Know-How does not include patents and patent applications.

 

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Launch Deadline ” has the meaning set forth in Exhibit A .

 

Licensed Technology ” means all tangible or intangible Know-How including improvements, patents and patent applications that (a) are owned or controlled (with the right to license or sublicense) by Adamis and (b) are either (i) necessary for use by Watson in performance of the Development Services to be performed by Watson or (ii) are necessary for the manufacture, use or sale of the Product in the Territory.

 

Losses ” has the meaning set forth in Section 10.1.

 

Manufacturing Facility ” means the manufacturing facility (or facilities) at which the Product to be supplied to Watson is manufactured.

 

Marketing Allowance ” means, for any period, [*] percent ([*]%) of the [*] of such Product in such period, for the selling, marketing and other expenses related to the Product incurred by Watson and its Affiliates.

 

Milestone Payments ” has the meaning set forth in Section 5.2.

 

Minimum Obligation means [*].

 

NDA(s) ” means a New Drug Application (as defined in the FDCA) filed with the FDA, including, without limitation, all amendments and supplements thereto.

 

Net Profit means (a) the sum of the following, without duplication: (i) Net Sales, (ii) [*], less (b) the sum of the following, without duplication: [*].

 

Net Sales ” means the gross amount invoiced by Watson or its Affiliates or any sub-licensees on all sales or other dispositions for value of Product in the Territory (excluding any sales among Watson and its Affiliates for resale), less the following items (to the extent not previously deducted and included in the gross amount invoiced or otherwise directly paid or incurred by the selling party):

 

(i)           any and all promotional allowances, rebates, government mandated rebates (i.e. Medicaid, etc.), charge backs, quantity and cash discounts, and other usual and customary discounts to customers actually allowed or taken,

 

(ii)          amounts repaid or credited by reason of rejections, returns or recalls of goods,

 

(iii)         retroactive price reductions and shelf stock adjustments,

 

(iv)         any sales, excise, turnover, inventory, value-added, and similar taxes and duties assessed on applicable sales of Products, but excluding national, state or local taxes assessed on income,

 

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(v)          allowances for doubtful accounts accrued in the ordinary course of business in accordance with Watson’s standard practices for doubtful accounts consistently applied, and

 

(vi)         transportation charges (including insurance costs) and handling charges for transportation of Products to Third Parties.

 

Components of Net Sales shall be determined using the accrual method of accounting in accordance with U.S. generally accepted accounting principles. There shall be no double-counting in determining the foregoing deductions.

 

In the event Watson or any of its Affiliates or sub-licensees transfers Product for consideration, in whole or in part, other than cash, the gross sales price for such Product shall be deemed the standard invoice price then being invoiced by Watson in arm’s length transactions with similar Third Party customers. In no event shall a sale be deemed to occur in the case of transfers of professional samples, product donations, or other samples or clinical research supplies at no charge.

 

Notwithstanding the foregoing, for any sales by Watson, its Affiliates or its sub-licensees to a Wholesaler Affiliate, Net Sales shall be deemed to be the [*] by Watson in [*] to Third Parties of Product during the fiscal quarter in which the sale to the Wholesaler Affiliate took place.

 

Other Costs ” means other [*] for which Watson or its Affiliates are responsible to pay in connection with the commercialization of the Product, including without limitation, (i) [*], (ii) [*], (iii) [*], and (iv) [*]. For the avoidance of doubt, Other Costs do not include [*].

 

Out-of-Pocket Expenses means any fees, costs or other expenses paid by a Party, as applicable, to Third Parties, excluding in all cases any Overhead Expenses. Under no circumstances shall Out-of-Pocket Expenses include [*].

 

Overhead Expenses means overhead, compensation paid by such Party to its employees, employee benefits, depreciation, taxes, insurance, rent, repairs and maintenance, supplies, utilities, administrative expenses and other fixed costs.

 

Party ” and “ Parties ” have the meanings set forth in the Caption.

 

Person ” means an individual, corporation, partnership, limited liability company, firm, association, joint venture, estate, trust, governmental or administrative body or agency, or other entity.

 

PFS ” means a pre-filled single dose syringe, which delivers epinephrine solution by injection, and is designed to be self-administered by the patient or by a caregiver.

 

Pharmacovigilance Agreement means an agreement between the Parties or their Affiliates, setting forth their respective responsibilities for adverse event reporting with respect to the Product.

 

[*] ” means [*].

 

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Product ” means each or both of the [*] Product and the 0.3mg Product.

 

Quality Agreement means an agreement between Adamis or Contract Manufacturer and Watson, setting forth the quality responsibilities with respect to the manufacture and supply of Product to Watson, which agreement shall be entered into prior to the delivery of any Product to Watson.

 

Recall ” has the meaning set forth in Section 6.2.

 

Regulatory Approvals shall mean any and all approvals, product and/or establishment licenses, registrations or authorizations, including, without limitation approvals under NDAs, of any Regulatory Authority or other Governmental Authority, which are necessary for the commercial manufacture, use, storage, importation, transport, marketing, promotion, pricing or sale of the Product in the Territory.

 

Regulatory Authority means the FDA and any other applicable Governmental Authority responsible for or involved in granting or issuing approvals, product and/or establishment licenses, registrations or authorizations for the commercial manufacture, use, storage, importation, transport, marketing, promotion, pricing or sale of the Product in the Territory.

 

Regulatory Dossier means all files regarding the Regulatory Approvals, including but not limited to correspondence, records, applications (including, without limitation NDAs), supplements, annual reports, adverse event reports, clinical studies and pre-clinical studies to the extent related to the Product owned or controlled by Adamis or its Affiliate.

 

Reimbursable Expense ” has the meaning set forth in Section 5.4.

 

Renewal Term ” has the meaning set forth in Section 11.1.

 

SEC ” has the meaning set forth in Section 8.3.

 

Supplement Approval Deadline has the meaning set forth in Exhibit A .

 

Term ” has the meaning set forth in Section 11.1.

 

Territory ” means the entirety of the United States of America and its territories and possessions (including, but not limited to, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the United States Virgin Islands, the Territory of Guam and United States’ military bases) and any other countries that the Parties agree, in writing, to add to the Territory.

 

Territory Supply Agreement ” means any agreement between Watson or its Affiliate and Catalent (or any other Contract Manufacturer) for commercial supply of the Product for the Territory and/or any agreement between Watson or its Affiliate and [*] (or any other Contract Manufacturer) for packaging of the Product for the Territory.

 

Third Party means any Person that is not a Party, or an Affiliate of a Party.

 

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Third Party Claim ” has the meaning set forth in Section 10.3.

 

Trademark ” means all of Adamis’ rights to the name “[*]”.

 

Warranties ” has the meaning set forth in Section 4.7.

 

Watson ” has the meaning set forth in the Caption.

 

Watson Indemnitee ” has the meaning set forth in Section 10.2.

 

Wholesaler Affiliate ” shall mean a Person that would be an Affiliate of Watson, but for the exclusion in the last sentence of the definition of Affiliate, whose primary business is wholesale distribution of pharmaceutical products (including, without limitation, ANDA, Inc.).

 

ARTICLE 2
DEVELOPMENT AND PROJECT MANAGEMENT

 

2.1           Development . Each Party agrees that it shall be responsible for performing all Development Services allocated to such Party in accordance with the Development Plan. Without limiting the generality of the foregoing, and as set forth in the Development Plan, (i) Adamis shall be responsible for all activities required for or associated with the development of the [*] Product, and the preparation, submission and approval of the NDAs for the Products, including all stability studies and process validations, including all costs related thereto, and (ii) Watson shall be responsible for [*] as well as the commercialization of the [*] Product in the Territory, including all costs related thereto. Each Party shall keep the other Party fully informed of the status and progress being made towards completion of their respective activities under the Development Plan and shall exchange all relevant information relating thereto (as of the Effective Date and from time to time thereafter). Watson shall be entitled to inspect Adamis’ work in progress related to its Development Services and any documents relating thereto (including at Adamis’ facilities, during normal business hours and upon reasonable notice). The Parties shall maintain records of Development Services in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes and shall properly reflect all work done and results achieved in the performance of its obligations under the Development Plan.

 

2.2           Materials and Facilities . Each Party shall conduct the Development Services to be performed by such Party in accordance with the requirements of Applicable Law.

 

2.3           Facility Qualification . Unless and until Watson enters into Territory Supply Agreements with Catalent and [*], Adamis shall, at its expense, use Commercially Reasonable Efforts to cause each of the Catalent and [*] Manufacturing Facility to be qualified and capable of manufacturing the Product as required under Applicable Law (including FDA requirements), in order to maintain Regulatory Approvals for the Product.

 

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ARTICLE 3
REGULATORY APPROVAL

 

3.1           NDA and Other Regulatory Dossiers . Adamis shall prepare and file, at its own expense, the NDA and any other Regulatory Dossier required to be made in connection with obtaining and maintaining the Regulatory Approval of the 0.3mg Product from the FDA and any other applicable Regulatory Authority in the Territory. Subject to completion of development of the [*] Product in accordance with Article 3, Adamis shall prepare and file, at its own expense, the NDA and any other Regulatory Dossier required to be made in connection with obtaining and maintaining the Regulatory Approval of the [*] Product from the FDA and any other applicable Regulatory Authority in the Territory. Adamis shall use Commercially Reasonable Efforts to (i) file the NDA and any other applicable Regulatory Dossier for the 0.30 mg Product and, subject to completion of development of the [*] Product in accordance with Article 3, the [*] Product with the FDA and any other applicable Regulatory Authority in the Territory as soon as reasonably practicable, and (ii) maintain each such NDA and other applicable Regulatory Dossiers after the FDA’s and/or other applicable Regulatory Authority’s approval thereof. The NDA and all other Regulatory Approvals for the Product in the Territory shall be filed in the name of, and will be owned exclusively by, Adamis. Watson shall, at its own expense, promptly provide Adamis with such assistance as may be reasonably requested by Adamis in connection with preparing the NDA or any other Regulatory Dossier and responding to any questions posed by the FDA or any other Regulatory Authority. Adamis shall provide Watson with a copy of any regulatory submissions (including the NDA and any other Regulatory Dossier) regarding the Product filed with, and correspondence received from, the FDA and any other Regulatory Authority, and Adamis shall keep Watson informed of all material regulatory developments related thereto, including the status of any such submissions filed by Adamis. Adamis shall not make any material modification of the NDA or any other Regulatory Dossier without the prior written consent of Watson, not to be unreasonably withheld or delayed, unless required by Applicable Law. Adamis and its Affiliates and licensees shall have the right to use all data and information contained or referenced in the NDA and any other Regulatory Dossier, and to cross-reference the NDA and any other Regulatory Dossier, in connection with developing, filing for, obtaining and maintaining regulatory approval of, and/or commercializing the Product outside the Territory.

 

3.2           Compliance . Each Party shall provide the other Party with all information necessary for the other Party to comply with Applicable Law with respect to activities contemplated by Section 3.1. Each Party shall promptly notify the other Party of any comments, responses or notices received from, or inspections by, the FDA or any other Regulatory Authority, which relate to the Product, and shall promptly inform the other Party of any responses to such comments, responses, notices or inspections and the resolution of any issue raised by the FDA or such other Regulatory Authority.

 

ARTICLE 4
SUPPLY

 

4.1           Supply . Adamis shall cooperate with Watson and use Commercially Reasonable Efforts to enable Watson or its Affiliate to enter into Territory Supply Agreements with Catalent and [*] (or other Contract Manufacturer) so that, if and when Regulatory Approval is obtained, the Contract Manufacturer shall supply the Product directly to Watson and its Affiliates and sub-licensees for the Territory and, until Watson or its Affiliate enters into Territory Supply Agreements with Catalent and [*] (or other Contract Manufacturer), Adamis shall supply or cause to be supplied by a Contract Manufacturer the Product to Watson and its Affiliates and sub-licensees for the Territory (any such commercial supply of the Product for the Territory, “ Commercial Supply ”). Watson shall pay the [*] for Commercial Supply supplied by or on behalf of Adamis. Adamis shall not supply Product to itself or any Third Party for use in the Territory during the Term, and until the Minimum Obligation has been met (to the extent that the Minimum Obligation remains an obligation of Adamis), Watson and its Affiliates and sub-licensees shall purchase sufficient Product from Adamis or its Contract Manufacturer to satisfy the Minimum Obligation. For so long as Watson or its Affiliates purchase Commercial Supply from Adamis that is manufactured by Catalent or packaged by [*], (i) the Parties shall use Commercially Reasonable Efforts to coordinate and plan their respective activities to timely make forecasts, place purchase orders, take deliveries and effect payments in accordance with the terms of the [*], and (ii) Adamis shall not amend any [*] to the extent it applies to the Territory without prior written consent of Watson, not to be unreasonably withheld; provided, however, that no consent of Watson shall be required for any amendment the sole purpose of which is to allow Catalent or [*] to enter into a Territory Supply Agreement with Watson or its Affiliate. After the Minimum Obligation has been met, Watson shall be able to obtain the Product that Watson and its Affiliates and sub-licensees require for the Territory from a supplier of its choosing, including any Contract Manufacturer.

 

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4.2           Back-Up Facility .

 

(a)           If either Party determines that a Contract Manufacturer for the Territory is or will be unable to meet the supply needs of the Parties for Product or that a better manufacturing alternative is available, the Parties shall in good faith discuss the situation and make a determination as to (i) whether an additional manufacturing facility (whether on its own or through any of its Affiliates or a Third Party manufacturer other than Catalent and [*]) should be qualified as a backup source of manufacturing for the Commercial Supply (a “ Back-up Facility ”) for the Territory or for Product needs of Adamis or its Affiliates or licensees outside of the Territory, and (ii) the Parties’ relative payment responsibility for such qualification .

 

(b)          Subject to the Parties’ obligations under Sections 4.1 and 4.2(a), either Party shall have the right (but not the obligation) to secure and qualify (and thereafter to maintain the qualification of) a Back-up Facility at any time during the Term.

 

(c)           If Watson chooses to qualify a Back-up Facility, Adamis shall use Commercially Reasonable Efforts to (i) provide Watson, its Affiliate or Contract Manufacturer with copies of any requested documentation in Adamis’ possession or control (including Licensed Technology) that is necessary or useful for the manufacture and release of the Product in the Territory, subject to execution of any such third party of confidentiality, nondisclosure and nonuse agreements or covenants in form and substance reasonably satisfactory to Adamis, (ii) assist Watson, its Affiliate or Contract Manufacturer with the transfer of all analytical methods, manufacturing procedures and Know-How in Adamis’ possession or control that is used in the manufacture and release of Product in the Territory, and (iii) make all required regulatory filings needed to qualify and maintain the Back-up Facility as a manufacturer of the Product under the Regulatory Approval, provided however, Watson shall be responsible for all Out-of-Pocket Expenses incurred by Adamis in connection with making any such filings .

 

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(d)          In the event that Watson or any of its Affiliates or sub-licensees qualifies a Back-up Facility for the Territory at its own initial expense (i.e., the Parties were unable to agree upon their respective payment responsibility for such qualification), Watson shall in good faith discuss with Adamis or any of its Affiliates or licensees the terms upon which Watson, its Affiliate or its Contract Manufacturer shall supply the Product to Adamis or its Affiliate for use outside the Territory.

 

(e)          In the event that Adamis or any of its Affiliates or sub-licensees qualifies a Back-up Facility for outside the Territory at its own initial expense, Adamis shall in good faith discuss with Watson or its Affiliates the terms upon which Adamis, its Affiliate or Contract Manufacturer will supply the Product to Watson for use in the Territory.

 

ARTICLE 5
COMMERCIALIZATION; MILESTONE & PROFIT SHARE PAYMENTS

 

5.1         Commercialization . Watson shall have the exclusive right, to the exclusion of Adamis and its Affiliates, to commercialize the Product in the Territory, at its sole cost and expense, subject to the terms and conditions of this Agreement. Watson shall have sole discretion and control as to the manner and extent of such commercialization of the Product in the Territory (including issues concerning labeling, market launch (including the timing thereof), terms of sale and pricing and customer contracts), subject to the terms and conditions of this Agreement.

 

5.2         Commercially Reasonable Efforts .

 

(a)          Watson shall use Commercially Reasonable Efforts to (x) commence the marketing and sale of the Product in the Territory within [*] ([*]) days from receipt of (i) the applicable Regulatory Approval, (ii) availability of sufficient Commercial Supply for initial launch of the Product in the Territory as ordered by Watson and (iii) the Initial Marketing and Regulatory Activities required to launch, and (y) following such commencement, continue the marketing and sale of the Product in the Territory during the Term. If Watson believes that, in the exercise of Commercially Reasonable Efforts, it is necessary to postpone or delay the launch of the Product as a result of then-prevailing market or economic conditions or pending, threatened or anticipated litigation with respect to the Product in the Territory, Watson shall provide Adamis with a detailed explanation of the reasons for such suggested postponement or delay and the Parties shall then discuss such reasons in good faith.

 

(b)           In the event that Adamis reasonably determines that Watson has failed to use Commercially Reasonable Efforts as required by Section 5.2(a), Adamis shall provide written notice thereof to Watson, and the Parties shall promptly discuss the matter in good faith for a period not to exceed [*] ([*]) days (or such longer period as may be agreed by the Parties) following the date of such notice. Such notice shall specify in reasonable detail the facts and circumstances constituting Adamis’ reasons for reaching such a determination. Following such [*] ([*]) day period (or such longer period as may be agreed by the Parties), unless otherwise agreed by the Parties, if Watson (i) has not cured such failure, or (ii) in the event that such failure is not capable of being cured in [*] ([*]) days or Watson is not using best efforts to cure such failure, Adamis shall have the right, exercisable in its sole discretion and effective [*] ([*]) days after written notice thereof by Adamis to Watson, to terminate this Agreement; provided that, any such determination shall be stayed if Watson challenges Adamis’ determination that Watson has failed to use Commercially Reasonable Efforts as required by Section 5.2(a) in accordance with the dispute resolution procedure in Article 12.

 

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5.3           Milestone Payments . Watson shall make each of the one-time milestone payments set forth in Exhibit A (the “ Milestone Payments ”) to Adamis after the achievement of the corresponding milestone event set forth in Exhibit A .

 

5.4           Reimbursement . Adamis shall invoice Watson for [*] (the “ Reimbursable Expense ”) as follows:

 

(a)          Following the first commercial sale by Watson of the Product, Adamis shall invoice Watson for its [*];

 

(b)          Following the Effective Date, Watson shall (i) [*], and (ii) [*]; and

 

(c)          Watson shall pay Adamis the invoiced Reimbursable Expense within [*] ([*]) days after the date of invoice.

 

5.5           Profit Share Payments . In each Calendar Year during the Term, Watson shall pay Adamis [*] percent ([*]%) of the first [*] ($[*]) of Net Profit, and [*] percent ([*]%) of any Net Profit in excess of [*] ($[*]). [*]. Each payment due hereunder shall be made within [*] ([*]) days of the end of each Calendar Quarter and shall be accompanied by a written report setting forth in reasonable detail the quantity of Product sold in the Territory (as measured in saleable units of Product) and Watson’s calculations of Net Sales and Net Profit for such period. In addition, the Parties shall in good faith discuss what additional reports, if any, that Watson may be able to provide with respect to the Net Sales and Net Profit earned during the preceding Calendar Quarter. Any adjustments to be made in respect of payments previously made to Adamis due to rebates, returns and the like, shall be factored into the calculation of subsequent payments.

 

5.6           Records and Audits . For a period of [*] ([*]) years after each payment made to Adamis, Watson shall keep complete and accurate records in sufficient detail to permit Adamis to confirm the accuracy of the calculation of such payment. Adamis shall have the right to audit or have its independent, certified public accountant (reasonably acceptable to Watson) audit Watson’s records solely to confirm the accuracy of the calculation of the payment of consideration for the preceding [*] ([*]) years. Such audits may be exercised during normal business hours no more than once in any [*] ([*]) month period upon at least [*] ([*]) days prior written notice. If an audit finds an underpayment to Adamis, Watson shall promptly pay Adamis the full amount of such underpayment. If an audit finds an underpayment by Watson of greater than [*] percent ([*]%) of what was due under this Agreement, Watson shall promptly pay the full amount of such underpayment and shall pay or reimburse Adamis for the cost of the audit.

 

5.7           Currency of Payments . All payments under this Agreement shall be made in U.S. Dollars by wire transfer to such bank account as Adamis may designate from time to time.

 

5.8           Taxes . Each Party is responsible for its own taxes, duties, levies, imposts, assessments, deductions, fees, withholdings or similar charges imposed on or measured by net income or overall gross income (including branch profits), gross receipts, capital, ability or right to do business and franchise or similar taxes imposed on it under Applicable Law.

 

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5.9           Late Payments . In the event that any payment due under this Agreement is not made within [*] ([*]) days of the date it was due, the payment shall accrue interest from the date due at a rate per annum equal to [*] percent ([*]%) above the U.S. Prime Rate (as set forth in the Wall Street Journal , Eastern U.S. Edition) for the date on which payment was due, calculated daily on the basis of a 365-day year, or similar reputable data source; provided that, in no event shall such rate exceed the maximum legal annual interest rate. The payment of such interest shall not limit the Party entitled to receive such payment from exercising any other rights it may have as a consequence of the lateness of any payment.

 

ARTICLE 6
PHARMACOVIGILANCE; RECALLS

 

6.1            Pharmacovigilance. Prior to the commercialization of the Product, the Parties shall enter into a Pharmacovigilance Agreement setting forth their respective pharmacovigilance responsibilities.

 

6.2           Product Recalls. In the event either Party is ordered by a Regulatory Authority or believes it is necessary to conduct a recall, field correction, market withdrawal, stock recovery or other similar action with respect to the Product in the Territory (each, a “ Recall ”), Watson shall determine the best manner in which to proceed in its sole discretion and shall be solely responsible for conducting such Recall. If a Recall is due to a Party’s willful or negligent act or omission or a breach of its obligations under this Agreement or Applicable Law, including, without limitation, the warranties or covenants made by Adamis or Watson, then that Party shall bear the cost of that Recall and shall reimburse the other Party for all Out-of-Pocket Expenses incurred by such other Party in connection with such Recall, in each case including the cost of any Product returned to Watson as a result of the Recall or destroyed as a result of the Recall.

 

ARTICLE 7
INTELLECTUAL PROPERTY

 

7.1           License .

 

  (a)          Subject to the terms and conditions of this Agreement, Adamis, on behalf of itself and its Affiliates, hereby grants to Watson and its Affiliates an exclusive (even as to Adamis and its Affiliates), sub-licensable license under the Licensed Technology to make or have made (subject to the obligations in Article 4), sell, offer for sale, distribute, promote, market, or otherwise commercially exploit the Product in the Territory during the Term. For the avoidance of doubt, Adamis retains the right under the Licensed Technology to have Contract Manufacturers manufacture and/or package the Product for Watson pursuant to this Agreement and to make and have made and/or package the Product for Adamis and its Affiliates and licensees for use outside the Territory.

 

  (b)          Subject to the license granted to Watson in Section 7.1(a), Adamis shall maintain all rights in and to the Licensed Technology. As part of the license granted under Section 7.1(a), during the Term, Watson and its Affiliates shall have the exclusive right, limited to the Territory, to reference any and all data owned by Adamis or its Affiliates that is submitted in the Regulatory Dossiers. Adamis shall not, and shall cause its Affiliates not to, sell, offer for sale, distribute or otherwise make available (nor contract with a Third Party to do any of the foregoing) the Product or any Competing Product to any Person other than Watson and its Affiliates in the Territory during the Term.

 

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  (c)          Subject to the terms and conditions of this Agreement, Adamis, on behalf of itself and its Affiliates, hereby grants to Watson and its Affiliates an exclusive (even as to Adamis and its Affiliates), sub-licensable license under the Trademark, to use and display the Trademark solely in connection with the sale, offer for sale, distribution, promotion, marketing, or other commercial exploitation of the Product in the Territory. All uses by Watson and its Affiliates and sub-licensees of the Trademark shall be in compliance with all Applicable Laws and shall be in accordance with such commercially reasonable quality standards as used by Watson for comparable products. In all packaging, labeling, advertising, promotional and other material of Watson and its Affiliates and sub-licensees referencing the Trademark, Watson and its Affiliates and sub-licensees shall not, without Adamis’s written consent: (i) vary the spelling, add or delete hyphens, abbreviate, make one word two, or use a possessive or plural form of the Trademark; (ii) modify the design, add or delete any elements or words, change any colors or proportion of the Trademark; (iii) use the Trademark in a manner that disparages Adamis or any of its products or services; or (iv) use the Trademark in a manner that interferes with or adversely affects Adamis’ use of the Trademark; in each case except to the extent required by Applicable Laws, provided that Watson will review and discuss with Adamis any such exceptions required by Applicable Laws before using the Trademark pursuant to such exception. At the request of Adamis, Watson will provide from time to time copies of packaging, labeling, advertising, promotional and other material of Watson or its Affiliates or sub-licensees referencing the Trademark to allow Adamis to confirm compliance with the foregoing.

 

  (d)          Any and all sublicenses to non-Affiliates granted under any license set forth in this Section 7.1 shall require the prior written consent of Adamis, which consent shall not be unreasonably withheld, conditioned or delayed. Any and all sublicenses granted under any license set forth in this Section 7.1 and distribution agreements or subcontracts for commercialization of the Product in the Territory shall be in writing and shall be subject to, and consistent with, the terms and conditions of this Agreement. Watson shall be responsible for the compliance of its Affiliates, sub-licensees, distributors and subcontractors with the terms and conditions of this Agreement. Within thirty (30) days after execution, Watson shall provide Adamis with a full and complete copy of each agreement granting a sub-license under any license set forth in this Section 7.1 to any Third Party or appointing any Third Party as a distributor or subcontractor for commercialization of the Product in the Territory (provided that Watson may redact any confidential information contained therein that is not necessary to confirm compliance with this Agreement). For the avoidance of doubt, the foregoing obligations do not apply to direct and indirect purchase and sale agreements between Watson and its customers.

 

7.2           Patent Filings . Upon agreement by the Parties, Adamis shall prepare and file any and all patent applications relating to, underlying or arising out of the Licensed Technology and shall take any other similar actions to secure, maintain, enhance, protect or perfect the intellectual property rights related to the Licensed Technology. Each Party shall cooperate, as reasonably requested by the other Party, in connection with such preparation, filing, prosecution and maintenance. Any such patent application and any patent that issues from such application(s) will be solely owned by Adamis.

 

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7.3           Infringement of Intellectual Property . Upon a Party learning of any infringement or threatened infringement of any Licensed Technology in the Territory, such Party shall promptly inform the other Party in writing of any such infringement and shall supply such other Party with all evidence pertaining to such infringement in such Party’s possession. In the event of any infringement or threatened infringement of the Licensed Technology by a Third Party in the Territory, Watson shall have the first right to file an action against any such infringing Third Party or seek abatement of the infringement by such Third Party at Watson’ sole cost and expense and by counsel of its own choice, and Adamis shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Adamis shall fully cooperate with Watson in any action brought by Watson, including by being joined as a party. In the event Watson does not file an action or seek abatement within (a) seventy-five (75) days following the notice of alleged infringement or (b) ten (10) days before the time limit, if any, set forth in the Applicable Laws, whichever comes first, then Adamis shall have the right, but not the obligation, to file an action against any such infringing Third Party or seek abatement of the infringement by such Third Party at Adamis’ sole cost and expense and by counsel of its own choice, and Watson shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Watson shall make reasonable efforts to promptly notify Adamis in writing if Watson decides not to file an action or seek abatement. Watson shall fully cooperate with Adamis in such action, including by being joined as a party. Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery or damages realized as a result of such action or proceeding with respect to Licensed Technology shall be used first to reimburse the documented Out-of-Pocket Expenses relating to the action or proceeding that were incurred by the Party that brought and controlled the action or proceeding, any remaining compensatory damages relating to the Product (including lost sales or lost profits with respect to the Product) shall be retained by the Party that brought and controlled such action or proceeding, , and any punitive damages shall be equally shared by the Parties. Notwithstanding the foregoing, (i) the Party bringing such action shall indemnify and reimburse the other Party for all reasonable Out-of-Pocket Expenses incurred by the other Party in connection with the action initiated pursuant to this Section 7.3, and (ii) if Watson brought and controlled the proceeding, the remaining compensatory damages (i.e., after reimbursement of its documented Out-of-Pocket Expenses) shall be included in Net Profits and subject to the provisions of Section 5.5.

 

7.4 Infringement of Third Parties’ Rights; Certain Generic Drug Filings .

 

(a)          In the event of any claim by a Third Party, or if either Party determines, that the manufacture, sale, offer for sale, distribution, promotion, marketing, other commercial exploitation or use of the Product by Watson or its Affiliate or sub-licensee infringes the intellectual property rights of a Third Party, Watson shall have the sole right and obligation, so long as rights to such Product are licensed to Watson hereunder, to defend and indemnify Adamis Indemnitees from and against such claim at Watson’s expense, including any judicial or administrative proceedings relating to such claim. If Adamis is put on notice of any such claim or makes any such determination of infringement, Adamis shall provide prompt notice to Watson of any such claim or determination. Adamis agrees to assist and cooperate with Watson in resolving any such claim. The procedures for indemnification under this Section 7.4 shall be the same as those set forth in Section 10.3. Watson shall reimburse Adamis for all reasonable Out-of-Pocket Expenses incurred by Adamis in the course of providing requested assistance and cooperation in accordance with this Section 7.4(a).

 

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(b)          Without limiting the foregoing, Watson and its attorneys, in consultation with Adamis and its attorneys, shall prepare any certifications or notices required to be filed or delivered to the FDA, other applicable Regulatory Authority or Third Party in connection with obtaining Regulatory Approval for the Product that requires an assessment as to whether the manufacture, use and sale of the Product would infringe any valid Third Party patent listed with the FDA or such other applicable Regulatory Authority, including, without limitation, such certifications and notices required pursuant to Sections 505(j)(2)(A) and (B) of the U.S. Food Drug and Cosmetic Act, as amended. Adamis agrees to assist and cooperate with Watson in preparation of such certifications and notices. As requested by Watson, Adamis shall incorporate, as applicable, such certifications and notices as prepared by Watson in the NDA and other Regulatory Dossiers to be filed by Adamis or in notices to be filed with Third Parties as required by Applicable Law. Watson shall have the sole right and authority to determine whether any patent held by a Third Party in the Territory shall be challenged in connection with the pursuit of any Regulatory Approval and shall have the sole right with prior notice to and consultation with Adamis to control all decisions that relate to or could impact such patent challenge (including, without limitation, appointment of counsel, strategies related to the prosecution of the Regulatory Approval or any related litigation and defense of any litigation or claim of infringement). Watson shall reimburse Adamis for all reasonable Out-of-Pocket Expenses incurred by Adamis in the course of providing its assistance and cooperation in accordance with this Section 7.4(b).

 

7.5            Improvements to the Licensed Technology . The Parties hereby agree that any improvements to the Licensed Technology made by either Party or jointly by the Parties shall be owned solely by Adamis, with such improvements becoming part of the Licensed Technology, so that Watson and its Affiliates shall have the sole and exclusive right to use such improvements in the Territory with respect to the Product during the Term. Watson shall and hereby does assign to Adamis any and all right title and interest of Watson or its Affiliates in any such improvements to the Licensed Technology, and Watson and its Affiliates shall, at Adamis’ request and expense, execute such documents and perform such acts as Adamis may deem reasonably necessary to confirm Adamis’ right, title and interest in and to any improvements to the Licensed Technology, and to enable and assist Adamis in procuring, maintaining, enforcing and defending patents, copyrights and other statutory protections with respect to such improvements to the Licensed Technology.

 

7.6            Trademark .

 

(a)          Adamis shall own and shall retain the ownership of the entire right, title and interest in and to the Trademark and goodwill related thereto. Watson acknowledges, as between the parties, the exclusive right, title and interest of Adamis in and to the Trademark and goodwill related thereto and will not do or cause to be done any act or thing contesting or, in any way, impairing any part of said right, title and interest for the Term and after its expiration. Watson will not, and will require that its Affiliates and sub-licensees not, make any representations or take any actions, which may be taken to indicate that it has any right title or interest in or to the ownership or use of the Trademark except under the terms of this Agreement, and acknowledges that nothing contained in this Agreement shall give Watson or any of its Affiliates or sub-licensees any right, title or interest in or to the Trademark and goodwill related thereto except the license rights granted under Section 7.1(c).

 

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(b)          Upon request by Adamis, Watson shall, and shall require its Affiliates and sub-licensees to, provide information to Adamis or its authorized representative as to its use of the Trademark and to render any assistance reasonably required by Adamis or its authorized representative to secure and/or maintain the registration(s) of the Trademark in the Territory.

 

(c)          Watson shall notify Adamis of any adverse use by a Third Party of the Trademark or of a mark or name confusingly similar to the Trademark. Watson agrees, and will require its Affiliates and sub-licensees to agree, to take no action with respect thereto except with the prior written authorization of Adamis. Adamis may thereupon take such action as it in its sole discretion deems advisable for the protection of its rights in and to the Trademark, including, without limitation, allowing Watson to bring and prosecute a claim against such Third Party at Watson’s expense, if Watson chooses to do so. Watson further agrees to provide full cooperation with any legal or equitable action by Adamis to protect Adamis’ right, title and interest in the Trademark. The Party responsible for bringing and prosecuting any infringement proceedings with respect to the Trademark and for the expenses associated with such proceedings shall have the sole right to retain any damages recovered in such proceedings. Notwithstanding the foregoing, (i) the Party bringing such action shall indemnify and reimburse the other Party for all reasonable Out-of-Pocket Expenses incurred by the other Party in connection with the action initiated pursuant to this Section 7.6, and (ii) if Watson brought and controlled the proceeding, the remaining damages received (i.e., after reimbursement of its documented Out-of-Pocket Expenses) shall be included in Net Profits and subject to the provisions of Section 5.5.

 

ARTICLE 8
CONFIDENTIALITY AND PUBLIC DISCLOSURE

 

8.1            Confidentiality . Each Party shall treat as confidential the Confidential Information of the other Party, and shall take all necessary precautions to assure the confidentiality of such Confidential Information. Each Party agrees to return to the other Party upon the expiration or termination of this Agreement all Confidential Information of such other Party, except as to such information it may be required to retain under Applicable Law, except for (a) one (1) copy of such Confidential Information to be retained by such Party’s legal department and (b) copies of laboratory books which Adamis shall require to keep for audits and inspections (in each case, which information which shall remain subject to ongoing obligations of confidentiality). During the Term and for a period of [*] ([*]) years following the expiration or termination of this Agreement, neither Party shall, without the other Party’s express prior written consent, use or disclose any such Confidential Information of the other Party for any purpose other than to carry out its obligations hereunder and under any other written agreement between the Parties. Each Party may disclose Confidential Information of the other Party to any Affiliates, actual and potential sub-licensees, employees, consultants, contractors or agents of such Party who have a need to know such information in order for such Party to exercise its rights or fulfill its obligations under this Agreement, provided that prior to disclosure of such Confidential Information of the other Party to any Affiliate, actual or potential sub-licensee, employee, consultant, contractor or agent, the Party making such disclosure shall ensure that such Person is bound in writing to observe obligations of confidentiality and non-use consistent with the provisions of this Article 8. Notwithstanding the obligations of confidentiality set forth in this Section 8.1, the receiving Party may disclose Confidential Information of the disclosing Party to the extent that such disclosure is required by Applicable Law or a court of competent jurisdiction; provided , however, that the receiving Party shall so notify the disclosing Party of its intent (so as to provide the disclosing Party a reasonable opportunity to seek relief from such required disclosure) and cooperate with the disclosing Party on reasonable measures to protect the confidentiality of the Confidential Information. Any such information disclosed as permitted by this Section 8.1 shall still be deemed Confidential Information and subject to the restrictions set forth in this Agreement.

 

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8.2            Public Disclosure . Except for such disclosure that is deemed necessary in the reasonable judgment of either Party to comply with Applicable Law, no public announcement, news release, statement, publication or presentation relating to the existence of this Agreement, the subject matter hereof or either Party’s performance hereunder shall be made without the other Party’s prior written approval, which approval shall not be unreasonably withheld, conditioned or delayed. In the event that the Parties mutually agree in writing to issue a public announcement, news release, statement, publication or presentation, the Parties agree that they shall use reasonable efforts to coordinate the initial public announcement, news release, statement, publication or presentation relating to the existence of this Agreement so that such public announcement, news release, statement, publication or presentation by each is made contemporaneously. Notwithstanding the foregoing, neither Party shall be obligated to issue any public announcement, news release, statement, publication or presentation in connection herewith. Each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is not inconsistent with prior public disclosures or public statements made in accordance with this Section 8.2 and which do not reveal non-public information about the other Party.

 

8.3            Filing of this Agreement . The Parties will coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with the U.S. Securities and Exchange Commission (“ SEC ”) or any stock exchange or governmental agency on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose to the SEC or any stock exchange or other governmental agency, as the case may be, and provided further that the Parties will use their reasonable efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies. Other than such obligation, neither Party (nor its Affiliates) will be obligated to consult with or obtain approval from the other Party with respect to any filings to the SEC or any stock exchange or other Governmental Authority.

 

8.4            Prior Nondisclosure Agreement . As of the Effective Date, the terms of this Article 8 shall supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties (or their Affiliates) dealing with the subject of this Agreement. Any information disclosed pursuant to any such prior agreement shall be deemed Confidential Information for purposes of this Agreement.

 

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8.5            Equitable Relief . Given the nature of the Confidential Information and the competitive damage that a Party would suffer upon unauthorized disclosure, use or transfer of its Confidential Information to any Third Party, the parties agree that monetary damages would not be a sufficient remedy for any breach of this Article 8. In addition to all other remedies, a Party shall be entitled to specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Article 8.

 

ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS; DISCLAIMER

 

9.1            Representations and Warranties by Each Party . Each Party hereby represents and warrants to the other Party as follows as of the Effective Date:

 

(a)           Existence . Such Party is a corporation or limited liability company duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated or formed (as applicable).

 

(b)           Authorization and Enforcement of Obligations . Such Party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms, subject to enforcement of remedies to applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting generally the enforcement of creditors’ rights and subject to a court’s discretionary authority with respect to the granting of a decree ordering specific performance or other equitable remedies.

 

(c)           Consents . All necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by such Party in connection with its execution and delivery of this Agreement have been obtained.

 

(d)           No Conflict . The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any Applicable Laws and (b) do not conflict with, or constitute a default under, any material contractual obligation of such Party.

 

(e)           No Debarment . Neither such Party nor any of its employees has ever been: (a) debarred, (b) convicted of a crime for which a person can be disbarred under Section 306 (a) or (b) of the Generic Drug Enforcement Act of 1992 (Article 306(a) or (b)), (c) threatened to be debarred or (d) indicted for a crime or otherwise engaged in conduct for which a person can be debarred under Section 306 (a) or (b).

 

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9.2            Covenants by Each Party . Each Party hereby covenants to the other Party as follows:

 

(a)           Debarment . In the event that either Party, or any of its officers, directors, or employees or other Person engaged by such Party performing services under this Agreement, (a) become debarred or receives notice of action or threat of action with respect to its debarment or (b) becomes the object of any investigation or subject of any report regarding such Party, or any of its officers, directors, or employees or other Person engaged by such Party performing services under this Agreement, in connection with any activity that could result in debarment or suspension or refusal of approval, including without limitation any inspection report, warning letter, notice of opportunity for hearing in a case of debarment, or any other Justice Department, FDA or other federal or state government inquiry or action bearing on potentially illegal activities, such Party shall notify the other Party immediately and such Party shall cease employing, contracting with, or retaining any such Person to perform any such services.

 

(b)           Compliance with Applicable Laws . In the performance of its obligations under this Agreement, such Party shall comply and shall cause its and its Affiliates’ employees and contractors to comply with all Applicable Laws.

 

9.3            Additional Representations, Warranties and Covenants by Adamis . Adamis also hereby represents, warrants and covenants to Watson that (a) as of the Effective Date it has sufficient legal or beneficial title, ownership or license rights in or to the Licensed Technology and the Trademark to grant the license as purported to be granted in Section 7.1 pursuant to this Agreement; (b) as of the Effective Date, it has not received any notice from a Third Party alleging that (i) the practice of the Licensed Technology infringes or may infringe such Third Party’s intellectual property right, or (ii) any research, development or manufacture of the Product by Adamis prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party; (c) it has not as of the Effective Date, and will not during the Term, grant any right to any Third Party under the Licensed Technology or the Trademark that would conflict with the licenses granted to Watson in this Agreement; and (d) to Adamis’ knowledge as of the Effective Date, there are no threatened or pending actions, claims or governmental investigations by or against Adamis that challenge the ownership of the Licensed Technology or the Product. If Watson or its Affiliates purchase Commercial Supply from Adamis, Adamis also provides the same representations and warranties regarding all such Product supplied to Watson that the Contract Manufacturer that manufactures such Product provides to Adamis under the [*].

 

9.4            Disclaimer . Except as expressly set forth in this Agreement, THE LICENSED TECHNOLOGY AND THE DEVELOPMENT SERVICES TO BE PROVIDED HEREUNDER ARE PROVIDED “AS IS,” AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OBTAINING SUCCESSFUL RESULTS, OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES.

 

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ARTICLE 10
INDEMNIFICATION; INSURANCE; LIMITATION OF LIABILITY

 

10.1          By Watson . Watson agrees to defend, indemnify and hold Adamis and its Affiliates and their respective directors, officers, employees, consultants, agents and successors and assigns of any of the foregoing (the “ Adamis Indemnitees ”) harmless from and against any and all costs, losses, liability and expenses (including reasonable attorney’s fees) (“ Losses ”) incurred by any Adamis Indemnitee resulting from claims made by any Third Party to the extent relating to or arising out of (a) the manufacture, marketing, distribution, sale, offer for sale, promotion or other commercial exploitation of the Product by Watson, including, without limitation, the infringement of any Third Party’s intellectual property matters, as set forth under Section 7.4, (b) a breach of any obligation, covenant, representation or warranty by Watson contained in this Agreement or (c) any negligent, grossly negligent or intentionally wrongful act or omission of Watson or its directors, officers or employees, in each case, except to the extent to, or for matters for, which Adamis would be required to indemnify Watson Indemnitees under Section 10.2.

 

10.2          By Adamis . Adamis agrees to defend, indemnify and hold Watson and its Affiliates and their respective directors, officers, employees, consultants, agents and successors and assigns of any of the foregoing (the “ Watson Indemnitees ”) harmless from and against any and all Losses incurred by any Watson Indemnitee resulting from claims made by any Third Party to the extent relating to or arising out of (a) performance of Development Services by Adamis, (b) a breach of any obligation, covenant, representation or warranty by Adamis contained in this Agreement or (c) any negligent, grossly negligent or intentionally wrongful act or omission of Adamis or its directors, officers, employees or agents, in each case, except to the extent to, or for matters for, which Watson would be required to indemnify Adamis Indemnitees under Section 10.1.

 

10.3          Procedures for Control of Third Party Claims . The Adamis Indemnitee or Watson Indemnitee, as applicable, entitled to make a claim for indemnification under this Article 10 shall be referred to as the “ Indemnified Party ” and the Party required to indemnify such claim shall be referred to as the “ Indemnifying Party .” In order for an Indemnified Party to be entitled to any indemnification provided for under this Agreement in respect of, arising out of or involving a claim or demand, made by any Third Party against the Indemnified Party (a “ Third Party Claim ”), such Indemnified Party must notify the Indemnifying Party in writing of the Third Party Claim within thirty (30) business days after receipt by such Indemnified Party of written notice of the Third Party Claim; provided , however , that failure to give such notification shall not affect the indemnification provided hereunder except to the extent the Indemnifying Party shall have been actually materially prejudiced as a result of such failure. If a Third Party Claim is made against an Indemnified Party, the Indemnifying Party shall be entitled to participate in the defense thereof and, upon notice to the Indemnified Party, to assume the defense thereof; provided , that (i) the Indemnifying Party’s counsel is reasonably satisfactory to the Indemnified Party and (ii) the Indemnifying Party shall thereafter consult with the Indemnified Party upon the Indemnified Party’s reasonable request for such consultation from time to time with respect to such suit, action or proceeding. If the Indemnifying Party assumes such defense, the Indemnified Party shall have the right (but not the duty) to participate in the defense thereof and to employ counsel, at its own expense, separate from the counsel employed by the Indemnifying Party. The Indemnifying Party shall be liable for the fees and expenses of counsel employed by the Indemnified Party for any period during which the Indemnifying Party has not assumed the defense thereof, but the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by the Indemnified Party in connection with the defense thereof. Whether or not the Indemnifying Party defends or prosecutes any Third Party Claim, the Parties shall cooperate in the defense or prosecution thereof. Such cooperation shall include the retention and (upon the Indemnifying Party’s request) the provision to the Indemnifying Party of records and information which are reasonably relevant to such Third Party Claim, and making employees or any other Indemnified Party available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder. Whether or not the Indemnifying Party shall have assumed the defense of a Third Party Claim, the Indemnified Party shall not admit any liability with respect to, or settle, compromise or discharge, such Third Party Claim without the Indemnifying Party’s prior written consent, which shall not be unreasonably withheld, conditioned or delayed. The Indemnifying Party shall be entitled to settle a Third Party Claim so long as such settlement does not impose any obligation or burden (including loss of goodwill) on the Indemnified Party. In no event shall the Indemnifying Party settle any Third Party Claim if such settlement would impose any obligation or burden on the Indemnified Party without the prior written consent of the Indemnified Party.

 

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10.4          Insurance . For the Term and for a period of two (2) years after the expiration or termination of this Agreement, Watson agrees to obtain and maintain (including through a self-insurance program) comprehensive general liability insurance, including Products Liability, Bodily Injury and Property Damage Insurance with a combined single limit of not less than $[*] per occurrence and $[*] in the aggregate annually.

 

10.5          LIMITATION OF LIABILITY . NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, EXCEPT WITH RESPECT TO (i) A BREACH OF ARTICLE 8, (ii) A PARTY’S INFRINGEMENT OF THE OTHER PARTY’S INTELLECTUAL PROPERTY AND/OR PROPRIETARY RIGHTS, AND (iii) THIRD PARTY CLAIMS PURSUANT TO THE INDEMNIFICATION OBLIGATIONS SET FORTH IN THIS ARTICLE 10, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES, INCLUDING FOR LOST PROFITS OR LOSS OF OPPORTUNITY OR USE OF ANY KIND SUFFERED BY THE OTHER PARTY, WHETHER IN CONTRACT, TORT OR OTHERWISE.

 

ARTICLE 11
TERM AND TERMINATION

 

11.1          Term . This Agreement shall become effective on the Effective Date. Unless earlier terminated in accordance with this Agreement, this Agreement shall expire [*] ([*]) years from the first sale of the 0.3mg Product by Watson or its Affiliate or sub-licensee in the Territory (the “ Initial Term ”). The term of this Agreement shall be automatically extended for additional [*] ([*]) year terms (each a “ Renewal Term ” and together with the Initial Term, collectively referred to herein as the “ Term ”), unless either Party notifies the other, in writing, that it will not extend the applicable Term and such notice is delivered no later than one (1) year prior to the expiration of the Initial Term or the then-current Renewal Term (as applicable).

 

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11.2         Termination for Breach . A Party may terminate this Agreement with written notice to the other Party at any time during the Term if the other Party is in breach of any material term of this Agreement, and has not cured such breach within [*] ([*]) days ([*] ([*]) days with respect to any payment breach) after written notice from the terminating Party requesting cure of such breach. In the event of a good faith dispute between the Parties as to whether a material breach (other than a payment breach) has occurred, the [*] ([*]) day cure period referenced in the preceding sentence shall be tolled during any action or proceeding concerning such good faith dispute.

 

11.3         Termination for Insolvency or Bankruptcy . This Agreement may be terminated prior to the expiration of its Term upon written notice by a Party: (a) in the event that the other Party shall (i) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator of itself or of all or a substantial part of its property, (ii) make a general assignment for the benefit of its creditors, (iii) commence a voluntary case under the United States Bankruptcy Code (or foreign equivalent), as now or hereafter in effect (the “ Bankruptcy Code ”), (iv) file a petition seeking to take advantage of any law (the “ Bankruptcy Laws ”) relating to bankruptcy, insolvency, reorganization, winding-up, or composition or readjustment of debts, (v) fail to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed against it in any involuntary case under the Bankruptcy Code or (vi) take any corporate action for the purpose of effecting any of the foregoing; or (b) if a proceeding or case shall be commenced against the other Party in any court of competent jurisdiction, seeking (i) its liquidation, reorganization, dissolution or winding-up, or the composition or readjustment of its debts, (ii) the appointment of a trustee, receiver, custodian, liquidator or the like of the party or of all or any substantial part of its assets or (iii) similar relief under any Bankruptcy Laws, or an order, judgment or decree approving any of the foregoing shall be entered and continue unstayed for a period of sixty (60) days; or (c) in the event that an order for relief against the other Party shall be entered in an involuntary case under the Bankruptcy Code.

 

11.4         Termination for Convenience .

 

(a)        [*]

 

(b)        [*]

 

(c)        [*]

 

11.5         Effect of Expiration or Termination .

 

(a)          If Watson or its Affiliate has entered into a Territory Supply Agreement with any Third Party Contract Manufacturer, then, effective on the date of any termination of this Agreement, at Adamis’ written election (to be made prior to such termination), Watson or its Affiliate shall either (i) assign that Territory Supply Agreement to Adamis (but only to the extent applicable to the terminated Product), and Adamis shall accept such assignment or (ii) terminate that Territory Supply Agreement so that Adamis may enter into an agreement directly with such Contract Manufacturer for supply of the Product for the Territory, provided however, under either scenario, as between the Parties, Adamis shall be solely responsible for any Minimum Obligations thereafter owing to the Contract Manufacturer with respect to the supply of the Product.

 

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( b)          Unless otherwise expressly set forth herein, the expiration or termination of this Agreement shall not relieve either Party of any obligation (including, without limitation, any payment obligation with respect to Net Sales of Product manufactured before the date of termination, but sold after the date of termination) or liability accruing prior to such expiration or termination, nor shall the expiration or termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement.

 

(c)          Articles 1, 8, 10, 12 and 13, Sections 5.6 (for the period specified therein), 6.1 (only with respect to a Recall with respect to Product commercialized in the Territory prior to expiration or termination), 9.4 and this Section 11.5 shall survive expiration or termination of this Agreement.

 

ARTICLE 12

DISPUTE RESOLUTION

 

12.1         Disputes . Subject to Section 12.3, upon the written request of either Party to the other Party, any claim, dispute, or controversy as to the breach, enforcement, interpretation or validity of this Agreement (a “ Dispute ”) shall be referred to a senior executive of Adamis and a senior executive of Watson. In the event that such senior executives are unable to resolve such Dispute within sixty (60) days after referral to them, the Dispute shall be referred to the Chief Executive Officer of Adamis and the Chief Executive Officer of Watson (or such executive’s designee with decision-making authority) for attempted resolution. In the event such Chief Executive Officers (or designees) are unable to resolve such Dispute within sixty (60) days after referral to them, then, upon the written demand of either Party, the Dispute shall be subject to arbitration, as provided in Section 11.2, except as expressly set forth in Section 11.3.

 

12.2         Arbitration .

 

(a)          Subject to Section 12.3 below, any Dispute that is not resolved under Section 12.1 within thirty (30) days after a Party’s initial written request for resolution, shall be resolved by final and binding arbitration before a panel of three neutral experts with relevant industry experience. The arbitration proceeding shall be administered in accordance with the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the American Arbitration Association (“ AAA ”), and the panel of arbitrators shall be selected in accordance with such rules. The arbitration and all associated discovery proceedings and communications shall be conducted in English, and the arbitration shall be held in San Diego, California. Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of arbitration without the prior written consent of both Parties.

 

(b)          The arbitrators shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The decision or award rendered by the arbitrators shall be final and non-appealable, and judgment may be entered upon it in any court of competent jurisdiction. Either Party may apply for interim injunctive relief with the arbitrators until the arbitration award is rendered or the controversy is otherwise resolved. The arbitrators shall be authorized to award compensatory damages, but shall not be authorized (i) to award non-economic damages, (ii) to award punitive damages or any other damages expressly excluded under this Agreement, or (iii) to reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided, however, that the damage limitations described in subsections (i) and (ii) of this sentence will not apply if such damages are statutorily imposed.

 

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(c)          Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators; provided, however, the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and at their discretion, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the AAA and the arbitrators.

 

12.3         Court Actions . Nothing contained in this Agreement shall deny either Party the right to seek, upon good cause, injunctive or other equitable relief from a court of competent jurisdiction in the context of an emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing dispute resolution discussions or arbitration proceedings. In addition, either Party may bring an action in any court of competent jurisdiction to resolve disputes pertaining to the validity, construction, scope, enforceability, infringement or other violations of intellectual property rights, and no such claim shall be subject to arbitration pursuant to Section 12.2.

 

ARTICLE 13

MISCELLANEOUS

 

13.1         Independent Contractor Status . The Parties’ relationship as established by this Agreement is solely that of independent contractors. This Agreement does not create any partnership, joint venture or similar business relationship between the Parties. Neither Party is a legal representative of the other Party, and neither Party can assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever. It is expressly agreed and understood that neither Adamis nor any of its employees or subcontractors is an employee or agent of Watson.

 

13.2         Expenses . Except as otherwise expressly provided herein, each Party shall pay its own expenses in connection with the negotiation of this Agreement, the performance of its obligations hereunder and the consummation of the transactions contemplated hereby.

 

13.3         Amendment; Modification . No amendment, modification or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.

 

25  

 

 

13.4         Waiver . No provision of this Agreement shall be waived by any act, omission, course of dealing or knowledge of a Party or its agents except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party.

 

13.5         Notices . All notices to be given hereunder shall be in writing, shall be effective when received, and shall be delivered personally, by facsimile or other electronic transmission (receipt verified), mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by express courier service, to the Parties at the following addresses (or at such other address for a Party as shall be specified by like notice, also effective only upon receipt thereof):

 

Notices to Watson : with a copy to :
   
Watson Laboratories, Inc. Watson, Inc.
Morris Corporate Center III Morris Corporate Center III
400 Interpace Parkway, Bldg. A 400 Interpace Parkway, Bldg. A
Parsippany, New Jersey 07054 Parsippany, New Jersey 07054
Attention:  Sr. VP, Business Development Attention:  Legal Department
Facsimile: Facsimile: 862-261-7911
E-mail: Daniel.Motto@Watson.com E-mail: USLegal@actavis.com
   
Notices to Adamis : with a copy to :
   
Adamis Pharmaceuticals, Inc.  
11682 El Camino Real, Suite 300  
San Diego, California 92130  
Attention: Sr. VP, Corporate Development  
Facsimile: 858-461-0842  
E-mail: dmarguglio@adamispharma.com  

 

13.6         Assignment . This Agreement and all of the provisions hereof shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Neither Party may assign any of its rights, liabilities or obligations hereunder without the prior written consent of the other Party and any assignment without such consent shall be void. Notwithstanding anything to the contrary in this Section 13.6, either Party may assign this Agreement and its rights, liabilities and obligations hereunder without the other Party’s consent:

 

(a)          in the case of either Party, in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a Third Party, whether by merger, sale of stock, sale of assets or otherwise; provided, however, that in the event of such a transaction (whether this Agreement is actually assigned or is assumed by the acquiring party by operation of law ( e.g. , in the context of a reverse triangular merger)), intellectual property rights of the acquiring party to such transaction (if other than one of the Parties to this Agreement) shall not be included in the technology licensed hereunder or otherwise subject to this Agreement; or

 

26  

 

 

(b)          to an Affiliate, provided that the assigning Party shall remain liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate.

 

13.7         No Strict Construction . The language used in this Agreement shall be deemed to be the language chosen by the Parties to express their mutual intent, and no rule of strict construction shall be applied against either Party.

 

13.8         Complete Agreement . This Agreement, together with all exhibits and schedules attached hereto, contains the complete agreement between the Parties with respect to the subject matter hereof and supersedes any prior understandings, agreements or representations by or between the Parties, written or oral, which may have related to the subject matter hereof in any way.

 

13.9         Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to the application of principles of conflicts of law.

 

13.10       Force Majeure . Each of the Parties hereto shall be excused from the performance of its obligations hereunder (except for payment obligations) in the event such performance is prevented by force majeure, provided that each of the Parties shall use reasonable commercial efforts to complete such performance by other means. Causes beyond the control of Adamis or Watson include but are not limited to acts of God, acts or laws of any government, war, civil commotion, destruction of production facilities or materials by fire, earthquake or storm, labor disturbances, epidemic and failure of public utilities or common carriers.

 

13.11       Counterparts . This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, and all of which shall be considered one and the same instrument.

 

13.12       Severability . If any provision of this Agreement shall be held invalid, illegal or unenforceable, the validity, legality or unenforceability of the other provisions of this Agreement shall not be affected thereby, and there shall be deemed substituted for the provision at issue a valid, legal and enforceable provision as similar as possible to the provision at issue.

 

[Signature page follows]

 

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IN WITNESS WHEREOF , this Agreement is effective as of the Effective Date.  

         
Watson Laboratories, Inc.   Adamis Pharmaceuticals Corporation
     
By:   /s/ Daniel N. Motto   By:   /s/ Dennis J. Carlo
Name: Daniel N. Motto   Name: Dennis J. Carlo
Title: SVP, Global Business Development   Title: Chief Executive Officer

 

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EXHIBIT A

 

MILESTONE PAYMENTS

 

Watson will make the following Milestone Payments to Adamis within 30 days of each of the following events:

 

a) $[*] upon execution of this Agreement (“ Execution Milestone Payment ”);

 

b) $[*] upon the [*] of the 0.3mg Product in the Territory (“ [*] ”);

 

c) $[*];

 

d) $[*] upon the [*] of the [*] Product in the Territory (“ [*] ”);

 

e) $[*];

 

f) $[*]; and

 

g) $[*].

 

Notwithstanding the foregoing,

 

(A) If the NDA for the 0.3mg Product has not received final marketing approval by [*](the “ Approval Deadline ”), Watson shall have the right to terminate this Agreement by providing written notice to Adamis no later than [*] ( [*] ) days after the Approval Deadline and receive a full refund from Adamis of the Execution Milestone Payment. If the NDA has not received FDA approval by the Approval Deadline and Watson has not provided notice of termination pursuant to the immediately preceding sentence, then Adamis will not be required to refund the Execution Milestone Payment.

 

(B) If the first commercial sale of the 0.3mg Product in the Territory has not occurred by [*] (the “ Launch Deadline ”), and the Launch Deadline is not missed as a result of matters within the reasonable control of Watson, then the [*] shall not become payable by Watson upon the achievement of the specified event. For the avoidance of doubt, a decision to delay the launch of the Product as a result of threatened or pending intellectual property litigation or other legal concerns that could be reasonably expected to impede marketing efforts, shall not be a matter within the reasonable control of Watson.

 

(C) If the NDA for the [*] Product has not received final marketing approval by [*], or such later date as agreed in writing by the Parties (the “ Supplement Approval Deadline ”) then the [*] shall not become payable by Watson upon the achievement of the specified event.

 

 

 

 

EXHIBIT B

 

DEVELOPMENT PLAN AND RESPONSIBILITY MATRIX

 

[*]

 

 

 

 

Adamis Pharmaceuticals Corporation 10-Q

 

Exhibit 31.1

CERTIFICATION PURSUANT TO SECTION 302 OF THE

SARBANES-OXLEY ACT OF 2002

I, Dennis J. Carlo, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Adamis Pharmaceuticals 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 annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and (15d-15(e)) for the registrant and we have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting disclosure to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial data; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 15, 2016   By: /s/ Dennis J. Carlo
        Chief Executive Officer

 

 

 
 
 
 

Adamis Pharmaceuticals Corporation 10-Q

 

Exhibit 31.2

CERTIFICATION PURSUANT TO SECTION 302 OF THE

SARBANES-OXLEY ACT OF 2002

I, Robert O. Hopkins, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Adamis Pharmaceuticals 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 annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and (15d-15(e)) for the registrant and we have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting disclosure to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial data; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Date: August 15, 2016   By: /s/ Robert O. Hopkins
        Vice President, Finance and Chief Financial Officer

 

 

 
 
 
 

Adamis Pharmaceuticals Corporation 10-Q

 

Exhibit 32.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT

The undersigned, Dennis J. Carlo, the Chief Executive Officer of Adamis Pharmaceuticals Corporation (the “Company”), pursuant to 18 U.S.C.  1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby certifies that, to the best of my knowledge:

(1) the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) 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.

 

  /s/ DENNIS J. CARLO
  Dennis J. Carlo
  Chief Executive Officer

Dated: August 15, 2016

This certification is being furnished to the SEC with this Quarterly Report on Form 10-Q pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934.

 

 

 
 
 
 

Adamis Pharmaceuticals, Corporation 10-Q

 

Exhibit 32.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT

The undersigned, Robert O. Hopkins, as Vice President, Finance and Chief Financial Officer of Adamis Pharmaceuticals, Corporation (the “Company”), pursuant to 18 U.S.C.  1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby certifies that, to the best of my knowledge:

(1) the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) 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.

 

  /s/ ROBERT O. HOPKINS
  Robert O. Hopkins
  Vice President and Chief Financial Officer

Dated: August 15, 2016

This certification is being furnished to the SEC with this Quarterly Report on Form 10-Q pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934.