UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

(Mark One)

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

 

For the quarterly period ended January 31, 2017

 

or

 

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

 

For the transition period from ______to______.

 

Commission File Number:  000-55330

 

OPIANT PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada   46-4744124
(State or other jurisdiction of incorporation or
organization)
  (I.R.S. Employer Identification No.)
     
401 Wilshire Blvd., 12th Floor, Santa Monica, CA   90401
(Address of principal executive offices)   (Zip Code)

 

(424) 252-4756  

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  x    No  ¨

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  x No  ¨

 

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

 

Large Accelerated Filer ¨ Accelerated Filer ¨
Non-Accelerated Filer ¨ (Do not check if a smaller reporting company) Smaller Reporting Company x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  ¨  No  x

 

As of March 7, 2017, the registrant had 2,036,904 shares of common stock outstanding.  

 

 

 

 

OPIANT PHARMACEUTICALS, INC.

 

Quarterly Report on Form 10-Q for the

Period Ended January 31, 2017

 

TABLE OF CONTENTS

 

PART I— FINANCIAL INFORMATION  
     
Item 1. Financial Statements (Unaudited) 4
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 16
Item 3. Quantitative and Qualitative Disclosures About Market Risk 33
Item 4. Control and Procedures 33
     
PART II— OTHER INFORMATION 34
     
Item 1. Legal Proceedings 34
Item 1A. Risk Factors 35
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 48
Item 3. Defaults Upon Senior Securities 48
Item 4. Mine Safety Disclosures 48
Item 5. Other Information 48
Item 6. Exhibits 49
     
SIGNATURES 50

  

2

 

 

CAUTIONARY STATEMENT ON FORWARD-LOOKING INFORMATION

 

This Quarterly Report on Form 10-Q (this “Report”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements discuss matters that are not historical facts. Because they discuss future events or conditions, forward-looking statements may include words such as “anticipate,” “believe,” “estimate,” “intend,” “could,” “should,” “would,” “may,” “seek,” “plan,” “might,” “will,” “expect,” “predict,” “project,” “forecast,” “potential,” “continue”, negatives thereof or similar expressions. Forward-looking statements speak only as of the date they are made, are based on various underlying assumptions and current expectations about the future and are not guarantees. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, level of activity, performance or achievement to be materially different from the results of operations or plans expressed or implied by such forward-looking statements.

 

We cannot predict all of the risks and uncertainties. Accordingly, such information should not be regarded as representations that the results or conditions described in such statements or that our objectives and plans will be achieved and we do not assume any responsibility for the accuracy or completeness of any of these forward-looking statements. These forward-looking statements are found at various places throughout this Report and include information concerning possible or assumed future results of our operations, including statements about potential acquisition or merger targets; business strategies; future cash flows; financing plans; plans and objectives of management, any other statements regarding future acquisitions, future cash needs, future operations, business plans and future financial results, and any other statements that are not historical facts.

 

From time to time, forward-looking statements also are included in our other periodic reports on Forms 10-K and 8-K, in our press releases, in our presentations, on our website and in other materials released to the public. Any or all of the forward-looking statements included in this Report and in any other reports or public statements made by us are not guarantees of future performance and may turn out to be inaccurate. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors. Many of those factors are outside of our control and could cause actual results to differ materially from the results expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report.

 

Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise.

 

CERTAIN TERMS USED IN THIS REPORT

 

When this Report uses the words “we,” “us,” “our,” “Opiant,” and the “Company,” they refer to Opiant Pharmaceuticals, Inc. “SEC” refers to the Securities and Exchange Commission.

 

3

 

 

Item 1.             Financial Statements (Unaudited).

 

Opiant Pharmaceuticals, Inc.

(formerly Lightlake Therapeutics Inc.)

 

Index to Financial Statements

January 31, 2017 and 2016

 

  Page
  Number
   
Consolidated Balance Sheets as of January 31, 2017 and July 31, 2016 (Unaudited) 5
   
Consolidated Statements of Operations for the three and six months ended January 31, 2017 and 2016 (Unaudited) 6
   
Consolidated Statement of Stockholders’ Equity (Deficit) for the six months ended January 31, 2017 (Unaudited) 7
   
Consolidated Statements of Cash Flows for the six months ended January 31, 2017 and 2016 (Unaudited) 8
   
Consolidated Notes to Financial Statements (Unaudited) 9 to 15
   

  

4

 

 

 Opiant Pharmaceuticals, Inc.

 

Consolidated Balance Sheets (Unaudited)

As of January 31, 2017 and July 31, 2016

  

    January 31,     July 31,  
    2017     2016  
             
Assets                
Current assets                
Cash and cash equivalents   $ 12,925,829     $ 1,481,393  
Accounts receivable     -       312,498  
Prepaid expenses     52,017       62,404  
Total current assets     12,977,846       1,856,295  
                 
Other assets                
Computer equipment (net of accumulated amortization of $2,900 at January 31, 2017 and $1,016 at July 31, 2016)     4,637       6,521  
Patents and patent applications (net of accumulated amortization of $9,074 at January 31, 2017 and $8,388 at July 31, 2016)     18,376         19,062  
                 
Total assets   $ 13,000,859     $ 1,881,878  
                 
Liabilities and Stockholders' Equity (Deficit)                
Liabilities                
Current liabilities                
Accounts payable and accrued liabilities   $ 756,212     $ 140,584  
Accrued salaries and wages     3,690,289       3,681,250  
Note payable     -       165,000  
Deferred revenue     750,000       250,000  
Total current liabilities     5,196,501       4,236,834  
                 
Deferred revenue     1,850,000       2,350,000  
Total liabilities     7,046,501       6,586,834  
                 
Stockholders' equity (deficit)                
Common stock; par value $0.001; 1,000,000,000 shares authorized;                
2,007,760 shares issued and outstanding at January 31, 2017 and 1,992,433 shares issued and outstanding at July 31, 2016     2,008       1,992  
Additional paid-in capital     57,088,530       56,478,394  
Accumulated deficit     (51,136,180 )     (61,185,342 )
Total stockholders' equity (deficit)     5,954,358       (4,704,956 )
Total liabilities and stockholders' equity (deficit)   $ 13,000,859     $ 1,881,878  

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

5

 

 

Opiant Pharmaceuticals, Inc.

Consolidated Statements of Operations (Unaudited)

For the three and six months ended January 31, 2017 and 2016

 

    For the     For the  
    Three Months Ended     Six Months Ended  
    January 31,     January 31,  
    2017     2016     2017     2016  
                         
Revenue                                
Royalty and licensing revenue   $ 13,535,000     $ 6,860,000     $ 14,656,142     $ 6,980,000  
      13,535,000       6,860,000       14,656,142       6,980,000  
                                 
Operating expenses                                
General and administrative     1,355,704       2,394,505       2,572,006       12,990,324  
Research and development     344,836       254,881       786,670       879,892  
Selling expenses     1,196,563       209,251       1,238,599       209,251  
Total operating expenses     2,897,103       2,858,637       4,597,275       14,079,467  
                                 
Income (loss) from operations     10,637,897       4,001,363       10,058,867       (7,099,467 )
                                 
Other income (expense)                                
Interest income (expense), net     877       (5,491 )     (1,367 )     (11,319 )
Income (loss) on foreign exchange     11,016       (25,832 )     (8,338 )     (29,191 )
Total other income (expense)     11,893       (31,323 )     (9,705 )     (40,510 )
                                 
Income (loss) before provision for income taxes     10,649,790       3,970,040       10,049,162       (7,139,977 )
                                 
Provision for income taxes     -       -       -       -  
                                 
Net income (loss)   $ 10,649,790     $ 3,970,040     $ 10,049,162     $ (7,139,977 )
                                 
Basic income (loss) per common share   $ 5.31     $ 2.11     $ 5.03     $ (3.83 )
Diluted income (loss) per common share   $ 4.91     $ 1.52     $ 4.55     $ (3.83 )
                                 
Basic weighted average common shares outstanding     2,006,181       1,880,279       1,999,307       1,865,230  
Diluted weighted average common shares outstanding     2,169,966       2,605,270       2,210,990       1,865,230  

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

6

 

 

Opiant Pharmaceuticals, Inc.

Consolidated Statement of Stockholders' Equity (Deficit) (Unaudited)

For the six months ended January 31, 2017

 

                Additional              
    Common Stock     Paid In     Accumulated        
    Shares     Amount     Capital     Deficit     Total  
                               
Balance at July 31, 2016     1,992,433     $ 1,992     $ 56,478,394     $ (61,185,342 )   $ (4,704,956 )
                                         
Stock issued for services     15,327       16       92,607       -       92,623  
                                         
Stock based compensation from issuance of stock options     -       -       517,529       -       517,529  
                                         
Net income     -       -       -       10,049,162       10,049,162  
                                         
Balance at January 31, 2017     2,007,760     $ 2,008     $ 57,088,530     $ (51,136,180 )   $ 5,954,358  

 

The accompanying notes are an integral part of these unaudited consolidated financial statements

 

7

 

 

Opiant Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows (Unaudited)

For the six months ended January 31, 2017 and 2016

 

    For the  
    Six Months Ended  
    January 31,     January 31,  
    2017     2016  
Cash flows used in operating activities                
Net income (loss)   $ 10,049,162     $ (7,139,977 )
Adjustments to reconcile net loss to net cash used by operating activities:                
Depreciation and amortization     2,570       686  
Issuance of common stock for services     92,623       456,483  
Stock based compensation from issuance of options     517,529       10,166,391  
                 
Changes in assets and liabilities:                
Decrease in prepaid expenses     10,387       6,060  
Increase in accounts receivable     312,498       -  
Decrease in deferred revenue     -       (4,300,000 )
Increase (decrease) in accounts payable     615,628       (280,245 )
Increase in accrued salaries and wages     9,039       734,441  
Net cash provided by (used in) operating activities     11,609,436       (356,161 )
                 
Cash flows provided by financing activities                
Proceeds from related parties notes payable     -       151,191  
Payments of related parties notes payable     -       (281,191 )
Repayment of notes payable     (165,000 )     -  
Investment received in exchange for royalty agreement     -       1,333,500  
Net cash provided by (used in) financing activities     (165,000 )     1,203,500  
                 
Net increase  in cash and cash equivalents     11,444,436       847,339  
Cash and cash equivalents, beginning of period     1,481,393       434,217  
Cash and cash equivalents, end of period   $ 12,925,829     $ 1,281,556  
                 
Supplemental disclosure                
Interest paid during the period   $ 4,828     $ 78,865  
Taxes paid during the period   $ -     $ -  

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

8

 

 

Opiant Pharmaceuticals, Inc.

 

Notes to Unaudited Consolidated Financial Statements

For the periods ended January 31, 2017 and 2016

 

1. Organization and Basis of Presentation

 

Opiant Pharmaceuticals, Inc. (the “Company”), a Nevada corporation, is a specialty pharmaceutical company which develops pharmacological treatments for substance use, addictive and eating disorders. The Company was incorporated in the State of Nevada on June 21, 2005 as Madrona Ventures, Inc. and, on September 16, 2009, the Company changed its name to Lightlake Therapeutics Inc. On January 28, 2016, the Company again changed its name to Opiant Pharmaceuticals, Inc. The Company is a specialty pharmaceutical company developing opioid antagonist treatments for substance use, addictive and eating disorders. The Company also has developed a treatment to reverse opioid overdoses, which is now known as NARCAN® (naloxone hydrochloride) Nasal Spray. The Company’s fiscal year end is July 31.

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America for interim financial information and with the instructions to Form 10-Q and Regulation S-X. Accordingly, these consolidated financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete consolidated financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included and such adjustments are of a normal recurring nature. These consolidated financial statements should be read in conjunction with the financial statements for the year ended July 31, 2016 and notes thereto and other pertinent information contained in the Form 10-K the Company has filed with the Securities and Exchange Commission (the “SEC”).

 

The results of operations for the three months and six months ended January 31, 2017 are not necessarily indicative of the results for the full fiscal year ending July 31, 2017. 

  

2. Summary of Significant Accounting Policies

 

Basis of Presentation and Use of Estimates

The Company prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”), which require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. 

 

The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited, a company incorporated on November 4, 2016 under the England and Wales Companies Act of 2006. Intercompany balances and transactions are eliminated upon consolidation.  

 

Basic and Diluted Net Income (Loss) Per Share

 

Earnings (loss) per share is calculated by dividing the net income (loss) available to common stockholders by the weighted average number of shares outstanding during the period. Diluted earnings per share reflect the potential dilution of securities that could share in earnings of an entity. Diluted income per share reflects the potential dilution that would occur if outstanding stock options and warrants were exercised utilizing the treasury stock method. In a loss year, dilutive common equivalent shares are excluded from the loss per share calculation as the effect would be anti-dilutive.

 

9

 

 

A reconciliation of the components of basic and diluted net income (loss) per common share is presented in the tables below:

 

    For the Three Months Ended January 31,  
    2017     2016  
    Income
$
    Weighted
Average
Common
Shares
Outstanding
    Per Share
$
    Income
$
    Weighted
Average
Common
Shares
Outstanding
    Per Share
$
 
Basic:                                    
Income attributable to common stock     10,649,790       2,006,181       5.31       3,970,040       1,880,279       2.11  
Effective of Dilutive Securities:                                                
Stock options and warrants           163,785                   724,991        
                                                 
Diluted:                                                
Income attributable to common stock, including assumed conversions     10,649,790       2,169,966       4.91       3,970,040       2,605,270       1.52  

  

    For the Six Months Ended January 31,  
    2017     2016  
    Income
(Loss)

$
    Weighted
Average
Common
Shares
Outstanding
    Per Share
$
    Income
(Loss)

$
    Weighted
Average
Common
Shares
Outstanding
    Per Share
$
 
Basic:                                                
Income (loss) attributable to common stock     10,049,162       1,999,307       5.03       (7,139,977 )     1,865,230       (3.83 )
Effective of Dilutive Securities:                                                
Stock options and warrants           211,683                          
                                                 
Diluted:                                                
Income (loss) attributable to common stock, including assumed conversions     10,049,162       2,210,990       4.55       (7,139,977 )     1,865,230       (3.83 )

 

Reclassification of Financial Statement Accounts

 

Certain amounts in the January 31, 2016 financial statements have been reclassified to conform to the presentation in the January 31, 2017 consolidated financial statements.

 

Recently Issued Accounting Pronouncements

 

The Company has implemented all new accounting pronouncements that are in effect and that may impact its consolidated financial statements and does not believe that there are any other new pronouncements that have been issued that might have a material impact on its financial position or results of operations.

 

3. Related Party Transactions

    

The Company uses office space provided by Dr. Michael Sinclair and Kevin Pollack free of charge.

 

10

 

 

4. Stockholders’ Equity

 

Common Stock

 

On November 2, 2016, the Company granted 1,000 restricted shares of Company’s Common Stock to a consultant pursuant to a consulting agreement dated October 12, 2016 for consulting services provided by the consultant. The shares issued in this transaction were valued using the stock price at issuance date and amounted to $7,520.

 

On November 10, 2016, the Company issued 14,327 shares of unregistered Common Stock pursuant to the LOI described in Note 6. The shares issued in this transaction were valued using the stock price at issuance date and amounted to $85,103.

 

Stock Options

 

As required by the Stock Compensation Topic, ASC 718, the Company measures and recognizes compensation expense for all share based payment awards made to the officers and directors based on estimated fair values at the grant date and over the requisite service period.

 

On October 6, 2016, the Company granted options to purchase a total of 50,000 shares of Common Stock exercisable on a cashless basis to two employees. These options all have an exercise price of $10.00 and a term of 10 years. The options vest as follows: 1,388 shares vest upon each of the first through twentieth month anniversaries of the grant date; 1,390 shares vest upon each of the twenty-first through thirty-sixth month anniversaries of the grant date. The Company has valued these options using the Black-Scholes option pricing model which resulted in a fair market value of $425,000, of which $145,920 has been recognized as expense for the six months ended January 31, 2017.

 

On November 4, 2016, the Company appointed Thomas T. Thomas to the Company’s Board of Directors (the “Board”) and granted Mr. Thomas options to purchase 35,000 shares of Common Stock exercisable on a cashless basis. Such options have an exercise price of $10.00, a term of 5 years and vest as follows: (i) 11,667 shares vest upon the uplisting of the Company to the NASDAQ Stock Market; (ii) 11,667 shares vest upon the cumulative funding of the Company of or in excess of $5,000,000 by institutional investors starting from November 4, 2016; and 11,666 shares vest upon the first submission of a New Drug Application to the U.S. Food and Drug Administration for one of Company’s products by Company itself or a Company licensee. The Company has valued these options using the Black-Scholes option pricing model which resulted in a fair market value of $220,116, of which $115,564 has been recognized as expense for the six months ended January 31, 2017.

 

On December 24, 2016, the Company granted options to purchase a total of 35,000 shares of Common Stock exercisable on a cashless basis to an employee. The options have an exercise price of $10.00 and a term of 10 years. The options vest as follows: 972 shares vest upon each of the first through twenty-eighth month anniversaries of the grant date; 973 shares vest upon each of the twenty-ninth through thirty-sixth month anniversaries of the grant date. The Company has valued these options using the Black-Scholes option pricing model which resulted in a fair market value of $219,450, of which $25,443 has been recognized as expense for the six months ended January 31, 2017.

 

The Company also recognized stock based compensation expense of $230,602 in connection with vested options granted in prior periods. 

 

The assumptions used in the valuation for all of the options granted for the six months ended January 31, 2017 and 2016 were as follows:

 

    2017     2016  
Market value of stock on measurement date     $ 5.61 to 8.71     $ 7.00  
Risk-free interest rate     0.88-2.55 %     2.05 %
Dividend yield     0 %     0 %
Volatility factor     112-348 %     373 %
Term     2.78-10.00 years       10 years  

 

11

 

 

Stock option activity for six months ended January 31, 2017 is presented in the table below:

 

    Number of
Shares
    Weighted-
average
Exercise
Price
    Weighted-
average
Remaining
Contractual
Term
(years)
    Aggregate
Intrinsic
Value
 
Outstanding at July 31, 2016     4,635,000       8.79       7.39     $ 2,731,250  
Granted     120,000       10.00                  
Outstanding at January 31, 2017     4,755,000       8.82       6.92     $ 4,243,250  
Exercisable at January 31, 2017     4,330,136       8.39       7.28     $ 4,243,250  

 

A summary of the status of the Company’s non-vested options as of January 31, 2017 and changes during the three months ended January 31, 2017 are presented below:

 

Non-vested options   Number of
Options
    Weighted Average
Grant Date
Fair Value
 
             
Non-vested at July 31, 2016     90,833     $ 7.27  
Granted     120,000       7.20  
Vested     (48,470 )     7.10  
Non-vested at January 31, 2017     162,363     $ 7.30  

 

At January 31, 2017, there was $795,321 of unrecognized compensation costs related to non-vested stock options.

 

Warrants

 

Warrant activity for the six months ended January 31, 2017 is presented in the table below:

 

    Number of
Shares
    Weighted-
average
Exercise
Price
    Weighted-
average
Remaining
Contractual
Term (years)
    Aggregate
Intrinsic
Value
 
Outstanding at July 31, 2016     1,215,385     $ 17.90       2.86     $ -  
Expired     (63,100 )     50.00                  
Outstanding at January 31, 2017     1,152,285     $ 16.15       2.50     $ 13,580  
Exercisable at January 31, 2017     427,285     $ 18.09       5.21     $ 13,580  

  

5. Commitments   

 

On December 18, 2014, the Company entered into a consulting agreement. Pursuant to the agreement, the consultant agreed to provide financial advisory services with regard to a licensing agreement. In exchange for these services, the Company incurred fixed fees of $225,000 and $75,000 during the years ended July 31, 2016 and 2015, respectively. The Company is also required to pay an additional fee equivalent to 3.75% of all amounts received by the Company pursuant to the licensing agreement in excess of $3,000,000, in perpetuity. Total fees incurred to the consultant pursuant to the agreement during the six months ended January 31, 2017 amounted to $551,099 (2016 - $209,251).

 

On April 25, 2016, the Company entered into a consulting agreement. Pursuant to the agreement, the consultant agreed to provide financial advisory services. In exchange for these services, the Company is required to pay a fee on all funding received by the Company as a result of assistance provided by the consultant. Pursuant to the agreement, the consultant’s fee will be equal to 5% of gross funding received by the Company up to $20,000,000 plus 3.5% of any proceeds received in excess of $20,000,000. Total fees incurred to the consultant pursuant to the agreement during the six months ended January 31, 2017 amounted to $687,500 (2016 - $0).

 

 

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On November 19, 2015, the Company issued 14,327 shares of unregistered Common Stock upon the execution of a binding letter of intent to agree to negotiate and enter into an exclusive license agreement and collaboration agreement (“LOI”) with a pharmaceutical company with certain desirable proprietary information. The shares issued in this transaction were valued using the stock price at issuance date and amounted to $120,347. Pursuant to the LOI, the Company is obligated to issue up to an additional 92,634 shares of unregistered Common Stock upon the occurrence of various milestones. A total of 3,582 shares had been issued as of July 31, 2016 due to achievement of certain milestones. On November 10, 2016, the Company issued an additional 14,327 shares of the unregistered Common Stock pursuant to the LOI. The shares issued in this transaction were valued using the stock price at issuance date and amounted to $85,103.

 

In October 2016, the Company in-licensed a heroin vaccine from Walter Reed Army Institute of Research. In consideration for the license the Company agreed to pay a royalty of 3% of net sales if the Company commercializes the vaccine, or 4% if the vaccine is sublicensed. In addition, the Company agreed to pay a minimum annual royalty of $10,000, as well as fixed payments of up to $715,672 if all of the specified milestones are met.

 

The Company leases office space in three locations. The Company’s headquarters are located on the 12 th Floor of 401 Wilshire Blvd., Santa Monica, CA 90401 for $5,056 per month. The lease with Premier Office Centers, LLC (“Premier”), as amended effective October 1, 2016, has an initial term of five months. On December 15, 2016, the Company entered into a new office license agreement (the “New Lease”) with Premier. The New Lease will be effective March 1, 2017, the date after which the term of the current lease with Premier expires. Pursuant to the terms of the New Lease, the Company will pay $5,157 per month to Premier. The New Lease has an initial term of 12 months and shall automatically renew for successive 12 month periods unless terminated by the Company at least 60 days prior to the termination date. Premier may terminate the New Lease for any reason upon 30 days’ notice to the Company.

 

The Company also leases office space in Suite 100 of 1180 North Town Center Drive, Las Vegas, NV 89144 for $299 per month. The lease with Regus Management Group, LLC expires on July 31, 2017.

 

Additionally, the Company leases office space in Euston Tower, L32 to L34, 286 Euston Road, London, England, NW1 3DP for a total of €1,932 for the initial five-month term ending March 31, 2017. The Company’s lease is with Euston Tower Serviced Offices Ltd.

 

6. Sale of Royalties

 

On December 13, 2016, the Company entered into a Purchase and Sale Agreement (the “Purchase Agreement”) with SWK Funding LLC (“SWK”) pursuant to which the Company sold, and SWK purchased, the Company’s right to receive, commencing on October 1, 2016, all Royalties arising from the sale by Adapt, pursuant to that certain License Agreement between the Company and Adapt, dated as of December 15, 2014, as amended (the “Adapt Agreement”), of NARCAN® (naloxone hydrochloride) Nasal Spray (“NARCAN®”) or any other Product, up to (i) $20,625,000 and then the Residual Royalty thereafter or (ii) $26,250,000, if Adapt has received in excess of $25,000,000 of cumulative Net Sales for any two consecutive fiscal quarters during the period from October 1, 2016 through September 30, 2017 from the sale of NARCAN® (the “Earn Out Milestone”), and then the Residual Royalty thereafter. The Residual Royalty is defined in the Purchase Agreement as follows: (i) if the Earn Out Milestone is paid, then SWK shall receive 10% of all Royalties; provided, however, if no generic version of NARCAN® is commercialized prior to the sixth anniversary of the Closing, then SWK shall receive 5% of all Royalties after such date, and (ii) if the Earn Out Milestone is not paid, then SWK shall receive 7.86% of all Royalties; provided, however, that if no generic version of NARCAN® is commercialized prior to the sixth anniversary of the Closing, then SWK shall receive 3.93% of all Royalties after such date. Under the Purchase Agreement, the Company received an upfront purchase price of $13,750,000 less $40,000 of legal fees at Closing, and will receive an additional $3,750,000 if the Earn Out Milestone is achieved (the “Purchase Price”). The Purchase Agreement also grants SWK (i) the right to receive the statements produced by Adapt pursuant to Section 5.6 of the Adapt Agreement and (ii) the right, to the extent possible under the Purchase Agreement, to cure any breach of or default under any Product Agreement by the Company. Under the Purchase Agreement, the Company granted SWK a security interest in the Purchased Assets in the event that the transfer contemplated by the Purchase Agreement is held not to be a sale. The Purchase Agreement also contains other representations, warranties, covenants and indemnification obligations that are customary for a transaction of this nature. Absent fraud by the Company, the Company’s indemnification obligations under the Purchase Agreement shall not exceed, individually or in the aggregate, an amount equal to the Purchase Price plus an annual rate of return of 12% (compounded monthly) as of any date of determination, with a total indemnification cap not to exceed 150% of the Purchase Price, less all Royalties received by SWK, without duplication, under the Purchase Agreement prior to and through resolution of the applicable claim. All capitalized terms not otherwise defined herein shall have the meanings ascribed to such terms in the Purchase Agreement. 

 

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During the six months ended January 31, 2017, the Company recognized proceeds of $13,710,000 as revenue immediately since 1) the executed agreement constituted persuasive evidence of an arrangement, (2) the Company has no current or future performance obligations, (3) the total consideration was fixed and known at the time of its execution and there were no rights of return, and (4) the cash was received and is non-refundable.

 

On December 15, 2014, in connection with the Purchase Agreement, the Company and Adapt entered into the Adapt Agreement which provides Adapt with a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment (the “Product”) in exchange for the Company receiving potential development and sales milestone payments of more than a total of $55 million plus up to double-digit royalties.

 

On December 13, 2016, the Company and Adapt entered into Amendment No. 1 to the Adapt Agreement (the “Amendment”) which amends the terms of the Adapt Agreement relating to the grant of a commercial sublicense outside of the Unites States and diligence efforts for commercialization of the Product. Under the terms of the Amendment, Adapt is required to use commercially reasonable efforts to commercialize the Product in the United States. In the event that Adapt wishes to grant a commercial sublicense to a third party in the European Union or the United Kingdom, the Company and Adapt have agreed to negotiate an additional amendment to the Adapt Agreement to include reduced financial terms with respect to the commercial sublicense in such territory. Under such terms, the Company would receive an escalating double-digit percentage of all net revenue received by Adapt from a commercial sublicensee in the European Union or the United Kingdom. Net revenue received by Adapt from a commercial sublicensee in European Union or the United Kingdom would be included in determining sales-based milestones due to the Company. 

  

7. Litigation

 

On January 3, 2017, the Company and Adapt Pharma, Inc. (“Adapt Inc.”) received notice from Teva Pharmaceuticals Industries Ltd. (“Teva Ltd.”) and Teva Pharmaceuticals USA, Inc., a wholly owned subsidiary of Teva Ltd. (“Teva USA” and, together with Teva Ltd., “Teva”), pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (the “January 2017 Notice Letter”), that Teva USA had filed Abbreviated New Drug Application (“ANDA”) No. 209522 (the “’747 ANDA”) with the United States Food and Drug Administration (“FDA”) seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray (“NARCAN®”) before the expiration of U.S. Patent No. 9,468,747 (the “’747 patent”). The ‘747 patent is listed with respect to NARCAN® in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluations publication (commonly referred to as the “Orange Book”) and expires on March 16, 2035. Teva’s January 2017 Notice Letter asserts that its generic product will not infringe the ‘747 patent or that the ‘747 patent is invalid or unenforceable. On February 8, 2017, Adapt Inc., Adapt Pharma Operations Limited (“Adapt”) and the Company (collectively, the “Plaintiffs”) filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva USA’s filing of the ‘747 ANDA with the FDA with respect to the ‘747 patent. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘747 ANDA be a date later than the expiration of the ‘747 patent, as well as equitable relief enjoining Teva from infringing the ‘747 patent and monetary relief as a result of any such infringement.

 

On September 15, 2016, the Company and Adapt received notice from Teva, pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), that Teva USA had filed ANDA No. 209522 (the “’253 ANDA”) with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of U.S. Patent No. 9,211,253 owned by the Company (the “’253 patent”). On October 21, 2016, the Plaintiffs filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva USA’s filing of the ‘253 ANDA with the FDA with respect to the ‘253 patent. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘253 ANDA be a date later than the expiration of the ‘253 patent, as well as equitable relief enjoining Teva from infringing the ‘253 patent and monetary relief as a result of any such infringement.

 

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8. Subsequent Events  

 

On February 3, 2017, the entered into an employment agreement with Phil Skolnick (the “Skolnick Employment Agreement”) whereby Mr. Skolnick will become the Company’s Chief Scientific Officer effective February 6, 2017.

 

The Skolnick Employment Agreement has an initial term of six (6) months. Following the initial term, the Skolnick Employment Agreement, unless otherwise terminated, shall extend on a month-to-month basis. Under the Skolnick Employment Agreement, Mr. Skolnick will (i) receive a one-time cash sign-on bonus of Forty Thousand Dollars ($40,000); (ii) receive a pro-rated annual base salary of Four Hundred Ten Thousand Dollars ($410,000); (iii) be eligible to earn an incentive bonus in an amount and structure as agreed upon by Mr. Skolnick and the Board, with achievement of such bonus to be determined in the sole discretion of the Board; and (iv) be granted options to purchase Two Hundred Thousand (200,000) shares of the Company’s common stock (the “Options”), each of which shall expire on the day that is the earlier of: (a) ninety (90) calendar days after Mr. Skolnick ceases to provide services to the Company, (b) ninety (90) calendar days after the expiration of the Skolnick Employment Agreement, (c) the date Mr. Skolnick is terminated or there is a Fundamental Transaction (as defined in the Skolnick Employment Agreement), each as contemplated in the Skolnick Employment Agreement, or (d) ten (10) years from the date of issuance. Each Option shall be exercisable on a cashless basis at an exercise price equal to $9.00. The Options shall vest as follows: (i) One Hundred Thousand (100,000) shares of common stock shall vest on the eighteenth month anniversary of the grant date; (ii) Five Thousand Five Hundred Fifty-Five (5,555) shares of common stock shall vest on each of the nineteenth, twentieth, twenty-first, twenty-second, twenty-third, twenty-fourth, twenty-fifth and twenty-sixth anniversaries of the date of grant; and (iii) Five Thousand Five Hundred Fifty-Six (5,556) shares of common stock shall vest on each of the twenty-seventh, twenty-eighth, twenty-ninth, thirtieth, thirty-first, thirty-second, thirty-third, thirty-fourth, thirty-fifth and thirty-sixth anniversaries of the grant date.

 

In addition, the Skolnick Employment Agreement provides for benefits if Mr. Skolnick’s employment is terminated under certain circumstances. In the event the Company terminates Mr. Skolnick’s employment for Cause (as defined in the Skolnick Employment Agreement), Mr. Skolnick will receive accrued but unpaid base salary and vacation through the date of termination of his employment (the “Termination Date”). In the event the Company terminates Mr. Skolnick’s employment or if Mr. Skolnick resigns within twelve (12) months of a Constructive Termination (as defined in the Skolnick Employment Agreement) of Mr. Skolnick’s employment, and in either case such termination is not for Cause, then the Company shall pay Mr. Skolnick the sum of: (i) accrued but unpaid base salary and vacation through the Termination Date; (ii) one (1) times his annual salary; and (iii) one (1) times his bonus cash compensation, excluding the signing bonus, awarded to Mr. Skolnick in 2017. In the event of such termination, all outstanding stock options, warrants, restricted share awards, performance grants held by Mr. Skolnick shall become fully vested and remain exercisable for the life of such award and shall not be forfeited for any reason whatsoever. In the event of a Fundamental Transaction, Mr. Skolnick shall be entitled to receive the sum of: (i) accrued but unpaid base salary and vacation through the Termination Date; (ii) one (1) times his annual salary; and (iii) one (1) times his bonus cash compensation, excluding the signing bonus, awarded to Mr. Skolnick in 2017. In the event of a Fundamental Transaction, all outstanding stock options, warrants, restricted share awards, performance grants held by Mr. Skolnick shall become fully vested and remain exercisable for the life of such award and shall not be forfeited for any reason whatsoever.

 

On March 13, 2017 (the “Effective Date”), the Company entered into a third amendment (the “Third Amendment”) to that certain Senior Advisor Agreement with Brad Miles, dated January 22, 2013 (the “Initial Agreement”), as previously amended on February 24, 2015 (the “First Amendment”) and March 19, 2015 (the “Second Amendment” and, together with the Initial Agreement, the First Amendment and the Third Amendment, the “Advisor Agreement”). Pursuant to the Third Amendment, and in consideration for Mr. Miles’ continued service to the Company as an advisor through December 31, 2017, the Company shall: (i) pay Mr. Miles, within 15 business days of the Effective Date, (x) a cash payment of $107,805, and (y) 1,875 shares of Common Stock; (ii) grant to Mr. Miles the right to receive, subject to adjustment per the terms of the Third Amendment, 1.25% of the Net Profit generated from the Product from the Effective Date (which amounts shall be paid quarterly per the terms of the Third Amendment), and, in the event of a Divestiture of the Company, 1.25% of the net proceeds of such sale, subject to adjustment per the terms of the Third Amendment, and, in the event of a sale of the Company, the Fair Market Value of the Product; (iii) pay Mr. Miles $17,000 per calendar quarter during 2017; and (iv) grant to Mr. Miles a warrant to purchase 45,000 shares of Common Stock (the “Warrant”). The Warrant is fully vested on the date of grant, has an exercise price of $10.00, an expiration date of three years from the date of grant and may be exercised solely by payment of cash. Additionally, pursuant to the Third Amendment, from the Effective Date until the fourth anniversary of the Effective Date, the Company shall have the right to buy back the Interest or any portion thereof from Mr. Miles upon written notice at a price of $187,500 per 1.25% of Interest (the “Buyback Amount”); provided, however, that, in the event that such written notice is provided within 2.5 years after the Effective Date, the Company shall pay Mr. Miles two times the Buyback Amount within ten business days after the provision of such notice; provided, further, that, in the event the Company provides such notice to Mr. Miles after 2.5 years after the Effective Date and prior to the four year anniversary of the Effective Date, the Company shall pay Mr. Miles 3.5 times the Buyback Amount within ten business days after the provision of such notice. Furthermore, pursuant to the Third Amendment, the Company is required to provide to Mr. Miles, following the end of each calendar year, an annual audit of Net Profit once the Product begins generating Net Profit. Capitalized terms not otherwise defined in this paragraph shall have the meanings ascribed to such terms in the Third Amendment.

 

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

 

The following discussion and analysis of the results of operations and financial condition for the three and six months ended January 31, 2017 and 2016 and should be read in conjunction with our financial statements, and the notes to those financial statements that are included elsewhere in this Report.

 

Overview

 

Opiant Pharmaceuticals, Inc. (“we”, “our” or the “Company”), a Nevada corporation, is a specialty pharmaceutical company which develops pharmacological treatments for substance use, addictive and eating disorders. The Company was incorporated in the State of Nevada on June 21, 2005 as Madrona Ventures, Inc. and, on September 16, 2009, the Company changed its name to Lightlake Therapeutics Inc. On January 28, 2016, the Company again changed its name to Opiant Pharmaceuticals, Inc. The Company’s fiscal year end is July 31.

 

The Company’s strategy is to develop pharmacological treatments for substance use, addictive and eating disorders based on the Company’s expertise using opioid antagonists. The Company has worked on developing a treatment for reversing opioid overdoses in collaboration with the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health (“NIH”). This treatment, now known as NARCAN® (naloxone hydrochloride) Nasal Spray (“NARCAN®”), was approved by the U.S. Food and Drug Administration (“FDA”) in November 2015, and is marketed by Adapt Pharma Operations Limited (“Adapt”), a wholly owned subsidiary of Adapt Pharma Limited, an Ireland-based pharmaceutical company.

 

The Company has not consistently attained profitable operations and has historically depended upon obtaining sufficient financing to fund its operations. The Company anticipates if revenues are not sufficient then additional funding will be required in the form of debt financing and/or equity financing from the sale of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and/or financings from the sale of interests in the Company’s prospective products and/or royalty transactions. However, the Company may not be able to generate sufficient revenues or raise sufficient funding to fund the Company’s operations.

 

The Company has not had a bankruptcy, receivership or similar proceeding. The Company has not had material reclassifications, mergers, consolidations, or purchase or sale of a significant amount of assets not in the ordinary course of business. The Company is required to comply with all regulations, rules and directives of governmental authorities and agencies applicable to the clinical testing and manufacturing and sale of pharmaceutical products.

 

In December 2014, the Company effected a one-for-one hundred reverse stock split of its Common Stock (the “1:100 Reverse Stock Split”) which decreased the number of shares of Common Stock issued and outstanding from approximately 182.0 million shares to approximately 1.82 million shares. Unless otherwise noted, all share amounts listed in this Report have been retroactively adjusted for the 1:100 Reverse Stock Split as if such stock split occurred prior to the issuance of such shares. Impacted amounts include but are not limited to shares of Common Stock issued and outstanding, stock options, shares reserved, exercise prices of warrants or options, and loss per share. There was no impact on preferred or Common Stock authorized resulting from the 1:100 Reverse Stock Split.

 

The Company developed NARCAN®, a treatment to reverse opioid overdoses, which was conceived, licensed, developed, approved by the FDA and commercialized in less than three years. The Company plans to replicate this relatively low cost, successful business strategy primarily through developing nasal opioid antagonists in the field of developing pharmacological treatments for substance use, addictive, and eating disorders. The Company aims to identify and progress drug development opportunities with the potential to file additional New Drug Applications (“NDA”) with the FDA within four years. The Company also plans to identify and progress drug development opportunities with potentially larger markets, potentially larger addressable patient populations and greater revenue potential. In addition, the Company plans to invest in long-term development opportunities by identifying early stage product candidates with novel modes of action.

 

The Company’s current pipeline of product candidates includes a treatment for Bulimia Nervosa (“BN”), a treatment for Binge Eating Disorder (“BED”), a treatment for Alcohol Use Disorder (“AUD”), a treatment for Cocaine Use Disorder (“CocUD”) and a heroin vaccine. The Company also is focused on other treatment opportunities.

 

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Principal Products or Services and Markets  

 

Opioid Overdose Reversal

 

Naloxone is a medicine that can reverse the overdose of prescription and illicit opioids and that historically has been available through injection. The Company’s intranasal delivery system of naloxone could widely expand its availability and use in preventing opioid overdose deaths.

 

On April 16, 2013, the Company entered into an agreement and subsequently received funding from an investor, Potomac Construction Limited (“Potomac”), in the amount of $600,000 for the research, development, marketing and commercialization of a product relating to the Company’s treatment to reverse opioid overdoses (the “Opioid Overdose Reversal Treatment Product”). In exchange for this funding, Potomac acquired a 6.0% interest (the “6.0% Potomac Interest”) in the “OORT Net Profit” generated from the product in perpetuity. “OORT Net Profit” is defined as any pre-tax profits received by the Company that was derived from the sale of the Opioid Overdose Reversal Treatment Product less any and all expenses incurred by and payments made by the Company in connection with the Opioid Overdose Reversal Treatment Product, including but not limited to an allocation of Company overhead based on the proportionate time, expenses and resources devoted by the Company to product-related activities, which allocation shall be determined in good faith by the Company. Potomac also has rights with respect to the 6.0% Potomac Interest if the Opioid Overdose Reversal Treatment Product is sold or the Company is sold.

 

On May 30, 2013, the Company entered into an agreement with Potomac and subsequently received additional funding totaling $150,000 for the research, development, marketing and commercialization of the Opioid Overdose Reversal Treatment Product. In exchange for this funding, Potomac acquired an additional 1.5% interest (the “1.5% Potomac Interest”) in the OORT Net Profit generated from the Opioid Overdose Reversal Treatment Product in perpetuity. Potomac also has rights with respect to the 1.5% Potomac Interest if the Opioid Overdose Reversal Treatment Product is sold or the Company is sold.

 

On March 14, 2014, the Company filed U.S. Provisional Application No. 61/953,379. This application addresses delivery devices and methods of treating opioid overdoses through the administration of intranasal naloxone.

 

On May 15, 2014, the Company entered into an agreement and subsequently received funding from an investor, Ernst Welmers (“Welmers”), in the amount of $300,000 for use by the Company for any purpose. In exchange for this funding, the Welmers acquired a 1.5% interest (the “1.5% Welmers Interest”) in the OORT Net Profit generated from the Opioid Overdose Reversal Treatment Product in perpetuity. Welmers also has rights with respect to the 1.5% Welmers Interest if the Opioid Overdose Reversal Treatment Product is sold or the Company is sold. If the Opioid Overdose Reversal Treatment Product was not approved by the FDA by May 15, 2016, Welmers would have had a 60 day option to exchange its 1.5% Welmers Interest for 37,500 shares of Common Stock of the Company. The Opioid Overdose Reversal Treatment Product was approved by the FDA on November 18, 2015, and, as a result, Welmers did not realize the option to exchange its 1.5% Welmers Interest for shares of Common Stock of the Company. During the year ended July 31, 2016, the Company recognized $300,000 as revenue because Welmers’ option to receive the shares of Common Stock was not realized, and the research and development work related to the Opioid Overdose Reversal Treatment Product was completed as of July 31, 2016.

 

On July 9, 2014, the Company filed U.S. Provisional Application No. 62/022,268 with respect to the Company’s treating opioid overdoses through the administration of intranasal naloxone.

 

On July 22, 2014, the Company received a $3,000,000 commitment from a foundation (the “Foundation”) which later assigned its interest to Valour Fund, LLC (“Valour”), from which the Company had the right to make capital calls from the Foundation for the research, development, marketing, commercialization and any other activities connected to the Opioid Overdose Reversal Treatment Product, certain operating expenses and any other purpose consistent with the goals of the Foundation. In exchange for funds invested by the Foundation, Valour currently owns a 6.0% interest in the OORT Net Profit (the “6.0% Valour Interest”) generated from the Opioid Overdose Reversal Treatment Product in perpetuity. Valour also has rights with respect to the 6.0% Valour Interest if the Opioid Overdose Reversal Treatment Product is sold or the Company is sold. Additionally, the Company may buy back, in whole or in part, the 6.0% Valour Interest within 2.5 years or after 2.5 years of the July 22, 2014 initial investment date at a price of two times or 3.5 times, respectively, the relevant investment amount represented by the interests to be bought back. If the Opioid Overdose Reversal Treatment Product was not approved by the FDA or an equivalent body in Europe for marketing and was not actually marketed by July 22, 2016, the Foundation would have had a 60 day option to receive shares of the Company’s Common Stock in lieu of the 6.0% Valour Interest in the Opioid Overdose Reversal Treatment Product at an exchange rate of 10 shares for every dollar of its investment. On July 28, 2014, the Company received an initial investment of $111,470 from the Foundation in exchange for a 0.22294% interest. On August 13, 2014, September 8, 2014, November 13, 2014 and February 17, 2015, the Company made capital calls of $422,344, $444,530, $1,033,614 and $988,042, respectively, from the Foundation in exchange for 0.844687%, 0.888906%, 2.067228% and 1.976085% interests, respectively, in the OORT Net Profit. The Opioid Overdose Reversal Treatment Product was approved by the FDA on November 18, 2015, and, as a result, the Foundation did not realize the option to exchange its 6.0% Valour Interest for shares of Common Stock of the Company. During the year ended July 31, 2016, the Company recognized $3,000,000 as revenue because the option to receive the shares of Common Stock was not realized, and the research and development work related to the Opioid Overdose Reversal Treatment Product was completed as of July 31, 2016.

 

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On September 9, 2014, the Company entered into an agreement with Potomac and subsequently received additional funding from Potomac in the amount of $500,000 for use by the Company for any purpose. In exchange for this funding, Potomac acquired an additional 0.98% interest in the OORT Net Profit (the “September 2014 0.98% Potomac Interest”) generated from the Opioid Overdose Reversal Treatment Product in perpetuity. Potomac also has rights with respect to the 0.98% Potomac Interest if the Opioid Overdose Reversal Treatment Product is sold or the Company is sold. Additionally, the Company may buy back, in whole or in part, the September 2014 0.98% Potomac Interest (i) within 2.5 years or (ii) after 2.5 years, but no later than four years, of the September 9, 2014 initial investment date, at a price equal to two times or 3.5 times, respectively, the relevant investment amount represented by the interests to be bought back. If the Opioid Overdose Reversal Treatment Product was not introduced to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months of the September 9, 2014 initial investment date, Potomac would have had a 60 day option to exchange the September 2014 0.98% Potomac Interest for 50,000 shares of Common Stock of the Company. The Opioid Overdose Reversal Treatment Product was approved by the FDA on November 18, 2015 and, as a result, Potomac did not realize the option to exchange the September 2014 0.98% Potomac Interest for 50,000 shares of Common Stock of the Company. During the year ended July 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of Common Stock was not realized, and the research and development work related to the Opioid Overdose Reversal Treatment Product was completed as of July 31, 2016.

 

On October 31, 2014, the Company entered into an agreement with Potomac and subsequently received additional funding from Potomac in the amount of $500,000 for use by the Company for any purpose. In exchange for this funding, Potomac acquired an additional 0.98% interest in the OORT Net Profit (the “October 2014 0.98% Potomac Interest”) generated from the Opioid Overdose Reversal Treatment Product in perpetuity. Potomac also has rights with respect to its October 2014 0.98% Potomac Interest if the Opioid Overdose Reversal Treatment Product is sold or the Company is sold. Additionally, the Company may buy back, in whole or in part, the October 2014 0.98% Potomac Interest from Potomac (i) within 2.5 years or (ii) after 2.5 years, but no later than four years, of the October 31, 2014 investment date at a price equal to two times or 3.5 times, respectively, the relevant investment amount represented by the interests to be bought back. If the Opioid Overdose Reversal Treatment Product was not introduced to the market and was not approved by the FDA or an equivalent body in Europe and not marketed by October 31, 2016, Potomac  would have had a 60 day option to exchange its October 2014 0.98% Potomac Interest for 50,000 shares of Common Stock of the Company. The Opioid Overdose Reversal Treatment Product was approved by the FDA on November 18, 2015 and, as a result, Potomac did not realize the option to exchange its October 2014 0.98% Potomac Interest for 50,000 shares of Common Stock of the Company. During the year ended July 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of Common Stock was not realized, and the research and development work related to the Opioid Overdose Reversal Treatment Product was completed as of July 31, 2016.

 

On December 15, 2014, the Company and Adapt entered into a license agreement (the “Adapt Agreement”). The Adapt Agreement has no set duration but may be terminated, among other ways, by Adapt in its sole discretion, either in its entirety or in respect of one or more countries, at any time by providing 60 days prior notice to the Company. Pursuant to the Adapt Agreement, Adapt received from the Company a global license to develop and commercialize the Company’s intranasal naloxone Opioid Overdose Reversal Treatment Product. In exchange for licensing its treatment to Adapt, the Company could receive total potential regulatory and sales milestone payments of more than $55 million, plus up to double-digit percentage royalties on net sales. The Adapt Agreement provided for an upfront and nonrefundable payment of $500,000, and monthly payments for up to one year for participation in joint development committee calls and the production and submission of an initial development plan. The Adapt Agreement also required the Company to contribute $2,500,000 of development, regulatory, and commercialization costs, some of which was credited for costs incurred by the Company prior to the execution of the Adapt Agreement. The Company fulfilled its requirement to contribute $2,500,000 during the three months ended October 31, 2015. Upon termination of the Adapt Agreement, (i) all rights granted by the Company thereunder shall immediately terminate; (ii) Adapt shall grant the Company an exclusive license, with the right to grant multiple tiers of sublicenses, under the “Adapt Applied Patents”, “Adapt Applied Know-How”, and Adapt’s rights under the “Joint Patents” and “Joint Know-How to Exploit Products” (as such terms in quotation marks are defined in the Adapt Agreement); (iii) Adapt shall assign to the Company, at Adapt’s expense, all of its right, title, and interest in and to all “Regulatory Approvals” applicable to any “Product”, and all “Regulatory Documentation” specific to such Regulatory Approvals then owned by Adapt or any of its “Affiliates”, and shall use “Commercially Reasonable Efforts” to cause any and all “Sublicensees” (as such terms in quotation marks are defined in the Adapt Agreement) to assign to the Company any such Regulatory Approvals and related Regulatory Documentation then owned by such Sublicensee; (iv) Adapt shall grant the Company an exclusive, license and right of reference, with the right to grant multiple tiers of sublicenses and further rights of reference, under all Regulatory Documentation (including any Regulatory Approvals) then owned or “Controlled” by Adapt or any of its Affiliates that are not assigned to the Company pursuant to (iii) above that are necessary or useful for the Company or any of its Affiliates or sublicensees to “Exploit” any Product and any improvement to any of the foregoing, as such Regulatory Documentation exists as of the effective date of such termination of the Adapt Agreement and Adapt shall use Commercially Reasonable Efforts to cause its “Commercial Sublicensees” (as such terms in quotation marks are defined in the Adapt Agreement) to grant comparable rights under all Regulatory Documentation (including any Regulatory Approvals) then owned or Controlled by such Commercial Sublicensees; (v) at the Company’s request, assign to the Company all right, title, and interest of Adapt in each “Product Trademark” (as defined in the Adapt Agreement) at Adapt’s expense; and (vi) at the Company’s request, assign to the Company all right, title, and interest in and to the “Development Data” (as defined in the Adapt Agreement) that Adapt is not precluded from disclosing or assigning to the Company pursuant to the terms of any applicable agreement with a “Third Party” (as defined in the Adapt Agreement); provided , however , that Adapt shall use Commercially Reasonable Efforts (which shall not include any obligation to expend money) to obtain the consent of the applicable Third Party for such disclosure and/or assignment in the event that Adapt is so precluded.

 

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On February 17, 2015, the Company announced that Adapt received “Fast Track” designation by the FDA.

 

On April 22, 2015, the Company announced that Adapt successfully completed a pharmacokinetic study of intranasal naloxone. This study had been designed and conducted by the Company in collaboration with NIDA. The pharmacokinetic study compared intranasal naloxone with an injectable formulation of naloxone. The study met its objectives and demonstrated the intranasal formulation of naloxone delivered the targeted naloxone dose as expected. 

 

On June 3, 2015, the Company announced that Adapt commenced a rolling submission of a NDA to the FDA for a nasal spray formulation of naloxone. A rolling submission allows completed portions of the NDA to be submitted and reviewed by the FDA on an ongoing basis.

 

On July 29, 2015, the Company announced that Adapt submitted a NDA to the FDA for NARCAN®, an investigational drug intended to treat opioid overdose.

 

On November 18, 2015, the FDA approved NARCAN® for the emergency treatment of known or suspected opioid overdose, to be marketed by Adapt.

 

On December 8, 2015, the Company entered into an agreement with Potomac to receive $500,000 for use by the Company for any purpose, which $500,000 was invested by December 18, 2015. In exchange for this funding, Potomac acquired an additional 0.75% interest in the OORT Net Profit (the “0.75% Potomac Interest”) generated from the Opioid Overdose Reversal Treatment Product in perpetuity. Potomac also has rights with respect to its 0.75% Potomac Interest if the Opioid Overdose Reversal Treatment Product is sold or the Company is sold. Additionally, the Company may buy back, in whole or in part, the 0.75% Potomac Interest, from Potomac (i) within 2.5 years or (ii) after 2.5 years, but no later than four years, of the December 8, 2015 initial investment date, at a price of two times or 3.5 times, respectively, the relevant investment amount represented by the interests to be bought back. Such buyback can be for a portion of the 0.75% Potomac Interest rather than for the entire interest. Potomac also had an option to invest an additional $1,000,000 by February 29, 2016 for use by the Company for any purpose in exchange for a 1.50% interest in the OORT Net Profit. If such investment were made, then Potomac also would have had rights with respect to its 1.50% interest if the Opioid Overdose Reversal Treatment Product was sold or the Company was sold. This investor option expired unexercised. During the year ended July 31, 2016, the Company recognized $500,000 as revenue because the investment did not contain any option to exchange the 0.75% Potomac Interest for shares of Common Stock of the Company, and the research and development work related to the Opioid Overdose Reversal Treatment Product was completed as of July 31, 2016.

 

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On December 15, 2015, the Company announced that it received a $2 million milestone payment from Adapt. This milestone payment was triggered by the FDA approval of NARCAN® (naloxone hydrochloride) Nasal Spray.

 

On January 19, 2016, the Company announced that Adapt announced that it has reached an agreement to facilitate the purchase of NARCAN® by offering its discounted public interest price to 62,000 agencies in state and local government and the non-profit sector. Adapt, in partnership with the National Association of Counties, National Governors Association, National League of Cities, and United States Conference of Mayors, will offer NARCAN® at a discounted public interest price of $37.50 per dose ($75 for a 2 pack carton) through the U.S. Communities Purchasing Alliance and Premier, Inc. Adapt’s discounted public interest price has been available to qualifying group purchasers, such as law enforcement, firefighters, first responders, departments of health, local school districts, colleges and universities and community-based organizations.

 

On January 27, 2016, the Company announced that Adapt announced two national programs at the Clinton Health Matters Initiative Activation Summit to assist in efforts to address the growing risk of opioid overdose among American high school students. Adapt offered a free carton of NARCAN® to all high schools in the U.S. through the state departments of education. This program will collaborate with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, as part of its work to scale naloxone access efforts nationally. In addition, Adapt has provided a grant to the National Association of School Nurses (NASN) to support their educational efforts concerning opioid overdose education materials.

 

On March 7, 2016, the Company announced the receipt of a $2.5 million milestone payment from Adapt. This milestone payment was triggered by the first commercial sale of NARCAN® in the U.S.

 

On April 29, 2016, the Company received $105,097 in royalty payments due from Adapt from commercial sales of NARCAN® in the U.S during the first quarter of Adapt’s fiscal year.

 

On August 8, 2016, the Company received $234,498 in royalty payments due from Adapt from commercial sales of NARCAN® in the U.S during the second quarter of Adapt’s fiscal year.

 

On May 6, 2016, the Company announced that Adapt submitted a new drug submission (NDS) for NARCAN® to Health Canada.

 

On September 15, 2016, the Company and Adapt received notice from Teva Pharmaceuticals USA, Inc. (“Teva”), pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (the “September 2016 Notice Letter”), that Teva had filed an Abbreviated New Drug Application No. 209522 (“’253 ANDA”) with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of U.S. Patent No. 9,211,253 (the “’253 patent”). The ‘253 patent is listed with respect to NARCAN® in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluation publication (commonly referred to as the “Orange Book”) and expires on March 16, 2035. Teva’s September 2016 Notice Letter asserts that its generic product will not infringe the ‘253 patent or that the ‘253 patent is invalid or unenforceable. The Company and Adapt have been evaluating Teva’s September 2016 Notice Letter. The Company has full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘253 patent will be vigorously defended from any infringement. The Company may receive additional notice letters from Teva and other companies seeking to market generic versions of NARCAN® in the future and, after evaluation, the Company may commence patent infringement lawsuits against such companies.

 

On October 5, 2016, the Company announced that Health Canada approved Adapt’s naloxone hydrochloride nasal spray to treat opioid overdose, to be marketed as NARCAN® Nasal Spray.

 

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On October 21, 2016, Adapt, Adapt Pharma Inc. and the Company (collectively, the “Plaintiffs”) filed a complaint for patent infringement against Teva and Teva Pharmaceuticals Industries Ltd. (collectively, the “Defendants”) in the U.S. District Court for the District of New Jersey arising from Teva’s U.S.’s filing of the ‘253 ANDA with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘253 ANDA be a date later than the expiration of the ‘253 patent, as well as equitable relief enjoining the Defendants from infringing the ‘253 patent and monetary relief as a result of any such infringement. The Company maintains full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘253 patent will continue to be vigorously defended from any infringement.

 

On October 27, 2016, the Company announced that its patent for NARCAN® is now listed in the FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, patent number 9468747.

 

On November 3, 2016, the Company received $524,142 in royalty payments in royalty payments due from Adapt from commercial sales of NARCAN® in the U.S during the third quarter of Adapt’s fiscal year.  

 

On December 13, 2016, the Company entered into a Purchase and Sale Agreement (the “Purchase Agreement”) with SWK Funding LLC (“SWK”) pursuant to which the Company sold, and SWK purchased, the Company’s right to receive, commencing on October 1, 2016, all Royalties arising from the sale by Adapt, pursuant to the Adapt Agreement, of NARCAN® or any other Product, up to (i) $20,625,000 and then the Residual Royalty thereafter or (ii) $26,250,000, if Adapt has received in excess of $25,000,000 of cumulative Net Sales for any two consecutive fiscal quarters during the period from October 1, 2016 through September 30, 2017 from the sale of NARCAN® (the “Earn Out Milestone”), and then the Residual Royalty thereafter. The Residual Royalty is defined in the Purchase Agreement as follows: (i) if the Earn Out Milestone is paid, then SWK shall receive 10% of all Royalties; provided, however, if no generic version of NARCAN® is commercialized prior to the sixth anniversary of the Closing, then SWK shall receive 5% of all Royalties after such date, and (ii) if the Earn Out Milestone is not paid, then SWK shall receive 7.86% of all Royalties; provided, however, that if no generic version of NARCAN® is commercialized prior to the sixth anniversary of the Closing, then SWK shall receive 3.93% of all Royalties after such date. Under the Purchase Agreement, the Company received an upfront purchase price of $13,750,000 less $40,000 of legal fees at Closing, and will receive an additional $3,750,000 if the Earn Out Milestone is achieved (the “Purchase Price”). The Purchase Agreement also grants SWK (i) the right to receive the statements produced by Adapt pursuant to Section 5.6 of the Adapt Agreement and (ii) the right, to the extent possible under the Purchase Agreement, to cure any breach of or default under any Product Agreement by the Company. Under the Purchase Agreement, the Company granted SWK a security interest in the Purchased Assets in the event that the transfer contemplated by the Purchase Agreement is held not to be a sale. The Purchase Agreement also contains other representations, warranties, covenants and indemnification obligations that are customary for a transaction of this nature. Absent fraud by the Company, the Company’s indemnification obligations under the Purchase Agreement shall not exceed, individually or in the aggregate, an amount equal to the Purchase Price plus an annual rate of return of 12% (compounded monthly) as of any date of determination, with a total indemnification cap not to exceed 150% of the Purchase Price, less all Royalties received by SWK, without duplication, under the Purchase Agreement prior to and through resolution of the applicable claim. All capitalized terms not otherwise defined in this paragraph shall have the meanings ascribed to such terms in the Purchase Agreement.

 

In addition, on December 13, 2016, in connection with the Purchase Agreement, the Company and Adapt entered into Amendment No. 1 to the Adapt Agreement (the “Amendment”) which amends the terms of the Adapt Agreement relating to the grant of a commercial sublicense outside of the U.S and diligence efforts for commercialization of the Company’s intranasal-naloxone opioid overdose reversal treatment (the “Product”). Under the terms of the Amendment, Adapt is required to use commercially reasonable efforts to commercialize the Product in the U.S. In the event that Adapt wishes to grant a commercial sublicense to a third party in the European Union or the United Kingdom, the Company and Adapt have agreed to negotiate an additional amendment to the Adapt Agreement to include reduced financial terms with respect to the commercial sublicense in such territory. Under such terms, the Company would receive an escalating double-digit percentage of all net revenue received by Adapt from a commercial sublicensee in the European Union or the United Kingdom. Net revenue received by Adapt from a commercial sublicensee in European Union or the United Kingdom would be included in determining sales-based milestones due to the Company. 

 

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On January 3, 2017, the Company and Adapt received notice from Teva pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (the “January 2017 Notice Letter”), that Teva had filed ANDA No. 209522 (the “’747 ANDA”) with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of U.S. Patent No. 9,468,747 (the “’747 patent”). The ‘747 patent is listed with respect to NARCAN® in the Orange Book and expires on March 16, 2035. Teva’s January 2017 Notice Letter asserts that its generic product will not infringe the ‘747 patent or that the ‘747 patent is invalid or unenforceable. The Company and Adapt have been evaluating Teva’s January 2017 Notice Letter. The Company has full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘747 patent will be vigorously defended from any infringement.

 

On January 26, 2017, the Company announced that the FDA has approved the 2mg formulation of NARCAN® for opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.

 

On February 8, 2017, the Plaintiffs filed a complaint for patent infringement against the Defendants in the U.S. District Court for the District of New Jersey arising from Teva’s U.S.’s filing of the ‘747 ANDA with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘747 ANDA be a date later than the expiration of the ‘747 patent, as well as equitable relief enjoining the Defendants from infringing the ‘747 patent and monetary relief as a result of any such infringement. The Company has full confidence in its intellectual property portfolio related to NARCAN® (naloxone hydrochloride) Nasal Spray and expects that the ‘747 patent will continue to be vigorously defended from any infringement.

 

On March 9, 2017, the Company announced that the U.S. Patent and Trademark Office issued U.S. Patent Numbers 9,480,644 and 9,561,177 covering methods of use for NARCAN®. These patents are listed in the FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

 

Bulimia Nervosa

 

Bulimia Nervosa (“BN”) is an eating disorder characterized by binging and purging, and is most common in young women. BN is thought to be significantly under-recognized. According to Hudson, JI, Hirpi, E, Pope, HG, et al. (The Prevalence and Correlates of Eating Disorders in National Comorbidity Survey Replication. Biol Psychiatry. 2—7;61:348-358), in the U.S., the lifetime prevalence of BN is 1% to 2%. Patients with BN have a 94.5% comorbidity with other psychiatric illnesses. For example, approximately 50% have major depressive episodes, and 33.7% engage in substance abuse. In extreme cases patients can develop life-threatening complications such as acute pancreatitis from repeat purging.

 

The only medication currently approved for BN is Prozac (fluoxetine). Only with a high dose do patients have a reduction in binge eating of 67% and vomiting of 56%. Only 50% of patients respond to this treatment.

 

The Company plans to evaluate the use of a nasal opioid antagonist to treat this condition. The Company aims to initiate a study before May 1, 2017.

 

Binge Eating Disorder

 

The Company is developing a treatment for BED. BED is defined in the American Psychiatric Association’s (APA) fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (“DSM-5”) chapter on feeding and eating disorders as a diagnosis for individuals who experience persistent, recurrent episodes of overeating, marked by loss of control and significant clinical distress. DSM-5 is used by clinicians and researchers to diagnose and classify mental disorders in order to improve diagnoses, treatment and research.

 

BED is the most common eating disorder in the U.S. Approximately eight million Americans are diagnosed with BED and it is correlated with obesity. In addition, according to the APA, BED is associated with significant physical and psychological problems.”

 

In 2015, Shire PLC received FDA approval to use Vyvanse to treat BED in adults. The Company considers naloxone to be a potentially compelling drug for the pharmacological treatment of BED. It has a well-known safety profile and has the potential to block the reward that patients experience from bingeing.

 

On May 23, 2013, the Company presented the results of the Company’s Phase 2 clinical trial of its nasal spray treatment for BED at the APA Annual Meeting in San Francisco.

 

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On December 17, 2013, the Company entered into an agreement with Potomac and subsequently received additional funding from Potomac totaling $250,000 for use by the Company for any purpose. In exchange for this funding, Potomac acquired a 0.5% interest in the Company’s BED treatment product (the “BED Treatment Product”) and 0.5% of the BED Net Profit in perpetuity (the “2013 0.5% Potomac Interest”). “BED Net Profit” is defined as the pre-tax profit generated from the BED Treatment Product after the deduction of all expenses incurred by and payments made by the Company in connection with the BED Treatment Product, including but not limited to an allocation of Company overhead. Although the BED Treatment Product was not approved by the FDA by December 17, 2016, Potomac’s 60 day option to exchange its entire 2013 0.5% Potomac Interest for 31,250 shares of Common Stock of the Company expired on February 17, 2017. 

 

On September 17, 2014, the Company entered into an agreement with Potomac and subsequently received funding totaling $500,000 for use by the Company for any purpose. In exchange for this funding, Potomac acquired an additional 1.0% interest in the Company’s BED Treatment Product and 1.0% of the BED Net Profit generated from the BED Treatment Product in perpetuity (the “1.0% Potomac Interest”). If the BED Treatment Product is not approved by the FDA by September 17, 2017, Potomac will have a 60 day option to exchange its entire 1.0% Potomac Interest for 62,500 shares of Common Stock of the Company.

 

On July 20, 2015, the Company entered into an agreement with Potomac and subsequently received additional funding from Potomac in the amount of $250,000 for use by the Company for any purpose. In exchange for this funding, the Potomac acquired an additional 0.50% interest in the BED Net Profit (the “2015 0.5% Potomac Interest”) generated from the BED Treatment Product in perpetuity. Potomac also has rights with respect to the 2015 0.5% Potomac Interest if the BED Treatment Product is sold or the Company is sold. If the product is not introduced to the market and not approved by the FDA or an equivalent body in Europe and not marketed by July 20, 2018, Potomac will have a 60 day option to exchange the 2015 0.5% Potomac Interest for 25,000 shares of Common Stock of the Company.

 

The Company now aims to collaborate with other parties and progress its drug development program for BED.

 

Alcohol Use Disorder

 

The Company has been focused on developing an opioid antagonist-based treatment, OPNT002, for the treatment of AUD. According to The Substance Abuse and Mental Health Services Administration (SAMHSA), there are approximately 17 million people in the U.S. who suffer from some form of AUD. While certain current therapies for AUD have limited efficacy and low levels of adherence, opioid antagonists have an established record of safety and efficacy, especially in AUD.

 

The Company has generated Phase 1 clinical data with OPNT002, demonstrating its rapid intranasal absorption. The Company expects that OPNT002 will be highly differentiated from other AUD therapies by being used on an ‘as needed’ basis, which represents a significant potential advancement in the treatment of AUD.

 

On February 28, 2017, the Company announced that it received supportive feedback from the FDA on a proposed development plan for OPNT002 for the treatment of AUD. The feedback was received pursuant to a recent Type B meeting with the FDA.

 

The Company plans to advance OPNT002 into additional clinical trials during 2017.

 

Cocaine Use Disorder

 

The Company has been conducting pilot studies to explore the potential of a nasal opioid antagonist as a treatment for CocUD. There are approximately 1.5 million current cocaine users in the U.S., as reported by SAMHSA. There are no FDA-approved pharmacological treatments for CocUD.

 

Cocaine is a strong central nervous system stimulant that increases levels of the neurotransmitter dopamine in brain circuits regulating pleasure and movement, with the opioid system strongly linked to the dopamine reward circuitry.

 

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The extraordinary cost of cocaine addiction, financially, medically and socially, is directly related to relapse: up to 80% of addicted individuals relapse within six months of treatment.

 

On December 23, 2015, the Company announced that an opioid antagonist drug will be tested in patients with CocUD at the University of Pennsylvania. The study has been conducted by the Department of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania, and began recruitment in December 2015. Funded by a Medications Development Centers of Excellence Cooperative (U54) Program from NIDA, the study uses functional Magnetic Resonance Imaging (fMRI) to better understand the impact of an opioid antagonist drug in the brain of patients with CocUD. Using an opioid antagonist and blocking the downstream release of dopamine through blocking the release of endorphins may reduce the reward patients receive from cocaine use.

 

Heroin Vaccine

 

Opioid addiction is a major global health issue, particularly in the U.S., where opioid painkiller abuse and subsequent addiction has become widespread and driven the increase in prevalence. As these painkillers have become more expensive, undergone tighter controls for distribution, and abuse deterrent formulations have become available, there has been an increase in heroin use, which is cheaper and often easier to obtain than painkillers.

 

Current FDA-approved treatments for heroin addiction are based on methadone-based and buprenorphine-based substitution therapies, and the use of naltrexone depot injections. With respect to these substitution therapies, patients still take opioid-based treatments, which for many is undesirable, and there is frequently diversion and misuse of these treatments amongst addicts. With respect to naltrexone depot injections, patients must undergo detoxification before initiating treatment, which for several patients severely limits compliance and willingness to undergo this method of treatment. Therefore, being able to provide a vaccine to patients that potentially provides specific immunity against heroin and its metabolites without the need for prior detoxification and enabling patients to remain opioid-free is an attractive solution.

 

In October 2016, the Company in-licensed a heroin vaccine from Walter Reed Army Institute of Research (“Walter Reed”). This is an early stage pre-clinical asset, based on adjuvant technology, and requires further pre-clinical research before human testing. The Company plans to work alongside Walter Reed scientists to advance the program into the clinic and to determine whether the product is viable in a heroin addict population.

 

Other Activities

 

On December 1, 2014, the Company and Aegis Therapeutics, LLC (“Aegis”), entered into a Material Transfer, Option and Research License Agreement (the “Aegis Agreement”) that provides the Company with an exclusive royalty-free research license for a period of time to Aegis’ proprietary delivery enhancement and stabilization agents, including Aegis’ ProTek® and Intravail® technologies (collectively, the “Technology”) to enable the Company to conduct a feasibility study of opioid antagonists when used with the Technology (the “Study”). During this period of time, the Company may also evaluate its interest in having an exclusive license to the Technology for use with opioid antagonists to treat, diagnose, predict, detect or prevent any disease, disorder, state, condition or malady in humans (the “Possible License”). Aegis has granted the Company an exclusive option to obtain the Possible License for a certain period after the study is completed. In consideration of the license granted to the Company pursuant to the Aegis Agreement, the Company is required to pay to Aegis a nonrefundable study fee.

 

On October 6, 2015, the Company entered into an amendment to the Aegis Agreement. This amendment had an effective date of May 19, 2015 and allowed the Company to evaluate the Technology through August 17, 2015. The amendment also provided an opportunity for the Company to elect to further extend the period of time during which the Company could evaluate the Technology through February 13, 2016. In exchange for electing to further extend this period of time, the Company paid Aegis $75,000 and issued 13,697 shares of the Company’s Common Stock. The shares issued in this transaction were using the stock price at issuance date and amounted to $106,152. During February 2016, the Company elected to further extend the period of time during which the Company could evaluate Aegis’ Technology through August 11, 2016. During February 2016, the Company paid Aegis $75,000 and issued 10,746 shares of the Company’s Common Stock. The shares issued in this transaction were using the stock price at issuance date and amounted to $106,385. On April 26, 2016, the Company entered into the Restated Aegis Agreement (as defined below).

 

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On April 26, 2016, the Company and Aegis entered into the Amended and Restated Material Transfer, Option and Research License Agreement (the “Restated Aegis Agreement”) which amended and restated in its entirety the Aegis Agreement. Under the Restated Aegis Agreement, the Company has been granted an exclusive royalty-free research license to Aegis’ Technology for a period of time (the “Compound Research Period”), to enable the Company to conduct a feasibility study of opioid antagonists when used with the Technology and evaluate the Company’s interest in licensing the Technology through use of a “Compound” (as defined in the Restated Aegis Agreement) in additional studies.

 

The Company agreed to pay Aegis (i) an aggregate of $300,000, of which the Company may elect to pay up to 50% by issuing shares of the Company’s Common Stock to Aegis, with the number of shares to be issued equal to 75% of the average closing price of the Company’s Common Stock over the 20 trading days preceding the date of payment as consideration for extending the Compound Research Period pursuant to two separate extension payments of $150,000 each, and (ii) 50,000 shares of Common Stock as partial consideration for entering into the Restated Aegis Agreement. The Company exercised such extensions through payment of the first and second extension fees prior to October 13, 2015 and prior to February 13, 2016, respectively. The Restated Aegis Agreement shall expire on the earlier of (i) the expiration of the “Opiant Negotiation Periods” (as defined in the Restated Aegis Agreement) and (ii) on 30 days’ prior written notice by the Company; provided , however , that Aegis shall have the right to terminate the license granted in the event the Company does not pursue commercially reasonable efforts to exploit a “Product”, defined as (i) pharmaceutical formulations containing the Compound as an active ingredient and (ii) Aegis’s proprietary chemically synthesizable excipient(s), including without limitation the Intravail® excipients pharmaceutical formulations containing certain ingredients of Aegis’ proprietary technology.

 

During the term of the Restated Aegis Agreement, the Company has a right of first refusal and option to add any, or all of the “Additional Compounds” (as defined in the Restated Aegis Agreement), which the Company may exercise at any time upon written notice to Aegis. The Company has granted Aegis a co-exclusive license with the Company to use the data from the Company’s Studies under the Restated Aegis Agreement for certain purposes. Pursuant to the Restated Aegis Agreement, Aegis granted the Company an exclusive option (the “Opiant Option”) to obtain an exclusive, worldwide, royalty-bearing license (with the right to grant sublicenses through multiple tiers) under Aegis’s interests in the Technology and any “Joint Invention” (as such term is defined in the Restated Aegis Agreement) to the Technology to research, develop, make, have made, use, sell, offer for sale, and import products containing the Compound or an Additional Compound. The Company may exercise such Opiant Option with respect to the Compounds by written notice to Aegis within 90 days of the completion of the Study for (i) the Compounds or (ii) the Additional Compounds. In the event the Company exercises the Opiant Option, the parties have 120 days to negotiate and execute a definitive license agreement. The terms of such license agreement have been contemplated and agreed upon by the parties under a letter agreement dated April 26, 2016 (the “Letter Agreement”). In the event the Company exercises the Opiant Option specific to the “Opioid Field” (as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis an additional $100,000 fee and any such products in the Opioid Field shall be subject to the same milestones, royalties and other monetary obligations set forth in the Letter Agreement and summarized below.

 

Under the Letter Agreement containing the terms of such license, the Company will pay Aegis development milestones for the Products ranging from $250,000 to $4,000,000. Additionally, commencing on the first anniversary and through the first Product approval, the Company is required to make minimum quarterly nonrefundable payments to Aegis in the amount of $25,000 (the “Quarterly Payments”), which Quarterly Payments are fully creditable and treated as a prepayment against future milestones or royalties. During the “Royalty Term” (as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis royalties (the “Aegis Royalties”) on annual net sales of Products ranging from (A) low single digits for Products with an aggregate annual “Net Sales” (as defined in Exhibit 1 to the Letter Agreement) during a calendar year of $50 million or less to (B) mid-single digits for Products with Net Sales of greater than $1 billion. Such Aegis Royalties are subject to reduction as provided in Exhibit 1 to the Restated Agreement but shall not be reduced by more than 50% of the regularly scheduled royalty payment. The Restated Aegis Agreement expired by its terms during the three months ended January 31, 2017 and Aegis and the Company are actively negotiating a new agreement.

 

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On September 22, 2015, the Company received a $1,600,000 commitment from the Foundation which later assigned its interest to Valour, from which the Company had the right to make capital calls from the Foundation for the research, development, any other activities connected to the Company’s opioid antagonist treatments for addictions and related disorders that materially rely on certain studies funded by the Foundation’s investment, excluding the Opioid Overdose Reversal Treatment Product (the “Certain Studies Products”), certain operating expenses, and any other purpose consistent with the goals of the Foundation. In exchange for funds invested by the Foundation, Valour currently owns a 2.1333% interest in the Certain Studies Products Net Profit (the “2.1333% Valour Interest”). The “Certain Studies Net Profit” is defined as any pre-tax revenue received by the Company that was derived from the sale of the Certain Studies Products less any and all expenses incurred by and payments made by the Company in connection with the Certain Studies Products, including but not limited to an allocation of Company overhead based on the proportionate time, expenses and resources devoted by the Company to Certain Studies Product-related activities, which allocation shall be determined in good faith by the Company. Valour also has rights with respect to its 2.1333% Valour Interest if the Certain Studies Product is sold or the Company is sold. Additionally, the Company may buy back, in whole or in part, the 2.1333% Valour Interest from Valour within 2.5 years or after 2.5 years of the initial investment at a price of two times or 3.5 times, respectively, the relevant investment amount represented by the interests to be bought back. If an aforementioned treatment is not introduced to the market by September 22, 2018, Valour will have a 60 day option to exchange its 2.1333% Valour Interest for shares of the Common Stock of the Company at an exchange rate of one-tenth of a share for every dollar of its investment. On October 2, 2015, December 23, 2015, and May 28, 2016, the Company made capital calls of $618,000, $715,500 and $266,500 from the Foundation in exchange for 0.824%, 0.954% and 0.355333% interests in the aforementioned treatments, respectively. The Company will defer recording revenue until such time as Valour’s option expires or milestones are achieved that eliminates Valour’s right to exercise the option. Upon expiration of the exercise option, the deliverables of the arrangement will be reviewed and evaluated under Accounting Standards Codification (ASC) 605. In the event Valour chooses to exchange its 2.1333% Valour Interest, in whole or in part, for shares of Common Stock of the Company, that transaction will be accounted for similar to a sale of shares of Common Stock for cash. 

 

On February 17, 2016, the Company announced the convening of a medical advisory board meeting to discuss its development programs in substance use, addictive and eating disorders. The Company has held other medical advisory board meetings, including on April 28, 2015, April 19, 2016 and September 14, 2016.

 

On November 4, 2016, the Registrar of Companies of England and Wales certified that Opiant Pharmaceuticals UK Limited (“OPUK”) was incorporated under the Companies Act of 2006 as a private company. OPUK is a wholly-owned subsidiary of the Company and Kevin Pollack, Chief Financial Officer, Director, Secretary and Treasurer of the Company, serves as Director of the OPUK.

 

On December 15, 2016, the Company entered into a new office license agreement (the “New Lease”) with Premier Office Centers, LLC (“Premier”) for its headquarters located on the 12th Floor of 401 Wilshire Blvd., Santa Monica, CA 90401. The New Lease became effective on March 1, 2017, the date after which the term of the prior lease with Premier expired. Pursuant to the terms of the New Lease, the Company will pay $5,157.40 per month to Premier. The New Lease has an initial term of 12 months and shall automatically renew for successive 12 month periods unless terminated by the Company at least 60 days prior to the termination date. Premier may terminate the New Lease for any reason upon 30 days’ notice to the Company.

 

On January 31, 2017, the Company announced that the Company’s Board of Directors (the “Board”) has established an Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee. Copies of the Committee charters, along with the Company’s Code of Business Conduct and Ethics, can be found on the Investor Relations section of the Company’s website.

 

On February 6, 2017, the Company announced its entry into an employment agreement with Phil Skolnick (the “Skolnick Employment Agreement”) on February 3, 2017 whereby Mr. Skolnick became the Company’s Chief Scientific Officer effective February 6, 2017.

 

The Skolnick Employment Agreement has an initial term of six (6) months. Following the initial term, the Skolnick Employment Agreement, unless otherwise terminated, shall extend on a month-to-month basis. Under the Skolnick Employment Agreement, Mr. Skolnick will (i) receive a one-time cash sign-on bonus of Forty Thousand Dollars ($40,000); (ii) receive a pro-rated annual base salary of Four Hundred Ten Thousand Dollars ($410,000); (iii) be eligible to earn an incentive bonus in an amount and structure as agreed upon by Mr. Skolnick and the Board, with achievement of such bonus to be determined in the sole discretion of the Board; and (iv) be granted options to purchase Two Hundred Thousand (200,000) shares of the Company’s common stock (the “Options”), each of which shall expire on the day that is the earlier of: (a) ninety (90) calendar days after Mr. Skolnick ceases to provide services to the Company, (b) ninety (90) calendar days after the expiration of the Skolnick Employment Agreement, (c) the date Mr. Skolnick is terminated or there is a Fundamental Transaction (as defined in the Skolnick Employment Agreement), each as contemplated in the Skolnick Employment Agreement, or (d) ten (10) years from the date of issuance. Each Option is exercisable on a cashless basis at an exercise price equal to $9.00. The Options shall vest as follows: (i) One Hundred Thousand (100,000) shares of common stock shall vest on the eighteenth month anniversary of the grant date; (ii) Five Thousand Five Hundred Fifty-Five (5,555) shares of common stock shall vest on each of the nineteenth, twentieth, twenty-first, twenty-second, twenty-third, twenty-fourth, twenty-fifth and twenty-sixth anniversaries of the date of grant; and (iii) Five Thousand Five Hundred Fifty-Six (5,556) shares of common stock shall vest on each of the twenty-seventh, twenty-eighth, twenty-ninth, thirtieth, thirty-first, thirty-second, thirty-third, thirty-fourth, thirty-fifth and thirty-sixth anniversaries of the grant date.

 

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In addition, the Skolnick Employment Agreement provides for benefits if Mr. Skolnick’s employment is terminated under certain circumstances. In the event the Company terminates Mr. Skolnick’s employment for Cause (as defined in the Skolnick Employment Agreement), Mr. Skolnick will receive accrued but unpaid base salary and vacation through the date of termination of his employment (the “Termination Date”). In the event the Company terminates Mr. Skolnick’s employment or if Mr. Skolnick resigns within twelve (12) months of a Constructive Termination (as defined in the Skolnick Employment Agreement) of Mr. Skolnick’s employment, and in either case such termination is not for Cause, then the Company shall pay Mr. Skolnick the sum of: (i) accrued but unpaid base salary and vacation through the Termination Date; (ii) one (1) times his annual salary; and (iii) one (1) times his bonus cash compensation, excluding the signing bonus, awarded to Mr. Skolnick in 2017. In the event of such termination, all outstanding stock options, warrants, restricted share awards, performance grants held by Mr. Skolnick shall become fully vested and remain exercisable for the life of such award and shall not be forfeited for any reason whatsoever. In the event of a Fundamental Transaction, Mr. Skolnick shall be entitled to receive the sum of: (i) accrued but unpaid base salary and vacation through the Termination Date; (ii) one (1) times his annual salary; and (iii) one (1) times his bonus cash compensation, excluding the signing bonus, awarded to Mr. Skolnick in 2017. In the event of a Fundamental Transaction, all outstanding stock options, warrants, restricted share awards, performance grants held by Mr. Skolnick shall become fully vested and remain exercisable for the life of such award and shall not be forfeited for any reason whatsoever.

 

Competition

 

The Company faces competition from other companies focused on pharmacological treatments for substance use, addictive and eating disorders. Some of these companies are larger and better-funded than the Company and there are no assurances that the Company can effectively compete with these competitors. Potential competitors include Indivior PLC, Alkermes PLC, H. Lundbeck A/S, Shire PLC, Camurus AB, Orexo AB, BioDelivery Services International, Inc., Titan Pharmaceuticals Inc., Cerecor Inc. In 2015, Shire PLC received FDA approval to use Vyvanse to treat BED in adults.

 

With respect to NARCAN®, the Company faces competition from other treatments, including injectable naloxone, auto-injectors and improvised nasal kits. Amphastar Pharmaceuticals, Inc. competes with NARCAN® with their naloxone injection. Kaléo competes with NARCAN® with their auto-injector known as EVZIO™ (naloxone HCl injection) Auto-Injector. In 2015, Indivior PLC received a Complete Response Letter from the FDA with respect to a naloxone nasal spray. In 2016, Teva filed the ‘253 ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of the ‘253 patent. In 2017, the Company received notice that Teva filed the ‘747 ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of the ‘747 patent. In 2016, Mundipharma AG announced its European Union regulatory submission for Nyxoid®, an intranasal naloxone spray for the reversal of opioid overdoses. In 2017, Amphastar Pharmaceuticals, Inc. received a Complete Response Letter from the FDA with respect to a naloxone nasal spray. Although NARCAN® was the first FDA-approved naloxone nasal spray for the emergency reversal of opioid overdoses and has advantages over certain other treatments, the Company expects the treatment to face additional competition.

 

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Results of Operations

 

The following compares Opiant’s operations during the three months ended January 31, 2017 to the same period at January 31, 2016.

 

Revenues

 

The Company generated $13,535,000 and $6,860,000 of revenue during the three months ended January 31, 2017 and 2016, respectively. This increase of $6,675,000 during the three months ended January 31, 2017 was primarily due to the Company recognizing net revenue of $13,710,000 from the sale to SWK of the Company’s right to receive, commencing on October 1, 2016, Royalties (as defined in the Purchase Agreement) arising from the Adapt Agreement between the Company and Adapt. The revenue received during the three months ended January 31, 2017 was decreased by revenue accrued for October 2016 which was assigned to SWK.

 

During the three months ended January 31, 2016, the Company recognized $4,800,000 of revenue from the sale of net profit interests in the Company’s treatment to reverse opioid overdoses. The revenue from these sales was recognized during the three months ended January 31, 2016 because either the investment did not contain an option to exchange net profit interests for shares or the product was approved by the FDA and marketed, which negated the investor’s option to exchange net profit interests for shares, and the research and development work related to the product was completed as of January 31, 2016. The Company also recognized $2,060,000 of revenue derived from the Adapt Agreement during the period ended January 31, 2016, which included $2,000,000 received as a result of the FDA’s approval of NARCAN® for the emergency treatment of known or suspected opioid overdose, one of the milestones set forth in the Adapt Agreement.

 

General and Administrative Expenses

  

The Company’s general and administrative expenses were $1,355,704 and $2,394,505 during the three months ended January 31, 2017 and 2016, respectively. This decrease of $1,038,801 was primarily due to a decrease in management compensation and consulting expenses. Management compensation decreased as a result of management meeting milestones and incurring bonuses during the three months ended January 31, 2016. The Company did not incur additional management compensation during the three months ended January 31, 2017. 

 

Research and Development Expenses

 

The Company’s research and development expenses were $344,836 and $254,881 during the three months ended January 31, 2017 and 2016, respectively. Research and development costs incurred during the three months ended January 31, 2017 increased by $89,955 compared to the three months ended January 31, 2016 as a result of increased research and development activity, including with respect to the Company’s BN study and the AUD treatment.

 

Selling Expenses

 

The Company’s selling expenses were $1,196,563 and $209,251 during the three months ended January 31, 2017 and 2016, respectively. The increase in revenues of $987,312 during the three months ended January 31, 2017 resulted in $987,312 of additional selling expenses due to expenses related to the sale of Royalties (as defined in the SWK Agreement) to SWK under the Purchase Agreement.

 

Interest Expense

 

During the three months ended January 31, 2017, the Company earned net interest income of $877 compared to net interest expense of $5,491 during the three months ended January 31, 2016. During the three months ended January 31, 2017, the reduction of net interest expense of $6,368 was primarily a result of a reduction in debt outstanding which resulted in a decrease in interest expense incurred and increased cash on hand which increased interest revenue earned.

 

Net Income

 

Net income during the three months ended January 31, 2017 and during the three months ended January 31, 2016 was $10,649,790 and $3,970,040, respectively. This increase in net income of $6,679,750 was due primarily to the increase in revenues as a result of the sale of Royalties (as defined in the SWK Agreement) to SWK under the Purchase Agreement.

 

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The following compares Opiant’s operations during the six months ended January 31, 2017 to the same period at January 31, 2016.

 

Revenues

 

The Company generated $14,656,142 and $6,980,000 of revenue during the six months ended January 31, 2017 and 2016, respectively. This increase of $7,676,142 was primarily due to the Company recognizing net revenue of $13,710,000 from the sale to SWK of the Company’s right to receive, commencing on October 1, 2016, Royalties (as defined in the Purchase Agreement) arising from the sale by Adapt, pursuant to that certain Adapt Agreement between the Company and Adapt. The Company also recognized $946,142 of revenue derived from the Adapt Agreement with Adapt prior to the sale of such Royalties. The revenue received during the six months ended January 31, 2017 was decreased by revenue accrued for October 2016 which was assigned to SWK.

 

During the six month period ended January 31, 2016, the Company recognized $4,800,000 of revenue from the sale of net profit interests in the Company’s treatment to reverse opioid overdoses. The revenue from these sales was recognized during the six months ended January 31, 2016, because either the investment did not contain an option to exchange net profit interests for shares or the product was approved by the FDA and marketed, which negated the investor’s option to exchange net profit interests for shares, and the research and development work related to the product was completed as of January 31, 2016. The Company also recognized $2,180,000 of revenue derived from the License Agreement during the six months ended January 31, 2016, which included $2,000,000 received as a result of the FDA’s approval of NARCAN® for the emergency treatment of known or suspected opioid overdose, one of the milestones set forth in the Adapt Agreement.

 

General and Administrative Expenses

  

The Company’s general and administrative expenses were $2,572,006 and $12,990,324 during the six months ended January 31, 2017 and 2016, respectively. This decrease of $10,418,318 was primarily due to a decrease in stock-based compensation, as the Company recorded $610,152 of stock-based compensation during the six months ended January 31, 2017 as compared to $10,622,874 during the six months ended January 31, 2016. A decrease in management compensation and consulting expenses also contributed to the decrease in general and administrative expenses. This overall decrease in general and administrative expenses was offset by an increase in professional fees. 

 

Research and Development Expenses

 

The Company’s research and development expenses were $786,670 and $879,892 during the six months ended January 31, 2017 and 2016, respectively. Research and development costs incurred during the six months ended January 31, 2017 decreased by $93,222 compared to the six months ended January 31, 2016 as a result of a decrease in common shares issued for research and development expenses.

 

Selling Expenses

 

The Company’s selling expenses were $1,238,599 and $209,251 during the six months ended January 31, 2017 and 2016, respectively. The increase in revenues of $1,029,348 during the six months ended January 31, 2017 resulted in additional selling expenses during the period related to the sale of Royalties (as defined in the Purchase Agreement) to SWK.

 

Interest Expense

 

During the six months ended January 31, 2017, interest expense decreased to $1,367 from $11,319 during the six months ended January 31, 2016. During the three months ended January 31, 2017, the reduction of interest expense of $9,952 was primarily a result of a reduction in debt outstanding which resulted in a decrease in interest expense incurred and increased cash on hand which increased interest revenue earned.  

 

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Net Income (Loss)

 

The net income for the six months ended January 31, 2017, was $10,049,162. Net loss for the six months ended January 31, 2016 was $7,139,977. The increase in net income of $17,189,139 was due primarily to the increase in revenue and a decrease in general and administrative expenses, particularly stock-based compensation during the six months ended January 31, 2017. In particular the increase in net income was due primarily to the increase in revenues as a result of the sale of Royalties (as defined in the Purchase Agreement) to SWK. This increase in net income was offset by an increase in selling expenses during the six months ended January 31, 2017.

 

The Company has not consistently attained profitable operations and has historically depended upon obtaining sufficient financing to fund its operations. In their report on the Company’s financial statements at July 31, 2016, contained in the Company’s Annual Report on Form 10-K for the year ended July 31, 2016, as filed with the SEC on October 28, 2016, the Company’s auditors raised substantial doubt about the Company’s ability to continue as a going concern.

 

Liquidity and Capital Resources

 

The Company’s cash balance at January 31, 2017 was $12,925,829 plus $7,046,501 of outstanding liabilities. The Company’s management believes that the Company’s current cash balance is sufficient to fund the Company’s current operations through at least March 2018. The Company will need to generate sufficient revenues and/or seek additional funding in the future. The Company currently does not have a specific plan of how it will obtain such funding; however, the Company anticipates that additional funding will be in the form of debt financing and/or equity financing from the sale of the Company’s Common Stock and/or financings from the sale of interests in the Company’s prospective products and/or in the royalty transactions. Such funds may also be derived pursuant to the terms of the Adapt Agreement, subject to the terms of the Purchase Agreement with SWK.

 

During the year ended July 31, 2016, the Company received $1,600,000 in funding from the Foundation in exchange for Certain Studies Products Net Profit interests as related to the Company’s opioid antagonist treatments for addictions and related disorders that materially rely on certain studies funded by the foundation’s investment, excluding the Opioid Overdose Reversal Treatment Product. This investment increased the cash position of the Company. The Company expects to continue to issue debt and/or equity and/or sell interests in the Company’s prospective products and/or enter into royalty transactions to sustain the implementation of the Company’s business plan, unless sufficient revenues are generated. During the quarter ended January 31, 2017, the Company received $13,710,000 of funding pursuant to the terms of the Purchase Agreement with SWK. During the quarter ended January 31, 2017, the Company received no other funding in exchange for interests in the Company’s Opioid Overdose Reversal Treatment Product, BED treatment, or Certain Studies Products.

 

At this time, the Company believes it has sufficient cash on hand to meet its obligations over the next twelve months.  The Company does not have any arrangements in place for any future financing. The Company has no material commitments for capital expenditures as of January 31, 2017.

 

The financial position of the Company at January 31, 2017 showed an increase in total assets from July 31, 2016 of $1,881,878 to $13,000,859 at January 31, 2017. This was due primarily to an increase in cash as a result of the sale of Royalties (as defined in the SWK Agreement) to SWK. This was offset by a decrease in royalties receivable at the period end as the Company was no longer receiving royalties from Adapt pursuant to the Adapt Agreement. Total liabilities at January 31, 2017 increased to $7,046,501 from $6,586,834 at July 31, 2016. This increase was the result of an increase in accounts payable and accrued liabilities.

 

Plan of Operation

 

During the fiscal year ending July 31, 2017, the Company aims to broaden the Company’s product pipeline and anticipates commencing further trials based on the Company’s existing as well as potential patents.

 

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After certain obligations with respect to the Purchase Agreement with SWK are satisfied, the Company anticipates receiving revenues pursuant to the Adapt Agreement. Pursuant to the Adapt Agreement, in exchange for licensing its treatment to Adapt, the Company could receive total potential development and sales milestone payments of more than $55 million, plus up to double-digit royalties. On November 18, 2015, the FDA approved NARCAN® for the emergency treatment of known or suspected opioid overdose, to be marketed by Adapt. On December 15, 2015, the Company announced that it received a $2 million milestone payment from Adapt. This milestone payment was triggered by the FDA approval of NARCAN®. On March 7, 2016, the Company announced the receipt of a $2.5 million milestone payment from Adapt. This milestone payment was triggered by the first commercial sale of NARCAN® in the U.S. On October 6, 2016, the Company received $500,000 from Adapt as a regulatory milestone payment pursuant to the Adapt Agreement. This payment was triggered by the Health Canada approval of NARCAN®. Pursuant to the Adapt Agreement, the Company also has received royalty payments. On April 29, 2016, the Company received $105,097 in royalty payments due from Adapt from commercial sales of NARCAN® in the U.S during the first calendar quarter of 2016. On August 8, 2016, the Company received $234,498 in royalty payments due from Adapt from commercial sales of NARCAN® in the U.S during the second calendar quarter of 2016. On November 3, 2016, the Company received $524,142 in royalty payments due from Adapt from commercial sales of NARCAN® in the U.S during the third calendar quarter of 2016.

 

The Company plans to evaluate the use of a nasal opioid antagonist to treat BN. The Company aims to initiate a study before May 1, 2017. The Company also plans to advance OPNT002, for the treatment of AUD, into additional clinical trials during 2017, aims to collaborate with other parties and progress its drug development program for BED, and has focused on developing a treatment for CocUD and a heroin vaccine.

 

Critical Accounting Policies and Estimates

 

The Company believes that the following critical policies affect the Company’s more significant judgments and estimates used in preparation of the Company’s financial statements.

 

The Company prepares its financial statements in conformity with generally accepted accounting principles in the United States of America. These principals require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management believes that these estimates are reasonable and have been discussed with the Board; however, actual results could differ from those estimates.

 

The Company issues restricted stock to consultants for various services and employees for compensation. Cost for these transactions are measured at the fair value of the consideration received or the fair value of the equity instruments issued, whichever is measurable more reliably measurable. The value of the Common Stock is measured at the earlier of: (i) the date at which a firm commitment for performance by the counterparty to earn the equity instruments is reached or (ii) the date at which the counterparty's performance is complete.

 

The Company issues options and warrants to consultants, directors, and officers as compensation for services. These options and warrants are valued using the Black-Scholes model, which focuses on the current stock price and the volatility of moves to predict the likelihood of future stock moves. This method of valuation is typically used to accurately price stock options and warrants based on the price of the underlying stock.

 

Long-lived assets such as property, equipment and identifiable intangibles are reviewed for impairment whenever facts and circumstances indicate that the carrying value may not be recoverable. When required impairment losses on assets to be held and used are recognized based on the fair value of the asset. The fair value is determined based on estimates of future cash flows, market value of similar assets, if available, or independent appraisals, if required. If the carrying amount of the long-lived asset is not recoverable from its undiscounted cash flows, an impairment loss is recognized for the difference between the carrying amount and fair value of the asset. When fair values are not available, the Company estimates fair value using the expected future cash flows discounted at a rate commensurate with the risk associated with the recovery of the assets. The Company did not recognize any impairment losses for any periods presented. 

 

Fair value estimates used in preparation of the financial statements are based upon certain market assumptions and pertinent information available to management. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values. These financial instruments include cash, accounts payable, note payable and due to related parties. Fair values were assumed to approximate carrying values for these financial instruments since they are short-term in nature and their carrying amounts approximate fair values or they are receivable or payable on demand.

 

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Revenue Recognition

 

The Company recognizes revenues from nonrefundable, up-front license fees related to collaboration agreements, on a straight-line basis over the contracted or estimated period of performance. The period of performance over which the revenues are recognized is typically the period over which the research and/or development is expected to occur or manufacturing services are expected to be provided. When the period of performance is based on the period over which research and/or development is expected to occur, the Company is required to make estimates regarding drug development and commercialization timelines. Because of the many risks and uncertainties associated with the development of drug candidates, these estimates regarding the period of performance may change.

 

In addition, the Company evaluates each arrangement to determine whether or not it qualifies as a multiple-deliverable revenue arrangement under ASC 605-25. If one or more of the deliverables have a standalone value, then the arrangement would be separated into multiple units of accounting. This normally occurs when the R&D services could contractually and feasibly be provided by other vendors or if the customer could perform the remaining R&D itself, and when the Company has no further obligations and the right has been conveyed. When the deliverables cannot be separated, any initial payment received is treated like an advance payment for the services and recognized over the performance period, as determined based on all of the items in the arrangement. This period is usually the expected research and development period.

 

The Company recognizes revenue from milestone payments upon achievement of the milestones and when the Company has no further involvement or obligation to perform services, as related to that specific element of the arrangement, provided the milestone is meaningful, and provided that collectability is reasonably assured and other revenue recognition criteria are met.

 

The Company recognizes revenue from royalty revenue when the Company has fulfilled the terms of the contractual agreement and has no material future obligation, other than inconsequential and perfunctory support, and the amount of the royalty fee is determinable and collection is reasonably assured.

 

The Company recognizes revenue from the sale of royalties when the executed agreement constitutes persuasive evidence of an arrangement, the Company has no current or future performance obligations, the total consideration is fixed and known, there are no rights of return, collection is reasonably assured and fees are non-refundable.

 

Licensing Agreement

 

On December 15, 2014, the Company entered into the Adapt Agreement with Adapt. Pursuant to the Adapt Agreement, the Company provided a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment, now known as NARCAN®. In exchange for licensing its treatment, the Company received a nonrefundable, upfront license fee of $500,000 in December 2014. The Company also received a monthly fee for one year for participation in joint development committee calls and the production and submission of an initial development plan. The initial development plan was completed and submitted in May 2015. Management evaluated the deliverables of this arrangement and determined that the licensing deliverable had a standalone value and therefore, the payments were recognized as revenue.

 

The Company could also receive additional payments upon reaching various sales and regulatory milestones as well as royalty payments for commercial sales of NARCAN generated by Adapt. During the year ended July 31, 2016, the Company received $4,500,000 of milestone payments and recognized royalty revenues of approximately $418,000 pursuant to the Adapt Agreement. During the six months ended January 31, 2017, the Company recognized royalty payments of approximately $946,000 pursuant to the Adapt Agreement.

 

In addition, pursuant to the Adapt Agreement, the Company is required to contribute $2,500,000 of development, regulatory and commercialization costs, some of which was credited for costs incurred by the Company prior to the execution of the Adapt Agreement. At July 31, 2016 and January 31, 2017, the Company had contributed the full $2,500,000.

 

The Company recognizes revenue for fees related to participation in the initial development plan and joint development calls as revenue once the fee is received and the Company has performed the required services for the period. 

 

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Treatment Investments

 

With respect to investments in interests in treatments, if an agreement provides an option that allows the investor in the treatment to convert an interest in a treatment into shares of Common Stock of the Company, then revenue is deferred until such time that the option expires or milestones are achieved that eliminate the investor’s right to exercise the option. Upon expiration of the exercise option, the deliverables of the arrangement are reviewed and evaluated under ASC 605. In the event the investor chooses to convert interests into shares of Common Stock, that transaction will be accounted for similar to a sale of shares of Common Stock for cash. 

 

Off-Balance Sheet Arrangements

 

The Company has no off-balance sheet arrangements. 

 

Recent Accounting Pronouncements

 

The Company has reviewed accounting pronouncements and interpretations thereof that have effectiveness dates during the periods reported and in future periods. The Company has carefully considered the new pronouncements that alter previous generally accepted accounting principles and does not believe that any new or modified principles will have a material impact on the Company’s reported financial position or operations in the near term. The applicability of any standard is subject to the formal review of the Company’s financial management and certain standards are under consideration. Those standards have been addressed in the notes to the audited financial statement and in this, the Company’s Quarterly Report, filed on Form 10-Q for the period ended January 31, 2017.

 

Item 3.          Quantitative and Qualitative Disclosures About Market Risk.

 

The Company is not required to provide the information required by this Item because the Company is a smaller reporting company.

 

Item 4.          Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

Under the supervision and with the participation of the Company’s management, including the Company’s principal executive officer and the principal financial officer, the Company has conducted an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures, as defined in Rule 13a-15(e) under the Exchange Act, as of January 31, 2017. Based on this evaluation, the Company’s principal executive officer and principal financial officer concluded as of January 31, 2017 that the Company’s disclosure controls and procedures were not effective due to the following material weaknesses: 

 

a)           Lack of proper segregation of duties due to limited personnel.

 

b)           Lack of a formal review process related to financial reporting that includes multiple levels of review.

 

The Company’s management is committed to improving the Company’s internal controls and will: (1) continue to use third party specialists to address shortfalls in staffing and to assist the Company with accounting and finance responsibilities; and (2) increase the frequency of independent reconciliations of significant accounts which will mitigate the lack of segregation of duties until there are sufficient personnel.

 

The Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, have discussed the material weakness noted above with the Company’s independent registered public accounting firm. Due to the nature of this material weakness, there is a more than remote likelihood that misstatements which could be material to the annual or interim financial statements could occur that would not be prevented or detected.

 

On January 29, 2017, the Board established an Audit Committee to oversee the engagement of the Company’s independent registered public accounting firm, review its audited financial statements, meet with its independent registered public accounting firm to review internal controls and review its financial plans. The Audit Committee currently consists of Thomas T. Thomas, who is the Chairperson, Ann MacDougall and Geoffrey Wolf, each of whom has been determined by the Board to be independent as that term is defined under the applicable independence listing standards of the Nasdaq Stock Market. Mr. Thomas is an “audit committee financial expert” as the term is defined under SEC regulations. The Audit Committee operates under a written charter. Both the Company’s independent registered public accounting firm and internal financial personnel will regularly meet with the Audit Committee and have unrestricted access to the Audit Committee.

 

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Changes in Internal Control over Financial Reporting

 

Except as described above in connection with the establishment of the Company’s Audit Committee, there were no changes in the Company’s internal control over financial reporting that occurred during the three months ended January 31, 2017 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

PART II— OTHER INFORMATION

 

Item 1.            Legal Proceedings.

 

On September 15, 2016, the Company and Adapt received the Notice Letter from Teva, pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), that Teva had filed the ‘253 ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of the ’253 patent. The ‘253 patent is listed with respect to NARCAN® in the FDA’s Orange Book and expires on March 16, 2035. Teva’s September 2016 Notice Letter asserts that its generic product will not infringe the ‘253 patent or that the ‘253 patent is invalid or unenforceable. The Company and Adapt have been evaluating Teva’s September 2016 Notice Letter. The Company has full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘253 patent will be vigorously defended from any infringement. The Company may receive additional notice letters from Teva and other companies seeking to market generic versions of NARCAN® in the future and, after evaluation, the Company may commence patent infringement lawsuits against such companies.

 

On October 21, 2016, the Plaintiffs filed a complaint for patent infringement against the Defendants in the U.S. District Court for the District of New Jersey arising from Teva’s U.S.’s filing of the ‘253 ANDA with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘253 ANDA be a date later than the expiration of the ‘253 patent, as well as equitable relief enjoining the Defendants from infringing the ‘253 patent and monetary relief as a result of any such infringement. The Company maintains full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘253 patent will continue to be vigorously defended from any infringement. There can be no assurances that the Company will be successful with respect to this litigation matter. Such a failure may have a material impact on the Company and its business operations in the future.

 

On January 3, 2017, the Company and Adapt received the January 2017 Notice Letter from Teva pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), that Teva had filed the ‘747 ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of the ’747 patent. The ‘747 patent is listed with respect to NARCAN® in the Orange Book and expires on March 16, 2035. Teva’s January 2017 Notice Letter asserts that its generic product will not infringe the ‘747 patent or that the ‘747 patent is invalid or unenforceable. The Company and Adapt have been evaluating Teva’s January 2017 Notice Letter. The Company has full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘747 patent will be vigorously defended from any infringement.

 

On February 8, 2017, the Plaintiffs filed a complaint for patent infringement against the Defendants in the U.S. District Court for the District of New Jersey arising from Teva’s U.S.’s filing of the ‘747 ANDA with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘747 ANDA be a date later than the expiration of the ‘747 patent, as well as equitable relief enjoining the Defendants from infringing the ‘747 patent and monetary relief as a result of any such infringement. The Company has full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘747 patent will continue to be vigorously defended from any infringement.

 

Except as described above, the Company is currently not involved in any litigation that the Company believes could have a materially adverse effect on the Company’s financial condition or results of operations. Except as described above, there is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or other body pending or, to the knowledge of the executive officers of the Company or any of the Company’s subsidiaries, threatened against or affecting the Company, the Company’s Common Stock, any of the Company’s subsidiaries or the Company’s or the Company’s subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.

 

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Item 1A.        Risk Factors.

 

Risks Related to the Company

 

The Company has generated limited revenue to date and expect to incur significant operating losses for the foreseeable future.

 

The Company was incorporated on June 21, 2005. The Company operates as a specialty pharmaceutical company which develops pharmacological treatments for substance use, addictive and eating disorders. The Company has generated limited revenues from inception through the date of this Report. The likelihood of the Company’s future success must be considered in light of the problems, expenses, difficulties, complications and delays often encountered in connection with the clinical trials that will be conducted and on the development of new solutions to common addictions and related disorders. These potential problems include, but are not limited to, unanticipated clinical trial delays, poor data, changes in the regulatory and competitive landscape and additional costs and expenses that may exceed current budget estimates. In order to complete certain clinical trials and otherwise operate pursuant to the Company’s current business strategy, the Company anticipates that it will incur increased operating expenses. In addition, the Company expects to incur significant losses for the foreseeable future and the Company also expects to experience negative cash flow for the foreseeable future as the Company funds the Company’s operating losses and capital expenditures. The Company recognizes that if the Company is unable to generate sufficient revenues or source funding, the Company will not be able to continue operations as currently contemplated, complete planned clinical trials or achieve profitability. The Company’s failure to achieve or maintain profitability will also negatively impact the value of the Company’s securities. There is no history upon which to base any assumption as to the likelihood that the Company will prove successful. If the Company is unsuccessful in addressing these risks, then the Company will most likely fail.

 

The Company’s independent auditor has issued an audit opinion for the Company in connection with the Company’s audited financial statements as of July 31, 2016 which includes a statement describing the company’s going concern status. The Company’s financial status creates a doubt whether the Company will continue as a going concern.

 

Based on the Company’s financial history since inception, the Company’s independent registered public accounting firm expressed substantial doubt as to the Company’s ability to continue as a going concern in connection with the Company’s audited financial statements as of July 31, 2016. The Company has generated limited revenue to date. The Company has not consistently attained profitable operations and has historically depended upon obtaining sufficient financing and generating limited revenues to fund its operations. The Company anticipates that its revenues will not be sufficient to support its current operations and additional funding will be required in the form of debt financing and/or equity financing and/or financings from the sale of interests in the Company’s prospective products and/or royalty transactions. Despite its best efforts, the Company may not be able to generate sufficient revenues or raise sufficient funding to fund the Company’s operations. If the Company is unable to achieve the foregoing, then the Company may be unable to continue operating as currently planned or to continue as a going concern.

 

The Company may not succeed in completing the development of the Company’s product candidates, commercializing the Company’s products, and generating significant revenues.

 

The Company’s pipeline includes a treatment for BED, a treatment for BN, a treatment for AUD, a treatment for CocUD, a heroin vaccine and additional treatment applications. The Company’s products have generated limited revenues. The Company’s ability to generate significant revenues and achieve profitability depends on the Company’s ability to successfully complete the development of its product candidates, obtain market approval, successfully launch its products and generate significant revenues. On December 15, 2014, the Company and Adapt entered into the Adapt Agreement that provides Adapt with a global license to develop and commercialize the Company’s intranasal naloxone Opioid Overdose Reversal Treatment Product, now known as NARCAN®. The loss for any reason of Adapt as a key partner could have a significant and adverse impact on the Company’s business. If the Company is unable to retain Adapt as a partner on commercially acceptable terms, the Company may not be able to commercialize the Company’s treatment as planned and the Company may experience delays in or suspension of the marketing of the treatment.

 

The future success of the Company’s business cannot be determined at this time, and the Company does not anticipate generating significant revenues from product sales for the foreseeable future. Notwithstanding the foregoing, the Company expects to generate revenues from NARCAN®, for which the Company is dependent on many factors, including the performance of the Company’s licensing partner Adapt and competition in the market. In addition, the Company has no experience in commercializing its treatments on its own and faces a number of challenges with respect to its commercialization efforts, including, among other challenges, that:

 

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the Company may not have adequate financial or other resources to complete the development of its product candidates;

 

the Company may not be able to manufacture its products in commercial quantities, at an adequate quality, at an acceptable cost or in collaboration with third parties;

 

The Company may experience delays or unplanned expenditures in product development, clinical testing or manufacturing;

 

the Company may not be able to establish adequate sales, marketing and distribution channels;

 

healthcare professionals and patients may not accept the Company’s treatments;

 

the Company may not be aware of possible complications from the continued use of its products since the Company has limited clinical experience with respect to the actual use of its products;

 

technological breakthroughs in reversing opioid overdoses and treating patients with BED, BN, AUD, CocUD and heroin addiction may reduce the demand for the Company’s products;

 

  changes in the market for reversing opioid overdoses and treating patients with BED, BN, AUD, CocUD and heroin addiction, new alliances between existing market participants and the entrance of new market participants may interfere with the Company’s market penetration efforts;

 

third-party payors may not agree to reimburse patients for any or all of the purchase price of the Company’s products, which may adversely affect patients’ willingness to purchase the Company’s products;

 

uncertainty as to market demand may result in inefficient pricing of the Company’s products;

 

the Company may face third party claims of intellectual property infringement;

 

the Company may fail to obtain or maintain regulatory approvals for its products in the Company’s target markets or may face adverse regulatory or legal actions relating to its products even if regulatory approval is obtained; and

 

the Company is dependent upon the results of clinical studies relating to its products and the products of its competitors. If data from a clinical trial is unfavorable, the Company would be reluctant to advance the specific product for the indication for which it was being developed.

 

If the Company is unable to meet any one or more of these challenges successfully, the Company’s ability to effectively commercialize its products could be limited, which in turn could have a material adverse effect on its business, financial condition and results of operations.

 

Given the Company’s lack of significant revenue and cash flow, the Company will need to raise additional capital, which may be unavailable to the Company or, even if consummated, may cause dilution or place significant restrictions on the Company’s ability to operate.

 

Since the Company may be unable to generate sufficient revenue or cash flow to fund its operations for the foreseeable future, the Company will need to seek additional equity or debt financing to provide the capital required to maintain or expand its operations. The Company may also need additional funding to continue the development of its product candidates, build its sales and marketing capabilities, promote brand identity or develop or acquire complementary technologies, assets and companies, as well as for working capital requirements and other operating and general corporate purposes.

 

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The Company does not currently have any arrangements or credit facilities in place as a source of funds, and there can be no assurance that the Company will be able to raise sufficient additional capital if needed on acceptable terms, or at all. If such financing is not available on satisfactory terms, or is not available at all, the Company may be required to delay, scale back or eliminate the development of its product candidates and other business opportunities and its ability to achieve its business objectives, its competitiveness and its operations and financial condition may be materially adversely affected. The Company’s inability to fund its business could thus lead to the loss of your investment.

 

If the Company raises additional capital by issuing equity securities and/or equity-linked securities, the percentage ownership of the Company’s existing stockholders may be reduced, and accordingly these stockholders may experience substantial dilution. The Company may also issue equity securities and/or equity-linked securities that provide for rights, preferences and privileges senior to those of its Common Stock. Given the Company’s need for cash and that equity and equity-linked issuances are very common types of fundraising for companies like the Company, the risk of dilution is particularly significant for stockholders of the Company.

 

Debt financing, if obtained, may involve agreements that include liens on the Company’s assets and covenants limiting or restricting the Company’s ability to take specific actions such as incurring additional debt. Debt financing could also be required to be repaid regardless of the Company’s operating results.

 

If the Company raises additional funds through collaborations and licensing arrangements, the Company may be required to relinquish some rights to its products or to grant licenses on terms that are not favorable to the Company.

 

The Company’s current and future operations substantially depend on the Company’s management team and the Company’s ability to hire other key personnel, the loss of any of whom could disrupt the Company’s business operations.

 

The Company’s business depends and will continue to depend in substantial part on the continued service of Dr. Roger Crystal and Kevin Pollack, the Company’s Chief Executive Officer and Chief Financial Officer, respectively. The loss of the services of either of these individuals would significantly impede implementation and execution of the Company’s business strategy and may result in the failure to reach its goals. The Company has $1 million of key man insurance coverage for each of Dr. Roger Crystal and Kevin Pollack.

 

The Company’s future viability and ability to achieve sales and profits will also depend on the Company’s ability to attract, train, retain and motivate highly qualified personnel in the diverse areas required for continuing its operations. There is a risk that the Company will be unable to attract, train, retain or motivate qualified personnel, both near term or in the future, and the Company’s failure to do so may severely damage its prospects.

 

  If the Company is unable to obtain and maintain patent protection for the Company’s products and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, the Company’s competitors could develop and commercialize products and product candidates similar or identical to the Company’s, and the Company’s ability to successfully commercialize the Company’s products and product candidates may be adversely affected.

 

The Company’s commercial success will depend, in part, on the Company’s ability to obtain and maintain patent protection in the U.S. and other countries with respect to the Company’s products and product candidates. The Company seeks to protect the Company’s proprietary position by filing patent applications in the U.S. and abroad related to the Company’s products and product candidates that are important to the Company’s business, as appropriate. The Company cannot be certain that patents will be issued or granted with respect to applications that are currently pending or that the Company may apply for in the future with respect to one or more of the Company’s products and product candidates, or that issued or granted patents will not later be found to be invalid and/or unenforceable.

 

The patent prosecution process is expensive and time-consuming, and the Company may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that the Company will fail to identify patentable aspects of the Company’s research and development output before it is too late to obtain patent protection. Although the Company may enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of the Company’s research and development output, such as the Company’s employees, distribution partners, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing the Company’s ability to seek patent protection.

 

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The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of the Company’s patent rights are highly uncertain. The Company’s pending and future patent applications may not result in patents being issued, and even if issued, the patents may not meaningfully protect the Company’s products or product candidates, effectively prevent competitors and third parties from commercializing competitive products or otherwise provide the Company with any competitive advantage. The Company’s competitors or other third parties may be able to circumvent the Company’s patents by developing similar or alternative products in a non-infringing manner.

 

Changes in either the patent laws, implementing regulations or interpretation of the patent laws in the U.S. and other countries may also diminish the value of the Company’s patents or narrow the scope of the Company’s patent protection. The laws of foreign countries may not protect the Company’s rights to the same extent as the laws of the U.S., and many companies have encountered significant difficulties in protecting and defending such rights in foreign jurisdictions.

 

The Company cannot be certain that the Company’s patents and patent rights will be effective in protecting the Company’s products, product candidates and technologies. Failure to protect such assets may have a material adverse effect on the Company’s business, operations, financial condition and prospects.

 

The Company may face litigation from third parties claiming that the Company’s products infringe on their intellectual property rights, or seek to challenge the validity of the Company’s patents.

 

The Company’s future success is also dependent in part on the strength of the Company’s intellectual property, trade secrets and know-how, which have been developed from years of research and development. In addition to the litigation with Teva discussed below, the Company may be exposed to additional future litigation by third parties seeking to challenge the validity of the Company’s rights based on claims that the Company’s technologies, products or activities infringe the intellectual property rights of others or are invalid, or that the Company has misappropriated the trade secrets of others.

 

Since the Company’s inception, the Company has sought to contract with manufacturers to supply commercial quantities of pharmaceutical formulations and products. As a result, the Company has disclosed, under confidentiality agreements, various aspects of the Company’s technology with potential manufacturers and suppliers. The Company believes that these disclosures, while necessary for the Company’s business, may have resulted and may result in the attempt by potential manufacturers and suppliers to improperly assert ownership claims to the Company’s technology in an attempt to gain an advantage in negotiating manufacturing and supplier rights.

 

On September 15, 2016, the Company and Adapt received the Notice Letter from Teva, pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), that Teva had filed the ‘253 ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of the ’253 patent. The ‘253 patent is listed with respect to NARCAN® in the FDA’s Orange Book and expires on March 16, 2035. Teva’s September 2016 Notice Letter asserts that its generic product will not infringe the ‘253 patent or that the ‘253 patent is invalid or unenforceable. The Company and Adapt have been evaluating Teva’s September 2016 Notice Letter. The Company has full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘253 patent will be vigorously defended from any infringement. The Company may receive additional notice letters from Teva and other companies seeking to market generic versions of NARCAN® in the future and, after evaluation, the Company may commence patent infringement lawsuits against such companies.

 

On October 21, 2016, the Plaintiffs filed a complaint for patent infringement against the Defendants in the U.S. District Court for the District of New Jersey arising from Teva’s U.S.’s filing of the ‘253 ANDA with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘253 ANDA be a date later than the expiration of the ‘253 patent, as well as equitable relief enjoining the Defendants from infringing the ‘253 patent and monetary relief as a result of any such infringement. The Company maintains full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘253 patent will continue to be vigorously defended from any infringement. There can be no assurances that the Company will be successful with respect to this litigation matter. Such a failure may have a material impact on the Company and its business operations in the future.

 

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On January 3, 2017, the Company and Adapt received the January 2017 Notice Letter from Teva pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), that Teva had filed the ‘747 ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® before the expiration of the ’747 patent. The ‘747 patent is listed with respect to NARCAN® in the Orange Book and expires on March 16, 2035. Teva’s January 2017 Notice Letter asserts that its generic product will not infringe the ‘747 patent or that the ‘747 patent is invalid or unenforceable. The Company and Adapt have been evaluating Teva’s January 2017 Notice Letter. The Company has full confidence in its intellectual property portfolio related to NARCAN® and expects that the ‘747 patent will be vigorously defended from any infringement.

 

On February 8, 2017, the Plaintiffs filed a complaint for patent infringement against the Defendants in the U.S. District Court for the District of New Jersey arising from Teva’s U.S.’s filing of the ‘747 ANDA with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ‘747 ANDA be a date later than the expiration of the ‘747 patent, as well as equitable relief enjoining the Defendants from infringing the ‘747 patent and monetary relief as a result of any such infringement. The Company has full confidence in its intellectual property portfolio related to NARCAN® (naloxone hydrochloride) Nasal Spray and expects that the ‘747 patent will continue to be vigorously defended from any infringement.

 

The expiration or loss of patent protection may adversely affect the Company’s future revenues and operating earnings.

 

The Company relies on patent, trademark, trade secret and other intellectual property protection in the discovery, development, manufacturing and sale of the Company’s products and product candidates. In particular, patent protection is important in the development and eventual commercialization of the Company’s products and product candidates. Patents covering the Company’s products and product candidates normally provide market exclusivity, which is important in order for the Company’s products and product candidates to become profitable.

 

Certain of the Company’s patents will expire in the next 18 to 21 years. While the Company is seeking additional patent coverage which may protect the technology underlying these patents, there can be no assurances that such additional patent protection will be granted, or if granted, that these patents will not be infringed upon or otherwise held enforceable. Even if the Company is successful in obtaining a patent, patents have a limited lifespan. In the U.S., the natural expiration of a utility patent typically is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for the Company’s products and product candidates, the Company may be open to competition from generic versions of such methods and devices.

 

The Company may be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon the Company should the Company be sued.

 

The Company’s business exposes the Company to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of pharmaceutical formulations and products. The Company cannot be sure that claims will not be asserted against the Company. A successful liability claim or series of claims brought against the Company could have a material adverse effect on the Company’s business, financial condition and results of operations.

 

The Company cannot give assurances that the Company will be able to continue to obtain or maintain adequate product liability insurance on acceptable terms, if at all, or that such insurance will provide adequate coverage against potential liabilities. Claims or losses in excess of any product liability insurance coverage that the Company may obtain could have a material adverse effect on the Company’s business, financial condition and results of operations.

 

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The Company’s products may have undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require it to be taken off the market, require it to include safety warnings or otherwise limit sales of the product.

 

Unforeseen side effects from the Company’s products and product candidates could arise either during clinical development or, if approved, after the Company’s products have been marketed. This could cause regulatory approvals for, or market acceptance of, the Company’s products to be harder and more costly to obtain.

 

To date, no serious adverse events have been attributed to the Company’s products and product candidates. The results of the Company’s planned or any future clinical trials may show that the Company’s products and product candidates causes undesirable or unacceptable side effects, which could interrupt, delay or halt clinical trials, and result in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, or result in marketing approval from the FDA and other regulatory authorities with restrictive label warnings. If the Company’s product candidates receive marketing approval and the Company or others later identify undesirable or unacceptable side effects caused by the use of the Company’s products:

 

regulatory authorities may withdraw their approval of the products, which would force the Company to remove its products from the market;

 

regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication, or field alerts to physicians, pharmacies and others;

 

the Company may be required to change instructions regarding the way the products are administered, conduct additional clinical trials or change the labeling of the products;

 

the Company may be subject to limitations on how it may promote the products;

 

sales of the products may decrease significantly;

 

the Company may be subject to litigation or product liability claims; and

 

the Company’s reputation may suffer.

 

Any of these events could prevent the Company or its potential future collaborators from achieving or maintaining market acceptance of the Company’s products or could substantially increase commercialization costs and expenses, which in turn could delay or prevent the Company from generating significant revenues from the sale of its products.

 

The Company currently has no marketing and sales organization and has no experience marketing pharmaceutical products. If the Company is unable to establish its own marketing and sales capabilities, or enter into agreements with third parties to market and sell the Company’s products after approval, the Company may not be able to generate product revenues.

 

The Company does not have a sales organization for the marketing, sales and distribution of any pharmaceutical products. In order to commercialize the Company’s products or any other product candidates the Company may develop or acquire in the future, the Company must develop these capabilities on its own or make arrangements with third parties for the marketing, sales and distribution of its products. The establishment and development of the Company’s own sales force will be expensive and time consuming and could delay any product launch, and the Company cannot be certain that it would be able to successfully develop this capability. As a result, the Company may seek one or more partners to handle some or all of the sales, marketing and distribution of its products. There also may be certain markets within the U.S. and elsewhere for the Company’s products for which the Company may seek a co-promotion arrangement. However, the Company may not be able to enter into arrangements with third parties to sell its products on favorable terms, or at all. In the event the Company is unable to develop its own marketing and sales force or collaborate with a third party marketing and sales organization, the Company will not be able to commercialize its products or any other product candidates that it develops, which will negatively impact its ability to generate product revenues. Furthermore, whether the Company commercializes products on its own or relies on a third party to do so, the Company’s ability to generate revenue would be dependent on the effectiveness of the sales force. In addition, to the extent the Company relies on third parties to commercialize its approved products, the Company would likely receive less revenues than if the Company commercialized these products itself.

 

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The market for the Company’s products is rapidly changing and competitive, and new drugs, which may be developed by others, could impair the Company’s ability to maintain and grow the Company’s business and remain competitive.

 

The pharmaceutical industry is subject to rapid and substantial technological change. Developments by others may render the Company’s technologies and products noncompetitive or obsolete. The Company also may be unable to keep pace with technological developments and other market factors. Technological competition from medical device, pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase. Many of these entities have significantly greater research and development capabilities and budgets than the Company does, as well as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significant competition for the Company.

 

The Company’s reliance on collaborations with third parties to develop and commercialize the Company’s products, such as the Adapt Agreement to develop and commercialize the Company’s intranasal naloxone Opioid Overdose Reversal Treatment Product, is subject to inherent risks and may result in delays in product development and lost or reduced revenues, restricting the Company’s ability to commercialize the Company’s products and adversely affecting the Company’s profitability.

 

With respect to the products the Company has licensed, the Company depends upon collaborations with third parties to develop these product candidates and the Company depends substantially upon third parties to commercialize these products. As a result, the Company’s ability to develop, obtain regulatory approval of, manufacture and commercialize the Company’s existing and possibly future product candidates depends upon the Company’s ability to maintain existing, and enter into and maintain new, contractual and collaborative arrangements with others. The Company also engages, and intends in the future to continue to engage, contract manufacturers and clinical trial investigators.

 

In addition, although not a primary component of the Company’s current strategy, the identification of new compounds or product candidates for development has led the Company in the past, and may continue to require the Company, to enter into license or other collaborative agreements with others, including other pharmaceutical companies and research institutions. Such collaborative agreements for the acquisition of new compounds or product candidates would typically require the Company to pay license fees, make milestone payments and/or pay royalties. Furthermore, these agreements may result in the Company’s revenues being lower than if the Company developed the Company’s product candidates on the Company’s own and in the Company’s loss of control over the development of the Company’s product candidates.

 

Contractors or collaborators may have the right to terminate their agreements with the Company or reduce their payments to the Company under those agreements on limited or no notice and for no reason or reasons outside of the Company’s control. For example, the Company may be unable to maintain its relationship with Adapt on a commercially reasonable basis, if at all, as the Adapt agreement may be terminated by Adapt in its sole discretion, either in its entirety or in respect of one or more countries, at any time by providing 60 days prior notice to the Company. In addition, Adapt may have similar or more established relationships with the Company’s competitors or larger customers which may negatively impact the Company’s relationship with Adapt. Moreover, the loss for any reason of Adapt as a key partner could have a materially significant and adverse impact on the Company’s business. If the Company is unable to retain Adapt as a partner on commercially acceptable terms, the Company may not be able to commercialize the Company’s products as planned and the Company may experience delays in or suspension of the marketing of the Company’s products. The same could apply to other product candidates the Company may develop or acquire in the future. The Company’s dependence upon third parties to assist with the development and commercialization of the Company’s product candidates may adversely affect the Company’s ability to generate profits or acceptable profit margins and the Company’s ability to develop and deliver such products on a timely and competitive basis. Additionally, the Restated Aegis Agreement expires on the earlier of (i) the expiration of the Opiant Negotiation Periods and (ii) on 30 days’ prior written notice by the Company; provided , however , that Aegis shall have the right to terminate the license granted in the event the Company does not pursue commercially reasonable efforts to exploit a Product. The Restated Aegis Agreement expired by its terms during the three months ended January 31, 2017 and Aegis and the Company are actively negotiating a new agreement.

 

If the Company’s current or future licensees exercise termination rights they may have, or if these license agreements terminate because of delays in obtaining regulatory approvals, or for other reasons, and the Company is not able to establish replacement or additional research and development collaborations or licensing arrangements, the Company may not be able to develop and/or commercialize the Company’s product candidates. Moreover, any future collaborations or license arrangements the Company may enter into may not be on terms favorable to the Company.

 

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A further risk the Company faces with the Company’s collaborations is that business combinations and changes in the collaborator or their business strategy may adversely affect their willingness or ability to complete their obligations to the Company.

 

The Company’s current or any future collaborations or license arrangements ultimately may not be successful. The Company’s agreements with collaborators typically allows them discretion in electing whether to pursue various development, regulatory, commercialization and other activities, such as the Adapt Agreement.

 

If any collaborator were to breach its agreement with the Company or otherwise fail to conduct collaborative activities in a timely or successful manner, the pre-clinical or clinical development or commercialization of the affected product candidate or research program would be delayed or terminated.

 

Other risks associated with the Company’s collaborative and contractual arrangements with others include the following:

 

the Company may not have day-to-day control over the activities of the Company’s contractors or collaborators;

 

the Company’s collaborators may fail to defend or enforce patents they own on compounds or technologies that are incorporated into the products the Company develops with them;

 

third parties may not fulfill their regulatory or other obligations; and

 

the Company may not realize the contemplated or expected benefits from collaborative or other arrangements; and disagreements may arise regarding a breach of the arrangement, the interpretation of the agreement, ownership of proprietary rights, clinical results or regulatory approvals.

 

These factors could lead to delays in the development of the Company’s product candidates and/or the commercialization of the Company’s products or reduction in the milestone payments the Company receives from the Company’s collaborators, or could result in the Company’s not being able to commercialize the Company’s products. Further, disagreements with the Company’s contractors or collaborators could require or result in litigation or arbitration, which would be time-consuming and expensive. The Company’s ultimate success may depend upon the success and performance on the part of these third parties. If the Company fails to maintain these relationships or establish new relationships as required, development of the Company’s product candidates and/or the commercialization of the Company’s products will be delayed or may never be realized.

 

The Company is exposed to product liability, non-clinical and clinical liability risks which could place a substantial financial burden upon the Company, should lawsuits be filed against the Company.

 

The Company’s business exposes the Company to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of pharmaceutical formulations and products. The Company expects that such claims are likely to be asserted against the Company at some point. In addition, the use in the Company’s clinical trials of pharmaceutical formulations and products and the subsequent sale of these formulations or products by the Company or the Company’s potential collaborators may cause the Company to bear a portion of or all product liability risks. Any claim under any existing insurance policies or any insurance policies secured in the future may be subject to certain exceptions, and may not be honored fully, in part, in a timely manner, or at all, and may not cover the full extent of liability the Company may actually face. Therefore, a successful liability claim or series of claims brought against the Company could have a material adverse effect on the Company’s business, financial condition and results of operations.

 

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Security breaches and other disruptions could compromise the Company’s information and expose the Company to liability, which would cause the Company’s business and reputation to suffer.

 

In the ordinary course of the Company’s business, the Company collects and store sensitive data, including intellectual property, the Company’s proprietary business information and that of the Company’s customers, suppliers and business partners and personally identifiable information of the Company’s customers and employees, in the Company’s data centers and on the Company’s networks. The secure processing, maintenance and transmission of this information is critical to the Company’s operations and business strategy. Despite the Company’s security measures, the Company’s information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Any such breach could compromise the Company’s networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, and regulatory penalties, disrupt the Company’s operations and the products the Company provides to customers, and damage the Company’s reputation, and cause a loss of confidence in the Company’s products, which could adversely affect the Company’s business/operating margins, revenues and competitive position.

 

Risks Related to Government Regulation of the Company’s Industry

 

Legislative or regulatory reform of the healthcare system may affect the Company’s ability to sell the Company’s products profitably.

 

In both the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact the Company’s ability to sell the Company’s future products and profitability. On March 23, 2010, former President Barack Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, “PPACA”), which includes a number of health care reform provisions and requires most U.S. citizens to have health insurance. The new law, among other things, imposes a significant annual fee on companies that manufacture or import branded prescription drug products, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, and establishes a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. Substantial new provisions affecting compliance also have been added, which may require modification of business practices with health care practitioners.

 

In the coming years, additional changes under the new Trump administration and future presidential administrations could be made to governmental healthcare programs that could significantly impact the success of the Company’s future products, and the Company could be adversely affected by current and future health care reforms.

 

The Company’s industry and the Company are subject to intense regulation from the U.S. Government and such other governments and quasi-official regulatory bodies where the Company’s products are and product candidates may be sold.

 

Both before and after regulatory approval to market a particular product candidate, including the Company’s product candidates, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, distribution and record keeping related to the product are subject to extensive, ongoing regulatory requirements, including, without limitation, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current Good Manufacturing Practices (“cGMP”) requirements and good clinical practice requirements for any clinical trials that the Company conduct post-approval. As a result, the Company is subject to a number of governmental and other regulatory risks, which include:

 

clinical development is a long, expensive and uncertain process; delay and failure can occur at any stage of the Company’s clinical trials;

 

the Company’s clinical trials are dependent on patient enrollment and regulatory approvals; the Company does not know whether the Company’s planned trials will begin on time, or at all, or will be completed on schedule, or at all;

 

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

 

the Company relies on third parties, such as consultants, contract research organizations, medical institutions and clinical investigators, to conduct clinical trials for the Company’s drug candidates and if the Company or any of the Company’s third-party contractors fail to comply with applicable regulatory requirements, such as cGMP requirements, the clinical data generated in the Company’s clinical trials may be deemed unreliable and the FDA, the European Medicines Agency or comparable foreign regulatory authorities may require the Company to perform additional clinical trials;

 

if the clinical development process is completed successfully, the Company’s ability to derive revenues from the sale of the Company’s product candidates will depend on the Company’s first obtaining FDA or other comparable foreign regulatory approvals, each of which are subject to unique risks and uncertainties;

 

there is no assurance that the Company will receive FDA or corollary foreign approval for any of the Company’s product candidates for any indication; the Company is subject to government regulation for the commercialization of the Company’s product candidates;

 

the Company has not received regulatory approval in the U.S. for the commercial sale of any of the Company’s product candidates;

 

even if one or more of the Company’s product candidates does obtain approval, regulatory authorities may approve such product candidate for fewer or more limited indications than the Company requests, may not approve the price the Company intends to charge for the Company’s products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate;

 

undesirable side effects caused by the Company’s product candidates could cause the Company or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities;

 

later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with the Company’s third-party manufacturers or manufacturing processes, or failure to comply with the regulatory requirements of FDA and other applicable U.S. and foreign regulatory authorities could subject the Company to administrative or judicially imposed sanctions;

 

the FDA's policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of the Company’s drug candidates, and if the Company is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if the Company is not able to maintain regulatory compliance, the Company may lose any marketing approval that the Company may have obtained; and

 

the Company may be liable for contamination or other harm caused by hazardous materials used in the operations of the Company’s business.

 

In addition, the Company’s operations are also subject to various federal and state fraud and abuse, physician payment transparency and privacy and security laws, including, without limitation:

 

The federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or providing remuneration to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare or Medicaid programs. This statute has been applied to pharmaceutical manufacturer marketing practices, educational programs, pricing policies and relationships with healthcare providers. A person or entity does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation;

 

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Federal civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower or qui tam actions that prohibit, among other things, knowingly presenting, or causing to be present, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statutes;

 

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations, which created federal criminal laws that prohibit, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

 

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, also imposes certain regulatory and contractual requirements regarding the privacy, security and transmission of individually identifiable health information;

 

Federal “sunshine” requirements imposed by the PPACA on drug manufacturers regarding any “transfer of value” made or distributed to physicians and teaching hospitals, and any ownership and investment interests held by such physicians and their immediate family members. Failure to submit the required information may result in civil monetary penalties of up an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws or regulations; and

 

State and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require drug manufacturers to comply with the industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of certain health information, many of which differ from each other in significant ways and often are not preempted by HIPAA.

 

Risks Related to the Company’s Common Stock

 

The trading in the Company’s shares is regulated by the SEC and is subject to the “Penny Stock” rules. These rules may have the effect of reducing trading activity in the Company’s stock and provide an illiquid market for the Company’s securities.

 

Although the Company’s shares are currently traded at a price higher than $5.00, the Company’s shares have frequently traded in the past at a price lower than $5.00. If the Company’s share price goes below $5.00, the shares will be defined as a “Penny Stock” under the Exchange Act and rules of the SEC. Penny Stocks generally are equity securities with a price of less than $5.00 (other than securities registered on certain national securities exchanges or quoted on the NASDAQ system). Penny Stock rules require a broker-dealer, prior to a transaction in a Penny Stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about Penny Stocks and the risks in the Penny Stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the Penny Stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each Penny Stock held in the customer’s account. The broker-dealer must also make a special written determination that the Penny Stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security that becomes subject to the Penny Stock rules. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers from effecting transactions in the Company’s securities, which could severely limit the market price and liquidity of the Company’s securities. These requirements may restrict the ability of broker-dealers to sell the Company’s Common Stock and may affect your ability to resell the Company’s Common Stock.

 

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The Company will incur ongoing costs and expenses for SEC reporting and compliance. Without revenue, the Company may not be able to remain in compliance, making it difficult for investors to sell their shares, if at all.

 

The Company’s shares are quoted on the OTCQB Market under the symbol “OPNT.” To be eligible for quotation, issuers must remain current in their filings with the SEC. In order for the Company to remain in compliance, the Company will require cash to cover the cost of these filings, which could comprise a substantial portion of the Company’s available cash resources. If the Company is unable to remain in compliance, it may be difficult for the Company’s stockholders to resell any shares, if at all.

 

The price of the Company’s Common Stock could be highly volatile due to a number of factors, which could lead to losses by investors and costly securities litigation.

 

The Company’s Common Stock is listed on the OTCQB Market under the symbol “OPNT.” The stock market in general, and the market for pharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The trading price of the Company’s Common Stock has experienced substantial volatility and is likely to continue to be highly volatile in response to a number of factors including, without limitation, the following:

 

limited daily trading volume resulting in the lack of a liquid market;

 

fluctuations in price and volume due to investor speculation and other factors that may not be tied to the financial performance of the Company;

 

performance by the Company in the execution of its business plan;

 

financial viability;

 

actual or anticipated variations in the Company’s operating results;

 

announcements of developments by the Company or the Company’s competitors;

 

market conditions in the Company’s industry;

 

announcements by the Company or the Company’s competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

 

adoption of new accounting standards affecting the Company’s industry;

 

additions or departures of key personnel;

 

introduction of new products by the Company or the Company’s competitors;

 

sales of the Company’s Common Stock or other securities in the open market;

 

regulatory developments in both the U.S. and foreign countries;

 

performance of products sold and advertised by licensees in the marketplace;

 

economic and other external factors;

 

period-to-period fluctuations in financial results; and;

 

other events or factors, including the other factors described in this “Risk Factors” section.

 

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Securities analysts do not currently and may not in the future cover the Company, which may have a negative impact on the market price of the Company’s Common Stock.

 

The trading market for the Company’s Common Stock will depend, in part, on the research and reports that securities or industry analysts publish about the Company and the Company’s business. The Company does not have any control over independent analysts and currently the Company is not covered by any such independent analysts. The Company has engaged various non-independent analysts historically, including Zacks Investment Research currently, to cover the Company and the Company’s business. The Company otherwise does not currently have and may never obtain research coverage by independent securities and industry analysts. If no independent securities or industry analysts commence coverage of the Company, the trading price for the Company’s Common Stock may continue to be negatively impacted.

 

The Company does not anticipate declaring any cash dividends on the Company’s Common Stock.

 

The Company currently intends to retain any future earnings for use in the operation and expansion of the Company’s business. Accordingly, the Company does not expect to pay any dividends in the foreseeable future, but will review this policy from time to time as circumstances dictate.

 

The Company may register an aggregate of at least 15,715 shares of Common Stock, at least 45,000 shares of Common Stock underlying warrants and at least 2,305,000 shares of Common Stock underlying options in the first half of 2017. The sales of such shares could depress the market price of the Company’s Common Stock.

 

The Company may register an aggregate of at least 15,715 shares of Common Stock, at least 45,000 shares of Common Stock underlying warrants and at least 2,305,000 shares of Common Stock underlying options under a registration statement on Form S-1 in the first half of 2017. Assuming 2,365,715 total shares were registered, it would represent approximately 116.14% of the Company’s shares of Common Stock outstanding as of March 7, 2017, assuming that all the security holders exercised all of their warrants and options. The sale of these shares into the public market could depress the market price of the Company’s Common Stock.

 

Certain of the Company’s executive officers and directors control the direction of the Company’s business by means of a significant collective ownership of the Company’s common stock. The concentrated beneficial ownership of the Company’s common stock may prevent other stockholders from influencing significant corporate decisions.

 

Dr. Roger Crystal, the Company’s Chief Executive Officer and a director, Kevin Pollack, the Company’s Chief Financial Officer and a director, Dr. Michael Sinclair, the Company’s Executive Chairman and Chairman of the Board, and Geoffrey Wolf, a director, Ann MacDougall, a director, Thomas T. Thomas, a director, and Dr. Gabrielle Silver, a director, collectively beneficially own approximately 70.56% of the Company’s outstanding Common Stock as of March 7, 2017. As a result, such executive officers and directors effectively control the Company and have the ability to exert substantial influence over all matters requiring approval by the Company’s stockholders, including the election and removal of directors, amendments to the Company’s Articles of Incorporation, and any proposed merger, consolidation or sale of all or substantially all of the Company’s assets and other corporate transactions. This concentration of ownership could be disadvantageous to other stockholders with differing interests from such executive officers and directors.

 

As an “emerging growth company” under applicable law, the Company is subject to lessened disclosure requirements, which could leave the Company’s stockholders without information or rights available to stockholders of more mature companies.

 

For as long as the Company remains an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (which we refer to herein as the “JOBS Act”), the Company has elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to:

 

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”);

 

taking advantage of an extension of time to comply with new or revised financial accounting standards;

 

reduced disclosure obligations regarding executive compensation in the Company’s periodic reports and proxy statements; and

 

exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

 

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The Company expects to take advantage of these reporting exemptions until the Company is no longer an “emerging growth company.” Because of these lessened regulatory requirements, the Company’s stockholders would be left without information or rights available to stockholders of more mature companies.

 

Because the Company has elected to use the extended transition period for complying with new or revised accounting standards for an “emerging growth company,” its financial statements may not be comparable to companies that comply with public company effective dates.

 

The Company has elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election allows the Company to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, the Company’s financial statements may not be comparable to companies that comply with public company effective dates, and thus investors may have difficulty evaluating or comparing the Company’s business, performance or prospects in comparison to other public companies, which may have a negative impact on the value and liquidity of the Company’s Common Stock.

 

The Company will incur ongoing costs and expenses for SEC reporting and compliance. Without significant revenue the Company may not be able to remain in compliance, making it difficult for investors to sell their shares, if at all.

 

The Company’s shares are quoted on the OTCQB Market under the symbol “OPNT”. To be eligible for quotation, issuers must remain current in their filings with the SEC. In order for the Company to remain in compliance, the Company will require cash to cover the cost of these filings, which could comprise a substantial portion of the Company’s available cash resources. If the Company is unable to remain in compliance it may be difficult for the Company’s stockholders to resell any shares, if at all.

 

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

   

None.

 

Item 3.            Defaults Upon Senior Securities.

 

None.

 

Item 4.            Mine Safety Disclosures.

 

Not applicable. 

  

Item 5.            Other Information.

 

On March 13, 2017 (the “Effective Date”), the Company entered into a third amendment (the “Third Amendment”) to that certain Senior Advisor Agreement with Brad Miles, dated January 22, 2013 (the “Initial Agreement”), as previously amended on February 24, 2015 (the “First Amendment”) and March 19, 2015 (the “Second Amendment” and, together with the Initial Agreement, the First Amendment and the Third Amendment, the “Advisor Agreement”). Pursuant to the Third Amendment, and in consideration for Mr. Miles’ continued service to the Company as an advisor through December 31, 2017, the Company shall: (i) pay Mr. Miles, within 15 business days of the Effective Date, (x) a cash payment of $107,805, and (y) 1,875 shares of Common Stock; (ii) grant to Mr. Miles the right to receive, subject to adjustment per the terms of the Third Amendment, 1.25% of the Net Profit generated from the Product from the Effective Date (which amounts shall be paid quarterly per the terms of the Third Amendment), and, in the event of a Divestiture of the Company, 1.25% of the net proceeds of such sale, subject to adjustment per the terms of the Third Amendment, and, in the event of a sale of the Company, the Fair Market Value of the Product; (iii) pay Mr. Miles $17,000 per calendar quarter during 2017; and (iv) grant to Mr. Miles a warrant to purchase 45,000 shares of Common Stock (the “Warrant”). The Warrant is fully vested on the date of grant, has an exercise price of $10.00, an expiration date of three years from the date of grant and may be exercised solely by payment of cash. Additionally, pursuant to the Third Amendment, from the Effective Date until the fourth anniversary of the Effective Date, the Company shall have the right to buy back the Interest or any portion thereof from Mr. Miles upon written notice at a price of $187,500 per 1.25% of Interest (the “Buyback Amount”); provided , however , tha t, in the event that such written notice is provided within 2.5 years after the Effective Date, the Company shall pay Mr. Miles two times the Buyback Amount within ten business days after the provision of such notice; provided , further , that , in the event the Company provides such notice to Mr. Miles after 2.5 years after the Effective Date and prior to the four year anniversary of the Effective Date, the Company shall pay Mr. Miles 3.5 times the Buyback Amount within ten business days after the provision of such notice. Furthermore, pursuant to the Third Amendment, the Company is required to provide to Mr. Miles, following the end of each calendar year, an annual audit of Net Profit once the Product begins generating Net Profit. Capitalized terms not otherwise defined in this paragraph shall have the meanings ascribed to such terms in the Third Amendment. The foregoing summary of the material terms of the Third Amendment is qualified in its entirety by reference to the full text of the Third Amendment, which is attached hereto as Exhibit 10.5 and incorporated herein by reference.

 

In addition, pursuant to the Initial Agreement, on January 22, 2013, the Company granted Mr. Miles a fully vested option to purchase 17,500 shares of Common Stock at an exercise price of $15.00 per share, which option expires on January 22, 2018. Moreover, pursuant to the Second Amendment, on March 19, 2015, the Company granted Mr. Miles (i) a fully vested option to purchase 48,000 shares of Common Stock at an exercise price of $10.00, which option expires on March 18, 2020; (ii) a fully vested option to purchase 32,000 shares of Common Stock at an exercise price of $15.00, which option expires on March 18, 2020; and (iii) a fully vested warrant to purchase 45,000 shares of Common Stock with an exercise price of $10.00, which warrant expires on March 18, 2020 and which may be exercised solely by payment of cash.

 

The Company may terminate the Advisor Agreement at any time for Cause upon which no severance pay or other consideration shall be payable to Mr. Miles, and Mr. Miles shall be entitled to shares of Common Stock underlying warrants and options which have vested. The Advisor Agreement also contains customary indemnification and confidentiality terms.

 

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Item 6.             Exhibits.

 

Exhibit
Number
  Exhibit Title
3.5   Amended and Restated Bylaws of Opiant Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.5 to the Company’s Current Report on Form 8-K filed on November 22, 2016).
     
10.1   Director Agreement, effective November 4, 2016, by and between Opiant Pharmaceuticals, Inc. and Thomas T. Thomas (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 10, 2016).
     
10.2*+   Purchase and Sale Agreement, dated as of December 13, 2016, by and between Opiant Pharmaceuticals, Inc. and SWK Funding LLC.
     
10.3*+   Amendment No. 1 to License Agreement, dated as of December 13, 2016, by and between Opiant Pharmaceuticals, Inc. and Adapt Pharma Operations Limited.
     
10.4   Office License Agreement Amendment, effective March 1, 2017, by and between Opiant Pharmaceuticals, Inc. and Premier Office Centers, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 19, 2016).
     
10.5*   Third Amendment to Senior Advisor Agreement, dated as of March 13, 2017, by and between Opiant Pharmaceuticals, Inc. and Brad Miles.
     
10.6*  

Senior Advisor Agreeme nt, dated as of January 22, 2013, by and between the Company (f/k/a Lightlake Therapeutics Inc.) and Brad Miles.

     

10.7*

 

First Amendment to Senior Advisor Agreement, dated as of February 24, 2015, by and between the Company (f/k/a Lightlake Therapeutics Inc.) and Brad Miles.

     
10.8*   Second Amendment to Senior Advisor Agreement, dated as of March 19, 2015, by and between the Company (f/k/a Lightlake Therapeutics Inc.) and Brad Miles.
     
31.1*   Certification of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2*   Certification of Principal Financial Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1**   Certification of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
32.2**   Certification of Principal Financial Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101*   The following materials fr om the Opiant Pharmaceuticals, Inc. Form 10-Q for the quarter ended January 31, 2017, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets as of January 31, 2017 and July 31, 2016 (Unaudited), (ii) Consolidated Statements of Operations for the three and six months ended January 31, 2017 and 2016 (Unaudited), (iii) Consolidated Statements of Stockholders’ (Deficit) Equity for the six months ended January 31, 2017 (Unaudited), (iv) Consolidated Statements of Cash Flows for the six months ended January 31, 2017 and 2016 (Unaudited), and (iv) Consolidated Notes to the Financial Statements (Unaudited).

   

_________________________________

 

* Filed herewith.

 

+ Confidential Treatment Requested. Confidential Materials omitted and filed separately with the Securities and Exchange Commission.

 

** In accordance with SEC Release 33-8238, Exhibit 32.1 and 32.2 are being furnished and not filed.

 

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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.

 

  OPIANT PHARMACEUTICALS, INC.  
       
Date: March 15, 2017 By: /s/  Dr. Roger Crystal  
    Name:  Dr. Roger Crystal  
    Title: Chief Executive Officer and Director  
    (Principal Executive Officer)  

 

Date: March 15, 2017 By: /s/  Kevin Pollack  
    Name: Kevin Pollack  
    Title: Chief Financial Officer and Director  
    (Principal Financial and Accounting Officer)  

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Exhibit 10.2

 

Execution Version

 

PURCHASE AND SALE AGREEMENT

 

dated as of December 13, 2016

 

between

 

OPIANT PHARMACEUTICALS, INC.

 

and

 

SWK Funding LLC

 

 

 

  

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Table of Contents

 

    Page
     
Article I
DEFINED TERMS AND RULES OF CONSTRUCTION
     
Section 1.1 Defined Terms 1
Section 1.2 Rules of Construction 9
     
Article II
PURCHASE AND SALE OF THE PURCHASED ASSETS
     
Section 2.1 Purchase and Sale 11
Section 2.2 Purchase Price 12
Section 2.3 No Assumed Obligations 12
Section 2.4 Excluded Assets 13
Section 2.5 Power of Attorney 13
     
Article III
REPRESENTATIONS AND WARRANTIES OF THE SELLER
     
Section 3.1 Organization 14
Section 3.2 No Conflicts 14
Section 3.3 Authorization 15
Section 3.4 Ownership 15
Section 3.5 Governmental and Third Party Authorizations 15
Section 3.6 No Litigation 16
Section 3.7 Solvency 16
Section 3.8 Tax Matters 16
Section 3.9 No Brokers’ Fees 16
Section 3.10 Compliance with Laws 17
Section 3.11 Intellectual Property Matters 17
Section 3.12 Regulatory Approval, Manufacturing and Marketing 19
Section 3.13 License Agreement 19
Section 3.14 Profit Sharing Arrangements 22
Section 3.15 UCC Matters 22
Section 3.16 Set-off and Other Sources of Royalty Reduction 22
Section 3.17 Investment Company Status 22

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Article IV
REPRESENTATIONS AND WARRANTIES OF THE PURCHASER
     
Section 4.1 Organization 22
Section 4.2 No Conflicts 23
Section 4.3 Authorization 23
Section 4.4 Governmental and Third Party Authorizations 23
Section 4.5 No Litigation 23
Section 4.6 Access to Information 24
Section 4.7 Funds Available 24
     
Article V
COVENANTS
     
Section 5.1 Books and Records; Notices 24
Section 5.2 Confidentiality; Public Announcement 25
Section 5.3 Further Assurances 26
Section 5.4 Payments on Account of the Purchased Assets 27
Section 5.5 Intellectual Property Matters 29
Section 5.6 License Agreement 30
Section 5.7 Termination of Product Agreements; Mergers, Consolidations and Asset Sales Involving Licensee; Manufacture of Product by Seller 33
Section 5.8 Audits 34
Section 5.9 Tax Matters 34
     
Article VI
THE CLOSING
     
Section 6.1 Closing 34
Section 6.2 Closing Deliverables of the Seller 34
Section 6.3 Closing Deliverables of the Purchaser 35
Section 6.4 Receipt 35
     
Article VII
INDEMNIFICATION
     
Section 7.1 Indemnification by the Seller 36
Section 7.2 Indemnification by the Purchaser 36
Section 7.3 Procedures 37
Section 7.4 Exclusive Remedy 38

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Article VIII
MISCELLANEOUS
     
Section 8.1 Survival 38
Section 8.2 Specific Performance 38
Section 8.3 Notices 38
Section 8.4 Successors and Assigns 40
Section 8.5 Independent Nature of Relationship 40
Section 8.6 Entire Agreement 40
Section 8.7 Governing Law 40
Section 8.8 Waiver of Jury Trial 41
Section 8.9 Severability 42
Section 8.10 Counterparts 42
Section 8.11 Amendments; No Waivers 42
Section 8.12 Table of Contents and Headings 42

 

Exhibit A Form of Bill of Sale
Exhibit B Form of Licensee Instruction
Exhibit C Form of Opinion of Special Counsel to the Seller
   
Schedule 3.6 Litigation
Schedule 3.11(a)(i) Product Specific Patents
Schedule 3.11 (a)(ii) Joint Patents
Schedule 3.11(b) Opiant Patents
Schedule 3.13(m) License Agreement Representations and Warranties
Schedule 3.14 Profit Sharing Arrangements

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.  

 

PURCHASE AND SALE AGREEMENT

 

This PURCHASE AND SALE AGREEMENT (this “ Agreement ”) dated as of December 13, 2016 is between Opiant Pharmaceuticals, Inc., a Nevada corporation (the “ Seller ”), and SWK Funding LLC, a Delaware limited liability company (the “ Purchaser ”).

 

WITNESSETH :

 

WHEREAS, the Seller has the right to receive milestones and royalties based on the worldwide net sales of Products under the License Agreement; and

 

WHEREAS, the Seller desires to sell, contribute, assign, transfer, convey and grant to the Purchaser, and the Purchaser desires to purchase, acquire and accept from the Seller, the Purchased Assets described herein, upon and subject to the terms and conditions set forth in this Agreement;

 

NOW, THEREFORE, in consideration of the premises and the mutual agreements, representations and warranties set forth herein and of other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties hereto covenant and agree as follows:

 

Article I
DEFINED TERMS AND RULES OF CONSTRUCTION

 

Section 1.1            Defined Terms . The following terms, as used herein, shall have the following respective meanings:

 

Adapt Agreements ” means the License Agreement and any sub-license agreements concerning any Product or Opiant Technology (as it relates to any Product) entered into by Licensee and any and all other related agreements concerning any Product or Opiant Technology (as it relates to any Product) by and between Seller and Licensee, or Licensee and a sub-licensee and/or a third party, as applicable, in each case only to the extent that such agreements relate to sale, manufacture, marketing, distribution or license of any Product or Opiant Technology (as it relates to any Product).

 

Adapt Applied Know-How ” has the meaning set forth in Section 1.2 of the License Agreement.

 

Adapt Applied Patents ” has the meaning set forth in Section 1.3 of the License Agreement.

 

Additional License Agreements means any New Arrangement and any additional revenue generating agreements entered into by Seller with Counterparties with respect to the sale, manufacture, marketing, distribution or licensing of any Product or Opiant Technology (as it relates to any Product), as well as any and all sub-license agreements entered into by such Counterparty and any and all other related agreements by and between Seller and such Counterparty, or such Counterparty and a sub-licensee, as applicable with respect to the sale, manufacture, marketing, distribution or license of any Product or Opiant Technology (as it relates to any Product).

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Affiliate ” means, with respect to any Person, any other Person that, directly or indirectly, controls, is controlled by or is under common control with such Person. For purposes of this definition, “ control ” of a Person means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of Voting Securities, by contract or otherwise, and the terms “ controlled ” and “ controlling ” have meanings correlative to the foregoing.

 

Applicable Law ” means, with respect to any Person, all laws, rules, regulations and orders of Governmental Authorities applicable to such Person or any of its properties or assets.

 

Bankruptcy Event ” means the occurrence of any of the following in respect of a Person: (a) an admission in writing by such Person of its inability to pay its debts generally or a general assignment by such Person for the benefit of creditors; (b) the filing of any petition or answer by such Person seeking to adjudicate itself as bankrupt or insolvent, or seeking for itself any liquidation, winding-up, reorganization, arrangement, adjustment, protection, relief or composition of such Person or its debts under any law relating to bankruptcy, insolvency, receivership, winding-up, liquidation, reorganization, examination, relief of debtors or other similar law now or hereafter in effect, or seeking, consenting to or acquiescing in the entry of an order for relief in any case under any such law, or the appointment of or taking possession by a receiver, trustee, custodian, liquidator, examiner, assignee, sequestrator or other similar official for such Person or for any substantial part of its property; (c) corporate or other action taken by such Person to authorize any of the actions set forth in clause (a) or clause (b) above; or (d) without the consent or acquiescence of such Person, the entering of an order for relief or approving a petition for relief or reorganization or any other petition seeking any reorganization, arrangement, composition, readjustment, liquidation, dissolution or other similar relief under any present or future bankruptcy, insolvency or similar statute, law or regulation, or the filing of any such petition against such Person, or, without the consent or acquiescence of such Person, the entering of an order appointing a trustee, custodian, receiver or liquidator of such Person or of all or any substantial part of the property of such Person.

 

Bill of Sale ” means that certain bill of sale dated as of the Closing Date executed by the Seller and the Purchaser substantially in the form of Exhibit A .

 

Business Day ” means any day that is not a Saturday, Sunday or other day on which commercial banks in New York City are authorized or required by Applicable Law to remain closed.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Capital Securities ” means, with respect to any Person, all shares, interests, participations or other equivalents (however designated, whether voting or non-voting) of such Person’s capital, whether now outstanding or issued after the Closing Date, including common shares, ordinary shares, preferred shares, membership interests or share capital in a limited liability company or other Person, limited or general partnership interests in a partnership, beneficial interests in trusts or any other equivalent of such ownership interest or any options, warrants and other rights to acquire such shares or interests, including rights to allocations and distributions, dividends, redemption payments and liquidation payments.

 

Capped Royalty Amount ” means $20,625,000 unless the Earn Out Milestone is achieved, then such Capped Royalty Amount means $26,250,000, it being understood and agreed that if any Royalties are required to be refunded, returned or otherwise paid by the Purchaser to Seller or to Licensee, such Royalties shall be disregarded for purposes of determining whether the Capped Royalty Amount has been reached; provided , however , that the Capped Royalty Amount shall be increased by 1.5 times the aggregate amount of any costs and expenses (including attorneys’ fees and expenses) incurred by the Purchaser in connection with (i) any defense or enforcement of the Opiant Technology under Section 5.5(e), or (ii) the participation or control of the Purchaser (with counsel appointed by it) under Section 5.6(d) of any meeting, discussion, action, suit or other proceeding relating to any breach, default or termination event or alleged breach, default or termination event by Licensee under the License Agreement, including any counterclaim, settlement discussions or meetings.

 

Commercial Sublicensee ” has the meaning set forth in Section 1.11 of the License Agreement.

 

Commercialize ” has the meaning set forth in Section 1.12 of the License Agreement.

 

Confidential Information ” means, as it relates to the Seller and its Affiliates, Products and the Opiant Technology, all information (whether written or oral, or in electronic or other form) involving or relating in any way, directly or indirectly, to Products, the License Agreement, the Purchased Assets or the Royalties, including (a) any license, sublicense, assignment, product development, royalty, sale, supply or other agreements (including the License Agreement) involving or relating in any way, directly or indirectly, to the Purchased Assets, the Royalties or the intellectual property, compounds or products giving rise to the Purchased Assets, and including all terms and conditions thereof and the identities of the parties thereto, (b) any reports, data, materials or other documents of any kind concerning or relating in any way, directly or indirectly, to the Seller, Products, the License Agreement, the Purchased Assets, the Royalties or the intellectual property, compounds or products giving rise to the Purchased Assets, and including reports, data, materials or other documents of any kind delivered pursuant to or under any of the agreements referred to in clause (a) above, and (c) any inventions, devices, improvements, formulations, discoveries, compositions, ingredients, patents, patent applications, know-how, processes, trial results, research, developments or any other intellectual property, trade secrets or information involving or relating in any way, directly or indirectly, to the Purchased Assets or the compounds or products giving rise to the Purchased Assets; provided , however , that, solely for purposes of this Agreement, Confidential Information shall not include information that is (i) already in the public domain at the time the information is disclosed other than as a result of disclosure in violation of the confidentiality undertakings in this Agreement, (ii) lawfully obtainable from other sources, (iii) required to be disclosed in any document to be filed with any Governmental Authority, or (iv) required to be disclosed by court or administrative order or under laws, rules and regulations applicable to the Seller or the Purchaser or their respective Affiliates (including securities laws, rules and regulations), as the case may be, or pursuant to the rules and regulations of any stock exchange or stock market on which securities of the Seller or the Purchaser or their respective Affiliates may be listed for trading.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Counterparty ” means Licensee and any other Persons counterparty to an Additional License Agreement.

 

Development ” has the meaning set forth in Section 1.17 of the License Agreement.

 

Dollar ” or the sign “ $ ” means United States dollars.

 

Earn Out Milestone ” means the point in time that Licensee has received in excess of $25,000,000 of cumulative Net Sales for any two consecutive fiscal quarters during the period from October 1, 2016 through September 30, 2017 from the sale of Narcan®.

 

Earn Out Milestone Payment ” means $3,750,000.

 

FDA ” means the U.S. Food and Drug Administration and any successor agency thereto.

 

GAAP ” means generally accepted accounting principles in effect in the United States from time to time.

 

Generic Competition ” has the meaning set forth in Section 5.4.3 of the License Agreement.

 

Generic Product ” has the meaning set forth in Section 1.30 of the License Agreement.

 

Governmental Authority ” means the government of the United States, any other nation or any political subdivision thereof, whether state or local, and any agency, authority (including supranational authority), commission, instrumentality, regulatory body, court, central bank or other Person exercising executive, legislative, judicial, taxing, regulatory or administrative powers or functions of or pertaining to government, including each Patent Office, the FDA and any other government authority in any country.

 

Indemnification Cap ” means the Purchase Price plus an annual rate of return of 12% (compounded monthly) as of any date of determination; provided, however, that in no event shall the indemnification cap exceed 150% of the Purchase Price.

 

Information ” has the meaning set forth in Section 1.32 of the License Agreement.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Intellectual Property Rights ” means the Opiant Technology, Adapt Applied Patents, Adapt Applied Know-How and Joint Intellectual Property Rights.

 

Joint Intellectual Property Rights ” has the meaning set forth in Section 6.1.2 of the License Agreement.

 

Joint Patents has the meaning set forth in Section 6.1.2 of the License Agreement.

 

License Agreement ” means that certain License Agreement dated as of December 15, 2014 between the Seller and Licensee, as amended by the License Amendment, and as further amended from time to time, and as further amended and supplemented by the Licensee Instruction. The term “ License Agreement ” shall include all rights that arise therefrom and relate thereto.

 

License Amendment ” means that certain Amendment No. 1 to License Agreement, dated December 13, 2016, by and between the Seller and Licensee.

 

Licensed Patents ” means the Product Specific Patents, Opiant Patents and Joint Patents.

 

Licensee ” means Adapt Pharma Operations Limited, an Irish limited company.

 

Licensee Instruction ” means the irrevocable direction to Licensee in the form set forth in Exhibit B .

 

Lien ” means any security interest, mortgage, pledge, hypothecation, assignment, deposit arrangement, encumbrance, lien (statutory or otherwise), charge against or interest in property or other priority or preferential arrangement of any kind or nature whatsoever, in each case to secure payment of a debt or performance of an obligation, including any conditional sale or any sale with recourse, other than obligations due under the License Agreement.

 

Lightlake Cost Cap ” has the meaning set forth in Section 3.8.1 of the License Agreement.

 

Loss ” means any loss, set-off, off-set, rescission, counterclaim, reduction, deduction, defense, cost, charge, expense, interest, fee, payment, demand, liability, claim, action, proceeding, penalty, fine, damages, judgment, order or other sanction.

 

Material Adverse Change ” means any event, circumstance or change resulting in a material adverse effect, in any respect, on (a) the legality, validity or enforceability of any of the Transaction Documents, any Product Agreement or the back-up security interest granted pursuant to Section 2.1(d), (b) the right or ability of the Seller (or any permitted assignee) or the Purchaser to perform any of its obligations under any of the Transaction Documents or any Product Agreement, in each case to which it is a party, or to consummate the transactions contemplated hereunder or thereunder, (c) the rights or remedies of the Purchaser under any of the Transaction Documents or of the Purchaser or the Seller under any Product Agreement, (d) the timing, amount or duration of the Royalties, (e) the Purchased Assets or (f) the Opiant Technology as it relates to the Product.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Narcan ® ” means Narcan® (naloxone HCI), the brand name for the product covered by NDA 208411.

 

NDA 208411 ” means New Drug Application 208411 granted to applicant Adapt Pharma Operations Limited and approved on November 18, 2015, and all additions, supplements, extensions and amendments thereof.

 

Net Sales ” has the meaning set forth in Section 1.45 of the License Agreement.

 

NIDA Agreement ” has the meaning set forth in Section 1.47 of the License Agreement.

 

Opiant Know-How ” has the meaning set forth in Section 1.38 of the License Agreement, defined as “Lightlake Know-How”.

 

Opiant Patents ” has the meaning set forth in Section 1.39 of the License Agreement, defined as “Lightlake Patents”.

 

Opiant Technology ” means the Opiant Know-How, Opiant Patents, Product Specific Patents and Seller’s interest in the Joint Intellectual Property Rights.

 

Orange Book ” means the Approved Drug Products with Therapeutic Equivalence Evaluations maintained by the FDA.

 

Patents ” has the meaning set forth in in Section 1.49 of the License Agreement.

 

Patent Office ” means the applicable patent office, including the United States Patent and Trademark Office and any comparable foreign patent office.

 

Person ” means any natural person, firm, corporation, limited liability company, partnership, joint venture, association, joint-stock company, trust, unincorporated organization, Governmental Authority or any other legal entity, including public bodies, whether acting in an individual, fiduciary or other capacity.

 

Product ” has the meaning set forth in Section 1.51 of the License Agreement. For the avoidance of doubt, “Product” includes Follow-On Products as defined in Section 5.2.5 of the License Agreement.

 

Product Agreements ” means the Adapt Agreements and any Additional License Agreements.

 

Product Specific Patents ” has the meaning set forth in Section 1.52 of the License Agreement.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Purchase Price ” means (a) the Upfront Purchase Price if the Earn Out Milestone is not achieved, and (b) the aggregate amount of (i) the Upfront Purchase Price and (ii) the Earn Out Milestone Payment, if such Earn Out Milestone is achieved.

 

Purchased Assets ” means, collectively, the Seller’s (a) right, title and interest in, to and under the Product Agreements to (i) receive all of the Royalties up to the Capped Royalty Amount, and thereafter to receive the Residual Royalty, and (ii) receive the statements produced by Licensee pursuant to Section 5.6 of the License Agreement and (b) right, to the extent possible under this Agreement, to cure any breach of or default under any Product Agreement by the Seller.

 

Regulatory Agency ” means a Governmental Authority with responsibility for the approval of the marketing and sale of pharmaceuticals or other regulation of pharmaceuticals in any country.

 

Regulatory Approvals ” means, collectively, all regulatory approvals, registrations, certificates, authorizations, permits and supplements thereto, as well as associated materials (including the product dossier) pursuant to which Products may be marketed, sold and distributed in a jurisdiction, issued by the appropriate Regulatory Agency.

 

Residual Royalty ” means (i) if the Earn Out Milestone is paid, then Purchaser shall receive 10% of all Royalties, provided , however , that if no generic version of Narcan® is commercialized prior to the sixth anniversary of the Closing, then Purchaser shall receive 5% of all Royalties after such date, and (ii) if the Earn Out Milestone is not paid, then Purchaser shall receive 7.86% of all Royalties, provided , however , that if no generic version of Narcan® is commercialized prior to the sixth anniversary of the Closing, then Purchaser shall receive 3.93% of all Royalties after such date.

 

Retained Royalties ” means all Royalties other than the Residual Royalties.

 

Retained Royalty Sale ” means a sale, transfer, conveyance, commercialization or monetization of any Retained Royalties.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Royalties ” means (a) all amounts or fees paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates arising out of, related to or resulting from the sale by Licensee or its Affiliates or its and their Sublicensees, successors and assigns, of Narcan® or any other Product, and, in each case, attributable to the period commencing on the Royalties Commencement Date, including (i) amounts pursuant to Section 5.4 of the License Agreement, (ii) post-termination royalties pursuant to Section 10.8.2 of the License Agreement and (iii) amounts pursuant to Section 5.13 of the License Agreement, (b) all milestone payments paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates pursuant to Sections 5.2 and 5.3 of the License Agreement, in each case paid or payable, owed or owing, accrued or otherwise required to be paid on or after the date hereof, (c) all indemnity payments, recoveries, damages, reimbursement of expenses or awards or settlement amounts paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates by Licensee or any third party and arising out of or relating to any Product or Opiant Technology (as it relates to any Product) or as a result of a breach by any Person (other than the Seller) of the License Agreement with respect thereto and attributable to the period commencing on the Royalties Commencement Date (other than reimbursements of Seller’s costs and expenses in connection with such action pursuant to the License Agreement to the extent that such costs and expenses have not been borne by the Purchaser), including pursuant to Section 6.4.3 of the License Agreement, (d) all interest on any amounts referred to in the foregoing clauses (a) , (b) and (c) , paid or payable, owed or owing or otherwise required to be paid to the Seller or any of its Affiliates, including pursuant to Section 5.9 of the License Agreement, (e) all amounts paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates by one or more licensees or sublicensees under any New Arrangement or due to a Self-commercialization Event, (f) all other amounts paid or payable, owed or owing or otherwise required to be paid to the Seller or any of its Affiliates by Licensee or any other Person arising out of, related to or resulting from Narcan® or any other Product, Opiant Technology (as it relates to any Product) or the Product Agreements and attributable to the period commencing on the Royalties Commencement Date, (g) all accounts (as defined under the UCC) evidencing the rights to the payments and amounts described herein and (h) all proceeds (as defined under the UCC) of any of the foregoing.

 

Royalties Commencement Date ” means October 1, 2016.

 

SEC ” means the U.S. Securities and Exchange Commission.

 

Set-off ” means any set-off, off-set, rescission, counterclaim, reduction, deduction or defense.

 

Specified Product ” means any Product in respect of which royalties or amounts will be due under the License Agreement.

 

Sublicensee ” has the meaning set forth in Section 1.61 of the License Agreement.

 

Subsidiary ” means, with respect to any Person, any other Person of which more than 50% of the outstanding Voting Securities of such other Person (irrespective of whether at the time Capital Securities of any other class or classes of such other Person shall or might have voting power upon the occurrence of any contingency) is at the time directly or indirectly owned or controlled by such Person, by such Person and one or more other Subsidiaries of such Person or by one or more other Subsidiaries of such Person.

 

Third Party ” has the meaning set forth in Section 1.62 of the License Agreement.

 

Third Party Royalty ” has the meaning set forth in Section 5.5 of the License Agreement.

 

Transaction Documents ” means this Agreement, the Bill of Sale and the Licensee Instruction.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

UCC ” means the Uniform Commercial Code as in effect from time to time in the State of Nevada; provided , that, if, with respect to any financing statement or by reason of any provisions of law, the perfection or the effect of perfection or non-perfection of the back-up security interest or any portion thereof granted pursuant to Section 2.1(d) is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of Nevada, then “ UCC ” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.

 

Upfront Payment ” means any payment from a Counterparty pursuant to an Additional License Agreement payable at the time such agreement is executed.

 

U.S. ” or “ United States ” means the United States of America.

 

Voting Securities ” means, with respect to any Person, Capital Securities of any class or kind ordinarily having the power to vote for the election of directors, managers or other voting members of the governing body of such Person.

 

Additional Definitions . The following definitions shall have the meaning ascribed to such definition in the corresponding section:

 

Defined Term   Section
Agreement   Preamble
Closing   6.1
Closing Date   6.1
Disputes   3.11(h)
Excluded Liabilities and Obligations   2.3
New Arrangement   5.7(a)
Nonassignable Assets   2.4
Purchaser   Preamble
Purchaser Account   5.4(b)
Purchaser Indemnified Party   7.1
Purchaser Offer Notice   5.8(b)
Retained Royalty Sale Notice   5.8(a)
Retained Royalty Sale Period   5.8(c)
Self-commercialization Event   5.7(c)
Seller   Preamble
Seller Account   5.4(d)
Seller Indemnified Party   7.2
Seller’s Notice   5.8(d)
Upfront Purchase Price   2.2

 

Section 1.2            Rules of Construction . Unless the context otherwise requires, in this Agreement:

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(a)           A term has the meaning assigned to it and an accounting term not otherwise defined has the meaning assigned to it in accordance with GAAP.

 

(b)           Unless otherwise defined, all terms used herein that are defined in the UCC shall have the meanings stated in the UCC.

 

(c)           Words of the masculine, feminine or neuter gender shall mean and include the correlative words of other genders, and words in the singular shall include the plural, and vice versa.

 

(d)          The terms “include”, “including” and similar terms shall be construed as if followed by the phrase “without limitation”.

 

(e)           References to an agreement or other document include references to such agreement or document as amended, restated, reformed, supplemented or otherwise modified in accordance with the terms hereof and thereof and include any annexes, exhibits and schedules attached thereto.

 

(f)           References to any statute or other legislative provision shall include any statutory or legislative modification or re-enactment thereof, or any substitution therefor.

 

(g)          References to any Person shall be construed to include such Person’s successors and permitted assigns.

 

(h)          The word “will” shall be construed to have the same meaning and effect as the word “shall”.

 

(i)           The words hereof ”, herein ”, “ hereunder and similar terms when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision hereof, and Article, Section and Exhibit references herein are references to Articles and Sections of, and Exhibits to, this Agreement unless otherwise specified.

 

(j)            In the computation of a period of time from a specified date to a later specified date, the word from means from and including and each of the words to and until means to but excluding”.

 

(k)           Where any payment is to be made, any funds are to be applied or any calculation is to be made under this Agreement on a day that is not a Business Day, unless this Agreement otherwise provides, such payment shall be made, such funds shall be applied and such calculation shall be made on the succeeding Business Day, and payments shall be adjusted accordingly.

 

(l)           Any reference herein to a term that is defined by reference to its meaning in the License Agreement shall refer to such term’s meaning in the License Agreement as in existence on the date hereof (and not to any new, substituted or amended version thereof unless the Purchaser has consented thereto).

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.  

 

Article II
PURCHASE AND SALE OF THE PURCHASED ASSETS

 

Section 2.1           Purchase and Sale .

 

(a)           Subject to the terms and conditions of this Agreement, on the Closing Date, the Seller hereby sells, contributes, assigns, transfers, conveys and grants to the Purchaser, and the Purchaser hereby purchases, acquires and accepts from the Seller, all of the Seller’s right, title and interest in and to the Purchased Assets, free and clear of any and all Liens, other than those Liens created in favor of the Purchaser by the Transaction Documents.

 

(b)           The Seller and the Purchaser intend and agree that the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets under this Agreement shall be, and are, a true, complete, absolute and irrevocable assignment and sale by the Seller to the Purchaser of the Purchased Assets and that such assignment and sale shall provide the Purchaser with the full benefits of ownership of the Purchased Assets. Neither the Seller nor the Purchaser intends the transactions contemplated hereunder to be, or for any purpose characterized as, a loan from the Purchaser to the Seller or a pledge or assignment or only a security agreement. The Seller waives any right to contest or otherwise assert that this Agreement does not constitute a true, complete, absolute and irrevocable sale and assignment by the Seller to the Purchaser of the Purchased Assets under Applicable Law, which waiver shall be enforceable against the Seller in any Bankruptcy Event relating to the Seller. The sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets shall be reflected on the Seller’s financial statements and other records as a sale of assets to the Purchaser (except to the extent GAAP or the rules of the SEC require otherwise with respect to the Seller’s consolidated financial statements).

 

(c)           The Seller hereby authorizes the Purchaser or its designee to execute, record and file, and consents to the Purchaser or its designee executing, recording and filing, at the Purchaser’s sole cost and expense, financing statements in the appropriate filing offices under the UCC (and continuation statements with respect to such financing statements when applicable), and amendments thereto or assignments thereof, in such manner and in such jurisdictions as are necessary or appropriate to evidence or perfect the sale, contribution, assignment, transfer, conveyance and grant by the Seller to the Purchaser, and the purchase, acquisition and acceptance by the Purchaser from the Seller, of the Purchased Assets and to perfect the security interest in the Purchased Assets granted by the Seller to the Purchaser pursuant to Section 2.1(d).

 

(d)           Notwithstanding that the Seller and the Purchaser expressly intend for the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets to be a true, complete, absolute and irrevocable sale and assignment, the Seller hereby assigns, conveys, grants and pledges to the Purchaser, as security for its obligations created hereunder in the event that the transfer contemplated by this Agreement is held not to be a sale, a security interest in and to all of the Seller’s right, title and interest in, to and under the Purchased Assets and, in such event, this Agreement shall constitute a security agreement.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(e)           The Purchaser acknowledges and agrees that, other than the representations and warranties of the Seller specifically contained in Article III, (a) there are no representations or warranties of the Seller either expressed or implied with respect to the Royalties or the Purchased Assets and that it does not rely on, and shall have no remedies in respect of, any representation or warranty not specifically set forth in Article III, and (b) nothing contained herein guarantees that sales of the Product and Royalties due to the Purchaser will meet the total Purchase Price or Capped Royalty Amount (it being understood and agreed that nothing in this Section 2.1(e) shall limit in any way the Seller’s obligations under Article VII).

 

Section 2.2           Purchase Price .

 

(a)           In partial consideration for the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets, and subject to the terms and conditions set forth herein, the Purchaser shall pay (or cause to be paid) to the Seller, or the Seller’s designee, on the Closing Date, the sum of $13,750,000.00, in immediately available funds by wire transfer to the Seller Account (the “ Upfront Purchase Price ”).

 

(b)           In partial consideration for the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets, and subject to the terms and conditions set forth herein, the Purchaser shall pay (or cause to be paid) to the Seller, or the Seller’s designee, the Earn Out Milestone Payment, in immediately available funds by wire transfer to the Seller Account, within five (5) Business Days of the date that the Earn Out Milestone has been achieved.

 

Section 2.3          No Assumed Obligations . Notwithstanding any provision in this Agreement, the License Agreement (including the last sentence of Section 11.3.1 thereof) or any other writing to the contrary, the Purchaser is purchasing, acquiring and accepting only the Purchased Assets and is not assuming any liability or obligation of the Seller or any of the Seller’s Affiliates of whatever nature, whether presently in existence or arising or asserted hereafter, including any liability or obligation of the Seller under the License Agreement whatsoever (and including, for the avoidance of doubt, the liabilities and obligations set forth in Section 10.8.1 thereof). All such liabilities and obligations shall be retained by and remain liabilities and obligations of the Seller or the Seller’s Affiliates (the “ Excluded Liabilities and Obligations ”).

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 2.4           Excluded Assets . The Purchaser does not, by purchase, acquisition or acceptance of the rights, title or interest granted hereunder or otherwise pursuant to any of the Transaction Documents, purchase, acquire or accept any assets or contract rights of the Seller under the License Agreement, other than the Purchased Assets, or any other assets of the Seller. Furthermore, nothing in this Agreement nor the consummation of the transactions contemplated hereby shall be construed as an attempt or agreement to assign any asset included in the Purchased Assets, including any contract, approval, authorization or other right, which by its terms or by Law is nonassignable without the consent of a third party or is cancelable by a third party in the event of an assignment (“ Nonassignable Assets ”) unless and until such consent shall have been obtained or to the extent any such assignment restriction is removed or expires by its term. Seller shall use its commercially reasonable efforts to cooperate with Purchaser in endeavoring to obtain such consents promptly. In the event consents to the assignment thereof cannot be obtained, such Nonassignable Assets shall be held by Seller in trust for Purchaser and the covenants and obligations thereunder shall be performed by Seller in Purchaser’s name and all benefits and obligations existing thereunder shall be for Purchaser’s account. Seller shall take such actions as Purchaser may reasonably request so as to provide Purchaser with the benefits of the Nonassignable Assets and to effect collection of money or other consideration that becomes due and payable under the Nonassignable Assets, and Seller shall promptly pay over to Purchases all money or other consideration received by it in respect of all Nonassignable Assets.

 

Section 2.5           Power of Attorney . Notwithstanding anything to the contrary in this Agreement but subject to Section 5.5, as of and from the Closing Date, Seller on behalf of itself and its Affiliates, and subject to the terms set forth in this Section 2.5, hereby irrevocably constitutes and appoints Purchaser, to the extent permitted by applicable Law and the terms of the Nonassignable Assets, with full power of substitution as Seller’s true and lawful attorney in fact with full irrevocable power and authority in the name and place of Seller and in the name of Seller or in its own name, to take any and all appropriate action and to execute and deliver any and all documents and instruments which may be necessary or desirable to accomplish the purposes of this Agreement and the Bill of Sale and, to the extent that Seller has the right under applicable Law and any applicable contract, Seller hereby grants to Purchaser the power and right, on behalf of Seller, to the extent Seller has the legal power or right to do such act for its own benefit without notice to or assent by Seller, and at any time, to do the following: (a) pay or discharge any taxes, Liens (other than Liens arising through Purchaser), security interests, or other encumbrances levied or placed on or threatened against the Purchased Assets; (b) communicate in its own name with any party to any contract with regard to the assignment of the right, title and interest of Seller in and under the Purchased Assets; (c) execute, in connection with the transfer of title, any endorsements, assignments or other instruments of conveyance or transfer with respect to the Purchased Assets, (d) to perform all the obligations and receive all the benefits of Seller under the Nonassignable Assets, and (e) defend, exercise or enforce any of Seller’s rights under the Product Agreements or Product Specific Patents in any manner reasonably necessary or advisable to protect Purchaser’s rights under this Agreement and appoint Purchaser their attorneys-in-fact to act in their name on their behalf. The power of attorney granted hereby is coupled with an interest, and may not be revoked or canceled by Seller without Purchaser’s written consent; provided, however that the term of the foregoing power of attorney shall be effective from the Closing Date and shall terminate upon Purchaser’s receipt of the Capped Royalty Amount. If reasonably requested by Purchaser, Seller shall execute a stand-alone power of attorney consistent with the terms of this Section 2.5 to enable Purchaser to present such power of attorney to other parties without disclosing this Agreement.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Article III
REPRESENTATIONS AND WARRANTIES OF THE SELLER

 

The Seller hereby represents and warrants to the Purchaser as of the date hereof as follows:

 

Section 3.1           Organization . The Seller is a corporation duly organized, validly existing and in good standing under the laws of the State of Nevada and has all corporate power and authority, and all licenses, permits, franchises, authorizations, consents and approvals of all Governmental Authorities, required to own its property and conduct its business as now conducted, to execute and deliver, and perform its obligations under, the Transaction Documents to which it is party and to exercise its rights and to perform its obligations under the License Agreement. The Seller is duly qualified to transact business as a foreign corporation and is in good standing in every jurisdiction in which the conduct of its business or the ownership or leasing of property requires such license or qualification is required by law (except where the failure to do so would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change).

 

Section 3.2           No Conflicts .

 

(a)           None of the execution and delivery by the Seller of any of the Transaction Documents to which the Seller is party, the performance by the Seller of the obligations contemplated hereby or thereby or the consummation of the transactions contemplated hereby or thereby will: (i) to Seller’s knowledge, contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, require prepayment under, or accelerate the performance provided by, in any respect, (A) any statute, law, rule, ordinance or regulation of any Governmental Authority, or any judgment, order, writ, decree, permit or license of any Governmental Authority, to which the Seller or any of its Subsidiaries or any of their respective assets or properties may be subject or bound, (B) any term or provision of any contract, agreement, indenture, lease, license, deed, commitment, obligation or instrument to which the Seller or any of its Subsidiaries is a party or by which the Seller or any of its Subsidiaries or any of their respective assets or properties is bound or committed (including the License Agreement) or (C) any term or provision of any of the organizational documents of the Seller or any of its Subsidiaries, except in the case of clauses (A) and (B), for such breaches, violations or defaults that, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Change; (ii) give rise to any additional right of termination, cancellation or acceleration of any right or obligation of the Seller or any of its Subsidiaries; or (iii) except as provided in any of the Transaction Documents to which it is party, result in or require the creation or imposition of any Lien on the Opiant Technology, Narcan® or any other Specified Product, the License Agreement or the Purchased Assets.

 

(b)           The Seller has not granted, nor does there exist, any Lien on the Transaction Documents, any Product Agreement, the Opiant Technology or the Purchased Assets. Except for the license granted by the Seller to Licensee under the License Agreement, there are no licenses, sublicenses or other rights under the Opiant Technology that have been granted to any other Person.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 3.3           Authorization . The execution and delivery of each of the Transaction Documents to which the Seller is party and the performance by the Seller of its obligations hereunder and thereunder have been duly authorized by the Seller. Each Transaction Document to which the Seller is party has been duly executed and delivered by the Seller and, when executed and delivered by all of the other parties thereto, such Transaction Document shall constitute the legal, valid and binding obligation of the Seller, enforceable against the Seller in accordance with its respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally, general equitable principles and principles of public policy.

 

Section 3.4          Ownership . The Seller is the exclusive owner of the entire right, title (legal and equitable) and interest in, to and under the Purchased Assets and the Opiant Technology and has good and valid title thereto, free and clear of all Liens. The Seller has duly and legally filed or applied for registration for its ownership interest in the Patents included in the Opiant Technology in the United States Patent and Trademark Office, and the Seller is the sole or joint “owner of record” of such Patents in the United States. The Purchased Assets sold, contributed, assigned, transferred, conveyed and granted to the Purchaser on the Closing Date have not been pledged, sold, contributed, assigned, transferred, conveyed or granted by the Seller to any other Person. The Seller has full right to sell, contribute, assign, transfer, convey and grant the Purchased Assets to the Purchaser. Upon the sale, contribution, assignment, transfer, conveyance and granting by the Seller of the Purchased Assets to the Purchaser, the Purchaser shall acquire good and marketable title to the Purchased Assets free and clear of all Liens, other than Liens in favor of the Purchaser, and shall be the exclusive owner of the Purchased Assets. The Purchaser has and shall have the same rights as the Seller would have with respect to the Purchased Assets (if the Seller were still the owner of such Purchased Assets) against any other Person.

 

Section 3.5          Governmental and Third Party Authorizations . The execution and delivery by the Seller of the Transaction Documents to which the Seller is party, the performance by the Seller of its obligations hereunder and thereunder and the consummation of any of the transactions contemplated hereunder and thereunder (including the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets to the Purchaser) do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority or any other Person (including any shareholder of, lender to or investor in, the Seller), except for the filing of a Current Report on Form 8-K with the SEC, the filing of UCC financing statements and the consent of Licensee contained in the Licensee Instruction.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 3.6           No Litigation . Except as set forth on Schedule 3.6 , there is no (a) action, suit, arbitration proceeding, claim, demand, citation, summons, subpoena, investigation or other proceeding (whether civil, criminal, administrative, regulatory, investigative or informal) pending or, to the knowledge of the Seller, threatened in respect of the Seller or any of its Subsidiaries, Narcan®, any other Specified Product or the Purchased Assets (including the License Agreement), at law or in equity, or (b) inquiry or investigation (whether civil, criminal, administrative, regulatory, investigative or informal) by or before a Governmental Authority pending or, to the knowledge of the Seller, threatened against the Seller or any of its Subsidiaries in respect of the Seller or any of its Subsidiaries, Narcan®, any other Specified Product or the Purchased Assets (including the License Agreement), that, in each case, (i) if adversely determined, would be a Material Adverse Change, or (ii) challenges or seeks to prevent or delay the consummation of any of the transactions contemplated by any of the Transaction Documents to which the Seller is party.

 

Section 3.7           Solvency . The Seller has determined that, and by virtue of its entering into the transactions contemplated by the Transaction Documents to which the Seller is a party and its authorization, execution and delivery of the Transaction Documents to which the Seller is a party, the Seller’s incurrence of any liability hereunder or thereunder or contemplated hereby or thereby is in its own best interests. Upon consummation of the transactions contemplated by the Transaction Documents and the application of the proceeds therefrom, (a) the fair saleable value of the Seller’s assets is greater than the sum of its debts, liabilities and other obligations, including contingent liabilities, (b) the present fair saleable value of the Seller’s assets is greater than the amount that would be required to pay its probable liabilities on its existing debts and other obligations existing as of the date hereof, including contingent liabilities, as they become absolute and matured (c) the Seller is able to realize upon its assets and pay its debts and other obligations existing as of the date hereof, including contingent obligations, as they mature (d) the Seller is not rendered insolvent, does not have unreasonably small capital with which to engage in its business and is not unable to pay its debts as they mature, (e) the Seller is not subject to any Bankruptcy Event and (f) the Seller is not rendered insolvent within the meaning of Section 101(32) of Title 11 of the United States Code.

 

Section 3.8           Tax Matters . No deduction or withholding for or on account of any tax has been made, or was required under Applicable Law to be made, from any payment to the Seller under the License Agreement and, following the Closing Date, the Seller believes that no such deduction or withholding will be made or required under currently Applicable Law to be made from any payment to the Purchaser under the License Agreement. The Seller has never filed any tax return or report under any name other than its exact legal name at the time of filing. The Seller has filed (or caused to be filed) all tax returns and reports required by law to have been filed by it and has paid all taxes required to be paid by it, except any such taxes that are being diligently contested in good faith by appropriate proceedings and for which adequate reserves in accordance with GAAP have been set aside on its books.

 

Section 3.9           No Brokers’ Fees . The Seller has not taken any action that would entitle any person or entity other than Torreya Partners LLC (whose fees and commissions are solely the responsibility of the Seller) to any commission or broker’s fee in connection with the transactions contemplated by this Agreement.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 3.10         Compliance with Laws . None of the Seller or any of its Subsidiaries (a) has violated or is in violation of, has been given actual notice of any violation of, or, to the knowledge of the Seller, is under investigation with respect to or has been threatened to be charged with, any law, statute, rule, ordinance or regulation of, or any judgment, order, writ, decree, injunction, stipulation, consent order, permit or license granted, issued or entered by, any Governmental Authority or (b) is subject to any judgment, order, writ, decree, injunction, stipulation, consent order, permit or license granted, issued or entered by any Governmental Authority, in each case, that would reasonably be expected to result in a Material Adverse Change. Each of the Seller and any Subsidiary of the Seller is in compliance with the requirements of all Applicable Laws, a breach of any of which would reasonably be expected to result in a Material Adverse Change.

 

Section 3.11         Intellectual Property Matters .

 

(a)           Attached hereto as Schedule 3.11(a)(i) and (ii) is a true, correct, and complete listing of all Product Specific Patents and Joint Patents, respectively, as of the date hereof.

 

(b)           Attached hereto as Schedule 3.11(b) is a true, correct, and complete listing of all Opiant Patents as of the date hereof.

 

(c)           The Seller is the sole and exclusive owner of the entire right, title and interest in the Opiant Know-How, Opiant Patents and Product Specific Patents, free and clear of any Liens (other than the License Agreement). The Seller is the joint owner with Licensee of the Joint Intellectual Property Rights, and the Seller’s interest therein is free and clear of any Liens (other than the License Agreement). To the knowledge of the Seller, there are no facts that would preclude the Seller from having clear title to the Opiant Technology. To the knowledge of the Seller, the Intellectual Property Rights constitute all Information and Patents owned or controlled by the Seller and Licensee that are necessary for the development, manufacture, having manufactured, import, use, sale, having sold, offering for sale or otherwise commercializing Narcan®.

 

(d)           Except as set forth on Schedule 3.6 , to the knowledge of the Seller, all of the issued Licensed Patents are valid and enforceable, and there is no reasonable basis or grounds for any Person to claim otherwise. The Seller has not received any opinion, whether preliminary in nature or qualified in any manner, which concludes that a challenge to the validity or enforceability of any of the Licensed Patents may succeed. Except as set forth on Schedule 3.6 , the Seller has not received any notice or other communication of any claim by any Person challenging, or threatening to challenge, the ownership of, or rights of the Seller in and to, or the validity or enforceability of, the Licensed Patents.

 

(e)           The Seller has not received any notice from any, and, to the knowledge of the Seller, there is no, Person who is or claims to be an inventor under any of the Licensed Patents who is not a named inventor thereof.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(f)           To the knowledge of the Seller, the Licensed Patents have been diligently prosecuted in each country in respect of which applications have been made in the respective Patent Office in accordance with applicable laws and regulations. To the knowledge of the Seller, each individual involved in the filing and prosecution of the Licensed Patents, including the named inventors of the Licensed Patents, has complied in all material respects with all applicable duties of candor and good faith in dealing with any Patent Office in connection with the filing and prosecution of the Licensed Patents, including any duty to disclose to any Patent Office all information known by such inventors to be material to the patentability of each of the Licensed Patents (including any relevant prior art), in each case, in those jurisdictions where such duties exist.

 

(g)           Except as described in the filings by the Seller with the SEC, or as set forth in the NIDA Agreement, to the knowledge of the Seller, no funding, facilities or resources of any governmental entity or any university, college or other educational institution or research center were used in the development of the Opiant Technology, and no governmental entity, university, college or other educational institution or research center has received from the Seller any ownership in or rights to any Opiant Technology.

 

(h)           There are no unpaid maintenance or renewal fees payable by the Seller to any third party that currently are overdue for any of the Licensed Patents. No Licensed Patents have lapsed or been abandoned, cancelled or expired. The Seller has not, and to the knowledge of the Seller, Licensee has not, committed any act, or failed to commit any required act, that could reasonably be expected to cause any of the Licensed Patents to expire prematurely or be declared invalid or unenforceable, or that estops the enforcement of any of the Licensed Patents against any third party.

 

(i)           Except as set forth on Schedule 3.6 , there is no pending, or, to the knowledge of the Seller, no threatened, opposition, interference, reexamination, reissue, inter partes review, post-grant review, cancellation, nullification, injunction, claim, suit, action, citation, summon, subpoena, hearing, inquiry, investigation (by the International Trade Commission or otherwise), complaint, arbitration, mediation, demand, decree or other dispute, disagreement, proceeding or claim (collectively, “ Disputes ”) challenging the legality, validity, enforceability or ownership of any of the Licensed Patents. There are no Disputes by or with any Person involving any Products. The Licensed Patents are not subject to any outstanding injunction, judgment, order, decree, ruling, settlement or other disposition of a Dispute.

 

(j)           To Seller’s knowledge, the exploitation of Narcan® will not infringe any Patent or other intellectual property or proprietary right of any Person. The Seller has not, and to the knowledge of the Seller, Licensee has not, received any notice or other communication of any claim by any Person asserting that the manufacture, importation, sale, offer for sale or use of Narcan® infringes or misappropriates any Patent or other intellectual property or proprietary right of any Person.

 

(k)           Narcan® is a Product.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(l)           Except as set forth on Schedule 3.6 , to the knowledge of the Seller, there is no Third Party infringing or threatening to infringe the Licensed Patents or misappropriating or threatening to misappropriate the Intellectual Property Rights. Except as set forth on Schedule 3.6 , the Seller has not received any written notice under the License Agreement of infringement of any of the Licensed Patents.

 

Section 3.12         Regulatory Approval, Manufacturing and Marketing .

 

(a)           Licensee is the sole and exclusive owner of all Regulatory Approvals related to Narcan®. To the knowledge of the Seller, Licensee has complied with its obligations to develop Narcan® and seek and obtain Regulatory Approval for Narcan® pursuant to the License Agreement. The Seller and, to the knowledge of the Seller, Licensee, and all of its and their contractors and consultants, conducted all development, manufacturing and other activities that served as the basis for Regulatory Approval of Narcan® in accordance with good laboratory practice, good clinical practice, and good manufacturing practice as applicable and defined by the FDA and Applicable Law.

 

(b)           Narcan® has received Regulatory Approval for marketing and distribution in the United States. Other than Narcan®, no other Products have received Regulatory Approval for marketing and distribution in the United States.

 

(c)           To the knowledge of the Seller, Licensee has complied with all obligations, including postmarketing and reporting requirements, necessary to maintain all Regulatory Approvals for Narcan®. The Seller has not received any notice or other communication from Licensee indicating that Licensee will not continue to comply with all obligations, including postmarketing and reporting requirements, necessary to maintain all Regulatory Approvals for Narcan®.

 

(d)           Neither the Seller nor, to the knowledge of the Seller, Licensee, has received any written or oral notice from the FDA or any other Regulatory Agency or Third Party alleging that the distribution, marketing, offering for sale, selling, manufacturing, labeling, storing or testing practices of Narcan® are unlawful, and Narcan® has not been the subject of any voluntary or involuntary recall.

 

Section 3.13         License Agreement .

 

(a)           Other than the Transaction Documents and the License Agreement, there is no contract, agreement or other arrangement (whether written or oral) to which the Seller or any of its Subsidiaries is a party or by which any of their respective assets or properties is bound or committed (i) that creates a Lien on, affects or otherwise relates in any material respect to the Purchased Assets, the License Agreement or the Opiant Technology, or (ii) for which breach, nonperformance, cancellation or failure to renew would reasonably be expected to result in a Material Adverse Change. To the knowledge of Seller, as of the Closing Date there are no Product Agreements other than the License Agreement. Except for the License Amendment, the License Agreement has not been amended or modified.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(b)           The Seller has provided to the Purchaser true, correct and complete copies of (i) the License Agreement, (ii) all royalty reports delivered to the Seller by Licensee pursuant to the License Agreement and (iii) all material notices and correspondence delivered to, or by, the Seller pursuant to, or relating to, the License Agreement since December 15, 2014.

 

(c)           The License Agreement is in full force and effect and is the legal, valid and binding obligation of the Seller and, to the knowledge of the Seller, Licensee, enforceable against the Seller and, to the knowledge of the Seller, Licensee in accordance with its terms, subject, as to enforcement of remedies, to bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally, general equitable principles and principles of public policy. The execution and delivery of, and performance of obligations under, the License Agreement were and are within the powers of the Seller and, to the knowledge of the Seller, Licensee. The License Agreement was duly authorized by all necessary action on the part of, and validly executed and delivered by, the Seller and, to the knowledge of the Seller, Licensee. The Seller is not in breach or violation of or in default under the License Agreement which would reasonably be expected to result in a Material Adverse Change. There is no event or circumstance that, upon notice or the passage of time, or both, could reasonably be expected to constitute or give rise to any breach or default in the performance of the License Agreement by the Seller or, to the knowledge of the Seller, Licensee.

 

(d)           The Seller has not waived any rights or defaults under the License Agreement or released Licensee, in whole or in part, from any of its obligations under the License Agreement. The Seller and Licensee have not agreed to amend or waive any provision of the License Agreement, and there is no current proposal to do so.

 

(e)           To the knowledge of the Seller, no event has occurred that would give the Seller or Licensee the right to terminate the License Agreement or cease paying Royalties or any other amounts thereunder. The Seller has not received any notice of an intention by Licensee to terminate or breach the License Agreement, in whole or in part, or challenging the validity or enforceability of the License Agreement or the obligation to pay the Royalties or any other amounts under the License Agreement, or that the Seller or Licensee is in default of its obligations under the License Agreement. To the knowledge of the Seller, there is no default, violation or breach by Licensee under or of the License Agreement. The Seller has not given Licensee any notice of termination of the License Agreement, in whole or in part.

 

(f)           Except as provided in the License Agreement, the Seller is not a party to any agreement providing for or permitting a sharing of, or Set-off or deduction against, the Royalties or any other amounts payable under the License Agreement to the Seller.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(g)           The Seller has not consented to an assignment by Licensee of any of Licensee’s rights or obligations under the License Agreement, and the Seller is not aware of any such assignment by Licensee. To the knowledge of the Seller, Licensee has not granted any sublicense under the Intellectual Property Rights to any Third Party. Except as contemplated by Section 2.1(a) and Section 2.1(d), the Seller has not assigned, in whole or in part, and has not granted, incurred or suffered to exist any Liens on the License Agreement, the Purchased Assets or any of the Seller’s right, title or interest in and to the Opiant Technology (other than, in the case of the Opiant Technology, the License Agreement).

 

(h)           Neither the Seller nor Licensee has made any claim of indemnification under the License Agreement.

 

(i)            The Seller has not exercised its rights to conduct an audit under the License Agreement.

 

(j)            To the knowledge of the Seller, the Seller has received all amounts owed to it under the License Agreement. The Seller has received (A) each payment pursuant to Section 5.1 of the License Agreement and each payment that was due prior to the date hereof pursuant to Section 5.4 of the License Agreement and (B) each applicable milestone payment pursuant to Sections 5.2.1 and 5.2.2 of the License Agreement. No payments under Sections 5.2.3, 5.2.4, 5.2.5, 5.2.6 or 5.3 of the License Agreement have become payable or have been paid as of the date hereof. No payments under Section 5.4.2 of the License Agreement shall be due and payable from and after the date hereof.

 

(k)           Licensee has not provided the Seller with any notice or document pursuant to Sections 3.3.1(b), 4.3.1, 5.5, 11.1 or 11.6 of the License Agreement, and the Seller has not provided Licensee with any notice pursuant to Sections 4.3.3, 11.1 or 11.6 of the License Agreement. The Seller has reached the Lightlake Cost Cap described in Section 3.8.1 of the License Agreement.

 

(l)            Except as set forth on Schedule 3.6 , no Generic Competition for Narcan® or Third Party Royalty in respect of Narcan® has occurred as of the date hereof and, to the knowledge of the Seller as of the date hereof, no Third Party has developed or is developing a Generic Product. To the knowledge of the Seller, no Product other than Narcan®, and no product containing any Product in combination with another active ingredient, has been or is being developed by Licensee or the Seller. The Seller has not received any communication indicating that Licensee has made any determination or election pursuant to clause (i) or (ii) of Section 5.5 of the License Agreement.

 

(m)          Except as set forth on Schedule 3.13(m) , all of the representations and warranties of Seller in the License Agreement remain true and correct as if made on the date hereof, except for the effects of the transactions set forth in the License Agreement.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 3.14        Profit Sharing Arrangements . Except as set forth on Schedule 3.14 , (i) no Person has the right pursuant to any contract, agreement or other arrangement (whether written or oral) between the Seller or any of its Affiliates and such Person to share or receive any payments, profits, financial return or other amounts relating to the Product, Licensed Patents (solely with respect to the Product) or Opiant Technology (solely with respect to the Product); and (ii) Seller has not assigned to any Person any rights that it has under the License Agreement to receive milestone payments, royalty payments or any other fees payable to Seller or any of its Affiliates under the License Agreement.

 

Section 3.15         UCC Matters . The Seller’s exact legal name is “Opiant Pharmaceuticals, Inc.”, and for the preceding 5 years has been either “Opiant Pharmaceuticals, Inc.” or “Lightlake Therapeutics Inc.”. The Seller was renamed from “Lightlake Therapeutics Inc.” to “Opiant Pharmaceuticals, Inc.” on January 28, 2016. The Seller’s principal place of business is, and for the preceding 5 years has been, either located in the State of Nevada, the State of California or the State of New York. The Seller’s jurisdiction of organization is the State of Nevada. For the preceding 5 years, the Seller has not been the subject of any merger or other corporate or other reorganization in which its identity or status was materially changed, except in each case when it was the surviving or resulting entity.

 

Section 3.16        Set-off and Other Sources of Royalty Reduction . Except as provided in the License Agreement, Licensee has no right of Set-off or deduction under any contract or other agreement against the Royalties or any other amounts payable to the Seller under the License Agreement. Licensee has not exercised, and, to the knowledge of the Seller, Licensee has not had the right to exercise and no event or condition exists that, upon notice or passage of time or both, could reasonably be expected to permit Licensee to exercise, any Set-off or deduction against the Royalties or any other amounts payable to the Seller under the License Agreement other than as provided under Sections 5.4.3 and 5.5. To the knowledge of the Seller, (i) there are no Third Party Patents that could reasonably be expected to provide a basis for a reduction in the Royalties due to the Seller pursuant to Section 5.5 of the License Agreement, or (ii) no event has occurred or fact exists that is likely to lead to a material reduction of the amount or frequency of the Royalties. There are no compulsory licenses granted or, to the knowledge of the Seller, threatened with respect to the Opiant Technology.

 

Section 3.17        Investment Company Status . The Seller is not, and will not be (immediately after giving effect to the Closing), an “investment company” within the meaning of the Investment Company Act of 1940, as amended.

 

Article IV
REPRESENTATIONS AND WARRANTIES OF THE PURCHASER

 

The Purchaser hereby represents and warrants to the Seller as of the date hereof as follows:

 

Section 4.1          Organization . The Purchaser is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware and has all organizational power and authority, and all licenses, permits, franchises, authorizations, consents and approvals of all Governmental Authorities, required to own its property and conduct its business as now conducted, to execute and deliver, and perform its obligations under, the Transaction Documents to which it is party.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 4.2           No Conflicts . None of the execution and delivery by the Purchaser of any of the Transaction Documents to which the Purchaser is party, the performance by the Purchaser of the obligations contemplated hereby or thereby or the consummation of the transactions contemplated hereby or thereby will contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, require prepayment under, or accelerate the performance provided by, in any respect, (i) any statute, law, rule, ordinance or regulation of any Governmental Authority, or any judgment, order, writ, decree, permit or license of any Governmental Authority, to which the Purchaser or any of its assets or properties may be subject or bound, (ii) any term or provision of any contract, agreement, indenture, lease, license, deed, commitment, obligation or instrument to which the Purchaser is a party or by which the Purchaser or any of its assets or properties is bound or committed or (iii) any term or provision of any of the organizational documents of the Purchaser.

 

Section 4.3           Authorization . The execution and delivery of each of the Transaction Documents to which the Purchaser is party and the performance by the Purchaser of its obligations hereunder and thereunder have been duly authorized by the Purchaser. Each Transaction Document to which the Purchaser is party has been duly executed and delivered by the Purchaser and, when duly executed and delivered by all of the parties thereto, such Transaction Document shall constitute the legal, valid and binding obligation of the Purchaser, enforceable against the Purchaser in accordance with its respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally, general equitable principles and principles of public policy.

 

Section 4.4           Governmental and Third Party Authorizations . The execution and delivery by the Purchaser of the Transaction Documents to which the Purchaser is party, the performance by the Purchaser of its obligations hereunder and thereunder and the consummation of any of the transactions contemplated hereunder and thereunder do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority or any other Person, except for the filing of UCC financing statements and the consent of Licensee contained in the Licensee Instruction.

 

Section 4.5           No Litigation . There is no (a) action, suit, arbitration proceeding, claim, demand, citation, summons, subpoena, investigation or other proceeding (whether civil, criminal, administrative, regulatory, investigative or informal) pending or, to the knowledge of the Purchaser, threatened by or against the Purchaser, at law or in equity, or (b) inquiry or investigation (whether civil, criminal, administrative, regulatory, investigative or informal) by or before a Governmental Authority pending or, to the knowledge of the Purchaser, threatened against the Purchaser, that, in each case, challenges or seeks to prevent or delay the consummation of any of the transactions contemplated by any of the Transaction Documents to which the Purchaser is party.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 4.6           Access to Information . The Purchaser acknowledges that it has (a) reviewed the License Agreement and such other documents and information relating to Narcan® and (b) had the opportunity to ask such questions of, and to receive answers from, representatives of the Seller concerning the License Agreement and Narcan®, in each case, as it deemed necessary to make an informed decision to purchase, acquire and accept the Purchased Assets in accordance with the terms of this Agreement. The Purchaser has such knowledge, sophistication and experience in financial and business matters that it is capable of evaluating the risks and merits of purchasing, acquiring and accepting the Purchased Assets in accordance with the terms of this Agreement.

 

Section 4.7           Funds Available . The Purchaser has sufficient funds on hand or binding and enforceable commitments to provide it with sufficient funds to satisfy its obligations, in each case to pay the Purchase Price, and the Purchaser has no reason to believe, and has not been provided with oral or written notice that any of its investors are not required or do not intend, for any reason, to satisfy their obligations under such commitments. The Purchaser acknowledges and agrees that its obligations under this Agreement are not contingent on obtaining financing.

 

Article V
COVENANTS

 

The parties hereto covenant and agree as follows:

 

Section 5.1            Books and Records; Notices .

 

(a)           After receipt by the Seller of notice of any action, claim, demand, dispute, investigation, arbitration or proceeding (commenced or threatened) relating to the transactions contemplated by any Transaction Document, the Purchased Assets or the Product Agreements or any default or termination by any Person under any Product Agreement, the Seller shall (i) promptly (but in no event more than five Business Days following receipt by the Seller) inform the Purchaser in writing of the receipt of such notice and the substance thereof and (ii) if such notice is in writing, promptly (but in no event more than five Business Days following receipt by the Seller) furnish the Purchaser with a copy of such notice and any related materials with respect thereto.

 

(b)           The Seller shall keep and maintain, or cause to be kept and maintained, at all times books and records adequate to reflect accurately all financial information it has received from Licensee with respect to the Purchased Assets.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(c)           Promptly after receipt by the Seller (but in no event more than five Business Days following receipt by the Seller) of any material notice, correspondence or communication (including, if requested by the Purchaser, any royalty reports) relating to any Product Agreement, the Royalties, the Intellectual Property Rights, the Purchased Assets or Narcan® or any other Product, which, for the avoidance of doubt, shall include a copy of any Sublicense agreement with a Commercial Sublicensee provided to the Seller pursuant to Section 4.3.1 of the License Agreement, the Seller shall (i) inform the Purchaser in writing of such receipt and (ii) furnish the Purchaser with a copy of such material notice or communication. Except for communications required to be given or made by the Seller under the License Agreement, the Seller shall not send any communication to Licensee or any of its Affiliates relating to, or involving, the Purchased Assets or the License Agreement, in each case, without the prior written consent of the Purchaser, and the Seller shall promptly provide to the Purchaser a copy of any such communication sent by the Seller to Licensee or any of its Affiliates.

 

(d)           The Seller shall provide the Purchaser with written notice as promptly as practicable (and in any event within five Business Days) after becoming aware of any of the following: (i) the occurrence of a Bankruptcy Event in respect of the Seller; (ii) any breach or default by the Seller of any covenant, agreement or other material provision of any Transaction Document to which it is party; (iii) any representation or warranty made by the Seller in any of the Transaction Documents or in any certificate delivered to the Purchaser pursuant to this Agreement shall prove to be untrue, inaccurate or incomplete in any material respect on the date as of which made; or (iv) any change, effect, event, occurrence, state of facts, development or condition that would reasonably be expected to result in a Material Adverse Change.

 

(e)           The Seller shall notify the Purchaser in writing not less than 30 days prior to any change in, or amendment or alteration of, the Seller’s (i) legal name, (ii) form or type of organizational structure or (iii) jurisdiction of organization.

 

(f)           Subject to applicable confidentiality restrictions and securities laws, the Seller shall make available such other information in the Seller’s possession, as the Purchaser may, from time to time, reasonably request with respect to the Purchased Assets, the Product Agreements, Narcan® or any other Product and the Intellectual Property Rights.

 

Section 5.2           Confidentiality; Public Announcement .

 

(a)           Except as otherwise required by law, by the rules and regulations of the SEC or any securities exchange or trading system or by the FDA or any other Governmental Authority with similar regulatory authority and except as otherwise set forth in this Section 5.2, all Confidential Information furnished by the Seller to the Purchaser, as well as the terms, conditions and provisions of this Agreement and any other Transaction Document, shall be kept confidential by the Purchaser and shall be used by the Purchaser only in connection with this Agreement and any other Transaction Document and the transactions contemplated hereby and thereby. Notwithstanding the foregoing, the Purchaser may disclose (i) such information to its Affiliates, actual and potential partners, directors, employees, managers, officers, agents, investors (including any holder of debt securities of the Purchaser and such holder’s advisors, agents and representatives), co-investors, insurers and insurance brokers, underwriters, financing parties, equity holders, brokers, bankers and trustees and to its and its Affiliates’ accountants, advisors, lawyers and representatives; provided , that such Person(s) shall be informed of the confidential nature of such information and shall be obligated to keep such information confidential pursuant to obligations of confidentiality no less onerous in the aggregate than those set out herein or shall have executed and delivered a confidentiality agreement in form and substance reasonably acceptable to the Seller; and (ii) the Purchase Price and the amount and nature of the Purchased Assets in the footnotes to the Purchaser’s financial statements, to the extent so required by the Purchaser’s independent accountants, and comparable disclosure in the Purchaser’s unaudited financial statements. The foregoing obligations shall expire on the second anniversary of the expiration or termination of the License Agreement in its entirety.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(b)           The Seller and the Purchaser acknowledge that each party hereto may, after execution of this Agreement, make a public announcement of the transactions contemplated by the Transaction Documents in the form mutually agreed upon by the Seller and Purchaser. The Seller and the Purchaser agree that, after the Closing Date, public announcements may be issued in the form of press release agreed upon by Seller and Purchaser, and in disclosures contained in documents to be filed with or furnished to the SEC, in each case subject to the Purchaser or the Seller having a reasonable prior opportunity to review such public announcement, and which announcement shall be in a form mutually acceptable to the Purchaser and the Seller, and either party hereto may thereafter disclose any information contained in such press release or SEC documents at any time without the consent of the other party hereto.

 

(c)           Notwithstanding Section 5.2(b), specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving party unless the combination and its principles are in the public domain or in the possession of the receiving party.

 

Section 5.3           Further Assurances .

 

(a)           Subject to the terms and conditions of this Agreement, each party hereto will use commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary under Applicable Laws to consummate the transactions contemplated by the Transaction Documents to which the Seller or the Purchaser, as applicable, is party, including to perfect the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets to the Purchaser pursuant to this Agreement. The Purchaser and the Seller agree to execute and deliver such other documents, certificates, instruments, agreements and other writings and to take such other actions as may be reasonably necessary or desirable, or reasonably requested by the other party hereto, in order to consummate or implement expeditiously the transactions contemplated by any Transaction Document to which the Seller or the Purchaser, as applicable, is party, and to perfect, protect, more fully evidence, vest and maintain in the Purchaser good, valid and marketable rights and interests in and to the Purchased Assets free and clear of all Liens (other than those Liens created in favor of the Purchaser by the Transaction Documents) or enable the Purchaser to exercise or enforce any of the Purchaser’s rights under any Transaction Document to which the Seller or the Purchaser, as applicable, is party, including following the Closing Date.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(b)           The Seller and the Purchaser shall cooperate and provide assistance as reasonably requested by the other party hereto, at the expense of such other party hereto, in connection with any litigation, arbitration or other proceeding (whether threatened, existing, initiated or contemplated prior to, on or after the date hereof) to which the other party hereto, any of its Affiliates or controlling persons or any of their respective officers, directors, equityholders, controlling persons, managers, agents or employees is or may become a party or is or may become otherwise directly or indirectly affected or as to which any such Persons have a direct or indirect interest, in each case relating to any Transaction Document, the Purchased Assets or the transactions described herein or therein but in all cases excluding any litigation brought by the Seller against the Purchaser or brought by the Purchaser against the Seller. For the avoidance of doubt, if and to the extent there is any overlap between the provisions of this Section 5.3(b) and the provisions of Sections 5.5, 5.6, 5.7 or 5.8, the provisions of Sections 5.5, 5.6, 5.7 and 5.8 shall govern.

 

(c)           The Seller shall comply with all Applicable Laws with respect to the Transaction Documents to which it is party, the Product Agreements, the Purchased Assets and all ancillary agreements related thereto, the violation of which would reasonably be expected to result in a Material Adverse Change.

 

(d)           The Seller shall not enter into any contract, agreement or other arrangement (whether written or oral), or exercise any of its rights under any Product Agreement in any manner, that could reasonably be expected to conflict with the Transaction Documents or serve or operate to limit or circumscribe any of the Purchaser’s rights under the Transaction Documents (or the Purchaser’s ability to exercise any such right).

 

Section 5.4           Payments on Account of the Purchased Assets .

 

(a)           If, notwithstanding the terms of the Licensee Instruction, Licensee or any other Person makes any future payment to the Seller (or any of its Subsidiaries) directly on account of the Purchased Assets, then (i) the portion of such payment that represents the Purchased Assets shall be held by the Seller (or such Subsidiary) in trust for the benefit of the Purchaser in a segregated account, (ii) the Seller (or such Subsidiary) shall have no right, title or interest whatsoever in such portion of such payment and shall not create or suffer to exist any Lien thereon and (iii) the Seller (or such Subsidiary) promptly, and in any event no later than five Business Days following the receipt by the Seller (or such Subsidiary) of such portion of such payment, shall remit such portion of such payment to the Purchaser Account pursuant to Section 5.4(b) in the exact form received with all necessary endorsements.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(b)           The Seller shall make all payments to be made by the Seller pursuant to this Agreement by wire transfer of immediately available funds, without Set-off or deduction, to the account set forth in the License Instruction (or to such other account as the Purchaser shall notify the Seller in writing from time to time) (the “ Purchaser Account ”).

 

(c)           If a Counterparty or any other Person makes any payment to the Purchaser of Royalties relating to periods prior to the Royalties Commencement Date or otherwise not comprising Purchased Assets, then (i) such payment (or the portion thereof not comprising Purchased Assets) shall be held by the Purchaser in trust for the benefit of the Seller in a segregated account, (ii) the Purchaser shall have no right, title or interest whatsoever in such payment (or the portion thereof not comprising Purchased Assets) and shall not create or suffer to exist any Lien thereon and (iii) the Purchaser promptly, and in any event no later than five Business Days following the receipt by the Purchaser of such payment (or the portion thereof not comprising Purchased Assets), shall remit such payment (or the portion thereof not comprising Purchased Assets) to the Seller Account pursuant to Section 5.4(d). For clarity, Purchaser shall receive Royalties for sales of Product made on or after the Royalties Commencement Date and the Purchased Assets do not include the payment of Royalties for sales of Product made prior to such Royalties Commencement Date but paid to Seller after such date.

 

(d)           The Purchaser shall make all payments of Royalties to be made by the Purchaser pursuant to Section 5.4(c) of this Agreement by wire transfer of immediately available funds, without Set-off or deduction, to the following account (or to such other account as the Seller shall notify the Purchaser in writing from time to time) (the “ Seller Account ”):

 

Bank Name: ****
ABA Number: ****
Account Number: ****
Account Name: ****
Swift: ****

 

(e)           If a Counterparty takes any Set-off (i) in accordance with the terms of the License Agreement where such Set-off (or any portion thereof) is made in respect of any event occurring, circumstance existing or action taken prior to the Royalties Commencement Date but has the effect of reducing amounts to be paid to the Purchaser following the Closing Date or (ii) against the Purchased Assets in respect of any right of such Counterparty (or any of its Affiliates) against the Seller (or any of its Affiliates) arising from or in connection with any matter (other than the Purchased Assets), then the Seller shall cause the amount of such Set-off (or portion thereof, as the case may be) to be paid in accordance with Section 5.4(b) promptly (but in no event later than five Business Days following such Set-off) to the Purchaser Account.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 5.5           Intellectual Property Matters

 

(a)          The Seller shall, in accordance with, and, subject to, Sections 6.2 and 6.3 of the License Agreement, (i) take such actions, and prepare, execute, deliver and file any and all agreements, documents and instruments, that are necessary or desirable to diligently preserve and maintain the Intellectual Property Rights, including all such actions to prosecute and maintain in effect the Licensed Patents and the Adapt Applied Patents and cause all required maintenance fees, annuities and like payments with respect to such Licensed Patents and the Adapt Applied Patents to be paid when due, and (ii) not disclaim (other than terminal disclaimers, as necessary) or abandon any of such Intellectual Property Rights, or fail to take any commercially reasonable action necessary to prevent the disclaimer or abandonment of such Intellectual Property Rights, without, in each case, the Purchaser’s prior written consent. The Seller shall not knowingly disclaim or abandon any of such Intellectual Property Rights, or fail to take any action necessary to prevent the disclaimer or abandonment of such Intellectual Property Rights, which would reasonably be expected to result in a Material Adverse Change. The Seller shall, when available in respect of Narcan® or any other Specified Product, obtain Patents and use commercially reasonable efforts (subject to subsection (d), below) for any corrections, substitutions, reissues and reexaminations thereof, obtain patent term extensions and any other forms of patent term restoration in any country and obtain patent listings in the FDA Electronic Orange Book.

 

(b)          The Seller may, and, if requested in writing by the Purchaser, shall, in accordance with, and, subject to, Section 6.4 of the License Agreement, use commercially reasonable efforts to defend and enforce any of the Intellectual Property Rights against infringement, misappropriation or interference by any other Person, and against any claims of invalidity or unenforceability in any relevant jurisdiction (including by bringing any legal action for infringement, misappropriation or interference, defending counterclaims of invalidity or unenforceability, or defending any action of any Person for declaratory judgment of non-infringement or non-interference). The Seller shall not, without the prior written consent of Purchaser, consent to any compromise or settlement relating to any claim, suit or action enforcing such Intellectual Property Rights against a Third Party that admits the invalidity or unenforceability of such Intellectual Property Rights or requires the payment of money, or otherwise adversely affects the rights of Purchaser with respect to its rights hereunder without the prior written consent of the Purchaser.

 

(c)          All costs and expenses (including attorneys’ fees and expenses) incurred by the Seller in connection with the prosecution, maintenance, defense or enforcement of the Intellectual Property Rights shall be borne by the Seller.

 

(d)          The Purchaser shall have the right to retain, at its sole expense, outside counsel, who shall be permitted (together with the Purchaser), where and when reasonably practical, to consult with the Seller and its counsel regarding the filing, prosecution, maintenance, enforcement and defense of the Intellectual Property Rights, and any actions taken or proposed to be taken by the Seller in respect thereof, including the strategy, preparation and presentation of any such actions. The Seller and its counsel shall give reasonable consideration to the views of the Purchaser and its counsel with respect thereto. In furtherance of the foregoing, the Seller shall provide the Purchaser with such information with respect to the filing, prosecution, maintenance, enforcement and defense of such Intellectual Property Rights as the Purchaser may, from time to time, request. The Seller shall consider in good faith such information provided by Purchaser or its counsel.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(e)          In the event that the Seller does not defend and/or enforce any of the Opiant Technology against infringement, misappropriation or interference by any other Person, or against any claims of invalidity or unenforceability (or, if after initiating any such action, at any time thereafter fails to diligently and vigorously pursue such action), in each case to the full extent of the Seller’s rights (in accordance with, and, subject to, the License Agreement), the Seller shall so notify the Purchaser as soon as possible and in any event at least 30 days before the time limit for bringing or otherwise maintaining such action or proceeding, and the parties shall discuss in good faith the reasons for the Seller’s decision within three Business Days of the Purchaser receiving such notice. In the event after such discussion the Purchaser disagrees with the Seller’s decision, then the Purchaser may commence or continue such defense and/or enforcement of any of such Opiant Technology against infringement, misappropriation or interference by any other Person, and against any claims of invalidity or unenforceability, and the Seller shall cooperate fully with the Purchaser in any such defense and enforcement, including, to the extent required, the furnishing of a power of attorney or joining such action as a necessary party, and executing all papers and instruments as reasonably requested by the Purchaser. The Purchaser may not enter into a settlement in connection with such defense and/or enforcement action or proceeding brought by the Purchaser relating to the Product without Licensee’s written consent. All costs and expenses (including attorneys’ fees and expenses) incurred by the Purchaser in connection with such defense and enforcement shall be borne by the Purchaser. Purchaser shall indemnify, defend and hold Seller Indemnified Parties harmless from and against, and will pay to each Seller Indemnified Party the amount of, any and all Losses (including attorneys fees) awarded against or incurred or suffered by such Seller Indemnified Party arising from any defense and/or enforcement action brought by Purchaser hereunder.

 

Section 5.6           License Agreement .

 

(a)           The Seller (i) shall perform and comply in all material respects with its duties and obligations under the License Agreement, (ii) shall not forgive, release or compromise any amount owed to or becoming owing to it under the License Agreement, (iii) shall not, without the prior written consent of the Purchaser, assign (other than in accordance with Section 8.4), amend, modify, supplement, restate, waive, cancel or terminate (or consent to any cancellation or termination of), in whole or in part, the License Agreement (which, for the avoidance of doubt, includes the Licensee Instruction) or any rights constituting or involving or affecting or relating to the Purchased Assets or the right to receive the Royalties, (iv) shall not breach any of the provisions of the License Agreement, (v) except pursuant to Section 5.7, shall not enter into any new agreement in respect of the Purchased Assets or Narcan® or any other Products, (vi) shall not waive any obligation of, or grant any consent to, Licensee under or in respect of Narcan® or any other Products, the License Agreement or the other Purchased Assets and (vii) shall not agree to do any of the foregoing.

 

(b)           The Seller shall not, without the prior written consent of the Purchaser, grant any consent or withhold any consent, exercise or waive any right or option, fail to exercise any right or option or take or fail to take any action in respect of, affecting or relating to the Purchased Assets, Narcan® or any other Products or the License Agreement in any manner that would, in each case, reasonably be expected to (i) result in a Material Adverse Change or (ii) cause an event of default under, or breach or termination of, this Agreement, any other Transaction Document or the License Agreement.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(c)           Promptly after (i) receiving notice from Licensee (A) terminating the License Agreement (in whole or in part), (B) alleging any breach of or default under the License Agreement by the Seller or (C) asserting the existence of any facts, circumstances or events that, alone or together with other facts, circumstances or events, could reasonably be expected (with or without the giving of notice or passage of time, or both) to give rise to a breach of or default under the License Agreement by the Seller or the right to terminate the License Agreement (in whole or in part) by Licensee or (ii) the Seller otherwise has knowledge of any fact, circumstance or event that, alone or together with other facts, circumstances or events, could reasonably be expected (with or without the giving of notice or passage of time, or both) to give rise to a breach of or default under the License Agreement by the Seller or give the right to terminate the License Agreement (in whole or in part) by Licensee, in each case, the Seller shall (A) promptly (and in any event within five Business Days) give a written notice to the Purchaser describing in reasonable detail the relevant breach, default or termination event, including a copy of any written notice received from Licensee, and, in the case of any breach or default or alleged breach or default by the Seller, describing in reasonable detail any corrective action the Seller proposes to take, and (B) use commercially reasonable efforts to promptly cure such breach or default and shall promptly (and in any event within five Business Days) give written notice to the Purchaser upon curing such breach or default; provided , however , that, if the Seller fails to cure such breach or default, the Purchaser shall, to the extent permitted by the License Agreement, be entitled to take any and all actions the Purchaser considers reasonably necessary to promptly cure such breach or default, and the Seller shall reasonably cooperate with the Purchaser for such purpose and reimburse the Purchaser promptly (but in no event later than five Business Days following notice thereof) for all costs and expenses incurred in connection therewith.

 

(d)           Promptly after the Seller obtains knowledge of a breach or default or alleged breach or default under the License Agreement by Licensee or of the existence of any facts, circumstances or events that, alone or together with other facts, circumstances or events, could reasonably be expected (with or without the giving of notice or passage of time, or both) to give rise to a breach or default under the License Agreement by Licensee or the right to terminate the License Agreement (in whole or in part) by the Seller, in each case, the Seller shall (i) within five Business Days of obtaining such knowledge, give a written notice to the Purchaser describing in reasonable detail the relevant breach, default or termination event and (ii) if requested by the Purchaser, proceed in consultation with the Purchaser and shall consider a request by Purchaser for Seller to take such permissible actions (including commencing legal action against Licensee with legal counsel selected by the Purchaser, such counsel to be reasonably satisfactory to the Seller and the costs and expenses of such counsel to be borne by the Seller) to enforce compliance by Licensee with the relevant provisions of the License Agreement and to exercise any or all of the Purchaser’s or the Seller’s rights and remedies, whether under the License Agreement or by operation of law, with respect thereto; provided, that any action taken by Seller shall be in Seller’s sole discretion. The Purchaser shall have the right, at its sole expense, to participate in and control, with counsel appointed by it, any meeting, discussion, action, suit or other proceeding relating to any such breach, default or termination event or alleged breach, default or termination event, including any counterclaim, settlement discussions or meetings; provided , that the fees and expenses of the Purchaser’s counsel in connection therewith shall be borne by the Seller if such breach, default or termination event or alleged breach, default or termination event results from, or is caused by, directly or indirectly, a breach or default by the Seller. The Seller shall make reasonably available its relevant records and personnel to the Purchaser in connection with any prosecution or litigation against Licensee to enforce any of the Purchaser’s or the Seller’s rights under the License Agreement. Notwithstanding anything to the contrary contained in this Article V, nothing herein shall prevent, restrict or limit the Purchaser from directly enforcing Licensee’s payment obligations in respect of the Purchased Assets with counsel selected by the Purchaser in its sole discretion and at its sole cost and expense.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(e)           Except in connection with an assignment by the Seller to any other Person with which the Seller may merge or consolidate or to which the Seller may sell all or substantially all of its assets or all of its assets related to Products in accordance with the provisions of Section 8.4, the Seller shall not dispose of, assign or otherwise transfer, or grant, incur or suffer to exist any Lien on the License Agreement, the Purchased Assets or any of the Seller’s right, title or interest in and to the Opiant Technology (in whole or in part), without the prior written consent of the Purchaser.

 

(f)           The Seller shall to the extent reasonably practicable make available its records and personnel to the Purchaser in connection with any prosecution of litigation by the Purchaser against Licensee to enforce any of the Purchaser’s or the Seller’s rights under the License Agreement, and provide reasonable assistance and authority to file and bring the litigation, including, if required to bring the litigation, being joined as a party plaintiff. The Purchaser shall reimburse the Seller for all out-of-pocket costs and expenses (including reasonable attorneys’ fees) incurred in connection with this Section 5.6(f).

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 5.7           Termination of Product Agreements; Mergers, Consolidations and Asset Sales Involving Licensee; Manufacture of Product by Seller .

 

(a)           Without limiting the provisions of Section 5.6, if a Counterparty or the Seller terminates or provides written notice of termination of any Product Agreement (in whole or in part), or any such Product Agreement is otherwise terminated (in whole or in part), then the Seller agrees to use commercially reasonable efforts to enter into replacement Product Agreements with suitable replacement Counterparties as soon as reasonably practicable (any such license, a “ New Arrangement ”). In the event Seller is unable to or unwilling to secure one or more replacement Product Agreements within one hundred twenty (120) days of any such termination, Seller agrees that Purchaser shall have the right to negotiate a New Arrangement and grant a license of the Opiant Technology for Products on substantially the same terms as those in the Product Agreement that is being replaced. Seller shall provide reasonable assistance to and cooperate with the Purchaser in such efforts as the Purchaser shall reasonably undertake in connection with the negotiation of a license, which shall include terms no less favorable in the aggregate to the Seller than those contained in the Product Agreement being replaced with respect to obligations and costs imposed on the Seller, disclaimers of the Seller’s liability, intellectual property ownership and control, commercialization diligence and indemnification of the Seller subject to the termination terms set forth therein, including but not limited to Section 10.8 of the License Agreement, if applicable. All costs and expenses (including reasonable attorneys’ fees and expenses) incurred by the Seller and the Purchaser in connection with the negotiation and consummation of the New Arrangement pursuant to this Section 5.7 shall be borne by the Seller. Should the Purchaser identify any New Arrangement, the Seller agrees to negotiate in good faith such New Arrangement that satisfies the foregoing requirements promptly upon the written request of the Purchaser. In the event the Seller enters into a New Arrangement, the Seller agrees to comply in all material respects with the provisions of this Agreement in connection with the New Arrangement and references herein to the Purchased Assets and the Product Agreements shall be deemed to be references to any new purchased asset and any new license agreement, constructed under the New Arrangement, and references to Licensee or other Counterparty shall be deemed to be references to the Counterparty to such new license agreement and that other party’s Affiliates and sublicensees or licensees, as the case may be. Such New Arrangement shall also provide, for no additional consideration from the Purchaser, that (i) the Purchaser shall have the same rights as those acquired under the Product Agreement pursuant to this Agreement and (ii) all payments and other consideration (including any Upfront Payment and other fees) thereunder be made by the other party to such New Arrangement directly to the Purchaser.

 

(b)           If there occurs a merger or consolidation of the Seller, on the one hand, and Licensee or its Affiliates, on the other hand, a sale of all or substantially all of the Seller’s assets to Licensee or its Affiliates or a sale or assignment of the License Agreement or the Opiant Technology by the Seller to Licensee or its Affiliates, and in any such case the License Agreement is terminated in connection therewith, the Seller (or its successor) shall pay to the Purchaser royalties on net sales of Specified Products for the term of the License Agreement on the same basis as if the License Agreement had continued and the Purchaser’s rights with respect to the Purchased Assets and the covenants of the Seller under this Agreement shall continue to apply on the same basis as if the License Agreement was in place between the Seller and Licensee.

 

(c)           For the avoidance of doubt, to the extent that Seller and or any of its Affiliate engages in any commercialization, direct sale, manufacture or other transfer of the Product other than pursuant to a Product Agreement (each a “ Self-commercialization Event ”), the definition of Royalties shall include any and all amounts received by Seller and/or any of its Affiliate in relation thereto and the subject matter of this Agreement shall be deemed to cover the amounts received by Seller and/or its Affiliate in connection therewith. In the event that Seller and/or its Affiliate engage in any such commercialization, direct sale, marketing or transfer of the Product, Seller and Purchaser shall reasonably cooperate to amend this Agreement to the extent reasonably necessary.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 5.8            Audits . Beginning on the Closing Date, the Seller shall, upon the Purchaser’s written request and at the Purchaser’s sole expense (and using an accountant designated by the Purchaser and reasonably satisfactory to the Seller), inspect and audit Licensee’s books and records at any time and from time to time, in accordance with Section 5.13 of the License Agreement for payments that are paid or payable to the Purchaser with respect to Royalties beginning on or after the Royalty Commencement Date. Notwithstanding the foregoing, the Seller shall retain the exclusive right to inspect and audit Licensee’s books and records at any time and from time to time, in accordance with Section 5.13 of the License Agreement, at its sole discretion and its sole expense, for payments that are paid or payable to the Seller pursuant to the License Agreement with respect to all amounts and payment obligations attributable to the period prior to the Royalties Commencement Date. The Seller and the Purchaser agree that all expenses of any inspection or audit carried out for the benefit of the Purchaser that would otherwise be borne by the Seller pursuant to the License Agreement shall instead be borne by the Purchaser, provided, that such inspection or audit (and any expenses related thereto) is approved in advance and in writing by the Purchaser.

 

Section 5.9          Tax Matters .

 

(a)           Notwithstanding the accounting treatment thereof, for United States federal, state and local tax purposes, the Seller and the Purchaser shall treat the transactions contemplated by the Transaction Documents as a sale for United States federal, state and local tax purposes .

 

(b)           The parties hereto agree not to take any position that is inconsistent with the provisions of this Section 5.9 on any tax return or in any audit or other administrative or judicial proceeding unless (i) the other party hereto has consented to such actions or (ii) the party hereto that contemplates taking such an inconsistent position has been advised by nationally recognized tax counsel in writing that there is no “reasonable basis” (within the meaning of Treasury Regulation Section 1.6662-3(b)(3)) for the position specified in this Section 5.9. If there is an inquiry by any Governmental Authority of the Seller or the Purchaser related to this Section 5.9, the parties hereto shall cooperate with each other in responding to such inquiry in a reasonable manner consistent with this Section 5.9.

 

Article VI
THE CLOSING

 

Section 6.1           Closing . The closing of the transactions contemplated hereby (the “ Closing ”) shall take place on the date hereof (the “ Closing Date ”) at the offices of DLA Piper LLP (US) located at 1650 Market Street, Suite 4900, Philadelphia, Pennsylvania 19103-7300, or such other place as the parties mutually agree.

 

Section 6.2           Closing Deliverables of the Seller . At the Closing, the Seller shall deliver or cause to be delivered to the Purchaser the following:

 

(a)           the Bill of Sale executed by the Seller;

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(b)           an irrevocable direction to Licensee to pay the Royalties directly to the Purchaser Account, and as to such other matters, in the form set forth in Exhibit B executed by the Seller and by Licensee;

 

(c)           a certificate of an executive officer of the Seller (the statements made in which shall be true and correct on and as of the Closing Date): (i) attaching copies, certified by such officer as true and complete, of (x) the organizational documents of the Seller and (y) resolutions of the governing body of the Seller authorizing and approving the execution, delivery and performance by the Seller of the Transaction Documents and the transactions contemplated herein and therein; (ii) setting forth the incumbency of the officer or officers of the Seller who have executed and delivered the Transaction Documents including therein a signature specimen of each officer or officers; and (iii) attaching a copy, certified by such officer as true and complete, of a recent good standing certificate of the appropriate Governmental Authority of the Seller’s jurisdiction of organization, stating that the Seller is in good standing under the laws of such jurisdiction;

 

(d)           opinions of DLA Piper LLP, special counsel to the Seller, and Rice Reuther Sullivan & Carroll, LLP, Nevada counsel to the Seller, dated the Closing Date, substantially in the form of Exhibit C ; and

 

(e)           such other certificates, documents and financing statements as the Purchaser may reasonably request, including (i) a financing statement reasonably satisfactory to the Purchaser to create, evidence and perfect the sale of the Purchased Assets pursuant to Section 2.1(c) and the back-up security interest granted pursuant to Section 2.1(d), (ii) a solvency certificate delivered by the Chief Financial Officer of the Seller in form and substance reasonably satisfactory to the Purchaser and (iii) the results of a recent Lien search with respect to the Seller, such search and results to be reasonably satisfactory to the Purchaser.

 

Section 6.3          Closing Deliverables of the Purchaser . At the Closing, the Purchaser shall deliver or cause to be delivered to the Seller the following:

 

(a)           the Bill of Sale executed by the Purchaser; and

 

(b)           payment of the Purchase Price in accordance with Section 2.2.

 

Section 6.4            Receipt . Following the Closing, the Seller shall deliver to the Purchaser a duly executed receipt for payment of the Purchase Price.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.  

 

Article VII
INDEMNIFICATION

 

Section 7.1          Indemnification by the Seller . The Seller agrees to indemnify and hold each of the Purchaser and its Affiliates and any and all of their respective partners, directors, managers, members, officers, employees, agents and controlling persons (each, a “ Purchaser Indemnified Party ”) harmless from and against, and will pay to each Purchaser Indemnified Party the amount of, any and all Losses (including attorneys fees) awarded against or incurred or suffered by such Purchaser Indemnified Party, whether or not involving a third party claim, demand, action or proceeding, to the extent directly arising out of (i) any breach of any representation, warranty or certification made by the Seller in any of the Transaction Documents to which the Seller is party or certificates given by the Seller to the Purchaser in writing pursuant to this Agreement, (ii) any breach of or default under any covenant or agreement by the Seller to the Purchaser pursuant to any Transaction Document to which the Seller is party, (iii) any fees, expenses, costs, liabilities or other amounts incurred or owed by the Purchaser to any brokers, financial advisors or comparable other Persons retained or employed by it in connection with the transactions contemplated by this Agreement, and (iv) any of Seller’s obligations and liabilities under any contract, agreement or other arrangement (whether written or oral) described on Schedule 3.14 ; provided , however , that the foregoing shall exclude any indemnification to any Purchaser Indemnified Party to the extent resulting from (A) the bad faith, gross negligence or willful misconduct of such Purchaser Indemnified Party or (B) acts or omissions of the Seller based upon the written instructions from any Purchaser Indemnified Party. Notwithstanding the foregoing, absent the Seller’s actual fraud, in no event shall the Seller’s indemnification obligations under clause (i) of this Section 7.1 exceed, individually or in the aggregate, an amount equal to the Indemnification Cap, less all Royalties received by the Purchaser, without duplication, under this Agreement prior to and through resolution of the applicable claim.

 

Section 7.2          Indemnification by the Purchaser . The Purchaser agrees to indemnify and hold each of the Seller and its Affiliates and any and all of their respective partners, directors, managers, members, officers, employees, agents and controlling Persons (each, a “ Seller Indemnified Party ”) harmless from and against, and will pay to each Seller Indemnified Party the amount of, any and all Losses (including attorneys’ fees) awarded against or incurred or suffered by such Seller Indemnified Party, whether or not involving a third party claim, demand, action or proceeding, to the extent directly arising out of (i) any breach of any representation, warranty or certification made by the Purchaser in any of the Transaction Documents to which the Purchaser is party or certificates given by the Purchaser in writing pursuant to this Agreement or (ii) any breach of or default under any covenant or agreement by the Purchaser pursuant to any Transaction Document to which the Purchaser is party; provided , however , that the foregoing shall exclude any indemnification to any Seller Indemnified Party to the extent resulting from (A) the bad faith, gross negligence or willful misconduct of such Seller Indemnified Party or (B) acts or omissions of the Purchaser based upon the written instructions from any Seller Indemnified Party. Notwithstanding the foregoing, absent the Purchaser’s actual fraud, in no event shall the Purchaser’s indemnification obligations under clause (i) of this Section 7.2 exceed, individually or in the aggregate, an amount equal to the Purchase Price, less all payments of Royalties received by the Seller prior to and through resolution of the applicable claim.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 7.3          Procedures . If any claim, demand, action or proceeding (including any investigation by any Governmental Authority) shall be brought or alleged against an indemnified party in respect of which indemnity is to be sought against an indemnifying party pursuant to Section 7.1 or Section 7.2, the indemnified party shall, promptly after receipt of notice of the commencement of any such claim, demand, action or proceeding, notify the indemnifying party in writing of the commencement of such claim, demand, action or proceeding, enclosing a copy of all papers served, if any; provided , that the omission to so notify such indemnifying party will not relieve the indemnifying party from any liability that it may have to any indemnified party under Section 7.1 or Section 7.2 unless, and only to the extent that, the indemnifying party is actually prejudiced by such omission. In case any such action is brought against an indemnified party and it notifies the indemnifying party of the commencement thereof, the indemnifying party will be entitled, at the indemnifying party’s sole cost and expense, to participate therein and, to the extent that it may wish, to assume the defense thereof, with counsel reasonably satisfactory to such indemnified party (who shall not, except with the consent of the indemnified party, be counsel to the indemnifying party), and, after notice from the indemnifying party to such indemnified party of its election so to assume the defense thereof, the indemnifying party will not be liable to such indemnified party under this Article VII for any legal or other expenses subsequently incurred by such indemnified party in connection with the defense thereof other than reasonable costs of investigation and except as provided below. In any such proceeding, an indemnified party shall have the right to retain its own counsel, but the reasonable and documented fees and expenses of such counsel shall be at the expense of such indemnified party unless (a) the indemnifying party and the indemnified party shall have mutually agreed to the retention of such counsel, (b) the indemnifying party has assumed the defense of such proceeding and has failed within a reasonable time to retain counsel reasonably satisfactory to such indemnified party or (c) the named parties to any such proceeding (including any impleaded parties) include both the indemnifying party and the indemnified party and representation of both parties by the same counsel would be inappropriate due to actual or potential conflicts of interests between them based on the advice of counsel to the indemnifying party. It is agreed that the indemnifying party shall not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the reasonable and documented fees and expenses of more than one separate law firm (in addition to local counsel where necessary) for all such indemnified parties. The indemnifying party shall not be liable for any settlement of any proceeding effected without its written consent (such consent not to be unreasonably withheld), but, if settled with such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party from and against any Loss by reason of such settlement or judgment. No indemnifying party shall, without the prior written consent of the indemnified party (such consent not to be unreasonably withheld), effect any settlement, compromise or discharge of any claim or pending or threatened proceeding in respect of which any indemnified party is or could have been a party and indemnity could have been sought hereunder by such indemnified party, unless such settlement, compromise or discharge, as the case may be, (i) includes an unconditional written release of such indemnified party, in form and substance reasonably satisfactory to the indemnified party, from all liability on claims that are the subject matter of such claim or proceeding, (ii) does not include any statement as to an admission of fault, culpability or failure to act by or on behalf of any indemnified party and (iii) does not impose any obligation or restriction on any indemnified party.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 7.4          Exclusive Remedy . Except in the case of fraud or intentional breach, following the Closing, the indemnification afforded by this Article VII shall be the sole and exclusive remedy for any and all Losses sustained or incurred by a party hereto in connection with the transactions contemplated by the Transaction Documents, including with respect to any breach of any representation, warranty or certification made by a party hereto in any of the Transaction Documents or certificates given by a party hereto in writing pursuant hereto or thereto or any breach of or default under any covenant or agreement by a party hereto pursuant to any Transaction Document. Notwithstanding anything in this Agreement to the contrary, in the event of any breach or failure in performance of any covenant or agreement contained in any Transaction Document, the non-breaching party shall be entitled to specific performance, injunctive or other equitable relief pursuant to Section 8.2.

 

Article VIII
MISCELLANEOUS

 

Section 8.1          Survival . All representations, warranties and covenants made herein and in any other Transaction Document or any certificates delivered pursuant to this Agreement shall survive the execution and delivery of this Agreement and the Closing. The rights hereunder to indemnification, payment of Losses or other remedies based on such representations, warranties and covenants shall not be affected by any investigation conducted with respect to, or any knowledge acquired (or capable of being acquired) at any time (whether before or after the execution and delivery of this Agreement or the Closing) in respect of the accuracy or inaccuracy of or compliance with, any such representation, warranty or covenant. The waiver of any condition based on the accuracy of any representation or warranty, or on the performance of or compliance with any covenant, shall not affect the rights hereunder to indemnification, payment of Losses or other remedies based on such representations, warranties and covenants.

 

Section 8.2          Specific Performance . Each of the parties hereto acknowledges that the other party hereto will have no adequate remedy at law if it fails to perform any of its obligations under any of the Transaction Documents. In such event, each of the parties hereto agrees that the other party hereto shall have the right, in addition to any other rights it may have (whether at law or in equity), to specific performance of this Agreement.

 

Section 8.3          Notices . All notices, consents, waivers and other communications hereunder shall be in writing and shall be effective (a) upon receipt when sent through the mails, registered or certified mail, return receipt requested, postage prepaid, with such receipt to be effective the date of delivery indicated on the return receipt, (b) upon receipt when sent by an overnight courier, (c) on the date personally delivered to an authorized officer of the party to which sent or (d) on the date transmitted by facsimile or other electronic transmission with a confirmation of receipt, in all cases, with a copy emailed to the recipient at the applicable address, addressed to the recipient as follows:

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

if to the Seller, to:

 

Opiant Pharmaceuticals, Inc.
Attention: Roger Crystal

401 Wilshire Blvd., 12th Floor
Santa Monica, CA 90401
Facsimile: 917-322-2105
Email: rcrystal@opiant.com

 

With a copy (that does not constitute notice) to:

 

DLA Piper LLP (US)

1650 Market Street, Suite 4900

Philadelphia, PA 19103

Facsimile: 215-606-3341
Email: Fahd.Riaz@dlapiper.com

Attn: Fahd M.T. Riaz, Esq.

 

if to the Purchaser, to:

 

SWK Funding LLC

c/o SWK Holdings

14755 Preston Road, Suite 105

Dallas, Texas 75254

Attn: Winston Black

 

With a copy (that does not constitute notice) to:

 

Holland & Knight LLP

200 Crescent Court, Suite 1600

Dallas, Texas 75201

Attn: Ryan Magee

 

Each party hereto may, by notice given in accordance herewith to each of the other party hereto, designate any further or different address to which subsequent notices, consents, waivers and other communications shall be sent.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 8.4           Successors and Assigns . Subject to the remainder of this Section 8.4, the provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns. The Seller shall not be entitled to assign or otherwise transfer any Transaction Document or any of its obligations, rights or interests under any of the Transaction Documents, in whole or in part, by operation of law, merger, change of control or otherwise, without the prior written consent of the Purchaser, and any purported assignment or transfer without such consent shall be void and of no effect; provided , however , that the Seller may, upon prior written notice to the Purchaser, but without the prior written consent of the Purchaser, assign any of its obligations or rights under this Agreement to any other Person with which it may merge or consolidate or to which it may sell all or substantially all of its assets or all of its assets related to the Products, provided that the Seller assigns all but not less than all, Product Agreements to the assignee and the assignee under such assignment agrees to be bound by the terms of the Transaction Documents and the Product Agreements and furnishes a written agreement (in form and substance reasonably satisfactory to the Purchaser) to the Purchaser to that effect. The Purchaser shall not be entitled to assign or otherwise transfer any Transaction Document or any of its obligations, rights or interests under any of the Transaction Documents, in whole or in part, without the prior written consent of the Seller which shall not be unreasonably withheld, conditioned or delayed; provided , however , that the Purchaser may, upon prior written notice to the Seller, but without the prior consent (written or otherwise) of the Seller, assign the Transaction Documents or any of the Purchaser’s rights, interests or obligations thereunder to (i) any Affiliate of the Purchaser which Affiliate shall agree in writing to be bound to the terms and conditions of all such Transaction Documents, (ii) a lender in connection with providing collateral security to such lender, or (iii) in connection with any sale of all or substantially all of the assets or securities of Purchaser or any of its Affiliates, including by way of merger. In the event of permitted assignment by the Purchaser, the Seller shall be under no obligation to reaffirm any representations, warranties or covenants made in this Agreement or any of the other Transaction Documents or take any other action in connection with any such assignment by the Purchaser.

 

Section 8.5            Independent Nature of Relationship . The relationship between the Seller and the Purchaser is solely that of seller and purchaser, and neither the Seller nor the Purchaser has any fiduciary or other special relationship with the other party hereto or any of its Affiliates. Nothing contained herein or in any other Transaction Document shall be deemed to constitute the Seller and the Purchaser as a partnership, an association, a joint venture or any other kind of entity or legal form.

 

Section 8.6            Entire Agreement . This Agreement, together with the Exhibits hereto (which are incorporated herein by reference), and the other Transaction Documents constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersede all prior agreements, understandings and negotiations, both written and oral, between the parties hereto with respect to the subject matter of this Agreement. No representation, inducement, promise, understanding, condition or warranty not set forth herein (or in the Exhibits hereto or the other Transaction Documents) has been made or relied upon by either party hereto. Neither this Agreement nor any provision hereof is intended to confer upon any Person other than the parties hereto and the other Persons referenced in Article VII any rights or remedies hereunder.

 

Section 8.7            Governing Law .

 

(a)           THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL SUBSTANTIVE LAWS OF THE STATE OF NEW YORK WITHOUT REFERENCE TO THE RULES THEREOF RELATING TO CONFLICTS OF LAW OTHER THAN SECTION 5-1401 OF THE GENERAL OBLIGATIONS LAW OF THE STATE OF NEW YORK, AND THE OBLIGATIONS, RIGHTS AND REMEDIES OF THE PARTIES HEREUNDER SHALL BE DETERMINED IN ACCORDANCE WITH SUCH LAWS.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

(b)           Each of the parties hereto hereby irrevocably and unconditionally submits, for itself and its property, to the non-exclusive jurisdiction of the Supreme Court of the State of New York sitting in New York County and of the United States District Court of the Southern District of New York, and any appellate court from any thereof, in any action or proceeding arising out of or relating to this Agreement, or for recognition or enforcement of any judgment, and each of the parties hereto hereby irrevocably and unconditionally agrees that all claims in respect of any such action or proceeding may be heard and determined in such New York State court or, to the extent permitted by law, in such federal court. Each of the parties hereto agrees that a final judgment in any such action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.

 

(c)           Each of the parties hereto hereby irrevocably and unconditionally waives, to the fullest extent it may legally and effectively do so, any objection that it may now or hereafter have to the laying of venue of any suit, action or proceeding arising out of or relating to this Agreement in any court referred to in Section 8.7(b). Each of the parties hereto hereby irrevocably waives, to the fullest extent permitted by law, the defense of an inconvenient forum to the maintenance of such action or proceeding in any such court.

 

(d)           Each of the parties hereto irrevocably consents to service of process in the manner provided for notices in Section 8.3. Nothing in this Agreement will affect the right of any party hereto to serve process in any other manner permitted by law. Each of the parties hereto waives personal service of any summons, complaint or other process, which may be made by any other means permitted by New York law.

 

Section 8.8           Waiver of Jury Trial . EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT, OR THE TRANSACTIONS CONTEMPLATED HEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY). EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF THE OTHER PARTY HERETO HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT THE OTHER PARTY HERETO WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 8.8.

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Section 8.9           Severability . If one or more provisions of this Agreement are held to be invalid or unenforceable by a court of competent jurisdiction, such provision shall be excluded from this Agreement and the balance of this Agreement shall be interpreted as if such provision were so excluded and shall remain in full force and effect and be enforceable in accordance with its terms. Any provision of this Agreement held invalid or unenforceable only in part or degree by a court of competent jurisdiction shall remain in full force and effect to the extent not held invalid or unenforceable.

 

Section 8.10         Counterparts . This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each party hereto shall have received a counterpart hereof signed by the other party hereto. Any counterpart may be executed by facsimile or other electronic transmission, and such facsimile or other electronic transmission shall be deemed an original.

 

Section 8.11         Amendments; No Waivers . Neither this Agreement nor any term or provision hereof may be amended, supplemented, restated, waived, changed or modified except with the written consent of the parties hereto. No failure or delay by either party hereto in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege. No notice to or demand on either party hereto in any case shall entitle it to any notice or demand in similar or other circumstances. No waiver or approval hereunder shall, except as may otherwise be stated in such waiver or approval, be applicable to subsequent transactions. No waiver or approval hereunder shall require any similar or dissimilar waiver or approval thereafter to be granted hereunder. The rights and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by law.

 

Section 8.12         Table of Contents and Headings . The Table of Contents and headings of the Articles and Sections of this Agreement have been inserted for convenience of reference only, are not to be considered a part hereof and shall in no way modify or restrict any of the terms or provisions hereof.

 

{SIGNATURE PAGE FOLLOWS}

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first written above.

 

  OPIANT PHARMACEUTICALS, INC.
     
  By: /s/ Roger Crystal
    Name:  Roger Crystal
    Title:  Chief Executive Officer
     
    SWK Funding LLC
     
  By: /s/ Winston Black
    Name: Winston Black
    Title: Chief Executive Officer

 

[ Signature Page to Purchase and Sale Agreement ]

 

 

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

EXHIBIT A

 

FORM OF BILL OF SALE

 

This BILL OF SALE is dated as of December 13, 2016 (the “ Closing Date ”) by Opiant Pharmaceuticals, Inc., a Nevada corporation (the “ Seller ”), in favor of SWK Funding LLC, a Delaware limited liability company (the “ Purchaser ”).

 

RECITALS

 

WHEREAS, the Seller and the Purchaser are parties to that certain Purchase and Sale Agreement, dated as of the Closing Date (the “ Agreement ”), pursuant to which, among other things, the Seller agrees to sell, contribute, assign, transfer, convey and grant to the Purchaser, and the Purchaser agrees to purchase, acquire and accept from the Seller, all of the Seller’s right, title and interest in, to and under the Purchased Assets, for the consideration described in the Agreement; and

 

WHEREAS, the parties hereto now desire to carry out the purposes of the Agreement by the execution and delivery of this instrument evidencing the Purchaser’s purchase, acquisition and acceptance of the Purchased Assets;

 

NOW, THEREFORE, in consideration of the premises and the mutual agreements set forth in the Agreement and of other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties hereto agree as follows:

 

1. The Seller, by this Bill of Sale, does hereby sell, contribute, assign, transfer, convey and grant to the Purchaser, and the Purchaser does hereby purchase, acquire and accept , the Purchased Assets.

 

2. The parties hereto acknowledge that the Purchaser is not assuming any of the Excluded Liabilities and Obligations.

 

3. This Bill of Sale (i) is made pursuant to, and is subject to the terms of, the Agreement and (ii) shall be binding upon and inure to the benefit of the Seller, the Purchaser and their respective successors and assigns, for the uses and purposes set forth and referred to above, effective immediately upon its delivery to the Purchaser.

 

4. THIS BILL OF SALE SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL SUBSTANTIVE LAWS OF THE STATE OF NEW YORK WITHOUT REFERENCE TO THE RULES THEREOF RELATING TO CONFLICTS OF LAW OTHER THAN SECTION 5-1401 OF THE GENERAL OBLIGATIONS LAW OF THE STATE OF NEW YORK, AND THE OBLIGATIONS, RIGHTS AND REMEDIES OF THE PARTIES HEREUNDER SHALL BE DETERMINED IN ACCORDANCE WITH SUCH LAWS.

 

  A- 1  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

5. This Bill of Sale may be executed in any number of counterparts, each of which so executed shall be deemed to be an original, but all of such counterparts shall together constitute but one and the same instrument.

 

6. The following terms as used herein shall have the following respective meanings:

 

· Adapt Agreements ” means the License Agreement and any sub-license agreements concerning any Product or Opiant Technology (as it relates to any Product) entered into by Licensee and any and all other related agreements concerning any Product or Opiant Technology (as it relates to any Product) by and between Seller and Licensee, or Licensee and a sub-licensee and/or a third party, as applicable, in each case only to the extent that such agreements relate to sale, manufacture, marketing, distribution or license of any Product or Opiant Technology (as it relates to any Product).

 

· Additional License Agreements ” means any New Arrangement and any additional revenue generating agreements entered into by Seller with Counterparties with respect to the sale, manufacture, marketing, distribution or licensing of any Product or Opiant Technology (as it relates to any Product), as well as any and all sub-license agreements entered into by such Counterparty and any and all other related agreements by and between Seller and such Counterparty, or such Counterparty and a sub-licensee, as applicable with respect to the sale, manufacture, marketing, distribution or license of any Product or Opiant Technology (as it relates to any Product).

 

· Affiliate ” means, with respect to any Person, any other Person that, directly or indirectly, controls, is controlled by or is under common control with such Person. For purposes of this definition, “control” of a Person means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of Voting Securities, by contract or otherwise, and the terms “controlled” and “controlling” have meanings correlative to the foregoing.

 

· Capital Securities ” means, with respect to any Person, all shares, interests, participations or other equivalents (however designated, whether voting or non-voting) of such Person’s capital, whether now outstanding or issued after the Closing Date, including common shares, ordinary shares, preferred shares, membership interests or share capital in a limited liability company or other Person, limited or general partnership interests in a partnership, beneficial interests in trusts or any other equivalent of such ownership interest or any options, warrants and other rights to acquire such shares or interests, including rights to allocations and distributions, dividends, redemption payments and liquidation payments.

 

  A- 2  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

· Capped Royalty Amount ” means $20,625,000 unless the Earn Out Milestone is achieved, then such Capped Royalty Amount means $26,250,000, it being understood and agreed that if any Royalties are required to be refunded, returned or otherwise paid by the Purchaser to Seller or to Licensee, such Royalties shall be disregarded for purposes of determining whether the Capped Royalty Amount has been reached; provided , however , that the Capped Royalty Amount shall be increased by 1.5 times the aggregate amount of any costs and expenses (including attorneys’ fees and expenses) incurred by the Purchaser in connection with (i) any defense or enforcement of the Opiant Technology under Section 5.5(e), or (ii) the participation or control of the Purchaser (with counsel appointed by it) under Section 5.6(d) of any meeting, discussion, action, suit or other proceeding relating to any breach, default or termination event or alleged breach, default or termination event by Licensee under the License Agreement, including any counterclaim, settlement discussions or meetings.

 

· Counterparty ” means Licensee and any other Persons counterparty to an Additional License Agreement.

 

· Earn Out Milestone ” means the point in time that Licensee has received in excess of $25,000,000 of cumulative Net Sales for any two consecutive fiscal quarters during the period from October 1, 2016 through September 30, 2017 from the sale of Narcan®.

 

· Excluded Liabilities and Obligations ” means all liabilities and obligations retained by the Seller or the Seller’s Affiliates.

 

· Joint Intellectual Property Rights ” has the meaning set forth in Section 6.1.2 of the License Agreement.

 

· License Agreement ” means that certain License Agreement dated as of December 15, 2014 between the Seller and Licensee, as amended by the License Amendment, and as further amended from time to time, and as further amended and supplemented by the Licensee Instruction. The term “License Agreement” shall include all rights that arise therefrom and relate thereto.

 

· Net Sales ” has the meaning set forth in Section 1.45 of the License Agreement.

 

  A- 3  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

· New Arrangement ” means a replacement Product Agreements with suitable replacement Counterparty in the event that a Counterparty or the Seller terminates or provides written notice of termination of any Product Agreement (in whole or in part), or any such Product Agreement is otherwise terminated (in whole or in part).

 

· Opiant Know-How ” has the meaning set forth in Section 1.38 of the License Agreement, defined as “Lightlake Know-How”.

 

· Opiant Patents ” has the meaning set forth in Section 1.39 of the License Agreement, defined as “Lightlake Patents”.

 

· Opiant Technology ” means the Opiant Know-How, Opiant Patents, Product Specific Patents and Seller’s interest in the Joint Intellectual Property Rights.

 

· Person ” means any natural person, firm, corporation, limited liability company, partnership, joint venture, association, joint-stock company, trust, unincorporated organization, Governmental Authority or any other legal entity, including public bodies, whether acting in an individual, fiduciary or other capacity.

 

· Product ” has the meaning set forth in Section 1.51 of the License Agreement. For the avoidance of doubt, “Product” includes Follow-On Products as defined in Section 5.2.5 of the License Agreement.

 

· Product Agreements ” means the Adapt Agreements and any Additional License Agreements.

 

· Product Specific Patents ” has the meaning set forth in Section 1.52 of the License Agreement.

 

· Purchased Assets ” means, collectively, the Seller’s (a) right, title and interest in, to and under the Product Agreements to (i) receive all of the Royalties up to the Capped Royalty Amount, and thereafter to receive the Residual Royalty, and (ii) receive the statements produced by Licensee pursuant to Section 5.6 of the License Agreement and (b) right, to the extent possible under this Agreement, to cure any breach of or default under any Product Agreement by the Seller.

 

· Residual Royalty ” means (i) if the Earn Out Milestone is paid, then Purchaser shall receive 10% of all Royalties, provided, however, that if no generic version of Narcan® is commercialized prior to the sixth anniversary of the Closing, then Purchaser shall receive 5% of all Royalties after such date, and (ii) if the Earn Out Milestone is not paid, then Purchaser shall receive 7.86% of all Royalties, provided, however, that if no generic version of Narcan® is commercialized prior to the sixth anniversary of the Closing, then Purchaser shall receive 3.93% of all Royalties after such date.
  A- 4  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

· Royalties ” means (a) all amounts or fees paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates arising out of, related to or resulting from the sale by Licensee or its Affiliates or its and their Sublicensees, successors and assigns, of Narcan® or any other Product, and, in each case, attributable to the period commencing on the Royalties Commencement Date, including (i) amounts pursuant to Section 5.4 of the License Agreement, (ii) post-termination royalties pursuant to Section 10.8.2 of the License Agreement and (iii) amounts pursuant to Section 5.13 of the License Agreement, (b) all milestone payments paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates pursuant to Sections 5.2 and 5.3 of the License Agreement, in each case paid or payable, owed or owing, accrued or otherwise required to be paid on or after the date hereof, (c) all indemnity payments, recoveries, damages, reimbursement of expenses or awards or settlement amounts paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates by Licensee or any third party and arising out of or relating to any Product or Opiant Technology (as it relates to any Product) or as a result of a breach by any Person (other than the Seller) of the License Agreement with respect thereto and attributable to the period commencing on the Royalties Commencement Date (other than reimbursements of Seller’s costs and expenses in connection with such action pursuant to the License Agreement to the extent that such costs and expenses have not been borne by the Purchaser), including pursuant to Section 6.4.3 of the License Agreement, (d) all interest on any amounts referred to in the foregoing clauses (a), (b) and (c), paid or payable, owed or owing or otherwise required to be paid to the Seller or any of its Affiliates, including pursuant to Section 5.9 of the License Agreement, (e) all amounts paid or payable, owed or owing, accrued or otherwise required to be paid to the Seller or any of its Affiliates by one or more licensees or sublicensees under any New Arrangement or due to a Self-commercialization Event, (f) all other amounts paid or payable, owed or owing or otherwise required to be paid to the Seller or any of its Affiliates by Licensee or any other Person arising out of, related to or resulting from Narcan® or any other Product, Opiant Technology (as it relates to any Product) or the Product Agreements and attributable to the period commencing on the Royalties Commencement Date, (g) all accounts (as defined under the UCC) evidencing the rights to the payments and amounts described herein and (h) all proceeds (as defined under the UCC) of any of the foregoing.
  A- 5  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

· Royalties Commencement Date ” means October 1, 2016.

 

· Sublicensee ” has the meaning set forth in Section 1.61 of the License Agreement.

 

· Voting Securities ” means, with respect to any Person, Capital Securities of any class or kind ordinarily having the power to vote for the election of directors, managers or other voting members of the governing body of such Person.

 

  A- 6  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

IN WITNESS WHEREOF, the parties hereto have executed this Bill of Sale as of the day and year first written above.

 

  OPIANT PHARMACEUTICALS, INC.
     
  By:  
    Name:  Roger Crystal
    Title: Chief Executive Officer
     
  SWK Funding LLC
     
  By:  
    Name:
    Title:

 

  A- 7  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

EXHIBIT B

 

FORM OF LICENSEE INSTRUCTION

 

December 13, 2016

 

VIA OVERNIGHT COURIER

ADVANCE COPY VIA EMAIL

 

Adapt Pharma Operations Limited

45 Fitzwilliam Square

Dublin 2, Ireland
Attention: Chief Financial Officer

 

SWK Holdings Corporation

14755 Preston Road, Suite 105

Dallas, Texas 75254

Attention: Winston Black

 

Ladies and Gentlemen:

 

Reference is hereby made to that certain License Agreement dated as of December 15, 2014 between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.), a Nevada corporation (“ Opiant ”), and Adapt Pharma Operations Limited, an Irish limited company (“ you ” or “ Adapt ”) (as amended by that certain Amendment No. 1 to License Agreement, dated December 13, 2016 (the “ Amendment ”), and as the same may be further amended in accordance with its terms from time to time, the “ License Agreement ”).

 

As you know and as evidenced by the Bill of Sale between SWK Funding LLC, a Delaware limited liability company (the “ Purchaser ”), and Opiant (the “ Bill of Sale ”), attached hereto as Appendix A , Opiant is, concurrently herewith, irrevocably selling, contributing, assigning, transferring, conveying and granting the “ Purchased Assets ”, as defined in such Bill of Sale, to the Purchaser on the date hereof (the “ Effective Date ”).

 

Accordingly, you are, for the benefit of the Purchaser, hereby irrevocably and unconditionally directed to make all payments of Royalties (as defined in the Bill of Sale) payable to Opiant by Adapt on or after the Effective Date by wire transfer in United States dollars to the following account:

 

****

****

****

Routing Number: ****

SWIFT: ****

Account Number: ****

Account Name: ****

 

  B- 1  

 

  

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

After payment in full of Royalties to Purchaser equal to the Capped Royalty Amount, unless otherwise instructed by Opiant and the Purchaser in writing, you are irrevocably and unconditionally directed to make all payments of Residual Royalties by wire transfer in United States dollars to the Purchaser pursuant to the wiring instructions set forth above, with all Retained Royalties to be paid to Opiant pursuant to the wiring instructions set forth below:

 

Bank Name: ****

ABA Number: ****

Account Number: ****

Account Name: ****

Swift: ****

 

Except for the payment directions set forth above, all Royalties shall be payable subject to and in accordance with the terms, conditions and requirements of the License Agreement.

 

In addition, you are, for the benefit of the Purchaser, hereby irrevocably and unconditionally instructed to send all statements produced by Adapt pursuant to Section 5.6 of the License Agreement, to the following party at the following address, with copies to Opiant, commencing with the first such report delivered after the Effective Date:

 

c/o SWK Holdings Corporation

14755 Preston Road, Suite 105

Dallas, Texas 75254

Attention: Winston Black

Email: wblack@swkhold.com

 

By signing below, you hereby acknowledge and agree that (i) you consent to the sale, contribution, assignment, transfer, conveyance and grant of the Purchased Assets to the Purchaser in accordance with the Bill of Sale and confirm that the last sentence of Section 11.3.1 of the License Agreement shall not apply to such sale, contribution, assignment, transfer, conveyance and grant and (ii) the Purchaser is not assuming any liability or obligation of Opiant whatsoever under the License Agreement and you shall look solely to Opiant for payment or performance of any such liability or obligation.

 

Opiant agrees and acknowledges, with respect to all Confidential Information (as defined in the License Agreement) of Adapt that is provided or disclosed to the Purchaser by Opiant, or by Adapt pursuant to this Licensee Instruction, that (i) all such Confidential Information shall be subject to the requirements of Article 7 of the License Agreement, (ii) the Purchaser is and shall at all times be bound by confidentiality and non-use covenants substantially the same as those contained in Article 7 of the License Agreement (it being understood and agreed that the duration of such covenants shall be no shorter than the duration of Article 7 of the License Agreement) and (iii) anything to the contrary notwithstanding, such Confidential Information shall be deemed to have been disclosed to the Purchaser by Opiant and Opiant shall remain responsible for any failure by the Purchaser or any of its employees, representatives or agents to treat such Confidential Information as required by this paragraph and Article 7 of the License Agreement.

 

Opiant agrees and acknowledges that nothing contained herein shall in any way diminish or otherwise affect or modify Opiant’s liabilities, duties and obligations under and pursuant to the License Agreement.

 

  B- 2  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

The Purchaser hereby agrees that it will not unreasonably delay, withhold or condition its consent to an amendment to the License Agreement, provided that Purchaser hereby agrees that Purchaser shall not object to any amendment on the basis of the financial terms in such amendment if such contains the financial terms set forth in Exhibit A to the Amendment.

 

Each of Adapt and Opiant agree and acknowledge, for the benefit of the Purchaser, that this Licensee Instruction may not be amended or modified except by an instrument signed by the Purchaser.

 

Thank you for your cooperation regarding this matter.

 

  Very truly yours,
   
  OPIANT PHARMACEUTICALS, INC.
     
  By:  
    Name: Roger Crystal
    Title: Chief Executive Officer

 

Acknowledged and agreed to by:  
   
ADAPT PHARMA OPERATIONS LIMITED  
     
By:    
  Name:  
  Title:  

 

Acknowledged and agreed to by:  
   
SWK Funding LLC  
   
By:  
  Name:  Winston Black  
  Title: Chief Executive Officer  

 

cc: Mayer Brown LLP  
  1221 Avenue of the Americas  
  New York, NY 10020  
  Attention: Reb D. Wheeler  
     
Enclosure: Bill of Sale  

 

  B- 3  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

EXHIBIT C

 

Form of Opinion under the law of the State of New York and federal law of the United States

 

1.          The Purchase Agreement and each document contemplated thereby, when executed and delivered by the Seller and all of the other parties thereto, shall constitute the legal, valid and binding obligations of the Seller, enforceable against the Seller in accordance with their respective terms.

 

2.          The execution, delivery and performance by the Seller of the Purchase Agreement and each document contemplated thereby to which the Seller is party and the consummation by the Seller of the transactions contemplated thereby will not violate any law or regulation of any Governmental Authority of the United States or the State of New York.

 

3.          The execution and delivery by the Seller of the Purchase Agreement and the documents contemplated thereby to which the Seller is party, the performance by the Seller of its obligations thereunder and the consummation of any of the transactions contemplated thereunder (including the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Assets to the Purchaser) do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority of the United States or the State of New York, except for the filing of a Current Report on Form 8-K with the SEC, the filing of UCC financing statements and the consent of Licensee contained in the Licensee Instruction.

 

Form of Opinion under Nevada Corporations Code

 

1.          Based solely on the Certificate of Existence with Status in Good Standing for Seller issued by the Nevada Secretary of State dated September 9, 2016, Seller is a Nevada corporation, duly incorporated, validly existing and in good standing under the laws of the State of Nevada.

 

2.          Seller has the corporate power and authority to execute and deliver the Purchase Agreement and each document contemplated thereby and to perform its obligations thereunder.

 

3.          The execution and delivery by Seller of the Purchase Agreement and each document contemplated thereby and the performance by Seller of its obligations thereunder has been duly authorized by all necessary corporate action.

 

4.          The Purchase Agreement and each document contemplated thereby have been duly executed and delivered by Seller.

 

5.          No consent, approval, authorization, or other action by, or filing or registration with, any Nevada governmental or regulatory authority or agency is required in connection with the execution and delivery by Seller of the Purchase Agreement and each document contemplated thereby or the performance by Seller of their obligations thereunder, except as contemplated in the Purchase Agreement and each document contemplated thereby.

 

  C- 1  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

6.          The execution and delivery by Seller of the Purchase Agreement and each document contemplated thereby and the performance by Seller of its obligations thereunder will not violate the provisions of the organizational documents of Seller and will not result in any violation of any Nevada law or administrative regulation applicable to Seller.

 

  C- 2  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Schedule 3.6

 

LITIGATION

 

On September 15, 2016, Opiant Pharmaceuticals, Inc. (the “Seller”) and ADAPT Pharma, Inc. (“Adapt”) received notice from TEVA Pharmaceuticals USA, Inc. (“TEVA”), pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (the “Notice Letter”), that TEVA had filed an Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray before the expiration of U.S. Patent No. 9,211,253 (the “’253 patent”). The ‘253 patent is listed with respect to NARCAN® (naloxone hydrochloride) Nasal Spray in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluation publication (commonly referred to as the “Orange Book”) and expires on March 16, 2035. TEVA’s Notice Letter asserts that its generic product will not infringe the ‘253patent or that the ‘253 patent is invalid or unenforceable. The Seller and Adapt have been evaluating TEVA’s Notice Letter. The Seller has full confidence in its intellectual property portfolio related to NARCAN® (naloxone hydrochloride) Nasal Spray and expects that the ‘253 patent will be vigorously defended from any infringement. The Seller may receive additional Notice Letters from other companies seeking to market generic versions of NARCAN® (naloxone hydrochloride) Nasal Spray in the future and, after evaluation, the Seller may commence patent infringement lawsuits against such companies.

 

On October 21, 2016, Adapt, Adapt Pharma Operations Limited and the Seller (collectively, the “Plaintiffs”) filed a complaint for patent infringement against TEVA and TEVA Pharmaceuticals Industries Ltd. (collectively, the “Defendants”) in the U.S. District Court for the District of New Jersey arising from TEVA’s U.S.’s filing of the ANDA with the FDA. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ANDA be a date later than the expiration of the ‘253 patent, as well as equitable relief enjoining the Defendants from infringing the ‘253 patent and monetary relief as a result of any such infringement. The Seller maintains full confidence in its intellectual property portfolio related to NARCAN® (naloxone hydrochloride) Nasal Spray and expects that the ‘253 patent will continue to be vigorously defended from any infringement.

 

  Schedule 3.6  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Schedule 3.11(a)(i)

 

PRODUCT SPECIFIC PATENTS

 

LLT0001-101-US   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Roger Crystal, Mike Weiss   61/953,379   03/14/2014                   Expired
LLT0001-201T-US   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Roger Crystal, Mike Weiss   14/659,472   03/16/2015   2015-0258019   09/17/2015   9,211,253   12/15/2015   Granted
LLT0001-201TC1-US   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Roger Crystal, Mike Weiss   14/950,707   11/24/2015                   Allowed
LLT0001-201TCIP-US   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Roger Crystal, Mike Weiss   14/942,344   11/16/2015                   Allowed
LLT0001-401-PC   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Roger Crystal, Mike Weiss   PCT/IB2015/000941   03/16/2015   WO 2015/136373   09/17/2015           Published
LLT0002-101-US   CO-PACKAGED DRUG PRODUCTS   Roger Crystal, Mike Weiss   62/022,268   07/09/2014                   Pending
LLT0002-201-US   CO-PACKAGED DRUG PRODUCTS   Roger Crystal, Mike Weiss   14/795,403   07/09/2015   2016-0008277   01/14/2016           Published
LLT0002-401-PC   CO-PACKAGED DRUG PRODUCTS   Roger Crystal, Mike Weiss   PCT/US2015/039720   07/09/2015   WO 2016/007729   01/14/2016           Published

 

  Schedule 3.11(a)(i)  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Schedule 3.11(a)(ii)

 

JOINT PATENTS

 

LLT0003-101-US   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Roger Crystal, Fintan Keegan   62/219,955   09/17/2015                   Pending
LLT0003-102-US   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Roger Crystal, Fintan Keegan   62/274,536   1/4/2016                   Pending
17040-000029-US-CPB (filed by HDP)   NASAL DRUG PRODUCTS AND METHODS OF THEIR USE   Fintan Keegan Robert Bell
Roger Crystal, Mike Weiss
  15/183,441   6/15/2016                   Pending
****   ****   ****   ****   ****                   ****

 

  Schedule 3.11(a)(ii)  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Schedule 3.11(b)

 

OPIANT PATENTS

 

None.

 

  Schedule 3.11(b)  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Schedule 3.13(m)

 

LICENSE AGREEMENT REPRESENTATIONS AND WARRANTIES

 

The following events have occurred since the effective date of the License Agreement which would revise the representations and warranties made by Seller in such License Agreement if made on the Closing Date:

 

Section 8.2.2 of the License Agreement – Seller has filed patent applications after the effective date of the License Agreement that would fall within the defined term “Lightlake Patent”.

 

Section 8.2.9 of the License Agreement – See Schedule 3.6 of this Agreement.

 

Section 8.2.10 of the License Agreement – Seller has entered into additional agreements that would be listed on Schedule 8.2.10 of the License Agreement, which agreements consist of the following:

· Amended and Restated Material Transfer, Option and Research License Agreement entered into by and between Seller and Aegis Therapeutics, LLC on April 26, 2016. While this agreement is not specific to the Product, data arising from this agreement may be useful for the Product.
· Collaboration Agreement entered into by and between Seller and the National Institute for Health and Welfare, Department of Tobacco, Gambling and Addictions, dated October 5, 2015.

 

  Schedule 3.13(m)  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Schedule 3.14

 

PROFIT SHARING ARRANGEMENTS

 

1.          Investment Agreement dated April 16, 2013 (and clarified in a letter agreement dated October 15, 2014), between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Potomac Construction Limited.

 

2.          Investment Agreement dated May 30, 2013 (and clarified in a letter agreement dated October 15, 2014), between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Potomac Construction Limited.

 

3.          Investment Agreement dated September 9, 2014 (and clarified in a letter agreement dated October 15, 2014), between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Potomac Construction Limited.

 

4.          Investment Agreement dated October 31, 2014 (and clarified in a letter agreement dated October 31, 2014), between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Potomac Construction Limited.

 

5.          Investment Agreement dated December 8, 2015, between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Potomac Construction Limited.

 

6.          Investment Agreement dated May 15, 2014 (and clarified in a letter agreement dated October 15, 2014), between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Ernst Welmers.

 

7.          Amended and Restated Interest Agreement dated October 25, 2016, but effective as of July 22, 2014, between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Valour Fund, LLC.

 

8.          Amended and Restated Consulting Agreement dated October 25, 2016, but effective as of July 17, 2013, between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc., the “ Company ”) and LYL Holdings Inc.

 

9.          Regulatory and Strategic Advisor Consultancy Agreement dated September 1, 2015, between Opiant Pharmaceuticals, Inc. (f/k/a Lightlake Therapeutics Inc.) and Mary Pendergast.

 

  Schedule 3.14  

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Exhibit 10.3

 

Execution Version

 

AMENDMENT NO. 1 TO LICENSE AGREEMENT

 

This Amendment No. 1 to License Agreement (this “ Amendment ”) is made as of December 13, 2016, by and among Opiant Pharmaceuticals, Inc. (formerly known as Lightlake Therapeutics Inc.), a Nevada corporation (“ Opiant ”), and Adapt Pharma Operations Limited, an Irish limited company (“ Adapt ”). Opiant and Adapt are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”. Capitalized terms used but not defined herein have the meanings given to them in the License Agreement (as defined below).

 

RECITALS

 

WHEREAS, the Parties entered into a License Agreement, dated as of December 15, 2014 (including the exhibits and schedules thereto, the “ License Agreement ”), pursuant to which Opiant licenses to Adapt certain intellectual property rights to develop and commercialize Products in accordance with the terms and conditions set forth therein;

 

WHEREAS, Section 11.9 of the License Agreement provides that no amendment or modification to the License Agreement shall be binding upon the Parties unless in writing and duly executed by authorized representations of both Parties; and

 

WHEREAS, the Parties desire to amend, modify and supplement the License Agreement in the manner specified in this Amendment.

 

NOW, THEREFORE, for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.            Amendment to Lightlake References .  Each instance of “Lightlake” appearing in the Agreement, including where such word is used as part of other defined terms, but excluding instances where such word is used as part of “Lightlake Therapeutics Inc.”, is hereby replaced with “Opiant”.

 

2.            Amendment to Section 1.11 of the License Agreement . Section 1.11 of the License Agreement is hereby deleted in its entirety and replaced with the following:

 

1.11          Commercial Sublicensee ” means a Sublicensee to whom Adapt has granted a right to offer for sale, have sold or sell one or more Products in all or a portion of the Territory including exclusive distributors, but excluding (i) Persons who Manufacture Product(s) or any element thereof and sell such Product(s) only to or at the direction of Adapt, Sublicensees or any of their respective Affiliates, (ii) wholesalers, (iii) pharmacies, (iv) Persons comprising the First Responder Market, (v) any Person performing third party logistics or warehousing services on behalf of Adapt or its Affiliates or Sublicensees, and (vi) any other Person who does not have any obligation to make an upfront, milestone, royalty or similar payment with respect to the applicable Products.”

 

 

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

3.            Amendment to Section 1.30 of the License Agreement .  Section 1.30 of the License Agreement is hereby amended by deleting clause (i) thereof and replacing such clause (i) with the following:

 

“(i) is sold by a Third Party (or any of such Third Party’s direct or indirect licensees or sublicensees) that is not a licensee or a Commercial Sublicensee of Adapt or its Affiliates (A) in the United States, under an Abbreviated New Drug Application (ANDA), (B) in the European Union, pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (C) in any other country or jurisdiction, pursuant to all equivalents of such provisions”.

 

4.            Amendment to Section 3.3.1(b) of the License Agreement . Section 3.3.1(b) of the License Agreement is hereby amended by (a) deleting the phrase “recall,” from the first sentence thereof and (b) deleting the word “such” from the second sentence thereof.

 

5.            Amendment to Section 3.5.2 of the License Agreement . Section 3.5.2 of the License Agreement is hereby amended by deleting the first sentence thereof and replacing such sentence with the following:

 

“Once a Product receives all requisite Regulatory Approvals in the United States necessary to Commercialize such Product therein, Adapt shall use Commercially Reasonable Efforts to Commercialize such Product in the United States.”

 

6.            Amendment to Section 3.6.2 of the License Agreement . Section 3.6.2 of the License Agreement is hereby amended by deleting the words “and Commercial Sublicensees” from the first sentence thereof.

 

7.            Amendment to Section 4.3.1 of the License Agreement . Section 4.3.1 of the License Agreement is hereby deleted in its entirety and replaced with the following:

 

4.3.1           Right to Grant Sublicenses .   Adapt shall have the right to grant Sublicenses (through multiple tiers of Sublicensees).  Adapt shall cause each Sublicensee to comply with the applicable terms and conditions of this Agreement.  Adapt shall remain responsible for the performance of its Affiliates and Sublicensees that are granted Sublicenses as permitted herein, and the grant of any such Sublicense shall not relieve Adapt of its obligations under this Agreement.  With respect to any such Sublicense, Adapt shall ensure that the agreement pursuant to which it grants such Sublicense (i) does not conflict with the terms and conditions of this Agreement and (ii) contains terms obligating the Sublicensee to comply with confidentiality and non-use provisions consistent with those set forth in this Agreement.  With respect to any such Sublicense to a Commercial Sublicensee that grants such Commercial Sublicensee rights to Commercialize a Product in the United States, Adapt shall use Commercially Reasonable Efforts to ensure that the agreement pursuant to which it grants such Sublicense contains (A) terms obligating such Commercial Sublicensee to permit Opiant rights of inspection, access, and audit substantially similar to those provided to Opiant in this Agreement and (B) terms relating to intellectual property and data ownership consistent with those set forth in this Agreement.  With respect to any such Sublicense to a Commercial Sublicensee that grants such Commercial Sublicensee rights to Commercialize a Product in the United States, Adapt shall ensure that the agreement pursuant to which it grants such sublicense contains an exclusivity provision consistent with that contained in Section 4.6.2 .  A copy of any Sublicense agreement with a Commercial Sublicensee executed by Adapt shall be provided to Opiant within fourteen (14) days after its execution; provided that the financial terms of any such Sublicense agreement may be redacted to the extent not pertinent to an understanding of a Party’s obligations or benefits under this Agreement.”

 

  2  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

8.            Amendment to Section 4.3.2 of the License Agreement . Section 4.3.2 of the License Agreement is hereby amended by replacing the first instance of the word “In” therein with the following:  “Subject to the provisions of Section 10.11 , in”.

 

9.            Amendment to Section 4.6.2 of the License Agreement . Section 4.6.2 of the License Agreement is hereby deleted in its entirety and replaced with the following:

 

4.6.2            During the term of any agreement pursuant to which a Commercial Sublicensee is granted a Sublicense to sell a Product in the United States or have a Product sold in the United States, other than as contemplated by this Agreement, each Party shall cause such Commercial Sublicensee not to (i) directly or indirectly, develop, commercialize or manufacture any Competing Product in the United States, or (ii) license, authorize, appoint, or otherwise enable any Third Party to directly or indirectly, develop, commercialize or manufacture any Competing Product in the United States.”

 

10.          Amendments to Article 6 of the License Agreement .

 

(a)          Section 6.3 of the License Agreement is hereby amended by adding a new Section 6.3.4 thereto, immediately after Section 6.3.3, as follows:

 

6.3.4           Commercial Sublicensees . Anything to the contrary herein notwithstanding, Adapt shall have the right to assign its rights and delegate its obligations under this Section 6.3 with respect to Patents in any country or territory outside the United States to any Commercial Sublicensee to whom Adapt has granted a right to sell the Product in such country or territory. In such event, Adapt shall remain responsible for ensuring that such Commercial Sublicensee performs any such delegated obligations in accordance with the terms of this Section 6.3 , as applicable.”

 

(b)          Section 6.4 of the License Agreement is hereby amended by adding a new Section 6.4.5 thereto, immediately after Section 6.4.4, as follows:

 

  3  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

6.4.5           Commercial Sublicensees . Anything to the contrary herein notwithstanding, Adapt shall have the right to assign its rights and delegate its obligations under Sections 6.4.2 and Section 6.4.3 with respect to actual or suspected infringement or misappropriation in any country or territory outside the United States to any Commercial Sublicensee to whom Adapt has granted a right to sell the Product in such country or territory. In such event, Adapt shall remain responsible for ensuring that such Commercial Sublicensee performs any such delegated obligations in accordance with the terms of Section 6.4.2 and 6.4.3 , as applicable.”

 

(c)          Section 6.5 of the License Agreement is hereby amended by adding the words “As between the parties,” immediately prior to the first occurrence of “Adapt” therein.

 

11.          Amendment to Section 7.5 of the License Agreement . Section 7.5 of the License Agreement is hereby amended by deleting the phrase “and Lightlake shall be provided with a copy of any such Publication in advance of public publication or presentation thereof and Adapt shall consider in good faith any comments Lightlake may have with respect thereto” from the second sentence thereof.

 

12.          Amendments to Article 10 of the License Agreement .

 

(a)          Section 10.3 of the License Agreement is hereby amended by adding the following as a new final sentence thereof:  “Notwithstanding the foregoing, in no event shall Opiant have the right to terminate this Agreement on the basis of any breach of any term hereof by a Sublicensee or attributable to the action or inaction of a Sublicensee.”

 

(b)          Section 10.4 of the License Agreement is hereby amended by deleting the words “or Commercial Sublicensees” and “or Commercial Sublicensee” therein.

 

(c)          Section 10.6 of the License Agreement is hereby amended by replacing the first instance of the word “In” therein with the following:  “Subject to Section 10.11 , in”.

 

(d)          Section 10.6.5 of the License Agreement is hereby deleted in its entirety and replaced with the following:

 

10.6.5         at Opiant’s request and subject to the terms of any applicable third party agreement, assign to Opiant all right, title and interest of Adapt in each Product Trademark at Adapt’s expense; and”.

 

(e)          Section 10.10 of the License Agreement is hereby amended by adding “, Section 10.11 ” after “ Section 10.10 ” in clause (i) thereof.

 

(f)          Article 10 of the License Agreement is hereby amended by adding the following after Section 10.10 thereof:

 

  4  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

10.11         Step-In Rights.  If this Agreement is properly terminated by Opiant pursuant to Sections 10.3 , 10.4 or 10.5 , then, provided that such Commercial Sublicensee is not then in material breach of the agreement pursuant to which its Sublicense has been granted (the “ Sublicense Agreement ”), any Commercial Sublicensee may (in its sole discretion), within thirty (30) days of receiving notice of such termination, upon written notice to Opiant and Adapt, elect to become a direct licensee of Opiant under rights and terms equivalent to the rights and terms of such Sublicense Agreement, effective from and after the effective date of such termination of this Agreement; provided that such Commercial Sublicensee shall not have any rights greater than the rights granted to Adapt under this Agreement and Opiant shall have no obligations under such Sublicense Agreement to such Commercial Sublicensee in excess of its obligations to Adapt. In the event that this Section 10.11 is invoked in respect of a particular Commercial Sublicensee, the references to Sublicensees and Commercial Sublicensees in Sections 10.6.3 and 10.6.4 shall thereupon be deemed not to refer to such Commercial Sublicensee in respect of which this Section 10.11 is invoked. If requested by Adapt, Opiant shall enter into a reasonable and customary letter agreement with any Commercial Sublicensee and Adapt containing terms consistent with this Section 10.11 and other terms reasonably acceptable to Opiant, Adapt and such Commercial Sublicensee.”

 

13.          Amendment to Section 11.8.2 of the License Agreement . Section 11.8.2 of the License Agreement is hereby amended by replacing the address for notice of Opiant set forth therein with the following:

 

If to Opiant, to:

 

Opiant Pharmaceuticals, Inc.

401 Wilshire Blvd., 12th Floor

Santa Monica, CA 90401

Attention: CEO

Facsimile: 1-917-322-2105

 

With a copy (which shall not constitute notice) to:

 

DLA Piper LLP (US)

1650 Market Street, Suite 4900

Philadelphia, PA 19103

Attention: Fahd M.T. Riaz

Facsimile: 1-215-606-2069

 

14.          Amendment to Section 11.12 of the License Agreement .  Section 11.12 of the License Agreement is hereby amended by replacing the word “Covenants” therein with the following:  “Except as otherwise provided in Section 10.11 hereof, covenants”.

 

15.          Possible Future Amendments .  If requested by Adapt in connection with the granting of a Sublicense to a Commercial Sublicensee in respect of Europe and/or the United Kingdom, the Parties shall promptly negotiate in good faith additional amendments to the License Agreement necessary to implement the changes to the financial terms of the License Agreement that are contemplated on Exhibit A to this Amendment, or such other terms as the Parties may mutually agree upon in good faith.

 

  5  

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

16.          References in the License Agreement . All references in the License Agreement to “this Agreement” shall mean the License Agreement as amended by this Amendment.

 

17.          Limitation of Amendment and Affirmation of License Agreement . Except as expressly provided herein, this Amendment shall not be deemed to be a waiver or modification of any term, condition or covenant of the License Agreement. Any conflict between the terms herein and in the License Agreement shall be governed by the terms of this Amendment. Except as expressly amended hereby, all terms and conditions set forth in the License Agreement are hereby affirmed by the Parties and shall remain in full force and effect.

 

18.          Incorporation by Reference . The provisions of Sections 11.3.1, 11.4, 11.5, 11.6, 11.7, 11.8, 11.10, 11.11, 11.12, 11.13, 11.14, 11.16 and 11.18 of the License Agreement are hereby incorporated by this reference, mutatis mutandis , as if the provisions were fully set forth herein.

 

[ Signature Page Follows ]

 

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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

IN WITNESS WHEREOF, this Amendment is hereby executed by the authorized representatives of the Parties as of the date first written above.

 

  OPIANT PHARMACEUTICALS, INC.

 

  By:   /s/ Roger Crystal
    Name:  Roger Crystal
    Title:    Chief Executive Officer

 

  ADAPT PHARMA OPERATIONS LIMITED

 

  By:   /s/ David Brabazon
    Name:   David Brabazon
    Title:     Director

 

 

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

EXHIBIT A

 

In the event that Adapt proposes to enter into an agreement with a Commercial Sublicensee who would Exploit a Product in the European Union and/or the United Kingdom (as applicable, “ Europe ”), at Adapt’s request, the Parties will negotiate in good faith to amend the License Agreement as necessary to implement the terms described below.

 

Term   Addition or Modification
Revenue sharing  

Opiant (or its designee) would share in royalties, milestone payments and payments for any supplied Product, less all costs incurred in generating such European revenues (including, amongst others, development, regulatory, licensing, safety, supply and distribution costs attributable to Europe) received by Adapt from a Sublicensee in Europe (“ Europe Net Revenues ”) based on the following:

 

·      ****% of all such amounts, up to $**** of cumulative revenue; and

 

·      ****% of all such amounts in excess of $**** million in cumulative revenue.

 

In the event that Opiant (or its designee) does not receive the $**** milestone contemplated by Section 5.2.4 of the License Agreement, then the $**** threshold contemplated above shall be reduced to $****.

 

Amounts comprising Europe Net Revenues and revenues earned by any Sublicensee in Europe would be excluded for purposes of determining Net Sales on which Opiant (or its designee) would otherwise be entitled to royalties under the License Agreement, subject to the provisions set forth below in Global Sales Milestones and Royalty Tiers.

 

Adapt shall make the revenue share payments in respect of the Europe Net Revenues to Opiant (or its designee) on a Calendar Quarter basis in accordance with the terms of Section 5.6 of the License Agreement and any other written instructions agreed to by Adapt.

     
Global Sales Milestones and Royalty Tiers   Europe Net Revenues received by Adapt from any Sublicensee in Europe would be included for purposes of determining Net Sales giving rise to sales-based milestones pursuant to Section 5.3.1 of the License Agreement and for purposes of determining royalty tiers set forth in Section 5.4.1 of the License Agreement.  Sublicensee revenues in Europe would be excluded for purposes of such determinations.

 

 

 

 

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Term   Addition or Modification
     
   

The $**** Annual Net Sales Milestone Threshold specified in Section 5.3.1 of the License Agreement would be changed to $****.

 

The $**** Annual Net Sales Milestone Threshold specified in Section 5.3.1 of the License Agreement would be changed to $****.

 

 

 

Exhibit 10.5

 

THIRD AMENDMENT TO SENIOR ADVISOR AGREEMENT

 

This third amendment (the “ Third Amendment ”) to the Senior Advisor Agreement by and between Brad Miles (“ Miles ”) and Opiant Pharmaceuticals, Inc. (the “ Company ”), dated January 22, 2013 and amended on February 24, 2015 and March 19, 2015 is entered into on March 13, 2017 (collectively, the “ Agreement ”) (the “ Effective Date ”), and hereby amends the terms of the Agreement. Company and Miles may be referred to herein as a “ Party ” or, collectively, as “ Parties ”. Capitalized terms used but not defined in this Third Amendment shall have the meaning ascribed to such term in the Agreement.

 

RECITALS:

 

WHEREAS, the Company is currently planning on developing a specific product that is not for the treatment of a specific addiction, that the Company internally references under the name “OPNT003” and that is undergoing a study during Q1 2017 (the “ Product ”);

 

WHEREAS, Miles is a Senior Advisor to the Company and in connection with the ongoing services (the “Services”) provided by Senior Advisor, the Company seeks to grant Miles the following interest in the Product and other compensation as set forth herein.

 

NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties hereby mutually agree to this Third Amendment as follows:

 

Article 1
DEFINITIONS

 

Unless otherwise specifically provided herein, the following terms shall have the following meanings

 

1.1 Affiliate ” means a Person that controls, is controlled by or is under common control with a Party, but only for so long as such control exists. For the purposes of this Section 1.1, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such Person or entity, whether by the ownership of more than fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.

 

1.2 Divestiture ” means a transaction in which the Company sells all intellectual property rights and regulatory approvals for the Product to a Third Party.  For clarity, a Sublicense is not a Divestiture.

 

1.3 FFDCA ” means the The United States Federal Food, Drug, and Cosmetic Act and all amendments thereto.

 

1.4 Law ” or “ Laws ” means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the binding effect of law of any governmental body.

 

1.5 Net Profit ” means any revenue received by the Company that was derived from Sales of the Product less any and all Product Expenses not previously deducted from revenue received by the Company (“ Revenue ”).  For clarity, Product Expenses shall be carried over until actually deducted and netted from Revenue.

 

 

 

 

1.6 Person ” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government or agency or political subdivision thereof.

 

1.7 Product Expenses ” means all costs and expenses incurred by and payments made by the Company or its Affiliates in connection with generating revenue from the Product, including all costs and expenses incurred (including allocation of Company overhead based on the proportionate time, expenses and resources devoted by the Company to activities related to the Product as determined by the Company in good faith) for (a) the research, development and commercialization of the Product and (b) for any transaction, directly or indirectly, related to the Product.

 

1.8 Regulatory Approval ” means the approval of a New Drug Application (as defined by the FFDCA) by the U.S. Food and Drug Administration necessary to commercially distribute, sell, offer for sale, market, import or use a Product in the United States including, pricing, reimbursement and labeling approval.

 

1.9 Sale of the Product ” means any transaction for which consideration is received by the Company for sale, use, transfer or other disposition of a Product to or for the benefit of a Third Party. For clarity, a Sale of the Product does not include a Divestiture.

 

1.10 Sublicense ” means a grant to a Third Party of a right under the Company’s intellectual property rights to make, use or sell the Product.

 

1.11 Third Party ” means any Person other than the Company, Miles or any of their respective Affiliates.  

 

1.12 Third Party Agreement ” shall mean any agreement between the Company and a Third Party related to the Product, including any assets material to the Product.

 

1.13 Other Terms . The definition of each of the following terms is set forth in the section of the Agreement indicated below:

 

Defined Term   Section
Agreement   Preamble
Audit   3.1
Audited NP   3.3
Buyback Amount   2.3
Company   Preamble
Effective Date   Preamble
Estimated NP   3.3
Fair Market Value   2.2
Interest   2.1
Interest Holder   2.5
Miles   Preamble
Notices   4.7
Party   Preamble
Product   Recitals
Revenue   1.4
Third Amendment   Preamble

  

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Article 2
GRANT AND OTHER RIGHTS

 

2.1 Extension of Term . Miles shall provide the Services and additional Services through December 31, 2017 (the “Term”), unless the Agreement is terminated as per its terms.

 

2.2 Consideration for Services .

 

2.2.1 Within fifteen (15) business days of the execution of this Third Amendment, Miles shall be paid $107,805 and be issued 1,875 shares of the Company’s common stock.

 

2.2.2 The Company hereby agrees to grant Miles the right to receive, pro rata, 1.25% of the Net Profit generated from the Product from the Effective Date (the “ Interest ”). In the event of a Divestiture, Miles shall receive 1.25% of the net proceeds of such sale, pro rata, and in the form of such net proceeds, after the deduction of Product Expenses not previously deducted. In the event that the Company is sold, then the Company shall engage an independent financial or accounting firm to determine the fair value of the Company which is directly attributable to the Product (“ Fair Market Value ”) and Miles shall receive 1.25% of such amount after the deduction of all expenses and costs related to such sale. Upon receipt of the payment described in this Section 2.2, the Interest shall be deemed either extinguished or transferred or sold back to the Company, at the Company’s direction, and have no further legal effect and Miles shall have no rights with respect to such Interest.

 

2.2.3 Subject to the terms of this Agreement, the Company agrees to pay Miles $17,000 per calendar quarter during 2017. The payment for the first calendar quarter of 2017 shall be made by the Company to Miles no later than fifteen (15) business days after the execution of this Third Amendment. The $17,000 payments for the second, third and fourth calendar quarters of 2017 shall be made by the Company to Miles no later than fifteen (15) business days after the start of each respective calendar quarter.

 

2.2.4 The Company shall grant Miles warrants (the “Warrants”) to purchase 45,000 shares of the Company’s common stock (the “Common Stock”) (with each share of Common Stock, a “Share”). All of the Warrants shall have an exercise price of $10.00, which shall be equal to or greater than the fair market value of a Share of Common Stock on the date of their grant. All of the Warrants shall be exercisable for cash. All of the Warrants shall contain standard adjustment provisions with respect to stock splits, recapitalizations, change of control and fundamental transactions but shall not contain any anti-dilution or price protection. All of the Warrants shall have a three-year life from their date of grant. Notwithstanding the foregoing, in the event that Miles is terminated by the Company for Cause pursuant to Article IV of this Third Amendment, then all of the Warrants not previously exercised shall expire on the day of such termination. All of the Warrants shall fully vest on their grant date. None of the Warrants are transferable except that in the event of Miles’s death the Warrants shall be transferrable to Miles’s estate.

 

All of the Warrants shall be in such form as the Form of Notice of Warrant Grant attached as Exhibit A hereto, which Warrants may be exercised, where applicable, pursuant to the Form of Notice of Exercise of Warrant attached as Exhibit B hereto.

 

Upon the exercise of such Warrants, the fair market value per Share of Common Stock shall be equal to the closing price of the Shares of Common Stock of the Company on the day prior to such exercise. Exercise of these Warrants shall occur by Miles’s: (i) surrendering the exercised Warrants at the principal office of the Company together with a properly completed and signed Notice of Exercise of Warrant (as per Exhibit B hereto), and (ii) providing via email a readable .pdf or scan of all of the documentation set forth in (i) to the email addresses of the Chief Executive Officer, Chief Financial Officer and Controller (if the Company has a Controller at such time) of the Company at the time of such surrender (the current applicable email addresses being: rcrystal@opiant.com and kpollack@opiant.com ).

 

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2.3 Buyback Right . Notwithstanding any other provisions of this Agreement, from the Effective Date until four (4) years from the Effective Date the Company shall have the right to buyback the Interest or any portion of the Interest by providing written or electronic notice to Miles. Any such notice shall include the percentage amount of the Interest to be bought back by the Company, and such notice shall also include the dollar amount that equals the percentage amount of the Interest to be bought back by the Company based on a rate of 1.25% of Interest being equal to one hundred eighty seven thousand five hundred dollars ($187,500) (the   Buyback Amount ”). In the event that such notice is provided within two and one half (2½) years of the Effective Date, then the Company shall pay Miles two (2) times the Buyback Amount within ten (10) business days of providing such notice. In the event that such notice is provided after two and one half (2½) years from the Effective Date and no later than four (4) years from the Effective Date, then the Company shall pay Miles three and one half (3½) times the Buyback Amount within ten (10) business days of providing such notice. Upon the Company’s paying to Miles the Buyback Amount with respect to the Interest or any portion of the Interest, such Interest or portion of the Interest, as appropriate, shall be deemed either extinguished or transferred or sold back to the Company, at the Company’s direction, and have no further legal effect and Miles shall have no rights with respect to such amount of Interest bought back by the Company.

 

2.4 Third Party Agreements . Miles agrees that the Company and its successors and assigns may freely enter into any Third Party Agreement without the prior written consent of Miles.  Further, Miles agrees and covenants for the benefit of the Company and its successors and assigns, and any Third Party that enters into a Third Party Agreement and its successors and assigns, and each of their respective shareholders, directors, officers and employees (each, an “Interest Holder”) that (a) it shall under no circumstances seek payment or other compensation for any amount due hereunder from any party other than the Company and its successors and assigns, including with respect to any Third Party Agreement and (b) that such Interest Holders shall be express Third Party beneficiaries of Miles’s covenants in this Section 2.4 and may enforce the provisions hereof and that the foregoing is a material inducement of such Third Parties to enter into any Third Party Agreement, if any.  In consideration of Miles agreeing to the consent granted in this Section 2.4, Company agrees and covenants for the benefit of Miles that in the event that the Company sells a portion of its Revenue stream to a Third Party, Miles’s original interest in Net Profit shall be adjusted upward to “equally offset” any reduction in the original interest that would be the result of such sale of the Revenue stream from which Miles would not receive anything.  For example, if ten percent of Revenue stream is sold and the original share of Miles of Net Profit was 1.25%, then Miles’s share of the Net Profit shall be adjusted by ten percent to 1.375% of Net Profit.

 

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Article 3
FINANCIAL PROVISIONS

 

3.1 Net Profit Audit . The Company shall provide Miles with an annual audit of Net Profits (the “ Audit ”), which Audit shall be completed after the end of each calendar year.  Notwithstanding the foregoing, this Section 3.1 shall not be applicable until the Product generates Net Profit from which amounts would be due to Miles.

 

3.2 Product Status Update . After the end of each quarter of the calendar year, the Company shall provide Miles with a written or electronic update with respect to the status of the Product.

 

3.3 Net Profit Distribution . After the end of each of the first three quarters of the calendar year, the Company shall distribute to Miles eighty percent (80%) of such calendar quarter’s Net Profits represented by the Interest, which amount shall be estimated in good faith by the Company. Upon the completion of the Audit for such calendar year, the Company shall distribute to Miles the Net Profits represented by the Interest, for the fourth quarter of the calendar year. In the event that the Audit for such calendar year determines the Net Profits represented by the Interest, for the first three quarters of the calendar year (the “ Audited NP ”) to be greater than the estimated Net Profits represented by the Interest, actually paid to Miles for the first three calendar quarters (the “ Estimated NP ”), then the Company shall distribute to Miles the difference between the Audited NP and the Estimated NP. In the event that the Audit for such calendar year determines the Audited NP to be less than the Estimated NP, then the Company shall deduct the difference between the Estimated NP and the Audited NP from the distribution for the fourth quarter of such calendar year and, if required, each following distribution until such amount is fully deducted.

 

Article 4
ADDITIONAL PROVISIONS

 

4.1 All compensation granted to Miles herein shall be in addition to compensation previously granted by the Company to Miles. No other compensation shall be owed or due to Miles unless set forth in this Third Amendment or in the Agreement.

 

4.2 Notwithstanding anything herein to the contrary, during the Term, the Company may terminate this Agreement at any time for Cause (as hereinafter defined). In such an event Miles shall be deemed effectively terminated as of the time of delivery of such notice. For the avoidance of doubt, there will be no severance pay or other special payment upon such termination by the Company for Cause and the Company shall not be obligated to provide any further compensation to Miles, except that Miles shall be entitled to all such options and warrants held by Miles that have vested. For purposes of this Agreement, “Cause” means: termination based upon Miles’s (i) willful breach or willful neglect of his duties and responsibilities; (ii) conviction of or a plea of no contest with respect to a felony occurring on or after the execution of this Agreement; (iii) material breach of this Agreement; (iv) acts of fraud, dishonesty, misappropriation, or embezzlement; (v) willful failure to comply with the Board of Directors of the Company’s reasonable orders or directives consistent with Miles’s position; or (vi) becoming disqualified or prohibited by law from serving as Senior Advisor of the Company; provided, however, that in the case of any act or failure to act described in clauses (i), (iii), or (v) above, such act or failure to act will not constitute Cause if, within ten (10) days after notice of such act or failure to act is given to Miles by the Company, Miles has corrected such act or failure to act (if it is capable of correction).

 

- v

 

 

4.3 This Third Amendment, together with any other documents incorporated herein by reference, including the Agreement, and related exhibits and schedules, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.

 

4.4 The Agreement, as amended by this Third Agreement, may only be amended, modified, or supplemented by an agreement in writing signed by each Party to the Agreement or, in the case of waiver, by the Party or Parties waiving compliance.

 

4.5 This Third Amendment shall be governed by and construed in accordance with the internal Laws of the State of California without giving effect to any choice or conflict of Law provision or rule. Each Party irrevocably submits to the exclusive jurisdiction and venue of the federal and state courts located in California in any legal suit, action or proceeding arising out of or based upon this Third Amendment or the Services and/or compensation provided hereunder.

 

4.6 If any term or provision of this Third Amendment is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Third Amendment or invalidate or render unenforceable such term or provision in any other jurisdiction.

 

4.7 This Third Amendment may be executed in multiple counterparts and by facsimile signature or by email of a PDF document, each of which shall be deemed an original and all of which together shall constitute one instrument.

 

4.8 All notices, requests, demands and other communications (collectively, “ Notices ”) given pursuant to this Agreement shall be electronic or in writing, and shall be delivered by email or by personal service, courier, facsimile transmission or by United States first class, registered or certified mail, postage prepaid, addressed to the Party at the address set forth below.  Any Notice, other than a Notice sent by registered or certified mail, shall be effective when received; a Notice sent by registered or certified mail, postage prepaid return receipt requested, shall be effective on the earlier of when received or the fifth day following deposit in the United States mails.  Any Party may from time to time change its address for further Notices hereunder by giving notice to the other Party in the manner prescribed in this Section. Notwithstanding the foregoing, the Company may send the information set forth in Sections 3.1 and 3.2 via email.

 

For Company with a copy to :
   

Opiant Pharmaceuticals, Inc.

401 Wilshire Blvd., 12 th Floor

Santa Monica, CA 90401

Attention: Roger Crystal

Email: rcrystal@opiant.com

DLA Piper LLP

One Liberty Place

1650 Market Street, Suite 4900

Attention: Fahd M.T. Riaz

Email: Fahd.Riaz@dlapiper.com

 

For Miles:

 
   
Brad Miles  
117 Sandcherry Court  
Pickering, Ontario Canada L1V 6V8     
Email: bmiles@opiant.com or
mb.miles@sympatico.ca
 

 

- vi

 

 

IN WITNESS WHEREOF, duly authorized representatives of the Parties have executed this Third Amendment as of the Effective Date.

 

OPIANT PHARMACEUTICALS, INC.   BRAD MILES
       
By: /s/ Kevin Pollack   By: /s/ Brad Miles
Name: Kevin Pollack   Title: Senior Advisor
Title: CFO      

 

- vii

 

 

EXHIBIT A

 

OPIANT PHARMACEUTICALS, INC.

401 Wilshire Blvd., 12 th Floor

Santa Monica, CA 90401

 

Form of Notice of Warrant Grant

 

Dear Brad Miles,

 

Pursuant to the Third Amendment to the Senior Advisor Agreement by and between you and Opiant Pharmaceuticals, Inc. (the “Company”), dated January 22, 2013 and amended on February 24, 2015, March 19, 2015 and March 13, 2017 (the “Third Amendment”) (collectively, the “Agreement”), the Company has granted you warrants (the “Warrants”) to purchase common stock of the Company (the “Common Stock”) (with each share of Common Stock, a “Share”) as follows:

 

Board Approval Date: March 11, 2017
   
Date of Grant: March __, 2017
   
Exercise Price per Share: US$10.00, which shall be equal to or greater than the fair market value of a Share of Common Stock on the Date of Grant.
   
Total Number of Shares Granted: 45,000
   
Method of Exercise: Cash exercise
   
Expiration Date: March  [   ], 2020
   
Termination Period: Except as otherwise provided below, these Warrants may be exercised for a period of three (3) years from the Date of Grant.  You are responsible for keeping track of these exercise periods.  The Company will not provide further notice of such periods.
   
  Notwithstanding the foregoing, in the event that you are terminated by the Company for Cause pursuant to Article IV of the Third Amendment, then the Warrants shall expire on the day of such termination.  
   
Transferability: The Warrants are not transferable except that in the event of your death the Warrants shall be transferrable to your estate.
   
Restriction on Exercise: Your ability to exercise these Warrants is contingent on your and your officers, agents, and representatives keeping confidential information shared with you and your officers, agents, and representatives confidential and complying with all applicable laws and regulations.
   
Vesting: 100% on March __, 2017

 

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These Warrants may only be exercised for cash.

 

Following receipt by the Company of evidence and/or an indemnity from you to the Company in a form reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of these Warrants or any certificates for representing the Shares underlying these Warrants and, in the event of mutilation, following the surrender and cancellation of such Warrants or stock certificate, the Company shall make and deliver replacement Warrants or stock certificate of like tenor and dated as of such cancellation, in lieu of these Warrants or stock certificate, without any charge therefor.  Any such replacement Warrants or stock certificates shall be subject to the same terms, conditions, and restrictions as these Warrants and any Shares underlying these Warrants. Proportionate adjustments shall automatically be made to both the Exercise Price and number of these Warrants in the event of a stock split, recapitalization, change of control and fundamental transaction. Upon the exercise of these Warrants, the fair market value per Share shall be equal to the closing price of the Shares on the day prior to such exercise.

 

Exercise of these Warrants shall occur by your: (i) surrendering the exercised Warrants at the principal office of the Company together with a properly completed and signed Notice of Exercise of Warrant (as per Exhibit B), and (ii) providing via email a readable .pdf or scan of all of the documentation set forth in (i) to the email addresses of the Chief Executive Officer, Chief Financial Officer and Controller (if the Company has a Controller at such time) of the Company at the time of such surrender (the current applicable email addresses being: rcrystal@opiant.com and kpollack@opiant.com).

 

If only a portion of the Warrants are exercised as of a particular date, the number of Shares issued shall be rounded down to the nearest whole share. However, the number of Shares issued is rounded up to 100% on the final exercise date with respect to the Warrants.

 

These Warrants may be delivered to you electronically with a scanned signature, in which case they shall have the same effect and force as if they had been delivered in original signed form.

 

You shall not have any of the rights of a stockholder with respect to the Shares of Common Stock until such Shares have been issued to you upon the due exercise of the Warrants. No adjustment will be made for dividends or distributions or other rights for which the record date is prior to the date such Shares are issued.

 

This Notice may be amended from time to time by the Company in its discretion; provided, however, that this Notice may not be modified in a manner that would have a materially adverse effect on the Warrants or Shares as determined in the discretion of the Company except as provided in a written document signed by you and the Company.

 

This Notice and the Warrants granted hereunder are intended to comply with, or otherwise be exempt from, Section 409A of the Code. This Notice and the Warrants shall be administered, interpreted and construed in a manner consistent with this intent. Nothing in this Notice shall be construed as including any feature for the deferral of compensation other than the deferral of recognition of income until the exercise of the Warrants. Should any provision of this Notice be found not to comply with, or otherwise be exempt from, the provisions of Section 409A of the Code, it may be modified and given effect, in the sole discretion of the Company and without requiring your consent, in such manner as the Company determines to be necessary or appropriate to comply with, or to effectuate an exemption from, Section 409A of the Code. The foregoing, however, shall not be construed as a guarantee or warranty by the Company of any particular tax effect to you.

 

Notwithstanding the foregoing, if at any time the Company determines that the delivery of Shares under this Notice is or may be unlawful under the laws of any applicable jurisdiction, or federal, state or foreign securities laws, the right to exercise the Warrants or receive Shares pursuant to the Warrants shall be suspended until the Company determines that such delivery is lawful. If at any time the Company determines that the delivery of Shares is or may violate the rules of the national securities exchange on which the shares are then listed for trade, the right to exercise the Warrants or receive Shares pursuant to the Warrants shall be suspended until the Company determines that such exercise or delivery would not violate such rules.

 

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By your signature and the signature of the Company’s representative below, you and the Company agree to the terms of these Warrants.

 

    OPIANT PHARMACEUTICALS, INC.
     
     
     
    Kevin Pollack, Chief Financial Officer

 

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EXHIBIT B

 

Form of Notice of Exercise of Warrant

 

Ladies and Gentlemen:

 

This letter constitutes an unconditional and irrevocable notice that I hereby exercise the warrant(s) granted to me by Opiant Pharmaceuticals, Inc., a Nevada corporation (the “Company”) on _______________ at a fair market value of US$ ______ per share. Pursuant to the terms of such warrant(s), I wish to purchase _______________ shares of the common stock covered by such warrant(s) at the exercise price(s) of US$ ______ per share via cash exercise, for a total aggregate purchase price of US$_______________, which I agree to promptly provide to the Company.

 

These shares should be delivered as follows:

 

Name:    
     
Address:    
     
     
     
     
     
Tax ID #:    

 

I represent that I will not dispose of such shares in any manner that would involve a violation of applicable securities laws.

 

Dated:     By:  
         
      Name:  

 

- xi

Exhibit 10.6

 

Senior Advisor Agreement

 

This Agreement is entered into by and between Lightlake Therapeutics Inc. (the “Company”) and Brad Miles (“Miles”) (collectively, the “Parties”) on January 22, 2013 (the “Agreement”).

 

WHEREAS Miles is a Senior Advisor to the Company;

 

WHEREAS the Company has requested that Miles provide additional services beneficial to the Company beyond the scope of what Miles has previously provided to the Company (the “Services”);

 

WHEREAS Miles has received compensation deemed by the Company to be inadequate to retain Miles as a Senior Advisor;

 

WHEREAS the Company seeks to retain Miles as a Senior Advisor; and

 

WHEREAS the Company seeks to provide Miles with additional incentive to remain a Senior Advisor and perform the Services;

 

NOW THEREFORE, in consideration of the mutual covenants herein contained, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby mutually agree as follows:

 

1) Miles shall provide the Services until one (1) year from the date hereof.

 

2) Any compensation granted herein shall be in addition to any other option compensation previously granted by the Company to Miles. Notwithstanding the foregoing, all options previously granted by the Company to Miles with an exercise price above $0.12 shall be cancelled and deemed ineffective on the date hereof and be surrendered to the Company within thirty (30) days of the date hereof.

 

3) Miles shall be granted stock options for one million seven hundred and fifty thousand (1,750,000) shares of stock of the Company, exercisable at US$0.15 (“Exercise Price”) with the life of such options being five (5) years (collectively, the “Options”). Such Options shall be exercisable in the form of Notice of Stock Option Grant attached as Exhibit A hereto, which Options may be exercised, where applicable, pursuant to the form of Notice of Exercise of Stock Option (the “Exercise Notice”) attached as Exhibit B hereto. Notwithstanding any provisions of the Options to the contrary, if the fair market value of one share of Common Stock (as defined in the Stock Option Plan of the Company effective December 15, 2010 (the “Stock Option Plan”)) is greater than the exercise price (at the date of calculation as set forth below), in lieu of exercising the Options for cash, the Holder (as defined in the Stock Option Plan) may elect to receive shares equal to the value (as determined below) of the Options (or the portion thereof being exercised) by surrender of the Options at the principal office of the Company together with the properly signed Exercise Notice in which event the Company shall issue to the Holder a number of shares of Common Stock computed using the following formula:

 

 

 

 

X= Y(A-B)  
  A  
     
Where X = the number of shares of Common Stock to be issued to the Holder
   
Y = the number of shares of Common Stock purchasable under the Options or, if only a portion of the Options are being exercised, the portion of the Options being exercised (at the date of such calculation)
   
A = the fair market value of one share of the Company’s Common Stock (at the date of such calculation)
   
B =

the Exercise Price per share (as adjusted to the date of such calculation)

 

Notwithstanding the foregoing, such Options may only be exercised between the following dates: (i) the earliest date on which the price per share of the Company’s Common Stock has traded at or above US$0.30 for at least three (3) trading days out of any ten (10) consecutive trading days; and (ii) their expiration date. Proportionate adjustments shall automatically be made to both the Exercise Price and number of such Options, and the price per share restriction set forth in this paragraph, in the event of a stock split, stock dividend, reclassification, recapitalization, or any other increase or decrease in the number of issued shares of the Company’s Common Stock effected without receipt of consideration by the Company, or upon any other event reasonably determined by a majority of the Board of Directors of the Company to justify such adjustments.

 

Within one (1) month following the date hereof, the Company shall deliver to Miles all Options granted herein. All such Options delivered to Miles as per this Agreement may be delivered to Miles electronically with a scanned signature, in which case they shall have the same effect and force as if they had been delivered in original signed form. For all Options granted to Miles electronic delivery of a signed Exercise Notice along with electronic delivery of such Options shall have the same exercise effect as surrendering such Options at the principal office of the Company together with the properly signed Exercise Notice.

 

 

 

  

4) In the event of termination of this Agreement, the Company shall not be obligated to provide any further compensation to Miles.

 

5) This Agreement shall be governed by and construed in accordance with the laws of the United States, and specifically the laws of the state of Nevada. Should a dispute arise, both parties shall subject themselves to exclusive jurisdiction of the courts of the state of Nevada.

 

6) This Agreement constitutes the entire understanding between the Parties relating to its subject matter, superseding all negotiations, prior discussions, preliminary agreements and agreements relating to the subject matter hereof made prior to the date hereof. No waiver by a Party of any breach by another Party of any term, provision or condition of this Agreement, to be performed by such other Party shall be deemed a waiver of similar or dissimilar provisions or conditions at the same time or at any prior or subsequent time. This Agreement may not be modified or amended except in writing signed by the Parties. Each of the Parties hereto agrees that this Agreement has been jointly prepared, and that no claim may be asserted by any Party that any ambiguity in this Agreement may be construed against any one Party.

 

7) This Agreement may be executed in counterparts, each of which shall constitute an original but together shall constitute one and the same Agreement. The Parties further agree that such counterparts may be provided via scan, email, and/or facsimile to one another, each of which shall be binding upon the signatory who sends the scan, email and/or facsimile that was signed by such sending signatory. The Parties further agree to exchange the original signature pages hereof as soon as practicable after sending such scan, email and/or facsimile, but in any dispute or controversy, the Parties hereto agree that it shall not be necessary for any such Party to provide the original signature pages of the other as a condition of enforcing this Agreement, it being understood that such scan, email and/or facsimile signature pages shall be sufficient to establish the consent of the Party who sent the scan, email and/or facsimile that was signed by such sending signatory to be bound by the terms of this Agreement.

 

8) This Agreement does not include any appropriate compensation that the Company would be obligated to provide Miles as a result of the relationships Miles developed with Pfizer Inc., AstraZeneca, and Purdue Pharma L.P. that result in a financial strategic partnership where any or all of the Company's treatments would receive funding to move clinical trials forward.

 

 

 

  

IN WITNESS WHEREOF the parties have executed this Agreement this 22 day of January 2013.

 

 

LIGHTLAKE THERAPEUTICS INC.

 

By: /s/ Roger Crystal  
Name: Roger Crystal  
Title: CEO  

 

 

 

By: /s/ Brad Miles  
Name: Brad Miles  
Title: Senior Advisor  

 

 

 

 

EXHIBIT A

 

FORM OF NOTICE OF STOCK OPTION GRANT

 

 

Dear Brad Miles (“Optionee”),

 

Reference is hereby made to (i) the Stock Option Plan of Lightlake Therapeutics Inc. (the “ Company ”) effective December 15, 2010 (the “ Stock Option Plan ”), and (ii) the Senior Advisor Agreement dated January 22, 2013 between the Company and Brad Miles (as amended, restated, or otherwise modified from time to time, the “ Letter ”). Capitalized terms utilized herein shall have the meanings ascribed to them in the Stock Option Plan unless otherwise defined herein.

 

You have been granted options to purchase Common Stock of the Company (with each share of Common Stock of the Company, a “ Share ”) as follows:

 

  Board Approval Date:  
     
  Date of Grant:  
     
  Exercise Price per Share: US$0.15
     
  Total Number of Shares Granted: 1,750,000
     
  Total Exercise Price: Cashless exercise as per the Letter
     
  Type of Options: Non-Qualified Stock Options
     
  Expiration Date: The date that is five (5) years from the Date of Grant
     
  Termination Period: These Options may be exercised for a period of five (5) years from the Date of Grant.  Optionee is responsible for keeping track of these exercise periods following termination for any reason of his service relationship with the Company, it being understood that Optionee is entitled to all rights, including compensation and vesting rights, with respect to this Option, as set forth in the Letter.  The Company will not provide further notice of such periods.
     
  Transferability: These Options may not be transferred, except as permitted by applicable laws and regulations.
     
  Restrictions on Exercise: These Options may only be exercised between the following dates: (i) the earliest date on which the price per Share has traded at or above US$0.30 for at least three (3) trading days out of any ten (10) consecutive trading days; and (ii) the Expiration Date.  Notwithstanding anything to the contrary contained in any agreement with the Company, it is an absolute condition of the Optionee’s right to exercise any Option that the Optionee be in full compliance with any other agreements between the Optionee and the Company, including without limitation any confidentiality agreements.
     
  Vesting: 100% on the date of the Senior Advisor Agreement referenced herein

 

 

 

 

Following receipt by the Company of evidence and/or an indemnity from the Optionee to the Company in a form reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of these Options or any certificates for representing the Shares underlying these Options and, in the event of mutilation, following the surrender and cancellation of such Options or stock certificate, the Company will make and deliver replacement Options or stock certificate of like tenor and dated as of such cancellation, in lieu of these Options or stock certificates, without any charge therefor, it being understood that the making and/or delivery of such replacement Options or stock certificates by the Company will not be unreasonably withheld.  Any such replacement Options or stock certificates shall be subject to the same terms, conditions, and restrictions as these Options and any Shares underlying these Options. Proportionate adjustments shall automatically be made to both the Exercise Price and number of these Options, and the Restrictions on Exercise, in the event of a stock split, stock dividend, reclassification, recapitalization, or any other increase or decrease in the number of issued Shares of the Company effected without receipt of consideration by the Company, or upon any other event reasonably determined by a majority of the Board of Directors of the Company to justify such adjustments.

 

To the extent that the terms of the Stock Option Plan differ from the terms of this Notice of Stock Option Grant (the “ Notice ”), the terms of this Notice supersede the terms of the Stock Option Plan.

 

By your signature and the signature of the Company’s representative below, you and the Company agree to the terms of these Options.

 

BRAD MILES   LIGHTLAKE THERAPEUTICS INC.
     
     
Optionee   Roger Crystal, Chief Executive Officer

 

 

 

 

EXHIBIT B

 

Form of Notice of Exercise of Stock Option

 

Ladies and Gentlemen:

 

This letter constitutes an unconditional and irrevocable notice that I hereby exercise the stock option(s) granted to me by Lightlake Therapeutics Inc., a Nevada corporation (the “ Company ”) on _______________ at a fair market value of US$ ______ per share. Pursuant to the terms of such option(s), I wish to purchase _______________ shares of the common stock covered by such option(s) at the exercise price(s) of US$ ______ per share via cashless exercise. These shares should be registered under the Securities Act of 1933, as amended, and delivered as follows:

 

Name:    
     
Address:    
     
     
     
     
     
Social Security Number:    

 

I represent that I will not dispose of such shares in any manner that would involve a violation of applicable securities laws.

 

Dated:       By:     
           
     

Name:

   

 

 

 

Exhibit 10.7

 

First Amendment to Senior Advisor Agreement

 

This amendment (the “First Amendment”) to the Senior Advisor Agreement by and between Brad Miles (“Miles”) and Lightlake Therapeutics Inc. (the “Company”) dated January 22, 2013 (the “Agreement”) is entered into on February 24, 2015, and hereby amends the terms of the Agreement.

 

WHEREAS Miles is a Senior Advisor to the Company;

 

WHEREAS the Company has requested that Miles provide additional Services (as defined in the Agreement);

 

WHEREAS Miles has received compensation deemed by the Company to be inadequate to retain Miles as a Senior Advisor;

 

WHEREAS the Company seeks to retain Miles as a Senior Advisor; and

 

WHEREAS the Company seeks to provide Miles with additional incentive to remain a Senior Advisor and perform the Services;

 

NOW THEREFORE, in consideration of the mutual covenants herein contained, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby mutually agree to this First Amendment as follows:

 

1) Miles shall provide the Services to the Company until December 31, 2016 (the “Term End Date”), unless the Agreement is terminated as per the terms of the Agreement or the terms herein.

 

2) Any compensation granted herein to Miles shall be in addition to any other option compensation previously granted by the Company to Miles.

 

3) Until the Term End Date the Company shall pay Miles Ten Thousand United States Dollars (US$10,000.00) for each calendar quarter that Miles provides Services to the Company (the “Quarterly Payment”), unless the Agreement is terminated as per the terms of the Agreement or the terms herein. The first Quarterly Payment shall be paid to Miles within three (3) business days of the date of this Amendment. Unless the Agreement is terminated as per the terms in the Agreement or the terms herein, subsequent Quarterly Payments shall be paid to Miles within twenty (20) business days of April 1, 2015, July 1, 2015, October 1, 2015, January 1, 2016, April 1, 2016, July 1, 2016, and October 1, 2016. All Quarterly Payments due to Miles shall be wired to Miles according to the following instructions:

 

 

 

 

Brad Miles

 

117 Sandcherry Court

 

Pickering, Ontario Canada, L1V 6V8

 

Bank of Montreal

 

726 Kingston Rd., Unit 1

 

Pickering West

 

Pickering Ontario Canada, L1V 1A9

 

Account#:

 

Swift Code:

 

Routing#:

 

4) The following language in Paragraph 3 of the Agreement:

 

“Such Options shall be exercisable in the form of Notice of Stock Option Grant attached as Exhibit A hereto, which Options may be exercised, where applicable, pursuant to the form of Notice of Exercise of Stock Option (the “Exercise Notice”) attached as Exhibit B hereto.”

 

is hereby deleted and replaced with the following language:

 

“Exercise of these Options shall occur by Miles’s: (i) surrendering the exercised Options at the then current official address listed in securities filings of the Company together with a properly completed and signed Notice of Exercise of Stock Option (as per Exhibit B), and (ii) providing via email a readable .pdf or scan of all of the documentation set forth in (i) to the following email addresses: roger.crystal@lightlaketherapeutics.com and kevin.pollack@lightlaketherapeutics.com.”

 

5) Miles shall follow all Company policies and procedures and comply with all laws and regulations.

 

6) The Agreement may be terminated at any time by the Company effective immediately by written or electronic notice by the Company, if Miles:

 

(a)        Commits any serious breach, or repeat (after previous written warning, which warning may be provided via email) of any breach, or is guilty of a continuing breach of any of the terms of the Agreement; or

 

(b)        Is guilty of any serious misconduct or willful neglect in the discharge of Miles’s obligations under the Agreement; or

 

 

 

 

(c)        Is declared bankrupt; or

 

(d)        Is convicted of any criminal offense (except minor traffic violations), which the Board of Directors of the Company (the “Board”) reasonably believes materially and/or adversely affects Miles’s ability to continue; or

 

(e)        Is convicted of any offense relating to insider dealing or any serious breach of any of the laws or regulations, as determined by the Board; or

 

(f)        Is the subject of, or cause the Company to be the subject of, a serious penalty or reprimand imposed by any regulatory authority by which the Company is governed or to which its activities are subject; or

 

(g)       Engages in any act of moral turpitude, including, but not limited to, an act of dishonesty, theft, or misappropriation of Company property, insubordination, or any act injuring, abusing, or endangering others, as determined by the Board.

 

7) In the event of termination of the Agreement, the Company shall not be obligated to provide any further compensation to Miles.

 

8) The Company and Miles each agrees to release, indemnify and hold harmless the other party from and against any third party claims for any loss, damages, liability, costs, or expenses, including reasonable attorney fees, arising from or relating to any negligence, wrongful acts or omissions by the other party or their respective officers, directors or employees.

 

9) During the course of Miles’s engagement as a Senior Advisor, from time to time, Miles is likely to obtain knowledge of trade secrets and other confidential information with regard to the business and financial affairs of the Company and its subsidiaries, whether currently existing or not, (together the “Group”) and its customers’ and suppliers’ details, and Miles has obtained such information while rendering past Services to the Company (collectively, the “Confidential Information”). Accordingly, Miles shall not (except in the proper course of his duties hereunder) at any time (such obligation continuing indefinitely), divulge any Confidential Information to any person, firm, corporation, or entity whomsoever other than as required by law or legal or similar proceedings, or as required to conduct the duties and responsibilities set forth in the Agreement. Miles shall use his best endeavors to prevent the unauthorized publication or disclosure of Confidential Information, and shall not use for his own purposes, or for any purposes other than those of the Company Confidential Information (which have come to Miles’s knowledge while rendering past Services to the Company and that may come to Miles’s knowledge during or in the course of the engagement hereunder or Miles’s engagement with any subsidiary of the Company). Such Confidential Information shall, without limitation, be deemed to include the following:

 

 

 

 

(a)       Any knowledge or information relating to any trade secret, process, invention, or concerning the business or finances of the Group or any dealings relating thereto;

 

(b)        Transactions or affairs of any of the Group, or of any officers, directors, shareholders, or employees of the Group, or any other information of a confidential character (including such information belonging to or relating to any third party);

 

(c)        Any information concerning the structure and format of the Group’s products, promotions, and services;

 

(d)        Any confidential business methods of the Group;

 

(e)        Any confidential pricing information or any information relating to prospective or actual tenders for contracts with prospective or actual suppliers or customers of the Group;

 

(f)        Any confidential client or customer lists of the Group; and

 

(g)        Any document or data of the Group marked confidential or which Miles might reasonably expect to be of a confidential nature.

 

All articles, notes, sketches, computer programs, plans, memoranda, records, and any other documents (whether in hard or electronic form) or copies thereof provided to, created or used by Miles in relation to any Confidential Information shall be and remain the property of the Company, or the relevant subsidiary of the Company, and shall be delivered together with all copies thereof, to the Company or as it shall direct from time-to-time, on demand, promptly after the Term End Date, or immediately when the Agreement is terminated .

 

The obligations in this Paragraph 9 shall not apply to information that is in the public domain other than by reason of breach of this Paragraph 9.

 

Miles’s obligations under this Paragraph 9 shall, with respect to each subsidiary of the Company, whether currently existing or not, constitute a separate and distinct covenant in respect of which Miles hereby covenant with the Company as trustee for each such other company.

 

Each of the sub-paragraphs of this Paragraph 9 shall be separate, distinct, and severable from each other. In the event that any of the sub-paragraphs is held void but would be valid if any part of the wording thereof were deleted, such restriction shall apply with such deletions as may be necessary to make it valid and effective.

 

 

 

  

10) This First Amendment, together with any other documents incorporated herein by reference, including the Agreement, and related exhibits and schedules, constitutes the sole and entire agreement of the parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.

  

11) The Agreement, as amended by this First Amendment, may only be amended, modified or supplemented by an agreement in writing signed by each party hereto, and any of the terms thereof may be waived, only by a written document signed by each party to the Agreement or, in the case of waiver, by the party or parties waiving compliance.

 

12) This First Amendment shall be governed by and construed in accordance with the internal laws of the State of New York without giving effect to any choice or conflict of law provision or rule. Each party irrevocably submits to the exclusive jurisdiction and venue of the federal and state courts located in New York in any legal suit, action or proceeding arising out of or based upon this First Amendment or the Services and/or compensation provided hereunder.

 

13) If any term or provision of this First Amendment is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this First Amendment or invalidate or render unenforceable such term or provision in any other jurisdiction

 

14) This First Amendment may be executed in multiple counterparts and by facsimile signature or by email of a PDF document, each of which shall be deemed an original and all of which together shall constitute one instrument.

 

 

 

 

IN WITNESS WHEREOF the parties have executed this First Amendment this 24 th day of February 2015.

 

 

LIGHTLAKE THERAPEUTICS INC.

 

BY: /s/ Kevin Pollack

 

Name: Kevin Pollack

 

Title: CFO

 

Address: 445 Park Avenue, 9 th Floor, New York, NY 10022

 

Email Addresses (for electronic Notice): Both kevin.pollack@lightlaketherapeutics.com and roger.crystal@lightlaketherapeutics.com

 

 

BRAD MILES

 

/s/ Brad Miles

 

Federal Tax Id. No./Social Security No.: N/A

 

Email Address (for electronic Notice):

 

Address: 117 Sandcherry Court, Pickering, Ontario Canada, L1V 6V8

 

Phone Number: 905-509-2372

 

 

 

Exhibit 10.8

 

Second Amendment to Senior Advisor Agreement

 

This amendment (the “Second Amendment”) to the Senior Advisor Agreement by and between Brad Miles (“Miles”) and Lightlake Therapeutics Inc. (the “Company”) dated January 22, 2013 and amended on February 24, 2015 (collectively, the “Agreement”), is entered into on March 19, 2015, and hereby amends the terms of the Agreement.

 

WHEREAS Miles is a Senior Advisor to the Company;

 

WHEREAS the Company has requested that Miles provide the Services (as defined in the Agreement) and additional Services;

 

WHEREAS Miles has received compensation deemed by the Company to be inadequate to retain Miles as a Senior Advisor;

 

WHEREAS the Company seeks to retain Miles as a Senior Advisor; and

 

WHEREAS the Company seeks to provide Miles with additional incentive to remain a Senior Advisor and perform the Services and additional Services;

 

NOW THEREFORE, in consideration of the mutual covenants herein contained, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby mutually agree to this Second Amendment as follows:

  

1) Miles shall provide the Company with the Services and additional Services through December 31, 2016, unless the Agreement is terminated as per the terms of the Agreement.

 

2) The Company shall grant Miles options (the “Options”) to purchase 80,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”). 48,000 of the Options shall have an exercise price of $10.00. 32,000 of the Options shall have an exercise price of $15.00. All of the Options shall contain a cashless exercise provision. All of the Options shall contain standard adjustment provisions with respect to stock splits, recapitalizations, change of control and fundamental transactions but shall not contain any anti-dilution or price protection. All of the Options shall have a five-year life from their date of grant and be non-transferable. The Options shall fully vest on their grant date. All of the Options shall be in such form as attached hereto as Exhibit A. All of the Options shall be exercised as per a notice in such form as attached hereto as Exhibit B, which notice shall be mailed to the Company’s then current official address listed in securities filings and also be sent to and received by both Company email addresses set forth at the bottom of this Second Amendment. Upon the exercise of the Options, the fair market value per share of Common Stock shall be equal to the closing price of the Common Stock on the day prior to such exercise.

 

 

 

  

3) The Company shall grant Miles warrants (the “Warrants”) to purchase 45,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”). All of the Warrants shall have an exercise price of $10.00. All of the Warrants shall be exercisable for cash and none of the Warrants shall contain a cashless exercise provision. All of the Warrants shall contain standard adjustment provisions with respect to stock splits, recapitalizations, change of control and fundamental transactions but shall not contain any anti-dilution or price protection. All of the Warrants shall have a five-year life from their date of grant and be transferable so long as any such transfer(s) comply with applicable laws and regulations. All of the Warrants shall fully vest on their grant date. All of the Warrants shall be in such form as attached hereto as Exhibit C. All of the Warrants shall be exercised as per a notice in such form as attached hereto as Exhibit D, which notice shall be mailed to the Company’s then current official address listed in securities filings and also be sent to and received by both Company email addresses set forth at the bottom of this Second Amendment. Upon the exercise of the Warrants, the fair market value per share of Common Stock shall be equal to the closing price of the Common Stock on the day prior to such exercise.

 

4) All compensation granted to Miles herein shall be in addition to compensation previously granted by the Company to Miles. No other compensation shall be owed to or due to Miles unless set forth in the Agreement or in a prior agreement executed in writing between the Company and Miles.

 

5) This Second Amendment, together with any other documents incorporated herein by reference, including the Agreement, and related exhibits and schedules, constitutes the sole and entire agreement of the parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.

 

6) The Agreement, as amended by this Second Amendment, may only be amended, modified or supplemented by an agreement in writing signed by each party hereto, and any of the terms thereof may be waived, only by a written document signed by each party to the Agreement or, in the case of waiver, by the party or parties waiving compliance.

 

7) This Second Amendment shall be governed by and construed in accordance with the internal laws of the State of New York without giving effect to any choice or conflict of law provision or rule. Each party irrevocably submits to the exclusive jurisdiction and venue of the federal and state courts located in New York in any legal suit, action or proceeding arising out of or based upon this Second Amendment or the Services and/or compensation provided hereunder.

 

8) If any term or provision of this Second Amendment is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Second Amendment or invalidate or render unenforceable such term or provision in any other jurisdiction

 

9) This Second Amendment may be executed in multiple counterparts and by facsimile signature or by email of a PDF document, each of which shall be deemed an original and all of which together shall constitute one instrument.

 

 

 

  

IN WITNESS WHEREOF the parties have executed this Second Amendment this 19th day of March 2015.

 

 

LIGHTLAKE THERAPEUTICS INC.

 

BY: /s/ Kevin Pollack

 

Name: Kevin Pollack

 

Title: CFO

 

Address: 445 Park Avenue, 9 th Floor, New York, NY 10022

 

Email Addresses (for electronic Notice): Both kevin.pollack@lightlaketherapeutics.com and roger.crystal@lightlaketherapeutics.com

 

 

BRAD MILES

 

/s/ Brad Miles

 

Federal Tax Id. No./Social Security No.: N/A

 

Email Address (for electronic Notice):

 

Address: 117 Sandcherry Court, Pickering, Ontario Canada, L1V 6V8

 

Phone Number: 905-509-2372

 

 

 

 

EXHIBIT A – Stock Option Grant

 

Dear Brad Miles (the “Option Holder”),

 

As per the Agreement dated January 22, 2013, as amended, between Lightlake Therapeutics Inc. (the “Company”) and you, you have been granted options (the “Options”) to purchase common stock (the “Common Stock”) of the Company (with each share of Common Stock of the Company, a “Share”) as follows:

 

  Date of Grant: March 19, 2015
     
  Exercise Price per Share: US$10.00 / US$15.00
     
  Total Number of Shares Granted: 48,000 / 32,000
     
  Total Exercise Price: Cashless exercise
     
  Type of Options: Non-Qualified Stock Options
     
  Expiration Date: March 18, 2020
     
  Termination Period: These Options may be exercised for a period of five (5) years from the Date of Grant.  You are responsible for keeping track of this exercise period.  The Company will not provide further notice of such period.
     
  Transferability: These Options may not be transferred, except as permitted by applicable laws and regulations.
     
  Restriction on Exercise: Your ability to exercise these Options is contingent on your and your officers, agents, and representatives keeping confidential information shared with you and your officers, agents, and representatives confidential and complying with all applicable laws and regulations.
     
  Vesting: 100% on the Date of Grant

 

Following receipt by the Company of evidence and/or an indemnity from you to the Company in a form reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of these Options or any certificates for representing the Shares underlying these Options and, in the event of mutilation, following the surrender and cancellation of such Options or stock certificate, the Company shall make and deliver replacement Options or stock certificate of like tenor and dated as of such cancellation, in lieu of these Options or stock certificate, without any charge therefor.  Any such replacement Options or stock certificates shall be subject to the same terms, conditions, and restrictions as these Options and any Shares underlying these Options. Proportionate adjustments shall automatically be made to both the Exercise Price and number of these Options in the event of a stock split, recapitalization, change of control and fundamental transaction. Upon the exercise of these Options, the fair market value per Share shall be equal to the closing price of the Shares on the day prior to such exercise.

 

 

 

  

Exercise of these Options shall occur by your: (i) surrendering the exercised Options at the then current official address listed in securities filings of the Company together with a properly completed and signed Notice of Exercise of Stock Option (as per Exhibit B), and (ii) providing via email a readable .pdf or scan of all of the documentation set forth in (i) to the following email addresses: roger.crystal@lightlaketherapeutics.com and kevin.pollack@lightlaketherapeutics.com.

 

By your signature and the signature of the Company’s representative below, you and the Company agree to the terms of these Options.

 

Brad Miles   LIGHTLAKE THERAPEUTICS INC.
     
     
     
    Name:
     
    Title:

 

 

 

 

EXHIBIT B – Form of Notice of Exercise of Stock Option

 

Ladies and Gentlemen:

 

This letter constitutes an unconditional and irrevocable notice that I hereby exercise the stock option(s) granted to me by Lightlake Therapeutics Inc., a Nevada corporation (the “Company”) on _______________ at a fair market value of US$ ______ per share (equal to the closing price of the shares of common stock of the Company on the day prior to this exercise). Pursuant to the terms of such option(s), I wish to purchase _______________ shares of the common stock covered by such option(s) at the exercise price(s) of US$ ______ per share via cashless exercise.

 

These shares should be delivered as follows:

 

Name:    
     
Address:    
     
     
     
     
     
Tax ID #:    

 

I represent that I will not dispose of such shares in any manner that would involve a violation of applicable securities laws.

 

Dated:       By:     
           
     

Name:

   

 

 

 

 

EXHIBIT C – Warrant Grant

 

Dear Brad Miles (the “Warrant Holder”),

 

As per the Agreement dated January 22, 2013, as amended, between Lightlake Therapeutics Inc. (the “Company”) and you, you have been granted warrants (the “Warrants”) to purchase common stock (the “Common Stock”) of the Company (with each share of Common Stock of the Company, a “Share”) as follows:

 

  Date of Grant: March 19, 2015
     
  Exercise Price per Share: US$10.00
     
  Total Number of Shares Granted: 45,000
     
  Type of Options: Non-Qualified Stock Options
     
  Expiration Date: March 18, 2020
     
  Termination Period: These Options may be exercised for a period of five (5) years from the Date of Grant.  You are responsible for keeping track of this exercise period.  The Company will not provide further notice of such period.
     
  Transferability: These Warrants may be transferred, except as prohibited by applicable laws and regulations.
     
  Restriction on Exercise: Your ability to exercise these Options is contingent on your and your officers, agents, and representatives keeping confidential information shared with you and your officers, agents, and representatives confidential and complying with all applicable laws and regulations.
     
  Vesting: 100% on the Date of Grant

 

These Warrants may only be exercised for cash.

 

 

 

  

Following receipt by the Company of evidence and/or an indemnity from you to the Company in a form reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of these Warrants or any certificates for representing the Shares underlying these Warrants and, in the event of mutilation, following the surrender and cancellation of such Warrants or stock certificate, the Company shall make and deliver replacement Warrants or stock certificate of like tenor and dated as of such cancellation, in lieu of these Warrants or stock certificate, without any charge therefor.  Any such replacement Warrants or stock certificates shall be subject to the same terms, conditions, and restrictions as these Warrants and any Shares underlying these Warrants. Proportionate adjustments shall automatically be made to both the Exercise Price and number of these Warrants in the event of a stock split, recapitalization, change of control and fundamental transaction. Upon the exercise of these Warrants, the fair market value per Share shall be equal to the closing price of the Shares on the day prior to such exercise.

 

Exercise of these Warrants shall occur by your: (i) surrendering the exercised Warrants at the then current official address listed in securities filings of the Company together with a properly completed and signed Notice of Exercise of Stock Warrant (as per Exhibit D), (ii) paying the proper amount of cash to the Company, and (iii) providing via email a readable .pdf or scan of all of the documentation set forth in (i) and (ii) to the following email addresses: roger.crystal@lightlaketherapeutics.com and kevin.pollack@lightlaketherapeutics.com.

 

By your signature and the signature of the Company’s representative below, you and the Company agree to the terms of these Warrants.

 

Brad Miles   LIGHTLAKE THERAPEUTICS INC.
     
     
     
    Name:
     
    Title:

 

 

 

 

 

EXHIBIT D

 

Form of Notice of Exercise of Warrant

Ladies and Gentlemen:

 

This letter constitutes an unconditional and irrevocable notice that I hereby exercise the warrant(s) granted to me by Lightlake Therapeutics Inc., a Nevada corporation (the “Company”) on _______________ at a fair market value of US$ ______ per share. Pursuant to the terms of such warrant(s), I wish to purchase _______________ shares of the common stock covered by such warrant(s) at the exercise price(s) of US$ ______ per share via cash exercise, for a total aggregate purchase price of US$_______________, which I agree to promptly provide to the Company.

 

These shares should be delivered as follows:

 

Name:    
     
Address:    
     
     
     
     
     
Tax ID #:    

 

I represent that I will not dispose of such shares in any manner that would involve a violation of applicable securities laws.

 

Dated:       By:     
           
     

Name:

   

 

 

 

 

EXHIBIT 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER,

PURSUANT TO 18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO SECTION 302

OF THE SARBANES–OXLEY ACT OF 2002

 

I, Dr. Roger Crystal, Chief Executive Officer of Opiant Pharmaceuticals, Inc., certify that:

 

1.   I have reviewed this Quarterly Report on Form 10-Q of Opiant Pharmaceuticals, Inc.;

 

2.   Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.   Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.   The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5.   The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: March 15, 2017

 

  By:   /s/ Dr. Roger Crystal  
    Dr. Roger Crystal  
    Chief Executive Officer  
    (Principal Executive Officer)  

  

 

EXHIBIT 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER,  

PURSUANT TO 18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO SECTION 302

OF THE SARBANES-OXLEY ACT OF 2002

 

I, Kevin Pollack, Chief Financial Officer of Opiant Pharmaceuticals, Inc., certify that:

 

1.   I have reviewed this Quarterly Report on Form 10-Q of Opiant Pharmaceuticals, Inc.;

 

2.   Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.   Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.   The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5.   The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: March 15, 2017

 

  By:   /s/ Kevin Pollack  
      Kevin Pollack  
    Chief Financial Officer  
    (Principal Financial and Accounting Officer)  

 

 

 

EXHIBIT 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of Opiant Pharmaceuticals, Inc. (the “Company”) for the period ended January 31, 2017, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Dr. Roger Crystal, as Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)  The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)  The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: March 15, 2017

 

  By:   /s/ Dr. Roger Crystal  
    Dr. Roger Crystal  
    Chief Executive Officer  
    (Principal Executive Officer)  

 

 

EXHIBIT 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of Opiant Pharmaceuticals, Inc. (the “Company”) for the period ended January 31, 2017, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Kevin Pollack, as Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)  The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)  The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: March 15, 2017

 

  By:   /s/ Kevin Pollack  
    Kevin Pollack  
    Chief Financial Officer  
    (Principal Financial and Accounting Officer)