UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

Form 10–Q

(Mark One)

 

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

 

For the quarterly period ended: March 31, 2021

 

OR

 

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

 

For the transition period from       to        

 

Commission File Number 001-38286

 

ENVERIC BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   95-4484725
(State or other jurisdiction
of incorporation or organization)
  (I.R.S. Employer
Identification No.)

 

4851 Tamiami Trail N, Suite 200

Naples, FL

  34103
(Address of principal executive offices)   (Zip Code)

 

(239) 302-1707

 

(Registrant’s telephone number, including area code)

 

Securities registered under section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on
which registered
Common Stock, $0.01 par value per share   ENVB   The Nasdaq Stock Market LLC
Warrants to Purchase Common Stock   AMRHW   N/A

 

Securities registered under section 12(g) of the Act:

 

  Title of class  
  Series B Preferred Stock  

 

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 every Interactive Data File required to be submitted 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 such files). Yes [X] No [  ]

  

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

 

Large accelerated filer [  ] Accelerated filer [  ]
Non-accelerated filer [X] Smaller reporting company [X]
Emerging growth company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

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 May 13, 2021, there were 21,390,290 shares of the registrant’s common stock, $0.01 par value per share, issued and outstanding.

 

 

 

 

 

  

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

 

FORM 10-Q

 

TABLE OF CONTENTS

 

  Page
PART I. FINANCIAL INFORMATION  
Item 1. Financial statements  
Condensed Consolidated Balance Sheets as of March 31, 2021 (Unaudited) and December 31, 2020 3
Condensed Consolidated Statements of Operations (Unaudited) for the three months ended March 31, 2021 and 2020 4
Condensed Consolidated Statement of Changes in Stockholders’ Equity (Unaudited) for the three months ended March 31, 2021 and 2020 5
Condensed Consolidated Statements of Cash Flows (Unaudited) for the three months ended March 31, 2021 and 2020 6
Notes to the Unaudited Condensed Consolidated Financial Statements 7
Item 2. Management’s discussion and analysis of financial condition and results of operations 15
Item 3. Quantitative and qualitative disclosures about market risk 23
Item 4. Controls and procedures 23
PART II. OTHER INFORMATION 24
Item 1. Legal proceedings 24
Item 1A. Risk factors 24
Item 2. Unregistered sales of equity securities and use of proceeds 24
Item 3. Defaults upon senior securities 24
Item 4. Mine safety disclosures 24
Item 5. Other information 24
Item 6. Exhibits 24
Signatures 25

 

2

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

    As of March 31,     As of December 31,  
    2021     2020  
      (unaudited)          
Assets                
Current assets:                
Cash   $ 22,657,150     $ 1,578,460  
Prepaid expenses and other current assets     767,298       700,710  
Total current assets     23,424,448       2,279,170  
                 
Intangible assets, net     2,362,177       1,817,721  
Total assets   $ 25,786,625     $ 4,096,891  
                 
Liabilities and Shareholders’ Equity (Deficit)                
                 
Liabilities                
Current liabilities:                
Accounts payable and accrued liabilities   $ 626,947     $ 681,250  
Total liabilities     626,947       681,250  
                 

Warrant liabilities

    6,168,000       -  

Total liabilities

    6,794,947       681,250  
                 
Commitments and contingencies (Note 6)                
                 
Shareholders’ Equity                
Preferred Stock, $0.01 par value, 20,000,000 shares authorized, 0 and 3,275,407 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively     -       32,754  
Common stock, $0.01 par value, 100,000,000 shares authorized, 19,449,975 and 10,095,109 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively     194,499       100,951  
Additional paid-in capital     33,952,988       15,222,770  
Accumulated deficit     (15,010,268 )     (11,759,557 )
Accumulated other comprehensive loss     (145,541 )     (181,277 )
Total shareholders’ equity     18,991,678       3,415,641  
Total liabilities and shareholders’ equity   $ 25,786,625     $ 4,096,891  

 

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

 

3

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 

    For the Three Months Ended March 31,  
    2021     2020  
             
Operating expenses                
General and administrative expenses   $ 6,607,045     $ 836,702  
Research and development     157,952       -  
Total operating expenses     6,764,997       836,702  
                 
Loss from operations     (6,764,997 )     (836,702 )
                 
Other income (expense)                
Inducement expense     (298,714 )   -  

Change in fair value of warrant liabilities

    3,813,000       -  
Interest expense     -       (261,759 )
Total other income (expense)     3,514,286        (261,759 )
                 
Net loss     (3,250,711 )     (1,098,461 )
                 
Other comprehensive loss                
Foreign currency translation     35,736       (12,698 )
                 
Comprehensive loss   $ (3,214,975 )   $ (1,111,159 )
                 
Net loss per share - basic and diluted   $ (0.20 )   $ (0.19 )
                 
Weighted average shares outstanding, basic and diluted     16,220,661       5,653,820  

 

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

 

4

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)

FOR THE THREE MONTHS ENDED MARCH 31, 2021 AND 2020

 

    Series B Preferred Stock     Common Stock     Additional paid-in     Accumulated     Accumulated Other Comprehensive        
    Shares     Amount     Shares     Amount     capital     Deficit     Loss     Total  
                                                 
Balance as of January 1, 2020     -       -       5,573,915     $ 55,739     $ 3,039,163     $ (4,894,881 )   $ (11,622 )   $ (1,811,601 )
                                                                 
Common stock issued for accounts payable     -       -       85,942       859       172,623       -       -       173,482  
Warrants issued in conjunction with notes payable     -       -       -       -       32,149       -       -       32,149  
Beneficial conversion feature issued with note payable     -       -       -       -       17,851       -       -       17,851  
Foreign exchange loss     -       -       -       -       -       -       (12,698 )     (12,698 )
Net loss     -       -       -       -       -       (1,098,461 )     -       (1,098,461 )
                                                                 
Balance as of March 31, 2020     -     $ -       5,659,857     $ 56,598     $ 3,261,786     $ (5,993,342 )   $ (24,320 )   $ (2,699,278 )
                                                                 
Balance as of January 1, 2021     3,275,407     $ 32,754       10,095,109     $ 100,951     $ 15,222,770     $ (11,759,557 )   $ (181,277 )   $ 3,415,641  
                                                                 
January 2021 registered direct offering     -       -       2,221,334       22,213       4,594,874       -       -       4,617,087  
February 2021 registered direct offering     -       -       3,007,026       30,070       6,986,331       -       -       7,016,401  
Stock based compensation     -       -       -       -       3,591,565       -       -       3,591,565  
Induced conversion of stock options into restricted stock awards     -       -       -       -       298,714       -       -       298,714  
Conversion of Series B Preferred Stock     (3,275,407 )     (32,754 )     3,275,407       32,754       -       -       -       -  
Exercise of warrants     -       -       851,099       8,511       3,258,734       -       -       3,267,245  
Foreign exchange gain     -       -       -       -       -       -       35,736       35,736  
Net loss     -       -       -       -       -       (3,250,711 )     -       (3,250,711 )
                                                                 
Balance as of March 31, 2021     -     $ -       19,449,975     $ 194,499     $ 33,952,988     $ (15,010,268 )   $ (145,541 )   $ 18,991,678  

 

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

 

5

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    For the Three Months Ended March 31,  
    2021     2020  
Cash Flows From Operating Activities:                
Net loss   $ (3,250,711 )   $ (1,098,461 )
Adjustments to reconcile net loss to cash used in operating activities:                
Extinguishment of note payable     -       233,240  
Accrued interest     -       28,519  

Change in fair value of warrant liability

    (3,813,000 )     -  
Stock-based compensation     3,591,565       -  
Inducement expense     298,714       -  
Amortization of intangible assets     136,640       -  
Change in operating assets and liabilities:                
Prepaid expenses and other current assets     (66,208 )     (49,588 )
Accounts payable and accrued liabilities     (59,278 )     (7,632 )
Net cash used in operating activities     (3,162,278 )     (893,922 )
                 
Cash Flows From Investing Activities:                
Purchase of license agreement     (675,000 )     -  
Net cash used in investing activities     (675,000 )     -  
                 
Cash Flows From Financing Activities:                
Proceeds from sale of common stock, net of offering costs     21,614,488       -  
Proceeds from convertible notes payable     -      

50,000

 
Proceeds from note payable     -      

1,319,910

 
Repayment of note payable     -      

(157,714

)
Proceeds from warrant exercises     3,267,245       -
Net cash provided by financing activities     24,881,733       1,212,196
                 
Effect of foreign exchange rate on cash     34,235       (86,677 )
                 
Net increase in cash     21,078,690       231,597
Cash - beginning of period     1,578,460       43,714  
Cash - end of period   $ 22,657,150     $ 275,311
                 
Supplemental non-cash financing activities:                
                 
Warrants issued in conjunction with notes payable issuances   $ -     $ 17,851  
Shares of common stock issued for note payable extensions   $ -     $ 32,149  
Shares of common stock issued for accounts payable   $ -     $ 173,482  

 

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

 

6

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 - Business

 

Nature of operations

 

Enveric Biosciences, Inc. (“Enveric Biosciences, Inc.” “Enveric” or the “Company”) (formerly known as Ameri Holdings, Inc.) (“Ameri”) is a pharmaceutical company developing innovative, evidence-based cannabinoid medicines. The head office of the Company is located in Naples, Florida.

 

On January 10, 2020, the Company entered into an Amalgamation Agreement (as amended on May 6, 2020), (the “Amalgamation Agreement”) with Jay Pharma Merger Sub, Inc., a company organized under the laws of Canada and a wholly owned subsidiary of the Company (“Merger Sub”), Jay Pharma Inc., a company organized under the laws of Canada (“Jay Pharma”), Jay Pharma ExchangeCo., Inc. a company organized under the laws of British Columbia and a wholly owned subsidiary of the Company (“ExchangeCo”), and Barry Kostiner, as the Company Representative, which provided that, among other things, Merger Sub and Jay Pharma would be amalgamated and would continue as one corporation (“Amalco”), with Amalco continuing as a direct wholly owned subsidiary of ExchangeCo and an indirect wholly owned subsidiary of Ameri, on the terms and conditions set forth in the Amalgamation Agreement. On August 12, 2020, the Company, Jay Pharma and certain other signatories thereto entered into a tender agreement (the “Tender Agreement”), which provided that, among other things, Ameri would make a tender offer (the “Offer”) to purchase all of the outstanding common shares of Jay Pharma for the number of shares of Enveric common stock equal to the exchange ratio set forth in the Tender Agreement, and Jay Pharma would become a wholly-owned subsidiary of Ameri, on the terms and conditions set forth in the Tender Agreement. The Tender Agreement terminated and replaced in its entirety the Amalgamation Agreement. On December 30, 2020, the Company, Jay Pharma, Merger Sub, and ExchangeCo completed the Offer and Jay Pharma became a wholly owned subsidiary of the Company. The transaction was treated as a reverse acquisition and recapitalization and accordingly, the historical financial statements prior to the date of the Business Combination in these unaudited condensed consolidated financial statements are those of Jay Pharma.

 

COVID-19

 

During 2020 and continuing into 2021, the world has been, and continues to be, impacted by the novel coronavirus (COVID-19) pandemic. COVID-19 and measures to prevent its spread impacted our business in a number of ways. The impact of these disruptions and the extent of their adverse impact on our financial and operating results will be dictated by the length of time that such disruptions continue, which will, in turn, depend on the currently unknowable duration and severity of the impacts of COVID-19, and among other things, the impact of governmental actions imposed in response to COVID-19 and individuals’ and companies’ risk tolerance regarding health matters going forward and developing strain mutations.

 

7

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 2 – SUMMARY OF Significant Accounting Policies

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2020 and related notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on April 1, 2021.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions include determining the fair value of transactions involving common stock and the valuation of stock-based compensation. Actual results could differ from those estimates.

 

Foreign Currency Translation

 

The reporting currency of the Company is the United States Dollar. The financial statements of companies located outside of the U.S. are measured in their functional currency, which is the local currency. The functional currency of the Company is the Canadian dollar. Monetary assets and liabilities are translated using public exchange rates at the balance sheet date. Income and expense items are translated using average monthly exchange rates. Shareholders’ equity accounts and non-monetary assets are translated at their historical exchange rates. Translation adjustments are included in accumulated other comprehensive loss in the accompanying balance sheets.

 

Cash and cash equivalents

 

The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents as of March 31, 2021 and December 31, 2020.

 

Warrant Liability

 

The Company accounts for warrants for shares of the Company’s common stock that are not indexed to its own stock as liabilities at fair value on the balance sheet. Such warrants are subject to remeasurement at each balance sheet date and any change in fair value is recognized as a component of other expense on the statement of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such common stock warrants. At that time, the portion of the warrant liability related to such common stock warrants will be reclassified to additional paid-in capital.

 

Offering Costs

 

The Company allocates offering costs to the different components of the capital raise on a pro rata basis. Any offering costs allocated to common stock are charged directly to additional paid-in capital. Any offering costs allocated to warrant liabilities are charged to general and administrative expenses on the Company’s statement of operations.

 

Net Loss per Share

 

Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants (using the treasury stock method) and convertible notes. The computation of basic net loss per share for the three months ended March 31, 2021 and 2020 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both basic and fully diluted.

 

Potentially dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share because the effect of their inclusion would have been anti-dilutive.

 

    For the three months ended March 31, 2021     For the three months ended March 31, 2020  
Warrants to purchase shares of common stock     5,979,611       1,504,593  
Convertible notes     -       380,920  
Restricted stock units     3,279,284      

-

 
Restricted stock awards     70,986      

-

 
Options to purchase shares of common stock     369,361       3,604,348  
Total potentially dilutive securities     9,699,242       5,489,861  

 

8

 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 2 – SUMMARY OF Significant Accounting Policies, continued

 

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution, which at times, may exceed the Federal depository insurance coverage of $250,000. The Company has not experienced losses on these accounts and management believes the Company is not exposed to significant risks on such accounts.

 

Fair Value Measurement

 

The Company follows Accounting Standards Codification (“ASC”) 820–10 “Fair Value Measurement” of the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification to measure the fair value of its financial instruments and disclosures about fair value of its financial instruments. ASC 820–10 establishes a framework for measuring fair value and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements and related disclosures, ASC 820–10 establishes a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three (3) broad levels.

 

The three (3) levels of fair value hierarchy defined by ASC 820–10 are described below:

 

Level 1   Quoted market prices available in active markets for identical assets or liabilities as of the reporting date.
     
Level 2   Pricing inputs other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reporting date.
     
Level 3   Pricing inputs that are generally unobservable inputs and not corroborated by market data.

 

Financial assets or liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.

 

The fair value hierarchy gives the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

 

The carrying amounts of the Company’s financial assets and liabilities, such as cash, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these instruments.

 

The Company uses Level 3 of the fair value hierarchy to measure the fair value of its warrant liabilities. The Company revalues such liabilities at every reporting period and recognizes gains or losses as change in fair value of warrant liabilities in the condensed consolidated statements of operations that are attributable to the change in the fair value of the warrant liabilities.

 

The following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of March 31, 2021 and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:

 

    Level     March 31, 2021  
Warrant liabilities – January Warrants     3     $ 3,164,000  
Warrant liabilities – February Warrants     3       3,004,000  
Fair value as of March 31, 2021           $ 6,168,000  

 

The Company had no assets or liabilities measured at fair value at December 31, 2020.

 

Both the January and February Warrants are classified as Level 3, for which there is no current market for these securities such as the determination of fair value requires significant judgment or estimation. Changes in fair value measurement categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate.

 

9
 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 2 – SUMMARY OF Significant Accounting Policies, continued

 

Fair Value Measurement, continued

 

Initial Measurement

 

The Company established the initial fair value of its warrant liabilities at the respective dates of issuance. The Company used a Black Scholes valuation model in order to determine their value. The key inputs into the Black Scholes valuation model for the initial valuations are below:

 

    January Warrants     February Warrants    
    January 13, 2021     February 12, 2021  
Term (years)     5.0       5.0  
Stock price   $ 4.21     $ 4.62  
Exercise price   $ 4.95     $ 4.95  
Dividend yield     0.0 %     0.0 %
Expected volatility     84.7 %     84.7 %
Risk free interest rate     0.5 %     0.5 %
                 
Number of shares     1,821,514       1,714,005  
Value (per share)   $ 2.66     $ 3.00  

 

Subsequent measurement

 

The following table presents the changes in fair value of the warrant liabilities:

 

    January Warrants     February Warrants     Total Warrant Liability  
Fair value as of December 31, 2020   $ -     $ -     $ -  
Initial value of warrant liability     4,846,000       5,135,000       9,981,000  
Change in fair value     (1,682,000 )     (2,131,000 )     (3,813,000 )
                         
Fair value as of March 31, 2021   $ 3,164,000     $ 3,004,000     $ 6,168,000  

 

The key inputs into the Black Scholes valuation model for the Level 3 valuations as of March 31, 2021 are below:

 

    January Warrants     February Warrants  
Term (years)     4.8       4.9  
Stock price   $ 3.07     $ 3.07  
Exercise price   $ 4.95     $ 4.95  
Dividend yield     0.0 %     0.0 %
Expected volatility     84.7 %     84.7 %
Risk free interest rate     0.9 %     0.9 %
                 
Number of shares     1,821,514       1,714,005  
Value (per share)   $ 1.74     $ 1.75  

 

10
 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 2 – SUMMARY OF Significant Accounting Policies, continued

 

Recent Accounting Pronouncements

 

In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2019-12, Income Taxes (Topic 740: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which removes certain exceptions to the general principles in Topic 740. ASU 2019-12 is effective for the fiscal years beginning after December 15, 2020, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements.

 

In October 2020, the FASB issued ASU 2020-10, “Codification Improvements.” The new accounting rules improve the consistency of the Codification by including all disclosure guidance in the appropriate Disclosure Section (Section 50) that had only been included in the Other Presentation Matters Section (Section 45) of the Codification. Additionally, the new rules also clarify guidance across various topics including defined benefit plans, foreign currency transactions, and interest expense. The new accounting rules were effective for the Company in the first quarter of 2021. The adoption of the new accounting rules did not have a material impact on the Company’s financial statements.

 

In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The amendments in ASU No. 2021-04 provides guidance to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this ASU No. 2021-04 are effective for all entities for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, including interim periods within those fiscal years. As a result, the Company will not be required to adopt ASU 2021-04 until October 1, 2022. The Company is currently evaluating the impact of the adoption of this principle on the Company’s condensed consolidated financial statements.

 

Subsequent Events

 

The Company has evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the financial statements were issued. Other than as described in these financial statements, the Company did not identify any subsequent events that would have required adjustment to or disclosure in the financial statements.

 

NOTE 3 – INTANGIBLE ASSETS

 

As of March 31, 2021, the Company’s intangible assets consisted of:

 

    Useful Life   Gross
Carrying
Amount
    Accumulated
Amortization
    Net  
                       
Skincare Assets and License Agreements   4 years   $ 1,944,689     $ (257,512 )   $ 1,687,177  
Diverse Bio License Agreement   4 years     675,000       -       675,000  
Total       $ 2,619,689     $ (257,512 )   $ 2,362,177  

 

During the three months ended March 31, 2021 and 2020, the Company recognized amortization expense of $136,640 and $0, respectively.

 

Acquisition of Diverse Bio License Agreement

 

On March 5, 2021, the Company entered into an Exclusive License Agreement (the “DB Agreement”) with Diverse Biotech, Inc. (“Diverse”), pursuant to which the Company acquired an exclusive, perpetual license to develop five therapeutic candidates (collectively, the “Agents”) with the goal of alleviating the side effects that cancer patients experience. Under the terms of the DB Agreement, Diverse has granted the Company an exclusive license to its intellectual property rights covering the Agents and its products. In exchange, the Company has granted Diverse the right to information relating to the Agents developed for the express purpose of using such information to obtain patent rights, which right terminates upon the issuance or denial of the patent rights.

 

Under the DB Agreement, the Company will maintain sole responsibility and ownership of the development and commercialization of the Agents and its products. Diverse has agreed not to develop or commercialize any agent or product that would compete with the Agents, or its products containing the Agents, at any time during or after the term of the DB Agreement. If Diverse intends to license, sell, or transfer any other molecules linked with cannabinoids not granted to the Company under the terms of the DB Agreement, the Company will have the first right, but not the obligation, to negotiate an agreement with Diverse for such cannabinoids. The Company has also agreed to pay Diverse an up-front investment payment in the amount of $675,000, as well as a running royalty starting with the first commercial sale by the Company to a third party in an arms’-length transaction.

 

The term of the DB Agreement shall continue for as long as the Company intends to develop or commercialize the new drugs, unless earlier terminated by either Party. The Agreement may be terminated by either party upon ninety (90) days written notice of an uncured material breach or in the event of bankruptcy or insolvency. In addition, the Company has the right to terminate the DB Agreement at any time upon sixty (60) days’ prior written notice to Diverse.

 

11
 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 4 – COMMITMENTS AND CONTINGENCIES

 

The Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s financial position, results of operations or cash flows.

 

Stockholder Demand Letter

 

On January 21, 2021, the Company received a stockholder litigation demand letter from the law firm of Purcell Julie & Lefkowitz LLP, on behalf of James Self, a purported stockholder of the Company. The letter demands that the Company (i) deem ineffective the December 30, 2020 amendment to our Amended and Restated Certificate of Incorporation in which the Company effected a one-for-four reverse stock split of its common stock due to the manner in which non-votes by brokers were tabulated, (ii) seek appropriate relief for damages allegedly suffered by the company and its stockholders or seek a valid stockholder approval of the amendment and reverse stock split, and (iii) adopt adequate internal controls to prevent a recurrence of the alleged misconduct. The Company disputes that the amendment was ineffective or that there were any inadequate internal controls related to the same. However, to eliminate any questions about the amendment, the Company ratified the amendment at a special stockholders’ meeting pursuant to Section 204 of the Delaware General Corporation Law. This special stockholders’ meeting occurred on May 14, 2021. On May 14, 2021, the Company filed a certificate of validation with the State of Delaware to ratify the reverse stock split on December 30, 2020.

 

Development and Clinical Supply Agreement

 

On February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “PureForm Agreement”) with PureForm Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”) for the Company’s development plans for cancer treatment and supportive care. Under the terms of the PureForm Agreement, PureForm has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term of the Agreement (contingent upon an initial minimum order volume during the first thirty (30) days from the effective date) and has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties. All inventions that are developed jointly by the parties in the course of performing activities under the PureForm Agreement will be owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information to the Company.

 

The initial term of the PureForm Agreement is three (3) years commencing on the effective date of the Agreement, subject to extension by mutual agreement of the parties. The PureForm Agreement may be terminated by either party upon thirty (30) days written notice of an uncured material breach or immediately in the event of bankruptcy or insolvency. The Agreement contains, among other provisions, representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for an agreement of this nature.

 

Appointment of Chief Financial Officer

 

On April 9, 2021, John M. Van Buiten resigned from his position as the Company’s chief financial officer, effective May 15, 2021. Mr. Van Buiten’s resignation was not the result of any disagreement regarding any matter relating to the Company’s operations, policies, or practices.

 

On April 9, 2021, Carter J. Ward, 56, was appointed as the Company’s chief financial officer, effective May 15, 2021 (the “Effective Date”).

 

In connection with Mr. Ward’s appointment as chief financial officer, Mr. Ward entered into an employment agreement with the Company on April 9, 2021 (the “Ward Employment Agreement”), effective as of May 15, 2021, pursuant to which Mr. Ward will receive a base salary of $295,000 (“Base Salary”) and is eligible to receive annual performance bonuses of up to 50% of his Base Salary, as determined from time-to-time by the Company’s board of directors.

 

NOTE 5 - SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS

 

Authorized Capital

 

The holders of the Company’s common stock are entitled to one vote per share. Holders of common stock are entitled to receive ratably such dividends, if any, as may be declared by the Board of Directors out of legally available funds. Upon the liquidation, dissolution, or winding up of the Company, holders of common stock are entitled to share rateably in all assets of the Company that are legally available for distribution. As of December 31, 2020, 100,000,000 shares of common stock and 20,000,000 shares of Series B Preferred Stock were authorized under the Company’s articles of incorporation. The Company’s Series B preferred stock is convertible by the holder at any time into common stock at a rate of one to one.

 

Conversion of Series B Preferred Stock

 

During the three months ended March 31, 2021, holders of an aggregate of 3,275,407 shares of Series B Preferred Stock converted their shares into 3,275,407 shares of common stock. Following those conversions, no Series B Preferred stock shares remain outstanding.

 

12
 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 5 - SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS, CONTINUED

 

Offerings

 

On January 14, 2021, the Company completed an offering of 2,221,458 shares of Common Stock and pre-funded warrants at approximately $4.50 per share and a concurrent private placement of warrants to purchase 1,666,019 shares of Common Stock at $4.9519 per share, exercisable immediately and terminating five years after the date of issuance for gross proceeds of approximately $10,000,000. The net proceeds to the Company after deducting financial advisory fees and other costs and expenses were approximately $8,806,087.

 

On February 11, 2021, the Company completed an offering of 3,007,026 shares of Common Stock and a concurrent private placement of warrants to purchase 1,503,513 shares of Common Stock at $4.90 per share, exercisable immediately and terminating five year from the date of issuance for gross proceeds of approximately $12,800,000. The net proceeds to Enveric from the offering after deducting financial advisory fees and other costs and expenses were approximately $11,624,401.

 

Stock Options

 

    Number of Shares     Weighted Average Exercise Price (USD)     Weighted Average Grant Date Fair Value (USD)     Weighted Average Remaining Contractual Term (years)     Aggregate Intrinsic Value (USD)  
                               
Outstanding – January 1, 2021     929,765     $ 1.53     $ 2.50                  
Expired forfeited, or cancelled     (560,404 )   $ 1.65     $ 1.66                  
Outstanding – December 31, 2020     369,361     $ 1.35     $ 3.80       5.2     $ 636,156  
                                         
Exercisable at December 31, 2020     369,361     $ 1.35     $ 3.80       5.2     $ 636,156  

 

The Company’s stock based compensation expense related to stock options for the three months ended March 31, 2021 and 2020 was $0 and $0, respectively. As of March 31, 2021, the Company had $0 in unamortized stock option expense.

 

During the three months ended March 31, 2021, the Company exchanged options to purchase 560,404 shares of common stock for 325,410 restricted stock units and 42,125 restricted stock awards. In connection with this exchange, the Company recognized $298,714 in inducement expense related to the increase in fair value of the new awards over the old awards, which is included in general and administrative expenses on the Company’s statement of operations and comprehensive loss.

 

Restricted Stock Awards

 

The Company’s activity in restricted common stock was as follows for the three months ended March 31, 2021:

 

   

Number of

shares

    Weighted
average
grant date
fair
value
 
Non–vested at January 1, 2021     -     $ -  
Granted     70,986     $ 4.16  
Vested     (44,390 )   $ 4.49  
Non–vested at March 31, 2021     26,596     $ 3.61  

 

For the three months ended March 31, 2021 and 2020, the Company recorded $32,112 and $0, in stock-based compensation expense related to restricted stock awards. As of March 31, 2021, unamortized stock-based compensation costs related to restricted share awards was $72,009, which will be recognized over a weighted average period of 0.47 years.

 

13
 

 

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 5 - SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS, CONTINUED

 

Issuance of Restricted Stock Units

 

The Company’s activity in restricted stock units was as follows for the three months ended March 31, 2021:

 

    Number of shares     Weighted average
grant date fair
value
 
Non–vested at January 1, 2021     -     $ -  
Granted     3,279,284     $ 4.41  
Vested     (1,207,825 )   $ 4.46  
Non–vested at March 31, 2021     2,071,459     $ 4.38  

 

For the three months ended March 31, 2021 and 2020, the Company recorded $3,559,453 and $0, respectively, in stock-based compensation expense related to restricted stock units, which is a component of general and administrative expenses in the condensed consolidated statement of operations. As of March 31, 2021, unamortized stock-based compensation costs related to restricted stock units was $9,416,205 and will be recognized over a weighted average period of 1.93 years.

 

Warrants

 

The following table summarizes information about shares issuable under warrants outstanding at March 31, 2021:

 

    Warrant
shares
outstanding
    Weighted
average
exercise price (USD)
    Weighted average remaining life     Intrinsic value  
Outstanding at January 1, 2021     3,661,178     $ 1.98                  
Issued     3,535,519     $ 4.93                  
Exercised     (851,099 )   $ 4.17                  
Outstanding at March 31, 2021     6,345,598     $ 3.33       4.9     $ 6,049,152  
                                 
Exercisable at March 31, 2021     6,345,598     $ 3.33       4.9     $ 6,049,152  

 

14
 

 

Item 2. Management’s discussion and analysis of financial condition and results of operations

 

The information set forth below should be read in conjunction with the condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company” and similar terms refer to Enveric Biosciences, Inc., a Delaware corporation.

 

Cautionary Note Regarding Forward-Looking Statements

 

This quarterly report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that,” “may,” “plans,” “seeks,” “projects,” “targets,” and “would” or the negative of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, future financial and operating results, the company’s plans, objectives, expectations and intentions and other statements that are not historical facts. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from our historical experience and our present expectations, or projections described under the sections in this Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. These risks and uncertainties include, but are not limited to:

 

our dependence on the success of our prospective product candidates, which are in early stages of development and may not reach a particular stage in development, receive regulatory approval or be successfully commercialized;
potential difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical development and IND application filings and into clinical development;
the impact of the novel coronavirus (COVID-19) on our business, including our current plans for product development, as well as any currently ongoing preclinical studies and clinical trials and any future studies or other development or commercialization activities;
the limited study on the effects of medical cannabinoids, and the chance that future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of cannabinoids;
the expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing interpretations;
the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;
the fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing the applicable developmental and regulatory prerequisites;
the ability to establish or maintain collaborations on the development of therapeutic candidates;
the ability to obtain appropriate or necessary governmental approvals to market potential products;
our ability to manufacture product candidates on a commercial scale or in collaborations with third parties;
our significant and increasing liquidity needs and potential requirements for additional funding;
our ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms;
the intense competition we face, often from companies with greater resources and experience than us;
our ability to retain key executives and scientists;
the ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection; and
political, economic, and military instability in Israel which may impede our development programs.

 

For a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item 1A of this Form 10-Q. Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. We undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise, except as required by law.

 

Business Overview

 

We are an early-development-stage biosciences company that is developing innovative, evidence-based prescription products and combination therapies containing cannabinoids to address unmet needs in cancer care. We seek to improve the lives of patients suffering from cancer, initially by developing palliative and supportive care products for people suffering from certain side effects of cancer and cancer treatment such as pain or skin irritation. We currently intend to offer such palliative and supportive care products in the United States, following approval through established regulatory pathways.

 

We are also aiming to advance a pipeline of novel cannabinoid combination therapies for hard-to-treat cancers, including glioblastoma multiforme (GBM) and several other indications, which are currently being researched.

 

15
 

 

We intend to bring together leading oncology clinicians and researchers, academic and industry partners so as to develop both external proprietary products and a robust internal pipeline of product candidates aimed at improving quality of life and outcomes for cancer patients. We intend to evaluate options to out-license its proprietary technology as it moves along the regulatory pathway as well as evaluating building a small, targeted selling organization and will potentially utilize a hybrid approach based on the product indication and the market opportunity.

 

In developing its product candidates, we intend to focus on cannabinoids derived from hemp, other botanical sources, and synthetic materials containing no tetrahydrocannabinol (THC) in order to comply with U.S. federal regulations. Of the potential cannabinoids to be used in therapeutic formulations, THC, which is responsible for the psychoactive properties of marijuana, can result in undesirable mood effects. Cannabidiol (CBD) and cannabigerol (CBG), on the other hand, are not psychotropic and are therefore more attractive candidates for translation into therapeutic practice. In the future, we may utilize cannabinoids that are derived from cannabis plants, which may contain THC; however, we only intend to do so in jurisdictions where THC is legal. These product candidates will then be studied through a typical FDA drug approval process.

 

Tender Offer, Spin-Off and Reverse Stock Split

 

On December 30, 2020, pursuant to the previously announced Tender Offer Support Agreement and Termination of Amalgamation Agreement dated August 12, 2020 (“Original Amalgamation Agreement”), as amended by that certain Amendment No. 1 to the Tender Offer Support Agreement and Termination of Amalgamation Agreement dated December 18, 2020 (as amended the “Tender Agreement”), the Company completed a tender offer (“Offer”) to purchase all of the outstanding common shares of Jay Pharma, Inc., a Canada corporation and a wholly-owned subsidiary of the Company (“Jay Pharma”), for the number of shares of Company common stock, par value $0.01 per share (“Common Stock”) or Series B Preferred Stock, as applicable, equal to the exchange ratio of 0.8849 (the “Exchange Ratio”), and Jay Pharma became a wholly-owned subsidiary of the Company, on the terms and conditions set forth in the Tender Agreement. In connection with the Offer, the Company changed its name from AMERI Holdings, Inc. to Enveric Biosciences, Inc. The Offer has been accounted for as a “reverse merger” under the acquisition method of accounting for business combinations with Jay Pharma treated as the accounting acquirer of Ameri. As such, the historical financial statements of Jay Pharma have become the historical financial statements of Ameri, or the combined company, and are included in this filing labeled “Enveric Biosciences, Inc.” As a result of the Offer, historical common stock, stock options and additional paid-in capital, including share and per share amounts, have been retroactively adjusted to reflect the equity structure of the combined company, including the effect of the Exchange Ratio and the Common Stock.

 

Prior to the completion of the Offer, on December 30, 2020, pursuant to a Share Purchase Agreement, Ameri contributed to Ameri100 Inc. (“Private Ameri”) all of the issued and outstanding equity interests of the existing subsidiaries of Ameri, constituting the entire business and operations of Ameri and its subsidiaries, and Private Ameri assumed the liabilities of such subsidiaries. All of the issued and outstanding shares of Series A preferred stock of Ameri were redeemed for an equal number of shares of Series A preferred stock of Private Ameri.

 

Immediately following the completion of the Offer, on December 30, 2020, the Company effected a 1-for-4 reverse stock split of the issued and outstanding Common Stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, the per share exercise price of, and the number of shares of Company Common Stock underlying, our stock options and warrants outstanding immediately prior to the Reverse Stock Split were automatically proportionally adjusted based on the 1-for-4 split ratio in accordance with the terms of such options and warrants, as the case may be. Share and per-share amounts of Common Stock, options and warrants included herein have been adjusted to give effect to the Reverse Stock Split. The Reverse Stock Split did not alter the par value of the Common Stock, $0.01 per share, or modify any voting rights or other terms of the Common Stock. Unless otherwise noted, the accompanying financial statements and notes thereto, including the Exchange Ratio applied to historical Jay Pharma common stock and stock options, give retroactive effect to the Reverse Stock Split for all periods presented.

 

16
 

 

Recent Financings

 

January 2021 Offering

 

On January 14, 2021, we closed a registered direct offering of 1,610,679 shares of common stock and pre-funded warrants to purchase 610,679 shares of common stock, pursuant to a Securities Purchase Agreement (the “January 2021 Purchase Agreement”) with certain institutional investors at an offering price of $4.5018 per share and $4.4918 per pre-funded warrant (the “Pre-funded Warrant”), for gross proceeds of approximately $10,000,000 before the deduction of fees and offering expenses.

 

The Pre-funded Warrants have an exercise price of $0.01 per share. The Pre-funded Warrants are immediately exercisable and may be exercised at any time after their original issuance until such Pre-funded Warrants are exercised in full. A holder of a Pre-funded Warrant may not exercise any portion of such holder’s Pre-funded Warrants to the extent that the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of the Company’s outstanding shares of Common Stock immediately after exercise (the “Beneficial Ownership Limitation”), except that upon at least 61 days’ prior notice from the holder to the Company, the holder may increase the Beneficial Ownership Limitation to up to 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise.

 

Pursuant to the January 2021 Purchase Agreement, in a concurrent private placement (the “January 2021 Private Placement”) that also closed on January 14, 2021, the Company issued to the investors unregistered warrants to purchase up to 1,666,018 shares of Common Stock (the “January 2021 Warrants”). The January 2021 Warrants are exercisable immediately upon issuance and terminate five years following issuance and are exercisable at an exercise price of $4.9519 per share, subject to adjustment as set forth therein. A holder of January 2021 Warrants does not have the right to exercise any portion of its January 2021 Warrants if the holder, together with its affiliates, would beneficially own in excess of the Beneficial Ownership Limitation; provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%.

 

February 2021 Offering

 

On February 11, 2021, we closed a registered direct offering of 3,007,026 shares of common stock, pursuant to a Securities Purchase Agreement (the “February 2021 Purchase Agreement”) with certain institutional investors at an offering price of $4.27 per share, for gross proceeds of approximately $12,800,000 before the deduction of fees and offering expenses. The shares were offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-233260), previously filed with the SEC on August 14, 2019, and declared effective by the SEC on November 19, 2019.

 

Pursuant to the February 2021 Purchase Agreement, in a concurrent private placement (the “February 2021 Private Placement”) that also closed on February 11, 2021, the Company issued to the investors unregistered warrants to purchase up to 1,503,513 shares of Common Stock (the “February 2021 Warrants”). The February 2021 Warrants are exercisable immediately upon issuance and terminate five years following issuance and are exercisable at an exercise price of $4.90 per share, subject to adjustment as set forth therein. A holder of February 2021 Warrants does not have the right to exercise any portion of its February 2021 Warrants if the holder, together with its affiliates, would beneficially own in excess of the Beneficial Ownership Limitation; provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%.

 

Palladium Warrants

 

In connection with its role as financial advisor to the Company in the January 2021 Direct Offering, the January 2021 Private Placement, the February 2021 Direct Offering, and the February 2021 Private Placement, the Company issued Palladium 155,493 warrants with an exercise price of $4.9519 and 210,492 warrants with an exercise price of $4.90 (the “Palladium Warrants”) on February 11, 2021.

 

17
 

 

Stockholder Demand Letter

 

On January 21, 2021, the Company received a stockholder litigation demand letter from the law firm of Purcell Julie & Lefkowitz LLP, on behalf of James Self, a purported stockholder of our Company. The letter demands that the Company (i) deem ineffective the December 30, 2020 amendment to our Amended and Restated Certificate of Incorporation in which the Company effected a one-for-four reverse stock split of its common stock due to the manner in which non-votes by brokers were tabulated, (ii) seek appropriate relief for damages allegedly suffered by the company and its stockholders or seek a valid stockholder approval of the amendment and reverse stock split, and (iii) adopt adequate internal controls to prevent a recurrence of the alleged misconduct. The Company disputes that the amendment was ineffective or that there were any inadequate internal controls related to the same. However, to eliminate any questions about the amendment, the Company ratified the amendment at a special stockholders’ meeting pursuant to Section 204 of the Delaware General Corporation Law. This special stockholders’ meeting occurred on May 14, 2021. On May 14, 2021, the Company filed a Certificate of Validation with the State of Delaware to ratify the reverse stock split on December 30, 2020.

 

Development and Clinical Supply Agreement

 

On February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “Agreement”) with PureForm Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”) for the Company’s development plans for cancer treatment and supportive care. Under the terms of the Agreement, PureForm has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term of the Agreement (contingent upon an initial minimum order volume during the first thirty (30) days from the effective date) and has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties. All inventions that are developed jointly by the parties in the course of performing activities under the Agreement will be owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information to the Company.

 

The initial term of the Agreement is three (3) years commencing on the effective date of the Agreement, subject to extension by mutual agreement of the parties. The Agreement may be terminated by either party upon thirty (30) days written notice of an uncured material breach or immediately in the event of bankruptcy or insolvency. The Agreement contains, among other provisions, representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for an agreement of this nature.

  

Acquisition of Diverse Bio License Agreement

 

On March 5, 2021, the Company entered into an Exclusive License Agreement (the “DB Agreement”) with Diverse Biotech, Inc. (“Diverse”), pursuant to which the Company acquired an exclusive, perpetual license to develop five therapeutic candidates (collectively, the “Agents”) with the goal of alleviating the side effects that cancer patients experience. Under the terms of the DB Agreement, Diverse granted the Company an exclusive license to its intellectual property rights covering the Agents and its products. In exchange, the Company has granted Diverse the right to information relating to the Agents developed for the express purpose of using such information to obtain patent rights, which right terminates upon the issuance or denial of the patent rights.

 

Under the DB Agreement, the Company will maintain sole responsibility and ownership of the development and commercialization of the Agents and its products. Diverse has agreed not to develop or commercialize any agent or product that would compete with the Agents, or its products containing the Agents, at any time during or after the term of the DB Agreement. If Diverse intends to license, sell, or transfer any other molecules linked with cannabinoids not granted to the Company under the terms of the DB Agreement, the Company will have the first right, but not the obligation, to negotiate an agreement with Diverse for such cannabinoids. The Company has also agreed to pay Diverse an up-front investment payment in the amount of $675,000, as well as a running royalty starting with the first commercial sale by the Company to a third party in an arms’-length transaction.

 

18
 

 

The term of the DB Agreement shall continue for as long as the Company intends to develop or commercialize the new drugs, unless earlier terminated by either Party. The DB Agreement may be terminated by either party upon ninety (90) days written notice of an uncured material breach or in the event of bankruptcy or insolvency. In addition, the Company has the right to terminate the DB Agreement at any time upon sixty (60) days’ prior written notice to Diverse.

  

Appointment of Chief Financial Officer

 

On April 9, 2021, John M. Van Buiten resigned from his position as the Company’s chief financial officer, effective May 15, 2021. Mr. Van Buiten’s resignation was not the result of any disagreement regarding any matter relating to the Company’s operations, policies, or practices.

 

On April 9, 2021, Carter J. Ward, 56, was appointed as the Company’s chief financial officer, effective May 15, 2021 (the “Effective Date”).

 

In connection with Mr. Ward’s appointment as chief financial officer, Mr. Ward entered into an employment agreement with the Company on April 9, 2021 (the “Ward Employment Agreement”), effective as of May 15, 2021, pursuant to which Mr. Ward will receive a base salary of $295,000 (“Base Salary”) and is eligible to receive annual performance bonuses of up to 50% of his Base Salary, as determined from time-to-time by the Company’s board of directors. Additionally, Mr. Ward will receive 525,000 restricted stock units (“RSUs”), 262,500 of such RSUs shall be subject to time-based vesting (the “Time Based RSUs”), and the remaining 262,500 of such RSUs shall be subject to performance-based vesting (the “Performance RSUs”). The RSUs shall be subject to the terms and conditions of the Company’s 2020 Long-Term Incentive Plan. The Time Based RSUs shall vest in quarters on each anniversary of the Effective Date, and the Performance RSUs shall vest based on the achievement of performance milestones established by the Company.

 

19
 

 

Key Components of Our Results of Operations

 

Operating Expenses

 

Our operating expenses include financial statement preparation services, tax compliance, various consulting and director fees, legal services, auditing fees, and stock-based compensation. These expenses have increased in connection with the Company’s product development and the Company’s management expects these expenses to continue to increase as the Company continues to develop its potential product candidates.

 

Results of Operations

 

The following table sets forth information comparing the components of net loss for the three months ended March 31, 2021 and the comparable period in 2020:

 

    Three Months Ended March 31,  
    2021     2020  
             
Operating expenses                
General and administrative     6,607,045       836,702  
Research and development     157,952       -  
Operating expenses   $ 6,764,997     $ 836,702  
                 
Loss from operations     (6,764,997 )     (836,702 )
                 
Other income (expense)                

Inducement expense

    (298,714 )     -  

Change in fair value of warrants

    3,813,000       -  
Interest Expense     -       261,759  
Total other income (expense)     3,514,286       261,759  
                 
Net Loss   $ (3,250,711 )   $ (1,098,461 )
                 
Other comprehensive loss                
Foreign currency translation     35,736       (12,698 )
                 
Comprehensive loss   $ (3,214,975 )   $ (1,111,159 )
                 
Net loss per share - basic and diluted   $ (0.20 )   $ (0.04 )
                 
Weighted average shares outstanding, basic and diluted     16,220,661       25,607,042  

 

General and Administrative Expenses

 

Our general and administrative expenses increased to $6,607,045, for the three months ended March 31, 2021 from $836,702 for the three months ended March 31, 2020, with an increase of $5,770,343, or 690%. This change was primarily driven by stock-based compensation of $3,591,565, stock option modification expense of $298,714, and an increase in public company costs of $582,667.

 

Research and Development Expense

 

Our research and development expense for the three months ended March 31, 2021 was $157,952 compared to $0 for the three months ended March 31, 2020. This increase was primarily driven by the preparations ongoing for our glioblastoma study and the formulation costs for our radio-dermatitis study.

 

Change in Fair Value of Warrant Liability

 

The Company’s change in fair value warrant liability was a gain of $3,813,000 for the three months ended March 31, 2021 due primarily to a decrease in the Company’s stock price.

 

Interest Expense

 

Our interest expense for the three months ended March 31, 2021 was $0 compared to $261,759 for the three months ended March 31, 2020. This decrease was primarily driven by promissory notes that were entered into by the Company during 2020, which no longer remained outstanding in 2021.

 

20
 

 

Foreign Currency Translation

 

Our foreign currency translation gain (loss) was $35,736 for the three months ended March 31, 2021 as compared to $(12,698) for the three months ended March 31, 2020, for an increase in $48,434. The increase in foreign exchange gain is primarily due to the U.S. Dollar weakening against the Canadian Dollar and the conversion of the Canadian Dollars into United States Dollars for payment of United States Dollar denominated expenses.

 

Liquidity and Capital Resources

 

The Company has incurred continuing losses from its operations. As of March 31, 2021, the Company has had an accumulated deficit of $15,010,268 and working capital of $16,629,501. Since inception, the Company’s operations have been funded principally through the issuance of debt and equity.

 

On January 14, 2021, the Company completed a registered direct offering of 2,221,458 shares of Common Stock at approximately $4.50 per share for gross proceeds of approximately $10,000,000. The net proceeds to the Company after deducting financial advisory fees and other costs and expenses were approximately $8,806,087. On February 11, 2021, the Company completed a registered direct offering of 3,007,026 shares of Common Stock for gross proceeds of approximately $12,800,000. The net proceeds to the Company after deducting financial advisory fees and other costs and expenses were approximately $11,624,401. As of May 14, 2021, the Company had cash on hand of approximately $22 million.

 

We believe that, as a result of these transactions, we currently have sufficient cash and financing commitments to meet our funding requirements over the next year. Notwithstanding, we expects that we will need to raise additional financing to accomplish our development plan over the next several years. We may seek to obtain additional funding through debt or equity financing in the future. There are no assurances that we will be able to raise capital on terms acceptable to us or at all, or that cash flows generated from our operations will be sufficient to meet our current operating costs. Our ability to obtain additional capital may depend on prevailing economic conditions and financial, business and other factors beyond our control. The COVID-19 pandemic has caused an unstable economic environment globally. Disruptions in the global financial markets may adversely impact the availability and cost of credit, as well as our ability to raise money in the capital markets. Current economic conditions have been and continue to be volatile. Continued instability in these market conditions may limit our ability to access the capital necessary to fund and grow our business. If we are unable to obtain sufficient amounts of additional capital, we may be required to reduce the scope of our planned development, which could harm our financial condition and operating results.

 

Cash Flows

 

Since inception, we have primarily used our available cash to fund our product development expenditures.

 

Cash Flows for the Three Months Ended March 31, 2021 and 2020

 

The following table sets forth a summary of cash flows for the periods presented:

 

    Three Months Ended March 31,  
    2021     2020  
Net cash used in operating activities   $ (3,162,278 )   $ (893,922 )
Net cash used in investing activities     (675,000 )     -  
Net cash provided by financing activities     24,881,733       1,212,196  
Effect of foreign exchange rate on cash     34,235       (86,667 )
Net increase in cash   $ 21,078,690     $ 231,597  

 

Operating Activities

 

Net cash used in operating activities was $3,162,278 during the three months ended March 31, 2021, which consisted primarily of a net loss of $3,250,711, offset by amortization of intangibles of $136,640, change in fair value of warrant liability of $3,813,000, stock-based compensation of $3,591,565, induced conversion of warrants of $298,714, and increases in prepaid expenses and other current assets for $66,208, offset by increases in accounts payable and accrued liabilities of $59,278.

 

Net cash used in operating activities was $893,922 during the three months ended March 31, 2020, which consisted primarily of a net loss of $1,098,461, offset by amortization of note discount of $233,240 and accrued interest of $28,519, increases in prepaid expenses and other current assets of $49,588, and decreases in accounts payable and accrued liabilities of $7,632.

 

Investing Activities

 

Net cash used in investing activities was $675,000 during the three months ended March 31, 2021, which consisted of the acquisition of intellectual property from Diverse Bio.

 

21
 

 

The Company did not have any investing activities during the three months ended March 31, 2020.

 

Financing Activities

 

Net cash provided by financing activities was $24,881,733 during the three months ended March 31, 2021, which consisted primarily of $9,463,087 in net proceeds from the January registered direct offering, $12,151,401 in net proceeds from February registered direct offering, and proceeds from the exercise of warrants of $3,267,245.

 

Net cash provided by financing activities was $1,212,196 during the three months ended March 31, 2020, which consisted of $50,000 in proceeds from convertible notes payable, and $1,319,910 in proceeds from notes payable, offset by $157,714 in repayment of notes payable.

 

Off-Balance Sheet Arrangements

 

The Company did not have any off-balance sheet financing arrangements or liabilities, guarantee contracts, retained or contingent interests in transferred assets, or any obligation arising out of a material variable interest in an unconsolidated entity. The Company does not have any subsidiaries to include or otherwise consolidate into the financial statements. Additionally, the Company does not have interests in, nor relationships with, any special purpose entities.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

The Company’s accounting policies are fundamental to understanding its management’s discussion and analysis. The Company’s significant accounting policies are presented in Note 3 to its financial statements for the year ended December 31, 2020. The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by U.S. GAAP. However, in the opinion of the management of the Company, all adjustments necessary for a fair presentation of the financial position and operating results have been included in the Company’s condensed financial statements.

 

Warrant Liability

 

The Company accounts for warrants for shares of the Company’s common stock that are not indexed to its own stock as liabilities at fair value on the balance sheet. Such warrants are subject to remeasurement at each balance sheet date and any change in fair value is recognized as a component of other expense on the statement of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such common stock warrants. At that time, the portion of the warrant liability related to such common stock warrants will be reclassified to additional paid-in capital.

 

Recent Accounting Standards

 

Management does not believe that any recently issued, but not yet effective accounting standards, when adopted, will have a material effect on the accompanying financial statements, other than those disclosed below.

 

In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2019-12, Income Taxes (Topic 740: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which removes certain exceptions to the general principles in Topic 740. ASU 2019-12 is effective for the fiscal years beginning after December 15, 2020, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements.

 

In October 2020, the FASB issued ASU 2020-10, “Codification Improvements.” The new accounting rules improve the consistency of the Codification by including all disclosure guidance in the appropriate Disclosure Section (Section 50) that had only been included in the Other Presentation Matters Section (Section 45) of the Codification. Additionally, the new rules also clarify guidance across various topics including defined benefit plans, foreign currency transactions, and interest expense. The new accounting rules were effective for the Company in the first quarter of 2021. The adoption of the new accounting rules did not have a material impact on the Company’s financial statements.

 

In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The amendments in ASU No. 2021-04 provides guidance to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this ASU No. 2021-04 are effective for all entities for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, including interim periods within those fiscal years. As a result, the Company will not be required to adopt ASU 2021-04 until October 1, 2022. The Company is currently evaluating the impact of the adoption of this principle on the Company’s condensed consolidated financial statements.

 

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution, which at times, may exceed the Federal depository insurance coverage of $250,000. The Company has not experienced losses on these accounts and management believes the Company is not exposed to significant risks on such accounts.

 

Foreign Currency Risk

 

The reporting currency of the Company is the United States dollar, while the functional currency of our subsidiary, Jay Pharma, Inc., is the Canadian dollar. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and the United States dollar.

 

The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency fluctuations in the future.

 

22
 

 

Item 3. Quantitative and qualitative disclosures about market risk

 

From inception through March 31, 2021, the reporting currency of the Company is the United States dollar while the functional currency of the Company is the Canadian dollar. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and the U.S. dollar.

 

The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations in the future.

 

Item 4. Controls and procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures designed to ensure that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified under the rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The matters that management identified in our Annual Report on Form 10-K for the year ended December 31, 2020, filed on April 1, 2021, continued to exist and were still considered material weaknesses in our internal control over financial reporting at March 31, 2021.

 

As required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive) and Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2021. Based on this evaluation, and in light of the material weaknesses found in our internal controls over financial reporting, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and 15d-15 under the Exchange Act) were not effective as of March 31, 2021.

 

Management’s Remediation Plan

 

As previously discussed in our Annual Report on Form 10-K for the year ended December 31, 2020, filed on April 1, 2021, management had concluded that our internal control over financial reporting was not effective as of December 31, 2019, because management identified inadequate segregation of duties to ensure the processing, review, and authorization of all transactions, including non-routine transactions resulting in deficiencies, which, in aggregate, amounted to a material weakness in the Company’s internal control over financial reporting.

 

As of March 31, 2021, there were control deficiencies which constituted a material weakness in our internal control over financial reporting. Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure controls.

 

While we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve the overall effectiveness of our internal controls over financial reporting.

 

Changes in Internal Control over Financial Reporting

 

Other than the changes discussed above in the Remediation Plan, there have been no other changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during the first quarter ended March 31, 2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

23
 

 

PART II. OTHER INFORMATION

 

Item 1. Legal proceedings

 

The Company is periodically involved in legal proceedings, legal actions and claims arising in the ordinary course of business. Other than as described below, we do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material adverse effect on our financial position, results of operations or cash flows.

 

Stockholder Demand Letter

 

On January 21, 2021, the Company received a stockholder litigation demand letter from the law firm of Purcell Julie & Lefkowitz LLP, on behalf of James Self, a purported stockholder of our Company. The letter demands that the Company (i) deem ineffective the December 30, 2020 amendment to our Amended and Restated Certificate of Incorporation in which the Company effected a one-for-four reverse stock split of its common stock due to the manner in which non-votes by brokers were tabulated, (ii) seek appropriate relief for damages allegedly suffered by the company and its stockholders or seek a valid stockholder approval of the amendment and reverse stock split, and (iii) adopt adequate internal controls to prevent a recurrence of the alleged misconduct. The Company disputes that the amendment was ineffective or that there were any inadequate internal controls related to the same. However, to eliminate any questions about the amendment, the Company ratified the amendment at a special stockholders’ meeting pursuant to Section 204 of the Delaware General Corporation Law. This special stockholders’ meeting occurred on May 14, 2021. On May 14, 2021, the Company filed a Certificate of Validation with the State of Delaware.

 

Item 1A. Risk factors

 

Political, economic, and military instability in Israel may impede our development programs, which could have a material adverse effect on our business.

 

We plan to conduct a clinical cancer study consisting of a Phase 1/2 study in Israel of oral synthetic CBD extract, given alone or in combination with clomiphene concurrently with dose-dense temolozomide chemotherapy for patients with recurrent or progressive GBM, designed as an open label, two-arm, randomized prospective study. We are currently waiting on primary approval from the Israeli Ministry of Health, Center for Cannabis (Yakar) to proceed with such study. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its neighboring countries. In May 2021, hostilities between Israel and Hamas escalated and there has been cross-border attacks in Israel and Gaza, including rocket attacks targeting Tel Aviv, where some of our key partners for the planned GBM study are located. The ongoing conflict and any hostilities involving Israel or political, economic, and military conditions in Israel and the surrounding region may directly affect our ability to obtain approvals needed for our GBM study and cause interruptions or delays in conducting such study or future studies we may conduct in Israel for an indeterminate time. Any armed conflicts, terrorist activities, or political instability in the region could impeded our development programs, which could have a material adverse effect on our business.

 

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

 

None.

 

INDEX TO EXHIBITS

 
Exhibit No.   Description
4.1   Form of Pre-Funded Warrant (issued in connection with the January 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 12, 2021).
4.2   Form of Warrant (issued in connection with the January 2021 Offering) (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 12, 2021).
4.3   Form of Warrant (issued in connection with the February 2021 Offering) (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 11, 2021).
10.1   Form of Securities Purchase Agreement, dated January 11, 2021, by and among the Company and the purchasers thereto (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 12, 2021).
10.2   Form of Registration Rights Agreement, dated January 11, 2021, by and among the Company and the purchasers thereto (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 12, 2021).
10.3   Form of Securities Purchase Agreement, dated February 9, 2021, by and among the Company and the purchasers thereto (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the Commission on February 11, 2021)
10.4   Form of Registration Rights Agreement, dated February 9, 2021, by and among the Company and the purchasers thereto (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the Commission on February 11, 2021)
10.5*+   Development and Clinical Supply Agreement, between the Company and PureForm Global, Inc., dated February 22, 2021.
10.6*+   Exclusive License Agreement, between the Company and Diverse Biotech, Inc. (“Diverse”), dated March 5, 2021.
10.7#   Employment Agreement between Carter J. Ward and the Company, effective May 15, 2021 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 12, 2021).
31.1*   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*   Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*   XBRL Instance Document
101.SCH*   XBRL Taxonomy Extension Schema
101.CAL*   XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*   XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*   XBRL Taxonomy Extension Label Linkbase Document
101.PRE*   XBRL Taxonomy Extension Presentation Linkbase Document
104*   Cover Page Interactive Data File*
     
*   Filed herewith.
#   Management contract or compensatory plan or arrangement

+

 

Information in this exhibit identified by brackets is confidential and has been excluded pursuant to Item 601(b)(10)(iv) of Regulation S-K because it is not material and would likely cause competitive harm to the Company if publicly disclosed. An unredacted copy of this exhibit will be furnished to the Securities and Exchange Commission on a supplemental basis upon request.

 

24
 

  

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.

 

  ENVERIC BIOSCIENCES, INC
May 17, 2021    
     
  By: /s/ David Johnson
    David Johnson
    President and Chief Executive Officer (Principal Executive Officer)

 

25

  

 

Exhibit 10.5

 

Confidential Draft – For Discussion Purposes

 

DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT

 

Between

 

PureForm Global, Inc. (“PureForm”) and

Enveric Biosciences (“Enveric”)

 

This Development and Clinical Supply Agreement (“Agreement”) is made by and between PureForm Global, Inc., a Delaware corporation with its principal office at 5700 Melrose Ave. #208, Los Angeles, California 90038 (“PureForm”) and Enveric Biosciences, Inc., a Delaware Corporation with its principal office at 4851 Tamiami Trail N, Suite 200, Naples, FL 34103 (“Enveric”) on February 22, 2021 (“Effective Date”). Enveric and PureForm may be referred to herein each as a “Party” and collectively the “Parties.”

 

WHEREAS, Enveric is a biotechnology company that, among other things develops treatments for the treatment of cancer side effects; and

 

WHEREAS, PureForm is a manufacturer of proprietary synthetic bioidentical cannabinoids not derived or extracted from hemp or cannabis; and

 

WHEREAS, Enveric desires to purchase certain active pharmaceutical ingredient from PureForm pursuant to the terms contained herein.

 

NOW, THEREFORE, in view of this foregoing premise and in consideration of the foregoing premises and in consideration of the mutual covenants set forth below, the parties agree as follows:

 

1. Definitions.

 

For the purposes of this Agreement, the following terms shall have the following respective meanings:

 

1.1 “API” shall mean synthetic cannabidiol manufactured by PureForm or acquired for resale by PureForm that is not derived or extracted from hemp or cannabis, for example, its cannabidiol products sold under the trademark, PureForm CBD™.

 

1.2 “Confidential Information” shall mean Information as defined in Section 1.5 which is clearly labeled and designated in writing as “Confidential” or would otherwise reasonably be understood to be Confidential Information based on the type and nature of the information disclosed and the context of the disclosure.

 

1.3 “Current GMP,” or “cGMP” means then current Good Manufacturing Practices promulgated by the United States Food & Drug Administration (FDA) or its counterpart governmental agencies in the Territory in the form of laws, regulations, or guidance documents.

 

 

 

 

1.4 “Development Program” means Enveric’s plan for preclinical and clinical testing of Product for the supportive/palliative care of subjects having radiodermatitis, glioblastoma and chemotherapy-induced neuropathy, as may be amended from time to time.

 

1.5 “Field” means development and commercialization of Product for cancer supportive/palliative care associated with radiodermatitis, chemotherapy induced peripheral neuropathy and glioblastoma.

 

1.6 “Information” means any data, results, and information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, customer information, business or financial information, expertise, stability, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures.

 

1.7 “Product” means a dosage form including API formulated for administration to human subjects for the treatment of a condition associated with chemotherapy or radiotherapy.

 

1.8 “Regulatory Requirements” means all laws, regulations, and other legal requirements applicable to the manufacture of API, CTM or the use thereof, including without limitation cGMP, FDA regulations, any applicable local laws and regulations in the place of manufacture, storage and handling, and any requirements set forth in an IND, NDA, Marketing Approval Application (MAA) and other regulatory filings or approvals.

 

1.9 “Specifications” means the specifications for the API and/or Product as then currently, mutually agreed upon in writing under this Agreement. The Specifications for the API at the time of execution of this Agreement is set forth in Exhibit A. The Specifications may be amended by mutual agreement of the Parties.

 

2. Development.

 

2.1 Continuing Development of a Product. Enveric shall use diligent commercial efforts to continue to pursue its Development Program for a Product in the Field.

 

2.2 Changes to the Specifications. Each Party shall be available to consult and shall cooperate with the other Party with respect to any changes to the Specifications requested by either Party to facilitate obtaining Marketing Approval for the Product or to satisfy Regulatory Requirements. Without limiting the foregoing, neither Party shall unreasonably withhold its approval for any requested changes to the Specifications that (a) Enveric reasonably determines are necessary for its efforts to obtain Marketing Approval or (b) PureForm reasonably determines are necessary to meet Regulatory Requirements or for the CMC section of any regulatory filing for a Product. The Party requesting such change shall be fully responsible for any reasonable delay, complications and/or cost increases connected to such change. For the avoidance of doubt, any change made to support an Enveric regulatory filing shall be deemed to have been requested by Enveric regardless of the Party initiating the change request and Enveric shall bear the cost connected with such change. Changes to the Specification which are mutually agreed upon in writing shall apply to all Product ordered after the date of such change, unless otherwise agreed upon by the Parties.

 

 

 

 

3. Forecast, Purchase Orders and Payment.

 

3.1 Enveric shall within fifteen (15) days of the first day of each Calendar Quarter following execution of the Agreement provide PureForm a good faith estimate of Enveric’s projected requirements of API for delivery during each of the two Calendar Quarters thereafter (each such estimate being a “Forecast”) whereby (i) the first three (3) months of such Forecast will be binding, committed requirements of API (the “Initial Demand Forecast”), (ii) the next three (3) months of such Forecast will be non-binding, good faith estimates provided solely to assist PureForm in production planning (“Demand Forecast”). By way of example, the Forecast issued in the first fifteen (15) days of Q1 would include good faith estimates for required API to be delivered in Q2 and Q3. By way of further example, if this Agreement is executed February 12, 2021, Enveric would issue a Forecast by April 15, 2021, for the calendar quarters beginning on July 1 (Initial Demand Forecast) and October 1 (Demand Forecast).

 

3.2 The purchase and sale of Product and API according to the Forecast shall be implemented by Enveric’s issuance of written orders to PureForm for specific quantities of API or Product and shall specify a delivery date (each a “Purchase Order”). Purchase Orders shall be placed at least thirty (30) days prior to the specified delivery date.

 

3.3 Each Purchase Order issued by Enveric constitutes the binding obligation of PureForm to manufacture, sell and deliver to Enveric the quantity of API by the delivery date specified in such Purchase Order, and the binding obligation of Enveric to purchase the quantity of API specified therein; provided, that if Enveric requests any increase in the quantity of any API in a Purchase Order in excess of 115 percent of the forecasted quantities, then PureForm shall use commercially reasonable efforts to supply the additional API quantity at the Purchase Price.

 

3.4 Each Purchase Order or any acknowledgment thereof, whether printed, stamped, typed, or written shall be governed by the terms of the Agreement and none of the provisions of such Purchase Order or acknowledgment shall be applicable except those specifying API and quantity ordered, delivery dates, special shipping instructions and invoice information. In the event of a conflict between the terms and conditions of the Agreement and any Purchase Order, the terms and conditions of the Agreement will prevail.

 

3.5 Unless otherwise agreed in writing by the Parties PureForm shall provide to Enveric for each Purchase Order one or more separate invoices. Payment of each invoice shall be made within thirty (30) days of such invoice.

 

3.6 Enveric shall pay all national, state, and municipal or other sales, use, excise, import, property, value added, or other similar taxes, assessments or tariffs assessed upon or levied against the sale of API or Product pursuant to this Agreement.

 

3.7 The purchase price for API shall be as set forth in Exhibit B.

 

 

 

 

4. Regulatory

 

4.1 It is understood that PureForm will provide Enveric with all reasonable assistance with respect to all filings with the FDA including the CMC section of any IND or NDA filing describing the manufacturing process for the Product.

 

4.2 PureForm agrees, upon request from Enveric, to promptly to provide such information as Enveric may reasonably require to complete any FDA regulatory filings and submissions.

 

4.3 PureForm agrees to notify Enveric promptly of any inspections by the FDA or any other regulatory authority which pertain to the API, or the results of which pertain to any other product that have implications to the overall quality systems potentially affecting, overall manufacturing activity of PureForm or the ability to supply the API to Enveric. PureForm will allow, and will provide Enveric with any required authorization to allow, the FDA (or other regulatory authority) or Enveric’s quality personnel (QA/QC) to inspect, audit and review the facilities at which the API is manufactured and all procedures, practices, books, records, and documents to the extent requested by the FDA (or such other regulatory authority) or Enveric quality personnel. PureForm will retain originals of all batch documentation, any and all other records or documentation generated by it in connection with the processing and testing of API under the terms of the Agreement, and all records that may be reasonably necessary to assist Enveric in the event of an API recall or adverse drug event, for the longer of (a) two (2) years after the expiration date of the batch of API to which they pertain and (b) the period required by Applicable Law.

 

5. Intellectual Property.

 

5.1 The parties acknowledge and agree that all proprietary Information, data, concepts, processes, methods, techniques, products, formula, dosages, know-how, trade secrets and/or improvements thereof (the “Prior Technology”) disclosed by one party to the other party in writing (or orally and thereafter reduced to writing) is and shall remain the property of the disclosing party.

 

5.2 Each Party shall own all inventions and Information made solely by it and its Affiliates and their respective employees agents and independent contractors in the course of conducting such Party’s activities under this Agreement (collectively, “Sole Inventions”). All inventions and Information that are made jointly by Affiliates, employees, agents, or independent contractors of each Party in the course of performing activities under this Agreement (collectively, “Joint Inventions”) shall be owned jointly by the Parties in accordance with joint ownership interests of co-inventors under US patent laws. Inventorship shall be determined in accordance with US patent laws.

 

5.3 The Parties may mutually agree to a further agreement (e.g., contract research, joint development, or other) under which Enveric will pay for research and/ or development services of PureForm on terms and conditions to be agreed upon and which may include an obligation of assignment, license, or joint exploitation of rights in any inventions and technical information developed in performance of the research, development, or other defined work that is related to the Product or scope of such further agreement.

 

 

 

 

5.4 The Parties shall promptly disclose to one another any Joint Inventions whether patentable or not.

 

5.5 The Parties shall collaborate and shall in good faith negotiate how best to exploit any Joint Inventions for the benefit of both Parties, unless otherwise agreed.

 

5.6 The Parties shall promptly share any Information received concerning the efficacy and safety of use of the API and Product(s) worldwide, including the exchange of Adverse Drug Reactions information and similar matters sufficient to permit each Party to comply with Regulatory Requirements (including, to the extent applicable, those obligations contained in ICH guidelines.

 

5.7 Enveric hereby grants PureForm a royalty-free, fully sublicensable, non-exclusive license to any safety and efficacy data relating to the non-clinical and clinical use of the API and relating to any Product as such data relates to non-clinical applications, subject to confidentiality required by applicable securities or privacy regulations. To the extent permissible, Enveric shall disclose such data promptly upon receipt and no later than reasonably following any publication of top-line results supported by such data.

 

5.8 PureForm hereby grants Enveric a royalty-free, fully sublicensable, non-exclusive license to any safety and efficacy data relating to the non-clinical and clinical use of the API and relating to any Product as such data relates to clinical applications. PureForm shall disclose such data promptly upon receipt and no later than reasonably following publication of top-line results supported by such data.

 

6. Exclusivity.

 

6.1 PureForm and Enveric agree that PureForm will be Enveric’s exclusive provider of synthetic CBD that is not derived or extracted from hemp or cannabis for use in the Field.

 

6.2 Subject to the Continuing Development in Section 2.1, PureForm grants Enveric the exclusive right to purchase API and Product for use in the Field during the Term, contingent upon an initial minimum order of 1 KG during the first thirty (30) days from the Effective Date.

 

6.3 The rights and grants of exclusivity under Sections 6.1 and 6.2 are world-wide.

 

6.4 To the extent PureForm is unable to provide API that is produced using cGMP meeting FDA standards for use in the United States, or is unable to provide API for use outside the United States that is produced in accordance with standards of an FDA-like regulatory authority having relevant jurisdiction over such use, Enveric may engage an alternative provider of API until PureForm is able to provide such API.

 

 

 

 

7. Representation and Warranties.

 

7.1 Enveric represents and warrants to PureForm that:

 

(a) Enveric has the full right, power, and authority to enter into this Agreement and perform its obligations hereunder without the consent of any third party and without breach of any agreements with or obligations to any third party. Enveric will not grant, transfer, assign or convey, directly or indirectly, any right, title, or interest in or to any Joint Invention to any third party unless otherwise permitted by the terms of this Agreement;

 

(b) Enveric has not entered and will not enter into any agreement with or obligation to a third party inconsistent, incompatible, or conflicting with its obligations under this Agreement.

 

7.2 PureForm represents and warrants to Enveric that:

 

(a) PureForm has the full right, power, and authority to enter into this Agreement and perform its obligations hereunder without the consent of any third party and without breach of any agreements with or obligations to any third party. PureForm will not grant, transfer, assign or convey, directly or indirectly, any right, title, or interest in or to any Joint Invention to any third party unless otherwise permitted by the terms of this Agreement;

 

(b) PureForm has not entered and will not enter into any agreement with or obligation to a third party inconsistent, incompatible, or conflicting with its obligations under this Agreement.

 

8. Indemnification and Limitation of Liability.

 

8.1 Each Party will defend, indemnify and hold harmless the other Party, its officers, directors, employees, sublicenses, customers and agents from and against any and all losses, liabilities, damages, expenses and costs (including reasonable attorney’s fees) (“Losses”) resulting from third party claims, demands, suits or proceedings “Claims”) arising out of the first Party’s violation of applicable law, gross negligence, recklessness or willful misconduct in the course of its activities carried out in connection with this Agreement. Enveric will further defend, indemnify, and hold harmless PureForm for and against any and all Losses, arising from Claims brought by third parties and resulting from Enveric’s use of any API or Product of PureForm under this Agreement.

 

8.2 Each Party will notify the other Party promptly upon learning of a Claim that might give rise to a Loss, and the potentially indemnifying Party may control defense and settlement thereof provided it does so diligently, in good faith, and using reasonably experienced counsel with expertise in the relevant field. A potentially indemnifying party shall not settle any Claim in which the potentially indemnified Party is named without the prior written consent of the potentially indemnified Party. The potentially indemnified Party will reasonably cooperate in such defense and/or settlement at the potentially indemnifying Party’s request and expense and may participate at its own expense using its own counsel.

 

(a) IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL, PUNITIVE, INCIDENTAL, OR INDIRECT DAMAGES, OR LOST PROFITS, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

 

 

 

 

(b) EXCEPT FOR ANY BREACH OF SECTION 9, IN NO EVENT WILL PUREFORM’S LIABILITY, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, BE GREATER THAN, PER CLAIM AND IN THE AGGREGATE THE FEES PAID FOR THE PRODUCT OR SERVICES THAT CAUSED SUCH LIABILITY.

 

9. Confidentiality and Press Release.

 

9.1 Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, for the Term and for five (5) years thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement any Confidential Information furnished to it by the other Party pursuant to this Agreement except for that portion of such information or materials that the receiving Party can demonstrate by competent written proof:

 

(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

 

(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

 

(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

 

(d) is subsequently disclosed to the receiving Party or its Affiliate by a Third Party without obligations of confidentiality with respect thereto; or

 

(e) is subsequently independently discovered or developed by the receiving Party or its Affiliate without the aid, application, or use of Confidential Information.

 

9.2 Authorized Disclosure. Each Party may disclose Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following situations:

 

(a) filing or prosecuting patents to a joint invention, provided that the Party whose Confidential Information is being disclosed has the opportunity to review and control the scope of such disclosure in such a patent application or patent;

 

(b) submitting regulatory filings and other filings with Governmental Authorities (including regulatory authorities), including filings with the SEC or the FDA, with respect to a Product;

 

 

 

 

(c) prosecuting or defending litigation relating to the subject matter of this Agreement, provided that the Party whose Confidential Information is being disclosed has the opportunity to object and require the other Party to seek a protective order;

 

(d) complying with Applicable Laws, including regulations promulgated by securities exchanges, provided that the Party seeking to make such disclosure shall, to the extent practicable, give reasonable advance notice to the other Party of such disclosure and use reasonable efforts to secure confidential treatment of such information;

 

(e) disclosure to its Affiliates, employees, agents, and independent contractors, and any sublicensees only on a need-to-know basis and solely as necessary in connection with the exercise of its rights or the performance of its obligations under this Agreement, provided that each person or entity receiving such Confidential Information must be bound by similar obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this Article prior to any such disclosure, provided that such confidentiality and non-use obligations may be subject to a shorter duration of no less than five (5) years; and

 

(e) disclosure to a bona fide investor or potential partner performing due diligence in relation to this Agreement and solely as necessary to facilitate such investor or potential partner’s understanding of the scope of the agreement and the exclusivity thereof. Each investor or potential partner receiving such Confidential Information (as allowed pursuant to this section) shall be bound by similar obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this Article prior to any such disclosure.

 

9.3 Press Release. The Parties agree that the terms of this Agreement are the Confidential Information of both Parties, subject to the authorized disclosure provisions set forth herein. The Parties have agreed to make a joint public announcement of the execution of this Agreement substantially in the form of the press release attached as Exhibit C on or after the Execution Date. In addition, following the initial press release announcing the execution of this Agreement, either Party shall be free to disclose, without the other Party’s consent, the existence of this Agreement, the identity of the other Party and those terms of this Agreement which have already been publicly disclosed in accordance with this Section 9.3.

 

After release of such press release, if either Party desires to make a public announcement concerning the material terms of, or material events occurring under, this Agreement, such Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein), such approval not to be unreasonably withheld.

 

10. Term and Termination.

 

10.1 The term of this Agreement shall commence on the Effective Date and continue for three (3) years from the Effective Date (the “Term”) unless earlier terminated under this Section 10 or extended by mutual written agreement of the parties.

 

(a) Either Party may terminate this Agreement for a material breach by the other Party upon thirty (30) days written notice specifying the breach unless such breach is cured within such thirty (30) day period.

 

 

 

 

 

(b) This Agreement may be terminated by one Party if the other Party is in breach of this Agreement and such breach is not capable of remedy or not remedied within thirty (30) days after it has occurred or immediately if insolvency or liquidation proceedings are commenced by or against such Party or either Party becomes bankrupt or otherwise incapable of paying its bills as they fall due or if a receiver or administrator in bankruptcy has been appointed to run such Party’s affairs.

 

(c) Expiration or termination of this Agreement shall not affect accrued rights or obligations of the Parties. Sections 4.1, 4.2, 5.4, 5.5, 5.8, 7, 8, 9 and 10.1(c)shall survive termination or expiration of this Agreement.

 

11. Acceptance of Shipments; Non-Conformance.

 

11.1 PureForm will manufacture, package and test API and/or Product according to the agreed upon Specifications.

 

11.2 For each shipment hereunder, PureForm shall provide a Certificate of Analysis and within thirty (30) days following delivery to Enveric, Enveric shall have the right to give PureForm notice of rejection of any shipment that, in whole or part, fails to meet Specifications. Enveric shall at all times supply PureForm with any evidence it has that relates to whether any API or Product delivered to Enveric is non-conforming as contemplated hereunder. Failure by Enveric to give notice of rejection within thirty (30) days of the date of its receipt shall constitute acceptance by it of the shipment to which the notice of rejection would have otherwise applied. In the event of any disagreement between PureForm and Enveric relating to API or Product conformance with Specifications, the parties will use best good faith efforts to reach an amicable resolution of such disagreement. In the event that resolution cannot be reached, a mutually agreed upon, neutral, independent third-party laboratory shall be brought in to resolve the disagreement upon the request of either party. The results of the independent laboratory shall be binding on the parties and non-appealable, and the cost of such independent laboratory shall be borne by the party hereunder determined by the independent laboratory to be the non-prevailing party in such disagreement. For any API or Product properly rejected pursuant to this Section 11.2, such API or Product shall be returned by Enveric to PureForm at PureForm’s expense and shall be replaced by PureForm at no extra charge to Enveric, subject to Enveric’s right to accept non-conforming API or Product at its sole discretion.

 

11.3 PureForm will deliver or arrange for the delivery of Product to Enveric, FOB Destination (Incoterms 2000) from PureForm’s logistics facility. Enveric shall bear the cost of shipping and insurance to cover the risk of loss during shipping. Title to API and Product will pass to Enveric upon delivery to the designated destination, whereupon Enveric will assume all risk of loss or damage.

 

 

 

 

12. General.

 

12.1 Choice of law and Venue. This Agreement shall be interpreted and enforced in accordance with the laws of the State of Delaware, U.S.A., regardless of its choice of law principles. In connection with any dispute arising hereunder or in connection with the subject matter hereof, each of the Parties hereby consents to the non-exclusive jurisdiction and venue of the U.S. federal courts located within the state of Delaware and of the Delaware state courts.

 

12.2 Notices. All notices under this Agreement shall be in writing and shall be deemed given upon personal delivery, e-mail delivery with confirmation of receipt, delivery by internationally- or nationally-recognized bonded courier service, or seven (7) days after sending by certified or registered mail, postage prepaid and return receipt requested, to the following addresses or e-mail address of the respective Parties or such other address as given by notice under this Section:

 

PureForm:

PureForm Global, Inc.

Attention: COO

5700 Melrose Ave. #208,

Los Angeles, California 90038

 

steve@pureformglobal.com

 

Enveric

Enveric Biosciences, Inc.

Attention: COO

4851 Tamiami Trail N

Suite 200

Naples, FL 34103

 

akanubaddi@enveric.com

 

12.3 Integration. This Agreement sets forth the complete, final, and exclusive agreement between the Parties and supersedes and terminates all prior agreements and understandings between the Parties. No amendment to, or waiver of right under, this Agreement is effective unless in writing signed by authorized representatives of the Parties. No waiver by a Party of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by a Party of any right under this Agreement shall be construed as a waiver of any other right. If any provision of this Agreement is judicially or administratively determined to be unenforceable, the provision will be reformed to most nearly approximate the Parties’ original intent, but otherwise this Agreement will continue in full force and effect.

 

12.4 PureForm’s relationship with Enveric will be that of an independent contractor, and nothing in this Agreement shall be construed to create a partnership, joint venture, or employer-employee relationship. The Parties are not agents of one another and are not authorized to make any representation, contract, or commitment of behalf of the other.

 

12.5 Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement.

 

12.6 Assignment. Except in connection with a sale of substantially all of a Party’s assets, the Parties shall not assign their rights or obligations under this agreement, and any purported assignment shall be null and void and without force or effect.

 

 

 

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the Effective Date.

 

PureForm Global, Inc.      
         
By: /s/ Richard Nanula      
         
Name: Richard Nanula Title: CEO
         
Enveric Biosciences, Inc.      
         
By: /s/ Avani V. Kanubaddi      
         
Name:  Avani V. Kanubaddi   Title: COO

 

 

 

 

Exhibit A

 

API Specifications

 

Omitted pursuant to Item 601(a)(5) of Regulation S-K.

 

 

 

 

Exhibit B

 

API Pricing

 

Omitted pursuant to Item 601(a)(5) of Regulation S-K.

 

 

 

 

Exhibit C

 

Press Release

 

Enveric Biosciences Launches Development Collaboration and Supply Agreement with PureForm
Global to Support Cannabinoid Clinical Programs

 

Enveric and PureForm to Develop High-Quality, Consistent, Pure CBD Formulations and Delivery Technology for Treating Pain and Inflammation Resulting from Cancer Treatments

 

NAPLES, Fla. – February 25, 2021 – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, announced today that it has launched a strategic development collaboration and exclusive supply agreement with PureForm Global, Inc. (“PureForm”), a biotechnology company focused on the research, development and commercialization of synthesized CBD and other cannabinoids, for treating pain and inflammation resulting from cancer treatments. The agreement allows two leading edge companies to bring their focus and resources to bear on superior products to serve unmet medical needs.

 

“For the millions of cancer patients that continue to suffer from debilitating treatment side effects, the status quo in supportive care options is no longer acceptable,” said David Johnson, Chairman and CEO, Enveric Biosciences. “As a market leader in producing pure, consistent, synthetic CBD from non-cannabis plant sources, PureForm perfectly complements Enveric’s supportive care expertise. Together, we will apply a high level of rigor in our scientific research, to create better treatment options that improve quality of life for cancer patients across the world.”

 

Under the terms of the agreement, PureForm will work exclusively to support Enveric’s development plans in the cancer treatment and supportive care space, with Enveric owning the intellectual property. With its work, Enveric is initially targeting supportive care indications that include radiodermatitis, chemotherapy-induced neuropathy, and glioblastoma.

 

“As Enveric’s exclusive synthetic, non-cannabis-based CBD supplier for all of the Company’s compounds, PureForm will work closely with the team to select and develop next-generation, cannabinoids to help serve physicians and patients,” added Richard Nanula, CEO, PureForm. “Through collaborating on this innovative discovery program, PureForm’s goal is to help Enveric fast-track its efforts to produce impactful, pharmaceutical-grade cannabinoid applications that will benefit the global medical community as a whole in the near future.”

 

“Next-generation medicines, including cannabinoids, may be beneficial in providing a solution for these patients with high unmet medical needs,” concluded Johnson. “By bringing the Enveric and PureForm teams’ unique expertise together to work on these novel compounds, we will not only advance our pipeline but also further our drug development efforts to benefit patients and their families.”

 

About Enveric Biosciences

 

Enveric Biosciences is a patient-first biotechnology company developing rigorously tested, novel cannabinoid medicines to improve quality of life for cancer patients. Initial indications include radiodermatitis, a common and often severe side effect of radiation therapy, and chemotherapy-induced neuropathy. For more information, please visit https://www.enveric.com/.

 

About PureForm Global, Inc.

 

Headquartered in Los Angeles, California, PureForm is a biotechnology company focused on the research, development, and commercialization of synthesized CBD and other cannabinoids. The company’s synthetic cannabinoids are 100% chemically identical to their plant-based counterparts and are manufactured using a proprietary process that produces pure, consistent and stable compounds free from THC, pesticides, and impurities. PureForm produces CBD at commercial scale in cGMP and FDA compliant facilities in the US and UK. It was founded in 2016 with a commitment to bringing pure, consistent, cannabinoids to market economically and at commercial scale in service to the world’s most quality-conscious brands. To learn more about PureForm CBDTM or our other initiatives, please visit www.pureformglobal.com.

 

 

 

 

Forward-Looking Statements

 

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, “ expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the failure of the offering described in this press release to close; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s registration statement on Form S-4 filed on May 28, 2020, as amended. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

Investor Contacts

 

Valter Pinto / Allison Soss

KCSA Strategic Communications

212.896.1254 / 212.896.1267

valter@kcsa.com / asoss@kcsa.com

 

Media Contacts

 

Caitlin Kasunich / Raquel Cona

KCSA Strategic Communications

212.896.1241 / 516.779.2630

ckasunich@kcsa.com / rcona@kcsa.com

 

 

 

Exhibit 10.6

 

EXCLUSIVE LICENSE AGREEMENT

 

Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***].

 

THIS EXCLUSIVE LICENSE AGREEMENT (“Agreement”), effective as of March 5, 2021 (the “Effective Date”), is made by and between Diverse Biotech, Inc., a corporation organized and existing under the laws of the State of Florida, having offices at 1000 Legion Place, Suite 1700, Orlando, FL 32801 ATTN: Jason Davis (“Diverse”), and Enveric Biosciences, Inc., a company organized and existing under the laws of the State of Delaware, having offices at 4851 Tamiami Trail N., Suite 200, Naples, FL 34103 (“Licensee” and “Enveric”) (each of Diverse and Enveric a “Party” and, collectively, the “Parties”).

 

RECITALS

 

WHEREAS, Diverse owns or otherwise controls certain Patent Rights, Know-How and other proprietary Information (each as defined below) related to five (5) therapeutic candidates developed by Diverse that are expected to be useful in various indications;

 

WHEREAS, Licensee engages in the discovery, development, and commercialization of pharmaceutical products; and

 

WHEREAS, Licensee desires to acquire and obtain, and Diverse is willing to grant to Licensee, all rights to the Agents (as defined below) and an exclusive license to Diverse’s intellectual property rights covering the Agents and Products (each as defined below) for the Territory (as defined below), and the results of any research and development activities by either Party related to the Agents thereto.

 

WHEREAS, this Agreement and any description, definition or provision below shall only apply to the Agents and Products (as defined below) and any future filings, protections or new filings that relate thereto, without bearing on the balance of other new molecules in the Patents, and Diverse will not be restricted, limited or otherwise encumbered in any manner with respect to the balance of the art contained in the Patents,

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

ARTICLE 1 – DEFINITIONS

Unless specifically set forth to the contrary herein, the following terms shall have the respective meanings set forth below:

 

1.1 “Affiliateshall mean, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under common control with such Person. A Person shall be deemed to control another Person if such Person possesses the power to direct or cause the direction of the management, business and policies of such Person, whether through the ownership of fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise.

 

1.2 “Agentmeans any of the following:

 

  1.3.1 Cannabinoid+[***]
  1.3.2 Cannabinoid+[***]
  1.3.3 Cannabinoid+[***]
  1.3.4 Cannabinoid+[***]
  1.3.5 Cannabinoid+[***]

 

along with any conjugate, analog, derivative, or prodrug thereof, whether each is taken alone, together, or any is taken in combination with another active pharmaceutical ingredient, for use in the diagnosis, cure, treatment, management or prevention of any disease, or any symptom thereof, in a human or an animal.

 

-1-

 

 

1.3 “Applicable Law(s)shall mean the applicable laws and regulations of any jurisdiction, which are applicable to any of the Parties or their respective Affiliates in carrying out activities hereunder, including all statutes, enactments, acts of legislature, laws, ordinances, rules, regulations, notifications, guidelines, directions, directives and orders of any statutory authority, tribunal, board, or court or any central or state government or local authority or other governmental entity in such jurisdictions, including without limitation the FCPA and Export Control Laws.

 

1.4 “Cannabinoid” shall mean any cannabinoid (including without limitation THC, CBD, or otherwise), or any combination thereof.

 

1.5 “Confidential Informationshall mean any and all non-public Information, whether communicated in writing by any other method and which is marked as being “Confidential” (or confirmed as such if the Information is provided orally), that is provided by or on behalf of one Party to the other Party in connection with this Agreement.

 

1.6 “Control, Controlsor Controlled byshall mean, with respect to any Patent Rights, Information, Know How or other intellectual property rights, the possession by Person of the ability (whether by ownership, license or other right, other than pursuant to a license granted under this Agreement) to grant access to, or a license of, such Patent Rights, Know-How, Information or other intellectual property rights without violating the terms of any agreement with any Person.

 

1.7 Cover” means (a) with respect to Know-How, such Know-How was used in making, having made, using, selling, offering to sell, importing, having sold, exporting or making improvements to the Product, and (b) with respect to a Patent Right, a Valid Patent Claim would (absent a license thereunder or ownership thereof) be infringed by making, having made, using, selling, offering to sell, importing, having sold, exporting or making improvements to the Product. Cognates of “Cover” shall have correlative meanings.

 

1.8 “Disputeshall have the meaning provided in Section 10.1.

 

1.9 “Diverse Know-Howshall mean all Know-How Controlled by Diverse or any Affiliate as of the Effective Date, or that is developed or Controlled by Diverse or any Affiliate after the Effective Date, or otherwise necessary or useful for: (i) the use or manufacture of any Agent, and any improvement thereto; or (ii) the research, development, use, manufacture and/or commercialization of any Product, and any improvement thereto. For clarity, “Diverse Know-How” will include without limitation the names of past and present leadership, scientific team members, suppliers, manufacturers and other vendors, and any other employees, consultants or agents involved in developing any of the Agents. For the purpose of clarity, Diverse retains the rights to use Know-How included within the Diverse Know-How except for its use with the Agents or Product(s) as provided in Article 2 of this Agreement.

 

-2-

 

 

1.10 “Diverse Patent Rightsshall mean all Patent Rights Covering any Agent or Product, or the use or manufacture thereof, and such Patent Rights are set forth in Exhibit A, as amended from time-to-time. For clarity, Diverse Patent Rights excludes Patent Rights set forth in Exhibit A that do not Cover any Agent or Product, or the use, manufacture, or sale thereof.

 

1.11 “Diverse Technologyshall mean Diverse Patent Rights and Diverse Know-How.

 

1.12 “Effective Dateshall have the meaning provided in the Preamble.

 

1.13 “Export Control Lawsshall mean all applicable U.S. laws and regulations relating to (a) sanctions and embargoes imposed by the Office of Foreign Assets Control of the U.S. Department of Treasury or (b) the export or re-export of commodities, technologies, or services, including the Export Administration Act of 1979, 24 U.S.C. §§2401-2420, the International Emergency Economic Powers Act, 50 U.S.C. §§1701-1706, the Trading with the Enemy Act, 50 U.S.C. §§1 et. seq., the Arms Export Control Act, 22 U.S.C. §§2778 and 2779, and the International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986 (as amended).

 

1.14 “FCPAshall mean the U.S. Foreign Corrupt Practices Act (15 U.S.C. §§78dd-1, et. seq.) as amended.

 

1.15 “Field” shall mean supportive care for conditions associated with cancer treatment or palliative care as described by the National Cancer Institute (NCI) Dictionary of Cancer Terms (e.g., care given to improve the quality of life of patients who have a serious or life-threatening disease), the goal of which is to prevent, treat, or manage as early as possible the symptoms of a disease or condition, side effects caused by such prevention, treatment, or management thereof, and psychological, social, and spiritual problems related thereto.

 

1.16 “Informationshall mean any and all proprietary data, information, materials and Know-How (whether patentable or not) that are not in the public domain, including, (a) ideas, discoveries, inventions, improvements, technology or trade secrets, (b) pharmaceutical, chemical and biological materials, products, components or compositions, (c) methods, procedures, formulas, processes, tests, assays, techniques, regulatory requirements and strategies, (d) biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information related thereto, (e) technical and non-technical data and other information related to the foregoing, and (f) drawings, plans, designs, diagrams, sketches, specifications or other documents containing or relating to such information.

 

1.17 “Know-Howshall mean any and all Information related to an Agent or a Product that is necessary or useful for the development, manufacture, commercialization or use of any of the foregoing.

 

1.18 “Net Salesshall mean, the aggregate gross sales for any licensed Product sold by or for Licensee (including by any Affiliate or sublicensee) actually received from Third Parties (other than Sublicensees), less returns, less allowances, and less discounts, each as permitted under Applicable Law and determined in accordance with GAAP as consistently applied.

 

1.19 “Patent Rightsshall mean all (i) patents and patent applications, including certificates of invention, utility models, and the like; (ii) divisionals, continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, patent term extensions, supplementary protection certificates and the like of any such patents and patent applications; (iii) foreign equivalents of the foregoing; and the right to claim priority to any of the foregoing.

 

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1.20 “Personmeans any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.

 

1.21 “Productshall mean any pharmaceutical composition or formulation including, constituting, or incorporating, any Agent.

 

1.22 “Regulatory Authorityshall mean any country, federal, regional, supranational, state or local regulatory agency, department, bureau or other governmental or regulatory authority having the administrative authority to regulate the development or marketing of pharmaceutical products in any country or other jurisdiction.

 

1.23 “Sale Transactionshall have the meaning provided in Section 11.5(a).

 

1.24 “Termshall have the meaning provided in Section 9.1.

 

1.25 “Territoryshall mean the entire world.

 

1.26 “Third Partyshall mean any Person other than the Parties or their Affiliates.

 

1.27 “Third Party Acquirershall have the meaning provided in Section 11.5(a).

 

1.28 “Valid Patent Claimshall mean a claim of an issued and unexpired patent included within the Diverse Patent Rights, which claim has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction (which decision is not appealable or has not been appealed within the time allowed for appeal), and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination, post-issuance review proceeding, disclaimer, or otherwise.

 

ARTICLE 2 – LICENSE GRANT AND NON-COMPETE

 

2.1 License Grant. Diverse hereby grants to Licensee and its Affiliates an exclusive (even as to Diverse and its Affiliates), irrevocable, perpetual, sublicensable, royalty-bearing license to the Diverse Technology to develop, make, have made, use, sell, have sold, offer for sale, market, export, import and otherwise commercialize and exploit the Agents and Products in the Territory.

 

2.2 Non-Compete. Diverse hereby covenants not to, and not to permit or cause any of its Affiliates, nor to directly or indirectly assist any Third Party, to commercially develop, or to use, make, have made, sell, have sold, offer for sale, export, import or otherwise commercialize any agent or product that incorporates a Cannabinoid conjugation technology as disclosed in the Diverse Patent Rights set forth in Exhibit A in the Territory at any time during or after the Term that would compete with the Agents or any Products in the Field.. For the purpose of this Section 2.2, the Agents include without limitation the non-Cannabinoid part of each Agent (e.g., betamethasone or dapsone) such that Diverse will not commercialize or otherwise grant rights to a Third Party to conjugate the non-Cannabinoid portion of each Agent.

 

2.3 Right of First Opportunity. To the extent that Diverse intends to license, sell, or otherwise transfer any molecules linked with Cannabinoid (as defined herein) that it has not granted to Licensee in Section 2.1, Diverse will present such molecule(s) to Licensee and will have the first right (but not the obligation) to negotiate an agreement between the Parties before Diverse presents the opportunity to any Third Party. Licensee will have fifteen (15) business days to confirm interest to Diverse, and if interest is confirmed by Licensee the Parties will exclusively negotiate only with each other in good faith for up to sixty (60) days to pursue an agreement. For the purpose of clarity, the Parties may agree to simply add such additional molecule(s) to the present Agreement with any other mutually agreed-upon terms.

 

2.4 Cross-License to Know-How. In exchange for the grant by Diverse of the Diverse Know-How, Licensee hereby grants Diverse the right to its Know-How developed under the Agreement regarding any Agent or Product only for the express purpose of Diverse using Licensee’s Know-How to assist in obtaining the Diverse Patent Rights licensed in Section 2.1. For the purpose of clarity, this right to Licensee’s Know-How will terminate upon issuance or denial of the Diverse Patent Rights. Additionally, if Licensee decides to sell or make for sale any Know-How developed under the Agreement that could be used with Diverse Know-How other than an Agent or Product, Licensee agrees to offer to sell or license such information to Diverse in parallel, or immediately prior to, making it available for general sale or license.

 

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ARTICLE 3 – ROYALTIES

 

3.1 Up-Front Investment Payment. Licensee agrees to pay Diverse the total of six hundred seventy-five thousand dollars ($675,000), payable in immediately available funds within seven (7) days of the Effective Date, in exchange for the rights granted under this Agreement. Diverse will identify in writing the account to which the funds are to be transferred within one (1) day of the Effective Date.

 

3.2 Royalty Due By LICENSEE. Licensee will pay a running royalty of five percent (5%) of Net Sales to Diverse starting with the first commercial sale of by Licensee or an Affiliate to an arms’-length third party in any country in the Territory (“Running Royalty”) for a period of five (5) years after such first commercial sale in such country (“Royalty Term”) for each Product. The Running Royalty will be paid with respect to Net Sales for each Product during the portion of each calendar quarter for the remainder of the Royalty Term; provided, however, that the foregoing Running Royalty will be waived in each such country such that no further amounts will be due to Diverse for a given Product: (i) if the Diverse Patent Rights pending as of the Effective Date have not issued so as to Cover a licensed Product within three (3) years of the Effective Date; or (ii) if Diverse Patent Rights pending as of the Effective Date have issued and Cover a licensed Product within three (3) years of the Effective Date, then no further Running Royalty will be due if the last patent of such Diverse Patent Rights in such country has expired or is found invalid before the end of the Royalty Term.

 

ARTICLE 4 –PAYMENTS; AUDIT REPORTS

 

4.1 Timing of Running Royalty Payments. Licensee will pay the Running Royalty to Diverse as set forth in Section 3.2 within sixty (60) days after the end of each calendar quarter, along with a report identifying the Products, Net Sales, and the computation of the Running Royalty payable to Diverse, beginning with the first commercial sale of a Product.

 

4.2 Currency for Payments. Payments must be in United States Dollars, remitted to Diverse at its address specified herein.

 

4.3 Recordkeeping by Licensee. Licensee must keep full and accurate books and records including any information necessary to allow the calculation of royalties to be paid. Licensee must permit Diverse, at Diverse’s sole expense (except as otherwise provided in Section 4.4), to retain an independent certified public accountant employed by Diverse and reasonably acceptable to Licensee, to examine relevant books and records at any reasonable time during business hours upon sufficient advance notice of not less than ten business days, within one (1) year of the rendering of the books and records. The accountant’s report to Diverse must not include any confidential information of Licensee, and must only include a summary and analysis of any under or overpayment of the Running Royalty. The Parties will promptly pay the under or overpayment, as applicable, to each other within thirty (30) days of such report.

 

4.4 Effect of Improper Recordkeeping by Licensee. If it is determined that there was an underpayment of royalties due Diverse by more than five percent (5%) of the correct amount, Licensee must also reimburse Diverse for the cost of such audit.

 

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ARTICLE 5 – COMMERCIALIZATION

 

5.1 Transfer of Regulatory Materials & Commercialization. Licensee shall have sole responsibility, and ownership, at its own cost, for the development and commercialization of the Product. Diverse will (i) assign and transfer to Licensee all regulatory materials, including any communications with any Regulatory Authority, and (ii) transfer to Licensee all Diverse Know-How necessary or useful to manufacture the Agents and proposed Products, in each case (i) and (ii) related to the Agents and any Products within ninety (90) days of the Effective Date of this Agreement.

 

ARTICLE 6 – CONFIDENTIALITY AND PUBLICATION

 

6.1 Confidential Information. Except to the extent expressly authorized by this Agreement, each Party (in such capacity, the “Receiving Party”) agrees that, during the Term and for five (5) years thereafter, it shall keep confidential and shall not publish or otherwise disclose to any Third Party, and shall not disseminate or use for any purpose other than as expressly provided for in this Agreement or any other written agreement between the Parties, any Confidential Information furnished or made available to it by or on behalf of the other Party (in such capacity, the “Disclosing Party”). The Receiving Party shall use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but in no event less than a commercially reasonable standard of care) to ensure that it, its Affiliates’, and its Permitted Representatives (as defined below) do not disclose or make any unauthorized use of the Confidential Information. The Receiving Party shall promptly notify the Disclosing Party upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information. It should be understood that all Diverse Know-How and other Diverse Information related specifically to the Agents being acquired hereunder will be considered the “Confidential Information” of Licensee.

 

6.2 Exceptions. Confidential Information shall not include any information which the Receiving Party can prove by competent evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party, generally known or available; (b) is known by the Receiving Party and/or any of its Affiliates at the time of receiving such information, as evidenced by competent written records; (c) is hereafter furnished to the Receiving Party and/or any of its Affiliates by a Third Party that has the right to do so without restriction on such disclosure; or (d) is independently discovered or developed by the Receiving Party and/or any of its Affiliates, without the use of Confidential Information of the Disclosing Party as evidenced by competent written records.

 

6.3 Authorized Disclosure. Notwithstanding the provisions of Section 6.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:

 

(a) filing, prosecuting, or maintaining Patent Rights as permitted by this Agreement, provided that Licensee has fifteen (15) days prior notice to review any such disclosure by Diverse or its Affiliates of any of Licensee’s Confidential Information, and may in its reasonable discretion require deletion of any or all of Licensee’s Confidential Information from any proposed disclosure;

 

(b) enforcing such Party’s rights under this Agreement (including registering the licenses granted hereunder with applicable authorities, provided that all financial terms are first redacted) and in performing its obligations under this Agreement.

 

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(c) prosecuting or defending litigation as permitted by this Agreement;

 

(d) complying with Applicable Laws, including the listing rules of any exchange on which the Receiving Party’s securities are traded; and

 

(e) disclosure to Affiliates, actual and potential sub-licensees, partners, employees, consultants financial or legal advisors, potential or actual investors, or agents, of the Receiving Party who have a need to know such information for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement (each a “Permitted Representative”), provided, in each case, that any such Permitted Representative agrees to be bound by terms of confidentiality and non-use comparable in scope to those set forth in this ARTICLE 6.

 

Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 6.3(c) or 6.3(d), it will, except where impracticable, give reasonable advance notice to the Disclosing Party of such disclosure and secure confidential treatment of such information using efforts at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than commercially reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of Confidential Information hereunder if confidential treatment is not available.

 

6.4 Publications. Each Party has the right to disclose the existence of this Agreement, but the specific terms hereof will be considered Confidential Information except as the Parties otherwise agree in writing. Any publications, including any press release, containing Diverse Technology licensed under this Agreement or otherwise related to the development of a Product will be subject to the prior written approval of Licensee which shall not be unreasonably withheld, delayed, or denied. Licensee shall have the right to review and comment on any material directed to any Agent or licensed Product, or the use or manufacture of such Agent or licensed Product, that is proposed for disclosure or publication by Diverse or its Affiliates, such as by oral presentation, manuscript or abstract. Before any such material is submitted for publication or disclosure, Diverse shall deliver a complete copy to Licensee at least thirty (30) days prior to submitting such material to a publisher or otherwise initiating such other disclosure, and Licensee shall review any such material and give its comments to Diverse within fifteen (15) days of the delivery of such material to Licensee. Diverse shall comply, or cause its Affiliates to comply (as applicable), with Licensee’s requests to delete references to Confidential Information in any such material in connection with approval of a potential publication and, if applicable, Diverse agrees to delay any submission for publication or other public disclosure for a period of up to an additional sixty (60) days for the purpose of Diverse at Licensee’s request preparing and filing appropriate patent applications.

 

ARTICLE 7 – REPRESENTATIONS AND WARRANTIES; COVENANTS

 

7.1 Mutual Representations and Warranties. Each Party represents and warrants to the other that, as of the Effective Date: (a) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement and to carry out the provisions hereof; (b) it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action; and (c) this Agreement is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

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7.2 Diverse Representations and Warranties. Diverse expressly represents and warrants to Licensee that, as of the Effective Date of this Agreement:

 

(a) Exhibit A attached hereto contains a true and complete list of the Diverse Patent Rights as it exists on the Effective Date. The Diverse Patent Rights listed in Exhibit A include all of the Patent Rights Controlled by Diverse as of the Effective Date that Cover any Product in the Territory, and the manufacture, use, sale, offer for sale or importation or other commercialization of the foregoing, and there is no other Patent Right that it owns, or has any other right or permission to use, anywhere in the Territory, now or hereafter acquired. Diverse expressly agrees that breach of this provision will be material, and it hereby additionally grants an irrevocable, non-exclusive, worldwide license, free of any additional royalty, to any such other patent rights that Cover a licensed Product or the above rights needed or useful to permit Licensee to enjoy the benefit of the licensed rights granted under this Agreement; provided that this additional grant will only become effective in the event of a breach of this Section 7.2(a);

 

(b) Diverse (i) has exclusive ownership of the Diverse Patent Rights, and to its knowledge has exclusive ownership of the Diverse Know-How, in each case including as to all Agents and licensed Products, (ii) has the right to grant the licenses that it purports to grant in Section 2.1; and (iii) has not granted to any Third Party any license or other right, nor entered any other agreement, with respect to any Product or Diverse Technology that limits or conflicts with the license and rights granted to Licensee herein;

 

(c) To Diverse’s knowledge, the issued and unexpired claims included in the Diverse Patent Rights existing as of the Effective Date are not invalid or unenforceable;

 

(d) No administrative proceeding or other dispute is pending or threatened in writing with respect to any Diverse Technology, including any Diverse Patent Right;

 

(e) Diverse has not received written notice from any Third Party claiming that the manufacture, use, sale, offer for sale or import of any Agent or Product infringes or would infringe the patent rights, or violate other intellectual property rights, of any Third Party; if Diverse receives any such written notice during the Term of this Agreement, Diverse covenants that it shall promptly provide such written notice to Licensee;

 

(f) There are no claims, judgments or settlements against or owed by Diverse (or any of its Affiliates) with respect to the Diverse Technology, and Diverse is not a party to any legal action, suit or proceeding relating to the Diverse Technology, or any Product, nor has Diverse received any written communication from any Third Party, including, without limitation, any Regulatory Authority or other government agency, threatening any such action;

 

(g) neither Diverse nor any of its Affiliates has obtained, or filed with any Regulatory Authority, for, any marketing approval for any Product, and, to the best of Diverse’s knowledge, no other Person has obtained, or filed for, the foregoing;

 

(h) all research and development conducted by or on behalf of Diverse or any of its Affiliates related to any Products before the Effective Date was conducted in compliance in all material respects with all Applicable Laws and, as applicable, GLP, GCP and/or GMP;

 

(i) Except for the Diverse Patent Rights, Diverse does not Control any other Patent Rights that would prevent Licensee from freely enjoying the rights licensed under this Agreement, including making, having made, using, selling, offering for sale, importing, developing and otherwise commercializing the Agents and Products, and Diverse hereby grants Licensee a covenant not to sue in the event it has any other such Patent Rights;

 

(j) Diverse and, to the best of its knowledge, its directors, officers, employees, and any agent, representative, subcontractor or other Third Party acting for or on its behalf, has not, directly or indirectly, offered, paid, promised to pay, or authorized such offer, promise or payment, of anything of value, to any Person for the purposes of obtaining or retaining business through any improper advantage in connection with the development, commercialization or exploitation of a Product, or that would otherwise violate any Applicable Laws, rules and regulations concerning or relating to public or commercial bribery or corruption including the FCPA, and Diverse’s books and accounting related to the Diverse Technology are complete and accurate;

 

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7.3 Diverse Covenants. In addition to any covenants made by Diverse in Section 7.2 and elsewhere in this Agreement, Diverse hereby covenants to Licensee that during the Term, Diverse will not grant any Third Party any license or other right with respect to any Diverse Technology in derogation of the license and rights granted to Licensee hereunder.

 

7.4 Mutual Covenants. In addition to any covenants made by a Party elsewhere in this Agreement, each Party hereby covenants to the other as follows:

 

(a) neither Party nor any of its Affiliates will, under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including such Party and its Affiliates, nor will such Party or any of its Affiliates directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement; and

 

(b) neither such Party nor any of its Affiliates (or any of their respective employees and contractors) shall cause the other Party to be in violation of the FCPA or Export Control Laws, or the equivalent laws in any other jurisdiction, in performing under this Agreement.

 

7.5 Performance by Affiliates and Subcontractors. The Parties recognize that each Party may perform some or all of its obligations or exercise some or all of its rights under this Agreement through one or more Affiliates, subcontractors, or, in the case of Licensee, provided, in each case, that (a) none of the other Party’s rights hereunder are diminished or otherwise adversely affected as a result of such delegation or subcontracting, and (b) each such Affiliate or subcontractor undertakes in writing obligations of confidentiality and non-use regarding Confidential Information and ownership of inventions which are substantially the same as those undertaken by the Parties pursuant to Article 6 and Section 8.1; and provided, further, that such Party shall at all times be fully responsible for the performance and payment of such Affiliate or subcontractor.

 

7.6 Limitation of Liability. EXCEPT FOR LIABILITY FOR BREACH OF ARTICLES 6 (CONFIDENTIALITY) OR 8 (INTELLECTUAL PROPERTY), SECTION 7.3, OR IN THE CASE OF FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER.

 

 

ARTICLE 8 – INTELLECTUAL PROPERTY

 

8.1 Ownership. Each Party shall be liable with respect to its own employees for compliance with any applicable legislation and its own policies concerning employee inventions, including payment of employee invention awards (if any). To the extent any intellectual property is developed by Licensee that (i) should be owned by Licensee but cannot be readily assigned by Diverse because it could affect the enforceability of any Diverse Patent Rights or (ii) Licensee is restricted from owning under Section 8.2.2, in each case (i) and (ii) Diverse hereby agrees to include all such intellectual property in the Diverse Technology and within the scope of the rights licensed to Licensee under this Agreement.

 

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8.2 Patent Prosecution and Maintenance.

 

8.2.1 Diverse Patent Rights. Diverse shall have the right to control the filing, prosecution and maintenance of Diverse Patent Rights, at Diverse’s sole expense. Diverse shall keep Licensee reasonably informed of progress with regard to the foregoing including copies of all patent office communications filed and received, and provide drafts of proposed filings to Licensee at least fifteen (15) business days before any deadline so that Licensee may provide comments to Diverse and its patent counsel. Diverse will seriously consider in good faith all Licensee comments and other input in finalizing such proposed filings. In the event that Diverse desires to abandon or cease prosecution or maintenance of any Diverse Patent Right in any country or jurisdiction (such country or jurisdiction, the “Abandoned Territory”), Diverse shall provide written notice to Licensee of such intention to abandon no later than sixty (60) days prior to the next deadline for any action that must be taken. In such case, upon receipt of a written request by Licensee to assume responsibility for prosecution and maintenance and exclusive ownership of such Diverse Patent Right, Diverse shall allow Licensee at its sole cost and expense and by counsel of its own choice, delivered no later than thirty (30) days after receipt of notice from Licensee, to assume such responsibility and exclusive ownership subject to Section 8.1. No royalties will be owed by Licensee on any such rights in the Abandoned Territory.

 

8.2.2 Licensee Patent Rights. As to any Patent Rights filed related to the Agents or Products, or the use or synthesis thereof, after the Effective Date, Licensee will exclusively own such Patent Rights as set forth in Section 8.1 and have exclusive rights to control the filing, prosecution, and maintenance of such Patent Rights, along with any Patent Rights in Abandoned Territory, all at Licensee’s expense using counsel of its own choice, so long as these patent rights (i) do not claim priority to any patent or patent application in the Patent Rights, (ii) do not rely on disclosure of any patent or patent application in the Patent Rights, in whole or in part, for enablement before the publication date of any such disclosure, (iii) do not rely on Diverse Know-How, in whole or in part, for enablement, written description, or any combination thereof, or (iv) any combination of (i)-(iii).

 

8.2.3 Cooperation of the Parties. Each Party agrees to cooperate fully in the filing, prosecution and maintenance of Patent Rights under this Agreement and in the obtaining and maintenance of any patent term extensions, supplementary protection certificates and the like with respect to any Patent Right as well as in registering the licenses granted hereunder with the applicable authorities. Such cooperation includes, but is not limited to: (i) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, so as to effectuate the exclusive ownership or either Party of its respective Patent Rights; and to enable the other Party to apply for and to prosecute patent applications in any country in accordance with the foregoing provisions of this Section 8.2; and (ii) promptly inform the other Party of any matters coming to such Party’s attention that may affect the filing, prosecution or maintenance of any such patent applications including prompt disclosure of inventions to be owned by the other Party under this Article 8.

 

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8.3 Enforcement and Defense of Patent Rights. Each Party shall notify the other Party in writing within ten (10) business days (except as expressly set forth below) of becoming aware of any alleged or threatened infringement by a Third Party of any of the Diverse Patent Rights (“Infringement”), including (x) any such alleged or threatened Infringement on account of a Third Party’s manufacture, use or sale of a Product, (y) any certification filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States or a comparable application for regulatory approval under Applicable Law in any country other than the United States) or other New Drug Application for a Product (a “Patent Certification”), and (z) any declaratory judgment action filed by a Third Party that is developing, manufacturing or commercializing a Product alleging the invalidity, unenforceability or non-infringement of any of the Diverse Patent Rights; provided, however, that each Party shall notify the other Party of any Patent Certification regarding any Diverse Patent Right that it receives, and such Party shall provide the other Party with a copy of such Patent Certification, within five (5) calendar days of receipt.

 

8.3.1 Third-Party Infringement. Licensee shall have the first right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to Infringement or any other administrative proceeding regarding a Diverse Patent Right that Covers a Product at Licensee’s own expense and by counsel of its own choice. If Licensee fails to bring any such action or proceeding within ninety (90) days following the notice of alleged Infringement, Diverse shall have the right to bring (or defend) and control any such action at its own expense and by counsel of its own choice, and Licensee shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.

 

8.3.2 Cooperation. In the event a Party brings (or defends) an Infringement action in accordance with this Section 8.3, or in the event a Party is entitled to bring (or defend) an Infringement action in accordance with this Section 8.3 but lacks standing to do so, the other Party shall cooperate fully, including, if required to bring (or defend) such action, the furnishing of a power of attorney and otherwise hereby agreeing to being named as a party to such suit or dispute proceeding. Neither Party shall enter into any settlement or compromise of any action under this Section 8.3 which would in any manner alter, diminish, or be in derogation of the other Party’s rights under this Agreement without the prior written consent of such other Party, which shall not be unreasonably withheld or delayed.

 

8.3.3 Recovery. Except as otherwise agreed by the Parties, any recovery realized by a Party as a result of any action or proceeding pursuant to this Section 8.3, whether by way of settlement or otherwise, shall be applied first to reimburse the documented out-of-pocket legal expenses of the Party that brought (or defended) and controlled such action incurred in connection with such action, and second to similarly reimburse the documented out-of-pocket legal expenses of the other Party, with and any remaining amounts shall be retained by the Party that brought (or defended) and controlled such action.

 

8.4 Patent Term Extensions. The Parties shall mutually agree and document in writing, on a case-by-case basis, the Diverse Patent Rights for which applications will be made for extension of patent term in any country and/or region for any Product, which Party will make such application and how to allocate resulting costs equitably. Each Party shall provide all reasonable assistance in good faith to the other in connection with such filings to ensure the maximum protection for the Agents and Products so as mutually benefit each of the Parties.

 

ARTICLE 9 - TERM AND TERMINATION

 

9.1 Term. Independently of the Royalty Term, the term of this Agreement shall commence on the Effective Date and, unless earlier terminated in accordance with this Article 9, continue for as long as Licensee intends to develop or commercialize an Agent or a licensed Product (the “Term”).

 

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9.2 Termination for Material Breach. Each Party shall have the right to terminate this Agreement in its entirety upon written notice to the other Party if such other Party is in material breach of this Agreement and has not cured such breach within ninety (90) days after notice from the terminating Party indicating the nature of such breach and the actions required to cure such breach if not apparent, or if such other Party is dissolved or liquidated or takes any corporate action for such purpose; makes a general assignment for the benefit of creditors; or has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business. Any such termination may be made through written notice to the breaching Party at the end of such ninety (90) day period unless the breaching party has cured such breach. Any right to terminate under this Section 9.2(a) shall be stayed and the cure period tolled in the event that the Party alleged to have been in material breach shall have a good faith Dispute and shall have initiated the dispute resolution under Article 10 regarding the alleged breach, which stay and tolling shall continue until such dispute has been resolved under Article 10.

 

9.3 At-Will Termination by Licensee. Licensee shall have the right to terminate this Agreement for convenience, in whole or in part, as to any of the Agents or Products on a country-by-country basis for any reason or for no reason at any time upon sixty (60) days’ prior written notice to Diverse, provided Licensee’s termination shall not be deemed to cure any breach existing as of the date of such termination.

 

9.4 Effect of Expiration. Upon expiration of this Agreement, all licenses granted by Diverse to Licensee shall survive on an exclusive basis and remain in effect indefinitely, on a fully paid-up basis. All other sharing of Information between the Parties all other obligations of Licensee to Diverse will cease upon expiration of the Agreement.

 

9.5 Effect of Termination.

 

9.5.1 Uncured Breach by Licensee. Upon termination of this Agreement by Diverse under Section 9.2 due to uncured material breach by Licensee, the license (on a country-by-country basis in the event of partial termination by Licensee under Section 9.3) granted to Licensee to the Diverse Technology pursuant to Section 2.1 shall automatically terminate and revert to Diverse, and all obligations for Licensee to pay any Running Royalty under this Agreement shall terminate. To the extent any sublicenses are then in effect and in good standing other than uncured breach by Licensee, such sublicensees will become direct Licensees of Diverse and owe all remaining obligations directly to Diverse.

 

9.5.2 Uncured Breach by Diverse. Upon termination of this Agreement by Licensee under Section 9.2 due to uncured material breach by Diverse, Licensee may elect to (i) fully terminate this Agreement entirely or as to any Product; or (ii) retain the licenses granted herein under Section 2.1 on an exclusive basis as if the Agreement expired under Section 9.4, at which time all other obligations of Licensee to Diverse will cease. For clarity, under option (ii), Licensee will irrevocably retain the fully paid-up right to commercialize Agents and licensed Products under the licenses granted in this Agreement.

 

9.5.3 Other Termination. Subject to Sections 9.5.1 and 9.5.2, upon any other termination of this Agreement before expiration of the Royalty Term, the license (on a country-by-country basis in the event of partial termination by Licensee under Section 9.3) granted to Licensee to the Diverse Patent Rights pursuant to Section 2.1 shall automatically terminate and revert to Diverse, and all other rights obligations under this Agreement shall terminate except where such rights extend beyond termination and or the Term.

 

9.6 Accrued Obligations; Survival. Neither expiration nor any termination of this Agreement shall relieve either Party of any obligation or liability accruing prior to such expiration or termination, nor shall expiration or any termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement. In addition, the Parties’ rights and obligations under Sections 2.2 (Non-Compete), 6.1, 6.2, 6.3, 7.6, Article 8, 9.4, 9.6, 9.7 and 9.8 and Articles 10 and 11 of this Agreement, along with any other provisions that should naturally survive, will survive expiration or any termination of this Agreement.

 

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9.7 Return of Confidential Information. Within thirty (30) days following the expiration or termination of this Agreement, except to the extent that a Party retains a license from the other Party as provided in this Article 9, each Party shall promptly return to the other Party, or delete or destroy, all relevant records and materials in such Party’s possession or control containing Confidential Information of the other Party; provided that such Party may keep one copy of such materials for archival purposes subject to continuing confidentiality obligations and may keep any such Confidential Information-containing materials to the extent stored electronically in the ordinary course of business as part of a system to archive business records of that Party until such archived records are ordinarily destroyed in the ordinary course.

 

9.8 Damages; Relief. Termination of this Agreement shall not preclude either Party from claiming any other damages, compensation or relief that it may be entitled to hereunder.

 

ARTICLE 10 - DISPUTE RESOLUTION

 

10.1 Disputes. Subject to Section 10.2, any claim, dispute, or controversy as to the breach, enforcement, interpretation or validity of, or otherwise related to or arising from, this Agreement (each, a “Dispute”) that cannot be resolved by the Parties within thirty (30) days that a Party is notified of such Dispute, will be referred to the Chief Executive Officer of Diverse and the Chief Executive Officer of Licensee for attempted resolution, with each party exercising good faith in such attempt. In the event such executives are unable to resolve such Dispute within thirty (30) days of such Dispute being referred to them, then, upon the written request of either Party to the other Party, as expressly set forth in Section 10.2.

 

10.2 Court Actions; Jurisdiction. Each of the Parties hereto: (i) consents to submit itself to the exclusive jurisdiction of any federal or state court located in the state of New York for any dispute that arises out of or relates to this Agreement, including without limitation to resolve disputes pertaining to the Patent Rights or other intellectual property rights hereunder, and (ii) agrees that it will not attempt to deny or defeat such jurisdiction by motion or other request for leave from any court, or to object to such courts as an inconvenient forum.

 

ARTICLE 11 - MISCELLANEOUS

 

11.1 Rights Upon Bankruptcy. All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code and other similar laws in any jurisdiction outside the U.S. (collectively, the “Bankruptcy Laws”), licenses of rights to be “intellectual property” as defined under the Bankruptcy Laws. If a case is commenced during the Term by or against a Party under Bankruptcy Laws then, unless and until this Agreement is rejected as provided in such Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession) and its successors and assigns (including a trustee) shall perform all obligations provided in this Agreement to be performed by such Party. If this Agreement is rejected as provided in the Bankruptcy Laws and Licensee elects to retain its rights hereunder as provided in the Bankruptcy Laws, then Diverse (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee), shall promptly provide to Licensee copies of all Information, including Diverse Know-How, necessary for Licensee to prosecute, maintain and enjoy its rights under the terms of this Agreement upon Licensee’s written request therefor. All rights, powers and remedies of Licensee as provided herein are in addition to any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, the Bankruptcy Laws).

 

11.2 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, excluding its conflicts of laws principles.

 

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11.3 Entire Agreement; Amendments. This Agreement (including the Exhibits hereto) is both a final expression of the Parties’ agreement and a complete and exclusive statement with respect to all its terms. This Agreement supersedes all prior and contemporaneous agreements and communications, whether oral, written or otherwise, concerning any and all matters contained herein. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.

 

11.4 Non-Waiver. The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance. Any waiver by a Party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by such Party.

 

11.5 Assignment. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided, however, that either Party may assign this Agreement and its rights and delegate its obligations hereunder without the other Party’s consent:

 

(a) in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a Third Party (“Third Party Acquirer”), whether by merger, sale of stock, sale of assets, operation of law, or otherwise (each, a “Sale Transaction”); or

 

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

 

The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void ab initio. In the event of an assignment and assumption of rights and obligations under this Agreement to a Third Party in connection with a Sale Transaction, the assigning Party shall be relieved of all obligations to the non-assigning Party assumed by the applicable Third Party.

 

11.6 Reasonable Assistance. Notwithstanding any other agreement that might restrict any Person from working with Licensee to commercialize the acquired Agents, including any non-compete, non-solicit, or non-circumvention agreements or provisions containing the same, Diverse hereby waives any such restrictions and Diverse and its past and present personnel will be available to provide all assistance reasonably needed by or useful to Licensee in developing and otherwise commercializing the Agents and licensed Products under this Agreement, including but not limited to providing access to any Person employed by or otherwise affiliated with Diverse that has been involved in developing or manufacturing any Agent, signing any documents necessary to pursue, maintain, or enforce any IP rights licensed under this Agreement, testifying in any legal proceedings, or otherwise. Diverse further agrees that Licensee may contact any such personnel to seek such assistance related to this Agreement without first seeking consent.

 

11.7 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace such provision(s) with valid, legal and enforceable provision(s) to implement the purposes of this Agreement.

 

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11.8 Notices. All notices which are required or permitted hereunder shall be in English, and in writing and sufficient if delivered personally, sent by electronic mail (if promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier, or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

 

  If to Diverse, to: Diverse Biotech, Inc.
    1000 LEGION PLACE, SUITE 1700
    ORLANDO, FL 32801
    Attn: Bill Fisher
    Email: wfisher@diversebiotech.com
     
  If to Licensee, to: Enveric Biosciences, Inc.
    4851 Tamiami Trail N., Suite 200
    Naples, FL 34103Attn: Avani Kanubaddi
    Email: akanubaddi@enveric.com
     
  with a copy (which shall not constitute notice) to:
     
    Haynes and Boone, LLP
    30 Rockefeller Plaza, 26th Floor
    New York, NY 10112
    Attn: Rick Werner, Esq.
    Email:  rick.werner@haynesboone.com
     
    Shuffield Lowman
    545 West Main Street
    Tavares, FL 32778
    Attn: Jason A. Davis
    Email: jdavis@shuffieldlowman.com

 

or to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered, if personally delivered or sent by email on a business day (or if delivered or sent on a non-business day, then on the next business day); (b) on the business day after dispatch, if sent by nationally-recognized express courier; or (c) on the third (3rd) business day following the date of mailing, if sent by mail.

 

11.9 Interpretation. The headings of clauses contained in this Agreement preceding the text of the sections, subsections and paragraphs hereof are inserted solely for convenience and shall not constitute any part of this Agreement, nor have any effect on its interpretation or construction. All references in this Agreement to the singular shall include the plural where applicable. The term “including” or “includes” as used in this Agreement means including, without limiting the generality of any description preceding such term, and the word “or” has the inclusive meaning represented by the phrase “and/or.” Unless otherwise specified, references in this Agreement to any section shall include all subsections and/or paragraphs in such section and/or subsection. Ambiguities and uncertainties in this Agreement, if any, shall not be interpreted against either Party.

 

11.10 Relationship between the Parties. The Parties’ relationship, as established by this Agreement, is solely that of independent contractors. This Agreement does not create any partnership, joint venture or similar business relationship between the Parties. Neither Party is a legal representative of the other Party, and neither Party may assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever.

 

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11.11 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

 

11.12 No Third-Party Rights. The provisions of this Agreement are for the exclusive benefit of the Parties, and no other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party.

 

11.13 Further Assurances. Each Party agrees to do and perform all such further acts and things and execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party deems advisable to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.

 

11.14 Compliance with Securities Laws. Diverse hereby acknowledges that it is aware of, and required to comply with, and Diverse shall advise its Affiliates’, employees, agents, consultants and other representatives as needed, U.S. securities laws that place certain restrictions on any person who has material, non-public information concerning an issuer, with respect to purchasing or selling securities of such issuer or from communicating such information to any other person.

 

11.15 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original document, and all of which, together with this writing, shall be deemed one instrument. This Agreement may be executed by facsimile or PDF signatures, which signatures shall have the same force and effect as original signatures.

 

IN WITNESS WHEREOF, the parties hereto have duly executed this Exclusive License Agreement as of the Effective Date.

 

DIVERGENT BIOTECH, INC. (LICENSOR)   ENVERIC BIOSCIENCES, INC. (LICENSEE)
     
     
By   By

Brian Longstreet

Title: Interim CEO

 

David Johnson

Title: CEO

 

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EXHIBIT A - Diverse Patent Rights

 

Patent No.   International Filing Date   Title/ Description

PCT/US2020/039234

(WO/2020/263888)

  JUNE 24, 2020   CANNABINOID CONJUGATE MOLECULES
         
PCT/US2020/039267   JUNE 24, 2020   CONJUGATE MOLECULES

 

Exhibit A

 

 

 

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO SARBANES–OXLEY ACT OF 2002

 

I, David Johnson, certify that:

 

1. I have reviewed this annual report on Form 10–Q of Enveric Biosciences, 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.

 

May 17, 2021 By: /s/ David Johnson
    David Johnson
    President and Chief Executive Officer
    (Principal Executive Officer)

 

 

 

 

Exhibit 31.2

 

CERTIFICATION PURSUANT TO SARBANES–OXLEY ACT OF 2002

 

I, Carter Ward, certify that:

 

1. I have reviewed this annual report on Form 10–Q of Enveric Biosciences, 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.

 

May 17, 2021 By: /s/ Carter Ward
   

Carter Ward

    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

 

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO SECTION 906

OF THE SARBANES–OXLEY ACT OF 2002

 

In connection with the Annual Report of Enveric Biosciences, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, in the capacities and on the dates indicated below, hereby certifies 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.

 

May 17, 2021 By: /s/ David Johnson
    David Johnson
   

President and Chief Executive Officer

(Principal Executive Officer)

 

May 17, 2021 By: /s/ Carter Ward
    Carter Ward
    Chief Financial Officer
    (Principal Financial and Accounting Officer)