U.S. 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 September 30, 2019

 

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

 

For the transition period from _______ to _______

 

Commission File No. 000-55167

 

PetVivo Holdings Inc.

(Name of small business issuer in its charter)

 

Nevada   99-0363559

(State or other jurisdiction of

incorporation or organization)

  (I.R.S. Employer
Identification No.)

 

5251 Edina Industrial Blvd.

Edina, Minnesota 55439

(Address of principal executive offices)

 

(952) 405-6216

(Issuer’s telephone number)

 

Securities registered pursuant to Section 12(b) of the Act:   Name of each exchange on which registered:
None    

 

Securities registered pursuant to Section 12(g) of the Act:

 

Common Stock, $0.001

(Title of Class)

 

Indicate by checkmark whether the issuer: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files. Yes [X] No [  ]

 

Indicate by check mark whether the registrant is a large accelerated filed, an accelerated filer, a non-accelerated filer, or a smaller reporting company.

 

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

 

Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X]

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the most practicable date:

 

Class   Outstanding as of September 30, 2019
Common Stock, $0.001   24,034,518

 

 

 

     
 

 

PETVIVO HOLDINGS, INC.

FORM 10-Q

FOR THE PERIOD ENDED September 30, 2019

 

INDEX

 

    Page
     
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS   3
       
PART I. FINANCIAL INFORMATION   4
       
Item 1. Financial Statements   4
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   19
Item 3. Qualitative and Quantitative Disclosures About Market Risk   24
Item 4. Controls and Procedures   24
     
PART II. OTHER INFORMATION   26
     
Item 1. Legal Proceedings   26
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   26
Item 3. Defaults Upon Senior Securities   26
Item 4. Mine Safety Disclosure   26
Item 5. Other information   26
Item 6. Exhibits   27
       
SIGNATURES   28

 

  2  
 

 

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995

 

Information included in this Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). This information may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of PetVivo Holdings Inc. (the “Company”), to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements. Forward-looking statements, which involve assumptions and describe future plans, strategies and expectations of the Company, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. These forward-looking statements are based on assumptions that may be incorrect, and there can be no assurance that these projections included in these forward-looking statements will come to pass. Actual results of the Company could differ materially from those expressed or implied by the forward-looking statements as a result of various factors. Except as required by applicable laws, the Company has no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.

 

  3  
 

 

PART I.

 

ITEM 1. FINANCIAL STATEMENTS

 

PETVIVO HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

   

September 30, 2019

(Unaudited)

    March 31, 2019  
             
Assets:                
Current Assets                
Cash and cash equivalents   $ 20,236     $ 6,460  
Inventory     12,495       12,495  
Employee advance     -       2,500  
Investments - equity securities receivable     1,500       -  
Prepaid expenses     143,606       34,327  
Total Current Assets     177,837       55,782  
                 
Property and Equipment:                
Property and equipment     148,798       149,802  
Less: accumulated depreciation     (121,872 )     (112,453 )
Total Property and Equipment     26,926       37,349  
                 
Other Assets:                
Trademark and patents-net     340,097       589,817  
Operating lease right-of-use asset     95,063       -  
Security deposit     8,201       8,201  
Total Other Assets     443,361       598,018  
Total Assets   $ 648,124     $ 691,149  
                 
Liabilities and Stockholders’ Equity (Deficit)                
                 
Current Liabilities                
Accounts payable and accrued expenses   $ 739,329     $ 854,990  
Accrued expenses - related party     264,737       576,393  
Operating lease liability     24,655       -  
Notes payable and accrued interest     -       18,831  
Notes payable and accrued interest - related party     68,090       85,752  
Total Current Liabilities     1,096,811       1,535,966  
                 
Other Liabilities:                
Convertible notes payable     280,000       -  
Operating lease liability     70,408       -  
Total Other Liabilities     350,408       -  
Total Liabilities   $ 1,447,219     $ 1,535,966  
                 
Commitments and Contingencies (Note 4)                
                 
Stockholders’ Equity (Deficit):                
Preferred stock, par value $0.001, 20,000,000 shares authorized 0 and 0 shares outstanding at September 30, 2019 and March 31, 2019, respectively                
Common stock, par value $0.001, 250,000,000 shares authorized 24,034,518 and 22,074,667 shares outstanding at September 30, 2019 and March 31, 2019, respectively     24,034       22,074  
Common stock to be issued     102,000       86,333  
Additional Paid-In Capital     52,600,843       51,552,688  
Accumulated Deficit     (53,525,972 )     (52,505,912 )
Total Stockholders’ Deficit     (799,095 )     (844,817 )
Total Liabilities and Stockholders’ Deficit   $ 648,124     $ 691,149  

 

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

 

  4  
 

 

PETVIVO HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

   

Three Months Ended

September 30,

   

Six Months Ended

September 30,

 
    2019     2018     2019     2018  
Revenues   $ -     $ -     $ -     $ -  
Cost of Sales - Inventory Write-Down     3,845               3,845          
Total Cost of Sales     3,845       -       3,845       -  
                                 
Gross Profit     (3,845 )     -       (3,845 )     -  
                                 
Operating Expenses:                                
                                 
Sales and Marketing     5,182       26,832       7,978       26,832  
Research and Development     7,132       77,873       7,132       77,873  
                                 
General and Administrative:                                
Depreciation and Amortization     141,040       161,622       285,130       322,741  
Other General and Administrative     272,415       461,265       619,250       2,397,234  
Total General and Administration     413,455       622,887       904,380       2,719,975  
                                 
Total Operating Expenses     425,769       727,592       919,490       2,824,680  
                                 
Operating Loss   $ (429,614 )   $ (727,592 )   $ (923,335 )   $ (2,824,680 )
                                 
Other Income (Expense)                                
Gain on Sale of Asset     -       -       450       -  
Loss on Debt Extinguishment     (81,738 )     -       (81,738 )     -  
Interest Expense     (7,821 )     (13,289 )     (15,437 )     (15,786 )
Total Other Expense     (89,559 )     (13,289 )     (96,725 )     (15,786 )
                                 
Net Loss before taxes   $ (519,173 )   $ (740,881 )   $ (1,020,060 )   $ (2,840,466 )
                                 
Income Tax Provision     -       -       -       -  
                                 
Net Loss     (519,173 )     (740,881 )     (1,020,060 )     (2,840,466 )
                                 
Net Loss Per Share:                                
Basic and Diluted   $ (0.02 )   $ (0.04 )   $ (0.05 )   $ (0.14 )
                                 
Weighted Average Common Shares Outstanding:                                
Basic and Diluted     22,229,867       20,321,529       22,187,882       19,855,091  

 

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

 

  5  
 

 

PETVIVO HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

 

Six Months Ended September 30, 2019

 

    Common Stock     Additional Paid-in     Accumulated    

Common

Stock to

       
    Shares     Amount     Capital     Deficit     be Issued     Total  
Balance at March 31, 2019     22,074,667     $ 22,074     $ 51,552,688     $ (52,505,912 )   $ 86,333     $ (844,817 )
Stock-based compensation     -       -       157,134       -       33,667       190,801  
Net loss     -       -       -       (500,887 )     -       (500,887 )
Balance at June 30, 2019     22,074,667     $ 22,074     $ 51,709,822     $ (53,006,799 )   $ 120,000     $ (1,154,903 )
Common stock issued     120,000       120       119,880       -       (120,000 )     -  
Common stock sold     400,000       400       99,600       -       -       100,000  
Stock-based compensation     -       -       135,278       -       102,000       237,278  
Stock granted for debt conversion     1,439,851       1,440       536,263       -       -       537,703  
Net loss     -       -       -       (519,173 )     -       (519,173 )
Balance at September 30, 2019     24,034,518     $ 24,034     $ 52,600,843     $ (53,525,972 )   $ 102,000     $ (799,095 )

 

Six Months Ended September 30, 2018

 

    Common Stock    

Additional

Paid-in

    Accumulated    

Common

Stock to

       
    Shares     Amount     Capital     Deficit     be Issued     Total  
Balance at March 31, 2018     18,279,075     $ 18,279     $ 47,257,557     $ (47,748,154 )   $ 608,966     $ 136,648  
Common stock issued     1,005,287       1,005       607,961       -       (608,966 )     -  
Stock-based compensation     -       -       279,312       -       -       279,312  
Stock granted for debt conversion     95,462       95       95,366       -       -       95,461  
Common stock issued to replace shares to officer     803,385       804       1,445,290       -       -       1,446,094  
Net loss     -       -       -       (2,099,585 )     -       (2,099,585 )
Balance at June 30, 2018     20,183,209     $ 20,183     $ 49,685,486     $ (49,847,739 )   $ -     $ (142,070 )
Common stock sold     307,786       308       153,585       -       -       153,893  
Stock-based compensation     27,093       27       293,332       -       26,333       319,692  
Stock granted for debt conversion     -       -       19,092       -       -       19,092  
Net loss     -       -       -       (740,881 )     -       (740,881 )
Balance at September 30, 2018     20,518,088     $ 20,518     $ 50,151,495     $ (50,588,620 )   $ 26,333     $ (390,274 )

 

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

 

  6  
 

 

PETVIVO HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

   

For the Six Months Ended

September 30,

 
    2019     2018  
CASH FLOWS FROM OPERATING ACTIVITIES:                
                 
Net Loss For The Period   $ (1,020,060 )   $ (2,840,466 )
Adjustments to Reconcile Net Loss to Net Cash Used in                
Operating Activities:                
Stock-based compensation     326,078       599,003  
Common stock issued to replace shares to officer     -       1,446,094  
Beneficial conversion feature     -       19,092  
Loss on debt extinguishment     81,738       -  
Depreciation and Amortization     285,130       322,741  
Changes in Operating Assets and Liabilities                
Increase in inventory     -       (32,221 )
Increase in prepaid expenses and employee advances     (4,779 )     (28,664 )
Decrease in receivables     -       163  
Interest accrued on convertible notes payable     11,479       -  
Interest accrued on notes payable – related party     3,039       -  
Interest accrued on notes payable     725       -  
Decrease in accounts payable and accrued expense     (37,807 )     53,980  
Increase in accrued expenses - related party     66,455       23,985  
Net Cash Used in Operating Activities     (288,002 )     (436,292 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES                
Decrease in security deposit     -       1,999  
Increase in investments - equity securities receivable     (1,500 )     -  
Purchase of equipment     -       (23,181 )
Increase in patents and trademarks     (24,987 )     (60,998 )
Net Cash Used in Investing Activities     (26,487 )     (82,180 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from stock sale     100,000       153,893  
Proceeds from convertible notes     280,000       -  
Proceeds from bridge notes, net of debt discount     -       133,186  
Proceeds from bridge notes – related party, net of debt discount     -       37,732  
Repayments of convertible notes     (11,479 )     -  
Repayments of notes payable     (19,556 )     -  
Repayments of notes payable – related party     (20,700 )     -  
Net Cash Provided by Financing Activities     328,265       324,811  
                 
Net Increase (Decrease) in Cash     13,776       (193,661 )
Cash at Beginning of Period     6,460       237,335  
Cash at End of Period   $ 20,236     $ 43,674  
                 
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:                
Cash Paid During the Period for:                
Interest   $ 15,437     $ 7,167  
Stock granted for debt conversion     455,965       114,553  

 

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

 

  7  
 

 

PetVivo Holdings, Inc.

Notes to Financial Statements

September 30, 2019

(Unaudited)

 

NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ORGANIZATION

 

(A) Organization and Description

 

The Company is in the business of licensing and commercializing our proprietary medical devices and biomaterials for the treatment of afflictions and diseases in animals, initially for dogs and horses. The Company’s operations are conducted from its headquarter facilities in suburban Minneapolis, Minnesota.

 

(B) Basis of Presentation

 

PetVivo Holdings, Inc. (the “Company”) was incorporated in Nevada under a former name in 2009 and entered its current business in 2014 through a stock exchange reverse merger with PetVivo, Inc., a Minnesota corporation. This merger resulted in Minnesota PetVivo becoming a wholly-owned subsidiary of the Company.

 

In April 2017, the Company acquired another Minnesota corporation, Gel-Del Technologies, Inc., through a statutory merger, which is also a wholly-owned subsidiary of the Company.

 

The accompanying condensed consolidated financial statements are unaudited. These unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and pursuant to the rules and regulations of the SEC. Certain information and note disclosures, which are included in annual financial statements, have been omitted pursuant to these rules and regulations. We believe the disclosures made in these interim unaudited financial statements are adequate to make the information not misleading.

 

Although these interim financial statements at September 30, 2019 and for the three and six months ended September 30, 2019 and 2018 are unaudited, in the opinion of our management, such statements include all adjustments (consisting of normal recurring entries) necessary to present fairly our financial position, results of operations and cash flows for the periods presented. The results for the three and six months ended September 30, 2019 are not necessarily indicative of the results to be expected for the year ended March 31, 2020 or for any future period.

 

These unaudited interim financial statements should be read and considered in conjunction with our audited financial statements and the notes thereto for the year ended March 31, 2019, included in our annual report on Form 10-K filed with the SEC.

 

(C) Principles of Consolidation

 

The accompanying consolidated financial statements include the accounts of the Company and its two wholly-owned Minnesota corporations. All intercompany accounts have been eliminated upon consolidation.

 

(D) Use of Estimates

 

In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates. Significant estimates include estimated useful lives and potential impairment of property and equipment, estimate of fair value of share-based payments and derivative instruments and recorded debt discount, valuation of deferred tax assets and valuation of in-kind contribution of services and interest.

 

  8  
 

 

(E) Cash and Cash Equivalents

 

The Company considers all highly-liquid, temporary cash investments with an original maturity of three months or less to be cash equivalents. At September 30, 2019, the Company had $20,236 in cash and no cash equivalents. At March 31, 2019, the Company had $6,460 in cash and no cash equivalents.

 

(F) Concentration-Risk

 

The Company maintains its cash with various financial institutions, which at times may exceed limits insured by the Federal Deposit Insurance Corporation (FDIC). At September 30, 2019, cash did not exceed the FDIC uninsured balances and management believes the Company is not exposed to any significant credit risk on cash.

 

(G) Property & Equipment

 

Property and equipment are recorded at cost less accumulated depreciation. Expenditures for major additions and betterments are capitalized. Maintenance and repairs are charged to operations as incurred. Depreciation is computed by the straight-line method (after taking into account their respective estimated residual values) over the asset’s estimated useful life of (3) years for equipment, (5) years for automobile, and (7) years for furniture and fixtures.

 

(H) Patents and Trademarks

 

The Company capitalizes direct costs for the maintenance and advancement of their patents and trademarks and amortizes these costs over the lesser of a useful life of 60 months or the life of the patent. We evaluate the recoverability of intangible assets periodically by taking into account events or circumstances that may warrant revised estimates of useful lives or that indicate the asset may be impaired.

 

(I) Loss Per Share

 

Basic loss per share is computed by dividing net loss by weighted average number of shares of common stock outstanding during each period. Diluted loss per share is computed by dividing net loss by the weighted average number of shares of common stock, common stock equivalents and potentially dilutive securities outstanding during the period.

 

The Company has 4,183,236 warrants outstanding as of September 30, 2019 with varying exercise prices ranging from $3.50 to $.30/share. The weighted average exercise price for these warrants is $.49/share. These warrants are excluded from the weighted average number of shares because they are considered antidilutive.

 

The Company had 4,243,236 warrants outstanding as of March 31, 2019 with varying exercise prices ranging from $3.50 to $.33/share. The weighted average exercise price for these warrants was $.50/share. These warrants are excluded from the weighted average number of shares because they are considered antidilutive.

 

The Company uses the guidance in ASC 260 to determine if-converted loss per share detailed in Note 14. ASC 260 states that convertible securities should be considered exercised at the later date of the first day of the reporting period’s quarter or the inception date of the debt instrument. Also, the if-converted method shall not be applied for the purposes of computing diluted EPS if the effect would be antidilutive.

 

At September 30, 2019, the Company had $280,000 in convertible notes outstanding that mature in our fiscal quarter ended June 30, 2021; see Note 8 to these financial statements for more information on these convertible notes. If converted, the $280,000 in outstanding convertible notes would convert into 430,770 shares of common stock at a rate of $.65 per share. At September 30, 2019 our if-converted weighted average number of shares outstanding was 22,426,915 and our if-converted loss per share for the six months ending September 30, 2019 remains consistent with our actual loss per share at ($.04).

 

  9  
 

 

(J) Revenue Recognition

 

The Company will recognize revenue on arrangements in accordance with FASB ASC No. 606, “Revenue From Contracts With Customers”. Revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration we expect to receive in exchange for those products or services. The Company adopted the guidance on April 1, 2018 using the cumulative catch-up transition method. This change in accounting did not have any material effect on the Company’s financial statements.

 

(K) Research and Development

 

The Company expenses research and development costs as incurred.

 

(L) Fair Value of Financial Instruments

 

The Company applies the accounting guidance under FASB ASC 820-10, “Fair Value Measurements”, as well as certain related FASB staff positions. This guidance defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact business and considers assumptions that marketplace participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance.

 

The guidance also establishes a fair value hierarchy for measurements of fair value as follows:

 

  Level 1 - quoted market prices in active markets for identical assets or liabilities.
     
  Level 2 - inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
     
  Level 3 - unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

The Company’s financial instruments consist of investments – equity securities receivable, notes payable and accrued interest, notes payable and accrued interest - related party, and convertible notes payable. The carrying amount of the Company’s financial instruments approximates their fair value as of September 30, 2019 and March 31, 2019, due to the short-term nature of these instruments and the Company’s borrowing rate of interest.

 

In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability. The valuation of the Company’s notes recorded at fair value is determined using Level 3 inputs, which consider (i) time value, (ii) current market and (iii) contractual prices.

 

The Company measured its investments – equity securities receivable at fair value at September 30, 2019, see Note 5 to the financial statements included in this Form 10-Q.

 

The Company had no assets and liabilities measured at fair value on a recurring basis at September 30, 2019.

 

  10  
 

 

(M) Stock-Based Compensation - Non-Employees

 

Equity Instruments Issued to Parties Other Than Employees for Acquiring Goods or Services

 

The Company accounts for equity instruments issued to parties other than employees for acquiring goods or services under guidance of Sub-topic 505-50 of the FASB Accounting Standards Codification (“Sub-topic 505-50”).

 

Pursuant to ASC Section 505-50-30, all transactions in which goods or services are the consideration received for the issuance of equity instruments are accounted for based on the fair value of the consideration received or the fair value of the equity instrument issued, whichever is more reliably measurable. The measurement date used to determine the fair value of the equity instrument issued is the earlier of the date on which the performance is complete or the date on which it is probable that performance will occur. If the Company is a newly formed corporation or shares of the Company are thinly traded the use of share prices established in the Company’s most recent private placement memorandum (“PPM”), or weekly or monthly price observations would generally be more appropriate than the use of daily price observations as such shares could be artificially inflated due to a larger spread between the bid and asked quotes and lack of consistent trading in the market.

 

The fair value of share options and similar instruments is estimated on the date of grant using a Black-Scholes option-pricing valuation model. The ranges of assumptions for inputs are as follows:

 

  Expected term of share options and similar instruments: Pursuant to Paragraph 718-10-50-2(f)(2)(i) of the FASB Accounting Standards Codification the expected term of share options and similar instruments represents the period of time the options and similar instruments are expected to be outstanding taking into consideration of the contractual term of the instruments and holder’s expected exercise behavior into the fair value (or calculated value) of the instruments. The Company uses historical data to estimate holder’s expected exercise behavior. If the Company is a newly formed corporation or shares of the Company are thinly traded the contractual term of the share options and similar instruments is used as the expected term of share options and similar instruments as the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term.
     
  Expected volatility of the entity’s shares and the method used to estimate it. Pursuant to ASC Paragraph 718-10-50-2(f)(2)(ii) a thinly-traded or nonpublic entity that uses the calculated value method shall disclose the reasons why it is not practicable for the Company to estimate the expected volatility of its share price, the appropriate industry sector index that it has selected, the reasons for selecting that particular index, and how it has calculated historical volatility using that index. If shares of a company are thinly traded the use of weekly or monthly price observations would generally be more appropriate than the use of daily price observations as the volatility calculation using daily observations for such shares could be artificially inflated due to a larger spread between the bid and asked quotes and lack of consistent trading in the market.
     
  Expected annual rate of quarterly dividends. An entity that uses a method that employs different dividend rates during the contractual term shall disclose the range of expected dividends used and the weighted-average expected dividends. The expected dividend yield is based on the Company’s current dividend yield as the best estimate of projected dividend yield for periods within the expected term of the share options and similar instruments.
     
  Risk-free rate(s). An entity that uses a method that employs different risk-free rates shall disclose the range of risk-free rates used. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods within the expected term of the share options and similar instruments.

 

Pursuant to Paragraphs 505-50-25-8 and 505-50-25-9, an entity may grant fully vested, non-forfeitable equity instruments that are exercisable by the grantee only after a specified period of time if the terms of the agreement provide for earlier exercisability if the grantee achieves specified performance conditions. Any measured cost of the transaction shall be recognized in the same period(s) and in the same manner as if the entity had paid cash for the goods or services or used cash rebates as a sales discount instead of paying with, or using, the equity instruments. A recognized asset, expense, or sales discount shall not be reversed if a share option and similar instrument that the counterparty has the right to exercise expires unexercised.

 

(N) Income Taxes

 

The Company accounts for income taxes under Accounting Standards Codification (ASC) Topic 740. Deferred tax assets and liabilities are determined based upon differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.

 

  11  
 

 

The Company accounts for income taxes under Accounting Standards Codification (ASC) Topic 740.

 

As required by ASC Topic 740, the Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company applied ASC Topic 740 to all tax positions for which the statute of limitations remained open. As a result of the implementation of ASC Topic 740, the Company did not recognize any change in the liability for unrecognized tax benefits.

 

The Company is not currently under examination by any federal or state jurisdiction.

 

The Company’s policy is to record tax-related interest and penalties as a component of operating expenses.

 

(O) Inventory

 

Inventories are recorded in accordance with ASC 330 and are stated at the lower of cost and net realizable value. We account for inventories using the first in first out (FIFO) methodology and capitalize costs on a project basis as they occur. The current marketed shelf life of our Kush inventory is 2 years. However, management reserves the right to review and adjust this as appropriate.

 

(P) Recently Issued and Adopted Accounting Pronouncements

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Topic 842 affects any entity that enters into a lease, with some specified scope exemptions. The guidance in this ASU supersedes Topic 840, Leases. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use (“ROU”) asset representing its right to use the underlying asset for the lease term. For public companies, the amendments in this ASU are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted ASU 2016-02 on April 1, 2019.

 

In January 2016, the FASB issued ASU No. 2016-01 Financial Instruments (Subtopic 825) to enhance the reporting model for financial instruments to provide users of financial statements with more decision-useful information. The amendments in this Update affect all entities that hold financial assets or owe financial liabilities. The amendments are meant to improve financial reporting by providing relevant information about an entity’s equity investments and reducing the number of items that are recognized in other comprehensive income since this Update requires equity securities to be measured at fair value with changes in the fair value recognized through net income. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company adopted ASU 2016-01 on April 1, 2018.

 

In August 2016, the FASB issued ASU No. 2016-15 Statement of Cashflows (Topic 230) to reduce diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The amendments in this Update apply to all entities, including both business entities and not-for-profit entities that are required to present a statement of cash flows under Topic 230. This Update addresses eight specific cash flow issues and their presentations in the statement of cash flows. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company adopted ASU 2016-15 on April 1, 2018.

 

All other newly issued accounting pronouncements but not yet effective have been deemed either immaterial or not applicable.

 

NOTE 2 - GOING CONCERN

 

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of the Company as a going concern.

 

The Company incurred a net loss of $1,020,060 during the six-month period ended September 30, 2019 and had net cash used in operating activities of $288,002 for the six-month period ending September 30, 2019. Additionally, the Company has an accumulated deficit of $53,525,972, stockholders’ deficit of $799,095, and working capital deficit of $918,974 at September 30, 2019. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months after the date of issuance on these financial statements. In view of these matters, the Company’s ability to continue as a going concern is dependent upon the Company’s ability to achieve a level of profitability and/or to obtain adequate financing through the issuance of debt or equity in order to finance its operations.

 

Management intends to raise additional funds either through a private placement or public offering of its equity securities. Management believes that the actions presently being taken to further implement its business plan will enable the Company to continue as a going concern. While the Company believes in its viability to raise additional funds, there can be no assurances to that effect. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to further implement its business plan and raise additional funds.

 

These financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

NOTE 3 – INVENTORY

 

As of March 31, 2019 and September 30, 2019, respectively, the Company had approximately $78,000 and $62,000 of finished goods inventory; however, reserves of equal amounts for each respective period were taken because of the substantial doubt in the Company’s ability to utilize this inventory to obtain material sales, primarily due to (among other things) the fact the Company has not obtained controlled study data detailing the successful use of Kush in animals.

 

As of March 31, 2019, all of the Company’s finished goods inventory was in quarantine due to a contamination issue. During the three months ended September 30, 2019, the Company cleared $16,636 in inventory for release to the public and is utilizing the product to gather data and establish strategic partner relationships. Of the $16,636, $9,791 is the value of the product before quarantined that remains reserved for and $3,845 is the expense incurred to clear this product for use during the three-month period ended September 30, 2019, which has been written down through Cost of Goods Sold. The Company plans to continue to clear the remainder of our inventory during the fiscal year ended March 31, 2020 and capitalize and take a reserve for certain expenses incurred, which are estimated to be approximately $9,000.

 

  12  
 

 

Total Inventory is broken out as follows:

 

    September 30, 2019     March 31, 2019  
Finished Goods   $ 62,168     $ 77,936  
Reserve for Obsolete Inventory     (62,168 )     (77,936 )
Work in Process     -0-       -0-  
Manufacturing Supplies     3,127       3,127  
Raw Materials     9,368       9,368  
Total Inventory   $ 12,495     $ 12,495  

 

NOTE 4 – LEASE AND COMMITMENTS

 

Rent expense for the three and six months ended September 30, 2019 was $13,434 and $24,245, respectively. Rent expense for the three and six months ended September 30, 2018 was $25,807 and $40,414, respectively.

 

On July 2nd, 2018 the Company gave its manufacturing contractor in Rochester, MN a 90-day notice to cancel the lease and agreement, which it had the right to do so, under which the Company was renting manufacturing and office space; while the Company has yet to recognize any expense directly related to this lease termination through the date of this filing besides approximately $2,000 in moving and labor costs. Subsequently, the Company entered into an one-year agreement on July 13, 2018 with a 60-day notice of termination clause for 1,000 square feet of manufacturing and office space in White Bear Lake, MN.

 

The Company entered into an eighty-four-month lease for 3,577 square feet of newly constructed office, laboratory and warehouse space located in Edina, Minnesota on May 3, 2017. The base rent is $2,078 per month and the Company is responsible for its proportional share of common space expenses, property taxes, and building insurance. This lease is terminable by the landlord if damage causes the property to no longer be utilized as an integrated whole and by the Company if damage causes the facility to be unusable for a period of 45 days.

 

The following is a maturity analysis of the annual undiscounted cash flows of the operating lease liabilities as of September 30, 2019:

 

Year Ended March 31,      
2020   $ 12,468  
2021     24,936  
2022     24,936  
2023     24,936  
2024     10,390  
    $ 97,666  

 

In compliance with ASC 842 the Company adopted new guidance in relation to lease accounting on April 1, 2019 whereby we recognized operating lease right-to-use assets and corresponding and equal operating lease liabilities. As of September 30, 2019, planned future base rent lease payments total $97,666, which has been discounted to $95,063 using the 52-week treasury bill coupon equivalent discount rate of 2.18% and a present value model. As of September 30, 2019, the Company only had one operating lease so that the weighted average remaining lease term and weighted average discount rate are approximately 4 years and 2.18%, respectively.

 

    September 30, 2019  
Present value of future base rent lease payments   $ 95,063  
Base rent payments included in prepaid expenses     -  
Present value of future base rent lease payments – net   $ 95,063  

 

  13  
 

 

As of September 30, 2019, the present value of future base rent lease payments – net is classified between current and non-current assets and liabilities as follows:

 

    September 30, 2019  
Operating lease right-of-use asset   $ 95,063  
Total operating lease assets     95,063  
         
Operating lease current liability     24,655  
Operating lease other liability     70,408  
Total operating lease liabilities   $ 95,063  

 

Pursuant to a lease wherein our subsidiary, Gel-Del Technologies, Inc., was the lessee until the lease’s termination in 2017, the Company owes approximately $330,000 to the lessor as of September 30, 2019; this amount is included in accounts payable.

 

NOTE 5 – INVESTMENTS – EQUITY SECURITIES

 

On June 28, 2019, the Company entered into a purchase agreement with a third-party to purchase 1,500,000 shares of Emerald Organic Products, Inc. (OTC Pink: “EMOR”) common stock for consideration of $1,500. The Company applied guidance from ASU No. 2016-01 Financial Instruments – Overall – Recognition and Measurement of Financial Assets and Financial Liabilities and ASC 820 to arrive at a fair value at September 30, 2019, of $1,500. The Company took into account many factors when determining the stock’s fair value including, but not limited to, the nature and duration of the restriction on the stock, the extent to which potential buyers would be limited by the restriction, and qualitative and quantitative factors specific to both the instrument and the issuer.

 

NOTE 6 – PROPERTY AND EQUIPMENT

 

The components of property and equipment were as follows:

 

    September 30, 2019     March 31, 2019  
Leasehold improvements   $ 4,602     $ 4,602  
Furniture and office equipment     10,130       10,130  
Production equipment     108,882       108,882  
R&D equipment     25,184       26,188  
Total, at cost     148,798       149,802  
Accumulated depreciation     (121,872 )     (112,453 )
Total, net   $ 26,926     $ 37,349  

 

During the three and six months ended September 30, 2019, depreciation expense was $3,442 and $10,423, respectively. During the three and six months ended September 30, 2018, depreciation expense was $2,174 and $3,826, respectively.

 

During the three months ended June 30, 2019, we recorded a gain on sale of asset in the amount of $450 wherein we sold an asset that was fully depreciated and originally purchased for $1,004 for $450.

 

NOTE 7 – INTANGIBLE ASSETS

 

The components of intangible assets, all of which are finite-lived, were as follows:

 

    September 30, 2019     March 31, 2019  
Patents   $ 3,844,092     $ 3,820,374  
Trademarks     24,098       22,829  
Total, at cost     3,868,190       3,843,203  
Accumulated Amortization     (3,528,093 )     (3,253,386 )
Total, net   $ 340,097     $ 589,817  

 

During the three and six-month periods ended September 30, 2019, amortization expense was $137,598 and $274,707, respectively. During the three and six-month periods ended September 30, 2018, amortization expense was $159,448 and $318,915, respectively.

 

  14  
 

 

NOTE 8 – CONVERTIBLE NOTES

 

At September 30, 2019, the Company is obligated for several convertible notes payable in the total amount of $280,000. The Company entered into these convertible notes during the quarter ended June 30, 2019. All of these convertible notes mature during the quarter ended June 30, 2021, two years from their inception dates. These convertible notes accrue interest at a rate of 10%. Accrued interest is due and payable each calendar quarter in cash; during the three and six months ended September 30, 2019, the Company paid out $6,118 and $11,479, respectively, in accrued interest to these convertible note holders. These convertible notes automatically convert into shares of common stock at a rate of $.65 per share at the earlier of the maturity date or an uplift to a national securities exchange (e.g. NASDAQ or New York Stock Exchange) provided that the Company’s stock price is at least $.78 at the time of the uplift. The convertible note holders have the right to convert their outstanding principal and interest into shares of the Company’s common stock at any time during their note’s term at $.65 per share. No note holders have converted their notes through the date of this 10-Q filing. As of September 30, 2019, these convertible notes did not include a beneficial conversion feature.

 

NOTE 9 – NOTES PAYABLE – RELATED PARTY

 

At September 30, 2019 and March 31, 2019 the Company was obligated for a related party note payable and accrued interest in the total amount of $68,090 and $85,752, respectively; the maturity date of this note is April 30, 2020. The related party note payable terms are accrual of interest at 8% annually with payments of $3,100 per month, which are applied to interest first, then principal. The terms also include a stipulation that if the Company receives additional financing during any 24-month period from the date of the note in the amount greater than $3,500,000, the Company will immediately pay the officer the principal amount of the note along with all interest due.

 

  15  
 

 

NOTE 10 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

At September 30, 2019 and March 31, 2019, the Company is obligated to pay $739,329 and $854,990, respectively, in accounts payable and accrued expenses. Of the total at September 30, 2019 of $739,329, $499,660 is made up of accounts payable, while the $239,669 in accrued expenses is made up of past employee’s accrued salaries and related payroll taxes payable. Of the total at March 31, 2019 of $854,990, $524,273 is made up of accounts payable, while the $330,717 in accrued expenses is made up of past employee’s accrued salaries and related payroll taxes payable. The Company has not paid the payroll taxes relating to the accrued salaries, consisting primarily of Social Security and Medicare taxes. At September 30, 2019 and March 31, 2019, respectively, we had accrued $22,464 and $21,482 in payroll taxes payable.

 

NOTE 11 – ACCRUED EXPENSES – RELATED PARTY

 

At September 30, 2019, the Company is obligated to pay $264,737 in accrued expenses due to related parties. Of the total, $18,569 is made up of payroll taxes payable.

 

At March 31, 2019, the Company was obligated to pay $576,393 in accrued expenses due to related parties. Of the total, $89,186 is made up of accounts payable, while $487,207 is made up of accrued salaries and payroll taxes payable.

 

NOTE 12 - COMMON STOCK AND WARRANTS

 

Common Stock

 

During the six months ended September 30, 2019, the Company issued 1,959,851 shares of common stock as follows:

 

i) 386,666 shares to John Lai pursuant to a Settlement Agreement whereby Mr. Lai agreed to release the Company of all claims through the date of the agreement, September 11, 2019, including accrued compensation he had earned in the amount of $116,000 and hold the shares for a period of at least 3 years;

ii) 639,786 shares to Randall Meyer pursuant to a Settlement Agreement whereby Mr. Meyer agreed to release the Company of all claims through the date of the agreement, September 11, 2019, including accrued compensation he had earned in the amount of $191,936 and hold the shares for a period of at least 3 years;

iii) 226,666 shares to John Dolan pursuant to a Settlement Agreement whereby Mr. Dolan agreed to release the Company of all claims through the date of the agreement, September 11, 2019, including accrued compensation he had earned in the amount of $68,000 and hold the shares for a period of at least 3 years; and

iv) 186,733 shares to a former employee pursuant to a Settlement Agreement dated August 29, 2019, whereby this individual agreed to release the Company of all claims, including compensation earned in the amount of $80,029; and

v) 120,000 shares to a service provider for services provided during the one-year period ended July 13, 2019 and valued at $1/share over that period on a pro-rata basis; and

vi) 400,000 shares to one shareholder that the Company sold in exchange for $100,000, which equates to a price per share of $.25/share.

 

John Lai (CEO, President & Director), Randall Meyer (Director), and John Dolan (Secretary & Director) are all related parties, and the reduction of $375,936 was included in Accrued Expenses – Related Party. The settlement of $80,029 for a former employee’s accrued salary was accounted for as a reduction of Accounts Payable and Accrued Expenses. A loss on extinguishment of debt was recorded in the amount of $81,738 related to these transactions.

 

Also, on September 18, 2019, the Company entered into a certain consulting agreement whereby a service provider agreed to provide 12 months of video production, investor relations, and promotional services in exchange for 300,000 shares of common stock that are not issued as of the balance sheet date. The scope of services includes but is not limited to airing 96 commercials nationally on a prominent world-wide T.V. network and producing 12, monthly, 10-minute interviews.

 

Warrants

 

During the six months ended September 30, 2019, the Company granted warrants to purchase a total of 300,000 shares of common stock including:

 

i) warrants for 300,000 shares, valued at $119,954, to three new Directors, Messrs. Scott Johnson, Gregory Cash, and James Martin, with 150,000 vested immediately and 150,000 vesting quarterly between August 2020 and May 2021, and exercisable over a five-year term at $.30/share.

 

These warrants’ values were arrived at by using the Black-Scholes valuation model with the following assumptions:

 

i) an expected volatility of the Company’s shares on the date of the grants of approximately 313%, which was arrived at by taking the number of trading days during the year ended on the date of the grant multiplied by the standard deviation of the percentage change in the closing market price on a day-by-day basis; and

ii) a risk-free rate identical to the U.S. Treasury 13-week treasury bill rate on the date of the grants of 2.30%

 

During the six months ended September 30, 2019, the Company cancelled 360,000 warrants to purchase a total of 300,000 shares of common stock including:

 

i) warrants for 300,000 shares, valued at $300,770 using the Black-Scholes model, $117,144 in expense of which had yet to be taken at the time of cancellation were cancelled pursuant to the terms of such warrants dictating cancellation upon the two-month anniversary of a cease of service; and

ii) warrants for 60,000 shares that were never originally valued, were to be vested upon billing from service providers, and were cancelled due to a lack of documentation existing in relation to these warrants.

 

  16  
 

 

A summary of warrant activity for the year ending March 31, 2019 and six-month period ending September 30, 2019 is as follows:

 

    Number of
Warrants
    Weighted-
Average
Exercise
Price
    Warrants
Exercisable
    Weighted-
Average
Exercisable
Price
 
                         
Outstanding, March 31, 2018     3,486,709       0.59       2,433,601       0.57  
                                 
Granted     1,980,531       0.41                  
                                 
Exercised     1,111,027       0.36                  
                                 
Expired     12,977       0.3                  
                                 
Canceled     100,000       1                  
                                 
Outstanding, March 31, 2019     4,243,236       0.5       3,372,261       0.49  
                                 
Granted     300,000       0.3                  
                                 
Cancelled     360,000       0.42                  
                                 
Outstanding, September 30, 2019     4,183,236       0.49       4,005,736       0.48  

 

At September 30, 2019, the range of warrant prices for shares under warrants and the weighted-average remaining contractual life is as follows:

 

    Warrants Outstanding     Warrants Exercisable  
Range of Warrant
Exercise Price
  Number of
Warrants
    Weighted-
Average
Exercise
Price
    Weighted-
Average
Remaining
Contractual
Life
(Years)
    Number of
Warrants
    Weighted-
Average
Exercise
Price
 
.30-.50     3,552,486       0.35       4.16       3,494,986       0.35  
                                         
.51-1.00     517,500       1       3.14       397,500       1  
                                         
1.01-3.50     113,250       2.35       1.83       113,250       2.35  
                                         
Total     4,183,236       0.49       3.97       4,005,736       0.48  

 

For the six-month periods ended September 30, 2019 and 2018, the total stock-based compensation on all instruments was $428,079 and $599,004, respectively. It is expected that the Company will recognize expense after September 30, 2019 related to warrants issued, outstanding, and valued using the Black Scholes pricing model as of September 30, 2019 in the amount of approximately $345,000.

 

  17  
 

 

NOTE 13 – INCOME TAXES

 

The following table presents the net deferred tax assets as of September 30, 2019 and March 31, 2019:

 

    September 30, 2019     March 31, 2019  
Net operating loss carryforwards:                
Federal   $ (4,008,742 )   $ (3,801,404 )
State     (1,870,746 )     (1,773,989 )
Total net operating loss carryforwards     (5,879,488 )     (5,575,393 )
Total deferred tax assets     (5,879,488 )     (5,575,393 )
Valuation allowance     5,879,488       5,575,393  
Net deferred tax assets   $     $  

 

Current income taxes are based upon the year’s income taxable for federal and state tax reporting purposes. Deferred income taxes (benefits) are provided for certain income and expenses, which are recognized in different periods for tax and financial reporting purposes.

 

Deferred tax assets and liabilities are computed for differences between the financial statements and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the period in which the differences are expected to affect taxable income. The Company’s deferred income taxes arise from the temporary differences between financial statement and income tax recognition of net operating losses. These loss carryovers would be limited under the Internal Revenue Code should a significant change in ownership occur within a three-year period.

 

At September 30, 2019 and March 31, 2019, respectively, the Company had net operating loss carryforwards of approximately $19,000,000 and $18,100,000. The deferred tax assets arising from the net operating loss carryforwards are approximately $5,880,000 and $5,580,000 as of September 30, 2019 and March 31, 2019, respectively. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, the projected future taxable income and tax planning strategies in making this assessment. Based on management’s analysis, they concluded not to retain a deferred tax asset since it is uncertain whether the Company can utilize this asset in future periods. Therefore, they have established a full reserve against this asset. The net operating loss carryforwards, if not utilized, will begin to expire in 2021 for federal and Minnesota purposes.

 

Of the approximately $19,000,000 in net operating loss carryforwards, approximately $7,000,000 has been accumulated in our pre-merger operating subsidiary, Gel-Del Technologies, Inc. IRC 382 provides guidance around whether or not the Company is able to utilize the pre-merger Gel-Del Technologies, Inc. net operating loss of approximately $7,000,000. Management believes that these pre-merger dollars will be allowable if our deferred tax asset is ever realized.

 

A reconciliation of the expected tax computed at the U.S. statutory federal income tax rate to the total benefit for income taxes at September 30, 2019 and 2018 is as follows:

 

    2019     2018  
Expected tax at 30.8%   $ (5,879,488 )   $ (4,984,867 )
Valuation allowance     5,879,488       4,984,867  
Provision for income taxes   $     $  

 

The Company’s continuing practice is to recognize interest and/or penalties related to income tax matters in income tax expense. As of September 30, 2019, and 2018, the Company had no accrued interest and penalties related to uncertain tax positions.

 

The Company is subject to taxation in the U.S. and Minnesota. Our tax years for 2016 and forward are subject to examination by tax authorities. The Company is not currently under examination by any tax authority.

 

Management has evaluated tax positions in accordance with FASB ASC 740, and has not identified any tax positions, other than those discussed above, that require disclosure.

 

NOTE 14 – SUBSEQUENT EVENTS

 

On October 31, 2019, the Company’s Board of Directors approved the issuance of 1,345,000 warrants with a strike price of $.50/share that are exercisable for a term of 5 years from the date of the grant, as follows:

 

i) 600,000 to John Lai, the Company’s CEO, whereby 400,000 are vested quarterly over a three-year term and 200,000 vest upon achieving performance-based milestones. These warrants were valued using the Black-Scholes model at $299,973; and

ii) 500,000 to John Carruth, the Company’s CFO, whereby 400,000 are vested quarterly over a three-year term and 100,000 vest upon achieving performance-based milestones. These warrants were valued using the Black-Scholes model at $249,977; and

iii) 245,000 to John Dolan, the Company’s Secretary, whereby 100,000 are vested quarterly over a three-year term, 100,000 vest upon achieving performance-based milestones, and 45,000 are vested immediately. These warrants were valued using the Black-Scholes model at $122,489. $22,498 in expense was recognized during the three-month period ended September 30, 2019 as the 45,000 warrants that vested immediately were granted for services provided prior to October 1, 2019.

 

On October 31, 2019, the Company’s Board of Directors also approved a compensation plan for John Lai that included his retention of 600,000 escrowed shares that he never returned to the Company’s Treasury.

 

After the balance sheet date through the date of this 10-Q filing, the Company entered into certain subscription agreements whereby we sold 540,000 shares of common stock for $135,000 effecting a purchase price of $.25/share.

 

During October 2019, the Company engaged Barry Kaplan and Associates to provide investor relations services in exchange for cash consideration and 100,000 shares of PetVivo common stock.

 

  18  
 

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

GENERAL

 

We were incorporated in Nevada in 2009 under a former name. In 2014, we entered our current business through a reverse merger with PetVivo Inc., a Minnesota corporation founded in 2013. From this merger, PetVivo Inc. became our wholly-owned subsidiary, and concurrently we changed our Nevada corporate name to PetVivo Holdings, Inc. Our common stock is publicly traded in the over-the-counter (OTC) market under the symbol “PETV.”

 

Minnesota PetVivo Inc.

 

On March 11, 2014, our Board of Directors authorized the execution of that certain securities exchange agreement dated March 11, 2014 (the “Securities Exchange Agreement”) with PetVivo Inc., a Minnesota corporation (“PetVivo”), and the shareholders of PetVivo. In accordance with the terms and provisions of the Securities Exchange Agreement, we acquired all of the issued and outstanding shares of stock of PetVivo, thus making PetVivo our wholly-owned subsidiary, in exchange for the issuance to the PetVivo shareholders of an aggregate 2,310,939,804 shares of our common stock.

 

PetVivo was founded in 2013 by John Lai and John Dolan, and is based in suburban Minneapolis, Minnesota. PetVivo is a biomedical device company engaged in the business of acquiring/in-licensing and adapting human biomedical technology and products for commercial sale in the veterinary market to treat pets and other animals suffering from arthritis and other afflictions. PetVivo’s initial product, which is now being commercialized, is a medical device featuring the injections of patented gel-like, protein-based biomaterials into the afflicted body parts of pets and other animals suffering from osteoarthritis. PetVivo obtained the exclusive rights in a License Agreement for commercialization of Gel-Del technology for the treatment of pets and other animals.

 

Gel-Del Technologies Inc.

 

Gel-Del is a biomaterial and medical device development and manufacturing company with its offices in Edina, Minnesota, and was founded in 1999 by Dr. David B. Masters. Dr. Masters developed Gel-Del’s proprietary biomaterials that simulate a body’s cellular tissue and thus can be readily and effectively utilized to manufacture implantable therapeutic medical devices. The chief advantage of Gel-Del biomaterials is their enhanced biocompatibility with living tissues throughout the body. We are commercializing this technology in the veterinary field for the treatment of osteoarthritis. Gel-Del has also successfully completed a phase II clinical trial using their novel thermoplastic biomaterial as dermal filler for human cosmetic applications. Gel-Del’s core competencies are developing and manufacturing medical devices containing its proprietary thermoplastic protein-based biomaterials that mimic the body’s tissue to allow integration, tissue repair, and regeneration for long-term implantation. These biomaterials are produced using a patented and scalable self-assembly production process. The inherent thermoplastic properties of these biomaterials are then utilized to manufacture or coat implantable devices.

 

While working together relating to the Licensing Agreement, in 2014 our management and the management of Gel-Del determined to combine the two companies into one business entity producing, marketing and selling medical products based on Gel-Del technology for both humans and animals.

 

Gel-Del Merger

 

In November 2014 the respective Boards of Directors and executive officers of our company and of Gel-Del Technologies, Inc., a Minnesota corporation, (“Gel-Del”) entered into a merger agreement between our company and Gel-Del, subject to approval of our shareholders and Gel-Del shareholders. Shareholder approval of this merger was obtained from shareholders of Gel-Del in March 2015 and from our shareholders in April 2015, and concurrently we also appointed the directors of Gel-Del to our Board of Directors. We then controlled Gel-Del, combined all Gel-Del operations with ours, and were responsible to provide future funding for Gel-Del. Accordingly, we concluded that Gel-Del was a VIE entity for which we were the primary beneficiary and that for accounting purposes, we would consolidate our financial statements with those of Gel-Del with the assets and liabilities of Gel-Del stated at their fair value. We also determined the fair value of the Gel-Del assets and liabilities was based on the $4.02 per share trading price of our common stock at April 10, 2015, resulting in the total purchase consideration being $18,978,462.

 

We were unable to consummate this initial merger agreement with Gel-Del due primarily to a substantial public market decline in the value of our common stock during 2015-2016. In order to complete the Gel-Del merger, in early 2017 we agreed to provide Gel-Del an additional 31.3% of our common shares than was required in the initial merger agreement. Accordingly, our management and Gel-Del management revised the structure and terms of the Gel-Del merger to provide for the issuance of these additional shares to Gel-Del and to effect the transaction through a statutory triangular merger. The Gel-Del merger was then completed under Minnesota Statutes whereby Gel-Del and a wholly-owned subsidiary of ours (which was incorporated in Minnesota expressly for this transaction) completed the triangular merger (the “Merger”). Pursuant to the Merger, Gel-Del was the surviving entity and concurrently became our wholly-owned subsidiary, resulting in our obtaining full ownership of Gel-Del. Our primary reason to effect the Merger was to obtain 100% ownership and control of Gel-Del and its patented bioscience technology, including ownership of Gel-Del’s Cosmeta subsidiary. The effective date for the Merger was April 10, 2017 when the Merger was filed officially with the Secretary of State of Minnesota.

 

  19  
 

 

Pursuant to the Merger, we issued a total of 5,450,000 shares of our common stock pro rata to the pre-merger shareholders of Gel-Del, resulting in each outstanding common share of Gel-Del being converted into 0.798 common share of the Company; .634 share was issued in relation to the merger and .164 share was issued pursuant to the License Agreement. The 5,450,000 represented approximately 30% of our total post-merger outstanding common shares and were valued at the closing price of our common shares on the effective date of the Merger of $0.40 per share, resulting in total consideration of $2,180,000. Incident to completion of the Merger, we also recorded an impairment loss of approximately $14,700,000 in order to account for the decline in our initial valuation of Gel-Del in 2015.

 

CURRENT BUSINESS OPERATIONS

 

We are an emerging biomedical device company focused on the licensing and commercialization of innovative medical devices and therapeutics for pets, based in Minneapolis, Minnesota. We operate in the $19 billion US veterinary care market that has grown at a CAGR of 4.8% over the past five years according to the American Pet Products Association. Despite the market size, veterinary clinics and hospitals have very few treatments and/or drugs for use in treating osteoarthritis in pets and other animals. Also, the role of pets in the family has greatly evolved in recent years. Many pet owners consider their pets an important member of the family. They are now willing to spend greater amounts of money on their pets to maintain their health and quality of life.

 

We intend to leverage investments already expended in the development of human therapeutics to commercialize treatments for pets in a capital and time-efficient way. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market earlier than the more-stringently regulated veterinary pharmaceuticals or human therapeutics.

 

On July 31, 2019, the Company entered into an exclusive license agreement with Emerald Organic Products, Inc. (“Emerald”) whereby PetVivo granted an exclusive license to Emerald to use PetVivo’s proprietary Technology in the formulation, manufacture and sale of Emerald’s nutritional supplements including its hemp-based CBD wellness products.

 

The Technology of PetVivo licensed to Emerald under the Agreement includes Patents and Know-how involved with protein-based active agent delivery systems and related carrier formulations for utilization in human nutritional supplement applications.

 

The Company’s CEO and President, John Lai, owns approximately 3% of Emerald’s outstanding common stock. The Company’s Secretary, John Dolan, owns approximately 2% of Emerald’s outstanding common stock.

 

We launched our lead product, Kush® in calendar Q2 2018. In Q4 2018 we issued a “Notice of Product Quarantine and Product Monitoring Period” notifying all product holders to suspend use of the product and place it in quarantine while the Company, through utilization of third-party testing vendors, perform additional testing of the product. During the three months ended September 30, 2019, the Company began clearing product for release to the general public for Company-directed strategic purposes; see Note 3 for additional details. Kush is a veterinarian-administered joint injection for the treatment of osteoarthritis and lameness in dogs and horses. The Kush device is made from natural components that are lubricious and cushioning to perform like cartilage for the treatment of pain and inflammation associated with osteoarthritis.

 

We believe that Kush is a superior treatment that safely improves joint function. The reparative Kush particles are lubricious, cushioning and long-lasting. The spongy, protein-based particles mimic the composition and protective function of cartilage (i.e., providing both a slippery cushion and healing scaffolding) and protect the joint as an artificial cartilage.

 

Using industry sources, we estimate osteoarthritis afflicts approximately 20 million owned dogs in the United States and the European Union, making canine osteoarthritis a $4 billion market opportunity if selling the product at $200 per canine unit; this does not factor in any contra-lateral usage of the product by veterinarians. See Johnston, Spencer A. “Osteoarthritis. Joint anatomy, physiology, and pathobiology.” The Veterinary clinics of North (1997):699-723;

 

http://www.humanesociety.org/issues/petoverpopulation/facts/pet_ownership_statistics.html;

and

http://www.americanpetproducts.org/press_industrytrends.asp.

 

In addition to being a treatment for osteoarthritis, the joint-cushioning and lubricity effects of Kush have shown an ability to treat equine lameness that is due to navicular disease (a problem associated with misalignment of joints and bones in the hoof and digits).

 

Based on a variety of industry sources we estimate that 1 million owned horses in the United Stated and European Union suffer from lameness and/or navicular disease each year, making the equine lameness and navicular disease market an annual opportunity worth $600 million if selling the product at $600 per equine unit; this does not factor in any contra-lateral usage of the product by veterinarians. See Kane, Albert J., Josie Traub-Dargatz, Willard C. Losinger, and Lindsey P. Garber; “The occurrence and causes of lameness and laminitis in the US horse population” Proc Am Assoc Equine Pract. San Antonio (2000): 277-80; Seitzinger, Ann Hillberg, J. L. Traub-Dargatz, A. J. Kane, C. A. Kopral, P. S. Morley, L. P. Garber, W. C. Losinger, and G. W. Hill. “A comparison of the economic costs of equine lameness, colic, and equine protozoal myeloencephalitis (EPM).” In Proceedings, pp. 1048-1050. 2000; and Kilby, E. R. 10 CHAPTER, The Demographics of the U.S. Equine Population, The State of the Animals IV: 2007.

 

  20  
 

 

Osteoarthritis is a condition with degenerating cartilage, creating joint stiffness from mechanical stress resulting in inflammation and pain. The lameness caused by osteoarthritis worsens with time from the ongoing loss of protective cushion and lubricity (i.e., loss of slippery padding). There are currently very few, if any, treatments for osteoarthritis; some of which are palliative pain therapy and joint replacement. Non-steroidal, anti-inflammatory drugs (NSAIDs) are used to alleviate the pain and inflammation, but long-term use has been shown to cause gastric problems. NSAIDs do not treat the cartilage degeneration issue to halt or slow the progression of the osteoarthritis condition.

 

We believe that our treatment of osteoarthritis in canines using Kush is far superior to the current methodology of using NSAIDs. NSAIDs have many side effects, especially in canines, whereas the company’s treatment using Kush, to our knowledge, has not elicited any adverse side effects in dogs. Remarkably, Kush-treated dogs have shown an increase in activity even after they no longer are receiving pain medication.

 

No special training is required for the administration of the Kush device. The treatment is injected into synovial joint space using standard intra-articular injection technique and multiple joints can be treated simultaneously. Kush immediately treats effects of osteoarthritis with no special post-treatment requirements.

 

Historically, drug sales represent up to 30% of revenues at a typical veterinary practice (Veterinary Practice News). Revenues and margins at veterinary practices are being eroded because online, big-box and traditional pharmacies recently started filling veterinary prescriptions. Veterinary practices are looking for ways to replace the lost prescription revenues. Our treatments expand practice revenues and margins because they are veterinarian-administered. The Kush device is veterinarian-administered to expand practice revenues and margins. We believe that the increased revenues and margins provided by Kush will accelerate its adoption rate and propel it forward as the standard of care for canine and equine lameness related to or due to synovial joint issues.

 

We anticipate growing our product pipeline through the acquisition or in-licensing of additional proprietary products from human medical device companies specifically for use in pets. In addition to commercializing our own products in strategic market sectors and in view of the company’s vast proprietary product pipeline, the Company is seeking to continue to develop strategic out-licensing partnerships to provide secondary revenues.

 

We plan to commercialize our products in the United States through distribution relationships supported by regional and national distributors and complemented by the use of digital marketing to educate and inform pet owners; and in Europe and the rest of the world through commercial partners. In fiscal September 2019, the Company entered into an agreement with a service provider to film a 12-part, monthly series of interviews with our CEO, John Lai, Company KOLs, and other media content to be aired on Bloomberg Television Network alongside 96 commercials throughout calendar year 2020.

 

Most veterinarians in the United States buy a majority of their equipment and supplies from one of four veterinary-product distributors. Combined, these four distributors deliver more than 85%, by revenue, of the products sold to companion animal veterinarians in the U.S. We plan to have our product distribution leverage the existing supply chain and veterinary clinic and clinician relationships already established by these large distributors. We plan to support this distribution channel with regional sales representatives. Our representatives will support our distributors and the veterinary clinics and hospitals. We will also target pet owners with product education and treatment awareness campaigns utilizing a variety of digital marketing tools. The unique nature and the anticipated benefits provided by our products are expected to generate significant consumer response.

 

Our biomaterials have been through a human trial and have been classified as a medical device. The FDA does not require submission of a 510(k) or formal pre-market approval for medical devices used in veterinary medicine.

 

RESULTS OF OPERATIONS

 

We are a development stage company with no history of commercial revenues, and we have incurred recurring substantial losses since inception. The following discussion should be read in conjunction with our unaudited financial statements and related notes included in this report.

 

Results of Operations for the Three Months Ended September 30, 2019 and 2018

 

Revenue – Revenue was $-0- for both three-month periods ended September 30, 2019 and September 30, 2018.

 

  21  
 

 

Cost of Sales – Cost of sales was $3,845 for the three-month period ended September 30, 2019, which was made up entirely of costs incurred to clear product from quarantine phase, and $-0- for the three-month period ended September 30, 2018.

 

Gross Profit – Gross profit was ($3,845) for the three-month period ended September 30, 2019 and $-0- for the three-month period ended September 30, 2018.

 

Operating Expenses – Operating expenses for the three months ended September 30, 2019 were $425,769 compared to $727,592 for the three months ended September 30, 2018; the decrease of $301,823 was primarily due to decreased depreciation expense of approximately $20,000, decreased stock-based compensation expense of approximately $80,000, decreased research and development costs of approximately $70,000, and decreased sales & marketing expense of approximately $20,000 during the three months ended September 30, 2019. During the three-month period ended September 30, 2019, operating expenses were primarily made up of $141,040 in depreciation and amortization and $237,278 in stock-based compensation. During the three-month period ended September 30, 2018, operating expenses were primarily made up of $161,622 in depreciation and amortization and approximately $319,692 in stock-based compensation.

 

Other Income (Expense) – Other Income (Expense) for the three months ended September 30, 2019 of ($89,559) is primarily due to a loss on extinguishment of debt of ($81,738) related to settling related party accrued salary for shares of common stock. Other Income (Expense) for the three months ended September 30, 2018 of ($13,289) is primarily due to interest accrued on notes payable, notes payable – related party, and convertible notes payable.

 

Net Loss before Taxes and Net Loss – Our net loss for the three months ended September 30, 2019 was ($519,173), or ($.02) per share, compared to ($740,881), or ($.04) per share, for the three months ended September 30, 2018. The decreased loss of ($221,708) was attributable primarily to the decrease in operating expenses during the three months ended September 30, 2018 described above in the Operating Expenses section. The weighted average number of shares outstanding during the three-month periods ended September 30, 2019 and September 30, 2018 were 22,229,867 and 20,321,529, respectively.

 

Results of Operations for the Six Months Ended September 30, 2019 and 2018

 

Revenue – Revenue was $-0- for both six-month periods ended September 30, 2019 and September 30, 2018.

 

Cost of Sales – Cost of sales was $3,845 for the six-month period ended September 30, 2019, which was made up entirely of costs incurred to clear product from quarantine phase, and $-0- for the six-month period ended September 30, 2018.

 

Gross Profit – Gross profit was ($3,845) for the six-month period ended September 30, 2019 and $-0- for the six-month period ended September 30, 2018.

 

Operating Expenses – Operating expenses for the six months ended September 30, 2019 were $919,490 compared to $2,824,680 for the six months ended September 30, 2018; the decrease of $1,905,190 was primarily due a grant of common stock issued to replace shares to officer whereby 803,385 shares valued at $1,446,094 were issued to John Lai during the six months ended September 30, 2018. During the six-month period ended September 30, 2019, operating expenses were primarily made up of $285,130 in depreciation and amortization and $428,079 in stock-based compensation. During the three-month period ended September 30, 2018, operating expenses were primarily made up of $322,741 in depreciation and amortization, $599,004 in stock-based compensation, and $1,446,094 in common stock issued to replace shares to officer.

 

Other Income (Expense) – Other Income (Expense) for the six months ended September 30, 2019 of ($96,725) is primarily due to ($81,738) in loss on extinguishment of debt. Other Income (Expense) for the six months ended September 30, 2018 of ($15,786) is primarily due to interest incurred related to notes payable and notes payable – related party.

 

Net Loss before Taxes and Net Loss – Our net loss for the six months ended September 30, 2019 was ($1,020,060), or ($.05) per share, compared to ($2,840,466), or ($.14) per share, for the six months ended September 30, 2018. The decreased loss of ($1,820,406) was attributable primarily to the decrease in operating expenses during the six months ended September 30, 2018 described above in the Operating Expenses section. The weighted average number of shares outstanding during the six-month periods ended September 30, 2019 and September 30, 2018 were 22,187,882 and 19,855,091, respectively

 

Liquidity and Capital Resources

 

Our financial position and future prospects depend significantly on our access to financing to fund our operations during our development stage. Much of our current cost structure is based on costs related to personnel and facilities, and not subject to material variability. In order to fund our operations and working capital needs, we historically have utilized loans from accredited investors and others, equity sales of common stock to accredited investors and others having pre-existing relationships with us, and substantial issuances of stock-based compensation to satisfy outstanding debt and pay for development, management, financial, professional and other services.

 

  22  
 

 

As of September 30, 2019, our current assets were $177,837 including approximately $20,236 in cash, $12,495 in inventory, $1,500 in investment – equity securities receivable, and $143,606 in prepaid expenses. In comparison, our current liabilities as of that date were $1,096,811 consisting of $739,329 of accounts payable and accrued expenses, $264,737 of accrued expenses – related party, $24,655 in operating lease liability and $68,090 in notes payable and accrued interest – related party. Our working capital deficiency as of September 30, 2019 was $918,974.

 

We will need to raise substantial additional capital through private or public offerings of our equity or debt securities, or a combination thereof, and we may have to use a material portion of any capital raised to repay past due debt obligations. To the extent any capital raised is insufficient to both satisfy operational working capital needs and meet any required debt payments, we will most likely need to either extend, refinance or convert to equity our outstanding indebtedness.

 

We currently have little cash to support our operations and projected commercial growth. Accordingly, we will require substantial additional financing to fund our operational working capital for at least the next 12 months. Financing may be sought by us from a number of sources such as private or public sales of our equity or convertible debt securities, and/or loans from affiliates, banks or other financial institutions. In the event we cannot obtain any such financing when needed on terms acceptable to us, if at all, our business would suffer substantially.

 

Liquidity represents the ability of a company to generate sufficient cash to provide for its immediate cash needs, which our continued losses have made it difficult for us to accomplish. Over the past several years; we have continued to incur substantial losses without any source of material revenues or liquid assets, which has caused a serious and harmful effect to our liquidity and a substantial strain on our ongoing business operations.

 

We have not generated any operating cash flows since we are a development stage company which has not yet realized any significant commercial revenues.

 

Net Cash Used in Operating Activities We used ($288,002) of net cash in operating activities for the six months ended September 30, 2019 compared to using ($436,292) of net cash for the six months ended September 30, 2018. This decrease in cash used in operating activities was attributable primarily to a decrease of approximately $50,000 in the amount spent on employee and officer compensation and a decrease of approximately $135,000 spent on inventory.

 

Net Cash Used in Investing Activities – We used ($26,487) of net cash in investing activities in the six months ended September 30, 2019, consisting of ($24,987) of costs capitalized to intangible assets and ($1,500) spent on equity securities of Emerald Organic Products (EMOR). This is compared to ($82,180) net cash used in investing activities in the six months ended September 30, 2018, which was primarily due to ($60,998) of costs capitalized to intangible assets and ($23,181) in equipment purchases.

 

Net Cash Provided by Financing Activities – During the three months ended September 30, 2019, we were provided by financing activities with net cash of $328,265 consisting of $280,000 in proceeds from entering into convertible notes payable and $100,000 in the sale of equity securities, which was partially offset by payments of debt principal and interest totaling ($51,735). In comparison, during the six months ended September 30, 2018, we were provided by financing activities with net cash of $324,811 primarily due to proceeds from sales of common stock of $153,893, $133,186 from entering into bridge notes shown net of debt discount.

 

Inventory

 

Inventories are stated at cost, subject to the lower of cost or net realizable value. Cost includes materials, labor, and manufacturing overhead related to the purchase and production of inventories. Net realizable value is the estimated selling price less estimated costs of completion, disposal, and transportation. We regularly review inventory quantities on hand through an inventory count.

 

As of September 30, 2019, the Company’s inventory has a carrying value of $12,495 and is broken down into $62,168 of finished goods inventory, fully offset by a ($62,168) reserve for obsolete inventory, $3,127 of manufacturing supplies and $9,368 of raw materials.

 

  23  
 

 

MATERIAL COMMITMENTS

 

Accrued Salary

 

We are indebted to related parties. At September 30, 2019, we are obligated for unpaid officer salaries and related payroll taxes and amounts payable to related parties of $264,737. This amount is included in accrued expenses – related party.

 

Notes Payable

 

As of September 30, 2019, we are obligated on the following notes:

 

1. Third Parties – Principal $ 280,000  
  Third Parties – Interest   0  
  Third Parties – Total   280,000  
         
2. Related Parties – Principal   67,631  
  Related Parties – Interest   459  
  Related Parties – Total   68,090  
  Total $ 348,090  

 

OFF-BALANCE SHEET ARRANGEMENTS

 

As of September 30, 2019, and as of the date of this Quarterly Report, we do not have any off balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

 

GOING CONCERN

 

The independent auditors’ report accompanying our March 31, 2019 Form 10-K and financial statements contains an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The financial statements have been prepared assuming that we will continue as a going concern, which contemplates that we will realize our assets and satisfy our liabilities and commitments in the ordinary course of business. We have suffered recurring losses from operations and have a working capital deficit. These factors raise substantial doubt about our ability to continue as a going concern.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable

 

ITEM 4. CONTROLS AND PROCEDURES

 

DISCLOSURE CONTROLS AND PROCEDURES

 

Evaluation of disclosure controls and procedures.

 

We maintain controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management including our principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosures.

 

Based upon their evaluation of those controls and procedures performed as of the end of the period covered by this report, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were not effective.

 

  24  
 

 

Management’s report on internal control over financial reporting.

 

Our chief executive officer and our chief financial officer are responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and 15d-15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

 

  Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
     
  Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and our directors; and
     
  Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

 

Because of its inherent limitations, our internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

Our management assessed the effectiveness of our internal control over financial reporting as of September 30, 2019. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control — Integrated Framework (revised 2013). This assessment included an evaluation of the design and procedures of our control over financial reporting. Management determined that internal control over financial reporting was not effective as of September 30, 2019.

 

  Deficiencies in Segregation of Duties. Lack of proper segregation of functions, duties and responsibilities with respect to our cash and control over the disbursements related thereto due to our very limited staff, including our accounting personnel.
     
  Deficiencies in the staffing of our financial accounting department. The number of qualified accounting personnel with experience in public company SEC reporting and GAAP is limited.
     
  Limited checks and balances in processing cash and other transactions.

 

As part of the preparation of this report, we have applied compensating procedures and processes as necessary to attempt to ensure the reliability of our financial reporting. Accordingly, management believes, based on its knowledge, that (1) this report does not contain any untrue statement of a material fact or omit to state a material face necessary to make the statements made not misleading with respect to the period covered by this report, and (2) the financial statements, and other financial information included in this report, fairly present in all material respects our financial condition, results of operations and cash flows for the years and periods then ended.

 

The existence of the material weaknesses in our internal control over financial reporting increases the risks that our financial statements may be misleading materially or even need to be restated. We are committed to improving our financial and oversight organization and procedures. During this fiscal year, we added three independent directors who have taken active roles in committees of the board of directors, and we added a fulltime, experienced CFO who is now responsible for helping to develop and implement our financial controls and procedures appropriate for the stage in which the Company is in.

 

Changes in internal control over financial reporting.

 

There were no significant changes in our internal control over financial reporting during the second quarter of our fiscal year ended March 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

  25  
 

 

AUDIT COMMITTEE

 

Our board of directors has established an audit committee consisting of three of our independent directors, Messrs James Martin (financial expert), Joseph Jasper, and David Deming. The audit committee’s primary function is to provide advice with respect to our financial matters and to assist our board of directors in fulfilling its oversight responsibilities regarding finance, accounting, and legal compliance. The audit committee’s primary duties and responsibilities are to: (i) serve as an independent and objective party to monitor our financial reporting process and internal control system; (ii) review and appraise the audit efforts of our independent accountants; (iii) evaluate our quarterly financial performance as well as its compliance with laws and regulations; (iv) oversee management’s establishment and enforcement of financial policies and business practices; and (v) provide an open avenue of communication among the independent accountants, management and our board of directors.

 

PART II. OTHER INFORMATION

 

ITEM 1. PENDING LEGAL PROCEEDINGS

 

Management is not aware of any legal proceedings pending by any governmental authority or any other party involving our properties or the Company. As of the date of this Quarterly Report, no director, officer or affiliate is (i) a party adverse to us in any pending legal proceeding, or (ii) has an adverse interest to us in any pending legal proceedings. Management is not aware of any other legal proceedings pending against our properties or the Company.

 

ITEM 1A. RISK FACTORS

 

Not required

 

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

 

During the three months ended September 30, 2019, the Company sold 400,000 shares of common stock to one shareholder for $100,000, issued 120,000 shares to a service provider for $120,000 worth of services, and issued 1,439,851 shares of common stock to 3 insiders and 1 past employee for settlement of $455,965 in accrued salary and release of all claims.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not required.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not required.

 

ITEM 5. OTHER INFORMATION

 

None

 

  26  
 

 

ITEM 6. EXHIBITS

 

The following exhibits are filed as part of this Quarterly Report.

 

            Incorporated by Reference

Exhibit

No.

  Description   Filed Herewith  

 

Form

 

Period

Ending

 

 

Exhibit

 

Filing

Date

10.24    Exclusive License Agreement PetVivo Muco-Adhesion to Emerald Organic Products, Inc.   X                
31.1   Certification of Principal Executive Officer Required By Rule 13a-14(A) of the Securities Exchange Act of 1934, As Amended, As Adopted Pursuant To Section 302 of the Sarbanes-Oxley Act of 2002   X                
31.2   Certification of Principal Financial Officer Required By Rule 13a-14(A) of the Securities Exchange Act of 1934, As Amended, As Adopted Pursuant To Section 302 of the Sarbanes-Oxley Act of 2002   X                
32.1   Certification of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   X                
32.2   Certification of Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   X                
101.ins   XBRL Instance Document                    
101.sch   XBRL Taxonomy Schema                    
101.cal   XBRL Taxonomy Calculation Linkbase                    
101.def   XBRL Taxonomy Definition Linkbase                    
101.lab   XBRL Taxonomy Label Linkbase                    
101.pre   XBRL Taxonomy Presentation Linkbase                    
101.ins   XBRL Instance Document                    

 

  27  
 

 

PETVIVO HOLDINGS, INC.

 

SIGNATURES

 

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

 

November 19, 2019 By: /s/ John Lai
    John Lai
  Its:

CEO, President and Director

(Principal Executive Officer)

     
November 19, 2019 By: /s/ John Carruth
    John Carruth
  Its:

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

  28  
 

 

 

Exhibit 10.24

 

EXCLUSIVE LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT is made and entered into as of 31st day of July, 2019, (the “Effective Date”) by and between PetVivo Holdings, Inc., a corporation of the State of Nevada, having its principal place of business at 5251 Edina Industrial Blvd., Edina, MN 55439, (hereinafter referred to as “Licensor”), and Emerald Organic Products, Inc., a corporation of the State of Nevada, having its principal place of business at 331 Dante Ct. St E, Holbrook, NY 11741, and its operating subsidiary, Pura Vida Health, LLC (hereinafter collectively referred to as “Licensee”).

 

WITNESSETH:

 

WHEREAS, Licensor owns and/or has the exclusive rights to Technology including Patents and Know-how related to protein-based active agent delivery systems, processes and active agent carrier formulations and excipients for utilization in nutritional supplement applications.

 

WHEREAS, Licensor intends to engage in the manufacture and distribution of products derived from the Technology, including protein-based active agent delivery systems and formulations which the parties believe are beneficial for the delivery of hemp-based cannabinoids, caffeine and citicoline.

 

WHEREAS, the Technology owned and/or licensed by Licensor includes confidential information (including trade secrets and other know-how) which is proprietary to Licensor and of which Licensor desires to continue to maintain the confidentiality of such information.

 

WHEREAS, Licensee is engaged in the manufacture and sale of products for use in the nutritional supplements field, and wishes to acquire an exclusive license of and to use Licensor’s Intellectual Property rights relating to hemp-based cannabinoid, caffeine and citicoline delivery in nutritional supplement products for human consumption, including patents, pending patent applications, and regulatory, manufacturing, marketing and advanced technology “know-how” relating to such products.

 

WHEREAS, Licensor and Licensee are parties to a Mutual Confidential Disclosure Agreement dated November 18, 2018 (“Prior Disclosure Agreement”);

 

AGREEMENTS:

 

NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties mutually agree as follows:

 

1
 

 

ARTICLE 1

DEFINITIONS

 

1.1 Specific Definitions. As used in this Agreement, the following definitions and terms shall have the designated meanings:

 

Affiliate” of a specified person (natural or juridical) means a person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, the person specified. “Control” shall mean ownership of more than 50% of the shares of stock entitled to vote for the election of directors in the case of a corporation, and more than 50% of the voting power in the case of a business entity other than a corporation.

 

Agreement” means this Agreement and all Exhibits and Schedules hereto.

 

Confidential Information” means know-how, trade secrets, and unpublished information disclosed (whether before or during the term of this Agreement) by or on behalf of one of the parties (the “disclosing party”) to the other party (the “receiving party”) or generated under this Agreement, excluding information which:

 

(a) was already in the possession of the receiving party prior to its receipt from the disclosing party (provided that the receiving party is able to provide the disclosing party with written proof thereof and, if received from a third party, that such information was acquired without any party’s breach of a confidentiality or non-disclosure obligation to the disclosing party related to such information);

 

(b) is or becomes part of the public domain by reason of acts not attributable to the receiving party;

 

(c) is or becomes available to the receiving party from a source other than the disclosing party which source has rightfully obtained such information and has no obligation of non-disclosure or confidentiality to the disclosing party with respect thereto; or

 

(d) has been independently developed by or for the receiving party without breach of this Agreement or use of any Confidential Information of the other party.

 

“Cost of Goods Sold” means the total amount of the cost of the materials used in creating a Sales Unit of Licensed Products along with the direct labor costs used to produce a Sales Unit of Licensed Products.

 

Expiration” or “Expired” means, with respect to a particular patent, the patent’s expiration, abandonment, cancellation, disclaimer, award to another party other than Licensor in an interference proceeding, or declaration of invalidity or unenforceability by a court or other authority of competent jurisdiction (including final rejection in a re-examination or re-issue proceeding). “Unexpired” shall mean a patent that has not Expired.

 

2
 

 

Field” means the use of an excipient formulation for the delivery of one or more hemp-based cannabinoids, caffeine and/or citicoline as a nutritional supplement for human consumption, which excipient formulation is either (x) the PetVivo Delivery Formulation as defined in Exhibit A that includes one or more hemp-based cannabinoids, caffeine and/or citicoline and is manufactured in single dose Sales Units, or (y) a substance that includes one or more hemp- based cannabinoids, caffeine and/or citicoline in an excipient formulation different from that identified in Exhibit A, but includes a formulation disclosed or suggested in the Intellectual Property of Licensor as identified in Exhibit B, but not (z) a substance that requires a new PMA or other regulatory approval submission.

 

First Commercial Sale” means the first commercial sale (excluding sales for use in test trials or other testing) of a Licensed Product for which royalties are due under Section 4.1 in the United States.

 

Intellectual Property” means U.S. and foreign patents and patent applications, trademarks, service marks and registrations thereof and applications therefor, copyrights and copyright registrations and applications, mask works and registrations thereof, know-how, trade secrets, inventions, discoveries, ideas, technology, data, information, processes, drawings, designs, licenses, computer programs and software, and technical information including but not limited to information embodied in material specifications, processing instructions, equipment specifications, product specifications, confidential data, electronic files, research notebooks, invention disclosures, research and development reports and the like related thereto, and all amendments, modifications, and improvements to any of the foregoing.

 

Invention” means any invention, discovery, know-how, trade secret, data, information, technology, process or concept, whether or not patented or patentable, and whether or not memorialized in writing.

 

Know-How” means all know-how, trade secrets, expertise, inventions, discoveries and technical information now or hereafter owned by or licensed (with the right to sublicense) to Licensor which are necessary or useful for using or selling products for use in the Field, including but not limited to information embodied in drawings, designs, copyrights, copyright registrations and applications, trademarks, service marks and registrations thereof and applications therefor, patent applications, material specifications, processing instructions, formulas, equipment specifications, product specifications, confidential data, computer software, electronic files, research notebooks, invention disclosures, research and development reports and the like related thereto, and all amendments, modifications and improvements to any of the foregoing.

 

Licensed Products” means drug delivery devices manufactured in separate single dosage Sales Units (e.g. wafers, lozenges, pills…) that include one or more hemp-based cannabinoids (“CBD”), caffeine and/or citicoline and the PetVivo Delivery Formulation or other acceptable delivery formulation agreed upon by the Parties and disclosed or suggested in the Intellectual Property and/or Know-How of the Licensor, wherein said drug delivery devices are packaged in accordance with Licensee’s specifications, as long as such specifications fall within the normal packaging standards, specifications and/or protocols of the Nutritional Supplement industry.

 

3
 

 

Patents” means (a) the patents and patent applications, together with any patents that may issue based thereon, set forth on Exhibit B; (b) any other patents or patent applications now or hereafter owned by or licensed (with the right to sublicense) to Licensor that are necessary or useful for using or selling products for use in the Field; (c) all continuation, continuation-in-part, divisional, re-issue, re-examination and substitution applications that may be filed by or for the benefit of Licensor based on the foregoing referenced patents or patent application, together with any patents that may issue based thereon; and (d) all foreign applications that may be filed by or for the benefit of Licensor based on the foregoing referenced U.S. patents and patent applications, together with all patents which may issue based thereon.

 

PetVivo Delivery Formulation” means the product, delivery system and/or the formulation as identified in Exhibit A.

 

Quarter” means a calendar quarter.

 

Royalty Year” means the twelve-month period corresponding to four (4) sequential Quarters. The first Royalty Year shall begin with the first day of the first Quarter that occurs after the First Commercial Sale by Licensee. Subsequent Royalty Years begin with the first Quarter after the end of the first Royalty Year as defined herein.

 

Sales Unit” means a product that consists of a single dosage of one or more hemp-based cannabinoids, caffeine and/or citicoline included in an industry acceptable carrier amount of PetVivo Delivery Formulation or other acceptable delivery formulation agreed upon by the Parties and disclosed or suggested in the Intellectual Property and/or Know-How of the Licensor; each Sales Unit shall be produced in single dosage configuration agreed upon by the Parties (e.g. wafer, lozenge, disc, pill, sheet, sprays…).

 

Technology” means the Know-How and the Patents, which shall include the corresponding intellectual property rights thereto.

 

Territory” means the entire United States, Canada and the European Union subject to the provisions of Section 4.2.

 

Notwithstanding the above, if any Licensed Product is sold both separately and as an integral part of a combination product containing one or more integral components in addition to that Licensed Product, gross sales of Licensed Product resulting from sales of that combination product will be calculated by multiplying the gross sales for the combination product as calculated above by the fraction A/B where A is the invoice price of the Licensed Product as sold separately and B is the invoice price of the combination product.

 

A Licensed Product shall be considered sold when it is shipped or when it is invoiced, whichever is earlier. To assure Licensor the full royalty payment contemplated in this Agreement, Licensee agrees that in the event any Licensed Product is sold to an Affiliate for purposes of resale, Earned Royalties for that Licensed Product shall be computed upon the selling price at which such Licensed Product would ordinarily be sold to a non-Affiliate, rather than on the selling price of Licensee to the Affiliate.

 

4
 

 

1.2 Other Terms. Other terms may be defined elsewhere in the text of this Agreement and shall have the meaning indicated throughout this Agreement.

 

1.3 Definitional Provisions.

 

The words “hereof,” “herein,” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provisions of this Agreement.

 

The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.

 

References to an “Exhibit” or to a “Schedule” are, unless otherwise specified, to one of the Exhibits or Schedules attached to or referenced in this Agreement, and references to an “Article” or a “Section” are, unless otherwise specified, to one of the Articles or Sections of this Agreement.

 

The term “person” includes any individual, partnership, joint venture, corporation, trust, unincorporated organization or government or any department or agency thereof.

 

The term “dollars” or “$” shall refer to the currency of the United States of America.

 

ARTICLE 2

LICENSE TO LICENSEE

 

2.1 Grant of License.

 

(a) Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee and its Affiliates an exclusive, sublicensable (subject to Section 2.1(b)), license to the Technology , in the Territory, to: (a) manufacture, use, distribute, sell, offer to sell and have sold Licensed Products in the Field; (b) practice methods of manufacture and use related to delivery of the active agent, hemp-based cannabinoids, caffeine and/or citicoline, in a formulation covered by the Technology] and utilizing corresponding Licensed Products in the Field; and (c) otherwise to commercialize and exploit Licensed Products in the Field.

 

(b) The license granted to Licensee under Section 2.1(a) shall include the right to grant sublicenses with respect to the license granted to Licensee directly from Licensor; each sublicense is conditioned upon the Licensee receiving written approval from the Licensor prior to closing a sublicense with a third party sublicensee. In the event that Licensee grants a sublicense to the Technology, all such sublicense agreements shall contain no terms which are contradictory to or exceed the scope of the terms contained in this Agreement and each such sublicensee shall agree to be bound by the provisions of Sections 4.5 and 7.2 of this Agreement. Licensee shall provide a summary of the material terms of any sublicense to Licensor.

 

5
 

 

2.2 Assistance. Licensor shall, upon Licensee’s reasonable request from time to time, provide to Licensee at no charge writings, drawings and materials, if any, that document the Technology, including copies of any patents, patent applications and documents representing embodiments of the Technology. In addition, Licensor will provide reasonable explanation and assistance to Licensee to allow Licensee to understand the inventions covered by the Technology. For any further assistance beyond that stated herein, Licensor will be reimbursed at an amount agreed upon in writing by the parties for Licensor’s assistance and/or services.

 

ARTICLE 3

DEVELOPMENT

 

3.1 Development. Licensor shall work in cooperation with Licensee to complete the final design, development and manufacture of the Sales Units utilized as the Licensed Products in the Field; this will include the sharing and/or providing of Know-How and expertise in the preparation of such Licensed Products from internal personnel and/or consultants introduced to Licensee by Licensor. Licensee shall enter into services/consulting agreements and compensate Licensor and/or third-party consultants introduced by Licensor for all fees and expenses incurred in the sharing and/or providing of the Know-How and expertise identified herein. Licensee shall be responsible for the manufacture and commercialization of Licensed Products in the Field, but will consider and, if determined beneficial, implement recommendations provided by Licensor.

 

3.2 Regulatory Approval. Licensee shall be responsible for obtaining any regulatory approvals, if necessary, for Licensee’s commercial sale of the Licensed Products in the Field, including any pre-clinical and clinical studies. All regulatory approvals for the Licensed Products will be in Licensee’s name and owned jointly by Licensor and Licensee.

 

ARTICLE 4

ROYALTIES AND REPORTS

 

4.1 Sales Unit Royalties. Subject to the terms of this Agreement, Licensee shall pay to Licensor a royalty equal to Twenty-five Cents ($0.25) (“Royalty Rate”) of each Sales Unit of Licensed Products including the Technology sold by Licensee at a sales price equaling four times the Cost of Goods Sold for a Licensed Product sold as the First Commercial Sale (“First Sales Price”). For all Licensed Products sold by Licensee at a sales price greater than the First Sales Price, the Royalty Rate will.increase from Twenty-five Cents ($0.25) to an amount proportionate with the increase in sales price that is greater than the First Sales Price. For example, if Licensor sells Licensed Product at a sales price of Two Dollars and Fifty Cents ($2.50) per Sales Unit and the First Sales Price was One Dollar and Twenty Five Cents ($1.25), the Royalty shall be Fifty Cents ($0.50), to wit. No more than one (1) payment calculated in accordance with this Section 4.1 shall be paid on any single Sales Unit of Licensed Product covered by the License. The Parties further agree that if exclusivity is removed for failure to meet the Minimum Royalties terms and conditions of Section 4.2, the Royalty Rate shall be reduced to an amount of Fifteen Cents ($0.15) per Sales Unit of Licensed Product sold by Licensee; the reduced Royalty Rate shall still remain subject to adjustments as identified within this Section 4.1 and all other adjustments as identified in this Agreement.

 

6
 

 

4.2 Minimum Royalties and Exclusivity. The Parties agree that Licensee shall complete a First Commercial Sale of a Licensed Product in each of the three identified Territories within eighteen (18) months of execution of this Agreement to retain the License for that particular country and/or region of the Territory as identified herein. For each Royalty Year commencing with the Thirty (30) month anniversary date following the First Commercial Sale, Licensee will pay Licensor a minimum royalty amount against royalties per Royalty Year to maintain its exclusive rights (“Maintenance Amount”) based on quota/performance criteria agreed to by Licensor and Licensor. The Maintenance Amount payable for any Royalty Year shall be agreed to by Licensor and Licensor before commencement of such Royalty Year. If the parties are unable to reach agreement on the Maintenance Amount for a Royalty Year before commencement of such Royalty Year, the parties will engage a mutually agreed upon third-party neutral to facilitate such agreement until an agreement is reached

 

4.3 Payment Reductions. The provisions of Section 4.1 shall be subject to the provisions of this Agreement relating to reductions in payments described in Section 8.5 relating to indemnification of Licensee for breach of representations and warranties of Licensor.

 

4.4 Reports and Payments. Within thirty (30) days after the end of each Quarter, Licensee shall provide Licensor with a written report indicating the amount of Sales Units of Licensed Products for which royalties are due under Section 4.1 during such preceding Quarter and the amount of the royalties due for such Quarter. Simultaneously with making such report, Licensee shall pay to Licensor the amount of royalties then due (i.e. royalties shall be paid within thirty (30) days of the end of each Quarter).

 

4.5 Records. Licensee agrees to keep accurate written records sufficient in detail to enable the royalties payable under this Agreement by Licensee to be determined and verified. Such records for a particular Quarter shall be retained by Licensee for a period of not less than three (3) years after the end of such Quarter.

 

4.6 Audit of Records. Upon reasonable notice and during regular business hours, Licensee shall from time to time (but no more frequently than once annually, unless Licensor discovers and notifies Licensee of an understatement of more than ten percent (10%) in the amount of royalties due for any Quarter as reported pursuant to Section 4.4) make available the records referred to in Section 4.5 for audit at Licensor’s expense by independent representatives selected by Licensor and reasonably acceptable to Licensee to verify the accuracy of the reports provided to Licensor. Such representatives shall execute a suitable confidentiality agreement reasonably acceptable to Licensee prior to conducting such audit. Such representatives may disclose to Licensor only their conclusions regarding the accuracy and completeness of royalty payments and of records related thereto, and shall not disclose Licensee’s confidential business information to Licensor without the prior written consent of Licensee unless there is an error in Licensee’s accounting. In the event such audit uncovers an understatement of more than ten percent (10%) in the amount of royalties due for any Quarter as reported pursuant to Section 4.4, Licensee shall be responsible for the cost of such audit. No claim may be asserted by Licensor against Licensee for errors discovered in the audit unless Licensor provides Licensee with detailed written notice and explanation of such understatement within six (6) months following completion of such examination or audit made pursuant to this Section 4.6 and unless such claim is asserted by Licensor within two (2) years following completion of such examination or audit made pursuant to this Section 4.6.

 

7
 

 

ARTICLE 5

INTELLECTUAL PROPERTY

 

5.1 Confidentiality. The parties agree to maintain and abide by the terms of the Prior Disclosure Agreement unless contrary to the terms identified herein. In such instance of contrary terms, the terms of the present Agreement will govern and all other remaining terms of the Prior Disclosure Agreement will remain enforceable. Additionally, the parties agree to maintain the confidentiality of all non-public information regarding the Technology, including but not limited to the status of any patent applications included in Exhibit B. Each party agrees not to disclose or use (except as permitted or required for performance by the party receiving such Confidential Information of its rights or duties hereunder) any Confidential Information of the other party obtained during the term of this Agreement. Each party further agrees to take appropriate measures to prevent any such prohibited disclosure by its present and future employees, officers, agents, subsidiaries, or consultants.

 

5.2 Protection of Technology.

 

(a) During the term of this Agreement, Licensor shall promptly inform Licensee and Licensee will inform Licensor of any Invention, improvement, upgrading or modification relating to the Technology to which Licensor has rights.

 

(b) Licensor agrees to protect the Technology licensed by it by ensuring that appropriate patent rights are obtained and maintained as recommended by reputable patent counsel which counsel has been approved by Licensee and Licensor. Licensee shall have the right to review and approve any filings or other correspondence relating to the Patents with the appropriate patenting authority. If Licensee determines, in its sole discretion, that any Invention conceived, reduced to practice or otherwise made, developed or acquired by one or more employees or agents of Licensor and having application to the Field is not being adequately protected by Patents, Licensee may so inform Licensor. If Licensee decides that Licensor’s response has been inadequate, Licensee may take whatever action it deems necessary at its expense to protect such Invention, provided, however, that Licensee agrees that it shall provide Licensor with notice of any action having a material impact on Licensor’s rights to the Patents outside of the Field prior to taking any proposed action, and, if Licensor determines in good faith that such proposed action would materially impair Licensor’s rights to the Patents outside the Field then Licensor shall provide Licensee with written notice of such determination and relevant personnel from each party shall meet to discuss Licensor’s concerns. To a commercially reasonable degree, Licensee’s actions shall take into consideration Licensor’s reasonable concerns. Each party shall execute and deliver such forms of assignment, power of attorney and other documents which are necessary to give effect to the provisions hereof, and shall provide its best efforts to make available the appropriate personnel, including any inventors, who are necessary to give effect to the provisions hereof. Furthermore, Licensor shall not abandon a claim of a pending patent application nor fail to pay any maintenance fees for a patent without first giving Licensee sufficient notice so that Licensee, may, if it desires, continue the prosecution of such claim or pay such maintenance fee.

 

8
 

 

5.3 Ownership of Intellectual Property. Subject to the rights and licenses granted to Licensee by this Agreement, (a) any Intellectual Property that includes the Technology and is conceived, reduced to practice or otherwise made, developed or acquired by one or more employees or agents of Licensor and/or Licensee shall be the property of Licensor.

 

5.4 Prosecution of Infringement of Technology.

 

(a) Each of Licensor and Licensee shall promptly notify the other if it knows or has reason to believe that rights to the Technology are being infringed or misappropriated by a third party within the Field of Use or that such infringement or misappropriation is threatened. Licensor shall, after learning of and investigating such alleged infringement or misappropriation, send notice to Licensee electing to do one of the following: (i) prosecute such alleged infringement or misappropriation for Licensor’s own account; (ii) offer Licensee the choice of participating in or engaging in such prosecution on behalf of Licensor, or (iii) decline to prosecute such alleged infringement or misappropriation.

 

(b) In the event Licensor elects to prosecute such alleged infringement or misappropriation for its own account pursuant to 5.4(a)(i) above, Licensor shall be solely responsible for payment of all of its own costs of prosecution and of negotiating settlement, and shall retain all proceeds from such prosecution. Licensor shall have the right to join Licensee as a party plaintiff to any such proceeding if Licensor believes it is necessary to successfully prosecute such infringement or misappropriation. Licensee shall cooperate in connection with the initiation and prosecution of such suit initiated by Licensor. Licensor shall retain all proceeds from such prosecution after reimbursement of Licensor’s and Licensee’s costs and expenses out of the proceeds of such matter.

 

(c) In the event Licensor offers Licensee the choice of participating in such prosecution pursuant to 5.4(a)(ii) above, upon receipt of Licensor’s notice, Licensee shall have thirty (30) days in which to notify Licensor in writing of Licensee’s election to participate in the prosecution of such alleged infringement or misappropriation. If Licensee elects to participate, Licensee shall be obligated to pay fifty percent (50%) of the costs and expenses incurred by Licensor and Licensee in connection with such prosecution and shall be entitled to receive fifty percent (50%) of the net proceeds realized from Licensor’s and Licensee’s prosecuting of such matter and remaining after reimbursement of Licensor’s and Licensee’s costs and expenses out of the proceeds of such matter.

 

(d) In the event Licensor elects not to prosecute pursuant to 5.4(iii) above, Licensee shall be entitled to prosecute such alleged infringement or misappropriation for its own account, in which event Licensee shall be solely responsible for all costs of prosecution and of negotiating settlement and shall retain all proceeds from such prosecution. Licensee shall have the right to join Licensor as a party plaintiff to any such proceeding if Licensee believes it is necessary to successfully prosecute such infringement or misappropriation. Licensor shall cooperate in connection with the initiation and prosecution by Licensee of such suit and Licensee will reimburse Licensor for all costs and expenses incurred for their assistance in such matter.

 

9
 

 

ARTICLE 6

RIGHT OF FIRST OFFER

 

6.1 New Nutritional Supplement Product. A “New Nutritional Supplement Product” shall mean any substance and/or formulation for delivery of an active agent as a nutritional supplement for human consumption that is not within the scope of the Field. Licensor agrees that it will provide Licensee with detailed written notice of any New Nutritional Supplement Product that the Licensor desires to pursue commercialization.

 

6.2 Right of First Offer. Prior to offering for sale or license any New Nutritional Supplement Product, Licensee shall have the right of first offer regarding sale or licensing of the New Nutritional Supplement Product. Licensor will negotiate in good faith with Licensee for a period of not less than 30 days for Licensee to acquire an exclusive license to rights in the New Nutritional Supplement Product. This 30 day period shall begin on the day Licensee receives written notice and documentation of the New Nutritional Supplement Product. During such 30 day period, Licensee shall be entitled to conduct due diligence with the reasonable cooperation of Licensor. If Licensor and Licensee do not enter into an agreement with respect to such New Nutritional Supplement Product during such 30 day period, Licensor shall be free to enter into an agreement with respect to the New Nutritional Supplement Product with a third party and subsequently consummate such an agreement and/or commercialize the New Nutritional Supplement Product.

 

ARTICLE 7

REPRESENTATIONS AND WARRANTIES

 

7.1 Representations of Licensor. Licensor represents, warrants and covenants to Licensee that:

 

(a) Licensor is a corporation duly organized, validly existing, and in good standing under the laws of the State of Nevada and has full corporate power to conduct the business in which it is presently engaged and to enter into and perform its obligations under this Agreement.

 

(b) Licensor has taken all necessary corporate action under the laws of the state of its incorporation and its certificate of incorporation and by-laws to authorize the execution and consummation of this Agreement and, when executed and delivered by Licensor, this Agreement shall constitute the valid and legally binding agreement of Licensor enforceable against Licensor in accordance with the terms hereof, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability relating to or affecting creditors’ rights and to general equity principles.

 

(c) Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated herein will violate any provision of the certificate of incorporation or bylaws of Licensor or any law, rule, regulation, writ, judgment, injunction, decree, determination, award or other order of any court or governmental agency or instrumentality, domestic or foreign, or conflict with or result in any breach of any of the terms of or constitute a default under or result in termination of or the creation or imposition of any mortgage, deed of trust, pledge, lien, security interest or other charge or encumbrance of any nature pursuant to the terms of any contract or agreement to which Licensor is a party or by which Licensor or any of its assets is bound.

 

10
 

 

(d) Licensor exclusively owns, or has valid and subsisting exclusive license rights (with the right to sublicense) to, all of the Technology and Licensed Products, subject to no lien, charge, security interest, mortgage, pledge, restriction, adverse claim or any other encumbrance whatsoever (and without any obligation to any person or entity for royalties, fees or commissions). Exhibits A and B set forth a true, correct and complete list of the Technology and the Licensed Products in existence as of the Effective Date,. No current or former stockholder, employee or consultant of Licensor has any rights in or to any of the Technology. To the best of Licensor’s knowledge, the Technology is valid and enforceable. The Technology has not been challenged in any judicial or administrative proceeding. As of the Effective Date, Licensor has the rights and authority to enter into this Agreement and to grant the license granted herein. To the best of Licensor’s knowledge, no person or entity nor such person’s or entity’s business or products has infringed, misused, misappropriated or conflicted with the Technology or currently is infringing, misusing, misappropriating or conflicting with such Technology. To the best of Licensor’s knowledge, the manufacture, use, sale and importation of the PetVivo Delivery Formulation do not and will not infringe the Intellectual Property of any third party.

 

(e) There are no actions, suits, claims, disputes or proceedings or governmental investigations pending or, to Licensor’s knowledge, threatened against Licensor or any of its Affiliates with respect to the Technology or the Licensed Products or the use thereof by Licensor, either at law or in equity, before any court or administrative agency or before any governmental department, commission, board, bureau, agency or instrumentality, or before any arbitration board or panel whether located in the United States or a foreign country. Licensor has not failed to comply with any law, rule, regulation, writ, judgment, injunction, decree, determination, award or other order of any court or other governmental agency or instrumentality, domestic or foreign, which failure in any case would in any material respect impair any rights of Licensee under this Agreement.

 

(f) All Technology identified in Exhibit B has the status indicated therein and all applications are still pending in good standing and have not been abandoned. Exhibit B includes all of the current patent applications having applicability to the Licensed Products and the use of the Technology in the Field, and to which Licensor owns or has received a license (with a right to sublicense).

 

(g) All PetVivo Delivery Formulations will comply with the specifications set forth in Exhibit A.

 

7.2 Representations of Licensee. Licensee represents, warrants and covenants to Licensor that:

 

(a) Licensee is a corporation duly organized, validly existing, and in good standing under the laws of the State of Nevada and has full corporate power to conduct the business in which it is presently engaged and to enter into and perform its obligations under this Agreement.

 

11
 

 

(b) Licensee has taken all necessary corporate action under the laws of the state of its incorporation and its articles of incorporation and bylaws to authorize the execution and consummation of this Agreement and, when executed and delivered by Licensee, this Agreement shall constitute the valid and legally binding agreement of Licensee enforceable against Licensee in accordance with the terms hereof, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability relating to or affecting creditors’ rights and to general equity principles.

 

(c) Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated herein will violate any provision of the articles and bylaws of Licensee or any law, rule, regulation, writ, judgment, injunction, decree, determination, award or other order of any court or governmental agency or instrumentality, domestic or foreign, or conflict with or result in any breach of any of the terms of or constitute a default under or result in termination of or the creation or imposition of any mortgage, deed of trust, pledge, lien, security interest or other charge or encumbrance of any nature pursuant to the terms of any contract or agreement to which Licensee is a party or by which Licensee or any of its assets is bound.

 

ARTICLE 8

INDEMNIFICATION/LIMITATION OF LIABILITY

 

8.1 Indemnification by Licensor. Licensor shall indemnify, defend and hold harmless Licensee and each of its subsidiaries, officers, directors, shareholder, employees, agents and affiliates (collectively, all such indemnitees are referred to in this Section as “Licensee”) against and in respect of any and all third party claims, demands, losses, obligations, liabilities, damages, deficiencies, actions, settlements, judgments, costs and expenses which Licensee may incur or suffer or with which it may be faced (including reasonable costs and legal fees incident thereto or in seeking indemnification therefor), (referred to as “Costs”) arising out of or based upon: (i) the breach by Licensor of any of its representations, warranties, covenants or agreements contained or incorporated in this Agreement or any agreement, certificate or document executed and delivered to Licensee by Licensor in connection with the transactions hereunder; (ii) personal injury, harm or death caused by the PetVivo Delivery Formulation arising from or related to the negligence or failure on the part of Licensor; or (iii) any allegation that the PetVivo Delivery Formulation, or its use as provided hereunder, infringes or misappropriates any intellectual property rights of any third party. An amount for which Licensee is entitled to indemnification pursuant hereto is referred to as an “Indemnified Amount.”

 

8.2 Indemnification by Licensee. Licensee shall indemnify, defend and hold harmless Licensor and each of its subsidiaries, officers, directors, shareholder, employees, agents and affiliates (collectively, all such indemnitees are referred to in this Section as “Licensor”) against and in respect of any and all third party claims, demands, losses, obligations, liabilities, damages, deficiencies, actions, settlements, judgments, costs and expenses which Licensor may incur or suffer or with which it may be faced (including reasonable costs and legal fees incident thereto or in seeking indemnification therefor), (referred to as “Costs”) arising out of or based upon: (i) the breach by Licensee of any of its representations, warranties, covenants or agreements contained or incorporated in this Agreement or any agreement, certificate or document executed and delivered to Licensor by Licensee in connection with the transactions hereunder or (ii) personal injury, harm or death caused by the manufacture and commercialization of Licensed Products by Licensee arising from or related to the negligence or failure on the part of Licensee. An amount for which Licensor is entitled to indemnification pursuant hereto is referred to as an “Indemnified Amount.”

 

12
 

 

8.3 Third Party Claims. If a claim by a third party is made against any indemnified party, and if the indemnified party intends to seek indemnity with respect thereto under this Article 8, such indemnified party shall promptly notify the indemnifying party of such claim; provided, however, that failure to give timely notice shall not affect the rights of the indemnified party so long as the failure to give timely notice does not adversely affect the indemnifying party’s ability to defend such claim against a third party. The indemnifying party shall be entitled to settle or assume the defense of such claim, including the employment of counsel reasonably satisfactory to the indemnified party. If the indemnifying party elects to settle or defend such claim, the indemnifying party shall notify the indemnified party within ten (10) days of the indemnifying party’s intent to do so. If the indemnifying party elects not to settle or defend such claim or fails to notify the indemnified party of the election within thirty (30) days (or such shorter period provided above) after receipt of the indemnified party’s notice of a claim of indemnity hereunder, the indemnified party shall have the right to contest, settle or compromise the claim without prejudice to any rights to indemnification hereunder. Regardless of which party is controlling the settlement of defense of any claim, (a) both the indemnified party and indemnifying party shall act in good faith, (b) the indemnifying party shall not thereby permit to exist any lien, encumbrance or other adverse charge upon any asset of any indemnified party or of its subsidiaries, (c) the indemnifying party shall permit the indemnified party to participate in such settlement or defense through counsel chosen by the indemnified party, with all fees, costs and expenses of such counsel borne by the indemnified party, (d) no entry of judgment or settlement of a claim may be agreed to without the written consent of the indemnified party, provided that such consent shall not be unreasonably withheld or delayed, and (e) the indemnifying party shall promptly reimburse the indemnified party for the full amount of such claim and the related expenses as incurred by the indemnified party pursuant to this Article 8. So long as the indemnifying party is reasonably contesting any such third party claim in good faith and the foregoing clause (b) is being complied with, the indemnified party shall not pay or settle any such claim. The controlling party shall upon request deliver, or cause to be delivered, to the other party copies of all correspondence, pleadings, motions, briefs, appeals or other written statements relating to or submitted in connection with the settlement or defense of any such claim, and timely notices of any hearing or other court proceeding relating to such claim.

 

8.4 Limitation of Liability. In no event shall either party be directly liable to the other party for special, indirect, incidental, consequential or punitive damages of any kind or nature whatsoever, whether arising under contract, warranty, or tort (including negligence or strict liability) or any other theory of liability either party may have against the other party. Notwithstanding the previous sentence, the parties agree that Costs shall not be considered to be special, indirect, incidental, consequential or punitive damages.

 

8.5 Set-Off. In the event Licensee is entitled to indemnification under this Article 8, Licensee shall be entitled in its discretion, without limitation of any other rights or remedies of Licensee, to set-off against any amounts which are then owed or thereafter become owed by Licensee to Licensor: (i) one hundred percent (100%) of any finally determined Indemnified Amount; (ii) fifty percent (50%) of any Indemnified Amount that is not finally determined, provided, however, that Licensee may set-off one hundred percent (100%) of such Indemnified Amount when such Indemnified Amount becomes finally determined. If Licensee defers payment of any amount to Licensor past the scheduled payment date because there exists a pending indemnification claim by Licensee pursuant to this Article the amount of which has not then been finally determined, the excess, if any, of such deferred amount over the finally determined amount of the indemnification claim shall be promptly paid upon such final determination, together with simple interest at the rate of eight percent (8%) per annum on such excess accrued from the originally scheduled payment date for such deferred amount.

 

13
 

 

ARTICLE 9

TERM AND TERMINATION

 

9.1 Term of License. Unless otherwise terminated under provisions of Section 9.2, this Agreement and the license (and/or sublicense as the case may be) granted under Section 2.1 shall continue until such time as all Patents have Expired or a period of fifteen (15) years following the first bona fide commercial sale of such Licensed Product has expired, whichever is longer, at which time the exclusive license (or sublicense as the case may be) rights of Licensee set forth in Section 2.1 shall be deemed to be a fully paid, exclusive, irrevocable, sublicensable, royalty-free license to use the Know-How in connection with the development, manufacture, sale, marketing and other exploitation of Licensed Products in the Territory.

 

9.2 Termination. Either party may terminate this Agreement, at its option and without prejudice to any of its other legal and equitable rights and remedies, in the event that the other party is in material breach of this Agreement, by giving the other party ninety (90) days notice in writing, particularly specifying the breach. Such notice of termination shall not be effective if the breaching party cures the specified breach within such ninety (90) day period. Further, this Agreement will terminate automatically if a party has not notified the other party that it has received its board’s approval of this Agreement within thirty (30) business days after the Effective Date.

 

9.3 Effect of Termination. Upon termination of this Agreement for any reason:

 

(a) all sublicenses granted by Licensee under this Agreement shall immediately cease;

 

(b) Licensee shall have the right, pursuant to the terms of this Agreement, to sell any Licensed Product that Licensee has remaining in inventory prior to the termination of this Agreement;

 

(c) all monies due and owed by Licensee as of the termination date shall be paid by Licensee in accordance with this Agreement;

 

(d) each party shall promptly return the other party’s Confidential Information and all copies thereof; and

 

(e) in the event of termination by Licensor or Licensee pursuant to Section 9.2, the license granted to Licensee in Section 2.1 of this Agreement shall terminate.

 

14
 

 

ARTICLE 10

FORCE MAJEURE

 

10.1 Force Majeure. Neither party shall be in default because of any failure to perform such party’s obligations under this Agreement if such failure arises from causes beyond the control of such party (“the first party”) and without the fault or negligence of such first party, including without limitation, Acts of God or of the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, earthquakes, epidemics, quarantine restrictions, strikes, or freight embargoes. In each instance, the failure to perform must be beyond the reasonable control and without the fault or negligence of the first party.

 

10.2 Notice. If it appears that performance of obligations may be delayed by an event of Force Majeure, the first party will immediately notify the other party as soon as practicable in writing at the address specified in this Agreement. During the period that the performance by one of the parties of its obligations has been suspended by reason of an event of Force Majeure, the other party may likewise suspend the performance of all or part of its obligations hereunder to the extent that such suspension is commercially reasonable.

 

ARTICLE 11

MISCELLANEOUS

 

11.1 Assignment. Neither party shall have the right to assign or otherwise transfer its rights and obligations under this Agreement (whether by merger, share exchange, combination or consolidation of any type, operation of Law, purchase or otherwise) except with the prior written consent of the other party, provided that: (i) Licensor or Licensee may assign its rights pursuant to this Agreement to an Affiliate; and (ii) Licensor or Licensee or any Affiliate of Licensor or Licensee may assign its rights pursuant to this Agreement to any entity who, by merger, share exchange, combination or consolidation of any type, purchase, operation of law, asset purchase or otherwise, acquires substantially all of the business of Licensor or Licensee or such Affiliate, to which this Agreement relates. Any prohibited assignment shall be null and void and, notwithstanding Section 8.2, the non-assigning party may immediately terminate this Agreement.

 

11.2 Complete Agreement. This Agreement and the Exhibits and Schedules hereto constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersede all prior agreements whether written or oral relating hereto.

 

11.3 Governing Law. This Agreement shall be governed by and interpreted in accordance with the laws of the State of Nevada, including all matters of construction, validity, performance and enforcement, without giving effect to principles of conflict of laws.

 

11.4 Waiver, Discharge, Amendment, Etc. The failure of any party hereto to enforce at any time any of the provisions of this Agreement shall not, absent an express written waiver signed by the party making such waiver specifying the provision being waived, be construed to be a waiver of any such provision, nor in any way to affect the validity of this Agreement or any part thereof or the right of the party thereafter to enforce each and every such provision. No waiver of any breach of this Agreement shall be held to be a waiver of any other or subsequent breach. Any amendment to this Agreement shall be in writing and signed by the parties hereto.

 

15
 

 

11.5 Notices. All notices or other communications to a party required or permitted hereunder shall be in writing and shall be delivered personally or by facsimile (receipt confirmed electronically) to such party (or, in the case of an entity, to an executive officer of such party) or shall be sent by a reputable express delivery service or by certified mail, postage prepaid with return receipt requested, addressed as follows:

 

if to Licensee, to:

 

Emerald Organic Products, Inc.

Attn: Ian Parker

331 Dante Ct. St E

Holbrook, NY 11741

 

if to Licensor, to:

 

PetVivo Holdings, Inc

Attn: John Lai

5251 Edina Industrial Blvd.

Edina, MN 55439

 

Any party may change the above-specified recipient and/or mailing address by notice to all other parties given in the manner herein prescribed. All notices shall be deemed given on the day when actually delivered as provided above (if delivered personally or by facsimile) or on the day shown on the return receipt (if delivered by mail or delivery service).

 

11.6 Expenses. Except as expressly provided herein, Licensor and Licensee shall each pay their own expenses incident to this Agreement and the preparation for, and consummation of, the transactions provided for herein.

 

11.7 Titles and headings; Construction. The titles and headings to Sections and Articles herein are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement. This Agreement shall be construed without regard to any presumption or other rule requiring construction hereof against the party causing this Agreement to be drafted.

 

11.8 Severability. If any provision of this Agreement is held invalid, illegal or unenforceable, such provision shall be enforced to the maximum extent permissible and the remaining provisions shall nonetheless be enforceable according to their terms.

 

11.9 Relationship. This Agreement does not make either party the employee, agent or legal representative of the other for any purpose whatsoever. Neither party is granted any right or authority to assume or to create any obligation or responsibility, express or implied, on behalf of or in the name of the other party. In fulfilling its obligations pursuant to this Agreement, each party shall be acting as an independent contractor.

 

16
 

 

11.10 Benefit. Nothing in this Agreement, expressed or implied, is intended to confer on any person other than the parties to this Agreement or their respective successors or permitted assigns, any rights, remedies, obligations or liabilities under or by reason of this Agreement.

 

11.11 Survival. All of the representations, warranties, and covenants made in this Agreement, and all terms and provisions hereof intended to be observed and performed by the parties after the termination hereof, shall survive such termination and continue thereafter in full force and effect, including but not limited to indemnification, payment obligations, audit right, limitation of liability and record retention, subject to applicable statutes of limitations.

 

11.12 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed as original and all of which together shall constitute one instrument.

 

11.13 Execution of Further Documents. Each party agrees to execute and deliver without further consideration any further applications, licenses, assignments or other documents, and to perform such other lawful acts as the other party may reasonably request to fully secure and/or evidence the rights or interests herein.

 

11.14 Public Announcement. In the event any party proposes to issue any press release or public announcement concerning any provisions of this Agreement or the transactions contemplated hereby, such party shall so advise the other parties hereto, and the parties shall thereafter use commercially reasonable efforts to cause a mutually agreeable release or announcement to be issued. Neither party will publicly disclose or divulge any provisions of this Agreement or the transactions contemplated hereby without the other party’s written consent, except as may be required by applicable law or stock exchange regulation or government regulation, and except for communications to such party’s employees or customers or investors or prospective investors (subject to appropriate confidentiality obligations); provided that, prior to disclosure of any provision of this Agreement that either party considers particularly sensitive or confidential to any governmental agency or stock exchange, the parties shall cooperate to seek confidential treatment or other applicable limitations on the public availability of such information.

 

11.15 Alternative Dispute Resolution. Any dispute arising out of or relating to this Agreement (including the formation, interpretation or alleged breach thereof) shall be settled by final and binding alternative dispute resolution conducted under the auspices of, and in accordance with, the provisions set forth in Exhibit C. The results of such arbitration proceedings shall be binding upon the parties hereto, and judgment may be entered upon the arbitration award in any court having jurisdiction thereof. Notwithstanding the foregoing, either party may seek interim injunctive relief from any court of competent jurisdiction.

 

[Signature Page to Follow]

 

17
 

 

IN WITNESS WHEREOF, each of the parties has caused this License Agreement to be executed in the manner appropriate to each.

 

  PETVIVO HOLDINGS, INC.
   
   
  John Lai
  President
   
  EMERALD ORGANIC PRODUCTS, INC.
   
   
  Ian Parker
  President

 

18
 

 

EXHIBIT A

 

Licensed Products Specification

 

19
 

 

EXHIBIT B

 

Patents

 

1. US Patent No. 8,529,939

2. CA Patent No. 2,548,822

3. EP Patent No. 1691746

 

20
 

 

EXHIBIT C

 

Alternative Dispute Resolution

 

The parties recognize that bona fide disputes as to certain matters may arise from time to time during the term of this Agreement which relate to either party’s rights and/or obligations. To have such a dispute resolved by this Alternative Dispute Resolution (“ADR”) provision, a party first must send written notice of the dispute to the other party for attempted resolution by good faith negotiations between their respective presidents (or their designees) of the affected subsidiaries, divisions, or business units within twenty-eight (28) days after such notice is received (all references to “days” in this ADR provision are to calendar days).

 

If the matter has not been resolved within twenty-eight (28) days of the notice of dispute, or if the parties fail to meet within such twenty-eight (28) days, either party may initiate an ADR proceeding as provided herein. The parties shall have the right to be represented by counsel in such a proceeding.

 

1. To begin an ADR proceeding, a party shall provide written notice to the other party of the issues to be resolved by ADR. Within fourteen (14) days after its receipt of such notice, the other party may, by written notice to the party initiating the ADR, add additional issues to be resolved within the same ADR.
   
2. Within twenty-one (21) days following receipt of the original ADR notice, the parties shall select a mutually acceptable neutral to preside in the resolution of any disputes in this ADR proceeding. If the parties are unable to agree on a mutually acceptable neutral within such period, either party may request the President of the CPR Institute for Dispute Resolution (“CPR”), 366 Madison Avenue, 14th Floor, New York, New York 10017, to select a neutral pursuant to the following procedures:

 

(a) The CPR shall submit to the parties a list of not less than ten (10) candidates within fourteen (14) days after receipt of the request, along with a Curriculum Vitae for each candidate. No candidate shall be an employee, director, or shareholder of either party or any of their subsidiaries or affiliates. To the extent possible, CPR shall include former judges of one of the U.S. District Courts or one of the U.S. Court of Appeals in the list.

 

(b) Such list shall include a statement of disclosure by each candidate of any circumstances likely to affect his or her impartiality.

 

(c) Each party shall have the right to eliminate from the list up to three (3) candidates, with or without any reason. Each party shall number the other candidates (the “Remaining Candidates”) in order of preference (with the number one (1) signifying the greatest preference) and shall deliver the list to the CPR within seven (7) days following receipt of the list of candidates. If a party believes a conflict of interest exists regarding any of the Remaining Candidates, that party shall provide a written explanation of the conflict to the CPR along with its list showing its order of preference for the remaining candidates. Any party failing to return a list of preferences on time shall be deemed to have no order of preference.

 

21
 

 

(d) If the parties collectively have identified fewer than three (3) of the Remaining Candidates deemed to have conflicts, the CPR immediately shall designate as the neutral the Remaining Candidate for whom the parties collectively have indicated the greatest preference. If a tie should result between two Remaining Candidates, the CPR may designate either candidate. If the parties collectively have identified three (3) or more Remaining Candidates deemed to have conflicts, the CPR shall review the explanations regarding conflicts and, in its sole discretion, may either (i) immediately designate as the neutral the Remaining Candidate for whom the parties collectively have indicated the greatest preference, or (ii) issue a new list of not less than ten (10) candidates, in which case the procedures set forth in subparagraphs 2(a) - 2(d) shall be repeated.

 

3. No earlier than twenty-eight (28) days or later than one hundred and twelve (112) days after selection, the neutral shall hold a hearing to resolve each of the issues identified by the parties. The ADR proceeding shall take place in Minneapolis, Minnesota.
   
4. The parties shall have the right to conduct and enforce limited pre-hearing document discovery under the control of and enforceable by the neutral. The neutral shall permit and facilitate such other limited discovery as the neutral shall determine is appropriate under the circumstances, provided there shall be no prehearing depositions. The neutral shall decide discovery disputes. The neutral is empowered:

 

(a) to issue subpoenas to compel pre-hearing document discovery;

 

(b) to enforce the discovery rights and obligations of the parties; and

 

(c) to otherwise control the scheduling and conduct of the proceedings.

 

Notwithstanding any contrary foregoing provisions, the neutral shall have the power and authority to, and to the fullest extent practicable shall, abbreviate arbitration discovery in a manner that is fair to all parties in order to expedite the arbitration proceeding.

 

5. Within 45 days after filing of notice of demand for binding arbitration, the neutral shall hold a pre-hearing conference to establish schedules for completion of discovery, for exchange of exhibit and witness lists, for arbitration briefs, for the hearing, and to decide procedural matters and all other questions that may be presented.
   
6. The hearing shall be limited to no more than five (5) days and be governed by the following rules:

 

(a) Each party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the party conducting the cross-examination.

 

22
 

 

(b) The party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address not only issues it raised but also any issues raised by the responding party. The responding party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.

 

(c) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.

 

(d) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances.

 

(e) The neutral shall establish all other procedural rules for the conduct of the arbitration, including the admissibility of any evidence, in accordance with the rules of arbitration of the CPR.

 

7. Within seven (7) days following completion of the hearing, each party may submit to the other party and the neutral a post-hearing brief in support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidence.
   
8. The neutral shall render a final decision within twenty eight (28) days following completion of the hearing. The neutral shall not issue any written opinion or otherwise explain the basis of the ruling.
   
9. The neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:

 

(a) If the neutral rules in favor of one party on all disputed issues in the ADR, the losing party shall pay 100% of such fees and expenses.

 

(b) If the neutral rules in favor of one party on some issues and the other party on other issues, the neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the parties. The neutral shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.

 

10. Except as required by law, the existence of the dispute, any settlement negotiations, the ADR hearing, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed Confidential Information. The neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.
   
11. In no event may a notice of demand of any kind be filed more than two years after the date the claim, dispute, controversy, or other matter in question was asserted by one party against another, and if such demand is not timely filed, the claim, dispute, controversy, or other matter in question referenced in the demand shall be deemed released, waived, barred, and unenforceable for all time, and barred as if by statute of limitations.
   
12. The neutral may not award punitive damages. The parties hereby waive the right to punitive damages.
   
13. The hearings shall be conducted in the English language.

 

23
 

 

 

 

EXHIBIT 31.1

 

Certification of Principal Executive Officer

Required By Rule 13a-14(A) of the Securities Exchange Act of 1934, As Amended,

As Adopted Pursuant To Section 302 of the Sarbanes-Oxley Act of 2002

 

I, John Lai, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of PetVivo Holdings, 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) 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(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 19, 2019 By: /s/ John Lai
   

John Lai

CEO, President and Director

(Principal Executive Officer)

 

     
 

 

 

EXHIBIT 31.2

 

Certification of Principal Financial Officer

Required By Rule 13a-14(A) of the Securities Exchange Act of 1934, As Amended,

As Adopted Pursuant To Section 302 of the Sarbanes-Oxley Act of 2002

 

I, John Carruth, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of PetVivo Holdings, 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) 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(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 19, 2019 By: /s/ John Carruth
   

John Carruth

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

     
 

 

 

EXHIBIT 32.1

 

Certification of Principal Executive Officer

Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

 

In connection with the Quarterly Report of PetVivo Holdings, Inc., a Nevada corporation (the “Company”), on Form 10-Q for the quarter ended September 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), John Lai, Principal Executive Officer of the Company, certifies to the best of his knowledge, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 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 result of operations of the Company.

 

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

 

Date: November 19, 2019 By: /s/ John Lai
   

John Lai

CEO, President and Director

(Principal Executive Officer)

 

     
 

 

EXHIBIT 32.2

 

Certification of Principal Financial Officer

Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

 

In connection with the Quarterly Report of PetVivo Holdings, Inc., a Nevada corporation (the “Company”), on Form 10-Q for the quarter ended September 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), John Carruth, Principal Financial Officer of the Company, certifies to the best of his knowledge, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 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 result of operations of the Company.

 

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

 

Date: November 19, 2019 By: /s/ John Carruth
   

John Carruth

Chief Financial Officer

(Principal Financial and Accounting Officer)