UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 10-Q

 

 

 

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

 

For the Quarterly Period Ended: March 31, 2017

 

or

 

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

 

For the transition period from ______________ to ______________

 

Commission File No. 000-53121

 

 

 

AYTU BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 47-0883144
(State or other jurisdiction of
incorporation or organization)
(IRS Employer
Identification No.)

 

373 Inverness Parkway, Suite 206

Englewood, Colorado 80112

(Address of principal executive offices, including zip code)

 

(720) 437-6580

(Registrant’s telephone number, including area code)

 

 

 

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

 

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

 

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

 

Large accelerated filer ¨ Accelerated filer ¨
Non-accelerated filer ¨   (Do not check if a smaller reporting company) Smaller reporting company x
Emerging Growth Company ¨    

 

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

 

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

 

As of May 1, 2017, there were 13,836,607 shares outstanding of Common Stock, par value $0.0001, of the registrant.

 

 

 

 

AYTU BIOSCIENCE, INC.

 

FOR THE QUARTER ENDED MARCH 31, 2017

INDEX

 

  Page
PART I—FINANCIAL INFORMATION
 
Item 1. Financial Statements 4
     
  Balance Sheets as of March 31, 2017 (unaudited) and June 30, 2016 (unaudited) 4
     
  Statements of Operations for the three and nine months ended March 31, 2017 (unaudited) and the three and nine months ended March 31, 2016 (unaudited) 5
     
  Statement of Stockholders’ Equity (unaudited) 6
     
  Statements of Cash Flows for the nine months ended March 31, 2017 (unaudited) and the nine months ended March 31, 2016 (unaudited) 7
     
  Notes to Financial Statements (unaudited) 8
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 23
     
Item 3. Quantitative and Qualitative Disclosures About Market Risk 30
     
Item 4. Controls and Procedures 30
     
PART II—OTHER INFORMATION
 
Item 1. Legal Proceeding 30
     
Item 1A. Risk Factors 31
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 31
     
Item 3. Defaults Upon Senior Securities 31
     
Item 4. Mine Safety Disclosures 31
     
Item 5. Other Information 31
     
Item 6. Exhibits 31
     
SIGNATURES 33

 

2

 

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as “may,” “will,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, without limitation: the planned expanded commercialization of our products and the potential future commercialization of our product candidates, our anticipated future cash position; the assimilation into our operations of acquired assets and entities; our plan to acquire additional assets; the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials; the anticipated designs of our future clinical trials; anticipated future regulatory submissions and events; and future events under our current and potential future collaborations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including without limitation the risks described in “Risk Factors” in Part I, Item 1A of our most recent Annual Report on Form 10-K, as amended by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. These risks are not exhaustive. Other sections of this Quarterly Report include additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We assume no obligation to update or supplement forward-looking statements.

 

This Quarterly Report on Form 10-Q includes trademarks, such as Aytu, Natesto, ProstaScint, MiOXSYS, RedoxSYS, and Luoxis, which are protected under applicable intellectual property laws and we own or have the rights to. Solely for convenience, our trademarks and trade names referred to in this Quarterly Report on Form 10-Q may appear without the ® or TM symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and trade names.  

 

3

 

 

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

AYTU BIOSCIENCE, INC.

 

Balance Sheets

 

(unaudited)

 

    March 31,     June 30,  
    2017     2016  
             
Assets                
Current assets                
Cash and cash equivalents   $ 3,470,158     $ 8,054,190  
Restricted cash     75,107       -  
Accounts receivable, net     342,537       162,427  
Inventory, net     208,197       524,707  
Prepaid expenses and other     342,113       215,558  
Prepaid research and development - related party (Note 11)     -       121,983  
Investment in Acerus     -       1,041,362  
Total current assets     4,438,112       10,120,227  
                 
                 
Fixed assets, net     271,276       231,430  
Developed technology, net     641,875       1,159,736  
Customer contracts, net     585,000       1,353,375  
Trade names, net     65,000       194,472  
Natesto asset, net     9,560,754       10,549,797  
Goodwill     74,000       221,000  
Patents, net     277,611       296,611  
Long-term portion of prepaid research and development - related party (Note 11)     -       213,471  
Deposits     2,888       2,888  
Total long-term assets     11,478,404       14,222,780  
                 
Total assets   $ 15,916,516     $ 24,343,007  
                 
Liabilities and Stockholders’ Equity                
Current liabilities                
Accounts payable and other   $ 1,408,953     $ 2,322,605  
Accrued liabilities     1,050,816       1,197,106  
Natesto payable     -       5,379,675  
Accrued compensation     845,571       1,200,930  
Deferred  rent     6,430       4,109  
Contingent consideration     42,667       -  
Total current liabilities     3,354,437       10,104,425  
                 
Contingent consideration     4,037,664       3,869,122  
Deferred rent     3,119       8,215  
Warrant derivative liability     -       275,992  
Total liabilities     7,395,220       14,257,754  
                 
Commitments and contingencies (Note 7)                
                 
Stockholders’ equity                
Preferred Stock, par value $.0001; 50,000,000 shares authorized; none issued     -       -  
Common Stock, par value $.0001; 100,000,000 shares authorized; shares issued and outstanding 13,836,607 and 3,741,944, respectively as of March 31, 2017 and June 30, 2016     1,384       374  
Additional paid-in capital     70,839,253       56,646,304  
Accumulated deficit     (62,319,341 )     (46,561,425 )
Total stockholders’ equity     8,521,296       10,085,253  
                 
Total liabilities and stockholders’ equity   $ 15,916,516     $ 24,343,007  

 

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

 

4

 

 

AYTU BIOSCIENCE, INC.

 

Statements of Operations

 

(unaudited)

 

    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
                         
Product revenue   $ 893,548     $ 647,112     $ 2,385,701     $ 1,560,854  
License revenue     -       21,429       -       64,286  
Total revenue     893,548       668,541       2,385,701       1,625,140  
                                 
Operating expenses                                
Cost of sales     324,438       340,796       1,067,654       622,222  
Research and development     279,049       1,143,676       774,526       3,308,009  
Research and development - related party (Note 11)     291,963       47,998       387,960       143,994  
Sales, general and administrative     4,385,145       2,165,135       13,732,226       5,416,038  
Sales, general and administrative - related party (Note 11)     35,767       79,612       137,311       254,680  
Amortization of finite-lived intangible assets     437,013       118,697       1,311,043       284,633  
Total operating expenses     5,753,375       3,895,914       17,410,720       10,029,576  
                                 
Loss from operations     (4,859,827 )     (3,227,373 )     (15,025,019 )     (8,404,436 )
                                 
Other (expense) income                                
Interest (expense)     (80,722 )     (4,074,668 )     (884,187 )     (4,428,136 )
Derivative income (expense)     16,662       27,983       212,809       (50,054 )
Unrealized gain on investment     -       -       230,936       -  
(Loss) on investment     (292,455 )     -       (292,455 )     -  
Total other (expense)     (356,515 )     (4,046,685 )     (732,897 )     (4,478,190 )
                                 
Net loss   $ (5,216,342 )   $ (7,274,058 )   $ (15,757,916 )   $ (12,882,626 )
                                 
Weighted average number of common shares outstanding     10,938,603       1,569,078       7,562,342       1,314,308  
                                 
Basic and diluted net loss per common share   $ (0.48 )   $ (4.64 )   $ (2.08 )   $ (9.80 )

 

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

 

5

 

 

AYTU BIOSCIENCE, INC.

 

Statement of Stockholders’ Equity

 

(unaudited)

 

    Common Stock     Additional
Paid-in
    Accumulated     Total
Stockholders’
 
    Shares     Amount     Capital     Deficit     Equity  
                               
Balance - June 30, 2016     3,741,944     $ 374     $ 56,646,304     $ (46,561,425 )   $ 10,085,253  
Lincoln Park Capital stock issuance, net of $24,247 in issuance costs     226,190       23       607,211       -       607,234  
Issuance of restricted stock     1,000,000       100       655,316       -       655,416  
Common stock issued to executives     142,457       14       509,982       -       509,996  
Issuance of warrants to initial investors     -       -       596,434       -       596,434  
Issuance of common stock, net of $997,865 in cash issuance costs     5,734,975       574       3,671,007       -       3,671,581  
Warrants issued in connection with equity financing     -       -       3,470,646       -       3,470,646  
Warrants issued in connection with equity financing to the placement agents for the over-allotment option     -       -       172,629       -       172,629  
Warrants issued in connection with equity financing to the placement agents, non-cash issuance costs     -       -       292,630       -       292,630  
Warrant tender offer, net of $332,567 in issuance costs     2,991,041       299       1,910,415       -       1,910,714  
Warrant amendments     -       -       64,690       -       64,690  
Stock-based compensation     -       -       2,241,989       -       2,241,989  
Net loss     -       -       -       (15,757,916 )     (15,757,916 )
Balance - March 31, 2017     13,836,607     $ 1,384     $ 70,839,253     $ (62,319,341 )   $ 8,521,296  

 

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

 

6

 

 

AYTU BIOSCIENCE, INC.

Statements of Cash Flows

(unaudited)

 

    Nine Months Ended March 31,  
    2017     2016  
             
Cash flows from operating activities                
Net loss   $ (15,757,916 )   $ (12,882,626 )
Adjustments to reconcile net loss to cash used in operating activities                
Stock-based compensation expense     2,241,989       547,109  
Depreciation, amortization and accretion     2,263,975       433,471  
Issuance of restricted stocks     655,416       -  
Amortization of debt issuance costs     -       178,338  
Amortization of beneficial conversion feature     -       3,942,613  
Derivative (income) expense     (212,809 )     50,054  
Amortization of prepaid research and development - related party (Note 11)     335,454       91,487  
Loss on investment     61,519       -  
Common stock issued to executives     509,996       -  
Issuance of warrants to initial investors     596,434       -  
(Gain) on sale of asset     (428,374 )     -  
Warrant amendment     1,507       -  
Changes in operating assets and liabilities:                
(Increase) decrease in accounts receivable     (180,110 )     72,784  
Decrease (increase) in inventory     290,984       (581,910 )
(Increase) in prepaid expenses and other     (126,555 )     (572,238 )
(Decrease) increase in accounts payable and other     (307,854 )     50,053  
(Decrease) in accrued liabilities     (146,290 )     (68,372 )
(Decrease) increase in accrued compensation     (355,359 )     591,451  
Increase in interest payable     -       208,941  
(Decrease) increase in deferred rent     (2,775 )     10,560  
(Decrease) in deferred revenue     -       (64,286 )
Net cash used in operating activities     (10,560,768 )     (7,992,571 )
                 
Cash flows used in investing activities                
Deposits     -       1,998  
Purchases of fixed assets     (53,435 )     (203,577 )
Purchase payment for Natesto asset     (6,000,000 )     -  
Sale of investment in Acerus     1,071,707       -  
Sale of investment in Acerus cost     (91,864 )     -  
Installment payments for Primsol asset     (750,000 )     (540,000 )
Sale of Primsol asset     1,750,000       -  
Net cash used in investing activities     (4,073,592 )     (741,579 )
                 
Cash flows from financing activities                
Ampio stock subscription payment     -       5,000,000  
Sale of stock subscription     -       200,000  
Costs related to the conversion of the convertible promissory notes to equity     -       (29,754 )
Proceeds from convertible promissory notes, net     -       5,175,000  
Debt issuance costs (Note 8)     -       (298,322 )
Issuance of common stock to Lincoln Park Capital     631,481       -  
Costs related to sale of common stock     (24,247 )     -  
Warrant tender offer     2,243,281       -  
Warrant tender offer cost     (332,567 )     -  
Registered offering     8,602,500       -  
Registered offering costs     (997,865 )     -  
Over-allotment warrants purchased by placement agents     2,852       -  
Net cash provided by financing activities     10,125,435       10,046,924  
                 
Net change in cash, cash equivalents and restricted cash     (4,508,925 )     1,312,774  
Cash, cash equivalents and restricted cash at beginning of period     8,054,190       7,353,061  
Cash, cash equivalents and restricted cash at end of period   $ 3,545,265     $ 8,665,835  
                 
Non-cash transactions:                
                 
Warrant derivative liability related to the issuance of the convertible promissory notes   $ -     $ 102,931  
Primsol business purchase included in primsol payable, $1,250,000 less future accretion of $173,000   $ -     $ 1,077,000  
Conversion of convertible promissory notes and interest of $143,000 to common stock   $ -     $ 4,268,000  
Reclassification of liability based warrants to equity presentation related to the convertible promissory notes   $ -     $ 87,000  
Beneficial conversion feature of $4,943,073 less $3,942,613 of accretion related to unconverted convertible promissory notes   $ -     $ 1,001,000  
Debt issuance costs related to notes that converted to equity   $ -     $ (183,000 )
Fixed asset purchases included in accounts payable   $ 58,683     $ -  
Warrants issued in connection with the equity financing to the placement agents   $ 292,630     $ -  
Warrants amended in connection with warrant tender offer   $ 63,183     $ -  

 

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

 

7

 

 

AYTU BIOSCIENCE, INC.

Notes to Financial Statements

(unaudited)

 

Note 1 – Business, Basis of Presentation, Business Combinations and Divestitures

 

Business

 

Aytu BioScience, Inc. (“Aytu”, the “Company” or “we”) was incorporated as Rosewind Corporation on August 9, 2002 in the State of Colorado. Aytu was re-incorporated in the state of Delaware on June 8, 2015. Aytu is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. Aytu is currently focused on addressing significant medical needs in the areas of hypogonadism, urological cancers, and male infertility.

 

Basis of Presentation

 

These unaudited financial statements represent the financial statements of Aytu. These unaudited financial statements should be read in conjunction with Aytu’s Annual Report on Form 10-K for the year ended June 30, 2016, which included all disclosures required by generally accepted accounting principles (“GAAP”). In the opinion of management, these unaudited financial statements contain all adjustments necessary to present fairly the financial position of Aytu for the balance sheet, the results of operations and cash flows for the interim periods presented. The results of operations for the period ended March 31, 2017 are not necessarily indicative of expected operating results for the full year. The information presented throughout this report as of and for the period ended March 31, 2017 is unaudited.

 

Through a multi-step reverse triangular merger, on April 16, 2015, Vyrix Pharmaceuticals, Inc. (“Vyrix”) and Luoxis Diagnostics, Inc. (“Luoxis”) merged with and into our Company (herein referred to as the Merger) and we abandoned our pre-Merger business plans to solely pursue the specialty healthcare market, including the business of Vyrix and Luoxis. In the Merger, we acquired the RedoxSYS, MiOXSYS and Zertane products. On June 8, 2015, we reincorporated as a domestic Delaware corporation under Delaware General Corporate Law and changed our name from Rosewind Corporation to Aytu BioScience, Inc., and effected a reverse stock split in which each common stockholder received one share of common stock for every 12.174 shares outstanding. On June 30, 2016, Aytu effected another reverse stock split in which each common stockholder received one share of common stock for every 12 shares outstanding (herein referred to collectively as the “Reverse Stock Splits”). All share and per share amounts in this report have been adjusted to reflect the effect of these Reverse Stock Splits.

 

Business Combination—ProstaScint

 

In May 2015, Aytu entered into and closed on an asset purchase agreement with Jazz Pharmaceuticals, Inc. (the “Seller”). Pursuant to the agreement, Aytu purchased assets related to the Seller’s product known as ProstaScint® (capromab pendetide), including certain intellectual property and contracts, and the product approvals, inventory and work in progress (together, the “ProstaScint Business”), and assumed certain of the Seller’s liabilities, including those related to product approvals and the sale and marketing of ProstaScint.

 

The purchase price consisted of the upfront payment of $1.0 million. Aytu also paid an additional $500,000 for the ProstaScint-related product inventory and $227,000 (which represents a portion of certain FDA fees). Aytu also will pay 8% as contingent consideration on its net sales made after October 31, 2017, payable up to a maximum aggregate payment of an additional $2.5 million. The contingent consideration was initially valued at $664,000. The total fair value consideration for the purchase was $2.4 million.

 

8

 

 

The Company’s allocation of consideration transferred for ProstaScint as of the purchase date of May 20, 2015 is as follows:

 

    Fair Value  
       
Tangible assets   $ 727,000  
         
Intangible assets     1,590,000  
         
Goodwill     74,000  
         
Total assets acquired   $ 2,391,000  

 

Included in the intangible assets is developed technology of $790,000, customer contracts of $720,000 and trade names of $80,000, each of which will be amortized over a ten-year period. The amortization expense was $40,000 for each of the three months ended March 31, 2017 and 2016, respectively. The amortization expense was $120,000 for each of the nine months ended March 31, 2017 and 2016, respectively.

 

As of March 31, 2017, the contingent consideration had increased to $746,000 due to accretion.

 

Business Combination—Primsol

 

In October 2015, Aytu entered into and closed on an Asset Purchase Agreement with FSC Laboratories, Inc. (the “Seller”). Pursuant to the agreement, Aytu purchased assets related to the Seller’s product known as Primsol® (trimethoprim solution), including certain intellectual property and contracts, inventory, work in progress and all marketing and sales assets and materials related solely to Primsol (together, the “Primsol Business”), and assumed certain of the Seller’s liabilities, including those related to the sale and marketing of Primsol arising after the closing.

 

Aytu paid $500,000 at closing for the purchase of the Primsol Business and paid an additional $142,000, of which $102,000 went to inventory and $40,000 towards the Primsol Business, for the transfer of the Primsol-related product inventory. We also agreed to pay an additional (a) $500,000 which was paid in April 2016, (b) $500,000 which was paid in July 2016, and (c) $250,000 which was paid in November 2016.

 

The Company’s allocation of consideration transferred for Primsol as of the purchase date of October 5, 2015 is as follows:

 

    Fair Value  
       
Tangible assets   $ 182,000  
         
Intangible assets     1,470,000  
         
Goodwill     147,000  
         
Total assets acquired   $ 1,799,000  

 

Included in tangible assets is $102,000 of inventory and $80,000 of work-in-process inventory. Included in the intangible assets is developed technology of $520,000, customer contracts of $810,000 and trade names of $140,000, each of which will be amortized over a six-year period. The amortization expense was $61,000 for each of the three months ended March 31, 2017 and 2016. The amortization expense was $184,000 and $112,000 for the nine months ended March 31, 2017 and 2016, respectively.

 

Divestiture – Primsol

 

On March 31, 2017, we entered into and closed on an Asset Purchase Agreement with Allegis Holdings, LLC (the “Purchaser”). Pursuant to the agreement, we sold to the Purchaser all of our assets related to our product known as Primsol, including certain intellectual property and contracts, inventory, work in process and all marketing assets and materials related solely to Primsol (together, the “Primsol Asset”). We retain any liability associated with the Primsol Asset that occurred prior to the closing. The Purchaser paid us $1,750,000 at the closing for the Primsol Asset. We recognized a gain of approximately $428,000 on the sale which is included in sales, general and administrative expense on our statement of operations.

 

9

 

 

We have evaluated this transaction and concluded that it is not significant to our business and therefore the results are included in continuing operations, as the criteria to be presented as discontinued operations was not satisfied.

 

License and Supply Agreement—Natesto

 

In April 2016, Aytu entered into and closed a license and supply agreement to acquire the exclusive U.S. rights to Natesto® (testosterone) nasal gel from Acerus Pharmaceuticals Corporation, or Acerus, which rights we acquired effective upon the expiration of the former licensee’s rights, which occurred on June 30, 2016. The license’s term runs for the greater of eight years or until the expiry of the latest to expire patent including claims covering Natesto and until the entry on the market of at least one AB-rated generic product.

 

Aytu paid Acerus an upfront fee of $2.0 million upon execution of the agreement. In October 2016, we paid an additional $2.0 million. In January 2017, Aytu paid the final upfront payment of $4.0 million. Aytu also purchased, on April 28, 2016, an aggregate of 12,245,411 shares of Acerus common stock for Cdn. $2,534,800 (approximately US $2.0 million), with a purchase price per share equal to Cdn. $0.207 or approximately US $0.16 per share. These shares were a held for sale trading security and were valued at fair market value. Aytu could not dispose of these shares until after August 29, 2016. During the three months ended March 31, 2017, Aytu sold all of these shares. The gross proceeds from the sales totaled $1,071,707, the cost of the sales totaled $91,864, and we recognized a loss on investment of $61,519.

 

In addition to the upfront payments, we must make the following one-time, non-refundable payments to Acerus within 45 days of the occurrence of the following event (provided that, the maximum aggregate amount payable under such milestone payments will be $37,500,000):

 

  $2,500,000 if net sales during any four consecutive calendar quarter period equal or exceed $25,000,000 (the “First Milestone”); the First Milestone payment is required to be paid even if the threshold is not met in the event that the agreement is terminated for any reason other than material breach by Acerus, bankruptcy of either party, or termination by Acerus because it believes the amounts payable to Aytu for agreed upon trial work would no longer make the agreement economically viable for Acerus;
     
  $5,000,000 if net sales during any four consecutive calendar quarter period equal or exceed $50,000,000;
     
  $7,500,000 if net sales during any four consecutive calendar quarter period equal or exceed $75,000,000;
     
  $10,000,000 if net sales during any four consecutive calendar quarter period equal or exceed $100,000,000; and
     
  $12,500,000 if net sales during any four consecutive calendar quarter period equal or exceed $125,000,000.

 

The fair value of the net identifiable asset acquired totaled $10.5 million which will be amortized over eight years. The amortization expense for the three months ended March 31, 2017 was $330,000. The amortization expense for the nine months ended March 31, 2017 was $989,000.

 

The contingent consideration was valued at $3.2 million using a Monte Carlo simulation, as of June 30, 2016.The contingent consideration accretion expense for the three and nine months ended March 31, 2017 was $61,000 and $164,000, respectively, resulting in the contingent consideration value of $3.3 million.

 

Adoption of Newly Issued Accounting Pronouncements

 

In November 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-18, “Statement of Cash Flows: Restricted Cash”.  The amendments address diversity in practice that exists in the classification and presentation of changes in restricted cash on the statement of cash flows.  ASU 2016-18 is effective for the fiscal year commencing after December 15, 2017. During the quarter ended December 31, 2016, the Company early adopted this pronouncement, the impact of which was very minimal as the Company just recently set aside restricted cash, which is now shown on the statements of cash flows within cash and cash equivalents.

 

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In August 2016, the FASB issued ASU 2016-15 Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, which provides guidance on the presentation of certain cash receipts and cash payments in the statement of cash flows in order to reduce diversity in existing practice. ASU 2016-15 is effective for interim and annual periods beginning after December 15, 2017. Early adoption is permitted. During the quarter ended September 30, 2016, the Company early adopted this standard. The primary cash flow categorization that will impact the Company will be contingent consideration payments, however, no such payments have been made to date.

 

In March 2016, the FASB issued ASU 2016-09, “Compensation –Stock Compensation (Topic 718): Improvements to Employee Share Based Payment Accounting.” The standard includes multiple provisions intended to simplify various aspects of the accounting for share based payments. The amendments are expected to impact net income, earnings per share, and the statement of cash flows. Implementation and administration may present challenges to companies with significant share based payment activities. The amendments are effective for public entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. The Company adopted this standard during the quarter ended March 31, 2017. Aytu has elected to account for forfeitures as they occur, rather than estimate expected forfeitures. As of the date of this Report, the Company had not estimated any forfeitures, therefore, no adjustments were necessary. Aytu is also operating at a net operating loss, therefore, there was no tax implication.

 

In July 2015, the FASB issued ASU 2015-11, “Simplifying the Measurement of Inventory.”  ASU 2015-11 clarifies that inventory should be held at the lower of cost or net realizable value.  Net realizable value is defined as the estimated selling price, less the estimated costs to complete, dispose and transport such inventory.  ASU 2015-11 will be effective for fiscal years and interim periods beginning after December 15, 2016.  ASU 2015-11 is required to be applied prospectively.  The amendments in ASU 2015-11 were adopted by the Company during the quarter ended March 31, 2017. The adoption of this standard did not have an impact on the Company’s financial position or results of operations .

 

In August 2014, the FASB issued ASU 2014-15, “Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”). ASU 2014-15 is intended to define management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures. The amendments in this ASU are effective for reporting periods ending after December 15, 2016. The Company adopted this standard during the quarter ended March 31, 2017 and has included the required disclosure in the Company’s financial statements (Note 2).

 

Recently Issued Accounting Pronouncements, Not Adopted as of March 31, 2017

 

In January 2017, the FASB issued ASU 2017-04, “Intangibles - Goodwill and Other (Topic 350).” The amendment simplifies the subsequent measurement of goodwill by removing the second step of the two-step impairment test. The amendment requires an entity to perform its annual, or interim goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An impairment charge should be recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. An entity still has the option to perform the qualitative assessment for a reporting unit to determine if the quantitative impairment test is necessary. The amendment should be applied on a prospective basis. ASU 2017-04 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company does not believe that adoption of this amendment will have a material impact on its financial statements.

 

In January 2017, the FASB issued ASU 2017-01, “Business Combinations (Topic 805) Clarifying the Definition of a Business.” The amendment clarifies the definition of a business, which is fundamental in the determination of whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. This determination is important given the diverging accounting models used for each type of transaction. The guidance is generally expected to result in fewer transactions qualifying as business combinations. The amendment is effective prospectively for public business entities for annual periods beginning after December 15, 2017, including interim periods within those periods. Early adoption is permitted. The Company does not expect an immediate impact from this codification however, if Aytu seeks to purchase additional assets in the future it could have an impact if that purchase is accounted for as a business combination or an asset purchase.

 

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In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842).” The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for leases for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact of its adoption of this standard on its financial statements.

 

In January 2016, the FASB issued ASU 2016-01, “Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities,” which requires that all equity investments be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under the equity method of accounting or those that result in consolidation of the investee). The amendments in this update also require an entity to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. In addition, the amendments in this update eliminate the requirement to disclose the fair value of financial instruments measured at amortized cost for entities that are not public business entities and the requirement to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet for public business entities. The amendment is effective for financial statements issued for fiscal years beginning after December 15, 2017. Early adoption is not permitted. The Company is currently evaluating the impact of this standard on its financial statements.

 

In May 2014, the FASB issuing ASU 2014-09, Topic 606, Revenue from Contracts with Customers (the “New Revenue Standard”). The amendments in this ASU provide a single model for use in accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance, including industry-specific revenue guidance. The core principle of the new ASU is that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. New disclosures about the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers are also required. In August 2015, the FASB issued ASU 2015-14 which deferred the effective date of the New Revenue Standard. In 2016, the FASB issued ASU 2016-08, ASU 2016-10, ASU 2016-11, and ASU 2016-12 to clarify, among other things, the implementation guidance related to principal versus agent considerations, identifying performance obligations, and accounting for licenses of intellectual property. The New Revenue Standard is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early application is not permitted. The amendments in this update are to be applied on a retrospective basis, either to each prior reporting period presented or by presenting the cumulative effect of applying the update recognized at the date of initial application. The New Revenue Standard will be effective for the Company in fiscal 2019. The Company is evaluating the adoption methodology and the impact of this ASU on its financial statements.

 

Note 2 – Going Concern

 

As reflected in the accompanying financial statements, for the nine months ended March 31, 2017, the Company had approximately $3.5 million in cash, with a net loss of $15.8 million. The net cash used in operations of $10.6 million, and stockholders’ equity of $8.5 million with an accumulated deficit of $62.3 million.  In addition, the Company is in the early stage of commercialization and has not yet generated profits. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

 

The Company expects that its current cash resources as well as expected lack of operating cash flows will not be sufficient to sustain operations for a period greater than one year from the date of this report. The ability of the Company to continue its operations is dependent on management’s plans, which include continuing to raise equity-based financing. There is no assurance that the Company will be successful in accomplishing this objective.

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.

 

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Note 3 – Fixed Assets

 

Fixed assets are recorded at cost and, once placed in service, are depreciated on the straight-line method over the estimated useful lives. Fixed assets consist of the following:

 

    Estimated   As of March 31,     As of June 30,  
    Useful Lives in years   2017     2016  
                 
Office equipment and furniture   3 - 5   $ 246,000     $ 201,000  
Leasehold improvements   3     112,000       45,000  
Lab equipment   3 - 5     90,000       90,000  
Manufacturing equipment   5     7,000       7,000  
Less accumulated depreciation and amortization         (184,000 )     (112,000 )
Fixed assets, net       $ 271,000     $ 231,000  

 

The depreciation expense was as follows:

 

    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
                         
Depreciation expense   $ 27,000     $ 18,000     $ 72,000     $ 37,000  

 

Note 4 – Patents

 

Costs of establishing patents, consisting of legal and filing fees paid to third parties, are expensed as incurred. The fair value of the Zertane patents, determined by an independent, third party appraisal to be $500,000, was being amortized over the remaining U.S. patent life of approximately 11 years from the date of Aytu’s acquisition of the patents. As of June 30, 2016, Aytu determined that this asset had no value because the Company was directing its resources towards its commercial-stage products, and therefore, Aytu did not have the resources to complete the necessary clinical trials and bring Zertane to market before the patents expire. The remaining fair value of the Zertane patents were expensed as of June 30, 2016.

 

The cost of the oxidation reduction potential (“ORP”) related patents was $380,000 when they were acquired and are being amortized over the remaining U.S. patent life of approximately 15 years as of the date Aytu acquired it. Patents consist of the following:

 

    As of March 31,     As of June 30,  
    2017     2016  
             
Patents   $ 880,000     $ 880,000  
Less accumulated amortization     (602,000 )     (583,000 )
Patents, net   $ 278,000     $ 297,000  

 

The amortization expense was as follows:

 

    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
                         
Amortization expense   $ 6,000     $ 18,000     $ 19,000     $ 53,000  

 

Note 5 – Revenue Recognition

 

The $894,000 and $647,000 of product revenue recognized during the three months ended March 31, 2017 and 2016, respectively, and the $2,386,000 and $1,561,000 of product revenue recognized during the nine months ended March 31, 2017 and 2016, respectively, represent sales of the Company’s Natesto, ProstaScint, and Primsol products and the MiOXSYS Systems.

 

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The license revenue of $0 and $21,000 recognized in the three months ended March 31, 2017 and 2016, respectively, and the license revenue of $0 and $64,000 recognized in the nine months ended March 31, 2017 and 2016, respectively represent the amortization of the upfront payments received from the Company’s Zertane licensing agreements. The initial payment of $500,000 from the license agreement for Zertane with a Korean pharmaceutical company was deferred and was being recognized over ten years. The initial payment of $250,000 from the license agreement for Zertane with a Canadian-based supplier was deferred and was being recognized over seven years.

 

At the end of fiscal 2016, Aytu determined that the Zertane asset had no value as Aytu did not have the resources to complete the necessary clinical trials and bring it to market before the patents expire. The remaining deferred revenue of $426,000 was recognized as of June 30, 2016.

 

Note 6 – Fair Value Considerations

 

Aytu’s financial instruments include cash, cash equivalents and restricted cash, accounts receivable, investments, accounts payable and accrued liabilities, contingent consideration and warrant derivative liability. The carrying amounts of cash, cash equivalents, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to their short maturities. The valuation policies are determined by the Chief Financial Officer and approved by the Company’s Board of Directors.

 

Authoritative guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the measurement date. The guidance establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of Aytu. Unobservable inputs are inputs that reflect Aytu’s assumptions of what market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy is broken down into three levels based on reliability of the inputs as follows:

 

  Level 1: Inputs that reflect unadjusted quoted prices in active markets that are accessible to Aytu for identical assets or liabilities;
     
  Level 2: Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and
     
  Level 3: Unobservable inputs that are supported by little or no market activity.

 

Aytu’s assets and liabilities which are measured at fair value are classified in their entirety based on the lowest level of input that is significant to their fair value measurement. Aytu’s policy is to recognize transfers in and/or out of fair value hierarchy as of the date in which the event or change in circumstances caused the transfer. Aytu has consistently applied the valuation techniques discussed below in all periods presented.

 

The following table presents Aytu’s financial assets and liabilities that were accounted for at fair value on a recurring basis, by level within the fair value hierarchy:

 

    Fair Value Measurements Using  
    Level 1     Level 2     Level 3     Total  
March 31, 2017                                
ASSETS                                
Investment in Acerus   $ -     $ -     $ -     $ -  
                                 
LIABILITIES                                
Warrant derivative liability   $ -     $ -     $ -     $ -  
Contingent consideration   $ -     $ -     $ 4,080,000     $ 4,080,000  
                                 
June 30, 2016                                
ASSETS                                
Investment in Acerus   $ 1,041,000     $ -     $ -     $ 1,041,000  
                                 
LIABILITIES                                
Warrant derivative liability   $ -     $ -     $ 276,000     $ 276,000  
Contingent consideration   $ -     $ -     $ 3,869,000     $ 3,869,000  

 

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The estimated fair value of the Company’s investment in Acerus, which is classified as Level 1 (quoted price is available), was $1,041,000 as of June 30, 2016. This investment was sold during the three months ended March 31, 2017.

 

The warrant derivative liability was valued using the Black-Scholes valuation methodology because that model embodies all of the relevant assumptions that address the features underlying these instruments. The warrants related to the warrant derivative liability are not actively traded and therefore classified as Level 3. Significant assumptions in valuing the warrant derivative liability, based on estimates of the value of Aytu common stock and various factors regarding the warrants, were as follows as of February 28, 2017 and at June 30, 2016:

 

    February 28, 2017     June 30, 2016  
Warrants:                
Volatility     160.7 %     75.0 %
Equivalent term (years)     4.18       4.84  
Risk-free interest rate     1.87 %     0.99 %
Dividend yield     0.00 %     0.00 %

 

The following table sets forth a reconciliation of changes in the fair value of the derivative financial liabilities classified as Level 3 in the fair value hierarchy:

 

    Derivative Instruments  
       
Balance as of June 30, 2016   $ 276,000  
Warrant issuances     -  
Change in fair value included in earnings (February 28, 2017)     (213,000 )
Reclassification of warrant from liability to equity upon amendment     (63,000 )
Balance as of March 31, 2017   $ -  

 

We classify our contingent consideration liability in connection with the acquisition of ProstaScint and Natesto within Level 3 as factors used to develop the estimated fair value are unobservable inputs that are not supported by market activity. We estimate the fair value of our contingent consideration liability based on projected payment dates, discount rates, probabilities of payment, and projected revenues. Projected contingent payment amounts are discounted back to the current period using a discounted cash flow model. There was no change in the fair value of the contingent consideration during the period ended March 31, 2017.

 

Note 7 – Commitments and Contingencies

 

Commitments and contingencies are described below and summarized by the following table for the designated fiscal years ending June 30, as of March 31, 2017:

 

          Remaining                                
    Total     2017     2018     2019     2020     2021     Thereafter  
Prescription database   $ 1,576,000     $ 405,000     $ 598,000     $ 573,000     $ -     $    -     $ -  
Natesto     2,500,000       -       -       -       2,500,000       -       -  
Manufacturing/commercial supply agreements     -       -       -       -       -       -       -  
Service agreement     72,000       72,000       -       -       -       -       -  
Office lease     211,000       36,000       145,000       30,000       -       -       -  
Sponsored research agreement with related party     -       -       -       -       -       -       -  
    $  4,359,000     $ 513,000     $   743,000     603,000     2,500,000     $ -     $ -  

 

Prescription Database

 

In May 2016, Aytu entered into an agreement with a company that will provide Aytu with prescription database information, whereby Aytu agreed to pay approximately $1.9 million over three years for access to the database of prescriptions written for Natesto. The payments have been broken down into quarterly payments, the first of which was made in November 2016, the second payment was made in January 2017 and the third payment was made in April 2017.

 

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Natesto

 

In April 2016, the Company entered into an agreement with Acerus whereby Aytu agreed to pay $8.0 million for the exclusive U.S. rights to Natesto (see Note 1). The first payment totaling $2.0 million was paid in April, the second installment payment was paid in October 2016. The final payment totaling $4.0 million was paid in January 2017. Additionally, Aytu is required to make the first milestone payment of $2.5 million even if the milestone is not reached.

 

Manufacturing/Commercial Supply Agreements

 

In October 2015, Aytu entered into a Master Services Agreement with Biovest International, Inc. (“Biovest”). The agreement provides that Aytu may engage Biovest from time to time to provide services in accordance with mutually agreed upon project addendums and purchase orders. Aytu expects to use the agreement from time to time for manufacturing services, including without limitation, the manufacturing, processing, quality control testing, release or storage of its products for the ProstaScint product. In September 2016, Aytu entered into a Commercial Supply Agreement with Grand River Aseptic Manufacturing, Inc. (“GRAM”). The agreement provides that Aytu may engage GRAM from time to time to provide services in accordance with mutually agreed upon work orders. As of March 31, 2017, both contracts were still on hold as the Company evaluates its strategic options for the ProstaScint product. If the contracts are not restarted, Aytu does not anticipate any future liability related to either contract.

 

Service Agreement

 

In July 2015, Aytu entered into an agreement with Ampio, whereby Aytu agreed to pay Ampio a set amount per month for shared overhead, which includes costs related to the shared corporate staff and other miscellaneous overhead expenses. This agreement was amended in November 2015, April 2016, July 2016, and again in January 2017 resulting in an amount of $12,000 per month. This agreement will be in effect until it is terminated in writing by both parties.

 

Office Lease

 

In June 2015, Aytu entered into a 37 month operating lease for a space in Raleigh, North Carolina. This lease has initial base rent of $3,000 a month, with total base rent over the term of the lease of approximately $112,000. In September 2015, the Company entered into a 37 month operating lease in Englewood, Colorado. This lease has an initial base rent of $9,000 a month with a total base rent over the term of the lease of approximately $318,000. The Company recognizes rental expense of the facilities on a straight-line basis over the term of the lease. Differences between the straight-line net expenses on rent payments are classified as liabilities between current deferred rent and long-term deferred rent. Rent expense for the respective periods is as follows:

 

    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
                         
Rent expense   $ 35,000     $ 35,000     $ 105,000     $ 86,000  

 

Sponsored Research Agreement with Related Party

 

In June 2013, Luoxis entered into a sponsored research agreement with Trauma Research LLC (“TRLLC”), an entity controlled by Ampio’s director and Chief Scientific Officer, Dr. David Bar-Or. The agreement, which was amended in January 2015, provides for Luoxis (now Aytu) to pay $6,000 per month to TRLLC in consideration for services related to research and development of the Oxidation Reduction Potential platform. In March 2014, Luoxis also agreed to pay a sum of $615,000 which is being amortized over the contractual term of 60.5 months and is divided between current and long-term on the balance sheet; as of September 2014, this amount had been paid in full. This agreement was terminated on March 31, 2017. Upon termination, Aytu recognized the remainder of the amortization on the prepaid research agreement, which totaled $254,000.

 

Note 8 – Convertible Promissory Notes

 

During July and August 2015, Aytu closed on note purchase agreements with institutional and high net worth individual investors for the purchase and sale of convertible promissory notes (“Notes”) with an aggregate principal amount of $5.2 million. The sale of the Notes was pursuant to a private placement. Debt issuance costs totaled $401,000, which included the $103,000 fair value of the placement agent warrants.

 

The Notes were an unsecured obligation. Aytu did not have the right to prepay the Notes prior to the maturity date. Interest accrued on the Notes in the following amounts: (i) 8% simple interest per annum for the first six months and (ii) 12% simple interest per annum thereafter if not converted during the first nine months. Interest accrued, was payable with the principal upon maturity, conversion or acceleration of the Notes and could have been paid in kind or in cash, in Aytu’s sole discretion.

 

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Placement agents for the offering sold the institutional portion of the offering of the Notes. Aytu sold the balance of the Notes to individuals and entities with whom Aytu had an established relationship. For Notes sold by the placement agent, Aytu paid the placement agent 8% of the gross proceeds of Notes sold by the placement agents and was obligated to issue warrants for an amount of shares equal to 8% of the gross number of shares of the Company stock issuable upon conversion of the Notes issued to investors introduced to the Company by the private placement agents in the private placement, in addition to a previously paid non-refundable retainer fee of $20,000. The placement agent warrants have a term of five years from the date of issuance of the related notes in July and August 2015, an exercise price equal to the conversion price per share at which the Notes are converted into common stock. Change in fair value is recorded in earnings. Fair value at the grant date was recorded as a debt discount and amortized over the term of the debt.

 

The warrants were recorded at fair value as long-term liabilities on the Balance Sheet and upon conversion were moved to equity classification.

 

Upon Aytu’s adoption of ASU 2015-3, the issuance costs associated with the Notes were recorded as a long–term liability and were presented in the Balance Sheet as a direct reduction of the carrying amount of the Notes on their inception date.

 

Pursuant to the terms of the convertible promissory note agreements, if Aytu sold equity securities at any time while the Notes were outstanding in a financing transaction that was not a Qualified Financing (a public offering of Aytu stock resulting in gross proceeds of at least $5.0 million (excluding indebtedness converted in such financing) prior to the maturity date of the Notes), the holders of the convertible promissory notes had the option, but not the obligation, to convert the outstanding principal and accrued interest as of the closing of such financings into a number of shares of Aytu capital stock in an amount equal to 120% of the number of such shares calculated by dividing the outstanding principal and accrued interest by the lesser of (a) the lowest cash price per share paid by purchasers of shares in such financing, or (b) $4.63. As a result of Aytu’s sale of common stock on January 20, 2016, the Company was obligated to provide notice to the above-referenced noteholders of such stock sales. In accordance with the convertible note terms, noteholders had the option to convert their entire balance (inclusive of accrued but unpaid interest) into a number of shares of Aytu common stock equal to 120% of the number of shares calculated by dividing such note balance by $7.80, which was the per share purchase price paid in the equity financing described above. On February 10, 2015, the date of the conversion, an aggregate of $4,125,000 of principal and $143,000 of accrued interest on the Notes converted into an aggregate of 656,591 shares of Aytu’s common stock under the original terms of the agreement.

 

In May 2016, Aytu completed a registered public offering which was considered a Qualified Financing and all outstanding Notes were automatically converted on the same terms as in the offering. At the insistence of the underwriters of the offering, all outstanding noteholders had signed lockup agreements which granted them an extra 10% on the conversion, increasing it to 130% of shares calculated by dividing such Note balance by $4.80, which was the per share purchase price in the registered offering. On May 6, 2016, the date of conversion, an aggregate of $1,050,000 of principal and $78,000 of accrued interest on the Notes converted into an aggregate of 305,559 shares of Aytu’s common stock and 305,559 warrants.

 

In connection with the conversion of the Aytu Notes, Aytu was obligated to issue to the placement agents for the convertible note offering warrants for an amount of shares equal to 8% of the number of shares of Aytu’s common stock for the Notes sold by the placement agents issued upon conversion of the Notes. As a result of the optional note conversion, on February 10, 2016, Aytu issued warrants to the placement agents to purchase an aggregate of 22,254 shares of common stock at an exercise price of $7.80 per share. As a result of the second Note conversion, on May 6, 2016, Aytu issued warrants to the placement agents to purchase an aggregate of 22,564 shares of common stock at an exercise price of $4.80 per share. These warrants are exercisable for five years from the date of issuance of the related Notes in July and August 2015. The warrants have a cashless exercise feature.

 

Also in connection with the conversion of the Notes, Aytu recorded a beneficial conversion feature of $4.9 million which was recorded as a debt discount; this amount represents that carrying amount of the Notes at the date of conversion. The beneficial conversion feature was expensed upon conversion of the Notes to interest expense.

 

Note 9 – Common Stock

 

Capital Stock

 

At March 31, 2017 and June 30, 2016, Aytu had 13,836,607 and 3,741,944 common shares outstanding, respectively, and no preferred shares outstanding at either March 31, 2017 or June 30, 2016. The Company has 100.0 million shares of common stock authorized with a par value of $0.0001 per share and 50.0 million shares of preferred stock authorized with a par value of $0.0001 per share.

 

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In May 2016, Aytu raised gross proceeds of approximately $7.5 million through a public offering of 1,562,500 Units. Offering costs totaled $1.2 million resulting in net proceeds of $6.3 million. Each Unit consisted of one share of Aytu common stock and a warrant to purchase one share of Aytu common stock. The common stock issued had a relative fair value of $4.2 million. The warrants have an exercise price of $6.00 per share and will expire five years from the date of issuance. These warrants have a relative fair value of $2.1 million. We also granted the underwriters a 45-day option (the Over-Allotment Option) to purchase up to an additional 234,375 shares of common stock and/or warrants. The underwriters exercised 170,822 of this over-allotment option for the warrants and paid $0.12 per over-allotment warrant resulting in proceeds of $20,000. These warrants have the same terms as the warrants sold in the registered offering.

 

On June 30, 2016, Aytu effected a reverse stock split in which each common stock holder received one share of common stock for each 12 shares. All share and per share amounts for all periods presented in this report have been adjusted to reflect the effect of this reverse stock split.

 

In July 2016, we entered into a purchase agreement (the “Purchase Agreement”), together with a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Upon signing the Purchase Agreement, Lincoln Park agreed to purchase 133,690 shares of our common stock for $500,000 as an initial purchase under the agreement. We also issued as a commitment fee to Lincoln Park of 52,500 shares of common stock. In September 2016, Lincoln Park purchased an additional 40,000 shares for $131,000, the issuance costs related to these purchases totaled $24,000, resulting in net proceeds for the quarter ended September 30, 2016 of $607,000.

 

In July 2016, we issued 1,000,000 shares of restricted stock as compensation to certain executive officers and directors, which vest in July 2026. This expense is included in sales, general and administrative. For the three and nine months ended March 31, 2017, the expense was $499,000 and $655,000, respectively. The original fair value of the restricted stock was $3,230,000. As of March 31, 2017, the remaining unrecognized expense is $2,575,000. During the quarter ended March 31, 2017, one of the Company’s executive officers resigned and his restricted stock vested in full upon this event. This resulted in the Company recognizing the remainder of the expense of $430,000.

 

In August 2016, we issued an aggregate of 142,457 shares of common stock as bonuses for performance in 2016 to three executive officers.

 

In November 2016, we raised gross proceeds of approximately $8.6 million through a public offering of 5,735,000 Units. Offering costs totaled $998,000 resulting in net cash proceeds of $7.6 million. We also issued underwriter warrants in connection with the offering with a fair value of $293,000, resulting in net proceeds of $7.3 million. Each Unit consisted of one share of Aytu common stock and a warrant to purchase one share of Aytu common stock. The common stock issued had a relative fair value of $3.7 million and a fair value of $4.4 million. The investor warrants have an exercise price of $1.86 per share and will expire five years from the date of issuance. These investor warrants have a relative fair value of $3.5 million and a fair value of $4.2 million. We also granted the underwriters a 45-day option (the Over-Allotment Option) to purchase up to an additional 860,250 shares of common stock and/or warrants. The underwriters purchased 285,245 of this Over-Allotment Option for the warrants and paid $0.01 per over-allotment warrant. These warrants have the same terms as the warrants sold in the registered offering. These warrants have a relative fair value of $173,000, a fair value of $208,000, and proceeds of $3,000, which was the purchase price per the underwriting agreement.

 

On February 28, 2017, the Company consummated its warrant tender offer to exercise, at a temporarily reduced exercise price of $0.75 per share, (i) outstanding warrants to purchase 1,733,322 shares of common stock with an exercise price of $6.00 per share, which were originally issued to investors in the Company’s May 2016 financing (the “May 2016 Warrants”), and (ii) outstanding warrants to purchase 6,020,245 shares of common stock with an exercise price of $1.86 per share, which were originally issued to investors in the Company’s October 2016 financing (the “October 2016 Warrants” and together with the May 2016 Warrants, the “Original Warrants”). Original warrants to purchase an aggregate of 2,991,041 shares of common stock were tendered and exercised in the warrant tender offer, for aggregate gross proceeds to the Company of approximately $2.2 million. Original warrants that were not tendered and exercised remain in effect at the pre-tender offer exercise prices of $6.00 per share and $1.86 per share, respectively (see Note 10).

 

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Note 10 – Equity Instruments

 

Stock Option Repricing

 

In March 2017, our Board of Directors approved a common stock option repricing program whereby all previously granted and unexercised options were repriced on a one-for-one basis to $0.82 per share which represented the closing price of our common stock as of the date of the repricing. There was no other modification to the vesting schedule of the previously issued options. As a result, 737, 279 unexercised options originally granted to purchase common stock at prices ranging from $3.23 to $55.56 per share were repriced under this program.

 

We treated the repricing as a modification of the original awards and calculated additional compensation costs for the difference between the fair value of the modified award and the fair value of the original award on the modification date. The repricing resulted in an incremental stock-based compensation expense of $34,000. The full expense was recognized during the three months ended March 31, 2017.

 

In July 2016, our Board of Directors approved a common stock option repricing program whereby previously granted and unexercised options held by our then current employees, consultants and directors with exercise prices above $6.00 per share were repriced on a one-for-one basis to $3.23 per share which represented the per share fair value of our common stock as of the date of the repricing. There was no other modification to the vesting schedule of the previously issued options. As a result, 316,051 unexercised options originally granted to purchase common stock at prices ranging from $6.72 to $18.12 per share were repriced under this program.

 

We treated the repricing as a modification of the original awards and calculated additional compensation costs for the difference between the fair value of the modified award and the fair value of the original award on the modification date. The repricing resulted in an incremental stock-based compensation expense of $318,000. Expense related to vested shares was expensed on the repricing date and expense related to unvested shares is being amortized over the remaining vesting period of such stock options.

 

Options

 

On June 1, 2015, Aytu’s stockholders approved the 2015 Stock Option and Incentive Plan (the “2015 Plan”), which, as amended in November 2016, provides for the award of stock options, stock appreciation rights, restricted stock and other equity awards for up to an aggregate of 2.0 shares of common stock. The shares of common stock underlying any awards that are forfeited, canceled, reacquired by Aytu prior to vesting, satisfied without any issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2015 Plan will be added back to the shares of common stock available for issuance under the 2015 Plan.

 

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Pursuant to the 2015 Stock Plan, 2.0 million shares of its common stock, are reserved for issuance. The fair value of options granted was calculated using the Black-Scholes option pricing model. In order to calculate the fair value of the options, certain assumptions are made regarding components of the model, including the estimated fair value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield and expected option life. Changes to the assumptions could cause significant adjustments to valuation. Aytu estimates the expected term based on the average of the vesting term and the contractual term of the options. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. The assumptions used for the nine months ended March 31, 2017 are as follows:

 

Expected volatility         182% - 185%
Risk free interest rate   0.97 % - 1.14%
Expected term (years)   5.0 - 6.5
Dividend yield   0%

 

Stock option activity is as follows:

 

    Number of
Options
    Weighted
Average
Exercise Price
      Weighted Average
Remaining Contractual
Life in Years
 
Outstanding June 30, 2016     322,302     $ 1.00       9.33  
Granted     441,999     $ 0.93          
Exercised     -     $ -          
Forfeited     (25,980 )   $ 4.42          
Cancelled     (1,355 )   $ 3.23          
Outstanding March 31, 2017     736,966     $ 0.82       8.53  
Exercisable at March 31, 2017     371,636     $ 0.82       8.04  
Available for grant at March 31, 2017     1,263,034                  

 

Stock-based compensation expense related to the fair value of stock options was included in the statements of operations as research and development expenses and selling, general and administrative expenses as set forth in the table below. Aytu determined the fair value as of the date of grant using the Black-Scholes option pricing model and expenses the fair value ratably over the vesting period. During the quarter ended March 31, 2017, one of the Company’s executive officers resigned and his options vested in full upon this event. This resulted in the Company recognizing the remainder of the expense of $520,000. The following table summarizes stock-based compensation expense for the stock option issuances for the three and nine months ended March 31, 2017 and three and nine months ended March 31, 2016:

 

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    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
Research and development expenses                                
Stock options   $ -     $ 38,000     $ -     $ 63,000  
Selling, general and administrative expenses                                
Stock options     817,000       258,000       2,242,000       484,000  
    $ 817,000     $ 296,000     $ 2,242,000     $ 547,000  
                                 
Unrecognized expense at March 31, 2017   $ 1,022,000                          
                                 
Weighted average remaining years to vest     2.06                          

 

Warrants

 

A summary of all warrants is as follows:

 

    Number of
Warrants
    Weighted
Average
Exercise Price
      Weighted Average
Remaining Contractual
Life in Years
 
Outstanding June 30, 2016     2,201,627     $ 6.19       4.71  
                         
Issuance of settlement warrants to initial investors     88,032     $ 4.00          
Warrants issued to investors in connection with the registered offering     6,020,245     $ 1.86          
Warrants issued to placement agents for the registered offering     401,450     $ 0.75          
Warrants exercised     (2,991,041 )   $ 0.75          
                         
Outstanding March 31, 2017     5,720,313     $ 2.51       4.48  

 

Included in the warrant balance at June 30, 2016 are warrants to purchase of 109,375 shares of common stock issued to the underwriters of our May registered offering. These warrants were accounted for under liability accounting and were fair valued at each reporting period (see Note 6). On February 28, 2017, these warrants had a fair value of $63,000. Upon the amendment to these warrant agreements, in connection with the closing of our warrant tender offer, this value was reclassified from liability accounting to equity after we removed any provision in the amendment that could cause this to be paid in cash.

 

Included in the warrant balance at June 30, 2016 are warrants to purchase of 8,566 shares of common stock issued to the bankers that assisted us with our Notes (see Note 8). In March 2017, the Company reduced the exercise price of $7.80 to $0.75. This modification resulted in an expense of $1,500 which was recognized during the quarter ended March 31, 2017 in sales, general and administrative.

 

During the nine months ended March 31, 2017, Aytu issued warrants to purchase 88,032 shares of common stock to initial investors of the Company at an exercise price of $4.00 and a term of five years from July 2016. These warrants generated a non-cash expense of $596,000 for the nine month period ended March 31, 2017, which is included in sales, general and administrative expense. These warrants are accounted for under equity treatment.

 

In connection with our November 2016 public offering, we issued to the underwriters of the public offering warrants to purchase an aggregate of 401,450 shares of common stock at an exercise price of $1.86 and a term of five years. These warrants are accounted for under equity treatment. In February, we reduced the exercise price of these warrants to $0.75.

 

Also in connection with our November 2016 public offering, we issued to investors warrants to purchase an aggregate of 6,020,245 shares of common stock, which includes the over-allotment warrants, at an exercise price of $1.86 with a term of five years. These warrants are accounted for under equity treatment (see Note 9).

 

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The warrants issued in connection with our November registered offering are all registered and tradable on the OTCQX under the ticker symbol “AYTUZ.”

 

On February 28, 2017, the Company consummated its warrant tender offer to exercise, at a temporarily reduced exercise price of $0.75 per share, (i) outstanding warrants to purchase 1,733,322 shares of common stock with an exercise price of $6.00 per share, which were originally issued to investors in the Company’s May 2016 financing (the “May 2016 Warrants”), and (ii) outstanding warrants to purchase 6,020,245 shares of common stock with an exercise price of $1.86 per share, which were originally issued to investors in the Company’s October 2016 financing (the “October 2016 Warrants” and together with the May 2016 Warrants, the “Original Warrants”). Original Warrants to purchase an aggregate of 2,991,041 shares of common stock were tendered and exercised in the warrant tender offer, for aggregate gross proceeds to the Company of approximately $2.2 million. Original warrants that were not exercised remain in effect at the pre-tender offer exercise prices of $6.00 per share and $1.86 per share, respectively. The incremental fair value, which had no book impact, was $178,000.

 

The Company also reduced the exercise prices of an aggregate of 510,825 warrants to purchase shares of common stock, which were originally issued as underwriters’ compensation in the May 2016 and October 2016 financings, from $6.00 per share and $1.86 per share, respectively, to $0.75 per share. The amended warrants related to the May 2016 financing adjusted the accounting for these warrants from liability classification to equity. The incremental fair value of these warrant modifications, which had no book impact, was $23,000.

 

All warrants were valued using the Black-Scholes option pricing model. In order to calculate the fair value of the warrants, certain assumptions were made regarding components of the model, including the selling price or fair market value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield, and expected life. Changes to the assumptions could cause significant adjustments to valuation. The Company estimated a volatility factor utilizing a weighted average of comparable published volatilities of peer companies. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. During the three months ended March 31, 2017, Aytu modified 3,510,432 warrants. We used the value of $0.76 per the valuation of our common stock issued in the March 31, 2017 quarter.

 

Significant assumptions in valuing the warrants modified during the March 31, 2017 quarter were as follows:

 

Expected volatility         156.64% - 169.22%
Risk free interest rate   1.63% - 1.87%
Contractual term (years)   3.46 - 4.67
Dividend yield   0%

 

Note 11 – Related Party Transactions

 

Executive/Director Stock Purchases

 

When Aytu completed the November 2016 registered offering, our executive officers Joshua Disbrow, Jarrett Disbrow and Gregory Gould and our director, Gary Cantrell, participated in this offering, purchasing 166,666, 166,666, 66,666 and 33,333 units respectively. The warrants received by these executives were all exercised in February as part of our warrant tender offer (see Note 10).

 

Ampio Loan Agreements

 

On April 16, 2015, Ampio received 396,816 shares of common stock of Aytu for (i) issuance to Aytu of a promissory note from Ampio in the principal amount of $10.0 million, maturing on the first anniversary of the Merger, and (ii) cancellation of indebtedness of $12.0 million to Ampio. The $10.0 million was paid to Aytu, with $5.0 million paid in June of 2015 and $5.0 million paid in December of 2015.

 

Services Agreement

 

The Company has a service agreement with Ampio which is described in Note 7.

 

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Sponsored Research Agreement

 

The Company had a service agreement with TRLLC which is described in Note 7.

 

Note 12 – Subsequent Events

 

On May 3, 2017, we entered into a Merger Agreement with Nuelle, Inc. and its stockholders, pursuant to which Nuelle would become our wholly owned subsidiary (the “Merger”). The Merger closed on May 5, 2017.

 

In the Merger, (i) each share of Nuelle common stock and each option or warrant to purchase Nuelle stock was cancelled, and (ii) each share of Nuelle preferred stock was converted into the right to receive shares of our common stock. We issued to the Nuelle preferred stockholders an aggregate of 2,500,000 shares of our common stock.

 

In addition, Nuelle preferred stockholders will be entitled to revenue earn-out payments equal to a designated percentage of net sales on tiers of net sales up to $100.0 million, with an average rate for all tiers in the mid-single digit range and a maximum aggregate payout of $6.9 million.

 

Nuelle stockholders additionally will be entitled to milestone earn-out payments of up to a potential aggregate of $24 million, upon the attainment by us of designated net sales thresholds over any sequential four calendar quarter period.

 

The first $1.0 million of earn-out payments will be paid in shares of our common stock and all other earn-out payments will be comprised of 60% cash and 40% shares of our common stock. The stock portion of any earn-out will be calculated by dividing each Nuelle stockholder’s portion of the earn-out by the average closing price of our common stock for the 10 trading days prior to the earlier of the date we deliver notice to the Nuelle stockholders of the earn-out or any public disclosure by us of the earn-out being due and payable.

 

In the event that we do not make all of the required earn-out payments to the Nuelle stockholders before May 3, 2022, and we also close a divestiture before May 3, 2022 of any of the products acquired in the Merger, we will pay the Nuelle stockholders a combination of (i) cash in an amount equal to 10% of the value of all cash, securities and other property paid to us in the divestiture (cash is to be 60% of the total consideration), and (ii) shares of our common stock equal to the Nuelle stockholders’ portion of the divestiture payment divided by the average closing price of our common stock for the 10 trading days prior to the earlier of the closing date of the divestiture or the public disclosure of the divestiture (shares of common stock are to be 40% of the total consideration).

 

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

 

This discussion should be read in conjunction with Aytu BioScience, Inc.’s Annual Report on Form 10-K for the year ended June 30, 2016, filed on September 1, 2016. The following discussion and analysis contains forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. For additional information regarding these risks and uncertainties, please see the risk factors included in Aytu’s Form 10-K filed with the Securities and Exchange Commission on September 1, 2016.

 

Overview  

 

We are a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. We are currently focused on addressing significant medical needs in the areas of hypogonadism, urological cancers, urinary tract infections and male infertility.

 

Through a multi-step reverse triangular merger, on April 16, 2015, Vyrix Pharmaceuticals, Inc. (“Vyrix”) and Luoxis Diagnostics, Inc. (“Luoxis”) merged with and into our Company (herein referred to as the Merger) and we abandoned our pre-Merger business plans to solely pursue the specialty healthcare market, including the business of Vyrix and Luoxis. In the Merger, we acquired the RedoxSYS, MiOXSYS and Zertane products. On June 8, 2015, we reincorporated as a domestic Delaware corporation under Delaware General Corporate Law and changed our name from Rosewind Corporation to Aytu BioScience, Inc., and effected a reverse stock split in which each common stock holder received one share of common stock for every 12.174 shares outstanding. On June 30, 2016, we effected another reverse stock split in which each common stock holder received one share of common stock for each 12 shares. All share and per share amounts in this report have been adjusted to reflect the effect of these two reverse stock splits (herein referred to collectively as the Reverse Stock Splits).

 

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In May 2015, we entered into an asset purchase agreement with Jazz Pharmaceuticals, Inc., pursuant to which we purchased assets related to Jazz Pharmaceuticals’ product known as ProstaScint (capromab pendetide), including certain intellectual property and contracts, and the product approvals, inventory and work in progress (together, the “ProstaScint Business”), and assumed certain of Jazz Pharmaceuticals’ liabilities, including those related to product approvals and the sale and marketing of ProstaScint. The purchase price consisted of the upfront payment of $1.0 million. We also paid an additional $500,000 within five days after transfer for the ProstaScint-related product inventory and $227,000 was paid on September 30, 2015 (which represents a portion of certain FDA fees). We also will pay 8% on net sales made after October 31, 2017, payable up to a maximum aggregate payment of an additional $2.5 million.

 

In October 2015, we entered into an asset purchase agreement with FSC Laboratories, Inc., or FSC. Pursuant to the agreement, we purchased assets related to FSC’s product known as Primsol (trimethoprim solution), including certain intellectual property and contracts, inventory, work in progress and all marketing and sales assets and materials related solely to Primsol (together, the “Primsol Business”), and assumed certain of FSC’s liabilities, including those related to the sale and marketing of Primsol arising after the closing. We paid $500,000 at closing for the Primsol Business and we paid an additional $142,000, of which $102,000 went to inventory and $40,000 towards the Primsol Business, for the transfer of the Primsol-related product inventory. We also paid $500,000 in April 2016, $500,000 in July 2016, and $250,000 in November 2016, for a total purchase price of $1,892,000.

 

In October 2015, we and Biovest International, Inc., or Biovest, (whose contract manufacturing business is now known as Cell Culture Company, or C3) entered into a Master Services Agreement, pursuant to which Biovest is to provide manufacturing services to us for our product ProstaScint. The agreement provides that we may engage Biovest from time to time to provide services in accordance with mutually agreed upon project addendums and purchase orders for ProstaScint. We expect to use the agreement from time to time for manufacturing services, including without limitation, the manufacturing, processing, quality control testing, release or storage of ProstaScint. The agreement provides customary terms and conditions, including those for performance of services by Biovest in compliance with project addendums, industry standards, regulatory standards and all applicable laws. Biovest will be responsible for obtaining and maintaining all governmental approvals, at our expense, during the term of the agreement. The agreement has a term of four years, provided that either party may terminate the agreement or any project addendum under the agreement on 30 days written notice of a material breach under the agreement. In addition, we may terminate the agreement or any project addendum under the agreement upon 180 days written notice for any reason. This contract is currently on hold as we evaluate our strategic options for the ProstaScint product.

 

In April 2016, we entered into a license and supply agreement to acquire the exclusive U.S. rights to Natesto nasal gel from Acerus Pharmaceuticals Corporation, or Acerus, which rights we received on July 1, 2016. We paid Acerus an upfront fee of $2.0 million upon execution of the agreement. In October 2016 we paid an additional $2.0 million and in January of 2017, we paid the final upfront payment of $4.0 million. We also purchased on April 28, 2016, an aggregate of 12,245,411 shares of Acerus common stock for Cdn. $2,534,800 (approximately US $2.0 million), with a purchase price per share equal to Cdn. $0.207 or approximately US $0.16 per share. We also agreed to make various payments based upon certain sales milestones up to an aggregate of $37.5 million based on net sales of Natesto. During the term of the agreement, we will purchase all of our Natesto product needs from Acerus at a designated price. In our third fiscal quarter of 2017, we sold all of the shares of common stock of Acerus Pharmaceutics Corporation that we acquired in April 2016 for approximately $2.0 million as a condition to our licensing of Natesto. The per share purchase price was Cdn. $0.207. Acerus common stock is traded on the Toronto Stock Exchange. The gross proceeds from the sale of the Acerus shares was approximately $1.1 million.

 

In May 2016, we sold in an underwritten public offering 1,562,500 shares of our common stock, par value $0.0001 per share, and warrants to purchase up to an aggregate 1,562,500 shares of common stock at a combined public offering price of $4.80 per share and related warrant. Each warrant is exercisable for five years from issuance and has an exercise price equal to $6.00. In addition, we granted the underwriters a 45-day option to purchase up to an additional 234,375 shares of common stock and/or 234,375 additional warrants. The underwriters elected a partial purchase of their over-allotment option to purchase 170,822 warrants. The net cash proceeds from the sale of the shares and warrants was approximately $6.6 million, after deducting underwriting discounts and commissions and estimated offering expenses.

 

In July 2016, Aytu issued 1.0 million shares of restricted stock to executive officers and directors.

 

In July 2016, we entered into a purchase agreement (the “Purchase Agreement”), together with a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), an Illinois limited liability company. Upon signing the Purchase Agreement, Lincoln Park agreed to purchase 133,690 shares of our common stock for $500,000 as an initial purchase under the agreement. We also issued as a commitment fee to Lincoln Park of 52,500 shares of common stock. In September 2016, Lincoln Park purchased an additional 40,000 shares for $131,000.

 

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Under the terms and subject to the conditions of the Purchase Agreement, we have the right to sell to and Lincoln Park is obligated to purchase up to an additional $10.0 million in amounts of shares of our common stock, subject to certain limitations, from time to time, over the 36-month period commencing on September 20, 2016 (the date that the registration statement that we filed with the Securities and Exchange Commission (the “SEC”) pursuant to the Registration Rights Agreement, was declared effective by the SEC and a final prospectus in connection therewith was filed.

 

In September 2016, Aytu entered into a Commercial Supply Agreement with Grand River Aseptic Manufacturing, Inc. (“GRAM”). The agreement provides that Aytu may engage GRAM from time to time to provide services in accordance with mutually agreed upon work orders. Aytu expects to use the agreement from time to time for the filling, labeling, and packaging of its ProstaScint product. As of March 31, 2017, this contract remains on hold.

 

On October 27, 2016, we priced an underwritten public offering of 5,735,000 shares of our common stock and warrants to purchase up to an aggregate of 5,735,000 shares of our common stock at a combined public offering price of $1.50 per share and related warrant. The gross proceeds from the offering to Aytu was $8.6 million, before deducting the underwriting discount and estimated offering expenses payable by Aytu, but excluding the exercise of any warrants. The Company also granted the representative of the underwriters a 45-day option to purchase up to an additional 860,250 shares and/or 860,250 additional warrants. The shares of common stock were immediately separable from the warrants and were issued separately. The warrants are exercisable immediately upon issuance, expire five years after the date of issuance and have an exercise price of $1.86 per share. On November 2, 2016, we completed the public offering. In connection with the closing, the underwriters purchased a portion of their 45-day option and purchased an additional 285,245 additional warrants at closing. Our net cash proceeds from the offering, after deducting the placement agent fees and the offering expenses, was $7.6 million.

 

On February 28, 2017, we consummated our warrant tender offer to exercise, at a temporarily reduced exercise price of $0.75 per share, (i) outstanding warrants to purchase 1,733,322 shares of our common stock with an exercise price of $6.00 per share, which were originally issued to investors in our May 2016 financing(the “May 2016 Warrants”), and (ii) outstanding warrants to purchase 6,020,245 shares of our common stock with an exercise price of $1.86 per share, which were originally issued to investors in our October 2016 financing (the “October 2016 Warrants” and together with the May 2016 Warrants, the “Original Warrants”).

 

The warrant tender offer expired at 11:59 p.m. Eastern Time on the evening of February 27, 2017 (the “Expiration Date”). Original warrants to purchase an aggregate of 2,991,041 shares of our common stock were tendered and exercised in the warrant tender offer, for aggregate gross proceeds to our company of approximately $2.2 million. Original warrants tendered and exercised represent approximately 38.6% of the original warrants outstanding immediately prior to the Expiration Date. Original warrants that were not tendered and exercised remain in effect at the pre-tender offer exercise prices of $6.00 per share and $1.86 per share, respectively.

 

Joseph Gunnar & Co., LLC and Fordham Financial Management, Inc. acted as warrant solicitation agents and received a fee equal to 6% of the aggregate gross proceeds to our company, plus reimbursement of approximately $25,000 in out-of-pocket expenses and indemnification against certain liabilities. We also reduced the exercise prices of an aggregate of 510,825 warrants to purchase shares of our common stock, which were originally issued as underwriters’ compensation in the May 2016 and October 2016 financings, from $6.00 per share and $1.86 per share, respectively, to $0.75 per share. In March, we also reduced the price of the 8,566 warrants issued to the bankers that helped us with the Convertible Promissory Notes in fiscal 2016 to an exercise price of $0.75.

 

On March 16, 2017, we reduced the exercise price of outstanding options issued to directors, employees and consultants to purchase an aggregate of 737,279 shares of our common stock from a weighted average exercise price of $3.53 to $0.82 to incentivize the holders of these options.

 

On March 31, 2017, we entered into and closed on an Asset Purchase Agreement with Allegis Holdings, LLC (the “Purchaser”). Pursuant to the agreement, we sold to the Purchaser all of our assets related to our Primsol Product, including certain intellectual property and contracts, inventory, work in process and all marketing assets and materials related solely to Primsol (together, the “Primsol Asset”). We have evaluated this transaction and concluded that it is not significant to our business.

 

As of the date of this Report, we have financed operations through a combination of private and public debt and equity financings. Although it is difficult to predict our liquidity requirements, based upon our current operating plan, as of the date of this Report, we believe we will have sufficient cash to meet our projected operating requirements for the next few months. See “Liquidity and Capital Resources.” We have been able to raise capital during the past two years and have a plan to raise additional capital within the next few months to continue our normal operations, although we cannot give any assurances that we will be successful in raising capital in the future.

 

We have only begun to generate revenues from the commercialization of our product candidates in the last fiscal year. We recognized approximately $2.1 million in revenue from ProstaScint, Primsol and RedoxSYS sales during fiscal 2016 and $894,000 and $2.4 million during the three and nine months ended March 31, 2017 which included sales of our Natesto and MiOXSYS products. We have incurred accumulated net losses since our inception, and at March 31, 2017, we had an accumulated deficit of $62.3 million. Our net loss was $5.2 million and $15.8 million, respectively, for the three and nine months ended March 31, 2017 and we used $10.6 million in cash from operations during the nine months ended March 31, 2017.

 

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ACCOUNTING POLICIES

 

Significant Accounting Policies and Estimates

 

Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to recoverability and useful lives of long-lived assets, stock compensation, valuation of derivative instruments, allowances and contingencies. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The methods, estimates, and judgments used by us in applying these critical accounting policies have a significant impact on the results we report in our financial statements. Our significant accounting policies and estimates are included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2016, filed with the SEC on September 1, 2016.

 

Information regarding our accounting policies and estimates can be found in the Notes to the Financial Statements.

 

Newly Issued Accounting Pronouncements

 

Information regarding the recently issued accounting standards (adopted and pending adoption as of March 31, 2017) is combined in Note 1 to the financial statements.

 

RESULTS OF OPERATIONS

 

Results of Operations – March 31, 2017 Compared to March 31, 2016

 

Results of operations for the three months ended March 31, 2017 and the three months ended March 31, 2016 reflected losses of approximately $5.2 million and $7.3 million, respectively. These losses include in part non-cash charges related to stock-based compensation, depreciation, amortization and accretion, loss on investment, and amortization of prepaid research and development – related party offset by the gain on sale of assets and warrant derivative income in the amount of $2.0 million for the three months ended March 31, 2017 and $4.5 million for the three months ended March 31, 2016, respectively. The non-cash charges decreased in the three months ended 2017 primarily due to the beneficial conversion feature on the convertible debt that we issued in fiscal 2016 that was recognized during the three months ended March 31, 2017.

 

Results of operations for the nine months ended March 31, 2017 and the nine months ended March 31, 2016 reflected losses of approximately $15.8 million and $12.9 million, respectively. These losses include in part non-cash charges related to stock-based compensation, depreciation, amortization and accretion, compensation through issuance of stock, issuance of warrants to initial investors, and amortization of prepaid research and development – related party, loss on sale of investment, offset by the gain on sale of assets and warrant derivative income in the amount of $6.0 million for the nine months ended March 31, 2017 and $5.2 million for the nine months ended March 31, 2016, respectively. The non-cash charges increased in the nine months ended 2017 primarily due to the increase in stock-compensation expense, the amortization of intangible assets, compensation through issuance of common stock and issuance of warrants which was offset by the beneficial conversion feature on the convertible debt that we issued in 2016.

 

Revenue

 

Product revenue

 

We recognized $894,000 and $647,000 for the three months ended March 31, 2017 and 2016, respectively, related to the sale of our products Natesto, ProstaScint, and Primsol, as well as the MiOXSYS System. Our revenues grew due to our acquisition of Natesto in April 2016 and expanded marketing of our products.

 

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We recognized $2.4 million and $1.6 million for the nine months ended March 31, 2017 and 2016, respectively, related to the sale of our products Natesto, ProstaScint, and Primsol, as well as the MiOXSYS System. Our revenue grew due to our acquisitions of Natesto in April 2016 and Primsol in October 2015 and expanded marketing of our products.

 

As is customary in the pharmaceutical industry, our gross product sales are subject to a variety of deductions in arriving at reported net product sales. Provisions for these deductions are recorded concurrently with the recognition of gross product sales revenue and include discounts, chargebacks, distributor fees, processing fees, as well as allowances for returns and Medicaid rebates. Provision balances relating to estimated amounts payable to direct customers are netted against accounts receivable and balances relating to indirect customers are included in accounts payable and accrued liabilities. The provisions recorded to reduce gross product sales and net product sales are as follows:

 

    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
             
Gross product and service revenue   $ 1,024,000     $ 950,000     $ 3,308,000     $ 2,093,000  
Provisions to reduce gross product sales to net product and service sales     (130,000 )     (282,000 )     (922,000 )     (532,000 )
Net product and service revenue   $ 894,000     $ 668,000     $ 2,386,000     $ 1,561,000  
                                 
Percentage difference in gross sales to net sales     87.3 %     70.3 %     72.1 %     74.6 %

 

License revenue

 

The license revenue of $0 and $21,000 recognized in the three months ended March 31, 2017 and 2016, respectively, represents the amortization of the upfront payments received from the Company’s license agreements. The license revenue of $0 and $64,000 recognized in the nine months ended March 31, 2017 and 2016, respectively, represents the amortization of the upfront payments received from the Company’s license agreements. In 2012, we received a payment of $500,000 under our out-license agreement for Zertane with a Korean pharmaceutical company. This payment was deferred and was being recognized over 10 years. In 2014, we received a payment of $250,000 under our out-license agreement for Zertane with a Canadian-based supplier. This payment was deferred and was being recognized over seven years. At June 30, 2016, Aytu determined that the Zertane asset had no value as Aytu did not have the resources to complete the necessary clinical trials and bring it to market before the patents expire. Therefore, the remaining unamortized deferred revenue of $426,000 which was outstanding as of the date it was determined not to proceed with the clinical trials was recognized as of June 30, 2016.

 

Expenses

 

Cost of Sales

 

The cost of sales of $324,000 and $1,068,000 recognized for the three and nine months ended March 31, 2017, respectively, and the cost of sales of $341,000 and $622,000 recognized for the three and nine months ended March 31, 2016, respectively, are related to the Natesto, ProstaScint and Primsol products and the MiOXSYS Systems. We expect to see cost of sales decrease as a percentage of revenues in future periods as our revenues grow and offset some of the set period cost in cost of sales.

 

Research and Development

 

Research and development costs consist of clinical trials and sponsored research, manufacturing transfer expense, labor, stock-based compensation, sponsored research – related party and consultants and other. These costs relate solely to research and development without an allocation of general and administrative expenses and are summarized as follows:

 

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    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
             
Clinical trials and sponsored research     278,000       976,000       771,000       2,882,000  
Labor     -       123,000       -       333,000  
Stock-based compensation     -       38,000       -       63,000  
Sponsored research - related party     292,000       48,000       388,000       144,000  
Consultants and other     1,000       7,000       3,000       30,000  
    $ 571,000     $ 1,192,000     $ 1,162,000     $ 3,452,000  

 

Comparison of Three and Nine Months Ended March 31, 2017 and 2016

 

Research and development expenses decreased $621,000, or 52.1%, for the three months ended March 31, 2017 compared to the three months ended March 31, 2016. Research and development expenses decreased $2.3 million, or 66.3%, for the nine months ended March 31, 2017 compared to the nine months ended March 31, 2016. This was due primarily to switching our focus towards our commercial products and eliminating expenses related to Zertane. We anticipate research and development expense will continue at approximately the same rate or slightly decrease for the remainder of fiscal 2017 as compared to the three months ended March 31, 2017.

 

Selling, General and Administrative

 

General and administrative expenses consist of labor costs including personnel costs for employees in executive, commercial, business development and operational functions; stock-based compensation; patents and intellectual property; professional fees including legal, auditing, accounting, investor relations, shareholder expense and printing and filing of SEC reports; occupancy, travel and other including rent, governmental and regulatory compliance, insurance, and professional subscriptions; directors fees; and management fee – related party. These costs are summarized as follows:

 

    Three Months Ended March 31,     Nine Months Ended March 31,  
    2017     2016     2017     2016  
             
Labor   $ 2,078,000     $ 958,000     $ 6,108,000     $ 2,270,000  
Stock-based compensation     1,316,000       258,000       2,897,000       484,000  
Patent costs     33,000       63,000       89,000       229,000  
Professional fees     235,000       121,000       745,000       694,000  
Occupancy, travel and other     683,000       765,000       3,774,000       1,739,000  
Directors Fees     40,000       -       120,000       -  
Management fee - related party     36,000       80,000       137,000       255,000  
    $ 4,421,000     $ 2,245,000     $ 13,870,000     $ 5,671,000  

 

Comparison of Three and Nine Months Ended March 31, 2017 and 2016

 

General and administrative costs increased $2.2 million, or 96.9%, for the three months ended March 31, 2017 compared to the three months ended March 31, 2016. General and administrative costs increased $8.2 million or 144.6%, for the nine months ended March 31, 2017 compared to the nine months ended March 31, 2016. The increase in labor costs, stock-based compensation, and occupancy, travel and other primarily relates to increased costs related to the increase in professional staffing due to our commercialization efforts for our Natesto and ProstaScint products. We expect general and administrative expenses to be approximately flat for the remainder of fiscal 2017 as compared to the three months ended March 31, 2017.

 

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Amortization of Intangible Assets

 

Amortization of intangible assets was $437,000 and $119,000 for the three months ended March 31, 2017 compared to the three months ended March 31, 2016. Amortization of intangible assets was $1.3 million and $285,000 for the nine months ended March 31, 2017 compared to the nine months ended March 31, 2016. This expense increased due to the acquisition of the Natesto, and Primsol businesses in fiscal 2016, and the corresponding amortization of their finite-lived intangible assets. We expect this expense to remain flat for the remainder of 2017.

 

Net Cash Used in Operating Activities

 

During the nine months ended March 31, 2017, our operating activities used $10.6 million in cash which was less than the net loss of $15.8 million, primarily as a result of the non-cash depreciation, amortization and accretion, stock-based compensation offset by a decrease in accrued compensation, accounts payable and the gain on sale of assets.

 

During the nine months ended March 31, 2016, our operating activities used $8.0 million in cash which was less than the net loss of $12.9 million primarily as a result of the increases to non-cash amortization of the beneficial conversion feature, stock-based compensation, depreciation, amortization and accretion and the increase in accrued compensation offset by increases in inventory and prepaid expenses and other.

 

Net Cash Used in Investing Activities

 

During the nine months ended March 31, 2017, we used cash in investing activities of $4.1 million, $53,000 of which was used to purchase fixed assets, $750,000 of which was paid as the second and third installments towards the Primsol asset and $6.0 million of which was paid as the installment payments of our Natesto licensing agreement. These investments were offset by our sale of the Primsol Asset and our investment in Acerus of $1,750,000 and $980,000, respectively.

 

During the nine months ended March 31, 2016, we used cash in investing activities of $742,000, of which $204,000 was used to purchase fixed assets and $540,000 was used to acquire the Primsol business. We also received a security deposit back of $2,000 during the period.

 

Net Cash from Financing Activities

 

Net cash provided by financing activities in the nine months ended March 31, 2017 of $10.1 million was primarily related to the registered offering of $8.6 million offset by the cash offering cost of $998,000, warrant tender offering of $2.2 million offset by the offering cost of $333,000 and common stock issuance of $631,000 offset by the issuance costs of $24,000 to Lincoln Park.

 

Net cash provided by financing activities in the nine months ended March 31, 2016 of $10.0 million was primarily related to the issuance of convertible promissory notes which reflects gross proceeds of $5.2 million offset by the cash portion of the debt issuance costs related to the convertible notes of $298,000, as well as the $5.0 million stock subscription payment from Ampio and $200,000 for a sale of stock subscriptions offset by the issuance costs of $30,000 related to the debt conversion.

 

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Liquidity and Capital Resources

 

We are a relatively young company and we have not yet generated substantial revenue as our primary activities are focused on commercializing our approved products, acquiring products and developing our product candidates, and raising capital. As of March 31, 2017, we had cash and cash equivalents totaling $3.5 million available to fund our operations offset by an aggregate of $2.5 million in accounts payable and accrued liabilities. Without additional capital, we do not have sufficient resources to fund our operations past our 2017 fiscal year, which ends on June 30, 2017. In January 2017, we made the final $4.0 million upfront payment for Natesto. We believe we have the ability to acquire adequate capital to continue operations, and grow our business through the end of fiscal 2017, based on the following factors: our resources at March 31, 2017, our ability to sell additional capital to Lincoln Park, and our expectation of being able to raise additional capital through equity or debt. We plan to raise additional capital in fiscal 2018 to fund operations. We will evaluate the capital markets from time to time to determine when to raise additional capital in the form of equity, convertible debt or other financing instruments, depending on market conditions relative to our need for funds at such time. We will seek to raise additional capital at such time as we conclude that such capital is available on terms that we consider to be in the best interests of our Company and our stockholders.

 

At this time, we expect to satisfy our future cash needs through private or public sales of our securities or debt financings. We cannot be certain that financing will be available to us on acceptable terms, or at all. Over the last three years, including recently, volatility in the financial markets has adversely affected the market capitalizations of many bioscience companies and generally made equity and debt financing more difficult to obtain. This volatility, coupled with other factors, may limit our access to additional financing.

 

If we cannot raise adequate additional capital in the future when we require it, we could be required to delay, reduce the scope of, or eliminate one or more of our commercialization efforts or our research and development programs. We also may be required to relinquish greater or all rights to product candidates at less favorable terms than we would otherwise choose. This may lead to impairment or other charges, which could materially affect our balance sheet and operating results.

 

Off Balance Sheet Arrangements

 

We do not have off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also known as “variable interest entities.”

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

We are not currently exposed to material market risk arising from financial instruments, changes in interest rates or commodity prices, or fluctuations in foreign currencies. We have not identified a need to hedge against any of the foregoing risks and therefore currently engages in no hedging activities.

 

Item 4. Controls and Procedures.

 

As of the end of the period covered by this Quarterly Report on Form 10-Q, an evaluation was carried out by our management, with the participation of the Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Based on such evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed in the reports we file or furnish under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and regulations, and are operating in an effective manner.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal controls over financial reporting that occurred during the last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

We are currently not a party to any material pending legal proceedings, whether routine or non-routine.

 

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Item 1A. Risk Factors.

 

Except as set forth below, there have been no material changes to the discussion of risk factors included in our most recent Annual Report on Form 10-K.

 

We have an immediate need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain necessary capital may force us to delay, limit or terminate our product expansion and development efforts or other operations, any of which would have a material adverse effect on our which could materially affect our business, financial condition and results of operations.

 

As of March 31, 2017, we had cash and cash equivalents totaling $3.5 million available to fund our operations, offset by an aggregate of $2.5 million in accounts payable and accrued liabilities. Without additional capital, we do not have sufficient resources to fund our operations past our 2017 fiscal year, which ends on June 30, 2017. Consequently, we have an immediate need for capital. While we believe we have the ability to acquire adequate capital to continue our operations, including our ability to sell additional capital to Lincoln Park, we might not be successful in raising sufficient additional capital when and as needed. We cannot be certain that financing will be available to us on acceptable terms, or at all. Over the last three years, including recently, volatility in the financial markets has adversely affected the market capitalizations of many bioscience companies and generally made equity and debt financing more difficult to obtain. This volatility, coupled with other factors, may limit our access to additional financing.

 

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to expand any existing product or develop and commercialize our product candidates. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

 

If we are unable to raise sufficient capital or reach other agreements as discussed above, we would be required to delay, reduce the scope of, or eliminate one or more of our commercialization efforts or our research and development programs, any of which would materially affect our business, financial condition and results of operations.

 

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

 

None.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

None.

 

Item 5. Other Information.

 

None.

 

Item 6. Exhibits.

 

Exhibit
Number  
  Description  
     
10.1   Asset Purchase Agreement, dated March 31, 2017, between Allegis Holdings, LLC and Aytu BioScience, Inc.
     
31.1   Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

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Exhibit
Number
  Description
     
31.2   Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1   Certificate of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*.
     
101   XBRL (eXtensible Business Reporting Language). The following materials from Aytu BioScience, Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 formatted in XBRL: (i) the Balance Sheet, (ii) the Statement of Operations, (iii) the Statement of Stockholders’ Equity (Deficit), (iv) the Statement of Cash Flows, and (v) the Notes to the Financial Statements.

 

* The certification attached as Exhibit 32.1 accompanying this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

 

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SIGNATURES

 

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

 

  AYTU BIOSCIENCE, INC.
     
  By: /s/ Joshua R. Disbrow
    Joshua R. Disbrow
    Chief Executive Officer
    Date: May 11, 2017
     
  By: /s/ Gregory A. Gould
    Gregory A. Gould
    Chief Financial Officer
    Date: May 11, 2017

 

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Exhibit 10.1

 

ASSET PURCHASE AGREEMENT

 

March 31, 2017

 

This ASSET PURCHASE AGREEMENT (this “ Agreement ”) is made by and between Aytu BioScience, Inc., a Delaware corporation (“ Seller ”), and Allegis Holdings, LLC, a Mississippi limited liability company (“ Purchaser ”), as of the date first written above (the “ Execution Date ”). Purchaser and Seller also may be referred to herein each as a “ Party ” and collectively as the “ Parties .” All capitalized terms used in this Agreement are defined in Section 1.1 below.

 

RECITALS

 

WHEREAS, Seller (i) markets, promotes and sells the Product in the United States; (ii) has regulatory approval with the FDA for the Product, and (iii) is willing to transfer to Purchaser all of its rights in, and certain assets and liabilities relating to, the Product in the Territory on the terms and conditions set forth herein; and

 

WHEREAS, the Parties desire that Seller sell, transfer and assign (or cause the sale, transfer and assignment) to Purchaser, and that Purchaser acquire and assume, all of the Purchased Assets and Assumed Liabilities, subject to the terms and conditions of this Agreement.

 

NOW, THEREFORE, in consideration of the premises and the mutual promises herein made, and in consideration of the representations, warranties, and covenants herein contained, the Parties agree as follows:

 

Article I

DEFINITIONS; INTERPRETATION

 

1.1          Definitions . The following terms shall have the following meanings for purposes of this Agreement:

 

Affiliate ,” as applied to any Person other than Seller or Purchaser, means any other Person directly or indirectly Controlling, Controlled by, or under common Control with, that Person.

 

Agreement ” has the meaning set forth in the Preamble.

 

Assigned Agreements ” has the meaning set forth in Section 2.1(c).

 

Assigned Intellectual Property ” has the meaning set forth in Section 2.1(a).

 

Assignment and Assumption Agreement ” means an Assignment and Assumption Agreement in substantially the form of Exhibit A hereto.

 

Assumed Liabilities ” has the meaning set forth in Section 2.3(a).

 

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Bill of Sale ” means a Bill of Sale in substantially the form of Exhibit B hereto.

 

Business Day ” means any day other than (i) a Saturday or a Sunday or (ii) a day on which banks are authorized to close in New York, NY.

 

cGMP ” means the regulatory requirements and quality standards for the current good manufacturing practices, which are defined in the United States Code of Federal Regulations 21 CFR Part 210 & Part 211, and all applicable rules, regulations, promulgations, policies and guidelines in effect at any given time during the applicable term.

 

Closing ” has the meaning set forth in Section 3.2.

 

Closing Date ” has the meaning set forth in Section 3.2.

 

Closing Payment ” “has the meaning set forth in Section 3.1(a).

 

Code ” means the United States Internal Revenue Code of 1986, as amended.

 

Competing Product ” means any liquid urinary tract anti-infective pharmaceutical or treatment product containing trimethoprim.

 

Confidential Information ” has the meaning set forth in Section 9.1

 

Contract ” means any contract, agreement, lease, license, commitment, indenture, mortgage, note, bond loan or other legally-binding arrangement, understanding, undertaking, commitment or obligation, whether written or oral and any written purchase orders.

 

Control ” (including, with correlative meanings, the terms “ Controlling ,” “ Controlled by ” and “ under common Control with ”) for purposes of the definition of “Affiliate,” as applied to any Person, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of that Person, whether through the ownership of voting securities or by contract.

 

Copyrights ” has the meaning set forth in the definition of the term “Intellectual Property.”

 

Disclosing Party ” has the meaning set forth in Section 9.1.

 

Excluded Assets ” has the meaning set forth in Section 2.2.

 

Excluded Liabilities ” has the meaning set forth in Section 2.3(b).

 

Execution Date ” has the meaning set forth in the Preamble.

 

Existing CDA ” has the meaning set forth in Section 9.1.

 

FDA ” means the United States Food and Drug Administration and any Governmental Authority successor thereto.

 

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FFDCA ” means the Federal Food, Drug, and Cosmetic Act and implementing regulations, as each has been or may be amended.

 

Fiscal Year ” means each twelve (12)-month period commencing on July 1 and ending on June 30.

 

GAAP ” means generally accepted accounting principles in the United States as in effect on the date hereof and from time to time thereafter, applied on a consistent basis.

 

General IP Assignment ” means a general assignment of the Assigned Intellectual Property in substantially the form of Exhibit C hereto.

 

Governmental Authority ” means any government or governmental or regulatory body thereof, or political subdivision thereof, whether foreign, federal, state or local, or any department, commission, bureau, agency, board, instrumentality or authority thereof, or any court or arbitrator (public or private) and including specifically those of each country in the Territory.

 

Indebtedness ” means all indebtedness of Seller or its Affiliates secured by Lien upon or with respect to any of the Purchased Assets.

 

Indemnification Claim ” has the meaning set forth in Section 7.4(b).

 

Indemnifying Party ” has the meaning set forth in Section 7.4(b).

 

Indemnified Persons ” shall mean the Purchaser’s Indemnified Persons or the Seller’s Indemnified Persons, as the case may be.

 

Intellectual Property ” means all right, title and interest in or relating to intellectual property, whether protected, created or arising under the Laws of the United States or any other jurisdiction, including: (i) all patents and applications therefor, including all continuations, divisionals, patents of additions and continuations-in-part thereof and patents issuing thereon, along with all reissues, reexaminations and extensions thereof, including all supplemental protection certificates (collectively, “ Patents ”); (ii) all trademarks, service marks, trade names, service names, brand names, trade dress rights, logos, corporate names, trade styles, logos and other source or business identifiers and general intangibles of a like nature, together with the goodwill associated with any of the foregoing, along with all applications, registrations, renewals and extensions thereof (collectively, “ Marks ”); (iii) all Internet domain names; (iv) all copyrights and all mask work, database and design rights, whether or not registered or published, all registrations and recordations thereof and all applications in connection therewith, along with all reversions, extensions and renewals thereof (collectively, “ Copyrights ”); and (v) all trade secrets, know how, information and data.

 

Inventory ” has the meaning set forth in Section 2.1(e).

 

Inventory Transfer ” has the meaning set forth in Section 6.5(b).

 

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Law ” means any law, statute, regulation, ordinance or rule of any Governmental Authority (including, for the sake of clarity, common law), in each case, as has been or may be amended.

 

Legal Proceeding ” means any judicial, administrative or arbitral action, claim, charge, suit, proceeding, litigation, hearing, investigation, labor dispute, arbitral action, mediation, governmental audit, inquiry, criminal prosecution, examination, investigation or unfair labor practice charge or complaint (in each case, whether public or private, at law or in equity, civil, criminal or administrative) by or before a Governmental Authority or any arbitrator or arbitral panel.

 

Liability ” means, collectively, any indebtedness, guaranties, endorsements, claims, losses, damages, deficiencies, costs, expenses, fines, penalties, liabilities, obligations or responsibilities, whether fixed or unfixed, known or unknown, choate or inchoate, liquidated or unliquidated, secured or unsecured, direct or indirect, matured or unmatured, determinable or indeterminable, absolute, contingent or otherwise, or in contract, tort, strict liability or otherwise, including any product liability and any related costs and expenses of any defense.

 

Lien ” or “ Liens ” means any lien, pledge, claim, charge, mortgage, encumbrance, or other security interest of any kind, whether arising by contract or by operation of Law.

 

Loss ” and “ Losses ” have the meanings set forth in Section 7.1.

 

Marks ” has the meaning set forth in the definition of the term “Intellectual Property.”

 

Material Adverse Effect ” means a material adverse effect on (a) the marketing, promotion and sale of the Product in the United States or (b) the ability of Seller to consummate the Transactions.

 

Matured Indemnifiable Loss ” means, with respect to any claim for indemnification under Section 7.1, Losses that are the subject of such claim and that (i) have been mutually agreed in this Agreement or otherwise writing by the Seller and the Purchaser to be indemnifiable under Section 7.1 or (ii) have been determined by a final, nonappealable judgment of a court of competent jurisdiction to be indemnifiable under Section 7.1, in each case subject to the limitations set forth in this Agreement.

 

Order ” means any order, injunction, judgment, doctrine, decree, ruling, writ, assessment, award or arbitration award of a Governmental Authority.

 

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

 

Patents ” has the meaning set forth in the definition of the term Intellectual Property.

 

Permitted Encumbrances ” has the meaning set forth in Section 4.6.

 

Person ” means an individual, a partnership, a corporation, a limited liability company, an association, a joint stock company, a trust, a joint venture, an unincorporated organization, any other business entity or a Governmental Authority.

 

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Product ” means Seller’s proprietary product known as Primsol®, as further described in the Product NDAs.

 

Product NDAs ” means (i) the New Drug Application N074973 for the 50mg/5mL product and (ii) the New Drug Application N074974 for the 25mg/5mL product (which is discontinued but not withdrawn), including, in each case, amendments, supplements, records, data, reports, correspondence, and documentation of related communications with the FDA, and any other submissions or filings to or with the FDA regarding the foregoing.

 

Product Records ” means all files, reports, books, records, documents and similar materials owned or in the possession of Seller or its Affiliates relating solely to (a)  the Purchased Assets and (b) the Products in the Territory, including its marketing, promotion, sale, regulatory approval, packaging, labeling, import or export, including any customer and supplier lists, marketing studies and assets, consultant reports, regulatory correspondence and other materials, medical information training materials and information, and all pharmacovigilance materials, in each case that relate solely to the Product.

 

Purchase Price ” has the meaning set forth in Section 3.1.

 

Purchased Assets ” has the meaning set forth in Section 2.1.

 

Purchaser ” has the meaning set forth in the Preamble.

 

Purchaser FDA Letter ” means the letter from Purchaser to the FDA, duly executed by Purchaser, to be delivered to Seller at the Closing, with regard to the Product NDA in the United States, the form of which is attached hereto as Exhibit D .

 

Purchaser’s Indemnified Persons ” has the meaning set forth in Section 7.1.

 

Receiving Party ” has the meaning set forth in Section 9.1.

 

Representatives ” means, with respect to any Person, the directors, officers, employees, agents or advisors (including attorneys, accountants, financial advisors and consultants) of such Person and its Affiliates, and representatives of any of the foregoing.

 

Seller ” has the meaning set forth in the Preamble.

 

Seller FDA Letter ” means the letter from Seller to the FDA, duly executed by Seller, to be delivered to Purchaser at the Closing, with regard to the Product NDA in the United States, the form of which is attached hereto as Exhibit E .

 

Seller’s Indemnified Persons ” has the meaning set forth in Section 7.2.

 

Seller’s Knowledge ” means the actual knowledge of Jarrett Disbrow and/or Joshua Disbrow, after reasonable inquiry.

 

Specifications ” has the meaning set forth in Section 4.7.

 

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Tax ” or “ Taxes ” any and all taxes, assessments, levies, tariffs, duties or other charges or impositions in the nature of a tax (together with any and all interest, penalties, additions to tax and additional amounts imposed with respect thereto) imposed by any Governmental Authority, including income, estimated income, gross receipts, profits, business, license, occupation, franchise, capital stock, real or personal property, sales, use, transfer, value added, employment or unemployment, social security, disability, alternative or add-on minimum, customs, excise, stamp, environmental, commercial rent or withholding taxes, and shall include any liability for Taxes of any other Person under applicable Law, as a transferee or successor, by contract or otherwise, including any interest or penalty thereon or addition thereto and any interest in respect of such additions or penalties.

 

Tax Return ” means any report, return (including any information return), claim for refund, election, estimated Tax filing or payment, request for extension, document, declaration or other information or filing supplied or required to be supplied to any Governmental Authority with respect to Taxes.

 

Territory ” means worldwide.

 

Transaction Documents ” means this Agreement, the Bill of Sale, the Assignment and Assumption Agreement, the General IP Assignment, and the other documents, instruments, exhibits, annexes, schedules or certificates contemplated hereby and thereby.

 

Transactions ” means the transactions contemplated by the Transaction Documents.

 

Treasury Regulations ” means the final and temporary regulations promulgated by the United States Department of Treasury pursuant to and in respect of provisions of the Code, as such regulations may be amended from time to time (including corresponding provisions of succeeding regulations).

 

1.2          Interpretation . References in this Agreement to any gender include references to all genders, and references to the singular include references to the plural and vice versa. The words “include,” “includes” and “including” when used in this Agreement shall be deemed to be followed by the phrase “without limitation.” Unless the context otherwise requires, references in this Agreement to Articles, Sections, Exhibits and Schedules shall be deemed references to Articles and Sections of, and Exhibits and Schedules to, this Agreement. Unless the context otherwise requires, the words “hereof,” “hereby” and “herein” and words of similar meaning when used in this Agreement refer to this Agreement in its entirety and not to any particular Article, Section or provision of this Agreement. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. Any reference to any Law shall be deemed also to refer to all rules and regulations promulgated thereunder, unless the context requires otherwise.

 

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Article II

PURCHASE AND SALE
OF ASSETS AND ASSUMPTION OF LIABILITIES

 

2.1          Purchase and Sale of Assets . On the terms and subject to the conditions set forth in this Agreement, at the Closing, for the Purchase Price, Seller does hereby (and shall hereby cause its Affiliates to) sell, transfer, assign, convey and deliver to Purchaser (or any of its designated Affiliates), and Purchaser (or its designated Affiliates) shall purchase, acquire and accept from Seller and its Affiliates, all right, title and interest in, to and under the Purchased Assets, free and clear of all Liens, except for Permitted Encumbrances. Subject to Section 2.2, the “ Purchased Assets ” shall mean all right, title and interest in and to the Product and the following assets and rights owned or held by Seller or its Affiliates as of the date of this Agreement:

 

(a)           (i) the Marks and the Internet domain names pertaining solely to the Product, all of which are set forth on Schedule 2.1(a)(i) , and all goodwill associated with the foregoing and (ii) all trade secrets, data, information, know-how and Copyrights owned or used by Seller or its Affiliates and relating solely to the Product in the Territory (the Intellectual Property described in clauses (i) and (ii) is referred to herein collectively as the “ Assigned Intellectual Property ”);

 

(b)          the Product NDAs;

 

(c)          the Contracts set forth on Schedule 2.1(c) (the “ Assigned Agreements ”);

 

(d)          the Product Records owned by or in the possession of Seller or its Affiliates;

 

(e)          the inventory of the Product set forth in Schedule 2.1(e) (the “ Inventory ”);

 

(f)          all containers, work in process, active pharmaceutical ingredients and other raw materials, labels, supplies, tools and equipment owned or used by Seller or by its Affiliates and solely used in the manufacture, distribution, marketing and sale of the Product and the Inventory; and

 

(g)          all marketing assets and materials related solely to the Product and in Seller’s possession.

 

2.2          Excluded Assets . The Parties acknowledge and agree that Seller shall not convey, transfer, deliver or assign to Purchaser, and Purchaser shall not purchase, take delivery of, or acquire, any rights to any assets, properties, interests or rights of Seller or any of its Affiliates other than the Purchased Assets specifically enumerated in Section 2.1 (collectively the “ Excluded Assets ”), which Excluded Assets include all of the rights, title and interests of Seller or any of its Affiliates:

 

(a)          pertaining to assets, products and services of Seller and its Affiliates other than the Purchased Assets;

 

(b)          relating to all Seller’s employees; and

 

(c)          under this Agreement or any of the Transaction Documents.

 

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2.3      Assumption of Liabilities .

 

(a)          On the terms and subject to the conditions set forth in this Agreement, at the Closing, Purchaser shall (or shall cause its designated Affiliates to) assume, effective as of the Closing, only the following Liabilities of Seller (collectively, the “ Assumed Liabilities ”):

 

(i)          all Liabilities of Seller related to the Product or under the Product NDAs, but only to the extent relating to the period from and after the Closing;

 

(ii)         all Liabilities arising out of, relating to, or otherwise in respect of, the Purchased Assets or the sale and marketing of the Product to the extent relating to the period from and after the Closing, including all Liabilities under the Assigned Agreements except to the extent arising from breach of the Assigned Agreements prior to the Closing; and

 

(b)          Purchaser will not assume or be liable for any Excluded Liabilities. Seller shall retain, be responsible for, perform, satisfy and discharge all Excluded Liabilities in all respects. “ Excluded Liabilities ” shall mean all Liabilities of Seller or of any of its Affiliates other than the Assumed Liabilities, including all of the following Liabilities:

 

(i)          all Liabilities to the extent arising out of, relating to, or otherwise in respect of, (A) the Purchased Assets or the Product in respect of the period before the Closing, including Liabilities arising out of Seller’s breach of the Assigned Agreements prior to the Closing, (B) Seller’s business, assets and operations prior to the Closing, (C) any Product sold prior to the Closing or (D) the Product prior to the Closing;

 

(ii)         all Liabilities under the Product NDA during the period before the Closing or any other Liabilities relating to the period prior to Closing;

 

(iii)        all Liabilities incurred as a result of any Legal Proceedings or violation of Law (regardless of when asserted or initiated) to the extent arising out of, relating to, or otherwise in respect of (A) any action, omission, occurrence, event, circumstance or condition relating to the Product, the marketing or sale of the Product or the ownership or operation of the Purchased Assets that occurred or existed at or before the Closing (whether asserted before, at or after the Closing) or (B) Seller’s business, assets and operations, the Product or the Purchased Assets to the extent the basis for such Legal Proceedings or violations arose out of, or related to, or is otherwise in respect of, any actions or omissions that occurred prior to the Closing (other than the Assumed Liabilities);

 

(iv)        all Liabilities incurred as a result of any actual or alleged infringement before the Closing (and not after the Closing) of any Patent, Copyright, Trademark or other Intellectual Property right of any third party by reason of the marketing or sale of the Product (regardless of when asserted or initiated) to the extent arising out of, relating to, or otherwise in respect of, any action, omission, occurrence, event, circumstance or condition relating to the marketing or sale of the Product or the ownership or operation of the Purchased Assets that occurred or existed at or before the Closing (whether asserted before, at or after the Closing);

 

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(v)         all Liabilities arising out of, relating to, or otherwise in respect of, the Excluded Assets.

 

Article III

CONSIDERATION; CLOSING

 

3.1          Purchase Price . The aggregate consideration for the Purchased Assets shall be the sum of (a) the Closing Payment, (b) the assumption of the Assumed Liabilities with respect to the Product and the Purchased Assets (collectively, the “ Purchase Price ”).

 

(a)           Closing Payment . At the Closing, Purchaser shall pay to Seller One Million Seven Hundred and Fifty Thousand Dollars ($1,750,000) (the “ Closing Payment ”).

 

3.2          The Closing . The consummation of the purchase and sale of the Purchased Assets and the assumption of the Assumed Liabilities provided for in Article II hereof (the “ Closing ”) shall take place remotely by the exchange of electronic pdf documents on the Execution Date and shall be effective at 11:59 p.m. Eastern Time (the date on which the Closing occurs is referred to herein as the “ Closing Date ”).

 

3.3          Closing Deliveries.

 

(a)           Deliveries by Seller . At the Closing, Seller shall deliver or cause to be delivered to Purchaser the following:

 

(i)          a certificate duly executed by Seller’s Chief Operating Officer or Chief Financial Officer, in a form and substance reasonably satisfactory to Purchaser, dated as of the Closing Date, that (A) attaches a good standing certificate from the State of Delaware for Seller, (B) that true, correct and complete copies of the resolutions of the board of directors authorizing this Agreement and the Transaction documents with the transactions contemplated hereby and thereby are attached thereto and (C) as to the incumbency and genuineness of the signatures of each person executing this Agreement and the Transaction Documents;

 

(ii)         (A) a duly executed Bill of Sale; (B) a duly executed Assignment and Assumption Agreement; and (C) a duly executed General IP Assignment;

 

(iii)        evidence reasonably satisfactory to Purchaser that all Liens affecting the Purchased Assets (other than Permitted Encumbrances) have been released, or will be released at Closing;

 

(iv)        duly executed assignments to Purchaser of all of the Assigned Agreements; it being understood between the Parties that the assignment of the Assigned Agreements is a material condition to Purchaser’s consummation of the Transactions; and

 

(v)         a copy of the executed Seller FDA Letter and a copy of the Product NDAs.

 

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(b)           Deliveries by Purchaser . At the Closing, Purchaser shall deliver to Seller the following:

 

(i)          a certificate duly executed by Purchaser’s Chief Executive Officer or Chief Financial Officer, in a form and substance reasonably satisfactory to Seller, dated as of the Closing Date, that (A) attaches a good standing certificate from the State of Mississippi for Purchaser, (B) that true, correct and complete copies of the resolutions of the board of directors authorizing this Agreement and the Transaction documents with the transactions contemplated hereby and thereby are attached thereto and (C) as to the incumbency and genuineness of the signatures of each person executing this Agreement and the Transaction Documents;

 

(ii)         the Closing Payment, in accordance with Section 3.1;

 

(iii)        a duly executed Assignment and Assumption Agreement;

 

(iv)        written notice of the address to which the Inventory shall be delivered in accordance with Section 6.5; and

 

(v)         a copy of the executed Purchaser FDA Letter.

 

3.4          Payment Method . All payments under Sections 3.1(a) and 3.1(b) must be made by wire transfer of immediately available funds to an account designated by Seller in writing prior to the applicable due date.

 

3.5          Withholding Tax . The Parties agree that, as of the Closing Date, none of the payments under Section 3.1 are subject to withholding Tax. If Purchaser is required to make a payment under Section 3.1 to Seller that is by Law subject to a deduction or withholding of Tax, then (i) if such withholding or deduction obligation arises as a result of any action by Purchaser, including any transfer, assignment, sublicense, or other action that changes the payor of any amounts payable hereunder or changes the jurisdiction of Purchaser, or any failure on the part of Purchaser to comply with applicable Laws or filing or record retention requirements, that has the effect of modifying the tax treatment of the Parties hereto (a “ Withholding Tax Action ”), then the sum payable by Purchaser under Section 3.1 (in respect of which such deduction or withholding is required to be made) shall be increased to the extent necessary to ensure that Seller receives a sum equal to the sum which it would have received had no such Withholding Tax Action occurred, and (ii) otherwise, the sum payable by Purchaser under Section 3.1 (in respect of which such deduction or withholding is required to be made) shall be made to Seller after deduction of the amount required to be so deducted or withheld, in the case of each of clauses (i) and (ii), which deducted or withheld amount shall be remitted to the proper Governmental Authority in accordance with applicable Laws (at which time such amount shall be treated as being paid to Seller for purposes of this Section 3.1). Purchaser shall provide Seller with proof of payment reasonably satisfactory to Seller with respect to any Taxes deducted and withheld from amounts payable hereunder.

 

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Article IV

REPRESENTATIONS AND WARRANTIES OF SELLER

 

Seller represents and warrants to Purchaser as follows as of the Execution Date:

 

4.1          Organization and Corporate Power . Seller is a corporation duly organized, validly existing and in good standing under the Laws of the State of Delaware. Seller has the requisite corporate power and authority to carry on its business as it is now being conducted and is qualified and in good standing in all jurisdictions where qualification is required by any Law, except where the failure to be so licensed or qualified would not have, or would not be reasonably expected to have, a Material Adverse Effect.

 

4.2          Due Authorization . Seller has the requisite corporate power and authority to execute and deliver the Transaction Documents and to consummate the Transactions. The execution, delivery and performance by Seller of the Transaction Documents and the consummation by Seller of the Transactions have been duly authorized by all necessary corporate action on the part of Seller, and no other corporate proceeding is necessary for the execution and delivery of the Transaction Documents by Seller, the performance by Seller of its obligations thereunder and the consummation by Seller of the Transactions. This Agreement has been duly executed and delivered by Seller and constitutes the legal, valid and binding obligation of Seller, enforceable against Seller in accordance with its terms, except as the same may be limited by (a) laws of general application relating to bankruptcy, insolvency and the relief of debtors and (b) rules of law governing specific performance, injunctive relief and other equitable remedies. When executed and delivered in accordance herewith, the other Transaction Documents will have been duly executed and delivered by Seller and will constitute legal, valid and binding obligations of Seller enforceable against Seller in accordance with their respective terms, subject to (a) laws of general application relating to bankruptcy, insolvency and the relief of debtors and (b) rules of law governing specific performance, injunctive relief and other equitable remedies.

 

4.3          No Violation; Consents .

 

(a)          The execution, delivery and performance by Seller of the Transaction Documents do not and will not: (i) violate any Law or order applicable to Seller or any of its properties or assets (including the Purchased Assets); (ii) result in the imposition of any Lien or encumbrance upon any of the Purchased Assets (except for the Permitted Encumbrances); (iii) violate or conflict with any provision of Seller’s certificate of incorporation and by-laws; or (iv) conflict with or result in a violation or breach in any material respect of or constitute a default under or accelerate any obligation under any of the Assigned Agreements or Product NDAs.

 

(b)          Except for the Purchaser FDA Letter and Seller FDA Letter, no consents, notices or approvals of, or filings or registrations by Seller with, any Governmental Authority or any other Person not a party to this Agreement is necessary in connection with the execution, delivery and performance of the Transaction Documents or the Transactions.

 

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4.4          Intellectual Property.

 

(a)          Except as set forth on Schedule 4.4(a) , Seller or its Affiliate owns, free and clear of all Liens (other than Permitted Encumbrances), all Assigned Intellectual Property.

 

(b)          No Third Party or Affiliate of Seller has any rights, ownership interests or options to, in any Assigned Intellectual Property or the other Purchased Assets.

 

(c)          Except for the Assigned Intellectual Property, neither Seller nor its Affiliates own, license or otherwise control (i) any unexpired Patents that contain claims covering the manufacture, use or sale of Product or (ii) Intellectual Property used by or on behalf of Seller or its Affiliates in the manufacture of the Product.

 

(d)          To Seller’s Knowledge, there are no Patents owned by third parties that would be infringed by the manufacture, use, sale, offer for sale, or importation of Product.

 

(e)          There is no Legal Proceeding pending or, to Seller’s Knowledge, threatened or asserted in writing, against Seller alleging that the marketing and sale of the Product in the approved formulations and indications set forth in the Product NDA infringes or misappropriates a Person’s Intellectual Property rights.

 

(f)          To Seller’s Knowledge, no Person is infringing upon or otherwise violating any of the Assigned Intellectual Property. Since October 5, 2015, neither Seller nor any of its Affiliates has brought or asserted any Legal Proceeding against any Person for infringing, misappropriating or otherwise violating any Assigned Intellectual Property.

 

4.5          Litigation and Claims . There is no Legal Proceeding pending against Seller or, to Seller’s Knowledge, threatened or asserted in writing, against Seller or any of its Affiliates (i) with respect to the Product or any other Purchased Asset, or (ii) that would (A) prohibit or materially hinder, delay or otherwise impair Seller’s ability to perform its obligations under the Transaction Documents, (B) affect the legality, validity or enforceability of the Transaction Documents, (C) prevent or delay the consummation of any of the Transactions, (D) affect the use of any of the Purchased Assets, or (E) affect the marketing and sale of the Product.

 

4.6          Title to Assets . Seller or one of its Affiliates has good and valid title to the Purchased Assets, free and clear of any Liens, except for: (a) Liens referred to in the Assigned Agreements; (b) statutory or common law Liens and encumbrances to secure obligations to landlords, lessors or renters under leases or rental agreements; (c) deposits or pledges made in connection with, or to secure payment of, workers’ compensation, unemployment insurance or similar programs mandated by applicable Law; and (d) statutory or common law Liens in favor of carriers, warehousemen, mechanics and materialmen, to secure claims for labor, materials or supplies, and other like liens, in the case of (a)-(d), for amounts not material or overdue and which shall be fully satisfied by Seller at or prior to the Closing (the items referred to in the preceding clauses “(a)” through “(d)” are collectively referred to herein as the “ Permitted Encumbrances ” and, if any, are explicitly set forth on Schedule 4.6 attached hereto and by this reference made a part hereof).

 

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4.7          Inventory . The quantity of the Inventory is set forth on Schedule 2.1(e) , all of which constitute saleable finished and packaged goods inventory that has a minimum remaining shelf life through the date 7 months from the Closing Date. To the Seller’s Knowledge, the Inventory (i) was manufactured, tested, packaged, labeled, stored, received, handled and processed in conformity with the specifications set forth in the Product NDA (the “ Specifications ”), cGMP and Laws; (ii) meets the Specifications, and (iii) is not adulterated or misbranded, and (iv) was acquired in the ordinary course consistent with past practice. To the Seller’s Knowledge, no previously sold Inventory is subject to returns in excess of those historically experienced by Seller.

 

4.8          Assigned Agreements .

 

(a)          Seller has made available to Purchaser true, correct and complete copies of each of the Assigned Agreements.

 

(b)          Neither Seller nor any of its Affiliates is in material breach or default (without regard to lapse of time, the giving of notice or discretion of another Party thereto) of any Assigned Agreement and, to the Knowledge of Seller, no other party to any such contract is in material breach of such contract.

 

(c)          There are no material disputes under any Assigned Agreement; and neither Seller nor any of its Affiliates has received any written notice that any party to any of the Assigned Agreements intends to cancel or terminate any Assigned Agreement;

 

(d)          Each of the Assigned Agreements is valid, in full force and effect and enforceable in accordance with its terms against any parties thereto; and

 

(e)          Each Assigned Agreement was entered into in the ordinary course of business and without the payment of any consideration that is or would be a violation of any Law.

 

4.9          Product NDA . Seller holds, possesses or has rights to, the Product NDAs. The Product NDAs constitute all registrations, applications, approvals, licenses or permits granted to Seller or its Affiliates by any Governmental Authority for the manufacture, distribution, use or sale of the Product for human therapeutic use.

 

4.10        Conveyance . No transfer of property is being made, and no obligation is being incurred, in connection with the Transactions with the intent to hinder, delay or defraud either present or future creditors of Seller or any of its Affiliates. Seller acknowledges that it is selling the Purchased Assets to Purchaser in exchange for reasonably “equivalent value,” as such term or similar terms are used in any potentially applicable fraudulent conveyance Laws.

 

4.11        Tax Matters .

 

(a)          Seller is not a “foreign person” within the meaning of Section 1445 of the Code.

 

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(b)          There are no Liens for Taxes (other than Taxes not yet due and payable) upon any of the Purchased Assets.

 

4.12        Broker’s Fees . Seller has not employed any broker, finder or investment banker, or incurred any Liability for any brokerage, finder’s or other fee or commission, in connection with the Transactions (other than such fees or commissions for which Seller is solely responsible).

 

4.13        Product Distribution . Since January 1, 2017, neither Seller nor its Affiliates has intentionally shipped and sold the Product in quantities that materially exceed reasonable historical or market demand for the Products.

 

4.14        Product Liability; Warranty . There are no pending or, to Seller’s Knowledge, threatened product liability, recall, warranty or other similar claims by any Third Party against Seller (whether based in contract or tort and whether relating to personal injury, including death, property damage or economic loss) arising from the manufacture, sale or use of Product.

 

4.15        Regulatory Matters . Seller has maintained the Product NDAs in accordance in all material respects with Laws and its normal business practices. The Product NDAs are full force and effect. There is no Legal Proceeding pending against Seller or, to Seller’s Knowledge, threatened seeking the revocation, or suspension of the Product NDA. All maintenance and other fees related to any Product NDA occurring prior to the Closing Date will be paid. Neither Seller nor its Affiliates have received: (i) any FDA Form 483’s concerning the Products; (ii) any notices from FDA alleging any signals of serious risks with respect to any Product; or (iii) any warning letters, untitled letters, or other compliance actions from the FDA concerning the Products in which the FDA asserted that the operations of Seller or its Affiliates (as it relates to the Purchased Assets and the Products) or the Products were not in compliance with applicable Laws in any material respect. There is no Legal Proceeding by the FDA, or any other Governmental Authority pending against Seller or, to Seller’s Knowledge, threatened against Seller relating to safety or efficacy of the Products or Seller’s production, distribution, or sale of the Products. Seller has completed and filed all annual reports required by the FDA in order to maintain the Product NDA, except for those reports not yet due. Purchaser agrees to pay all product-related regulatory fees (PDUFA) while Seller agrees to reimburse Purchaser on a pro rata basis based on proportional timing (e.g. ¼ fee(s) for Seller) owed for calendar year 2017.

 

4.16        Compliance . Seller is in compliance with all U.S. Laws in all material respects applicable to the Purchased Assets, including the United States Federal Food, Drug and Cosmetic Act, including all regulations promulgated thereunder. Seller has all material Authorizations of all U.S. Governmental Authorities necessary for the sale of the Product.

 

EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF SELLER. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

 

  Page 14 of 25  

 

 

Article V

REPRESENTATIONS AND WARRANTIES OF PURCHASER

 

Purchaser represents and warrants to Seller as follows as of the Execution Date:

 

5.1          Organization and Corporate Power . The execution, delivery and performance by Purchaser of the Transaction Documents do not and will not: (i) violate any material Law applicable to Purchaser or any of its properties or assets; (ii) violate or conflict with, result in a breach of, constitute a default (or an event which, with or without notice or lapse of time or both, would constitute a default) under, permit cancellation of, or result in the creation of any Lien upon any of Purchaser’s properties or assets, including the Purchased Assets (other than any Lien imposed by Purchaser’s lenders under its existing credit facilities, as may be amended from time to time) under, any material Contract to which Purchaser is a party or by which it or its properties and assets are bound; or (iii) violate or conflict with any provision of the certificate of incorporation and by-laws or comparable organizational documents of Purchaser.

 

5.2          Due Authorization . Purchaser has the requisite corporate power and authority to execute and deliver the Transaction Documents and to consummate the Transactions. The execution, delivery and performance by Purchaser of the Transaction Documents and the consummation by Purchaser of the Transactions have been duly authorized by all necessary corporate action on the part of Purchaser and no other corporate proceeding is necessary for the execution and delivery of the Transaction Documents by Purchaser, the performance by Purchaser of its obligations thereunder and the consummation by Purchaser of the Transactions. This Agreement has been duly executed and delivered by Purchaser and constitutes the legal, valid and binding obligation of Purchaser, enforceable against Purchaser in accordance with its terms, except as the same may be limited by bankruptcy, insolvency, moratorium, reorganization or other Laws of general applicability relating to or affecting the enforcement of creditor’s rights and general principles of equity. When executed and delivered in accordance herewith, the other Transaction Documents will have been duly executed and delivered by Purchaser and will constitute legal, valid and binding obligations of Purchaser, enforceable against Purchaser in accordance with their respective terms, subject to (a) laws of general application relating to bankruptcy, insolvency and the relief of debtors and (b) rules of law governing specific performance, injunctive relief and other equitable remedies.

 

5.3          No Violation; Consents.

 

(a)          The execution, delivery and performance by Purchaser of the Transaction Documents do not and will not: (i) violate any material Law applicable to Purchaser or any of its properties or assets; (ii) violate or conflict with any provision of the certificate of incorporation and by-laws or comparable organizational documents of Purchaser.

 

(b)          Except for the Purchaser FDA Letter, no consents, notices or approvals of, or filings or registrations by Purchaser with, any Governmental Authority or any other Person not a party to this Agreement, are necessary in connection with the execution, delivery and performance of the Transaction Documents or the Transactions.

 

  Page 15 of 25  

 

 

5.4          Litigation . There is no Legal Proceeding pending or, to Purchaser’s knowledge, threatened or asserted in writing, against Purchaser or any of its Affiliates that would prohibit or materially hinder, delay or otherwise impair the Purchaser’s ability to perform its obligations under the Transaction Documents, that would affect the legality, validity or enforceability of the Transaction Documents, or that would prevent or materially delay the consummation of the Transactions.

 

5.5          Broker’s Fees . Purchaser has not employed any broker, finder or investment banker, or incurred any Liability for any brokerage, finder’s or other fee or commission, in connection with the Transactions (other than such fees or commissions for which Purchaser is solely responsible).

 

EXCEPT AS EXPRESSLY STATED IN THIS IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, ARE MADE OR GIVEN BY OR ON BEHALF OF PURCHASER. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

 

Article VI

COVENANTS AND AGREEMENTS

 

6.1          FDA Letter . Purchaser and Seller shall file the Purchaser FDA Letter and the Seller FDA Letter, respectively, with the FDA on the Closing Date via overnight courier. Transfer of title to the Product NDA to Purchaser shall be effective as of the Closing Date.

 

6.2          Joint Communication Plan . Promptly following the date hereof, Representatives from each of Seller and Purchaser shall jointly develop a mutually acceptable communication plan for use between the date hereof and the Closing Date and for use to communicate the transaction contemplated hereby to pricing compendia and customers, and the Parties shall (and shall cause their respective Representatives to) operate in accordance with that communication plan.

 

6.3          Publicity . Except as may be required by Law, neither Party will (and neither Party will permit any of its advisors or representatives to) issue any press release or make any public statement regarding this Agreement or any of the transactions contemplated by this Agreement, without the other Party’s prior written consent (which will not be unreasonably withheld).

 

6.4          Further Assurances .

 

(a)          If, at any time following the Closing, either of the Parties or their respective Affiliates discovers any rights or assets of the nature of the Purchased Assets, including Intellectual Property, that relate solely to the Product that were not, in fact, sold, transferred, assigned, conveyed and delivered to Purchaser at the Closing, then such Party will promptly notify the other Party of such assets and, if Purchaser agrees, then Seller or its Affiliates shall sell, transfer, assign, convey and deliver such assets (at Seller’s cost) to Purchaser or its designated Affiliates for no additional consideration, and such assets shall become Purchased Assets and subject to the terms hereof.

 

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(b)          If, at any time following the Closing, Purchaser discovers any rights or assets (of whatever nature), including without limitation documents that were delivered to Purchaser together with the Product Records, that were not, in fact, sold, transferred, and assigned to Purchaser at the Closing, then Purchaser will promptly notify Seller of such assets and if Seller agrees, Purchaser shall promptly deliver such assets (at Purchaser’s cost) to Seller or its designated Affiliates, and such assets shall not be Purchased Assets hereunder.

 

(c)          Each of Purchaser and Seller shall, at the request of the other Party and at such other Party’s expense, promptly execute and deliver to such other Party all such further instruments, assignments (including any Intellectual Property assignments in addition to those specified in Section 3.3(a)(ii)), assurances, filings and other documents and take any actions as such other Party may reasonably request in connection with the carrying out and effectuating the Transaction Documents and the Transactions (including without limitation, filing with the FDA, any other notices, assignments, documents and/or other materials required by the FFDCA and its implementing regulations). Except as provided in connection with the actions described in Section 6.4(a), the Party making any request pursuant to this Section 6.4(c) shall promptly reimburse the other Party for all documented, out-of-pocket expenses reasonably incurred by such other Party in providing further assurances requested by such requesting Party.

 

6.5          Delivery of Purchased Assets.

 

(a)          Seller shall physically deliver, at Purchaser’s sole but reasonable expense, the tangible embodiments of the Purchased Assets (that are not already in Purchaser’s possession) to Purchaser within ten (10) Business Days after the Closing Date, other than the Inventory.

 

(b)          Within five (5) days of Purchaser’s written request, Seller shall deliver to Purchaser, at the address set forth in the request, the Inventory (the “ Inventory Transfer ”). Purchaser agrees to make request for the Inventory Transfer within ninety (90) days of the Execution Date. Seller shall bear all risk of loss or damage, and costs of insurance and transportation associated with the Inventory until such Inventory is tendered to Purchaser’s designated facility. Title to and risk of loss of Inventory shall automatically transfer to Purchaser when Seller tenders the shipment to Purchaser at its designated facility. Seller will send Purchaser via facsimile the certificates of analysis and certificates of conformance relating to the Inventory on or before the date of delivery.

 

(c)          At Closing, Seller shall file any and all UCC Termination Statements applicable to the Purchased Assets and shall provide Purchaser with evidence confirming such filing.

 

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6.6          Returns, Rebates, Chargebacks, Etc.

 

(a)           Returns . The Purchaser and the Seller acknowledge and agree that the Purchaser is only acquiring, and shall only sell, lots of Product that have not been sold by Seller. The Seller shall be responsible for all returns of Products sold prior to Closing that have an expiration date earlier than December, 2017 or earlier (and such returns shall be “Excluded Liabilities” for all purposes hereunder), and the Purchaser shall be responsible for all returns of Products sold before Closing with an expiration date of December, 2017 or later, or sold after Closing (and such returns shall be “Assumed Liabilities” for all purposes hereunder).

 

(b)         Rebates and Chargebacks . The Seller shall be responsible for all rebates (including Medicaid rebates), chargebacks and other similar items (other than returns) related to Products having Seller’s NDC codes (and such liabilities shall be “Excluded Liabilities” for all purposes hereunder). Purchaser agrees to not adjust Product pricing under either Party’s NDC until after 12/31/2017.

 

(c)           Processing . In the event that either Party receives and processes returns, rebates, chargebacks or other similar items related to Products that are the responsibility of the other Party pursuant to Sections 6.6(a) or 6.6(b) above, then such receiving Party shall submit a schedule of such items, together with reasonable supporting documentation, to the responsible Party on a monthly basis and such responsible Party shall reimburse the receiving Party for all valid items within 15 days of receipt of such schedule and documentation.

 

(d)           NDC Codes . Purchaser shall have the right to use the Seller’s NDC codes for the Product in order to sell the Inventory it acquires from Seller, but shall not have the right to have manufactured or sell any other Product utilizing the Seller NDC codes.

 

6.7          Noncompete . For a period of twenty four (24) months after the Closing Date, Seller shall not directly or indirectly sell, market, promote, advertise or distribute in the Territory any Competing Products.

 

Article VII

INDEMNIFICATION

 

7.1          Indemnification by Seller . Subject to all of the limitations set forth in this Article VII, Seller agrees to indemnify, defend and hold Purchaser, its Affiliates and each of their respective directors, officers, employees, agents, attorneys, representatives, successors and permitted assigns (Purchaser and such Persons are collectively hereinafter referred to as “ Purchaser’s Indemnified Persons ”), harmless from and against any and all losses, Liabilities, or damages including interest, penalties, reasonable costs of preparation and investigation, and reasonable attorneys’ fees and disbursements (individually a “ Loss ,” and collectively, “ Losses ”), that Purchaser’s Indemnified Persons may suffer, sustain, incur or become subject to, to the extent arising out of or due to: (a) direct claims or third party claims based on the failure of any representation or warranty of Seller in Article IV to be true and correct as the Closing Date; (b) direct claims or third party claims based on the breach of any covenant, undertaking, agreement or other obligation of Seller under this Agreement; (c) direct claims or third party claims based on any Excluded Asset or Excluded Liability; or (d) any liability related to the Product or the Purchased Assets for any period prior to Closing.

 

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7.2          Indemnification by Purchaser . Subject to all of the limitations set forth in this Article VII, Purchaser agrees to indemnify, defend and hold Seller, its Affiliates and each of their respective directors, officers, employees, agents, attorneys, representatives, successors and permitted assigns (Seller and such Persons are hereinafter collectively referred to as “ Seller’s Indemnified Persons ”), harmless from and against any and all Losses that Seller’s Indemnified Persons may suffer, sustain, incur or become subject to, to the extent arising out of or due to: (a) direct claims or third party claims based on the failure of any representation or warranty of Purchaser in Article V to be true and correct as of the Closing Date; (b) direct claims or third party claims based on the breach of any covenant, undertaking, agreement or other obligation of Purchaser under this Agreement; (c) direct claims or third party claims based on any Assumed Liability arising after the Closing Date or (d) any liability related to the Product or the Purchased Assets for any period after Closing.

 

7.3          Survival of Representations and Warranties; Limitations.

 

(a)          The representations and warranties of the Parties contained in this Agreement shall survive the Closing Date for a period of one (1) year.

 

(b)          Notwithstanding anything to the contrary herein, neither Party shall be entitled to any recovery with respect to any breach of any representations and warranties unless and until the aggregate amount of all Losses suffered, sustained or incurred by the asserting Party, or to which such Party becomes subject, by reason of any and all breaches hereunder, shall exceed $25,000, calculated on a cumulative basis and not a per item basis, and in such event, the recovering Party shall only be entitled to Losses in excess of such amount.

 

(c)          No party shall be required to indemnify any of the other party’s Indemnified Persons to the extent of any Losses resulting from the bad faith, gross negligence or willful misconduct of the Party seeking indemnification or any of its Indemnified Persons, or breach of this Agreement by the Party seeking indemnification.

 

(d)          Any liability for indemnification under this Article VII shall be determined without duplication of recovery by reason of the state of facts giving rise to such liability constituting a breach of more than one representation, warranty, covenant or agreement.

 

(e)           Notwithstanding any other provision in this Agreement, neither Seller nor Purchaser shall in any event be liable to the other Party or any of the other Party’s Indemnified Persons OR ENTITLED TO INDEMNIFICATION, on account of any indemnity obligation set forth in Section 7.1 or Section 7.2 or otherwise under this agreement, for (i) any Losses that are not direct, actual damages or (ii) any special, incidental or punitive damages, in each case, unless such Losses are paid pursuant to a third party claim. notwithstanding anything to the contrary in this agreement, EXCEPT FOR PURCHASER’S PAYMENT OBLIGATIONS UNDER THIS AGREEMENT, EACH PARTY’S total liability under this aGREEMENT, for claims made under section 7.1 of this agreement OR OTHERWISE (INCLUDING IN TORT) shall not exceed the amount of the closing payment.

 

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7.4          Indemnification Procedur e.

 

(a)          A claim for indemnification for any matter not involving a third-party claim may be asserted by notice issued in accordance with Section 10.2 to the Party from whom indemnification is sought.

 

(b)          In the event that an Indemnified Person becomes aware of a third party claim in respect of which indemnification may be sought under Sections 7.1 and 7.2 hereof (regardless of the limitations set forth in Section 7.3) (an “ Indemnification Claim ”), the Indemnified Person shall notify the Party against whom indemnification is sought (the “ Indemnifying Party ”) of such Indemnification Claim, including a statement of the basis for such claim. The failure of the Indemnified Person to give reasonably prompt notice of any Indemnification Claim shall not release, waive or otherwise affect the Indemnifying Party’s obligations with respect thereto, except to the extent that the Indemnifying Party is materially prejudiced as a result of such failure. The Indemnifying Party shall have the right, at its sole option and expense, to be represented by counsel of its choice and to defend against, negotiate, settle or otherwise deal with, any Indemnification Claim that relates to any Losses indemnified against by it hereunder, subject to the remainder of this Section 7.4(b). If the Indemnifying Party elects to defend against, negotiate, settle or otherwise deal with any Indemnification Claim that relates to any Losses indemnified against by it hereunder, it shall within thirty (30) days (or sooner, if the nature of the Indemnification Claim so requires) notify the Indemnified Person of its intent to do so. If the Indemnifying Party elects not to defend against, negotiate, settle or otherwise deal with, any Indemnification Claim that relates to any Losses indemnified against hereunder, the Indemnified Person may defend against, negotiate, settle or otherwise deal with, such Indemnification Claim at the Indemnifying Party’s expense. If the Indemnifying Party shall assume the defense of any Indemnification Claim, the Indemnified Person may participate, at his or its own expense, in the defense of such Indemnification Claim; provided , however , that such Indemnified Person shall be entitled to participate in any such defense with separate counsel at the expense of the Indemnifying Party if (i) so requested by the Indemnifying Party to participate or, (ii) in the reasonable opinion of counsel to the Indemnified Person, a conflict or potential conflict exists between the Indemnified Person and the Indemnifying Party that would make such separate representation advisable. The parties hereto agree to cooperate fully with each other in connection with the defense, negotiation or settlement of any such Indemnification Claim. The Indemnifying Party shall have the right to settle or otherwise dispose of the Indemnification Claim on such terms as the Indemnifying Party, in its sole discretion, shall deem appropriate; provided, however, that notwithstanding anything in this Section 7.4 to the contrary, (i) the Indemnified Person shall not settle or compromise any Indemnification Claim or permit a default or consent to entry of any judgment without the written consent of the Indemnifying Party, which shall not be unreasonably withheld, conditioned or delayed, and (ii) the Indemnifying Party shall not, without the written consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed, settle or compromise any Indemnification Claim or permit a default or consent to entry of any judgment if (A) such settlement or compromise does not include a full release of claims against the other Party, (B) such settlement or compromise includes an admission of guilt or fault of the other Party, or (C) as a result thereof, the Indemnified Person would become subject to injunctive or other equitable relief or any remedy other than the payment of money by the Indemnifying Party.

 

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7.5          Calculation of Losses . The amount of any Losses for which indemnification is provided under this Article VII shall be net of any amounts recoverable by the Indemnified Party under insurance policies with respect to such Losses (net of any Tax or expenses incurred in connection with such recovery). Each Indemnified Person shall take, and shall cause its Affiliates to take, all commercially reasonable efforts to mitigate and otherwise minimize the Losses upon, and after becoming aware of, any event which would reasonably be expected to give rise to any Losses.

 

7.6          Exclusive Remedy . From and after the Closing, the sole and exclusive remedies for and liability under this Agreement, including (a) any breach or failure to be true and correct, or alleged breach or failure to be true and correct, of any representation or warranty in this Agreement or (b) any breach, or alleged breach, of any covenant or agreement in this Agreement required to be performed prior to the Closing or (c) any tort claim or other basis of liability related to this Agreement, in each case shall be indemnification in accordance with this Article VII; provided, however, that no Party shall be deemed to have waived any rights, claims, causes of action or remedies if and to the extent that (i) such rights, claims, causes of action or remedies may not be waived under applicable Law or (ii) such Party proves the other Party’s actual fraud.

 

Article VIII

TAX MATTERS

 

8.1          Cooperation on Tax Matters .

 

(a)          Notwithstanding anything to the contrary herein, Seller and Purchaser agree to furnish or cause to be furnished to the other, upon request, as promptly as practicable, such information (including access to books and records) relating to the Purchased Assets and the Assumed Liabilities as is reasonably necessary for the filing of any Tax Return, the preparation for any Tax audit, or the prosecution or defense of any claim relating to any proposed Tax adjustment. Purchaser and Seller shall keep all such information and documents received by them confidential in accordance with Article IX.

 

(b)          Notwithstanding anything to the contrary herein, Purchaser and Seller shall reasonably cooperate with each other in the conduct of any audit or other proceedings relating to the Purchased Assets or the Assumed Liabilities.

 

8.2          Transfer Taxes . Seller and Purchaser will bear and pay equally any sales Taxes, use taxes, transfer Taxes, documentary charges, recording fees, filing fees or similar Taxes, charges, fees or expenses imposed by a Governmental Authority that may become payable in connection with the sale of the Purchased Assets to Purchaser, the assumption by Purchaser of the Assumed Liabilities or any of the other transactions contemplated by this Agreement.

 

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Article IX

CONFIDENTIALITY

 

9.1          Confidential Information. That certain Confidential Disclosure Agreement dated as of February 1, 2016 by and between Purchaser and Seller (the “ Existing CDA ”) shall continue in full force and effect from and after the Closing Date.

 

Article X

MISCELLANEOUS

 

10.1        Expenses . Except as specifically provided herein, Seller and Purchaser shall each pay its own expenses (including the fees and expenses of their respective agents, representatives, counsel and accountants) incidental to the preparation, negotiation, and consummation of the Transaction Documents and the Transactions.

 

10.2        Notices . Any notice, request, demand or other communication given by any Party under this Agreement shall be in writing, may be given by a Party or its legal counsel, and shall be deemed to be duly given (i) when personally delivered (or refused), or (ii) upon delivery (or refused) by an internationally recognized express courier service which provides evidence of delivery (or refused), or (iii) when three (3) days have elapsed after its transmittal by registered or certified mail, postage prepaid, return receipt requested, addressed to the Party to whom directed at that Party’s address as it appears below or another address of which that Party has given notice, or (iv) when delivered by facsimile transmission if a copy thereof is also delivered in person or by overnight courier. Notices of address change shall be effective only upon receipt notwithstanding the provisions of the foregoing sentence.

 

If to Purchaser, to:

 

Allegis Holdings, LLC

276 Nissan Parkway, F100

Canton, MS 39046

Attn: Rett Crowder
Facsimile: 601-859-0041

 

If to Seller, to:

 

Aytu BioScience, Inc.

373 Inverness Parkway, Suite 206

Englewood, CO 80112

Attn: Joshua Disbrow

Facsimile: (720) 437-6501

 

provided, however, that if any Party shall have designated a different address by notice to the other Party, then to the last address so designated.

 

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10.3        Successors and Assigns; Assignment . This Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Neither Party may assign any of its rights or delegate any of its obligations under this Agreement (whether voluntarily, involuntarily, by way of merger or otherwise) to any other Person without the prior written consent of the other Party; provided, however, that Seller may, before or after the Closing, assign to any Person its right to receive all or any portion of any of the Purchase Price; and provided further, that (without limiting Purchaser’s obligations under or relating to this Agreement) Purchaser may, without the consent of Seller: (i) before the Closing, assign its right to receive all or any of the Purchased Assets to an Affiliate of Purchaser (ii) collaterally assign all or any portion of its rights under this Agreement and the related documents delivered at Closing to its lender or lenders, equity sponsor or sponsors or other financing source or sources in connection with obtaining any financing (or any refinancing thereof)..

 

10.4        Entire Agreement; Modification . The Transaction Documents supersede all prior agreements and understandings between the Parties (written or oral) relating to the subject matter hereof and thereof, including any term sheets, and the Transaction Documents are the entire and complete statement of the terms of the agreement between the Parties with respect to such subject matter, other than the Existing CDA. This Agreement may be amended, modified or supplemented only in a writing signed by Seller and Purchaser.

 

10.5        Waivers . The failure of a Party hereto at any time or times to require performance of any provision hereof shall in no manner affect its right at a later time to enforce the same. No waiver by a Party of any condition or of any breach of any term, covenant, representation or warranty contained in this Agreement shall be effective unless in writing, and no waiver in any one or more instances shall be deemed to be a further or continuing waiver of any such condition or breach in other instances or a waiver of any other condition or breach of any other term, covenant, representation or warranty.

 

10.6        Governing Law . Any controversy, dispute or claim arising under, or in connection with, or otherwise related to this Agreement (including the existence, validity, interpretation or breach hereof and any claim based on contract, tort or statute) shall be exclusively interpreted in accordance with, and governed by, the Laws of the State of Mississippi without regard to the conflicts of law rules thereof.

 

10.7        Arbitration . Any controversy or claim arising out of or relating to this Agreement, or the breach thereof, excluding those for equitable relief (e.g., injunctive relief or specific performance), shall be settled by arbitration administered by the American Arbitration Association under its Commercial Arbitration Rules, and judgment on the award rendered by the arbitrators will be final and may be entered in any court having jurisdiction thereof. The number of arbitrators shall be three, and the place of arbitration shall be Canton, Mississippi. The Parties also agree that the AAA Optional Rules for Emergency Measures of Protection shall apply to the proceedings.

 

10.8        Severability . Any provision of this Agreement which is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof, and any such prohibition and unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. The Parties agree to negotiate in good faith to substitute replace any such provision with a valid and enforceable provision therefor which, as nearly as possible, achieves the desired economic effect and mutual understanding of the Parties under this Agreement.

 

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10.9        No Third Party Beneficiaries . Neither this Agreement nor any provision hereof is intended to confer upon any Person (other than the Parties hereto and, solely for purposes of Article VII, the Indemnified Persons, each of whom shall be an express third party beneficiary entitled to enforce the obligations of the Indemnifying Party thereunder as if an original party hereto) any rights or remedies hereunder.

 

10.10      Construction . The Parties have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement.

 

10.11      Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original, and such counterparts shall together constitute one and the same instrument. A facsimile or other electronic transmission of an executed counterpart signature page shall be deemed an original.

 

10.12      Incorporation of Schedules and Exhibits . The schedules and exhibits hereto are incorporated into this Agreement and shall be deemed a part hereof as if set forth herein in full. In the event of any conflict between the provisions of this Agreement and any such schedule or exhibit, the provisions of this Agreement shall control.

 

[ The remainder of this page is left blank intentionally .]

 

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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement on the day and year first written above.

 

  PURCHASER
   
  ALLEGIS HOLDINGS, LLC

 

  By:  
    Name:
    Title:

 

  SELLER
   
  AYTU BIOSCIENCE, INC.

 

  By:  
    Name:
    Title:

 

  Page 25 of 25  

 

 

Schedules and Exhibits:

 

Schedule 2.1(a)(i) Marks
Schedule 2.1(c) Assigned Agreements
Schedule 2.1(e) Inventory
Schedule 2.3 Purchase Order
Schedule 4.15 Regulatory Matters
   
Exhibit A Assignment and Assumption Agreement
Exhibit B Bill of Sale
Exhibit C General IP Assignment
Exhibit D Purchaser FDA Letter
Exhibit E Seller FDA Letter

 

 

 

 

Schedule 2.1(a)(i)

Marks and Internet Domains

 

PRIMSOL United States 77/368,235 3,487,990 08/19/08 IC 005: Pharmaceutical Preparation for the Treatment of Bacterial Infection Renewal due 08/19/2018
PRIMSOL Hong Kong 301626129 301626129 11/16/10 IC 005: Pharmaceutical Preparation for the Treatment of Bacterial Infection Renewal due 05/27/2020

 

PRIMSOLSOLUTION.COM

 

PRIMSOL-SAMPLES.COM

 

PRIMSOL.NET

 

 

 

 

Schedule 2.1(c)

Assigned Agreements

 

1) Manufacturing Agreement by and between Seller and Halo Pharmaceutical Incorporated dated March 21, 2013.

 

2) Assignment of Rights in U.S. Patents from Taro Pharmaceuticals North America, Inc. to Seller dated March 2, 2005

 

Schedule 2.1(e)

Inventory

 

Description   LotNumber   ExpDate   StockOnHand &
On Order
Primsol samples            
Primsol trade            
TMP - API (___ kg)   Raw Material        

 

 

 

 

Schedule 4.15

Regulatory Matters

 

Not all annual periodic adverse drug experience reports were submitted within 60 days of the anniversary date of the approval of the application. Specifically, the periodic adverse drug experience report for January 2008-January 2009 for NDA 74-973 Primsol Solution (Trimethoprim hydrochloride oral solution 50 mg/ 5mL) was not submitted until June 2009. All reports have been submitted.

 

 

 

Exhibit 31.1

 

AYTU BIOSCIENCE, INC.

Certification by Chief Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Joshua R. Disbrow, certify that:

 

1. I have reviewed this report on Form 10-Q of Aytu BioScience, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a—15(e) and 15d—15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a—15(f) and 15d—15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant 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 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.

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies or 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: May 11, 2017   /s/ Joshua R. Disbrow
  By: Joshua R. Disbrow
  Title: Chief Executive Officer

 

 

 

 

Exhibit 31.2

 

AYTU BIOSCIENCE, INC.

Certification by Chief Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Gregory A Gould, certify that:

 

1. I have reviewed this report on Form 10-Q of Aytu BioScience, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a—15(e) and 15d—15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a—15(f) and 15d—15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant 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 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.

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies or 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: May 11, 2017   /s/ Gregory A. Gould
  By: Gregory A. Gould
  Title: Chief Financial Officer

 

 

 

 

Exhibit 32.1

 

AYTU BIOSCIENCE, INC.

 

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

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

In connection with the filing of the quarterly report on Form 10-Q for the quarter ended March 31, 2017 (the “Report”) by Aytu BioScience, Inc. (the “Company”), each of the undersigned hereby certifies that:

 

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and

 

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Dated: May 11, 2017 /s/ Joshua R. Disbrow
  Joshua R. Disbrow
  Chief Executive Officer
   
Dated: May 11, 2017 /s/ Gregory A. Gould
  Gregory A. Gould
  Chief Financial Officer