0001515971-19-000071.txt : 20190515 0001515971-19-000071.hdr.sgml : 20190515 20190515124909 ACCESSION NUMBER: 0001515971-19-000071 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 62 CONFORMED PERIOD OF REPORT: 20190331 FILED AS OF DATE: 20190515 DATE AS OF CHANGE: 20190515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: INTERNATIONAL ISOTOPES INC CENTRAL INDEX KEY: 0001038277 STANDARD INDUSTRIAL CLASSIFICATION: INDUSTRIAL INSTRUMENTS FOR MEASUREMENT, DISPLAY, AND CONTROL [3823] IRS NUMBER: 742763837 STATE OF INCORPORATION: TX FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-22923 FILM NUMBER: 19826630 BUSINESS ADDRESS: STREET 1: 4137 COMMERCE CIRCLE CITY: IDAHO FALLS STATE: ID ZIP: 83401 BUSINESS PHONE: 2085245300 MAIL ADDRESS: STREET 1: 4137 COMMERCE CIRCLE CITY: IDAHO FALLS STATE: ID ZIP: 83401 10-Q 1 inis10q033119.htm 10-Q International Isotopes Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2019

 

OR

 

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

 

For the transition period from _____________ to _______________

 

Commission file number:

0-22923

 

INTERNATIONAL ISOTOPES INC.

(Exact name of registrant as specified in its charter)

 

Texas   74-2763837

(State or other jurisdiction of

incorporation or organization)

   (IRS Employer Identification No.)

  

4137 Commerce Circle

Idaho Falls, Idaho, 83401

(Address of principal executive offices, including zip code)

 

(208) 524-5300

(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. ý Yes ¨ No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ý Yes ¨ No

 

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

 

Large accelerated filer ¨ Accelerated filer ¨
Non-accelerated filer ¨ Smaller reporting company ý
  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 pursuant to Section 13(a) of the Exchange Act. ¨

 

1 

 

 

 

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

 

As of May 6, 2019, the number of shares of common stock, $.01 par value, outstanding was 419,574,105.

 

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

 

Title of Each class Trading Symbol Name of Each Exchange on Which Registered
None Not Applicable Not Applicable

 

 

 

 

 

 

 

 

 

 

 

2 

 

 

 

INTERNATIONAL ISOTOPES INC.

Form 10-Q

For The Quarter Ended March 31, 2019

 

TABLE OF CONTENTS

 

    Page No.
PART I – FINANCIAL INFORMATION  
     
Item 1. Financial Statements  
  Unaudited Condensed Consolidated Balance Sheets at March 31, 2019 and December 31, 2018 4
  Unaudited Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2019 and 2018 5
  Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2019 and 2018 6
  Unaudited Statement of Stockholders’ Equity for the Three Months Ended March 31, 2019 and 2018 7
  Notes to Unaudited Condensed Consolidated Financial Statements 8
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 20
Item 4. Controls and Procedures 28
     
PART II – OTHER INFORMATION  
     
Item 1.         Legal Proceedings 28
Item 1A. Risk Factors 28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 29
Item 6. Exhibits 29
Signatures 30

 

 

 

 

 

3 

 

 

 

Part I. Financial Information

     Item I. Financial Statements 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

 

   March 31,   December 31, 
   2019   2018 
Assets  (unaudited)     
Current assets          
Cash and cash equivalents  $398,604   $828,039 
Accounts receivable   1,356,924    820,370 
Inventories   3,086,126    2,765,729 
Prepaids and other current assets   287,245    315,042 
Total current assets   5,128,899    4,729,180 
           
Long-term assets          
Restricted cash   625,845    622,428 
Property, plant and equipment, net   1,885,914    1,906,182 
Operating lease right-of-use asset   782,449    —   
Goodwill   1,384,255    1,384,255 
Patents and other intangibles, net   4,308,398    4,348,031 
Total long-term assets   8,986,861    8,260,896 
Total assets  $14,115,760   $12,990,076 
           
Liabilities and Stockholders' Equity          
Current liabilities          
Accounts payable  $2,519,770   $2,285,165 
Accrued liabilities   721,711    939,918 
Current portion of unearned revenue   3,736,310    3,783,541 
Current portion of operating lease right-of-use liability   97,580    —   
Current portion of related party notes payable   180,000    180,000 
Current installments of notes payable   8,091    7,956 
Total current liabilities   7,263,462    7,196,580 
           
Long-term liabilities          
Obligation for lease disposal costs   517,355    507,968 
Unearned revenue, net of current portion   7,500    7,500 
Related party notes payable, net of current portion and debt discount   453,061    446,356 
Notes payable, net of current portion   18,712    20,786 
Operating lease right-of-use liability, net of current portion   684,869    —   
Mandatorily redeemable convertible preferred stock, net of discount   4,688,835    4,656,752 
Total long-term liabilities   6,370,332    5,639,362 
Total liabilities   13,633,794    12,835,942 
           
Commitments and contingencies (Note 8)   —      —   
           
Stockholders' equity          
Common stock, $0.01 par value; 750,000,000 shares authorized;416,912,686 and 413,168,301 shares issued and outstanding respectively   4,169,127    4,131,683 
Additional paid in capital   121,039,851    120,805,997 
Accumulated deficit   (126,593,379)   (126,541,421)
Deficit attributable to International Isotopes Inc. stockholders   (1,384,401)   (1,603,741)
Equity attributable to noncontrolling interest   1,866,367    1,757,875 
Total equity   481,966    154,134 
Total liabilities and stockholders' equity  $14,115,760   $12,990,076 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

4 

 

 

  

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Operations

 

   Three months ended March 31, 
   2019   2018 
         
Sale of product  $2,527,852   $2,801,026 
Cost of product   1,088,429    1,442,408 
Gross profit   1,439,423    1,358,618 
           
Operating costs and expenses          
Salaries and contract labor   623,699    569,459 
General, administrative and consulting   626,863    533,134 
Research and development   46,304    106,420 
Total operating expenses   1,296,866    1,209,013 
           
Net operating income   142,557    149,605 
           
Other income (expense):          
Other income   24,632    53,362 
Interest income   3,422    1,307 
Interest expense   (114,077)   (106,034)
Total other expense   (86,023)   (51,365)
Net income   56,534    98,240 
Less income attributable to noncontrolling interest   108,492    63,836 
           
Net (loss) income attributable to International Isotopes Inc.  $(51,958)  $34,404 
           
Net income (loss) per common share - basic:  $—     $—   
           
Net income (loss) per common share - diluted:  $—     $—   
           
Weighted average common shares outstanding -          
basic:   413,906,700    407,423,051 
           
Weighted average common shares outstanding -          
diluted   413,906,700    526,418,051 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

5 

 

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Cash Flows

 

   Three months ended March 31, 
   2019   2018 
Cash flows from operating activities          
Net income  $56,534   $98,240 
Adjustments to reconcile net income to net cash (used in) provided by operating activities          
Depreciation and amortization   64,985    69,974 
Accretion of obligation for lease disposal costs   9,387    2,392 
Accretion of beneficial conversion feature and discount   38,788    38,790 
Equity based compensation   63,737    73,704 
Changes in operating assets and liabilities:          
Accounts receivable   (536,554)   (215,842)
Inventories   (320,397)   (475,443)
Prepaids and other current assets   27,797    (78,488)
Accounts payable and accrued liabilities   222,378    650,501 
Unearned revenues   (47,231)   (35,988)
Net cash (used in) provided by operating activities   (420,576)   127,840 
           
Cash flows from investing activities:          
Purchase of property, plant and equipment   (5,084)   (19,708)
Net cash used in investing activities   (5,084)   (19,708)
           
Cash flows from financing activities:          
Proceeds from sale of stock   1,581    1,527 
Principal payments on notes payable   (1,939)   (1,813)
Net cash used in financing activities   (358)   (286)
           
Net (decrease) increase in cash, cash equivalents, and restricted cash   (426,018)   107,846 
Cash, cash equivalents, and restricted cash at beginning of period   1,450,467    1,250,368 
Cash, cash equivalents, and restricted cash at end of period  $1,024,449   $1,358,214 
           
Supplemental disclosure of cash flow activities:          
Cash paid for interest  $59,127   $150,179 
           
Supplemental disclosure of noncash financing and investing transactions:          
Decrease in accrued interest and increase in equity for conversion of dividends to stock  $205,980   $205,980 

 

 

6 

 

 

 

Reconciliation of cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows is presented in the table below:

 

   Three months ended March 31, 
   2019   2018 
Cash and cash equivalents  $398,604   $356,432 
Restricted cash included in current assets   —      387,467 
Restricted cash included in long-term assets   625,845    614,315 
Total cash, cash equivalents, and restricted cash shown in statement of cash flows  $1,024,449   $1,358,214 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

 

 

 

 

 

 

 

 

 

 

7 

 

 

 

INTERNATIONAL ISOTOPES INC AND SUBSIDIARIES

Statement of Stockholders' Equity

Three Months Ended March 31, 2019 and 2018

(Unaudited)

 

   Common stock       Deficit         
                   Attributable   Equity     
                   to   Attributable     
           Additional       Internat'l   to     
   Shares   Common   Paid-in   Accumulated   Isotopes   Noncontrolling   Total 
   Outstanding   Stock   Capital   Deficit   Shareholders   Interest   Equity 
Balance, January 1, 2019   413,168,301   $4,131,683   $120,805,997   $(126,541,421)  $(1,603,741)  $1,757,875   $154,134 
                                    
Shares issued under employee stock purchase plan   31,618    316    1,265    —      1,581    —      1,581 
                                    
Stock grant   279,767    2,798    (2,798)   —      —      —      —   
                                    
Stock in lieu of dividends on convertible preferred C   3,433,000    34,330    171,650         205,980         205,980 
                                    
Stock based compensation   —      —      63,737    —      63,737    —      63,737 
                                    
Net (loss) income   —      —      —      (51,958)   (51,958)   108,492    56,534 
Balance, March 31, 2019   416,912,686   $4,169,127   $121,039,851   $(126,593,379)  $(1,384,401)  $1,866,367   $481,966 

 

   Common stock       Deficit         
                  Attributable    Equity     
                   to   Attributable     
           Additional       Internat'l   to     
   Shares   Common   Paid-in   Accumulated   Isotopes   Noncontrolling   Total 
   Outstanding   Stock   Capital   Deficit   Shareholders   Interest   Equity 
Balance, January 1, 2018   406,790,703   $4,067,907   $120,398,620   $(125,696,845)  $(1,230,318)  $1,577,245   $346,927 
                                    
Shares issued under employee stock purchase plan   21,811    219    1,308    —      1,527    —      1,527 
                                    
Adjustment        —      —      —      —      —      —   
                                    
Stock grant   209,825    2,098    (2,098)   —      —      —      —   
                                    
Stock in lieu of dividends on convertible preferred C   2,288,646    22,886    183,094    —      205,980    —      205,980 
                                    
Shares issued for exercise of employee stock options   611,111    6,111    (6,111)   —      —      —      —   
                                    
Stock based compensation        —      73,704    —      73,704    —      73,704 
                                    
Net income   —      —      —      34,404    34,404    63,836    98,240 
Balance, March 31, 2018   409,922,096   $4,099,221   $120,648,517   $(125,662,441)  $(914,703)  $1,641,081   $726,378 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

   

8 

 

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Notes to Unaudited Condensed Consolidated Financial Statements

For the Quarter Ended March 31, 2019

 

(1)       The Company and Basis of Presentation

 

International Isotopes Inc. (INIS) was incorporated in Texas in November 1995. The accompanying unaudited condensed consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (GAAP) and include all operations and balances of INIS and its wholly owned subsidiaries. The unaudited condensed consolidated financial statements also include the accounts of INIS’s 50% owned joint venture, TI Services, LLC (TI Services), and the accounts of INIS’s 24.5% interest in RadQual, LLC (RadQual). TI Services is headquartered in Youngstown, Ohio and was formed with RadQual in December 2010 to distribute products and services for nuclear medicine, nuclear cardiology and Positron Emission Tomography (PET) imaging. RadQual is a global supplier of molecular imaging quality control and calibration devices, and is headquartered in Idaho Falls, Idaho. In August 2017, affiliates of INIS purchased 75.5% of RadQual and at the time INIS was named as one of the two managing members of RadQual. As a result of this ownership change, INIS has significant influence in management decisions with regard to RadQual’s business operations. INIS, its wholly owned subsidiaries, TI Services, and RadQual are collectively referred to herein as the “Company,” “we,” “our” or “us.”

 

Nature of Operations – INIS and its subsidiaries, TI Services and RadQual, manufacture a full range of nuclear medicine calibration and reference standards, a wide range of products, including cobalt teletherapy sources, and a varied selection of radioisotopes and radiochemicals for medical research, pharmacy compounding, and clinical applications. The Company also distributes a varied selection of radioisotopes and radiochemicals for medical and clinical research applications and offers contract manufacturing services for certain pharmaceutical products. The Company also provides a host of transportation, recycling, and radiological field services on a contract basis for customers and holds several patents for a fluorine extraction process that it plans to use in conjunction with a proposed commercial depleted uranium de-conversion facility which would be located in Lea County, New Mexico (the “De-Conversion Facility”). The Company’s business consists of five business segments: Nuclear Medicine Standards, Cobalt Products, Radiochemical Products, Fluorine Products, and Radiological Services. The Company’s headquarters and all operations, with the exception of TI Services, are located in Idaho Falls, Idaho.

 

With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products is considered to be two to three years. Accordingly, preliminary payments received on cobalt contracts, where shipment will not take place for greater than one year, have been recorded as unearned revenue and, depending upon estimated ship dates, classified under either current or long-term liabilities on the Company’s consolidated balance sheets. These unearned revenues are being recognized as revenue in the periods during which the cobalt shipments take place. All assets expected to be realized in cash or sold during the normal operating cycle of business are classified as current assets.

 

Principles of Consolidation – The accompanying unaudited condensed consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (GAAP) and include all operations and balances of INIS and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. See Note 4. “Investment and Business Consolidation” for additional information regarding the consolidation of RadQual.

 

Interim Financial Information – The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, all adjustments and reclassifications considered necessary in order to make the financial statements not misleading and for a fair and comparable presentation have been included and are of a normal recurring nature. Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC on March 22, 2019.

 

9 

 

 

 

Recent Accounting Pronouncements – In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updated ASU 2016-02, “Leases”, which was issued to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The amendments in ASU 2016-02 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Results for reporting periods beginning January 1, 2019 are presented in accordance with Topic 842, while prior-period amounts have not been retrospectively adjusted and continue to be reported in accordance with Topic 840, Leases. Based upon the Company’s leases, the Company was not required to make an adjustment to the opening balance of retained earnings as of January 1, 2019. See Note 10, “Leases” for further discussion.

 

In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which expands the scope of Topic 718 to include all share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 specifies that Topic 718 applies to all share-based payment transactions in which the grantor acquires goods and services to be used or consumed in its own operations by issuing share-based payment awards. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under ASC 606. The amendments in ASU 2018-07 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted this standard effective January 1, 2019, and there was no material impact on the financial statements.

 

(2)       Current Developments and Liquidity

 

Business Condition – Since inception, the Company has incurred substantial losses. During the three-month period ended March 31, 2019, the Company reported a net loss of $51,958, net of non-controlling interest, and net cash used in operating activities of $420,576. During the three-month period ended March 31, 2018, the Company reported net income of $34,404, net of non-controlling interest, and net cash provided by operating activities of $127,840.

 

During the three months ended March 31, 2019, the Company continued its focus on its long-standing core business segments which consist of its radiochemical products, cobalt products, nuclear medicine standards, and radiological services, and in particular, the pursuit of new business opportunities within those segments.

 

Additionally, the Company holds a Nuclear Regulatory Commission (NRC) construction and operating license for the depleted uranium facility in, as well as the property agreement with, Lea County, New Mexico, where the plant is intended to be constructed. The NRC license for the de-conversion facility is a forty (40) year operating license and is the first commercial license of this type issued in the United States.  There are no other companies with a similar license application under review by the NRC. Therefore, the NRC license represents a significant competitive barrier and the Company considers it a valuable asset.

 

The Company expects that cash from operations, cash raised through equity or debt financing and its current cash balance will be sufficient to fund operations for the next twelve months. Future liquidity and capital funding requirements will depend on numerous factors, including, contract manufacturing agreements, commercial relationships, technological developments, market factors, available credit, and voluntary warrant redemption by shareholders. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.

 

(3)       Net Income (Loss) Per Common Share - Basic and Diluted

 

For the three months ended March 31, 2019, the Company had 27,205,000 stock options outstanding, 20,090,000 warrants outstanding, 4,213 outstanding shares of Series C redeemable convertible preferred stock (Series C Preferred Stock), and 850 outstanding shares of Series B redeemable convertible preferred stock (Series B Preferred Stock), each of which were not included in the computation of diluted income (loss) per common share because they would be anti-dilutive.

 

For the three months ended March 31, 2018, the Company had 31,850,000 stock options outstanding, 45,090,000 warrants outstanding, 4,213 outstanding shares of Series C Preferred Stock, and 850 outstanding shares of Series B Preferred Stock, each of which were included in the computation of diluted income per common share.

 

10 

 

 

 

The table below summarizes common stock equivalents outstanding at March 31, 2019 and 2018:

 

   March 31, 
   2019   2018 
Stock options   27,205,000    31,850,000 
Warrants   20,090,000    45,090,000 
850 Shares of Series B redeemable convertible preferred stock   425,000    425,000 
4,213 Shares of Series C redeemable convertible preferred stock   42,130,000    42,130,000 
    89,850,000    119,495,000 

 

(4)       Investment and Business Consolidation

 

The Company owns a 24.5% interest in RadQual, with which the Company has an exclusive manufacturing agreement for nuclear medicine products. In August 2017, affiliates of the Company, including the Company’s Chairman of the Board and the Chief Executive Officer, acquired the remaining 75.5% interest in RadQual. The Company’s Chairman of the Board and its Chief Executive Officer also each serve as the managing members of RadQual. As a result of this change in ownership, and other factors, the Company determined that it gained the ability to exercise significant management control over the operations of RadQual. Because of this increased management control, and pursuant to GAAP, the Company has consolidated the accounts of RadQual into its financial statements.

 

(5)       Inventories

 

Inventories consisted of the following at March 31, 2019 and December 31, 2018:

 

   March 31, 2019   December 31, 2018 
Raw materials  $42,911   $42,911 
Work in process   3,041,387    2,719,786 
Finished goods   1,828    3,032 
   $3,086,126   $2,765,729 

 

Work in process includes cobalt-60 targets that are located in the U.S. Department of Energy’s (DOE) Advanced Test Reactor (ATR) located outside of Idaho Falls, Idaho. These targets are owned by the Company and contain cobalt-60 material at various stages of irradiation. The carrying value of the targets is based on accumulated irradiation and handling costs which have been allocated to each target based on the length of time the targets have been held and processed at the ATR. At March 31, 2019, and at December 31, 2018, this cobalt target inventory had a carrying value of $403,076 and $389,293, respectively.

 

Work in process also includes costs to irradiate cobalt-60 material under a contract with the DOE. This material has been placed in the ATR and the Company is making progress payments designed to coincide with the completion of the irradiation period. The Company has contracted with several customers for the sale of some of this product material and has collected advance payments for project management, up-front handling, and other production costs from those customers. The advance payments from customers were recorded as unearned revenue which are recognized in the Company’s consolidated financial statements as cobalt products are completed and shipped. For the three months ended March 31, 2019, the Company recognized approximately $94,000 of revenue in its consolidated statements of operations for customer orders filled during the period under these cobalt contracts.

 

(6)       Stockholders’ Equity, Options, and Warrants

 

Employee Stock Purchase Plan

 

The Company has an employee stock purchase plan pursuant to which employees of the Company may participate to purchase shares of common stock at a discount. During the three months ended March 31, 2019 and 2018, the Company issued 31,618 and 21,811 shares of common stock, respectively, to employees under the employee stock purchase plan for proceeds of $1,581 and $1,527, respectively. As of March 31, 2019, 543,312 shares of common stock remain available for issuance under the employee stock purchase plan.

 

11 

 

 

Stock-Based Compensation Plans

 

2015 Incentive Plan - In April 2015, the Company’s Board of Directors approved the International Isotopes Inc. 2015 Incentive Plan (as amended, the 2015 Plan), which was subsequently approved by the Company’s shareholders in July 2015. The 2015 Plan was amended and restated in July 2018 to increase the number of shares authorized for issuance under the 2015 Plan by an additional 20,000,000 shares. The 2015 Plan provides for the grant of incentive and non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units, and other stock or cash-based awards.  The 2015 Plan amended and restated the Company’s Amended and Restated 2006 Equity Incentive Plan (2006 Plan). The 2015 Plan authorizes the issuance of up to 80,000,000 shares of common stock, plus 11,089,967 shares authorized, but not issued under the 2006 Plan. At March 31, 2019, there were 33,712,718 shares available for issuance under the 2015 Plan.

 

Employee/Director Grants - The Company accounts for issuances of stock-based compensation to employees by recognizing, as compensation expense, the cost of employee services received in exchange for equity awards. The compensation expense is based on the grant date fair value of the award. Stock option compensation expense is recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period).

 

Non-Employee Grants - The Company accounts for its issuances of stock-based compensation to non-employees by measuring the value of any awards that were vested and non-forfeitable at their date of issuance based on the grant date fair value of the award. The non-vested portion of awards that are subject to the future performance of the counterparty are adjusted at each reporting date to their fair values based upon the then current market value of the Company’s stock and other assumptions that management believes are reasonable.

 

Option awards outstanding as of March 31, 2019, and changes during the three months ended March 31, 2019, were as follows:

 

Fixed Options  Shares   Weighted Average Exercise Price   Weighted Average Remaining Contractual Life   Aggregate Intrinsic Value 
Outstanding at December 31, 2018   27,805,000   $0.06           
Granted   —                  
Exercised   —                  
Expired   —                  
Forfeited   (600,000)  $0.04           
Outstanding at March 31, 2019   27,205,000   $0.05    5.9   $332,500 
Exerciseable at March 31, 2019   19,301,000   $0.05    4.9   $332,500 

 

The intrinsic value of outstanding and exercisable shares is based on the closing price of the Company’s common stock on the OTCQB of $0.06 per share on March 29, 2019, the last trading day of the quarter.

 

As of March 31, 2019, there was $118,884 of unrecognized compensation expense related to stock options that will be recognized over a weighted-average period of 1.84 years.

 

Total stock-based compensation expense for the three months ended March 31, 2019 and 2018 was $63,737 and $73,704, respectively.

 

Pursuant to an employment agreement with its Chief Executive Officer, the Company awarded 466,667 fully vested shares of common stock to its Chief Executive Officer in February 2019 under the 2015 Plan. The number of shares awarded was based on a $28,000 stock award using a price of $0.06 per share. The employment agreement provides that the number of shares issued will be based on the average closing price of common stock for the 20 trading days prior to issue date but not less than $0.05 per share. Compensation expense recorded pursuant to this stock grant was $16,786, which was determined by multiplying the number of shares awarded by the closing price of the common stock on February 28, 2019, which was $0.06 per share. The Company withheld 186,900 shares of common stock to satisfy the employee’s payroll tax obligations in connection with this issuance. The net shares issued on February 28, 2019 totaled 279,767.

 

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Warrants

 

Warrants outstanding at March 31, 2019, included 17,165,000 Class M Warrants which are immediately exercisable at an exercise price of $0.12 per share and expire on February 17, 2022; and, 2,925,000 Class N Warrants which are immediately exercisable at an exercise price of $0.10 per share and expire on May 12, 2022. All 25,000,000 Class L Warrants expired on December 23, 2018.

 

Warrants outstanding at March 31, 2019, included 25,000,000 Class L Warrants with an exercise price of $0.06 per share and an expiration date of December 23, 2018, 17,165,000, Class M Warrants which are immediately exercisable at an exercise price of $0.12 per share and expire on February 17, 2022; and, 2,925,000 Class N Warrants which are immediately exercisable at an exercise price of $0.10 per share and expire on May 12, 2022.

 

Preferred Stock

 

At March 31, 2019, there were 850 shares of the Series B Preferred Stock outstanding with a mandatory redemption date of May 2022 at $1,000 per share or $850,000. The shares of Series B Preferred Stock are also convertible into 425,000 shares of the Company’s common stock at a conversion price of $2.00 per share. These Series B Preferred Stock does not carry any dividend preferences. Due to the mandatory redemption provision, the Series B Preferred Stock has been classified as a liability in the accompanying condensed consolidated balance sheets.

 

At March 31, 2019, there were 4,213 shares of the Series C Preferred Stock outstanding with a mandatory redemption date of February 2022 at $1,000 per share in either cash or shares of common stock, at the option of the holder. Holders of the Series C Preferred Stock do not have any voting rights except as required by law and in connection with certain events as set forth in the Statement of Designation of the Series C Preferred Stock. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17th of each year. The Series C Preferred Stock are convertible at the option of the holders at any time into shares of the Company's common stock at an initial conversion price equal to $0.10 per share, subject to adjustment.

 

During the three months ended March 31, 2019 and 2018 dividends paid totaled $252,780 and $241,730, respectively. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. For the three months ended March 31, 2019 the Company issued 3,433,000 shares of common stock in lieu of a dividend payment of $205,980. The remaining $46,800 of dividend payable was settled with cash. For the same period in 2018, the Company issued 2,288,646 shares of common stock in lieu of a dividend payment of $205,980. The remaining $35,750 of dividend payable was settled in cash.

 

(7)       Debt

 

In December 2013, the Company entered into a promissory note agreement with its former Chairman of the Board and one of its major shareholders pursuant to which the Company borrowed $500,000 (the 2013 Promissory Note). The 2013 Promissory Note is unsecured and bears interest at 6% per annum and was originally due on June 30, 2014. According to the terms of the 2013 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of the Company’s common stock. In connection with the 2013 Promissory Note, each of the two lenders was issued 5,000,000 warrants to purchase shares of the Company’s common stock at $0.06 per share. The warrants were immediately exercisable. In June 2014, the Company renegotiated the terms of the 2013 Promissory Note. Pursuant to the modification, the maturity date was extended to December 31, 2017 and each lender was granted an additional 7,500,000 warrants to purchase shares of the Company’s common stock at $0.06 per share. The warrants were immediately exercisable. In December 2016, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2022, with all remaining terms unchanged. On December 23, 2018, all 25,000,000 warrants expired. At March 31, 2019, the balance of the 2013 Promissory Note was $500,000 and accrued interest payable on the note was $159,234. Interest expense recorded for the three-month period ended March 31, 2019, was $7,500.

 

In March 2016, the Company entered into a note payable for the purchase of a vehicle. The principal amount financed was $47,513. The term of the note is six years and carries an interest rate of 6.66% per annum. Monthly payments are $805 and the note matures April 2022. The note is secured by the vehicle that was purchased with the note’s proceeds.

 

13 

 

 

In August 2017, the Company entered into a promissory note agreement with its Chairman of the Board pursuant to which the Company borrowed $60,000 (the 2017 Promissory Note). The 2017 Promissory Note accrues interest at 5% per annuum, which is payable upon maturity of the 2017 Promissory Note, and at March 31, 2019, the amount of accrued interest on the 2017 Promissory Note was $4,867. The 2017 Promissory Note is unsecured and was scheduled to mature on June 30, 2018. Pursuant to an amendment to the 2017 Promissory Note on June 29, 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2017 Promissory Note on February 2019, the maturity date was extended to July 31, 2019 with all other provisions of the 2017 Promissory Note remaining unchanged. On April 30, 2019, the 2017 Promissory Note and accrued interest were repaid in full with a cash payment of $65,367.

 

On April 9, 2018, the Company borrowed $120,000 from its Chief Executive Officer and its Chairman of the Board pursuant to a short-term promissory note (the 2018 Promissory Note). The 2018 Promissory Note accrues interest at 6% per annum, which is payable upon maturity of the 2018 Promissory Note. The 2018 Promissory Note is unsecured and originally matured on August 1, 2018. At any time, the holder of the 2018 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of the Company’s common stock based on the average price of the shares over the previous 20 trading days. Pursuant to an amendment to the 2018 Promissory Note on June 29, 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2018 Promissory Note on February 12, 2019, the maturity date was extended to July 31, 2019, with all other provisions remaining unchanged. At March 31, 2019, accrued interest on the 2018 Promissory Note totaled $7,020.

 

In February 2019, the Company borrowed $185,474 from RadQual pursuant to a short-term promissory note with a stated interest rate of 6% and a maturity date of July 31, 2019. The promissory note is unsecured.

 

(8)       Commitments and Contingencies

 

Dependence on Third Parties

 

The production of High Specific Activity Cobalt is dependent upon the DOE, and its prime operating contractor, which controls the ATR and laboratory operations at the ATR located outside of Idaho Falls, Idaho. In October 2014, the Company signed a ten-year contract with the DOE for the irradiation of cobalt targets for the production of cobalt-60. The Company will be able to purchase cobalt targets for a fixed price per target with an annual 5% escalation in price. The contract term is October 1, 2014, through September 30, 2024, however, the contract may be extended beyond that date. Also, the DOE may end the contract if it determines termination is necessary for the national defense, security or environmental safety of the United States. If this were to occur, all payments made by the Company, for partially irradiated undelivered cobalt material, would be refunded.

 

Nuclear Medicine Reference and Calibration Standard manufacturing is conducted under an exclusive contract with RadQual, which in turn has an agreement in place with several companies for distributing the products. The radiochemical product sold by the Company is supplied to the Company through agreements with several suppliers. A loss of any of these customers or suppliers could adversely affect operating results by causing a delay in production or a possible loss of sales.

 

Contingencies

 

Because all the Company’s business segments involve the handling or use of radioactive material, the Company is required to have an operating license from the NRC and specially trained staff to handle these materials. The Company has amended this operating license numerous times to increase the amount of material permitted within the Company’s facility. Although this license does not currently restrict the volume of business operations performed or projected to be performed in the upcoming year, additional processing capabilities and license amendments could be implemented that would permit processing of other reactor-produced radioisotopes by the Company. The financial assurance required by the NRC to support this license has been provided for with a surety bond held with North American Specialty Insurance Company which is supported by a restricted money market account held with Merrill Lynch in the amount of $625,845.

 

 

14 

 

 

In August 2011, the Company received land from Lea County, New Mexico, pursuant to a Project Participation Agreement (PPA), whereby the land was deeded to the Company for no monetary consideration. In return, the Company committed to construct a uranium de-conversion and Fluorine Extraction Process facility on the land.  In order to retain title to the property, the Company was to begin construction of the de-conversion facility no later than December 31, 2014, and complete Phase I of the project and have hired at least 75 persons to operate the facility no later than December 31, 2015, although commercial operations need not have begun by that date. In 2015, the Company negotiated a modification to the PPA that extended the start of construction date to December 31, 2015, and the hiring milestone to December 31, 2016. Those dates were not met, and the Company is currently in the process of renegotiating a second modification to the agreement to further extend those dates. If the Company is not successful in reaching an amendment to extend the performance dates in the PPA. then it may, at its sole option, either purchase or re-convey the property to Lea County, New Mexico.  The purchase price of the property would be $776,078, plus interest at the annual rate of 5.25% from the date of the closing to the date of payment.  The Company has not recorded the value of this property as an asset and will not do so until such time that sufficient progress on the project has been made to meet the Company’s obligations under the agreements for permanent transfer of the title.

 

(9)       Revenue Recognition

 

Revenue from Product Sales

 

The following tables present the Company’s revenue disaggregated by business segment and geography, based on management’s assessment of available data:

 

   Three Months Ended March 31, 2019   Three Months Ended March 31, 2018 
   U.S.   Outside U.S.   Total Revenues   % of Total Revenues   U.S.   Outside U.S.   Total Revenues   % of Total Revenues 
Radiochemical Products  $459,967   $3,265   $463,232    18%  $528,917   $54,924   $583,841    21%
Cobalt Products   336,089    40,000    376,089    15%   327,778    —      327,778    12%
Nuclear Medicine Products   1,080,472    20,450    1,100,922    44%   997,733    4,380    1,002,113    35%
Radiological Services   587,609    —      587,609    23%   139,172    748,422    887,594    32%
Fluorine Products   —      —      —      0%   —      —      —      0%
   $2,464,137   $63,715   $2,527,852    100%  $1,993,600   $807,726   $2,801,326    100%

 

Under ASC Topic 606, the Company recognizes revenue when it satisfies a performance obligation by transferring control of the promised goods or services to its customers, in an amount that reflects the consideration the Company expects to receive in exchange for the product or service.

 

Product sales consist of a single performance obligation that the Company satisfies at a point in time.  Most transactions in the radiochemical products and nuclear medicine standards segments fall into this category. Most sales transactions in the cobalt products business segment fall into this category but other cobalt product sales are recorded as deferred income as discussed below. The Company recognizes product revenue when the following events have occurred: (a) the Company has transferred physical possession of the products, (b) the Company has a present right to payment, (c) the customer has legal title to the products, and (d) the customer bears significant risks and rewards of ownership of the products.   Based on the Company’s historical practices and shipping terms specified in the sales agreements and invoices, these criteria are generally met when the products are:

 

·Invoiced.
·Shipped from the Company’s facilities (“FOB shipping point”, which is the Company’s standard shipping term). For these sales, the Company determined that the customer is able to direct the use of, and obtain substantially all of the benefits from, the products at the time the products are shipped.

 

15 

 

 

 

In the radiological services segment, the Company performs services under multiple types of contracts. In this segment, the Company processes gemstones and recovers various types of radioactive and/or hazardous materials from third-party facilities. Contracts for gemstone processing include two performance obligations and revenue for these contracts is recognized when each obligation is met. Recovery projects typically have only one performance obligation which is delivery of the final product or service. Under these contracts, the Company recognizes revenue once the work is complete and the customer has obtained substantially all of the benefits from the services, and the performance obligations under the contract have been met. Some recovery contracts have milestones at which point the Company can invoice and receive payments from the customer. With these contracts, the company considers each milestone a performance obligation and records revenue at the time each milestone is completed, and the customer has inspected and accepted the results of the services. The Company’s standard payment terms for its customers are generally 30 days after the Company satisfies the performance obligations.

 

The Company’s revenue consists primarily of products manufactured for use in the nuclear medicine industry, distribution of radiochemicals, cobalt source manufacturing, and providing radiological services on a contract basis for customers. With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products is considered to be two to three years. Accordingly, preliminary payments received on cobalt contracts, where shipment will not take place for greater than one year, have been recorded as unearned revenue on the Company’s consolidated balance sheets and classified under current or long-term liabilities, depending upon estimated ship dates. For the three months ended March 31, 2019, the Company reported current unearned cobalt products revenue of $3,736,310 and non-current unearned revenue of $7,500. For the period ended December 31, 2018, the Company reported current unearned revenue of $3,783,541 and non-current unearned revenue of $7,500. These unearned revenues will be recognized as revenue in the periods during which the cobalt shipments take place.

 

Contract Balances

 

The Company records a receivable when it has an unconditional right to receive consideration after the performance obligations are satisfied.  As of March 31, 2019, and December 31, 2018, accounts receivable totaled $1,356,924 and $820,370, respectively.  For the three months ended March 31, 2019, the Company did not incur material impairment losses with respect to its receivables.

 

Practical Expedients

 

The Company has elected the practical expedient not to determine whether contracts with customers contain significant financing components.

 

(10)       Leases

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 replaced most existing lease accounting guidance. In July 2018 the FASB approved an Accounting Standards Update which, among other changes, allowed a company to elect to adopt ASU 2016-02 using the modified retrospective method applying the transition provisions at the beginning of the period of adoption, rather than at the beginning of the earliest comparative period presented in these financial statements. ASU 2016-02 was effective for the Company beginning on January 1, 2019 and required the Company to record a right-of-use asset and a lease liability for its facilities leases that were previously treated as operating leases. The effect of ASU 2016-02 was to record a cumulative-effect adjustment on January 1, 2019 as a right-of-use asset and an operating lease liability totaling $810,367. The Company has made an accounting policy election to not apply the recognition requirements of ASU 2016-02 to its short-term leases, which are leases with a term of one year or less. The Company has also elected certain practical expedients under ASU 2016-02 including not separating lease and non-lease components on its operating leases, not reassessing whether any existing contracts contained leases, not reconsidering lease classification, not reassessing initial direct costs and using hindsight in determining the reasonably certain term of its leases.

 

16 

 

 

 

The Company leases office and warehouse space under operating leases. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments under the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the reasonably certain lease term. The implicit rates with the Company’s operating leases are generally not determinable and the Company uses its incremental borrowing rate at the lease commencement date to determine the present value of its lease payments. The determination of the Company’s incremental borrowing rate requires judgement. The Company determines its incremental borrowing rate for each lease using its then-current borrowing rate. Certain of the Company’s leases include options to extend or terminate the lease. The Company establishes the number of renewal options periods used in determining the operating lease term based upon its assessment at the inception of the operating lease. The option to renew the lease may be automatic, at the option of the Company, or mutually agreed to between the landlord and the Company. Once the facility lease term has begun, the present value of the aggregate future minimum lease payments is recorded as a right-of-use asset. Lease expense is recognized on a straight-line basis over the term of the lease.

 

   Three Months Ended 
   March 31, 2019 
Operating lease costs  $36,853 
Short-term operating lease costs  $1,902 
Operating cash flows from operating leases  $(38,755)
Right-of-use assets obtained in exchange for new operating lease liabilities  $810,367 
Weighted-average remaining lease term (years) - operating leases   7 
Weighted-average discount rate - operating leases   6.75%

 

The future minimum payments under these operating lease agreements are as follows:

 

2019 (excluding the three months ended March 31, 2019)  $110,560 
2020   145,563 
2021   136,313 
2022   136,313 
2023   136,313 
Thereafter   318,063 
   Total minimum operating lease obligations   983,125 
Less-amounts representing interest   (200,676)
   Present value of minimum operating lease obligations   782,449 
Current maturities   (97,580)
Lease obligations, net of current maturities  $684,869 

 

(11)       Segment Information

 

The Company has five reportable segments which include: Nuclear Medicine Standards, Cobalt Products, Radiochemical Products, Fluorine Products, and Radiological Services. Information regarding the operations and assets of these reportable business segments is contained in the following table:

 

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   Three months ended March 31, 
Sale of Product  2019   2018 
Radiochemical Products  $463,232   $583,541 
Cobalt Products   376,089    327,778 
Nuclear Medicine Standards   1,100,922    1,002,113 
Radiological Services   587,609    887,594 
Fluorine Products   —      —   
Total Segments   2,527,852    2,801,026 
Corporate revenue   —      —   
Total Consolidated  $2,527,852   $2,801,026 

 

   Three months ended March 31, 
Depreciation and Amortization  2019   2018 
Radiochemical Products  $8,817   $5,014 
Cobalt Products   1,080    4,043 
Nuclear Medicine Standards   15,619    17,938 
Radiological Services   8,636    12,039 
Fluorine Products   26,095    26,095 
Total Segments   60,248    65,130 
Corporate depreciation and amortization   4,737    4,844 
Total Consolidated  $64,985   $69,974 

 

   Three months ended March 31, 
Segment Income (Loss)  2019   2018 
Radiochemical Products  $96,006   $40,520 
Cobalt Products   192,870    184,792 
Nuclear Medicine Standards   216,822    223,942 
Radiological Services   311,279    402,012 
Fluorine Products   (37,495)   (31,299)
Total Segments   779,481    819,966 
Corporate loss   (831,439)   (785,562)
Net Income (Loss)  $(51,958)  $34,404 

 

   Three months ended March 31, 
Expenditures for Segment Assets  2019   2018 
Radiochemical Products  $—     $—   
Cobalt Products   3,494    —   
Nuclear Medicine Standards   —      18,148 
Radiological Services   —      —   
Fluorine Products   1,590    1,560 
Total Segments   5,084    19,708 
Corporate purchases   —      —   
Total Consolidated  $5,084   $19,708 

 

   March 31,   December 31, 
Segment Assets  2019   2018 
Radiochemical Products  $287,605   $344,994 
Cobalt Products   3,095,941    2,611,939 
Nuclear Medicine Standards   2,200,139    2,113,960 
Radiological Services   535,829    281,077 
Fluorine Products   5,563,206    5,590,053 
Total Segments   11,682,720    10,942,023 
Corporate assets   2,416,416    2,048,053 
Total Consolidated  $14,099,136   $12,990,076 

 

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(12)       Subsequent Events

 

On April 5, 2019, the Company entered into a manufacturing and supply agreement with Progenics Pharmaceuticals Inc. Under this agreement, the Company will provide contract manufacturing services for AZEDRA® (Ultratrace® Iobenguane I-131) and other iodine products.

 

In April 2019, 1,500,000 qualified stock options were exercised under a cashless exercise. The Company withheld 875,000 shares to satisfy the exercise price and issued 625,000 shares of common stock. The options exercised were granted under the 2015 Plan, and, accordingly, there will not be any income tax effect in the condensed consolidated financial statements for the three months ended June 30, 2019. In addition, in April 2019, 2,000,000 non-qualified stock options were exercised for a cash payment of $70,000. The options exercised were granted under the 2015 Plan and, accordingly, there will not be any income tax effect in the condensed consolidated financial statements for the three months ended June 30, 2019. On May 1, 2019, 200,000 non-qualified stock options were exercised for cash payments of $14,000. The options were granted under the 2015 Plan and, accordingly, there will not be any income tax effect in the condensed consolidated financial statements for the three months ended June 30, 2019.

 

On May 3, 2019, the Company’s radiological services team was involved in a contamination event at an off-site location in the state of Washington. The Company is currently supporting clean-up operations at that location and is in discussions with regulatory agencies regarding any possible violations that may have occurred. The Company has reported this incident to its insurance carrier and a claim is being processed to address the cost of recovery operations. The Company believes any costs associated with this event will be covered by insurance. At this time, the total cost of recovery is unknown, and it is not known whether the Company will be cited by the regulator for any violations related to this event. If the clean-up efforts in connection with this event are not covered by insurance, the clean-up costs, together with any regulatory fines, would have a material adverse effect on the Company’s financial statements.

 

 

 

 

 

 

 

 

 

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

 

This Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding industry prospects and future results of operations or financial position, made in this Quarterly Report are forward-looking statements. Words such as “anticipates,” “believes,” “should,” “expects,” “future,” “intends” and similar expressions identify forward-looking statements.  In particular, statements regarding the future prospects of our business segments, future cash flow from operations, the Company’s ability to achieve profitability, the business prospects and growth projection for our business segments, the FDA approval for certain of our products, and the status of our proposed uranium de-conversion facility, are forward-looking statements. Forward-looking statements reflect management’s current expectations, plans or projections, and are inherently uncertain. Actual results could differ materially from management's expectations, plans or projections.  Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report. Certain risks and uncertainties that could cause our actual results to differ significantly from management’s expectations are described in the risk factors set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed with the Securities and Exchange Commission (SEC) on March 22, 2019 and in the other reports we file with the SEC. These factors describe some but not all of the factors that could cause actual results to differ significantly from management’s expectations. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are urged, however, to review the risks and other factors set forth in the reports that we file from time to time with the SEC.

 

BUSINESS OVERVIEW

 

International Isotopes Inc., its subsidiaries and joint venture, TI Services, LLC, and RadQual, LLC (collectively, the Company, we, our, or us) manufacture a full range of nuclear medicine calibration and reference standards, a wide range of products including cobalt teletherapy sources, a varied selection of radioisotopes and radiochemicals for medical research and clinical applications, and provide contract manufacturing of radiochemical products. We also hold several patents for a fluorine extraction process that we intend to use in conjunction with a planned commercial depleted uranium de-conversion facility, and provide a host of transportation, recycling, and processing services on a contract basis for clients. We also own a 24.5% interest in, and have management control of, RadQual, LLC (RadQual), a global supplier of molecular imaging quality control and calibration devices, with which we have an exclusive manufacturing agreement.

 

In August 2017, affiliates of the Company, including the Company’s Chairman of the Board and the Chief Executive Officer, acquired the remaining 75.5% interest in RadQual. The Company’s Chairman of the Board and its Chief Executive Officer also serve as the managing members of RadQual. As a result of this change in ownership, and other factors, the Company determined that it had gained the ability to exercise significant management control over the operations of RadQual. Because of this increased management ability and pursuant to GAAP, the Company has consolidated the accounts of RadQual into its financial statements beginning as of August 2017. See Note 4 “Investment and Business Consolidation” to our unaudited consolidated financial statements in this report for additional information.

 

Our business consists of the following five major business segments:

 

Nuclear Medicine Standards. Our Nuclear Medicine Standards segment consists of the manufacture of sources and standards associated with Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) imaging. These sources are used for indication of patient positioning for SPECT imaging, SPECT camera operational testing, and calibration of dose measurement equipment. Revenue from nuclear medicine products includes consolidated sales from TI Services, LLC (TI Services), a 50/50 joint venture that we formed with RadQual in December 2010 to distribute our products, as well as consolidated sales from RadQual, pursuant to the change in RadQual’s ownership in August 2017, as discussed above. Our nuclear medicine standards products include a host of specially designed items used in the nuclear medicine industry. In addition to the manufacture of these products, we have developed a complete line of specialty packaging for the safe transport and handling of these products.

 

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Cobalt Products. Our Cobalt Products segment includes the production of bulk cobalt (cobalt-60), fabrication of cobalt capsules for radiation therapy and various industrial applications, and recycling of expended cobalt sources. We are the only company in the U.S. that can provide all these unique services. There has been a significant increase in regulation by the Nuclear Regulatory Commission (NRC) in recent years that has created a significant barrier to new entrants into this market.

 

Radiochemical Products. Our Radiochemical Products segment includes production and distribution of various isotopically pure radiochemicals for medical, industrial, or research applications. These products are either directly produced by us or are purchased in bulk form from other producers and distributed by us in customized packages and chemical forms tailored to meet customer requirements. In addition, we provide contract manufacturing of radiochemical products for our customers, discussed below. This segment will also include our generic radiopharmaceutical and pharmaceutical products we plan to begin producing and selling pending U.S. Food and Drug Administration (FDA) approval.

 

We have submitted an abbreviated New Drug Application (aNDA) to the FDA for a radiochemical product. The FDA has granted the Company’s request for an expedited review of the application which could accelerate the approval of the product. Once approved we anticipate a quick start-up of commercial sales of the drug product which should have a significant positive impact on our revenues. We are also considering other generic drug opportunities and plan to expand the range of products offered within this business segment in the coming years.

 

Fluorine Products. We established the Fluorine Products segment in 2004 to support production and sale of the gases that we expected to produce using our Fluorine Extraction Process (FEP) in conjunction with the operation of the proposed depleted uranium de-conversion facility in Lea County, New Mexico. Near the end of 2013, due to changes in the nuclear industry, we placed further engineering work on this project on hold. We continue to hold discussions with potential future customers seeking this type of service, however, further development activity within this segment will be deferred until market and industry conditions change to justify resuming design and construction of the facility. In the meantime, the Company expects to continue to incur some costs associated with the maintenance of licenses and other necessary project investments, and to continue to keep certain agreements in place that will support resumption of project activities at the appropriate time.

 

Radiological Services. Our Radiological Services segment consists of a wide variety of miscellaneous services such as decommissioning disused irradiation units, performing sealed source exchanges in irradiation and therapy units, and gemstone processing. We are licensed through the NRC to perform certain field service activities in connection with the U.S. Department of Energy’s (DOE) Orphan Source Recovery Program (OSRP).  These activities include services to support recovery of disused sources under the DOE’s OSRP and installation or removal of certain cobalt therapy units. We designed and built a mobile hot cell unit to use in the performance of OSRP field service jobs. This type of field service work is expected to generate the majority of revenue within this business segment in the coming years and has expanded to include similar international contract opportunities through the International Atomic Energy Agency (IAEA).

 

RECENT UPDATES

 

On May 3, 2019, our radiological services team was involved in a contamination event at an off-site location in the state of Washington. We are currently supporting clean-up operations at that location and are in discussions with regulatory agencies regarding any possible violations that may have occurred. We have reported this incident to our insurance carrier and a claim is being processed to address the cost of recovery operations. We believe any costs associated with this event will be covered by insurance. At this time, the total cost of recovery is unknown, and it is not known whether we will be cited by the regulator for any violations related to this event. If the clean-up efforts in connection with this event are not covered by insurance, the clean-up costs, together with any regulatory fines, would have a material adverse effect on our results of operations and financial statements.

 

CRITICAL ACCOUNTING POLICIES

 

From time-to-time, management reviews and evaluates certain accounting policies that are considered to be significant in determining our results of operations and financial position.

 

A description of the Company’s critical accounting policies that affect the preparation of the Company’s financial statements is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 22, 2019.

 

RESULTS OF OPERATIONS

 

Three Months Ended March 31, 2019 Compared to Three Months Ended March 31, 2018

 

Revenue for the three months ended March 31, 2019 was $2,527,852 as compared to $2,801,026 for the same period in 2018, an overall decrease of $273,174, or approximately 10%. This decrease in revenue was largely the result of decreased revenue in our radiochemical and radiological services segments, as discussed in detail below.

 

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The following table presents a period-to-period comparison of total revenue by segment for the three months ended March 31, 2019 and 2018:

 

  

For the three-months

ended March 31,

  

For the three-months

ended March 31,

         
Sale of Product  2019   2018   $ change   % change 
Radiochemical Products  $463,232   $583,541   $(120,309)   -21%
Cobalt Products   376,089    327,778    48,311    15%
Nuclear Medicine Standards   1,100,922    1,002,113    98,809    10%
Radiological Services   587,609    887,594    (299,985)   -34%
Fluorine Products   —      —      —      0%
Total Consolidated  $2,527,852   $2,801,026   $(273,174)   -10%

 

Cost of sales decreased to $1,088,429 for the three months ended March 31, 2019 from $1,442,408 for the same period in 2018. This is a decrease of $353,979, or approximately 25%. The decrease in cost of sales in the three-month comparison was primarily due to the decreased sales activity in two of our five business segments, particularly the radiochemical and radiological services segments, as discussed in detail below. Gross profit for the three months ended March 31, 2019 was $1,439,423, compared to $1,358,618 for the same period in 2018. This represents an increase in gross profit of $80,805, or approximately 6%.

 

The following table presents cost of sales and gross profit data for each of our business segments for the three months ended March 31, 2019 and 2018:

 

  

For the three-

months ended

March 31,

  

% of

Total Sales

  

For the three-

months ended

March 31,

  

% of

Total Sales

 
   2019   2019   2018   2018 
Total Sales  $2,527,852        $2,801,026      
Cost of Sales                    
Radiochemical Products  $279,650    11%  $491,453    18%
Cobalt Products   120,145    5%   80,514    3%
Nuclear Medicine Standards   471,142    19%   473,051    17%
Radiological Services   217,492    9%   397,390    14%
Fluorine Products   —      —      —      —   
Total Segments   1,088,429    44%   1,442,408    50%
                     
Gross Profit  $1,439,423        $1,358,618      
Gross Profit %   57%        49%     

 

Operating expense increased approximately 7% to $1,296,866 for the three months ended March 31, 2019, from $1,209,013 for the same period in 2018. This increase of $87,853, is primarily due to an approximate 18% increase in General, Administrative and Consulting costs combined with an approximate 10% increase in Salaries and Contract Labor costs. The increase in General, Administrative and Consulting costs is a result of increased legal and general operating supply costs incurred during the three months ended March 31, 2019, as compared to the same period in 2018. The increase in Salaries and Contract Labor was a result of adding staff to our payroll. Research and Development costs decreased to $46,304, for the three months ended March 31, 2019, as compared to $106,420, for the same period in 2018. This is a decrease of $60,116, or approximately 56% and is primarily the result of a decrease in expenditures for product development in several of our business segments for the three months ended March 31, 2019, as compared to the same period in 2018.

 

The following table presents a comparison of total operating expense for the three months ended March 31, 2019 and 2018:

 

   For the three-months ended March 31,   For the three-months ended March 31,         
Operating Costs and Expenses:  2019   2018   % change   $ change 
Salaries and Contract Labor  $623,699   $569,459    10%  $54,240 
General, Administrative and Consulting   626,863    533,134    18%   93,729 
Research and Development   46,304    106,420    -56%   (60,116)
Total operating expenses  $1,296,866   $1,209,013    7%  $87,853 

  

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Other income was $24,632 for the three months ended March 31, 2019, as compared to $53,362 for the same period in 2018. This is a decrease of $28,730, or approximately 54%. The decrease is the result of recording prior period activities of our investment in RadQual as other income for the three months ended March 31, 2018. There was no similar income to record for the same period in 2019. Interest expense for the three months ended March 31, 2019 was $114,077, compared to $106,034 for the same period in 2018. This is an increase of $8,043, or approximately 8%. Interest expense includes dividends accrued on our Series C Redeemable Convertible Preferred Stock (Series C Preferred Stock). As discussed below, we issued Series C Preferred Stock in February 2017 and May 2017. For the three months ended March 31, 2019, we accrued dividends payable of $51,892, which have been recorded as interest expense. Additionally, non-cash interest expense in the amount of $32,084 was recorded for this same period for the issuance of warrants related to the preferred stock issuances. In April 2018, we borrowed $120,000 from our Chief Executive Officer and our Chairman of the Board. Interest recorded for the three months ended March 31, 2019 was $1,800 whereas there was no similar interest expense for the same period in 2018. Interest was also paid on a loan for a vehicle purchased in May 2016. See Note 7 “Debt” to our unaudited consolidated financial statements in this Quarterly Report for additional information about our indebtedness and the associated interest expense.

 

Our net loss for the three months ended March 31, 2019, was $51,958, compared to net income of $34,404, for the same period in 2018. This is a decrease in income of $86,362 and is the result of our decreased sales and the increase in operating expense for the three months ended March 31, 2019, as compared to the same period in 2018.

 

Radiochemical Products. Revenue from the sale of radiochemical products for the three months ended March 31, 2019 was $463,232, compared to $583,541 for the same period in 2018. This is a decrease of $120,609, or approximately 21%. The decrease is primarily the result of supply interruptions caused by production issues from our primary radiochemical supplier. The supplier has taken steps to correct those production shortcomings and we expect higher production capability and enhanced reliability from this supplier going forward.

 

Gross profit of radiochemical products for the three months ended March 31, 2019 was $183,582, compared to $92,088, for the same period in 2018, and gross profit percentages were approximately 40% and 16% for the three months ended March 31, 2019 and 2018, respectively. Cost of sales for radiochemical products decreased to $279,650 for the three months ended March 31, 2019, as compared to $491,453 for the same period in 2018. This is a decrease of $211,803, or approximately 43%, and was primarily the result of decreased sales of product and improvements in the utilization of raw material purchased in this segment, in the three-month comparison. Our decrease in material costs is due to a reduction in freight charges as a result of purchasing our material within the U.S. thus eliminating international shipping and customs fees. We expect this cost savings in shipping to continue with future shipments from this domestic supplier. Operating expense for this segment increased to $87,576 for the three months ended March 31, 2019, compared to $51,568 for the same period in 2018. This increase in operating expense of $36,008, or approximately 70%, is primarily due to increased costs for labor, training, and repairs and maintenance for the three-month period ended March 31, 2019, as compared to the same period in 2018. This segment reported net income of $96,006 for the three months ended March 31, 2019, as compared to net income of $40,520 for the same period in 2018. The increase in net income of $55,486 or approximately 137%, is primarily the result of the significant decrease in cost of goods sold as discussed above, partially offset by the decrease in revenue, as discussed above.

 

In April 2019, we entered into a contract manufacturing and supply agreement with Progenics Pharmaceuticals, Inc. (Progenics). Under the agreement, we will provide contract manufacturing services for AZEDRA® (Ultratrace® Iobenguane I-131) and other iodine products. We believe that this contract manufacturing for Progenics helps further broaden our customer base and technical experience and positions us for future additional agreements under which we can use our license qualifications and experience in handling iodine-131.

 

Cobalt Products. Revenue from the sale of cobalt products for the three months ended March 31, 2019 was $376,089, compared to $327,778, for the same period in 2018. This represents an increase of $48,311, or approximately 15%. Our cobalt sealed source manufacturing is largely dependent on our ability to procure cobalt material from the DOE’s Advanced Test Reactor (ATR). Although we have not been able to obtain cobalt from the ATR reactor since late 2013, we have been able to contract with another supplier for the purchase of cobalt material, and during the three months ended March 31, 2019, we were able to manufacture products for customers using this material. In addition, we have begun to supply cobalt to customers who previously paid for the material under supply agreements entered into with us in 2015. As we have supplied this material to our customers, we have recognized the sales on our statement of operations.

 

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In November 2018, we entered into a supply agreement with an additional customer under which we will begin delivering cobalt material in late 2019 or early 2020. During the three months ended March 31, 2019, we began fulfilling contract milestones of this agreement. All pre-payments for material have been recorded as unearned revenue on our consolidated balance sheets.

 

We have experienced delays in the delivery of cobalt material from the DOE’s ATR. Because of these delays, we have been forced to purchase cobalt material, at lower activity levels, from alternate suppliers in order to meet contract obligations.

 

In October 2014, we entered into a ten-year agreement with the DOE for the irradiation of cobalt targets. It takes approximately three to four years to irradiate the cobalt targets to the desired level of activity and we anticipate having high specific activity cobalt available to our customers late in 2019 and every year thereafter through at least 2024. As mentioned above, we are continuing to purchase some bulk cobalt from another supplier, which will allow us to complete some additional source manufacturing sales during 2019 in advance of the cobalt that is being produced in the ATR.

 

As of March 31, 2019, we continued to hold many in-progress, old design cobalt targets at the ATR. We believe that many of the older design targets we hold at the ATR, and that we report as inventory, still hold significant market value in excess of their current carrying values and we have concluded that no impairment existed at that time. We will periodically continue to review the residual value of this cobalt material for potential impairment and make adjustments as deemed appropriate.

 

During 2015, we entered into cobalt-60 supply agreements with several customers. The terms of the agreements required pre-payments to secure cobalt material in future years. Those prepayments were recorded as unearned revenue on our consolidated balance sheet. During the three months ended March 31, 2019, we began supplying material to some customers and have accordingly recognized approximately $94,000 of revenue as a result of these deliveries.

 

In April 2019, because of our inability to supply high specific activity cobalt material produced by the DOE’s ATR, we were forced to modify a supply agreement with one of our cobalt customers. The modifications require that we refund approximately $1,100,000, of payments received for prior year undelivered material, plus interest at 12% per year, payable over a one-year period. We have also agreed with this customer to refund approximately $1,100,000 paid for material that was to have been delivered in later years. There will be no interest charge on this refund. In addition, we have identified another customer ready to purchase this material. The Company does not anticipate any significant net negative effect of this change as sales under the new agreement are expected to completely offset refunds made under the old agreement. Accordingly, we will classify refund payments due within one year as a short-term liability and payments due beyond one year as a long-term liability, rather than as short-term deferred revenue on our consolidated balance sheets.

 

Cost of sales for the three months ended March 31, 2019, was $120,145, as compared to $80,514, for the same period in 218. Gross profit for cobalt products for the three months ended March 31, 2019 was $255,944 compared to $247,264 for the same period in 2018. This is an increase of $8,680, or approximately 4% and is primarily attributable to our increase in source manufacturing for the three months ended March 31, 2019, as compared to the same period in 2018. Our gross profit percentages were approximately 68% and 76% for the three-month periods ended March 31, 2019 and 2018, respectively. The decrease in the gross profit percentage for the three months ended March 31, 2019 is primarily due to increased costs of raw material used in the manufacture of sealed sources. Operating expense in this segment increased to $63,074 for the three months ended March 31, 2019, from $62,472 for the same period in 2018. This is an increase of $602, or approximately 1%. Our net income for cobalt products was $192,870 for the three months ended March 31, 2019, as compared to a net income of $184,792 for the same period in 2018. The increase in net income of $8,077, or approximately 4%, was attributable to the increased sales of cobalt products during the quarter.

 

Nuclear Medicine Standards. Revenue from nuclear medicine products for the three months ended March 31, 2019, was $1,100,922, compared to $1,002,113 for the same period in 2018. This represents an increase in revenue of $98,809, or approximately 10%. As discussed above, due to a change in the member ownership of RadQual, in August 2017 we began reporting our investment in RadQual on a consolidated basis. Therefore, revenue in this segment includes all sales of RadQual and TI Services with all intercompany sales for the consolidated period eliminated.

 

24 

 

 

 

We anticipate that our sales through RadQual will remain strong and that, because of our RadQual ownership, we will continue to have significant future opportunities to work on new product development and to further expand our international sales. Additionally, we have continued to work with TI Services on marketing strategies to boost customer service and sales of some unique nuclear medicine and pharmacy products.

 

Cost of sales for our nuclear medicine standards segment for the three months ended March 31, 2019, was $471,142, as compared to $473,051 for the same period in 2018. The small decrease in cost of sales in the period-to-period comparison of $1,909, or less than 1%, is due to slight decreases in material purchased for flood source manufacturing for the three-month period ended March 31, 2019, as compared to the same period in 2018. Gross profit for our nuclear medicine standards segment for the three months ended March 31, 2019 was $629,780 compared to $529,062 for the same period in 2018. This is an increase in gross profit of $100,718, or approximately 19%. The increase in gross profit in the period-to-period comparison is primarily the result of the increased sales.

 

Operating expense for this segment for the three months ended March 31, 2019 increased to $422,062, from $304,462 for the same period in 2018. This is an increase of $117,600, or approximately 39%, and is the result of increased wage expense for the three months ended March 31, 2019, as compared to the same period in 2018. Operating expense also includes consolidated net operating expense reported for RadQual of $139,894 and non-controlling member interest expense of $103,389, for the three months ended March 31, 2019, as compared to $123,853 of net operating expense and non-controlling member interest expense of $64,363 for the same period in 2018. Net operating expense included for TI Services was $32,725 for the three months ended March 31, 2019, and $36,975 for the same period in 2018. TI Services non-controlling interest included was $5,102 for the three-month period ended March 31, 2019, as compared to ($527) for the same period in 2018. The $5,629 increase in the TI Services non-controlling interest expense is the result of TI Services reporting net income for the three-month period ended March 31, 2019 as compared to a net loss reported for the same period in 2018. Net income for this segment for the three months ended March 31, 2019 was $216,822, compared to $223,942 for the same period in 2018. This is a decrease in net income of $7,120, or approximately 4% and is primarily the result of the increase in operating expense reported for the three months ended March 31, 2019, as compared to the same period in 2018.

 

Radiological Services. Revenue from all radiological services for the three months ended March 31, 2019 was $587,609, compared to $887,594, for the same period in 2018, a decrease of $299,985 or approximately 34%. The majority of our revenue in this segment is generated by the performance of activities in connection with contracts for the DOE and the International Atomic Energy Agency (IAEA). The decrease in the revenue for the period comparison is the result of the random timing of the work performed by us for these agencies. These contracts are historically awarded sporadically over time and thus will continue to create fluctuations in the period-to-period comparisons in radiological services revenue.

 

The work performed for the DOE and the IAEA includes services to support recovery of disused sources and installation or removal of certain devices. Based on the number of orphan sources identified both in the U.S. and internationally that will need to be recovered and disposed of, we expect this source removal and installation work to continue at least through 2019. During October 2018, we were awarded over one dozen field service contracts that will be completed during 2018 and 2019. We expect that there will be additional DOE and IAEA work forthcoming as well.

 

Cost of sales for the three months ended March 31, 2019, was $217,492, as compared to $397,390, for the same period in 2018. Gross profit for this segment for the three months ended March 31, 2019 was $370,117, compared to $490,203, reported for the same period in 2018. The decrease in gross profit of $120,086, or approximately 25%, is the result of the decrease in service contracts completed and reported in this segment for the three months ended March 31, 2019, as compared to the same period in 2018. Operating expense for the three months ended March 31, 2019 was $58,839, as compared to $88,191, reported for the same period in 2018. This decrease of $29,353, or approximately 33%, is the result of a decrease in costs in performing field services activities. Net income for this segment for the three months ended March 31, 2019 was $311,279, compared to $402,012, for the same period in 2018. This is a decrease in net income of $90,733, or approximately 23% and is the result of the decrease in revenue reported for the three months ended March 31, 2019, as compared to the same period in 2018.

 

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Fluorine Products. There was no revenue to report from the fluorine products segment for the three months ended March 31, 2019, or for the same period in 2018. During the three months ended March 31, 2019, we incurred $37,495 of expense related to items in support of future planning and design for the proposed de-conversion facility, as compared to $31,299 for the same three-month period in 2018. The increase of $6,196, or approximately 20% is the result of increased travel and wage costs recorded in the period-to-period comparison.

 

We established the Fluorine Products segment in 2004 to support production and sale of the gases produced using our FEP. Our FEP patents offer a unique opportunity to provide certain high-purity fluoride compounds while also offering a “for fee” de-conversion service to the uranium enrichment industry. From 2004 to 2012, we used a pilot facility to develop production processes for various high-purity products and to test methods of scaling up the size of FEP production in support of the planned de-conversion facility in Lea County, New Mexico. In 2012, we completed our testing of individual components and analytical processes and in 2013 we closed the pilot plant facility. Also, in 2013, we made the decision to place continued formal design work on the proposed de-conversion facility on hold until we are able to secure additional de-conversion services contracts. We continue to be in discussions with potential future customers of our deconversion services, however, until such time that agreements are reached and work can resume on the project, we will limit our expenditures to essential items such as maintenance of the NRC license, land use agreements, communication with our prospective FEP product customers, and interface with the State of New Mexico and Lea County officials. We believe that our investment made in the FEP process and the de-conversion facility and the NRC operating license that we hold provide us with a valuable asset that holds significant future opportunity.

 

LIQUIDITY AND CAPITAL RESOURCES

 

At March 31, 2019, we had cash and cash equivalents of $398,604 as compared to $828,039 at December 31, 2018. This is a decrease of $429,435 or approximately 52%. For the three months ended March 31, 2019, net cash used in operating activities was $420,576, and for the three months ended March 31, 2018, net cash provided by operating activities was $127,840. The increase in cash used in operating activities and decrease in cash and cash equivalents at period end in the period-to-period comparison is the result of increased inventory reported as well as an increase in accounts receivable.

 

Inventories at March 31, 2019 totaled $3,086,126, and inventories at December 31, 2018 totaled $2,765,729. A significant amount of our inventory consists of work-in-process cobalt raw material held at the ATR located outside of Idaho Falls, Idaho. At March 31, 2019, this raw cobalt material inventory accounted for approximately 92% of our work-in-process inventory. At December 31, 2018, this in-process raw material inventory accounted for approximately 89% of our work in process inventory. We periodically evaluate the carrying value of our raw materials to determine their future market value to the Company. As of March 31, 2019, we determined that no impairment of this raw material inventory was necessary.

 

Cash used in investing activities was $5,084 for the three months ended March 31, 2019, and cash used in investing activities was $19,708 for the same period in 2018. The cash used for the three months ended March 31, 2019, and for the same period in 2018, was for the purchase of equipment.

 

Financing activities used cash of $358, during the three months ended March 31, 2019, and cash used in financing activities for the same period in 2018 was $286. During the three months ended March 31, 2019, cash paid for interest was $59,127 and during the same three-month period in 2018, cash paid for interest was $150,176. Additionally, during the three months ended March 31, 2019, we received $1,581in proceeds from the sale of our common stock through our Employee Stock Purchase Plan, as compared to $1,527 for the same period in 2018.

 

In February 2017, we entered into subscription agreements with certain investors, including two of our directors, for the sale of (i) an aggregate of 3,433 shares of Series C Preferred Stock, and (ii) Class M warrants to purchase an aggregate of 17,165,000 shares of our common stock (Class M Warrants), for gross proceeds of $3,433,000. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17th of each year, commencing on February 17, 2018.  Shares of Series C Preferred Stock are convertible at the option of the holder at any time into shares of our common stock at an initial conversion price equal to $0.10 per share, subject to adjustment.

 

26 

 

 

At any time after February 17, 2019, if the volume-weighted average closing price of our common stock over a period of 90 consecutive trading days is greater than $0.25 per share, we may redeem all or any portion of the outstanding Series C Preferred Stock at the original purchase price per share plus any accrued and unpaid dividends, payable in shares of common stock.  All outstanding shares of Series C Preferred Stock must be redeemed by us on February 17, 2022 at the original purchase price per share, payable in cash or shares of common stock, at the option of the holder. Holders of Series C Preferred Stock do not have any voting rights, except as required by law and in connection with certain events as set forth in the Statement of Designation of the Series C Preferred Stock. The Class M Warrants are immediately exercisable at an exercise price of $0.12 per share, subject to adjustment as set forth in the warrant, and have a term of five years.

 

In February 2019, the Company paid its second annual dividend on the Series C Preferred Stock. Dividends payable totaled $252,780. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. The Company issued 3,433,000 shares of common stock in lieu of a dividend payment of $205,980. The remaining $46,800 of dividend payable was settled with cash.

 

Total decrease in cash for the three-month period ended March 31, 2019, was $426,018 compared to a cash increase of $107,846 for the same period in 2018.

 

We expect that cash from operations, cash raised via equity financing, and our current cash balance will be sufficient to fund operations for the next twelve months. Our future liquidity and capital funding requirements will depend on numerous factors, including, contract manufacturing agreements, commercial relationships, technological developments, market factors, available credit, and voluntary warrant redemption by shareholders. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.

 

At March 31, 2019, there were 20,090,000 outstanding warrants to purchase our common stock. Included in this number are 17,165,000 Class M Warrants issued February 17, 2017, with an exercise price of $0.12 per share and an expiration date of February 17, 2022; and, 2,925,000 Class N Warrants issued May 12, 2017, with an exercise price of $0.10 per share and an expiration date of May 12, 2022.

 

Debt

 

In December 2013, we entered into a promissory note agreement with our then Chairman of the Board and one of our major shareholders, pursuant to which we borrowed $500,000. The $500,000 note bears interest at 6% per annum and was originally due June 30, 2014. At any time, the lenders may settle any or all of the principal and accrued interest with shares of our common stock. In connection with the promissory note, each of the two lenders was issued 5,000,000 warrants to purchase shares of our common stock at $0.06 per share. The warrants were immediately exercisable. In June 2014, we renegotiated the terms of this promissory note. Pursuant to the modification, the maturity date was extended to December 31, 2017 and each lender was granted an additional 7,500,000 warrants to purchases shares of our common stock at $0.06 per share. The warrants were immediately exercisable. In December 2016, the note was further modified to extend the maturity date to December 31, 2022, with all remaining terms unchanged. All warrants issued under this note expired December 23, 2018. At March 31, 2019, the balance of the promissory note was $500,000 and accrued interest on the note was $159,234. Interest expense for the note recorded for the three-month period ended March 31, 2019, was $7,500.

 

In March 2016, we entered into a note payable for the purchase of a vehicle. The principal amount financed was $47,513. The term of the note is six years and the note carries an interest rate of 6.66%. Monthly payments are $805 and the note matures April 2022. The note is secured by the vehicle that was purchased with the note’s proceeds.

 

In August 2017, we entered into a short-term promissory note agreement with our Chairman of the Board, pursuant to which we borrowed $60,000 (the “2017 Promissory Note”). The 2017 Promissory Note bears interest at 5% annum and was scheduled to mature on June 30, 2018 and was unsecured. On June 29, 2018, the maturity date was extended to March 31, 2019, with all other terms of the note remaining unchanged. On February 12, 2019, the maturity date was extended to July 31, 2019. The 2017 Promissory Note was repaid in full in cash in May 2019, at which time $60,000 of principal and $5,367 interest was paid.

 

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In April 2018, we borrowed $120,000 from our Chief Executive Officer and Chairman of the Board pursuant to a short-term promissory note (the “2018 Promissory Note”). The 2018 Promissory Note accrues interest at 6% per annum, which is payable upon maturity of the 2017 Promissory Note. The 2018 Promissory Note is unsecured and originally matured on August 1, 2018. At any time, the holder of the 2018 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of our common stock based on the average price of the shares over the previous 20 trading days. Pursuant to an amendment to the 2018 Promissory Note on June 29, 2018, the maturity date was extended to March 31, 2019, with all other provisions remaining unchanged. Pursuant to a second amendment to the 2018 Promissory Note on February 12, 2019, the maturity date was extended to July 31, 2019, with all other terms remaining unchanged. At March 31, 2019, accrued interest on the 2018 Promissory Note totaled $7,020.

 

In February 2019, we borrowed $185,474 from RadQual pursuant to a short-term promissory note with a stated interest rate of 6% and a maturity date of July 31, 2019. The promissory note is unsecured

 

OFF-BALANCE SHEET ARRANGEMENTS

 

As of March 31, 2019, we had no off-balance sheet arrangements or obligations.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act), that are designed to ensure that material information relating to us is made known to the officers who certify our financial reports and to other members of senior management and the Board of Directors. These disclosure controls and procedures are designed to ensure that information required to be disclosed in our reports that are filed or submitted under the Exchange Act are recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.

 

Management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness, as of March 31, 2019, of our disclosure controls and procedures. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2019.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

We were not a party to any legal proceedings that we believe to be material and we are not aware of any pending or threatened litigation against us that we believe could have a material adverse effect on our business, operating results, financial condition, or cash flows.

 

ITEM 1A. RISK FACTORS

 

There have been no material changes or updates to the risk factors previously disclosed in Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2018.

  

 

28 

 

 

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

 

In February 2019, the Company paid a dividend on the Series C Preferred Stock. Dividends payable totaled $252,780. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. For the dividend paid in February 2019, the Company issued 3,433,000 shares of common stock in lieu of a dividend payment of $205,980. The remaining $46,800 of dividend payable was settled with cash.

 

ITEM 6. EXHIBITS

 

Exhibit No.Description

 

3.1Restated Certificate of Formation, as amended (incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q for quarter ended June 30, 2010).

 

3.2Statement of Designation of the Series C Convertible Redeemable Preferred Stock of International Isotopes Inc. (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed on February 24, 2017).

 

3.3Bylaws (incorporated by reference to Exhibit 3.2 of the Company's Registration Statement on Form SB-2 filed on May 1, 1997 (Registration No. 333-26269)).

 

10.1†Manufacturing and Supply Agreement, dated April 5, 2019, between International Isotopes Inc. and Progenics Pharmaceuticals, Inc.+

 

31.1Certification by the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.*

 

31.2Certification by the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.*

 

32.1Certification by the Chief Executive Officer furnished pursuant to 18 U.S.C. Section 1350 adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**

 

32.2Certification by the Chief Financial Officer furnished pursuant to 18 U.S.C. Section 1350 adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**

 

101

The following financial statements, formatted in XBRL: (i) Unaudited Condensed Consolidated Balance Sheets as of March 31, 2019 and December 31, 2018, (ii) Unaudited Condensed Consolidated Statements of Operations for the three months ended March 31, 2019 and 2018, (iii) Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2019 and 2018, (iv) Unaudited Statement of Stockholders’ Equity for the three months ended March 31, 2019 and 2018, and (v) Notes to Unaudited Condensed Consolidated Financial Statements.*

 

________________

* Filed herewith.

** Furnished herewith.

† Certain portions of the exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.

+ Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K under the Securities Exchange Act of 1934, as amended. The Company hereby undertakes to supplementally furnish copies of any omitted schedules to the Securities and Exchange Commission upon request.

 

 

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SIGNATURES

 

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

 

Date:  May 15, 2019 International Isotopes Inc.
   
     
  By: /s/ Steve T. Laflin
    Steve T. Laflin
    President and Chief Executive Officer
     
     
  By: /s/ Laurie McKenzie-Carter
    Laurie McKenzie-Carter
    Chief Financial Officer

 

 

 

 

 

 

 

 

 

 30

 EX-10.1 2 exhibit101.htm EXHIBIT 10.1 Exhibit 10.1

 Exhibit 10.1

 

 

 

PORTIONS OF THIS EXHIBIT MARKED BY [**] HAVE BEEN OMITTED PURSUANT TO RULE 601(B)(10) OF REGULATION S-K. THE OMITTED INFORMATION IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MANUFACTURING AND SUPPLY AGREEMENT BETWEEN

INTERNATIONAL ISOTOPES INC. AND

PROGENICS PHARMACEUTICALS, INC.

 

Dated as of April 5, 2019

 

 

 

 

 

 

 

 

 

 
 

MANUFACTURING AND SUPPLY AGREEMENT

 

This Manufacturing and Supply Agreement (this “Agreement”), effective as of this 5th day of April, 2019 (the “Effective Date”), is entered into by and between INTERNATIONAL ISOTOPES INC., a Texas corporation, with its principal place of business located at 4137 Commerce Circle, Idaho Falls, Idaho 83401 (“INIS”), and PROGENICS PHARMACEUTICALS, INC., a Delaware corporation, with its principal place of business at 1 World Trade Center, 47th Floor, Suite J, New York, New York 10007 (“Progenics”). INIS and Progenics may also be referred to in this Agreement individually as a “Party” and together as the “Parties”. Certain capitalized terms used herein have the meanings ascribed to them in Section 1 below.

 

R E C I T A L S

 

WHEREAS, Progenics seeks to establish a source for the production and supply of designated clinical and/or commercial quantities of Products (as defined below); and

 

WHEREAS, INIS intends to construct and commission a dedicated commercial manufacturing facility which shall include [**] (the “Dedicated Facility”) in a committed space at the existing INIS facility located at 4137 Commerce Circle, Idaho Falls, Idaho 83401 (the “Facility”), at which INIS intends to produce clinical and commercial supply of Products for Progenics, all upon the terms and conditions set forth in this Agreement.

 

NOW THEREFORE, in consideration of the mutual representations, warranties and covenants contained herein, the Parties hereto agree as follows.

 

1.

DEFINITIONS

 

When used herein, the following terms shall have the respective meanings set forth

below.

 

1.1             “Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder from time to time.

 

1.2             “Affiliate” means with respect to any Party, any Person that is controlled by, controls, or is under common control with, that Party. For this purpose, “control” of a corporation or other business entity shall mean direct or indirect beneficial ownership of more than fifty percent (50%) of the voting interest in, or more than fifty percent (50%) in the equity of, or the right to appoint more than fifty percent (50%) of the directors or management of, such corporation or other business entity.

 

1.3             “Batch” means the quantity of a Product of uniform character and quality, yielded from the same cycle of Manufacturing, manufactured using [**] radioactivity, as directed by Progenics in a Purchase Order or otherwise.

 

 

 

 

  

1.4             “Business Day” means any day other than a Saturday, Sunday or another day on which commercial banks in New York, New York are authorized or required by Law to close. Any reference herein to a day other than a Business Day shall mean a calendar day.

 

1.5             “cGMP” means the Current Good Manufacturing Practice Regulations of the U.S. Code of Federal Regulations, as set forth in 21 CFR Parts 210 and 211 (or their respective successors as in effect from time to time) and all other applicable rules and regulations under each of the foregoing, each as amended from time to time.

 

1.6“FDA” means the U.S. Food and Drug Administration or any successor agency.

 

1.7             “Field Alert” means any field alert report submitted or required to be submitted to the FDA to identify quality defects in any Product pursuant to 21 CFR 314.81(b)(1).

 

1.8             “Indemnified Parties” means (i) with respect to claims arising under Section 12.1, Progenics Indemnified Parties, and (ii) with respect to claims arising under Section 12.2, INIS Indemnified Parties.

 

1.9             “Indemnifying Party” means (i) with respect to claims arising under Section 12.1, INIS, and (ii) with respect to claims arising under Section 12.2, Progenics.

 

1.10          “INIS Background Technology” means any Technology (i)(A) owned or controlled by INIS or any of its Affiliates as of the Effective Date, or (B) developed or obtained by or on behalf of INIS or any of its Affiliates after the Effective Date independent of this Agreement and without use of any Progenics Technology or Confidential Information of Progenics; and (ii) all intellectual property rights in any of the foregoing. All INIS materials and information owned or controlled by INIS or any of its Affiliates as of the Effective Date associated with [**] is considered an example of INIS Background Technology.

 

1.11          “INIS Program Technology” means Program Technology that is developed using Confidential Information of INIS and that (A) (i) is not based on and does not incorporate, rely on or include any Progenics Technology, (ii) is an improvement or modification to INIS manufacturing processes and is designed to perform generalized functions not specific to the particular requirements of Progenics, (iii) does not contain and is not generated from, nor derived from or developed using, any Progenics Technology, and (iv) is not developed at the request or direction of Progenics; and (B) all intellectual property rights in any of the foregoing.

 

1.12          “INIS Technology” means INIS Background Technology and INIS Program Technology. INIS Technology shall constitute INIS Confidential Information.

 

1.13          “Labeling” means all labels, package inserts, carton imprints and all other markings on packaging for, or other similar materials related to a Product that are defined as labels or labeling under any applicable Law.

 

1.14          “Labeling Specifications” means the labeling and packaging specifications for the Products, as determined by Progenics from time to time.

 

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1.15“Landlord” means, the landlord of the Facility.

 

1.16          “Law” means all applicable federal, state and local laws, statutes or ordinances (including, without limitation, the Act) governing the Manufacture, marketing, advertising, distribution and sale of the Products and use of the Products in clinical trials, including, without limitation, all regulations, rules or published guidelines or pronouncements having the effect of Law, promulgated by any Regulatory Authority.

 

1.17          “Manufacture,” “Manufactured,” or “Manufacturing” means the manufacturing, formulating, finishing (including packaging), filling, and quality control testing (including in- process, release and stability testing) of the Products in accordance with this Agreement and the Quality Agreement.

 

1.18          “Manufacturing Authorization” means any authorization necessary to Manufacture the Products as granted by the applicable Regulatory Authority.

 

1.19          “Master Batch Record” means the document approved in writing by the Parties specifying or referencing the complete set of formal instructions agreed upon by the Parties for the Manufacturing of Product, as such document may be amended, supplemented or otherwise modified from time to time by mutual written agreement of the Parties.

 

1.20          “Materials” means all ingredients and components required to Manufacture the Product, including active ingredients, excipients, packaging components, labels and printed materials.

 

1.21          “Non-conforming Product” means any unit of the Product that, at the time it is delivered to Progenics in accordance with Section 6 hereof, does not conform to the provisions of Section 3.2 hereof or is otherwise defective, damaged or unusable.

 

1.22          “Person” means any natural person, corporation, company, partnership, limited partnership, limited liability company, firm, association, trust, government, governmental agency or any other entity, whether acting in an individual, fiduciary or other capacity.

 

1.23         “Product” means each of (i) Azedra® (Ultratrace® Iobenguane I-131) and (ii) [**].

 

1.24          “Product Specifications” means the specifications and quality standards (including, without limitation, tests, analytical procedures and acceptance criteria) for each Product attached hereto as Exhibit A, other than the Labeling Specifications, as such specifications and quality standards may be amended, supplemented or otherwise modified from time to time by mutual written agreement of the Parties. The Parties anticipate that the Product Specifications for each Product may be modified slightly during the process validation and the stability study, in each case within the parameters set forth on Exhibit A.

 

1.25           “Progenics Background Technology” means (i)(A) any Technology owned or controlled by Progenics or any of its Affiliates as of the Effective Date, including the formulation for each Product, and all modifications and improvements thereof, or (B) any Technology, other than Program Technology, developed or obtained by or on behalf of Progenics or any of its Affiliates after the Effective Date; and (ii) all intellectual property rights in any of the foregoing.

 

1.26          “Progenics Program Technology” means all Program Technology other than INIS Program Technology.

 

3 

 

 

 

1.27          “Progenics Technology” means Progenics Background Technology and Progenics Program Technology. Progenics Technology shall constitute Progenics Confidential Information.

 

1.28          “Program Technology” means all Technology created, developed, generated or derived by or on behalf of either Party or any of its Affiliates in the course of the activities contemplated by this Agreement.

 

1.29          “Project Worker” means (i) an employee of INIS assigned to a position referenced on Exhibit B and approved by Progenics, and (ii) any other Person that may be assigned by INIS and approved by Progenics to perform INIS’ obligations under this Agreement, including but not limited to any Subcontractor engaged by INIS for such purpose.

 

1.30          “Quality Agreement” means the Quality Agreement to be executed between the Parties after the Effective Date and attached (or deemed attached) to this Agreement as Exhibit C hereto, as such agreement may be amended, supplemented or otherwise modified from time to time by mutual written agreement of the Parties.

 

1.31          “Recall” means any stock recovery of any Product during the clinical phase or any recall, field correction or withdrawal of any Product from the market.

 

1.32          “Regulatory Authority” means the FDA or any court, tribunal, arbitrator, agency, commission, official or other instrumentality of any federal, state, county, city or other political subdivision, domestic or foreign, that performs a function for such jurisdiction similar to the function performed by the FDA.

 

1.33          “Regulatory Standards” means all Laws, rules, regulations and Regulatory Authority advisory opinions or orders applicable to the Manufacturing, Labeling, storing, marketing, sale, reimbursement and/or pricing of the Products.

 

1.34          “Specifications” means, collectively, the Master Batch Record, the Product Specifications and the Labeling Specifications.

 

1.35          “Subcontractor” means any Person to whom INIS subcontracts or otherwise delegates any of its obligations under this Agreement (including the Quality Agreement).

 

1.36“Suite” means [**].

 

1.37          “[**]” means the [**] manufacturing suite to be constructed in the Dedicated Facility, as indicated on the manufacturing area layout plan set forth on Exhibit D attached hereto.

1.38          “[**]” means the [**] manufacturing suite to be constructed in the Dedicated Facility, as indicated on the manufacturing area layout plan set forth on Exhibit D attached hereto.

 

1.39          “Supply Price” means the Initial Supply Price for each Product, as adjusted from time to time in accordance with Section 7.2.

 

1.40          “Technology” means all discoveries, inventions, know-how, developments, methods, techniques, trade secrets, innovations, updates, modifications, enhancements, improvements, copyrights, data, documentation, processes, procedures, specifications and other intellectual property of any kind, whether or not protectable under patent, trademark, copyright or similar laws.

 

4 

 

 

 

1.41          “Third Party” means any Person other than the Parties to this Agreement and their Affiliates.

 

1.42          Other Definitions. Each of the following terms is defined in the section of this Agreement referenced opposite such term:

 

Term  Section 
Confidential Information       13.1
Dedicated Facility   Recitals 
Disclosing Party       13.1
Dispute       14.5
Facility   Recitals 
Forecast       3.1
Losses       12.1
INIS Indemnified Parties       12.2
Initial Supply Price       7.1
Manufacturing Space       2.1
Milestone   Exhibit B 
[**]   Exhibit B 
Minimum Amount       3.1
Parties   Preamble 
Party   Preamble 
PPI   7.2(a)
PPI Increase   7.2(a)
Progenics Equipment       2.3
Progenics Indemnified Parties       12.1
Purchase Order       3.1
Receiving Party       13.1
Specifications       2.2
Startup Activities       2.1
Term       11.1
Title 11       11.4
Third Party Claim       12.1

 

2.

DEDICATED FACILITY

 

2.1             Build-out of Dedicated Facility; Startup.

 

(a)                                                  Manufacturing and related services performed by INIS hereunder (without

 

5 

 

 

 

subcontracting or delegation) shall occur at the Dedicated Facility within the committed space set forth on Exhibit D attached hereto (the “Manufacturing Space”). INIS will design, construct and commission the Dedicated Facility, which shall include [**], within the Manufacturing Space. INIS will submit to Progenics the design, construction and acquisition agreements with the Third Party contractors and vendors of the Dedicated Facility for Progenics’ prior approval. It is understood that the construction of the INIS building addition that will house the Progenics Dedicated Facility/Manufacturing Space will be the responsibility of INIS and its Landlord at their own expense pursuant to a separate agreement or lease amendment to be entered into between the Landlord and INIS. INIS shall otherwise be responsible for the design, construction and equipping of the Dedicated Facility. Exhibit B hereto contains the general specifications for the Dedicated Facility and required equipment and the timeline for the design, construction and equipping of the Dedicated Facility.

 

(b)                 No later than May 17, 2019 INIS shall complete the design work for the Dedicated Facility and submit to Progenics for its approval detailed specifications and detailed budget and list of required equipment, which shall be based on and not exceed the amounts or change the types of items set forth in Exhibit B hereto without Progenics’ prior written approval. Upon approval by Progenics of such detailed specifications, budget and list of equipment and the applicable design, construction and/or acquisition agreements, Progenics shall be responsible for the payment of the costs set forth in such budget, without markup, which shall be paid in accordance with Exhibit B attached hereto; provided, however, (i) the amounts and types of such costs to be paid by Progenics shall in no event exceed the amounts and types of costs contained in such detailed specifications, budget and list of equipment, and (ii) payments to Third Party vendors or contractors shall be made directly to such parties by Progenics.

 

(c)                                                      The manufacturing area layout plan for the Dedicated Facility Manufacturing Space attached as Exhibit D has been reviewed and approved by Progenics. Any changes made to this plan shall be subject to the prior written approval of Progenics. The Dedicated Facility shall be dedicated full time and solely to the Manufacture and supply of Products pursuant to this Agreement and shall not be shared with or used for any other projects or customers of INIS with the exception of the Quality Laboratory which may be used in part by INIS for its other products or as otherwise approved by Progenics in accordance with Exhibit B hereto.

 

(d)                                             INIS will perform all necessary engineering work, equipment acquisition and commissioning, training, qualification, and validation activities, and other work required in order to be able to Manufacture, supply, and ship Products and fulfill its obligations under this Agreement, including each of the activities described in more detail in Exhibit B attached hereto (collectively, “Startup Activities”) per cGMP as applicable.

 

(e)                                                  Progenics will pay to INIS each of the Milestone Payments upon achievement of each of the Milestones as set forth in Exhibit B attached hereto.

 

(f)                                                    The estimated timeline for the design and construction of the Dedicated Facility, the Startup Activities and the start of Manufacturing activities is set forth in Exhibit B attached hereto.

 

2.2             Process Transfer and Validation. Progenics shall define the specifications required for the transfer of the manufacturing processes, and including analytical test and validation methods, for the Products and INIS shall perform the services to transfer and validate the processes in accordance with such specifications as a part of the Startup Activities.

 

2.3             Equipment. Progenics shall own and hold all title to all equipment paid for by Progenics pursuant to Section 2.1 or otherwise pursuant to this Agreement (the “Progenics Equipment”) and shall provide Progenics Equipment to INIS pursuant to a bailment arrangement with INIS as bailee. INIS’ use

 

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and custody of Progenics Equipment as Progenics’ bailee shall continue to be subject to the terms and conditions set forth in Exhibit E hereto.

 

3.

MANUFACTURE AND SUPPLY OF PRODUCT

 

3.1             Batches. Commencing upon completion of all of (i) Milestones 1 through 6, and

(ii)   the first to occur of Milestone 7 or Milestone 11, then during the Term, and subject in each case to the terms and conditions set forth in this Agreement:

 

(a)                                             INIS shall at all times during the Term ensure that it has sufficient manufacturing capacity available at the Dedicated Facility to Manufacture and supply to Progenics all the Products ordered by Progenics from time to time, in a minimum amount of at least [**] (the “Minimum Amount”), subject to adjustment for semiannual shutdown periods pursuant to Section 3.1(e). Progenics shall submit Purchase Orders to INIS for the Minimum Amount of Batches per calendar month (taking into account Batches manufactured at [**] in the Dedicated Facility), subject to adjustment for semiannual shutdown periods pursuant to Section 3.1(e). Purchase orders shall be prepared on a mutually acceptable purchase order form (each a “Purchase Order”) for each order for Product placed by Progenics under this Agreement. Each Purchase Order shall be subject to the terms and conditions of this Agreement. In the event that the Minimum Amount requirement for Purchase Orders set forth in this Section 3.1(a) is not met for any calendar month due to Progenics cancelling or failing to deliver sufficient Purchase Orders, INIS shall reserve the right to invoice Progenics on a calendar monthly basis the difference in total Supply Price between the total Supply Price for the actual Batches ordered for such month and the total Supply Price for the number of Batches in the Minimum Amount for such month. In the event that any such difference in Supply Price for a Batch shortfall below the Minimum Amount for any month is invoiced by INIS and paid for by Progenics, Progenics shall be entitled to a credit for such payment against future excess Batch orders as provided in Section 7.2(e). For the avoidance of doubt, nothing contained in this Section 3.1 or otherwise in this Agreement shall require Progenics to purchase or pay for any failed Batch or any Non-conforming Product.

 

(b)                                            Notwithstanding the Minimum Amount, from time to time, at its option, Progenics may request that INIS Manufacture and supply more than the Minimum Amount per calendar month, up to the maximum capacity of the Dedicated Facility.

 

(c)                               If for any reason there are no patient ([**]) Batches of a Product ordered during a calendar month or if a previously ordered Batch of a Product is cancelled, INIS will manufacture a Batch of such Product to maintain site qualification. This material will be available for patient ([**]) use if needed and will be billed for as per the terms of this Agreement.

 

(d)                                            No later than the first day of each calendar quarter, Progenics shall provide to INIS a good faith projection or estimate of Progenics’ requirements for Products during each month of such quarter (the “Forecast”), which approximates, as nearly as possible, based on information available at the time to Progenics, the quantity of Product that Progenics may order for each such month, for the period beginning with the first day of such calendar quarter. Forecasts are for information purposes only and do not create any binding obligations on behalf of either Party.

 

(e)                                              There will be [**] shutdowns of each Suite in the Dedicated Facility of two (2) weeks per Suite for maintenance to be scheduled by mutual agreement of the Parties; provided that only one (1) Suite may be shut down for such maintenance at any one time. Notwithstanding the foregoing, Progenics may not unreasonably withhold its agreement to a maintenance period proposed by INIS should INIS believe it necessary to complete within a recommended period to ensure its commitments under this

 

7 

 

 

 

Agreement are achievable; provided that [**] shall not be shut down for such maintenance at the same time. Minimum calendar month Batch charges shall not apply during shutdown periods if no Suite remains available for supply of Product; and if no other Suite is then available for supply of Product, the Minimum Amount applicable for any calendar month in which a shutdown occurs shall be pro rated accordingly, rounded down to the lower Batch amount (i.e., there would be no partial Batch production or ordering requirement).

 

3.2             Certain Quality and Other Standards. INIS shall Manufacture and supply all quantities of Product ordered by Progenics in accordance with this Agreement (a) in a fully packaged and labeled form, with all inserts and warnings and other Labeling required in accordance with this Agreement, and (b) in accordance with Laws, Regulatory Standards, the Specifications, applicable cGMPs and the other terms and conditions of this Agreement (including the Quality Agreement).

3.3             Competitive Activities. INIS shall not, and shall ensure that its Affiliates do not, directly or indirectly, develop for itself or a Third Party or contract manufacture for a Third Party a radiopharmaceutical (as defined below) to treat (1) MIBG-avid tumors or (2) PSMA-avid prostate cancer. A radiopharmaceutical as defined for purposes of this Section 3.3 is any chemical entity (either small molecule or biologics) bearing any kind of radioisotope (alpha, beta or gamma emitter or any combination of thereof) designed to image or treat certain diseases.

 

3.4             Non-Exclusive Purchases. Nothing in this Agreement shall prohibit Progenics from entering into other Manufacturing and supply arrangements with Third Parties for Products. However, none of the third-party agreements shall reduce Progenics obligation to order the minimum calendar monthly Batch requirements from INIS under this Agreement.

 

3.5             Training. INIS shall provide appropriate training to Project Workers and other INIS support personnel to Manufacture Products.

 

3.6             Project Workers. All Project Workers identified on Exhibit B hereto as full time shall be dedicated full time to the Startup Activities and Manufacture and supply of Products and performance of INIS’ other obligations hereunder. Although none of the Project Workers shall be employees or independent contractors of Progenics, (a) Progenics shall have the right to approve the proposed assignment by INIS of each Project Worker to the transactions contemplated by this Agreement, which approval will not be unreasonably withheld, and (ii) if at any time Progenics becomes reasonably dissatisfied with the performance, qualifications or conduct of a Project Worker, Progenics shall have the right to direct INIS to remove such Project Worker from any involvement with the Startup Activities and Manufacture and supply arrangements hereunder, and INIS shall comply promptly with such request. If a full time Project Worker identified on Exhibit B hereto leaves the employ of INIS, INIS shall, subject to the approval of Progenics, promptly replace such Project Worker. INIS shall not reassign any such full time Project Worker away from the Startup Activities and/or Manufacture and supply of Products and performance of INIS’ other obligations hereunder, even if at any given time, such Project Worker is idle, without the express prior written consent of Progenics, in its sole discretion. Progenics will not be liable for any compensation or employee benefits due to any Project Worker or any other costs or expenses relating to any Project Worker, all of which shall be borne by INIS.

 

3.7             Support Staff. INIS shall provide such part time additional support staff as required to support the startup of the Dedicated Facility, routine Batch production operations, and performance of maintenance and inspections. The selection of INIS support staff shall be at the sole discretion of INIS and are expected to include the Quality Assurance Manager, Production Manager, Radiological Control Technicians, and Administrative staff, however, additional disciplines may be utilized if required by INIS. Progenics will not be liable for any compensation or employee benefits due to any such support staff or any other costs or expenses relating to any such support staff, all of which shall be borne by INIS.

  

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3.8             Qualified Personnel. INIS shall engage and employ only professionally qualified Project Workers and other Support Staff to perform INIS’ obligations under this Agreement. INIS shall not in performance under this Agreement use the services of any person debarred or suspended under the Act (as more specifically set forth in Section 9.1(e)). INIS does not as of the Effective Date have, and covenants that it will not during the Term of this Agreement hire, as an officer or an employee, any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any product under the Act.

 

4.

MATERIALS; SUBCONTRACTING

 

4.1                                           Purchase of Materials. INIS shall obtain from Third Parties at its expense all Materials required for Startup Activities and to Manufacture and supply the Products consistent with the quantities of Products ordered by Progenics. INIS shall purchase such Materials from qualified suppliers in accordance with the Quality Agreement. Progenics shall reimburse INIS all out-of-pocket costs incurred by INIS in purchasing Materials, [**] of such costs as provided in and subject to Exhibit B attached hereto. Progenics, at its own expense, shall supply to INIS (or cause a Third Party to supply to INIS) the Product precursor, [**] required to Manufacture each Batch of Product. IF INIS supplies the I131 required to Manufacture a Batch of Product Progenics shall pay [**]. Notwithstanding anything herein to the contrary, the failure of INIS to timely deliver Products to Progenics to the extent a result of Progenics failure to timely deliver the Materials specified in the foregoing sentence shall not constitute a breach by INIS under this Agreement.

 

4.2                                           Subcontracting. INIS may not subcontract or otherwise delegate any of its obligations hereunder without the prior written consent of Progenics, in its sole discretion. Prior to use of any permitted Subcontractor, INIS shall ensure that (a) such Subcontractor has all Manufacturing Authorizations required for the performance of such activities, and (b) to the extent required by applicable Law, a supplement to such Manufacturing Authorizations permitting such Subcontractor’s performance of the applicable Manufacturing activities in respect of the Product in such Subcontractor’s facilit(ies) has been approved by the FDA and any other applicable Regulatory Authority. Notwithstanding any subcontracting pursuant to this Section 4.2, INIS shall remain responsible for ensuring that the Products are Manufactured in accordance with this Agreement, including with respect to conformity to applicable Law and the relevant Specifications, and any action, omission, negligence, breach or other action by any Subcontractor shall be deemed that of INIS for the purposes of this Agreement and the Quality Agreement.

 

5.

MANUFACTURING

 

5.1                                           Stability Testing. INIS shall perform stability testing for each Product to support process development, technical transfer, process validation, product registration and Regulatory Authority post-approval commitments in accordance with cGMP, Marketing Authorizations and the terms and conditions set forth in the Quality Agreement and shall provide all stability results to Progenics promptly after obtaining such results. If either Progenics or INIS believes any additional stability testing is required or recommended, each Party shall provide the other with advance, written notice of such proposed additional testing, and shall in all cases obtain Progenics’ written consent to such testing. Handling of costs for any such additional testing shall be agreed; provided that in no event shall Progenics be obligated to pay for any costs to the extent additional testing is required or proposed as the result of or related to any deviation or failure caused in whole or in part by INIS or any of its Subcontractors.

 

5.2                                           Product Testing. INIS shall test the Products supplied pursuant to this Agreement according

 

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to the applicable methods of analysis set forth in the Specifications and Quality Agreement. All tests [**] must be completed prior to delivery of such Products by INIS to Progenics. Due to the time required for analysis, [**] results are received post-delivery and post-dosing. If any quantity of Product is found not to be in compliance with the Specifications, INIS shall, at its own expense, notify Progenics in writing of any such non-compliance and handle, store, transport, treat and dispose of such quantity of such Product, all in accordance with all applicable Laws (including but not limited to Laws pertaining to the environment and employee health and safety). For the avoidance of doubt, failure of any quantity of such Product to comply with Specifications or to pass tests as set forth in the Quality Agreement shall not excuse INIS from its supply obligations under this Agreement.

 

5.3Acceptance and Rejection.

 

(a)                     Delivery. INIS shall deliver to Progenics all of the Products in accordance with Section 6 hereof, and shall include a bill of materials describing the contents of such shipment, a certificate of analysis, and any other documents and materials related to the Products contained in such shipment that are required pursuant to the Quality Agreement.

 

(b)Non-conforming Product.

 

(i)                                                 Except as expressly set forth herein to the contrary, Progenics may (before or after any payment therefor) reject all or any portion of a shipment of Product that is found to contain Non-conforming Product. Progenics shall give written notice to INIS, specifying the grounds for such rejection and providing a sample of such allegedly Non- conforming Product. Once declared to be Non-conforming Product in accordance with this Section 5.3(b), subject to final determination of the cGMP expert as set forth in subsection (iii) below, such Product shall be deemed to be the property of INIS (including all risk of loss), and Progenics shall not be obligated to make any payment therefor.

 

(ii)                                              As promptly as practicable, but in any case within no more than thirty (30) days, after receipt of any shipment of Product, Progenics shall, or shall cause its agent to, assess the quantity and visually inspect the quality of such Product to determine conformity of the shipment of Product with the applicable Purchase Order and identify any readily observable damage or defects and promptly notify INIS of any shortage or any such readily observable defect. If Progenics elects to undertake testing of any shipment of Product hereunder for conformity to the applicable Specifications, then such testing shall be undertaken within five (5) days, and Progenics shall notify INIS of the results thereof in writing promptly upon completion of such testing. Notwithstanding the foregoing or anything to the contrary in this Agreement, (i) Progenics may reject Product as Non-conforming Product on the basis of any latent defect (which, in the case that Progenics undertakes testing of the Product, as described above, is not readily discoverable through such testing) by written notice to INIS within thirty (30) days from the date such defect was actually discovered, and (ii) INIS’ warranties with respect to the Product and otherwise hereunder shall remain in effect notwithstanding any failure by Progenics to reject Product supplied hereunder. Any such notice shall describe in reasonable detail the defect or non-conformity and shall include samples of the Product being rejected and, if available, copies of written reports relating to tests, studies or investigations performed by or on behalf of Progenics on the Product being rejected.

 

(iii)                                           If INIS in good faith disputes Progenics’ rejection of all or part of any shipment of Product, and such dispute is not resolved by mutual agreement of the Parties within thirty (30) days of Progenics’ notice of rejection, such dispute shall be referred to an independent, cGMP expert organization of recognized repute within the pharmaceutical industry reasonably acceptable to, and appointed by, both INIS and Progenics, for final assessment of product quality and acceptability. Such organization shall act as an expert and not as an arbitrator. The results of such assessment shall be binding on Progenics and INIS and cannot be the subject of any appeal. The expense of hiring and fees and

 

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disbursements of such organization shall be paid by the Party whose position is rejected by such expert organization.

 

(c)                      If the Parties agree, or results of Third Party assessment pursuant to subsection (iii) above show, that any portion of any shipment of Product is not in accordance with the applicable Purchase Order quantity or is Non-conforming Product, then, at Progenics’ option, INIS shall make up any quantity shortfall and/or replace the Non-conforming Product as promptly as practicable and at no additional cost to Progenics or, if INIS is unable or unwilling to make such replacement within thirty (30) days after Progenics’ notice of Non-conforming Product (or after the assessing firm’s result if disputed pursuant to subsection (iii) above), refund within thirty (30) days thereafter the total cost of all Non-conforming Product to Progenics. Notwithstanding the foregoing, INIS shall have no liability or obligation to Progenics under this Section 5.3 if it is determined that any such defect or non-conformance is attributable to the failure by any Person (including Progenics) to store, transport or care for such Product in a proper manner after such Product left INIS’ or its agent’s possession. Upon INIS’ instructions, Progenics shall destroy or return the Non-conforming Product, in either case at Progenics’ option and at INIS’ cost; provided that if it is determined that any such defect or non-conformance is attributable to the failure by any Third Party or Progenics to store, transport or care for such Product in a proper manner after such Product left INIS’ or its agent’s possession, such destruction or return shall be at Progenics’ cost.

 

5.4Labeling and Packaging.

 

(a)                     Progenics shall provide to INIS and shall bear responsibility for ensuring the accuracy of the information contained in, all Labeling and for compliance thereof with all Regulatory Standards. All Labels shall be created in accordance with the Labeling Specifications.

 

(b)                     For so long as INIS is responsible for procuring Labeling for any Product, should Progenics desire or be required to change any component of the Labeling of any Product, or to introduce a new packaging component to which such Labeling will be affixed, Progenics shall so inform INIS and shall be responsible for updating the artwork or text, as applicable, and providing it to INIS in camera-ready or electronic form and in compliance with the Labeling Specifications. INIS shall make all necessary arrangements for such Labeling to be printed and shall provide to Progenics printer’s proofs of all Labeling for Progenics’ review within thirty (30) days after (x) its receipt of the artwork or text, as applicable, from Progenics and (y) Progenics’ consent to the expenditures associated with such Labeling in accordance with the remainder of this Section 5.4(b). Within fifteen (15) Business Days of its receipt of such proofs, Progenics shall either provide to INIS any necessary corrections thereto or notify INIS of its approval of such proofs. Upon Progenics’ acceptance thereof, INIS shall return all artwork provided by Progenics. INIS shall give Progenics notice and obtain Progenics’ consent to any expenditure related to changes to labeling and/or packaging; provided, however, that (i) INIS shall have no obligation to supply the Product hereunder bearing such modified labeling and/or packaging until Progenics has given such consent, and (ii) if any such modification is required by applicable Law or Regulatory Standards, then INIS shall have no obligation to supply the Product hereunder until Progenics has given such consent.

 

(c)                      The Products shall be packaged in the standard lead containment packaging (which is described on Exhibit F hereto) and dry ice suitable for transportation to the site of administration, together with all related release and shipping documentation and temperature monitoring equipment as designated by Progenics. The incremental cost of the standard containment packaging, or any non-standard, specially designed lead containment packaging and any return shipment costs of such packaging for re-use will be borne by Progenics.

 

5.5Records and Audit.

  

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(a)                     INIS shall maintain complete and up to date manufacturing and regulatory records in connection with the Manufacture of Product and other activities performed by it pursuant to this Agreement, including all records necessary to evidence compliance in all respects with (i) the applicable cGMP regulations, environmental, health and safety regulations, federal requirements for handling of radioactive materials and regulations for the transport of dangerous goods as related to the supply and manufacture of Products; (ii) the Specifications; and (iii) obligations under this Agreement. Such books and records shall be open to inspection and copying by Progenics.

 

(b)                     INIS shall maintain complete and up to date books and records of any costs of INIS for which Progenics is responsible under this Agreement. Such books and records shall be open to the inspection and copying by Progenics and, if Progenics reasonably determines that such books and records reflect an overpayment by Progenics under this Agreement, a firm of certified public accountants selected by Progenics and reasonably acceptable to INIS who shall have executed appropriate confidentiality agreements, for the limited purpose of verifying such costs for which Progenics is responsible under this Agreement. Except as otherwise provided in this Section 5.5, the cost of any such examination shall be paid by Progenics. In the event that any such inspection reveals that Progenics has been charged in excess of the costs for which it is responsible hereunder, INIS shall promptly refund to Progenics the amount of such overpayment, plus interest at a rate equal to six percent (6%) annually. In the event that any such overpayment by Progenics is in excess of the greater of (i) [**], in the aggregate, INIS shall pay for the reasonable, documented fees and expenses of the firm of certified public accountants conducting such inspection. In the event that any such inspection reveals an underpayment by Progenics, Progenics shall promptly pay the amount of such underpayment to INIS.

 

5.6                                           Product Storage. INIS shall maintain, at its expense, adequate storage areas for Products at the Dedicated Facility prior to the delivery of such Products to Progenics. Such areas shall comply with cGMP and the applicable Product Specifications, and INIS shall be solely responsible for loss, damage or contamination with respect to any Product (including to packaging) while stored therein.

 

6.

DELIVERY OF PRODUCT

 

6.1       Delivery. Upon release of Product by INIS in accordance with the Quality Agreement, delivery shall be made within two (2) Business Days prior to or after the delivery date specified in the Purchase Order. The Product shall be delivered Free Carrier (FCA), INIS’ Facility (per Incoterms 2010) and drop shipments shall be made by INIS directly to sites of administration via Progenics’ designated carrier and mode of transportation, at Progenics’ expense. Progenics shall designate a carrier and mode of shipment on each Purchase Order for Product submitted to INIS. INIS shall pack and label the cartons of Product supplied in accordance with the Specifications and the Quality Agreement. If requested, at Progenics’ cost and expense, INIS shall arrange for any insurance desired by Progenics on shipments of Product, in amounts that Progenics shall determine, and naming Progenics as the loss payee. When shipping Product, INIS shall comply with all applicable Laws.

 

7.

SUPPLY PRICE; PAYMENTS

 

7.1           Initial Supply Prices for Products. Subject to Section 7.2, Progenics shall pay INIS [**] for each Batch of finished and packaged Azedra® and [**], in each case shipped to the site of administration (as applicable, the “Initial Supply Price”). The Initial Supply Price does not include the cost of the standard lead containment packaging (which is described on Exhibit F hereto), the temperature monitoring equipment as designated by Progenics, or the cost of returning such packaging to INIS for re-use. The Initial Supply Price does include the dry ice suitable for transportation to the site of administration

 

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and all related release and shipping documentation. The incremental cost of any other non-standard, specially designed lead containment packaging and any incremental return shipment costs of such non-standard packaging for re-use will be borne by Progenics. The Initial Supply Prices shall be subject to adjustment in accordance with Section 7.2.

 

7.2Adjustment of Supply Prices.

 

(a)                     Annual PPI Increases. Following the completion of the first full calendar year of the Term, INIS may increase the Supply Price of each Product no more than once in each calendar year during the Term; provided that such increase shall not exceed the lesser of (i) [**]. For the avoidance of doubt, any change to the Supply Price of a Product pursuant to Section 8.2 shall not be subject to this Section 7.2(a).

 

(b)                     Notice and Disputes. INIS shall notify Progenics of each increase in any Supply Price it intends to take under Section 7.2(a), which notice shall be accompanied by reasonable supporting documentation supporting such increase as appropriate. In the event that Progenics disputes the amount of any increase in the Supply Price of any Product in accordance with the foregoing and such Supply Price is subsequently adjusted upon resolution of such dispute, then Progenics shall be entitled to a credit or a refund, at its option, equal to the difference between the amount, if any, paid by Progenics for any such Product delivered prior to such resolution and invoiced at the higher Supply Price, and the amount that should have been invoiced to Progenics for such Product based on the adjusted Supply Price.

 

(c)                      In the event that, with respect to any calendar month, Progenics submits Purchase Orders to INIS for [**], then the Initial Supply Price of [**] shall be adjusted downward for each such Batch in excess of such [**] for each Batch of finished and packaged Products.

 

(d)                     Progenics shall submit Purchase Orders to INIS for the Minimum Amount of Batches per calendar month (taking into account Batches manufactured at both Suites in the Dedicated Facility).

 

(e)                      In the event that any difference in Supply Price for a Batch shortfall below the Minimum Amount for any month is invoiced by INIS and paid for by Progenics pursuant to Section 3.1(a), Progenics shall be entitled to a credit for such payment on a Batch-by-Batch basis against the Supply Price for the next Batch(es), if any, in excess of the Minimum Amount ordered by Progenics for any month in the next twelve (12) months after the month in which such shortfall occurred. Such credit for each shortfall Batch shall be automatically applied to reduce the Supply Price of each such excess Batch to zero (0), without regard to whether the Supply Price of the shortfall Batch and the Supply Price of the later excess Batch would otherwise be the same. [**]

 

7.3       Invoice and Payment. INIS shall invoice Progenics for the applicable Supply Price for each quantity of Product supplied pursuant to this Agreement promptly upon delivery of such quantity of Product in accordance herewith. Progenics shall pay the applicable invoices within thirty (30) days of receipt of the invoice. Progenics shall notify INIS in writing of any dispute with any invoice (along with substantiating documentation and a reasonably detailed description of the dispute). Progenics will be deemed to have accepted all invoices for which INIS does not receive timely notification of dispute and shall pay all undisputed amounts due under such invoices within the period set forth above. All payments to be made pursuant to this Agreement shall be paid in United States dollars. To the extent required by applicable Laws, Progenics shall withhold from any payment any amounts required to be withheld in accordance with the applicable taxing or other governmental authorities.

 

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8.

REGULATORY AND QUALITY MATTERS

 

8.1            Quality Agreement. Quality and regulatory requirements, including use of qualified Materials’ suppliers, Manufacturing in full compliance with cGMPs and maintaining cGMP compliant facilities, storing and handling of Materials, temperature and moisture control, prevention of product contamination (including cross-contamination), implementation of required changes to Specifications and Manufacturing processes, retention of samples, stability testing, failure reporting and other quality related matters shall be governed by, and performed by the Parties in accordance with, the terms and conditions of the Quality Agreement. The Parties shall negotiate in good faith and execute the Quality Agreement within thirty (30) days of the Effective Date. The Quality Agreement is intended to supplement this Agreement, and shall be incorporated in this Agreement in its entirety, except that in the event of a conflict between any term, condition or provision of this Agreement and any term, condition or provision of the Quality Agreement, the applicable term, condition or provision of this Agreement shall control unless otherwise agreed in writing by the Parties.

 

8.2Changes to Specifications, etc.

 

(a)         In the event Progenics proposes a change to Specifications or otherwise in the Materials, equipment, processes or procedures used to Manufacture Product, Progenics shall deliver written notice to INIS describing such proposed change. INIS shall use good faith efforts to implement all proposed changes and respond to any such notice with an assessment of the feasibility of making such change, an estimate of the costs associated with such change and a proposed time-line for implementation. The reasonable costs associated with implementation of any change under this Section 8.2(a) shall be borne by Progenics. Prior to implementing any such change, INIS shall provide an estimate to Progenics of the impact such change shall have on pricing and obtain Progenics’ written approval thereof. New pricing shall be effective upon implementation of the applicable change.

 

(b)        In the event changes in Specifications or otherwise or in the Materials, equipment, processes or procedures used to Manufacture Product are required by a Regulatory Authority or are required as the result of any new regulations, instructions, requirements, specifications or guidances under cGMP or other applicable Law, the Party receiving notice of such change shall promptly notify the other Party. In response to such change, INIS shall use good faith efforts to implement all proposed changes and provide Progenics with a written description of any actions proposed to be taken to comply with new or revised cGMPs or other regulatory or legal requirement, and a cost estimate for implementing such actions and the schedule for implementation of such change. The reasonable costs associated with implementation of any change under this Section 8.2(b) shall be borne by Progenics, except where INIS determines that the changes are not specific to Progenics’ Product or Manufacturing activities, in which case, the costs of implementation of such change shall be borne by INIS. Prior to implementing any such change, INIS shall provide an estimate to Progenics of the impact such change shall have on pricing and obtain Progenics’ written approval thereof. New pricing shall be effective upon implementation of the applicable change.

 

(c)          INIS may not make any changes to Specifications or otherwise or in the Materials, equipment, processes or procedures used to Manufacture Product without the approval of Progenics, in its sole discretion.

 

8.3           Manufacturing Facility Audits. INIS shall give access to representatives of Progenics during the Term and during regular business hours to the Dedicated Facility, and, if relevant to the Products or performance of INIS’ obligations hereunder, to other parts of the Facility and to INIS’ Subcontractors’ manufacturing facilities, if applicable, to conduct reasonable inspections in accordance with the inspection procedures set forth in the Quality Agreement and in a manner that is not disruptive of INIS’ business operations. Each Party shall be responsible for its own costs associated with such inspections. INIS shall

 

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promptly address and correct any deficiencies identified in any inspection or audit of the Dedicated Facility or of the Facility in a manner reasonably satisfactory to Progenics. Progenics shall have the right to have an employee or representative present to inspect or be consulted on the Startup Activities and/or Manufacturing and supply activities hereunder at all or any time during the Term of this Agreement. INIS shall permit Progenics’ representative to have unfettered access to the Dedicated Facility and, if relevant to the Products or performance of INIS’ obligations hereunder, other parts of the Facility for such purposes.

 

8.4            Inspections by Regulatory Authorities. INIS shall promptly notify Progenics Product Manager of any site visit to the Facility, the Dedicated Facility and/or its Subcontractors’ manufacturing facility by any Regulatory Authority, the purpose of which is to inspect the Manufacture, testing, storage, disposal or transportation of the Products or is otherwise related to any Product, shall permit such Regulatory Authority to make such visit and inspection, and, to the extent legally permissible, shall permit Progenics and/or its representative to be present for such visit and inspection. INIS’ costs in connection with inspections by any Regulatory Authority shall be borne by Progenics. INIS shall furnish to Progenics all material information supplied to, or supplied by, any Regulatory Authority, including the Form 483 observations and responses, or warning letters or other communications, in each case, to the extent that such information relates to the Product or the ability of INIS to comply with the terms of this Agreement. INIS shall provide Progenics with an opportunity to comment on any response to such Regulatory Authority with respect to a Product. INIS shall promptly undertake and complete any corrective action necessary or required, based on the results of any such inspection report, warning letter or Regulatory Authority enforcement action.

 

8.5          Regulatory Filings, etc. Progenics shall be responsible, in its sole discretion, for all Product-specific regulatory filings including any fees for regulatory filings to the U.S. Food and Drug Administration but not including any filings or fees related to the Facility. All information, documents and updates with regard to the Manufacturing of Product which are in the possession or control of INIS and required or requested by any Regulatory Authority shall, as reasonably requested by Progenics in connection with such filings, be provided by INIS, in a timely manner, to such Regulatory Authority, or, if needed in connection with a regulatory filing of Progenics, shall be provided directly to Progenics. INIS shall, to the extent legally permissible, submit to all inquiries and inspections by any such Regulatory Authority in connection with regulatory submissions of Progenics related to Product. INIS shall work with Progenics, at the direction of Progenics, to assist in providing a timely response to any FDA or other Regulatory Authority deficiencies and any other support required to obtain and maintain FDA or other regulatory approval for the Products during the Term of this Agreement. Without limiting the foregoing, Progenics shall have the right to reference any data or information owned or generated by INIS in connection with the Products (or the Manufacturing thereof) or the Dedicated Facility (or INIS’ Subcontractors’ facilities, if applicable) for the purpose of complying with applicable legal and regulatory requirements, protecting intellectual property or obtaining regulatory approvals.

 

8.6            Field Alerts and Product Recalls. Except with respect to a Field Alert or Recall attributable to a breach of INIS’ warranties or obligations hereunder, Progenics shall bear one hundred percent (100%) of the cost and expense of any Field Alert or Recall related to Product manufactured by INIS pursuant to the terms of this Agreement and shall reimburse INIS for any such costs or expenses incurred by INIS in relation thereto promptly following INIS’ request. With respect to any Field Alert or Recall attributable to a breach of INIS’ obligations hereunder, (a) INIS shall bear one hundred percent (100%) of the cost and expense thereof and shall reimburse Progenics for any such reasonable costs or expenses incurred by Progenics in relation thereto promptly following Progenics’ request, and (b) INIS shall replace the units of the Product as promptly as practicable and at no cost to Progenics following Progenics’ request for such replacement.

 

8.7            Product Returns. In the event that INIS (or any of its Affiliates) receives any return of Product from a Third Party, INIS shall notify Progenics of such returned goods and, at Progenics’ option,

 

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either destroy such returned goods or deliver such returned goods to Progenics, in each case at Progenics’ expense, except to the extent caused by INIS, in which case it shall be at INIS’ expense. In the event that an adverse event is reported with respect to the Product, INIS shall, in accordance with the Quality Agreement and at Progenics’ expense, perform any and all appropriate testing of corresponding retention samples and provide the results thereto to Progenics as soon as reasonably practicable.

 

9.

REPRESENTATIONS AND WARRANTIES; COVENANTS

 

9.1                    Representations, Warranties and Covenants of INIS. INIS hereby represents, warrants and covenants to Progenics as follows:

 

(a)                                    Organization. INIS is duly organized, validly existing and in good standing under the laws of the State of Texas.

 

(b)                                   Power and Authorization. The execution and delivery by INIS of this Agreement, and the performance of INIS’ obligations hereunder and the consummation of the transactions contemplated hereby are, within the power and authority of INIS and have been duly authorized by all necessary action on the part of INIS. This Agreement (a) has been duly executed and delivered by a duly authorized representative of INIS, and (b) is the legal, valid and binding obligation of INIS, enforceable against INIS in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar Laws now or hereafter in effect relating to or affecting creditors’ rights generally.

 

(c)Noncontravention.

 

(i)             The execution, delivery and performance by INIS of this Agreement does not and will not (A) violate any Law or any decree or judgment of any court or other Regulatory Authority applicable to INIS or violate or conflict with any provision of the Articles of Incorporation or By-laws of INIS, or (B) conflict with, or require any consent under, any contractual obligation of INIS or its Affiliates.

 

(ii)             Except for such consents and approvals as have already been obtained by INIS, are currently in INIS’ possession or will be obtained by INIS in connection with the construction and commissioning of the Dedicated Facility, no consents or approvals of, or filings or registrations by INIS with, any Regulatory Authority or any other Third Party are necessary in connection with the execution, delivery and performance of this Agreement by INIS.

 

(d)                                     Conforming Product; Manufacturing. INIS (i) shall perform its obligations hereunder (including in connection with the Quality Agreement) in compliance with, and the Products supplied by INIS to Progenics hereunder shall have been Manufactured, Labeled, tested, handled, stored and transported in accordance with, this Agreement, including all applicable Specifications, applicable cGMP and all applicable Laws and Regulatory Standards, and (ii) has and will maintain throughout the Term all Manufacturing Authorizations necessary in order to Manufacture the Products in the Dedicated Facility. All quantities of the Products produced by INIS and supplied to Progenics shall:

 

(i)              conform to the Product Specifications;

 

(ii)be free from defects in processing, materials and workmanship;

 

(iii)           have been manufactured, packaged, tested and stored in conformity with

 

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cGMPs as required by the FDA and any other applicable Regulatory Authority, together with applicable guidance documents relating to manufacturing and quality control practices, including, without limitation International Conference on Harmonization (ICH) guidelines, all as updated, amended, and revised from time to time;

 

(iv)           not be adulterated or misbranded within the meaning of the Act or any other applicable Law; and

 

(v)            not be an article that may not be introduced into interstate commerce under the provisions of Section 404 or 505 of the Act.

 

(e)                                              Debarment. As of the date of this Agreement and continuously during the Term of this Agreement, neither INIS nor any of its or its Affiliate’s employees or agents or Affiliates concerned with the performance of this Agreement has been (i) debarred or convicted of a crime for which a Person can be debarred, under Section 335(a) or 335(b) of the Act, (ii) threatened to be debarred under the Act, or (iii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred under the Act. INIS agrees that it shall promptly notify Progenics in writing in the event it receives notification of any such debarment, conviction, threat or indictment.

 

(f)                                                Non-Infringement; Title. (i) INIS’ manufacturing processes, techniques, materials and internal specifications in connection with the Manufacture of the Products and performance of its other obligations under this Agreement do not and, unless altered at the request or with the prior written consent of Progenics, will not infringe, misappropriate or otherwise conflict with or misuse the intellectual property rights of any Person, (ii) there are no pending or threatened suits, proceedings, claims, demands, actions or investigations of any other nature or kind against INIS relating to the Manufacture of the Products, the Dedicated Facility or the Facility, and (iii) Progenics shall receive good title to all Products delivered by INIS to Progenics hereunder, free and clear of any liens, security interests, charges or other encumbrances of any kind.

 

(g)                                             Maintenance of Dedicated Facility. INIS shall maintain the Dedicated Facility and the Facility (and INIS’ Subcontractors shall maintain their facilities) in compliance with all applicable Laws, by qualified personnel duly certified or licensed by any jurisdiction or Regulatory Authority required by Law, and in the same manner it conducts similar activities with respect to its own proprietary pharmaceutical products.

 

(h)                                            Personnel. INIS shall perform all of its obligations under this Agreement by using qualified personnel possessing such expertise as may be required to support and carry out such obligations, all in accordance with Sections 3.6, 3.7, and 3.8 and Exhibit B hereto.

 

(i)                                                 Licenses and Permits. INIS has and shall maintain any and all facility or other licenses (including without limitation distribution licenses), permits, registrations, and any regulatory approvals necessary to manufacture, handle, store, label, package, prepare, ship and transport under cGMP conditions. This includes, but is not limited to, the use and handling of radioactive materials. In the event that any new fees are enacted or promulgated after the Effective Date and charged by the FDA for INIS’s contract manufacturing role of any Products, Progenics shall bear the cost of those fees solely to the extent such fees are directly related to the Products. For greater certainty INIS will abide, at its expense, by all laws, rules and regulations as applicable, including those promulgated by the U.S. Nuclear Regulatory Commission and any other applicable United States governmental authority or agency, excluding any new FDA fees attributable to the contract manufacturing of the Products to the extent Progenics has agreed to bear such fees pursuant to this Section 9.1(i).

 

(j)                                                LIMITATION. EXCEPT AS EXPRESSLY SET FORTH IN THIS

 

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AGREEMENT AND EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN THE QUALITY AGREEMENT, INIS MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, ALL OF WHICH OTHER REPRESENTATIONS AND WARRANTIES (A) ARE HEREBY DISCLAIMED AND PROGENICS HEREBY WAIVES SUCH OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, ARISING BY THIS AGREEMENT, AND (B) SHALL NOT BE EXTENDED, ALTERED OR VARIED EXCEPT BY WRITTEN INSTRUMENT SIGNED BY THE PARTIES HERETO.

 

9.2                    Representation and Warranties of Progenics. Progenics hereby represents and warrants to INIS as follows:

 

(a)                                   Organization. Progenics is duly organized, validly existing and in good standing under the laws of the State of Delaware.

 

(b)                                  Power and Authorization. The execution and delivery by Progenics of this Agreement, and the performance of Progenics’ obligations hereunder and the consummation of the transactions contemplated hereby, are within the power and authority of Progenics and have been duly authorized by all necessary action on the part of Progenics. This Agreement (a) has been duly executed and delivered by a duly authorized representative of Progenics, and (b) is the legal, valid and binding obligation of Progenics, enforceable against Progenics in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar Laws now or hereafter in effect relating to or affecting creditors’ rights generally.

 

(c)Noncontravention.

 

(i)           The execution, delivery and performance by Progenics of this Agreement does not and will not violate any Law or any decree or judgment of any court or other Regulatory Authority applicable to Progenics or violate or conflict with any provision of the organizational documents of Progenics.

 

(ii)          No material consents or approvals of, or filings or registrations by Progenics with, any Regulatory Authority or any other Third Party are necessary in connection with the execution, delivery and performance of this Agreement by Progenics.

 

(d)                                  Non-Infringement. To the knowledge of Progenics, Progenics Background Technology related to the Products do not and will not infringe, misappropriate or otherwise conflict with or misuse the intellectual property rights of any Person, and (ii) there are no pending or threatened suits, proceedings, claims, demands, actions or investigations of any other nature or kind against Progenics relating to the Products.

 

(e)                                    LIMITATION. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT AND EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN THE QUALITY AGREEMENT, PROGENICS MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, ALL OF WHICH OTHER REPRESENTATIONS AND WARRANTIES (A) ARE HEREBY DISCLAIMED AND INIS HEREBY WAIVES SUCH OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, ARISING BY THIS AGREEMENT, AND (B) SHALL NOT BE EXTENDED, ALTERED OR VARIED EXCEPT BY WRITTEN INSTRUMENT SIGNED BY THE PARTIES HERETO.

 

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10.

OWNERSHIP OF INTELLECTUAL PROPERTY

 

10.1                            Progenics Background Technology. INIS agrees that Progenics has and shall retain sole and exclusive rights of ownership in and to any and all Progenics Confidential Information and other Progenics Background Technology. INIS does not acquire any license or other right to any Progenics Background Technology or other Progenics Confidential Information except to the extent expressly set forth in this Agreement.

 

10.2                            INIS Background Technology. Progenics agrees that INIS has and shall retain sole and exclusive rights of ownership in and to any and all INIS Confidential Information and other INIS Background Technology. Progenics does not acquire any license or other right to any INIS Background Technology or other INIS Confidential Information except to the extent expressly set forth in this Agreement.

 

10.3Program Technology.

 

(a)                                             All Progenics Program Technology shall be and remain the exclusive property of Progenics, and INIS hereby assigns and vests, and agrees to assign and vest, all of its right, title and interest thereto to Progenics, and to take such actions as are reasonably requested by Progenics, at Progenics’ expense, to effect the foregoing assignment and in connection with Progenics’ efforts to secure patent protection for such Progenics Program Technology, including that INIS agrees to execute, acknowledge and deliver to and in the favor of Progenics such assignments and other instruments and documents reasonably necessary for Progenics to obtain or maintain intellectual property protection in any and all countries. Without limiting the foregoing, INIS hereby agrees that all patentable or copyrightable Progenics Program Technology shall constitute “work for hire” to the extent allowable under applicable law, with all right, title and interest in such Progenics Program Technology belonging to Progenics. INIS shall disclose all Progenics Program Technology promptly and fully to Progenics in writing and to no others. Progenics may file, prosecute, defend and enforce patent rights on all Progenics Program Technology as it deems appropriate, in its sole discretion.

 

(b)                                            All INIS Program Technology shall be and remain the exclusive property of INIS, and Progenics hereby assigns and vests, and agrees to assign and vest, all of its right, title and interest thereto to INIS, and to take such actions as are reasonably requested by INIS, at INIS’ expense, to effect the foregoing assignment and in connection with INIS’ efforts to secure patent protection for such INIS Program Technology, including that Progenics agrees to execute, acknowledge and deliver to and in the favor of INIS such assignments and other instruments and documents reasonably necessary for INIS to obtain or maintain intellectual property protection in any and all countries. Progenics shall disclose all INIS Program Technology promptly and fully to INIS in writing and to no others. INIS may file, prosecute, defend and enforce patent rights on all INIS Program Technology as it deems appropriate, in its sole discretion.

 

10.4Licenses.

 

(a)                                             Progenics hereby grants to INIS a limited, non-exclusive, royalty-free license (with a right to sublicense solely to permitted Subcontractors) to use Progenics

 

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Background Technology and Progenics Program Technology for the limited purpose of carrying out INIS’ obligations hereunder. Such limited, non-exclusive, royalty-free license shall expire upon the completion of such obligations or the expiration or termination of this Agreement, whichever is the first to occur.

 

(b)                                            INIS hereby grants to Progenics a non-exclusive, perpetual, fully paid-up, royalty-free, worldwide, transferable (in accordance with Section 14.6) license (with the right to sublicense), to any and all INIS Technology that INIS incorporates into any Manufacturing process or otherwise uses in performing Manufacturing or other services for Progenics, or that is necessary for the development or manufacturing of the Products or to make, have made, use, sell and have sold the Products.

 

10.5                            Product Patent Rights. Except as otherwise specifically set forth in Section 10.3, Progenics shall have all rights and responsibility, in its sole discretion, for the prosecution of patent applications and maintenance and enforcement of patents related to any Product or otherwise useful for the development, Manufacture or commercialization of any Product.

 

10.6                            No Other Licenses. Except as expressly set forth in this Agreement, nothing in this Agreement shall be deemed to grant to either Party any right or license under any Technology (including, without limitation, any patents, patent applications, know-how, technology, inventions or other intellectual property) of the other Party.

 

11.

TERM AND TERMINATION

 

11.1                            Term. This Agreement shall commence as of the Effective Date and, unless earlier terminated in accordance with this Section 11 or extended by written agreement of both Parties, shall continue in effect for a period of four (4) years and shall automatically renew for successive two (2) year periods unless either Party gives written notice of non-renewal at least six (6) months prior to the end of the term then in effect (the “Term”).

 

11.2Termination by Progenics.

 

(a)          Without limiting Progenics’ rights under Section 11.3, Progenics may terminate this Agreement by giving written notice to INIS in the event that the construction and commissioning of the Dedicated Facility (including achievement of all Azedra® Milestones 1 through 6 under INIS's control) have not been completed by December 31, 2019.

 

(b)           Progenics may terminate this Agreement with respect to any Product in the event that (i) Progenics determines that market or other conditions are such that the development or commercialization of such Product is economically unviable or Progenics has realized a negative margin with respect to such Product or (ii) such Product is withdrawn from the market, in the case of an FDA approved product, or testing of such Product is terminated, in the case of an unapproved drug. Progenics shall provide written notification to INIS of Progenics’ intent to terminate this Agreement with respect to a Product pursuant to this Section 11.2(b) and the termination date with respect to such Product shall be effective one hundred twenty (120) days after such notification, or such later date that Progenics may elect in its sole option.

 

11.3                            Termination for Breach. Either Party may terminate this Agreement in the event of a material breach by the other Party, provided the breaching Party fails to cure such breach within sixty (60) days (or thirty (30) days with respect to a failure by a Party to pay any amounts hereunder when due other than with respect to amounts which such Party, in good faith, disputes are due to the other Party) after receipt of written notice from the non-breaching Party describing the nature of the breach.

 

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11.4Insolvency, etc.

 

(a)           This Agreement may, at the terminating Party’s option, be terminated by either Party if the other Party becomes insolvent, files or has filed against it a petition under any insolvency law of any jurisdiction (and in the case the petition is filed against it, the petition is dismissed within sixty (60) days)), makes an assignment for the benefit of creditors, or if a receiver, trustee or similar agent is appointed with respect to any property or business of the other Party.

 

(b)          All rights and licenses granted by INIS under or pursuant to this Agreement are licenses of rights to "intellectual property" as defined in Section 365(n) of Title 11 of the United States Code (“Title 11”). INIS agrees that Progenics, as licensee of such rights under this Agreement shall retain and may fully exercise all of its rights and elections under Title 11. INIS agrees to create and maintain current copies or, if not amenable to copying, detailed descriptions or other appropriate embodiments, to the extent feasible, of all such intellectual property. If a case is commenced by or against INIS under Title 11, INIS (in any capacity, including debtor-in• possession) and its successors and assigns (including, without limitation, a Title 11 trustee) shall: 

 

request:

(i)               as Progenics may elect in a written request, immediately upon such

 

(A)            perform all of the obligations provided in this Agreement to be performed by INIS including, where applicable and without limitation, providing to Progenics portions of such intellectual property (including embodiments thereof) held by INIS and such successors and assigns or otherwise available to them; and/or

 

(B)            provide to Progenics all such intellectual property (including all embodiments thereof to the extent provided by applicable non-bankruptcy law and this Agreement) held by INIS and such successors and assigns or otherwise available to them; and

 

(ii)             not interfere with the rights of Progenics under this Agreement, or any agreement supplemental hereto, to such intellectual property (including such embodiments), including any right to obtain such intellectual property (or such embodiments) from another entity, to the extent provided in Section 365(n) of Title 11.

 

(c)            Rights to Intellectual Property. If (i) a Title 11 case is commenced by or against INIS, (ii) this Agreement is rejected as provided in Title 11, and (iii) Progenics elects to retain its rights under this Agreement as provided in Title 11, then INIS (in any capacity, including debtor-in-possession) and its successors and assigns (including, without limitation, a

 

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Title 11 trustee) shall provide to Progenics all such intellectual property (including all embodiments thereof) held by INIS and such successors and assigns, or otherwise available to them, immediately upon Progenics’ written request. Whenever INIS or any of its successors or assigns provides to Progenics any of the intellectual property licensed under this Agreement (or any embodiment thereof to the extent provided by applicable non-bankruptcy law and this Agreement) pursuant to this Section 11.4, Progenics shall have the right to perform the obligations of INIS under this Agreement with respect to such intellectual property, but neither such provision nor such performance by Progenics shall release INIS from any such obligation or liability for failing to perform it.

 

(d)                     Additional Rights. All rights, powers and remedies of Progenics provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, Title 11) in the event of the commencement of a Title 11 case by or against INIS. Progenics, in addition to the rights, power and remedies expressly provided herein, shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at law or in equity (including, without limitation, Title 11) in such event. The Parties agree that they intend the foregoing rights to extend to the maximum extent permitted by law, including, without limitation, for purposes of Title 11:

 

(i)                                                 the right of access to any intellectual property (including all embodiments thereof) of INIS, or any Third Party with whom INIS contracts to perform an obligation of INIS under this Agreement, and, in the case of the Third Party, which is necessary for the development and manufacture of the Product; and

 

(ii)the right to contract directly with any Third Party to complete the

contracted work.

 

11.5                                    Return of Confidential Information. Upon any expiration or termination of this Agreement, but subject to the license grant by INIS to Progenics set forth in Section 10.4(b), each Party shall cease to use all Confidential Information of the other Party. Upon thirty (30) days of written request from a Party, the other Party shall deliver to the requesting Party, all Confidential Information of the requesting Party except for any documents or records that the Party is required to retain by applicable Law. In the event of termination of this Agreement as to any but not all of the Products pursuant to Section 11.2(b), then the provisions of this Section

11.5           shall apply only to Confidential Information specifically relating to the Products with respect to which such termination occurred.

 

11.6License Grant.

 

(a)                                             In the event of any termination hereunder (other than by INIS pursuant to Section 11.3 or 11.4) then, effective immediately upon such termination, INIS shall grant to Progenics, and shall automatically be deemed to have granted to Progenics:

 

(i)                                                 a non-terminable, irrevocable, perpetual, exclusive, fully paid up, royalty-free, worldwide, transferable, license (with a right to sublicense) to any and all INIS Technology necessary or useful to enable Progenics or its designee to Manufacture and supply the Products and otherwise carry out INIS’ obligations under this Agreement; and

 

(ii)                                              a non-terminable, irrevocable, perpetual, non-exclusive, fully paid up, royalty-free, worldwide, transferable, license (with a right to sublicense) to any and all INIS Technology that INIS incorporates into any Manufacturing process or otherwise uses in performing Manufacturing or other services for Progenics, or that is necessary for the development or manufacturing of the Products or

 

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  to make, have made, use, sell and have sold the Products.

 

11.7                  Survival. Termination or expiration of this Agreement will not affect any rights and obligations of the Parties that arose prior to such termination or expiration, but neither Party shall be liable for or have any obligation to pay any amount or payment accruing or becoming payable under this Agreement after the date of termination or expiration of this Agreement. In addition, Sections 5.3(b), 5.5, 8.6, 8.7, 10, 11.4(b), 11.5, 11.6, 11.7, 12, 13 and 14 shall survive termination or expiration of this Agreement.

 

12.

INDEMNIFICATION AND INSURANCE

 

12.1            INIS Indemnification. In addition to other remedies provided by INIS or available to Progenics under this Agreement or applicable Law, INIS shall indemnify, defend and hold harmless Progenics, its Affiliates and its and their respective past, present and future directors, officers, employees, contractors, agents and representatives (each, an “Progenics Indemnified Party”) from and against all losses, liabilities, damages, fines, penalties, forfeitures, judgments, arbitral awards, amounts paid in settlement, costs and expenses (including, reasonable attorneys’ fees) (collectively, “Losses”) arising out of any Third Party claims, proceedings or investigations (“Third Party Claims”) that such Progenics Indemnified Parties may incur as a result of (i) any material breach by INIS of any of its representations, warranties, covenants, agreements or obligations under this Agreement (including, for the avoidance of doubt, the failure of the Product delivered by INIS hereunder to meet the representations and warranties set forth in this Agreement), (ii) the negligence or willful misconduct of any INIS Indemnified Party, or (iii) a claim by a Third Party that the use of any INIS Technology in the Manufacture of Product or the performance by INIS of any of activities contemplated by this Agreement infringes or misappropriates such Third Party’s intellectual property rights; provided, however, that INIS’ obligations pursuant to this Section 12.1 shall not apply to the extent that Progenics has an indemnity obligation with respect thereto pursuant to Section 12.2.

 

12.2             Progenics Indemnification. In addition to other remedies provided by Progenics or available to INIS under this Agreement or applicable Law, Progenics shall indemnify, defend and hold harmless INIS, its Affiliates and its and their respective past, present and future directors, officers, employees, contractors, agents and representatives (each, a “INIS Indemnified Party”) from and against all Losses arising out of any Third Party Claims that such INIS Indemnified Parties may incur as a result of (i) any material breach by Progenics of any of its representations, warranties, covenants, agreements or obligations under this Agreement, (ii) the negligence or willful misconduct of any Progenics Indemnified Party, or (iii) a claim by a Third Party that the use of any Progenics Technology in the Manufacture of Product or the performance by Progenics of any activities contemplated by this Agreement infringes or misappropriates such Third Party’s intellectual property rights; provided, however, that Progenics’ obligations pursuant to this Section 12.2 shall not apply to the extent that INIS has an indemnity obligation with respect thereto pursuant to Section 12.1.

 

12.3Third Party Claims.

 

(a)           If any Third Party notifies an Indemnified Party with respect to any matter which may give rise to a claim for Losses against the Indemnifying Party under Section 12.1 or Section 12.2, as applicable, then the Indemnified Party shall promptly give written notice to the Indemnifying Party; provided, however, that no delay on the part of the Indemnified Party in notifying the Indemnifying Party shall relieve the Indemnifying Party from any obligation under this Section 12, except and only to the extent such delay actually prejudices the Indemnifying Party.

 

(b)           The Indemnifying Party shall be entitled to participate in the defense of any Third-

 

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Party Claim that is the subject of a notice given by an Indemnified Party pursuant to Section 12.3(a). In addition, the Indemnifying Party shall have the right to defend the Indemnified Party against the Third Party Claim with counsel of its choice reasonably satisfactory to the Indemnified Party so long as (i) the Indemnifying Party gives written notice to the Indemnified Party of its assumption of control and defense of the Third Party Claim within fifteen (15) Business Days after the Indemnified Party has given notice of the Third Party Claim to the Indemnifying Party, (ii) the Indemnifying Party provides the Indemnified Party with evidence reasonably acceptable to the Indemnified Party that such Indemnifying Party has and will have adequate financial resources to defend against the Third Party Claim and fulfill its indemnification obligations hereunder, (iii) the Third Party Claim involves primarily money damages and does not seek any material injunction or other material equitable relief against the Indemnified Party, (iv) the Third Party Claim does not relate to or otherwise arise in connection with any criminal or regulatory enforcement action, and (v) the Indemnifying Party conducts the defense of the Third Party Claim in good faith and with reasonable diligence. The Indemnified Party may retain separate co-counsel at its own cost and expense and participate in the defense of the Third-Party Claim. Notwithstanding anything to the contrary contained herein, whether or not an Indemnifying Party assumes the defense of any Third Party Claim hereunder shall not constitute a presumption or omission with respect to whether the Losses related to such Third- Party Claim are, in fact, subject to indemnification hereunder.

 

(c)            The Indemnifying Party may not consent to the entry of any judgment or enter into any compromise or settlement with respect to the Third Party Claim without the prior written consent of the Indemnified Party unless such judgment, compromise or settlement provides for the payment by the Indemnifying Party of money as sole relief for the claimant, (ii) results in the full and general release of the Indemnified Parties from all liabilities arising or relating to, or in connection with, the Third Party Claim, and (iii) involves no finding or admission of any violation of legal requirements or the rights of any Person and no material adverse effect on any other claims that may be made against any Indemnified Party.

 

(d)         The Indemnified Party may not consent to the entry of any judgment or enter into any compromise or settlement with respect to a Third-Party Claim with respect to which indemnification is being sought hereunder without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume the control and defense of a Third Party Claim under Section 12.3(b), the Indemnified Party may defend such Third Party Claim and seek indemnification hereunder from the Indemnifying Party for any Losses associated therewith, including by providing reasonable access to applicable personnel and books and records. The Indemnifying Party or the Indemnified Party, as the case may be, shall at all times use reasonable efforts to keep the other reasonably apprised of the status of the defense of any Third-Party Claim and to cooperate in good faith with each other with respect to the defense of any such matter.

 

12.4         Consequential Damages. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, IN NO EVENT SHALL EITHER PARTY OR ITS AFFILIATES OR ANY OF THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS BE LIABLE TO THE OTHER PARTY UNDER ANY THEORY, INCLUDING NEGLIGENCE, FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE OR EXEMPLARY DAMAGES, WHETHER IN CONTRACT OR TORT LAW (INCLUDING STRICT LIABILITY AND NEGLIGENCE) SUCH AS, BUT NOT LIMITED TO, LOSS OF USE, REVENUE, PROFIT, BUSINESS OPPORTUNITIES AND THE LIKE, DEPRECIATION OR DIMINUTION IN VALUE, EVEN IF SUCH PARTY HAD BEEN ADVISED, OR KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED THAT THE FOREGOING LIMITATIONS OF LIABILITY SHALL NOT APPLY TO ANY (I) CLAIMS ARISING FROM A PARTY’S BREACH OF OBLIGATIONS UNDER SECTION 13 (CONFIDENTIALITY), OR (II) ANY SUCH DAMAGES PAYABLE TO A THIRD PARTY PURSUANT TO A THIRD PARTY CLAIM THAT GIVES RISE TO AN INDEMNIFICATION OBLIGATION HEREUNDER.

 

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12.5           Insurance. At all times during the Term and for a period of three (3) years thereafter, each Party shall:

 

[**]

 

Each Party shall obtain the insurance policies described in this Section 12.5 from nationally known and reputable commercial insurers. Each Party shall list the other Party as an additional insured on such policies. For the avoidance of doubt, the minimum insurance limits in no way limits the liability of each Party.

 

13.

CONFIDENTIALITY

 

13.1                                          General. Pursuant to the terms of this Agreement, each of INIS and Progenics (in such capacity, the “Disclosing Party”) may disclose to the other Party, and to its Affiliates and to their respective officers, directors, employees, agents and/or representatives (in such capacity, the “Receiving Party”) certain secret, confidential or proprietary data, trade secrets, know-how, intellectual property and related information, including operating methods and procedures, marketing, Manufacturing, distribution and sales methods and systems, sales figures, pricing policies and price lists and other business information (“Confidential Information”). The Receiving Party shall make no use of any Confidential Information of the Disclosing Party except in the exercise of its rights and the performance of its obligations set forth in this Agreement. The Receiving Party (a) shall keep and hold as confidential, and shall cause its officers, directors, employees, agents and representatives to keep and hold as confidential, all Confidential Information of the Disclosing Party, and (b) shall not disclose, and shall cause its officers, directors, employees, agents and representatives not to disclose, any Confidential Information of the Disclosing Party to any Third Party; provided, however, that INIS shall have the right to disclose Confidential Information of Progenics to Third Parties involved in the Manufacturing, to the extent necessary for such Third Parties to perform their respective Manufacturing obligations. Confidential Information disclosed by the Disclosing Party shall remain the sole and absolute property of the Disclosing Party, subject to the rights granted in this Agreement.

 

13.2                                          Exceptions. The above restrictions on the use and disclosure of Confidential Information shall not apply to any information which (a) is already known to the Receiving Party at the time of disclosure by the Disclosing Party, as demonstrated by competent proof (other than as a result of prior disclosure under any agreement between or among the Parties with respect to confidentiality), (b) is or becomes generally available to the public other than through any act or omission of the Receiving Party in breach of this Agreement, (c) is acquired by the Receiving Party from a Third Party who is not, directly or indirectly, under an obligation of confidentiality to the Disclosing Party with respect to same, or (d) is developed independently by the Receiving Party without use, direct or indirect, of information that is required to be held confidential under this Agreement. In addition, nothing in this Section 13 shall be interpreted to limit the ability of any Party to use or disclose its own Confidential Information in any manner or to any other Person.

 

13.3                                       Permitted Disclosures. It shall not be a breach of Section 13.1 if a Receiving Party discloses Confidential Information of a Disclosing Party (a) pursuant to requirement of applicable Law or a Regulatory Authority, or (b) in a judicial, administrative or arbitration proceeding to enforce such Party’s rights under this Agreement. In such event, the Receiving Party shall (i) provide the Disclosing Party with as much advance written notice as possible of the required disclosure, (ii) reasonably cooperate with the Disclosing Party in any attempt to prevent or limit the disclosure, and (iii) limit disclosure, if any, to the specific purpose at issue. Additionally, either Party may make any disclosures that its legal advisor determines are required to make in connection with the Securities Exchanges Rules.

 

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13.4     Confidential Terms. Each Party acknowledges and agrees that the terms and conditions of this Agreement shall be considered Confidential Information of each Party and shall be treated accordingly. Notwithstanding the foregoing, each Party acknowledges and agrees that the other may be required to disclose some or all of the information included in this Agreement in order to comply with its obligations under securities Laws or the rules or regulations of any securities exchange or market on which the Disclosing Party’s or its Affiliate’s stock is traded, and hereby consents to such disclosure to the extent deemed necessary by its respective counsel (but only after consulting with the other to the extent practicable, including with respect to the propriety and practicality of seeking confidential treatment of any aspects of such information).

 

13.5      Equitable Remedies. Each Party specifically recognizes that any breach by it of this Section 13 may cause irreparable injury to the other Party and that actual damages may be difficult to ascertain, and in any event, may be inadequate. Accordingly, (and without limiting the availability of legal or equitable, including injunctive, remedies under any other provisions of this Agreement), each Party agrees that in the event of any such breach, the other Party shall be entitled to seek, by way of private litigation in the first instance, injunctive relief and such other legal and equitable remedies as may be available.

 

13.6                                                                  Publicity. Unless otherwise required by a Law, no Party or its Affiliate shall make any public announcements in respect of this Agreement or the transactions contemplated hereby or otherwise communicate with any news media without the prior written consent of the other Party (which consent shall not be unreasonably withheld, conditioned or delayed), and the Parties shall reasonably cooperate as to the timing and contents of any such announcement.

 

14.

MISCELLANEOUS

 

14.1                  Independent Contractor. Neither INIS nor Progenics, together in each case with their respective employees or representatives, are under any circumstances to be considered as employees or agents or representatives of the other by virtue of this Agreement, and neither shall have the authority or power to bind the other or contract in the other’s name.

 

14.2                   Notices. Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed given when so delivered in person, by reputable overnight courier, by facsimile transmission (with receipt confirmed by automatic transmission report) or two (2) Business Days after being sent by registered or certified mail (postage prepaid, return receipt requested), as follows:

 

if to Progenics, to:

 

Progenics Pharmaceuticals, Inc. 1 World Trade Center

47th Floor, Suite J New York, NY 10007

Attention: Head of Manufacturing Facsimile: 646-707-3626

 

with a copy to:

 

Progenics Pharmaceuticals, Inc. 1 World Trade Center

47th Floor, Suite J New York, NY 10007 Attention: CEO

 

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Facsimile: 646-707-3626 if to INIS, to:

International Isotopes Inc.

4137 Commerce Circle Idaho Falls, Idaho 83401

Attn: Radiopharmaceutical Production Manager with a copy to:

International Isotopes Inc.

4137 Commerce Circle Idaho Falls, Idaho 83401 Attn: Steve Laflin, CEO

 

Either Party may by notice given in accordance with this Section 14.2 to the other Party designate another address or person for receipt of notices hereunder.

 

14.3                    Amendment; Waiver. This Agreement may not be amended except by an instrument signed by each of the Parties hereto. Any Party hereto may (a) extend the time for the performance of any of the obligations or other acts of another Party hereto or (b) waive compliance with any of the agreements of another Party or any conditions to its own obligations, in each case only to the extent such obligations, agreements, or conditions are intended for its benefit; provided, however, that any such extension or waiver shall be binding upon a Party only if such extension or waiver is set forth in a writing executed by such Party.

 

14.4                    Entire Agreement. This Agreement and the Quality Agreement contain the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements, written or oral among the Parties thereto.

 

14.5Dispute Resolution; Governing Law; Jurisdiction.

 

(a)          Resolution. In the event of a dispute regarding payment or the performance of obligations pursuant to this Agreement (each, a “Dispute”), the Parties shall endeavor to negotiate in good faith an agreeable solution. If after ten (10) Business Days following receipt of a Party’s written notification of a Dispute such Dispute has not been resolved, the Dispute shall be brought to the attention of the CEO of each Party and such CEO or his/her designee will negotiate in good faith to define and implement a final resolution. The intent of this Section 14.5 is to encourage the Parties to work together to resolve any Dispute without having to rely on arbitration or any other legal proceeding. However, nothing in this Section 14.5 shall prevent or inhibit either Party to institute any other action (including seeking injunctive relief). This Agreement shall be governed by and construed in accordance with the laws of the State of New York (without giving effect to any conflicts of law principles that require the application of the law of a different state).

 

(b)          Jurisdiction. The Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the federal and state courts sitting in New York County, State of New York, for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial.

 

(c)           Venue. The Parties hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the federal or state courts sitting in New York County, State of New York, and hereby

 

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further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.

 

(d)          Service. Each Party agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 14.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.

 

14.6           Binding Effect; Assignment. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Neither INIS nor Progenics may assign any of its rights or delegate any of its liabilities or obligations hereunder without the prior written consent of the other; provided, that no prior consent shall be required (a) in connection with an assignment by Progenics of all or substantially all of its business or assets relating to the Products, whether by merger, reorganization, acquisition, sale, strategic transaction or otherwise, or (iii) in connection with an assignment by Progenics to its Affiliate; provided that Progenics shall remain jointly and severally liable with such Affiliate in respect of all obligations so assigned. Any attempt to assign this Agreement in violation of this Section 14.6 shall be void.

 

14.7           No Third-Party Beneficiaries. Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person other than the Parties and their respective successors and permitted assigns any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

 

14.8           Section Headings; Construction; Interpretation. The headings of Sections in this Agreement are provided for convenience only and will not affect its construction or interpretation. All references to “Section” or “Sections” refer to the corresponding Section or Sections of this Agreement. All schedules and exhibits attached to this Agreement constitute an integral part of this Agreement and are incorporated herein. Unless the context of this Agreement clearly requires otherwise, (a) the singular shall include the plural and the plural shall include the singular wherever and as often as may be appropriate; (b) the masculine shall include the feminine and the feminine shall include the masculine wherever or as often as may be appropriate; (c) the words “include” and “including” shall mean “including without limitation”, and (d) the words “hereof,” “herein,” “hereunder,” and similar terms in this Agreement shall refer to this Agreement as a whole and not to any particular section or article in which such words appear.

 

14.9           Counterparts. This Agreement may be executed in counterparts and such counterparts may be delivered in electronic format (including by fax and email). Such delivery of counterparts shall be conclusive evidence of the intent to be bound hereby and each such counterpart and copies produced therefrom shall have the same effect as an original. To the extent applicable, the foregoing constitutes the election of the Parties to invoke any applicable Law authorizing electronic signatures.

 

14.10        Severability. If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement shall remain in full force and effect. Any provision of this Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable. The Parties further agree to replace such invalid or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable provision.

 

14.11        Rules of Construction. The Parties hereto agree that they have been represented by counsel during the negotiation and execution of this Agreement and, therefore, waive the application of any law, regulation, holding or ruling of construction providing that ambiguities in an agreement or other document will be construed against the Party drafting such agreement or document.

 

14.12        Waiver of Jury Trial. EACH OF PROGENICS AND INIS HEREBY IRREVOCABLY WAIVES THE RIGHT TO A TRIAL BY JURY IN ANY ACTION, PROCEEDING OR

 

28 

 

 

  

COUNTERCLAIM (WHETHER BASED IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT, OR ANY COURSE OF CONDUCT, COURSE OF DEALINGS, STATEMENT OR ACTION RELATED HERETO OR THERETO.

 

14.13        Expenses. Except as expressly set forth herein, each Party hereto shall bear all fees and expenses incurred by such Party in connection with, relating to or arising out of the execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby, including attorneys’, accountants’ and other professional fees and expenses.

 

14.14        No Implied Waivers; Rights Cumulative. No failure on the part of INIS or Progenics to exercise and no delay in exercising any right, power, remedy or privilege under this Agreement, or provided by statute or at law or in equity or otherwise, including the right or power to terminate this Agreement, shall impair, prejudice or constitute a waiver of any such right, power, remedy or privilege or be construed as a waiver of any breach of this Agreement or as an acquiescence therein, nor shall any single or partial exercise of any such right, power, remedy or privilege preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege.

 

14.15        Force Majeure. Neither Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement if such failure or delay is caused by or results from force majeure events outside of the reasonable control of such Party, including without limitation (i) acts of nature; (ii) flood, fire, earthquake or explosion; (iii) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or other civil unrest; (iv) requirements of law applicable generally and not specific to such Party; (v) actions, embargoes or blockades in effect on or after the date of this Agreement; (vi) action by any governmental authority (whether or not having the effect of law) applicable generally and not specific to such Party; (vii) national or regional emergency; (viii) strikes, labor stoppages or slowdowns or other industrial disturbances; (ix) shortages of or delays in receiving raw materials; or (x) shortage of adequate power or transportation facilities (each, a “Force Majeure Event”). Notwithstanding the foregoing, the occurrence of a Force Majeure Event shall not excuse the performance of any obligations under this Agreement but shall merely suspend such performance during the continuation of the Force Majeure Event.

 

[Remainder of page intentionally left blank]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

29 

 

 

  

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed and delivered as of the date first stated above.

 

INTERNATIONAL ISOTOPES INC.
   
   
By: /s/ Steve Laflin
Name: Steve Laflin
Title:   CEO
   
   
PROGENICS PHARMACEUTICALS, INC.
   
   
By: /s/ Patrick Fabbio
Name:  Patrick Fabbio
Title:  CFO

 

 

 

 

 

 

 

 

 

 

 

30

 

 EX-31.1 3 exhibit311.htm EXHIBIT 31.1 Exhibit 31.1

Exhibit 31.1

 

 

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002

 

I, Steve T. Laflin, certify that:

 

1.       I have reviewed this quarterly report on Form 10-Q of International Isotopes Inc.;

 

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

 

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

 

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

 

(a)       Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)       Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)       Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)       Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

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

 

(a)       All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)       Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 15, 2019

 

/s/ Steve T. Laflin

Steve T Laflin, Chief Executive Officer

 

 EX-31.2 4 exhibit312.htm EXHIBIT 31.2 Exhibit 31.2

Exhibit 31.2

 

 

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002

 

I, Laurie McKenzie-Carter, certify that:

 

1.       I have reviewed this quarterly report on Form 10-Q of International Isotopes Inc.;

 

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

 

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

 

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

 

(a)       Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)       Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)       Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)       Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

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

 

(a)       All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)       Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 15, 2019

 

 

/s/ Laurie McKenzie-Carter

Laurie McKenzie-Carter, Chief Financial Officer

 

 EX-32.1 5 exhibit321.htm EXHIBIT 32.1 Exhibit 32.1

Exhibit 32.1

 

 

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of International Isotopes Inc. and subsidiaries (the “Company”) for the period ended March 31, 2019, as filed with the Securities and Exchange Commission (the “Form 10-Q”), I, Steve T. Laflin, Chief Executive Officer of the Company, in my capacity as such, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

(1)The Form 10-Q fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended (15 U.S.C. 78m or 78o(d)); and

 

(2)The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

May 15, 2019 /s/ Steve T. Laflin
  Steve T. Laflin
  Chief Executive Officer

 

 EX-32.2 6 exhibit322.htm EXHIBIT 32.2 Exhibit 32.2

Exhibit 32.2

 

 

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of International Isotopes Inc. and subsidiaries (the “Company”) for the period ended March 31, 2019, as filed with the Securities and Exchange Commission (the “Form 10-Q”), I, Laurie McKenzie-Carter, Chief Financial Officer of the Company, in my capacity as such, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

(1)The Form 10-Q fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended (15 U.S.C. 78m or 78o(d)); and

 

(2)The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

May 15, 2019 /s/ Laurie McKenzie-Carter
  Laurie McKenzie-Carter
  Chief Financial Officer

 

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May 06, 2019
Document And Entity Information    
Entity Registrant Name INTERNATIONAL ISOTOPES INC  
Entity Central Index Key 0001038277  
Document Type 10-Q  
Document Period End Date Mar. 31, 2019  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Is Entity's Reporting Status Current? Yes  
Is Entity Emerging Growth Company? false  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Common Stock, Shares Outstanding   419,574,105
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2019  
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Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Current assets    
Cash and cash equivalents $ 398,604 $ 828,039
Accounts receivable 1,356,924 820,370
Inventories 3,086,126 2,765,729
Prepaids and other current assets 287,245 315,042
Total current assets 5,128,899 4,729,180
Long-term assets    
Restricted cash 625,845 622,428
Property, plant and equipment, net 1,885,914 1,906,182
Operating lease right-of-use asset 782,449  
Goodwill 1,384,255 1,384,255
Patents and other intangibles, net 4,308,398 4,348,031
Total long-term assets 8,986,861 8,260,896
Total assets 14,115,760 12,990,076
Current liabilities    
Accounts payable 2,519,770 2,285,165
Accrued liabilities 721,711 939,918
Current portion of unearned revenue 3,736,310 3,783,541
Current portion of operating lease right-of-use liability 97,580  
Current portion of related party notes payable 180,000 180,000
Current installments of notes payable 8,091 7,956
Total current liabilities 7,263,462 7,196,580
Long-term liabilities    
Obligation for lease disposal costs 517,355 507,968
Unearned revenue, net of current portion 7,500 7,500
Related party notes payable, net of current portion and debt discount 453,061 446,356
Notes payable, net of current portion 18,712 20,786
Operating lease right-of-use liability, net of current portion 684,869  
Mandatorily redeemable convertible preferred stock 4,688,835 4,656,752
Total long-term liabilities 6,370,332 5,639,362
Total liabilities 13,633,794 12,835,942
Commitments and contingencies
Stockholders' Equity    
Common stock 4,169,127 4,131,683
Additional paid-in capital 121,039,851 120,805,997
Accumulated deficit (126,593,379) (126,541,421)
Deficit attributable to International Isotopes Inc. stockholders (1,384,401) (1,603,741)
Equity attributable to noncontrolling interest 1,866,367 1,757,875
Total equity 481,966 154,134
Total liabilities and stockholders' equity $ 14,115,760 $ 12,990,076
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Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Mar. 31, 2019
Dec. 31, 2018
Statement of Financial Position [Abstract]    
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Common stock, shares authorized 750,000,000 750,000,000
Common stock, shares issued 416,912,686 413,168,301
Common stock, shares outstanding 416,912,686 413,168,301
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Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
 3 Months Ended
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Income Statement [Abstract]    
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Cost of product 1,088,429 1,442,408
Gross profit 1,439,423 1,358,618
Operating costs and expenses:    
Salaries and contract labor 623,699 569,459
General, administrative and consulting 626,863 533,134
Research and development 46,304 106,420
Total operating expenses 1,296,866 1,209,013
Net operating income 142,557 149,605
Other income (expense):    
Other income 24,632 53,362
Interest income 3,422 1,307
Interest expense (114,077) (106,034)
Total other expense (86,023) (51,365)
Net income 56,534 98,240
Less income attributable to non-controlling interest 108,492 63,836
Net (loss) income attributable to International Isotopes Inc. $ (51,958) $ 34,404
Net income (loss) per common share - basic
Net income (loss) per common share - diluted
Weighted average common shares outstanding - basic 413,906,700 407,423,051
Weighted average common shares outstanding - diluted 413,906,700 526,418,051
XML 17 R5.htm IDEA: XBRL DOCUMENT v3.19.1
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Cash flows from operating activities:    
Net loss $ 56,534 $ 98,240
Adjustments to reconcile net income (loss) to net cash provided by operating activities:    
Depreciation and amortization 64,985 69,974
Accretion of obligation for lease disposal costs 9,387 2,392
Accretion of beneficial conversion feature and discount 38,788 38,790
Equity based compensation 63,737 73,704
Changes in operating assets and liabilities:    
Accounts receivable (536,554) (215,842)
Inventories (320,397) (475,443)
Prepaids and other current assets 27,797 (78,488)
Accounts payable and accrued liabilities 222,378 650,501
Unearned revenues (47,231) (35,988)
Net cash (used in) provided by operating activities (420,576) 127,840
Cash flows from investing activities:    
Purchase of property, plant and equipment (5,084) (19,708)
Net cash used in investing activities (5,084) (19,708)
Cash flows from financing activities:    
Proceeds from sale of stock 1,581 1,527
Principal payments on notes payable (1,939) (1,813)
Net cash used in financing activities (358) (286)
Net (decrease) increase in cash, cash equivalents and restricted cash (426,018) 107,846
Cash, cash equivalents and restricted cash at beginning of period 1,450,467 1,250,368
Cash, cash equivalents and restricted cash at end of period 1,024,449 1,358,214
Supplemental disclosure of cash flow activities:    
Cash paid for interest 59,127 150,179
Supplemental disclosure of noncash financing and investing transactions:    
Decrease in accrued interest and increase in equity for conversion of dividends to stock 205,980 205,980
Reconciliation of cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows is presented in the table below:    
Cash and cash equivalents 398,604 356,432
Restricted cash included in current assets 387,467
Restricted cash included in long-term assets 625,845 614,315
Total cash, cash equivalents and restricted cash shown in statement of cash flows $ 1,024,449 $ 1,358,214
XML 18 R6.htm IDEA: XBRL DOCUMENT v3.19.1
Statement of Stockholders' Equity - USD ($)
Common Stock
Additional Paid-In Capital
Accumulated Deficit
Deficit Attributable to Internat'l Isotopes Shareholders
Equity Attributable to Noncontrolling Interest
Total
Beginning balance, value at Dec. 31, 2017 $ 4,067,907 $ 120,398,620 $ (125,696,845) $ (1,230,318) $ 1,577,245 $ 346,927
Beginning balance, shares at Dec. 31, 2017 406,790,703          
Shares issued under employee stock purchase plan, value $ 219 1,308   1,527   1,527
Shares issued under employee stock purchase plan, shares 21,811          
Stock grant, value $ 2,098 (2,098)        
Stock grant, shares 209,825          
Stock in lieu of dividends on convertible preferred C shares, value $ 22,886 183,094   205,980   205,980
Stock in lieu of dividends on convertible preferred C shares, shares 2,288,646          
Shares issued for exercise of employee stock options, value $ 611 (6,111)        
Shares issued for exercise of employee stock options, shares 611,111          
Stock based compensation   73,704   73,704   73,704
Net loss (income)     34,404 34,404 63,836 98,240
Ending balance, value at Mar. 31, 2018 $ 4,099,221 120,648,517 (125,662,441) (914,703) 1,641,081 726,378
Ending balance, shares at Mar. 31, 2018 409,922,096          
Beginning balance, value at Dec. 31, 2018 $ 4,131,683 120,805,997 (126,541,421) (1,603,741) 1,757,875 154,134
Beginning balance, shares at Dec. 31, 2018 413,168,301          
Shares issued under employee stock purchase plan, value $ 316 1,265   1,581   1,581
Shares issued under employee stock purchase plan, shares 31,618          
Stock grant, value $ 2,798 (2,798)        
Stock grant, shares 279,767          
Stock in lieu of dividends on convertible preferred C shares, value $ 34,330 171,650   205,980   205,980
Stock in lieu of dividends on convertible preferred C shares, shares 3,433,000          
Stock based compensation   63,737   63,737   63,737
Net loss (income)     (51,958) (51,958) 108,492 56,534
Ending balance, value at Mar. 31, 2019 $ 4,169,127 $ 121,039,851 $ (126,593,379) $ (1,384,401) $ 1,866,367 $ 481,966
Ending balance, shares at Mar. 31, 2019 416,912,686          
XML 19 R7.htm IDEA: XBRL DOCUMENT v3.19.1
The Company and Basis of Presentation
 3 Months Ended
Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
The Company and Basis of Presentation

(1)       The Company and Basis of Presentation

 

International Isotopes Inc. (INIS) was incorporated in Texas in November 1995. The accompanying unaudited condensed consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (GAAP) and include all operations and balances of INIS and its wholly owned subsidiaries. The unaudited condensed consolidated financial statements also include the accounts of INIS’s 50% owned joint venture, TI Services, LLC (TI Services), and the accounts of INIS’s 24.5% interest in RadQual, LLC (RadQual). TI Services is headquartered in Youngstown, Ohio and was formed with RadQual in December 2010 to distribute products and services for nuclear medicine, nuclear cardiology and Positron Emission Tomography (PET) imaging. RadQual is a global supplier of molecular imaging quality control and calibration devices, and is headquartered in Idaho Falls, Idaho. In August 2017, affiliates of INIS purchased 75.5% of RadQual and at the time INIS was named as one of the two managing members of RadQual. As a result of this ownership change, INIS has significant influence in management decisions with regard to RadQual’s business operations. INIS, its wholly owned subsidiaries, TI Services, and RadQual are collectively referred to herein as the “Company,” “we,” “our” or “us.”

 

Nature of Operations – INIS and its subsidiaries, TI Services and RadQual, manufacture a full range of nuclear medicine calibration and reference standards, a wide range of products, including cobalt teletherapy sources, and a varied selection of radioisotopes and radiochemicals for medical research, pharmacy compounding, and clinical applications. The Company also distributes a varied selection of radioisotopes and radiochemicals for medical and clinical research applications and offers contract manufacturing services for certain pharmaceutical products. The Company also provides a host of transportation, recycling, and radiological field services on a contract basis for customers and holds several patents for a fluorine extraction process that it plans to use in conjunction with a proposed commercial depleted uranium de-conversion facility which would be located in Lea County, New Mexico (the “De-Conversion Facility”). The Company’s business consists of five business segments: Nuclear Medicine Standards, Cobalt Products, Radiochemical Products, Fluorine Products, and Radiological Services. The Company’s headquarters and all operations, with the exception of TI Services, are located in Idaho Falls, Idaho.

 

With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products is considered to be two to three years. Accordingly, preliminary payments received on cobalt contracts, where shipment will not take place for greater than one year, have been recorded as unearned revenue and, depending upon estimated ship dates, classified under either current or long-term liabilities on the Company’s consolidated balance sheets. These unearned revenues are being recognized as revenue in the periods during which the cobalt shipments take place. All assets expected to be realized in cash or sold during the normal operating cycle of business are classified as current assets.

 

Principles of Consolidation – The accompanying unaudited condensed consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (GAAP) and include all operations and balances of INIS and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. See Note 4. “Investment and Business Consolidation” for additional information regarding the consolidation of RadQual.

 

Interim Financial Information – The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, all adjustments and reclassifications considered necessary in order to make the financial statements not misleading and for a fair and comparable presentation have been included and are of a normal recurring nature. Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC on March 22, 2019.

 

Recent Accounting Pronouncements – In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updated ASU 2016-02, “Leases”, which was issued to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The amendments in ASU 2016-02 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Results for reporting periods beginning January 1, 2019 are presented in accordance with Topic 842, while prior-period amounts have not been retrospectively adjusted and continue to be reported in accordance with Topic 840, Leases. Based upon the Company’s leases, the Company was not required to make an adjustment to the opening balance of retained earnings as of January 1, 2019. See Note 10, “Leases” for further discussion.

 

In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which expands the scope of Topic 718 to include all share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 specifies that Topic 718 applies to all share-based payment transactions in which the grantor acquires goods and services to be used or consumed in its own operations by issuing share-based payment awards. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under ASC 606. The amendments in ASU 2018-07 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted this standard effective January 1, 2019, and there was no material impact on the financial statements.

 
XML 20 R8.htm IDEA: XBRL DOCUMENT v3.19.1
Current Developments and Liquidity
 3 Months Ended
Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Current Developments and Liquidity

(2)       Current Developments and Liquidity

 

Business Condition – Since inception, the Company has incurred substantial losses. During the three-month period ended March 31, 2019, the Company reported a net loss of $51,958, net of non-controlling interest, and net cash used in operating activities of $420,576. During the three-month period ended March 31, 2018, the Company reported net income of $34,404, net of non-controlling interest, and net cash provided by operating activities of $127,840.

 

During the three months ended March 31, 2019, the Company continued its focus on its long-standing core business segments which consist of its radiochemical products, cobalt products, nuclear medicine standards, and radiological services, and in particular, the pursuit of new business opportunities within those segments.

 

Additionally, the Company holds a Nuclear Regulatory Commission (NRC) construction and operating license for the depleted uranium facility in, as well as the property agreement with, Lea County, New Mexico, where the plant is intended to be constructed. The NRC license for the de-conversion facility is a forty (40) year operating license and is the first commercial license of this type issued in the United States.  There are no other companies with a similar license application under review by the NRC. Therefore, the NRC license represents a significant competitive barrier and the Company considers it a valuable asset.

 

The Company expects that cash from operations, cash raised through equity or debt financing and its current cash balance will be sufficient to fund operations for the next twelve months. Future liquidity and capital funding requirements will depend on numerous factors, including, contract manufacturing agreements, commercial relationships, technological developments, market factors, available credit, and voluntary warrant redemption by shareholders. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.

 
XML 21 R9.htm IDEA: XBRL DOCUMENT v3.19.1
Net Income (Loss) Per Common Share - Basic and Diluted
 3 Months Ended
Mar. 31, 2019
Earnings Per Share [Abstract]  
Net Income (Loss) Per Common Share - Basic and Diluted

(3)       Net Income (Loss) Per Common Share - Basic and Diluted

 

For the three months ended March 31, 2019, the Company had 27,205,000 stock options outstanding, 20,090,000 warrants outstanding, 4,213 outstanding shares of Series C redeemable convertible preferred stock (Series C Preferred Stock), and 850 outstanding shares of Series B redeemable convertible preferred stock (Series B Preferred Stock), each of which were not included in the computation of diluted income (loss) per common share because they would be anti-dilutive.

 

For the three months ended March 31, 2018, the Company had 31,850,000 stock options outstanding, 45,090,000 warrants outstanding, 4,213 outstanding shares of Series C Preferred Stock, and 850 outstanding shares of Series B Preferred Stock, each of which were included in the computation of diluted income per common share.

 

The table below summarizes common stock equivalents outstanding at March 31, 2019 and 2018:

 

    March 31,  
    2019     2018  
Stock options     27,205,000       31,850,000  
Warrants     20,090,000       45,090,000  
850 Shares of Series B redeemable convertible preferred stock     425,000       425,000  
4,213 Shares of Series C redeemable convertible preferred stock     42,130,000       42,130,000  
      89,850,000       119,495,000  

 
XML 22 R10.htm IDEA: XBRL DOCUMENT v3.19.1
Investment and Business Consolidation
 3 Months Ended
Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Investment and Business Consolidation

(4)       Investment and Business Consolidation

 

The Company owns a 24.5% interest in RadQual, with which the Company has an exclusive manufacturing agreement for nuclear medicine products. In August 2017, affiliates of the Company, including the Company’s Chairman of the Board and the Chief Executive Officer, acquired the remaining 75.5% interest in RadQual. The Company’s Chairman of the Board and its Chief Executive Officer also each serve as the managing members of RadQual. As a result of this change in ownership, and other factors, the Company determined that it gained the ability to exercise significant management control over the operations of RadQual. Because of this increased management control, and pursuant to GAAP, the Company has consolidated the accounts of RadQual into its financial statements.

 
XML 23 R11.htm IDEA: XBRL DOCUMENT v3.19.1
Inventories
 3 Months Ended
Mar. 31, 2019
Inventory Disclosure [Abstract]  
Inventories

(5)       Inventories

 

Inventories consisted of the following at March 31, 2019 and December 31, 2018:

 

    March 31, 2019     December 31, 2018  
Raw materials   $ 42,911     $ 42,911  
Work in process     3,041,387       2,719,786  
Finished goods     1,828       3,032  
    $ 3,086,126     $ 2,765,729  

 

Work in process includes cobalt-60 targets that are located in the U.S. Department of Energy’s (DOE) Advanced Test Reactor (ATR) located outside of Idaho Falls, Idaho. These targets are owned by the Company and contain cobalt-60 material at various stages of irradiation. The carrying value of the targets is based on accumulated irradiation and handling costs which have been allocated to each target based on the length of time the targets have been held and processed at the ATR. At March 31, 2019, and at December 31, 2018, this cobalt target inventory had a carrying value of $403,076 and $389,293, respectively.

 

Work in process also includes costs to irradiate cobalt-60 material under a contract with the DOE. This material has been placed in the ATR and the Company is making progress payments designed to coincide with the completion of the irradiation period. The Company has contracted with several customers for the sale of some of this product material and has collected advance payments for project management, up-front handling, and other production costs from those customers. The advance payments from customers were recorded as unearned revenue which are recognized in the Company’s consolidated financial statements as cobalt products are completed and shipped. For the three months ended March 31, 2019, the Company recognized approximately $94,000 of revenue in its consolidated statements of operations for customer orders filled during the period under these cobalt contracts.

 
XML 24 R12.htm IDEA: XBRL DOCUMENT v3.19.1
Stockholders' Equity, Options and Warrants
 3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
Stockholders' Equity, Options and Warrants

(6)       Stockholders’ Equity, Options, and Warrants

 

Employee Stock Purchase Plan

 

The Company has an employee stock purchase plan pursuant to which employees of the Company may participate to purchase shares of common stock at a discount. During the three months ended March 31, 2019 and 2018, the Company issued 31,618 and 21,811 shares of common stock, respectively, to employees under the employee stock purchase plan for proceeds of $1,581 and $1,527, respectively. As of March 31, 2019, 543,312 shares of common stock remain available for issuance under the employee stock purchase plan.

 

Stock-Based Compensation Plans

 

2015 Incentive Plan - In April 2015, the Company’s Board of Directors approved the International Isotopes Inc. 2015 Incentive Plan (as amended, the 2015 Plan), which was subsequently approved by the Company’s shareholders in July 2015. The 2015 Plan was amended and restated in July 2018 to increase the number of shares authorized for issuance under the 2015 Plan by an additional 20,000,000 shares. The 2015 Plan provides for the grant of incentive and non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units, and other stock or cash-based awards.  The 2015 Plan amended and restated the Company’s Amended and Restated 2006 Equity Incentive Plan (2006 Plan). The 2015 Plan authorizes the issuance of up to 80,000,000 shares of common stock, plus 11,089,967 shares authorized, but not issued under the 2006 Plan. At March 31, 2019, there were 33,712,718 shares available for issuance under the 2015 Plan.

 

Employee/Director Grants - The Company accounts for issuances of stock-based compensation to employees by recognizing, as compensation expense, the cost of employee services received in exchange for equity awards. The compensation expense is based on the grant date fair value of the award. Stock option compensation expense is recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period).

 

Non-Employee Grants - The Company accounts for its issuances of stock-based compensation to non-employees by measuring the value of any awards that were vested and non-forfeitable at their date of issuance based on the grant date fair value of the award. The non-vested portion of awards that are subject to the future performance of the counterparty are adjusted at each reporting date to their fair values based upon the then current market value of the Company’s stock and other assumptions that management believes are reasonable.

 

Option awards outstanding as of March 31, 2019, and changes during the three months ended March 31, 2019, were as follows:

 

Fixed Options   Shares     Weighted Average Exercise Price     Weighted Average Remaining Contractual Life     Aggregate Intrinsic Value  
Outstanding at December 31, 2018     27,805,000     $ 0.06                  
Granted     —                            
Exercised     —                            
Expired     —                            
Forfeited     (600,000 )   $ 0.04                  
Outstanding at March 31, 2019     27,205,000     $ 0.05       5.9     $ 332,500  
Exerciseable at March 31, 2019     19,301,000     $ 0.05       4.9     $ 332,500  

 

The intrinsic value of outstanding and exercisable shares is based on the closing price of the Company’s common stock on the OTCQB of $0.06 per share on March 29, 2019, the last trading day of the quarter.

 

As of March 31, 2019, there was $118,884 of unrecognized compensation expense related to stock options that will be recognized over a weighted-average period of 1.84 years.

 

Total stock-based compensation expense for the three months ended March 31, 2019 and 2018 was $63,737 and $73,704, respectively.

 

Pursuant to an employment agreement with its Chief Executive Officer, the Company awarded 466,667 fully vested shares of common stock to its Chief Executive Officer in February 2019 under the 2015 Plan. The number of shares awarded was based on a $28,000 stock award using a price of $0.06 per share. The employment agreement provides that the number of shares issued will be based on the average closing price of common stock for the 20 trading days prior to issue date but not less than $0.05 per share. Compensation expense recorded pursuant to this stock grant was $16,786, which was determined by multiplying the number of shares awarded by the closing price of the common stock on February 28, 2019, which was $0.06 per share. The Company withheld 186,900 shares of common stock to satisfy the employee’s payroll tax obligations in connection with this issuance. The net shares issued on February 28, 2019 totaled 279,767.

 

Warrants

 

Warrants outstanding at March 31, 2019, included 17,165,000 Class M Warrants which are immediately exercisable at an exercise price of $0.12 per share and expire on February 17, 2022; and, 2,925,000 Class N Warrants which are immediately exercisable at an exercise price of $0.10 per share and expire on May 12, 2022. All 25,000,000 Class L Warrants expired on December 23, 2018.

 

Warrants outstanding at March 31, 2019, included 25,000,000 Class L Warrants with an exercise price of $0.06 per share and an expiration date of December 23, 2018, 17,165,000, Class M Warrants which are immediately exercisable at an exercise price of $0.12 per share and expire on February 17, 2022; and, 2,925,000 Class N Warrants which are immediately exercisable at an exercise price of $0.10 per share and expire on May 12, 2022.

 

Preferred Stock

 

At March 31, 2019, there were 850 shares of the Series B Preferred Stock outstanding with a mandatory redemption date of May 2022 at $1,000 per share or $850,000. The shares of Series B Preferred Stock are also convertible into 425,000 shares of the Company’s common stock at a conversion price of $2.00 per share. These Series B Preferred Stock does not carry any dividend preferences. Due to the mandatory redemption provision, the Series B Preferred Stock has been classified as a liability in the accompanying condensed consolidated balance sheets.

 

At March 31, 2019, there were 4,213 shares of the Series C Preferred Stock outstanding with a mandatory redemption date of February 2022 at $1,000 per share in either cash or shares of common stock, at the option of the holder. Holders of the Series C Preferred Stock do not have any voting rights except as required by law and in connection with certain events as set forth in the Statement of Designation of the Series C Preferred Stock. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17th of each year. The Series C Preferred Stock are convertible at the option of the holders at any time into shares of the Company's common stock at an initial conversion price equal to $0.10 per share, subject to adjustment.

 

During the three months ended March 31, 2019 and 2018 dividends paid totaled $252,780 and $241,730, respectively. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. For the three months ended March 31, 2019 the Company issued 3,433,000 shares of common stock in lieu of a dividend payment of $205,980. The remaining $46,800 of dividend payable was settled with cash. For the same period in 2018, the Company issued 2,288,646 shares of common stock in lieu of a dividend payment of $205,980. The remaining $35,750 of dividend payable was settled in cash.

 
XML 25 R13.htm IDEA: XBRL DOCUMENT v3.19.1
Debt
 3 Months Ended
Mar. 31, 2019
Debt Disclosure [Abstract]  
Debt

(7)       Debt

 

In December 2013, the Company entered into a promissory note agreement with its former Chairman of the Board and one of its major shareholders pursuant to which the Company borrowed $500,000 (the 2013 Promissory Note). The 2013 Promissory Note is unsecured and bears interest at 6% per annum and was originally due on June 30, 2014. According to the terms of the 2013 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of the Company’s common stock. In connection with the 2013 Promissory Note, each of the two lenders was issued 5,000,000 warrants to purchase shares of the Company’s common stock at $0.06 per share. The warrants were immediately exercisable. In June 2014, the Company renegotiated the terms of the 2013 Promissory Note. Pursuant to the modification, the maturity date was extended to December 31, 2017 and each lender was granted an additional 7,500,000 warrants to purchase shares of the Company’s common stock at $0.06 per share. The warrants were immediately exercisable. In December 2016, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2022, with all remaining terms unchanged. On December 23, 2018, all 25,000,000 warrants expired. At March 31, 2019, the balance of the 2013 Promissory Note was $500,000 and accrued interest payable on the note was $159,234. Interest expense recorded for the three-month period ended March 31, 2019, was $7,500.

 

In March 2016, the Company entered into a note payable for the purchase of a vehicle. The principal amount financed was $47,513. The term of the note is six years and carries an interest rate of 6.66% per annum. Monthly payments are $805 and the note matures April 2022. The note is secured by the vehicle that was purchased with the note’s proceeds.

 

In August 2017, the Company entered into a promissory note agreement with its Chairman of the Board pursuant to which the Company borrowed $60,000 (the 2017 Promissory Note). The 2017 Promissory Note accrues interest at 5% per annuum, which is payable upon maturity of the 2017 Promissory Note, and at March 31, 2019, the amount of accrued interest on the 2017 Promissory Note was $4,867. The 2017 Promissory Note is unsecured and was scheduled to mature on June 30, 2018. Pursuant to an amendment to the 2017 Promissory Note on June 29, 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2017 Promissory Note on February 2019, the maturity date was extended to July 31, 2019 with all other provisions of the 2017 Promissory Note remaining unchanged. On April 30, 2019, the 2017 Promissory Note and accrued interest were repaid in full with a cash payment of $65,367.

 

On April 9, 2018, the Company borrowed $120,000 from its Chief Executive Officer and its Chairman of the Board pursuant to a short-term promissory note (the 2018 Promissory Note). The 2018 Promissory Note accrues interest at 6% per annum, which is payable upon maturity of the 2018 Promissory Note. The 2018 Promissory Note is unsecured and originally matured on August 1, 2018. At any time, the holder of the 2018 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of the Company’s common stock based on the average price of the shares over the previous 20 trading days. Pursuant to an amendment to the 2018 Promissory Note on June 29, 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2018 Promissory Note on February 12, 2019, the maturity date was extended to July 31, 2019, with all other provisions remaining unchanged. At March 31, 2019, accrued interest on the 2018 Promissory Note totaled $7,020.

 

In February 2019, the Company borrowed $185,474 from RadQual pursuant to a short-term promissory note with a stated interest rate of 6% and a maturity date of July 31, 2019. The promissory note is unsecured.

 
XML 26 R14.htm IDEA: XBRL DOCUMENT v3.19.1
Commitments and Contingencies
 3 Months Ended
Mar. 31, 2019
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

(8)       Commitments and Contingencies

 

Dependence on Third Parties

 

The production of High Specific Activity Cobalt is dependent upon the DOE, and its prime operating contractor, which controls the ATR and laboratory operations at the ATR located outside of Idaho Falls, Idaho. In October 2014, the Company signed a ten-year contract with the DOE for the irradiation of cobalt targets for the production of cobalt-60. The Company will be able to purchase cobalt targets for a fixed price per target with an annual 5% escalation in price. The contract term is October 1, 2014, through September 30, 2024, however, the contract may be extended beyond that date. Also, the DOE may end the contract if it determines termination is necessary for the national defense, security or environmental safety of the United States. If this were to occur, all payments made by the Company, for partially irradiated undelivered cobalt material, would be refunded.

 

Nuclear Medicine Reference and Calibration Standard manufacturing is conducted under an exclusive contract with RadQual, which in turn has an agreement in place with several companies for distributing the products. The radiochemical product sold by the Company is supplied to the Company through agreements with several suppliers. A loss of any of these customers or suppliers could adversely affect operating results by causing a delay in production or a possible loss of sales.

 

Contingencies

 

Because all the Company’s business segments involve the handling or use of radioactive material, the Company is required to have an operating license from the NRC and specially trained staff to handle these materials. The Company has amended this operating license numerous times to increase the amount of material permitted within the Company’s facility. Although this license does not currently restrict the volume of business operations performed or projected to be performed in the upcoming year, additional processing capabilities and license amendments could be implemented that would permit processing of other reactor-produced radioisotopes by the Company. The financial assurance required by the NRC to support this license has been provided for with a surety bond held with North American Specialty Insurance Company which is supported by a restricted money market account held with Merrill Lynch in the amount of $625,845.

 

In August 2011, the Company received land from Lea County, New Mexico, pursuant to a Project Participation Agreement (PPA), whereby the land was deeded to the Company for no monetary consideration. In return, the Company committed to construct a uranium de-conversion and Fluorine Extraction Process facility on the land.  In order to retain title to the property, the Company was to begin construction of the de-conversion facility no later than December 31, 2014, and complete Phase I of the project and have hired at least 75 persons to operate the facility no later than December 31, 2015, although commercial operations need not have begun by that date. In 2015, the Company negotiated a modification to the PPA that extended the start of construction date to December 31, 2015, and the hiring milestone to December 31, 2016. Those dates were not met, and the Company is currently in the process of renegotiating a second modification to the agreement to further extend those dates. If the Company is not successful in reaching an amendment to extend the performance dates in the PPA. then it may, at its sole option, either purchase or re-convey the property to Lea County, New Mexico.  The purchase price of the property would be $776,078, plus interest at the annual rate of 5.25% from the date of the closing to the date of payment.  The Company has not recorded the value of this property as an asset and will not do so until such time that sufficient progress on the project has been made to meet the Company’s obligations under the agreements for permanent transfer of the title.

 
XML 27 R15.htm IDEA: XBRL DOCUMENT v3.19.1
Revenue Recognition
 3 Months Ended
Mar. 31, 2019
Revenue from Contract with Customer [Abstract]  
Revenue Recognition

(9)       Revenue Recognition

 

Revenue from Product Sales

 

The following tables present the Company’s revenue disaggregated by business segment and geography, based on management’s assessment of available data:

 

    Three Months Ended March 31, 2019     Three Months Ended March 31, 2018  
    U.S.     Outside U.S.     Total Revenues     % of Total Revenues     U.S.     Outside U.S.     Total Revenues     % of Total Revenues  
Radiochemical Products   $ 459,967     $ 3,265     $ 463,232       18 %   $ 528,917     $ 54,924     $ 583,841       21 %
Cobalt Products     336,089       40,000       376,089       15 %     327,778       —         327,778       12 %
Nuclear Medicine Products     1,080,472       20,450       1,100,922       44 %     997,733       4,380       1,002,113       35 %
Radiological Services     587,609       —         587,609       23 %     139,172       748,422       887,594       32 %
Fluorine Products     —         —         —         0 %     —         —         —         0 %
    $ 2,464,137     $ 63,715     $ 2,527,852       100 %   $ 1,993,600     $ 807,726     $ 2,801,326       100 %

 

Under ASC Topic 606, the Company recognizes revenue when it satisfies a performance obligation by transferring control of the promised goods or services to its customers, in an amount that reflects the consideration the Company expects to receive in exchange for the product or service.

 

Product sales consist of a single performance obligation that the Company satisfies at a point in time.  Most transactions in the radiochemical products and nuclear medicine standards segments fall into this category. Most sales transactions in the cobalt products business segment fall into this category but other cobalt product sales are recorded as deferred income as discussed below. The Company recognizes product revenue when the following events have occurred: (a) the Company has transferred physical possession of the products, (b) the Company has a present right to payment, (c) the customer has legal title to the products, and (d) the customer bears significant risks and rewards of ownership of the products.   Based on the Company’s historical practices and shipping terms specified in the sales agreements and invoices, these criteria are generally met when the products are:

 

  · Invoiced.
  · Shipped from the Company’s facilities (“FOB shipping point”, which is the Company’s standard shipping term). For these sales, the Company determined that the customer is able to direct the use of, and obtain substantially all of the benefits from, the products at the time the products are shipped.

In the radiological services segment, the Company performs services under multiple types of contracts. In this segment, the Company processes gemstones and recovers various types of radioactive and/or hazardous materials from third-party facilities. Contracts for gemstone processing include two performance obligations and revenue for these contracts is recognized when each obligation is met. Recovery projects typically have only one performance obligation which is delivery of the final product or service. Under these contracts, the Company recognizes revenue once the work is complete and the customer has obtained substantially all of the benefits from the services, and the performance obligations under the contract have been met. Some recovery contracts have milestones at which point the Company can invoice and receive payments from the customer. With these contracts, the company considers each milestone a performance obligation and records revenue at the time each milestone is completed, and the customer has inspected and accepted the results of the services. The Company’s standard payment terms for its customers are generally 30 days after the Company satisfies the performance obligations.

 

The Company’s revenue consists primarily of products manufactured for use in the nuclear medicine industry, distribution of radiochemicals, cobalt source manufacturing, and providing radiological services on a contract basis for customers. With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products is considered to be two to three years. Accordingly, preliminary payments received on cobalt contracts, where shipment will not take place for greater than one year, have been recorded as unearned revenue on the Company’s consolidated balance sheets and classified under current or long-term liabilities, depending upon estimated ship dates. For the three months ended March 31, 2019, the Company reported current unearned cobalt products revenue of $3,736,310 and non-current unearned revenue of $7,500. For the period ended December 31, 2018, the Company reported current unearned revenue of $3,783,541 and non-current unearned revenue of $7,500. These unearned revenues will be recognized as revenue in the periods during which the cobalt shipments take place.

 

Contract Balances

 

The Company records a receivable when it has an unconditional right to receive consideration after the performance obligations are satisfied.  As of March 31, 2019, and December 31, 2018, accounts receivable totaled $1,356,924 and $820,370, respectively.  For the three months ended March 31, 2019, the Company did not incur material impairment losses with respect to its receivables.

 

Practical Expedients

 

The Company has elected the practical expedient not to determine whether contracts with customers contain significant financing components.

 
XML 28 R16.htm IDEA: XBRL DOCUMENT v3.19.1
Leases
 3 Months Ended
Mar. 31, 2019
Leases [Abstract]  
Leases

(10)       Leases

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 replaced most existing lease accounting guidance. In July 2018 the FASB approved an Accounting Standards Update which, among other changes, allowed a company to elect to adopt ASU 2016-02 using the modified retrospective method applying the transition provisions at the beginning of the period of adoption, rather than at the beginning of the earliest comparative period presented in these financial statements. ASU 2016-02 was effective for the Company beginning on January 1, 2019 and required the Company to record a right-of-use asset and a lease liability for its facilities leases that were previously treated as operating leases. The effect of ASU 2016-02 was to record a cumulative-effect adjustment on January 1, 2019 as a right-of-use asset and an operating lease liability totaling $810,367. The Company has made an accounting policy election to not apply the recognition requirements of ASU 2016-02 to its short-term leases, which are leases with a term of one year or less. The Company has also elected certain practical expedients under ASU 2016-02 including not separating lease and non-lease components on its operating leases, not reassessing whether any existing contracts contained leases, not reconsidering lease classification, not reassessing initial direct costs and using hindsight in determining the reasonably certain term of its leases.

 

 

The Company leases office and warehouse space under operating leases. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments under the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the reasonably certain lease term. The implicit rates with the Company’s operating leases are generally not determinable and the Company uses its incremental borrowing rate at the lease commencement date to determine the present value of its lease payments. The determination of the Company’s incremental borrowing rate requires judgement. The Company determines its incremental borrowing rate for each lease using its then-current borrowing rate. Certain of the Company’s leases include options to extend or terminate the lease. The Company establishes the number of renewal options periods used in determining the operating lease term based upon its assessment at the inception of the operating lease. The option to renew the lease may be automatic, at the option of the Company, or mutually agreed to between the landlord and the Company. Once the facility lease term has begun, the present value of the aggregate future minimum lease payments is recorded as a right-of-use asset. Lease expense is recognized on a straight-line basis over the term of the lease.

 

    Three Months Ended  
    March 31, 2019  
Operating lease costs   $ 36,853  
Short-term operating lease costs   $ 1,902  
Operating cash flows from operating leases   $ (38,755 )
Right-of-use assets obtained in exchange for new operating lease liabilities   $ 810,367  
Weighted-average remaining lease term (years) - operating leases     7  
Weighted-average discount rate - operating leases     6.75 %

 

The future minimum payments under these operating lease agreements are as follows:

 

2019 (excluding the three months ended March 31, 2019)   $ 110,560  
2020     145,563  
2021     136,313  
2022     136,313  
2023     136,313  
Thereafter     318,063  
   Total minimum operating lease obligations     983,125  
Less-amounts representing interest     (200,676 )
   Present value of minimum operating lease obligations     782,449  
Current maturities     (97,580 )
Lease obligations, net of current maturities   $ 684,869  

 
XML 29 R17.htm IDEA: XBRL DOCUMENT v3.19.1
Segment Information
 3 Months Ended
Mar. 31, 2019
Segment Reporting [Abstract]  
Segment Information

(11)       Segment Information

 

The Company has five reportable segments which include: Nuclear Medicine Standards, Cobalt Products, Radiochemical Products, Fluorine Products, and Radiological Services. Information regarding the operations and assets of these reportable business segments is contained in the following table:

 

    Three months ended March 31,  
Sale of Product   2019     2018  
Radiochemical Products   $ 463,232     $ 583,541  
Cobalt Products     376,089       327,778  
Nuclear Medicine Standards     1,100,922       1,002,113  
Radiological Services     587,609       887,594  
Fluorine Products     —         —    
Total Segments     2,527,852       2,801,026  
Corporate revenue     —         —    
Total Consolidated   $ 2,527,852     $ 2,801,026  

 

    Three months ended March 31,  
Depreciation and Amortization   2019     2018  
Radiochemical Products   $ 8,817     $ 5,014  
Cobalt Products     1,080       4,043  
Nuclear Medicine Standards     15,619       17,938  
Radiological Services     8,636       12,039  
Fluorine Products     26,095       26,095  
Total Segments     60,248       65,130  
Corporate depreciation and amortization     4,737       4,844  
Total Consolidated   $ 64,985     $ 69,974  

 

    Three months ended March 31,  
Segment Income (Loss)   2019     2018  
Radiochemical Products   $ 96,006     $ 40,520  
Cobalt Products     192,870       184,792  
Nuclear Medicine Standards     216,822       223,942  
Radiological Services     311,279       402,012  
Fluorine Products     (37,495 )     (31,299 )
Total Segments     779,481       819,966  
Corporate loss     (831,439 )     (785,562 )
Net Income (Loss)   $ (51,958 )   $ 34,404  

 

    Three months ended March 31,  
Expenditures for Segment Assets   2019     2018  
Radiochemical Products   $ —       $ —    
Cobalt Products     3,494       —    
Nuclear Medicine Standards     —         18,148  
Radiological Services     —         —    
Fluorine Products     1,590       1,560  
Total Segments     5,084       19,708  
Corporate purchases     —         —    
Total Consolidated   $ 5,084     $ 19,708  

 

    March 31,     December 31,  
Segment Assets   2019     2018  
Radiochemical Products   $ 287,605     $ 344,994  
Cobalt Products     3,095,941       2,611,939  
Nuclear Medicine Standards     2,200,139       2,113,960  
Radiological Services     535,829       281,077  
Fluorine Products     5,563,206       5,590,053  
Total Segments     11,682,720       10,942,023  
Corporate assets     2,416,416       2,048,053  
Total Consolidated   $ 14,099,136     $ 12,990,076  
XML 30 R18.htm IDEA: XBRL DOCUMENT v3.19.1
Subsequent Events
 3 Months Ended
Mar. 31, 2019
Subsequent Events [Abstract]  
Subsequent Events

(12)       Subsequent Events

 

On April 5, 2019, the Company entered into a manufacturing and supply agreement with Progenics Pharmaceuticals Inc. Under this agreement, the Company will provide contract manufacturing services for AZEDRA® (Ultratrace® Iobenguane I-131) and other iodine products.

 

In April 2019, 1,500,000 qualified stock options were exercised under a cashless exercise. The Company withheld 875,000 shares to satisfy the exercise price and issued 625,000 shares of common stock. The options exercised were granted under the 2015 Plan, and, accordingly, there will not be any income tax effect in the condensed consolidated financial statements for the three months ended June 30, 2019. In addition, in April 2019, 2,000,000 non-qualified stock options were exercised for a cash payment of $70,000. The options exercised were granted under the 2015 Plan and, accordingly, there will not be any income tax effect in the condensed consolidated financial statements for the three months ended June 30, 2019. On May 1, 2019, 200,000 non-qualified stock options were exercised for cash payments of $14,000. The options were granted under the 2015 Plan and, accordingly, there will not be any income tax effect in the condensed consolidated financial statements for the three months ended June 30, 2019.

 

On May 3, 2019, the Company’s radiological services team was involved in a contamination event at an off-site location in the state of Washington. The Company is currently supporting clean-up operations at that location and is in discussions with regulatory agencies regarding any possible violations that may have occurred. The Company has reported this incident to its insurance carrier and a claim is being processed to address the cost of recovery operations. The Company believes any costs associated with this event will be covered by insurance. At this time, the total cost of recovery is unknown, and it is not known whether the Company will be cited by the regulator for any violations related to this event. If the clean-up efforts in connection with this event are not covered by insurance, the clean-up costs, together with any regulatory fines, would have a material adverse effect on the Company’s financial statements.
XML 31 R19.htm IDEA: XBRL DOCUMENT v3.19.1
Accounting Policies (Policies)
 3 Months Ended
Mar. 31, 2019
Accounting Policies [Abstract]  
Principles of Consolidation

Principles of Consolidation – The accompanying unaudited condensed consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (GAAP) and include all operations and balances of INIS and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. See Note 4. “Investment and Business Consolidation” for additional information regarding the consolidation of RadQual.

 
Interim Financial Information

Interim Financial Information – The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, all adjustments and reclassifications considered necessary in order to make the financial statements not misleading and for a fair and comparable presentation have been included and are of a normal recurring nature. Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC on March 22, 2019.

 
Recent Accounting Pronouncements

Recent Accounting Pronouncements – In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updated ASU 2016-02, “Leases”, which was issued to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The amendments in ASU 2016-02 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Results for reporting periods beginning January 1, 2019 are presented in accordance with Topic 842, while prior-period amounts have not been retrospectively adjusted and continue to be reported in accordance with Topic 840, Leases. Based upon the Company’s leases, the Company was not required to make an adjustment to the opening balance of retained earnings as of January 1, 2019. See Note 10, “Leases” for further discussion.

 

In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which expands the scope of Topic 718 to include all share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 specifies that Topic 718 applies to all share-based payment transactions in which the grantor acquires goods and services to be used or consumed in its own operations by issuing share-based payment awards. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under ASC 606. The amendments in ASU 2018-07 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted this standard effective January 1, 2019, and there was no material impact on the financial statements.

 
XML 32 R20.htm IDEA: XBRL DOCUMENT v3.19.1
Net Income (Loss) Per Common Share - Basic and Diluted (Tables)
 3 Months Ended
Mar. 31, 2019
Earnings Per Share [Abstract]  
Schedule of Common Stock Equivalents
    March 31,  
    2019     2018  
Stock options     27,205,000       31,850,000  
Warrants     20,090,000       45,090,000  
850 Shares of Series B redeemable convertible preferred stock     425,000       425,000  
4,213 Shares of Series C redeemable convertible preferred stock     42,130,000       42,130,000  
      89,850,000       119,495,000  
XML 33 R21.htm IDEA: XBRL DOCUMENT v3.19.1
Inventories (Tables)
 3 Months Ended
Mar. 31, 2019
Inventory Disclosure [Abstract]  
Schedule of Inventory, Current
    March 31, 2019     December 31, 2018  
Raw materials   $ 42,911     $ 42,911  
Work in process     3,041,387       2,719,786  
Finished goods     1,828       3,032  
    $ 3,086,126     $ 2,765,729  
XML 34 R22.htm IDEA: XBRL DOCUMENT v3.19.1
Stockholders' Equity, Options and Warrants (Tables)
 3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
Schedule of Share-Based Compensation Stock Option Activity
Fixed Options   Shares     Weighted Average Exercise Price     Weighted Average Remaining Contractual Life     Aggregate Intrinsic Value  
Outstanding at December 31, 2018     27,805,000     $ 0.06                  
Granted     —                            
Exercised     —                            
Expired     —                            
Forfeited     (600,000 )   $ 0.04                  
Outstanding at March 31, 2019     27,205,000     $ 0.05       5.9     $ 332,500  
Exerciseable at March 31, 2019     19,301,000     $ 0.05       4.9     $ 332,500  
XML 35 R23.htm IDEA: XBRL DOCUMENT v3.19.1
Revenue Recognition (Tables)
 3 Months Ended
Mar. 31, 2019
Revenue from Contract with Customer [Abstract]  
Summary of Sales from Contracts with Customers Disaggregated by Business Segment and Geography
    Three Months Ended March 31, 2019     Three Months Ended March 31, 2018  
    U.S.     Outside U.S.     Total Revenues     % of Total Revenues     U.S.     Outside U.S.     Total Revenues     % of Total Revenues  
Radiochemical Products   $ 459,967     $ 3,265     $ 463,232       18 %   $ 528,917     $ 54,924     $ 583,841       21 %
Cobalt Products     336,089       40,000       376,089       15 %     327,778       —         327,778       12 %
Nuclear Medicine Products     1,080,472       20,450       1,100,922       44 %     997,733       4,380       1,002,113       35 %
Radiological Services     587,609       —         587,609       23 %     139,172       748,422       887,594       32 %
Fluorine Products     —         —         —         0 %     —         —         —         0 %
    $ 2,464,137     $ 63,715     $ 2,527,852       100 %   $ 1,993,600     $ 807,726     $ 2,801,326       100 %
XML 36 R24.htm IDEA: XBRL DOCUMENT v3.19.1
Leases (Tables)
 3 Months Ended
Mar. 31, 2019
Leases [Abstract]  
Schedule of Lease Expense
    Three Months Ended  
    March 31, 2019  
Operating lease costs   $ 36,853  
Short-term operating lease costs   $ 1,902  
Operating cash flows from operating leases   $ (38,755 )
Right-of-use assets obtained in exchange for new operating lease liabilities   $ 810,367  
Weighted-average remaining lease term (years) - operating leases     7  
Weighted-average discount rate - operating leases     6.75 %
Schedule of Future Minimum Payments under Operating Lease Agreements
2019 (excluding the three months ended March 31, 2019)   $ 110,560  
2020     145,563  
2021     136,313  
2022     136,313  
2023     136,313  
Thereafter     318,063  
   Total minimum operating lease obligations     983,125  
Less-amounts representing interest     (200,676 )
   Present value of minimum operating lease obligations     782,449  
Current maturities     (97,580 )
Lease obligations, net of current maturities   $ 684,869  
XML 37 R25.htm IDEA: XBRL DOCUMENT v3.19.1
Segment Information (Tables)
 3 Months Ended
Mar. 31, 2019
Segment Reporting [Abstract]  
Schedule of Segment Reporting Information by Segment

    Three months ended March 31,  
Sale of Product   2019     2018  
Radiochemical Products   $ 463,232     $ 583,541  
Cobalt Products     376,089       327,778  
Nuclear Medicine Standards     1,100,922       1,002,113  
Radiological Services     587,609       887,594  
Fluorine Products     —         —    
Total Segments     2,527,852       2,801,026  
Corporate revenue     —         —    
Total Consolidated   $ 2,527,852     $ 2,801,026  

 

    Three months ended March 31,  
Depreciation and Amortization   2019     2018  
Radiochemical Products   $ 8,817     $ 5,014  
Cobalt Products     1,080       4,043  
Nuclear Medicine Standards     15,619       17,938  
Radiological Services     8,636       12,039  
Fluorine Products     26,095       26,095  
Total Segments     60,248       65,130  
Corporate depreciation and amortization     4,737       4,844  
Total Consolidated   $ 64,985     $ 69,974  

 

    Three months ended March 31,  
Segment Income (Loss)   2019     2018  
Radiochemical Products   $ 96,006     $ 40,520  
Cobalt Products     192,870       184,792  
Nuclear Medicine Standards     216,822       223,942  
Radiological Services     311,279       402,012  
Fluorine Products     (37,495 )     (31,299 )
Total Segments     779,481       819,966  
Corporate loss     (831,439 )     (785,562 )
Net Income (Loss)   $ (51,958 )   $ 34,404  

 

    Three months ended March 31,  
Expenditures for Segment Assets   2019     2018  
Radiochemical Products   $ —       $ —    
Cobalt Products     3,494       —    
Nuclear Medicine Standards     —         18,148  
Radiological Services     —         —    
Fluorine Products     1,590       1,560  
Total Segments     5,084       19,708  
Corporate purchases     —         —    
Total Consolidated   $ 5,084     $ 19,708  

 

    March 31,     December 31,  
Segment Assets   2019     2018  
Radiochemical Products   $ 287,605     $ 344,994  
Cobalt Products     3,095,941       2,611,939  
Nuclear Medicine Standards     2,200,139       2,113,960  
Radiological Services     535,829       281,077  
Fluorine Products     5,563,206       5,590,053  
Total Segments     11,682,720       10,942,023  
Corporate assets     2,416,416       2,048,053  
Total Consolidated   $ 14,099,136     $ 12,990,076  
XML 38 R26.htm IDEA: XBRL DOCUMENT v3.19.1
The Company and Basis of Presentation (Details Narrative)
Mar. 31, 2019
Dec. 31, 2017
TI Services, LLC    
Ownership interest, percentage by parent 50.00%  
RadQual, LLC    
Ownership interest, percentage by parent 24.50%  
RadQual, LLC | Affiliates of the Company    
Ownership interest, percentage by parent   75.50%
XML 39 R27.htm IDEA: XBRL DOCUMENT v3.19.1
Current Developments and Liquidity (Details Narrative) - USD ($)
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Net (loss) income attributable to International Isotopes Inc. $ (51,958) $ 34,404
Net cash (used in) provided by operating activities $ (420,576) $ 127,840
Operating license term, description NRC license for the de-conversion facility for a 40 year operating license.  
XML 40 R28.htm IDEA: XBRL DOCUMENT v3.19.1
Net Income (Loss) Per Common Share - Basic and Diluted - Schedule of Common Stock Equivalents (Details) - shares
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
Stock options, outstanding 27,205,000 31,850,000 27,805,000
Warrants, outstanding 20,090,000 45,090,000  
Weighted average shares outstanding 89,850,000 119,495,000  
Series B Convertible Redeemable Preferred Stock      
Redeemable convertible preferred stock, outstanding 850 850  
Weighted average shares outstanding 425,000 425,000  
Series C Redeemable Convertible Preferred Stock      
Redeemable convertible preferred stock, outstanding 4,213 4,213  
Weighted average shares outstanding 42,130,000 42,130,000  
XML 41 R29.htm IDEA: XBRL DOCUMENT v3.19.1
Net Income (Loss) Per Common Share - Basic and Diluted (Details Narrative) - shares
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Series B Convertible Redeemable Preferred Stock    
Stock equivalents excluded from the computation of diluted net loss per common share 850 850
Series C Redeemable Convertible Preferred Stock    
Stock equivalents excluded from the computation of diluted net loss per common share 4,213 4,213
Stock Options    
Stock equivalents excluded from the computation of diluted net loss per common share 27,205,000 31,850,000
Warrants    
Stock equivalents excluded from the computation of diluted net loss per common share 20,090,000 45,090,000
XML 42 R30.htm IDEA: XBRL DOCUMENT v3.19.1
Investment and Business Consolidation (Details Narrative) - RadQual, LLC
Mar. 31, 2019
Dec. 31, 2017
Ownership interest, percentage by parent 24.50%  
Affiliates of the Company    
Ownership interest, percentage by parent   75.50%
XML 43 R31.htm IDEA: XBRL DOCUMENT v3.19.1
Inventories - Schedule of Inventory, Current (Details) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Inventory, Net, Items Net of Reserve    
Raw materials $ 42,911 $ 42,911
Work in process 3,041,387 2,719,786
Finished goods 1,828 3,032
Total inventory $ 3,086,126 $ 2,765,729
XML 44 R32.htm IDEA: XBRL DOCUMENT v3.19.1
Inventories (Details Narrative) - USD ($)
 3 Months Ended
Mar. 31, 2019
Dec. 31, 2018
Inventory, Work in Process and Raw Materials    
Inventory, cobalt-60 isotopes, carrying value $ 403,076 $ 389,293
Approximate revenue from contract with customer $ 94,000  
XML 45 R33.htm IDEA: XBRL DOCUMENT v3.19.1
Shareholders' Equity, Options and Warrants - Schedule of Stock Option Activity (Details)
 3 Months Ended
Mar. 31, 2019
USD ($)
$ / shares
shares
Share-Based Compensation Arrangement By Share-Based Payment Award Options Outstanding  
Stock options outstanding, beginning of period | shares 27,805,000
Stock options, granted | shares
Stock options, exercised | shares
Stock options, expired | shares
Stock options, forfeited | shares (600,000)
Stock options outstanding, end of period | shares 27,205,000
Stock options exercisable, end of period | shares 19,301,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price  
Weighted average exercise price outstanding, beginning of period | $ / shares $ 0.06
Weighted average exercise price, granted | $ / shares
Weighted average exercise price, exercised | $ / shares
Weighted average exercise priced, expired | $ / shares
Weighted average exercise priced, forfeited | $ / shares 0.04
Weighted average exercise price outstanding, end of period | $ / shares 0.05
Weighted average exercise price exercisable, end of period | $ / shares $ 0.05
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures  
Weighted average remaining contractual life outstanding, end of period 5 years 11 months
Weighted average remaining contractual life exercisable, end of period 4 years 11 months
Average intrinsic value outstanding, end of period | $ $ 332,500
Average intrinsic value, exercisable, end of period | $ $ 332,500
XML 46 R34.htm IDEA: XBRL DOCUMENT v3.19.1
Shareholders' Equity, Options and Warrants - Employee Stock Purchase Plan (Details Narrative) - USD ($)
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]    
Proceeds from issuance of shares during the period $ 1,581 $ 1,527
Employee Stock Purchase Plan    
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]    
Number of shares available for issuance 543,312  
Shares issued during period 31,618 21,811
Proceeds from issuance of shares during the period $ 1,581 $ 1,527
XML 47 R35.htm IDEA: XBRL DOCUMENT v3.19.1
Shareholders' Equity, Options and Warrants - Stock-Based Compensation Plans (Details Narrative) - USD ($)
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
Warrants outstanding 20,090,000 45,090,000  
Mandatorily redeemable convertible preferred stock $ 4,688,835   $ 4,656,752
Dividends paid 252,780 $ 241,730  
Unrecognized compensation expense $ 118,884    
Weighted average period 1 year 10 months    
Recognized compensation expense $ 63,737 $ 73,704  
Share price $ 0.06    
Series B Convertible Redeemable Preferred Stock      
Preferred stock outstanding 850 850  
Redemption date May 31, 2022    
Redemption price per share $ 1,000    
Mandatorily redeemable convertible preferred stock $ 850,000    
Number of warrants convertible into shares 425,000    
Number of warrants convertible into shares, price per share $ 2.00    
Series C Redeemable Convertible Preferred Stock      
Preferred stock outstanding 4,213 4,213  
Redemption date Feb. 28, 2022    
Redemption price per share $ 1,000    
Preferred stock dividend rate 6.00%    
Conversion price per share $ 0.10    
Value of shares issued in lieu of dividend payment $ 205,980 $ 205,980  
Preferred stock dividend, settlement in cash $ 46,800 $ 35,750  
Common stock issued in lieu of dividend 3,433,000 2,288,646  
Class M Warrants      
Warrants outstanding 17,165,000 17,165,000  
Exercise price of warrants $ 0.12 $ 0.12  
Maturity date of warrants Feb. 17, 2022 Feb. 17, 2022  
Class N Warrants      
Warrants outstanding 2,925,000 2,925,000  
Exercise price of warrants $ 0.10 $ 0.10  
Maturity date of warrants May 12, 2022 May 12, 2022  
Class L Warrants      
Warrants outstanding   25,000,000  
Exercise price of warrants   $ 0.06  
Maturity date of warrants   Dec. 23, 2018  
Warrants expired 25,000,000    
2015 Incentive Plan      
Number of shares authorized [1] 80,000,000    
Shares available for issuance 33,712,718    
2015 Incentive Plan | Chief Executive Officer      
Shares issued 466,667    
Shares issued, value $ 28,000    
Net shares issued 279,767    
Shares issued, price per share $ 0.06    
Shares withheld to satisfy payroll tax liabilities 186,900    
Compensation expense $ 16,786    
2006 Equity Incentive Plan      
Number of shares authorized 11,089,967    
[1] In July 2018, the Plan was amended and restated to increase the number of shares authorized for issuance by an additional 20,000,000.
XML 48 R36.htm IDEA: XBRL DOCUMENT v3.19.1
Debt (Details Narrative) - USD ($)
 1 Months Ended 3 Months Ended 12 Months Ended
Apr. 30, 2019
Mar. 31, 2019
Mar. 31, 2016
Dec. 31, 2018
Dec. 31, 2017
Dec. 31, 2016
Dec. 31, 2014
Dec. 31, 2013
RadQual, LLC                
Interest rate   6.00%            
Maturity date   Jul. 31, 2019            
Proceeds from short term debt   $ 185,474            
Chairman of the Board of Directors | Promissory Note                
Accrued interest   $ 4,867            
Note payable, related party, interest rate         5.00%      
Note payable, related party, maturity date   Jul. 31, 2019   Mar. 31, 2019 Jun. 30, 2018      
Promissory note         $ 60,000      
Chairman of the Board of Directors | Subsequent Event | Promissory Note                
Accrued interest paid $ 65,367              
Chief Executive Officer and Chairman of the Board                
Accrued interest   $ 7,020            
Note payable, related party, interest rate       6.00%        
Note payable, related party, maturity date   Jul. 31, 2019   Mar. 31, 2019        
Promissory note       $ 120,000        
Notes Payable | Vehicle                
Interest rate     6.66%          
Maturity date     Apr. 01, 2022          
Note payable     $ 47,513          
Note payable, monthly payments     $ 805          
Notes Payable | Former Chairman of the Board                
Warrant exercise price             $ 0.06 $ 0.06
Warrants issued             15,000,000 10,000,000
Warrants expired       25,000,000        
Debt instrument, description           The due date of the $500,000 note was extended to December 31, 2020, with all other terms of the note remaining unchanged. The due date of the $500,000 note was extended to December 31, 2017.  
Note payable, related party   $ 500,000           $ 500,000
Accrued interest   159,234            
Note payable, related party, interest rate               6.00%
Note payable, related party, maturity date           Dec. 31, 2022 Dec. 31, 2017 Jun. 30, 2014
Interest expense   $ 7,500            
XML 49 R37.htm IDEA: XBRL DOCUMENT v3.19.1
Commitments and Contingencies (Detail Narrative)
 3 Months Ended
Mar. 31, 2019
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
Restricted cash $ 625,845
Other commitments, description In August 2011, the Company received land from Lea County, New Mexico, pursuant to a Project Participation Agreement (PPA), whereby the land was deeded to the Company for no monetary consideration. In return, we committed to construct a uranium de-conversion and Fluorine Extraction Process (FEP) facility on the land. In order to retain title to the property, we were to begin construction of the de-conversion facility no later than December 31, 2014, and complete Phase I of the project and have hired at least 75 persons to operate the facility no later than December 31, 2015, although commercial operations need not have begun by that date. In 2015, the Company negotiated a modification to the PPA agreement that extended the start of construction date to December 31, 2015, and the hiring milestone to December 31, 2016. Those dates were not met and the Company is currently in the process of renegotiating a second modification to the agreement to further extend those dates. If the Company is not successful in extending the performance dates in the agreement then it may, at its sole option, either purchase or re-convey the property to Lea County, New Mexico. The purchase price of the property would be $776,078, plus interest at the annual rate of 5.25% from the date of the closing to the date of payment. The Company has not recorded the value of this property as an asset and will not do so until such time that sufficient progress on the project has been made to meet our obligations under the agreements for permanent transfer of the title.
Long-term purchase commitment, description In October 2014, the Company signed a ten-year contract with the DOE for the irradiation of cobalt targets for the production of cobalt-60. The Company will be able to purchase cobalt targets for a fixed price per target with an annual 5% escalation in price. The contract term is October 1, 2014, through September 30, 2024, however, the contract may be extended beyond that date. Also, the DOE may end the contract if it determines termination is necessary for the national defense, security or environmental safety of the United States. If this were to occur, all payments made by the Company, for partially irradiated undelivered cobalt material, would be refunded.
XML 50 R38.htm IDEA: XBRL DOCUMENT v3.19.1
Revenue Recognition - Summary of Sales from Contracts with Customers by Business Segment and Geography (Details) - USD ($)
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Disaggregation of Revenue [Line Items]    
Total revenues $ 2,527,852 $ 2,801,326
Percent of total revenues 100.00% 100.00%
U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues $ 2,464,137 $ 1,993,600
Outside U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues 63,715 807,726
Radiochemical Products    
Disaggregation of Revenue [Line Items]    
Total revenues $ 463,232 $ 583,841
Percent of total revenues 18.00% 21.00%
Radiochemical Products | U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues $ 459,967 $ 528,917
Radiochemical Products | Outside U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues 3,265 54,924
Cobalt Products    
Disaggregation of Revenue [Line Items]    
Total revenues $ 376,089 $ 327,778
Percent of total revenues 15.00% 12.00%
Cobalt Products | U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues $ 336,089 $ 327,778
Cobalt Products | Outside U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues 40,000
Nuclear Medicine Products    
Disaggregation of Revenue [Line Items]    
Total revenues $ 1,100,922 $ 1,002,113
Percent of total revenues 44.00% 35.00%
Nuclear Medicine Products | U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues $ 1,080,472 $ 997,733
Nuclear Medicine Products | Outside U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues 20,450 4,380
Radiological Services    
Disaggregation of Revenue [Line Items]    
Total revenues $ 587,609 $ 887,594
Percent of total revenues 23.00% 32.00%
Radiological Services | U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues $ 587,609 $ 139,172
Radiological Services | Outside U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues 748,422
Fluorine Products    
Disaggregation of Revenue [Line Items]    
Total revenues $ 0 $ 0
Percent of total revenues 0.00% 0.00%
Fluorine Products | U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues $ 0 $ 0
Fluorine Products | Outside U.S.    
Disaggregation of Revenue [Line Items]    
Total revenues $ 0 $ 0
XML 51 R39.htm IDEA: XBRL DOCUMENT v3.19.1
Revenue Recognition (Details Narrative) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Unearned revenue, current $ 3,736,310 $ 3,783,541
Unearned revenue, noncurrent 7,500 7,500
Accounts receivable 1,356,924 820,370
Cobalt Products    
Unearned revenue, current 3,736,310 3,783,541
Unearned revenue, noncurrent $ 7,500 $ 7,500
XML 52 R40.htm IDEA: XBRL DOCUMENT v3.19.1
Leases - Schedule of Lease Expense (Details)
 3 Months Ended
Mar. 31, 2019
USD ($)
Leases [Abstract]  
Operating lease costs $ 36,853
Short-term operating lease costs 1,902
Operating cash flows from operating leases (38,755)
Right-of-use assets obtained in exchange for new operating lease liabilities $ 810,367
Weighted-average remaining lease term (years) - operating leases 7 years
Weighted-average discount rate - operating leases 6.75%
XML 53 R41.htm IDEA: XBRL DOCUMENT v3.19.1
Leases - Schedule of Future Minimum Payments under Operating Lease Agreements (Details)
Mar. 31, 2019
USD ($)
Leases [Abstract]  
2019 (excluding the three months ended March 31, 2019) $ 110,560
2020 145,563
2021 136,313
2022 136,313
2023 136,313
Thereafter 318,063
Total minimum operating lease obligations 983,125
Less-amounts representing interest (200,676)
Present value of minimum operating lease obligations 782,449
Current maturities (97,580)
Lease obligations, net of current maturities $ 684,869
XML 54 R42.htm IDEA: XBRL DOCUMENT v3.19.1
Leases (Details Narrative)
Mar. 31, 2019
USD ($)
Cumulative-effect adjustment as a right-of-use asset and an operating lease liability $ 782,449
Accounting Standards Update 2016-02  
Cumulative-effect adjustment as a right-of-use asset and an operating lease liability $ 810,367
XML 55 R43.htm IDEA: XBRL DOCUMENT v3.19.1
Segment Information - Schedule of Segment Reporting Information by Segment (Details) - USD ($)
 3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
Segment Reporting Information [Line Items]      
Sale of Product $ 2,527,852 $ 2,801,026  
Depreciation and Amortization 64,985 69,974  
Segment Income (Loss) (51,958) 34,404  
Expenditures for Segment Assets 5,084 19,708  
Segment Assets 14,115,760   $ 12,990,076
Operating Segments      
Segment Reporting Information [Line Items]      
Sale of Product 2,527,852 2,801,026  
Depreciation and Amortization 60,248 65,130  
Segment Income (Loss) 779,481 819,966  
Expenditures for Segment Assets 5,084 19,708  
Segment Assets 11,682,720   10,942,023
Operating Segments | Radiochemical Products      
Segment Reporting Information [Line Items]      
Sale of Product 463,232 583,541  
Depreciation and Amortization 8,817 5,014  
Segment Income (Loss) 96,006 40,520  
Expenditures for Segment Assets  
Segment Assets 287,605   344,994
Operating Segments | Cobalt Products      
Segment Reporting Information [Line Items]      
Sale of Product 376,089 327,778  
Depreciation and Amortization 1,080 4,043  
Segment Income (Loss) 192,870 184,792  
Expenditures for Segment Assets 3,494  
Segment Assets 3,095,941   2,611,939
Operating Segments | Nuclear Medicine Standards      
Segment Reporting Information [Line Items]      
Sale of Product 1,100,922 1,002,113  
Depreciation and Amortization 15,619 17,938  
Segment Income (Loss) 216,822 223,942  
Expenditures for Segment Assets 18,148  
Segment Assets 2,200,139   2,113,960
Operating Segments | Radiological Services      
Segment Reporting Information [Line Items]      
Sale of Product 587,609 887,594  
Depreciation and Amortization 8,636 12,039  
Segment Income (Loss) 311,279 402,012  
Expenditures for Segment Assets  
Segment Assets 535,829   281,077
Operating Segments | Fluorine Products      
Segment Reporting Information [Line Items]      
Sale of Product  
Depreciation and Amortization 26,095 26,095  
Segment Income (Loss) (37,495) (31,299)  
Expenditures for Segment Assets 1,590 1,560  
Segment Assets 5,563,206   5,590,053
Corporate Allocation      
Segment Reporting Information [Line Items]      
Sale of Product  
Depreciation and Amortization 4,737 4,844  
Segment Income (Loss) (831,439) (785,562)  
Expenditures for Segment Assets  
Segment Assets $ 2,416,416   $ 2,048,053
XML 56 R44.htm IDEA: XBRL DOCUMENT v3.19.1
Segment Information (Details Narrative)
 3 Months Ended
Mar. 31, 2019
Integer
Segment Reporting [Abstract]  
Number of reportable segments 5
XML 57 R45.htm IDEA: XBRL DOCUMENT v3.19.1
Subsequent Events (Details Narrative) - USD ($)
 1 Months Ended 3 Months Ended
May 13, 2019
Apr. 30, 2019
Mar. 31, 2019
Subsequent Event [Line Items]      
Stock options exercised    
Subsequent Event | 2015 Incentive Plan | Qualified Stock Options      
Subsequent Event [Line Items]      
Stock options exercised   1,500,000  
Shares withheld to satisfy the exercise price   875,000  
Net shares issued   625,000  
Subsequent Event | 2015 Incentive Plan | Non-Qualified Stock Options      
Subsequent Event [Line Items]      
Stock options exercised 200,000 2,000,000  
Proceeds from exercise of stock options $ 14,000 $ 70,000  
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