United States

Securities And Exchange Commission
Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT Pursuant to

Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): October 16, 2020

 

Isoray, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

001-33407
(Commission
File Number)

41-1458152
(IRS Employer
Identification No.)

 

350 Hills Street, Suite 106, Richland, Washington 99354

(Address of Principal Executive Offices) (Zip Code)

 

(509) 375-1202

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

☐ 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

 

 

☐ 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

 

 

☐ 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

 

 

☐ 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value

ISR

NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company ☐

 

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

 

 
 

 

Item 1.01     Entry into a Material Definitive Agreement.

 

On October 16, 2020, Isoray Medical, Inc. (“Medical”), a wholly owned subsidiary of Isoray, Inc., entered into an Amendment to Amended and Restated Manufacturing and Supply Agreement (the “Amendment”) with GT Medical Technologies, Inc., a Delaware corporation (“GT Tech”).

 

The Amendment amends and restates in its entirety the exclusivity provision of the Amended and Restated Manufacturing and Supply Agreement dated April 26, 2019 (the “Original Agreement”) to provide that Medical will supply Seeds (as defined in the Original Agreement) exclusively to GT Tech for use in the Product (as defined in the Original Agreement) in application of brachytherapy in brain cancer and will not sell Seeds to any other person or entity for brachytherapy in brain tumors, except that Medical may continue to manufacture and supply Seeds, braided strands of Seeds, and other Seed-containing materials or products, other than the Product, for brain cancer treatment directly to end-users. The Amendment also provides that GT Tech will purchase Seeds for application of brachytherapy in brain cancer exclusively from Medical.

 

The Amendment is filed as Exhibit 10.1 to this Current Report on Form 8-K, and the description of the Amendment is qualified in its entirety by reference to such exhibit.

 

Item 9.01     Financial Statements and Exhibits.

 

(d)     Exhibits

 

 

10.1

Amendment to Amended and Restated Manufacturing and Supply Agreement between Isoray Medical, Inc. and GT Medical Technologies, Inc., dated October 16, 2020.

 

 
 

 

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 hereunto duly authorized.

 

Dated: October 16, 2020

 

Isoray, Inc., a Delaware corporation

 

 

By: /s/ Lori A. Woods                                                     

       Lori A. Woods, CEO

 

 

 

Exhibit 10.1

 

AMENDMENT TO AMENDED & RESTATED

MANUFACTURING & SUPPLY AGREEMENT

 

This Amendment to the Amended and Restated Manufacturing and Supply Agreement ("Amendment") is made and entered this 16th day of October 2020 ("Effective Date") by and between Isoray Medical, Inc. ("lsoray") and GT Medical Technologies, Inc. ("GT MED TECH").

 

WHEREAS, Isoray and GT MED TECH entered into a Manufacturing and Supply Agreement, dated January 3, 2018 and later amended and restated such Agreement effective April 26, 2019 for the manufacture and supply of certain brachytherapy product incorporating Isoray's Cesium-131 sources for use and/or sale for the treatment of certain tumors ("Restated Agreement");

 

WHEREAS, as permitted under the Restated Agreement, Isoray and GT MED TECH wish to further amend the Restated Agreement as set forth below.

 

NOW, THEREFORE, in consideration of the covenants contained in this Amendment and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Isoray and GT MED TECH agree as follows:

 

1. Continued Validity. All terms used in this Amendment and denoted by their initial capitalization shall have the meanings set forth in the Restated Agreement unless otherwise defined herein. Except as expressly amended by this Amendment, the Restated Agreement will remain in effect in accordance with its terms and conditions.

 

2. Exclusivity. Isoray and GT MED TECH agree to delete and replace in its entirety Section 2: Exclusivity of the Restated Agreement with the following text:

 

For the Term of this Agreement, (a) Isoray shall supply exclusively to GT MED TECH the Seeds as used for the Product in application of brachytherapy in brain cancer and shall not sell or otherwise provide Cs 131 seeds to any person or entity (other than GT MED TECH) for brachytherapy in brain tumors, except that Isoray may continue to manufacture and supply individual Seeds, braided strands of Seeds, or other Seed-containing materials or products other than the Product, for brain cancer treatment directly to end-users; and, (b) GT MED TECH shall purchase Seeds for application of brachytherapy in brain cancer exclusively from Isoray.

 

3. Counterparts; Execution. This Amendment may be executed in multiple counterparts, each of which shall constitute an original and all of which shall constitute the same document. This Amendment may be signed electronically or by hand, and signed copies may be delivered to the other Party by electronic means, such as facsimile or electronic mail in Aodobe Portable Format (.pdf) or similar format. All signatures made by a Party and transmitted by such means will be deemed original signatures.

 

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IN WITNESS WHEREOF, Isoray and GT MED TECH, by the signatures of their duly authorized representatives, have caused this Amendment to be effective as of the Effective Date set forth above.

 

Isoray Medical, Inc.     GT Medical Technologies, Inc.
     
/s/ Lori A. Woods                                                                                                   October 16, 2020   /s/ Matthew E. Likens                                                                                                   October 16, 2020

Signature                                                                                                                           Date

 

Signature                                                                                                                                  Date

     

Lori A. Woods

 

Matthew E. Likens

Name (Please Print)

 

Name (Please Print)

     

CEO

 

President & CEO

Title

 

Title

 

 

 

 

 

 

,,

 

 

 

 

 

 

 

 

Signature Page for the Amendment to

 

Amended & Restated Manufacturing & Supply Agreement

 

 

 

 

 

 

 

 

 

 

 

 

 

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