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
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 p r ovisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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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. ☐
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Item 1 .01 |
Entry into a Material Definitive Agreement . |
On May 28, 2019, Isoray Medical, Inc. (“Medical”), a wholly owned subsidiary of Isoray, Inc., entered into an Amendment to Exhibit B (the “Amendment”) of its Amended and Restated Manufacturing and Supply Agreement (“Supply Agreement”) with GT Medical Technologies, Inc., a Delaware corporation (“GT Tech”), originally dated April 26, 2019. Pursuant to the Supply Agreement, Medical manufactures and supplies a brachytherapy product that incorporates Cesium-131 seeds within customizable carriers for the treatment of brain tumors (the “GammaTile ™ Product”) for end users designated by GT Tech. Additionally, Medical supplies loose or braided Cesium-131 seeds for brachytherapy brain cancer treatment to GT Tech on a non-exclusive basis. The Amendment modifies the prices to be paid by GT Tech for material, labor, overhead, and Cesium-131 seeds used in the GammaTile ™ Product, and separately specifies pricing for additional services.
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Item 9 .01 |
Financial Statements and Exhibits. |
(d) Exhibits
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10.1 |
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: May 28, 2019
Isoray, Inc., a Delaware corporation
By: /s/ Jonathan Hunt
Jonathan Hunt, CFO
Exhibit 10.1
Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
AMENDMENT TO EXHIBIT B OF MANUFACTURING AND SUPPLY AGREEMENT
IsoRay Medical, Inc., a Delaware corporation with offices at 350 Hills Street, Suite 106, Richland, WA 99352 (“IsoRay”), and GT Medical Technologies, Inc., a Delaware corporation having its principal place of business at 1809 S. Holbrook Lane, Suite 107, Tempe, AZ 85281 (“GT Med Tech”), previously entered into an Amended and Restated Manufacturing and Supply Agreement dated April 26, 2019 (the “Agreement”). The parties now desire to modify the pricing of Exhibit B of the Agreement as outlined on the attached page.
In witness whereof, the parties have caused their respective authorized representatives to execute this Amendment to Exhibit B of the Manufacturing and Supply Agreement as of May 28, 2019 (“the Effective Date”).
| GT Medical Technologies, Inc. | IsoRay Medical, Inc. | |||
| By: /s/ Hernan Lopez | By: /s/ Jonathan Hunt | |||
| Name: Hernan Lopez | Name: Jonathan Hunt | |||
| Title: Vice President of Operations | Title: Chief Financial Officer | |||
Exhibit B
Open-Book Pricing Formula & Pricing Schedule
Open-Book Pricing Formula for GammaTile TM 3-pack Product
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Description |
Price |
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Materials (excluding Duragen) |
$110.37 |
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Labor |
[**] |
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50% Profit Margin |
[**] |
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Seeds (high activity 3.5U Cesium-131 source – assumes 4 seeds per GammaTile TM ) |
[**] |
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Overhead* |
[**] |
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Total price of each GammaTile TM 3-pack Product |
[**] |
Open-Book Pricing Formula for GammaTile TM 6 -pack Product
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Description |
Price |
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Materials (excluding Duragen) |
$135.24 |
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Labor |
[**] |
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50% Profit Margin |
[**] |
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Seeds (high activity 3.5U Cesium-131 source – assumes 4 seeds per GammaTile TM ) |
[**] |
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Overhead* |
[**] |
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Total price of each GammaTile TM 6-pack Product |
[**] |
Open-Book Pricing Formula for Duragen Validation
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Description |
Price |
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Materials (excluding Duragen) |
$28.62 |
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Labor |
[**] |
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50% Profit Margin |
[**] |
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Simulation Seeds |
[**] |
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Overhead |
[**] |
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Total price of each Duragen Validation |
[**] |
Pass-Through Costs
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Sterilization: Sterilization costs shall be billed either directly to GT Med Tech or invoiced as a separate line item as a pass-through cost by IsoRay. No mark-up to sterilization or other pass-through costs for the Product will be assessed by IsoRay. |
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● |
Bacterial Endotoxin Testing: Bacterial Endotoxin Testing (“BET”) costs shall be billed either directly to GT Med Tech or invoiced as a separate line item as a pass-through cost by IsoRay. No mark-up to BET or other pass-through costs for the Product will be assessed by IsoRay. |
*The Overhead charge is to compensate Isoray for assistance with facility radioactive materials licenses, customer support activities, quality assurance and regulatory assurance including upkeep of supplier qualifications (not including site visits or audits), risk assessments, and compliance maintenance, and general administration associated with the pass-through costs.