Amendment to Exhibit A and Amendment No. 2 to Exhibit B of Amended and Restated Manufacturing and Supply Agreement, dated effective January 13, 2020, between Isoray Medical, Inc. and GT Medical Technologies, Inc. (confidential portions of the exhibit have been omitted)

EX-10.1 2 ex_169510.htm EXHIBIT 10.1 ex_169510.htm

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 A AND AMENDMENT NO. 2 TO EXHIBIT B OF AMENDED AND RESTATED 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 and an Amendment to Exhibit B of the Manufacturing and Supply Agreement dated May 28, 2019 (collectively the “Agreement”). The parties now desire to modify the Product Specifications of Exhibit A and 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 Exhibits A and B of the Manufacturing and Supply Agreement as of January 13, 2020 (“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 A

Specifications

A single GammaTile^TM unit is comprised of four Cesium-131 radioactive seeds loaded into a Vicryl® (polyglactin 910) strand and embedded in collagen matrix material.

GT-01 through GT-06: A GammaTile^TM Pack is comprised of between one and six GammaTile^TM units (as appropriate per the product code), all contained in one outer pouch for aseptic presentation, labeled and sterilized.

GT-07 through GT-12: Two GammaTile^TM packs (GT-01 through GT-06) contained in one shipping carton, with one confirmation assay and certificate of conformance per shipping carton.

GT-13 through GT-18: A GammaTile^TM 12 Pack in one shipping carton and a GT-01 through GT-06 in a second shipping carton.

GT-19 through GT-24: A GammaTile^TM 12 Pack in one shipping carton and a GT-07 through GT-12 in a second shipping carton.

Exhibit B

Open-Book Pricing Formula & Pricing Schedule

Open-Book Pricing Formula for GammaTile^TM

No. of Tiles / Item Code	Materials	Labor	50% Profit Margin	Seeds (high activity 3.5U Cesium-131 source – assumes 4 seeds per GammaTile^TM)	Overhead*	Total Price
GT-01	$134.25	[**]	[**]	[**]	[**]	[**]
GT-02	$134.25	[**]	[**]	[**]	[**]	[**]
GT-03	$134.25	[**]	[**]	[**]	[**]	[**]
GT-04	$134.25	[**]	[**]	[**]	[**]	[**]
GT-05	$134.25	[**]	[**]	[**]	[**]	[**]
GT-06	$134.25	[**]	[**]	[**]	[**]	[**]
GT-07	$229.85	[**]	[**]	[**]	[**]	[**]
GT-08	$229.85	[**]	[**]	[**]	[**]	[**]
GT-09	$229.85	[**]	[**]	[**]	[**]	[**]
GT-10	$229.85	[**]	[**]	[**]	[**]	[**]
GT-11	$229.85	[**]	[**]	[**]	[**]	[**]
GT-12	$229.85	[**]	[**]	[**]	[**]	[**]
GT-13	$363.31	[**]	[**]	[**]	[**]	[**]
GT-14	$363.31	[**]	[**]	[**]	[**]	[**]
GT-15	$363.31	[**]	[**]	[**]	[**]	[**]
GT-16	$363.31	[**]	[**]	[**]	[**]	[**]
GT-17	$363.31	[**]	[**]	[**]	[**]	[**]
GT-18	$363.31	[**]	[**]	[**]	[**]	[**]
GT-19	$458.90	[**]	[**]	[**]	[**]	[**]
GT-20	$458.90	[**]	[**]	[**]	[**]	[**]
GT-21	$458.90	[**]	[**]	[**]	[**]	[**]
GT-22	$458.90	[**]	[**]	[**]	[**]	[**]
GT-23	$458.90	[**]	[**]	[**]	[**]	[**]
GT-24	$458.90	[**]	[**]	[**]	[**]	[**]

Open-Book Pricing Formula for Duragen Validation

Description	Price
Materials (excluding Duragen)	$28.76
Labor	[**]
50% Profit Margin	[**]
Simulation Seeds	[**]
Overhead	[**]

Total price of each Duragen Validation	[**]

Pass-Through Costs

●

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.

●

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.