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 GammaTileTM 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 GammaTileTM Pack is comprised of between one and six
GammaTileTM 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 GammaTileTM 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 GammaTileTM 12 Pack in one shipping carton and a GT-01
through GT-06 in a second shipping carton.

 

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

 

[ex_169510img001.gif]

 

 

--------------------------------------------------------------------------------

 

 

Exhibit B

Open-Book Pricing Formula & Pricing Schedule

 

Open-Book Pricing Formula for GammaTileTM

No. of Tiles

/ Item Code

Materials

Labor

50% Profit

Margin

Seeds (high

activity 3.5U

Cesium-131

source –

assumes 4

seeds per

GammaTileTM)

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.