a. ~mnru~~2m~m.j:rr w;ti!l§j!~~gql!!s~2!!!, as · conversation scheduled for thursday, august 15,...

August 12, 2019

Sara A. Forster, M.S.

Health Physicist

Materials Licensing Branch

RE: Notification of Transfer of Control for License #13-32726-0lMD and #13-32726-02

Dear Ms. Forster:

Thank you for your time on August 8, 2019. Per our conversation Spectron mrc, LL.C. intends to enter

into agreement with NukeMed Inc., dba SpectronRx under the direction of Chief Executive Officer, John

A. Zehner, R.Ph., the purchase of Spectron mrc, L.LC. assets. The following letter and attached

information for transfer of control are to provide timely notification, provide the required information

pursuant of 10 CFR 30.34 and to seek the commis~ion's written consent upon review of the provided

information.

Attached you wi!! find Information needed for Transfer of Control for both NRC lie. No. 13-32726-0lMD

and NRC Lie. No. 13-32726-02 {Attachment 1) and update Decommissioning Funding Plan (Attachment

2). We will intend to provide any additional documentation to support the decommissioning cost

estimate, Certification of Financial Assurance, updated Standby Trust Agreement(s) following our

conversation scheduled for Thursday, August 15, 2019.

If you have any questions, please feel free to contact Gregory S. Hiatt, R.Ph./RSO., by email at

~ru~~QfilUJ},fil.or by cell at 574-298-9616. Additionally, John A. Zehner, R.Ph., can also be reached

at John A. Zehner at ~mnru~~2M~m.J:rr or W;TI!l§J!~~gQL!!S~2!!!, as well as, at his main number at 317-459-8315.

Sincerely,

Gregory S. Hiatt R.PhJRSO

CEO

Spectron mrc, LL.C.

CC: John A. Zehner, R.Ph.

CEO

NukeMed Inc., dba SpectronRx

Attachment 1

Information Needed For Transfer of Control Application

NRC Region: Region Ill Contact: John A. Zehner -----·------'---Telephone: ( 317 ) 459 - 8315 Fax: { ) ~---------

Definitions:

Control: Control of a license is in the hands of the person or persons who are empowered to

decide when and how that license will be used. That control is to be found in the person or persons

who, because of ownership or authority explicitly delegated by the owners, possess the power to

determine corporate policy and, thus, the direction of the activities under the license.

Transferee: A transferee is an entity that proposes to purchase or otherwise gain control of an

NRC-licensed operation.

Transferor: A transferor is an NRC licensee selling or otherwise giving up control of a licensed

operation.

Information Needed for Transfer of Control

L Description of Transaction:

Upon the commission's review of the following information and written consent for Transfer of

Control, NukeMed Inc., dba. SpectronRx under the direction of Chief Executive Officer John A. Zehner, R.Ph.(Transferee) will assume control from Gregory S. Hiatt, R.Ph./RSO and Chief

Executive Office of Spectron MRC LLC {Transferor) the operations of the licensed pharmacy

under license# 13-32726-0lMD and control of the accelerator under license# 13-327226-02

located at 17490 Dugdale Dr., South Bend, IN 46635. The transfer of control will be an asset

purchase, and NukeMed Inc., dba. SpectronRx would take responsibility from the Spectron mrc

LLC for administration of all facility functions, for radiation safety activities, and for providing

onsite management and continuing oversight of production activities, as well as make updates

or modifications to equipment and/or facilities improvements.

New licensee information:

Name: NukeMed Inc., dba SpectronRx

Mailing Address: 17490 Dugdale Dr.

South Bend, IN 46635

Contact: John A. Zehner1 CEO

Email: [email protected]

Phone Number: (317) 459-8315

Board of Directors:

John A. Zehner - CEO

Ke!!l Lightfoot-Secretary

Page 1 of 5

Attachment 1


NRC Region: Region Ill ------"'------Contact: ---------John A. Zehner

Telephone: 317 459 - 8315 ------~-~------ Fax: -'----"--------Oefi n itions:



who, because of ownership or authority explicitly delegated by the owners, possess the power to





operation.

information Needed for Transfer of Control

l. Description of Transaction:


Control, NukeMed Inc., dba. SpectronRx under the direction of Chief Executive Officer John A.

Zehner, R.Ph.(Transferee) will assume control from Gregory 5. Hiatt, R.Ph./RSO and Chief

Executive Office of Spectron MRC LLC (Transferor} the operations of the licensed pharmacy


located at 17490 Dugdale Dr., South Bend, IN 46635. The transfer of control will be an asset


LLC for administration of all facility functions, for radfation safety activities, and for providing

onsite management and continuing oversight of production activities, as well as make updates






Contact: John A. Zehner, CEO


Phone Number: (317) 459-8315

Board of Directors;


Kelli Lightfoot - Secretary

Page 1 of 5

Attachment 1


NRC Region: Region Ill Contact: John A. Zehner ---------Telephone; ( 317 ) 459 - 8315 Fax: ( } -'---~-------

Definitions:



who; because of ownership or authority explicitly delegated by the owners, possess the power to





operation.

Information Needed for Transfer of Control

1. Description of Transaction:


Control, Nuke Med Inc., dba. SpectronRx under the direction of Chief Executive Officer John A.

Zehner, R.Ph.(Transferee) will assume control from Gregory S. Hiatt, R.Ph./RSO and Chief

Executive Office of Spectron MRC LLC (Transferor) the operations of the licensed pharmacy


located at 17490 Dugdale Dr., South Bend, fN 46635. The transfer of control will be an asset


LLC for administration of all facility functions, for radiation safety actMties, and for providing

onsite managementand continuing oversight of production activities, as well as make updates






Contact: John A. Zehner, CEO


Phone Number: (317} 459-8315

Board of Directors:


Kelli Lightfoot - Secretary

Page 1 of 5

Attachment 1


2. Changes to Personnel

a. Operations license (License# 13-32726-0lMD):

Radiation Safety Officer (RSO):

RSO duties and responsibilities will be transferred from Gregory S. Hiatt, R.Rh./RSO to

John A. Zehner, R.Ph. (See Delegation of Authority Memo dated 08 Aug 2019):

John A Zehner's experience:

• Indiana pharmacy license #26017457A.

• Mr. Zehner was educated at Purdue University in nuclear pharmacy.

• Mr. Zehner has been a Radiation Safety Officer on Various NRC and State Licenses

for over 25 years.

• Mr. Zehner has handled Curie quantities of 1-131, F-18 and Tc-99m, as well as,

hundreds of mCi's at a time of C-11, N-13, as well as compounding 1-131 capsules at

various nuclear pharmacies and cyclotron facilities during his over 25 year career

that began as a Nuclear Pharmacist in Maryland in August of 1991. • Mr. Zehner is currently listed as an Authorized Nuclear Pharmacist on license# 13-

32726-0lMD.

• Previously, Mr. Zehner was RSO on NIK Uc. No. 13-35179-02 and NRC Uc. No. 24-

32827-0lMD at Zevacor Molecular in Noblesville, IN.

Authorized Nudear Pharmacist:

All existing authorized Nuclear.Pharmacists will remain unchanged: Greg Hiatt, R.Ph.,

Stanley Miller, R.Ph., Bettina Hickman, R.Ph., Mark Peters, R.Ph., Todd Holiday, R.Ph.,

and John A. Zehner, R.Ph.

Authorized Users:

All existing authorized users will remain unchanged: David Trump, Ph.D

Additic,>n Authorized Users:

Additional Authorized Nuclear Pharmacists:

Kirk Rozyckt R.Ph.

o Ucensed nuclear pharmacist and listed as AU on NRC He. No. 13·3272.6-02.

o Was previously listed as AU and RSO on NRC Uc. No. 13-32726-01MD

Additional Authorized Users:

Robert Galloway, Cyclotron Operator, listed as AU on license# 13-32726-02.

Beth Kraemer, R.Ph.

o Licensed nuclear pharmacist listed as AU and RSO on multiple licenses:

• NJSL-10826/01 (Siemens-PetNet)

Page 2 of S

Attachment 1


• NYC-DOH 52-2878-04 (Colombia University-Columbia Presbyterian

Medical Center)

• RAD110003-452369 {!BA Molecular North America-Zevacor)

Pulak Chakraborty, Ph.D.

o Research investigator at the Department of Nuclear Medicine, University of

Michigan. Holds a Ph.D. in Chemistry, and has previous experience with F-

18, C-11, N-13 and 0-15 Children's Hospital of Michigan, Detroit.

o listed as AU on previous license:

• 21-03298-06

A. Lake Wooten, Ph.O

o Holds a Ph.D. in Biomedical engineering from Washington University, and

has received }ob specific radiation safety training at Washington Univ. in St.

Louis, Brookhaven National Laboratory, University of Washington, Zevac:or

Molecular, and SpectronRx

o Experience producing/handling sz,;;4Mn, 72Se/72As, 32Sr/82Rb, 36Y, 89Zr, 64Cu, 7"Br, 124

11 nm,

Maxim l<iselev, Ph.D

o Has over 25 years of experience in manufacturing management, engineering

and radiochemistry.

o Is currently listed as an AU on license# 13-35179-02.

o Was previously listed as an AU on State of Florida license# 3287-1

o Was previously listed as an RSO on Commonwealth of Virginia license# 107-559-1.

b. Accelerator license (License# 13-32726-02):

Radiation Safety Officer (RSO}:

Existing RSO duties and responsibilities will be transfered from Greg Hiatt, R.Rh. to John

A. Zehner, R.Ph. (See Delegation of Authority Memo dated 08 Aug 2019)

See John A. Zehner's experience listed in 2.a. above.

Authorized Users:

Af! existing authorlzed users will remain unchanged: Greg Hiatt, R.Ph., Kirk Rozycki R.Ph.,

Robert Galloway, David Trump, Ph.D, Mark Hiatt, and John A. Zehner, R.Ph.

Additional Authorized Users:

Beth Kraemer, R.Ph. - See Beth Kraemer's experience listed in 2.a. above.

Pulak Chakraborty, Ph.D. - See Pulak Chakraborty's experience listed in 2.a. above.

Maxim Kise!ev, Ph.D - -See Maxim Kiseiev's experience listed in 2.a. above.

Page 3 of 5

Attachment 1


3. Changes of Location. Equipment, and Procedures:

The physical location of the licensed pharmacy and accelerator will remain at the

current location at 17490 Dugdale Dr. South Bend, IN 46635; however, expansion and upgrade

to the facilities equipment will be necessary to accommodate plans to increase possession and

use of 1-131.

Changes to existing procedures include adding 1-131 storage, monitoring, handling and

waste disposal to the licensed pharmacy audit Additional changes to procedures include

implementing a bioassay procedure that follows the methods and criteria described in

Regulatory Guide 8.20- Applications for Bioassay for Radioiodine. The update to the facility

layout, restricted area where radioactive material will be used or stored, including changes to

restrictive access controls is provided {see appendix I). The transferee will maintain the control

to modify and update equipment as needed to better accommodate handling licensed material

and/or improve general safety.

4. Surveillence Records:

The license facility keeps all instrumentation calibrated (as applicable), performs efficiency and

constancy testing {as applicable) and area wipes and surveys on days in which RAM is handled. All

facility employees are given radiation safety training at a minimum general classroom and on-the-job

instruction during on-boarding and classroom instruction annually thereafter, as well as job specific onthe-job radiation safety training as needed. Review of records demonstrate no known contamination

and therefore decontamination is not applicable. All calibration, leak tests, area survey, wipe test,

training, and quality control records are current and in accordance with licensee commitments.

Decommissioning Funding Plan:

Pursuant to 10 CFR 30.35{g), we shall maintain drawings and records important to decommissioning and

will transfer these records to an NRCor Agreement State licensee before licensed activities are

transferred; or we will transfer the records to the appropriate NRC regional office before the

license is terminated.

• The Transferor has agreed to make available to the Transferee and leave all records at the

facility location before or by on the Transfer of Control.

• The Transferee commits to maintain the records received from the transferor.

• Daily facility survey will confirm no contamination prior to the transfer.

• No decommissioning is planned before or after the transfer of control.

• The transferee commits that operations will continue,during and after the transfer process; and

the transforee agrees to accept the facillty "as is" on the date of transfer.

Page 4of 5

Attachment 1


5. Decommissioning Records Transfer:

The transferor has made available to the transferee all records concerning the safe and effective

decommissioning of the facility, and the DFP has been provided to the NRC for the purpose of reviewing

Financial Assurance.

6. Agreement to Transfer of Control:

I, Gregory S. Hiatt - CEO, Spectron MRC LLC, and John A Zehner- CEO. NukeMed Inc, /Transferor} (Tran,jeree)

agree to transferring control of the licensed material and activity, and the conditions of transfer, and

that John A. Zehner - CEO, Nuke Med Inc. (Transferee} has been made aware of any open inspection

items and responsibility for possible resulting enforcement actions.

Transferor:_,_)~---....,·.+'"-'~-~,_ .. ..;..~...c....,' -~--

~ '1-1iatt CEO, Spectron MRC LLC

I

Transferee: _....,/-;/1 ..... ·'_~{....._/_VL ___ .... / ___ ·_·· __ _ ir/·f.L I John A~ehner

CEO, NukeMed Inc.

7, Transferee1s Commitment to Abide by the Transferor's Commitments:

Date

Date

I, John A Zehner- CEO, NukeMed Inc. (Transferee) will abide by all constraints, conditions,

requirements, representations, and commitments of the transferor or will submit a complete

description of the proposed licensed program.

Date

Page 5 of 5

Song, Taehoon

From: Forster, Sara Sent: To: Cc:

Friday, August 16, 2019 2:37 PM Song, Taehoon; Pavon, Sandy Tomczak, Tammy

Subject: FVv: Re: Re: 13-32726-02 Attachments: Transfer of Control Application Attachment 1 Aug 12 2019.pdf; Signed Letter_ TO(_

16Aug2019 (1).pdf

Good afternoon Tae and Sandy,

Could you please have this request scanned in and then pass along to Tammy/Patty to be Controlled in as a Transfer of Control notification? The action should be assigned to me.

Thank you!

Sara

From: John Zehner <[email protected]> Sent: Friday, August 16, 2019 12:29 PM To: Forster, Sara <[email protected]> Subject: [External_Sender] Re: Re: 13-32726-02

Ms. Forster,

Here is the information for transfer of control. I included the cover letter again as well.

Thanks,

John Z

On Fri, Aug 16, 2019 at 12:09 PM Forster, Sara <[email protected]> wrote:

Thank you for the update to the Financial Assurance and the Transfer of Control action. I have gone through both emails you sent and cannot find the "information needed for transfer of control" referenced in your letter. Could you please resend this message including the "information needed for transfer of control?"

We have set a call time of 10:45 am central for Thursday 8/28.

Sincerely,

Sara A. Forster, Health Physicist Licensing Reviewer

U.S. Nuclear Regulatory Commission - Region III 1

Division of Nuclear Materials Safety

2443 Warrenville Rd. - Ste. 210

Lisle, IL 60532-4352

[email protected]

Direct: ( 630) 829-9892

Facsimile: (630) 515-1078

!"--,~ U.S.NR C

From: John Zehner <[email protected]> Sent: Friday, August 16, 2019 10:57 AM To: Forster, Sara <[email protected]> Cc: Christopher Ritter <[email protected]>; This is Greg Hiatt <[email protected]> Subject: [External_Sender] Re: 13-32726-02

Ms. Forster,

Here is the DFP with the signed cover letter.

I am available on August 29th until 4pm Central Time.

Thanks,

John Zehner

On Fri, Aug 16, 2019 at 11:52 AM Forster, Sara <[email protected]> wrote:

Dear Mr. Zehner:

2

Thank you for the message. However, there is no attachment. When submitting the updated decommissioning cost estimate, please assure to submit that under a signed and dated cover letter. Also, regarding the status of the decommissioning financial assurance review, we would like to set up a call with you on Thursday, August 291h. Could you please let us know your availability for a call, on that date? We are unable to schedule a call sooner.

Thank you,

Sara A. Forster, Health Physicist Licensing Reviewer

U.S. Nuclear Regulatory Commission - Region III

Division of Nuclear Materials Safety

2443 Warrenville Rd. - Ste. 210

Lisle, IL 60532-4352

[email protected]

Direct: (630) 829-9892

Facsimile: (630) 515-1078

U.S.NRC

From: John Zehner <[email protected]> Sent: Friday, August 16, 2019 10:37 AM To: Forster, Sara <[email protected]> Cc: Christopher Ritter <[email protected]>; This is Greg Hiatt <[email protected]> Subject: [External_Sender] 13-32726-02

MS. Forster,

Here is the DFP for the cyclotron. I sent the supporting documents in a prior email.

3

John A. Zehner

Chief Executive Officer

SpectronRx

Therapeutic & Diagnostic Isotope Solutions

Excellence in Facilities, Experience and Personnel

Mob: 317.459.8315

[email protected] I www.SpectronRx.com

17490 Dugdale Drive, South Bend, IN 46635

CONFIDENTIALITY NOTICE

This email transmission, including I materials transmitted herewith, may contain information that is considered material inside informat n under Federal or State securities laws that is otherwise confidential. Such information is proprietary and is inte ed for use only by the person(s) reflected herein . In the event this email transmission is received by anyone ot~an the designated recipient(s), you are hereby requested to immediately direct this correspondence and relate~a.ttachments to the proper party and, you are hereby notified that any disclosure, copying, distribution or the ta ·ng of any action based in whole or in part on the information transmitted herewith, may constitute a vio tion of law and is prohibited. If you received this transmission in error please notify me immediately by e-mail resp nse, then delete this transmission, including all materials transmitted herewith. Thank you.

John A. Zehner ·


SpectronRx



Mob: 317.459.8315

4

[email protected] [ www.Spectrnn.Rx.com



This email transmission, including all mate · Is transmitted herewith, may contain information that is considered material inside information unde ederal or State securities laws that is otherwise confidential. Such information is proprietary and is intended for use only by the person(s) reflected herein . In the event this email transmission is received by anyone other than tt"'1esignated recipient(s), you are hereby requested to immediately direct this correspondence and related attachments to the proper party and, you are hereby notified that any disclosure, copying, distribution or the taking of a action based in whole or in part on the information transmitted herewith, may constitute a violation o aw and is prohibited. If you received this transmission in error please notify me immediately by e-mail response, th n delete this transmission, including all materials transmitted herewith. Thank you.

John A. Zehner


SpectronRx



Mob: 317.459.8315

[email protected] i www.Spectron.Rx.com



This email transmission, including I materials transmitted herewith, may contain information that is considered material inside informat1 n under Federal or State securities laws that is otherwise confidential. Such information is proprietary and is inte ed for use only by the person(s) reflected herein . In the event this email transmission is received by anyone oth than the designated recipient(s), you are hereby requested to immediately direct this correspondence and related a •ta$,hments to the proper party and, you are hereby notified that any disclosure, copying, distribution or the taking of any fjtion based in whole or in part on the information transmitted herewith, may constitute a violation of law and is prohibited. If you received this transmission in error please notify me immediately by e-mail response, then delete this transmissio\ncluding all materials transmitted herewith. Thank you. •

-~&~A-. ,Jo e,ai\-tick~of ~f\~ l

\ 0 I 1/ 2-0\ Ci l:rr

5

a. ~mnru~~2m~m.j:rr w;ti!l§j!~~gql!!s~2!!!, as · conversation scheduled for thursday, august 15,...

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