ML19211C089

Enclosure 2: Shine Medical Technologies, LLC - General and Financial Information

ML19211C089
Person / Time
Site:	SHINE Medical Technologies
Issue date:	07/17/2019
From:	SHINE Medical Technologies
To:	Office of Nuclear Reactor Regulation
References
2019-SMT-0054
Download: ML19211C089 (6)

Text

ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE GENERAL AND FINANCIAL INFORMATION PUBLIC VERSION 5 pages follow

GENERAL AND FINANCIAL INFORMATION

1. Introduction

2. General Information in Accordance with 10 CFR 50.33 2.1 Applicant Information 2.2 Company Structure, Directors, and Principal Officers 2.3 Foreign Ownership or Control 2.4 Class and Type of License 2.5 Financial Qualification and Shareholder Relationships 2.6 Decommissioning

3. Fee Information in Accordance with 10 CFR 50.30(e) and 10 CFR 170.21

4. Planned Start of Operations in Accordance with 10 CFR 50.30(d)

5. Classified Information Agreement in Accordance with 10 CFR 50.37

6. Technical Qualifications in Accordance with 10 CFR 50.34(b)(7)

7. References

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ATTACHMENTS:

1. Directors and Principal Officers of Illuminated and SHINE Page 1 of 5

1. Introduction The following information supports the SHINE Medical Technologies, LLC (SHINE) operating license (OL) application. SHINE has applied for a license to operate a medical isotope production facility for the purpose of producing molybdenum-99 (Mo-99) and other isotopes used for nuclear medicine procedures.

2. General Information in Accordance with 10 CFR 50.33 2.1 Applicant Information The SHINE company address is:

SHINE Medical Technologies, LLC 101 E. Milwaukee St., Suite 600 Janesville, Wisconsin, 53545 The SHINE facility produces the medical isotope Mo-99, which is the parent isotope of the diagnostic imaging isotope, technetium-99m (Tc-99m). The SHINE facility also produces other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133). The SHINE facility location in Janesville, Wisconsin, is described in the SHINE Final Safety Analysis Report (FSAR), Section 2.1.

2.2 Company Structure, Directors, and Principal Officers SHINE is a single member, Delaware limited liability company, owned and controlled by Illuminated Holdings, Inc. (Illuminated), a Delaware corporation. SHINE is member managed by Illuminated. Attachment 1 includes information regarding the directors and principal officers of Illuminated and SHINE. The directors and principal officers of SHINE and Illuminated are U.S.

citizens except as indicated otherwise in Attachment 1.

2.3 Foreign Ownership or Control SHINE is not owned, controlled, or dominated by an alien, a foreign corporation, or a foreign government. SHINE is not acting as an agent or representative of another person in filing the OL application. SHINE is a private company. SHINE is wholly-owned by Illuminated and Illuminated is its only shareholder. To the best of SHINEs knowledge, current shareholders holding 1 percent or more of Illuminated stock are U.S. citizens or entities owned or controlled by U.S. citizens.

One member of the Illuminated Board of Directors is a Canadian citizen with U.S. permanent resident status as indicated in Attachment 1. The appointment of one citizen of Canada as a director of Illuminated does not impact compliance with the requirements regarding foreign ownership, control, or domination in 10 CFR 50.38.

Page 2 of 5

Proprietary Information - Withheld from Public Disclosure Under 10 CFR 2.390(a)(4) 2.4 Class and Type of License SHINE is requesting issuance of a 30 year operating license under 10 CFR 50 for the operation of the SHINE medical isotope production facility. The SHINE medical isotope production facility includes eight utilization facilities and one production facility as defined in 10 CFR 50.2. SHINE is requesting a Class 103 license, in accordance with 10 CFR 50.22, for commercial and industrial facilities. Operation of the SHINE facility also includes receipt, possession, and use of byproduct material in accordance with 10 CFR 30, source material in accordance with 10 CFR 40, and special nuclear material in accordance with 10 CFR 70.

The NRC previously authorized construction of the SHINE medical isotope production facility via the issuance and subsequent amendment of Construction Permit No. CPMIF-001 (Reference 7.1).

2.5 Financial Qualification and Shareholder Relationships In accordance with 10 CFR 50.33(f), information sufficient to demonstrate that SHINE is financially qualified to operate the SHINE medical isotope production facility is provided in Section 15.2 of the FSAR. SHINE has demonstrated reasonable assurance of obtaining the funds necessary to cover estimated operation costs for the period of the license. Financial reports and certified financial statements are submitted annually in accordance with 10 CFR 50.71(b). SHINE submitted the most recent financial report, including certified financial statements, via Reference 7.2.

The relationship between SHINE and Illuminated is described in Section 2.2 and Attachment 1.

SHINE is a private company, member managed by Illuminated, whose shareholders elect the Illuminated Board of Directors. Shareholder votes are dependent on the number of shares and class of stock held.

SHINE has a financing arrangement with Deerfield Management Company, L.P. (Deerfield), a Delaware series limited partnership (Series C). The agreement includes a $150 million financing commitment to SHINE. Deerfield provides financing for SHINE to draw upon in several tranches over time. [

]PROP 2.6 Decommissioning In accordance with 10 CFR 50.33(k), information in the form of a report, as described in 10 CFR 50.75, indicating how reasonable assurance will be provided that funds will be available to decommission the facility, is provided in Section 15.3 of the FSAR.

Page 3 of 5

3. Fee Information in Accordance with 10 CFR 50.30(e) and 10 CFR 170.21 SHINE shall pay fees in accordance with 10 CFR 50.30(e) and 10 CFR 170.21.

4. Planned Start of Operations in Accordance with 10 CFR 50.30(d)

The SHINE medical isotope production facility is expected to be ready for operation in the fourth quarter of 2021.

5. Classified Information Agreement in Accordance with 10 CFR 50.37 The SHINE OL application does not contain Restricted Data as defined in 10 CFR 50.2 or classified National Security Information as defined in 10 CFR 25.5 and 10 CFR 95.5. SHINE will not permit any individual to have access to any facility to possess Restricted Data or classified National Security Information until the individual and/or facility has been approved for access under the provisions of 10 CFR 25 and/or 10 CFR 95.

6. Technical Qualifications in Accordance with 10 CFR 50.34(b)(7)

SHINE is technically qualified to operate the facility. The primary basis for the SHINE technical qualification is the technical acumen of the SHINE management and staff. The NRC confirmed the technical qualification of SHINE via issuance of the Safety Evaluation by the Office of Nuclear Reactor Regulation for Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 (Reference 7.3). Since the initial issuance of the construction permit, SHINE has hired additional staff, including engineering staff, and updated the design of the facility, including the elimination of complex processes. SHINE continues to develop its technical qualifications through the construction and ongoing testing of an accelerator prototype similar to that which will be used within the irradiation units of the SHINE medical isotope production facility. SHINE has also established partnerships with Baker Concrete Construction, Inc.; Rock Creek Innovations, LLC; and Phoenix, LLC; companies specializing in construction, instrumentation and control protection systems, and accelerator technology, respectively.

Additional information regarding staffing, organizational structure, training, and personnel qualifications is provided in Chapter 12 of the FSAR.

7. References 7.1 NRC letter to SHINE Medical Technologies, LLC, SHINE Medical Technologies, LLC -

Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No.

CPMIF-001 (EPID NO. L-2018-LLM-0154) dated July 1, 2019 (ML19162A024) 7.2 SHINE Medical Technologies, Inc., letter to the NRC, SHINE Medical Technologies, Inc.

Submittal of Annual Financial Report, dated June 10, 2019 (ML19163A132) 7.3 NRC letter to SHINE Medical Technologies, Inc., SHINE Medical Technologies, Inc. -

Order Approving Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 (EPID NO. L-2018-LLM-0154), dated May 20, 2019 (ML19102A323)

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ATTACHMENT 1 DIRECTORS AND PRINCIPAL OFFICERS OF ILLUMINATED AND SHINE COMPANY NAME: Illuminated Holdings, Inc.

STATE OF INCORPORATION A Delaware corporation

& CORPORATE FORM:

BUSINESS ADDRESS (for 101 E. Milwaukee St., Suite 600 Illuminated, as well as directors Janesville, WI 53545 and principal officers):

BOARD OF DIRECTORS: Dr. Gregory Piefer Dr. Thomas "Rock" Mackie

• Philip M. Halpern Todd Asmuth Gregory OD Smith Brad Wucherpfennig Gordon Gunnlaugsson LIST OF PRINCIPAL Dr. Gregory Piefer, Chief Executive Officer OFFICERS: Todd Asmuth, President & Chief Financial Officer

• Canadian Citizen and U.S. Permanent Resident COMPANY NAME: SHINE Medical Technologies, LLC STATE OF INCORPORATION A Delaware limited liability company

& CORPORATE FORM:

BUSINESS ADDRESS (for 101 E. Milwaukee St., Suite 600 SHINE, as well as principal Janesville, WI 53545 officers):

Member Manager: Illuminated Holdings, Inc.

LIST OF PRINCIPAL Dr. Gregory Piefer, Chief Executive Officer OFFICERS: Todd Asmuth, President & Chief Financial Officer Steve Miltenberger, Chief Operating Officer Page 5 of 5