ML18016B108

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NRC-006A - Northwest Medical Isotopes, LLC, Construction Permit Application - Cover Letter and General and Financial Information (Feb. 5, 2015) (ADAMS Accession Nos. ML15086A262 and ML15086A263 (in Part))
ML18016B108
Person / Time
Site: Northwest Medical Isotopes
Issue date: 02/15/2015
From:
NRC/OGC
To:
NRC/OCM
SECY RAS
References
50-609-CP, Construction Permit Mndtry Hrg, RAS 54181
Download: ML18016B108 (14)
v • d • e


Text

NRC-006A

.2*D. NWMI NORTHWEST ISOTOPES MEOICAL February 5, 2015 NWMI-LTR-2015-003 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk 11555 Rockville Pike Washington, DC 20555 RE: NRC PROJECT NO. 0803 - NORTHWEST MEDICAL ISOTOPES, LLC, SUBMITTAL PART 1 CONSTRUCTION PERMIT APPLICATION FOR A RADIOISOTOPE PRODUCTION FACILITY - WITHDRAWL OF PART 1 APPLICATION SUBMITTED ON NOVEMBER 7,2014 AND RESUBMITTAL OF APPLICATION References

1. Letter from Northwest Medical Isotopes, LLC to U.S. Nuclear Regulatory Commission, "Request for Exemption to Submit a Construction Permit Application in Two Parts as Described in 10 CFR Part 2.101," NWMI-LTR-007, August 9, 2013 (MLI3227A295)
2. Letter from U.S. Nuclear Regulatory Commission to Northwest Medical Isotopes, LLC, "Exemption from Certain Requirements of Title 10 Code of Federal Regulations, Section 2.101 (a)(5), Regarding the Submission of a Construction Permit Application in Two Parts (TAC No. MF2288)."

(ML13238A335)

3. Letter from Northwest Medical Isotopes, LLC to U.S. Nuclear Regulatory Commission, "Submittal of Part 1 Construction Permit Application for a Radioisotope Production Facility", NWMI-LTR-2014-019, dated November 7, 2014.

This letter and Part 1 Construction Permit Application submission supercedes and withdraws the submission dated November 7, 2014 (NWMI-LTR-2014-019, from Northwest Medical Isotopes, LLC to U.S. Nuclear Regulatory Commission) and resubmits the application.

Background

Northwest Medical Isotopes, LLC, (NWMI) is pleased to submit Part 1 of our Construction Permit Application to construct a medical radioisotope production facility (RPF) to be located at the Discovery Ridge Research Park in Columbia, Missouri. NWMI is submitting this application in two parts in accordance with Reference 1, whereby NWMI requested exemption from certain requirements of Title 10, Code of FederalRegulations (CFR), Part 50.12 (10 CFR 50.12), which would allow the submittal of an application for construction permit in two parts, in accordance with 10 CFR 2.101(a)(5).

The U.S. Nuclear Regulatory Commission (NRC) granted NWMI the exemption, as noted in Reference 2.

Part 1 of NWMI's Construction Permit Application provides the following:

  • Agreement limiting access to classified information required by 10 CFR 50.37 Part 2 of NWMI's application will include the remaining sections of the Construction Permit Application per 10 CFR 50.34(a) and will be submitted in accordance with 10 CFR 2.101 (a)(5).

Northwest Medical Isotopes, LLC I 815 NW 9th Ave, Suite 256 1 Corvallis, OR 97330

NWMI ISOTOPES NORTHWEST MEOICAL NWMI is applying to the NRC to obtain a license for a production facility under Title 10, Code of FederalRegulations (CFR) Part 50 (10 CFR 50), "Domestic Licensing of Production and Utilization Facilities." Embedded in the 10 CFR 50-licensed facility will be several activities subject to 10 CFR 70, "Domestic Licensing of Special Nuclear Material," to receive, possess, use, and transfer special nuclear material and 10 CFR 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material,"

to process and transport molybdenum-99 (99Mo) for medical applications.

NWMI intends to submit a single 10 CFR 50 license application for the radioisotope production facility (RPF) following the guidance in NUREG- 1537, Guidelinesfor Preparingand Reviewing Applicationsfor the Licensing ofNon-Power Reactors - Format and Content, that encompasses activities regulated under different NRC requirements (e.g., 10 CFR 70 and 10 CFR 30), in accordance with 10 CFR 50.31, "Combining Applications," and 10 CFR 50.32, "Elimination of Repetition."

The NRC has determined that a radioisotope separation and processing facility, which also conducts separation of special nuclear material, will be considered a production facility and as such, will be subject to licensing under 10 CFR 50. A significant portion of the NWMI RPF is focused on the disassembly of irradiated low-enriched uranium (LEU) targets, separation and purification of fission product 99Mo, and the recycle of LEU that is licensed under 10 CFR 50. The RPF will also include the fabrication of LEU targets, which will be licensed under 10 CFR 70. These targets will be shipped to NWMI's network of research or test reactors for irradiation (considered a connected action) and returned to the RPF for processing. The LEU used for the production of the LEU target materials will be obtained from the U.S.

Department of Energy (DOE) and from LEU reclaimed from processing the irradiated targets.

NWMI's licensing approach for the R.PF defines the following unit processes and areas that fall under the following NRC regulations:

10 CFR 50, "Domestic Licensing of Production and Utilization Facilities"

- LEU Target receipt (from network of university research or test reactors)

- Irradiated LEU Target disassembly and dissolution

- 99M0 recovery and purification

- Uranium recovery and recycle

- Waste management

- Associated laboratory and support areas 10 CFR 70, "Domestic Licensing of Special Nuclear Material"

- Receipt of fresh LEU (from DOE)

- LEU target fabrication

- Associated laboratory and support areas Any byproduct materials produced or extracted in the RPF will be licensed under 10 CFR 30.

Deliverables NWMI's description and safety assessment of the proposed RPF site's geology, seismology, and geotechnical engineering (Chapter 2.0) was developed using existing data for the Discovery Ridge Research Park in Columbia, Missouri. Although these data are relevant to the overall research park, in some cases, the information is not specific to the exact location of the RPF. NWMI will be completing additional site-specific geotechnical data in support of the facility preliminary safety analysis report (PSAR) and design. NWMI is in the process of collecting geotechnical data specific to the site on which the RPF is proposed to be built. This data will augment the description or analysis of the site's geology, seismology, or geotechnical engineering, and an amendment to the application will be submitted in accordance with 10 CFR 50.4, "Written Communications."

Page 2 of 8

$NWMI

- .. "NORTHWEST MEDICAL ISOTOPES The Council for Environmental Quality regulations implementing the National Environmental Policy Act (NEPA) requires that the cumulative impacts of a proposed action be assessed (40 CFR 1500-1508).

A cumulative impact is defined by the Council as "the impact on the environment which results from the incremental impact of the action when added to other past, present, and reasonably foreseeable future actions regardless of what agency (Federal or nonfederal) or person undertakes such other actions" (40 CFR 1508.7, "Cumulative Impact"). Cumulative impacts can result from individually minor but collectively significant actions taking place over a period of time (40 CFR 1508.7).

The Council on Environmental Quality guidance for considering cumulative effects states that NEPA documents "should compare the cumulative effects of multiple actions with appropriate national, regional, State, or community goals to determine whether the total effect is significant."

Within the Environmental Review (Chapter 19.0), NWMI documented the existing environment at the proposed Columbia, Missouri, site and surround area, and summarized the environmental impacts of construction, operation, and decommissioning. NWMI also considered appropriate impact-mitigation measures and reviewed alternate sites and technologies. The analysis documented within the Environmental Review determined that the impacts associated with construction, operation, and decommissioning of the proposed RPF facility would be small or nonexistent. Extensive consultation with local stakeholders reveals that the facility is non-controversial, and these stakeholders have indicated support for establishment of the facility. Based on these factors, NWMI considers an Environmental Assessment to be the appropriate level of NEPA review for this project.

The required affidavit to withhold information from public disclosure is provided in Attachment 1.

NWMI considers the information in Attachment 2 to be proprietary and requests that the attachment be withheld from public disclosure, pursuant to 10 CFR 2.390 "Public Inspections, Exemptions, Requests for Withholding." The attachments to this letter include the following:

" Attachment I - The required affidavit to withhold information from public disclosure per 10 CFR 2.390

  • Attachment 2 - Non-public (proprietary and business sensitive) version of the NWMI Part 1 Construction Permit Application; the information is provided on in hard copy
  • Attachment 3 - Public (non-proprietary) version of the NWMI Part 1 Construction Permit Application; the information is provided in hard copy NWMI requests that Attachment 2 be withheld from pubic disclosure pursuant to 10 CFR 2.390 and be uncontrolled or can be made available to the public.

If you have questions, I can be reached at (509) 430-6921 or carolyn.haassnwmedicalisotopes.com.

Sincerely, Carolyn C. Haass Vice President and Technical Program Director cc: Alexander Adams, Branch Chief William Schuster, Project Manager Research and Test Reactors Licensing Branch Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Office of Nuclear Reactor Regulation Page 3 of 8

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NORTHWEST MEDICAL ISOTOPES ATTACHMENT 1 AFFIDAVIT TO WITHOLD PROPRIETARY INFORMATION FROM PUBLIC DISCLOSURE (Pursuant to 10 CFR 2.390)

Page 4 of 8

~u:.NWM NORTHWEST I

ISOTOPES MEDICAL 10 CFR 2.390 AFFIDAVIT OF Carolyn C. Haass I, Carolyn C. Haass, herby affirm and state as follows:

1. I am a Vice President and Officer of Northwest Medical Isotopes, LLC (NWMI), and I have been authorized to execute this affidavit on behalf of NWMI.
2. The information contained in the enclosed letter dated November 7, 2014, is proprietary commercial information related to NWMI becoming a domestic supplier of Molybdenum-99 (99Mo). The proprietary information (Re-Submission of Part 1 Construction Permit Application, non-Pubic Version) includes sensitive business information created by or for NWMI. This information should be held in confidence by the U.S. Nuclear Regulatory Commission (NRC) and withheld from public disclosure.
3. In making this application for withholding of proprietary information of which it is the owner, NWMI believes that the information qualifies for withholding under the exemption from disclosure set forth in the Freedom of Information Act (FOIA), 5 U.S.C. Section 552(b)(4), the Trade Secrets Act, 18 U.S.C. Section 1905, and NRC regulations in 10 CFR 2.390(a)(4) for trade secrets and commercial information because:
a. This information is and has been held in confidence by NWMI.
b. This information is of a type that is customarily held in confidence by NWMI, and there is a rational basis for doing so because the information includes sensitive business information.
c. The information is being transmitted to the NRC voluntarily and in confidence.
d. This information is not available in public sources and could not be gathered readily from other publicly available information.
e. Public disclosure of this information would create substantial harm to the competitive position of NWMI by disclosing certain business decisions NWMI has made or is considering, and the analysis that went behind those decisions. Development and evaluation of this commercial information was achieved at, and disclosure could lead to additional, significant cost to NWMI.
f. Public disclosure of the information sought to be withheld is likely to cause substantial harm to NWMI'S competitive position and foreclose or reduce the availability of profit-making opportunities. The value of the information goes beyond the disclosure of actual information pertaining to NWMI's potential business, and includes substantial time and work towards developing the project by NWMI and its associates. The research, development, engineering, and analytical costs comprise a substantial investment of time and money by NWMI. The precise value of the information is difficult to quantify, but clearly is substantial.
g. NWMI's competitive advantage will be lost if its competitors are able to use the results of NWMI's activities to aid their own commercial activities. The value of this information to NWMI would be lost if the information was disclosed to the public. Making such information available to other entities without their having been required to undertake a similar expenditure of resources would unfairly provide competitors with a significant advantage, and deprive NWMI of the opportunity to exercise its competitive advantage to seek an adequate return on a large investment.

Page 5 of 8

' O *NORTHWEST MEDICAL ISOTOPES Carolyn C. Haass, Vice President Subscribed and swam before me, a Notary Public, in and for the State of Washington, this day of January, 2015.

Witne: Seal.

m Notary Public My Date Page 6 of 8

  • . I

. ISOTOPES NORTHWEST MEDICAL ATTACHMENT 2 CONTAINS PROPRIETARY INFORMATION INACCORDANCE WITH 10CFR 2.390 Northwest Medical Isotopes, LLC Part One, Construction Permit Application Non-Public Version

" General Information per 10 CFR 50.33, filing fee required by 10 CFR 50.30(e) and 10 CFR 170.21, and Classified Information Agreement in Accordance with 10 CFR 50.37

" Chapter 2 - Site Characteristics

  • Chapter 19 - Environmental Review Information is being provided via hard copy Page 7 of 8

"" WMI NORTHWEST MEDICAL ISOTOPES ATTACHMENT 3 Northwest Medical Isotopes, LLC Part One, Construction Permit Application Public Version

" General Information per 10 CFR 50.33, filing fee required by 10 CFR 50.30(e) and 10 CFR 170.21, and Classified Information Agreement in Accordance with 10 CFR 50.37

" Chapter 2 - Site Characteristics

" Chapter 19 - Environmental Review Information is being provided via hard copy Page 8 of 8

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"NORTHWEST MEDICAL ISOTOPES ATTACHMENT 3 Northwest Medical Isotopes, LLC Part One, Construction Permit Application Public Version
  • Chapter 2 - Site Characteristics
  • Chapter 19 - Environmental Review Information is being provided via hard copy Page 8 of 8

'::; NWMI NORTHWEST ISOTOPES MEDICAL GENERAL INFORMATION REQUIRED BY 10 CFR 50.33 AND FILING FEE REQUIRED BY 10 CFR 50.30(E) AND 10 CFR 170.21

1. GENERAL INFORMATION IN ACCORDANCE WITH 10 CFR 50.33 Name of Applicant [10 CFR 50.33(a)] and Address [10 CFR 50.33(b)]:

Northwest Medical Isotopes, LLC 815 NW 9h Street, Suite 256 Corvallis, Oregon 97330 Description of Business/Occupation of Applicant 110 CFR 50.33(c)1 Northwest Medical Isotopes, LLC (NWMI) was established in 2010 to ensure a domestic, secure, and reliable supply of molybdenum-99 (99Mo) for medical applications.

Ownership Information [10 CFR 50.33(d)]

NWMI is a limited liability company formed under the laws of the state of Oregon. NWMI's corporate headquarters is located in Corvallis, Oregon. NWMI intends to construct and operate a Radioisotope Production Facility (RPF) to recover and purify 99Mo in Columbia, Missouri, at Discovery Ridge Research Park (Discovery Ridge), an emerging research park development owned and managed by the University of Missouri (MU) System. The proposed 3 hectare (ha) (7.4-acre) RPF site is situated within Discovery Ridge, north of Discovery Ridge Drive. Discovery Ridge is located in the City of Columbia, Boone County, Missouri.

Corporate Structure, Directors and Principal Officers - NWMI is the applicant for the Construction Permit Application and will construct and operate the RPF. This application and the demonstration of financial capability are based on the current corporate structure and financial situation of NWMI.

NWMI business operations are managed under the direction of a Board of Managers and through the officers of NWMI. The NWMI Board currently consists of six managing members and two executive officers (identified in Table 1). All managers and officers are U.S. citizens.

Table 1. Northwest Medical Isotopes, LLC Managing Members and Executive Officers Maagn Mebr - I Excuiv Oficr Nicholas Fowler - Chairman Nicholas Fowler, President and CEO 2260 NW Independence Hwy, Albany, OR 97321 2260 NW Independence Hwy, Albany, OR 97321 Larry Mullins 3600 NW Samaritan Drive, Corvallis, OR 97330 Manoja Lecamwasam, PhD 185 Berry Street, Suite 300, Lobby 2 San Francisco. CA 94107 1

" NWMI NORTHWEST MEDICALISOTOPES Ownership Information 110 CFR 50.33(d)]:

Table 2 provides the name, citizenship, and address of each partner and principal business location of the partners having a membership interest of more than two percent.

Table 2. Northwest Medical Isotopes, LLC Ownership Summary Mebeship Copn/drs Sttecmpn stucur interests-

[Proprietary Information] [Proprietary Information] [Proprietary Information]

[Proprietary Information] [Proprietary Information] [Proprietary Information]

[Proprietary Information] [Proprietary Information] [Proprietary Information]

[Proprietay Irdoxbuttou4 [Proprietary Inforation] [Proprietary Inxformation]

[Proprietary Information] [Proprietary Information] [Proprietary Information]

Wropreta Infomatin). Prpitary Informaton [Popietary Information]

[Proprietary Information] [Proprietary Information]

[Poprietary Inormation][roretr Inform~ation]

[Proprietary Information]

Class of License/Duration of License 110 CFR 50.33(e)]

NWMI is applying to the U.S. Nuclear Regulatory Commission (NRC) to obtain a Class 103 license for a production facility under Title 10 Code of FederalRegulations (CFR) Part 50 (10 CFR 50), "Domestic Licensing of Production and Utilization Facilities." Embedded in the 10 CFR 50-licensed facility will be several activities subject to 10 CFR 70, "Domestic Licensing of Special Nuclear Material," to receive, possess, use, and transfer special nuclear material, and 10 CFR 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material," to process and transport 99Mo for medical applications.

NWMI expects to request an Operating License term of 30 years.

Financial Qualifications 110 CFR 50.33(f)I The NRC requires that an applicant for a Construction Permit Application submit sufficient financial information to demonstrate reasonable assurance that the applicant can obtain the necessary funds to cover the estimated design, construction, and startup costs for the RPF, and the related fuel-cycle costs (e.g., low enriched uranium from the U.S. Department of Energy) pursuant to 10 CFR 50.33(t). In addition, the applicant is required to indicate the source(s) of funds to cover these costs.

The financial guidelines the applicant needs to follow are provided in 10 CFR 50, Appendix C. This appendix (1) distinguishes between applicants that are established organizations and those that are newly formed entities organized primarily for the purpose of engaging in the activity for which the permit is sought, and (2) provides a guide for the financial data and related information required to establish financial qualifications for construction permits. NWMI is considered a newly formed entity per Appendix C.

2

  • NORTHWEST MEDICAL ISOTOPES Financial Ability to Construct a Facility - NWMI is submitting information demonstrating that the company possesses or has reasonable assurance of obtaining the necessary funds to cover estimated design, construction, and startup costs, and related fuel-cycle costs. The estimated NWMI costs to construct an RPF are summarized below. These estimates are based on the conceptual design of the RPF that was completed by NWMI's design facility architect/engineer.

Total facility costs [Proprietary Information]

Plant equipment [Proprietary Information]

Low-enriched uranium costs for RPF startup [Proprietary Information]

and first year Total estimated costs [Proprietary Information]

NWMI prepared an RPF base estimate that covers all components of the project (e.g., scope, conditions, and characteristics), including engineering and construction equipment, materials, and labor. The estimate incorporated data from previous and similar projects, and the cost base estimating. The base estimate also used inputs from the completed project file, project schedule, and knowledge of site conditions, which were escalated to the year of construction dollars using a construction cost index and the mid-point of construction. NWMI has developed clear and concise documentation for traceability that will allow future updates, review, and validation of the estimate.

NWMI obtained financing for the development and construction project using various sources of financing, including equity and debt. To date, NWMI has received the following monies and commitments.

Equity financing [Proprietary Information]

Facility financing [Proprietary Information]

Total estimated costs [Proprietary Information]

NWMI research and development, preliminary design, regulatory, and permitting cost projections are fully funded through existing equity financing receipts and commitments. NWMI has established a wholly owned subsidiary for the RPF and expects construction to be debt-financed.

Financial Ability to Safely Operate Facility - NWMI is providing financial information that demonstrates that the company possesses or has reasonable assurance of obtaining the funds necessary to cover estimated facility operational costs for the term of the operating license. Table 3 provides the RPF estimated operating costs and expected revenues for the first five years of the commercial operations.

Table 3. Estimated Radioisotope Production Facility Operating Costs and Expected Revenues for Years 1 - 5 ($000) 207 8 2 I9 e m Revenue [Proprietary Information] [Proprietary Information] [Proprietary Information] [Proprietary Information] [Proprietary Information]

%Gross Profit [Proprietary Information] [Proprietary Information] [Proprietary Information] [Proprietary Information] [Propirietary Information)

Operating Expenses [Proprietary Information] [Proprietary Information] [Proprietary Information] [Proprietary Information] [Proprietary Information]

Non-Operating Expenses [Proprietary Information] [Proprietary Intormation] [Proprietary Intormation] [Proprietary Intormation] [Proprietary Information]

Net Income [Proprietary Information] [Proprietary Information] [Proprietary Information] [Proprietary Intormation] [Proprietary Information]

3

NORTHWEST MEDICAL ISOTOPES Pursuant to 10 CFR 50.33(f)(2), the sources of funds to cover these costs will be funded from the expected revenues associated with the sale of 99Mo. NWMI expects that such revenue will be significantly more than the operating costs incurred.

NWMI prepared an RPF operations base estimate based on previous and similar projects, and the cost base estimating. The base estimate also used inputs from NWMI's preliminary RPF time-cycle logistical study, which includes data for labor requirements, materials, and operations and maintenance. NWMI has developed clear and concise documentation for traceability that will allow future updates, review, and validation of the estimate.

Financial Ability to Safely Decommission a Facility - NWMI will provide financial information that demonstrates reasonable assurance that funds will be available to decommission the RPF in accordance with 10 CFR 50.33(f), as part of the Operating License Application. This financial information will be submitted in accordance with 10 CFR 50.75(d), "Reporting and Recordkeeping for Decommissioning Planning."

Pursuant to 10 CFR 50.75(e), the NWMI RPF Decommissioning Plan will provide financial assurances, including a cost estimate for RPF decommissioning, identification of which method(s) will be used to provide funds for decommissioning, and a description of the means of adjusting the cost estimate and associated funding level periodically over the operational life of the RPF to account for changes in labor, energy, and waste disposal.

Based on previous experience and discussions with nuclear industry experts, NWMI's preliminary cost estimate for decommissioning the RPF is [Proprietary Information]. NWMI's current business strategy anticipates that the decommission of the RPF will be financed by an external escrow account in which deposits will be made annually, coupled with either a surety method, insurance, or some other form of guarantee. Financial projections assume that the annual escrow deposit will be approximately

[Proprietary Information] per year, and adjusted for inflation periodically, which provides reasonable assurance that decommissioning funds will be available for the RPF. NWMI's RPF Decommissioning Plan with detailed costs and associated financial assurances will be provided in the operating license application. The estimated costs of decommissioning will be developed using the analysis of the RPF design and the analysis of estimates and actual costs of decommissioning similar facilities.

Foreign Ownership, Control, or Domination - NWMI understands that the NRC will evaluate our application in a manner that is consistent with the guidance provided in the Standard Review Plan (SRP) regarding "Foreign Ownership, Control, or Domination of applicants for Reactor Licenses," June 1999, referred to as the "SRP on FOCD." This evaluation will determine whether NWMI is owned, controlled, or dominated by an alien, a foreign corporation, or a foreign government.

The NRC's position outlined in the SRP on FOCD states "the foreign control prohibition should be given an orientation toward safeguarding the national defense and security." Furthermore, the SRP on FOCD outlines how the effects of foreign ownership may be mitigated through implementation of a "negation action plan" to ensure that any foreign interest is effectively denied control or domination over the applicant.

NWMI fully understands that a financial analyst will review all of the information submitted by the company to determine whether there is FOCD. If it is determined that there is FOCD, additional action would be necessary to negate FOCD, and the applicant would be advised and requested to submit a Negative Action Plan. "

NWMI is a limited liability company organized under the laws of the state of Oregon. NWMI is not owned, controlled, or dominated by alien, foreign corporation, or foreign government. In addition, NWMI is not acting as an agent or representative of another person or company in filing the Construction Permit Application.

4

NORTHWEST MEDICAL ISOTOPES NWMI is governed and managed by a six-member Board of Managers, all of whom are U.S. citizens.

NWMI currently has 18 members. To the best of our knowledge, all members holding more than one percent of NWMI's membership interests are U.S. citizens or entities owned or controlled by U.S.

citizens.

Construction Earliest and Latest Date for Construction Completion [10 CFR 50.33(h)]

NWMI currently expects to complete construction of the facility at the earliest and latest by fourth quarter 2016 and first quarter 2017, respectively.

2. Fee Information in Accordance with 10 CFR 50.30(e) and 10 CFR 170.21 NWMI shall pay fees in accordance with 10 CFR 50.30(e) and 10 CFR 170.21, "Schedule of Fees for Production or Utilization Facilities, Review of Standard Referenced Design Approvals, Special Projects, Inspections, and Import and Export Licenses," Facility Category G, "Other Production or Utilization Facility." NWMI shall pay "Full Cost" fees for the following categories of services:

" Application for Construction Permit

" Construction Permit

" Operating License

  • Amendment, Renewal, and Other Approvals

" Inspections.

Fees will be paid pursuant to 10 CFR 170.1, 170.12, and 170.20.

3. Classified Information Agreement in Accordance with 10 CFR 50.37 NWMI will not allow access to Restricted Data or classified National Security Information until the individual and/or the facility has been approved for access under provisions of 10 CFR 25, "Access Authorization," and/or 10 CFR 95, "Facility Security Clearance and Safeguarding of National Security Information and Restricted Data."

I declare under penalty of perjury that the foregoing is true and correct. Executed on January 30, 2015.

Sincerely, Carolyn C. Haass Vice President Northwest Medical Isotopes, LLC Project No.: Project No. 0803 5

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