Letter Sequence Response to RAI |
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Administration
- Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance
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MONTHYEARML13172A3612013-05-31031 May 2013 Part Two of the Shine Medical Technologies, Inc. Application for Construction Permit Project stage: Request ML13269A3782013-09-25025 September 2013 Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan Project stage: Other ML14119A0432014-03-17017 March 2014 Affidavit for Shine Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting Project stage: Request ML14121A5342014-05-0808 May 2014 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML14195A1592014-09-19019 September 2014 Shine Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML14356A5282014-12-0303 December 2014 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15005A4072015-01-0606 January 2015 Shine Medical Technologies, Inc., Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15043A3952015-02-0606 February 2015 Shine Medical Technologies, Inc. - Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15037A2492015-03-0303 March 2015 Shine Medical Technologies, Inc., - Proposed Review Schedule, Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures Project stage: Other ML15037A1082015-03-0404 March 2015 Federal Register Notice - Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information for Contention Preparation on a Construction Permit f Project stage: Request ML15092A4072015-03-23023 March 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information 11.1-9 Project stage: Response to RAI ML15055A1162015-03-25025 March 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15120A2412015-04-10010 April 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15099A6072015-04-15015 April 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit(Tac Nos. MF2305, MF2307, and MF2308) Project stage: RAI ML15131A4622015-05-0101 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15147A2032015-05-14014 May 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15140A7342015-05-20020 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information 13a2.2-5 Project stage: Response to RAI ML15140A7222015-05-21021 May 2015 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7232015-05-21021 May 2015 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7242015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7252015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7262015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7312015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15161A3432015-05-21021 May 2015 Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Revisions Resulting from Request for Additional Information Responses Project stage: Request ML15175A2132015-06-16016 June 2015 Shine Medical Technologies V. 0 - Chapter 06 - Engineered Safety Features Project stage: Request ML15175A1312015-06-16016 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit Revision to Sections 13b.3 and 19.4 of the Preliminary Safety Analysis Report Project stage: Request ML15183A2902015-06-19019 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15222A2012015-07-23023 July 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information 6b.3-30 Project stage: Response to RAI ML15236A1272015-08-0707 August 2015 Shine Medical Technologies, Inc. Application for Construction Permit Submittal of Atkins-NS-TR-SHN-15-06, Revision 1 Project stage: Request ML15219A3032015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A2632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3352015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1822015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3852015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A4252015-08-27027 August 2015 Shine Medical Technologies Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15244A7712015-08-27027 August 2015 Draft Request for Additional Information Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Supporting a Construction Permit Application Project stage: Draft RAI ML15244A5062015-08-27027 August 2015 E-mail from Steven Lynch to Jim Costedio Transmitting Draft Request for Additional Information Supporting Shine PSAR Project stage: Draft RAI ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15259A0242015-09-15015 September 2015 Shine Medical Technologies, Inc. - Application for Construction Permit, Revision 1 of Shine Response to Request for Additional Information 6b.3-34 Project stage: Response to RAI ML15259A1642015-09-24024 September 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15267A2912016-01-0606 January 2016 June 19, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15267A2672016-01-0606 January 2016 July 23, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance 2015-04-15
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Category:License-Application for Construction Permit DKT 50
MONTHYEARML22279A9512022-10-0606 October 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML22091A0932022-04-0101 April 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML21232A6202021-08-20020 August 2021 Shine Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 - Response to Request for Additional Information ML21119A1682021-04-29029 April 2021 Enclosure 2: Request to Amend Construction Permit No. CPMIF-001 ML18347A2152018-12-11011 December 2018 Shine Medical Technologies - Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information ML15258A3692015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 01 - the Facility ML15258A4302015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.5.2-006 Through 19.5.2-009 ML15258A4292015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.5.2-001 Through 19.5.2-005 ML15258A4282015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.4.1-001 Through 19.4.13-001 ML15258A4262015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.3.4-001 Through 19.3.4-008 ML15258A4242015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.3.3-001 Through 19.3.3-007 ML15258A4232015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.3.2-001 Through 19.3.2-036 ML15258A4222015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.3.1-007 Through 19.3.1-009 ML15258A4202015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Figures 19.2.1-001 Through 19.2.3-001 ML15258A4182015-08-27027 August 2015 Shine Medical Technologies V. 0 - Section 19.07 - References ML15258A4172015-08-27027 August 2015 Shine Medical Technologies V. 0 - Section 19.06 - Conclusions ML15258A4162015-08-27027 August 2015 Shine Medical Technologies V. 0 - Section 19.05 - Alternatives ML15258A4152015-08-27027 August 2015 Shine Medical Technologies V. 0 - Section 19.04 - Impacts of Proposed Construction, Operations, and Decommissioning ML15258A4142015-08-27027 August 2015 Shine Medical Technologies V. 0 - Section 19.03 - Description of the Affected Environment ML15258A4132015-08-27027 August 2015 Shine Medical Technologies V. 0 - Section 19.02 - Proposed Action ML15258A4122015-08-27027 August 2015 Shine Medical Technologies V. 0 - Section 19.01 - Introduction to the Environmental Report ML15258A4192015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 19 - Environmental Review ML15258A4112015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 12 - Figure 12.1-001 ML15258A4102015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 11 - Figures 11.1-001 and 11.1-003 ML15258A4092015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 09 - Figures 9b.2-001 Through 9b.7-008 ML15258A4082015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 09 - Figures 9a2.1-001 Through 9a2.7-001 ML15258A4072015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 08 - Figure 8a2.2-001 ML15258A4062015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 08 - Figure 8a2.1-001 ML15258A4042015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 07 - Figures 7a2.1-001 Through 7a2.6-002 ML15258A3892015-08-27027 August 2015 Shine Medical Technologies V. 0 - PSAR Master Table of Contents ML15258A3702015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 02 - Site Characteristics ML15258A3902015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 01 - Figures 1.3-001 Through 1.3-006 ML15258A3912015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 02 - Figures 2.1-001 Through 2.1-026 ML15258A3922015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 02 - Figures 2.2-001 Through 2.2-002 ML15258A3932015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 02 - Figures 2.3-001 Through 2.3-036 ML15258A3982015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 02 - Figures 2.5-007 Through 2.5-023 ML15258A3712015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 03 - Design of Structures, Systems, and Components ML15258A3722015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 04 - Irradiation Unit and Radioisotope Production Facility Description ML15258A3732015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 05 - Cooling Systems ML15258A3742015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 06 - Engineered Safety Features ML15258A3752015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 07 - Instrument and Control Systems ML15258A3782015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 08 - Electrical Power Systems ML15258A3792015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 09 - Auxiliary Systems ML15258A3812015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 11 - Radiation Protection Program and Waste Management ML15258A4052015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 07 - Figure 7b.2-001 ML15258A4032015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 05 - Figures 5a2.1-001 Through 5a2.4-001 ML15258A4022015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 04 - Figures 4b.3-001 Through 4b.4-007 ML15258A4002015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 04 - Figures 4a2.1-001 Through 4a2.8-002 ML15258A3992015-08-27027 August 2015 Shine Medical Technologies V. 0 - Chapter 03 - Figures 3.4-001 Through 3.4-014 2022-04-01
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jSHINETh Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 May 14, 2015 SMT-2015-018 10 CFR 50.30 50- 606 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A324)
(3) NRC letter to SHINE Medical Technologies, Inc., dated April 15, 2015, SHINE Medical Technologies, Inc. -Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML15099A607)
SHINE Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2). Via Reference (3), the NRC staff determined that additional information was required to enable the staff's continued review of the SHINE construction permit application.
Enclosure 1 provides the non-public (proprietary) version of the SHINE response to the NRC staff's request for additional information.
Enclosure 1 is being provided via optical storage media (OSM) as OSM#1. Enclosure 1 contains security-related information which was identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31.SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.Enclosure 2 provides the public (non-proprietary) version of the SHINE response to the NRC staff's request for additional information.
Enclosure 2 is being provided via OSM as OSM#2.Enclosure 1 contains security-related information.
Enclosure 3 contains both proprietary and security-related information.
Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.
2555 Industrial Drive I Monona, WI 53713 1 P (608) 210-1060 1 F (608) 210-2504 1 www.shinemed.com Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 Enclosure 3 provides a non-public (proprietary) revision to the SHINE Preliminary Safety Analysis Report (PSAR), incorporating changes based on the SHINE responses to the NRC staff's request for additional information.
Enclosure 3 is provided via OSM as OSM#3.In addition to proprietary information, Enclosure 3 contains security-related information which was identified utilizing the guidance contained RIS 2005-31. SHINE requests that the NRC withhold Enclosure 3 from public disclosure under 10 CFR 2.390.Enclosure 4 provides a public (non-proprietary) revision to the SHINE PSAR, incorporating changes based on the SHINE responses to the NRC staff's request for additional information.
Enclosure 4 is provided via OSM as OSM#4.Enclosure 5 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information pursuant to 10 CFR 2.390. Enclosure 3 contains information proprietary to SHINE.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.
If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.
I declare under the penalty of perjury that the foregoing is true and correct.Executed on May 14, 2015.Very truly yours, m, Ph.D.Chief Operating Officer SHINE Medical Technologies, Inc.Docket No. 50-608 Enclosures cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosures 1 and 3)Enclosure 1 contains security-related information.
Enclosure 3 contains both proprietary and security-related information.
Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.
ENCLOSURE1 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION NON-PUBLIC VERSION (OSM#1),%ISHINE Mdcal Technologies SMT-201 5-018 SHINE Medical Technologies, Inc.Application for Construction Permit Response to Request for Additional Information N~. Non-Public Version (OSM#1)Enclosure 1 contains security-related information.
Enclosure 3 contains both proprietary and security-related information.
Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.
ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION PUBLIC VERSION (OSM#2)HN SHINE Medical Technologies SMT-201 5-018 SHINE Medical Technologies, Inc.Application for Construction Permit Response to Request for Additional Information
'K Public Version (OSM#2)
ENCLOSURE 3 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION PRELIMINARY SAFETY ANALYSIS REPORT NON-PUBLIC VERSION (OSM#3)Enclosure 1 contains security-related information.
Enclosure 3 contains both proprietary and security-related information.
Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.
ENCLOSURE 4 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION PRELIMINARY SAFETY ANALYSIS REPORT PUBLIC VERSION (OSM#4)
ENCLOSURE 5 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION AFFIDAVIT OF RICHARD VANN BYNUM 2 pages follow
))ss.COUNTY OF DANE )I, Richard Vann Bynum, Chief Operating Officer of SHINE Medical Technologies, Inc. (SHINE), do hereby affirm and state: 1. I am authorized to execute this affidavit on behalf of SHINE. I am authorized to review information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from public disclosure.
The purpose of this affidavit is to provide the information required by 10 CFR 2.390(b) in support of SHINE's request for proprietary treatment of certain confidential commercial and financial information submitted in the SHINE response to the NRC staff's requests for additional information transmitted by letter SMT-2015-018 with enclosures.
SHINE requests that the confidential information contained in Enclosure 3 be withheld from public disclosure in its entirety.2. I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential.
- 3. Pursuant to the provisions of paragraph (a)(4) of 10 CFR 2.390, the following is furnished for consideration by the NRC in determining whether the information sought to be withheld from public disclosure should be withheld.a. The information sought to be withheld from public disclosure contained in Enclosure 3 of SMT-2015-018 is owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality.
This information is and has been held in confidence by SHINE.b. The information sought to be protected in Enclosure 3 is not available to the public to the best of my knowledge and belief.1
- c. The information contained in Enclosure 3 is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial financial information, commercial information, or information that is subject to export controls.
SHINE limits access to these elements to those with a "need to know," and subject to maintaining confidentiality.
- d. The proprietary information sought to be withheld from public disclosure in Enclosure 3 includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope facility, process and system locations, and process details. This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings.
Public disclosure of the information in Enclosure 3 would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality.
- e. Public disclosure of the information in Enclosure 3 would create substantial harm to SHINE because it would reveal valuable business information regarding SHINE's competitive expectations, assumptions, processes, and current position.
Its use by a competitor could substantially improve their competitive position in the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.f. The information contained in Enclosure 3 of SMT-2015-018 is transmitted to the NRC in confidence and under the provisions of 10 CFR 2.390; it is to be received in confidence by the NRC. The information is properly marked.I declare under the penalty of perjury that the foregoing is true and correct.Executed on May 14, 2015.Va~n~nBynum, Ph.D.COO -SHINE Medical Technologies, Inc.2