SEC Comment Letter for VIVOS INC (RDGL) (CIK 0001449349) (RDGL) — Nov 1, 2011
VIVOS INC (RDGL) (CIK 0001449349)
Date: Nov. 1, 2011 · CIK: 0001449349 · Accession: 0000000000-11-063584
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November 1, 2011
Via Facsimile
Mr. L. Bruce Jolliff Chief Financial Officer Advanced Medical Isotope Corporation 6208 W Okanogan Ave. Kennewick, WA 99336
RE: Advanced Medical Isotope Corporation
Form 10-K for the Fiscal Ye ar ended December 31, 2010
Filed March 1, 2011
Form 10-Q for the Fiscal Quarter ended June 30, 2011 Filed August 4, 2011 File No. 0-53497
Dear Mr. Jolliff:
We have reviewed your filings and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response. If you do not believe our comments apply to your fact s and circumstances or do not
believe an amendment is appropriate, pl ease tell us why in your response.
After reviewing any amendment to your filing and the information you provide in
response to these comments, we ma y have additional comments.
Form 10-K for the Year Ended December 31, 2010
Facing Page
1. Please update Advanced Medical Isotope’s EDGAR company profile to reflect the current
address of its principal executive offices.
Mr. L. Bruce Jolliff Advanced Medical Isotope Corporation November 1, 2011 Page 2
Item 1 – Business, page 1
Manufacturing, page 4; Customers, page 5, Re search and Development/Intellectual Property,
page 6
2. Please file the affiliation agreement with United Pharmacy Partners Inc., the research
agreements with the University of Utah and the University of Missouri, and the license
agreements for the patent rights with the Un iversity of Missouri and Battelle Memorial
Institute as exhibits to the Form 10-K. See
Item 601(b)(10) of Regulation S-K.
Customers, page 5
3. Disclosure that sales to customers whose sales were greater than 10% of total sales for the
year ended December 31, 2009 totaled 70.3% is inconsistent with disclosure under
“Accounts Receivable” in note 13 to the financia l statements that one customer represented
61.3% and 70.0% of total revenues for th e years ended December 31, 2010 and 2009. In
future filings, disclose in the business section sales to any customer on an individual basis
whose sales were greater than 10% of total sales for the periods presented in the financial statement.
License Agreement, page 6
4. Disclosure indicates that Advanced Medical Is otope acquired the assets , including a license
agreement with the Regents of the University of California, of Neu-Hope Technologies, Inc.
from UTEK Corporation. Please file the license agreement as an exhibit to the Form 10-K.
See
Item 601(b)(10) of Regulation S-K.
Item 1A – Risk Factors, page 9
We were in default on our capital lease obligations, page 9
5. Please file the agreements representing the capita l lease obligations as exhibits to the Form
10-K. See
Item 601(b)(10) of Regulation S-K.
Item 2 - Properties, page 16; Contractual Obli gations (payments due by period as of December
31, 2010), page 24
6. Disclosures indicate that Adva nced Medical Isotope has ente red into lease agreements.
Advise what consideration Advanced Medical Isotope has given to filing the lease agreements as exhibits to the Form 10-K. See
Item 601(b)(10) of Regulation S-K.
Mr. L. Bruce Jolliff Advanced Medical Isotope Corporation November 1, 2011 Page 3
Item 5 – Market for Registrant’s Common E quity, Related Stockholder Matters and Issuer
Purchases of Equity Securities, page 17
Securities Authorized for Issuance Unde r Equity Compensation Plans, page 18
7. Disclosure indicates that Advanced Me dical Isotope has individual compensation
arrangements under which equity securities ar e authorized for issuance in exchange for
consideration in the form of goods or services. Advise what consideration Advanced
Medical Isotope has given to f iling the individual compensation a rrangements as exhibits to
the Form 10-K. See
Item 601(b)(10) of Regulation S-K.
Item 9A(T) – Controls and Procedures, page 32
Management’s Annual Report on Internal C ontrol Over Financial Reporting, page 32
8. Disclosure indicates that manage ment has determined that there is a material weakness due to
the lack of segregation of duties in Advan ced Medical Isotope’s internal control over
financial reporting as of December 31, 2010. In view of this disclosure, tell us how
Advanced Medical Isotope’s chief executive officer and chief financial officer were able to
conclude that its disclosure controls and pr ocedures were effective as of December 31, 2010.
Please also revise to disclose wh en this weakness was identified.
9. You disclose that you had a material weakness due to the lack of segreg ation of duties, but it
does not appear that you disclosed whether or not your internal control over financial
reporting was effective. As such, please disclo se your conclusion as to whether your internal
control over financial reporting wa s effective or ineffective, whic hever the case may be, in an
amendment to your Form 10-K. See Item 308 of Regulation S-K.
Item 10 – Directors, Executive Officer s and Corporate Governance, page 34
Background and Business Experien ce, page 34; Identification of Significant Employees, page 35
10. In future filings, describe br iefly the business experience duri ng the past five years of Mr.
Bruce W. Ratchford and Drs. Robert E. Sche nter, Michael K. Korenko, Nigel R. Stevenson,
and Donald A Ludwig. See Item 401(e)(1) of Regulation S-K.
Involvement in Certain Le gal Proceedings, page 36
11. Item 401(f) of Regulation S-K requires disclosure of specified events that occurred during
the past 10 years. Please confirm this to us and revise in future filings.
Mr. L. Bruce Jolliff Advanced Medical Isotope Corporation November 1, 2011 Page 4
Item 11 – Executive Compensation, page 38
Summary Compensation Table, page 38
12. Supplementally, please explain why you are reporting the extra payments to Mr. Jolliff in the
salary column.
Item 15 – Exhibits, page 44
Signatures, page 45
13. Advanced Medical Isotope’s c ontroller or principa l accounting officer also must sign the
annual report on Form 10-K. Further, any person who occupies more than one of the specified positions, for example, principal financial officer and controller or principal accounting officer, must indicate each capaci ty in which he signs the report. See
subparagraphs (a) and (b) General Instruction D(2) to Form 10-K, and revise in future filings.
Financial Statements
Report of Independent Registered Public Accounting Firm, page F-2
14. Please make arrangements with your auditor to revise their report to include language that
refers to substantial doubt about your ability to continue as a going conc ern. Please refer to
paragraphs .12 - .16 of AU Section 341. Please in clude this revised auditor’s report in your
amended Form 10-K, along with an explanatory paragraph at the begi nning of the amended
Form 10-K that explains to inve stors the reasons you are filing an amendment. Ensure that
you include certifications that are currently dated and refer to the Form 10-K/A.
Statements of Operations, page F-4
15. Since you do not allocate a portion of your deprec iation and amortization expense to cost of
goods sold, please remove the gross profit subt otal from the face of your statements of
operations in future filings. In addition, in futu re filings please also e ither remove the gross
profit and gross margin measures and any relate d discussions from the rest of your filing or
identify these measures as non-GAAP measures and ensure you comply with the disclosure
requirements set forth in Item 10(e) of Regulation S-K.
Form 10-Q for the Quarter Ended June 30, 2011
General
16. Please address the above comments in your in terim filings as well, as applicable.
Mr. L. Bruce Jolliff Advanced Medical Isotope Corporation November 1, 2011 Page 5
Item 4 – Controls and Procedures, page 31
Changes in Internal Control over Financial Reporting, page 31
17. You disclose that there has been no change in your internal control over financial reporting
that occurred during your first fiscal quarter of 2011. Given th at this Form 10-Q is for your
second fiscal quarter of 2011, pleas e ensure that you refer to the appropriate period in future
filings. Refer to Item 308 of Regulation S-K.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comments, please provi de a written statement from the company
acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
You may contact Edward M. Ke lly, Senior Counsel, at (202) 551-3728 or, in his absence,
Craig E. Slivka, Special Counsel , at (202) 551-3729 if you have a ny questions regarding legal or
disclosure matters. Please contact Jeffrey Gor don, Staff Accountant, at (202) 551-3866 or, in his
absence, the undersigned at (202) 551-3769 if you have questions regarding comments on the
financial statements and related matters. Sincerely, /s/ Rufus Decker Rufus Decker Accounting Branch Chief