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SEC Comment Letter for PharmaCyte Biotech, Inc. (PMCB) (CIK 0001157075) (PMCB) — Apr 24, 2014

PharmaCyte Biotech, Inc. (PMCB) (CIK 0001157075)
Date: April 24, 2014 · CIK: 0001157075 · Accession: 0000000000-14-020830

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
April 24, 2014
Author
/s/ Daniel Greenspan for
Form
UPLOAD
Company
PharmaCyte Biotech, Inc. (PMCB) (CIK 0001157075)

Letter

April 24, 2014 Via E -mail Kenneth L. Waggoner Chief Executive Officer and President Nuvilex, Inc. 12510 Prosperity Drive Suite 310 Silver Spring, Maryland 20904

Re: Nuvilex, Inc. Form 10-K Filed July 29, 2013 File No. 333 -68008

Dear Mr. Waggoner :

We have reviewed your filing an d 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 advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstance s or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments.

Item 1. Business

1. We note your disclosure that you, SG Austria and Austrianova Singapore Private Limited “are now partners working together on multiple fronts.” Please expand your disclosure to more specifically describe your partnership activities and arrangeme nts, including the terms of any material contracts. If any such contracts exist, please also file them as exhibits.

Kenneth L. Waggoner Nuvilex, Inc. April 24, 2014 Page 2

Cell Therapy Product Development , page 5

2. We note your reference to the “successfully” completed Phase 1/2 studies of your live - cell encapsulation technology in the treatment of pancreatic cancer. Please expand your description of these trials to provide specific details, parameters and results of the studies, including:

 Date(s) of trials and location;  Identity of trial sponsor(s);  Trial design (e.g., single -arm, open label);  Patient information (e.g., number of patients enrolled and treated and the criteria for participation in the study);  Duration of treatment and dosage information (both amount and frequency);  Specific clinical endpoints established by the trial protocol;  Observational metrics utilized and the actual results observed;  Comparisons to standard of care; and  Conclusions drawn and the extent to which the data suggested safety and/or efficacy, including whether stati stical significance was demonstrated. Please include a brief discussion of the importance and use of statistical significance in clinical trial analytics, including a discussion of “p -values”

Patents, Intellectual Property and Trade Secrets, page 9

3. We note your statement that “Nuvilex and its subsidiaries…own, co -own or have exclusive worldwide licensing rights to numerous patents in multiple countries over four technical areas: live cell encapsulation, pigment modification, microencapsulation and disinfectant/germicidal compositions.” For each of these technical areas, please expand your disclosure to provide your material patents and any pending patent applications to the extent you have not already done so, including the following:

 A list of speci fic products, product groups and technologies to which such patents relate;  Whether such patents are owned or licensed from third parties;  Type of patent protection such as composition of matter, use or process;  Patent expiration dates;  Identification of a ll applicable jurisdictions, including non -U.S.; and  Contested proceedings and/or third -party claims

4. We note your discussion of your rights to the material patents owned by Bavarian Nordic and GSF. Please file any agreements governing these rights betwee n Bio Blue Bird or other related entities and Bavarian Nordic and GSF, as well as any other material license agreements, as exhibits pursuant to Item 601(b)(10) of Regulation S -K. In addition,

Kenneth L. Waggoner Nuvilex, Inc. April 24, 2014 Page 3

please provide a detailed discussion of any such agreement(s) that sets forth the material terms of the agreement(s). These include the following, as applicable:

 Nature and scope of the intellectual property transferred;  Duration of agreement and of any royalties owed;  Termination provisions;  Investment features or share purchases; and  A description of any other material rights and obligations of the parties , including material payment obligations, which may include:

o Aggregate amounts paid or received to date under agreement; o Aggregate future potential milestone payments to be paid or received; o Royalty rates; o Profit or revenue -sharing provisions; and o Minimum purchase requirements, if applicable

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Recent Issuance of Unregistered Securities, page 16

5. In compliance with Item 701 of Regulation S -K, for each issuance of unregistered securities within the past three years, please name the persons or identify the class of persons to whom the securities were sold and indicate the section of the Securities Act or the rule of the Commission under which exemption from registration was claimed and state briefly the facts relied upon to make the exemption available.

Item 11. Executive Compensa tion, page 39

6. Please provide all of the disclosure required by Item 402(p) of Regulation S -K, “Outstanding Equity Awards at Fiscal Year -End.”

Item 15. Exhibits, page 44

7. Please file the employment agreements of all of your named executive officers, including Patricia Gruden, Dr. Robert F. Ryan and Dr. Gerald W. Crabtree as exhibits to your Form 10-K and include such in your list of exhibits.

8. We note that the Third Addendu m to Asset Purchase Agreement by and between Nuvilex and SG Austria, dated June 25, 2013 and listed as Exhibit 2.6 to your Form 10 -K (incorporated by reference to Form 8 -K filed July 17, 2013) omits well over one hundred pages of the agreement. Please ref ile this agreement in its entirety. If you wish to request confidential treatment under Exchange Act Rule 24b -2, you may do so by following the procedures set forth in the Division of Corporation Finance’s Staff Legal Bulletin 1A, available at http://www. sec.gov/interps/legal/slbcf1r.htm.

Kenneth L. Waggoner Nuvilex, Inc. April 24, 2014 Page 4

Item 13. Certain Relationships and Related Transactions, and Director Independence, page 43

9. Please provide all of the disclosure required by Item 404 of Regulation S -K, “Transactions with Related Persons.” Specifically, you must disclose the information required by Item 404(a) with respect to all qualifying transactions since the beginning of your last fiscal year and provided information concerning your policy and procedures for reviewing and approving related party tran sactions required by Item 404(b).

Signatures, page 46

10. Please amend your 10 -K to provide the signature of your Principal Accounting Officer.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be cert ain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible fo r the accuracy and adequacy of the disclosures they have made.

In responding to our comments, please provide a written statement from the company acknowledging that:

 the company is responsible for the adequacy and accuracy of the disclosure in the fil ing;

 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 Co mmission or any person under the federal securities laws of the United States.

Please contact Christina De Rosa at (202) 551 -3577, Dan Greenspan at (202) 551 -3623 or me at (202) 551 -3715 with any questions.

Sincerely,
/s/ Daniel Greenspan for

Show Raw Text
April 24, 2014

Via E -mail
Kenneth L. Waggoner
Chief Executive Officer and President
Nuvilex, Inc.
12510 Prosperity Drive
Suite 310
Silver Spring, Maryland 20904

Re: Nuvilex, Inc.
 Form 10-K
Filed July 29, 2013
File No. 333 -68008

Dear Mr. Waggoner :

We have reviewed your filing an d 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 advising us when you will provide the requested
response.   If you do not believe our comments apply to your facts and circumstance s or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your filing and the information you provide in
response to these  comments, we may have  additional comments.

Item 1.  Business

1. We note your disclosure that you, SG Austria and Austrianova Singapore Private Limited
“are now partners working together on multiple fronts.”  Please expand your disclosure to
more specifically describe your partnership activities and arrangeme nts, including the
terms of any material contracts.  If any such contracts exist, please also file them as
exhibits.

Kenneth L. Waggoner
Nuvilex, Inc.
April 24, 2014
Page 2

 Cell Therapy Product Development , page 5

2. We note your reference to the “successfully” completed Phase 1/2 studies of your live -
cell encapsulation technology in the treatment of pancreatic cancer.  Please expand your
description of these trials to provide specific details, parameters and results of the studies,
including:

 Date(s) of trials and location;
 Identity of trial sponsor(s);
 Trial design (e.g., single -arm, open label);
 Patient information (e.g., number of  patients enrolled and treated and the criteria
for participation in the study);
 Duration of treatment and dosage information (both amount and frequency);
 Specific clinical endpoints established by the trial protocol;
 Observational metrics utilized and the actual results observed;
 Comparisons to standard of care; and
 Conclusions drawn and the extent to which the data suggested safety and/or
efficacy, including whether stati stical significance was demonstrated.  Please
include a brief discussion of the importance and use of statistical significance in
clinical trial analytics, including a discussion of “p -values”

Patents, Intellectual Property and Trade Secrets, page 9

3. We note your statement that “Nuvilex and its subsidiaries…own, co -own or have
exclusive worldwide licensing rights to numerous patents in multiple countries over four
technical areas:  live cell encapsulation, pigment modification, microencapsulation and
disinfectant/germicidal compositions.”   For each of these technical areas, please expand
your disclosure to provide your material patents and any pending patent applications to
the extent you have not already done so, including the following:

 A list of speci fic products, product groups and technologies to which such patents
relate;
 Whether such patents are owned or licensed from third parties;
 Type of patent protection such as composition of matter, use or process;
 Patent expiration dates;
 Identification of a ll applicable jurisdictions, including non -U.S.; and
 Contested proceedings and/or third -party claims

4. We note your discussion of your rights to the material patents owned by Bavarian Nordic
and GSF.  Please  file any agreements governing these rights betwee n Bio Blue Bird or
other related entities and Bavarian Nordic and GSF, as well as any other  material license
agreements, as exhibits pursuant to Item 601(b)(10) of Regulation S -K.  In addition,

Kenneth L. Waggoner
Nuvilex, Inc.
April 24, 2014
Page 3

 please provide a detailed  discussion of any such  agreement(s) that sets forth  the material
terms of the agreement(s).  These include the following, as applicable:

 Nature and scope of the intellectual property transferred;
 Duration of agreement and of any royalties owed;
 Termination provisions;
 Investment features or share purchases; and
 A description of any other material  rights and obligations of the parties , including
material payment obligations, which may include:

o Aggregate amounts paid or received to date under agreement;
o Aggregate future  potential milestone payments to be paid or received;
o Royalty rates;
o Profit or revenue -sharing provisions; and
o Minimum purchase requirements, if applicable

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
Recent Issuance of Unregistered Securities, page 16

5. In compliance with Item 701 of Regulation S -K, for each issuance of unregistered
securities within the past three years,  please name the persons or identify the class of
persons to whom  the securities were sold and indicate  the section of the Securities Act or
the rule of the Commission under which exemption from registration was claimed and
state briefly the facts relied upon to make the exemption available.

Item 11. Executive Compensa tion, page 39

6. Please provide all of the disclosure required by Item 402(p) of Regulation S -K,
“Outstanding Equity Awards at Fiscal Year -End.”

Item 15. Exhibits, page 44

7. Please file the employment agreements of all of your named executive officers, including
Patricia Gruden, Dr. Robert F. Ryan and Dr. Gerald W. Crabtree as exhibits to your Form
10-K and include such in your list of exhibits.

8. We note that the Third Addendu m to Asset Purchase Agreement by and between Nuvilex
and SG Austria, dated June 25, 2013 and listed as Exhibit 2.6 to your Form 10 -K
(incorporated by reference to Form 8 -K filed July 17, 2013) omits well over one hundred
pages of the agreement.  Please ref ile this agreement in its entirety.  If you wish to
request confidential treatment under Exchange Act Rule 24b -2, you may do so by following
the procedures set forth in the Division of Corporation Finance’s Staff Legal Bulletin 1A,
available at http://www. sec.gov/interps/legal/slbcf1r.htm.

Kenneth L. Waggoner
Nuvilex, Inc.
April 24, 2014
Page 4

 Item 13. Certain Relationships and Related Transactions, and Director Independence, page 43

9. Please provide all of the disclosure required by Item 404 of Regulation S -K,
“Transactions with Related Persons.” Specifically, you must disclose the information
required by Item 404(a) with respect to all qualifying transactions since the beginning of
your last fiscal year and provided information concerning your policy and procedures for
reviewing and approving related party tran sactions required by Item 404(b).

Signatures, page 46

10. Please amend your 10 -K to provide the signature of your Principal Accounting Officer.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be cert ain that the filing includes the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require.   Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible fo r the accuracy
and adequacy of the disclosures they have made.

 In responding to our comments, please provide  a written statement from the company
acknowledging that:

 the company is responsible for the adequacy and accuracy of the disclosure in the fil ing;

 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 Co mmission or any person under the federal securities laws of the United States.

Please contact Christina De Rosa at (202) 551 -3577, Dan Greenspan  at (202) 551 -3623  or
me at (202) 551 -3715  with any  questions.

Sincerely,

 /s/ Daniel Greenspan for

 Jeffrey P. Riedler
Assistant Director