SEC Company Response from PharmaCyte Biotech, Inc. (PMCB) (CIK 0001157075) (PMCB) — Jul 11, 2014
PharmaCyte Biotech, Inc. (PMCB) (CIK 0001157075)
Date: July 11, 2014 · CIK: 0001157075 · Accession: 0001019687-14-002710
AI Filing Summary & Sentiment
File numbers found in text: 333-68008
Referenced dates: June 30, 2014
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CORRESP
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July 11, 2014
Mr. Jeffrey P. Riedler
Assistant Director
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Re: Nuvilex, Inc.
Form 10-K for Fiscal Year Ended April 30, 2013
Filed July 29, 2013
Response Dated May 27, 2014
File No. 333-68008
Dear Mr. Riedler:
Nuvilex, Inc. (“Company or Nuvilex”)
hereby provides responses to comments issued in a letter dated June 30, 2014 (“Staff’s Letter”) regarding the
Company’s Annual Report on Form 10-K for the fiscal year ended April 30, 2013 (Form 10-K”) filed with the Securities
and Exchange Commission (“Commission”) on July 29, 2013.
In order to facilitate your review, we have responded
to each of the comments set forth in the Staff’s Letter on a point-by-point basis. The numbered paragraphs respond to the
Staff’s comments and correspond to the numbered paragraphs in the Staff’s Letter. As discussed with the Staff, we
propose to file responsive disclosures in the Company’s Annual Report on Form 10-K for the period ended April 30, 2014 after
resolving the issues raised in the comments below. We expect to file the Form 10-K by July 29, 2014.
Item 1. Business
1. We note your response to our prior comment 1 and
proposed disclosure to be included in footnote 2 to your next annual report on Form 10-K. Instead of or in addition to footnote
2, however, please ensure that the discussion of your relationship and arrangements with SG Austria, Austrianova Singapore, Bio
Blue Bird and Drs. Günzburg and Salmons appears in the body of your annual report under the section entitled “Item 1
– Business.”
12510 Prosperity Drive | Suite
310 | Silver Spring | Maryland 20904-1643
Office: 917.595.2850 | Facsimile: 917.595.2851 | Mobile: 917.595.2852 | kwaggoner@nuvilex.com
Mr. Jeffrey P. Riedler
Assistant Director
Securities and Exchange Commission
Page 2
RESPONSE:
In response to the Staff’s comment, we will modify the following disclosure under
Item 1- Business in our future filings to include the
discussion of our relationship and arrangements with SG Austria Pte. Ltd., Austrianova Singapore Pte. Ltd., Bio Blue Bird AG and
Drs. Walter H. Günzburg and Brian Salmons.
2. We note your statement in response to our prior comment
1 that you will file certain agreements with your next annual report on Form 10-K. Please acknowledge that these agreements include:
· The licenses with Bavarian Nordic A/S and GSF Forschungszentrum fur Unwelt u.
Gesundeit GmbH, obtained in the acquisition of Bio Blue Bird; and
· The Manufacturing Framework Agreement with Austrianova Singapore
In addition, you should also file as exhibits:
· The Master Services Agreements with Inno Biologics and ViruSure;
· The July 2013 license from Austrianova Singapore for the use of its encapsulation
technology in diabetes treatments and the Cell-in-a-Box trademark;
· If a final, definitive agreement has been signed, The Collaborative Research
Agreements with the University of Veterinary Medicine, Vienna and the University of Munich
RESPONSE:
In response to the Staff’s comments, with the exception of the agreements with the University of Veterinary
Medicine Vienna and the University of Munich (which have not yet been finalized), we will file each of the foregoing agreements
as an exhibit to and a description of the material terms in the Business section contained in the Annual Report on Form 10-K we
expect to file by July 29, 2014 for the fiscal year ended April 30, 2014. We note that we will be seeking confidential treatment
under Rule 24b-2 under the Securities Exchange Act of 1934, as amended, for portions of these agreements.
3. We note your response to our prior comment 4. To the
extent such information is not already disclosed, please provide all of the following information for each of your material license
and/or collaboration agreements:
· The nature and scope of any intellectual property transferred;
· The duration of the agreement and of any royalties owed;
Mr. Jeffrey P. Riedler
Assistant Director
Securities and Exchange Commission
Page 3
· A summary of termination provisions;
· Any 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
RESPONSE: The Company proposes to provide the following
additional disclosure in its future filings:
Third Addendum to Asset Purchase Agreement
On May 26, 2011, the Company entered into an
Asset Purchase Agreement (“SG Austria APA”) with SG Austria Pte. Ltd. (“SG Austria”) to purchase 100% of
the assets and liabilities of SG Austria. As a result, Austrianova Singapore Pte. Ltd. ("Austrianova Singapore") and
Bio Blue Bird AG ("Bio Blue Bird"), wholly-owned subsidiaries of SG Austria, were to become wholly owned subsidiaries
of the Company on the condition that the Company pay SG Austria $2.5 million and 100,000,000 shares of the Company’s common
stock and for the Company to receive 100,000 shares of Austrianova Singapore’s common stock and nine Bio Blue Bird bearer
shares.
In June 2011, the Company and SG Austria entered
into a First Addendum to the SG Austria APA to extend the due date for the sums to be paid to SG Austria. In June 2012, the Company
and SG Austria entered into the Second Addendum to the SG Austria APA for the same purpose. In June 2013, the Company and SG Austria
entered into a Third Addendum to the SG Austria APA.
Under the terms of the Third Addendum, the
transaction contemplated by the SG Austria APA was materially changed. The Third Addendum provided that the Company was to acquire
100% of the equity interests in Bio Blue Bird and receive a 14.5% equity interest in SG Austria. In addition, the Company received
nine bearer shares of Bio Blue Bird representing the 100% ownership. Under the Third Addendum, the Company paid: (i) $500,000 to
retire all outstanding debt of Bio Blue Bird; and (ii) $1.0 million to SG Austria. The Company paid SG Austria $1,572,195 in cash
in exchange for its 14.5% equity interest. The Third Addendum returned the original 100,000,000 shares of common stock to the Company
treasury and the 100,000 Austrianova Singapore shares to SG Austria.
Mr. Jeffrey P. Riedler
Assistant Director
Securities and Exchange Commission
Page 4
The acquisition of Bio Blue Bird
provided the Company with exclusive, worldwide licenses to use a proprietary cellulose-based live cell encapsulation
technology for the development of treatments for all forms of cancer with a right to sublicense. The licenses are pursuant to
patents licensed from Bavarian Nordic A/S and GSF-Forschungszentrum für Umwelt u. Gesundeit GmbH (collectively,
“Bavarian Nordic/GSF”). These licenses enable the Company to carry out the research and development of cancer
treatments that are based upon the live cell encapsulation technology known as “Cell-in-a-Box®. The
license relates in general terms to encapsulation of cells that: (i) produce viral particles; (ii) express biomolecules; or
(iii) convert molecules from one form to another pursuant to a License Agreement from Bavarian Nordic/GSF as the licensor and
Bio Blue Bird as the licensee, as amended by an Amendment to License Agreement between the same parties (“License
Agreements”).
The Third Addendum requires the Company to make the following payments
for the purchased assets, which payments were timely made in full under the payment deadlines set forth in the Third Addendum:
· $60,000 payment due under the SG Austria APA;
· A payment of Stamp Duty estimated to be $10-17,000 to the Singapore Government;
· $500,000 to be used to pay off the existing debt of Bio Blue Bird; and
· $1,000,000.
The Third Addendum provides that if the payments listed above are
insufficient or fail to meet specified payment deadlines, the Third Addendum and the SG Austria APA automatically terminate and
shall be deemed null and void.
The Third Addendum requires the Company to pay SG Austria, pursuant
to a manufacturing agreement between the parties, a one-time manufacturing setup fee in the amount of $633,144.05 of which 50%
is required to be paid on the signing of a manufacturing agreement and 50% is required to be paid three months later. In addition,
the Third Addendum requires the Company to pay a fee for producing the final encapsulated cell product of $633.14 per vial of 300
capsules after production with a minimum purchased batch size of 400 vials of any Cell-in-a-Box® product.
The Third Addendum is an outright purchase
and has no “term.” The Third Addendum requires the Company to make future royalty and milestone payments as follows:
· Two percent royalty on all gross sales received by the Company or its affiliates;
· Ten percent royalty on gross revenues received by the Company or its affiliates from
any sublicense or right to use the patents or the licenses granted by the Company or its affiliates;
Mr. Jeffrey P. Riedler
Assistant Director
Securities and Exchange Commission
Page 5
· Milestone payments of $100,000 due 30 days after enrollment
of the first human patient in the first clinical trial for each product; $300,000 due 30 days after enrollment of the first human
patient in the first Phase 3 clinical trial for each product; and $800,000 due 60 days after having a Biologics License Application
(“BLA”) approved at the FDA or a Marketing Authorization Application (“MAA”) approved in Europe or its
equivalent based on the country in which it is accepted for each product; and
· Milestone payments of $50,000 due 30 days after enrollment of
the first veterinary patient in the first trial for each product and $300,000 due 60 days after having a BLA or an MAA or its equivalent
approved based on the country in which it is accepted for each veterinary product.
The Third Addendum granted to Nuvilex a right
of first refusal with respect to any offers made by SG Austria related to the granting of a license with respect to any
patents or technologies related to live cell encapsulation that can be applied to use the Cell-in-a-Box®
technology to create products in the following areas: (i) dermal fillers; (ii) medical marijuana; (iii) diabetes; and (iv)
virally caused infectious diseases.
Licensing Agreement
The Company acquired from
Austrianova Singapore the exclusive, worldwide license to use the cellulose-based live cell encapsulation technology for the
development of a treatment for diabetes and the use of Austrianova Singapore’s
“Cell-in-a-Box®” trademark for this technology with a right to sublicense. The licensed rights
pertain to genetically modified or non-modified non-stem cell lines and certain stem cells specifically designed to produce
insulin or other critical components for the treatment of diabetes.
Under the Licensing Agreement, the Company
is required to make a payment of $2,000,000 in two equal payments of $1,000,000 each. The Company made its first $1,000,000 payment
on October 30, 2013. The second payment of $1,000,000 was made on February 25, 2014.
The Licensing Agreement requires the Company to pay Austrianova
Singapore, pursuant to a manufacturing agreement between the parties, a one-time manufacturing setup fee in the amount of $633,144.05,
of which 50% is required to be paid on the signing of a manufacturing agreement and 50% is required to be paid three months later.
In addition, the Licensing Agreement requires the Company to pay a fee for producing the final encapsulated cell product of $633.14
per vial of 300 capsules after production with a minimum purchased batch size of 400 vials of any Cell-in-a-Box®
product.
Mr. Jeffrey P. Riedler
Assistant Director
Securities and Exchange Commission
Page 6
The Licensing Agreement requires the Company
to make future royalty and milestone payments as follows:
· Ten percent royalty of the gross sale of all products sold by the Company;
· Twenty percent royalty of the amount actually received by the Company from sub-licensees
on sub-licensees’ gross sales value; and
· Milestone payments of $100,000 within 30 days of beginning the first pre-clinical experiments using the encapsulated
cells; $500,000 within 30 days after enrollment of the first human patient in the first clinical trial; $800,000 within 30 days
after enrollment of the first human patient in the first Phase 3 clinical trial; and $1,000,000 due 60 days after having a BLA
approved at the FDA or a MAA approved in Europe or its equivalent based on the country in which it is accepted for each product.
The license under the Licensing Agreement may be terminated and
all rights shall revert to Austrianova Singapore if any of the following milestone events do not occur within the following timeframes:
· If the Company does not enter into a research program with technology in the scope
of the license involving European academic university partners providing a total funding equal to or greater than $400,000 within
three years of the effective date of the Licensing Agreement; or
· If the Company does not enter into a clinical trial or its equivalent for a product
within seven years of the effective date of the Licensing Agreement.
4. Please expand your proposed disclosure
to clarify the factual basis for your statement that “Austrianova Singapore is considered the world’s foremost expert
in this unique and proprietary technology” or make clear that this is your opinion.
RESPONSE: The Company proposes to modify this statement
as follows in future filings: “In our opinion, Austrianova Singapore is the world’s foremost expert in this unique
and proprietary technology. This is based on the fact that its leaders were involved in the discovery and development of cellulose-based
live cell encapsulation technology, in which, to our knowledge, no other company or entity is engaged.”
Mr. Jeffrey P. Riedler
Assistant Director
Securities and Exchange Commission
Page 7
5. We note your statement on the top of page four of your
response letter that “Drs. Günzburg and Salmons together are serving as if they were Nuvilex’s Chief Scientific
Officer(s), and are so in all but name only.” In the following paragraph, you state that “Gunzburg and Salmons have
agreed to function as the ‘Chief Scientific Officers’ of Nuvilex for its preclinical studies and clinical trials in
diabetes.” Please clarify your relationship with Drs. Gunzburg and Salmons, as the extent of their positions and involvement
with Nuvilex is not well defined. Please discuss the specifics of their duties and responsibilities, whether they
are expected to be officially appointed as the company’s Chief Scientific Officers, whether and the extent to which they
are compensated for their services, any contractual restrictions on their use of the company’s proprietary information and
assets, and the specific nature and extent of their involvement in the company’s scientific endeavors. In addition, if the
company’s relationship with Drs. Günzburg and Salmons is governed by contract, please file all applicable contracts
as exhibits and disclose their material terms.
RESPONSE: The Company proposes to include the following
disclosure in its future filings:
“The
Company notes that Drs. Walter H. Günzburg and Brian Salmons are not officially Chief Scientific Officers of Nuvilex
nor is there any plan to appoint them as such. Rather, they function in the capacity of Chief Scientific Officers simply
because all of Nuvilex’s scientific endeavors are centered upon the cellulose-based live cell encapsulation technology
developed by them. They are included in virtually all of the scientific meetings within the Company. They assist the Company
in developing th