SEC Company Response from Advaxis, Inc. (ADXS) (CIK 0001100397) — Jun 1, 2005
Advaxis, Inc. (ADXS) (CIK 0001100397)
Date: June 1, 2005 · CIK: 0001100397 · Accession: 0001144204-05-017832
AI Filing Summary & Sentiment
File numbers found in text: 333-122504
Letter
REITLER BROWN & ROSENBLATT LLC 800 Third Avenue, 21st Floor ----------------------- New York, NY 10022-7604 ATTORNEYS AT LAW Tel (212) 209-3050 Fax (212) 371-5500 June 1, 2005 CONFIDENTIAL VIA OVERNIGHT COURIER The Secretary Securities and Exchange Commission 450 Fifth Street, N.W. Washington, D.C. 20549
RE: Advaxis, Inc. - Amendment No. 3 to Form SB-2 (Registration No. 333-122504) Objection to Public Disclosure of Information ---------------------------------------------
Dear Sir:
In connection with the filing by Advaxis, Inc., a Colorado corporation (the "Company"), of its Amendment No. 3 to Form SB-2 under the Securities Act of 1933, as amended (the "Form SB-2"), the Company hereby applies for an order of the Securities and Exchange Commission (the "Commission"), pursuant to Rule 24b-2 ("Rule 24b-2") promulgated under the Securities Exchange Act of 1934 as amended (the "Act"), granting confidential treatment to selected portions (hereinafter referred to as the "Confidential Information") of that certain Clinical Research Services Agreement, dated April 6, 2005, between Pharm-Olam International Ltd., a Texas limited partnership, and the Company. The Agreement was filed as Exhibit 10.26 to the Form SB-2.
Enclosed is a copy of Exhibit 10.26 clearly marked "CONFIDENTIAL TREATMENT" with the specific portions the Company desires to keep confidential bracketed and highlighted to identify where confidential treatment is requested. With the exception of the Confidential Information, the Agreement has been filed in its entirety as Exhibit 10.26. A copy of Amendment No. 3 to the Form SB-2 is also enclosed for your review.
In accordance with subsection (b) of Rule 24b-2, Exhibit 10.26 was filed with the Form SB-2 with asterisks to indicate that the omitted material was filed separately with the Commission.
The paragraphs below set forth the following:
(I) An explanation of the basis for the Company's request for confidential treatment with respect to the Confidential Portions of the Agreement;
(II) An item by item presentation of the information for which the Company is requesting confidential treatment;
<PAGE>
(III) An explanation of why disclosure of this information is not necessary to protect investors;
(IV) The time period for which confidential treatment is requested with respect to the Agreement and an explanation of the basis for such request;
(V) A representation by the Company of its willingness to permit disclosure to other governmental agencies, offices or bodies (including, without limitation, the Congress) of the Confidential Portions;
(VI) An objection to public disclosure of this letter; and
(VII) The name, address and telephone number of the person to whom all notices and orders issued under this rule at any time should be directed.
I. Basis of Confidential Treatment Request.
Legal Background
Rule 24b-2 of the Act provides that the Commission may grant confidential treatment if it determines that such treatment is justified under the Freedom of Information Act, 5 U.S.C. ss.552 (the "FOIA"). Subsection (b)(4) of 5 U.S.C. ss.552 ("Exemption 4") exempts from the broad public disclosure requirements of the FOIA "trade secrets and commercial or financial information obtained from a person and privileged or confidential." This exemption is intended to protect both the interests of commercial entities that submit proprietary information to the government and the interests of the government in receiving continued access to such data.
According to the decision in Public Citizen Health Research Group v. Food and Drug Administration, 704 F.2d 1280, 1286 (D.C. Cir. 1983), there are two alternative tests under which information could be found to fall within Exemption 4: (i) the information can be found to consist of "trade secrets," in which case no further inquiry is necessary, or (ii) the information can be found to consist of commercial or financial information, in which case the exemption will apply only if such information was obtained on a privileged or confidential basis.
"Trade secret," for purposes of Exemption 4, is a secret, commercially valuable plan, formula, process, or device that is used for making, preparing, compounding, or processing trade commodities and that can be said to be the end product of either innovation or substantial effort. Burnside-Ott Aviation Training Center. Inc. v. United States, 617 F. Supp. 279 (S.D. Fla. 1985).
"Commercial or financial information" has been construed by the courts in accordance with its plain meaning, and broadly encompasses information relating to commerce or compiled in pursuit of profit. Critical Mass Energy Project v. Nuclear Regulatory Commission, 644 F. Supp. 344 (D.D.C. 1986), vacated on other grounds, 830 F.2d 278 (D.C. Cir. 1987). Commercial or financial information is confidential within the meaning of Exemption 4 if it is not customarily released to the public from the person from whom it was obtained, and is likely to impair the Government's ability to obtain necessary information in the future or to cause substantial harm to the competitive position of the person from whom the information was obtained. S.Rep. No. 813, 89th Cong., 1st Sess. 9 (1965); National Parks and Conservation Association v. Morton, 498 F.2d 765 (1974); Burke Energy Corporation v. Department of Energy, 583 F. Supp. 507
<PAGE>
(1984). Evidence revealing actual competition and the likelihood of substantial competitive injury is sufficient to classify commercial information as confidential. Public Citizen, 704 F.2d at 1291.
Company Background and Competitive Environment
The Company is a development stage biotechnology company utilizing multiple mechanisms of immunity with the intent to develop cancer vaccines that are more effective and safer than existing vaccines. To that end, the Company has licensed rights from The Trustees of the University of Pennsylvania ("Penn") to use a patented system to engineer a live attenuated Listeria monocytogenes bacteria (the "Listeria System") to secrete a protein sequence containing a tumor-specific antigen. Using the Listeria System, the Company believes it will force the body's immune system to process and recognize the antigen as if it were foreign, creating the immune response needed to attack the cancer. The Company's licensed Listeria System, developed at Penn over the past 10 years, provides a scientific basis for believing that this therapeutic approach induces a significant immune response to a tumor. Accordingly, the Company believes that the Listeria System is a broadly enabling platform technology that can be applied to many types of cancers. In addition, the Company believes there may be useful applications in infectious diseases and auto-immune disorders.
Reference is also made to the following sections of the Form SB-2, filed with the Commission on February 3, 2005, as amended on April 7, 2005 and as further amended on May __, 2005, as it may be further amended: PROSPECTUS SUMMARY, RISK FACTORS ("We are dependent upon our license agreement with Penn, as well as proprietary technology of others."; "We have no manufacturing, sales, marketing or distribution capability and we must rely upon third parties for such."; "The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises.") and BUSINESS ("Partnerships and Agreements"; "Manufacturing" and "Competition").
General Basis for Confidential Treatment Request
A. Protectable Trade Secrets.
The Company requests confidential treatment of the Confidential Portions contained in the Agreement on the basis that such Confidential Portions contain confidential and commercially valuable technical information of the Company. Specifically, some of the Confidential Portions may describe the range of functions provided by the Company's proprietary technologies, and the plans and processes by which such technologies are applied to address customer specifications - each of which make the Company's services unique and protectable under state and federal intellectual property rights laws. To the extent that the Company is required to publicly disclose Confidential Portions relating to the functions of its proprietary technologies, the Company's competitive advantages vis-a-vis its competitors - who provide similar services using different technologies applied in accordance with different plans and processes - would be materially compromised.
B. Protectable Commercial Information.
The Company has expended considerable time and effort in negotiating the terms of the Agreement. If the Confidential Portions are made public, the Company's competitors will gain an advantage since such competitors will seek to
<PAGE>
negotiate similar or more advantageous terms with potential joint development parties, licensors or licensees. This is particularly true with respect to the provisions regarding pricing and commissions paid to such parties. Public disclosure of the Confidential Portions of the Agreement would provide competitors of the Company with a reference to offer marginally more attractive terms to potential clients thereby undercutting the Company's ability to enter into agreements with others or greatly reducing the competitive position of the Company.
C. Material Adverse Effect on the Formation of New Business Relationships.
Public knowledge of the Confidential Portions of the Agreement would also place the Company in an adverse negotiating position with respect to potential clients. The Company would have great difficulty negotiating similar future agreements on more favorable terms because each potential contracting party, aware of the terms of the Agreement, would be disinclined to accept terms less attractive than those accepted by our current clients and business partners in the Agreement. Further, such potential contracting parties would know what concessions the Company was previously willing to bear. Thus, the Company may be unable to negotiate terms more favorable to it than are present in the Agreement if the Confidential Portions are disclosed.
Public disclosure of the Confidential Portions of the Agreement could also make it very difficult for the Company to enter into similar agreements with third parties in the future, because such entities may be reluctant to contract with the Company if there is a strong likelihood that the sensitive terms of such contracts would be publicly disclosed by the Company. Such potential business partners may be more likely to seek a more substantial partner that would not consider the contract sufficiently material to merit public disclosure (as might be the case with a larger company) or a partner that is not subject to such disclosure obligations.
D. General Considerations.
The Company's Agreement would be worth little to the Company or the other parties to the Agreement if, by reducing their arrangements to writing, they made the public dissemination of commercially sensitive information more likely. Written contracts ensure against future misunderstandings. Public disclosure of such confidential commercial material could be a disincentive to reduce agreements to writing, with a consequent increase in risk to both parties. Additionally, such an approach would impair the government's ability to obtain necessary information in the future.
Finally, disclosure of the Confidential Portions of the Agreement is wholly unnecessary for the protection of investors since such disclosure would not contribute at all to an understanding of the Company's business, and would, for the reasons described above in Sections A-D of this Article I, only compromise the future prospects of the business in which such investors are considering investing.
II. Itemization of Confidential Portions of the Agreement.
The Company requests confidential treatment of the following Confidential Portions of the Agreement, as marked on the enclosed copy. Such Confidential Portions are deal specific negotiated terms which disclosure would
<PAGE>
have a material adverse affect on the business, operations and financial condition of the Company. For a more complete discussion of the reasons that the Confidential Portions require protection, see Articles I and III hereof.
Exhibit 10.26; Agreement. The Agreement is an agreement between the Company and Pharma-Olam International Ltd. ("POI").
Page and Section Reason ---------------- ------ Attachment I Confidential pricing and fee information and confidential commercial information and deal specific negotiated terms Attachment II Confidential commercial information
III. Investors' Interests Protected without Disclosure.
In addition to the foregoing, the Company further believes that disclosure of this information is not necessary for the protection of investors in light of the broad disclosure as to the Company's overall commercial and financial status and the disclosure of a substantial portion of the Agreement in the Form SB-2. Confidential treatment is not requested for the material terms of the Agreement taken as a whole in that the Confidential Portions are specifically limited to proprietary technical and pricing and other commercial provisions. Indeed, the material for which confidential treatment has been requested is limited, and substantially all of the Agreement would otherwise be available for public inspection.
The Confidential Portions of the Agreement are deal specific negotiated terms between the parties and such disclosure would have a material adverse affect on the business, operations and financial conditions of the Company. The Company believes that the only parties that would benefit from public disclosure of such information would be actual and potential competitors of the Company and/or its corporate partners and third parties who could use the Confidential Portions to the substantial detriment of the Company's business interests. For these reasons, the Company believes that disclosure would harm its stockholders and prospective investors. In contrast, knowledge of the Confidential Portions of the Agreement would demonstrate little to an investor with respect to his or her decision to purchase securities.
For the above reasons, the Company believes that disclosure of the Confidential Portions of the Agreement would substantially harm the competitive position of the Company. The information contained in the Confidential Portions is not generally available to the public and the Company
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REITLER
BROWN &
ROSENBLATT LLC 800 Third Avenue, 21st Floor
----------------------- New York, NY 10022-7604
ATTORNEYS AT LAW Tel (212) 209-3050
Fax (212) 371-5500
June 1, 2005
CONFIDENTIAL
VIA OVERNIGHT COURIER
The Secretary
Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549
RE: Advaxis, Inc. - Amendment No. 3 to Form SB-2
(Registration No. 333-122504)
Objection to Public Disclosure of Information
---------------------------------------------
Dear Sir:
In connection with the filing by Advaxis, Inc., a Colorado corporation
(the "Company"), of its Amendment No. 3 to Form SB-2 under the Securities Act of
1933, as amended (the "Form SB-2"), the Company hereby applies for an order of
the Securities and Exchange Commission (the "Commission"), pursuant to Rule
24b-2 ("Rule 24b-2") promulgated under the Securities Exchange Act of 1934 as
amended (the "Act"), granting confidential treatment to selected portions
(hereinafter referred to as the "Confidential Information") of that certain
Clinical Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd., a Texas limited partnership, and the Company. The Agreement
was filed as Exhibit 10.26 to the Form SB-2.
Enclosed is a copy of Exhibit 10.26 clearly marked "CONFIDENTIAL
TREATMENT" with the specific portions the Company desires to keep confidential
bracketed and highlighted to identify where confidential treatment is requested.
With the exception of the Confidential Information, the Agreement has been filed
in its entirety as Exhibit 10.26. A copy of Amendment No. 3 to the Form SB-2 is
also enclosed for your review.
In accordance with subsection (b) of Rule 24b-2, Exhibit 10.26 was
filed with the Form SB-2 with asterisks to indicate that the omitted material
was filed separately with the Commission.
The paragraphs below set forth the following:
(I) An explanation of the basis for the Company's request for
confidential treatment with respect to the Confidential Portions of the
Agreement;
(II) An item by item presentation of the information for which the
Company is requesting confidential treatment;
<PAGE>
(III) An explanation of why disclosure of this information is not
necessary to protect investors;
(IV) The time period for which confidential treatment is requested with
respect to the Agreement and an explanation of the basis for such request;
(V) A representation by the Company of its willingness to permit
disclosure to other governmental agencies, offices or bodies (including, without
limitation, the Congress) of the Confidential Portions;
(VI) An objection to public disclosure of this letter; and
(VII) The name, address and telephone number of the person to whom all
notices and orders issued under this rule at any time should be directed.
I. Basis of Confidential Treatment Request.
Legal Background
Rule 24b-2 of the Act provides that the Commission may grant
confidential treatment if it determines that such treatment is justified under
the Freedom of Information Act, 5 U.S.C. ss.552 (the "FOIA"). Subsection (b)(4)
of 5 U.S.C. ss.552 ("Exemption 4") exempts from the broad public disclosure
requirements of the FOIA "trade secrets and commercial or financial information
obtained from a person and privileged or confidential." This exemption is
intended to protect both the interests of commercial entities that submit
proprietary information to the government and the interests of the government in
receiving continued access to such data.
According to the decision in Public Citizen Health Research Group v.
Food and Drug Administration, 704 F.2d 1280, 1286 (D.C. Cir. 1983), there are
two alternative tests under which information could be found to fall within
Exemption 4: (i) the information can be found to consist of "trade secrets," in
which case no further inquiry is necessary, or (ii) the information can be found
to consist of commercial or financial information, in which case the exemption
will apply only if such information was obtained on a privileged or confidential
basis.
"Trade secret," for purposes of Exemption 4, is a secret, commercially
valuable plan, formula, process, or device that is used for making, preparing,
compounding, or processing trade commodities and that can be said to be the end
product of either innovation or substantial effort. Burnside-Ott Aviation
Training Center. Inc. v. United States, 617 F. Supp. 279 (S.D. Fla. 1985).
"Commercial or financial information" has been construed by the courts
in accordance with its plain meaning, and broadly encompasses information
relating to commerce or compiled in pursuit of profit. Critical Mass Energy
Project v. Nuclear Regulatory Commission, 644 F. Supp. 344 (D.D.C. 1986),
vacated on other grounds, 830 F.2d 278 (D.C. Cir. 1987). Commercial or financial
information is confidential within the meaning of Exemption 4 if it is not
customarily released to the public from the person from whom it was obtained,
and is likely to impair the Government's ability to obtain necessary information
in the future or to cause substantial harm to the competitive position of the
person from whom the information was obtained. S.Rep. No. 813, 89th Cong., 1st
Sess. 9 (1965); National Parks and Conservation Association v. Morton, 498 F.2d
765 (1974); Burke Energy Corporation v. Department of Energy, 583 F. Supp. 507
2
<PAGE>
(1984). Evidence revealing actual competition and the likelihood of substantial
competitive injury is sufficient to classify commercial information as
confidential. Public Citizen, 704 F.2d at 1291.
Company Background and Competitive Environment
The Company is a development stage biotechnology company utilizing
multiple mechanisms of immunity with the intent to develop cancer vaccines that
are more effective and safer than existing vaccines. To that end, the Company
has licensed rights from The Trustees of the University of Pennsylvania ("Penn")
to use a patented system to engineer a live attenuated Listeria monocytogenes
bacteria (the "Listeria System") to secrete a protein sequence containing a
tumor-specific antigen. Using the Listeria System, the Company believes it will
force the body's immune system to process and recognize the antigen as if it
were foreign, creating the immune response needed to attack the cancer. The
Company's licensed Listeria System, developed at Penn over the past 10 years,
provides a scientific basis for believing that this therapeutic approach induces
a significant immune response to a tumor. Accordingly, the Company believes that
the Listeria System is a broadly enabling platform technology that can be
applied to many types of cancers. In addition, the Company believes there may be
useful applications in infectious diseases and auto-immune disorders.
Reference is also made to the following sections of the Form SB-2,
filed with the Commission on February 3, 2005, as amended on April 7, 2005 and
as further amended on May __, 2005, as it may be further amended: PROSPECTUS
SUMMARY, RISK FACTORS ("We are dependent upon our license agreement with Penn,
as well as proprietary technology of others."; "We have no manufacturing, sales,
marketing or distribution capability and we must rely upon third parties for
such."; "The biotechnology and biopharmaceutical industries are characterized by
rapid technological developments and a high degree of competition. We may be
unable to compete with more substantial enterprises.") and BUSINESS
("Partnerships and Agreements"; "Manufacturing" and "Competition").
General Basis for Confidential Treatment Request
A. Protectable Trade Secrets.
The Company requests confidential treatment of the Confidential
Portions contained in the Agreement on the basis that such Confidential Portions
contain confidential and commercially valuable technical information of the
Company. Specifically, some of the Confidential Portions may describe the range
of functions provided by the Company's proprietary technologies, and the plans
and processes by which such technologies are applied to address customer
specifications - each of which make the Company's services unique and
protectable under state and federal intellectual property rights laws. To the
extent that the Company is required to publicly disclose Confidential Portions
relating to the functions of its proprietary technologies, the Company's
competitive advantages vis-a-vis its competitors - who provide similar services
using different technologies applied in accordance with different plans and
processes - would be materially compromised.
B. Protectable Commercial Information.
The Company has expended considerable time and effort in negotiating
the terms of the Agreement. If the Confidential Portions are made public, the
Company's competitors will gain an advantage since such competitors will seek to
3
<PAGE>
negotiate similar or more advantageous terms with potential joint development
parties, licensors or licensees. This is particularly true with respect to the
provisions regarding pricing and commissions paid to such parties. Public
disclosure of the Confidential Portions of the Agreement would provide
competitors of the Company with a reference to offer marginally more attractive
terms to potential clients thereby undercutting the Company's ability to enter
into agreements with others or greatly reducing the competitive position of the
Company.
C. Material Adverse Effect on the Formation of New Business Relationships.
Public knowledge of the Confidential Portions of the Agreement would
also place the Company in an adverse negotiating position with respect to
potential clients. The Company would have great difficulty negotiating similar
future agreements on more favorable terms because each potential contracting
party, aware of the terms of the Agreement, would be disinclined to accept terms
less attractive than those accepted by our current clients and business partners
in the Agreement. Further, such potential contracting parties would know what
concessions the Company was previously willing to bear. Thus, the Company may be
unable to negotiate terms more favorable to it than are present in the Agreement
if the Confidential Portions are disclosed.
Public disclosure of the Confidential Portions of the Agreement could
also make it very difficult for the Company to enter into similar agreements
with third parties in the future, because such entities may be reluctant to
contract with the Company if there is a strong likelihood that the sensitive
terms of such contracts would be publicly disclosed by the Company. Such
potential business partners may be more likely to seek a more substantial
partner that would not consider the contract sufficiently material to merit
public disclosure (as might be the case with a larger company) or a partner that
is not subject to such disclosure obligations.
D. General Considerations.
The Company's Agreement would be worth little to the Company or the
other parties to the Agreement if, by reducing their arrangements to writing,
they made the public dissemination of commercially sensitive information more
likely. Written contracts ensure against future misunderstandings. Public
disclosure of such confidential commercial material could be a disincentive to
reduce agreements to writing, with a consequent increase in risk to both
parties. Additionally, such an approach would impair the government's ability to
obtain necessary information in the future.
Finally, disclosure of the Confidential Portions of the Agreement is
wholly unnecessary for the protection of investors since such disclosure would
not contribute at all to an understanding of the Company's business, and would,
for the reasons described above in Sections A-D of this Article I, only
compromise the future prospects of the business in which such investors are
considering investing.
II. Itemization of Confidential Portions of the Agreement.
The Company requests confidential treatment of the following
Confidential Portions of the Agreement, as marked on the enclosed copy. Such
Confidential Portions are deal specific negotiated terms which disclosure would
4
<PAGE>
have a material adverse affect on the business, operations and financial
condition of the Company. For a more complete discussion of the reasons that the
Confidential Portions require protection, see Articles I and III hereof.
Exhibit 10.26; Agreement. The Agreement is an agreement between the Company and
Pharma-Olam International Ltd. ("POI").
Page and Section Reason
---------------- ------
Attachment I Confidential pricing and fee information and
confidential commercial information and deal
specific negotiated terms
Attachment II Confidential commercial information
III. Investors' Interests Protected without Disclosure.
In addition to the foregoing, the Company further believes that
disclosure of this information is not necessary for the protection of investors
in light of the broad disclosure as to the Company's overall commercial and
financial status and the disclosure of a substantial portion of the Agreement in
the Form SB-2. Confidential treatment is not requested for the material terms of
the Agreement taken as a whole in that the Confidential Portions are
specifically limited to proprietary technical and pricing and other commercial
provisions. Indeed, the material for which confidential treatment has been
requested is limited, and substantially all of the Agreement would otherwise be
available for public inspection.
The Confidential Portions of the Agreement are deal specific negotiated
terms between the parties and such disclosure would have a material adverse
affect on the business, operations and financial conditions of the Company. The
Company believes that the only parties that would benefit from public disclosure
of such information would be actual and potential competitors of the Company
and/or its corporate partners and third parties who could use the Confidential
Portions to the substantial detriment of the Company's business interests. For
these reasons, the Company believes that disclosure would harm its stockholders
and prospective investors. In contrast, knowledge of the Confidential Portions
of the Agreement would demonstrate little to an investor with respect to his or
her decision to purchase securities.
For the above reasons, the Company believes that disclosure of the
Confidential Portions of the Agreement would substantially harm the competitive
position of the Company. The information contained in the Confidential Portions
is not generally available to the public and the Company