SEC Comment Letter for 22nd Century Group, Inc. (XXII) (CIK 0001347858) (XXII) — Sep 9, 2011
22nd Century Group, Inc. (XXII) (CIK 0001347858)
Date: Sept. 9, 2011 · CIK: 0001347858 · Accession: 0000000000-11-054079
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-173420
Referenced dates: August 29, 2011
Letter
September 9, 2011 Via E-mail Joseph Pandolifino Chief Executive Officer 22nd Century Group, Inc. 9530 Main Street Clarence, NY 14031 Re: 22nd Century Group, Inc. Amendment No. 6 to Registra tion Statement on Form S-1 Filed September 6, 2011 File No. 333-173420
Dear Mr. Pandolifino: We have reviewed your responses to the co mments in our letter dated August 29, 2011 and have the following additional comments. All page numbers below correspond to the marked version of your filing.
Prospectus Summary, page 1
1. We note your revised disclosure on page 22 regarding your failure to meet certain required development and commercialization te rms of your exclusive worldwide license agreement with NCSU. Please add this di sclosure to your prospectus summary, your Overview section on page 36 and your Inte llectual Property section on page 48.
Risk Factors, page 9 Risks Related to Regulatory Approvals and Insurance Reimbursement, page 14
If we fail to obtain FDA and foreign regulatory approvals of X-22, page 14
2. Please revise to clarify what you mean by “compliance” on page 14.
Joseph Pandolifino 22nd Century Group, Inc. September 9, 2011 Page 2
Please contact Sonia Bednarowski at (202) 551-3666 or me at (202) 551-3859 with any questions. Sincerely, /s/ John Dana Brown John Dana Brown Attorney-Advisor cc: Via E-mail
Patrick G. Quick Foley & Lardner LLP
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September 9, 2011
Via E-mail
Joseph Pandolifino Chief Executive Officer 22nd Century Group, Inc. 9530 Main Street Clarence, NY 14031
Re: 22nd Century Group, Inc.
Amendment No. 6 to Registra tion Statement on Form S-1
Filed September 6, 2011
File No. 333-173420
Dear Mr. Pandolifino:
We have reviewed your responses to the co mments in our letter dated August 29, 2011
and have the following additional comments. All page numbers below correspond to the marked version of your filing.
Prospectus Summary, page 1
1. We note your revised disclosure on page 22 regarding your failure to meet certain
required development and commercialization te rms of your exclusive worldwide license
agreement with NCSU. Please add this di sclosure to your prospectus summary, your
Overview section on page 36 and your Inte llectual Property section on page 48.
Risk Factors, page 9
Risks Related to Regulatory Approvals and Insurance Reimbursement, page 14
If we fail to obtain FDA and foreign regulatory approvals of X-22, page 14
2. Please revise to clarify what you mean by “compliance” on page 14.
Joseph Pandolifino 22nd Century Group, Inc. September 9, 2011 Page 2
Please contact Sonia Bednarowski at (202) 551-3666 or me at (202) 551-3859 with any
questions.
Sincerely,
/s/ John Dana Brown John Dana Brown
Attorney-Advisor
cc: Via E-mail
Patrick G. Quick Foley & Lardner LLP