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DBV Technologies S.A.
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1 company response(s)
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DBV Technologies S.A.
Response Received
1 company response(s)
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SEC wrote to company
2023-04-13
DBV Technologies S.A.
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Company responded
2023-04-13
DBV Technologies S.A.
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DBV Technologies S.A.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2022-08-05
DBV Technologies S.A.
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2022-08-09
DBV Technologies S.A.
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DBV Technologies S.A.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-08-05
DBV Technologies S.A.
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Company responded
2022-08-09
DBV Technologies S.A.
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DBV Technologies S.A.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-09-12
DBV Technologies S.A.
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2019-09-27
DBV Technologies S.A.
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DBV Technologies S.A.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-02-05
DBV Technologies S.A.
Summary
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DBV Technologies S.A.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-11-14
DBV Technologies S.A.
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Company responded
2017-12-14
DBV Technologies S.A.
References: November 14, 2017
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DBV Technologies S.A.
Response Received
2 company response(s)
High - file number match
Company responded
2015-07-10
DBV Technologies S.A.
Summary
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Company responded
2015-07-10
DBV Technologies S.A.
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SEC wrote to company
2015-07-13
DBV Technologies S.A.
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DBV Technologies S.A.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2014-10-03
DBV Technologies S.A.
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2014-10-07
DBV Technologies S.A.
References: October 2, 2014
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Company responded
2014-10-17
DBV Technologies S.A.
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2014-10-17
DBV Technologies S.A.
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2014-10-17
DBV Technologies S.A.
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DBV Technologies S.A.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-09-15
DBV Technologies S.A.
Summary
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DBV Technologies S.A.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-08-21
DBV Technologies S.A.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-27 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2025-05-23 | SEC Comment Letter | DBV Technologies S.A. | France | 333-287393 | Read Filing View |
| 2023-04-13 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2023-04-13 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-09 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-09 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-05 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-05 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2019-09-27 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2019-09-12 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2018-02-05 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2017-12-14 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2017-11-14 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2015-07-13 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2015-07-10 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2015-07-10 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-17 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-17 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-17 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-07 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-03 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-09-15 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-08-21 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-23 | SEC Comment Letter | DBV Technologies S.A. | France | 333-287393 | Read Filing View |
| 2023-04-13 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-05 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-05 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2019-09-12 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2018-02-05 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2017-11-14 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2015-07-13 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-03 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-09-15 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-08-21 | SEC Comment Letter | DBV Technologies S.A. | France | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-27 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2023-04-13 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-09 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2022-08-09 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2019-09-27 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2017-12-14 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2015-07-10 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2015-07-10 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-17 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-17 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-17 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
| 2014-10-07 | Company Response | DBV Technologies S.A. | France | N/A | Read Filing View |
2025-05-27 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm CORRESP May 27, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tyler Howes Re: DBV Technologies S.A. Registration Statement on Form S-3 Filed May 19, 2025 File No. 333-287393 Acceleration Request Requested Date: May 29, 2025 Requested Time: 4:00 p.m. Eastern Time Dear Tyler Howes: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-287393) (the “ Registration Statement ”), to become effective on May 29, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission’s staff. The Registrant hereby authorizes Richard Segal of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Richard Segal of Cooley LLP at (212) 479 6997. [Signature page follows] Very truly yours, DBV Technologies S.A. By: /s/ Daniel Tassé Daniel Tassé Chief Executive Officer cc: Darah Protas, Cooley LLP Evan Leitner, Cooley LLP
2025-05-23 - UPLOAD - DBV Technologies S.A. File: 333-287393
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 23, 2025 Daniel Tass Chief Executive Officer DBV Technologies S.A. 107 avenue de la R publique 92320 Ch tillon France Re: DBV Technologies S.A. Registration Statement on Form S-3 Filed May 19, 2025 File No. 333-287393 Dear Daniel Tass : This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Evan Leitner, Esq. </TEXT> </DOCUMENT>
2023-04-13 - UPLOAD - DBV Technologies S.A.
United States securities and exchange commission logo
April 13, 2023
Michele Robertson
Chief Legal Officer, Vice President
DBV Technologies S.A.
106 Allen Road
Suite 400
Basking Ridge, New Jersey 07920
Re:DBV Technologies S.A.
Registration Statement on Form S-3
Filed April 6, 2023
File No. 333-271166
Dear Michele Robertson:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Segal, Esq.
2023-04-13 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm CORRESP DBV TECHNOLOGIES S.A. 177-181 Avenue Pierre Brossolette 92120 Montrouge France April 13, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Daniel Crawford RE: DBV Technologies S.A. Registration Statement on Form S-3 File No. 333-271166 Acceleration Request Requested Date: Monday, April 17, 2023 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Exchange Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-271166) (the “Registration Statement”) to become effective at 4:00 p.m. Eastern Time on Monday, April 17, 2023, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Richard Segal of Cooley LLP, counsel to the registrant, at (212) 479-6997. [Signature page follows] Sincerely, DBV TECHNOLOGIES S.A. By: /s/ Daniel Tassé Daniel Tassé Chief Executive Officer cc: Richard Segal, Cooley LLP Michael Mencher, Cooley LLP [Signature Page to S-3 Acceleration Request]
2022-08-09 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm CORRESP DBV TECHNOLOGIES S.A. 177-181 Avenue Pierre Brossolette 92120 Montrouge France August 9, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Dillon Hagius RE: DBV Technologies S.A. Registration Statement on Form S-3 File No. 333-266449 Acceleration Request Requested Date: Thursday, August 11, 2022 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Exchange Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-266449) (the “Registration Statement”) to become effective at 4:00 p.m. Eastern Time on Thursday August 11, 2022, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Richard Segal of Cooley LLP, counsel to the registrant, at (212) 479-6997. [Signature page follows] Sincerely, DBV TECHNOLOGIES S.A. By: /s/ Daniel Tassé Daniel Tassé Chief Executive Officer cc: Richard Segal, Cooley LLP Michael Mencher, Cooley LLP
2022-08-09 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm CORRESP DBV TECHNOLOGIES S.A. 177-181 Avenue Pierre Brossolette 92120 Montrouge France August 9, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Dillon Hagius RE: DBV Technologies S.A. Registration Statement on Form S-3 File No. 333-266448 Acceleration Request Requested Date: Thursday, August 11, 2022 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Exchange Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-266448) (the “Registration Statement”) to become effective at 4:00 p.m. Eastern Time on Thursday August 11, 2022, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Richard Segal of Cooley LLP, counsel to the registrant, at (212) 479-6997. [Signature page follows] Sincerely, DBV TECHNOLOGIES S.A. By: /s/ Daniel Tassé Daniel Tassé Chief Executive Officer cc: Richard Segal, Cooley LLP Michael Mencher, Cooley LLP
2022-08-05 - UPLOAD - DBV Technologies S.A.
United States securities and exchange commission logo
August 5, 2022
Daniel Tassé
Chief Executive Officer
DBV Technologies S.A.
106 Allen Road
Suite 400
Basking Ridge, New Jersey 07920
Re:DBV Technologies S.A.
Registration Statement on Form S-3
Filed August 1, 2022
File No. 333-266449
Dear Mr. Tassé:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Madison Jones
2019-09-27 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm CORRESP 177-181 Avenue Pierre Brossolette 92120 Montrouge France September 27, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Christine Westbrook Re: DBV Technologies S.A. Registration Statement on Form F-3 Filed September 6, 2019 File No. 333-233651 Acceleration Request Requested Date: October 1, 2019 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File No. 333-233651) (the “Registration Statement”) to become effective at 4:00 p.m. Eastern Time on October 1, 2019, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Richard Segal of Cooley LLP, counsel to the Registrant, at (617) 937-2332. [Signature page follows] Very truly yours, DBV TECHNOLOGIES S.A. By: /s/ Daniel Tassé Daniel Tassé Chief Executive Officer cc: Marc Recht, Cooley LLP Richard Segal, Cooley LLP Divakar Gupta, Cooley LLP
2019-09-12 - UPLOAD - DBV Technologies S.A.
September 12, 2019
Daniel Tassé
Chief Executive Officer
DBV Technologies S.A.
177-181 Avenue Pierre Brossolette
92120 Montrouge France
Re:DBV Technologies S.A.
Registration Statement on Form F-3
Filed September 6, 2019
File No. 333-233651
Dear Mr. Tassé:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Richard Segal, Esq.
2018-02-05 - UPLOAD - DBV Technologies S.A.
February 2, 2018
David Schilansky
Chief Financial Officer and Chief Operating Officer
DBV Technologies S.A.
177-181 avenue Pierre Brossolette
92120 Montrouge France
DBV Technologies S.A.
Form 20-F for the Fiscal Year Ended December 31, 2016
Filed March 22, 2017
File No. 001-36697Re:
Dear Mr. Schilansky:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence by the staff.
Division of Corporation Finance
Office of Healthcare & Insurance
2017-12-14 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm CORRESP DBV Technologies S.A. 177-181 avenue Pierre Brossolette 92120 Montrouge, France December 14, 2017 U.S. Securities and Exchange Commission Division of Corporation Finance 100 First Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Kevin Vaughn VIA EDGAR RE: DBV Technologies S.A. Form 20-F for the Fiscal Year Ended December 31, 2016 Filed March 22, 2017 File No. 001-36697 Ladies and Gentlemen: DBV Technologies S.A. (the “Company”) is hereby responding to the comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), by letter dated November 14, 2017 (the “Comment Letter”), with respect to the above-referenced Annual Report on Form 20-F for the fiscal year ended December 31, 2016 (the “Form 20-F”). On November 20, 2017 and December 14, 2017, the Staff confirmed to our counsel, Richard Segal, Cooley LLP, that it would grant the Company an extension to December 15, 2017 to respond to the Comment Letter. For your convenience, the comments from the Comment Letter are repeated here, followed by the Company’s responses and the paragraph numbering below corresponds to the numbering in the Comment Letter. Form 20-F for the Fiscal Year Ended December 31, 2016 Item 5. Operating and Financial Review and Prospects A. Operating Results Comparison for the Years Ended December 31, 2015 and 2016, page 71 1. Please tell us the amount of direct research and development expenses for Viaskin Peanut and Viaskin Milk separately for each period presented. Please explain your consideration of disclosing these costs separately in your filing. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it will disclose the amount of direct research and development expenses for Viaskin Peanut and Viaskin Milk separately for each period presented in future periodic filings, beginning with its filing for the fiscal year ending December 31, 2017. Report of Independent Registered Public Accounting Firm, page F-2 2. You disclose on page F-11 that your financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. However, your auditors opinion indicates that the financial statements are in conformity with accounting principles generally accepted in the United States of America. Please obtain and file a revised audit report in an amendment to your Form 20-F which references International Financial Reporting Standards as issued by the International Accounting Standards Board consistent with your Statement of Compliance on page F-11. Response: In response to the Staff’s comment, the Company intends to amend its Form 20-F to include a revised audit report that states that the Company’s financial statements are in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board, as well as the required certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002. The proposed forms of the revised audit report and certifications are set forth hereto as Appendix A and B, respectively. Notes to the Financial Statements Note 3: Accounting Principles 3.12 Other Income Collaboration agreement with Nestle Health Science, page F-17 3. Please tell us the length of the service obligation over which you are recognizing the deferred revenue from Nestle. Please also tell us your consideration of disclosing this period in your filing. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that deferred revenue related to its collaboration agreement with Nestle is being recognized ratably over the Company’s service obligation period under the Nestle agreement. In response to the Staff’s comment, the Company will disclose the service obligation period over which it is recognizing deferred revenue related to its collaboration agreement with Nestle in future periodic filings, beginning with its filing for the fiscal year ending December 31, 2017. * * * * If the Staff has any questions with regard to this response, needs further information or would like to discuss any of the information covered in this letter, please contact either the undersigned at +33 (0)6 7081 8707 or Richard Segal of Cooley LLP at +1 617 937 2332. Sincerely, /s/ David Schilansky David Schilansky cc: Dr. Pierre-Henri Benhamou, DBV Technologies S.A. Marc Recht, Cooley LLP Richard Segal, Cooley LLP Appendix A Form of Revised Audit Report To the Board of Directors and Shareholders of DBV Technologies S.A. Paris, France We have audited the accompanying statements of consolidated financial position of DBV Technologies S.A. and subsidiary (the “Company”) as of December 31, 2014, 2015 and 2016, and the related consolidated statements of (loss), comprehensive (loss), shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2016. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of DBV Technologies SA and subsidiary as of December 31, 2014, 2015 and 2016, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2016, in conformity with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board. We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of December 31, 2016, based on the criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 22, 2017 expressed an unqualified opinion on the Company’s internal control over financial reporting. [ ] Represented by Julien Razungles Neuilly-sur-Seine, France March 22, 2017 Appendix B Forms of Section 302 and 906 Certifications Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Pierre-Henri Benhamou, certify that: 1. I have reviewed this Amendment No. 1 to the Annual Report on Form 20-F of DBV Technologies S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; and 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report. Date: [ ], 2017 Name: Pierre-Henri Benhamou Title: Chief Executive Officer (Principal Executive Officer) Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, David Schilansky, certify that: 1. I have reviewed this Amendment No. 1 to the Annual Report on Form 20-F of DBV Technologies S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; and 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report. Date: [ ], 2017 Name: David Schilansky Title: Chief Financial Officer and Chief Operating Officer (Principal Financial Officer) Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the filing of this Amendment No.1 to the Annual Report of DBV Technologies S.A. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2016 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Pierre-Henri Benhamou, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge: 1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and 2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: [ ], 2017 Name: Pierre-Henri Benhamou Title: Chief Executive Officer (Principal Executive Officer) Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the filing of this Amendment No. 1 to the Annual Report of DBV Technologies S.A. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2016 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David Schilansky, Chief Financial Officer and Chief Operating Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge: 1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and 2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: [ ], 2017 Name: David Schilansky Title: Chief Financial Officer and Chief Operating Officer (Principal Financial Officer)
2017-11-14 - UPLOAD - DBV Technologies S.A.
November 14, 2017
David Schilansky
Chief Financial Officer and Chief Operating Officer
DBV Technologies S.A.
177-181 avenue Pierre Brossolette
92120 Montrouge France
Re:DBV Technologies S.A.
Form 20-F for the Fiscal Year Ended December 31, 2016
Filed March 22, 2017
File No. 001-36697
Dear Mr. Schilansky:
We have limited our review of your filing to the financial statements and related
disclosures 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 20-F for the Fiscal Year Ended December 31, 2016
Item 5. Operating and Financial Review and Prospects
A. Operating Results
Comparison for the Years Ended December 31, 2015 and 2016, page 71
1.Please tell us the amount of direct research and development expenses for Viaskin Peanut
and Viaskin Milk separately for each period presented. Please explain your consideration
of disclosing these costs separately in your filing.
Report of Independent Registered Public Accounting Firm, page F-2
2.You disclose on page F-11 that your financial statements are prepared in accordance with
International Financial Reporting Standards as issued by the International Accounting
FirstName LastNameDavid Schilansky
Comapany NameDBV Technologies S.A.
June 16, 2017 Page 2
FirstName LastName
David Schilansky
DBV Technologies S.A.
November 14, 2017
Page 2
Standards Board. However, your auditors opinion indicates that the financial statements
are in conformity with accounting principles generally accepted in the United States of
America. Please obtain and file a revised audit report in an amendment to your Form 20-
F which references International Financial Reporting Standards as issued by the
International Accounting Standards Board consistent with your Statement of Compliance
on page F-11.
Notes to the Financial Statements
Note 3: Accounting Principles
3.12 Other Income
Collaboration agreement with Nestle Health Science, page F-17
3.Please tell us the length of the service obligation over which you are recognizing the
deferred revenue from Nestle. Please also tell us your consideration of disclosing this
period in your filing.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Vanessa Robertson at 202-551-3649 or Kevin Vaughn at 202-551-3494
with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2015-07-13 - UPLOAD - DBV Technologies S.A.
July 13, 2015
Via E -mail
Dr. Pierre -Henri Benhamou
Chief Executive Officer
DBV Technologies S.A.
Green Square - Bâtiment
D 80/84 rue des Meuniers
92220 Bagneux France
Re: DBV Technologies S.A.
Registration Statement on Form F-1
Filed July 2, 2015
File No. 333-205474
Dear Dr. Benhamou :
This is to advise you that we have not reviewed and will not review your registration
statement .
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities Act rules require. 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 the event you request acceleration of the effective date of the pending regist ration
statement , please provide a written statement from the company acknowledging that:
should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action wit h respect
to the filing;
the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in th e filing; and
the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Dr. Pierre -Henri Benhamou
DBV Technologies S.A.
July 13, 2015
Page 2
Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .
Please contact Christina De Rosa at (202) 551 -3577 or me at (202) 551 -3715 with any
questions.
Sincerely,
/s/ Daniel Greenspan for
Jeffrey P. Riedler
Assistant Director
cc: Via E -mail
Richard Segal, Esq.
Cooley LLP
500 Boylston Street
Boston, MA 02116
2015-07-10 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm Correspondence July 10, 2015 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Christina De Rosa Re: DBV Technologies S.A. Registration Statement on Form F-1 File No. 333-205474 Acceleration Request Requested Date: July 14, 2015 Requested Time: 5:15 p.m., Eastern Daylight Time Ladies and gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Citigroup Global Markets Inc., Morgan Stanley & Co. LLC, Barclays Capital Inc. and Leerink Partners LLC, as representatives of the several underwriters, hereby join DBV Technologies S.A. in requesting that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form F-1 (File No. 333-205474) (the “Registration Statement”) to become effective on Tuesday, July 14, 2015, at 5:15 p.m., Eastern Daylight Time, or as soon as practicable thereafter. Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. We will comply, and have been informed by the participating underwriters that they will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable. Very truly yours, Citigroup Global Markets Inc. By: /s/ Russell Chong Name: Russell Chong Title: Managing Director Morgan Stanley & Co. LLC By: /s/ David Lederman Name: David Lederman Title: Vice President Barclays Capital Inc. By: /s/ Victoria Hale Name: Victoria Hale Title: Vice President Leerink Partners LLC By: /s/ John I. Fitzgerald, Esq. Name: John I. Fitzgerald, Esq. Title: Managing Director cc: Pierre-Henri Benhamou, DBV Technologies S.A. Stuart Cable, Esq., Goodwin Procter LLP Edwin O’Connor, Esq., Goodwin Procter LLP Marc Recht, Esq., Cooley LLP Div Gupta, Esq., Cooley LLP
2015-07-10 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm Correspondence DBV Technologies S.A. Green Square-Bâtiment D 80/84 rue des Meuniers 92220 Bagneux France July 10, 2015 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Christina De Rosa Re: DBV Technologies S.A. Registration Statement on Form F-1 File No. 333-205474 Acceleration Request Requested Date: Tuesday, July 14, 2015 Requested Time: 5:15 p.m., Eastern Daylight Time Ladies and gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form F-1 (File No. 333-205474) (the “Registration Statement”) to become effective on July 14, 2015, at 5:15 p.m., Eastern Daylight Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each of Marc Recht, Divakar Gupta, Richard Segal, Courtney Thorne and Danielle Gershowitz of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Marc Recht of Cooley LLP, counsel to the Registrant, at (617) 937-2316, or in his absence, Richard Segal at (617) 937-2332. In connection with this request, the Registrant acknowledges that: • should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, DBV Technologies S.A. By: /s/ Dr. Pierre-Henri Benhamou Name: Dr. Pierre-Henri Benhamou Title: Chief Executive Officer cc: Marc A. Recht, Esq., Cooley LLP Divakar Gupta, Esq., Cooley LLP Edwin O’Connor, Goodwin Proctor LLP
2014-10-17 - CORRESP - DBV Technologies S.A.
CORRESP
1
filename1.htm
Unassociated Document
[CITIBANK LETTERHEAD]
October 17, 2014
Via EDGAR and Telecopier
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Paul Dudek, Esq
Office of International Corporate Finance
Fax: (202) 772-9207
Re:
DBV Technologies S.A.
Registration Statement on Form F-6 (File No.: 333-199231)
Dear Mr. Dudek:
Citibank N.A., as depositary (the “Depositary”) and acting solely on behalf of the legal entity created by the Form of Deposit Agreement, by and among the Depositary, DBV Technologies S.A., a company organized and existing under the laws of the Republic of France (the “Company”), and all Holders and Beneficial Owners of American Depositary Shares (“ADS”) issued thereunder, each American Depositary Share representing the right to receive one-half (1/2) of one fully paid ordinary share, nominal value €0.10 per share, of the Company, hereby requests that the effectiveness of Registration Statement on Form F-6 (Registration No.: 333-199231) be accelerated to coincide with the accelerated effectiveness of the Company’s Registration Statement on Form F-1 (File No.: 333-198870).
Please call me at (212) 816-6351 if you have any questions.
Very truly yours,
CITIBANK, N.A.
By:
/s/ Keith Galfo
Name:
Keith Galfo
Title:
Vice President
cc: Herman H. Raspé, Esq. (Patterson Belknap Webb & Tyler LLP)
2014-10-17 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm CORRESP October 17, 2014 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Jeffrey P. Riedler Re: DBV Technologies S.A. Registration Statement on Form F-1 (File No. 333-198870) Ladies and Gentlemen: In connection with the above-captioned Registration Statement, we wish to advise that approximately 1,485 copies of the Preliminary Prospectus included therein are expected to be distributed as follows: 400 to prospective underwriters and 1,085 to institutional investors. We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Tuesday, October 21, 2014, or as soon thereafter as practicable. [signature page follows] Very truly yours, Citigroup Global Markets Inc. Leerink Partners LLC As representatives of the Prospective Underwriters By: Citigroup Global Markets Inc. By: /s/ Kristian F. Humer Name: Kristian F. Humer Title: Managing Director BY: Leerink Partners LLC By: /s/ John I. Fitzgerald, Esq. Name: John I. Fitzgerald, Esq. Title: Managing Director SIGNATURE PAGE TO ACCELERATION REQUEST
2014-10-17 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm ACCELERATION REQUEST VIA EDGAR AND FACSIMILE October 17, 2014 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler Re: DBV Technologies S.A. Acceleration Request for Registration Statement on Form F-1 File No. 333-198870 Dear Mr. Riedler: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), DBV Technologies S.A. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to October 21, 2014, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Michael H. Bison at (617) 570-1933. We also respectfully request that a copy of the written order from the Securities and Exchange Commission (the “Commission”) verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Michael H. Bison, by facsimile to (617) 523-1231. In connection with the foregoing, the Company hereby acknowledges the following: • should the Commission or the staff of the Commission, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; • the action of the Commission or the staff of the Commission, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. If you have any questions regarding this request, please contact Michael H. Bison of Goodwin Procter LLP at (617) 570-1933. Sincerely, DBV TECHNOLOGIES S.A. /s/ Dr. Pierre-Henri Benhamou Dr. Pierre-Henri Benhamou Chairman and Chief Executive Officer cc: David Schilansky, DBV Technologies S.A. Mitchell S. Bloom, Goodwin Procter LLP Michael H. Bison, Goodwin Procter LLP
2014-10-07 - CORRESP - DBV Technologies S.A.
CORRESP 1 filename1.htm Response Letter Michael H. Bison 617.570.1933 mbison@goodwinprocter.com Goodwin Procter LLP Counselors at Law Exchange Place Boston, MA 02109 T: 617.570.1000 F: 617.523.1231 October 7, 2014 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler Re: DBV Technologies, S.A. Registration Statement on Form F-1 Filed September 22, 2014 File No. 333-198870 Dear Mr. Riedler: This letter is being submitted on behalf of DBV Technologies, S.A. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form F-1 submitted on September 22, 2014 (the “Registration Statement”), as set forth in your letter dated October 2, 2014 addressed to Dr. Pierre-Henri Benhamou, Chairman and Chief Executive Officer of the Company (the “Comment Letter”). For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the Staff’s comments refer to the Registration Statement. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Estimates October 7, 2014 Page 2 Conditional Advances, page 69 1. Please refer to prior comment 3 and address the following additional comments: • Tell us why it is appropriate to recognize the conditional advances as a financial liability under IAS 32 and IAS 39. Also, tell us why the amount of the conditional advance in excess of the minimum amount repayable, if the project is a failure, is not a forgivable loan under paragraph 10 of IAS 20; RESPONSE: The Company confirms to the Staff that it has reviewed paragraph 10 of IAS 20 Accounting for Government Grants and Disclosure of Government Assistance (“IAS 20”), which states that a forgivable loan shall be treated as a government grant only “when there is reasonable assurance that the entity will meet the terms for forgiveness of the loan”. In the case of the conditional advances from OSEO, the total amount of the advance is repayable subject to reduction only in the event OSEO determines the project is not successful. In the case of the third OSEO advance, which is related to the funding of certain formulation, stability studies and preclinical studies of Viaskin Milk, a reduction in the reimbursable amount would occur only in the event OSEO determines the project to be a “partial technical success” or a “technical failure,” which determination is made by OSEO based on its review progress reports provided by the Company describing its performance in comparison to established goals for the program. In the case of the fourth OSEO advance, which is related to the funding of a collaborative project in the field of HDM allergies, a reduction in the reimbursable amount would occur only in the event of a “commercial failure” of the Company which is defined as “a total absence of operations or a significant deterioration of operating conditions.” Importantly, the Company notes that none of the OSEO advances include regulatory milestones or metrics milestones. As a result, the Company has determined that the conditional advance from OSEO for all periods presented are akin to obtaining a loan at favorable terms and that, if certain conditions are met (such as a technical or commercial failure, as stated above), the loan becomes forgivable. Therefore, the Company considers the conditional advances to represent a financial liability as defined in paragraph 11(a)(i) of IAS 32 Financial Instruments: Presentation, as the Company has a contractual obligation to reimburse such conditional advances by delivering cash to OSEO. The Company advises the Staff that, at inception and as of the applicable statements of financial position dates presented in the Registration Statement, the Company has concluded that there is no reasonable assurance that the conditions specified above will occur thereby resulting in the loan to become forgivable or in a reduction in the reimbursable amount. Moreover, the Company believes this determination is reasonable in light of its past experience with OSEO conditional advances. The Company notes that the first two conditional advances received by the Company were repaid by the Company in full in 2011 (for the first OSEO advance) and 2013 (for the second OSEO advance). October 7, 2014 Page 3 • Assuming you can substantiate why accounting under IAS 32 and IAS 39 is appropriate, tell us how the amount of the liability you record represents its fair value, as required by paragraph 43 of IAS 39. Also, explain how the probability of attaining only partial technical or commercial success or having a failure for the underlying project is considered in determining fair value; RESPONSE: The Company has determined that the discounted amount of the financial liability should be the fair value for measuring the conditional advance as the Company is not able to reliably estimate the timing of repayment and the amount that will be repaid by the Company given the uncertainties around the advancement of the development programs and the determination by OSEO as to whether the project is a partial or total success. As a result, the Company has determined that measuring the financial liability at the nominal amount of the conditional advance, taking into account the effect of the discount, is appropriate under IAS 39 Financial Instruments: Recognition and Measurement paragraph 43. In measuring the amount of the conditional advance, the Company considered the guidance under paragraph 10A of IAS 20 that applies to loans at favorable terms received from a government agency and measured the amount of the grant to be recognized in “Other income” as the difference between present value at market rate and the cash received. The Company notes that the amount of “Other income” recognized was not material to its net income as of and for any of the applicable statement of financial position dates presented in the Registration Statement, as ultimately the Company believes the amount of grant income to be recognized over the relevant program period should not exceed the amount of accreted interest expense until it becomes reasonably assured that the loan will become forgiven. As noted in our response to comment 3 below, the amount of “Other income” recognized in relation to the conditional advances in application of paragraph 10A of IAS 20 for the years ended December 31, 2013 and 2012 was €21.1 thousand and €15.5 thousand respectively. • Tell us why it is appropriate to deem that the project will be a total technical or commercial success, when the conditions for success are not specified in the contract and are subject to the sole discretion of the OSEO; and RESPONSE: The Company refers the Staff to its response above concerning the determination of “technical success” (in the case of the third OSEO conditional advance) and “commercial failure” (in the case of the fourth OSEO conditional advance). In the case of the third OSEO conditional advance, this assessment is made by OSEO based on its review progress reports provided by the Company describing its performance in comparison to established goals for the program. As of the date of this letter, pre-clinical activities have now been completed, and the Company is about to enter into clinical with a Phase Ib/II trial by the end of the year. Therefore, the Company expects that it will repay the full advance as per contract. October 7, 2014 Page 4 In the case of the fourth OSEO conditional advance, this assessment is made by OSEO based on its review of evidence submitted by the Company. Based on the Company’s own assessment of its program progress and financial condition, the Company has concluded that there is no reasonable assurance that the program will be a “commercial failure”, defined as “a total absence of operations or a significant deterioration of operating conditions”, thereby resulting in a reduction in the reimbursable amount. • Tell us the “minimum amount” due to OSEO in the event of project failure. Also, tell us the amounts due and timing under the “specified repayment schedule” that are subject to renegotiation for projects deemed to be only a partial success. RESPONSE: The Company advises the Staff that in the case of the third OSEO conditional advance, in the event of a “technical failure” the minimum amount due to OSEO would be a fixed sum of €256,000 and in the event of a “partial technical success” an alternative payment schedule may be established by mutual agreement (otherwise the full amount would be due). The Company advises the Staff that in the case of the fourth OSEO conditional advance, in the event of a characterized “commercial failure”, the Company would not be required to reimburse any sum. At the end of a 10-year period after the last payment was received from OSEO, any remaining loan amount would become forgiven. The Company will revise the disclosure on page 78 of the Registration Statement to clarify the conditions as follows: “OSEO advance: In 2011, we obtained a conditional advance by OSEO for a total amount of €640,000 to finance the development of our programs to treat CMPA. This amount has been fully received, with a first payment of €256,000 in December 2011, a second payment of €256,000 in June 2013 and remaining €128,000 balance paid in January 2014. If the program is deemed to be technically or commercially successful, as determined by OSEO in its sole and subjective discretion it will be repaid in 16 quarterly instalments defined as follows: four payments of €64,000 starting on September 30, 2014, then 12 payments of €32,000 starting on September 30, 2015, until June 30, 2018. If this project is deemed to be a technical or commercial failure, we will still be obligated to repay OSEO the amount of €256,000. OSEO advance: In 2013, we obtained a conditional advance by OSEO for a total amount of €3.2 million in the context of a research and clinical development collaborative project in the field of HDM allergies in young children. We refer to this development program as the ImmunaVia project. €903,500 was received in April 2013, €903,500 is expected to be received in October 2014, €918,000 is expected in October 2015 and €481,162 is expected in April 2018. If the program is deemed to be technically or commercially successful Unless OSEO deems the Company to be a commercial failure, we will reimburse €400,000 no later than June 30, 2021, €800,000 no later than June 30, 2022, €1.1 million no later than June 30, 2023 and €1.5 million no later than June 30, 2024. In addition, we received from OSEO a total of €1,919,056 in the form of a non-refundable subsidy.” Notes to Financial Statements Note 3: Accounting Principles 3.1 Intangible Assets, page F-10 2. Please revise your disclosure regarding the potential capitalization as internally-developed intangible assets in your research and development expenses section to clarify that only development expenses may be capitalized, as stipulated in paragraph 57 of IAS 38. Otherwise, please tell us how your policy complies with IFRS. October 7, 2014 Page 5 RESPONSE: In response to the Staff’s comment, the Company will revise the disclosure on page F-10 of the Registration Statement to clarify that only development expenses may be capitalized as follows: “3.1 Intangible Assets In application of the provisions in IAS 38 Intangible Assets (“IAS 38”), intangible assets acquired are posted as assets on the statement of financial position at their acquisition cost. Research and Development Expenses Research expenses are recorded in the financial statements as expenses. In accordance with IAS 38, research development expenses are recorded in the financial statements as intangible assets only if all the following criteria are met: (a) technical feasibility necessary for the completion of the development project; (b) intention on the part of the Company to complete the project and to utilize it; (c) capacity to utilize the intangible asset; (d) proof of the probability of future economic benefits associated with the asset; (e) availability of the technical, financial, and other resources for completing the project; and (f) reliable evaluation of the development expenses. Because of the risks and uncertainties related to regulatory authorizations and to the research and development process, the Company believes that the six criteria stipulated by IAS 38 are only fulfilled once the Marketing Authorization has been obtained.” Note 11: Financial Liabilities, page F-22 3. Please disclose the discount rates applied to each conditional advance presented in the table on page F-23. Also, explain the factors underlying the difference between funding for the Fourth OSEO Advance of €3,206,162 and related repayments €3,750,000. October 7, 2014 Page 6 RESPONSE: In response to the Staff’s comment, the Company will revise the disclosure on page F-23 of the Registration Statement to add the range of discount rates applied to each conditional advance as follows: 2nd OSEO advance 3rd OSEO advance 4th OSEO advance COFACE Total Opening Balance Sheet Debt as of 1/1/2012 450,713 246,238 — 122,501 819,452 + receipts — — — — — —repayments (200,000 ) — — — (200,000 ) +/- other transactions 6,701 3,661 — 4,251 14,613 Opening Balance Sheet Debt as of 12/31/2012 257,414 249,899 — 126,752 634,065 Of which: Non-current portion Current portion 376,651 257,414 + receipts — 256,000 903,500 — 1,159,500 —repayments (260,000 ) — — — (260,000 ) +/- other transactions 2,586 (1,579 ) (111,047 ) 19,300 (90,740 ) Balance Sheet Debt as of 12/31/2013 — 504,320 792,453 146,052 1,442,825 Of which: Non-current portion 1,316,533 Current portion 126,292 Stated interest rate None None 2.05% None Discount rate 1.2%-2.5% 0.4%-1.9% 1.5%-1.8% 4.25% Maturity (in years) 2-4 1-4 8-10 — The Company respectfully notes to the Staff that the discount rate applied to each tranche varies depending on the maturity as follows: 2nd OSEO advance: between 1.2% and 2.50% for a maturity between 2 and 4 years 3rd OSEO advance: between 0.40% and 1.90% for a maturity between 1 and 4 years 4th OSEO advance (i.e. related to the ImmunaVia development program): between 1.50% and 1.80% for a maturity between 8 and 10 years. COFACE advance: 4.25%. As noted in our response to comment 1 above, the amount of “Other income” recognized in relation to the conditional advances for the years ended December 31, 2013 and 2012 was €21.1 thousand and €15.5 thousand respectively. Although the discount rates applied as per the revised table above may be considered as more favorable than market conditions, the Company respectfully advises the Staff that, based on the amounts and maturities of each advance, the sensitivity of the Company’s results of operations to the discount rate is very low. As an illustration, the Company has performed a sensitivity analysis and concluded that using a significantly higher discount rate (e.g. 20.0%) would not result in a October 7, 2014 Page 7 material impact on its results of operations for any of the years presented (although it would have resulted in an increase in “Other income” and an increase in “Financial expenses” related to the larger interest accretion). In response to the Staff’s
2014-10-03 - UPLOAD - DBV Technologies S.A.
October 2, 2014 Via E -mail Dr. Pierre -Henri Benhamou Chairman and Chief Executive Officer DBV Technologies S.A. Green Square -Bâtiment D 80/84 rue des Meuniers 92220 Bagneux France Re: DBV Technologies, S.A. Registration Statement on Form F -1 Filed September 22, 2014 File No. 333 -198870 Dear Dr. Benhamou : We have reviewed your registration statement 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 by amending your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstanc es or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Manage ment’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Estimates Conditional Advances, page 69 1. Please refer to prior comment 3 and address the following additional comments: Tell us why it is appropriate to recognize the conditional advances as a financial liability under IAS 32 and IAS 39. Also, tell us why the amount of the conditional advance in excess of the minimum amount repayable, if the project is a failure, is not a forgivable loan un der paragraph 10 of IAS 20; Assuming you can substantiate why accounting under IAS 32 and IAS 39 is appropriate, tell us how the amount of the liability you record represents its fair value, as required by paragraph 43 of IAS 39. Also, explain how the p robability Dr. Pierre -Henri Benhamou DBV Technologies S.A. October 2, 2014 Page 2 of attaining only partial technical or commercial success or having a failure for the underlying project is considered in determining fair value; Tell us why it is appropriate to deem that the project will be a total technical or commercial su ccess, when the conditions for success are not specified in the contract and are subject to the sole discretion of the OSEO; and Tell us the “minimum amount” due to OSEO in the event of project failure. Also, tell us the amounts due and timing under the “specified repayment schedule” that are subject to renegotiation for projects deemed to be only a partial success . Notes to Financial Statements Note 3: Accounting Principles 3.1 In tangible Assets, page F -10 2. Please revise your disclosure regarding the potential capitalization as internally - developed intangible assets in your research and development expenses section to clarify that only development expenses may be capitalized, as st ipulated in paragraph 57 of IAS 38. Otherwise, please tell us how your policy complies with IFRS. Note 11: Financial Liabilities, page F -22 3. Please disclose the discount rates applied to each conditional advance presented in the table on page F -23. Also, explain the factors underlying the difference between funding for the Fourth OSEO Advance of €3,206,162 and related repayments €3,750,000. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certai n that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the acc uracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and Dr. Pierre -Henri Benhamou DBV Technologies S.A. October 2, 2014 Page 3 the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding reque sts for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securitie s Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effectiv e date of the registration statement. You may contact Frank Wyman at (202) 551 -3660 or Mark Brunhofer at (202) 551 -3638 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, John Krug at (202) 551 -3862 or me at (202) 551 - 3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Mitchell S. Bloom , Esq. Michael H. Bison, Esq. Goodwin Procter LLP Exchange Place 55 State Street Boston, MA 02109
2014-09-15 - UPLOAD - DBV Technologies S.A.
September 12, 2014 Via E -mail Dr. Pierre -Henri Benhamou Chairman and Chief Executive Officer DBV Technologies S.A. Green Square -Bâtiment D 80/84 rue des Meuniers 92220 Bagneux France Re: DBV Technologies, S.A. Amendment No. 1 to Draft Registration Statement on Form F -1 Submitted August 29, 2014 CIK No. 0001613780 Dear Dr. Benhamou : We have reviewed your amended draft registration statement 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 by providing the requested information and either submitting another amended draft registration statement or pub licly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe a further amendment is appropriate, please tell us why in your response. After reviewing the information you p rovide in response to these comments and your second amended draft registration statement or filed registration statement, we may have additional comments. Use of Proceeds, page 5 5 1. We note your response to prior comment 13. While we recognize the unce rtainty involved in predicting the clinical stage you will achieve for your product candidates, we believe that such estimates are a material part of your disclosure. Please amend your registration statement to state the clinical stage you hope to achieve for both Viaskin Peanut and Viaskin Milk using your offering proceeds. You may note that your clinical development is subject to multiple external factors that may impact its progress. 2. We note your response to prior comment 14 and we re -issue the comment in part. From your revised disclosure it appears that you have a specific plan to allocate a portion of your anticipated offering proceeds toward research and development. Please amend your registration statement to indicate the approximate amount to be allocated for research and Dr. Pierre -Henri Benhamou DBV Technologies S.A. September 12 , 2014 Page 2 development and limit the disclosure concerning the remainder of your net proceeds to working capital, capital expenditures, etc. Management’s Discussion an d Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Estimates Repayable Advances, page 67 3. Please refer to prior comment 16. As originally requested, please explain the nature of the underlying milestone events and the factors that you considered in determining the timing for repayment of the repayable advances. In particular, revise your disclosure to describe what “technical or commercial success” means in each instance and clarify whether you record the repayment obligation because you have met the repayment requirements or because you believe it is probable that an outflow of resources will be required to settle the obligation (under paragraph 14 of IAS 37). To the extent you record the obligation under some othe r authoritative guidance, separately explain to us what guidance you follow. Notes to Financial Statements Note 1: The Company, page F -7 4. Please refer to prior comment 25. We acknowledge the information provided in your response. However, your reference to “near term periods” is unclear. Please provide an approximate quantification of this term. Also, separately describe to us the key terms governing your strategic research partnership s and othe r collaboration arrangements , such as those with Sanofi, Jaf fe Food, Stallergenes, Institut National de la Sante and BioNet - Asia. Note 3: Accounting Principles 3.10 Subsidies and Conditional Advances, page F -13 5. Please refer to prior comment 27. Please describe to us the technical and commercial achievements of ImmunaVia that governed your recognition and deferral of subsidies income. In addition, please explain to us how the technical and commercial achievements governing the accounting treatment for the OSEO repayable conditional advances and the subsidies are consistent with one another. Also, explain how revenue recognition for subsidies based upon “technical and commercial achievements” is consistent with revenue “recognized ratably through income,” as disclosed on page F -13. Note 24: Events After the Clo se of the Year, page F -47 6. Please refer to prior comment 29. We acknowledge the information provided in your response. However, your reference to “near term periods” is unclear. Please provide an approximate quantification of this term. Also, separately de scribe to us the key terms governing your agreement with the Ichan School of Medicine. Dr. Pierre -Henri Benhamou DBV Technologies S.A. September 12 , 2014 Page 3 If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guid ance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . Please keep in mind that we may publicly post filing review correspondence in accorda nce with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, p lease properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. You may contact Frank Wyman at (202) 551 -3660 or Mark Brunhofer at (202) 551 -3638 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, John Krug at (202) 551 -3862 or me at (202) 551 - 3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Mitchell S. Bloom , Esq. Michael H. Bison, Esq. Goodwin Procter LLP Exchange Place 55 State Street Boston, MA 02109
2014-08-21 - UPLOAD - DBV Technologies S.A.
August 20, 2014 Via E -mail Dr. Pierre -Henri Benhamou Chairman and Chief Executive Officer DBV Technologies S.A. Gren Square -Bâtiment D 80/84 rue des Meuniers 92220 Bagneux France Re: DBV Technologies, S.A. Draft Registration Statement on Form F -1 Confidentially Submitted July 25, 2014 CIK No. 0001613780 Dear Dr. Benhamou : We have reviewed your draft registration statement 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 by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statem ent on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and you r amended draft registration statement or filed registration statement, we may have additional comments. General 1. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports abou t you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. Dr. Pierre -Henri Benhamou DBV Technologies S.A. August 20, 2014 Page 2 2. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If those are not the only graphics, please provide any additional graphics prior to their use for our review. 3. Please be advise d that the Office of International Corporate Finance is performing a concurrent review of your registration statement. We will issue comments resulting from that review, if any, under separate cover once it is complete. 4. We note that you have submitted an application for confidential treatment relating to several of your exhibits. Please be advised that all comments issued as a result of that review, if any, must be resolved prior to your filing a request for acceleration. Summary 5. In the table on page 1 , please adjust the arrow for Viaskin Peanut to the midpoint of the Phase II column and the arrow for Viaskin Milk to the end of the Pre -Clinical column, to more accurately reflect the current status of each product candidate. Please do the same to the co rresponding table on page 75. Company Overview, page 1 6. Please explain the meaning of the phrase “tolerogenic immune response .” 7. Please briefly describe the significance of a “fast -track” designation by the Food and Drug Administration. 8. Please clarify here and wherever else applicable in your filing that your only pre -clinical candidate at this time is Viaskin HDM and that your product development efforts for allergens other than peanuts, cow’s milk and house dust mice have not yet result ed in any product candidates. Risk Factors Risks Related to Product Development, Regulatory Approval and Commercialization “Our product candidates are expected to undergo clinical trials that are time -consuming and expensive . . .,” page 15 9. Please amend this risk factor to cite as an example of negative clinical trial results the fact that no adolescents qualified as responders in the ARACHILD clinical trial at any of six, 12 or 18 months. ‘We face substantial competition from companies with considerably more resources and experience than we have . . .,” page 24 10. Please amend this risk factor to include the name(s) of your principal competitor(s) and their product(s) or product candidate(s), similar to your disclosure on pages 91 -92. Dr. Pierre -Henri Benhamou DBV Technologies S.A. August 20, 2014 Page 3 “Produc t liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our product candidates,” page 37 11. Please expand the discussion to clarify whether you currently have liability insurance and the extent of such coverage. Special Note Regarding Forward -Looking Statements, page 49 12. Please remove the statement “(w)e have not independently verified any third -party information” from your filing. This assertion could be construed as disclaiming responsibility for some of the information included in your registration statement, which is not appropriate. Use of Proceeds, page 53 13. Please indicate the clinical stage you hope to achieve for Viaskin Peanut and Viaskin Milk using the proceeds of your offering. 14. Please separate the amount of proceeds you intend to allocate toward research and development activities from those to be directed toward general corporate purposes and working capital. Management’s Discussion and Analysis of Financial Condition and Results of Operations Financial Operations review Research Tax Credits, page 62 15. Please expand your disclosure to describe the terms governing the research tax credits received from French tax authorities and the a ssociated revenue recognition basis. Separately tell us why it is appropriate to classify these tax credits as ‘other income’ in the operating revenues section of your statements of income and reference for us the authoritative literature you rely upon to support your accounting and classification. Critical Accounting Policies and Estimates Repayable Advances, page 65 16. You classified repayable advances of €1,442,825 at December 31, 2013, as both current (€126,292) and non -current (€1,316,533). Presumably, you based this classification on the expected timing of technical and commercial achievements of your development programs. Please expand your disclosure to explain the contractual terms governing these repayment advances, particularly the nature of the underlying milestone events and the factors that you considered in determining the timing of their occurrence. Dr. Pierre -Henri Benhamou DBV Technologies S.A. August 20, 2014 Page 4 Liquidity and Capital Resources Cash and Funding Sources, page 69 17. You state in the fourth bullet on page 70 that “ Since Diallertest Milk has been requalified by the relevant authorities, we may only market it for export after a Phase III clinical trial in the perspective of a marketing authorization.” Also on page 62, you state that “Diallertest Milk is currently available on the French market with a temporary exemption status. Regulatory authorities are requesting a pivotal Phase III trial to complete the marketing file for this product.” Please explain these statements, specifically clarifying the nature of remaining clinical testing and regulatory approval s tatus for this product in France and other planned export markets. Revise your disclosure accordingly. JOBS Act Exemptions, page 73 18. Please revise your disclosure to explicitly indicate whether you will take advantage of the extended transition period pro vided in Securities Act Section 7(a)(2)(B) for complying with new or revised accounting standards. To the extent you elect not to take advantage of the extended transition period, disclose that your election is irrevocable. See Question 13 of the Jumpsta rt Our Business Startups Act Frequently Asked Questions. Business Our Solution: Epicutaneous Im munotherapy (EPIT) using our Vi askin Technology Platform, page 79 19. In your discussion of Langerhans cells on page 8 1, please explain the terminology “down -regulation of Th2 response” and the significance of Th1 expression remaining stable during this process. Our Product Candidates , page 81 20. Please confirm that you have filed INDs for both Viaskin Peanut and Viaskin Milk for the peanut and cow’s milk protein allergies, respectively, with the FDA, the approximate dates of filing and that, to your knowledge, both INDs are active. 21. Please disclose your involvement, if any, in the ARACHILD and CoFAR6 clinical trials and explain why, to your knowledge, the AP -HP and CoFAR ch ose to launch trials to evaluate Viaskin Peanut. 22. Please disclose the primary and secondary endpoints of the ARACHILD trial and how the results observed matched against those endpoints. 23. In your discussion of Viaskin milk, please explain the terms “IgE -mediated” and “specific IgE ” and distinguish them from your other references to the IgE antibody. Dr. Pierre -Henri Benhamou DBV Technologies S.A. August 20, 2014 Page 5 Principal Shareholders, page 126 24. Please identify the individual(s) who has voting and investment control over the shares held by the Bpifrance entities. Notes to Financial Statements Note 1: The Company, page F -7 25. Please describe to us the key terms governing your strategic research partnership s and other collaboration arrangements , such as those with Sanofi, Jaffe Food, Stallergenes, Institut national de la Sante and BioNe t-Asia, and the expected impact of these arrangements on your financial statements . Revise your disclosure accordingly. Note 3: Accounting Principles 3.6 Cash and Cash Equivalents, page F -12 26. You indicate that you include long -term investments that can be liquidated immediately without penalty in cash equivalents. Please tell us how inclusion of these amounts complies with the definition of cash equivalents in paragraph 6 of IAS 7. In addition, please tell us how long -term investments are subject to o nly a negligible risk of change in value. In your response, tell us the amount of long -term investments and tell us the amount and duration of investment securities included in your cash equivalents at both December 31, 2012 and 2013. 3.10 Subsidies and Conditional Advances, page F -13 27. Please revise your policy disclosure to address the following: Explain the difference between a subsidy and a conditional advance. If subsidies are grants that are non -repayable, please clarify; Clarify what you mean i n the first paragraph on page F -14 by revenue being recorded “for the fiscal year during which the debt becomes owned as a receivable.” In this regard, we usually associate debt with being owed not as being owned; and Disclose when you recognize revenue for subsidies received in advance of fulfillment of the underlying requirement. If you do not receive subsidies in advance, please separately tell us how you have €793,720 of deferred revenues from subsidies at December 31, 2013 as reported in Note 13.2 on page F -27. Dr. Pierre -Henri Benhamou DBV Technologies S.A. August 20, 2014 Page 6 Note 20: Commitments, page F -43 28. Please explain your basis for not disclosing the information on page 91, regarding the assignment, development and co -ownership agreements with AP -HP and UHD. Explain the contractual terms governing these arrangements and the expected impact of these arrangements on your financial statements . Revise your disclosure accordingly. Note 24: Events After the Close of the Year, page F -46 29. Please explain the terms governing the collaboration agreement with the I cahn School of Medicine and the liquidity agreement held by Natixis and the expected impact of these arrangements on your financial statements. Revise your disclosure accordingly. If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingproced ures101512.htm . Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letter s to you. You may contact Frank Wyman at (202) 551 -3660 or Mark Brunhofer at (202) 551 -3638 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, John Krug at (202) 551 -3862 or me at (202) 551 - 3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Mitchell S. Bloom , Esq. Michael H. Bison, Esq. Goodwin Procter LLP Exchange Place 55 State Street Boston, MA 02109