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SEC Comment Letters
Company Responses
Letter Text
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
JOHNSON & JOHNSON
Response Received
23 company response(s)
High - file number match
Company responded
2007-09-21
JOHNSON & JOHNSON
Summary
Generating summary...
↓
SEC wrote to company
2007-11-29
JOHNSON & JOHNSON
References: September 21, 2007
Summary
Generating summary...
↓
Company responded
2007-12-13
JOHNSON & JOHNSON
References: November 29, 2007
Summary
Generating summary...
↓
Company responded
2008-02-14
JOHNSON & JOHNSON
References: November 29, 2007
Summary
Generating summary...
↓
Company responded
2009-06-22
JOHNSON & JOHNSON
Summary
Generating summary...
↓
Company responded
2011-05-09
JOHNSON & JOHNSON
References: May 3, 2011
Summary
Generating summary...
↓
Company responded
2011-05-27
JOHNSON & JOHNSON
References: May 3, 2011
Summary
Generating summary...
↓
Company responded
2011-06-28
JOHNSON & JOHNSON
References: June 24, 2011
Summary
Generating summary...
↓
Company responded
2011-07-20
JOHNSON & JOHNSON
References: June 24, 2011
Summary
Generating summary...
↓
Company responded
2011-07-25
JOHNSON & JOHNSON
References: June 24, 2011
Summary
Generating summary...
↓
Company responded
2012-06-08
JOHNSON & JOHNSON
References: June 1, 2012
Summary
Generating summary...
↓
Company responded
2012-06-28
JOHNSON & JOHNSON
References: June 1, 2012
Summary
Generating summary...
↓
Company responded
2013-04-04
JOHNSON & JOHNSON
References: March 28, 2013
Summary
Generating summary...
↓
Company responded
2013-04-23
JOHNSON & JOHNSON
References: March 28, 2013
Summary
Generating summary...
↓
Company responded
2013-05-15
JOHNSON & JOHNSON
Summary
Generating summary...
↓
Company responded
2014-05-14
JOHNSON & JOHNSON
References: May 2, 2014
Summary
Generating summary...
↓
Company responded
2014-06-18
JOHNSON & JOHNSON
References: June 16, 2014
Summary
Generating summary...
↓
Company responded
2014-07-11
JOHNSON & JOHNSON
References: June 16, 2014
Summary
Generating summary...
↓
Company responded
2016-04-27
JOHNSON & JOHNSON
References: April 12, 2016
Summary
Generating summary...
↓
Company responded
2016-05-25
JOHNSON & JOHNSON
References: April 12, 2016
Summary
Generating summary...
↓
Company responded
2019-07-24
JOHNSON & JOHNSON
References: July 18, 2019
Summary
Generating summary...
↓
Company responded
2019-08-22
JOHNSON & JOHNSON
References: July 18, 2019 | May 25, 2016
Summary
Generating summary...
↓
Company responded
2021-05-04
JOHNSON & JOHNSON
Summary
Generating summary...
↓
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-05-27
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-04-27
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-09-20
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-07-24
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-06-06
JOHNSON & JOHNSON
References: April 12, 2016
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-04-12
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-08-13
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-06-17
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-05-02
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-05-16
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-03-29
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-07-17
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-06-01
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-08-26
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2011-06-24
JOHNSON & JOHNSON
Summary
Generating summary...
↓
Company responded
2011-08-22
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-05-05
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2010-12-03
JOHNSON & JOHNSON
References: November 23, 2010
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2010-11-30
JOHNSON & JOHNSON
References: November 23, 2010
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2010-11-29
JOHNSON & JOHNSON
References: November 23, 2010
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-07-08
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-06-08
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2008-12-23
JOHNSON & JOHNSON
References: December 17, 2008 | December 19, 2008 | December 22, 2008
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2008-12-19
JOHNSON & JOHNSON
References: December 17, 2008
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2008-12-17
JOHNSON & JOHNSON
References: December 12, 2008
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2008-12-17
JOHNSON & JOHNSON
References: December 12, 2008
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2008-12-15
JOHNSON & JOHNSON
References: December 12, 2008
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-02-15
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-01-25
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2006-08-03
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2006-08-02
JOHNSON & JOHNSON
Summary
Generating summary...
JOHNSON & JOHNSON
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2006-05-31
JOHNSON & JOHNSON
Summary
Generating summary...
↓
Company responded
2006-06-13
JOHNSON & JOHNSON
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-02 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | 001-03215 | Read Filing View |
| 2025-04-23 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2025-04-16 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | 001-03215 | Read Filing View |
| 2021-05-27 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2021-05-04 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2021-04-27 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-09-20 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-08-22 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-07-24 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-07-24 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-06-06 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-05-25 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-04-27 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-04-12 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-08-13 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-07-11 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-06-18 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-06-17 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-05-14 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-05-02 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-05-16 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-05-15 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-04-23 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-04-04 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-03-29 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-07-17 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-06-28 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-06-08 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-06-01 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-08-26 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-08-22 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-07-25 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-07-20 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-06-28 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-06-24 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-05-27 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-05-09 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-05-05 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2010-12-03 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2010-11-30 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2010-11-29 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2009-07-08 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2009-06-22 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2009-06-08 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-23 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-19 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-17 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-17 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-15 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-02-15 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-02-14 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-01-25 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2007-12-13 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2007-11-29 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2007-09-21 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-08-03 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-08-02 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-06-13 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-05-31 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-02 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | 001-03215 | Read Filing View |
| 2025-04-16 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | 001-03215 | Read Filing View |
| 2021-05-27 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2021-04-27 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-09-20 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-07-24 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-06-06 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-04-12 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-08-13 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-06-17 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-05-02 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-05-16 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-03-29 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-07-17 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-06-01 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-08-26 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-06-24 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-05-05 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2009-07-08 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2009-06-08 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-02-15 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-01-25 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2007-11-29 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-08-03 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-05-31 | SEC Comment Letter | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-23 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2021-05-04 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-08-22 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2019-07-24 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-05-25 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2016-04-27 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-07-11 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-06-18 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2014-05-14 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-05-15 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-04-23 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2013-04-04 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-06-28 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2012-06-08 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-08-22 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-07-25 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-07-20 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-06-28 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-05-27 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2011-05-09 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2010-12-03 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2010-11-30 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2010-11-29 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2009-06-22 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-23 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-19 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-17 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-17 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-12-15 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2008-02-14 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2007-12-13 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2007-09-21 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-08-02 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
| 2006-06-13 | Company Response | JOHNSON & JOHNSON | NJ | N/A | Read Filing View |
2025-05-02 - UPLOAD - JOHNSON & JOHNSON File: 001-03215
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 2, 2025 Joseph J. Wolk Chief Financial Officer JOHNSON & JOHNSON One Johnson & Johnson Plaza New Brunswick, New Jersey 08933 Re: JOHNSON & JOHNSON Form 10-K for Fiscal Year Ended December 29, 2024 File No. 001-03215 Dear Joseph J. Wolk: We have completed our review of your filings. 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. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-04-23 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm Joseph J. Wolk Executive Vice President Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, New Jersey 08893 April 23, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 29, 2024 File No. 001-03215 Dear Mr. Atallah and Mr. Gordon: Johnson & Johnson (the “Company”) is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated April 16, 2025, with respect to Johnson & Johnson’s Form 10-K filed with the Commission on February 13, 2025 (the “2024 Form 10-K”). Set forth below is the heading and text of the comment followed by our response: Form 10-K for the Fiscal Year Ended December 29, 2024 Item 1. Business, page 1 1. We note your statement on page 3 indicating that the licensed patents related to your Darzalex and Darzalex Faspro products are material to your business. In future filings, please revise to disclose the material terms of your licensing agreement with Genmab A/S relating to your Darzalex and Darzalex Faspro products or tell us why you believe such disclosure is not required. Your revisions should include the aggregate amount paid to Genmab, royalty rates or royalty rate ranges, and term and termination provisions. Please also file this agreement as an exhibit to your annual report. Refer to Item 601 of Regulation S-K for guidance. Response: In response to the Staff’s comment, we respectfully provide the following information: The Company advises the Staff that the Company believes the license agreement (the “License Agreement”) with Genmab A/S (“Genmab”) does not need to be filed as an exhibit to the Company’s annual report under Item 601(b)(10)(i) of Regulation S-K, because the License Agreement was made in the ordinary course of business and does not meet any of the exceptions enumerated under Item 601(b)(10)(ii). In particular, the Company’s business is not “substantially dependent” on the License Agreement, as the Company is solely responsible for the development, manufacturing, promotion and distribution of its products, including DARZALEX and DARZALEX FASPRO. As disclosed in the 2024 Form 10-K, the Company relies on its own patents, in addition to patents licensed from Genmab pursuant to the License Agreement, which is of a nature that would ordinarily accompany the kind of business conducted by the Company. Although the Company does not believe that disclosure of the material terms of the License Agreement would be required in its annual report, the Company will add disclosure substantially similar to the following in its future Form 10-K filings to the extent still relevant: • Royalty rate ranges between 12% - 20% of total DARZALEX net sales; and • Fiscal year 2024 and 2025 royalty amounts paid to Genmab of approximately $2 billion and $[X] billion, respectively. The Company acknowledges that it and its management are responsible for the accuracy and adequacy of its disclosures, notwithstanding any review, comments, action or absence of action by the Staff. Please do not hesitate to contact us with any questions or comments you may have. Sincerely, /s/ Joseph J. Wolk EVP & Chief Financial Officer (732) 524-1142 Copy: Elizabeth Forminard, EVP and Chief Legal Officer Robert Decker, VP Corporate Controller and Chief Accounting Officer 2
2025-04-16 - UPLOAD - JOHNSON & JOHNSON File: 001-03215
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 16, 2025 Joseph J. Wolk Chief Financial Officer JOHNSON & JOHNSON One Johnson & Johnson Plaza New Brunswick, New Jersey 08933 Re: JOHNSON & JOHNSON Form 10-K for Fiscal Year Ended December 29, 2024 File No. 001-03215 Dear Joseph J. Wolk: We have reviewed your filing and have the following comment. Please respond to this letter 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 a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for Fiscal Year Ended December 29, 2024 Item 1. Business, page 1 1. We note your statement on page 3 indicating that the licensed patents related to your Darzalex and Darzalex Faspro products are material to your business. In future filings, please revise to disclose the material terms of your licensing agreement with Genmab A/S relating to your Darzalex and Darzalex Faspro products or tell us why you believe such disclosure is not required. Your revisions should include the aggregate amount paid to Genmab, royalty rates or royalty rate ranges, and term and termination provisions. Please also file this agreement as an exhibit to your annual report. Refer to Item 601 of Regulation S-K for guidance. 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. April 16, 2025 Page 2 Please contact Eric Atallah at 202-551-3663 or Daniel Gordon at 202-551-3486 if you have questions regarding comments on the financial statements and related matters. Please contact Tyler Howes at 202-551-3370 or Chris Edwards at 202-551-6761 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2021-05-27 - UPLOAD - JOHNSON & JOHNSON
United States securities and exchange commission logo
May 27, 2021
Joseph J. Wolk
Chief Financial Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
Re:Johnson & Johnson
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 22, 2021
File No. 001-03215
Dear Mr. Wolk:
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 of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-05-04 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
filename1.htm
Joseph J. Wolk
Executive Vice President
Chief Financial Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08893
May 4, 2021
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
Re:
Johnson & Johnson
Form 10-K for the Fiscal Year Ended January 3, 2021
Filed February 22, 2021
File No. 001-03215
Dear Ms. Ignat and Ms. Connell:
Johnson & Johnson (the “Company”) is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”), dated April 27, 2021, with respect to Johnson & Johnson’s Form 10-K filed with the Commission on February 22, 2021 (the “Form 10-K”).
Please note that the Company is requesting confidential treatment pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83 with respect to
portions of the Company’s response that have been redacted from the version of this letter filed via EDGAR and marked by bracketed asterisks (“[***]”). An unredacted version of this letter is being provided to the Commission under separate cover
along with the request for confidential treatment.
Set forth below is the heading and text of the comment followed by our response:
Form 10-K for the Fiscal Year Ended January 3, 2021
Management’s Discussion and Analysis of Results of Operations and Financial Condition
Results of Operations
Research and Development Expense, page 27
1.
You disclose that one of the drivers of your increase in research and development expense during 2020 was portfolio progression including the COVID-19 vaccine in the
Pharmaceutical business, net of government reimbursement. Please tell us your consideration of disclosing material agreements entered into with U.S. and other governments for the development and distribution of your COVID-19 vaccine, the
significant terms of such agreements and how related amounts have been recognized in your financial statements. In this regard, we note in August 2020 you announced an agreement with the Biomedical Advanced Research and Development Authority
(BARDA) whereby
1
BARDA committed over $1 billion in funding in exchange for the development and delivery of 100 million doses of the vaccine in the U.S. You
also announced that this vaccine would be provided at a global non-for-profit basis for emergency pandemic use.
Response: In response to the Staff’s comment, we respectfully provide the following information:
The Company considers both quantitative and qualitative factors when assessing all material agreements and determining disclosure requirements. Consistent with the application of
these factors we determined the above-referenced agreement with BARDA is not material and our disclosures are adequate as further outlined below.
In March 2020, the Company announced a cost-sharing agreement with BARDA (“the Agreement”) of up to $1 billion. The Agreement stipulates that the Company and BARDA each bear a
percentage of qualifying costs incurred by the Company associated with the research, development and clinical testing of its COVID-19 vaccine candidate for emergency pandemic use. The Agreement provides reimbursement up to $1 billion from BARDA for
qualifying costs, once approved, over a six-year period from 2020 through 2025. Similar cost-share arrangements are common in the biopharmaceutical industry.
The Company incurred total research and development expenses associated with the development of a COVID-19 vaccine for emergency pandemic use of approximately [***] in fiscal
2020. Under the Agreement, the Company recognized approximately [***] as a reduction of research and development expense in fiscal 2020, in accordance with the guidance in ASC
730-20 Research and Development, which reduced the Company’s COVID-19 vaccine research and development expenses to approximately [***] on a net basis. The [***] expense was one of several components of the Company’s year over year increase
in total research and development expenses from $11.4 billion in fiscal 2019 to $12.2 billion in fiscal 2020.
As is customary practice, the Company considered the quantitative and qualitative elements of agreements with the U.S. and other governments for the development, purchase, and
distribution of its COVID-19 vaccine as part of its disclosure assessment. The [***] of cost reimbursements from BARDA relating to fiscal 2020 for cost-sharing of the COVID-19 vaccine represents approximately [***] of the Company’s total research
and development expense of $12.2 billion and less than [***] of total operating expenses in fiscal 2020. Neither the quantitative impact nor the nature of the Agreement was deemed material based upon the Company’s reporting thresholds and disclosure
review processes. In addition, the contractual period of the Agreement is over multiple years and not expected to be material in any period covered by the Agreement.
Separately and distinctly from the Agreement, the Company has entered into advanced purchase agreements with governments and government related organizations around the world for
its COVID-19 vaccine and has committed to a not-for profit price for emergency pandemic use. In relation to the Agreement and costs incurred in fiscal 2020, the net [***] of COVID-19 vaccine research and development costs are included in the
Company’s determination of its not-for-profit price. There was no revenue recognized by the Company in fiscal 2020 related to its COVID-19 vaccine.
2
Please do not hesitate to contact us with any questions or comments you may have.
Sincerely,
/s/ Joseph J. Wolk
EVP & Chief Financial Officer
(732) 524-1142
Copy:
Michael Ullmann, EVP and General Counsel
Robert Decker, VP Corporate Controller and Chief Accounting Officer
3
2021-04-27 - UPLOAD - JOHNSON & JOHNSON
United States securities and exchange commission logo
April 27, 2021
Joseph J. Wolk
Chief Financial Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
Re:Johnson & Johnson
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 22, 2021
File No. 001-03215
Dear Mr. Wolk:
We have reviewed your filing and have the following comment. In our comment we may
ask you to provide us with information so we may better understand your disclosure.
Please respond to the comment 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
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended January 3, 2021
Management's Discussion and Analysis of Results of Operations and Financial Condition
Results of Operations
Research and Development Expense, page 27
1.You disclose that one of the drivers of your increase in research and development expense
during 2020 was portfolio progression including the COVID-19 vaccine in the
Pharmaceutical business, net of governmental reimbursements. Please tell us your
consideration of disclosing material agreements entered into with U.S. and other
governments for the development and distribution of your COVID-19 vaccine, the
significant terms of such agreements and how related amounts have been recognized in
your financial statements. In this regard, we note in August 2020 you announced an
agreement with the Biomedical Advanced Research and Development Authority
(BARDA) whereby BARDA committed over $1 billion in funding in exchange for the
development and delivery of 100 million doses of the vaccine in the U.S. You also
announced that this vaccine would be provided at a global non-for-profit basis for
FirstName LastNameJoseph J. Wolk
Comapany NameJohnson & Johnson
April 27, 2021 Page 2
FirstName LastName
Joseph J. Wolk
Johnson & Johnson
April 27, 2021
Page 2
emergency pandemic use.
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 Ibolya Ignat at (202) 551-3636, or Angela Connell at (202) 551-
3426 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-09-20 - UPLOAD - JOHNSON & JOHNSON
September 20, 2019
Joseph J. Wolk
Chief Financial Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
Re:Johnson & Johnson
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed January 22, 2019
File No. 001-03215
Dear Mr. Wolk:
We have completed our review of your filings. 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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-08-22 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm Document Joseph J. Wolk Executive Vice President Chief Financial Officer One Johnson & Johnson Plaza New Brunswick, NJ 08933 August 22, 2019 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 30, 2018 Filed February 20, 2019 Form 8-K dated January 22, 2019 Filed January 22, 2019 File No. 001-03215 Dear Ms. Ignat and Ms. Connell: Johnson & Johnson (the “Company”) is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated July 18, 2019, with respect to Johnson & Johnson’s Form 10-K filed with the Commission on February 20, 2019 (the “Form 10-K”) and Form 8-K filed on January 22, 2019 (the “Form 8-K”) (SEC File No. 001-03215). Set forth below is the heading and text of each comment followed by our response: Form 10-K for the Fiscal Year Ended December 31, 2018 General 1. In your letter to us dated May 25, 2016, you discussed contacts with Syria and Sudan. Johnson & Johnson Customer Connect’s website lists Syria under its Europe, Middle East and Africa region, and a May 28, 2019 Business Monitor Online report on the Sudan Pharmaceuticals & Healthcare Competitive Landscape reports that you import products into Sudan. As you are aware, Syria and Sudan are designated by the State Department as state sponsors of terrorism and are subject to U.S. economic sanctions and/or export controls. Your Form 10-K does not provide disclosure about those countries. Please describe to us the nature and extent of any past, current, and anticipated contacts with Syria and Sudan since your 2016 letter, including contacts with those countries’ governments, whether through subsidiaries, distributors, affiliates, or other direct or indirect arrangements. Response: There have been no significant changes in the Company’s contacts with Syria and Sudan since the letter dated May 25, 2016. The Company and its affiliates (collectively “J&J”) are organized into three segments: Pharmaceutical, Consumer and Medical Devices. The Pharmaceutical and Medical Devices segments have sold products to Syria and/or Sudan primarily for humanitarian purposes and through distributors. In the case of distributors, these entities are not controlled by, or agents of, J&J and take ownership and control of products upon sale by J&J. The Company routinely complies with the terms of General Licenses applicable to transactions involving medicines or medical devices or obtains licenses from the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) and/or the US Department of the Treasury’s Office of Foreign Asset Control (“OFAC”), as applicable. With respect to business conducted in Syria or Sudan, the Company complies with the terms of General Licenses or has all required BIS and/or OFAC licenses. An overview of each segment’s business with Syria and Sudan is provided below. Pharmaceutical Syria J&J has sold pharmaceutical products to Syrian distributors and international health organizations for end-use at hospitals, clinics and pharmacies in Syria. In addition, J&J sells pharmaceutical products to the General Foreign Trade Organization, an entity controlled by the Government of Syria, for distribution to government hospitals, clinics, and pharmacies in Syria. Since September 2010, J&J’s Belgian affiliate has maintained a scientific office in Syria to comply with regulatory, safety, and quality requirements provided for under local regulations. Sudan J&J sells pharmaceutical products into Sudan, generally through Sudanese distributors, for end-use at hospitals, clinics, and pharmacies in Sudan. In addition, J&J sells pharmaceutical products to Central Medical Supplies, an entity controlled by the Government of Sudan, for distribution to government hospitals, clinics, and pharmacies in Sudan. Consumer Since 2015, J&J has not and does not sell consumer products into Syria or Sudan and has no specific plans to do so in the future. Medical Devices Syria J&J sells medical devices into Syria through distributors for end-use at hospitals and clinics in Syria. Sudan J&J sells medical devices into Sudan, generally through distributors, for end-use at hospitals, clinics and pharmacies in Sudan. 2. Please discuss the materiality of any contacts with Syria and Sudan, in quantitative terms and in terms of qualitative factors that a reasonable investor would deem important in making an investment decision. Tell us the approximate dollar amounts of any revenues, assets and liabilities associated with those countries for the last three years and the subsequent interim periods. Address for us the potential impact of the investor sentiment evidenced by divestment and similar initiatives that have been directed toward companies that have operations associated with state sponsors of terrorism. Response: As stated in the Commission’s Concept Release 33-8860, dated November 16, 2007: The federal securities laws do not impose a specific disclosure requirement that addresses business activities in or with a country based upon its designation as a State Sponsor of Terrorism. However, the federal securities laws do require disclosure of business activities in or with a State Sponsor of Terrorism if this constitutes material information that is necessary to make a company’s statements, in the light of the circumstances under which they are made, not misleading. In accordance with the above, the Company has not disclosed its contacts in or with Syria and Sudan in our Form 10-K as the Company believes those activities are de minimis and not material. Quantitative Factors The Company believes that its contacts in or with, and revenue derived from, Syria and Sudan are de minimis and not material. Except for the scientific office maintained by J&J’s Belgian affiliate in Syria to comply with certain regulatory, safety, and quality requirements under local regulations and sales activities discussed in this letter, J&J does not have a presence or conduct any activities in Syria or Sudan. The Company’s assets and liabilities in either Syria and Sudan, including the scientific office maintained by J&J’s Belgian affiliate in Syria are less than $1 million. The below table summarizes the revenues from the Company’s activities with Syria and Sudan and the associated percentage impact to the Company’s consolidated financial statements referenced in the Staff’s letter. Period Syria Revenue Sudan Revenue J&J Company Total Syria & Sudan % 2016 $3.6 million $5.5 million $71.9 billion 0.013% 2017 $5.7 million $6.2 million $76.5 billion 0.016% 2018 $7.3 million $4.8 million $81.6 billion 0.015% Q2 2019 (YTD) $7.5 million $3.0 million $40.8 billion 0.026% Qualitative Factors The Company does not believe a reasonable investor would deem these activities important in making an investment decision, given: (i) J&J routinely obtains licenses from BIS and/or OFAC as required; (ii) these activities involve the sale of humanitarian products and products that promote human health and (iii) the financial impact of such activities are insignificant when compared to the Company’s global operations and its consolidated financial statements. Further, the various divestment initiatives and policies referred to in the Staff’s letter generally provide exceptions for companies that sell humanitarian goods, such as our products, or otherwise expressly or implicitly permit decision makers discretion to take such factors into account when making investment decisions. As a result, we believe that few, if any, of these initiatives or policies would require a pension or other fund to divest itself of J&J shares. In addition, we believe the same exception for humanitarian goods generally fits with investor sentiment. As a provider of a broad range of products in the health care field, including certain critical and lifesaving products, we believe that reasonable investors would not expect the Company to deny access to its products and services to patients, doctors, nurses and other healthcare providers in any country, including Syria and Sudan. The Company is committed to maintaining compliance with U.S. sanctions laws and regulations, and will continue to review and monitor its activities globally to ensure compliance with U.S. law. Consolidated Financial Statements Notes to Consolidated Financial Statements 21. Legal Proceedings, page 84 3. You disclose that for your litigation and regulatory matters for which a loss is probable or reasonably possible, you are unable to estimate the possible loss or range of loss beyond the amounts already accrued. Please address the following: • Clarify for us whether this statement applies to all, or just a portion, of your litigation and regulatory matters. For example, as it specifically relates to the various legal proceedings and regulatory matters associated with your body powder products containing talc, you disclose an adverse verdict received in July 2018 in the amount of $4.7 billion. You are appealing this verdict and have accrued for defense costs only in connection with this product liability litigation. Please explain to us whether you believe that it is at least reasonably possible that you will not prevail on appeal and would therefore be subject to the $4.7 billion judgment. If so, it would appear that at a minimum you would be able to estimate a range of reasonably possible losses for this case for disclosure purposes pursuant to ASC 450-20-4. • Explain to us the factors you consider and procedures you undertake to attempt to develop a range of reasonably possible loss for disclosure. In this regard, with respect to various litigation and regulatory matters you disclose that the type of relief sought may include damages, fines, penalties and/or other monetary relief. In cases where monetary relief is sought and has been quantified, explain to us why that would not be considered as part of a reasonable estimate of reasonably possible losses. • For each material matter disclosed (including, but not limited to, your talc and opioid related matters), explain to us what factors are causing your inability to estimate and when you expect those factors to be alleviated. Response: The Company respectfully advises the Staff that the statement pertaining to litigation and regulatory matters for which a loss is probable or reasonably possible and for which a future loss cannot be estimated beyond amounts already accrued applies to all litigation and regulatory matters unless otherwise disclosed. Please see below for the requested information regarding talc related matters and a discussion of the procedures followed in attempting to develop ranges of reasonably possible loss and the factors that may prevent us from estimating ranges of reasonably possible loss. Talc related matters With respect to the $4.7 billion adverse verdict received in July 2018 (the “July 2018 verdict”), the Company, having consulted with external counsel, believes that it has strong grounds on appeal to overturn the July 2018 verdict and it will prevail on appeal. This assertion is based on factors, including but not limited to: (i) procedural and jurisdictional issues in the litigation process; (ii) the fact that all verdicts that have been through the appellate process have been overturned in the Company’s favor; and (iii) independent scientific studies supporting the Company’s position. Accordingly, the Company believes it is not reasonably possible that the Company will not prevail. In addition, the Company does not expect to be subject to the July 2018 verdict and, therefore, cannot estimate a range of reasonably possible losses beyond defense costs for the case pursuant to ASC 450-20-50. In the spirit of transparency and in an effort to acknowledge the recent publicity and investor interest in the matter, the Company felt it was appropriate to include a reference to the July 2018 verdict in its Form 10-K. The Company’s overall position, as stated publicly, is that JOHNSONS® Baby Powder is safe, is asbestos free and does not cause cancer. The number of pending talc related product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has successfully defended a number of these cases but there have been verdicts against the Company including, the July 2018 verdict. There have been several regulatory bodies affirming the Company’s scientific positions that its talc products are safe and no regulatory body, foreign or domestic, has issued product re-call concerns to date. Over the years, the FDA has repeatedly conducted independent testing on commercial cosmetic talc products, including the Company’s talc products, and stated in 1986 and 2014 that these products need not contain a cancer warning. As recently as March of this year, the FDA restated its latest test results, which used “the most sensitive” techniques and showed that the Company’s talc was safe and did not contain asbestos. Finally, the Company’s position has been affirmed by juries and courts. Of the jury verdicts related to mesothelioma claims, the Company has prevailed in seven cases, and the juries have not been able to come to a decision in five additional cases, resulting in mistrials. The Company has received five adverse verdicts which the Company has appealed or plans to appeal. These results do not include a substantial number of cases where plaintiffs voluntarily dismissed their cases. With respect to the ovarian claims, not a single adverse verdict has yet been upheld on appeal, while three verdicts have been overturned. These results do not include a substantial number of cases where plaintiffs voluntarily dismissed their cases. For example, plaintiff lawyers recently voluntarily dismissed, after extensive discovery, a case in federal court in California alleging that the Company’s Baby Powder should contain a warning pursuant to the California Safe Drinking Water and Toxic Enforcement Act, known as Proposition 65, and as a result the court ordered plaintiff lawyers to pay a portion of the Company’s legal fees. Factors Considered and Procedures in Developing Loss Ranges Key legal and financial management meets frequently (at least quarterly) with both internal and external legal counsel to monitor legal actions pending against the Company in order to determine whether an estimate of a reasonably possible loss or range of loss can be disclosed. This information includes, among other things, the following: (i) the nature of the litigation or claim; (ii) any progress or developments in the specific matter or the general matter type; (iii) prior experience in similar matters; (iv) any changes or developments in the underlying legal or factual background; and (v) any changes or developments in the Company’s approach to the defense of the litigation or claim. This information and underlying factors can change, and often do, as more information is obtained and as litigation progresses. For example, factors considered when evaluating current information include whether the monetary damages sought in the proceedings are unsubstantiated or indeterminate; scientific and legal discovery has not commenced or is not complete; proceedings are in early stages; matters present legal uncertainties; there are significant facts in dispute; or there are numerous parties involved. Each of these factors are considered individually and in aggregate when assessing an estimate of reasonably possible losses. Further examples of factors influencing the Company’s ability or inability to
2019-07-24 - UPLOAD - JOHNSON & JOHNSON
July 18, 2019
Joseph J. Wolk
Chief Financial Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
Re:Johnson & Johnson
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed January 22, 2019
Form 8-K dated January 22, 2019
Filed January 22, 2019
File No. 001-03215
Dear Mr. Wolk:
We have reviewed your filings 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 10-K for the Fiscal Year Ended December 31, 2018
General
1.In your letter to us dated May 25, 2016, you discussed contacts with Syria and Sudan.
Johnson & Johnson Customer Connect’s website lists Syria under its Europe, Middle East
and Africa region, and a May 28, 2019 Business Monitor Online report on the Sudan
Pharmaceuticals & Healthcare Competitive Landscape reports that you import products
into Sudan. As you are aware, Syria and Sudan are designated by the State Department as
state sponsors of terrorism and are subject to U.S. economic sanctions and/or export
controls. Your Form 10-K does not provide disclosure about those countries. Please
describe to us the nature and extent of any past, current, and anticipated contacts with
Syria and Sudan since your 2016 letter, including contacts with those countries’
governments, whether through subsidiaries, distributors, affiliates, or other direct or
FirstName LastNameJoseph J. Wolk
Comapany NameJohnson & Johnson
July 18, 2019 Page 2
FirstName LastNameJoseph J. Wolk
Johnson & Johnson
July 18, 2019
Page 2
indirect arrangements.
2.Please discuss the materiality of any contacts with Syria and Sudan, in quantitative terms
and in terms of qualitative factors that a reasonable investor would deem important in
making an investment decision. Tell us the approximate dollar amounts of any revenues,
assets and liabilities associated with those countries for the last three fiscal years and the
subsequent interim period. Address for us the potential impact of the investor sentiment
evidenced by divestment and similar initiatives that have been directed toward companies
that have operations associated with state sponsors of terrorism.
Consolidated Financial Statements
Notes to Consolidated Financial Statements
21. Legal Proceedings, page 84
3.You disclose that for your litigation and regulatory matters for which a loss is probable or
reasonably possible, you are unable to estimate the possible loss or range of loss beyond
the amounts already accrued. Please address the following:
•Clarify for us whether this statement applies to all, or just a portion, of your litigation
and regulatory matters. For example, as it specifically relates to the various legal
proceedings and regulatory matters associated with your body powder products
containing talc, you disclose an adverse verdict received in July 2018 in the amount of
$4.7 billion. You are appealing this verdict and have accrued for defense costs only in
connection with this product liability litigation. Please explain to us whether you
believe that it is at least reasonably possible that you will not prevail on appeal and
would therefore be subject to the $4.7 billion judgment. If so, it would appear that at a
minimum you would be able to estimate a range of reasonably possible losses for this
case for disclosure purposes pursuant to ASC 450-20-4.
•Explain to us the factors you consider and procedures you undertake to attempt to
develop a range of reasonably possible loss for disclosure. In this regard, with respect
to various litigation and regulatory matters you disclose that the type of relief sought
may include damages, fines, penalties and/or other monetary relief. In cases where
monetary relief is sought and has been quantified, explain to us why that would not be
considered as part of a reasonable estimate of reasonably possible losses.
•For each material matter disclosed (including, but not limited to, your talc and opioid-
related matters), explain to us what factors are causing your inability to estimate and
when you expect those factors to be alleviated.
Form 8-K filed January 22, 2019
Exhibit 99.20
Reconciliation of Non-GAAP Financial Measures, page 1
4.We note that you exclude litigation expenses from your non-GAAP Measures. Please
explain to us why these are not normal, recurring, cash operating expenses necessary to
FirstName LastNameJoseph J. Wolk
Comapany NameJohnson & Johnson
July 18, 2019 Page 3
FirstName LastName
Joseph J. Wolk
Johnson & Johnson
July 18, 2019
Page 3
operate your business. See Question 100.01 of the updated Non-GAAP Compliance and
Disclosure Interpretations issued on May 17, 2016.
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 Ibolya Ignat at (202) 551-3636 or Angela Connell at (202) 551-3426
with any questions
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-07-24 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm Document Ronald A. Kapusta Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 July 24, 2019 Via EDGAR Ms. Ibolya Ignat Ms. Angela Connell Division of Corporation Finance Office Healthcare & Insurance U.S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 30, 2018 Filed January 22, 2019 Form 8-K dated January 22, 2019 Filed January 22, 2019 File No. 001-03215 Dear Ms. Ignat and Ms. Connell: We have received the comment letter dated July 18, 2019 (the “comment letter”) from the Securities and Exchange Commission (the “Commission”) to Mr. Joseph J. Wolk, Chief Financial Officer, in which the staff of the Commission has requested certain information with respect to the above-referenced Form 10-K and Form 8-K. As discussed with Ms. Connell, we would like to respectfully request an extension for our response to the comment letter to no later than Friday, August 30. This extension will ensure that we can devote the appropriate time and resources to consider the Staff’s comments and prepare our response. If you have any questions, please contact me at 732-524-6567. Sincerely, /s/ Ronald A. Kapusta Vice President Corporate Controller Chief Accounting Officer
2016-06-06 - UPLOAD - JOHNSON & JOHNSON
Mail Stop 4628 June 6 , 2016 Via E-mail Dominic J. Caruso Chief Financial Officer and Vice President Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 3, 2016 Filed February 24 , 2016 File No. 1-3215 Dear Mr. Caruso : We refer you to our comment letter dated April 12, 2016 regarding business contacts with Syria and Sudan . We have completed our review of this subject matter. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff c omments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain th at the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require . Sincerely, /s/ Cecilia Blye Cecilia Blye, Chief Office of Global Security Risk cc: Ron Kapusta, Controller and Chief Accounting Officer Johnson & Joh nson Suzanne Hayes Assistant Director Division of Corporation Finance
2016-05-25 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm Document Dominic J. Caruso Chief Financial Officer Executive Vice President One Johnson & Johnson Plaza New Brunswick, NJ 08933 May 25, 2016 Via EDGAR Cecilia Blye, Chief Office of Global Security Risk Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 3, 2016 Filed February 24, 2016 File No. 001-3215 Dear Ms. Blye: Johnson & Johnson (the “Company”) is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated April 12, 2016, with respect to the Company’s Form 10-K filed with the Commission on February 24, 2016 for the fiscal year ended January 3, 2016 (the “Form 10-K”) (SEC File No. 001-03215). Set forth below is the heading and text of each comment followed by our response: 1. We are aware of recent publicly available information which reports that your Dubai office controls your supply chain operations for countries including Syria. We also are aware of a February 2016 OFAC Enforcement Information stating that in 2010 Johnson & Johnson Middle East Inc. exported consumer hygiene products to Sudan. Syria and Sudan are designated by the State Department as state sponsors of terrorism, and are subject to U.S. economic sanctions and export controls. Your Form 10-K does not provide disclosure about these countries. Please describe to us the nature and extent of your past, current, and anticipated contacts with Syria and Sudan, whether through subsidiaries, affiliates, distributors, resellers or other direct or indirect arrangements. You should describe any products or services you have provided to Syria and Sudan, directly or indirectly, and any agreements, commercial arrangements, or other contacts with the governments of those countries or entities they control. The Company and its affiliates (collectively, “J&J”) are organized into three business segments: Consumer, Pharmaceutical, and Medical Devices. The Consumer segment includes a broad range of products used in the baby care, oral care, skin care, over-the-counter pharmaceutical, women’s health, and wound care markets. The Pharmaceutical segment is focused on five therapeutic areas: immunology; infectious diseases and vaccines; neuroscience; oncology; and cardiovascular and metabolic diseases. The Medical Devices segment includes a broad range of products used in the orthopedic, surgery, cardiovascular, diabetes care, and vision care fields. Each of these business segments has sold products to Syria and/or Sudan primarily for humanitarian purposes and through distributors. The distributors are not controlled by or agents of J&J-- they take title and risk of ownership of product. To the extent sales to Syria or Sudan trigger US jurisdiction and as required, J&J routinely obtains licenses from the US Department of Commerce’s Bureau of Industry and Security (“BIS”) and/or the US Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), as applicable. An overview of each business segment’s business with Syria and Sudan is provided below. Consumer Syria While J&J sold consumer products to a Syrian distributor in recent years, it ceased these sales at the end of 2015. J&J does not currently have any specific plans to recommence sales of consumer products to Syria. Sudan J&J does not and has not sold consumer products to Sudan in recent years and has no specific plans to do so in the future. Pharmaceutical Your letter notes that J&J’s "Dubai office" controls supply chain operations for countries including Syria. As of January 2016, Johnson & Johnson Middle East FZ LLC in Dubai manages sales of pharmaceutical products to both Syria and Sudan. Previously such sales were directly transacted by subsidiaries of the Company based in Belgium, Ireland and Switzerland. Additional information on J&J’s sales of pharmaceutical products to Syria and Sudan is set out below. Syria J&J has sold pharmaceutical products to Syrian distributors and international health organizations for end-use at hospitals, clinics, and pharmacies in Syria. In addition, J&J sells pharmaceutical products to the General Foreign Trade Organization, an entity controlled by the Government of Syria, for distribution to government hospitals, clinics, and pharmacies in Syria. Since September 2010, J&J’s Belgian affiliate has maintained a scientific office in Syria to comply with regulatory, safety, and quality requirements provided for under local regulations. Sudan J&J sells pharmaceutical products to Sudan, generally through Sudanese distributors, for end-use at hospitals, clinics, and pharmacies in Sudan. In addition, J&J sells pharmaceutical products to Central Medical Supplies, an entity controlled by the Government of Sudan, for distribution to government hospitals, clinics, and pharmacies in Sudan. Medical Devices The Dubai branch of Johnson & Johnson (Middle East) Inc. manages sales of medical devices to both Syria and Sudan. Additional information on J&J’s sales of medical devices to Syria and Sudan is set out below. Syria J&J sells medical devices to Syria through distributors for end-use at hospitals and clinics in Syria. Sudan J&J sells medical devices to Sudan, generally through distributors, for end-use at hospitals, clinics, and pharmacies in Sudan. 2. Please discuss the materiality of the contacts with Syria and Sudan you describe in response to the comment above, and whether those contacts constitute a material investment risk for your security holders. You should address materiality in quantitative terms, including the approximate dollar amounts of any associated revenues, assets, and liabilities for the last three fiscal years and the subsequent interim period. Also, address materiality in terms of qualitative factors that a reasonable investor would deem important in making an investment decision, including the potential impact of corporate activities upon a company’s reputation and share value. Various state and municipal governments, universities, and other investors have proposed or adopted divestment or similar initiatives regarding investment in companies that do business with U.S.-designated state sponsors of terrorism. You should address the potential impact of the investor sentiment evidenced by such actions directed toward companies that have operations associated with Syria and Sudan. The Company believes that its contacts with, and revenue derived from, Sudan and Syria are immaterial and it does not consider those contacts to be a material investment risk for its security holders. In making this determination, the Company considered both quantitative and qualitative factors that it believes a reasonable investor would deem important in making an investment decision, including the potential impact upon a company's reputation and share value that may arise as a result of contacts with U.S.-designated state sponsors of terrorism. Except for the scientific office maintained by J&J’s Belgian affiliate in Syria to comply with certain regulatory, safety, and quality requirements under local regulations and sales activities discussed in this letter, J&J does not have a presence, or conduct any activities, in Sudan or Syria. J&J has no material assets in either Sudan or Syria, including the scientific office maintained by J&J’s Belgian affiliate in Syria. In aggregate, the value of J&J’s sales to Sudan and Syria since 2013 was approximately as follows: Year Value of Sudan Transactions (USD) Value of Syria Transactions (USD) 2013 $3.3 million $1.9 million 2014 $2.3 million $3.1 million 2015 $3.3 million $0.9 million 2016 (Q1) $2.2 million $0.08 million In comparison, overall Company revenue for 2013, 2014, 2015 and (Q1) 2016 was approximately $71.3 billion, $74.3 billion, $70.1 billion and $ 17.5 billion, respectively. Accordingly, revenue resulting from product sales to these countries in 2013, 2014, 2015 and (Q1) 2016 (using the three-month year-to-date revenue), represented 0.007%, 0.007%, 0.006% and 0.01%, respectively, of that year's revenue. The Company does not believe these activities to be qualitatively important to security holders, given that (i) J&J routinely obtains licenses from BIS and/or OFAC, as applicable, as required and to the extent sales to Syria or Sudan trigger US jurisdiction; (ii) these activities involve the sale of humanitarian products and products that promote human health and (iii) the amount of products sold and revenue received are small when compared to the Company’s overall revenue and operations. Thus, from a qualitative and quantitative standpoint, the Company does not believe that its activities as described herein pose a material risk to investors, and a reasonable investor would not deem additional information about these activities important in making an investment decision. The Company is committed to maintaining compliance with U.S. sanctions laws and regulations. Given the Company’s global reach, the Company strives to educate its foreign subsidiaries and personnel regarding U.S. legal requirements. The Company will continue to review and monitor its activities globally to ensure compliance with U.S. law. As requested, we acknowledge that: • The Company is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to this filing; and • The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at 732-524-1721 or the Company’s Corporate Controller, Ronald Kapusta, at 732-524-6567 with any questions or comments you may have. Sincerely, /s/ Dominic J. Caruso Dominic J. Caruso Chief Financial Officer Executive Vice President c: Ronald Kapusta
2016-04-27 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm CORRESP Ronald A. Kapusta Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 April 27, 2016 Via EDGAR Ms. Cecilia Blye Chief, Office of Security Risk U.S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 3, 2016 Filed February 24, 2016 File No. 001-03215 Dear Ms. Blye: We have received the comment letter dated April 12, 2016 from you to Mr. Dominic J. Caruso, Chief Financial Officer, regarding the comments of the staff of the Securities and Exchange Commission with respect to the above-referenced Form 10-K for the fiscal year ended January 3, 2016. Confirming my e-mail with Ms. Jennifer Hardy, we have requested an extension for our response to the comment letter to Friday, May 27, 2016. We are committed to responding promptly but due to our size, complexity and international operations, we respectfully request this further extension. This extension will ensure that we have sufficient time to prepare our response. If you have any questions, please contact me at 732-524-6567. Sincerely, /s/ Ronald A. Kapusta Vice President Corporate Controller Chief Accounting Officer
2016-04-12 - UPLOAD - JOHNSON & JOHNSON
Mail Stop 4628 April 1 2, 2016 Via E-mail Dominic J. Caruso Chief Financial Officer and Vice President Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 3, 2016 Filed February 24 , 2016 File No. 1-3215 Dear Mr. Caruso : We have limited our review of your filing to your contacts with countries that have been identified as state sponsors of terrorism, and we have the following comments. Our review with respect to this issue does not preclude further review by the Assistant Director group with respect to other issues. In our comments , we ask you to provide us with information so we may bett er understand your disclosure. Please respond to these comments within ten busine ss days by providing the requested information or advis e us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstanc es, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. General 1. We are aware of recent publicly available information which reports that your Dubai office controls your supply chai n operations for countries including Syria. We also are aware of a February 2016 OFAC Enforcement Information stating that in 2010 Johnson & Johnson Middle East Inc. exported consumer hygiene products to Sudan. Syria and Sudan are designated by the Stat e Department as state sponsors of terrorism, and are subject to U.S. economic sanctions and export controls. Your Form 10 -K does not provide disclosure about these countries. Please describe to us the nature and extent of your past, current, and anticip ated contacts with Syria and Sudan, whether through subsidiaries, affiliates, distributors, resellers or other direct or indirect arrangements. You should describe any products or services you have provided to Syria and Sudan, Dominic J. Caruso Johnson & Johnson April 1 2, 2016 Page 2 directly or indirectly, and any agreements, commercial arrangements, or other contacts with the governments of those countries or entities they control. 2. Please discuss the materiality of the contacts with Syria and Sudan you describe in response to the comment above, and whether th ose contacts constitute a material investment risk for your security holders. You should address materiality in quantitative terms, including the approximate dollar amounts of any associated revenues, assets, and liabilities for the last three fiscal year s and the subsequent interim period . Also, address materiality in terms of qualitative factors that a reasonable investor would deem important in making an investment decision, including the potential impact of corporate activities upon a company’s reputa tion and share value. Various state and municipal governments, universities, and other investors have proposed or adopted divestment or similar initiatives regarding investment in companies that do business with U.S. - designated state sponsors of terrorism . You should address the potential impact of the investor sentiment evidenced by such actions directed toward companies that have operations associated with Syria and Sudan. We urge all persons who are responsible for the accuracy and adequacy of the dis closure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s dis closure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may contact Jennifer Hardy, Special Counsel, at (202) 551 -3767 or me at (202) 551 - 3470 if you have any questions about the comments or our review. Sincerely, /s/ Cecilia Blye Cecilia Blye, Chief Office of Global Security Risk Dominic J. Caruso Johnson & Johnson April 1 2, 2016 Page 3 cc: Ron Kapusta, Controller and Chief Accounting Officer Johnson & Johnson Suzanne Hayes Assistant Director Division of Corporation Finance
2014-08-13 - UPLOAD - JOHNSON & JOHNSON
August 13, 2014 Via E-mail Mr. Dominic J. Caruso Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 21, 2014 File No . 001-03215 Dear Mr. Caruso: We have completed our review of your filing. We remind you that our comment s or changes to disclo sure in response to our comment s do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comment s as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable rules require. Sincer ely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2014-07-11 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm july112014commentletter Stephen J. Cosgrove Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 July 11, 2014 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 29, 2013 Filed February 21, 2014 File No. 001-03215 Dear Mr. Rosenberg: Johnson & Johnson (the “Company”) is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated June 16, 2014, with respect to Johnson & Johnson’s Form 10-K filed with the Commission on February 21, 2014 for the fiscal year ended December 29, 2013 (the “Form 10-K”) (SEC File No. 001-03215). This letter expands upon the Company’s previous response dated May 14, 2014 and the telephone discussion on June 18, 2014 with Ms. Lisa Vanjoske, Assistant Chief Accountant, and Ms. Christine Allen Torney, Staff Accountant. Set forth below is the heading and text of the comment followed by our response: Exhibit 13 Notes to Consolidated Financial Statements 19. Selected Quarterly Financial Data, page 50 • Your response to comment 2 did not fully explain how you determined the pre-tax amount required to be recognized in each quarter and why such amounts were not required to be recognized in an earlier period. Please provide to us your computation of the pre-tax amounts included in the total net litigation expense of $391 million, $308 million, $720 million and $227 million in each of the four quarters in 2013 disaggregated by matter. Tell us the pre-tax amount that was recorded in each quarter of all years related to each product liability matter with charges recognized in 2013, that is, the timeline of accounting for expense recognized for each major product liability matter with expenses in 2013. Tell us if you recognized any product liability expenses in the first quarter of 2014. Response: • The pre-tax amounts included in total net litigation expense were $529 million, $375 million, $872 million and $506 million in the first, second, third and fourth quarters of 2013, respectively. Of these amounts, $345 million, $361 million, $844 million and $418 million related specifically to product liability in the first, second, third and fourth quarters of 2013, respectively. The balance of the amounts related to various other litigation matters. Individual product liability matters are aggregated, as disaggregating matters could put the Company in a disadvantageous position in settlement negotiations. The Company’s single largest product liability matter in 2013 was related to projected claims on certain metal-on-metal hip replacement products, the ASRTM and ASRTM XL Hip (“ASRTM Hip”). • The quarterly accruals and adjustments described above were recorded in the respective quarters based on the information available at the time. Amounts accrued for legal contingencies often result from a complex series of judgments about future events and uncertainties that rely heavily on estimates and assumptions. In particular, the product liability accruals represent projected product liability claims for thousands of claimants in approximately 55 countries around the world, each in different litigation environments and with different fact patterns. As described in the Company’s letter of May 14, 2014, each quarter, the expense recorded represents the Company’s best estimate of liability based on information available at the time. Amounts accrued for product liability matters were adjusted in each quarter of 2013 as new information from various third-party sources around the world became available, enabling the Company to better estimate the number of projected claimants. Additionally, accruals were adjusted as settlement negotiations progressed and as new, actual settlements occurred, allowing for more accurate estimates of the total estimated product liabilities. The Company’s product liability accruals are recorded in accordance with ASC-450-20-25. • Total product liability pre-tax charges, in excess of recurring periodic self-insurance expense, recorded in prior periods for all product liability issues with charges recognized in 2013 were $2,474 million. The first of these charges, $455 million, was recorded in the fourth quarter of 2010, then $30 million in the first quarter of 2011, $48 million in the second quarter of 2011, $1,381 million in the fourth quarter of 2011, $89 million in the third quarter of 2012 and $471 million in the fourth quarter of 2012. Again, these accruals represent projected product liability claims for thousands of claimants in approximately 55 countries around the world, each in different litigation environments and with different fact patterns. Quarterly accrual amounts were recorded when new information in each market became available, when the projected number of claimants was revised due to updated information received in the quarter and when actual settlements occurred or settlement negotiations progressed. For example, in the fourth quarter of 2011, as reported in the Company’s Annual Report on Form 10-K for 2011, the Company increased its accruals for the ASRTM Hip product liability after the Company completed an analysis of new information, including the number of expected claims, recently updated revision rates of the recalled products and product liability expense per case. • There were no product liability expenses in excess of recurring periodic self-insurance expense recognized in the first quarter of 2014. However, accruals may be increased or reduced in subsequent quarters depending on how the facts and circumstances develop. As requested, we acknowledge that: • Johnson & Johnson is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to this filing; and • Johnson & Johnson may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at 732-524-1307 with any questions or comments you may have. Sincerely, /s/ Stephen J. Cosgrove Vice President Corporate Controller Chief Accounting Officer C: Dominic J. Caruso
2014-06-18 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm june182014extensionletter Stephen J. Cosgrove Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 June 18, 2014 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 29, 2013 Filed February 21, 2014 File No. 001-03215 Dear Mr. Rosenberg: We have received the comment letter dated June 16, 2014 from you to Mr. Dominic J. Caruso, Chief Financial Officer, regarding the comments of the staff of the Securities and Exchange Commission with respect to the above-referenced Form 10-K for the fiscal year ended December 29, 2013. Confirming my phone conversation today with Ms. Lisa Vanjoske, Assistant Chief Accountant, and Ms. Christine Allen Torney, Staff Accountant, we have requested an extension for our response to the comment letter to Tuesday, July 15, 2014. This extension will ensure that we have sufficient time to prepare our response. If you have any questions, please contact me at 732-524-3737. Sincerely, /s/ Stephen J. Cosgrove Vice President Corporate Controller Chief Accounting Officer
2014-06-17 - UPLOAD - JOHNSON & JOHNSON
June 16, 2014 Via E-mail Mr. Dominic J. Caruso Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 21, 2014 File No . 001-03215 Dear Mr. Caruso: We have reviewed your May 1 4, 201 4 response to our May 2, 2014 letter and have the following comment. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe the comment appl ies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your response to our comment. After reviewing any information you provide in response to the comment , we may have additional comments. Exhibit 13 Notes to Consolidated Financial Statements 19. Selected Quarterly Financial Data, page 50 1. Your response to comment 2 did not fully explain how you determined the pre -tax amount required to be recognized in eac h quarter and why such amounts were not required to be recognized in an earlier period. Please p rovide to us your computation of the pre -tax amounts included in the total net litigation expense of $391 million, $308 million, $720 million and $227 million i n each of the four quarters in 2013 disaggregated by matter. Tell us the pre -tax amount that was recorded in each quarter of all years related to each product liability matter with charges recognized in 2013, that is, the timeline of accounting for expens e recognized for each major product liability matter with expenses in 2013. Tell us if you recognized any product liability expenses in the first quarter of 2014. Mr. Dominic J. Caruso Johnson & Johnson June 16, 201 4 Page 2 You may contact Christine Allen Torney , Staff Accountant , at (202) 551 -3652 or Lisa Vanjos ke, Assistant Chief Accountant, at (202) 551 -3614 if you have questions regarding the comment . In this regard, do not hesitate to contact me at (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2014-05-14 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm May 2014 Response Stephen J. Cosgrove Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 May 14, 2014 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 29, 2013 Filed February 21, 2014 File No. 001-03215 Dear Mr. Rosenberg: Johnson & Johnson is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated May 2, 2014, with respect to Johnson & Johnson’s Form 10-K filed with the Commission on February 21, 2014 for the fiscal year ended December 29, 2013 (the “Form 10-K”) (SEC File No. 001-03215). Set forth below is the heading and text of the comment followed by our response: Exhibit 13 Notes to Consolidated Financial Statements 8. Income Taxes, page 36 1. You state “The decrease in the 2013 effective tax rate as compared to 2012 was attributable to a tax benefit associated with the write-off of assets for tax purposes associated with Scios Inc., increased taxable income in lower tax jurisdictions relative to higher tax jurisdictions.” Please provide us an analysis that explains: • What caused the write-off of assets for tax purposes related to Scios, why the tax benefit was recognized in fourth quarter of 2013, and when the assets were written off for financial reporting purposes; and • What caused the increased taxable income in lower tax jurisdictions relative to higher tax jurisdictions and whether you expect this trend to continue? Response: • In 2003, Johnson & Johnson acquired the stock of Scios Inc. (“Scios”) a biopharmaceutical company with a marketed product, NATRECOR®, for cardiovascular disease and research projects focused on auto-immune diseases for approximately $2.5 billion. At the time of the acquisition the fair value purchase price allocation included $1.5 billion for intangible assets, $.4 billion accounted for as Goodwill and $.7 billion as IPR&D, which was expensed upon acquisition with no tax benefit. By 2007, the use of Scios’ main product, NATRECOR®, was significantly restricted leading to impairment charges of $.7 billion realized in the fourth quarter of 2007 for financial reporting purposes (FAS 142/ASC 350). This impairment charge was not deductible for tax purposes as this acquisition was a stock purchase. The Company continued to amortize the remaining intangibles. The tax benefit was recognized in the fourth quarter of 2013 due to the requirements of the worthless stock deduction rules under section 165(g) of the Internal Revenue Code. Liabilities incurred by Scios during the fourth quarter of 2013 caused Scios to become insolvent. In addition, Scios’ business was discontinued and Scios was liquidated for tax purposes during the quarter. Scios’ insolvency, its liquidation for tax purposes and the discontinuance of its business during the fourth quarter of 2013 gave rise to a worthless stock deduction under section 165(g) of the Internal Revenue Code in the fourth quarter of 2013. Prior to this event, this benefit was not recognizable for financial reporting purposes, thus, no benefit was recorded until the fourth quarter of 2013 when the benefit became realizable. • The mix of taxable income for Johnson & Johnson is primarily a function of where sales occur, where products are sourced and where Research & Development (R&D) is funded. In 2013, sales, either sold in or sourced from lower tax jurisdictions grew at a faster rate than sales either sold in or sourced from higher tax jurisdictions. Trends associated with the mix of where products are sourced or sold are difficult to predict as the mix is impacted by the launch and success of new products and the sales of existing products in new markets. Trends associated with where R&D is funded (and if successful, which entity owns Intellectual Property) is a function of the outcomes of clinical trials which are difficult to predict. For example, in the first quarter of 2014, new product sales in high tax jurisdictions outpaced sales in lower tax jurisdictions resulting in a higher tax rate on earnings (excluding the impacts of tax adjustments not related to current period sales) than the prior period and the prior year. Also during 2013, the Company recognized a gain on the sale of Elan, Inc. shares and reduced research spending related to an Alzheimer’s project in a low tax jurisdiction. The Company is unable to predict trends in the mix of taxable income as a number of factors impact the mix such as product approvals, launch schedules by market, sourcing locations, full re-launch of Over the Counter Pharmaceutical products in the United States and competition. Also, asset sales, research spending, changing tax rates and currency can have an overall impact on the tax rate of the Company. 19. Selected Quarterly Financial Data, page 50 2. You disclose that you recognized after-tax charges for net litigation expense of $391 million, $308 million, $720 million and $227 million in each of the four quarters in 2013. Tell us: • The nature of these expenses and confirm if they relate to product liability expenses described in your accounting policy; • How you determined the pre-tax amount required to be recognized in each quarter and why such amounts were not required to be recognized in an earlier period; • Why you are unable to determine an estimate of the possible loss or range of loss beyond the amount already accrued; and • Your consideration of disclosing pre-tax amounts for those items disclosed in the notes to the table. Response: • Accruals for product liability claims are recorded, on an undiscounted basis, when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated based on existing information (ASC-450-20-25). The accruals are adjusted periodically as additional information becomes available. The Company accrued expenses in connection with product liabilities in each quarter of 2013. Of the total $1.6 billion of after-tax litigation charges ($2.3 billion pre-tax) incurred in 2013, approximately 95% of the expenses were associated with product liability matters, with one product liability issue accounting for over 70% of the total product liability expenses in 2013. The largest single product liability matter in 2013 was related to the ASRTM and ASRTM XL Hip (“ASRTM Hip”) sold between 2003 and 2010 by DePuy, Inc. (“DePuy”), a Johnson & Johnson subsidiary. DePuy sold approximately 99,000 ASRTM Hips worldwide, with over 36,000 sold in the United States. In August 2010, DePuy announced a voluntary recall of the ASRTM Hips and accrued estimated liabilities associated with patient monitoring and follow-up. In addition, the Company accrued product liability expenses based on the Kaplan Meier statistical analysis model, which projected the number of revisions using variables such as the number of hips implanted by market, the number of hip revisions performed by market, and the years which have passed since the hips were implanted (among other variables). These revision rates were based on statistical data which is accumulated by third party national registries in Australia and the U.K. For other markets, rates are developed by management by analogy to the U.K. market. These projections were then valued using estimates of per case settlement amounts by market based historical experience with similar claims, reported claims, actual settlements and in-process negotiations by market, where available. The Company has accrued for the ASRTM Hip matter and will continue to monitor each related legal issue and adjust the accrual as might be warranted based on new information and further developments in accordance with ASC-450-20-25. • Accrued amounts for the ASRTM Hip matter were adjusted as new information on the number of claimants was updated, new settlements occurred and as settlement negotiations progressed. During each quarter of 2013 the variables used to project these liabilities were updated as follows: in the first quarter, primarily due to updated information for the U.S. (updated revision rates), South Africa and India (updated claims data); in the second quarter, primarily due to new information for the U.S. (additional updates to the revision rates), Italy (additional reported claims) and India (additional reported claims); in the third quarter, primarily due to the establishment of a higher value settlement program in the U.S. with an estimated 8,000 patients participating (resulting in the largest quarterly adjustment); and in the fourth quarter, an adjustment was made to reflect an increase in projected claims. • The facts and circumstances in the ASRTM Hip product liability cases are much more developed than other product liability cases. For cases in earlier stages of development, the Company has established accruals if a potential loss is probable and reasonably estimable. The Company accrues an amount based on the best available information. The Company does not, as a matter of course, record an accrual at the low end of a range. Each quarter the expense recorded represents the Company’s best estimate of the liability based on the available information. These amounts can change, and often do, as more information is obtained and as litigation discussions progress. For these and other litigation and regulatory matters for which a loss is probable or reasonably possible, the Company is unable to determine an estimate of the possible loss or range of loss beyond the amounts already accrued. These matters can be affected by various factors, including whether damages sought in the proceedings are unsubstantiated or indeterminate; scientific and legal discovery has not commenced or is not complete; proceedings are in early stages; matters present legal uncertainties; there are significant facts in dispute; or there are numerous parties involved. • Significant pre-tax litigation expenses are currently disclosed by segment on an annual basis in Note 18, Segments of Business and Geographic Areas. In future Form 10-K filings the Company will also provide, within Note 19, Selected Quarterly Financial Data, the pre-tax expense correlating to the after-tax litigation amounts disclosed in Note 19. As requested, we acknowledge that: • Johnson & Johnson is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to this filing; and • Johnson & Johnson may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at 732-524-1307 with any questions or comments you may have. Sincerely, /s/ Stephen J. Cosgrove Vice President Corporate Controller Chief Accounting Officer C: Dominic J. Caruso
2014-05-02 - UPLOAD - JOHNSON & JOHNSON
Corrected May 2, 201 4 Via E-mail Mr. Dominic J. Caruso Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 21, 2014 File No . 001-03215 Dear M r. Caruso : We have limited our review of your filing to your financial statements and related disclosures and do not intend to expand our review to other portions of your document. In our comment s, we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response . If you do not believe a comment applies to your facts and circumstanc es, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may have additional comments and/or request that you a mend your filing. Exhibit 13 Notes to Consolidated Financial Statements 8. Income Taxes, page 36 1. You state “ The decrease in the 2013 effective tax rate as compared to 2012 was attributable to a tax benefit associated with the write -off of assets for tax purposes associated with Scios Inc., increased taxable income in lower tax jurisdictions relative to higher tax jurisdictions…” . Please p rovide us an analysis that explains : What caused the write -off of assets for tax purposes related to Scios, why the t ax benefit was recognized in fourth quarter of 2013, and when the assets were written off for financial reporting purposes ; and What caused the increased taxable income in lower tax jurisdictions relative to higher tax jurisdictions and whether you expect this trend to continue. Mr. Dominic J. Caruso Johnson & Johnson May 2, 201 4 Page 2 19. Selected Quarterly Financial Data, page 50 2. You disclose that you recognized after -tax charges for net litigation expense of $391 million, $308 million, $720 million and $227 million in each of the four quarters in 2013. Tell us: The nature of these expenses and confirm if they relate to product liability expenses described in your accounting policy; How you determined the pre -tax amount required to be recognized in each quarter and why such amounts were not required to be rec ognized in an earlier period; Why you are unable to determine an estimate of the possible loss or range of loss beyond the amounts already accrued ; and Your consideration of disclosing pre -tax amounts for those items disclosed in the notes to the table. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the compa ny 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 responding to our comment s, please provide a written statement from the co mpany acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect t o the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may contact Christine Torney , Staff Accountant, at (202) 551 -3652 or Lisa Vanjoske , Assistant Chief Accountant, at (202) 551 -3614 if you have questions regarding the comments . In this regard, do not hesitate to contact me at (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2013-05-16 - UPLOAD - JOHNSON & JOHNSON
May 16 , 2013 Via E -mail Mr. Dominic J. Caruso Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10 -K for the Fiscal Year Ended December 30, 2012 Filed February 22, 2013 File No. 001-03215 Dear Mr. Caruso : We have completed our review of your filing. We remind you that our comments or chan ges to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any p erson under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Joel Parker Joel Parker Accounting Branch Chief
2013-05-15 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm Verbal Comment - May 2013 Stephen J. Cosgrove Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 May 15, 2013 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 30, 2012 Filed February 22, 2013 File No. 001-03215 Dear Mr. Rosenberg: Johnson & Johnson is submitting this letter in response to the verbal comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), communicated on May 14, 2013, with respect to Johnson & Johnson's Form 10-K filed with the Commission on February 22, 2013 for the fiscal year ended December 30, 2012 (the “Form 10-K”) (SEC File No. 001-03215). Set forth below is the verbal comment followed by our response: Verbal Comment: 1. We note your response to prior comment 2. Please confirm that you will revise your disclosure in future filings to replace the reference to the purchase method with the acquisition method. Response: In response to the Staff's verbal comment, the Company will replace the reference to the purchase method with the acquisition method in future filings. Verbal Comment: 2. We note your response to prior comment 3. Please provide revised disclosure to be included in future periodic reports which includes the useful life information in your response, specifically the weighted asset life for each asset class (Customer Relationships and Patents and Technology) and how the weighted asset lives were determined. Response: In response to the Staff's verbal comment, the Company will provide the response to prior comment 3 filed with the Commission on April 23, 2013 as disclosure in future periodic reports. As requested, we acknowledge that: • Johnson & Johnson is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to this filing; and • Johnson & Johnson may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at 732-524-3737 with any questions or comments you may have. Sincerely, /s/ Stephen J. Cosgrove Vice President Corporate Controller Chief Accounting Officer cc: Dominic J. Caruso
2013-04-23 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm April 2013 Comment Letter Stephen J. Cosgrove Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 April 23, 2013 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 30, 2012 Filed February 22, 2013 File No. 001-03215 Dear Mr. Rosenberg: Johnson & Johnson is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated March 28, 2013, with respect to Johnson & Johnson's Form 10-K filed with the Commission on February 22, 2013 for the fiscal year ended December 30, 2012 (the “Form 10-K”) (SEC File No. 001-03215). Set forth below is the heading and text of the comment followed by our response: Business Patents and Trademarks, page 2 1. We note your statement on page 2 that you believe the patents related to REMICADE® are material to the company. Please amend your disclosure to explain: • whether you own or license these patents, and from whom you license them, if applicable; • the material jurisdictions in which you hold these patents; and • the expiration dates of these patents. In addition, please describe your anticipated response to the loss of protection, including for example, any plans to apply for exclusivity extensions and the basis for such actions. If you do not intend to take any such actions please disclose that as well. Response: Johnson & Johnson follows the guidance of Item 101(c)(1)(iv) of Regulation S-K with regard to patents. The Company's practice has been to disclose material products supported by patents. The expiration dates of such associated patents are also disclosed when expiration is scheduled to occur within two years of the annual filing on Form 10-K. Additionally, quarterly filings include disclosures of the potential impact to revenue for those material products subject to patent expiration within the next year. We confirm that in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended December 29, 2013, the Company will expand the disclosure in Item 1 - BUSINESS, Patents and Trademarks, to include the following, updated as necessary: There are two sets of patents related to REMICADE® (infliximab). The first set of patents is co-owned by Janssen Biotech, Inc., a wholly-owned subsidiary of Johnson & Johnson, and New York University Medical Center (NYU). Janssen Biotech, Inc. has an exclusive license to NYU's interests in the patents. Patents have been granted in the United States, certain countries in the European Union (certain of these patents have been extended by Supplementary Patent Certificates), and Australia. These patents expired in Canada in March 2012. However, sales in Canada have not been impacted as a generic competitor has not entered the market. In the United States, the patent expires in September 2018. In certain countries in Europe the patent has been extended to February 2015 (Germany, Spain, United Kingdom, Sweden, Austria, Belgium, Switzerland, Denmark, France, Greece, Italy, Luxembourg and The Netherlands). In Australia, the patent expires in March 2017. The second set of patents related to REMICADE® was granted to the Kennedy Institute of Rheumatology in the United Kingdom in Europe, Canada, Australia and the United States. Janssen Biotech, Inc. has an exclusive license to these patents which expire in 2017 outside of the United States and 2018 in the United States. The validity of these patents has been challenged and is currently in litigation. Johnson & Johnson does not expect that any additional extensions will be available for the patents related to REMICADE®. In addition to competing in the immunology market with REMICADE®, the Company is currently marketing STELARA® (ustekinumab) and SIMPONI® (golimumab), next generation immunology products with remaining patent lives in excess of 10 years. Exhibit 13 Notes to Consolidated Financial Statements Note 20. Business Combinations and Divestitures, page 50 2. Throughout your note, you reference to purchase price allocations. Please tell us how using purchase price allocation complies with the acquisition method as described in ASC 805. Response: In response to the Staff's request to explain how using purchase price allocation complies with the acquisition method as described in ASC 805, please find additional details as follows: Johnson & Johnson follows ASC 805 when accounting for business combinations using the acquisition method. As a result of applying the acquisition method, Johnson & Johnson measures the identifiable assets acquired, the liabilities assumed, and any non-controlling interest in the acquired business at the acquisition date fair values. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. When appropriate, independent third party valuation firms are engaged to value the net assets acquired. In accordance with US GAAP, fair value is determined by the price that would be received from the sale of an asset or paid to transfer a liability in an orderly transaction between market participants. In accordance with ASC 820, Johnson & Johnson used the income approach as the basis for the purchase price allocations referenced in Note 20. 3. Please explain to us your basis for concluding that the estimated useful life of the Synthes amortizable intangibles was a weighted average of 21 years. Please breakout this analysis between customer relationships and patents and technology. Response: In response to the Staff's request to explain the basis for concluding the estimated useful life of the Synthes amortizable intangibles, please find additional details as follows: The Customer Relationship ($9.9 billion) intangible lives were determined using the projected customer retention period based on historical experience. Synthes has a broad product portfolio including trauma, spine, cranio-maxillofacial, biomaterials and power tools. An analysis was performed to determine the lives for each of the customer relationship assets in the distinct product areas. The calculations to determine useful lives included attrition rates and discounted future cash flows by product area. This analysis resulted in a weighted average life of 22 years for the Customer Relationship assets. The Patents and Technology ($1.5 billion) intangible lives were derived based on technology obsolescence rates that are commensurate with the nature of the Synthes businesses. New product introductions are predominantly incremental enhancements to existing platforms and are infrequently transformational. An analysis was performed to determine the lives for each of the Patents and Technology assets in each distinct product area. The calculations to determine useful lives included assumptions on technology obsolescence and discounted future cash flows by product area. This analysis resulted in a weighted average life of 18 years for the Patents and Technology assets. A weighted average of the values and lives ascribed to the Customer Relationship and Patents and Technology intangible assets results in a 21 year weighted average life. As requested, we acknowledge that: • Johnson & Johnson is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to this filing; and • Johnson & Johnson may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to contact me at 732-524-1831 with any questions or comments you may have. Sincerely, /s/ Stephen J. Cosgrove Vice President Corporate Controller Chief Accounting Officer cc: Dominic J. Caruso
2013-04-04 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm Extension Letter Stephen J. Cosgrove Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 April 4, 2013 Via EDGAR Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended December 30, 2012 Filed February 22, 2013 File No. 001-03215 Dear Mr. Rosenberg: We have received the comment letter dated March 28, 2013 from you to Mr. Dominic J. Caruso, Chief Financial Officer, regarding the comments of the staff of the Securities and Exchange Commission with respect to the above-referenced Form 10-K for the fiscal year ended December 30, 2012. Confirming my phone conversation today with Ms. Dana Hartz, Staff Accountant, we have requested an extension for our response to the comment letter to Thursday, April 25, 2013. This extension will ensure that we have sufficient time to prepare our response. If you have any questions, please contact me at 732-524-3737. Sincerely, /s/ Stephen J. Cosgrove Vice President Corporate Controller Chief Accounting Officer
2013-03-29 - UPLOAD - JOHNSON & JOHNSON
March 28, 201 3 Via E -mail Mr. Dominic J. Caruso Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10 -K for the Fiscal Year Ended December 30, 2012 Filed February 22, 2013 File No. 001-03215 Dear Mr. Caruso: We have reviewed your filing 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 within 10 business days by amending your filing, providing the requested information or by advising us when you will provide the requested response. If you do not b elieve a n amendment is appropriate or that a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that key s your response s to our comment s. After reviewing the amended filing and the information you provide in response to th ese comment s, we may have additional comments . Business Patents and Trademarks, page 2 1. We note your statement on page 2 that you believe the patents related to REMICADE® are material to the c ompany. Please amend your disclosure to explain: whether you own or license these patents, and from whom you license them, if applicable; the material jurisdictions in which you hold these patents ; and the expiration dates of these patents . In addition , please describe your anticipated response to the loss of protection, including for example, any plans to apply for exclusivity extensions and the basis for such actions. If you do not intend to take any such actions please disclose that as well. Mr. Dominic J. Caruso Johnson & Johnson March 28, 201 3 Page 2 Exhibit 13 Notes to Consolidated Financial Statements Note 20. Business Combinations and Divestitures, page 50 2. Throughout your note, you reference to purchase price allocations. Please tell us how using purchase price allocation complies with the acquisition met hod as described in ASC 805. 3. Please explain to us your basis for concluding that the estimated useful life of the Synthes amortizable intangibles was a weighted average of 21 years. Please breakout this analysis between customer relationships and patents and technology. We urge all persons who are responsible for the accuracy and a dequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comment s, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to this filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under th e federal securities laws of the United States. You may c ontact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Joel Parker , Accounting Branch Chief , at (202) 551 -3651 if you have questions regarding the processing of your response as well as any quest ions regarding comments on the financial statements and related matters. Please contact Amy Reischauer , Staff Attorney, at (202) 551 -3793 or Jeffrey P. Riedler , Assistant Director, at (202) 551 -3715 with questions on comment one . In this regard, do not hesitate to contact me at (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2012-07-17 - UPLOAD - JOHNSON & JOHNSON
July 16, 2012 Via E -mail Mr. Dominic J. Caruso Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10 -K for the Fiscal Year Ended January 1 , 201 2 Filed February 23, 2012 File No. 001-03215 Dear Mr. Caruso : We have comp leted our review of your filing s. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respe ct to the company or the filing s and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any per son under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filin gs include s the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Joel Parker Joel Parker Accounting Branch Chief
2012-06-28 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
filename1.htm
Comment Letter
Stephen J. Cosgrove
Vice President
Corporate Controller
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
June 28, 2012
Via EDGAR
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re: Johnson & Johnson
Form 10-K for the Fiscal Year Ended January 1, 2012
Filed February 23, 2012
Form 10-Q for the Quarterly Period Ended April 1, 2012
Filed May 7, 2012
File No. 001-03215
Dear Mr. Rosenberg:
Johnson & Johnson is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated June 1, 2012, with respect to Johnson & Johnson's Form 10-K filed with the Commission on February 23, 2012 for the fiscal year ended January 1, 2012 (the “Form 10-K”) and Form 10-Q filed with the Commission on May 7, 2012 for the interim period ended April 1, 2012 (the “Form 10-Q”) (SEC File No. 001-03215).
Set forth below is the heading and text of the comment followed by our response:
Form 10-K for the Annual Period Ended January 1, 2012
Exhibit 13
Results of Operations
Analysis of Consolidated Earnings Before Provisions for Taxes on Income, page 29
1.
Please provide us proposed disclosure to be included in future periodic filings that quantifies the individual items that impact the changes for the three years presented. You state that the decrease in consolidated earnings was due to costs associated with product liability and litigation expense, the impact of the OTC and DePuy Hip recalls and the restructuring expense related to the Cardiovascular Care business and that it was also impacted by investment spending, the fee on branded pharmaceutical products incurred due to U.S. health care reform and integration costs associated with the acquisition of Crucell. You should consider a tabular presentation. Please also apply this to other sections of the Results of Operations such as but not limited to: cost of products sold, selling, marketing and administrative expenses and research and development expenses.
Response:
In response to the Staff's comments, in future periodic filings, beginning with the period ended July 1, 2012, we propose to enhance the Company's disclosure to quantify individual items that impact Consolidated earnings before provision for taxes on income, cost of products sold, selling and marketing and administrative expenses and research and development expenses. An example of a future periodic disclosure would be as follows:
Analysis of Consolidated Earnings Before Provision for Taxes on Income (2011 versus 2010)
“Consolidated earnings before provision for taxes on income decreased by $4.5 billion to $12.4 billion in 2011 as compared to $16.9 billion in 2010, a decrease of 27.1%. Consolidated earnings before provision for taxes on income was unfavorably affected by increases of approximately $X.X billion of costs associated with product liability and litigation expenses, $X.X billion related to the OTC recalls, $X.X billion related to the DePuy ASR™ Hip recalls and $X.X billion restructuring expense related to the Cardiovascular Care business. Additionally, 2011 included an adjustment of $X.X billion to the value of the currency option and deal costs related to the planned acquisition of Synthes, Inc. and a $X.X billion fee on branded pharmaceutical products incurred due to the U.S. health care reform legislation. This was partially offset by higher gains on the divestitures of businesses of $X.X billion as compared to 2010.”
Concentration of Credit Risk, page 32
2.
You disclose that recent economic challenges in Italy, Spain, Greece and Portugal have impacted certain payment patterns. Please tell us the following information:
•
The amount of sales in 2011 and accounts receivable as of January 1, 2012 and April 1, 2012 by country from Italy, Spain, Greece and Portugal separately by amounts from/funded by each country's government;
•
The amount past due from each of those countries and the number days of past due separately by amounts from/funded by each country's government; and
•
The amount of allowance for doubtful accounts recognized at January 1, 2012 and April 1, 2012 related to these countries and why you believe the amounts to be adequate.
Response:
In response to the Staff's questions related to the Company's disclosure regarding the impact of recent economic challenges in Italy, Spain, Greece and Portugal, please find additional details as follows:
In 2011, sales to government owned or supported health care customers in Italy, Spain, Greece and Portugal were $1,087 million, $509 million, $94 million and $106 million, respectively. The gross accounts receivable balances from government owned or supported health care customers as of January 1, 2012 were $839 million, $680 million, $97 million and $75 million for Italy, Spain, Greece and Portugal, respectively. The gross accounts receivable balances from government owned or supported health care customers as of April 1, 2012 were $761 million, $779 million, $108 million and $101 million for Italy, Spain, Greece and Portugal, respectively.
Based on historical trends, the Company considers receivables from government owned or supported health care customers in Italy, Spain, Greece and Portugal which are outstanding for greater than 365 days to be past due. The past due gross accounts receivable balances as of January 1, 2012 for sales to government owned or supported health care customers were $207 million, $223 million, $29 million and $10 million for Italy, Spain, Greece and Portugal, respectively. The past due gross accounts receivable balances as of April 1, 2012 for sales to government owned or supported health care customers were $198 million, $308 million, $27 million and $12 million for Italy, Spain, Greece and Portugal, respectively. The average number of days past due as of January 1, 2012 were approximately 348, 264, 268 and 166 for Italy, Spain, Greece and Portugal, respectively. The average number of days past due as of April 1, 2012 were approximately 355, 315, 266 and 152 for Italy, Spain, Greece and Portugal, respectively.
The Company has recognized allowances for doubtful accounts of $99 million as of January 1, 2012 and $110 million as of April 1, 2012 primarily related to government owned or supported heath care customers in these countries. The allowances for doubtful accounts reflect the Company's latest experience in collections including where payment discounts have been requested and granted. The Company believes that the allowances for doubtful accounts are adequate as payments from customers that have not requested discounts continue to be made in full, and in some cases with late payment premiums. The Company collected receivables of $1,576 million in 2011 and $480 million during the first quarter of 2012 from government owned or supported health care customers. The Company continues to monitor the economic situation in the region and work closely with these customers on payment plans. As a result of the payment plans, during the second quarter of 2012 approximately 60% of the receivables from government owned or supported health care customers in Spain were collected.
Based on the details provided, the Company believes that its year end disclosure as of January 1, 2012 and its quarterly disclosure as of April 1, 2012 adequately reflects its exposure of the current economic situation in Southern Europe.
Note 1. Summary of Significant Accounting Policies
Research and Development, page 43
3.
During our review of your Form 10-K for the Fiscal Year Ended January 2, 2011 in your response dated May 27, 2011, you stated that you would enhance your disclosure to clarify that no individual research and development investment is material to your consolidated operating results, for as long as that remains the case. If this is still the case, please confirm this and provide us proposed disclosure to be included in future periodic filings that clarifies this fact.
Response:
We confirm that in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended December 30, 2012, the Company will include the following disclosure in Note 1, Summary of Significant Accounting Policies - Research and Development (page 43 of the 2011 Annual Report):
“For all years presented, there was no individual project that represented greater than 5% of the total annual consolidated research and development expense.”
Income Taxes, page 43
4.
During the prior SEC staff review of your Form 10-K for the Fiscal Year Ended January 2, 2011 you provided us proposed disclosure to include in future filings which addressed the disclosure required under ASC 740-30-50-2c. Please confirm that you will include disclosure in future filings which discloses the amount of the unrecognized deferred tax liability for temporary differences related to investments in foreign subsidiaries or state that the determination of the liability amount is not practicable.
Response:
We confirm that in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended December 30, 2012, the Company will include the following disclosure in Note 1, Summary of Significant Accounting Policies - Income Taxes (page 43 of the 2011 Annual Report), to address disclosure requirements applicable to unrecognized deferred tax liabilities associated with undistributed earnings:
“At December 30, 2012 and January 1, 2012, the cumulative amounts of undistributed international earnings were approximately $XX billion and $41.6 billion, respectively. At December 30, 2012 and January 1, 2012, the Company's foreign subsidiaries held balances of cash and cash equivalents in the amounts of $XX.X billion and $24.5 billion, respectively. The Company has not provided deferred taxes on the undistributed earnings from certain international subsidiaries where the earnings are considered to be permanently reinvested. The Company intends to continue to reinvest these earnings in international operations. If the Company decided at a later date to repatriate these earnings to the U.S., the Company would be required to provide for the net tax effects on these amounts. The Company does not determine the deferred tax liability associated with these undistributed earnings, as such determination is not practicable.”
Form 10-Q for the Quarterly Period ended April 1, 2012
RISPERDAL®, page 19
5.
You disclose on page 20 of your filing that you did not establish an accrual for the verdicts against you in the RISPERDAL® trials with the State of Arkansas, the State of South Carolina and the State of Louisiana. The verdicts were approximately $1.2 billion, $327.1 million and $330.7 million, respectively. Please tell us how, given that this was the third state judgment against you, there are ongoing settlement discussion with the federal government regarding the off-label promotion of this drug and your settlement with the State of Texas, you determined that the potential for an unfavorable outcome is not probable. Specifically address why you believe it is probable that the verdicts will be overturned.
Response:
The Company believes there are multiple errors supporting reversal on appeal in the Louisiana, South Carolina, and Arkansas cases. The three cases are based substantially on the use of an FDA-approved label and/or on the receipt by Janssen Pharmaceuticals, Inc. (JPI), of an FDA warning letter. In all three cases, Johnson & Johnson and/or JPI are arguing, or will argue, on appeal, that such claims are preempted by federal law and/or that they fall within state statutory exemptions for "regulated activity." In all three cases, Johnson & Johnson and/or JPI challenge the trial courts' unduly expansive interpretations of state statutes. In Arkansas, for example, the trial court concluded that the state's Medicaid Fraud False Claims Act could be used to challenge compliance with federal prescription drug labeling law, even though there was no "Medicaid fraud" and there were no "false claims." In all three cases, Johnson & Johnson and/or JPI challenge the admission into evidence of a warning letter, which is hearsay not within any exception to the rules barring the introduction of hearsay evidence, and which is unfairly prejudicial. In both South Carolina and Arkansas, Johnson & Johnson and/or JPI argue, on appeal, that penalties were imposed for "violations" not found by the jury. In Arkansas, there are significant appellate issues regarding the sufficiency of the jury interrogatories, which did not inquire into each element of the asserted violations. There are other important issues in each case, including federal and state constitutional issues, statute of limitations issues, and other evidentiary issues. Therefore, the Company believes there is a strong likelihood of success on appeal in these cases and that a loss in the amount of the existing judgments is not probable.
6.
You disclose “In 2011, the Company established an accrual with respect to the above state matters.” Please provide us proposed disclosure to be included in future periodic filings that clarifies which state matters this disclosure refers to since several matters state that no accrual has been made.
Response:
Since the time of our last disclosure there has been significant progress in reaching settlements of many of the outstanding claims. In future filings beginning with the Form 10-Q for the period ending July 1, 2012, we intend to make an additional disclosure to cover the following developments:
As previously disclosed, the Company reached an agreement in principle with the United States Attorney's Office for the Eastern District of Pennsylvania on key issues relevant to a disposition of criminal charges regarding the promotion of RISPERDAL® pursuant to a single misdemeanor violation of the Food, Drug & Cosmetic Act.
The Company has also now reached an agreement in principle with the Department of Justice (“DOJ”) to settle three pending civil False Claims Act matters that are pending in (1) the Eastern District of Pennsylvania concerning sales and marketing of RISPERDAL® and INVEGA®, including payments to health care providers; (2) the Northern District of California regarding the sales and marketing of NATRECOR®; and (3) the District of Massachusetts alleging that the defendants provided the Omnicare, Inc. (Omnicare) long-term care pharmacy with rebates and other payments regarding RISPERDAL® and other products. Assuming these agreements are finalized, they will resolve the federal government's claims under the federal False Claims Act, resolve all pending state and federal government litigation regarding Omnicare and NATRECOR®, and settle the RISPERDAL®-related Medicaid fraud claims for those states that opt into the settlement. On a parallel track, the Company has reached an agreement in principle with representatives of a group of 38 states and the District of Columbia to settle potential consumer fraud actions in connection with the sales and marketing of RISPERDAL® and INVEGA®. With all the tentative settlement agreements described above, issues remain open that must be resolved before the settlements can be finalized.
The Company has accrued amounts, including an additional accrual made in the second quarter of 2012, to cover these tentative settlement agreements. However, the settlements will not resolve all pending state litigation matters regarding RISPERDAL®, and some states may elect to opt out of the settlements. To the extent any state has a claim and has or will elect to opt out of these settlements, the Company has accrued an amount equal to what that state would receive if it was participa
2012-06-08 - CORRESP - JOHNSON & JOHNSON
CORRESP 1 filename1.htm June SEC Comment Letter Stephen J. Cosgrove Vice President Corporate Controller One Johnson & Johnson Plaza New Brunswick, NJ 08933 June 8, 2012 Mr. Jim B. Rosenberg Senior Assistant Chief Accountant U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 1, 2012 Filed February 23, 2012 Form 10-Q for the Quarterly Period Ended April 1, 2012 Filed May 7, 2012 File No. 001-03215 Dear Mr. Rosenberg: We have received the comment letter dated June 1, 2012 from you to Mr. Dominic J. Caruso, Chief Financial Officer, regarding the comments of the staff of the Securities and Exchange Commission (the “Commission”) with respect to the above-referenced Form 10-K for the fiscal year ended January 1, 2012 and Form 10-Q for the quarter ended April 1, 2012. Confirming a phone conversation yesterday between Mr. Philip A. Savas, Vice President, Assistant Corporate Controller and Ms. Dana Hartz, Staff Accountant, we have requested an extension of our response to the comment letter to Friday, June 29, 2012. This extension will allow us sufficient time to prepare our response to the comment letter. If you have any questions, please contact me at 732-524-1831. Sincerely, /s/ Stephen J. Cosgrove Vice President Corporate Controller Chief Accounting Officer
2012-06-01 - UPLOAD - JOHNSON & JOHNSON
June 1, 2012 Via E -mail Mr. Dominic J. Caruso Chief Financial Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10 -K for the Fiscal Year Ended January 1 , 201 2 Filed February 23, 2012 Form 10 -Q for the Quarterly Period Ended April 1 , 201 2 Filed May 7 , 2012 File No. 001-03215 Dear Mr . Caruso : We have limited our review to only your financial statements and related disclosures and do not intend to expand our review to other portions of your document s. In our comments, we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response . If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that key s your response s to our comments. After reviewing the information you pr ovide in response to these comments , we may have additional comments and/or request that you amend your filing s. Form 10 -K for the Annual Period Ended January 1, 2012 Exhibit 13 Results of Operations Analysis of Consolidated Earnings Before Provisions for Taxes on Income, page 29 1. Please provide us proposed disclosure to be included in future periodic filings that quantifies the individual items that impact the changes for the three years presented. You state that the decrease in consolidate d earnings was due to costs associated with product liability and litigation expense, the impact of the OTC and DePuy Hip recalls and the restructuring expense related to the Cardiovascular Care business and that it was also impacted by investment spending , the fee on branded pharmaceutical products incurred due to U.S. health Mr. Dominic J. Caruso Johnson & Johnson June 1, 2012 Page 2 care reform and integration costs associated with the acquisition of Crucell. You should consider a tabular presentation. Please also apply this to other sections of the Results of Operations such as but not limited to: cost of products sold, selling, marketing and administrative expenses and research and development expenses. Concentration of Credit Risk, page 32 2. You disclose that recent economic challenges in Italy, Spain, Greece and Portugal have impacted certain payment patterns. Please tell us the following information: The amount of sales in 2011 and accounts receivable as of January 1, 2012 and April 1, 2012 by country from Italy, Spain, Greece and Portugal separately by amoun ts from/funded by each country’s government; The amount past due from each of those countries and the number days of past due separately by amounts from/funded by each country’s government; and The amount of allowance for doubtful accounts recognized at Ja nuary 1, 2012 and April 1, 2012 related to these countries and why you believe the amounts to be adequate. Note 1. Summary of Significant Accounting Policies Research and Development, page 43 3. During our review of your Form 10 -K for the Fiscal Year Ended January 2, 2011 in your response dated May 27, 2011, you stated that you would enhance your disclosure to clarify that no individual research and deve lopment investment is material to your conso lidated operating results, for as long as that remains the case. If this is still the case, please confirm this and provide us proposed disclosure to be included in future periodic filings that clarifies this fact. Income Taxes, page 43 4. During the pri or SEC staff review of your Form 10 -K for the Fiscal Year Ended January 2, 2011 you provided us proposed disclosure to include in future filings which addressed the disclosure required under ASC 740 -30-50-2c. Please confirm that you will include disclosur e in future filings which discloses the amount of the unrecognized deferred tax liability for temporary differences related to investments in foreign subsidiaries or state that the determination of the liability amount is not practicable. Form 10 -Q for th e Quarterly Period ended April 1, 2012 RISPERDAL®, page 19 5. You disclose on page 20 of your filing that you did not establish an accrual for the verdicts against you in the RISPERDAL® trials with the State of Arkansas, the State of South Carolina and the S tate of Louisiana. The verdicts were approximately $1.2 billion, $327.1 million and $330.7 million, respectively. Please tell us how, given that thi s was the third state judgment against you , there are ongoing settlement discussion with the federal governm ent regarding the off -label promotion of this drug and your settlement with the State of Texas, Mr. Dominic J. Caruso Johnson & Johnson June 1, 2012 Page 3 you determined that the potential for an unfavorable outcome is not probable. Specifically address why you believe it is probable that the verdicts will be over turned. 6. You disclose “In 2011, the Company established an accrual with respect to the above state matters.” Please provide us proposed disclosure to be included in future periodic filings that clarifies which state matters this disclosure refers to since several matters state that no accrual has been made. We urge all persons who are responsible for the accuracy and a dequacy of the disclosure in the se filing s to be certain that the filing s include the information the Securities Exchange Act of 1934 and a ll applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing s; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the se filing s; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may c ontact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Lisa Vanjoske , Assistant Chief Accountant , at (202) 551 -3614 if you have questions regarding these comments. In this regard, do not hesitate to contact me at (202) 551 -3679 . Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2011-08-26 - UPLOAD - JOHNSON & JOHNSON
August 26, 2011 Via E-Mail Stephen J. Cosgrove Vice President, Corporate Controller Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 2, 2011 Filed February 24, 2011 File No. 001-03215 Form 10-Q for the Quarterly Period Ended April 3, 2011 Filed May 10, 2011 Dear Mr. Cosgrove: We have completed our review of your f ilings. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or the filings and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi lings to be certain that the filings include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Joel Parker Joel Parker Accounting Branch Chief
2011-08-22 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
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augustseccommentletter.htm
Stephen J. Cosgrove
One Johnson & Johnson Drive
Vice President
New Brunswick, NJ 08933
Corporate Controller
August 22, 2011
Via EDGAR
Ms. Tabatha Akins
Staff Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re: Johnson & Johnson
Form 10-Q for the Quarterly Period Ended April 3, 2011
Filed May 10, 2011
Dear Ms. Akins:
Johnson & Johnson is submitting this letter in response to the verbal comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), per discussions held on August 9, 2011 and August 11, 2011, with respect to Johnson & Johnson’s Form 10-Q filed with the Commission on May 10, 2011 for the interim period ended April 3, 2011 (the “Form 10-Q”).
Set forth below is the comment followed by our response:
Form 10-Q for the Interim Period Ended April 3, 2011
Part I, Item1
Notes to Consolidated Financial Statements
11. Legal Proceedings
Product Liability, page 18
1. We believe the quantitative disclosure outside of the financial statements specified in SAB (Topic 5Y question 3: What disclosures regarding loss contingencies may be necessary outside the financial statements?) should be made related to aggregate claims related to product liability such as aggregate settlement, disclosure of the number of claims pending at each balance sheet date, the number of claims filed for each period presented, the number of claims dismissed, settled, or otherwise resolved for each period, and the average settlement amount per claim. We also believe that historical and expected trends in these amounts and their reasonably likely effects on operating results and liquidity should also be disclosed pursuant to the SAB. Please provide proposed disclosure.
Based on our discussion the disclosure should address material matters.
Response:
In response to the staff’s verbal comment and request for information the Company will enhance disclosure related to product liability in future filings beginning with Form 10Q for the period ended October 2, 2011 as follows:
PRODUCT LIABILITY
The Company’s subsidiaries are involved in numerous product liability cases. The damages claimed are substantial, and while the Company’s subsidiaries are confident of the adequacy of the warnings and instructions for use that accompany the products at issue, it is not feasible to predict the ultimate outcome of litigation. The Company has established product liability accruals in compliance with ASC 450-20 based on currently available information, which in some cases may be limited. Changes to the accruals may be required in the future as additional information becomes available.
Multiple products of the Company’s subsidiaries are subject to numerous product liability claims and lawsuits. There are a significant number of claimants who have pending lawsuits or claims regarding injuries allegedly due to ORTHO EVRA®, RISPERDAL®, LEVAQUIN®, DURAGESIC®/fentanyl patches, pelvic meshes, the CHARITÉ™ Artificial Disc, CYPHER® Stent, and ASR™ Hip. These claimants seek substantial compensatory and, where available, punitive damages.
In August 2010, DePuy Orthopaedics, Inc. (DePuy) announced a worldwide voluntary recall of its ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System used in hip replacement surgery. Claims for personal injury have been made against DePuy and the Company. There are approximately xxx claimants who have filed lawsuits, which are currently pending, regarding injuries allegedly due to the DePuy ASR™ Hip. The Company has received limited information to date with respect to potential costs associated with this recall. The Company’s product liability accrual has been increased in part due to an increase in anticipated product liability litigation settlements and costs associated with the DePuy ASR™ Hip recall program. Changes to the accruals may be required in the future as additional information becomes available.
The Company believes that the ultimate resolution of these matters based on historical and reasonably likely future trends is not expected to have a material adverse effect on the Company’s financial position, annual results of operations and cash flows. The resolution in any interim reporting period could have a material impact on the Company’s results of operations and cash flows for that period.
As requested, we acknowledge that:
·
Johnson & Johnson is responsible for the adequacy and accuracy of the disclosure in the filing;
·
Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and
·
Johnson & Johnson may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact me at 732-524-1831 with any questions or comments you may have.
Sincerely,
/s/ Stephen J. Cosgrove
Vice President
Corporate Controller
Chief Accounting Officer
Copy:
Joel Parker, Accounting Branch Chief
Jim B. Rosenberg, Senior Assistant Chief Accountant
2011-07-25 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
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julytwentyfifthsecletter.htm
Stephen J. Cosgrove
One Johnson & Johnson Drive
Vice President
New Brunswick, NJ 08933
Corporate Controller
July 25, 2011
Via EDGAR
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re: Johnson & Johnson
Form 10-K for the Fiscal Year Ended January 2, 2011
Filed February 24, 2011
File No. 001-03215
Form 10-Q for the Quarterly Period Ended April 3, 2011
Filed May 10, 2011
Dear Mr. Rosenberg:
Johnson & Johnson is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated June 24, 2011, with respect to Johnson & Johnson’s Form 10-K filed with the Commission on February 24, 2011 for the fiscal year ended January 2, 2011 (SEC File No. 001-03215) (the “Form 10-K”) and Form 10-Q filed with the Commission on May 10, 2011 for the interim period ended April 3, 2011 (the “Form 10-Q").
Set forth below is the heading and text of the comment followed by our response:
Form 10-K for the Fiscal Year Ended January 2, 2011
Exhibit 13
Management’s Discussion and Analysis of Results of Operations and Financial Condition
Income Taxes, page 38
1. Please refer to your response to our comment three. As previously requested, please provide
us proposed disclosure to be included in future filings of the amount of cash and cash
equivalents held by foreign subsidiaries as of the latest balance sheet date presented, which
are only available at the subsidiary level because earnings are considered permanently
reinvested. We believe this information will provide further context with respect to your
sources of liquidity.
Response:
In response to the Staff's comment, in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended January 1, 2012, the Company will revise its disclosure on cash and cash equivalents held outside the United States with the following:
Income Taxes: Income taxes are recorded based on amounts refundable or payable for the current year and include the results of any difference between U.S. GAAP accounting and tax reporting, recorded as deferred tax assets or liabilities. The Company estimates deferred tax assets and liabilities based on current tax regulations and rates. Changes in tax laws and rates may affect recorded deferred tax assets and liabilities in the future. Management believes that changes in these estimates would not have a material effect on the Company’s results of operations, cash flows or financial position.
In 2007, in accordance with U.S. GAAP, the Company adopted the standard related to accounting for uncertainty in income taxes. The Codification prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Codification also provides guidance on derecognition, classification and other matters. See Note 8 to the Consolidated Financial Statements for further information regarding income taxes.
At January 1, 2012 and January 2, 2011, the cumulative amounts of undistributed international earnings were approximately $xx billion and $37 billion, respectively. At January 1, 2012 and January 2, 2011, the Company’s foreign subsidiaries held balances of cash and cash equivalents in the amounts of $xx billion and $18.7 billion, respectively. The Company intends to continue to reinvest its undistributed international earnings to expand its international operations; therefore, no U.S. tax expense has been recorded with respect to the undistributed portion not intended for repatriation.
Form 10-Q for the Quarterly Period Ended April 3, 2011
Notes to Consolidated Financial Statements
Note 11 – Legal Proceedings
Government Proceedings
RISPERDAL®, page 25
2. During the quarter ended April 3, 2011, you recorded a reserve for a potential settlement of
the penalties under the Food Drug and Cosmetic Act related to Risperdal. Please tell us:
o
The amount recorded and why you believe it is a reasonable estimate of the probable
loss; and
o
Why you were unable to reasonably estimate an amount of loss or range of loss at
December 31, 2010. In this regard, include a chronology of the facts and
circumstances from the time you filed your Form 10-K for the year ended December
31, 2010 to the date you determined an estimate of the loss.
Response:
The Company’s 10-Q filing on May 10, 2011 included the disclosure below on the history of the Risperdal charges.
“In January 2004, Janssen Pharmaceutica Inc. (Janssen) (now Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI)) received a subpoena from the Office of the Inspector General of the United States Office of Personnel Management seeking documents concerning sales and marketing of, any and all payments to physicians in connection with sales and marketing of, and clinical trials for, RISPERDAL® from 1997 to 2002. Documents subsequent to 2002 have also been requested by the Department of Justice. An additional subpoena seeking information about marketing of, and adverse reactions to, RISPERDAL® was received from the United States Attorney’s Office for the Eastern District of Pennsylvania in November 2005. Numerous subpoenas seeking testimony from various witnesses before a grand jury were also received. OMJPI cooperated in responding to these requests for documents and witnesses. The United States Department of Justice and the United States Attorney’s Office for the Eastern District of Pennsylvania (the Government) are continuing to actively pursue both criminal and civil actions. In February 2010, the Government served Civil Investigative Demands seeking additional information relating to sales and marketing of RISPERDAL® and sales and marketing of INVEGA® . The focus of these matters is the alleged promotion of RISPERDAL® and INVEGA® for off-label uses. The Government has notified OMJPI that there are also pending qui tam actions alleging off-label promotion of RISPERDAL® . The Government informed OMJPI that it will intervene in these qui tam actions and file a superseding complaint.
Discussions are ongoing in an effort to resolve criminal penalties under the Food Drug and Cosmetic Act and civil claims under the False Claims Act (the qui tam actions) related to the promotion of RISPERDAL®. During the quarter ended April 3, 2011, OMJPI recorded a reserve for a potential settlement of the penalties under the Food Drug and Cosmetic Act. No complaint asserting civil False Claims Act claims has yet been served and no reserve has been established with respect to the civil False Claims Act claims. If a negotiated resolution cannot be reached, criminal and civil litigation relating to the allegations of off- label promotion of RISPERDAL® and/or INVEGA® is likely. The ultimate resolution of these matters is not expected to have a material adverse effect on the Company’s financial position, although the resolution in any reporting period could have a material impact on the Company’s results of operations and cash flows for that period.
The Attorneys General of multiple states and the Office of General Counsel of the Commonwealth of Pennsylvania filed actions against Janssen (now OMJPI) seeking reimbursement of Medicaid or other public funds for RISPERDAL® prescriptions written for off-label use, compensation for treating their citizens for alleged adverse reactions to RISPERDAL® , civil fines or penalties, damages for “overpayments” by the state and others, punitive damages, or other relief. The Attorney General of Texas has joined a qui tam action in that state seeking similar relief. The trial of the Texas action is scheduled to commence in October 2011. Certain of these actions also seek injunctive relief relating to the promotion of RISPERDAL® . The Attorneys General of approximately 40 other states have indicated a potential interest in pursuing similar litigation against OMJPI, and have obtained a tolling agreement staying the running of the statute of limitations while they pursue a coordinated civil investigation of OMJPI regarding potential consumer fraud actions in connection with the marketing of RISPERDAL® .”
During the period of time between the receipt of the initial subpoena in 2004 and the end of 2010 the parties exchanged information and met numerous times and were unable to agree on the facts or the applicable legal principles underlying the government claims. Accordingly, the Company was unable to reasonably estimate an amount of loss or range of loss for the Risperdal matters through February 25, 2011, the date the 2010 form 10-K was filed. The Company continued to believe that it had meritorious defenses to the allegations brought by the Government and planned to continue to vigorously defend the case if a reasonable settlement could not be reached.
Subsequent to the filing of the 2010 form 10-K and throughout the first quarter of 2011, the Company held numerous additional discussions with government officials regarding settlement of potential criminal charges. During those discussions the parties were able to narrow the issues relevant to a settlement of potential criminal charges. The Company determined a liability was probable and estimable and an accrual was recorded.
As disclosed in the first quarter 10-Q dated April 3, 2011, the Company established a pre-tax litigation liability of $291 million, which was recorded primarily for the criminal portion of the Risperdal matter.
Discussions as to the final details of the potential criminal charges and the corresponding financial component of a settlement have continued through the second quarter of 2011. As a result of these additional discussions which further narrowed the disagreement as to potential charges and the related financial component of a criminal settlement, the Company adjusted the accrued amount. Key issues pertinent to a settlement of the potential criminal charges have been resolved, but several significant issues exist before a settlement can be finalized. However, these issues are not expected to impact the amount of the recorded accrual.
Discussions with state and federal government representatives to resolve the separate civil claims related to the marketing of Risperdal are ongoing. The Company continues to believe there are meritorious defenses to these claims, and it remains unclear whether a settlement can be reached as discovery has not commenced or is not complete, there are significant facts in dispute, the damages sought in the claims are unsubstantiated and indeterminate, there are numerous parties involved, and possible outcomes are uncertain. For these reasons, the Company is unable to estimate a range of loss. However, future negotiations may lead to a narrowing of the areas of disagreement and the liability may then become reasonably estimable in accordance with applicable accounting principles under ASC450-20-25.
General Litigation, page 31
3. You state that the ultimate legal and financial liability of the Company in respect to all
claims, lawsuits and proceedings referred to above often [emphasis added] cannot be
reasonably estimated. We do not believe that this disclosure meets the requirements of ASC
450-20-50-4b. For those claims, lawsuits and proceedings that you can estimate, please
provide us proposed disclosure to be included in future periodic reports disclosing an
estimate of the possible loss or range of loss. For those claims, lawsuits and proceedings that
you cannot estimate, please provide us proposed disclosure to be included in future periodic
reports disclosing that such an estimate cannot be made. In addition for those matters for
which you cannot estimate an amount or range, please provide us with an explanation of the
procedures you undertake on a quarterly basis to reach that determination.
Response:
In response to the Staff’s comment and request for information, the following summarizes the procedures the Company follows relating to accounting for litigation matters:
Litigation matters are reviewed jointly by the General Counsel, Chief Financial Officer, Controller, Associate General Counsel for Litigation, and Assistant Controller at the end of each quarter or more frequently, if necessary. Litigation matters are further reviewed at the time of filing Forms 10-Q and 10-K for completeness and accuracy.
The Company records a liability for litigation and regulatory matters when the loss contingency is probable and the amount of the loss can be reasonably estimated in accordance with ASC450-20-25. The Company continually monitors litigation and regulatory matters for new information and further developments that could affect the amount of the previously established accrued liability.
There are other disclosed matters for which a loss is probable or reasonably possible, but an estimate cannot be made. For those matters, the Company is unable to estimate the possible loss or range of loss due to the inherently unpredictable nature of these legal proceedings. These matters can be affected by various factors, including, damages sought in the proceedings are unsubstantiated or indeterminate; scientific and legal discovery are not complete; proceedings are in early stages; matters present legal uncertainties; there are significant facts in dispute; there are numerous parties involved. If the Company is able to determine an estimate of the possible loss or range of loss in future periods, the Company will provide the disclosure required by ASC 450 in future filings.
In future filings beginning with the Form 10-Q for the period ending July 3, 2011, the Company will revise this disclosure as follows:
“Through the period ended July 3, 2011, the Company has determined that the liabilities associated with certain litigation matters are probable and can be reasonably estimated. The Company has accrued for these matters and will continue to monitor each related legal issue and adjust accruals for new information and further developments in accordance with ASC 450-20-25. For these and other litigation and regulatory matters currently disclosed for which a loss is probable or reasonably possible, the Company is unable to determine an estimate of the possible loss or range of loss beyond the amounts already accrued. These matters can be affected by various factors, including, damages sought in the proceedings are unsubstantiated and indeterminate; scientific and legal discovery has not commenced or is not complete; proceedings are in early stages; matters present legal uncertainties; there are significant facts in dispute; there are numerous parties involved.
In the Company’s opinion, based on its examination of these matters, its experience to date and discussions with counsel, the ultimate outcome of legal proceedings, net of liabilities accrued in the Company’s balance sheet, is not expected to have a material adverse effect on the Company’s financial position, although the resolution in any reporting period of one or more of these matters, either alone or in the aggregate, may have a material adverse effect on the Company’s results of operations, and cash flows for that period.”
As requested, we acknowledge that:
·
Johnson & Johnson is responsible for the adequacy and accuracy of the disclosure in the filing;
·
Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and
·
Johnson & Johnson may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact me at 732-
2011-07-20 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
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Stephen J. Cosgrove
One Johnson & Johnson Plaza
Vice President
New Brunswick, NJ 08933
Corporate Controller
July 20, 2011
VIA EDGAR
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re:
Johnson & Johnson
Form 10-K for the Fiscal Year Ended January 2, 2011
Filed February 24, 2011
File No. 001-03215
Form 10-Q for the Quarterly Period Ended April 3, 2011
Filed May 10, 2011
Dear Mr. Rosenberg:
We have received your comment letter dated June 24, 2011, regarding the comments of the staff of the Securities and Exchange Commission (the “Commission”) with respect to the above-referenced Form 10-K for the fiscal year ended January 2, 2011 and Form 10-Q for the quarterly period ended April 3, 2011. Confirming our phone conversation today with yourself, Mr. Joel Parker and Ms. Tabatha Akins, we have requested and you have agreed to an extension of our response to the comment letter to Tuesday, July 26, 2011. This extension will allow us sufficient time to prepare our response to the comment letter.
If you have any questions, please contact me at 732-524-1831.
Sincerely,
/s/ Stephen J. Cosgrove
Stephen J. Cosgrove
Vice President
Corporate Controller
Chief Accounting Officer
2011-06-28 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
filename1.htm
junesecextensionletter.htm
Stephen J. Cosgrove
One Johnson & Johnson Plaza
Vice President
New Brunswick, NJ 08933
Corporate Controller
June 28, 2011
VIA EDGAR
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re:
Johnson & Johnson
Form 10-K for the Fiscal Year Ended January 2, 2011
Filed February 24, 2011
File No. 001-03215
Form 10-Q for the Quarterly Period Ended April 3, 2011
Filed May 10, 2011
Dear Mr. Rosenberg:
We have received your comment letter dated June 24, 2011, regarding the comments of the staff of the Securities and Exchange Commission (the “Commission”) with respect to the above-referenced Form 10-K for the fiscal year ended January 2, 2011 and Form 10-Q for the quarterly period ended April 3, 2011. Confirming my phone conversation today with Mr. Joel Parker, we have requested and you have agreed to an extension of our response to the comment letter to Friday, July 22, 2011. This extension will allow us sufficient time to prepare our response to the comment letter.
If you have any questions, please contact me at 732-524-1831.
Sincerely,
/s/ Stephen J. Cosgrove
Stephen J. Cosgrove
Vice President
Corporate Controller
Chief Accounting Officer
2011-06-24 - UPLOAD - JOHNSON & JOHNSON
June 24, 2011 Stephen J. Cosgrove Vice President, Corporate Controller Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 2, 2011 Filed February 24, 2011 File No. 001-03215 Form 10-Q for the Quarterly Period Ended April 3, 2011 Filed May 10, 2011 Dear Mr. Cosgrove: We have reviewed your May 27, 2011 response to our May 3, 2011 letter and have the following comments. Please respond to this letter within te n business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. Form 10-K for the Fiscal Year Ended January 2, 2011 Exhibit 13 Management’s Discussion and Analysis of Re sults of Operations and Financial Condition Income Taxes, page 38 1. Please refer to your response to our comment thr ee. As previously requested, please provide us proposed disclosure to be included in future filings of the amount of cash and cash equivalents held by foreign subsidiaries as of the latest balance sheet date presented, which are only available at the subs idiary level because earnings are considered permanently reinvested. We believe this information will provide further context with respect to your sources of liquidity. Stephen J. Cosgrove Johnson & Johnson June 24, 2011 Page 2 Form 10-Q for the Quarterly Period Ended April 3, 2011 Notes to Consolidated Financial Statements Note 11 – Legal Proceedings Government Proceedings RISPERDAL®, page 25 2. During the quarter ended April 3, 2011, you record ed a reserve for a pot ential settlement of the penalties under the Food Drug and Cosmetic Ac t related to Risperda l. Please tell us: The amount recorded and why you believe it is a reasonable estimate of the probable loss; and Why you were unable to reasonably estimate an amount of loss or range of loss at December 31, 2010. In this regard, include a chronology of the facts and circumstances from the time you filed your Form 10-K for the year ended December 31, 2010 to the date you determined an estimate of the loss. General Litigation, page 31 3. You state that the ultimate le gal and financial liability of the Company in respect to all claims, lawsuits and proceedings referred to above often [emphasis added] cannot be reasonably estimated. We do not believe that th is disclosure meets the requirements of ASC 450-20-50-4b. For those claims, lawsuits a nd proceedings that you can estimate, please provide us proposed disclosure to be included in future pe riodic reports disclosing an estimate of the possible loss or range of loss. For those claims, lawsuits and proceedings that you cannot estimate, please provide us proposed di sclosure to be includ ed in future periodic reports disclosing that such an estimate canno t be made. In addition for those matters for which you cannot estimate an amount or range, pl ease provide us with an explanation of the procedures you undertake on a quarterly ba sis to reach that determination. You may contact Tabatha Akin s, Staff Accountant, (202) 551-3658 or Joel Parker, Accounting Branch Chief, at (202) 551-3651 if you have any questions regarding the comments. In this regard, do not hesitate to contact me, at (202) 551-3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2011-05-27 - CORRESP - JOHNSON & JOHNSON
CORRESP
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may2011secletter.htm
Stephen J. Cosgrove
Vice President
Corporate Controller
One Johnson & Johnson Drive
New Brunswick, NJ 08933
May 27, 2011
Via EDGAR
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re: Johnson & Johnson
Form 10-K for the Fiscal Year Ended January 2, 2011
Filed February 24, 2011
File No. 001-03215
Dear Mr. Rosenberg:
Johnson & Johnson is submitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated May 3, 2011, with respect to Johnson & Johnson’s Form 10-K filed with the Commission on February 24, 2011 for the fiscal year ended January 2, 2011 (SEC File No. 001-03215) (the “Form 10-K”).
Set forth below is the heading and text of the comment followed by our response:
Exhibit 13
Management’s Discussion and Analysis of Results of Operations and Financial Condition Analysis of Sales By Business Segment
Analysis of Consolidated Earnings Before Provision for Taxes on Income, page 33
1. In order to help us evaluate your disclosure about your research and development activities, please provide us the following information:
·
A description of the research and development process for each of your segments;
·
For those projects that require an FDA approval, quantify the number of projects that were in preclinical phase, Phase I, Phase II, and Phase III of the clinical development and those for which a NDA was filed as of December 31, 2010;
·
For each segment requiring FDA approval, the breakout of research and development expense incurred during 2010, if practicable, by development phase (i.e., preclinical, Phase I, Phase II, Phase III) and by therapeutic class; and
·
For each of your late phase development projects (i.e., Phase III projects), please provide the following:
o
A description of the nature and its indication;
o
Indicate the month and the year that it entered the phase;
o
Identify the significant patents associated with the projects and their expiration date;
o
The significant developments of the project during the period such as significant milestones, filing for regulatory approval, approval and other responses from regulatory agencies; suspension or termination and the reasons therefore; and
o
Your estimate of the next future milestone such as completion of a development phase, date of filing an NDA with regulatory agency, or approval from a regulatory agency is it can be reliably determined.
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Response:
Johnson & Johnson is one of the world’s largest and most comprehensive health care manufacturing companies and competes in three broad Segments of human health care; Medical Devices and Diagnostics, Pharmaceutical and Consumer. Johnson & Johnson companies around the world compete in local markets in a highly decentralized structure, making local product and investment decisions working within global strategies and standards provided by Segment and Corporate managements.
Within this overall structure, research and development activities are carried out in all three Segments and in approximately 50 facilities around the world. These facilities support initiatives for local markets, global markets and across multiple segments. The research and development processes carried out in these facilities include discovery, product improvement and clinical and technical support required to demonstrate effectiveness and compliance with local laws in support of gaining approval to market from numerous authorities around the world.
A majority of products currently sold in all three Segments require approvals from global regulatory authorities (including the FDA) before becoming available in the market. In any one year, Johnson & Johnson’s companies have hundreds of applications for product approvals with these regulatory authorities. With respect to the US FDA only, businesses in all three Segments of Business of Johnson & Johnson submit applications for approvals of products. Due to the number of product applications, it would be impractical to disclose the exact number of ongoing applications or to estimate the timing of future approval or cost associated with these applications for approval. All applications for approval are inherently uncertain, the timing of expenses vary for each application and may be misleading to investors.
The Company recognizes that the Staff’s comments are largely focused on additional details of US pharmaceutical projects. While the US Pharmaceutical business application process includes all the development phases detailed in the comment above, this business represents only 20% of the annual consolidated sales of Johnson & Johnson. Additionally, across all three Segments, research and development investments in support of any one new or improved product represents less than 5% of total annual consolidated research and development investments and less than 1% of total consolidated expenses. Over the past five years, no new product approval in any Segment of Business has added more than 0.5% to the current year’s total consolidated sales or 2% to the current year Segment annual consolidated sales.
The Company does not believe that a detailed description of research and development projects, even projects in late stages, would add meaningfully to the discussion of the Company’s results of operations. The Company believes the current disclosure (pg. 34 of the 2010 Annual Report) by Segment of the three-year investments in research and development in both dollars and as a percent of Segment sales is the best representation of the Company’s commitment to the hundreds of products in all phases of development at any one time.
Research and Development expense (excluding purchased in-process research and development charges) by segment of business was as follows:
2010
2009
2008
(Dollars in Millions)
Amount
% of Sales*
Amount
% of Sales*
Amount
% of Sales*
Consumer
$
609
4.2
%
632
4.0
624
3.9
Pharmaceutical
4,432
19.8
4,591
20.4
5,095
20.7
Medical Devices and Diagnostics
1,803
7.3
1,763
7.5
1,858
8.0
Total research and development expense
$
6,844
11.1
%
6,986
11.3
7,577
11.9
Percent (decrease)/increase over the prior year
(2.0)
%
(7.8
)
(1.3
)
* As a percent to segment sales
This disclosure provides the reader with the best indicator of the Company’s commitments to research and development by segment, provides an effective measure of the Company’s management of total research and development investments and is less subject to the changing priorities and timing associated with any one product.
In response to the Staff’s comments, in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended January 1, 2012, we propose to enhance the Company’s disclosure to clarify that no individual research and development investment is material to the Company’s consolidated operating results, for as long as that remains the case.
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Research & Development Expense, Page 34
2. You state that research and development expenditures relate to technical support of products and compliance with governmental regulations for the protection of consumers and patients. Please tell us how these activities meet the definition of research and development per ASC 730-10-20.
Response:
The Research and Development expenditures that relate to technical support of products and compliance with governmental regulations for the protection of consumers and patients represent costs associated with either plans or designs for new products or processes or for significant improvements to an existing product or process. These projects are carried out to meet the varied requirements to achieve regulatory approval in the various jurisdictions around the world and are incurred prior to regulatory approval and commercial launch, or after launch if required in conjunction with regulatory approvals.
In response to the Staff’s comment, in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended January 1, 2012, we propose to enhance the Company’s disclosure to clarify the definition of research and development expense with the following:
“Research and Development Expense:
Research and development activities represent a significant part of the Company’s business. These expenditures relate to the processes of discovering, testing and developing new products, improving existing products, as well as ensuring product efficacy and regulatory compliance prior to launch. The Company remains committed to investing in research and development with the aim of delivering high quality and innovative products.”
Income Taxes, page 38
3. You state “January 2, 2011 and January 3, 2010, the cumulative amounts of undistributed international earnings were approximately $37.0 billion and $32.2 billion, respectively.” Please revise to disclose the amount of cash and investments that are currently held by your foreign subsidiaries that are considered reinvested indefinitely and its expected effect on your liquidity and capital resources. Refer to Item 303(a) (1) of Regulation S-K and Section IV of SEC Release 33-8350
Response:
The Company believes that the current disclosures related to liquidity and capital resources captures any known trends or any known demands that could result in or that are reasonably likely to result in the Company’s liquidity increasing or decreasing in any material way. The Company's current liquidity needs are met through its operating cash flows. Additionally, the Company has adequate borrowing capacity should it need to supplement the cash flows generated from operations. In response to the Staff's comment, in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended January 1, 2012, we propose to enhance the Company’s disclosure to address liquidity with the following:
“While the Company has the financial capacity to repatriate to the United States substantially all of the undistributed international earnings, the Company has no financial need to repatriate these earnings, and, as such, these funds are considered permanently reinvested.”
Notes to Consolidated Financial Statements
8. Income Taxes, page 52
4. Please provide the disclosures required under ASC 740-30-50-2c.
Response:
In response to the Staff’s comment, in future Annual Reports on Form 10-K, beginning with the Annual Report on Form 10-K for the fiscal year ended January 1, 2012, we propose to enhance the Company’s disclosure in Note 1, Summary of Significant Accounting Policies - Income Taxes (page 47 of the 2010 Annual Report), to address disclosure requirements applicable to unrecognized deferred tax liabilities associated with undistributed earnings with the following:
“As of the end of 2011 and 2010, the Company has not provided deferred taxes on $xx billion and $37 billion of undistributed earnings from certain international subsidiaries where the earnings are considered to be permanently reinvested. The Company intends to continue to reinvest these earnings in international operations. If the Company decided at a later date to repatriate these earnings to the U.S., the Company would be required to provide for the net tax effects on these amounts. The Company does not determine the deferred tax liability associated with these undistributed earnings, as such determination is not practicable."
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As requested, we acknowledge that:
·
Johnson & Johnson is responsible for the adequacy and accuracy of the disclosure in the filing;
·
Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and
·
Johnson & Johnson may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact me at 732-524-1831 with any questions or comments you may have.
Sincerely,
/s/ Stephen J. Cosgrove
Vice President
Corporate Controller
Chief Accounting Officer
2011-05-09 - CORRESP - JOHNSON & JOHNSON
CORRESP
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may2011secletter.htm
Stephen J. Cosgrove
Vice President
Corporate Controller
One Johnson & Johnson Drive
New Brunswick, NJ 08933
May 9, 2011
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re: Johnson & Johnson
Form 10-K for the Fiscal Year Ended January 2, 2011
Filed February 24, 2011
File No. 001-03215
Dear Mr. Rosenberg:
We have received the comment letter dated May 3, 2011 from you to Mr. William C. Weldon, regarding the comments of the staff of the Securities and Exchange Commission (the “Commission”) with respect to the above-referenced Form 10-K for the fiscal year ended January 2, 2011. Confirming my phone conversation today with Ms. Tabatha Atkins, we have requested and you have agreed to an extension of our response to the comment letter to Tuesday, May 31, 2011. This extension will allow us sufficient time to prepare our response to the comment letter.
If you have any questions, please contact me at 732-524-1831.
/s/ Stephen J. Cosgrove
Vice President
Corporate Controller
Chief Accounting Officer
2011-05-05 - UPLOAD - JOHNSON & JOHNSON
May 3, 2011 W. C. Weldon Chairman, Board of Directors, and Chief Executive Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Form 10-K for the Fiscal Year Ended January 2, 2011 Filed February 24, 2011 File No. 001-03215 Dear Mr. Weldon: We have limited our review of your filing to those issues we have addressed in our comments. In our comments, we ask you to pr ovide us with information so we may better understand your disclosure. Please respond to this letter within te n business days by providing the requested information or by advising us when you will provide the requested response. Where a comment requests you to revise disclosu re, the information you provide s hould show us what the revised disclosure will look like and identify the annual or quarterly filing, as applicable, in which you intend to first include it. If you do not be lieve a comment applies to your facts and circumstances, please tell us why in your res ponse. Please furnish us a letter on EDGAR under the form type label CORRESP that ke ys your response to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. Exhibit 13 Management’s Discussion and Analysis of Re sults of Operations and Financial Condition Analysis of Sales by Business Segment Analysis of Consolidated Earnings Befo re Provision for Taxes on Income, page 33 1. In order to help us evaluate your disclosure about your research and development activities, please provide us the following information: A description of the research and devel opment process for each of your segments; For those projects that require an FDA approva l, quantify the number of projects that were in preclinical phase, Phase I, Phase II, and Phase III of the clinical development and those for which a NDA was filed as of December 31, 2010; W. C. Weldon Johnson & Johnson May 3, 2011 Page 2 For each segment requiring FDA approval, th e breakout of research and development expense incurred during 2010, if practicable, by development phase (i.e. preclinical, phase I, phase II phase III) and by therapeutic class; and For each of your late phase development proj ects (i.e. Phase III projects) please provide the following: o A description of the natu re and its indication; o Indicate the month and the year that it entered that phase; o Identify the significant patents associated with the project and their expiration date; o The significant developments of the projec t during the period such as significant milestones, filing for regulatory approva l, approval and other responses from regulatory agencies; suspension or termin ation and the reasons therefore; and o Your estimate of the next future milestone such as completion of a development phase, date of filing an NDA with a re gulatory agency, or approval from a regulatory agency is it can be reliably determined. Research and Development Expense, page 34 2. You state that research and development expenditures relate to technical support of products and compliance with governmental regulations fo r the protection of consumers and patients. Please tell us how these activities meet the de finition of research and development per ASC 730-10-20. Income Taxes, page 38 3. You state “At January 2, 2011 and January 3, 20 10, the cumulative amounts of undistributed international earnings were approximately $37.0 billion and $32.2 bill ion, respectively.” Please revise to disclose the amount of cash a nd investments that are currently held by your foreign subsidiaries that are c onsidered reinvested indefinitely and its expected effect on your liquidity and capital resources. Refer to Item 303(a)(1) of Regulation S-K and Section IV of SEC Release 33-8350. Notes To Consolidated Financial Statements 8. Income Taxes, page 52 4. Please provide the disclosures required under ASC 740-30-50-2c. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. 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. W. C. Weldon Johnson & Johnson May 3, 2011 Page 3 In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. You may contact Tabatha Akin s, Staff Accountant, (202) 551-3658 or Joel Parker, Accounting Branch Chief, at (202) 551-3651 if you have any questions regarding the comments. In this regard, do not hesitate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2010-12-03 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
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corresp.htm
(212) 474-1876
December 3, 2010
Crucell N.V.
Schedule TO-T filed on November 12, 2010
Filed by JJC Acquisition Company B.V. and Johnson & Johnson
File No. 005-51066
Dear Ms. Chalk:
On behalf of Johnson & Johnson and JJC Acquisition Company B.V. (“JJC Acquisition” and, together with Johnson & Johnson, the “Filing Persons”), and in response to discussions we have had with you regarding the above-referenced matter, we are writing to supplement our letter to you dated November 30, 2010 (“Response Letter”), which sets forth our responses to certain comments of the Staff contained in the letter dated November 23, 2010, providing comments to the Schedule TO filed by the Filing Persons with the Commission on November 12, 2010 (the “Schedule TO”) in connection with the proposed tender offer (the “Offer”) by JJC Acquisition for all of the issued and outstanding shares in Crucell N.V. (“Crucell”).
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Capitalized terms used and not defined herein have the meanings ascribed to them in the Offer Document filed as Exhibit 99(a)(1)(A) to the Schedule TO.
1. We are supplementing our response to comment #1 in our Response Letter by confirming that we will include disclosure in the “Questions and Answers About the Offer and Granting Proxies” section of the Offer Document substantially in the form set forth below:
“Why is the Company convening both an Offer EGM and a Post Offer EGM?
The Offer EGM and the Post Offer EGM are separate meetings requiring separate shareholder action under Dutch law. Dutch law requires that a company that is the subject of a tender offer convene an extraordinary general meeting of shareholders before the expiration of such offer in order to inform its shareholders of the terms and conditions of the offer. The Offer EGM has been convened, therefore, to fulfill this Dutch legal requirement. The Post Offer EGM is being convened because the Asset Sale pursuant to the Business Purchase Agreement, which may be pursued as the Post Closing Restructuring following consummation of the Offer, requires the approval of at least a majority of the issued and outstanding Shares of the Company.
Why is Shareholder action required at the Offer EGM?
At the Offer EGM, Shareholders will be asked to adopt, in accordance with the DCC, the Governance Resolutions, which will implement certain changes to the corporate governance structure of the Company. These changes are customary in Dutch tender offer practice and, while adopted at the Offer EGM, will only become effective as of the Settlement Date. The Governance Resolutions are necessary to permit the Offeror to exercise some modicum of control over Crucell during the period between the Settlement Date and the completion of the Post Closing Restructuring that will provide the Offeror full ownership of all of Crucell’s outstanding Shares and business.
Why are Shareholders being asked to grant Proxies relating to corporate action of Crucell that will follow consummation of the Offer?
As is customary in Dutch tender offer practice, corporate action of Crucell following consummation of the Offer is contemplated to provide the Offeror full ownership of all of Crucell’s outstanding Shares and business. The most straight-forward manner in which the Offeror may acquire the outstanding shares of minority Shareholders following the closing of the Offer is through a Statutory Buy-Out. A Statutory Buy-Out, however, can only be initiated if the Offeror acquires at least 95% of the issued and outstanding share capital of Crucell. If the Offeror acquires less than 95% of the issued and outstanding share capital of Crucell, it must effectuate some other post-Offer restructuring to acquire full ownership of all of Crucell’s outstanding Shares and business. The Offeror and Crucell have agreed that the most feasible post-Offer restructuring alternative if a Statutory Buy-Out may not be initiated is the Asset Sale. Under Dutch law, shareholder approval is required to pursue any post-Offer restructuring other than a Statutory Buy-Out, including the Asset Sale. Specifically, pursuant to clause 2:107a of the DCC, shareholders have the authority, at an extraordinary general meeting of shareholders, to approve board decisions concerning a significant change of identity or character of a company or business, such as transfers of the entire business to a third party, as is contemplated by the Asset Sale. If the Asset Sale is pursued (i.e., because the Offeror has not acquired sufficient shares to initiate a Statutory Buy-Out), the Post Offer EGM must be convened to approve the resolution of the Crucell Management Board approved by the Crucell Supervisory Board to enter into the Asset Sale.”
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2. We are supplementing our response to comment #8 in our Response Letter by acknowledging that, in connection with the potential reduction of the minimum tender condition from 95% to 80% as contemplated by the terms of the Merger Agreement, we intend to comply with the conditions described under the heading “Terminating Withdrawal Rights Immediately After Reducing or Waiving a Minimum Acceptance Condition” in Release No. 33-8957 (September 19, 2008) (the “Interpretative Release”). We specifically note that, with respect to the condition in the Interpretative Release requiring that “the Offer must remain open for at least five business days after the waiver or reduction of the minimum acceptance condition”, the Offeror has contractually agreed, pursuant to the terms of the Merger Agreement (and as disclosed in the Offer Document), to provide a Subsequent Offering Period to enable Shareholders that did not tender their Shares during the Acceptance Period to tender their Shares following the Acceptance Period under the same terms and conditions applicable to the Offer. The Offeror confirms that it will hold such Subsequent Offering Period open for a period of not less than five business days to satisfy such condition.
3. We are supplementing our response to comment #9 in our Response Letter by:
(A) replacing the last paragraph of Section 5.10 of the Offer Document with the following:
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“If the Offeror elects to pursue the Asset Sale described in Section 7.15 (Post Closing Restructuring and Future Legal Structure), and a Shareholder did not tender its Shares in the Offer, such Shareholder will receive the same amount of cash per Share that it would have received had it tendered its Shares in the Offer, without any interest being paid on such amount and with such amount being subject to any required withholding taxes. The withholding taxes and other taxes, if any, imposed on such Shareholder may be different from, and possibly greater than, the taxes imposed upon a Shareholder that tenders its Shares in the Offer. Consequently, if the Asset Sale is pursued, the net amount received by a Shareholder for Shares that are not tendered in the Offer (and who remains a Shareholder of Crucell up to and including the time of the Asset Sale and any subsequent liquidation) will depend upon such Shareholder’s individual tax circumstances and the amount of any required withholding or other taxes, as further described in Section 12.1.6 (Asset Sale Pursuant to the Business Purchase Agreement).”
(B) replacing the fourth paragraph of Section 7.15.3 of the Offer Document with the following:
The purchase price payable to Crucell under the Business Purchase Agreement shall be an amount equal to the product of (i) the Offer Price multiplied by (ii) the total number of Shares issued and outstanding immediately prior to completion of the Asset Sale without interest and subject to dividend withholding or other taxes. The withholding taxes and other taxes, if any, imposed on such Shareholder may be different from, and possibly greater than, the taxes imposed upon a Shareholder that tenders its Shares in the Offer. Consequently, if the Asset Sale is pursued, the net amount received by a Shareholder for Shares that are not tendered in the Offer (and who remains a Shareholder of Crucell up to and including the time of the Asset Sale and any subsequent liquidation) will depend upon such Shareholder’s individual tax circumstances and the amount of any required withholding or other taxes, as further described in Section 12.1.6 (Asset Sale Pursuant to the Business Purchase Agreement). The Business Purchase Agreement provides that the Offeror shall procure, if necessary by making adjustments to the purchase price, that the purchase price payable to Crucell shall be sufficient to pay out EUR 24.75 per Share to the Shareholders per issued and outstanding Share, without interest and subject to dividend withholding or other taxes, if any. The Crucell Boards received financial adviser opinions, based upon and subject to the assumptions, factors and qualifications set forth therein, as to the fairness, from a financial point of view and as of 5 October 2010, to Crucell of the purchase price payable to Crucell in the Asset Sale.”
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4. We are supplementing our response to comment #12 in our Response Letter as follows:
Johnson & Johnson notes that in Section 10.2 (Prospective Financial Information) of Crucell’s Shareholders’ Circular (which constitutes a part of the Solicitation/Recommendation Statement of Crucell on Schedule 14D-9), Crucell has provided its shareholders with summary financial projections for the fiscal years 2011 through 2015. At the outset of Johnson & Johnson’s due diligence review, in June of 2010, Crucell provided Johnson & Johnson with a set of financial projections for the same periods and also for a longer range into the future (the financial projections for the longer range into the future, the “Longer Range Projections”). The Longer Range Projections covered multiple years well into the future (over 10 years into the future), and by their nature are inherently speculative and unreliable. In addition, the Longer Range Projections relate to products that are currently in the development stage by Crucell and have not yet been introduced into the market, and given the risks and uncertainties related to the research, clinical testing and commercialization of development-stage products, Johnson & Johnson believes that any forecasts prepared by Crucell for products in development constitute nothing more than speculation. Accordingly, in light of the foregoing, Johnson & Johnson did not rely on the Longer Range Projections and does not believe that such additional information is material to Crucell shareholders.
_______________
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If you have any questions regarding the contents of this letter, please do not hesitate to contact me at the above number.
Sincerely,
/s/ Damien R. Zoubek
Damien R. Zoubek
Christina Chalk, Esq.
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Copy to:
Eric Jung, Esq.
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
VIA EDGAR, FACSIMILE AND FEDERAL EXPRESS
2010-11-30 - CORRESP - JOHNSON & JOHNSON
CORRESP
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filename1.htm
corresp.htm
November 30, 2010
Crucell N.V.
Schedule TO-T filed on November 12, 2010
Filed by JJC Acquisition Company B.V. and Johnson & Johnson
File No. 005-51066
Dear Ms. Chalk:
On behalf of Johnson & Johnson and JJC Acquisition Company B.V. (“JJC Acquisition” and, together with Johnson & Johnson, the “Filing Persons”), we are writing to respond to the comments set forth in the letter of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated November 23, 2010, providing comments to the Schedule TO filed by the Filing Persons with the Commission on November 12, 2010 (the “Schedule TO”) in connection with the proposed tender offer (the “Offer”) by JJC Acquisition for all of the issued and outstanding shares in Crucell N.V. (“Crucell”), that we did not address in our letter to you dated November 29, 2010.
For the convenience of the Staff, each of the Staff’s comments is reproduced below in its entirety in italics and is followed by the corresponding response
of the Filing Persons. Capitalized terms used and not defined herein have the meanings ascribed to them in the Offer Document filed as Exhibit 99(a)(1)(A) to the Schedule TO.
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Schedule TO-T
Exhibit 99(a)(1)(A)-Offer to Purchase
General
1. We note that you will seek shareholder approval of certain corporate governance and other matters at two separate meetings of Crucell shareholders, one to occur before the expiration of the offer and another after. For our information and in order to clarify certain Dutch legal requirements necessitating these approvals, please briefly explain in your response letter why these matters must be approved by shareholders and what the impact will be on the bidder’s ability to integrate Crucell after the offer. For example, why is it necessary for shareholders to approve the transfer of the business of Crucell to the Offeror or its Affiliate? How is this different from the position an Offeror would be in after purchasing a majority stake in a target in a US offer? We may have additional comments after reviewing your response.
Response:
The Offer EGM
The Offer EGM and the Post Offer EGM are separate meetings requiring separate shareholder action under Dutch law.
Dutch law requires that a company that is the subject of an offer convene an extraordinary general meeting before the expiration of any offer in order to inform shareholders of the terms and conditions of the offer. The Offer EGM therefore fulfils this Dutch legal requirement. Also, at the Offer EGM, as is customary in Dutch tender offer practice, Crucell shareholders will be requested to adopt, in accordance with the Dutch Civil Code and subject to the Offer being declared unconditional, the following governance resolutions necessary to facilitate the Offer:
● certain amendments to Crucell’s articles of association (pursuant to clause 2:121 of the Dutch Civil Code); and
● the reconstitution of the Crucell Supervisory Board to include 9 designees of the Offeror and 2 incumbent Crucell Supervisory Board members.
3
The actions contemplated by the governance resolutions, while taken at the Offer EGM, will only become effective upon the Offer being declared unconditional. These actions are necessary in order to permit the Offeror to exercise some modicum of control over Crucell during the period from the closing of the Offer to the consummation of the post-tender offer steps that will provide the Offeror with ownership of 100% of the interests in Crucell. This is consistent with the mechanics implemented in U.S. tender offers where, upon closing of the tender offer, the subject company agrees to reconstitute its board of directors in order to provide the offeror with majority board representation at the subject company during the period from the closing of the offer to the subsequent squeeze-out of the shares that were not tendered into the offer. The difference here is that in the Netherlands, those actions require approval at a shareholders meeting, while in the United States those actions can be taken without a shareholder meeting.
The Post Offer EGM
The means by which an offeror may acquire full ownership of a company and/or its business after the completion of a tender offer is quite different under Dutch law and U.S. law. For example, an offeror is not able pursue a “short-form” merger under Dutch law upon the acquisition of 90% of the issued and outstanding share capital of a company. Additionally, if an offeror acquires between 50% and 90% of the issued and outstanding share capital of a company, there is no statutory “long-form” merger available under Dutch law to cash-out the shares that are not tendered in an offer.
Accordingly, it is common in Dutch tender offer practice to contemplate one or more transactions to achieve this result, as has been done in this Offer. The most straight-forward manner by which the Offeror may acquire the outstanding shares of minority shareholders following the closing of the Offer is through statutory buy-out proceedings. Such proceedings, however, can only be initiated if the Offeror acquires at least 95% of the issued and outstanding share capital of Crucell. If the Offeror acquires less than 95% of the issued and outstanding share capital of Crucell, it must effectuate some other post-tender offer settlement restructuring to acquire full ownership of Crucell and/or its business. The Offeror and Crucell have agreed that the most feasible post-tender offer settlement restructuring alternative is the Asset Sale.
Under Dutch law, shareholder approval is required to pursue any post-tender offer settlement restructuring other than the statutory buy-out, including the Asset Sale. Specifically, pursuant to clause 2:107a of the Dutch Civil Code, shareholders have the authority, at a general meeting of shareholders, to approve board decisions concerning a significant change of identity or character of a company or business, such as transfers of the entire business to a third party as is contemplated by the Asset Sale. If the Asset Sale is pursued (i.e., because the Offeror has not acquired sufficient shares to utilize the statutory buy-out), the Post Offer EGM must be convened to approve the resolution of the Crucell Management Board to enter into the Asset Sale.
3. As you know, the offer must remain open for at least twenty U.S. business days from the date of the offer materials are published, sent or given to target shareholders. See Rule 14e-1(a). Note that December 24th and December 31st will not be considered business days this year, given that the SEC and EDGAR will be closed on those dates. In addition, your offer is set to expire at 11:30 a.m. on an unspecified date; since “business day” is defined in our rules to extend from 12:01 a.m. through 12:00 midnight Eastern Time, please ensure that the offer period is open for the full twenty U.S. business days as that term is defined in Rule 13e-4(a)(3).
4
Response:
We acknowledge the Staff’s comment and will ensure that the Offer period is open for 20 U.S. business days at minimum. We also respectfully submit that Section 7.25.1 of the Offer Document contains disclosure specifying that the Offeror is required to keep the Offer open for acceptance for a period of at least 55 days, and in any event not less than the full 20 U.S. business days as defined in Rule 14d-1(g) of the Exchange Act, which sets forth the same requirements as Rule 13e-4(a)(3) of the Exchange Act.
4. Consider reducing the number of defined terms in your offer document. On the first page of the offer materials alone, you define 19 terms. Some of the defined terms seem self-evident and unnecessary, such as defining bidder “Johnson & Johnson” as “Johnson & Johnson,” or using separate defined terms for “Acceptance Closing Date,” “Acceptance Closing Time,” and “Acceptance Period.”
Response:
We have taken this comment under advisement and have revised the Offer Document to reflect your suggestions.
5. We note that bidder JJC Acquisition Company is a wholly owned direct subsidiary of Cilag Holding AG, which is itself a subsidiary of bidder Johnson & Johnson. Tell us why you have not included Cilag as a bidder, or revise to include it.
Response:
We acknowledge the Staff’s comment and have revised the Schedule TO and the Offer Document to include Cilag Holding AG as an offeror.
Questions and Answers about the Offer and Granting Proxies―Does the Offeror have the Financial Resources to Make Payment?, page 2
6. You state that one of the Offeror’s affiliates may provide the Offeror with sufficient funds to purchase tendered Shares. Any entity that provides funding for the Offer may need to be included as a bidder on the Schedule TO, in which case, it would have to provide and disseminate all of the disclosure required by that Schedule. This might also necessitate an extension of the offer period, depending on when it occurred. Please confirm your understanding in your response letter.
5
Response:
Johnson & Johnson, as the ultimate parent company of the Offeror and the Offeror’s affiliates, has full control over the funds within the Johnson & Johnson Group and will ensure that sufficient funds are readily available to purchase shares tendered into the Offer. Johnson & Johnson has been included as an offeror in the Schedule TO and the Offer Document, and the relevant disclosure regarding Johnson & Johnson required by that Schedule will be disseminated to Crucell’s shareholders. Additionally, cash is fungible, and Johnson & Johnson directs the movement of cash among its affiliated companies for a myriad of operational, financing and other reasons in the normal course of its business, including the funding of acquisitions. Accordingly, information regarding any potential movement of funds among the Johnson & Johnson Group would be impractical to provide in advance and, we respectfully submit, would be confusing to shareholders. Shareholders have been ensured certainty of funds in respect of the aggregate cash consideration payable in the Offer by the Offeror in the Offer Document.
Can the Offer be extended and under what circumstances?, page 3
7. For changes other than a change in the offer price, we note your disclosure that the Acceptance Period may only be extended once, absent extenuating circumstances. In your response letter, tell us what you will do if the US rules would require an extension of the offer period but Dutch rules would not permit such an extension. We may have further comments.
Response:
As described in Section 6.4 (The Acceptance Period and Extension of the Acceptance Period) of the Offer Document, the Acceptance Period may be extended more than once if the AFM grants dispensation for further extensions, which will only be given in exceptional circumstances. In the event that U.S. rules would require an extension of the Acceptance Period but Dutch rules would not permit such an extension, we intend to request such a dispensation from the AFM to allow for the required extension. If the AFM refused to grant such a dispensation, we would respectfully request relief from the SEC and would provide the SEC with sufficient time to consider the request. Under those circumstances, we believe that the SEC would have grounds to grant the Offeror an exemption from such a requirement to extend the Offer, should it agree to do so.1 If the Offeror would be unable to obtain relief from either the AFM or the SEC, the Offeror would allow the Offer to lapse and would subsequently commence a new offer.
1 The SEC will consider any applications for exemptions beyond those provided by Tier II status on a case-by-case basis to address direct conflicts between the U.S. laws and practice and those of the home jurisdiction of the target company. See Cross-Border Tender and Exchange Offers, Business Combinations and Rights Offerings, Release No. 33-7759 (Oct. 22, 1999). See also Banco Bilbao Vizcaya Argentaria, S.A., SEC No-Action Letter (Mar. 9, 2001) (no-action relief under Rule 14d-10 granted where “Colombian regulations do not permit the Offer Time to be changed, while an extension of the U.S. Offer period might be required under applicable U.S. rules and regulations”).
6
What are the most significant conditions to the Offer?, page 5
8. You disclose that if certain other offer conditions are satisfied, the 95% minimum tender condition will be reduced to 80%. In your response letter, tell us how mechanically you will handle the reduction in the minimum tender condition, including how and when you will make this change, how you will notify shareholders, whether withdrawal rights will exist after such reduction, etc. See the guidance on reducing or waiving a minimum tender condition in a cross-border offer provided in Release No. 33-8957 (September 19, 2008).
Response:
In response to the Staff’s comment, we note that the Offer Document discloses that the minimum acceptance condition is 80% in the event that (x) the Favourable IRS Ruling is obtained by Johnson & Johnson and (y) Proxies are received in respect of at least 80% of the Shares that will allow the Offeror to vote, at the Post Offer EGM, in favour of the Asset Sale that may be pursued as a Post Closing Restructuring following the consummation of the Offer. Shareholders are made aware, and should assume, as of the commencement of the Offer that if the events in subclauses (x) and (y) above are satisfied, the minimum acceptance condition is 80% on the Announcement Date. This occurs by the very terms of the minimum acceptance condition itself, which terms were agreed to in advance by Crucell and the Offeror (as set forth in the Merger Agreement and in the Offer Document) so that the minimum acceptance condition would not have to be reduced or waived under these circumstances. Said differently, the application of the 80% condition in lieu of the 95% condition is an express term of the Offer that tendering shareholders are aware of at the time they tender their shares into the Offer, and the application of the 80% condition is not the result of a waiver or amendment to the terms of the Offer.
Therefore, we note that the conditions set forth in Section II.C.5 of Release No. 33-8957 (September 19, 2008) are inapplicable to the Offer, since such conditions only apply to a waiver or reduction of the minimum acceptance condition. As stated above, given the minimum acceptance condition (including the circumstances under which the condition is 95% and the circumstances under which it is 80%) is disclosed to the shareholders in the Offer Document at the commencement of the Offer and given that the reduction to 80% occurs automatically pursuant to the terms of the minimum acceptance condition itself upon the occurrence of the above-specified events (under which events neither the Offeror nor Crucell would be able to prevent the automatic reduction without further amendment), the Offeror would not be waiving or reducing the minimum acceptance condition by announcing that the minimum acceptance condition is 80% on the Announcement Date.
7
Shareholders will be notified if the minimum acceptance condition is 80% on the Announcement Date. As disclosed in the Offering Document, the Offeror will notify shareholders by making a public announcement on the Announcement Date, in accordance with article 16, paragraph 1 of the Decree.
We also respectfully note that shareholders may withdraw any shares tendered pursuant to the Offer at any time prior to the Acceptance Closing Time and the Offer Document informed shareholders that such withdrawal rights will not apply during any Subsequent Offering Period.
If I decide not to tender, what will happen to my Shares?, page 9
9. Quantify how much less shareholders may receive in the Asset Sale and subsequent liquidation than by
2010-11-29 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
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(212) 474-1876
November 29, 2010
Crucell N.V.
Schedule TO-T filed on November 12, 2010
Filed by JJC Acquisition Company B.V. and Johnson & Johnson
File No. 005-51066
Dear Ms. Chalk:
On behalf of Johnson & Johnson and JJC Acquisition Company B.V. (“JJC Acquisition” and, together with Johnson & Johnson, the “Filing Persons”), we are writing to respond to Comment #2 set forth in the letter (the “Comment Letter”) of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated November 23, 2010, providing comments to the Schedule TO filed by the Filing Persons with the Commission on November 12, 2010 (the “Schedule TO”) in connection with the proposed tender offer (the “Offer”) by JJC Acquisition for all of the issued and outstanding shares in Crucell N.V. (“Crucell”).
For the convenience of the Staff, Comment #2 of the Staff is reproduced below in its entirety in italics and is followed by the corresponding response of the Filing Persons. Capitalized terms used and not defined herein have the meanings ascribed to them in the Offer Document filed as Exhibit 99(a)(1)(A) to the Schedule TO.
Schedule TO-T
Exhibit 99(a)(1)(A)-Offer to Purchase
General
2. We note that Johnson & Johnson indirectly holds (through its affiliate JHC Nederland B.V.) 17.9% of Crucell’s total issued share capital. It appears these shares were purchased pursuant to the Equity Purchase Agreement dated September 28, 2009 included as an exhibit to Crucell’s Form 20-F filed on April 7, 2010. Given this pre-offer ownership stake and the rights afforded to Johnson & Johnson under the Collaboration Agreements and the Shareholder and Registration Rights Agreement, tell us why Johnson & Johnson is not an affiliate of Crucell and why this transaction is not subject to Rule 13e-3. Your analysis should address the level of influence, whether actual or potential, Johnson & Johnson had on Crucell, whether through share ownership, existing business relationships, board representation or otherwise. In addition, it should focus on Johnson & Johnson’s access to non-public information about Crucell by virtue of these agreements or otherwise. In this regard, it appears that Johnson & Johnson became interested in acquiring Crucell by virtue of its involvement with the company through these agreements, versus being contacted by Crucell or its representatives as part of an “auction” process. We may have further comments after reviewing your analysis.
Response:
Rule 13e-3(a)(1) under the Exchange Act defines an “affiliate” of the issuer as “a person that directly or indirectly through one or more intermediaries controls, is controlled by, or is under common control with such issuer”. Rule 12b-2 under the Exchange Act defines “control” to mean “the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract or otherwise”. The determination of whether a person is in control of an issuer “does not turn solely on the ownership of any specific percentage of securities”,1 but rather is “based upon the particular facts and circumstances of each situation”.2
We respectfully submit that Johnson & Johnson does not have such a control relationship with Crucell and is not an “affiliate” of Crucell within the meaning of Rule 13e-3, and therefore that the Filing Persons are not required to file a Rule 13e-3 Transaction Statement in connection with the Offer. No control contemplated by the rule is afforded Johnson & Johnson by virtue of its share ownership level, contractual rights or commercial relationship with Crucell. In fact, Johnson & Johnson’s general rights as a shareholder have been limited by other contractual rights Crucell has against Johnson & Johnson and by the positions of certain other Crucell shareholders. In particular, we note the following:
1 See SEC Release No. 34-17719 (1981) at 9 n.28.
2 See id. at 6.
●
No Control Through Share Ownership. Johnson & Johnson, through its affiliate JHC Nederland B.V., holds only 17.9% of the issued and outstanding share capital of Crucell. This share ownership is not sufficient to enable Johnson & Johnson, acting alone, to approve any action as a shareholder of Crucell or cause Crucell to take any action. We note supplementally that several cases have found that shareholdings of similar size, and many significantly greater shareholdings, have failed to constitute the control necessary for “affiliate” status.3
●
Meaningful Influence of Other Significant Shareholders. Crucell has other significant shareholders, one of which owns more than 10% of Crucell’s issued and outstanding share capital. This shareholder has been active in expressing its views with respect to the management and corporate actions of Crucell and has been vocal in its opposition to the proposed transaction between Johnson & Johnson and Crucell. This shareholder has also expressed an intention to contact other Crucell shareholders in an attempt to thwart the proposed transaction. In response to a request from this shareholder, Crucell has agreed to schedule an informational extraordinary general meeting of shareholders for the sole purpose of giving this shareholder a forum to express its view of the Offer. Because of the shareholdings of this significant shareholder, and the influence we believe it may be able to exert with other Crucell shareholders (as illustrated in the context of the current transaction), we believe other Crucell shareholders have a meaningful opportunity to influence the control of Crucell and, if they deem it appropriate, to prevent the actions supported by Johnson & Johnson4--further supporting the conclusion that Johnson & Johnson’s own shareholding does not provide it with any “control”.
3 Woodward & Lothrop, Inc. v. Schnabel, 593 F.Supp. 1385, 1400-01 (D.D.C. 1984) (holding that a shareholder was not an “affiliate” within the meaning of Rule 13e-3 because the shareholder’s ownership of 32% of the issuer’s common stock did not give the shareholder control over the company); Ranco Incorporated, SEC No-Action Letter (May 1, 1987) (no-action relief granted because the purchaser was not an “affiliate” within the meaning of Rule 13e-3, where the shareholder could vote 14% of the issuer’s shares, was the beneficial owner of 50.1% of the shares, did not have the power to elect any directors or officers and had no representation on the board). See also World Financial Bank, SEC No-Action Letter (May 28, 1996) (no-action relief granted with respect to availability of exemption from registration for shares of The Limited to be issued under the terms of a stock bonus plan of World Financial Network National Bank (“WFNNB”), where analysis turned on the determination that The Limited was not an “affiliate” of WFNNB, despite The Limited’s ownership of 40% of the common stock of WFNNB); Ivanhoe Partners v. Newmont Mining Corp., 535 A.2d 1334, 1342-44 (Del. 1987) (holding that control of a Delaware company had not been sold to a 49.7% stockholder where other factors prevented that stockholder from exercising control as a practical matter (namely, a standstill agreement that limited stock ownership to 49.7% and its board representation to 40%)).
4 As described in the Offer Document, the most straight-forward manner by which the Offeror may acquire the outstanding shares of minority shareholders following the closing of the Offer is through statutory buy-out proceedings. Such proceedings, however, can only be initiated if the Offeror acquires at least 95% of the issued and outstanding share capital of Crucell. Without the support of this shareholder, statutory buy-out proceedings will not be possible. Further, other post-closing restructuring alternatives discussed in the Offer Document, including the Asset Sale, would require at least 80% of the issued and outstanding share capital of Crucell.
●
No Board Representation. Johnson & Johnson and its affiliates have no designees on the Crucell Supervisory Board or Crucell Management Board, nor are they entitled to designate any members of either such board.
●
Limitations Imposed by Shareholder Agreement. The Shareholder Agreement imposes two significant restrictions on Johnson & Johnson’s shareholding in Crucell that, we submit, further demonstrate the limited nature of its influence over Crucell and (absent the completion of the proposed transaction) its ability to exert influence in the future.
●
Standstill Restrictions. Until September 28, 2012, Johnson & Johnson and its affiliates cannot, among other things, acquire additional Crucell shares or commence a public offer for additional Crucell shares without Crucell’s prior approval.
●
Drag-Along Restrictions. Johnson & Johnson and its affiliates must agree to sell all of their shares into a bona fide public offer by a third party that is supported by the Crucell Management Board and Crucell Supervisory Board and the holders of at least 70% of Crucell’s shares, if Johnson & Johnson has not made a matching offer or an alternate proposal meeting certain criteria.
●
No Control Rights Provided by Shareholder or Registration Rights Agreements. Johnson & Johnson’s other rights under the Shareholder and Registration Rights Agreements are solely designed to maintain Johnson & Johnson’s percentage ownership of Crucell at its existing level, by protecting Johnson & Johnson from dilution in some circumstances and from increasing concentration in others. (We also note that these protections are not indefinite—they would expire upon Johnson & Johnson’s ceasing to hold at least a certain specified percentage of Crucell’s shares.) However, these agreements do not extend any other rights or control with respect to Crucell.
●
Collaboration Agreements Do Not Provide or Further Control. The Collaboration Agreements do not, by either their terms or their practical effects, provide Johnson & Johnson with any influence or control over Crucell’s overall management or business. These agreements relate to research and development work for a specific series of products that are merely in early stage development—not any products currently sold by Crucell and not any other of Crucell’s products in development. Further, these types of collaboration arrangements are customary in the pharmaceutical industry as a way for companies to share the cost and risk in researching and developing products. In particular, it should be noted that the collaboration contemplated by the Collaboration Agreements is but one of several research and development collaborations that Crucell has with different pharmaceutical companies, including DSM Biologics, MedImmune, Merck, Novartis, sanofi pasteur and Wyeth.5 We further note that Johnson & Johnson currently has no relationship with Crucell relating to any of its pediatric vaccines, which account for 67% of Crucell’s product sales.6
5 See Crucell’s Form 20-F, filed with the SEC on April 7, 2010.
6 See Crucell’s Form 6-K regarding Crucell’s third quarter 2010 results, filed with the SEC on November 9, 2010.
●
No Rights to Non-Public Information. Other than through Crucell’s negotiation with Johnson & Johnson of the proposed transaction, Johnson & Johnson has had no rights to non-public information about Crucell that could have enabled Johnson & Johnson to otherwise effectively exert control or influence over Crucell, or was otherwise used by Johnson & Johnson in evaluating the transaction. As described in the Offer Document under “Background of the Offer”, Johnson & Johnson obtained access to a dataroom containing due diligence in order to evaluate whether it wanted to initiate discussions with Crucell regarding a potential transaction, and then conducted several weeks of due diligence. Further, Johnson & Johnson was not permitted to conduct any on-site due diligence at Crucell’s research and development locations until the end of September 2010. Moreover, Johnson & Johnson would not have engaged in an extensive due diligence exercise, which would not have been necessary or appropriate, if Johnson & Johnson had access to non-public information about Crucell prior to that time.
We, on behalf of the Filing Persons, will respond to the Staff’s other comments set forth in the Comment Letter in due course. If you have any questions regarding the contents of this letter, please do not hesitate to contact me at the above number.
Sincerely
/s/ Damien R. Zoubek
Damien R. Zoubek
Christina Chalk, Esq.
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Copy to:
Eric Jung, Esq.
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
VIA EDGAR, FACSIMILE AND FEDERAL EXPRESS
2009-07-08 - UPLOAD - JOHNSON & JOHNSON
Via Facsimile and U.S. Mail Mail Stop 4720 July 8, 2009 Mr. W. C. Weldon Chairman, Board of Directors, and Chief Executive Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, New Jersey 08933
Re: Johnson & Johnson
Form 10-K for the Period Ended December 31, 2008 Filed February 20, 2009
File No. 001-03215
Dear Mr. Weldon:
We have completed our review of the a bove filing and have no further comments at
this time.
S i n c e r e l y ,
Gus Rodriguez Accounting Branch Chief
2009-06-22 - CORRESP - JOHNSON & JOHNSON
CORRESP
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Stephen J. Cosgrove One Johnson
& Johnson Plaza
Vice
President New Brunswick, NJ
08933
Corporate
Controller (732)
524-3737
June 22,
2009
Mr. Jim
B. Rosenberg
Senior
Assistant Chief Accountant
Securities
and Exchange Commission
Washington,
DC 20549
Re: Johnson
& Johnson
File No. 001-03215
Dear Mr.
Rosenberg:
We have
reviewed the comments included in your letter of June 8, 2009 and have prepared
the following responses. For your convenience, we have included your
comments with this letter. Our response uses the same numbering as
your letter.
Comment
1: Please revise your contractual obligations table to include interest expense
since it is part of your contractual obligation of debt.
Response
1: Below is what the contractual obligations and commitments table,
revised to include interest expense, would have looked like in the Company’s
Annual Report for the fiscal year ended December 28, 2008. The
Company intends to include this table in its Annual Report for the 2009 fiscal
year using the same presentation as shown below.
CONTRACTUAL
OBLIGATIONS AND COMMITMENTS
The
Company has contractual obligations, primarily lease, debt obligations and
related interest and unfunded retirement plans, with no other significant
obligations. To satisfy these obligations, the Company will use cash from
operations. The following table summarizes the Company’s contractual obligations
and their aggregate maturities as of December 28, 2008 (see Notes 4, 6 and 13 to
the Consolidated Financial Statements for further details):
(Dollars
in Millions)
Interest
on
Unfunded
Operating
Debt
Debt
Retirement
Leases
Obligations
Obligations
Plans
Total
2009
$
171
221
475
56
923
2010
145
22
456
58
681
2011
123
18
453
62
656
2012
107
620
440
66
1,233
2013
89
507
410
70
1,076
After
2013
93
6,953
4,927
436
12,409
Total
$
728
8,341
7,161
748
16,978
-2-
Comment
2: Refer to your disclosure “sales returns allowances represent a reserve for
products that may be returned due to expiration, destruction in the field, or in
specific areas, product recall.” Revise your disclosure to
address:
·
Whether
you refund the sales price by issuing cash or a credit, or whether you
exchange product from your inventory for the returned
product;
·
Whether
the returned product is resalable;
and
·
If
you exchange product from your inventory for the returned product, how you
account for your estimate of returns at the time of the product sale and
how you account for returns when they are actually returned and make the
exchange. Provide us an analysis supporting your accounting
treatment with reference to authoritative literature. It also
may be helpful to provide us an example showing the journal entries
made.
Response
2: In accordance with the Company’s accounting policies, the Company
generally issues credit to customers for returned goods. The
Company’s sales return reserves are accounted for in accordance with FASB
Statement No. 48 “Revenue Recognition When Right of Return
Exists.” Sales return reserves are recorded at full sales
value. Sales returns in the Consumer and Pharmaceutical segments are
almost exclusively not resalable. While sales returns in the Medical
Devices & Diagnostics segment are generally not resalable, certain
franchises in this segment may receive returned product that is resalable,
however such amounts have not been significant in the past. The
Company rarely exchanges products from inventory for returned
products. Sales return reserves are based on historical return trends
by product. The sales returns reserve for the total Company has
ranged between 1.1% and 1.2% of annual net trade sales during the prior three
fiscal reporting years 2006-2008.
The
Company will expand its disclosures in its annual report for the 2009 fiscal
year to include response 2 above.
The
Company acknowledges that it is responsible for the adequacy and accuracy of all
disclosures in its filings. The Company understands that SEC staff
comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filings and the
Company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United
States of America.
If you
have any questions or comments, please call me at (732) 524-3737 or Phil Savas,
Assistant Corporate Controller at (732) 524-3566.
Sincerely,
/s/
Stephen
J. Cosgrove
Vice
President, Controller
(Principle Accounting Officer)
2009-06-08 - UPLOAD - JOHNSON & JOHNSON
Via Facsimile and U.S. Mail Mail Stop 4720 June 8, 2009 Mr. W. C. Weldon Chairman, Board of Directors, and Chief Executive Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, New Jersey 08933 Re: Johnson & Johnson Form 10-K for the Period Ended December 31, 2008 Filed February 20, 2009 File No. 001-03215 Dear Mr. Weldon: We have reviewed your filing and have the following comments. In our comments, we ask you to provide us with information to better understand your disclosure. Where a comment requests you to revise disclosure, the information you provide should show us what the revised disc losure will look like and identify the annual or quarterly filing, as applicab le, in which you intend to firs t include it. If you disagree, we will consider your explanation as to why our comments are inapplicable or a revision is unnecessary. After reviewing the info rmation provided, we may raise additional comments and/or request that you amend your filing. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Exhibit 13 Management’s Discussion and Analysis of Re sults of Operations and Financial Condition Liquidity and Capital Resources Contractual Obligations and Commitments, page 40 1. Please revise your contractual obligations table to include interest expense since it is part of your contractual obligation of debt. Mr. W. C. Weldon Johnson & Johnson June 8, 2009 Page 2 Consolidated Financial Statements Notes to Consolidated Financial Statements Summary of Significan t Accounting Policies Revenue Recognition, page 49 2. Refer to your disclosure “sal es returns allowances repr esent a reserve for products that may be returned due to expiration, de struction in the field, or in specific areas, product recall.” Revise your disclosure to address: • Whether you refund the sales price by i ssuing cash or a credit, or whether you exchange product from your inventory for the returned product; • Whether the returned product is resalable; and, • If you exchange product from your i nventory for the returned product, how you account for your estimate of returns at the time of the product sale and how you account for returns when they are actually returned and make the exchange. Provide us an analysis supporting your accounting treatment with reference to authoritativ e literature. It also may be helpful to provide us an example showing the journal entries made. * * * * Please respond to these comments within 10 business days or tell us when you will provide us with a response. Please furnish a letter that keys your responses to our comments and provides the requested information. Detailed letters greatly facilitate our review. Please furnish your letter on EDGAR under the form type label CORRESP. 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 all in formation required under the Securities Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclosure in the filing; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the company may not assert staff comme nts as a defense in any proceeding initiated by the Commission or any person under the federal secu rities laws of the United States. Mr. W. C. Weldon Johnson & Johnson June 8, 2009 Page 3 In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comments on your filing. Please contact Kei Ino, Staff Accountant, at (202) 551-3659 or Gus Rodriguez, Accounting Branch Chief, at (202) 551- 3614, if you have questions regarding these comments. In this regard, do not hes itate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2008-12-23 - CORRESP - JOHNSON & JOHNSON
CORRESP
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December
23, 2008
Mentor
Corporation
Schedule TO-T/A filed
December 19, 2008
Filed by Maple Merger Sub,
Inc. and Johnson & Johnson
SEC File
No. 005-35178
Dear Ms.
Kim:
On behalf
of Johnson & Johnson (“J&J”) and Maple
Merger Sub, Inc. (“Merger Sub”), this
letter responds to your letter dated December 22, 2008 (the “Comment Letter”),
providing comments to the Schedule TO-T filed with the Securities and Exchange
Commission (the “Commission”) by
J&J and Merger Sub on December 12, 2008, the Schedule TO-T/A filed with the
Commission by J&J and Merger Sub on December 17, 2008 and the Schedule
TO-T/A filed with the Commission by J&J and Merger Sub on December 19, 2008
(as amended, the “Schedule
TO”). For your convenience, each comment from the Comment
Letter has been reproduced below, followed by J&J’s and Merger Sub’s
response to such comment. Capitalized terms defined in the Schedule
TO and used in the following responses without definition have the meanings
specified in the Schedule TO.
Offer to
Purchase
[Certain Information
Concerning Parent and the Purchaser], page 10
1.
We
note your response to comment 4 in our letter dated December 17, 2008;
however, we reissue our comment. Please revise to omit the
disclaimer language that you take no responsibility for the accuracy or
completeness of the information contained in the Offer to Purchase with
respect to Seller.
2
J&J
and Merger Sub acknowledge the Staff’s comment, and have revised their
disclosure to delete the last sentence of the second paragraph under the caption
“Certain Information Concerning Seller” in the Offer to Purchase and, in lieu
thereof, have added the following sentence to the end of the second paragraph
under that caption:
“Although
the Purchaser has no knowledge that any information included in the
periodic reports, proxy statements and other information filed by Seller
with the SEC is inaccurate, incomplete or untrue, such reports, statements
and information were prepared by Seller and the Purchaser was not involved
in the preparation of such reports, statements and
information.”
Conditions to the Offer,
page 27
2.
We
note your response to comment 5 in our letter dated December 17, 2008;
however, we reissue our comment. Please revise the language
that the tender offer conditions may be asserted or waived “at any time
and from time to time.” All conditions to the tender offer, other than
those conditions dependent upon the receipt of necessary government
approvals, must be satisfied or waived prior to the expiration of the
tender offer.
J&J
and Merger Sub have further reviewed the rules and regulations of the Commission
relating to the satisfaction of conditions to tender offers and have carefully
considered the Staff’s comment, including in connection with the receipt of the
Staff’s December 17, 2008 letter in respect of the Schedule
TO. However, as set forth in the letter from J&J and Merger Sub
to the Staff dated December 19, 2008, and as further discussed with the Staff on
December 22, 2008, J&J and Merger Sub respectfully disagree with the Staff’s
comment.
_______________
For your
convenience, we have enclosed a copy of the Schedule TO as amended.
3
If you
have any questions regarding the contents of this letter, please do not hesitate
to contact me at the above number.
Sincerely,
/s/ Damien R.
Zoubek
Damien R.
Zoubek
Ms. Peggy
Kim
Special
Counsel
U.S.
Securities and Exchange Commission
Office of
Mergers & Acquisitions
100 F
Street, N.E.
Washington,
D.C. 20549-3628
Copy
to:
James
Bergin, Esq.
Johnson
& Johnson
One
Johnson & Johnson Plaza
New
Brunswick, NJ 08933
FAX and
FEDERAL EXPRESS
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
SCHEDULE
TO
Amendment
No. 3
Tender
Offer Statement under Section 14(d)(1) or 13(e)(1)
of
the Securities Exchange Act of 1934
MENTOR
CORPORATION
(Name of
Subject Company (Issuer))
MAPLE
MERGER SUB, INC.
(Offeror)
A Wholly
Owned Subsidiary of
JOHNSON
& JOHNSON
(Offeror)
(Names of
Filing Persons (identifying status as offeror, issuer or other
person))
COMMON
STOCK, $0.10 PAR VALUE
(Title of
Class of Securities)
587188103
(CUSIP
Number of Class of Securities)
Allen
Y. Kim, Esq.
Johnson
& Johnson
One
Johnson & Johnson Plaza
New
Brunswick, NJ 08933
(732)
524-6400
(Name,
address, and telephone numbers of person authorized to receive notices and
communications on behalf of filing persons)
Copies
to:
Robert
I. Townsend, III, Esq.
Damien
R. Zoubek, Esq.
Cravath,
Swaine & Moore LLP
Worldwide
Plaza
825
Eighth Avenue
New
York, NY 10019-7475
(212)
474-1000
CALCULATION
OF FILING FEE
Transaction
Valuation(1)
Amount
of Filing Fee(2)
$1,256,184,542
$49,368.06
(1) Estimated
for purposes of calculating the filing fee only. This amount was determined by
multiplying 40,522,082 shares of Mentor Corporation common stock (representing
the shares of common stock outstanding, in-the-money options, shares of common
stock issuable upon the exercise of outstanding performance stock unit awards
and shares of common stock issuable upon conversion of Mentor Corporation’s
outstanding 2.75% Convertible Subordinated Notes, due 2024, in each case
outstanding as of November 28, 2008 and the shares of common stock subject to
outstanding rights under the employee stock purchase plan of Mentor Corporation
as of December 1, 2008), by $31.00 per share (which is the offer
price).
(2) The
filing fee was calculated in accordance with Rule 0-11 under the Securities
Exchange Act of 1934 and Fee Rate Advisory #6 for fiscal year 2008, issued
December 27, 2007, by multiplying the transaction value by
.0000393.
x Check the
box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify
the filing with which the offsetting fee was previously paid. Identify the
previous filing by registration statement number, or the form or schedule and
the date of its filing.
Amount
Previously Paid: $49,368.06
Filing
Party: Johnson & Johnson and Maple Merger Sub, Inc.
Form
of Registration No.: Schedule TO
Date
Filed: December 12, 2008
o Check
the box if the filing relates solely to preliminary communications made before
the commencement of a tender offer.
Check the
appropriate boxes below to designate any transactions to which the statement
relates:
x Third-party
tender offer subject to Rule 14d-1.
o Issuer
tender offer subject to Rule 13e-4.
o Going-private
transaction subject to Rule 13e-3.
o Amendment
to Schedule 13D under Rule 13d-2.
Check the
following box if the filing is a final amendment reporting the results of the
tender offer. o
This
Amendment No. 3 to the Tender Offer Statement on Schedule TO (this “Amendment”)
is filed by (i) Maple Merger Sub, Inc., a Minnesota corporation (the
“Purchaser”) and wholly owned subsidiary of Johnson & Johnson, a New Jersey
corporation (“Parent”), and (ii) Parent. This Amendment amends and supplements
the Tender Offer Statement on Schedule TO filed with the Securities and Exchange
Commission on December 12, 2008, as amended, (together with any amendments and
supplements thereto, the “Schedule TO”), and relates to the offer (the “Offer”)
by the Purchaser to purchase all of the outstanding shares of common stock, par
value $0.10 per share (the “Shares”), of Mentor Corporation, a Minnesota
corporation (“Seller”), at a purchase price of $31.00 per Share net to the
seller in cash, without interest and less any required withholding taxes, upon
the terms and subject to the conditions set forth in the Offer to Purchase dated
December 12, 2008 (together with any amendments and supplements thereto, the
“Offer to Purchase”), and in the related Letter of Transmittal.
Capitalized
terms used and not defined herein shall have the meanings assigned to such terms
in the Offer to Purchase.
Item
11. Additional Information.
The second paragraph under Section
7—“Certain Information Concerning Seller” of the Offer to Purchase, as amended,
is hereby further amended by restating the final sentence of such paragraph as
follows:
“Although
the Purchaser has no knowledge that any information included in the periodic
reports, proxy statements and other information filed by Seller with the SEC is
inaccurate, incomplete or untrue, such reports, statements and information were
prepared by Seller and the Purchaser was not involved in the preparation of such
reports, statements and information.”
SIGNATURE
After due
inquiry and to the best of my knowledge and belief, I certify that the
information set forth in this statement is true, complete and
correct.
MAPLE
MERGER SUB, INC.
By
/s/
Richard D. Gooding
Name: Richard
D. Gooding
Title: Vice
President
Date: December
23, 2008
JOHNSON
& JOHNSON
By
/s/
John A. Papa
Name: John
A. Papa
Title: Treasurer
Date: December
23, 2008
2008-12-19 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
filename1.htm
corresp.htm
(212)
474-1876
December
19, 2008
Mentor
Corporation
Schedule TO-T filed December
12, 2008
Schedule TO-T/A filed
December 17, 2008
Filed by Maple Merger Sub,
Inc. and Johnson & Johnson
SEC File
No. 005-35178
Dear Ms.
Kim:
On behalf of Johnson & Johnson
(“J&J”) and
Maple Merger Sub, Inc. (“Merger Sub”), this
letter responds to your letter dated December 17, 2008 (the “Comment Letter”),
providing comments to the Schedule TO-T filed with the Securities and Exchange
Commission (the “Commission”) by
J&J and Merger Sub on December 12, 2008 and the Schedule TO-T/A filed with
the Commission by J&J and Merger Sub on December 17, 2008 (as amended, the
“Schedule
TO”). For your convenience, each comment from the Comment
Letter has been reproduced below, followed by J&J’s and Merger Sub’s
response to such comment. Capitalized terms defined in the Schedule
TO and used in the following responses without definition have the meanings
specified in the Schedule TO.
Schedule
TO-T
General
1.
We
note that Johnson & Johnson has signed the Schedule TO and is listed
as a filing person. Please revise the cover of the Schedule TO
to clarify that Johnson & Johnson is a co-bidder and not merely the
parent of Maple Merger Sub. Refer to Section II.D.2. of the
Current Issues and Rulemaking Projects Outline (November 14,
2000).
J&J and Merger Sub acknowledge the
Staff’s comment and have revised the cover of their Schedule TO filing in
accordance therewith.
2
Offer to
Purchase
Terms of the Offer, page
2
2.
We
note that the offer is conditioned on the tender of a majority of the
total number of outstanding shares. Please note that if you
waive the minimum condition, which in our view is a material offer
condition, five business days must remain in the offer and the offer
document must be amended to disclose the change. Please confirm
your understanding.
As disclosed in the Schedule TO, the
Merger Agreement provides that the Purchaser cannot change, waive or modify the
Minimum Tender Condition without the consent of Seller. Neither
J&J nor Merger Sub anticipate waiving the Minimum Tender
Condition. However, while J&J and Merger Sub do not agree or
disagree with the Staff’s view that the Minimum Tender Condition is a material
offer condition, J&J and Merger Sub will confirm that, in this transaction,
in the event they waive the Minimum Tender Condition, at least five business
days will remain in the Offer and the Schedule TO will be amended to disclose
the waiver and any related change in the Expiration Date of the
Offer.
Determination of Validity,
page 7
3.
Explain
to us the purpose of the language that your interpretation of the terms
and conditions of the offer will be final and binding. Please
disclose, here and throughout your document, that only a court of
competent jurisdiction can make a determination that will be final and
binding upon the parties. In addition, please disclose that
security holders may challenge your
determinations.
J&J and Merger Sub acknowledge the
Staff’s comment and have revised the disclosure by deleting from page 7 of the
Offer to Purchase the sentence “The Purchaser’s interpretation of the terms and
conditions of the Offer (including the Letter of Transmittal and the
instructions thereto) will be final and binding”. In addition, in
acknowledgment of the Staff’s comment, J&J and Merger Sub have revised their
disclosure on pages 3, 7 and 8 of the Offer to Purchase to clarify that the
Purchaser’s determination as to any questions relating to the validity, form,
eligibility and acceptance for payment of any tender of Shares will be subject
to any Offer participant disputing the Purchaser’s determination in a court of
competent jurisdiction.
[Certain Information
Concerning Parent and the Purchaser], page 10
4.
Please
revise to omit the disclaimer language that you take no responsibility for
the accuracy or completeness of information contained in the Offer to
Purchase with respect to Seller.
J&J and Merger Sub acknowledge the
Staff’s comment, and have revised their disclosure to delete the third paragraph
under the caption “Certain Information Concerning Seller” in the Offer to
Purchase and, in lieu thereof, have added the following sentence to the end of
the second paragraph under that caption:
3
“Although
the Purchaser has no knowledge that any information included in the periodic
reports, proxy statements and other information filed by Seller with the SEC is
untrue, the Purchaser takes no responsibility for the accuracy or completeness
of such information or for any failure by Seller to disclose any events which
may have occurred or may affect the significance or accuracy of any such
information.”
Conditions to the Offer,
page 27
5.
All
conditions to the tender offer, other than those conditions dependent upon
the receipt of necessary government approvals, must be satisfied or waived
prior to the expiration of the tender offer. We note that the
language in the second-to-last paragraph to this section indicates that
the tender offer conditions may be asserted or waived “at any time and
from time to time.” Please revise.
J&J and Merger Sub have reviewed
carefully the rules and regulations of the Commission relating to the
satisfaction of conditions to tender offers, the expiration of tender offers and
the acceptance for payment of shares tendered pursuant to tender offers and the
Commission’s published interpretations of those rules and regulations, as well
as the court decisions interpreting those rules and regulations, including the
Second Circuit’s opinion in MacFadden Holdings, Inc. v. JB Acquisition Corp.,
802 F.2d 62 (2d Cir. 1986) (the Blair
case). Under Rule 14e-1(c), the Purchaser is required to pay the
consideration offered or return the securities deposited promptly after the
termination or withdrawal of the Offer. As is disclosed in the
Schedule TO, the Purchaser will comply with this Rule. Under Rule
14e-1(d), the Purchaser may not extend the Offer without issuing a notice of
extension by press release or other public announcement not later than the
earlier of 9:00 a.m., eastern time, on the next business day after the scheduled
expiration date of the Offer and the first opening of the New York Stock
Exchange on the next business day after the scheduled expiration date of the
Offer. As is disclosed in the Schedule TO, the Purchaser will comply
with this Rule if it extends the Offer.
J&J and the Purchaser believe that
the Schedule TO and the Offer comply fully with the letter and spirit of all the
rules and regulations of the Commission relating to the satisfaction of
conditions to tender offers, the expiration of tender offers and the acceptance
for payment of shares tendered pursuant to tender offers and the Commission’s
published interpretations of those rules and regulations, as well as the court
decisions interpreting those rules and regulations. In addition, the
language identified in the Staff’s comment and set forth in the second-to-last
paragraph of the Offer to Purchase under the caption “Certain Conditions of the
Offer” is identical to the corresponding language in the Merger Agreement and
resulted from an arms’-length negotiation between J&J and
Seller. Accordingly, J&J and Merger Sub believe that it is
appropriate to disclose this information to holders of Shares, as it reflects
the terms of the Merger Agreement, and believe that to disclose otherwise would
be misleading to such holders.
4
Miscellaneous, page
31
6.
We
note that you state that the offer “is not being made to (nor will tenders
be accepted from or on behalf of) holders of Shares in any jurisdiction in
which the making of the Offer or the acceptance thereof would not be in
compliance with the securities, blue sky or other laws of such
jurisdiction.” Please note that the all-holders provision in
Rule 14d-10 applies equally to U.S. as well as non-U.S. target holders.
While you are not required to disseminate the offer materials in
jurisdictions outside of the United States, the statement in your
parenthetical that tenders from security holders in certain foreign
jurisdictions will not be accepted should be revised. Refer to
the interpretive guidance in section II.G.1 of SEC Release
33-8957. To the extent you intended to limit your offer
solely in reliance on Rule 14-10(b)(2), please clarify that in your
response. Otherwise, please revise to ensure compliance with
Rule 14d-10.
J&J and Merger Sub acknowledge the
Staff’s comment and have revised the disclosure by deleting the parenthetical
“(nor will tenders be accepted from or on behalf of)” from page 31 of the Offer
to Purchase.
_______________
For your convenience, we have enclosed
a copy of the Schedule TO as amended.
As requested by the Staff in the
closing comments of the Comment Letter, attached hereto as Annex A is a written
acknowledgement from J&J and Merger Sub.
5
If you have any questions regarding the
contents of this letter, please do not hesitate to contact me at the above
number.
Sincerely,
/s/
Damien R. Zoubek
Damien
R. Zoubek
Ms. Peggy
Kim
Special
Counsel
U.S.
Securities and Exchange Commission
Office of
Mergers & Acquisitions
100 F
Street, N.E.
Washington,
D.C. 20549-3628
Copy
to:
Allen
Kim, Esq.
Johnson
& Johnson
One
Johnson & Johnson Plaza
New
Brunswick, NJ 08933
FAX and
FEDERAL EXPRESS
Annex
A
Each of
the undersigned hereby acknowledges that in connection with each Schedule TO-C
filed December 2, 2008, the Schedule TO-T filed December 12, 2008 and the
Schedule TO-T/A filed December 17, 2008 (File No. 005-35178):
●
Each
of the undersigned is responsible for the adequacy and accuracy of the
disclosure in its filings with the Securities and Exchange Commission (the
“Commission”);
●
Comments
of the Staff of the Commission or changes to disclosure in response to
Staff comments do not foreclose the Commission from taking any action with
respect to the filings; and
●
The undersigned may not assert
Staff comments as a defense in any proceeding initiated by the Commission
or any person under the Federal securities laws of the United
States.
JOHNSON
& JOHNSON
by
/s/
Allen Y. Kim
Name:
Allen Y. Kim
Title: Attorney-in-Fact
MAPLE
MERGER SUB, INC.
by
/s/
Susan E. Morano
Name:
Susan E. Morano
Title:
Chief Executive Officer
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
SCHEDULE
TO
Amendment
No. 2
Tender
Offer Statement under Section 14(d)(1) or 13(e)(1)
of
the Securities Exchange Act of 1934
MENTOR
CORPORATION
(Name of
Subject Company (Issuer))
MAPLE
MERGER SUB, INC.
(Offeror)
A Wholly
Owned Subsidiary of
JOHNSON
& JOHNSON
(Offeror)
(Names of
Filing Persons (identifying status as offeror, issuer or other
person))
COMMON
STOCK, $0.10 PAR VALUE
(Title of
Class of Securities)
587188103
(CUSIP
Number of Class of Securities)
Allen
Y. Kim, Esq.
Johnson
& Johnson
One
Johnson & Johnson Plaza
New
Brunswick, NJ 08933
(732)
524-6400
(Name,
address, and telephone numbers of person authorized to receive notices and
communications on behalf of filing persons)
Copies
to:
Robert
I. Townsend, III, Esq.
Damien
R. Zoubek, Esq.
Cravath,
Swaine & Moore LLP
Worldwide
Plaza
825
Eighth Avenue
New
York, NY 10019-7475
(212)
474-1000
CALCULATION
OF FILING FEE
Transaction
Valuation(1)
Amount
of Filing Fee(2)
$1,256,184,542
$49,368.06
(1) Estimated
for purposes of calculating the filing fee only. This amount was determined by
multiplying 40,522,082 shares of Mentor Corporation common stock (representing
the shares of common stock outstanding, in-the-money options, shares of common
stock issuable upon the exercise of outstanding performance stock unit awards
and shares of common stock issuable upon conversion of Mentor Corporation’s
outstanding 2.75% Convertible Subordinated Notes, due 2024, in each case
outstanding as of November 28, 2008 and the shares of common stock subject to
outstanding rights under the employee stock purchase plan of Mentor Corporation
as of December 1, 2008), by $31.00 per share (which is the offer
price).
(2) The
filing fee was calculated in accordance with Rule 0-11 under the Securities
Exchange Act of 1934 and Fee Rate Advisory #6 for fiscal year 2008, issued
December 27, 2007, by multiplying the transaction value by
.0000393.
x Check the
box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify
the filing with which the offsetting fee was previously paid. Identify the
previous filing by registration statement number, or the form or schedule and
the date of its filing.
Amount
Previously Paid: $49,368.06
Filing
Party: Johnson & Johnson and Maple Merger Sub, Inc.
Form
of Registration No.: Schedule TO
Date
Filed: December 12, 2008
o Check
the box if the filing relates solely to preliminary communications made before
the commencement of a tender offer.
Check the
appropriate boxes below to designate any transactions to which the statement
relates:
x Third-party
tender offer subject to Rule 14d-1.
o Issuer
tender offer subject to Rule 13e-4.
o Going-private
transaction subject to Rule 13e-3.
o Amendment
to Schedule 13D under Rule 13d-2.
Check the
following box if the filing is a final amendment reporting the results of the
tender offer. o
This Amendment No. 2 to the Tender
Offer Statement on Schedule TO (this “Amendment”) is filed by (i) Maple Merger
Sub, Inc., a Minnesota corporation (the “Purchaser”) and wholly owned subsidiary
of Johnson & Johnson, a New Jersey corporation (“Parent”), and (ii) Parent.
This Amendment amends and supplements the Tender Offer Statement on Schedule TO
filed with the Securities and Exchange Commission on December 12, 2008, as
amended, (together with any amendments and supplements thereto, the “Schedule
TO”), and relates to the offer (the “Offer”) by the Purchaser to purchase all of
the outstanding shares of common stock, par value $0.10 per share (the
“Shares”), of Mentor Corporation, a Minnesota corporation (“Seller”), at a
purchase pr
2008-12-17 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
filename1.htm
corresp.htm
(212)
474-1788
December
16, 2008
Omrix Biopharmaceuticals,
Inc.
Schedule TO-C filed November
24, 2008
Schedule TO-T filed November
25, 2008
Schedule TO-T/A filed
December 1, 2008
Filed by Binder Merger Sub,
Inc. and Johnson & Johnson
SEC File
No. 5-82558
Dear Ms.
Griffith:
On behalf
of Johnson & Johnson (“J&J”) and Binder
Merger Sub, Inc. (“Merger Sub”), this
letter responds to your letter dated December 12, 2008 (the “Comment Letter”)
providing comments to the Schedule TO-C filed with the Securities and Exchange
Commission (the “Commission”) by
J&J and Merger Sub on November 24, 2008 and the Schedule TO-T filed with the
Commission by J&J and Merger Sub on November 25, 2008 (as amended, the
“Schedule
TO”). For your convenience, each comment from the Comment
Letter has been reproduced below, followed by J&J’s and Merger Sub’s
response to such comment. Capitalized terms defined in the Schedule
TO and used in the following responses without definition have the meanings
specified in the Schedule TO.
Schedule
TO-C
1.
Refer
to the press release filed November 24, 2008, in your Schedule
TO-C. Your press release refers to the safe harbor protections
for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995, which do not apply to statements made in
connection with a tender offer. See Section 21E(b)(2)(C) of the
Securities Exchange Act of 1934. Please do not refer to the
safe harbor provisions in future press releases or other communications
relating to this tender offer.
J&J
and Merger Sub acknowledge the staff’s comment and will refrain from making such
references in future press releases and other communications relating to this
tender offer.
Schedule
TO-T
General
2.
At
the commencement of the offer, Johnson & Johnson Development
Corporation (“JJDC”), a subsidiary of Parent, had a $5 million cash
investment in Omrix, and Ethicon, Inc., a wholly owned subsidiary of
Parent, was party to a development agreement to develop certain of Omrix’s
biosurgery products. In view of these relationships, and of the
fact that Johnson & Johnson and Omrix have discussed the possibility
of Parent’s acquiring Seller in the past, please advise us what
consideration you have given to the application of Rule 13e-3 to this
transaction.
J&J
and Merger Sub considered the application of Rule 13e-3 (including the matters
set forth in the foregoing comment) and determined that this transaction is not
a Rule 13e-3 transaction because neither J&J nor Merger Sub (nor any other
subsidiary of J&J, including JJDC and Ethicon) is an “affiliate” of Omrix as
defined under Rule 13e-3(a)(1); none of J&J or any of its subsidiaries
controls, is controlled by, or is under common control with,
Omrix. J&J and Merger Sub do not believe that the matters
referred to in the foregoing comment (each of which is addressed separately
below) are, individually or collectively, sufficient to confer “control” within
the meaning of Rule 13e-3(a)(1).
JJDC, in
connection with its $5 million cash investment in Omrix in July 2004, acquired
435,257 Shares and warrants to acquire an additional 36,364 Shares, which
together represent only approximately 2.58% of the total number of Shares as of
November 20, 2008.1 The Shares and warrants to purchase
Shares held by JJDC neither entitle JJDC to any representation on Omrix’s board
of directors nor otherwise provide JJDC with any ability to influence the
management decisions of Omrix, other than JJDC’s right to vote the Shares held
by it in its capacity as the holder of such Shares. J&J and
Merger Sub do not believe that, as a general matter, the right to vote 2.58% of
the Shares of Omrix is sufficient to confer “control” within the meaning of Rule
13e-3(a)(1). This is particularly true in light of the fact that the
Chief Executive Officer of Omrix (together with two entities that are controlled
by him) beneficially owns approximately 16% of the total number of Shares, and
that at least three institutional holders also beneficially own more than 5% of
the total number of Shares (based on publicly available information), thus
materially diluting any influence JJDC’s relatively small shareholdings would
otherwise provide.
1 As
disclosed on page 1 of the Offer to Purchase, Omrix has advised J&J that, as
of November 20, 2008, 17,130,332 Shares were issued and outstanding, 1,090,909
Shares were reserved for issuance under Omrix’s equity plans, and 38,903 Shares
were reserved for issuance upon the exercise of outstanding warrants, for a
total of 18,260,144 Shares.
2
Ethicon’s
development agreement and distribution and supply agreement with Omrix2, which were entered into in September 2003 and
cover the development and distribution of certain of Omrix’s products, are
commercial arrangements that were entered into by the parties through
arms’-length negotiations. None of the provisions in the development
agreement or the distribution and supply agreement provide J&J, Ethicon or
any other subsidiary of J&J with power to control or influence the
operations of Omrix beyond the contractual right to enforce the commercial terms
relating to the development and distribution of specified products, and neither
agreement grants or purports to grant Ethicon any rights with respect to the
election of directors of Omrix or the selection or decision-making of Omrix
management. In addition, the majority of Omrix’s overall business is
derived from product lines that are independent of Omrix’s commercial
arrangements with Ethicon and in which J&J and its subsidiaries have no
involvement; the commercial arrangements between Ethicon and Omrix represented
only approximately 31% of Omrix’s revenue in fiscal year 2007.
Contractually,
the terms of the agreements do not prohibit Omrix from entering into strategic
transactions with other third parties, and such agreements permit Omrix to
assign such agreements to a company acquiring all or substantially all of
Omrix’s assets or voting stock without Ethicon’s prior consent. Any
ability Ethicon has to terminate the commercial arrangements does not give rise
to any additional element of control over Omrix. Such termination by
Ethicon requires a substantial payment to Omrix and would require Ethicon to
abandon the substantial investments it has made in marketing and development
under the existing commercial arrangements, and to forego the profitable
business opportunity. Such termination also requires six months
notice, thus providing an extended period in which Omrix would have significant
ability to secure another partner (and, in fact, this notice provision was
designed in large part to ensure that Omrix has such an opportunity to seek
another partner in the event of termination). Because of such
substantial downsides to Ethicon, Ethicon has never considered terminating the
commercial arrangements with Omrix.
J&J
and Merger Sub do not believe that, as a general matter, prior preliminary
contacts regarding possible acquisition transactions confer “control” within the
meaning of Rule 13e-3(a)(1). In any event, based on further review
and as noted in the response to staff comment 5 below, J&J and Omrix have
determined that no negotiations or material contacts regarding an acquisition of
Omrix by J&J (other than the present transaction) occurred during the two
years prior to the date of the Schedule TO filing.
In
addition, the contemplated second-step merger in the transaction (as described
in the Offer to Purchase) will be undertaken in accordance with
Rule
13e-3(g)(1)(i).
In sum,
for the foregoing reasons, J&J and Merger Sub have determined that they are
not “affiliates” of Omrix within the meaning of Rule 13e-3, and therefore that
this transaction is not subject to Rule 13e-3.
2 Copies
of the development agreement and the distribution and supply agreement (and
amendments thereto) have been publicly filed by Omrix as Exhibits 10.4, 10.5,
10.6 and 10.7 to Omrix’s registration statement on Form S-1, filed January 18,
2006.
3
3.
We
note that Johnson & Johnson has signed the Schedule TO and is listed
as a filing person. Please revise the cover of the Schedule TO
to clarify that Johnson & Johnson is a bidder and not merely the
parent of Binder Merger Sub.
J&J
and Merger Sub acknowledge the staff’s comment and have revised the cover of
their Schedule TO filing in accordance therewith.
Offer to
Purchase
Certain Information
Concerning Parent and Purchaser, page 12
4.
Please explain whether Ethicon
is contractually obligated to make future payments in respect of research
and development expenses, milestone and transfer
payments. State what impact the tender offer is expected to
have on these payments.
Under the
development agreement between Ethicon and Omrix, Ethicon is contractually
obligated to pay Omrix all of the development costs and one-half of the labor
costs relating to the research and development of products covered by the
development agreement, as well as certain milestone payments contingent on the
first sales of products covered by the development agreement or the receipt of
certain regulatory or marketing clearances for such products. Under
the distribution and supply agreement between Ethicon and Omrix, Ethicon is
contractually obligated to pay Omrix certain additional milestone payments, as
well as periodic transfer payments for the purchase of products by Ethicon from
Omrix. Under the agreements, Ethicon paid to Omrix approximately
$27.1 million during fiscal year 2007 (including $4.0 million in milestone
payments, $9.9 million in research and development payments and $13.2 million in
transfer payments) and expects to pay approximately $32.7 million during fiscal
year 2008 (including $8.8 million in research and development payments and $23.9
million in transfer payments). Two contractual milestone payments
totaling $2.75 million related to the fibrin pad program and the product revenue
targets remain under one of the agreements. Future research and
development payments and transfer payments would be based on the level of
research and development activity and product supply needs,
respectively. Given the contingent nature of these future payments,
it is not possible to quantify them with certainty, or to determine with
certainty whether and when such payments may ultimately be payable.
Upon the
completion of the tender offer and the subsequent merger, both Ethicon and Omrix
will be wholly owned subsidiaries of J&J, and the development agreement and
the distribution and supply agreement will become intercompany arrangements
within the consolidated J&J organization. J&J will therefore
have the ability to unilaterally determine, after the completion of the tender
offer and the subsequent merger, whether to terminate or amend such agreements
or maintain such agreements in place, based on tax and other considerations
relevant to the J&J organization. While no final determination in
this regard has yet been made, it is currently contemplated that such agreements
will remain in force through the respective terms of the contracts.
J&J
and Merger Sub have revised the disclosure on page 13 of the Offer to Purchase
to clarify the information describe above.
4
Background of the Offer,
page 14
5.
Describe
in greater detail the nature and timing of the general preliminary
discussions between Seller and Parent regarding the possibility of an
acquisition (see Item 1005(b) and (c) of Regulation M-A), and identify the
person or persons who initiated each discussion (see also the Instruction
to paragraphs (b) and (c) of Item
1005).
Based on
further review, J&J and Merger Sub have determined that, during the two
years prior to the date of the Schedule TO filing, Omrix and J&J did not in
fact engage in any negotiations or material contacts regarding an acquisition of
Omrix by J&J or any other transaction that is required to be disclosed by
Item 1005(b) or (c) of Regulation M-A, other than with respect to the present
transaction (all of which negotiations and material contacts in connection with
the present transaction are currently disclosed in the “Background of the Offer”
section of the Offer to Purchase). Nonetheless, J&J and Merger
Sub have revised the disclosure on page 14 of the Offer to Purchase to note that
in 2005 there were preliminary discussions concerning a possible acquisition of
Omrix by another subsidiary of J&J (Ethicon), which discussions did not
result in an acquisition offer being made by J&J or any of its
subsidiaries.
6.
Provide
further detail concerning the price that Purchaser offered for the
securities. We note that on August 26, 2008, you proposed a
price of $25.00 per share, which you subsequently raised to $29.00 per
share, and then revised back to $25.00 after the market
break. Please disclose the reasons for the revised offer
price.
Given the
competitive bidding process, J&J raised its proposed price for Omrix to
$29.00 per share on September 8, 2008 based on information that was then
available to J&J, as well as more Omrix-favorable assumptions made with
respect to information that had not yet been made available by Omrix,
recognizing that (and communicating to Omrix through its financial advisor that)
the increased offer price would be subject to the validation of J&J’s
assumptions in further due diligence, including with respect to information
included in a data room to which J&J had not yet been provided
access. The assumptions made by J&J included those with respect
to Omrix’s capital expansion plans and the period of overcapacity likely to
result from such plans, the manufacturing process and relationships between
Omrix’s product lines in terms of Omrix’s total cost structure, the level of
investment required to upgrade Omrix’s information, infrastructure and control
systems to integrate such systems with J&J’s and the overall risks relating
to the business integration and the immunotherapy product line. After
completing its further due diligence, J&J determined that those more
favorable assumptions underlying its September 8, 2008 proposal could not be
supported, and therefore reduced its proposed price for Omrix to $25.00 per
share on October 22, 2008. J&J and Merger Sub have revised the
disclosure on pages 16 and 17 of the Offer to Purchase to further clarify the
basis and limitations of its $29.00 per share proposal as described above,
including by adding additional detail regarding the underlying
assumptions.
5
Throughout
the negotiation process, J&J determined its proposed offer prices for Omrix
using its own internal financial modeling based on a variety of assumptions
(including those described above) that were subject to verification through its
diligence review. There was no specific document or piece of
information (including any confidential information made available in the data
room referred to above) that was material to J&J’s determination of its
proposed offer prices. In particular, J&J never received a copy
of the internal projections of Omrix that were used by Omrix’s financial advisor
in connection with the fairness opinion delivered to Omrix, and the preliminary
forecast
2008-12-17 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
filename1.htm
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(212) 474-1788
December
17, 2008
Omrix Biopharmaceuticals,
Inc.
Schedule TO-C filed November
24, 2008
Schedule TO-T filed November
25, 2008
Schedule TO-T/A filed
December 1, 2008
Schedule TO-T/A filed
December 17, 2008
Filed by Binder Merger Sub,
Inc. and Johnson & Johnson
SEC File
No. 5-82558
Dear Ms.
Griffith:
On behalf
of Johnson & Johnson (“J&J”) and Binder
Merger Sub, Inc. (“Merger Sub”), this
letter supplements J&J’s and Merger Sub’s written response, dated December
16, 2008 (the “Response Letter”), to
your letter dated December 12, 2008 (the “Comment Letter”)
providing comments to the Schedule TO-C filed with the Securities and Exchange
Commission (the “Commission”) by
J&J and Merger Sub on November 24, 2008 and the Schedule TO-T filed with the
Commission by J&J and Merger Sub on November 25, 2008 (as amended, the
“Schedule TO”).
The supplemental information set forth below is being provided in response to
your verbal request for additional information on December 17, 2008. For your
convenience, we have reproduced comment 2 from the Comment Letter, followed by
J&J’s and Merger Sub’s supplemental response to such comment and to your
further verbal inquiry with respect thereto. Capitalized terms
defined in the Schedule TO and used in the following responses without
definition have the meanings specified in the Schedule TO.
Schedule
TO-T
General
2.
At
the commencement of the offer, Johnson & Johnson Development
Corporation (“JJDC”), a subsidiary of Parent, had a $5 million cash
investment in Omrix, and Ethicon, Inc., a wholly owned subsidiary of
Parent, was party to a development agreement to develop certain of Omrix’s
biosurgery products. In view of these relationships, and of the
fact that Johnson & Johnson and Omrix have discussed the possibility
of Parent’s acquiring Seller in the past, please advise us what
consideration you have given to the application of Rule 13e-3 to this
transaction.
We refer
to the full response to the foregoing comment set forth in the Response
Letter.
As
indicated in the Response Letter, J&J and Merger Sub believe that this
transaction is not a Rule 13e-3 transaction because neither J&J nor Merger
Sub (nor any other subsidiary of J&J, including JJDC and Ethicon) is an
“affiliate” of Omrix as defined under Rule 13e-3(a)(1); none of J&J or any
of its subsidiaries controls, is controlled by, or is under common control with,
Omrix.
In
response to the staff’s first supplemental comment, J&J and Merger Sub
advise the staff that they are aware of no non-public information of Omrix made
available to J&J and Merger Sub that was material to the formulation of
their proposed offer price for Omrix and that was not available to other
potential bidders or that would not have been made available to other potential
bidders had they advanced in the sale process. J&J and Merger Sub note that,
as described in the Schedule TO, they were provided with a management
presentation and given access to a virtual data room by Omrix that, to J&J’s
and Merger Sub’s knowledge, were not ultimately made available to other bidders.
However, as is customary in transaction processes of this type, such information
was provided only after J&J and Merger Sub had submitted an indicative offer
for Omrix and advanced to the second round of the sale process. J&J and
Merger Sub expect and believe that any other bidder, if such bidder had
submitted an indicative offer for Omrix, would have been given access to the
same information at the same stage in the sale process.
In
addition, although J&J’s subsidiary Ethicon has a commercial relationship
with Omrix with respect to certain of Omrix’s products and, in that connection,
has had access to information with respect to the development and marketing of
such products, J&J and Merger Sub believe that substantially all information
with respect to such products (including, without limitation, historical sales
information and sales guidance for fiscal year 2008) that was significant to the
formulation of their bid for Omrix is publicly available. Furthermore, to the
limited extent that any such information is not publicly available, such
information is in the possession of Omrix, and J&J and Merger Sub expect and
believe that Omrix would have made it available to any potential bidder that
submitted an indicative offer for Omrix.
In sum,
J&J and Merger Sub do not believe that they had access to any material
information that was unavailable to any other bidder willing to make a
preliminary non-binding indication of interest to acquire Omrix. In this
connection, J&J and Merger Sub note that, as disclosed in the Schedule TO,
the Investor Group presented Omrix with a target cash price range of $21.00 to
$25.00 per Share that was based solely on public information. This price range
is substantially consistent with J&J’s and Merger Sub’s final bid of $25.00
per Share. As disclosed in the Schedule TO, the Investor Group chose not to
submit a bid in the sale process in September and October.
2
In
response to the staff’s second supplemental comment, J&J and Merger Sub
advise the staff that revenues derived from sales of those of Omrix’s products
that are the subject of Omrix’s commercial arrangements with Ethicon comprised
approximately 38% of Omrix’s total revenues for the nine months ended September
30, 2008.
As
indicated in the Response Letter, J&J and Merger Sub do not believe that the
commercial arrangements between Ethicon and Omrix can be fairly concluded to
confer “control” within the meaning of Rule 13e-3(a)(1), including, without
limitation, for the following reasons:
·
the
applicable agreements are arms’-length commercial product development and
supply arrangements having terms with no bearing on the election of
directors of Omrix or the selection or direction of Omrix management, and
imposing no limitation on the ability of Omrix to enter into strategic
combination transactions with other parties;
·
the
contractual right to enforce purely commercial product terms does not and
should not be interpreted to constitute the kind of “control” influence
contemplated by the Rule 13e-3(a)(1) “affiliate” definition (to conclude
otherwise would expand the application of Rule 13e-3 well beyond its
intended scope and purpose);
·
Ethicon
does not derive any “control” influence as contemplated by Rule
13e-3(a)(1) by virtue of its contractual rights to terminate the
commercial arrangements, particularly in light of the fact that any such
termination would require Ethicon to make substantial payments to Omrix
and would require Ethicon to abandon the substantial investments it has
made under the existing arrangements (as well as forego a profitable
business arrangement); and
·
in
the event that any termination did occur, the contracts are drafted to
ensure that Omrix would have an extended period in which to replace
Ethicon (and J&J and Merger Sub believe that Omrix would in fact have
substantial opportunities to find a replacement
counterparty).
_______________
Each of J&J and Merger Sub
acknowledges that the supplemental responses contained herein are subject to the
written acknowledgement
from J&J and Merger Sub attached as Annex A to the Response
Letter.
3
If you have any questions regarding the
contents of this letter, please do not hesitate to contact me at the above
number.
Sincerely,
/s/ Eric L. Schiele,
Esq.
Eric L. Schiele,
Esq.
Ms. Julia
E. Griffith
Special
Counsel
U.S.
Securities and Exchange Commission
Office of
Mergers & Acquisitions
100 F
Street, N.E.
Washington,
D.C. 20549-3628
Copy
to:
Allen
Kim, Esq.
Johnson
& Johnson
One
Johnson & Johnson Plaza
New
Brunswick, NJ 08933
FAX
and FEDERAL EXPRESS
4
2008-12-15 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
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(212)
474-1788
December
15, 2008
Omrix Biopharmaceuticals,
Inc.
Schedule TO-C filed November
24, 2008
Schedule TO-T filed November
25, 2008
Schedule TO-T/A filed
December 1, 2008
Filed by Binder Merger Sub,
Inc. and Johnson & Johnson
SEC File
No. 5-82558
Dear Ms.
Griffith:
As
discussed during our telephone conversation this morning, enclosed please find a
draft copy of the letter to the staff in response to the staff’s comments on the
Schedule TO-C filed by Johnson & Johnson (“J&J”) and Binder
Merger Sub, Inc. (“Merger Sub”) on
November 24, 2008 and the Schedule TO-T filed by J&J and Merger Sub on
November 25, 2008 (as amended, the “Schedule
TO”). We have also included a draft amendment to the Schedule
TO showing changes to the information in the Offer to Purchase in response to
the staff’s comments. To the extent applicable, we will make further
changes to the Schedule TO to conform to changes to be made by Omrix to its
Schedule 14D-9 filing based on the staff’s comments, which further changes are
not yet reflected in the enclosed draft amendment to the Schedule
TO.
Please do not hesitate to contact me at the above
number if you have any
questions.
Sincerely,
/s/ Eric L. Schiele,
Esq.
Eric L. Schiele,
Esq.
Ms. Julia
E. Griffith
Special
Counsel
U.S.
Securities and Exchange Commission
Office of
Mergers & Acquisitions
100 F
Street, N.E.
Washington,
D.C. 20549-3628
VIA
FAX
[Draft--12/15/08]
[Letterhead
of]
CRAVATH,
SWAINE & MOORE LLP
[New York
Office]
(212) 474-1964
December
16, 2008
Omrix
Biopharmaceuticals, Inc.
Schedule
TO-C filed November 24, 2008
Schedule
TO-T filed November 25, 2008
Schedule
TO-T/A filed December 1, 2008
Filed
by Binder Merger Sub, Inc. and Johnson & Johnson
SEC
File No. 5-82558
Dear Ms.
Griffith:
On behalf of Johnson & Johnson
(“J&J”) and
Binder Merger Sub, Inc. (“Merger Sub”), this
letter responds to your letter dated December 12, 2008 (the “Comment Letter”)
providing comments to the Schedule TO-C filed with the Securities and Exchange
Commission (the “Commission”) by
J&J and Merger Sub on November 24, 2008 and the Schedule TO-T filed with the
Commission by J&J and Merger Sub on November 25, 2008 (as amended, the
“Schedule
TO”). For your convenience, each comment from the Comment
Letter has been reproduced below, followed by J&J’s and Merger Sub’s
response to such comment. Capitalized terms defined in the Schedule
TO and used in the following responses without definition have the meanings
specified in the Schedule TO.
Schedule
TO-C
1.
Refer
to the press release filed November 24, 2008, in your Schedule
TO-C. Your press release refers to the safe harbor protections
for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995, which do not apply to statements made in
connection with a tender offer. See Section 21E(b)(2)(C) of the
Securities Exchange Act of 1934. Please do not refer to the
safe harbor provisions in future press releases or other communications
relating to this tender offer.
J&J and Merger Sub acknowledge the
staff’s comment and will refrain from making such references in future press
releases and other communications relating to this tender offer.
Schedule
TO-T
General
2.
At
the commencement of the offer, Johnson & Johnson Development
Corporation (“JJDC”), a subsidiary of Parent, had a $5 million cash
investment in Omrix, and Ethicon, Inc., a wholly owned subsidiary of
Parent, was party to a development agreement to develop certain of Omrix’s
biosurgery products. In view of these relationships, and of the
fact that Johnson & Johnson and Omrix have discussed the possibility
of Parent’s acquiring Seller in the past, please advise us what
consideration you have given to the application of Rule 13e-3 to this
transaction.
J&J and Merger Sub considered the
application of Rule 13e-3 (including the matters set forth in the foregoing
comment) and determined that this transaction is not a Rule 13e-3 transaction
because neither J&J nor Merger Sub (nor any other subsidiary of J&J,
including JJDC and Ethicon) is an “affiliate” of Omrix as defined under Rule
13e-3(a)(1); none of J&J or any of its subsidiaries controls, is controlled
by, or is under common control with, Omrix. J&J and Merger Sub do
not believe that the matters referred to in the foregoing comment (each of which
is addressed separately below) are, individually or collectively, sufficient to
confer “control” within the meaning of Rule 13e-3(a)(1).
JJDC, in connection with its $5 million
cash investment in Omrix in July 2004, acquired 435,257 Shares and warrants to
acquire an additional 36,364 Shares, which together represent only approximately
2.58% of the total number of Shares as of November 20, 2008.1
The Shares and warrants to purchase Shares held by JJDC neither entitle JJDC to
any representation on Omrix’s board of directors nor otherwise provide JJDC with
any ability to influence the management decisions of Omrix, other than JJDC’s
right to vote the Shares held by it in its capacity as the holder of such
Shares. J&J and Merger Sub do not believe that, as a general
matter, the right to vote 2.58% of the Shares of Omrix is sufficient to confer
“control” within the meaning of Rule 13e-3(a)(1). This is
particularly true in light of the fact that the Chief Executive Officer of Omrix
(together with two entities that are controlled by him) beneficially owns
approximately 16% of the total number of Shares, and that at least three
institutional holders also beneficially own more than 5% of the total number of
Shares (based on publicly available information), thus materially diluting any
influence JJDC’s relatively small shareholdings would otherwise
provide.
____________________________
1 As disclosed
on page 1 of the Offer to Purchase, Omrix has advised J&J that, as of
November 20, 2008, 17,130,332 Shares were issued and outstanding,
1,090,909 Shares were reserved for issuance under Omrix’s equity plans,
and 38,903 Shares were reserved for issuance upon the exercise of
outstanding warrants, for a total of 18,260,144
Shares.
2
Ethicon’s
development agreement and distribution and supply agreement with Omrix2,
which were entered into in September 2003 and cover the development and
distribution of certain of Omrix’s products, are commercial arrangements that
were entered into by the parties through arms’-length
negotiations. None of the provisions in the development agreement or
the distribution and supply agreement provide J&J, Ethicon or any other
subsidiary of J&J with power to control or influence the operations of Omrix
beyond the contractual right to enforce the commercial terms relating to the
development and distribution of specified products, and neither agreement grants
or purports to grant Ethicon any rights with respect to the election of
directors of Omrix or the selection or decision-making of Omrix
management. Furthermore, the terms of the agreements do not prohibit
Omrix from entering into strategic transactions with other third parties, and
such agreements permit Omrix to assign such agreements to a company acquiring
all or substantially all of Omrix’s assets or voting stock without Ethicon’s
prior consent.
J&J and Merger Sub do not believe
that, as a general matter, prior preliminary contacts regarding possible
acquisition transactions confer “control” within the meaning of Rule
13e-3(a)(1). In any event, based on further review and as noted in
the response to staff comment 5 below, J&J and Omrix have determined that no
negotiations or material contacts regarding an acquisition of Omrix by J&J
(other than the present transaction) occurred during the two years prior to the
date of the Schedule TO filing.
In addition, the contemplated
second-step merger in the transaction (as described in the Offer to Purchase)
will be undertaken in accordance with Rule 13e-3(g)(1)(i).
In sum, for the foregoing reasons,
J&J and Merger Sub have determined that they are not “affiliates” of Omrix
within the meaning of Rule 13e-3, and therefore that this transaction is not
subject to Rule 13e-3.
3.
We
note that Johnson & Johnson has signed the Schedule TO and is listed
as a filing person. Please revise the cover of the Schedule TO
to clarify that Johnson & Johnson is a bidder and not merely the
parent of Binder Merger Sub.
J&J
and Merger Sub acknowledge the staff’s comment and have revised the cover of
their Schedule TO filing in accordance therewith.
Offer
to Purchase
Certain Information
Concerning Parent and Purchaser, page 12
4.
Please explain whether Ethicon
is contractually obligated to make future payments in respect of research
and development expenses, milestone and transfer
payments. State what impact the tender offer is expected to
have on these payments.
____________________________
2 Copies of the
development agreement and the distribution and supply agreement (and
amendments thereto) have been publicly filed by Omrix as Exhibits 10.4,
10.5, 10.6 and 10.7 to Omrix’s registration statement on Form S-1, filed
January 18, 2006.
3
Under the
development agreement between Ethicon and Omrix, Ethicon is contractually
obligated to pay Omrix all of the development costs and one-half of the labor
costs relating to the research and development of products covered by the
development agreement, as well as certain milestone payments contingent on the
first sales of products covered by the development agreement or the receipt of
certain regulatory or marketing clearances for such products. Under
the distribution and supply agreement between Ethicon and Omrix, Ethicon is
contractually obligated to pay Omrix certain additional milestone payments, as
well as periodic transfer payments for the purchase of products by Ethicon from
Omrix. Under the agreements, Ethicon paid to Omrix approximately
$27.1 million during fiscal year 2007 (including $4.0 million in milestone
payments, $9.9 million in research and development payments and $13.2 million in
transfer payments) and expects to pay approximately $32.7 million during fiscal
year 2008 (including $8.8 million in research and development payments and $23.9
million in transfer payments). Two contractual milestone payments
totaling $2.75 million related to the fibrin pad program and the product revenue
targets remain under one of the agreements. Future research and
development payments and transfer payments would be based on the level of
research and development activity and product supply needs,
respectively. Given the contingent nature of these future payments,
it is not possible to quantify them with certainty, or to determine with
certainty whether and when such payments may ultimately be payable.
Upon the completion of the tender offer
and the subsequent merger, both Ethicon and Omrix will be wholly owned
subsidiaries of J&J, and the development agreement and the distribution and
supply agreement will become intercompany arrangements within the consolidated
J&J organization. J&J will therefore have the ability to
unilaterally determine, after the completion of the tender offer and the
subsequent merger, whether to terminate or amend such agreements or maintain
such agreements in place, based on tax and other considerations relevant to the
J&J organization. While no final determination in this regard has
yet been made, it is currently contemplated that such agreements will remain in
force through the respective terms of the contracts.
J&J and Merger Sub have revised the
disclosure on page 13 of the Offer to Purchase to clarify the information
describe above.
Background of the Offer,
page 14
5.
Describe
in greater detail the nature and timing of the general preliminary
discussions between Seller and Parent regarding the possibility of an
acquisition (see Item 1005(b) and (c) of Regulation M-A), and identify the
person or persons who initiated each discussion (see also the Instruction
to paragraphs (b) and (c) of Item
1005).
Based on further review, J&J and
Merger Sub have determined that, during the two years prior to the date of the
Schedule TO filing, Omrix and J&J did not in fact engage in any negotiations
or material contacts regarding an acquisition of Omrix by J&J or any other
transaction that is required to be disclosed by Item 1005(b) or (c) of
Regulation M-A, other than with respect to the present transaction (all of which
negotiations and material contacts in connection with the present transaction
are currently disclosed in the “Background of the Offer” section of the Offer to
Purchase). J&J and Merger Sub have revised the disclosure on page
14 of the Offer to Purchase in accordance with the information described
above.3
__________________________
3 The amendment
to the Schedule TO may provide additional disclosure regarding any
contacts between J&J and Omrix prior to such two-year period, to the
extent appropriate.
4
6.
Provide
further detail concerning the price that Purchaser offered for the
securities. We note that on August 26, 2008, you proposed a
price of $25.00 per share, which you subsequently raised to $29.00 per
share, and then revised back to $25.00 after the market
break. Please disclose the reasons for the revised offer
price.
Given the competitive bidding process,
J&J raised its proposed price for Omrix to $29.00 per share on September 8,
2008 based on information that was then available to J&J, as well as more
Omrix-favorable assumptions made with respect to information that had not yet
been made available by Omrix, recognizing that (and communicating to Omrix
through its financial advisor that) the increased offer price would be subject
to the validation of J&J’s assumptions in further due diligence, including
with respect to information included in a data room to which J&J had not yet
been provided access. The assumptions made by J&J included those
with respect to Omrix’s capital expansion plans and the period of overcapacity
likely to result from such plans, the manufacturing process and relationships
between Omrix’s product lines in terms of Omrix’s total cost structure, the
level of investment required to upgrade Omrix’s information, infrastructure and
control systems to integrate such systems with J&J’s and the overall risks
relating to the business integration and the immunotherapy product
line. After completing its further due diligence, J&J determined
that those more favorable assumptions underlying its September 8, 2008 proposal
could not be supported, and therefore reduced its proposed price for Omrix to
$25.00 per share on October 22, 2008.
J&J and Merger Sub have revised the
disclosure on pages 16 and 17 of the Offer to Purchase to further clarify the
basis and limitations of i
2008-02-15 - UPLOAD - JOHNSON & JOHNSON
Mail Stop 6010 February 15, 2008 Steven M. Rosenberg, Esq. Secretary and Assistant General Counsel Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Definitive Proxy Statement Filed March 14, 2007 File No. 001-03215 Dear Mr. Rosenberg: We have completed our review of your executive compensation and related disclosure and have no further comments at this time. Please note that the company is responsib le for the adequacy and accuracy of the disclosure in its filing. We are not approving any proposed disclosure you may have included in your response lette r or any disclosure you include in your future filings in response to our comments. If you have any further questions regardi ng our review of your filing, please call me at (202) 551-3635. S i n c e r e l y , T i m B u c h m i l l e r S e n i o r A t t o r n e y
2008-02-14 - CORRESP - JOHNSON & JOHNSON
CORRESP
1
filename1.htm
correspondence.htm
STEVEN
M. ROSENBERG
SECRETARY
ASSISTANT
GENERAL COUNSEL
ONE
JOHNSON & JOHNSON PLAZA
NEW
BRUNSWICK, NJ 08933-0026
(732)
524-2452
FAX: (732)
524-2185
SROSENB@CORUS.JNJ.COM
February
14, 2008
Mr. Tim
Buchmiller
Senior
Attorney
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Mail Stop
6010
100 F
Street, N.E.
Washington,
DC 20549
Re:
Letter
dated November 29, 2007 Regarding Definitive Proxy Statement Filed March
14, 2007 (File No. 001-03215)
Dear
Mr. Buchmiller:
The
following sets forth the responses of Johnson & Johnson (the “Company”) to
the comments on the above referenced proxy statement in your letter of November
29, 2007 to our Chairman and Chief Executive Officer, Mr. William C. Weldon. For
you convenience, we have included your comments with the letter. Our responses
use the same numbering as your letter.
Annual
Performance Bonus. page 18
Comment
1: We note from your response to prior comment 5 that you may
omit specific targets or performance objectives in your future filings if you
believe it is appropriate to do so. If the specific targets or performance
objectives that you may omit in future filings are similar to the targets or
objectives that you omitted in your definitive proxy statement filed on March
14, 2007, please provide us with a detailed explanation supporting your
conclusion that disclosure of those targets or objectives would result in
competitive harm such that the information could be excluded under Instruction 4
to Item 402(b) of Regulation S-K.
Response: The
Company notes the staff’s comment. If the specific targets or performance
objectives for 2007 disclosed in its 2008 Proxy Statement are similar to the
specific targets or objectives that the Company omitted in its March 14, 2007
Proxy Statement and are material, then the Company will disclose those 2007
targets and objectives in its 2008 Proxy Statement.
2006 Bonus and Long-Term
Incentive Awards…, page 22
Comment
2: It is not clear from your response to prior comment 6 that
you will identify the companies in your financial peer group in your future
filings. Please tell us whether you will identify the companies in your
financial peer group in future filings.
Response: The
Company notes the staff’s comment. The Company will identify the companies in
its 2007 financial peer groups in its 2008 Proxy Statement.
If you have any questions or comments,
please call Douglas Chia, Senior Counsel and Assistant Corporate Secretary at
732-524-3292 or me at 732-524-2452.
Very
truly yours,
/s/
Steven M. Rosenberg
Steven
M. Rosenberg
SMR/cms
CORPSECGEN\SECltrFeb08
cc: W. C. Weldon
R. C.
Deyo
D. K.
Chia
2008-01-25 - UPLOAD - JOHNSON & JOHNSON
Mail Stop 6010 August 21, 2007 William C. Weldon Chief Executive Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Definitive Proxy Statement Filed March 14, 2007 File No. 001-03215 Dear Mr. Weldon: We have limited our review of your definitive proxy statement to your executive compensation and other related disclosure a nd have the following comments. Our review of your filing is part of the Division’s focused review of executive compensation disclosure. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filings. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call me at the telephone number listed at the end of this letter. In some comments we have asked you to provide us with additional information so we may better understand your disclosure. Pl ease do so within the time frame set forth below. You should comply with the remain ing comments in all future filings, as applicable. Please confirm in writing that you will do so and also explain to us how you intend to comply. Please unders tand that after ou r review of all of your responses, we may raise additional comments. If you disagree with any of these commen ts, we will consider your explanation as to why our comment is inapplicable or a revisi on is unnecessary. Please be as detailed as necessary in your explanation. Johnson & Johnson August 21, 2007 Page 2 Compensation Discussion and Analysis, page 16 1. The Compensation Discussion and Analysis should be sufficiently precise to capture material differences in compensation policies with respect to individual named executive officers. Refer to S ection II.B.1 of Commi ssion Release No. 33- 8732A. In this regard, we note the signifi cant disparity in the value of the stock and option awards, and the amount awar ded under the non-equity incentive plan compensation, to Mr. Weldon as compared to the similar types of awards to your other named executive officers. Plea se expand your Compensation Discussion and Analysis to include a more deta iled discussion of how and why the compensation of your chief executive officer s has materially differed from that of the other named executive officers. If policies or decisions relating to a named executive officer are materially different from those that apply to the other named executive officers, please discuss those polic ies or decisions on an individualized basis. 2. Please expand your Compensation Discu ssion and Analysis to discuss how specific forms of compensation are struct ured and implemented to reflect your named executive officer's individual perfor mance and to describe the elements of individual performance that are taken in to account in determining compensation. Refer to Item 402(b)(2)(vii) of Regulation S-K. 3. You disclose on page 11 that the Comm ittee has retained a representative of Towers Perrin as its consultant for ma tters related to executive and director compensation. Please provide the full di sclosure required by Item 407(e)(3)(iii) of Regulation S-K including a description of the nature and scope of the consultant's assignment or the material elem ents of the instructions or directions given to the consultant with respect to the performance of its duties under the engagement. 4. We note your references to the J ohnson & Johnson Credo throughout your Compensation Discussion and Analysis. Plea se clarify what the Credo values are and how they specifically factor into your compensation decisions. Annual Performance Bonus, page 18 5. You disclose that you have established specific individual, business unit, and overall corporate goals in connection with the calculation of the amounts to be awarded as annual performance bonuses, a nd that those amounts can be further increased or decreased based upon performa nce measured against preset financial and strategic objectives. Please disclose the specific goals and the weighting and measurement process associated with those goals. See Item 402(b)(2)(v) and Instruction 2 to Item 402(b). To the ex tent you believe that disclosure of the Johnson & Johnson August 21, 2007 Page 3 information would result in competitive harm such that the information could be excluded under Instruction 4 to Item 402( b), please provide us with a detailed explanation supporting your conclusion. To the extent that it is appropriate to omit specific targets or performance obj ectives, you are required to provide appropriate disclosure pursua nt to Instruction 4 to Item 402(b) of Regulation S-K. Refer also to Question 3.04 of the Item 402 of Regulation S-K Interpretations available on our website at www.sec.gov . In discussing how difficult or likely it will be for the registrant to achieve the target levels or other factors, you should provide as much detail as necessary wit hout disclosing information that poses a reasonable risk of competitive harm. 2006 Bonus and Long-Term Incentive Awards…, page 22 6. Please identify the companies in your financial peer group. Use of Tally Sheets, page 26 7. You disclose that the Compensation Committ ee uses “tally sheets” to assist them in making compensation decisions. Please add disclosure addressing the extent to which the information in the tally sheets comprised information in addition to or different from the information presen ted in your Summary Compensation Table and how and why the Compensation Comm ittee found the tally sheets useful in determining the various elements of compensation for the named executive officers. The information contained in the tally sheets and how the Committee’s analysis of such information resulted in specific awards should be described in complete detail. Outstanding Equity Awards At Fiscal Year-End, page 34 8. Please disclose the vesting dates of the op tions and stock awards held at fiscal- year end by footnote to the applicable column. Refer to Instruction 2 to Item 402(f)(2) of Regulation S-K. Non-Qualified Deferred Compensation, page 37 9. As required by the Instruction to Item 402( i)(2) of Regulation S-K, please provide a footnote quantifying the extent to which amounts reported in the contributions and earnings columns are reported as comp ensation in the last completed fiscal year in your Summary Compensation Table. Johnson & Johnson August 21, 2007 Page 4 Director Compensati on Table, page 38 10. Disclose the assumptions made in the valuation of the stock awards by reference to a discussion of those assumptions in your financial statements , footnotes to the financial statements or discussion in Management’s Discussion and Analysis. Refer to the Instruction to Item 402(k) of Regulation S-K. Please respond to our comments by September 21, 2007, or tell us by that time when you will provide us with a response. 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 all in formation required under the Securities Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. When you respond to our comments, please provide, in writing, a statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclosure in the filing; • staff comments or changes to disclo sure in response to comments do not foreclose the Commission from taking a ny action with respect to the filing; and • the company may not assert staff comme nts as a defense in any proceeding initiated by the Commission or any pers on under the federal s ecurities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Di vision of Corporation Finance in connection with our review of your filing or in response to comments. Please contact me at (202) 551-3635 with any questions. Sincerely, Tim Buchmiller Senior Attorney
2007-12-13 - CORRESP - JOHNSON & JOHNSON
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
December 13, 2007
Mr. Tim Buchmiller
Senior Attorney
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 6010
100F Street, N.E.
Washington, DC 20549
Re: SEC Comment Letter Dated November 29, 2007
Regarding Definitive Proxy Statement
(File No. 001-03215)
Dear Mr. Buchmiller:
This is to confirm our conversation last week regarding
our response to the above-captioned letter. In your letter
you requested that we respond to your comments by December
13, 2007 or tell you by that date when we will provide you a
response. As I explained, we received your letter two days
after the Compensation and Benefits Committee of our Board
of Directors last met. That Committee is not scheduled to
meet again until late January, and it may be difficult to
convene a special meeting during the holidays. Since we
feel it is important that we discuss our response to the
SEC's comments with the Committee, we plan to submit our
response by the end of January. We will respond earlier if
we are in a position to do so. Please let me know if that
causes any concern for the SEC.
If you would like to discuss this further, please call
either Doug Chia, our Senior Counsel and Assistant Corporate
Secretary at 732-524-3292,or me at 732-524-2452.
Very truly yours,
/s/ Steven M. Rosenberg
Steven M. Rosenberg
cc: W.C. Weldon
R.C. Deyo
D.K. Chia
</TEXT>
</DOCUMENT>
2007-11-29 - UPLOAD - JOHNSON & JOHNSON
Mail Stop 6010 November 29, 2007 William C. Weldon Chief Executive Officer Johnson & Johnson One Johnson & Johnson Plaza New Brunswick, NJ 08933 Re: Johnson & Johnson Response Letter dated September 21, 2007 Regarding Definitive Proxy Statement File No. 001-03215 Dear Mr. Weldon: We have reviewed your response letter dated September 21, 2007 and have the following comments. Please respond to our comments by December 13, 2007 or tell us by that time when you will provide us with a response. If the comments request revised disclosure in future filings, please confir m in writing that you will comply with the comments in your future filings and also ex plain to us how you intend to comply. We welcome any questions you may have about our comments or any other aspect of our review. Annual Performance Bonus, page 18 1. We note from your response to prior comment 5 that you may omit specific targets or performance objectives in your future filings if you believe it is appropriate to do so. If the specific targets or performance objectives that you may omit in future filings are similar to the targets or objectives that you omitted in your definitive proxy statement filed on March 14, 2007, please provide us with a detailed explanation supporting your conclusion that disclosure of those targets or objectives would result in co mpetitive harm such that the information could be excluded under Instruction 4 to Item 402(b) of Regulation S-K. 2006 Bonus and Long-Term Incentive Awards…, page 22 2. It is not clear from your response to pr ior comment 6 that you will identify the companies in your financial peer group in your future filings. Please tell us whether you will identify the companies in your financial peer group in future filings. Johnson & Johnson November 29, 2007 Page 2 Please contact me at (202) 551-3635 with any questions. Sincerely, Tim Buchmiller Senior Attorney cc: Steven M. Rosenberg, Esq. (via fax)
2007-09-21 - CORRESP - JOHNSON & JOHNSON
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
September 21, 2007
Mr. Tim Buchmiller
Senior Attorney
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 6010
100 F Street, N.E.
Washington, DC 20549
Re: Johnson & Johnson Definitive Proxy Statement
Filed March 14, 2007 (File No. 001-03215)
Dear Mr. Buchmiller:
The following sets forth the responses of Johnson &
Johnson (the "Company") to the comments on the above
referenced proxy statement included in your letter of
August 21, 2007 to our Chairman and Chief Executive
Officer, Mr. William C. Weldon. For your convenience,
we have included your comments with this letter. Our
responses use the same numbering as your letter.
Compensation Discussion and Analysis, page 16
Comment 1: The Compensation Discussion and Analysis
should be sufficiently precise to capture material
differences in compensation policies with respect to
individual named executive officers. Refer to Section
II.B.1 of Commission Release No. 33-8732A. In this
regard, we note the significant disparity in the value
of the stock and option awards, and the amount awarded
under the non-equity incentive plan compensation, to
Mr. Weldon as compared to the similar types of awards
to your other named executive officers. Please expand
your Compensation Discussion and Analysis to include a
more detailed discussion of how and why the
compensation of your chief executive officers has
materially differed from that of the other named
executive officers. If policies or decisions relating
to a named executive officer are materially different
from those that apply to the other named executive
officers, please discuss those policies or decisions on
an individualized basis.
Response: The Company notes the Staff's comment. The
requested type of disclosure appears on page 21 of the
Company's Definitive Proxy Statement dated March 14,
2007 (the "2007 Proxy Statement") under the heading
"Executive Compensation Awarded in 2006 and 2007-
Performance Assessment Process." As requested, the
Company intends to expand the Compensation Discussion
and Analysis (the "CD&A") section in its proxy
statement for the 2008 Annual Meeting of Shareholders
(the "2008 Proxy Statement") to include a more detailed
discussion of how and why the compensation of the
Chairman/CEO has materially differed from that of the
other named executive officers (the "NEOs").
Comment 2: Please expand your Compensation Discussion
and Analysis to discuss how specific forms of
compensation are structured and implemented to reflect
your named executive officer's individual performance
and to describe the elements of individual performance
that are taken into account in determining
compensation. Refer to Item 402(b)(2)(vii) of
Regulation S-K.
Response: The Company notes the Staff's comment. The
requested type of disclosure appears throughout the
CD&A section of the 2007 Proxy Statement. For example,
see the description of the "business bonus multiplier"
under the heading "Annual Performance Bonus" on page
18. As requested, the Company intends to expand the
CD&A in the 2008 Proxy Statement to clarify how
specific forms of compensation are structured and
implemented to reflect each NEO's individual
performance and to describe the material elements of
individual performance that are taken into account in
determining compensation.
Comment 3: You disclose on page 11 that the Committee
has retained a representative of Towers Perrin as its
consultant for matters related to executive and
director compensation. Please provide the full
disclosure required by Item 407(e)(3)(iii) of
Regulation S-K including a description of the nature
and scope of the consultant's assignment or the
material elements of the instructions or directions
given to the consultant with respect to the performance
of its duties under the engagement.
Response: The Company notes the Staff's comment. The
requested type of disclosure appears in the "Corporate
Governance" section on page 12 and under the heading
"Target Pay Philosophy" on page 17 of the 2007 Proxy
Statement. As requested, the Company intends to expand
the CD&A in the 2008 Proxy Statement to include further
description of the nature and scope of the executive
compensation consultant's engagement.
Comment 4: We note your references to the Johnson &
Johnson Credo throughout your Compensation Discussion
and Analysis. Please clarify what the Credo values are
and how they specifically factor into your compensation
decisions.
Response: The Company notes the Staff's comment and
intends to expand the CD&A in the 2008 Proxy Statement
as requested to clarify what the Credo values are and
how they factor into compensation decisions, which are
described under the heading "Importance of Credo
Values" on page 16 of the 2007 Proxy Statement.
Annual Performance Bonus, page 18
Comment 5: You disclose that you have established
specific individual, business unit, and overall
corporate goals in connection with the calculation of
the amounts to be awarded as annual performance
bonuses, and that those amounts can be further
increased or decreased based upon performance measured
against preset financial and strategic objectives.
Please disclose the specific goals and the weighting
and measurement process associated with those goals.
See Item 402(b)(2)(v) and Instruction 2 to Item 402(b).
To the extent you believe that disclosure of the
information would result in competitive harm such that
the information could be excluded under Instruction 4
to Item 402(b), please provide us with a detailed
explanation supporting your conclusion. To the extent
that it is appropriate to omit specific targets or
performance objectives, you are required to provide
appropriate disclosure pursuant to Instruction 4 to
Item 402(b) of Regulation S-K. Refer also to Question
3.04 of the Item 402 of Regulation S-K Interpretations
available on our website at www.sec.gov. In discussing
how difficult or likely it will be for the registrant
to achieve the target levels or other factors, you
should provide as much detail as necessary without
disclosing information that poses a reasonable risk of
competitive harm.
Response: The Company notes the Staff's comment and
intends to expand the CD&A in the 2008 Proxy Statement
as requested to describe, in all material respects and
to the extent applicable, the goals and the weighting
and measurement process associated with those goals.
To the extent that the Company believes it is
appropriate to omit specific targets or performance
objectives, the Company will provide appropriate
disclosure pursuant to Instruction 4 to Item 402(b) of
Regulation S-K. As certain goals and measurements that
factor into compensation decisions are subjective and
within the discretion of the Compensation & Benefits
Committee and/or management (i.e., not formulaic), the
Company will also describe such goals and measurements
in all material respects.
2006 Bonus and Long-Term Incentive Awards..., page 22
Comment 6: Please identify the companies in your
financial peer group.
Response: The Company notes the Staff's comment. As
described on page 17 of the 2007 Proxy Statement, the
compensation of the Company's NEOs is benchmarked
against the compensation of executives with comparable
responsibilities at 12 companies, which comprise the
Company's Executive Peer Group. These 12 companies are
listed on page 17 of the 2007 Proxy Statement. As
described on pages 18-19 and 25 of the 2007 Proxy
Statement, the Company's performance against a
financial peer group is one of a number of factors
taken into consideration to determine the bonus for the
CEO and the "business bonus multiplier," for the other
NEOs. As discussed on page 17 under the heading
"Components of Executive Compensation," the annual
performance bonus is one of three major components of
the Company's executive compensation program. In
response to the Staff's comment, the Company intends to
expand the CD&A in the 2008 Proxy Statement to include
further description of the makeup of the financial peer
group and how the financial peer group is used as part
of the performance assessment of the NEOs.
Use of Tally Sheets, page 26
Comment 7: You disclose that the Compensation
Committee uses "tally sheets" to assist them in
making compensation decisions. Please add disclosure
addressing the extent to which the information
in the tally sheets comprised information in
addition to or different from the information presented
in your Summary Compensation Table and how and why the
Compensation Committee found the tally sheets useful
in determining the various elements of compensation
for the named executive officers. The information
contained in the tally sheets and how the
Committee's analysis of such information resulted in
specific awards should be described in complete
detail.
Response: The Company notes the Staff's comment and
respectfully submits that all material information
contained in the tally sheets referred to on page 26 of
the 2007 Proxy Statement have been disclosed in the
2007 Proxy Statement and that further details of the
tally sheets are not required to be disclosed.
Furthermore, tally sheets are provided to the
Compensation & Benefits Committee for its members to
see what each executive might receive upon a
hypothetical termination of employment with the Company
and are not used to determine the various elements of
compensation or the actual amounts of compensation to
be approved. Should the Committee continue to use
tally sheets, the Company intends to add disclosure to
the 2008 Proxy Statement to clarify these points.
Outstanding Equity Awards At Fiscal Year-End, page 34
Comment 8: Please disclose the vesting dates of the
options and stock awards held at fiscal-year end by
footnote to the applicable column. Refer to
Instruction 2 to Item 402(f)(2) of Regulation S-K.
Response: The Company notes the Staff's comment and,
as requested, intends to expand the Outstanding Equity
Awards at Fiscal Year-End Table in the 2008 Proxy
Statement to disclose the vesting dates of the options
and stock awards held at fiscal-year end.
Non-Qualified Deferred Compensation, page 37
Comment 9: As required by the Instruction to Item
402(i)(2) of Regulation S-K, please provide a footnote
quantifying the extent to which amounts reported in the
contributions and earnings columns are reported as
compensation in the last completed fiscal year in your
Summary Compensation Table.
Response: The Company notes the Staff's comment and,
as requested, intends to add disclosure in the 2008
Proxy Statement to quantify the extent to which amounts
reported in Columns B, C and D in the Non-Qualified
Deferred Compensation Table are reported as
compensation in the last completed fiscal year in the
Summary Compensation Table.
Director Compensation Table, page 38
Comment 10: Disclose the assumptions made in the
valuation of the stock awards by reference to a
discussion of those assumptions in your financial
statements, footnotes to the financial statements or
discussion in Management's Discussion and Analysis.
Refer to the Instruction to Item 402(k) of Regulation S-
K.
Response: The Company notes the Staff's comment and
respectfully submits that no assumptions are made in
the valuation of restricted stock awards to the
Company's NonEmployee Directors. In the past, Non-
Employee Directors received stock options and the
Company was required to make certain assumptions
regarding the present value of stock options in order
to determine the numbers of options to be awarded. The
Company's Non-Employee Directors now receive a
combination of cash and restricted stock. As described
in the second paragraph under the heading "Director
Fees and Equity Compensation" on page 29 of the 2007
Proxy Statement, those Directors are granted the number
of shares of restricted stock required to achieve a
predetermined dollar amount (currently $100,000) based
on the market price for the Company's stock on a
particular date.
The Company acknowledges that (a) it is
responsible for the adequacy and accuracy of the
disclosures in the above-referenced filing; (b) SEC
Staff comments or changes to disclosure in response to
comments do not foreclose the Commission from taking
any action with respect to the filing; and (c) it may
not assert SEC Staff comments 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 or comments, please call
me at (732) 524-2452 or Douglas K. Chia, Senior Counsel &
Assistant Corporate Secretary at (732) 524-3292.
Sincerely,
/S/ STEVEN M. ROSENBERG
Steven M. Rosenberg
cc: W. C. Weldon
R. C. Deyo
</TEXT>
</DOCUMENT>
2006-08-03 - UPLOAD - JOHNSON & JOHNSON
Via Facsimile and U.S. Mail
Mail Stop 6010
August 3, 2006
Mr. William C. Weldon
Chairman, Board of Directors and Chief Executive Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
Re: Johnson & Johnson
Form 10-K for Fiscal Year Ended January 1, 2006
File No. 1-03215
Dear Mr. Weldon:
We have completed our review of your Form 10-K and have no further comments
at this time.
S i n c e r e l y ,
Kevin Woody
B r a n c h C h i e f
2006-08-02 - CORRESP - JOHNSON & JOHNSON
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
August 2, 2006
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re: Johnson & Johnson
Form 10-K for Fiscal Year Ended January 1, 2006
File No. 1-03215
Dear Mr. Rosenberg:
On July 25, 2006, in a phone conference with Mr. Mark
Brunhofer, we discussed four follow-up requests to our
response to your letter of May 31, 2006. The items were as
follows:
1. Relocate Schedule II - Valuation and Qualifying Accounts
currently included in the Form 10-K to Management's
Discussion and Analysis of Results of Operations and
Financial Condition in the Annual Report.
2. Disaggregate the accrued rebates, returns and promotions
line within Schedule II to three distinct line items.
3. Enhance the disclosure of sales returns allowances within
Management's Discussion and Analysis of Results of
Operations and Financial Condition.
4. Include an assertion regarding the impact that reasonably
likely changes to our assumptions could have on our
financial statements.
Our response to these items is as follows:
1. We will include Schedule II type disclosure- Valuation
and Qualifying Accounts within Management's Discussion and
Analysis of Results of Operations and Financial condition
beginning with the fiscal year ended December 31, 2006 and
for all subsequent year end filings. This schedule will be
included by segment for the current year and the prior year.
A summary schedule for our three segments of business in the
aggregate for the current year and 2 prior years will
continue to be included as Schedule II in our Form 10-K.
2. We will disaggregate the accrued rebates, returns and
promotions line into three distinct line items in both the
segment disclosure within Management's Discussion and
Analysis of Results of Operations and Financial Condition
and the summary schedule appearing as Schedule II within the
Form 10-K. We will include this beginning with the fiscal
year ended December 31, 2006 and for all subsequent year end
filings.
3. Beginning in our Form 10-K for the fiscal year ended
December 31, 2006, the disclosure of sales returns
allowances will be enhanced to include the following
language:
Sales Returns Allowances represent a reserve for products
that may be returned due to expiration, destruction in the
field, or in specific areas, product recall. The returns
reserve is based on historical return trends by product and
by market as a percent to gross sales. We will also include
the balance of the reserve for sales returns by segment for
the current year and prior year end.
4. Beginning in our Form 10-K for the fiscal year ended
December 31, 2006, we will include an assertion regarding
the impact that reasonably likely changes to our assumptions
could have on our financial statements.
If you have any questions or comments, please call me at
(732) 524-3737 or Phil Savas, Assistant Corporate
Controller, Financial Reporting and Analysis at (732) 524-
3566.
Sincerely,
Stephen J. Cosgrove
cc: W. C. Weldon
R. J. Darretta
S. M. Rosenberg
P. A. Savas
</TEXT>
</DOCUMENT>
2006-06-13 - CORRESP - JOHNSON & JOHNSON
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
June 13, 2006
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re: Johnson & Johnson
Form 10-K for Fiscal Year Ended January 1, 2006
File No. 1-03215
Dear Mr. Rosenberg:
We have reviewed the comments included in your letter of May
31, 2006 to our Chairman and Chief Executive Officer, Mr.
William C. Weldon, and have prepared the following
responses. For your convenience, we have included your
comments with this letter. Our responses use the same
numbering as your letter.
Comment 1: We believe that your disclosure related to
estimates that reduce gross pharmaceutical revenue such as
rebates, sales incentives, trade promotions, coupons,
product returns, chargebacks, and other discounts and
allowances could be improved. Please provide us with the
following information in a disclosure-type format:
Comment a.: The nature and amount of each accrual at the
balance sheet date.
Response: Johnson & Johnson is a comprehensive and broadly
based manufacturer of health care products. Accordingly,
the Company has disclosed all gross to net revenue
adjustments for the total Company, including the
Pharmaceutical, Medical Devices and Diagnostics and Consumer
segments. This disclosure can be found in Schedule II -
Valuation and Qualifying Accounts in the Company's Form 10-K
for the fiscal year ended January 1, 2006 (the "2005 Form 10-
K"). All meaningful adjustments related to reserve balances
are disclosed in Schedule II.
Although the Staff did not request our Schedule II
disclosure by segment, we believe a segment disclosure is an
enhancement and have provided this information in Appendix I
to this letter. The Company believes that this is more
relevant than providing the components of accrued rebates,
returns and promotions, as meaningful adjustments are
already disclosed in Schedule II. The $0.3 billion decrease
in accrued rebates, returns and promotions between fiscal
2004 and fiscal 2005 included in Schedule II was due to:
Reserve reductions resulting from lower sales and program
changes for various Pharmaceutical products $(0.2) billion
Reserve increases resulting from increased sales and program
changes for various Consumer and Medical Devices & Diagnostics
products 0.1 billion
Disclosed adjustment to previously estimated performance-
based rebate allowances in managed care contracts (0.2) billion
Total decrease in rebates/managed care allowances $(0.3) billion
Sales returns and promotions allowances remained flat at
approximately $1.0 billion at the end of fiscal 2004 and 2005.
Schedule II detailed by segment will be provided in future
filings beginning in the Company's Form 10-K for the fiscal
year ending December 31, 2006 (the "2006 Form 10-K").
Comment b: The factors that you consider in estimating each
accrual. Discuss all material assumptions such as, but not
limited to, historical product returns, levels of inventory
in the distribution channel, estimated remaining shelf life,
price changes from competitors and introductions of generics
and/or new products.
Response: As disclosed on page 36 in Management's
Discussion and Analysis of Results of Operations and
Financial Condition in Exhibit 13 of the Company's 2005 Form
10-K-:
Rebates
Rebates, the largest being the Medicaid rebate provision,
are estimated based on sales terms, historical experience,
trend analysis and projected market conditions in the
various markets served. The Company evaluates market
conditions for products or groups of products primarily
through the analysis of wholesaler and other third party
sell-through and market research data, as well as internally
generated information.
Returns
Sales returns are generally estimated and recorded based on
historical sales and returns information. Products that
exhibit unusual sales or return patterns due to dating,
competition or other marketing matters are specifically
investigated and analyzed as part of the accounting for
sales returns accruals.
The Company will expand its Critical Accounting Policies in
its 2006 Form 10-K to include the following:
Anticipated levels of returns associated with products are
calculated using historical experiences with similar
products, past product introductions, levels of inventory in
the distribution channel, and market sales projections.
These factors vary by product and by market. The Company
monitors the level of inventory in the distribution channel
principally on information received from the major
wholesalers under contractual arrangements.
Promotional programs, such as product listing allowances and
cooperative advertising arrangements, are recorded in the
year incurred. Continuing promotional programs include
coupons and volume-based sales incentive programs. The
redemption cost of consumer coupons is based on historical
redemption experience by product and value. Volume-based
incentive programs are based on the estimated sales volumes
for the incentive period and are recorded as products are sold.
Comment c: To the extent that information you consider in b
is quantifiable, provide both quantitative and qualitative
information and discuss to what extent information is from
external sources; such as end-customer prescription demand,
third-party market research data, wholesaler inventory
levels, etc. For example, in discussing your estimate of
potential product returns please explain, preferably by
major product and in tabular format, the total amount of
products in sales dollars that could potentially be returned
as of the balance sheet date.
Response: Sales Returns Allowances represent a reserve for
products that may be returned due to expiration, destruction
in the field, or in specific areas, product recall. The
returns reserve is based on historical return trends by
product and by market as a percent to gross sales. The
reserve for sales returns for the Pharmaceutical segment was
$287 million at January 1, 2006 and $265 million at January
2, 2005. The reserve for sales returns for the Medical
Devices and Diagnostics segment was $170 million at January
1, 2006 and $134 million at January 2, 2005. The reserve
for sales returns for the Consumer segment was $78 million
at January 1, 2006 and $58 million at January 2, 2005. A
similar process is used among all three segments to
calculate the required reserve levels. Any reserve
adjustments resulting from meaningful product recalls would
be disclosed in the Company's Management's Discussion and
Analysis of Results of Operations and Financial Condition in
the Company's future Form 10-Q and/or 10-K filings.
Rebates, the largest being the Medicaid rebate provision,
are estimated based on sales terms, historical experience,
trend analysis and projected market conditions in the
various markets served. The Company evaluates market
conditions for products or groups of products primarily
through the analysis of wholesaler and other third party
sell-through and market research data, as well as internally
generated information.
Sales returns are generally estimated and recorded based on
historical sales and returns information. Products that
exhibit unusual sales or return patterns due to dating,
competition or other marketing matters are specifically
investigated and analyzed as part of the accounting for
sales returns accruals. Anticipated levels of returns
associated with products are calculated using historical
experiences with similar products, past product
introductions, levels of inventory in the distribution
channel, and market sales projections. These factors vary
by product and by market. The Company monitors the level of
inventory in the distribution channel principally on
information received from the major wholesalers under
contractual arrangements.
Promotional programs, such as product listing allowances and
cooperative advertising arrangements, are recorded in the
year incurred. Continuing promotional programs include
coupons and volume-based sales incentive programs. The
redemption cost of consumer coupons is based on historical
redemption experience by product and value. Volume-based
incentive programs are based on the estimated sales volumes
for the incentive period and are recorded as products are sold.
Comment d: The effect that reasonably likely changes to
your assumptions could have on your financial statements.
In this regard, please quantify the reasonably likely change
in your assumptions and the dollar impact it would have on
your recognized reserves.
Response: The Company currently discloses the impact of
changes to assumptions in the quarter in which there is a
financial statement impact. As disclosed on page 30 in
Management's Discussion and Analysis of Results of
Operations and Financial Condition in Exhibit 13 of the
Company's 2005 Form 10-K, Pharmaceutical segment sales in
fiscal 2005 and 2004 included a benefit from adjustments
related to previously estimated performance-based rebate
allowances and managed care contracts. These adjustments
were less than 1.0% of sales in both years. Please note
that the impact on total Company sales was less than 0.4% of
sales in both years. Additionally, Schedule II - Valuation
and Qualifying Accounts included in the 2005 Form 10-K notes
that these adjustments were $186 million in fiscal 2005 and
$170 million in fiscal 2004.
The Company has not recorded any meaningful adjustments to
the reserves for returns or promotions due to a change in
assumptions.
In the unlikely event that there is a 1.0% change in
assumptions, across all segments of the Company's business
and all in the same direction, there would be an
approximately $55 million before tax impact on the reserve
for rebates, returns and promotions.
Comment e: A roll forward of the accrual for each estimate
for each period presented showing the following:
Beginning balance,
Current provision related to sales made in the current
period,
Current provision related to sales made in prior
periods,
Actual returns or credits in current period related to
sales made in current period,
Actual returns or credits in current period related to
sales made in prior periods, and
Ending balance.
Response: The accrual roll forward requested has been
disclosed in Schedule II - Valuation and Qualifying Accounts
in the Company's 2005 Form 10-K, which is also provided in
Appendix I to this letter. Please note that footnotes 2 and
3 include the impact of a change in prior year estimates on
current year accruals.
Comment f: If applicable, any shipments made as a result of
incentives and/or in excess of your customer's ordinary
course of business inventory level. Discuss your revenue
recognition policy for such shipments.
Response: The Company does not have a practice of providing
incentives to wholesalers to hold inventory in excess of the
wholesalers ordinary course of business inventory level. In
fact, the Company instructs its businesses not to engage in
this practice. Additionally, there is a financial
disincentive for wholesalers to elect to hold excess
inventory. The Company believes that in the United States,
the Company's trade inventory levels are among the lowest in
the industry.
Comment g: Regarding your discussion of results of
operations for the period to period variations in revenue,
include the amount of and reason for fluctuations for each
type of reduction of gross revenue, including the effect
that changes in your estimates of these items had on your
revenues and operations.
Response: As disclosed on page 30 in Management's
Discussion and Analysis of Results of Operations and
Financial Condition in Exhibit 13 of the Company's 2005 Form
10-K, Pharmaceutical segment sales in fiscal 2005 and 2004
included a benefit from adjustments related to previously
estimated performance-based rebate allowances and managed care
contracts. These adjustments were less than 1.0% of sales
in both years. Please note that the impact on total Company
sales was less than 0.4% of sales in both years.
Additionally, Schedule II - Valuation and Qualifying
Accounts included in the 2005 Form 10-K notes that these
adjustments were $186 million in fiscal 2005 and $170
million in fiscal 2004. There were no significant
adjustments experienced by the Consumer and Medical Devices
and Diagnostics segments.
The Company believes that the period to period variation in
revenue, resulting from fluctuations for each type of
reduction of gross revenue was not significant.
If you have any questions or comments, please call me at
(732) 524-3737 or Phil Savas, Assistant Corporate
Controller, Financial Reporting and Analysis at (732) 524-
3566.
Sincerely,
Stephen J. Cosgrove
Vice President,
Corporate Controller
Att: Appendix I
CC: W. C. Weldon
R. J. Darretta
P. A. Savas
M. H. Ullmann
Appendix I - Page 1 of 4
JOHNSON & JOHNSON AND SUBSIDIARIES
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
Fiscal Years Ended January 1, 2006, January 2, 2005 and December 28, 2003
(Dollars in Millions)
Balance
at Balance at
Beginning Payments/ End
of Period Accruals Other of Period
2005
Accrued rebates, returns
and promotions (1) $ 2,785 7,798 (2) (8,095) 2,488
Reserve for doubtful
accounts 206 19 (61) 164
Reserve for cash
discounts 62 861 (866) 57
$ 3,053 8,678 (9,022) 2,709
2004
Accrued rebates, returns
and promotions (1) $ 2,622 7,514 (3) (7,351) 2,785
Reserve for doubtful
accounts 192 29 (15) 206
Reserve for cash
discounts 55 736 (729) 62
$ 2,869 8,279 (8,095) 3,053
2003
Accrued rebates returns
and promotions (1) $ 2,035 5,850 (5,263) 2,622
Reserve for doubtful
accounts 191 28 (27) 192
Reserve for cash
discounts 62 597 (604) 55
$ 2,288 6,475 (5,894) 2,869
(1) Includes reserve for customer rebates of $471 million, $488 million
and $314 million at January 1, 2006, January 2, 2005 and December 28,
2003, respectively.
(2) Includes $186 million related to previously estimated performance-
based rebate allowances in managed care contracts.
(3) Includes $170 million related to previously estimated performance-
based rebate allowances in managed care contracts.
Appendix I - Page 2 of 4
JOHNSON & JOHNSON AND SUBSIDIARIES - CONSUMER SEGMENT
SCHEDULE II - VALUATIO
2006-05-31 - UPLOAD - JOHNSON & JOHNSON
Via Facsimile and U.S. Mail
Mail Stop 6010
May 31, 2006
Mr. William C. Weldon
Chairman, Board of Directors and Chief Executive Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
Re: Johnson & Johnson
Form 10-K for Fiscal Year Ended January 1, 2006
File No. 1-03215
Dear Mr. Weldon:
We have limited our review of your filing to the issue we have addressed in our
comment. In our comment, we ask you to provi de us with more information so we may
better understand your disclosure. After re viewing this information, we may raise
additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filings. We look forward to working with you in these respects. We
welcome any questions you may have about our comment or any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-K for the year ended January 1, 2006
Exhibit 13: Annual Report
Management’s Discussion and Analysis of Re sults of Operations and Financial Condition
Critical Accounting Policies and Estimates, page 36
1. We believe that your disclosure rela ted to estimates that reduce gross
pharmaceutical revenue such as rebates, sales incentives, trade promotions,
coupons, product returns, chargebacks, and other discounts and allowances could
be improved. Please provide us the following information in a disclosure-type
format:
a. The nature and amount of each accr ual at the bala nce sheet date.
Mr. W illiam C. W eldon
Johnson & Johnson
May 31, 2006
Page 2
b. The factors that you consider in estimating each accrual. Discuss all material
assumptions such as, but not limited to, historical product returns, levels of
inventory in the distribut ion channel, estimated re maining shelf life, price
changes from competitors and introductions of generics and/or new products.
c. To the extent that information you consid er in b. is quantifiable, provide both
quantitative and qualitative informa tion and discuss to what extent
information is from external sources; such as end-customer prescription
demand, third-party market research data , wholesaler invent ory levels, etc.
For example, in discussing your estim ate of potential product returns please
explain, preferably by major product and in tabular format, the total amount of
product in sales dollars that could potent ially be returned as of the balance
sheet date.
d. The effect that reasonably likely cha nges to your assumptions could have on
your financial statements. In this regard, please quantify th e reasonably likely
change in your assumptions and the dollar impact it would have on your recognized reserves.
e. A roll forward of the accrual for each estimate for each period presented showing the following:
• Beginning balance,
• Current provision related to sales made in current period,
• Current provision related to sales made in prior periods,
• Actual returns or credits in current period related to sales made in current
period,
• Actual returns or credits in current period related to sales made in prior periods, and
• Ending balance.
f. If applicable, any shipments made as a re sult of incentives and/or in excess of
your customer’s ordinary course of business inventory level. Discuss your
revenue recognition policy for such shipments.
g. Regarding your discussion of results of operations for the period to period
variations in revenue, in clude the amount of and reason for fluctuations for
each type of reduction of gross revenue, including the effect that changes in your estimates of these items had on your revenues and operations.
Please respond to this comment within 10 business days or tell us when you will
provide us with a response. Please furnis h a letter that provides the requested
information. Detailed letters greatly facilitate our review. Please file your letter on
EDGAR under the form type label CORRESP.
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 all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
Mr. W illiam C. W eldon
Johnson & Johnson
May 31, 2006
Page 3
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our comment, please provide , in your letter, a
statement from the company acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions, please contact Mark Brunhofer, Staff Accountant, at
(202) 551-3638 or Donald Abbott, Senior Staff Accountant, at (202) 551-3608. In this
regard, do not hesitate to contact me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant