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BAXBaxter International

Health care · Medical Instruments · NYSE
Employees
37,500
Headquarters
Deerfield, IL
CEO
Andrew P. Hider
Next results
around Feb 11, 2027
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When the SEC's staff reviews a filing, it writes to the company with numbered questions, and the company answers each one in a letter. SEC publishes the exchange once the review is over, at least 20 business days later. Below: what the staff asked BAX, and the company's answer to each question, quoted from the letters. A question is not an accusation; most reviews end with the company adding detail to its next filing.

Form S-4

2022-05-04 to 2022-05-09 · 1 question · 1 letter from the SEC, 3 from the company
No closing letter
SEC asked
We note that you are registering the exchange notes in reliance on our position enunciated in Exxon Capital Holdings Corp., SEC No-Action Letter (April 13, 1988). See also Morgan Stanley & Co. Inc., SEC No-Action Letter (June 5, 1991) and Shearman & Sterling, SEC No-Action Letter (July 2, 1993). However, the prospectus does not contain all of the representations required by the no-action letters.
Rest of the question

Specifically, the Company must represent that it has not entered into any arrangement or understanding with any person who will receive exchange securities in the exchange offer to distribute those securities following completion of the offering, and that it is not aware of any person that will participate in the exchange offer with a view to distribute the exchange securities. Please revise your prospectus to include these representations on behalf of the Company. Alternatively, you may provide us with a supplemental letter that includes these representations.

BAX answered
In response to the Staff’s comment, the Company hereby makes the following representations to the Commission:

1. The Company has not entered into any arrangement or understanding with any person who will receive exchange securities in the exchange offer to distribute those following completion of the offering and, to the best of the Company’s information and belief, each person participating in the exchange offer is acquiring the exchange securities in its ordinary course of business and has no arrangement or understanding with any person to participate in the distribution of the exchange
Rest of the answer

securities to be received in the exchange offer. In this regard, the Company will make each person participating in the exchange offer aware (through the exchange offer prospectus or otherwise) that any securityholder using the exchange offer to participate in a distribution of the exchange securities to be acquired in the exchange offer

(1) cannot rely on the Staff’s position in the Exxon Capital Holdings Corporation, SEC No-Action Letter (available May 13, 1988), Morgan Stanley & Co.

Incorporated, SEC No-Action Letter (available June 5, 1991) and Shearman & Sterling, SEC No-Action Letter (available July 2,

1993) or similar letters and (2) must comply with registration and prospectus delivery requirements of the Securities Act of 1933, as amended (the “Securities Act”) in connection with a secondary resale transaction.

The Company acknowledges that such a secondary resale transaction should be covered by an effective registration statement containing the selling securityholder information required by Item 507 of Regulation

S-K under the Securities Act.

Read in the reply ↗

Also in this review: company letter, 2022-05-09, company letter, 2022-05-09

Form 10-K for the Fiscal Year Ended December 31, 2016

2017-03-31 to 2017-05-10 · 2 questions · 1 letter from the SEC, 1 from the company
Review closed 2017-05-10
Russia and UkraineRevenue
General
SEC asked (1)
You stated in your letter to us dated November 25, 2014 that you sold products to Sudan and Syria, countries which 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 describe your business with those countries.
Rest of the question

Please describe to us the nature and extent of your past, current and anticipated contacts with Sudan and Syria since the referenced letter, whether through subsidiaries, distributors, sales agents or other direct or indirect arrangements. You should describe any goods, technology or services you have provided into Sudan and Syria, directly or indirectly, and any agreements, arrangements or other contacts you have had with the governments of those countries or entities they control.

BAX answered
The Company, through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with kidney disease, trauma and other chronic and acute medical conditions. A description of the Company’s business dealings with Sudan and Syria is provided below.

In addition, the Company donates lifesaving and sustaining medical products through its humanitarian aid partners, and such products have been sent through these partners to both Sudan and Syria.
Rest of the answer

The Company donated product valued at approximately $135,000 for distribution in Syria and Sudan between 2014 and 2016.

Cecilia Blye

Page

Sudan

The Company sells a range of life saving and sustaining medical products to Sudan, including anesthetics, dialysis equipment and solutions, IV sets and accessories, and nutritional products. Such sales are made primarily by two foreign subsidiaries, Baxter A.G., a Swiss entity, operating through its Dubai office, and Gambro A.B., a Swedish entity, to or through distributors who sell the products to

Central Medical Supplies (“CMS”), the Sudanese government-owned provider of medical products in Sudan. Total sales by the Company for distribution in Sudan in 2014, 2015 and 2016 were approximately $8.8 million,

$6.6 million and $6.0 million, respectively, and for the three-month period ended March 31, 2017 were approximately $300,000. The Company also engages in support activities related to its indirect sales in Sudan, including order processing, promotional and marketing assistance and education, carried out by employees of Baxter A.G. and Gambro A.B.

The Company believes that the sales and support activities described above were carried out in accordance with applicable laws and regulations, including the terms and conditions of individual export licenses obtained by the Company from the Office of Foreign Assets Control.

Syria

The Company sells a limited portfolio of life saving and sustaining medical products to Syria, primarily oncology medicine and dialysis equipment and solutions. These sales are made by two subsidiaries, Baxter A.G. and Gambro A.B., to distributors who sell the products to end-users in Syria. The Company also sells product to the World Health Organization for use in relief efforts in Syria.

Total sales by the Company to Syria in 2014, 2015 and 2016 were approximately $870,000, $240,000 and $350,000, respectively, and for the three-month period ended March 31, 2017 were approximately $35,000. The Company also engages in support activities related to its sales in Syria, including order processing, promotional and marketing assistance, and education carried out by employees of Baxter

A.G. and Gambro A.B.

The Company believes that the sales and support activities described above were carried out in accordance with applicable laws and regulations.

Read in the reply ↗
General
SEC asked (2)
Please discuss the materiality of any contacts with Sudan and Syria you describe in response to the comment above, and whether the contacts constitute a material investment risk for your security holders. You should address materiality in quantitative terms, including the approximate dollar amounts of any revenues, assets and liabilities associated with Sudan and Syria for the last three fiscal years and the
Rest of the question

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. As you know, 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 Sudan and Syria.

BAX answered
Based on an assessment of both quantitative and qualitative factors, the Company believes that our activities in Sudan and Syria are not material to the Company and do not constitute a material investment risk. In assessing materiality of such activities, we considered materiality based on quantitative factors as well as qualitative factors that a reasonable investor would deem important in making an investment decision in the Company’s securities, including the potential impact on the Company’s reputation and share value.

We refer the Staff to our response to Comment No.
Rest of the answer

1 for a description of the Company’s sales in each named country during each of the past three years. In the aggregate, the Company’s total sales to (or for distribution within) Sudan and Syria for each of the past three years totaled approximately $9.7 million, $6.9 million and $6.4 million in 2014, 2015 and 2016 respectively, and were approximately $335,000 for the three-month period ended March 31, 2017.

The Company’s total net sales (after adjusted for the June 2015 spin-off of Baxalta Incorporated) were approximately $10.7 billion in 2014, $10.0 billion in 2015, $10.2 billion in 2016 and $2.5 billion in the quarter ended March 31, 2016. As such, the Company’s sales to Sudan and Syria, individually and in the aggregate, accounted for less than one-tenth of one percent of the Company’s total sales in each of these periods. Therefore, we believe that our activities and contacts in those countries are quantitatively immaterial to our investors, our business and our financial condition.

In addition, to the extent that the following qualitative factors may be suggested to impact an analysis of materiality, we believe that our activities in

Sudan and Syria are not material to our investors, our business, or our financial condition. We believe that our business and humanitarian efforts in these markets are conducted in compliance with applicable U.S. and local laws, which have been enacted to ensure that all people, regardless of the actions of their governments, have access to essential medical treatment. The Company maintains a trade compliance program, supported by resources from internal legal and supply chain departments and external legal counsel, to ensure the Company’s compliance with applicable economic sanctions regulations and laws administrated by OFAC and BIS, including the terms and conditions of general and specific export licenses that may be required to conduct business in these markets.

The Company is aware of legislation and guidelines that have been adopted by certain states and organizations permitting or requiring divestment from, or reporting of interests in, companies that do business with certain U.S.-designated state sponsors of terrorism. We do not believe that such legislation has, to date, had a material impact on our reputation or share value. The Company will continue to monitor the status of such legislation, as well as legislation proposed but not yet enacted, and whether it may have any material impact on us and our investors.

In addition, the Company acknowledges that:

• the Company is responsible for the adequacy and accuracy of the disclosure in its filings with the Commission;

Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the Company’s 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.

Read in the reply ↗

Also in this review: request for more time, 2017-04-14, closing letter, 2017-05-10

Form S-4

2016-04-29 to 2016-04-29 · 8 questions · 1 letter from the SEC, 0 from the company
No closing letter
Reserves and insuranceIncome taxesResults discussion (MD&A)
SEC letter of 2016-04-29 ↗ no reply letter on EDGAR (the company may have answered in an amended filing)
Cover Page of Form S-4
SEC asked (1)
We note the legend on the cover page of Form S-4 states “[t]he information in this prospectus is not complete and may be changed.” We also recognize that a preliminary prospectus used to commence an exchange offer early under Rule 162 must include the “red herring” legend required by Item 501(b)(10) of Regulation S-K.
Rest of the question

The sample legend provided in Item 501(b)(10)(iv) that indicates information in the prospectus is “not complete and may be changed,” however, should be appropriately tailored to explain that the instant prospectus may simply be amended. The legend should not state that the prospectus is not complete. Please refer to our publicly available Telephone Interpretation Manual Supplement dated July 2001, Section I.E.2, for an example of a legend that may be used when an exchange offer is commenced early in reliance upon Rule 162. How many shares of Baxalta common stock will I receive for my shares of Baxter common stock accepted in the exchange offer?, page 4

BAX answered

No reply letter found.

Cover Page of Form S-4
SEC asked (2)
Please revise to indicate with more specificity the date on which $100 value of Baxter common stock will be determined. At present, the disclosure could be interpreted to suggest that such value may be determined upon the date of acceptance and only based on a VWAP.
Rest of the question

For example, the disclosure could be clarified to expressly state that the $100 per-share value of Baxalta common stock on the date of acceptance will be determined at the end of the Averaging Period.

BAX answered

No reply letter found.

Summary | Question and Answer Number 16
SEC asked (3)
The disclosure indicates that “the maximum number of shares of Baxter common stock that will be accepted if the exchange offer is completed will be equal to 12,800,000 shares of Baxalta common stock held by Baxter divided by the final exchange ratio (which will be subject to the upper limit).” Please quantify, in this answer and with a view toward making conforming changes elsewhere in the offer document, the
Rest of the question

maximum amount of Baxter’s common stock that is sought in the issuer tender offer. For example, please revise to state, if true, that the maximum amount of Baxter common stock that will be acquired is 11,316,418 shares. Refer to Item 4 of Schedule TO and corresponding Item 1004(a) of Regulation M-A.

BAX answered

No reply letter found.

Baxter Selected Historical Financial Data, page 20
SEC asked (4)
Item 10(a) of Schedule TO incorporates by reference financial information included as Item 8 and Exhibit 12 in Baxter’s Annual Report on Form 10-K for the annual period ending December 31, 2015. Under Instruction 6 to Item 10 of Schedule TO, however, a summary of such financial information must be published in the offering document and provided in accordance with Item 1010(c) of Regulation M-A to the extent so
Rest of the question

incorporated. The summary disclosures under the above heading appear incomplete for this purpose, please revise to provide complete summary financial information that complies with Item 1010(c) of Regulation M-A for all periods required by Item 10 of Schedule TO. For example, the ratio of earnings to fixed charges and balance sheet information requested under Item 1-02(bb)(1) of Regulation S-X must be expressly disclosed. For more guidance, see Interpretation I.H.7, accessible via the following link: http://www.sec.gov/interps/telephone/phonesupplement3.htm

BAX answered

No reply letter found.

Conditions to Completion of the Exchange Offer, page 82
SEC asked (5)
Baxter’s failure to exercise its rights under any of the above conditions does not represent a waiver of these rights. If a material offer condition is triggered, however, and Baxter determines to proceed with the offer anyway and without disclosure, we continue to believe that this decision is tantamount to a waiver of the triggered condition.
Rest of the question

Please revise the disclosure to remove the implication that Baxter reserves the right not to timely disclose the existence of offer conditions which have been triggered. Refer to Rule 13e4(d)(2).

BAX answered

No reply letter found.

U.S. Federal Income Tax Consequences, page 180
SEC asked (6)
We note your revised disclosures and responses to prior comments 1 and 3. We refer to your revised disclosure that if the merger is consummated, participants in the instant transaction will recognize gain or loss upon receipt of cash and Shire securities in the merger; however, the disclosure should also discuss what the tax consequences will be for the instant transaction, particularly given that the Shire merger
Rest of the question

is subject to various conditions, including stockholder approval. As the consequences of the exchange offer itself appear to be material to shareholders based on your disclosure that you believe participants in the exchange offer will not recognize gain or loss upon receipt of Baxalta shares in the exchange offer, please revise your disclosure to clearly state, if true, that the exchange offer will be tax-free to participants pursuant to Sections 355 and 361 of the Code and provide the opinion required by Item 601(b)(8) of Regulation S-K. If counsel providing the opinion believes that there is a lack of authority directly addressing the material tax consequences or there is conflicting authority or significant doubt about the material tax consequences, then counsel may issue an opinion subject to a degree of uncertainty. In such case, please provide the additional disclosure required by Section III.C.4 of Staff Legal Bulletin No. 19.

BAX answered

No reply letter found.

U.S. Federal Income Tax Consequences, page 180
SEC asked (7)
We note your revision in response to prior comment 2. Please revise the first paragraph of this section to remove “general” and clarify that the summary addresses all material U.S. federal income tax consequences. Please refer to Section III.C.1 of Staff Legal Bulletin No. 19.
BAX answered

No reply letter found.

Exhibit 99.2 | Instruction Booklet to the Letter of Transmittal
SEC asked (8)
Under paragraph 13, Baxter discloses that it “reserves the absolute right in its sole discretion, subject to applicable law, to waive any of the specified conditions, in whole or in part, to the exchange offer at any time…” Please revise to remove the implication that offer conditions may be waived after the tender offer has expired.
BAX answered

No reply letter found.

3 other letters: notices that a filing will not be reviewed, requests to declare a registration effective, and the like

From the SEC's correspondence on EDGAR: staff letters (form UPLOAD) and company letters (form CORRESP), 12 letters filed since 2016-05-13. Questions and answers are matched by their numbers; topics come from words in each question. The reports are compared word for word (same form, before the first SEC letter against the first report after the company's reply). No AI.

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