Baxter International Inc., Claris Lifesciences Limited, and Arjun Handa; Analysis To Aid Public Comment, 35526-35528 [2017-16017]

Download as PDF 35526 Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices and to estimate financial costs as part of its estimate of rental income of persons in the national income and product accounts (NIPAs). Indirectly, the data are used in the industry annual and quarterly Input-Output and GDP-byIndustry accounts in the estimates of gross output and value added for the real estate sub-sector. In accordance with the requirements of 5 CFR 1320.10(a), FHFA is publishing this second notice to request comments regarding the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA’s estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments should be submitted in writing to both OMB and FHFA as instructed above in the COMMENTS section. Dated: July 25, 2017. Kevin Winkler, Chief Information Officer, Federal Housing Finance Agency. 1. Scott H. Soderberg, Eden Prairie, Minnesota, individually and as trustee of the Elizabeth Ann Soderberg Irrevocable Trust dated 12/20/12, New Richmond, Wisconsin, and Elizabeth A. Soderberg, Minnetonka, Minnesota, individually and as trustee of the Scott H. Soderberg Irrevocable Trust dated 12/20/12, New Richmond, Wisconsin; to acquire voting shares of One Corporation and thereby indirectly acquire shares of First National Community Bank, both of New Richmond, Wisconsin. B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Robert L. Lampert Trust No. 1 and the Andra V. Lampert Trust No. 1, both of Beloit, Kansas; individually and part of the Lamber Family Group to retain voting shares of First National Bankshares of Beloit, Inc. (the company), and thereby indirectly retain shares of The First National Bank of Beloit, both of Beloit, Kansas. Additionally, the Larry D. Lampert Trust No. 1, Beloit, Kansas, to join the the Lampert Family Group, which acting in concert controls the company. [FR Doc. 2017–16042 Filed 7–28–17; 8:45 am] Board of Governors of the Federal Reserve System, July 26, 2017. Yao-Chin Chao, Assistant Secretary of the Board. BILLING CODE 8070–01–P [FR Doc. 2017–16065 Filed 7–28–17; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM FEDERAL TRADE COMMISSION sradovich on DSKBCFCHB2PROD with NOTICES Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company [File No. 171 0052] The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 15, 2017. A. Federal Reserve Bank of Minneapolis (Brendan S. Murrin, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291: VerDate Sep<11>2014 17:38 Jul 28, 2017 Jkt 241001 Baxter International Inc., Claris Lifesciences Limited, and Arjun Handa; Analysis To Aid Public Comment Federal Trade Commission. Proposed Consent Agreement. AGENCY: ACTION: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent orders—embodied in the consent agreement—that would settle these allegations. DATES: Comments must be received on or before August 21, 2017. ADDRESSES: Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: ‘‘In the Matter of Baxter International Inc., File No. 171–0052’’ SUMMARY: PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 on your comment, and file your comment online at https:// ftcpublic.commentworks.com/ftc/ baxterclarisconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write ‘‘In the Matter of Baxter International Inc., File No. 171–0052’’ on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC– 5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Kari Wallace (202–326–3085), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580. SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for July 20, 2017), on the World Wide Web, at https:// www.ftc.gov/news-events/commissionactions. You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 21, 2017. Write ‘‘In the Matter of Baxter International Inc., File No. 171–0052’’ on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at https:// www.ftc.gov/policy/public-comments. Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https:// ftcpublic.commentworks.com/ftc/ baxterclarisconsent by following the instructions on the web-based form. If this Notice appears at http:// E:\FR\FM\31JYN1.SGM 31JYN1 sradovich on DSKBCFCHB2PROD with NOTICES Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices www.regulations.gov/#!home, you also may file a comment through that Web site. If you prefer to file your comment on paper, write ‘‘In the Matter of Baxter International Inc., File No. 171–0052’’ on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC– 5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Because your comment will be placed on the publicly accessible FTC Web site at https://www.ftc.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else’s Social Security number; date of birth; driver’s license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any ‘‘trade secret or any commercial or financial information which . . . is privileged or confidential’’—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled ‘‘Confidential,’’ and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment VerDate Sep<11>2014 17:38 Jul 28, 2017 Jkt 241001 has been posted on the public FTC Web site—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC Web site, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request. Visit the FTC Web site to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before August 21, 2017. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/ site-information/privacy-policy. Analysis of Agreement Containing Consent Orders To Aid Public Comment I. Introduction The Federal Trade Commission (‘‘Commission’’) has accepted, subject to final approval, an Agreement Containing Consent Orders (‘‘Consent Agreement’’) from Baxter International Inc. (‘‘Baxter’’) and Claris Lifesciences Limited and Arjun Handa (collectively ‘‘Claris’’) that is designed to remedy the anticompetitive effects resulting from Baxter’s acquisition of voting securities of certain entities and related assets from Claris. Under the terms of the proposed Consent Agreement, the parties are required to divest all of Claris’s rights and assets related to fluconazole in saline intravenous bags and milrinone in dextrose intravenous bags to Renaissance Lakewood LLC (‘‘Renaissance’’). The proposed Consent Agreement has been placed on the public record for thirty days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will again evaluate the proposed Consent Agreement, along with any comments received, to make a final decision as to whether it should withdraw from the proposed Consent Agreement or make final the Decision and Order (‘‘Order’’). Pursuant to agreements dated December 15, 2016, Baxter proposes to acquire voting securities of certain entities and related assets from Claris in two related transactions valued at approximately $625 million (the ‘‘Proposed Acquisition’’). The Commission alleges in its Complaint that the Proposed Acquisition, if PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 35527 consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by lessening current competition in the market for fluconazole in saline intravenous bags and future competition in the market for milrinone in dextrose intravenous bags in the United States. The proposed Consent Agreement will remedy the alleged violations by preserving the competition that otherwise would be eliminated by the Proposed Acquisition. II. The Products and Structure of the Markets The Proposed Acquisition would reduce the current competition in the market for fluconazole in saline intravenous bags, and reduce future competition in the market for milrinone in dextrose intravenous bags. Fluconazole is an antifungal agent used to treat a variety of fungal and yeast infections. Five companies currently sell generic intravenous fluconazole bags in the United States: Baxter, Claris, Pfizer Inc. (‘‘Pfizer’’), Sagent Pharmaceuticals, and Hikma Pharmaceuticals PLC (‘‘Hikma’’), but only four of these companies are significant competitors. Baxter and Claris have a combined estimated market share of nearly 60%. Intravenous milrinone is a vasodilator that dilates the blood vessels, lowering blood pressure and allowing blood to flow more easily through the cardiovascular system. The product is used as a short-term treatment for lifethreatening heart failure. Three companies—Baxter, Hikma, and Pfizer—currently sell the product in the United States. Claris is expected to enter this market shortly, once its pending application at the FDA is approved, a development expected to occur in the very near future. III. Entry Entry into the two markets at issue would not be timely, likely, or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive effects of the Proposed Acquisition. The combination of drug development times and regulatory requirements, including approval by the United States Food and Drug Administration (‘‘FDA’’), is costly and lengthy. IV. Effects The Proposed Acquisition likely would cause significant anticompetitive harm to consumers by eliminating current competition between Baxter and Claris in the market for fluconazole in saline intravenous bags. Fluconazole in E:\FR\FM\31JYN1.SGM 31JYN1 35528 Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices sradovich on DSKBCFCHB2PROD with NOTICES saline intravenous bags is a commodity product, and prices typically are inversely correlated with the number of competitors in each market. As the number of suppliers offering a therapeutically equivalent drug increases, the price for that drug generally decreases due to the direct competition between the existing suppliers and each additional supplier. The Proposed Acquisition would combine two of only four significant companies selling the product, likely leading consumers to pay higher prices. Customers also have indicated that the presence of an independent Claris has allowed them to negotiate lower prices for fluconazole bags. In addition, the Proposed Acquisition likely would cause significant anticompetitive harm to consumers by eliminating future competition that would otherwise have occurred if Baxter and Claris remained independent in the market for milrinone in dextrose intravenous bags. The evidence shows that the Proposed Acquisition, absent a remedy, would eliminate an additional independent entrant in the currently concentrated market for milrinone in dextrose intravenous bags, which would have enabled customers to negotiate lower prices. Customers and competitors have observed—and pricing data confirms—that the price of these pharmaceutical products decreases with new entry even after several other suppliers have entered the market. Thus, absent a remedy, the Proposed Acquisition likely will cause U.S. consumers to pay significantly higher prices for milrinone in dextrose intravenous bags in the future. divestitures is not acceptable, the proposed Order requires the parties to unwind the sale of rights to Renaissance and then divest the products to a Commission-approved acquirer within six months of the date the Order becomes final. The proposed Order further allows the Commission to appoint a trustee in the event the parties fail to divest the products as required. The proposed Consent Agreement and Order contain several provisions to help ensure that the divestitures are successful. Baxter will supply Renaissance with fluconazole in saline intravenous bags and milrinone in dextrose intravenous bags for up to five years while the company transfers the manufacturing technology to Renaissance or its contract manufacturing designee. The proposed Order also requires Baxter to provide transitional services to Renaissance to assist it in establishing its manufacturing capabilities and securing all of the necessary FDA approvals. These transitional services include technical assistance to manufacture fluconazole in saline intravenous bags and milrinone in dextrose intravenous bags in substantially the same manner and quality employed or achieved by Claris. It also includes advice and training from knowledgeable employees of the parties. Under the proposed Consent Agreement, the Commission also will appoint an Interim Monitor. The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Order or to modify its terms in any way. V. The Consent Agreement The proposed Consent Agreement effectively remedies the competitive concerns raised by the acquisition in both markets at issue by requiring Claris to divest all its rights to fluconazole in saline intravenous bags and milrinone in dextrose intravenous bags to Renaissance. Renaissance is a pharmaceutical corporation that develops, manufacturers, sells, and distributes injectable pharmaceutical products in the United States. The parties must accomplish these divestitures no later than ten days after they consummate the Proposed Acquisition. The Commission’s goal in evaluating possible purchasers of divested assets is to maintain the competitive environment that existed prior to the Proposed Acquisition. If the Commission determines that Renaissance is not an acceptable acquirer, or that the manner of the By direction of the Commission. Donald S. Clark, Secretary. VerDate Sep<11>2014 17:38 Jul 28, 2017 Jkt 241001 [FR Doc. 2017–16017 Filed 7–28–17; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000–0024; Docket 2017– 0053; Sequence 2] Information Collection; Federal Acquisition Regulation: Buy American, Trade Agreements, and Duty-Free Entry Department of Defense (DOD), General Services Administration (GSA), AGENCY: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 and National Aeronautics and Space Administration (NASA). ACTION: Notice of request for public comments regarding an extension to an existing OMB clearance. Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division (MVCB) will be submitting to the Office of Management and Budget (OMB) a request for revision and an extension to existing OMB clearances regarding the Buy American statute, Trade Agreements, and duty-free entry. DATES: Submit comments on or before September 29, 2017. ADDRESSES: Submit comments identified by Information Collection 9000–0024, Buy American, Trade Agreements, and Duty-Free Entry, by any of the following methods: • Regulations.gov: http:// www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number 9000–0024. Select the link ‘‘Comment Now’’ that corresponds with ‘‘Information Collection 9000–0024, Buy American, Trade Agreements, and Duty-Free Entry. Follow the instructions provided on the screen. Please include your name, company name (if any), and ‘‘Information Collection 9000–0024, Buy American, Trade Agreements, and DutyFree Entry’’ on your attached document. • Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Sosa/IC 9000–0024, Buy American, Trade Agreements, and Duty-Free Entry. Instructions: Please submit comments only and cite Information Collection 9000–0024, Buy American, Trade Agreements, and Duty-Free Entry, in all correspondence related to this collection. Comments received generally will be posted, without change, to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail). FOR FURTHER INFORMATION CONTACT: Ms. Cecelia L. Davis, Procurement Analyst, Acquisition Policy Division, GSA (202) 219–0202 or email cecelia.davis@ gsa.gov. SUPPLEMENTARY INFORMATION: A. This information collection requirement pertains to information that an offeror must submit in response to SUMMARY: E:\FR\FM\31JYN1.SGM 31JYN1

Agencies

[Federal Register Volume 82, Number 145 (Monday, July 31, 2017)]
[Notices]
[Pages 35526-35528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16017]


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FEDERAL TRADE COMMISSION

[File No. 171 0052]


Baxter International Inc., Claris Lifesciences Limited, and Arjun 
Handa; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

-----------------------------------------------------------------------

SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair methods of competition. 
The attached Analysis to Aid Public Comment describes both the 
allegations in the complaint and the terms of the consent orders--
embodied in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before August 21, 2017.

ADDRESSES: Interested parties may file a comment online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write: ``In the Matter of 
Baxter International Inc., File No. 171-0052'' on your comment, and 
file your comment online at https://ftcpublic.commentworks.com/ftc/baxterclarisconsent by following the instructions on the web-based 
form. If you prefer to file your comment on paper, write ``In the 
Matter of Baxter International Inc., File No. 171-0052'' on your 
comment and on the envelope, and mail your comment to the following 
address: Federal Trade Commission, Office of the Secretary, 600 
Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, 
or deliver your comment to the following address: Federal Trade 
Commission, Office of the Secretary, Constitution Center, 400 7th 
Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Kari Wallace (202-326-3085), Bureau of 
Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing a consent order to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis to Aid Public Comment describes the terms of the 
consent agreement, and the allegations in the complaint. An electronic 
copy of the full text of the consent agreement package can be obtained 
from the FTC Home Page (for July 20, 2017), on the World Wide Web, at 
https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before August 21, 2017. 
Write ``In the Matter of Baxter International Inc., File No. 171-0052'' 
on your comment. Your comment--including your name and your state--will 
be placed on the public record of this proceeding, including, to the 
extent practicable, on the public Commission Web site, at https://www.ftc.gov/policy/public-comments.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/baxterclarisconsent by following the instructions on the web-based 
form. If this Notice appears at http://

[[Page 35527]]

www.regulations.gov/#!home, you also may file a comment through that 
Web site.
    If you prefer to file your comment on paper, write ``In the Matter 
of Baxter International Inc., File No. 171-0052'' on your comment and 
on the envelope, and mail your comment to the following address: 
Federal Trade Commission, Office of the Secretary, 600 Pennsylvania 
Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver 
your comment to the following address: Federal Trade Commission, Office 
of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, 
Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your 
paper comment to the Commission by courier or overnight service.
    Because your comment will be placed on the publicly accessible FTC 
Web site at https://www.ftc.gov, you are solely responsible for making 
sure that your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
sensitive personal information, such as your or anyone else's Social 
Security number; date of birth; driver's license number or other state 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. You are also 
solely responsible for making sure that your comment does not include 
any sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 
16 CFR 4.10(a)(2)--including in particular competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on the public FTC Web site--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC Web site, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    Visit the FTC Web site to read this Notice and the news release 
describing it. The FTC Act and other laws that the Commission 
administers permit the collection of public comments to consider and 
use in this proceeding, as appropriate. The Commission will consider 
all timely and responsive public comments that it receives on or before 
August 21, 2017. For information on the Commission's privacy policy, 
including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Agreement Containing Consent Orders To Aid Public Comment

I. Introduction

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Baxter International Inc. (``Baxter'') and Claris 
Lifesciences Limited and Arjun Handa (collectively ``Claris'') that is 
designed to remedy the anticompetitive effects resulting from Baxter's 
acquisition of voting securities of certain entities and related assets 
from Claris. Under the terms of the proposed Consent Agreement, the 
parties are required to divest all of Claris's rights and assets 
related to fluconazole in saline intravenous bags and milrinone in 
dextrose intravenous bags to Renaissance Lakewood LLC 
(``Renaissance'').
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments from interested persons. 
Comments received during this period will become part of the public 
record. After thirty days, the Commission will again evaluate the 
proposed Consent Agreement, along with any comments received, to make a 
final decision as to whether it should withdraw from the proposed 
Consent Agreement or make final the Decision and Order (``Order'').
    Pursuant to agreements dated December 15, 2016, Baxter proposes to 
acquire voting securities of certain entities and related assets from 
Claris in two related transactions valued at approximately $625 million 
(the ``Proposed Acquisition''). The Commission alleges in its Complaint 
that the Proposed Acquisition, if consummated, would violate Section 7 
of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the 
Federal Trade Commission Act, as amended, 15 U.S.C. 45, by lessening 
current competition in the market for fluconazole in saline intravenous 
bags and future competition in the market for milrinone in dextrose 
intravenous bags in the United States. The proposed Consent Agreement 
will remedy the alleged violations by preserving the competition that 
otherwise would be eliminated by the Proposed Acquisition.

II. The Products and Structure of the Markets

    The Proposed Acquisition would reduce the current competition in 
the market for fluconazole in saline intravenous bags, and reduce 
future competition in the market for milrinone in dextrose intravenous 
bags.
    Fluconazole is an antifungal agent used to treat a variety of 
fungal and yeast infections. Five companies currently sell generic 
intravenous fluconazole bags in the United States: Baxter, Claris, 
Pfizer Inc. (``Pfizer''), Sagent Pharmaceuticals, and Hikma 
Pharmaceuticals PLC (``Hikma''), but only four of these companies are 
significant competitors. Baxter and Claris have a combined estimated 
market share of nearly 60%.
    Intravenous milrinone is a vasodilator that dilates the blood 
vessels, lowering blood pressure and allowing blood to flow more easily 
through the cardiovascular system. The product is used as a short-term 
treatment for life-threatening heart failure. Three companies--Baxter, 
Hikma, and Pfizer--currently sell the product in the United States. 
Claris is expected to enter this market shortly, once its pending 
application at the FDA is approved, a development expected to occur in 
the very near future.

III. Entry

    Entry into the two markets at issue would not be timely, likely, or 
sufficient in magnitude, character, and scope to deter or counteract 
the anticompetitive effects of the Proposed Acquisition. The 
combination of drug development times and regulatory requirements, 
including approval by the United States Food and Drug Administration 
(``FDA''), is costly and lengthy.

IV. Effects

    The Proposed Acquisition likely would cause significant 
anticompetitive harm to consumers by eliminating current competition 
between Baxter and Claris in the market for fluconazole in saline 
intravenous bags. Fluconazole in

[[Page 35528]]

saline intravenous bags is a commodity product, and prices typically 
are inversely correlated with the number of competitors in each market. 
As the number of suppliers offering a therapeutically equivalent drug 
increases, the price for that drug generally decreases due to the 
direct competition between the existing suppliers and each additional 
supplier. The Proposed Acquisition would combine two of only four 
significant companies selling the product, likely leading consumers to 
pay higher prices. Customers also have indicated that the presence of 
an independent Claris has allowed them to negotiate lower prices for 
fluconazole bags.
    In addition, the Proposed Acquisition likely would cause 
significant anticompetitive harm to consumers by eliminating future 
competition that would otherwise have occurred if Baxter and Claris 
remained independent in the market for milrinone in dextrose 
intravenous bags. The evidence shows that the Proposed Acquisition, 
absent a remedy, would eliminate an additional independent entrant in 
the currently concentrated market for milrinone in dextrose intravenous 
bags, which would have enabled customers to negotiate lower prices. 
Customers and competitors have observed--and pricing data confirms--
that the price of these pharmaceutical products decreases with new 
entry even after several other suppliers have entered the market. Thus, 
absent a remedy, the Proposed Acquisition likely will cause U.S. 
consumers to pay significantly higher prices for milrinone in dextrose 
intravenous bags in the future.

V. The Consent Agreement

    The proposed Consent Agreement effectively remedies the competitive 
concerns raised by the acquisition in both markets at issue by 
requiring Claris to divest all its rights to fluconazole in saline 
intravenous bags and milrinone in dextrose intravenous bags to 
Renaissance. Renaissance is a pharmaceutical corporation that develops, 
manufacturers, sells, and distributes injectable pharmaceutical 
products in the United States. The parties must accomplish these 
divestitures no later than ten days after they consummate the Proposed 
Acquisition.
    The Commission's goal in evaluating possible purchasers of divested 
assets is to maintain the competitive environment that existed prior to 
the Proposed Acquisition. If the Commission determines that Renaissance 
is not an acceptable acquirer, or that the manner of the divestitures 
is not acceptable, the proposed Order requires the parties to unwind 
the sale of rights to Renaissance and then divest the products to a 
Commission-approved acquirer within six months of the date the Order 
becomes final. The proposed Order further allows the Commission to 
appoint a trustee in the event the parties fail to divest the products 
as required.
    The proposed Consent Agreement and Order contain several provisions 
to help ensure that the divestitures are successful. Baxter will supply 
Renaissance with fluconazole in saline intravenous bags and milrinone 
in dextrose intravenous bags for up to five years while the company 
transfers the manufacturing technology to Renaissance or its contract 
manufacturing designee. The proposed Order also requires Baxter to 
provide transitional services to Renaissance to assist it in 
establishing its manufacturing capabilities and securing all of the 
necessary FDA approvals. These transitional services include technical 
assistance to manufacture fluconazole in saline intravenous bags and 
milrinone in dextrose intravenous bags in substantially the same manner 
and quality employed or achieved by Claris. It also includes advice and 
training from knowledgeable employees of the parties. Under the 
proposed Consent Agreement, the Commission also will appoint an Interim 
Monitor.
    The purpose of this analysis is to facilitate public comment on the 
proposed Consent Agreement, and it is not intended to constitute an 
official interpretation of the proposed Order or to modify its terms in 
any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2017-16017 Filed 7-28-17; 8:45 am]
 BILLING CODE 6750-01-P