Baxter International Inc., Claris Lifesciences Limited, and Arjun Handa; Analysis To Aid Public Comment, 35526-35528 [2017-16017]
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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,
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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:
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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
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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 https://
E:\FR\FM\31JYN1.SGM
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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
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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
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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
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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.
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[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:
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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: https://
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
https://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:
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]]>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 https://
[[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
