Boston Scientific Corporation; Analysis of Agreement Containing Consent Orders To Aid Public Comment, 40411-40413 [2019-17460]
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
Dated: August 9, 2019.
Rachel Dickon,
Secretary.
[FR Doc. 2019–17464 Filed 8–13–19; 8:45 am]
Board of Governors of the Federal Reserve
System, August 9, 2019.
Yao-Chin Chao,
Assistant Secretary of the Board.
BILLING CODE 6731–AA–P
[FR Doc. 2019–17447 Filed 8–13–19; 8:45 am]
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FEDERAL RESERVE SYSTEM
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
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
29, 2019.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Julia L. Koellner, Fort Madison,
Iowa, individually, and acting in concert
with Kathleen K. Bentler, Le Claire,
Iowa; the Paula M. Friedman
Declaration of Trust-II with Paula M.
Friedman as trustee, both of Dubuque,
Iowa; the Terrance J. Friedman
Declaration of Trust-II with Terrance J.
Friedman as trustee, both of Dubuque,
Iowa; the Revocable Trust Agreement of
Agnes L. Koellner, with Agnes L.
Koellner as trustee, both of Fort
Madison, Iowa; the Revocable Trust
Agreement of Steven M. Koellner, with
Steven M. Koellner as trustee, both of
Fort Madison, Iowa; Kevin P. Koellner,
Bettendorf, Iowa; Nicole M. Koellner,
Bettendorf, Iowa; the J. Patrick Koellner
Irrevocable Trust Agreement,
Burlington, Iowa, with Kevin P. Koellner
as voting proxy; Kimberly E. Mendez,
Fort Madison, Iowa; and Christine A.
Smith, Le Claire, Iowa; to retain voting
shares of Lee Capital Corp, and thereby
retain shares of Lee County Bank, both
of Fort Madison, Iowa.
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than September 12,
2019.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Ames National Corporation, Ames,
Iowa; to acquire 100 percent of Iowa
State Savings Bank, Creston, Iowa.
Board of Governors of the Federal Reserve
System, August 9, 2019.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2019–17448 Filed 8–13–19; 8:45 am]
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FEDERAL TRADE COMMISSION
[File No. 191 0039]
Boston Scientific Corporation;
Analysis of Agreement Containing
Consent Orders To Aid Public
Comment
Federal Trade Commission.
Proposed Consent Agreement;
Request for Comment.
AGENCY:
ACTION:
The consent agreement in this
matter settles alleged violations of
federal law prohibiting unfair methods
of competition. The attached Analysis of
Agreement Containing Consent Orders
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 September 13, 2019.
ADDRESSES: Interested parties may file
comments online or on paper, by
following the instructions in the
Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Write: ‘‘Boston Scientific
Corporation; File No. 191 0039’’ on your
comment, and file your comment online
at https://www.regulations.gov by
following the instructions on the webbased form. If you prefer to file your
comment on paper, 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:
Jonathan Ripa (202–326–2230), Bureau
of Competition, Federal Trade
Commission, 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
SUMMARY:
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40412
Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
Home Page (for August 7, 2019), 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 September 13, 2019. Write
‘‘Boston Scientific Corporation; File No.
191 0039’’ 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 https://
www.regulations.gov website.
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 through the https://
www.regulations.gov website.
If you prefer to file your comment on
paper, write ‘‘Boston Scientific
Corporation; File No. 191 0039’’ 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 website at
https://www.regulations.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,
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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
website—as legally required by FTC
Rule 4.9(b)—we cannot redact or
remove your comment from the FTC
website, 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 website at https://
www.ftc.gov 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 September 13,
2019. For information on the
Commission’s privacy policy, including
routine uses permitted by the Privacy
Act, see https://www.ftc.gov/siteinformation/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 Boston Scientific
Corporation (‘‘BSC’’) designed to
remedy the anticompetitive effects
resulting from BSC’s proposed
acquisition of BTG plc (‘‘BTG’’). The
proposed Decision and Order (‘‘Order’’)
contained in the Consent Agreement
requires BSC to divest all rights and
assets related to its drug eluting bead
(‘‘DEB’’) business, as well as its closely
related bland bead business, to Varian
Medical Systems (‘‘Varian’’).
The proposed Consent Agreement has
been placed on the public record for
thirty days for receipt of comments by
interested persons. Comments received
during this period will become part of
the public record. After thirty days, the
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Commission will review the comments
received and decide whether it should
withdraw, modify, or make the Consent
Agreement final.
Under the terms of the Co-Operation
Agreement dated November 20, 2018,
BSC will acquire BTG in exchange for
cash consideration of $4.2 billion (the
‘‘Acquisition’’). The Commission’s
Complaint alleges 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 substantially
lessening competition in the U.S.
market for DEBs. The proposed Consent
Agreement will remedy the alleged
violations by preserving the competition
that otherwise would be lost in this
market as a result of the proposed
Acquisition.
II. The Parties
BSC, headquartered in Marlborough,
Massachusetts, is a global supplier of
medical devices that are used in a broad
range of interventional medical
specialties. BSC currently offers its
products through seven core business
segments: Interventional Cardiology,
Cardiac Rhythm Management,
Endoscopy, Peripheral Interventions,
Urology and Pelvic Health,
Neuromodulation, and
Electrophysiology. The Peripheral
Interventions segment—which includes
BSCs DEB business—focuses on
products that treat an array of diseases,
including arterial diseases, vascular
diseases, as well as various cancers.
BTG is headquartered in London,
England, with operational headquarters
in Conshohocken, Pennsylvania. The
company develops, manufacturers, and
sells products used in various
interventional medicine applications,
and it also has a portfolio of specialty
pharmaceutical products.
III. The Relevant Product and Structure
of the Market
DEBs are microscopic beads used in
transarterial chemoembolization
(‘‘TACE’’) procedures for treating
primary and secondary liver cancers.
TACE involves the use of embolic
agents (typically microscopic beads)
mixed with chemotherapy drugs (often
doxorubicin) that are delivered to the
targeted tumor in the liver via a catheter
inserted into the patient’s artery that
leads to the tumor. When used in TACE
procedures, DEBs work by blocking the
flow of blood to the liver tumor, causing
it to shrink over time, while
simultaneously slowly releasing a
chemotherapy agent that also attacks the
tumor.
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
BTG and BSC are the two leading
suppliers of DEBs in the United States
and are each other’s closest competitors.
The only other participant in the U.S.
DEB market is Merit Medical (‘‘Merit’’),
which is substantially smaller than
either BSC or BTG.
IV. The Relevant Geographic Market
The United States is the relevant
geographic market in which to assess
the competitive effects of the proposed
Acquisition. DEBs are medical devices
that are regulated by the U.S. Food and
Drug Administration (‘‘FDA’’). As such,
DEBs sold outside the United States, but
not approved for sale in the United
States, do not provide viable
competitive alternatives for U.S.
consumers.
V. Competitive Effects of the
Acquisition
The proposed Acquisition would
likely result in substantial competitive
harm to consumers in the market for
DEBs. The parties are two of only three
significant suppliers of DEBs in the
United States. Eliminating the head-tohead competition between BSC and
BTG in this highly concentrated market
would allow the combined firm to
exercise market power unilaterally,
resulting in higher prices, reduced
innovation, and less choice for
consumers.
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VI. Entry Conditions
Entry in the relevant market would
not be timely, likely, or sufficient in
magnitude, character, and scope to deter
or counteract the anticompetitive effects
of the proposed Acquisition. New entry
would require significant investment of
time and money for product research
and development, regulatory approval
by the FDA, developing clinical history
supporting the long-term efficacy of the
product, and establishing a U.S. sales
and service infrastructure. Such
development efforts are difficult, timeconsuming, and expensive, and often
fail to result in a competitive product
reaching the market.
VII. The Consent Agreement
The Consent Agreement eliminates
the competitive concerns raised by the
proposed Acquisition by requiring BSC
to divest its DEB business and closely
related bland bead business to Varian. A
sale of BSC’s DEB business without its
bland business could undermine the
divestiture’s effectiveness. The two
products share key intellectual property,
and BSC manufactures bland beads on
the same production line as DEBs. Thus,
including the bland bead business in the
divestiture package will ensure that
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Varian has outright ownership of all
necessary intellectual property and
allow it to manufacture DEBs at a cost
and output level comparable to that of
BSC. BSC must divest all assets and
rights to research, develop,
manufacture, market, and sell the BSC
DEB and bland bead products, including
all related intellectual property and
other confidential business information,
manufacturing technology, existing
inventory, and all related agreements to
manufacture and distribute the
products. Additionally, to ensure that
the divestiture is successful and
maintain continuity of supply, the
proposed Order requires BSC to supply
Varian with DEBs and bland beads for
a limited time while Varian establishes
its own manufacturing capability. The
provisions of the Consent Agreement
ensure that Varian becomes an
independent, viable, and effective
competitor in the U.S. market in order
to maintain the competition that
currently exists.
Headquartered in Palo Alto,
California, Varian operates globally and
develops, manufactures, and markets a
variety of medical devices and software
for treating cancer and other medical
conditions. Varian’s existing
interventional oncology business
includes products that are highly
complementary to the divestiture assets.
Varian has the expertise, U.S. sales
infrastructure, and resources to restore
the competition that otherwise would
have been lost due to the proposed
Acquisition.
BSC must accomplish the divestitures
no later than ten days after
consummating the proposed
Acquisition. If the Commission
determines that Varian is not an
acceptable acquirer, or that the manner
of the divestitures is not acceptable, the
proposed Order requires BSC to unwind
the sale of rights and assets to Varian
and then divest the affected products to
a Commission-approved acquirer within
six months of the date the Order
becomes final. To ensure compliance
with the Order, the Commission has
agreed to appoint a Monitor to ensure
that BSC complies with all of its
obligations pursuant to the Consent
Agreement and to keep the Commission
informed about the status of the transfer
of the DEB and bland bead rights and
assets to Varian. The proposed Order
further allows the Commission to
appoint a trustee in the event that BSC
fails to divest the products as required.
The purpose of this analysis is to
facilitate public comment on the
Consent Agreement, and it is not
intended to constitute an official
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40413
interpretation of the proposed Order or
to modify its terms in any way.
By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2019–17460 Filed 8–13–19; 8:45 am]
BILLING CODE 6750–01–P
GENERAL SERVICES
ADMINISTRATION
[Notice-MA–2019–07; Docket No. 2019–
0002; Sequence No. 19]
Maximum Per Diem Reimbursement
Rates for the Continental United States
(CONUS)
Office of Government-wide
Policy (OGP), General Services
Administration (GSA).
ACTION: Notice of GSA Per Diem
Bulletin FTR 20–01, Fiscal Year (FY)
2020 CONUS per diem reimbursement
rates.
AGENCY:
The GSA Fiscal Year FY 2020
per diem reimbursement rates review
has resulted in lodging and meal
allowance changes for certain locations
within CONUS to provide for
reimbursement of Federal employees’
subsistence expenses while on official
travel.
SUMMARY:
Applicability Date: This notice
applies to travel performed on or after
October 1, 2019, through September 30,
2020.
FOR FURTHER INFORMATION CONTACT: For
clarification of content, contact Ms. Jill
Denning, Program Analyst, Office of
Government-wide Policy, Office of
Asset and Transportation Management,
at 202–208–7642, or by email at
travelpolicy@gsa.gov. Please cite Notice
of GSA Per Diem Bulletin FTR 20–01.
SUPPLEMENTARY INFORMATION:
DATES:
Background
The CONUS per diem reimbursement
rates prescribed in Bulletin 20–01 may
be found at www.gsa.gov/perdiem. GSA
bases the maximum lodging allowance
rates on the average daily rate that the
lodging industry reports to an
independent organization. If a
maximum lodging allowance rate and/or
a meals and incidental expenses (M&IE)
per diem reimbursement rate is
insufficient to meet necessary expenses
in any given location, Federal executive
agencies can request that GSA review
that location. Please review questions
six and seven of GSA’s per diem
Frequently Asked Questions page at
www.gsa.gov/perdiem for more
information on the special review
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Agencies
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40411-40413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17460]
=======================================================================
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FEDERAL TRADE COMMISSION
[File No. 191 0039]
Boston Scientific Corporation; Analysis of Agreement Containing
Consent Orders To Aid Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed Consent Agreement; Request for Comment.
-----------------------------------------------------------------------
SUMMARY: The consent agreement in this matter settles alleged
violations of federal law prohibiting unfair methods of competition.
The attached Analysis of Agreement Containing Consent Orders 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 September 13, 2019.
ADDRESSES: Interested parties may file comments online or on paper, by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Write: ``Boston Scientific
Corporation; File No. 191 0039'' on your comment, and file your comment
online at https://www.regulations.gov by following the instructions on
the web-based form. If you prefer to file your comment on paper, 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: Jonathan Ripa (202-326-2230), Bureau
of Competition, Federal Trade Commission, 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
[[Page 40412]]
Home Page (for August 7, 2019), 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 September 13,
2019. Write ``Boston Scientific Corporation; File No. 191 0039'' 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 https://www.regulations.gov website.
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 through the https://www.regulations.gov website.
If you prefer to file your comment on paper, write ``Boston
Scientific Corporation; File No. 191 0039'' 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
website at https://www.regulations.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 website--as legally required by FTC Rule
4.9(b)--we cannot redact or remove your comment from the FTC website,
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 website at https://www.ftc.gov 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 September 13, 2019. 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 Boston Scientific Corporation (``BSC'') designed to
remedy the anticompetitive effects resulting from BSC's proposed
acquisition of BTG plc (``BTG''). The proposed Decision and Order
(``Order'') contained in the Consent Agreement requires BSC to divest
all rights and assets related to its drug eluting bead (``DEB'')
business, as well as its closely related bland bead business, to Varian
Medical Systems (``Varian'').
The proposed Consent Agreement has been placed on the public record
for thirty days for receipt of comments by interested persons. Comments
received during this period will become part of the public record.
After thirty days, the Commission will review the comments received and
decide whether it should withdraw, modify, or make the Consent
Agreement final.
Under the terms of the Co-Operation Agreement dated November 20,
2018, BSC will acquire BTG in exchange for cash consideration of $4.2
billion (the ``Acquisition''). The Commission's Complaint alleges 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 substantially
lessening competition in the U.S. market for DEBs. The proposed Consent
Agreement will remedy the alleged violations by preserving the
competition that otherwise would be lost in this market as a result of
the proposed Acquisition.
II. The Parties
BSC, headquartered in Marlborough, Massachusetts, is a global
supplier of medical devices that are used in a broad range of
interventional medical specialties. BSC currently offers its products
through seven core business segments: Interventional Cardiology,
Cardiac Rhythm Management, Endoscopy, Peripheral Interventions, Urology
and Pelvic Health, Neuromodulation, and Electrophysiology. The
Peripheral Interventions segment--which includes BSCs DEB business--
focuses on products that treat an array of diseases, including arterial
diseases, vascular diseases, as well as various cancers.
BTG is headquartered in London, England, with operational
headquarters in Conshohocken, Pennsylvania. The company develops,
manufacturers, and sells products used in various interventional
medicine applications, and it also has a portfolio of specialty
pharmaceutical products.
III. The Relevant Product and Structure of the Market
DEBs are microscopic beads used in transarterial chemoembolization
(``TACE'') procedures for treating primary and secondary liver cancers.
TACE involves the use of embolic agents (typically microscopic beads)
mixed with chemotherapy drugs (often doxorubicin) that are delivered to
the targeted tumor in the liver via a catheter inserted into the
patient's artery that leads to the tumor. When used in TACE procedures,
DEBs work by blocking the flow of blood to the liver tumor, causing it
to shrink over time, while simultaneously slowly releasing a
chemotherapy agent that also attacks the tumor.
[[Page 40413]]
BTG and BSC are the two leading suppliers of DEBs in the United
States and are each other's closest competitors. The only other
participant in the U.S. DEB market is Merit Medical (``Merit''), which
is substantially smaller than either BSC or BTG.
IV. The Relevant Geographic Market
The United States is the relevant geographic market in which to
assess the competitive effects of the proposed Acquisition. DEBs are
medical devices that are regulated by the U.S. Food and Drug
Administration (``FDA''). As such, DEBs sold outside the United States,
but not approved for sale in the United States, do not provide viable
competitive alternatives for U.S. consumers.
V. Competitive Effects of the Acquisition
The proposed Acquisition would likely result in substantial
competitive harm to consumers in the market for DEBs. The parties are
two of only three significant suppliers of DEBs in the United States.
Eliminating the head-to-head competition between BSC and BTG in this
highly concentrated market would allow the combined firm to exercise
market power unilaterally, resulting in higher prices, reduced
innovation, and less choice for consumers.
VI. Entry Conditions
Entry in the relevant market would not be timely, likely, or
sufficient in magnitude, character, and scope to deter or counteract
the anticompetitive effects of the proposed Acquisition. New entry
would require significant investment of time and money for product
research and development, regulatory approval by the FDA, developing
clinical history supporting the long-term efficacy of the product, and
establishing a U.S. sales and service infrastructure. Such development
efforts are difficult, time-consuming, and expensive, and often fail to
result in a competitive product reaching the market.
VII. The Consent Agreement
The Consent Agreement eliminates the competitive concerns raised by
the proposed Acquisition by requiring BSC to divest its DEB business
and closely related bland bead business to Varian. A sale of BSC's DEB
business without its bland business could undermine the divestiture's
effectiveness. The two products share key intellectual property, and
BSC manufactures bland beads on the same production line as DEBs. Thus,
including the bland bead business in the divestiture package will
ensure that Varian has outright ownership of all necessary intellectual
property and allow it to manufacture DEBs at a cost and output level
comparable to that of BSC. BSC must divest all assets and rights to
research, develop, manufacture, market, and sell the BSC DEB and bland
bead products, including all related intellectual property and other
confidential business information, manufacturing technology, existing
inventory, and all related agreements to manufacture and distribute the
products. Additionally, to ensure that the divestiture is successful
and maintain continuity of supply, the proposed Order requires BSC to
supply Varian with DEBs and bland beads for a limited time while Varian
establishes its own manufacturing capability. The provisions of the
Consent Agreement ensure that Varian becomes an independent, viable,
and effective competitor in the U.S. market in order to maintain the
competition that currently exists.
Headquartered in Palo Alto, California, Varian operates globally
and develops, manufactures, and markets a variety of medical devices
and software for treating cancer and other medical conditions. Varian's
existing interventional oncology business includes products that are
highly complementary to the divestiture assets. Varian has the
expertise, U.S. sales infrastructure, and resources to restore the
competition that otherwise would have been lost due to the proposed
Acquisition.
BSC must accomplish the divestitures no later than ten days after
consummating the proposed Acquisition. If the Commission determines
that Varian is not an acceptable acquirer, or that the manner of the
divestitures is not acceptable, the proposed Order requires BSC to
unwind the sale of rights and assets to Varian and then divest the
affected products to a Commission-approved acquirer within six months
of the date the Order becomes final. To ensure compliance with the
Order, the Commission has agreed to appoint a Monitor to ensure that
BSC complies with all of its obligations pursuant to the Consent
Agreement and to keep the Commission informed about the status of the
transfer of the DEB and bland bead rights and assets to Varian. The
proposed Order further allows the Commission to appoint a trustee in
the event that BSC fails to divest the products as required.
The purpose of this analysis is to facilitate public comment on the
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.
April J. Tabor,
Acting Secretary.
[FR Doc. 2019-17460 Filed 8-13-19; 8:45 am]
BILLING CODE 6750-01-P