1405008 Informal Interpretation

39388 	Federal Register / Vol. 79, No. 132 / Thursday, July 10, 2014 / Notices
1 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), 16 CFR 4.9(c).
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 August 4, 2014.
A. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. Exchange Company, Kearney,
Nebraska; to acquire 100 percent of the
voting shares of JCK, Inc., parent of The
First National Bank and Trust Company
of Junction City, both in Junction City,
Kansas.
Board of Governors of the Federal Reserve
System, July 7, 2014.
Michael J. Lewandowski,
Assistant Secretary of the Board.
[FR Doc. 2014–16140 Filed 7–9–14; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL TRADE COMMISSION
[File No. 141 0098]
Actavis plc and Forest Laboratories;
Analysis of Proposed Consent Order
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 of
Agreement Containing Consent Order to
Aid Public Comment describes both the
allegations in the draft complaint and
the terms of the consent order—
embodied in the consent agreement—
that would settle these allegations.
DATES : Comments must be received on
or before July 30, 2014.
ADDRESSES : Interested parties may file a
comment at https://
ftcpublic.commentworks.com/ftc/
actavisdivestapp online or on paper, by
following the instructions in the
Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Write ‘‘Actavis plc and Forest
Laboratories—Consent Agreement; File
No. 141 0098’’ on your comment and
file your comment online at https://
ftcpublic.commentworks.com/ftc/
actavisdivestapp 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:
Christine Tasso, Bureau of Competition,
(202–326–2232), 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 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 June 30, 2014), on the
World Wide Web, at http://www.ftc.gov/
os/actions.shtm.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before July 30, 2014. Write ‘‘Actavis plc
and Forest Laboratories—Consent
Agreement; File No. 141 0098’’ 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 http://www.ftc.gov/os/
publiccomments.shtm. As a matter of
discretion, the Commission tries to
remove individuals’ home contact
information from comments before
placing them on the Commission Web
site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’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, like medical records or
other individually identifiable health
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which . . . is
privileged or confidential,’’ as discussed
in 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). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c).1 Your comment will be kept
confidential only if the FTC General
Counsel, in his or her sole discretion,
grants your request in accordance with
the law and the public interest.
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/
actavisdivestapp by following the
instructions on the web-based form. If
this Notice appears at http://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘Actavis plc and Forest
Laboratories—Consent Agreement; File
No. 141 0098’’ 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.
Visit the Commission Web site at
http://www.ftc.gov to read this Notice
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39389	Federal Register / Vol. 79, No. 132 / Thursday, July 10, 2014 / Notices
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 July 30, 2014. You can find more
information, including routine uses
permitted by the Privacy Act, in the
Commission’s privacy policy, at http://
www.ftc.gov/ftc/privacy.htm.
Analysis of Proposed Consent Order to
Aid Public Comment
The Federal Trade Commission
(‘‘Commission’’) has accepted, subject to
final approval, an Agreement
Containing Consent Orders (‘‘Consent
Agreement’’) from Actavis plc
(‘‘Actavis’’) that is designed to remedy
the anticompetitive effects in three
current generic pharmaceutical markets
and two future markets resulting from
Actavis’ acquisition of Forest
Laboratories, Inc. (‘‘Forest’’). Under the
terms of the proposed Consent
Agreement, the parties are required to:
(1) Return all of Forest’s rights and
assets related to generic diltiazem
hydrochloride (AB4) to Valeant
Pharmaceuticals International, Inc.
(‘‘Valeant’’), (2) divest all of Actavis’
rights and assets to generic ursodiol and
generic lamotrigine ODT to Impax
Laboratories, Inc. (‘‘Impax’’), and (3)
divest all of Forest’s rights and assets to
generic propranolol hydrochloride to
Catalent Pharma Solutions, Inc.
(‘‘Catalent’’).
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 the comments received, in order 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 an Agreement and Plan of
Merger dated February 17, 2014, Actavis
plans to acquire, 100% of the voting
securities of Forest for a total value of
approximately $25 billion (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 competition in
three current relevant product markets:
(1) Generic diltiazem hydrochloride
extended release capsules (AB4)
(generic Tiazac) (‘‘generic diltiazem
hydrochloride (AB4)’’; (2) generic
ursodiol tablets (‘‘generic ursodiol’’);
and (3) generic propranolol
hydrochloride extended release
capsules (‘‘generic propranolol
hydrochloride’’), and the future relevant
market of lamotrigine orally
disintegrating tablets (‘‘ODT’’) and its
generic equivalent. The proposed
Consent Agreement will remedy the
alleged violations by preserving the
competition that would otherwise be
eliminated by the Proposed Acquisition.
The Products and Structure of the
Markets
The Proposed Acquisition would
reduce the number of suppliers in three
current relevant markets, each of which
has only a limited number of market
participants. It would also likely delay
the introduction of generic competition
against Lamictal ODT, the branded
lamotrigine orally disintegrating tablets
marketed by Forest.
Generic versions of drugs are usually
launched after a branded product’s
patents expire, or a generic supplier
successfully challenges such patents in
court or reaches a legal settlement with
the branded manufacturer. When only
one generic product is available, the
price for the 2 branded product acts as
a ceiling above which the generic
manufacturer cannot price its product.
During this period, the branded product
competes directly with the generic.
Once multiple generic suppliers enter a
market, the branded drug manufacturer
usually ceases to provide any
competitive constraint on the prices for
generic versions of the drug. Rather, the
generic suppliers compete only against
each other. In generic pharmaceutical
product markets, price generally
decreases as the number of generic
competitors increases. Accordingly, the
reduction in the number of suppliers
within each relevant market would
likely have a direct and substantial
anticompetitive effect on pricing.
The Proposed Acquisition would
reduce current competition in markets
for three currently marketed generic
prescription drugs—generic diltiazem
hydrochloride (AB4), which is used to
treat hypertension and chronic stable
angina, generic ursodiol, which is used
to treat primary biliary cirrhosis of the
liver, and generic propranolol
hydrochloride, an extended release drug
indicated for the treatment of
hypertension. The structure of these
markets is as follows:
• The generic diltiazem
hydrochloride (AB4) market currently
has three suppliers: Actavis, Forest, and
Sun Pharmaceutical Industries, Ltd. The
Proposed Acquisition would reduce the
number of suppliers in this market from
three to two.
• The generic ursodiol market
currently has four suppliers: Actavis,
Forest, which distributes its product
through Prasco Laboratories, Glenmark
Pharmaceuticals, Ltd., and Par
Pharmaceutical Companies. The
Proposed Acquisition would reduce the
number of suppliers in this market from
four to three.
• The generic propranolol
hydrochloride market currently has four
suppliers: Actavis, Forest, which
distributes its product through
Breckenridge Pharmaceutical, LLC,
Rouses Point Pharmaceuticals, and
Upsher-Smith Laboratories. The
Proposed Acquisition would reduce the
number of suppliers in this market from
four to three.
In addition to reducing current
competition in three generic
prescription markets, the proposed
transaction would significantly reduce
competition in the future market of
lamotrigine orally disintegrating tablets:
• Lamictal ODT is a lamotrigine
orally disintegrating tablet indicated for
seizures. Forest currently manufactures
Lamictal ODT for GlaxoSmithKline plc
(‘‘GSK’’). GSK owns the New Drug
Application for Lamictal ODT and
markets the product. Actavis holds the
only approved Abbreviated New Drug
Application to market generic
lamotrigine ODT. Thus, Actavis appears
likely to be the first generic entrant and
would be the sole competitor to Forest/
GSK’s branded Lamictal ODT product
for a significant period of time. The
Acquisition would likely delay or
preclude the entry of Actavis’ generic
product.
Entry
Entry into the markets for the
Products would not be timely, likely, or
sufficient in magnitude, character, and
scope to deter or counteract the
anticompetitive effects of the
acquisition. The combination of drug
development times and regulatory
requirements, including U.S. Food and
Drug Administration (‘‘FDA’’) approval,
is costly and lengthy. Industry
participants also note that expertise and
facilities associated with manufacturing
extended release products and orally
disintegrating tablets is sufficiently
specialized that a relatively small
number of firms participate in such
markets.
Effects
The Proposed Acquisition would
likely cause significant anticompetitive
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39390 	Federal Register / Vol. 79, No. 132 / Thursday, July 10, 2014 / Notices
harm to consumers in the relevant
generic pharmaceutical markets by
eliminating current and/or future
competition in concentrated existing
generic markets or in future generic
markets. In generic pharmaceuticals
markets, price is heavily influenced by
the number of participants with
sufficient supply. Market participants
consistently characterize generic drug
markets as commodity markets in which
the number of generic suppliers has a
direct impact on pricing. Customers and
competitors alike have confirmed that
the prices of the generic pharmaceutical
products at issue continue to decrease
with new entry even after a number of
suppliers have entered these generic
markets. Further, customers generally
believe that having at least four
suppliers in a generic pharmaceutical
market produces more competitive
prices than if fewer suppliers are
available to them.
The evidence shows that
anticompetitive effects are likely to
result from the Proposed Acquisition
due to a decrease in the number of
independent competitors in the markets
at issue. In each of the current generic
prescription markets, industry
participants have indicated that the
presence of Forest as a competitor has
allowed them to negotiate lower prices
from other suppliers, including Actavis,
and has allowed them to locate
additional supply in times of product
shortages from their existing suppliers.
The evidence also shows that the
Proposed Acquisition would eliminate
significant future competition between
Actavis and Forest in the market for
lamotrigine orally disintegrating tablets
because, absent the Proposed
Acquisition, Actavis likely would have
been the first generic supplier to enter
the market.
By eliminating the significant current
and future competition between the
parties, the Proposed Acquisition will
likely cause U.S. consumers to pay
significantly higher prices for these
generic drugs, absent a remedy.
The Consent Agreement
The proposed Consent Agreement
effectively remedies the Proposed
Acquisition’s anticompetitive effects in
each of the relevant product markets.
Pursuant to the Consent Agreement, the
parties are required to return all of
Forest’s rights and assets related to
generic diltiazem hydrochloride (AB4)
to Valeant, divest all of Actavis’ rights
and assets to generic ursodiol and
generic lamotrigine ODT to Impax, and
provide all of Forest’s rights and assets
to 4 generic propranolol hydrochloride
to Catalent. The parties must
accomplish these divestitures and
relinquish their rights no later than ten
days after the Proposed Acquisition is
consummated.
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 Valeant,
Impax, or Catalent is not an acceptable
acquirer, or that the manner of the
divestiture is not acceptable, the
proposed D&O requires the parties to
unwind the sale and then divest the
products within six months of the date
the D&O becomes final to another
Commission-approved acquirer or
acquirers. The proposed D&O further
allows the Commission to appoint a
trustee in the event the parties fail to
divest the products.
The proposed Consent Agreement
contains several provisions to help
ensure that the divestitures are
successful. With regard to generic
diltiazem hydrochloride (AB4), the
proposed Consent Agreement requires
that Forest transfer to Valeant all
confidential business information and
requires that Actavis and Forest take all
actions that are necessary to maintain
the full viability and marketability of
the product until Valeant commences
the distribution, marketing, and sale of
the product. With regard to generic
ursodiol, generic lamotrigine ODT, and
generic propranolol hydrochloride
(termed ‘‘Contract Manufacture
Products’’ in the Consent Agreement),
the proposed Consent Agreement
requires Actavis and Forest to
manufacture and supply generic
ursodiol and generic lamotrigine ODT to
Impax and generic propranolol to
Catalent following the divestiture while
they seek the necessary FDA approval.
The Commission has agreed to
appoint Frank Civille to act as an
interim monitor to assure that Actavis
and Forest expeditiously comply with
all of their obligations and perform all
of their responsibilities pursuant to the
Consent Agreement. In order to ensure
that the Commission remains informed
about the status of the transfer of rights
and assets, the Consent Agreement
requires Actavis and Forest to file
reports with the interim monitor who
will report in writing to the Commission
concerning performance by the parties
of their obligations under the Consent
Agreement.
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. 2014–16147 Filed 7–9–14; 8:45 am]
BILLING CODE 6750–01–P
FEDERAL TRADE COMMISSION
[File No. 122 3016]
L’Ore´ al USA, Inc.; Analysis of
Proposed Consent Order 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 or
deceptive acts or practices. The attached
Analysis of Proposed Consent Order to
Aid Public Comment describes both the
allegations in the draft complaint and
the terms of the consent order—
embodied in the consent agreement—
that would settle these allegations.
DATES : Comments must be received on
or before July 30, 2014.
ADDRESSES : Interested parties may file a
comment at https://ftcpublic
.commentworks.com/ftc/l’orealconsent
online or on paper, by following the
instructions in the Request for Comment
part of the SUPPLEMENTARY INFORMATION
section below. Write ‘‘L’Ore´al USA,
Inc.—Consent Agreement; File No. 122
3016’’ on your comment and file your
comment online at https://
ftcpublic.commentworks.com/ftc/
l’orealconsent 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:
Elizabeth Nach, Bureau of Consumer
Protection, (202–326–2611), 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 consent
order to cease and desist, having been
filed with and accepted, subject to final
approval, by the Commission, has been
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