Schering Plough Corporation Analysis of Agreement Containing bronchitis

Document Sample
Schering Plough Corporation Analysis of Agreement Containing  bronchitis Powered By Docstoc
					                      Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices                                        67727

will have to pay the EZ Fuel fee,            ‘‘sunsetting’’ the order after twenty (20)               U.S. postal mail in the Washington area
regardless of whether they return the        years, with certain exceptions.                          and at the Commission is subject to
vehicle with a full gas tank, unless they       The purpose of this analysis is to                    delay due to heightened security
present a gas receipt.                       facilitate public comment on the                         precautions. Comments that do not
   The complaint further alleges that        proposed order, and it is not intended                   contain any nonpublic information may
Budget failed to disclose and failed to      to modify the terms of the proposed                      instead be filed in electronic form as
disclose adequately that consumers who       order in any way.                                        part of or as an attachment to email
drive their rental vehicle fewer than 75        By direction of the Commission.                       messages directed to the following email
miles and refuel can have the EZ Fuel                                                                 box:
                                             Donald S. Clark,
fee reversed only if they present a fuel                                                                 The FTC Act and other laws the
receipt. In addition, Budget failed to                                                                Commission administers permit the
                                             [FR Doc. E7–23293 Filed 11–29–07: 8:45 am]
disclose that consumers without                                                                       collection of public comments to
                                             BILLING CODE 6750–01–S
corporate accounts would have to                                                                      consider and use in this proceeding as
present their fuel receipt inside at the                                                              appropriate. All timely and responsive
rental counter after returning their                                                                  public comments, whether filed in
                                             FEDERAL TRADE COMMISSION
rental vehicle and checking out on the                                                                paper or electronic form, will be
return lot. These facts would be material    [File No. 071 0132]                                      considered by the Commission, and will
to consumers in their rental transaction.                                                             be available to the public on the FTC
The failure to disclose these facts, in      Schering-Plough Corporation;                             website, to the extent practicable, at
light of the representations made, was a     Analysis of Agreement Containing                As a matter of discretion,
deceptive practice.                          Consent Orders to Aid Public                             the FTC makes every effort to remove
   The proposed order contains               Comment                                                  home contact information for
provisions designed to prevent Budget        AGENCY:    Federal Trade Commission.                     individuals from the public comments it
from engaging in similar acts and            ACTION:   Proposed Consent Agreement.                    receives before placing those comments
practices in the future. Part I prohibits                                                             on the FTC website. More information,
Budget from misrepresenting (A) that         SUMMARY:   The consent agreement in this                 including routine uses permitted by the
renters who return their vehicle with a      matter settles alleged violations of                     Privacy Act, may be found in the FTC’s
full tank of gas will not incur any fuel-    federal law prohibiting unfair or                        privacy policy, at
related charges; (B) any fuel-related        deceptive acts or practices or unfair                    ftc/privacy.htm.
charge, fee, cost, or requirement; or, (C)   methods of competition. The attached                     FOR FURTHER INFORMATION CONTACT:
any charge, fee, or cost, or term or         Analysis to Aid Public Comment                           Jacqueline K. Mendel, Bureau of
condition, relating to the rental of any     describes both the allegations in the                    Competition, 600 Pennsylvania Avenue,
vehicle.’’ Part II of the proposed order     draft complaint and the terms of the                     NW, Washington, D.C. 20580, (202)
requires that Budget disclose, clearly       consent order—embodied in the consent                    326–2603.
and conspicuously, at the time of rental     agreement—that would settle these
transaction: (A) any fuel related charges,   allegations.                                             SUPPLEMENTARY INFORMATION:      Pursuant
fee, or costs; (B) any material                                                                       to section 6(f) of the Federal Trade
                                             DATES:  Comments must be received on                     Commission Act, 38 Stat. 721, 15 U.S.C.
requirements related to the fuel-related
                                             or before December 19, 2007.                             46(f), and § 2.34 of the Commission
charge; and (C) the manner, if any, in
which the renter can avoid such fuel-        ADDRESSES: Interested parties are                        Rules of Practice, 16 CFR 2.34, notice is
related charges. Finally, Part III of the    invited to submit written comments.                      hereby given that the above-captioned
proposed order prohibits Budget from         Comments should refer to ‘‘Schering-                     consent agreement containing a consent
making any representation about the          Plough, File No. 071 0132,’’ to facilitate               order to cease and desist, having been
benefits, costs, or parameters of any        the organization of comments. A                          filed with and accepted, subject to final
fuel-related option unless it discloses      comment filed in paper form should                       approval, by the Commission, has been
clearly and conspicuously, and in close      include this reference both in the text                  placed on the public record for a period
proximity to the representation, any         and on the envelope, and should be                       of thirty (30) days. The following
material terms or conditions relating to     mailed or delivered to the following                     Analysis to Aid Public Comment
that fuel option. These conduct              address: Federal Trade Commission/                       describes the terms of the consent
provisions prohibit the deceptive            Office of the Secretary, Room 135-H,                     agreement, and the allegations in the
practices alleged in the complaint, but      600 Pennsylvania Avenue, N.W.,                           complaint. An electronic copy of the
do not prohibit Budget from imposing         Washington, D.C. 20580. Comments                         full text of the consent agreement
fuel-related charges, so long as such        containing confidential material must be                 package can be obtained from the FTC
charges are disclosed as required by the     filed in paper form, must be clearly                     Home Page (for November 16, 2007), on
proposed order.                              labeled ‘‘Confidential,’’ and must                       the World Wide Web, at http://
   Parts IV through VII of the proposed      comply with Commission Rule 4.9(c).             A
order are reporting and compliance           16 CFR 4.9(c) (2005).1 The FTC is                        paper copy can be obtained from the
provisions. Part IV requires Budget to       requesting that any comment filed in                     FTC Public Reference Room, Room 130–
retain documents relating to its             paper form be sent by courier or                         H, 600 Pennsylvania Avenue, NW,
compliance with the order. Part V            overnight service, if possible, because                  Washington, D.C. 20580, either in
requires dissemination of the order now                                                               person or by calling (202) 326–2222.
                                               1 The comment must be accompanied by an
and in the future to persons with            explicit request for confidential treatment,
                                                                                                         Public comments are invited, and may
responsibilities relating to the subject     including the factual and legal basis for the request,   be filed with the Commission in either
matter of the order. Part VI ensures         and must identify the specific portions of the           paper or electronic form. All comments
notification to the FTC of changes in        comment to be withheld from the public record.           should be filed as prescribed in the
                                             The request will be granted or denied by the
corporate status. Part VII mandates that     Commission’s General Counsel, consistent with
                                                                                                      ADDRESSES section above, and must be
Budget submit compliance reports to the      applicable law and the public interest. See              received on or before the date specified
FTC. Part VIII is a provision                Commission Rule 4.9(c), 16 CFR 4.9(c).                   in the DATES section.
67728                  Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices

Analysis of Agreement Containing              replacing the lost competition that         cholera vaccines, and the only providers
Consent Order to Aid Public Comment           would result from the acquisition in        of a PM-1 strain of the vaccine. Organon
   The Federal Trade Commission               each of these markets.                      BioSciences is the market leader with its
(‘‘Commission’’) has accepted, subject to                                                 CHOLERVAC-PM-1 product, accounting
                                              The Products and Structure of the
final approval, an Agreement                                                              for approximately fifty-three percent of
Containing Consent Orders (‘‘Consent                                                      the live fowl cholera vaccines sold in
                                                 The markets for the Georgia 98 strain    the United States. Schering-Plough is
Agreement’’) from Schering-Plough             of infectious bronchitis, fowl cholera,
Corporation (‘‘Schering-Plough’’), which                                                  the second leading supplier with its PM-
                                              and live MG vaccines are highly             ONEVAC-C and M-NINEVAX products,
is designed to remedy the                     concentrated, with Schering-Plough and
anticompetitive effects of its acquisition                                                accounting for thirty-two percent of
                                              Intervet accounting for significant         sales in the market. Together, Schering-
of Organon BioSciences N.V. (‘‘Organon        market shares in each of these markets.
BioSciences’’) from Akzo-Nobel N.V.                                                       Plough and Organon BioSciences
                                              The proposed acquisition would create       account for approximately eighty-five
(‘‘Akzo-Nobel’’). Under the terms of the      a monopolist in the live Georgia 98         percent of the sales in this highly
proposed Consent Agreement, Schering-         vaccine market and would give               concentrated market. Accordingly, the
Plough would be required to divest to         Schering-Plough shares of                   Acquisition would significantly increase
Wyeth: (1) the Schering-Plough rights         approximately eighty-five percent and       the concentration levels in the United
and assets necessary to develop,              seventy-two percent in the markets for      States in the market for live vaccines for
manufacture, and market live vaccines         live fowl cholera and live MG vaccines,     the prevention and treatment of fowl
for the prevention and treatment of the       respectively.                               cholera due to Pasteurella multocida in
Georgia 98 strain of infectious                  The Georgia 98 strain of infectious      poultry.
bronchitis virus in poultry; (2) the rights   bronchitis is a highly contagious              MG is a respiratory disease that is
and assets necessary to develop,              respiratory disease in poultry spread by    transmitted laterally between chickens
manufacture, and market live vaccines         contact with infected respiratory           or through infected eggs. The relevant
for the prevention and treatment of fowl      discharge and feces. Live Georgia 98        market for the manufacture,
cholera due to Pasteurella multocida in       vaccines are the only vaccines that can     distribution, and sale of live
poultry; and (3) the rights and assets        effectively prevent and treat the Georgia   Mycoplasma gallisepticum vaccines in
necessary to develop, manufacture, and        98 strain of infectious bronchitis virus.   the United States is highly concentrated.
market live vaccines for the prevention       Other infectious bronchitis virus           Respondent Schering-Plough and
and treatment of Mycoplasma                   vaccine strains, administered either        Organon BioSciences are the two
gallisepticum (‘‘MG’’) in poultry.            individually or in multiple-antigen         leading suppliers of live vaccines for the
   The proposed Consent Agreement has         combination vaccines, do not provide        prevention and treatment of
been placed on the public record for          adequate protection against the Georgia     Mycoplasma gallisepticum in poultry in
thirty (30) days for receipt of comments      98 serotype to act as a sufficient          the United States. Akzo Nobel is the
by interested persons. Comments               alternative to the live Georgia 98          market leader with its MYCOVAC-L
received during this period will become       vaccines. The relevant market for the       product, while Schering Plough
part of the public record. After thirty       manufacture, distribution, and sale of      competes with its F-VAX MG. Together,
(30) days, the Commission will again          live vaccines for the prevention and        they account for over seventy-two
review the proposed Consent Agreement         treatment of the Georgia 98 strain of       percent of the sales in this highly
and the comments received, and will           infectious bronchitis virus in poultry in   concentrated market. Accordingly, the
decide whether it should withdraw from        the United States is highly concentrated.   Acquisition would significantly increase
the proposed Consent Agreement,               Respondent Schering-Plough and              theconcentration levels in the United
modify it, or make final the Decision         Organon BioSciences are the only            States in the market for live vaccines for
and Order (‘‘Order’’).                        suppliers of live vaccines for the          the prevention and treatment of
   Pursuant to the terms of a Letter of       prevention and treatment of the Georgia     Mycoplasma gallisepticum in poultry.
Intent dated March 12, 2007, Schering-        98 strain of infectious bronchitis virus
Plough proposes to acquire from Akzo          in poultry in the United States.            Entry
Nobel 100 percent of the outstanding          Schering-Plough’s Avimune IB98                Entry into any relevant line of
shares of Organon BioSciences voting          product is the market leader with an        commerce would not be timely, likely,
stock. The Commission’s Complaint             estimated seventy-nine percent market       or sufficient to deter or counteract the
alleges that the proposed acquisition, if     share, while Intervet competes with its     anticompetitive effects of the
consummated, would violate Section 7          MILDVAC GA-98 product, selling the          Acquisition. Entry into any of these
of the Clayton Act, as amended, 15            remaining twenty-one percent in the         markets would require overcoming three
U.S.C. § 18, and Section 5 of the Federal     United States. The acquisition would        major obstacles: lengthy development
Trade Commission Act, as amended, 15          create a monopoly by combining the          periods, USDA approval requirements,
U.S.C. § 45, by lessening competition in      only two companies with products on         and customer acceptance. As a result,
the U.S. markets for the manufacture          the market.                                 new entry into any of these markets
and sale of the following poultry                Live fowl cholera vaccines prevent an    sufficient to achieve a significant market
vaccines: (1) live vaccines for the           infectious bacterial disease in poultry     impact within two years is unlikely.
prevention and treatment of the Georgia       caused by a common pathogenic
98 strain of infectious bronchitis virus      bacterium, Pasteurella multocida. The       Effects
in poultry; (2) live vaccines for the         relevant market for the manufacture,          The markets for the Georgia 98 strain
prevention and treatment of fowl              distribution, and sale of live vaccines     of infectious bronchitis, fowl cholera,
cholera due to Pasteurella multocida in       for the prevention and treatment of fowl    and MG live vaccines are highly
poultry; and (3) live vaccines for the        cholera due to Pasteurella multocida in     concentrated, with Schering-Plough and
prevention and treatment of                   poultry in the United States is highly      Intervet accounting for substantial
Mycoplasma gallisepticum in poultry.          concentrated. Respondent Schering-          shares of sales in each of these markets.
The proposed Consent Agreement will           Plough and Organon BioSciences are          The proposed acquisition would create
remedy the alleged violations by              two of only three suppliers of live fowl    a monopolist in the live Georgia 98
                      Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices                              67729

vaccine market and would give                products and animal health care              experience resolving disputes between
Schering-Plough shares of                    products. In 2006, it had net sales of $20   companies and the USDA.
approximately eighty-five percent and        billion. Wyeth’s Fort Dodge Animal              Dr. Espeseth is an excellent candidate
seventy-two percent in the markets for       Health division offers a broad range of      to handle the expected duties and
live fowl cholera vaccine and live MG        biological and pharmaceutical products       responsibilities of the Interim Monitor
vaccines, respectively.                      for the companion animal, equine,            Trustee in this matter. He has the
   The competitive concerns can be           livestock, swine and poultry industries.     requisite capability and applicable
characterized as unilateral in nature.       Significantly, Wyeth already has an          knowledge to ensure the proper transfer
Schering-Plough and Organon                  established poultry vaccine line             of the divested assets, oversee the
BioSciences are each other’s closest         comprised of internally developed            transfer of the relevant technology,
competitors in all of the relevant           vaccines as well as several vaccines that    monitor the critical manufacturing and
markets. Consumers have benefitted           it has acquired and transferred to its       supply activities of the Respondent,
from the price competition between           manufacturing facilities. Fort Dodge has     ensure the Respondent’s compliance
Schering-Plough and Organon                  its own distribution network and an          with the Order and related agreements,
BioSciences. If unremedied, the              experienced sales force with existing        respond to Commission needs, and
proposed acquisition would likely cause      relationships with major poultry             perform other related services as may be
higher prices and reduce incentives to       producers. The three vaccines being          required. Accordingly, the Commission
improve service or product quality,          divested to Fort Dodge are all               has appointed Dr. Espeseth as the
resulting in significant harm to             established products that have been on       Interim Monitor Trustee.
consumers in the U.S. markets for these      the market for at least two years. Fort         The purpose of this analysis is to
vaccines.                                    Dodge has its own manufacturing              facilitate public comment on the
The Consent Agreement                        facilities with excess capacity and          proposed Consent Agreement, and it is
                                             intends to bring the manufacturing of all    not intended to constitute an official
   The proposed Consent Agreement                                                         interpretation of the proposed Order or
                                             of the products it is acquiring from
remedies the competitive harm caused                                                      to modify its terms in any way.
                                             Schering-Plough in-house. For these
by the proposed transaction. Pursuant to                                                     By direction of the Commission.
                                             reasons, Wyeth is a strong buyer that
the Consent Agreement, Schering-
                                             appears well positioned to replace the       Donald S. Clark,
Plough must divest or license all of the
                                             competition lost by the acquisition.         Secretary.
assets relating to Schering-Plough’s live
vaccine for the Georgia 98 strain of            If the Commission determines that         [FR Doc. E7–23291 Filed 11–29–07: 8:45 am]
infectious bronchitis (Avimune IB98),        Wyeth is not an acceptable acquirer of       BILLING CODE 6750–01–S
Intervet’s live fowl cholera vaccine         the assets to be divested, the parties
(CHOLERVAC-PM-1) and Schering-               must unwind the sale and divest the
Plough’s live MG vaccine (F VAX-             Products within six months of the date
                                                                                          DEPARTMENT OF HEALTH AND
MG)(‘‘the assets to be divested’’), to the   the Order becomes final to another
                                                                                          HUMAN SERVICES
Fort Dodge division of Wyeth, within         Commission-approved acquirer. If the
ten days after the date Schering-Plough      parties fail to divest within six months,    Meeting of the National Biodefense
acquires Organon BioSciences. The            the Commission may appoint a trustee         Science Board
assets to be divested include research       to divest the Product assets.
                                                The proposed remedy contains              AGENCY:  Office of the Secretary,
and development, customer, supplier
                                             several provisions to ensure that the        Department of Health and Human
and manufacturing contracts and any
                                             divestitures are successful. The Order       Services.
intellectual property including existing
licenses, but excluding trademarks. Fort     requires Schering-Plough to provide          ACTION: Notice.
Dodge plans to bring all manufacturing       transitional services to enable the
                                                                                          SUMMARY:   As stipulated by the Federal
of the three vaccines in-house to its own    Commission-approved acquirer to
                                                                                          Advisory Committee Act, the
manufacturing facilities and to add the      obtain all of the necessary approvals
                                                                                          Department of Health and Human
three to its own portfolio of poultry        from the USDA. These transitional
                                                                                          Services is hereby giving notice that the
vaccines. While Fort Dodge undertakes        services include technology transfer
                                                                                          National Biodefense Science Board
the process of obtaining USDA                assistance to manufacture the Products
                                                                                          (NBSB) will be holding its inaugural
regulatory approvals and bringing            in substantially the same manner and
                                                                                          meeting. The meeting is open to the
vaccine production in-house, Schering-       quality employed or achieved by
Plough will provide Fort Dodge with the      Schering-Plough and Akzo-Nobel.
                                                The Commission has appointed Dr.          DATES: The meeting will be held on
vaccines pursuant to a supply and
transition services agreement with a         David A. Espeseth to oversee the             December 17, 2007, from 9 a.m. to 5
term of two years, and an option to          implementation of the Order as the           p.m., and on December 18, 2007, from
extend it another year, individually for     Interim Monitor Trustee. Dr. Espeseth        9 a.m. to 5 p.m.
each of the three vaccines, if required.     retired in 1998 from a career at the         ADDRESSES: The Ronald Reagan
   The acquirer of the divested assets       USDA, where his last position was as         Building and International Trade
must receive the prior approval of the       Special Assistant to the Deputy              Center, Atrium Ballroom, 1300
Commission. The Commission’s goal in         Administrator of Veterinary Services         Pennsylvania Avenue, NW.,
evaluating possible purchasers of            and where he spent the majority of his       Washington, DC 2004. Phone: 202–312–
divested assets is to maintain the           37 years regulating veterinary biologic      1300.
competitive environment that existed         products (vaccines). Today, he is a          FOR FURTHER INFORMATION CONTACT:
prior to the acquisition. A proposed         consultant to animal health companies,       CAPT Leigh A. Sawyer, DVM, MPH,
acquirer of divested assets must not         assisting with regulatory issues before      Executive Director, National Biodefense
itself present competitive problems.         the USDA and technology transfers. Dr.       Science Board, Office of the Assistant
   Wyeth, headquartered in Madison,          Espeseth’s strengths are his strong          Secretary for Preparedness and
New Jersey, is a global leader in            regulatory background, his experience        Response, U.S. Department of Health
pharmaceuticals, consumer health care        overseeing technology transfers, and         and Human Services, 200 Independence