[Federal Register Volume 60, Number 2 (Wednesday, January 4, 1995)]
[Notices]
[Pages 459-464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-96]
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[[Page 460]]
FEDERAL TRADE COMMISSION
[[File No. 951 0015]
Wright Medical Technology, Inc., et al.; Proposed Consent
Agreement with Analysis to Aid Public Comment
agency: Federal Trade Commission.
action: Proposed consent agreement.
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summary: In settlement of alleged violations of federal law prohibiting
unfair acts and practices and unfair methods of competition, this
consent agreement, accepted subject to final Commission approval, would
require, among other things, a Tennessee-based research and development
corporation to transfer to the Mayo Foundation, the licensor of the
implant technology to Orthomet, Inc., a complete copy of all assets
relating to Orthomet's business of researching and developing
orthopaedic implants for use in human hands, and would also require
Wright Medical Technology to obtain Commission approval before
acquiring any interest in any firm that has received, or has applied
for, Food and Drug Administration approval to market orthopaedic hand
implants in the United States.
dates: Comments must be received on or before March 6, 1995.
addresses: Comments should be directed to: FTC/Office of the Secretary,
Room 159, 6th St. and Pa. Ave., N.W., Washington, D.C. 20580.
for further information contact: Richard Dagen or Benjamin Tahyar, FTC/
S-2627, Washington, D.C. 20580. (202) 326-2628 or 326-2889.
supplementary information: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Section 2.34 of
the Commission's Rules of Practice (16 CFR 2.34), notice is hereby
given that the following 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 sixty (60) days. Public comment is invited. Such
comments or views will be considered by the Commission and will be
available for inspection and copying at its principal office in
accordance with Section 4.9(b)(6)(ii) of the Commission's Rules of
Practice (16 CFR 4.9(b)(6)(ii)).
Agreement Containing Consent Order
In the Matter of Wright Medical Technology, Inc., a corporation,
Kidd, Kamm Equity Partners, L.P., a limited partnership, Kidd, Kamm
Investments, L.P., a limited partnership, and Kidd, Kamm
Investments, Inc., a corporation.
The Federal Trade Commission (``Commission''), having initiated an
investigation of the acquisition of all the outstanding shares of
common and convertible preferred stock of Orthomet, Inc. (``Orthomet'')
by Wright Medical Technology, Inc. (``WMTI''), a subsidiary of Kidd,
Kamm Equity Partners, Inc. (``KKEP''), KKEP's general partner, Kidd,
Kamm Investments, L.P. (``KKI''), and KKI's general partner, Kidd, Kamm
Investments, Inc. (``KKI, Inc.''), and it now appearing that WMTI,
KKEP, KKI, and KKI, Inc., hereinafter sometimes referred to as
``Proposed Respondents,'' are willing to enter into an Agreement
Containing Consent Order (``Agreement'') to (i) divest and license
certain assets, (ii) cease and desist from certain acts, and (iii)
provide for certain other relief:
It is hereby agreed by and between Proposed Respondents, by their
duly authorized officers and their attorneys, and counsel for the
Commission that:
1. Proposed Respondent WMTI is a corporation organized, existing,
and doing business under and by virtue of the laws of the State of
Delaware, with its principal place of business located at 5677 Airline
Road, Arlington, Tennessee 38002.
2. Proposed Respondent KKEP is a limited partnership organized,
existing, and doing business under and by virtue of the laws of the
State of Delaware, with its principal place of business located at
Three Pickwick Plaza, Greenwich, Connecticut 06830.
3. Proposed Respondent KKI is a corporation organized, existing,
and doing business under and by virtue of the laws of the State of
Delaware, with its principal place of business located c/o Kidd, Kamm &
Company, 9454 Wilshire Boulevard, Suite 920, Beverly Hills, California
90212.
4. Proposed Respondent KKI, Inc. is a corporation organized,
existing, and doing business under and by virtue of the laws of the
State of Delaware, with its principal place of business located at
Kidd, Kamm & Company, 9454 Wilshire Boulevard, Suite 920, Beverly
Hills, California 90212.
5. Proposed Respondents admit all the jurisdictional facts set
forth in the draft of complaint.
6. Proposed Respondents waive:
(a) any further procedural steps;
(b) the requirement that the Commission's decision contain a
statement of findings of fact and conclusions of law;
(c) all rights to seek judicial review or otherwise to challenge or
contest the validity of the order pursuant to this Agreement; and
(d) any claims under the Equal Access to Justice Act.
7. This Agreement shall not become part of the public record of the
proceeding unless and until it is accepted by the Commission. If this
Agreement is accepted by the Commission it, together with the draft of
complaint contemplated thereby, will be placed on the public record for
a period of sixty (60) days and information in respect thereto publicly
released. The Commission thereafter may either withdraw its acceptance
of this Agreement and so notify the Proposed Respondents, in which
event it will take such action as it may consider appropriate, or issue
and serve its complaint (in such form as the circumstances may require)
and decision, in disposition of the proceeding.
8. This Agreement is for settlement purposes only and does not
constitute an admission by the Proposed Respondents that the law has
been violated as alleged in the draft of complaint, or that the facts
as alleged in the draft complaint, other than jurisdictional facts, are
true.
9. This Agreement contemplates that, if it is accepted by the
Commission, and if such acceptance is not subsequently withdrawn by the
Commission pursuant to the provisions of Section 2.34 of the
Commission's Rules, the Commission may, without further notice to
Proposed Respondents, (1) issue its complaint corresponding in form and
substance with the draft of complaint and its decision containing the
following Order to divest and license and to cease and desist in
disposition of the proceeding, and (2) make information public with
respect thereto. When so entered, the Order shall have the same force
and effect and may be altered, modified, or set aside in the same
manner and within the same time provided by statute for other orders.
The Order shall become final upon service. Delivery by the United
States Postal Service of the complaint and decision containing the
agreed-to Order to Proposed Respondents' addresses as stated in this
Agreement shall constitute service. Proposed Respondents waive any
right they may have to any other manner of service. The complaint may
be used in construing the terms of the Order, and no agreement,
understanding, representation, or interpretation not contained in the
Order or the Agreement may be used to vary or contradict the terms of
the Order.
10. Proposed Respondents have read the proposed complaint and Order
contemplated hereby. Proposed Respondents understand that once the
[[Page 461]] Order has been issued, they will be required to file one
or more compliance reports showing they have fully complied with the
Order. Proposed Respondents further understand that they may be liable
for civil penalties in the amount provided by law for each violation of
the Order after it becomes final.
Order
I.
It is ordered that, as used in this Order, the following
definitions shall apply:
A. ``WMTI'' means Wright Medical Technology, Inc., its
subsidiaries, divisions, groups and affiliates controlled by WMTI, and
their respective directors, officers, employees, agents and
representatives, and their respective successors and assigns.
B. ``KKEP'' means Kidd, Kamm Equity Partners, L.P., its
subsidiaries (including WMTI), divisions, groups and affiliates
controlled by KKEP, and their respective general partners, directors,
officers, employees, agents and representatives, and their respective
successors and assigns.
C. ``KKI'' means Kidd, Kamm Investments, L.P., its divisions,
groups and affiliates controlled by KKI, and their respective general
partners, directors, officers, employees, agents and representatives,
and their respective successors and assigns.
D. ``KKI, Inc.'' means Kidd, Kamm Investments, Inc., its
subsidiaries, divisions, groups and affiliates controlled by KKI, Inc.,
and their respective directors, officers, employees, agents and
representatives, and their respective successors and assigns.
E. ``Orthomet'' means Orthomet, Inc., a corporation organized,
existing, and doing business under and by virtue of the laws of the
State of Minnesota, with its principal place of business located at
6301 Cecilia Circle, Minneapolis, Minnesota 55439.
F. ``Respondents'' mean WMTI, KKEP, KKI, and KKI, Inc.
G. ``Commission'' means the Federal Trade Commission.
H. ``Acquisition'' means the acquisition by WMTI of outstanding
shares of stock of Orthomet pursuant to a cash tender offer commenced
on October 17, 1994.
I. ``Mayo'' means the Mayo Foundation for Medical Education and
Research, a Minnesota Charitable Corporation, with its principal place
of business located at 200 First Street SW, Rochester, Minnesota 55439.
J. ``Mayo PIP Orthopaedic Finger Implant Design'' means the Mayo
proximal interphalangeal prosthesis design together with modifications,
enhancements, and improvements, whether or not patentable, that is the
subject of a technology license contract between Mayo and Orthomet
dated as of December 24, 1992.
K. ``Mayo MCP Orthopaedic Finger Implant Design'' means the
metacarpophalangeal prosthesis design developed as a cooperative effort
between Mayo and Orthomet, together with modifications, enhancements,
and improvements, whether or not patentable, that is the subject of a
technology license contract between Mayo and Orthomet dated as of May
1, 1993.
L. ``Mayo CMC Orthopaedic Finger Implant Design'' means the
carpometacarpal prosthesis design developed as a cooperative effort
between Mayo and Orthomet, together with modifications, enhancements,
and improvements, whether or not patentable, that is the subject of a
technology license contract between Mayo and Orthomet dated as of May
1, 1993.
M. ``Licensed Inventions'' means (1) the Mayo PIP Orthopaedic
Finger Implant Design, (2) the Mayo MCP Orthopaedic Finger Implant
Design, and (3) the Mayo CMC Orthopaedic Finger Implant Design.
N. ``Technology License Contracts'' means the contracts between
Mayo and Orthomet (1) relating to the Mayo PIP Orthopaedic Finger
Implant Design and any amendments thereto, (2) relating to the Mayo MCP
Orthopaedic Finger Implant Design and any amendments thereto, and (3)
relating to the Mayo CMC Orthopaedic Finger Implant Design and any
amendments thereto.
O. ``Orthopaedic Finger Implants'' means orthopaedic implants
designed for use in the proximal interphalangeal joint, the
metacarpophalangeal joint, and the carpometacarpal joint of the human
hand.
P. ``Orthomet/Mayo Orthopaedic Finger Implant Business'' means
Orthomet''s or WMTI's business of researching and developing
Orthopaedic Finger Implants for eventual commercialization based upon
the Licensed Inventions.
Q. ``Orthomet/Mayo Orthopaedic Finger Implant Research Assets''
means all tangible and intangible assets constituting or otherwise
relating to the Orthomet/Mayo Orthopaedic Finger Implant Business,
including but not limited to:
1. All books, records, CAD files and other documents;
2. All data, materials, and information relating to the Orthomet/
Mayo Orthopaedic Finger Implant Business, including, but not limited
to, FDA approvals for Orthopaedic Finger Implants, list of clinicians,
clinical testing, surgical techniques and protocols, surgical
instrumentation design development, and biomechanical materials;
3. All intellectual property, including, but not limited to,
patents and patent applications, formulas, processes, technology, know-
how, trade secrets, manufacturing information, specifications, plans,
drawings, designs and data, product prototypes, and other tangible
embodiments of know-how, including, but not limited to, the technology
and know-how required to manufacture commercially acceptable products;
and
4. All products testing and laboratory research data and samples,
including, but not limited to, bench testing, wear testing, and
materials testing.
R. ``Orthopaedic Finger Implant Licensee'' means the party or
parties, other than Respondents, to whom Mayo licenses the Licensed
Inventions.
S. ``FDA'' means the United States Food and Drug Administration.
T. ``510(k) Application'' means an application made to the FDA
pursuant to 21 U.S.C. Sec. 350(k), or successor provisions.
U. ``IDE Application'' means an application made to the FDA
pursuant to 21 C.F.R. Sec. 812.20, or successor provisions, for an
investigational device exemption.
II.
It is further ordered That: A. Within five (5) days after the date
this Order becomes final, Respondents shall:
1. Transfer to Mayo a full and complete copy of the Orthomet/Mayo
Orthopaedic Finger Implant Research Assets;
2. Grant Mayo a license to such assets, where applicable, with full
right of sublicense thereunder, in perpetuity; and
3. Make any and all such arrangements and transfers as are
necessary to enable Mayo to license an Orthopaedic Finger Implant
Licensee.
B. Upon reasonable notice and request from the Orthopaedic Finger
Implant Licensee, Respondents shall provide reasonable assistance to
the Orthopaedic Finger Implant Licensee regarding the Orthomet/Mayo
Orthopaedic Finger Implant Research Assets transferred pursuant to
Paragraph II.A of this Order. Such assistance shall include
consultation with knowledgeable employees of Respondents as the
Orthopaedic Finger Implant Licensee's facilities or at such other place
as is [[Page 462]] mutually satisfactory to Respondents and the
Orthopaedic Finger Implant Licensee for a period of time sufficient to
satisfy the Orthopaedic Finger Implant Licensee's management. However,
Respondents shall not be required to continue providing such assistance
for more than six (6) months. Respondents may require reimbursement
from the Orthopaedic Finger Implant Licensee for all the actual hourly
cost of pay and benefits for Respondents' personnel providing the
assistance and, if travel is required, the travel cost and per diem
subsistence incurred by Respondents in providing the assistance to the
Orthopaedic Finger Implant Licensee.
C. Pending the transfer (and licensing, where applicable) of
Orthomet/Mayo Orthopaedic Finger Implant Research Assets, Respondents
shall take such actions as are necessary to maintain the viability and
marketability of Orthomet/Mayo Orthopaedic Finger Implant Research
Assets and to prevent the destruction, removal, wasting, deterioration,
or impairment of Orthomet/Mayo Orthopaedic Finger Implant Research
Assets except for ordinary wear and tear.
III.
It is further ordered That: A. If Respondents do not, within six
(6) months of the date this Order becomes final, obtain the
Commission's approval for an Orthopaedic Finger Implant Licensee
pursuant to the procedures set forth in Sec. 2.41(f) of the
Commission's Rules of Practice, 16 C.F.R. Sec. 2.41(f), Respondents
shall:
1. Take whatever steps are necessary to effect the immediate
termination of the Technology License Contracts within five (5) days
after the end of the six (6)-month period;
2. After the termination of the Technology Licensee Contracts,
refrain from entering into any agreement of any sort with Mayo relating
to the Licensed Inventions or to the Orthomet/Mayo Orthopaedic Finger
Implant Research Assets; and
3. Within ten (10) days of the termination of the Technology
License Contracts ordered in this Paragraph, divest to Mayo absolutely
and in good faith the Orthomet/Mayo Orthopaedic Finger Implant Research
Assets and grant Mayo, where applicable, a license to such assets with
full right of sublicense thereunder, in perpetuity. Respondents shall
retain no interest or rights in the Orthomet/Mayo Orthopaedic Finger
Implant Research Assets. Mayo shall have the exclusive power and
authority to grant a license relating to the Licensed Inventions.
The purpose of licensing an Orthopaedic Finger Implant Licensee
other than Respondents is to ensure the continuation of the Orthomet/
Mayo Orthopaedic Finger Implant Research Assets as an ongoing research
project for Orthopaedic Finger Implants to be approved by the FDA for
sale in the United States and to remedy the lessening of competition
resulting from the Acquisition as alleged in the Commission's
complaint.
B. Upon reasonable notice and request from the Orthopaedic Finger
Implant Licensee, Respondents shall provide reasonable assistance to
the Orthopaedic Finger Implant Licensee regarding the Orthomet/Mayo
Orthopaedic Finger Implant Research Assets divested pursuant to
Paragraph III.A of this Order. Such assistance shall include
consultation with knowledgeable employees of Respondents at the
Orthopaedic Finger Implant Licensee's facilities or at such other place
as is mutually satisfactory to Respondents and the Orthopaedic Finger
Implant Licensee for a period of time sufficient to satisfy the
Orthopaedic Finger Implant Licensee's management. However, Respondents
shall not be required to continue providing such assistance for more
than six (6) months. Respondents may require reimbursement from the
Orthopaedic Finger Implant Licensee for all the actual hourly cost of
pay and benefits for Respondents' personnel providing the assistance,
and, if travel is required, the travel cost and per diem subsistence
incurred by Respondents in providing the assistance to the Orthopaedic
Finger Implant Licensee.
IV.
It is further ordered That Respondents shall not without the prior
approval of the Commission, directly or indirectly, through
subsidiaries, partnerships, or otherwise:
A. For a period of ten (10) years from the date this Order becomes
final, acquire more than 1% of the stock, share capital, equity, or
other interest in any concern, corporate or non-corporate, that (1) has
filed a 510(k) Application or IDE Application relating to Orthopaedic
Finger Implants or, within two (2) years prior to any such proposed
acquisition, has announced publicly its intention to submit either of
such applications, or (2) has received FDA approval relating to
Orthopaedic Finger Implants.
B. For a period of ten (10) years from the date this Order becomes
final, acquire any assets (including, but not limited to, any
technology, know-how, and other intellectual property) that relate to
Orthopaedic Finger Implants (1) for which a 510(k) Application or IDE
Application has been filed or for which the intention to file such
applications has been publicly announced within two (2) years prior to
any such proposed acquisition, or (2) for which FDA approval has been
received. The foregoing prohibition shall not apply to (i) the
acquisition of materials, supplies, inventory, testing equipment or
manufacturing equipment in the ordinary course of business, or (ii) the
acquisition of product evaluations and product testing and laboratory
research data (relating to Orthopaedic Finger Implants owned by
Respondents), including, but not limited to, bench testing, wear
testing and materials testing, from outside laboratories, outside
testing facilities or other third parties, in the ordinary course of
Respondents' business.
C. For a period of ten (10) years from the date the Technology
License Contracts are terminated pursuant to Paragraph III.A of this
Order, enter into any agreement with Mayo relating to Orthopaedic
Finger Implants.
V.
It is further ordered That,
A. Within sixty (60) days after the date this Order becomes final
and every sixty (60) days thereafter until Respondents have fully
complied with the provisions of Paragraphs II and III of this Order,
Respondents shall submit to the Commission a verified written report
setting forth in detail the manner and form in which they intend to
comply, are complying, and have complied with Paragraphs II and III of
this Order. Respondents shall include in their compliance reports,
among other things that are required from time to time, a full
description of the efforts being made to comply with these Paragraphs
of this Order, including a description of all substantive contacts or
negotiations undertaken by Respondents, and assistance offered by
Respondents to Mayo for accomplishing the provision (and licensing,
where applicable) of Orthomet/Mayo Orthopaedic Finger Implant Research
Assets required by this Order, including the identity of all parties
contacted by Respondents. Respondents shall include in their compliance
reports copies of all written communications to and from such parties,
all internal memoranda, and all reports and recommendations concerning
the requirements of Paragraphs II and III of this Order.
B. One (1) year from the date this Order becomes final, annually
for the next nine (9) years on the anniversary of the date this Order
becomes final, and [[Page 463]] at other times the Commission may
require, Respondents shall file with the Commission verified written
reports setting forth in detail the manner and form in which they have
complied and are complying with Paragraph IV of this Order.
VI.
It is further Ordered That, for the purpose of determining or
securing compliance with this Order, Respondents shall permit any duly
authorized representatives of the Commission:
A. Access, during office hours and in the presence of counsel, to
inspect and copy all books, ledgers, accounts, correspondence,
memoranda and other records and documents in the possession or under
the control of Respondents, relating to any matters contained in this
consent order; and
B. Upon five (5) days' notice to Respondents, and without restraint
or interference from Respondents, to interview officers of employees of
Respondents.
VII.
It is further Ordered That Respondents shall notify the Commission
at least thirty (30) days prior to any proposed change in Respondents
such as dissolution, assignment, sale resulting in the emergence of a
successor, or the creation or dissolution of subsidiaries or any other
change that may affect compliance obligations arising out of the Order.
VIII.
It is further ordered That, notwithstanding any other provision of
this Order, this Order shall terminate twenty (20) years from the date
this Order becomes final.
Analysis of Proposed Consent Order to Aid Public Comment
The Federal Trade Commission (``Commission'') has accepted
provisionally an agreement containing a proposed Consent Order from
Wright Medical Technology, Inc. (``Wright''), a subsidiary of Kidd,
Kamm Equity Partners, L.P. (``KKEP''), a limited partnership, KKEP's
general partner, Kidd, Kamm Investments, LP (``KKI''), and KKI's
general partner, Kidd, Kamm Investments, Inc. (collectively, the
``Respondents''), under which Respondents would transfer and license
certain assets relating to orthopaedic finger implants as well as cease
and desist from certain acts.
The proposed Consent Order has been placed on the public record for
sixty (60) days for reception of comments by interested people.
Comments received during this period will become part of the public
record. After sixty (60) days the Commission will again review the
agreement and the comments received and will decide whether it should
withdraw from the agreement or make final the agreement's proposed
Order.
On October 17, 1994, Respondents commenced a cash tender offer to
acquire substantially all of the outstanding shares of common and
convertible preferred stock issued by Orthomet, Inc. (``Orthomet'').
The proposed complaint alleges that the proposed acquisition, if
consummated, would constitute a violation of Section 7 of the Clayton
Act, as amended, 15 U.S.C. Sec. 45 in the market for the sale of
orthopaedic implants used or intended for use in the human hand
approved by the United States Food and Drug Administration (``FDA'')
and in the market for the research and development of such orthopaedic
implants.
For the past several years, Orthomet has been the exclusive
licensee of the Mayo Foundation for Medical Education and Research
(``Mayo Foundation'') relating to certain orthopaedic joint implants
used or intended for use in the human hand originally designed by
orthopaedic surgeons working at the Mayo Foundation. During that period
Orthomet worked alongside the Mayo Foundation to develop and refine the
Mayo Foundation's original design with a goal towards eventual
commercialization. As a result of the proposed acquisition, the
exclusive license agreements between Orthomet and the Mayo Foundation
relating to the orthopaedic implants, which have since been made non-
exclusive, would be assigned to Wright.
The proposed Consent Order provides that within five (5) days of
the Order becoming final, Respondents shall transfer to the Mayo
Foundation a complete copy of all assets relating to Orthomet's
business of researching and developing orthopaedic implants used or
intended for use in the human hand and, where applicable, grant to the
Mayo Foundation a license to such assets with full rights of sublicense
in perpetuity. The proposed Consent Order is intended to free the Mayo
Foundation to find another non-exclusive licensee, in addition to
Wright, to develop for eventual commercialization orthopaedic implants
used or intended for use in the human hand.
In the event that the Mayo Foundation has not found another non-
exclusive licensee acceptable to the Commission within six (6) months
of the date the proposed Consent Order becomes final, Respondents shall
take whatever steps are necessary to terminate the license agreements
between the Mayo Foundation and Wright relating to orthopaedic implants
used or intended for use in the human hand and divest to the Mayo
Foundation all assets relating to Orthomet's business of researching
the developing orthopaedic implants used or intended for use in the
human hand. The Mayo foundation shall then be free to license, whether
exclusively or non-exclusively, any firm other than Respondents to
develop for eventual commercialization orthopaedic implants used or
intended for use in the human hand.
Under the provisions of the Order, Respondents are also required to
provide to the Commission a report of their compliance with the
transfer and divestiture provisions of the Order within sixty (60) days
following the date this Order becomes final, and every sixty (60) days
thereafter until Respondents have either transferred or completely
divested all assets relating to Orthomet's business of researching and
developing orthopaedic implants used or intended for use in the human
hand. The proposed Order will also require Respondents to cease and
desist for ten (10) years from acquiring, without Federal Trade
Commission approval, any interest in any firm that either has received
FDA approval to market orthopaedic implants used or intended for use in
the human hand in the United States or has filed a 510(k) or
investigational device exemption (``IDE'') application for approval
from the FDA or has publicly announced its intention to do so. The
proposed Order also requires the Respondents, for ten years, to seek
Federal Trade Commission approval before acquiring any assets relating
to market orthopaedic implants used or intended for use in the human
hand for which a 510(k) or IDE application has been filed or for which
the intention to file such applications has been publicly announced, or
for which FDA approval has been received. Finally, in the event that
Respondents are required to terminate their license agreements with the
Mayo Foundation, the proposed Order will also prohibit Respondents for
ten (10) years from entering into any agreement with the Mayo
Foundation relating to orthopaedic implants used or intended for use in
the human hand, without Federal Trade Commission approval. One year
from the date the Order becomes final and annually thereafter for nine
(9) years, Respondents will be required to provide [[Page 464]] to the
Commission a report of their compliance with the cease and desist
provisions of the proposed Order.
The purpose of this analysis is to facilitate public comment on the
proposed Order, and it is not intended to constitute an official
interpretation of the agreement and proposed Order or to modify in any
way their terms.
Benjamin I. Berman,
Acting Secretary.
[FR Doc. 95-96 Filed 1-3-95; 8:45 am]
BILLING CODE 6750-01-M