[Federal Register Volume 60, Number 60 (Wednesday, March 29, 1995)]
[Notices]
[Pages 16139-16144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7630]
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FEDERAL TRADE COMMISSION
[File No. 951-0054]
Glaxo plc; 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 British drug company to divest, within
nine months, Wellcome's worldwide research and development assets for
certain non-injectable drugs used to treat migraine headaches, or else
agree to have a Commission-appointed trustee complete the transaction.
In addition, the consent agreement would require Glaxo, for a period to
ten years, to obtain Commission approval before acquiring more than a
one percent interest in any entity involved in the clinical
development, manufacture or sale of non-injectable migraine drugs.
DATES: Comments must be received on or before May 30, 1995.
ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,
[[Page 16140]] Room 159, 6th St. and Pa. Ave., NW., Washington, DC
20580.
FOR FURTHER INFORMATION CONTACT:
Claudia Higgins or Ann Malester, FTC/S-2224, Washington, DC 20580.
(202) 326-2682.
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: Glaxo plc, a corporation.
The Federal Trade Commission (``Commission''), having initiated an
investigation of the Acquisition of certain stock of Wellcome plc
(``Wellcome'') by Glaxo plc (``Glaxo''), and it now appearing that
Glaxo, hereinafter sometimes referred to as ``Proposed Respondent,'' is
willing to enter into an Agreement Containing Consent Order to (i)
divest certain assets, (ii) cease and desist from certain acts, and
(iii) provide for certain other relief:
It is hereby agreed by and between Proposed Respondent, by its duly
authorized officers and its attorneys, and counsel for the Commission
that:
1. Proposed Respondent Glaxo is a corporation organized, existing,
and doing business under and by virtue of the laws of England, with its
principal place of business located at Landsdowne House, Berkeley
Square, London W1X 6BQ, England.
2. Proposed Respondent admits all the jurisdictional facts set
forth in the draft of complaint here attached.
3. Proposed Respondent waives:
(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 entered pursuant to this Agreement;
and
(d) Any claim under the Equal Access to Justice Act.
4. 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 Proposed Respondent, 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.
5. This Agreement is for settlement purposes only and does not
constitute an admission by Proposed Respondent that the law has been
violated as alleged in the draft of complaint here attached, or that
the facts as alleged in the draft complaint, other than jurisdictional
facts, are true.
6. 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 Respondent, (1) issue its complaint corresponding in form and
substance with the draft of complaint here attached and its decision
containing the following Order to divest 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 Respondent's counsel, Charles E. Koob,
Esquire, of Simpson, Thacher & Bartlett at 425 Lexington Avenue, New
York, New York 10017-3954, shall constitute service. Proposed
Respondent waives any right it 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.
7. Proposed Respondent has read the proposed Complaint and Order
contemplated hereby. Proposed Respondent understands that once the
Order has been issued, it will be required to file one or more
compliance reports showing it has fully complied with the Order.
Proposed Respondent further understands that it 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. ``Respondent'' or ``Glaxo'' means Glaxo plc, its directors,
officers, employees, agents and representatives, successors and
assigns; its subsidiaries, divisions, groups and affiliates controlled
by Glaxo plc; and the respective directors, officers, employees, agents
and representatives, and the respective successors and assigns of each.
B. ``Wellcome'' means Wellcome plc, its directors, officers,
employees, agents and representatives, successors and assigns; its
subsidiaries, divisions, groups and affiliates controlled by Wellcome
plc; and the respective directors, officers, employees, agents and
representatives, and the respective successors and assigns of each.
C. ``Commission'' means the Federal Trade Commission.
D. ``Acquisition'' means the acquisition by Glaxo of the capital
stock of Wellcome pursuant to an offer announced on January 23, 1995.
E. ``Sumatriptan'' means the compound with the formula 3-[2-
(Dimethylamino)ethyl]-N-methylindole-5-methanosulfonamide and/or or the
butanedioate (I:I) salt thereof [i.e. the ``succinate''] in respect of
its therapeutic indication for the treatment of the disease migraine.
F. ``311C90'' means the compound with the formula (S)-4-[[3-2-
(dimethylamino)ethyl]-]H-indol-5-yl]methyl]-2-oxazolidinone and/or a
pharmaceutically acceptable salt thereof in respect of its therapeutic
indication for the treatment of the disease migraine.
G. ``Wellcome's 311C90 Assets'' means Wellcome's worldwide assets
relating to the worldwide research and development, manufacture,
distribution and sale of 311C90 that are not part of Wellcome's
physical facilities. ``Wellcome's 311C90 Assets'' include, but are not
limited to, all formulations, patents, trade secrets, technology, know-
how, specifications, designs, drawings, processes, production
information, manufacturing information, testing and quality control
data, research materials, technical information, distribution
[[Page 16141]] information, customer lists, information stored on
management information systems (and specifications sufficient for the
Acquirer to use such information), software used in connection with
Wellcome's 311C90, inventory sufficient for the Acquirer to complete
all clinical trials or bioequivalency studies necessary to obtain
United States Food and Drug Administration (``FDA'') approvals and all
data, contractual rights, materials and information relating to
obtaining FDA approvals and other government or regulatory approvals
for the United States or other countries for Wellcome's 311C90.
H. ``Glaxo's Sumatriptan Assets'' means Glaxo's worldwide assets
relating to the worldwide research and development, manufacture,
distribution and sale of Glaxo's Sumatriptan that are not part of
Glaxo's physical facilities. ``Glaxo's Sumatriptan Assets'' include,
but are not limited, to all formulations, patents, trade secrets,
technology, know-how, specifications, designs, drawings, processes,
production information, manufacturing information, testing and quality
control data, research materials, technical information, distribution
information, customer lists, information stored on management
information systems (and specifications sufficient for the Acquirer to
use such information), software used in connection with Glaxo's
Sumatriptan, inventory sufficient for the Acquirer to complete all
clinical trials or bioequivalency studies necessary to obtain FDA
approvals and all data, contractual rights, materials and information
relating to obtaining FDA approvals and other government or regulatory
approvals for the United States or other countries for Glaxo's
Sumatriptan.
I. ``Alternative Assets to be Divested'' means Wellcome's 311C90
Assets or Glaxo's Sumatriptan Assets at the discretion of the trustee
to be appointed pursuant to Paragraph IV. of this Order.
J. ``Acquirer'' means the entity to whom Glaxo shall divest either
Wellcome's 311C90 Assets or Glaxo's Sumatriptan Assets pursuant to this
Order.
K. ``Non-injectable 5HT1D agonists'' means any 5HT1D
agonist medicine formulation intended for the treatment of the disease
migraine to be administered to patients by any method other than
subcutaneous, intramuscular or intravenous injection.
II
It is further ordered that:
A. Respondent shall divest, absolutely and in good faith, within
nine (9) months of the date this Order becomes final Wellcome's 311C90
Assets.
B. Respondent shall divest Wellcome's 311C90 Assets only to an
Acquirer that receives the prior approval of the Commission and only in
a manner that receives the prior approval of the Commission. The
purpose of the divestiture of Wellcome's 311C90 Assets is to ensure
continued research and development of Wellcome's 311C90, in the same
manner in which Wellcome's 311C90 would be researched and developed
absent the proposed Acquisition, and to remedy the lessening of
competition resulting from the proposed Acquisition as alleged in the
Commission's Complaint.
C. The time period for divestiture pursuant to this Paragraph II.
of this Order shall be tolled if and when Respondent:
1. Provides to the Commission objective evidence, including, but
not limited to, results of clinical trials, indicating that, based on
311C90's medical profile, and through no fault of Respondent,
Wellcome's 311C90 Assets are not viable or marketable; and
2. Petitions the Commission to modify this Order, pursuant to
section 5(b) of the FTC Act and Section 2.51 of the Commission's Rules
of Practice, based on the circumstances described in Subparagraph
II.C.1 of this Order.
This tolling of the time period for divestiture shall end when the
Commission rules on Respondent's petition to modify this Order.
III
It is further ordered that:
A. Within forty-five (45) days of the date this Order becomes
final, the Commission shall appoint a trustee to ensure that Glaxo
expeditiously performs its responsibilities required by this Order.
Glaxo shall consent to the following terms and conditions regarding the
trustee's powers, duties, authorities, and responsibilities:
1. The Commission shall select the trustee, subject to the consent
of Respondent which consent shall not be unreasonably withheld. If
Respondent has not opposed, in writing, including the reasons for
opposing, the selection of any proposed trustee with ten (10) days
after notice by the staff of the Commission to Respondent of the
identity of any proposed trustee, Respondent shall be deemed to have
consented to the selection of the proposed trustee.
2. Within ten (10) days after the appointment of the trustee, Glaxo
shall execute a trust agreement that, subject to the prior approval of
the Commission, confers on the trustee all the rights and powers
necessary to permit the trustee to assure Glaxo's compliance with the
terms of this Order. As part of the trustee agreement, the trustee
shall execute confidentiality agreement(s) with Glaxo.
3. The trustee shall serve until either (a) the Acquirer has filed
with the FDA for approval to manufacture and sell a product based on
Wellcome's 311C90 Assets (or Glaxo's Sumatriptan Assets, if Glaxo's
Sumatriptan Assets are divested to the Acquirer pursuant to Paragraph
IV.A. of this Order); (b) the trustee determines that the Acquirer has
abandoned its efforts to obtain FDA approval to manufacture and sell a
product based upon Wellcome's 311C90 Assets (or Glaxo's Sumatriptan
Assets, if Glaxo's Sumatriptan Assets are divested to the Acquirer
pursuant to Paragraph IV.A. of this Order); or (c) the trustee
determines that the Acquirer has failed to exercise reasonable
diligence in research and development toward obtaining FDA approval to
manufacture and sell a product based upon Wellcome's 311C90 Assets (or
Glaxo's Sumatriptan Assets, if Glaxo's Sumatriptan Assets are divested
to the Acquirer pursuant to Paragraph IV.A. of this Order), which lack
of diligence will have been certified to and accepted by the
Commission, whichever comes first. The trustee's service shall continue
for no more than two (2) years following divestiture of Wellcome's
311C90 Assets or the Alternative Assets to be Divested.
4. The trustee shall have full and complete access to the
personnel, books, records, facilities and technical information related
to Wellcome's 311C90 Assets and Glaxo's Sumatriptan Assets or to any
other relevant information as the trustee may reasonably request,
including but not limited to all records kept in the normal course of
business that relate to the research and development of, and the cost
of manufacturing, Wellcome's 311C90 and Glaxo's Sumatriptan. Respondent
shall develop such financial or other information as the trustee may
request and shall cooperate with the trustee. Respondent shall take no
action to interfere with or impede the trustee's accomplishment of his
or her responsibilities pursuant to this Order.
5. The trustee shall serve, without bond or other security, at the
cost and expense of Respondent, on such reasonable and customary terms
and conditions as the Commission may set. The trustee shall have
authority to employ, at the cost and expense of Respondent, such
consultants, accountants, attorneys and other representatives and
assistants as are reasonably necessary to carry out the
[[Page 16142]] trustee's duties and responsibilities. The trustee shall
account for all expenses incurred. The Commission shall approve the
account of the trustee, including fees for his or her services.
6. Respondent shall indemnify the trustee and hold the trustee
harmless against any losses, claims, damages, liabilities, or expenses
arising out of, or in connection with, the performance of the trustee's
duties including all reasonable fees of counsel and other expenses
incurred in connection with the preparations for, or defense of, any
claim whether or not resulting in any liability, except to the extent
that such liabilities, losses, damages, claims or expenses result from
misfeasance, gross negligence, willful or wanton acts, or bad faith by
the trustee.
7. If the trustee ceases to act or fails to act diligently a
substitute trustee shall be appointed in the same manner as provided in
Paragraph III.A. of this Order.
8. The Commission may on its own initiative or at the request of
the trustee issue such additional orders or directions as may be
necessary or appropriate to accomplish the requirements of this Order.
9. The trustee shall report in writing to Respondent and the
Commission every one hundred and eighty (180) days concerning the
trustee's obligation pursuant to this Paragraph III.
B. Respondent shall comply with all reasonable directives of the
trustee regarding Respondent's obligations to comply with this Order.
C. The trustee may require Glaxo to manufacture Wellcome's 311C90
(or Sumatriptan, if Glaxo's Sumatriptan Assets are divested to the
Acquirer pursuant to Paragraph IV.A. of this Order) for use by the
Acquirer in conducting clinical trials or bioequivalency studies if:
1. The Acquirer has depleted its inventory of 311C90 (or
Sumatriptan, if Glaxo's Sumatriptan Assets are divested to the Acquirer
pursuant to Paragraph IV.A. of this Order) acquired pursuant to the
divestiture;
2. The Acquirer has a need to conduct further clinical development
trials or bioequivalency studies prior to submission of an application
to the FDA to manufacture and sell a product based on Wellcome's 311C90
Assets (or Glaxo's Sumatriptan Assets, if Glaxo's Sumatripan Assets are
divested to the Acquirer pursuant to Paragraph IV.A. of this Order);
and
3. Despite good faith support to establish its own manufacturing
capability for 311C90 (or Sumatripan, if Galaxo's Sumatriptan Assets
are divested to the Acquirer pursuant to Paragraph IV.A. of this
Order), the Acquirer has not succeeded in doing so as of the time
311C90 (or Sumatripan, if Galaxo's Sumatriptan Assets are divested to
the Acquirer pursuant to Paragraph IV.A. of this Order) is needed for
such clinical trials or bioequivalency studies. The trustee shall
determine reasonable compensation for Glaxo, based upon the costs of
manufacture, for such production.
IV
It is further ordered that:
A. If Glaxo has not divested, absolutely and in good faith and with
the Commission's prior approval, Wellcome's 311C90 Assets within the
time required by Paragraphs II.A. and II.C. of this Order, the
Commission may direct the trustee appointed pursuant to Paragraph III.
of this Order to divest the Alternative Assets to be Divested. Neither
the decision of the Commission to direct the trustee nor the decision
of the Commission not to direct the trustee to divest the Alternative
Assets to be Divested shall preclude the Commission or the Attorney
General from seeking civil penalties or any other relief available to
it, including a court-appointed trustee, pursuant to section 5(l) of
the Federal Trade Commission Act, or any other statute enforced by the
Commission, for any failure by the Respondent to comply with this
Order.
B. If the trustee is directed under Subparagraph A. of this
Paragraph to divest the Alternative Assets to be Divested, Respondent
shall consent to the following terms and conditions regarding the
trustee's powers, duties, authority, and responsibilities:
1. The Commission shall extend the authority and responsibilities
of the trustee appointed under Paragraph III. of this Order to include
divesting the Alternative Assets to be Divested.
2. Subject to the prior approval of the Commission, the trustee
shall have the exclusive power and authority to divest the Alternative
Assets to be Divested.
3. Within ten (10) days after the extension of the trustee's
authority and responsibilities, Respondent shall amend the existing
trust agreement in a manner that, subject to the prior approval of the
Commission and, in the case of a court-appointed trustee, of the court,
transfers to the trustee all rights and powers necessary to permit the
trustee to effect the divestiture required by this Order.
4. The trustee shall have twelve (12) months from the date the
Commission approves the extension of the trustee's authorities and
responsibilities as described in Paragraph IV.B.3. to accomplish the
divestiture, which shall be subject to the prior approval of the
Commission. If, however, at the end of the twelve month period, the
trustee has submitted a plan of divestiture or believes that
divestiture can be achieved within a reasonable time, the divestiture
period may be extended by the Commission, or, in the case of a court-
appointed trustee, by the court; provided, however, the Commission may
extend this period only two (2) times.
5. The trustee shall have full and complete access to the personnel
books, records, facilities and technical information related to
Wellcome's 311C90 Assets and Glaxo's Sumatriptan Assets, or to any
other relevant information, as the trustee may reasonable request,
including but not limited to all records kept in the normal course of
business that relate to research and development of, and the cost of
manufacturing, Wellcome's 311C90 and Glaxo's Sumatriptan. Respondent
shall develop such financial or other information as the trustee may
request and shall cooperate with the trustee. Respondent shall take no
action to interfere with or impede the trustee's accomplishment of the
divestiture. Any delays in divestiture caused by Respondent shall
extend the time for divestiture under this Paragraph in an amount equal
to the delay as determined by the Commission or, for a court-appointed
trustee, by the court.
6. The trustee shall serve, without bond or other security, at the
cost and expense of Respondent, on such reasonable and customary terms
and conditions as the Commission may set. The trustee shall have
authority to employ, at the cost and expense of Respondent, such
consultants, accountants, attorneys and other representatives and
assistants as are reasonably necessary to carry out the trustee's
duties and responsibilities. The trustee shall account for all monies
derived from the sale and all expenses incurred. After approval by the
Commission and, in the case of a court-appointed trustee, by the court,
of the account of the trustee, including fees for his or her services,
all remaining monies shall be paid at the direction of the Respondent.
The trustee's compensation shall be based at least in significant part
on a commission arrangement contingent on the trustee's divesting the
Alternative Assets to be Divested.
7. Respondent shall indemnify the trustee and hold the trustee
harmless against any losses, claims, damages, liabilities, or expenses
arising out of, or in connection with, the performance of the trustee's
duties, including all reasonable fees of counsel and other
[[Page 16143]] expenses incurred in connection with the preparations
for, or defense of, any claim whether or not resulting in any
liability, except of the extent that such liabilities, losses, damages,
claims or expenses result from misfeasance, gross negligence, willful
or wanton acts, or bad faith by the trustee.
8. If the trustee ceases to act or fails to act diligently, a
substitute trustee shall be appointed in the same manner as provided in
Paragraph III.A. of this Order.
9. The Commission or, in the case of a court-appointed trustee, the
court may on its own initiative or at the request of the trustee issue
such additional orders or directions as may be necessary or appropriate
to accomplish the divestiture required by this Order.
10. The trustee shall report in writing to Respondent and the
Commission every sixty (60) days concerning the trustee's efforts to
accomplish divestiture.
11. If a divestiture application filed pursuant to this Paragraph
IV. is pending before the Commission, and Respondent petitions the
Commission to modify this Order based on the conditions in Paragraph
II.C., then the Commission shall not approve the divestiture
application until it rules on the petition to modify.
V
It is further ordered that:
A. Upon reasonable notice and request from the Acquirer to Glaxo,
Glaxo shall provide information, technical assistance and advice to the
Acquirer with respect to Wellcome's 311C90 Assets (or Glaxo's
Sumatriptan Assets, if Glaxo's Sumatriptan Assets are divested to the
Acquirer pursuant to Paragraph IV.A. of this Order) such that the
Acquirer will be capable of continuing the current research and
development. Such assistance shall include reasonable consultation with
knowledgeable employees of Glaxo and training at the Acquirer's
facility for a period of time sufficient to satisfy the Acquirer's
management that its personnel are adequately knowledgeable about
Wellcome's 311C90 Assets (or Glaxo's Sumatriptan Assets, if Glaxo's
Sumatriptan Assets are divested to the Acquirer pursuant to Paragraph
IV.A. of this Order). However, Respondent shall not be required to
continue providing such assistance for more than twelve (12) months
after divestiture of Wellcome's 311C90 Assets or the Alternative Assets
to be Divested. Respondent may require reimbursement from the Acquirer
for all of its own direct costs incurred in providing the services
required by this Subparagraph V.A. Direct costs, as used in this
Subparagraph V.A., means all actual costs incurred exclusive of
overhead costs.
B. Pending divestiture of Wellcome's 311C90 Assets pursuant to
Paragraph II. of this Order or the Alternative Assets to be Divested
pursuant to Paragraph IV. of this Order, Respondent shall:
1. Take such actions as are necessary to prevent the destruction,
removal, wasting, deterioration or impairment of Wellcome's 311C90
Assets and Glaxo's Sumatriptan Assets, except for ordinary wear and
tear; and
2. Maintain research and development of Wellcome's 311C90 Assets
and Glaxo's Sumatriptan Assets at the levels planned by Wellcome for
311C90 and Glaxo for Sumatriptan as of January 1, 1995.
C. Glaxo shall maintain physical assets necessary to manufacture
Wellcome's 311C90 and Glaxo Sumatriptan until the Acquirer has filed
with the FDA for approval to manufacture and sell a product based upon
Wellcome's 311C90 Assets (or Glaxo's Sumatriptan Assets, if Glaxo's
Sumatriptan Assets are divested pursuant to Paragraph IV.A. of this
Order). The maintenance of physical assets described in this
Subparagraph shall not exceed two (2) years following divestitute of
Wellcome's 311C90 Assets or the Alternative Assets to be Divested.
Provided however, that Glaxo shall be allowed to discontinue
maintenance of the physical assets necessary to manufacture Glaxo's
Sumatriptan if Glaxo divests Wellcome's 311C90 Assets pursuant to this
Order.
VI
It is further ordered that, for a period of ten (10) years from the
date this Order becomes final, Respondent shall not without the prior
approval of the Commission, directly or indirectly, through
subsidiaries, partnerships, or otherwise:
A. Acquire more than 1% of the stock, share capital, equity, or
other interest in any concern, corporate or noncorporate, engaged in at
the time of such acquisition, or within the two years preceding such
acquisition engaged in, (1) the clinical development of non-injectable
5HT1D agonists for approval by the FDA for the treatment of
migraines or (2) the manufacture and sale of non-injectable 5HT1D
agonists for approval by the FDA for the treatment of migraines; or
B. Acquire any assets currently used for or previously used for
(and still suitable for use for) (1) the clinical development of non-
injectable 5HT1D agonists approved by the FDA for the treatment of
migraines or (2) the manufacture and sale of noninjectable 5HT1D
agonists approved by the FDA for the treatment of migraines.
Provided, however, that this Paragraph VI. shall not apply to the
acquisition of products or services in the ordinary course of business.
VII
It is further ordered that:
A. Within sixty (60) days after the date this Order becomes final
and every sixty days (60) days thereafter until Respondent has fully
complied with the provisions of Paragraphs II., III., IV., V.A. and
V.B. of this Order, Respondent shall submit to the Commission a
verified written report setting forth in detail the manner and form in
which it intends to comply, is complying, and has complied with
Paragraphs II., III., IV. and V. of this Order. Respondent shall
include in its compliance reports, among other things that are required
from time to time, a full description of the efforts being made to
comply with Paragraphs II., III., IV. and V. of this Order, including a
description of all substantive contacts or negotiations for
accomplishing the divestiture and the identity of all parties
contacted. Respondent shall include in its compliance reports copies of
all written communications to and from such parties, all internal
memoranda, and all reports and recommendations concerning divestiture.
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 at other times as the Commission may require,
Respondent shall file a verified written report with the Commission
setting forth in detail the manner and form in which it has complied
and is complying with this Order.
VIII
It is further ordered that, for the purpose of determining or
securing compliance with this Order, Respondent 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 or Respondent, relating to any matters contained in this
Order; and
B. Upon five (5) days' notice to Respondent, and without restraint
or interference from Respondent, to interview officers, directors, or
employees of Respondent, who may [[Page 16144]] have counsel present
regarding such matters.
IX
It is further ordered that Respondent shall notify the Commission
at least thirty (30) days prior to any proposed change in Respondent
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 this
Order.
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
Glaxo plc (``Glaxo'') under which Glaxo would be required to divest
worldwide assets relating to the research and development, manufacture,
distribution and sale of a therapeutic compound for the treatment of
migraine headaches (``Wellcome's 311C90 Assets'') to a Commission-
approved purchaser.
The proposed Consent Order has been placed on the public record for
sixty (60) days for reception of comments by interested persons.
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.
Pursuant to an offer announced on January 23, 1995, Glaxo, a
British company, will acquire all of the capital stock of Wellcome plc
(``Wellcome''), a British company.
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. 18, and Section 5 of the FTC Act, as
amended, 15 U.S.C. 45, in the market for the research and development
of non-injectable 5HT1D agonists. 5HT1D agonists are a
specific class of drugs known to act on receptors in the human body
that are responsible for migraine attacks.
The proposed consent order would remedy the alleged violation by
replacing the lost competition that would result from the acquisition.
Under the proposed Consent Order, Glaxo is required to provide
technical assistance and advice to assist the purchaser of Wellcome's
311C90 Assets in obtaining FDA approval to manufacture and sell non-
injectable 5HT1D agonists. The proposed Order also provides for a
trustee to assure that Glaxo appropriately divests the Wellcome 311C90
Assets. If Glaxo fails to divest the Wellcome 311C90 Assets within nine
months, then the trustee's authority may be extended to include
responsibility to divest either Wellcome's 311C90 Assets or Glaxo's
Sumatriptan Assets.\1\ The potential that the trustee could ultimately
divest Sumatriptan, a highly-valued product already on the market to
treat migraine, ensures that Glaxo will exert all possible efforts to
divest Wellcome's 311C90 Assets.
\1\Glaxo's Sumatriptan, marketed under the brand name
Imitrex, is currently on the market in the U.S. to treat
patients with migraine attacks. It is available in the U.S. only in
injectable form.
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Under the provisions of the order, Glaxo is also required to
provide to the Commission a report of compliance with the divestiture
provisions of the order within sixty (60) days following the date this
order becomes final, and every sixty (60) days thereafter until Glaxo
has completely divested its interest in Wellcome's 311C90 Assets.
The proposed Consent Order will also prohibit Glaxo, for a period
of ten (10) years, from acquiring more than a one percent interest in
any entity involved in, or any assets used for, the clinical
development or manufacture and sale of non-injectable 5HT1D
agonists either to be approved by or already approved by the Food and
Drug Administration (``FDA'') for the treatment of migraines.
One year from the date the Order becomes final and annually
thereafter for nine (9) years, Glaxo will be required to provide to the
Commission a report of its compliance with the Consent Order. The
Consent Order also requires Glaxo to notify the Commission at least
thirty (30) days prior to any change in the structure of Glaxo
resulting in the emergence of a successor.
The purpose of this analysis is to facilitate public comment on the
proposed Order, and it not intended to constitute an official
interpretation of the agreement and proposed Order or to modify in any
way their terms.
Donald S. Clark,
Secretary.
[FR Doc. 95-7630 Filed 3-28-95; 8:45 am]
BILLING CODE 6750-01-M