[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 5HT<INF>1D agonists'' means any 5HT<INF>1D 
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 
5HT<INF>1D agonists for approval by the FDA for the treatment of 
migraines or (2) the manufacture and sale of non-injectable 5HT<INF>1D 
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 5HT<INF>1D agonists approved by the FDA for the treatment of 
migraines or (2) the manufacture and sale of noninjectable 5HT<INF>1D 
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 5HT<INF>1D agonists. 5HT<INF>1D 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 5HT<INF>1D 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<Register>, 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 5HT<INF>1D 
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