UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
- COMMISSIONERS:
- Robert Pitofsky, Chairman
- Sheila F. Anthony
- Mozelle W. Thompson
- Orson Swindle
- Thomas B. Leary
In the Matter of
Pfizer Inc., a
corporation; and
Warner-Lambert Company, a corporation.
Docket No.
DECISION AND ORDER
The Federal Trade Commission ("Commission") having initiated an
investigation of the proposed merger of Respondent Warner-Lambert Company
("Warner") and Respondent Pfizer Inc. ("Pfizer"), hereinafter referred
to as "Respondents," and Respondents having been
furnished thereafter with a copy of a draft of Complaint that the Bureau of Competition
presented to the Commission for its consideration and which, if issued by the Commission,
would charge Respondents with violations of Section 7 of the Clayton Act, as amended, 15
U.S.C. § 18, and Section 5 of the Federal Trade Commission Act, as amended, 15
U.S.C. § 45; and
Respondents, their attorneys, and counsel for the Commission having thereafter executed
an Agreement Containing Consent Orders ("Consent Agreement"), containing an
admission by Respondents of all the jurisdictional facts set forth in the aforesaid draft
of Complaint, a statement that the signing of said Consent Agreement is for settlement
purposes only and does not constitute an admission by Respondents that the law has been
violated as alleged in such Complaint, or that the facts as alleged in such Complaint,
other than jurisdictional facts, are true, and waivers and other provisions as required by
the Commission's Rules; and
The Commission having thereafter considered the matter and having determined that it
had reason to believe that Respondents have violated the said Acts, and that a Complaint
should issue stating its charges in that respect, and having thereupon issued its
Complaint and an Order to Maintain Assets, and having accepted the executed Consent
Agreement and placed such Consent Agreement on the public record for a period of thirty
(30) days for the receipt and consideration of public comments, now in further conformity
with the procedure described in Commission Rule 2.34, 16 C.F.R. § 2.34, the
Commission hereby makes the following jurisdictional findings and issues the following
Order:
- 1. Respondent Pfizer is a corporation organized, existing and doing business under and
by virtue of the laws of the state of Delaware, with its office and principal place of
business located at 235 East 42nd Street, New York, New York 10017.
-
- 2. Respondent Warner is a corporation organized, existing and doing business under and
by virtue of the laws of the state of Delaware, with its office and principal place of
business located at 201 Tabor Road, Morris Plains, New Jersey 07950.
-
- 3. The Federal Trade Commission has jurisdiction of the subject matter of this
proceeding and of Respondents, and the proceeding is in the public interest.
ORDER
I.
IT IS ORDERED that, as used in this order, the following definitions
shall apply:
- A. "Pfizer" means Pfizer Inc., its directors, officers, employees, agents,
representatives, predecessors, successors, and assigns; its joint ventures, subsidiaries,
divisions, groups and affiliates controlled by Pfizer Inc. and the respective directors,
officers, employees, agents, representatives, successors, and assigns of each.
-
- B. "Warner" means Warner-Lambert Company, its directors, officers, employees,
agents, representatives, predecessors, successors, and assigns; its joint ventures,
subsidiaries, divisions, groups and affiliates controlled by Warner-Lambert Company
(including, but not limited to, the Parke-Davis Division), and the respective directors,
officers, employees, agents, representatives, successors, and assigns of each.
-
- C. "Respondents" means Pfizer and Warner, individually and collectively.
-
- D. "Merger" means the proposed merger of Pfizer and Warner by means of an
Agreement and Plan of Merger dated as of February 6, 2000 among Pfizer, Seminole
Acquisition Sub. Corp., and Warner.
E. "Commission" means the Federal Trade Commission.
-
- F. "Forest" means Forest Laboratories, Inc., a corporation organized, existing
and doing business under and by virtue of the laws of the State of Delaware, with its
offices and principal place of business located at 909 Third Avenue, New York, New York
10022.
-
- G. "First Horizon" means First Horizon Pharmaceutical Corporation, a
corporation organized, existing and doing business under and by virtue of the laws of the
State of Delaware, with its offices and principal place of business located at 660 Hembree
Parkway, Suite 106, Roswell, Georgia 30076.
-
- H. "Bayer" means Bayer Corporation, a corporation organized, existing and
doing business under and by virtue of the laws of the State of Indiana, with its offices
and principal place of business located at 36 Columbia Road, Morristown, New Jersey
07962-1910.
-
- I. "OSI" means OSI Pharmaceuticals, Inc., a corporation organized, existing
and doing business under and by virtue of the laws of the State of Delaware, with its
offices and principal place of business located at 106 Charles Lindbergh Boulevard,
Uniondale, New York, 11553-3649.
-
- J. "Celexa" means any pharmaceutical preparation containing the drug substance
citalopram HBr that is the subject of the Celexa Co-Promotion Agreement and the Celexa
Amendment. Celexa includes any and all of its constituent elements, active ingredients or
intermediaries, and all rights relating to the research, development, manufacture and sale
of Celexa.
-
- K. "Celexa Co-Promotion Agreement" means the Agreement dated March 27, 1998 by
and between Forest and the Parke-Davis Division of Warner attached hereto as non-public
Appendix I.
-
- L. "Celexa Amendment" means the Amendment to the Celexa Co-Promotion Agreement
between Forest and the Parke-Davis Division of Warner, dated September 1, 1999, attached
hereto as non-public Appendix II.
M. "Celexa Assets" mean all rights granted to Warner pursuant to the Celexa
Co-Promotion Agreement and Celexa Amendment.
-
- N. "Celexa Termination Agreement" means the Amendment No. 2 and Termination
Agreement terminating the Celexa Co-Promotion Agreement and Celexa Amendment by and
between Forest and Warner, dated May 11, 2000, attached hereto as non-public Appendix III.
-
- O. "Know-how" means all technological, technical, scientific, chemical,
biological, pharmacological, toxicological, regulatory and marketing materials and
information used to develop, make, use, sell, offer for sale, import or seek regulatory
approval in any country to market a Product, including without limitation all: formulae;
trade secrets; inventions; techniques; intellectual property (including patents and patent
applications) whether or not patentable; discoveries; compounds; compositions of matter,
assays, reagents, and biological materials; trademarks; research data; technical data and
information; testing data; preclinical and clinical data; toxicological and
pharmacological data; regulatory files; statistical analyses; analytical data; clinical
protocols; specifications; designs; drawings; processes; testing and quality
assurance/quality control data; manufacturing data and information; regulatory
submissions; and any other information and experience, whether recorded on paper or
electronically.
-
- P. "Celexa Know-how" means all Confidential Business Information and Know-how
in the possession or control of Warner as of the date Warner signed the Celexa Termination
Agreement that relates in whole or in part to Celexa, including without limitation
information and documents stored on all computer files and management information systems;
written, recorded and graphic materials of every kind; proprietary software used in
connection with Celexa; all data, contractual rights, materials, documents and information
relating to obtaining FDA approvals and other government or regulatory approvals for
Celexa; and any other information, documents and experience relating to Celexa. Celexa
Know-how shall be deemed to include all information comprised by Celexa Assets. Celexa
Know-how includes, but is not limited to:
-
- 1. notes, minutes and other documents relating to speaker programs, "lunch and
learn" programs, and meetings with medical advisers to Forest or Warner in connection
with the Celexa Co-Promotion Agreement (and Celexa Amendment), including plans for future
programs and meetings, market research data and proposals relating to Celexa;
2. all marketing plans including written fiscal year and contract year marketing plans,
media placement plans, public relations plans, convention plans, symposia plans,
publication plans, pricing plans, and line extension plans related to Celexa;
3. minutes of all Celexa meetings, and intracompany and intercompany correspondence
related to such meetings;
-
- 4. all advisory board and consultants' correspondence related to Celexa;
-
- 5. all correspondence with advertising, public relations
and medical education agencies related to Celexa;
-
- 6. speaker training materials and all other medical education materials related to
Celexa;
-
- 7. all market research, including both primary and secondary, whether conducted by
Forest or Warner's Parke-Davis Division related to Celexa;
-
- 8. all forecasts and assumptions, including sample production forecasts related to
Celexa;
-
- 9. all presentation materials used at national sales meetings or manager meetings
related to Celexa;
-
- 10. all physician targeting data and call plans including reach and frequency plans
related to Celexa;
-
- 11. all communications with the FDA and DDMAC related to Celexa;
12. all Phase IV clinical study plans and protocols provided to Warner related to Celexa;
-
- 13. all regulatory and development information including information on Celexa line
extensions, tablet strengths and SKUs related to Celexa;
-
- 14. any and all information provided from the Celexa NDA, investigators' brochures or
study reports;
-
- 15. all professional affairs letters related to Celexa utilized to respond to physician
inquiries; and
-
- 16. all information related to Celexa pertaining to
managed care, government accounts, hospitals, long-term care and other channels. This
includes all contracts and contracting templates and strategies.
-
- Provided, however, that Celexa Know-how does not include information which
becomes or became available to Respondents on a non-confidential basis from a source other
than Forest, if such source is not under obligation (whether contractual, legal or
fiduciary) to Forest to keep such information confidential.
-
- Q. "Confidential Business Information" means all information that is not in
the public domain concerning the research, development, marketing, distribution, cost,
pricing, sale and commercialization of a Product or of a Product in development.
-
- R. "Celexa Material Confidential Information" means any information not in the
public domain obtained by Respondents directly or indirectly from Forest pursuant to the
Celexa Co-Promotion Agreement and Celexa Amendment prior to the date this Order becomes
final, and includes, but is not limited to, Celexa Know-how and Confidential Business
Information relating to Celexa.
-
- S. "FDA" means the United States Food and Drug Administration.
T. "DDMAC" means the Division of Drug
Marketing, Advertising and Communication of the FDA.
-
- U. "NDA" means a New Drug Application filed or to be filed with the FDA, any
preparatory work, drafts and data necessary for the preparation thereof, and Know-how, and
includes without limitation both supplemental and abbreviated NDAs.
-
- V. "Zoloft" means any pharmaceutical preparation containing the drug substance
sertraline hydrochloride, any of its constituent elements, active ingredients or
intermediaries, and all rights relating to the research, development, manufacture and sale
of Zoloft, which is manufactured, marketed and distributed by Pfizer.
-
- W. "SSRI/SNRI" means any selective serotonin reuptake inhibitor/serotonin
norepinephrine reuptake inhibitor, including, but not limited to, branded, generic or
isomer forms of the following drugs: Paxil, Prozac, Zoloft, Luvox, Effexor, and Celexa.
-
- X. "Cognex" means any pharmaceutical preparation containing the drug substance
tacrine hydrochloride. Cognex includes any of its constituent elements, active
ingredients, intermediaries, and all rights relating to the research, development,
manufacture and sale of Cognex and the once daily controlled release formulation
containing Tacrine as the HCl salt and using the gastrointestinal therapeutic system
technology from ALZA Corporation.
-
- Y. "Tacrine" means the active pharmaceutical ingredient produced at Warner's
chemical manufacturing facility in Holland, Michigan.
-
- Z. "Cognex Divestiture Assets" mean all assets relating to Cognex and Tacrine
as defined in the Cognex Divestiture Agreement.
-
- AA. "Cognex Divestiture Agreement" means the asset purchase agreement between
Warner and First Horizon relating to the sale of the Cognex Divestiture Assets, dated
April 14, 2000, attached hereto as non-public Appendix IV.
BB. "EGFr-tk" means any pharmaceutical preparation containing the drug substance
Epidermal Growth Factor receptor tyrosine kinase inhibitor, CP 358,774. EGFr-tk shall also
include all salts and prodrug forms of CP 358,774.
CC. "EGFr-tk Assets" means all assets relating to EGFr-tk to be licensed or
transferred to OSI pursuant to the EGFr-tk Divestiture Agreement. Provided, however,
that if OSI requests such assets, the EGFr-tk Assets shall also include intellectual
property and technology (including Joint Technology) arising
under the OSI/Pfizer Collaboration Research Agreements and OSI/Pfizer License Agreements
which relate to CP 358,774 and to salts and prodrug forms of CP 358,774, and which are
reasonably necessary to research, develop, manufacture, or sell EGFr-tk.
-
- DD. "OSI/Pfizer Collaboration Research Agreements" means the Agreement dated
April 1, 1986, the Agreement dated April 1, 1991 and the Agreement dated April 1, 1996, by
and between OSI and Pfizer, attached hereto as non-public Appendix V.
-
- EE. "OSI/Pfizer License Agreements" means the Agreements dated December 14,
1990 and April 1, 1996, by and between OSI and Pfizer, attached hereto as non-public
Appendix VI.
-
- FF. "EGFr-tk Divestiture Agreement" means the Agreement between Pfizer and OSI
dated May 23, 2000, attached hereto as non-public Appendix VII.
-
- GG. "Joint Technology" means all technology and technical information relating
to EGFr-tk pursuant to the OSI/Pfizer Collaboration Research Agreements.
HH. "Ownership Interest" means any right(s), present or contingent, to hold
voting or nonvoting interest(s), equity interest(s), and/or beneficial ownership(s) in the
capital stock of OSI.
-
- II. "RID" means Pfizer's rights and assets relating to any Product containing
the active ingredient pyrethrum that is a lice treatment or related Product, including all
rights relating to the research, development, manufacture and sale of lice treatments or
related Products, including but not limited to individual, kit, advance systems and bulk
SKUs containing RID spray, shampoo, egg loosener gel, mousse or comb.
-
- JJ. "RID Assets" means all assets relating to RID as defined in the RID
Divestiture Agreement.
-
- KK. "RID Divestiture Assets" means:
-
- 1. all intellectual property, including pending patent applications, licenses,
inventions, technology, Know-how, patents, trademarks, brand names, trade names, trade
dress, trade secrets, and copyrights;
2. all research materials, formulations, new product formulations, line extensions, patent
rights, trade secrets, specifications, protocols, technical information, regulatory
information and approvals, manufacturing information, management information systems,
software, specifications, designs, drawings, processes and quality control data;
-
- 3. all customer lists, vendor lists, medical marketing lists, catalogs, sales promotion
literature, promotional materials, displays, tokens, advertising materials, marketing
plans and strategies, price and discount strategies, price lists, sales forecasts,
distribution information, trade booths, medical marketing convention floor space and
related items, telephone and facsimile numbers, as well as other customer support
materials (including, without limitation, web sites);
-
- 4. inventory and storage capacity;
-
- 5. all third party agreements and contracts that are related to the research,
development, manufacture, marketing, sale or use of RID, including but not limited to
contract manufacturing arrangements;
-
- 6. inventories, including finished goods inventory of RID, works in progress, raw
material and packaging materials for RID, including but not limited to the active
ingredient pyrethrum;
-
- 7. all rights, titles and interests in and to the contracts entered into in the ordinary
course of business with customers (together with associated bid and performance bonds),
suppliers, sales representatives, distributors, agents, personal property lessors,
personal property lessees, licensors, licensees, consignors and consignees;
8. all rights under warranties and guarantees, express or implied;
9. all books, records and files; and
-
- 10. all items of prepaid expense.
-
- Provided, however, that the RID Divestiture Assets shall also include all
research, development and manufacturing assets necessary to produce RID in a
government-approved facility if the person acquiring the RID Divestiture Assets requests
such assets.
-
- LL. "RID Divestiture Agreement" means the asset purchase agreement between
Bayer and Pfizer dated April 11, 2000, attached hereto as non-public Appendix VIII.
-
- MM. "Product" means any finished pharmaceutical composition containing any
formulation or dosage of a compound as its pharmaceutically active ingredient.
-
- NN. "RID Closing" means the date that Bayer acquires the RID Assets from
Pfizer.
-
- OO. "Public Record Date" means the date that the Commission places the Consent
Agreement on the public record pursuant to Commission Rule 2.34, 16 C.F.R. § 2.34.
-
- PP. "EPA" means the United States Environmental Protection Agency.
-
- QQ. "SKU" means stock keeping unit.
RR. "Key Employees" means the individuals identified in public Appendix IX
attached hereto.
II.
IT IS FURTHER ORDERED that:
- A. Not later than (10) days after the Public Record Date, Respondents shall terminate,
absolutely and in good faith, the Celexa Co-Promotion Agreement and Celexa Amendment,
pursuant to and in accordance with the terms of the Celexa Termination Agreement. The
Celexa Termination Agreement is incorporated by reference into this Order and made a part
hereof as non-public Appendix III. Failure to comply with all of the terms of the Celexa
Termination Agreement shall constitute a failure to comply with this Order.
-
- B. Respondents shall return and submit to Forest at its New York corporate office, at
Respondents' expense, all Celexa Know-how pursuant to the terms of the Celexa Termination
Agreement. Respondents shall not retain any copies of Celexa Know-how except as required
by law.
-
- C. Respondents shall provide Forest with the opportunity to enter into employment
contracts with the Key Employees listed in Appendix IX attached to this Order through
March 31, 2001. Respondents shall provide Forest an opportunity to inspect the personnel
files and other documentation relating to these employees, to the extent permissible under
applicable laws, at the request of Forest any time after execution of the Celexa
Termination Agreement. Respondents shall not interfere with the employment by Forest of
these employees and shall remove any impediments that may deter such employees from
accepting employment with Forest, including, but not limited to, any non-compete
provisions of employment or other contracts with Respondents that would affect the ability
or incentive of those individuals to be employed by Forest.
D. Respondents shall not use, disclose or convey, directly or indirectly, any Celexa
Know-how or any Confidential Business Information relating to the research, development,
manufacturing or marketing of Celexa to any other person.
E. Respondents shall require each Key Employee to sign a confidentiality agreement
pursuant to which such employee shall be required to maintain all Celexa Know-how
(including, without limitation, all field experience) strictly confidential, including
from all other employees, executives or other personnel of Respondents. (A copy of this
confidentiality agreement is appended hereto as public Appendix X). Respondents shall
ensure that Key Employees (listed in Appendix IX) shall not be involved in the marketing,
sale or promotion of Zoloft or any SSRI/SNRI Product other than Celexa through March 31,
2001.
F. Respondents shall also provide written notification of the restrictions on the use of
Celexa Know-how by former Warner personnel and of the restrictions on the Warner personnel
from selling Zoloft, or accompanying Pfizer personnel involved with the sale or marketing
of Zoloft, for the time periods set forth in the Celexa Termination Agreement, to all
Warner employees involved in the sale or marketing of Celexa (other than the Key
Employees) and all Pfizer employees involved with the sale or marketing of Zoloft.
Respondents shall provide such notification by email with return receipt requested or
similar transmission. (A copy of this confidentiality notification is appended hereto as
Appendix XI). Respondents shall also obtain from each employee covered by the requirements
of this subparagraph an agreement to abide by these restrictions. Respondents shall
maintain complete records of all such statements at Respondents' corporate headquarters
and shall provide an officer's certificate to the Commission, stating that such
acknowledgment program has been implemented and is being complied with. Respondents shall
monitor the implementation by their sales forces of these restrictions, including the
provision of written reminders to all sales personnel at three (3) month intervals until
the expiration of the time periods set forth in the Celexa Termination Agreement, and take
corrective actions for the failure of sales personnel to comply with such restrictions or
to furnish the written acknowledgments required by this Order.
G. Pending the termination of the Celexa Co-Promotion Agreement and the Celexa Amendment,
Respondents shall take such actions as are necessary to maintain the viability and
marketability of Celexa and to prevent the destruction, removal, wasting, deterioration,
or impairment of any Celexa Assets, except for ordinary wear and tear.
-
- H. Except as required by law, Respondents shall not receive or have access to, or use or
continue to use, any Celexa Material Confidential Information.
-
- I. The purpose of Paragraph II of this Order is to ensure the continued use of the
Celexa Assets in the same business in which the Celexa Assets are engaged at the time of
the Merger, and to remedy the lessening of competition resulting from the Merger as
alleged in the Commission's complaint.
III.
IT IS FURTHER ORDERED that:
- A. Not later than ten (10) days after the Public Record Date, Warner shall divest the
Cognex Divestiture Assets to First Horizon pursuant to and in accordance with the Cognex
Divestiture Agreement, and such agreement is incorporated by reference into this Order and
made part hereof as non-public Appendix IV.
-
- B. Failure to comply with all terms of the Cognex Divestiture Agreement shall constitute
a failure to comply with this Order.
C. Pending divestiture of the Cognex Divestiture Assets, Respondents shall take such
actions as are necessary to maintain the viability and marketability of the Cognex
Divestiture Assets and to prevent the destruction, removal, wasting, deterioration, or
impairment of any of the Cognex Divestiture Assets except for ordinary wear and tear.
-
- D. The purpose of Paragraph III of this Order is to ensure the continued use of the
Cognex Divestiture Assets in the same business in which the Cognex Divestiture Assets are
engaged at the time of the Merger, and to remedy the lessening of competition resulting
from the Merger as alleged in the Commission's complaint.
IV.
IT IS FURTHER ORDERED that:
- A. Not later than ten (10) days after the Public Record Date, Pfizer shall divest the
RID Assets to Bayer pursuant to and in accordance with the RID Divestiture Agreement, and
such agreement is incorporated by reference into this Order and made part hereof as
non-public Appendix VIII. Provided, however, that if Respondents have
divested the RID Assets to Bayer prior to the date this Order becomes final, and if, at
the time the Commission determines to make this Order final, the Commission notifies
Respondents that Bayer is not an acceptable purchaser of the RID Assets or that the manner
in which the divestiture was accomplished is not acceptable, then Respondents shall
immediately rescind the transaction with Bayer and shall divest the RID Divestiture Assets
within six (6) months from the date the Order becomes final, absolutely and in good faith,
at no minimum price, to an acquirer that receives the prior approval of the Commission and
only in a manner that receives the prior approval of the Commission.
-
- B. Failure to comply with all terms of the RID Divestiture Agreement shall constitute a
failure to comply with this Order.
-
- C. Pending divestiture of the RID Divestiture Assets, Respondents shall take such
actions as are necessary to maintain the viability and marketability of the RID
Divestiture Assets and to prevent the destruction, removal, wasting, deterioration, or
impairment of any of the RID Divestiture Assets except for ordinary wear and tear.
-
- D. The purpose of Paragraph IV of this Order is to ensure the continued use of the RID
Assets or RID Divestiture Assets in the same business in which the RID Assets or RID
Divestiture Assets are engaged at the time of the Merger, and to remedy the lessening of
competition resulting from the Merger as alleged in the Commission's complaint.
V.
IT IS FURTHER ORDERED that:
- A. Not later than ten (10) days after the Public Record Date, Respondents shall transfer
and surrender, absolutely and in good faith, all of Pfizer's EGFr-tk Assets, pursuant to
and in accordance with the EGFr-tk Divestiture Agreement to OSI, and such agreement is
incorporated by reference into this Order and made a part hereof as non-public Appendix
VII. Failure by Respondents to comply with the requirements of the EGFr-tk Divestiture
Agreement shall constitute a failure to comply with this Order.
-
- B. Upon reasonable notice and request from OSI to
Respondents, Respondents shall provide to OSI, in a timely manner and at no cost to OSI,
any assistance, advice or EGFr-tk Assets as may be reasonably necessary for OSI to obtain
FDA approvals to manufacture and sell EGFr-tk.
-
- C. Respondents shall not, directly or indirectly: (i) exercise dominion or control over,
or otherwise seek to influence, the management, direction or supervision of the business
of OSI; (ii) seek or obtain representation on the Board of Directors of OSI; (iii)
exercise any voting rights attached to any ownership of OSI shares of stock; (iv) seek or
obtain access to any Confidential Business Information of OSI relating to EGFr-tk and not
otherwise necessary to comply with this Order; or (v) take any action or omit to take any
action in a manner that would be incompatible with the status of Respondents as passive
investors in OSI. The requirements of Paragraph V.C. shall continue and remain in effect
so long as the Respondents retain any Ownership Interest in OSI.
-
- D. Pending the completion of the transfer of the EGFr-tk Assets, Respondents shall take
such actions as are necessary to maintain the viability and marketability of the EGFr-tk
Assets, and to prevent the destruction, deterioration, or impairment of any of the EGFr-tk
Assets. Respondents shall also take such actions as are necessary to maintain the
viability and marketability of the EGFr-tk Assets, and to prevent the destruction,
deterioration, or impairment of any of the EGFr-tk Assets.
E. The purpose of Paragraph V of this Order is to ensure the continued use of the EGFr-tk
Assets in the same business in which the EGFr-tk Assets are engaged at the time of the
Merger, and to remedy the lessening of competition resulting from the Merger as alleged in
the Commission's complaint.
VI.
IT IS FURTHER ORDERED that:
- A. At any time after Respondents sign the Consent Agreement in this matter, the
Commission may appoint an Interim Trustee to assure that Respondents expeditiously perform
their responsibilities as required by this Order and the EGFr-tk Divestiture Agreement.
-
- B. If an Interim Trustee is appointed pursuant to Paragraph VI of this Order,
Respondents shall consent to the following terms and conditions regarding the powers,
duties, authorities, and responsibilities of the Interim Trustee:
-
- 1. The Commission shall select the Interim Trustee, subject to the consent of
Respondents, which consent shall not be unreasonably withheld. If Respondents have not
opposed, in writing, including the reasons for opposing, the selection of any proposed
trustee within ten (10) days after notice by the staff of the Commission to Respondents of
the identity of any proposed trustee, Respondents shall be deemed to have consented to the
selection of the proposed trustee.
2. The Interim Trustee shall have the power and authority to monitor Respondents'
compliance with the terms of this Order and with the terms of the EGFr-tk Divestiture
Agreement, and shall exercise such power and authority and carry out the duties and
responsibilities of the Interim Trustee in a manner consistent with the purposes of this
Order and in consultation with the Commission.
-
- 3. Within ten (10) days after appointment of the Interim Trustee, Respondents shall
execute a trust agreement that, subject to the prior approval of the Commission, confers
on the Interim Trustee all the rights and powers necessary to permit the Interim Trustee
to monitor Respondents' compliance with the terms of this Order and with the terms of the
EGFr-tk Divestiture Agreement in a manner consistent with the purposes of this Order.
-
- 4. The Interim Trustee shall serve until the last obligation under the EGFr-tk
Divestiture Agreement has been fully performed; provided, however, the Commission may
extend this period as may be necessary or appropriate to accomplish the purposes of this
Order.
-
- 5. The Interim Trustee shall have full and complete access to Respondents' personnel,
books, records, documents, facilities and technical information relating to the research,
development and manufacture of EGFr-tk, or to any other relevant information, as the
Interim Trustee may reasonably request, including, but not limited to, all documents and
records kept in the normal course of business that relate to the manufacture of EGFr-tk
and all materials and information relating to FDA and other government or regulatory
approvals. Respondents shall cooperate with any reasonable request of the Interim Trustee.
Respondents shall take no action to interfere with or impede the Interim Trustee's ability
to monitor Respondents' compliance with this Order and the EGFr-tk Divestiture Agreement.
-
- 6. The Interim Trustee shall serve, without bond or other security, at the expense of
Respondents, on such reasonable and customary terms and conditions as the Commission may
set. The Commission may, among other things, require the Interim Trustee to sign an
appropriate confidentiality agreement relating to Commission materials and information
received in connection with performance of the Interim Trustee's duties. The Interim
Trustee shall have authority to employ, at the expense of Respondents, such consultants,
accountants, attorneys and other representatives and assistants as are reasonably
necessary to carry out the Interim Trustee's duties and responsibilities. The Interim
Trustee shall account for all expenses incurred, including fees for his or her services,
subject to the approval of the Commission.
-
- 7. Respondents shall indemnify the Interim Trustee and hold the Interim Trustee harmless
against any losses, claims, damages, liabilities or expenses arising out of, or in
connection with, the performance of the Interim 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 losses, claims, damages, liabilities, or expenses result from misfeasance, gross
negligence, willful or wanton acts, or bad faith by the Interim Trustee.
-
- 8. If the Commission determines that the Interim Trustee has ceased to act or failed to
act diligently, the Commission may appoint a substitute Interim Trustee in the same manner
as provided in Paragraph VI.A. of this Order.
-
- 9. The Commission may on its own initiative or at the request of the Interim Trustee
issue such additional orders or directions as may be necessary or appropriate to assure
compliance with the requirements of this Order and the EGFr-tk Divestiture Agreement.
-
- 10. The Interim Trustee shall obtain and evaluate reports submitted to it by OSI with
respect to the performance of Respondents' obligations under the EGFr-tk Divestiture
Agreement. The Interim Trustee shall report in writing to the Commission every two (2)
months from the date the Interim Trustee is appointed concerning compliance by Respondents
and OSI with the provisions of this Order and the EGFr-tk Divestiture Agreement until the
last obligation under the EGFr-tk Divestiture Agreement has been fully performed.
VII.
IT IS FURTHER ORDERED that:
- A. If Respondents have not fully complied with the
obligations specified in Paragraph IV of this Order, the Commission may appoint an
individual to serve as a trustee to divest the RID Divestiture Assets. In the event that
the Commission or the Attorney General brings an action pursuant to § 5(l)
of the Federal Trade Commission Act, 15 U.S.C. § 45(l), or any other
statute enforced by the Commission, Respondents shall consent to the appointment of a
trustee in such action to divest the RID Divestiture Assets. Neither the appointment of a
trustee nor a decision not to appoint a trustee under this Paragraph 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 § 5(l) of
the Federal Trade Commission Act, or any other statute enforced by the Commission, for any
failure by the Respondents to comply with this Order.
-
- B. If a trustee is appointed by the Commission or a court
pursuant to Paragraph VII.A. of this Order, Respondents shall consent to the following
terms and conditions regarding the trustee's powers, duties, authority, and
responsibilities:
1. The Commission shall select the trustee, subject to the
consent of Respondents, which consent shall not be unreasonably withheld. The trustee
shall be a person with experience and expertise in acquisitions and divestitures. If
Respondents have not opposed, in writing, including the reasons for opposing, the
selection of any proposed trustee within ten (10) days after notice by the staff of the
Commission to Respondents of the identity of any proposed trustee, Respondents shall be
deemed to have consented to the selection of the proposed trustee.
-
- 2. Subject to the prior approval of the Commission, the
trustee shall have the exclusive power and authority to divest the RID Divestiture Assets.
-
- 3. Within ten (10) days after appointment of the trustee,
Respondents shall execute a trust agreement 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 Paragraph IV of this Order.
-
- 4. The trustee shall have twelve (12) months from the date
the Commission approves the trust agreement described in Paragraph VII.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 the 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 the
divestiture period only two (2) times.
5. The trustee shall have full and complete access to the
personnel, books, records and facilities related to RID or to any other relevant
information, as the trustee may request. Respondents shall develop such financial or other
information as the trustee may request and shall cooperate with the trustee. Respondents
shall take no action to interfere with or impede the trustee's accomplishment of the
divestiture. Any delays in divestiture caused by Respondents 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 use his or her best efforts to
negotiate the most favorable price and terms available in each contract that is submitted
to the Commission, subject to Respondents' absolute and unconditional obligation to divest
at no minimum price. The divestiture shall be made in the manner and to an acquirer as set
out in Paragraph IV of this Order; provided, however, if the trustee
receives bona fide offers from more than one acquiring entity, and if the Commission
determines to approve more than one such acquiring entity, the trustee shall divest to the
acquiring entity selected by Respondents from among those approved by the Commission; provided
further, however, that Respondents shall select such entity within five (5)
business days of receiving notification of the Commission's approval.
-
- 7. The trustee shall serve, without bond or other security,
at the cost and expense of Respondents, on such reasonable and customary terms and
conditions as the Commission or a court may set. The trustee shall have the authority to
employ, at the cost and expense of Respondents, such consultants, accountants, attorneys,
investment bankers, business brokers, appraisers, and other representatives and assistants
as are necessary to carry out the trustee's duties and responsibilities. The trustee shall
account for all monies derived from the divestiture 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 Respondents, and the trustee's power shall be
terminated. The compensation of the trustee shall be based at least in significant part on
a commission arrangement contingent on the divestiture all of Respondents' RID Divestiture
Assets.
8. Respondents 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 preparation
for, or defense of, any claim, whether or not resulting in any liability, except to the
extent that such losses, claims, damages, liabilities, or expenses result from misfeasance, gross negligence, willful or wanton acts,
or bad faith by the trustee.
-
- 9. 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 VII.B.
of this Order.
10. 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.
-
- 11. The trustee shall have no obligation or authority to
operate or maintain the RID Divestiture Assets.
-
- 12. The trustee shall report in writing to Respondents and
the Commission every sixty (60) days concerning the trustee's efforts to accomplish the
divestiture.
VIII.
IT IS FURTHER ORDERED that:
- A. Within thirty (30) 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, III, IV, and V.A. 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 this Order. Respondents shall submit at the same
time a copy of their report concerning compliance with this Order to the Interim Trustee
if any Interim Trustee has been appointed. Respondents shall include in their reports,
among other things that are required from time to time, a full description of the efforts
being made to comply with Paragraphs II through V of the Order, including a description of
all substantive contacts or negotiations for the divestitures and the identity of all
parties contacted. Respondents shall include in their reports copies of all written
communications to and from such parties, all internal memoranda, and all reports and
recommendations concerning completing the obligations.
B. One (1) year from the date this Order becomes final, annually for the next five (5)
years on the anniversary of the date this Order becomes final, and at other times as the
Commission may require, Respondents shall file a verified written report with the
Commission setting forth in detail the manner and form in which they have complied and are
complying with this Order.
IX.
IT IS FURTHER ORDERED that Respondents shall notify the Commission at
least thirty (30) days prior to any proposed change in the corporate Respondents such as
dissolution, assignment, sale resulting in the emergence of a successor corporation, or
the creation or dissolution of subsidiaries or any other change in the corporation that
may affect compliance obligations arising out of the Order.
X.
IT IS FURTHER ORDERED that, for the purpose of determining or securing
compliance with this Order, and subject to any legally recognized privilege, and upon
written request with reasonable notice to Respondents made to their principal United
States office, Respondents shall permit any duly authorized representative of the
Commission:
- A. Access, during office hours of Respondents and in the presence of counsel, to all
facilities and access to inspect and copy all books, ledgers, accounts, correspondence,
memoranda and all other records and documents in the possession or under the control of
Respondents relating to compliance with this Order; and
-
- B. Upon five (5) days' notice to Respondents and without restraint or interference from
Respondents, to interview officers, directors, or employees of Respondents, who may have
counsel present, regarding such matters.
XI.
IT IS FURTHER ORDERED that this Order shall terminate twenty (20)
years after the date on which this Order is issued by the Commission.
By the Commission.
Donald S. Clark
Secretary
SEAL
ISSUED:
APPENDIX I [non-public]
Celexa Co-Promotion Agreement
APPENDIX II. [non-public]
Amendment to Celexa Co-Promotion Agreement
APPENDIX III. [non-public]
Celexa Termination Agreement
APPENDIX IV. [non-public]
Cognex Divestiture Agreement
APPENDIX V. [non-public]
OSI/Pfizer Collaboration Agreements (1986, 1991 and 1996)
Appendix VI [non-public]
OSI/Pfizer License Agreements (1990 and 1996)
Appendix VII (non-public)
EGFr-tk Divestiture Agreement
Appendix VIII (non-public)
RID Divestiture Agreement
Appendix IX (public)
Key Employees
Parke-Davis Celexa Team Members
John Woychick |
VP NE CBU |
Doug Saltel |
VP CNS Marketing |
Tim George |
Dir. Strategic Alliances |
Katie MacFarlane |
Dir. Marketing |
Garry Callendar |
Dir., Strategic Planning &
Information Management |
Jim LaMartina |
Dir., Sales Training |
Scott Van Acker* |
Dir., Health Care Management
(Field) |
Rich Weiss * |
Dir., Health Care Management
(Marketing) |
Ken Massey |
Sr. Dir., Medical & Scientific
Affairs |
Victor Delimata |
Sr. Product Manager-CNS Disease
Team |
Patrick Runde* |
Sr. Marketing Manager |
George Cavic* |
VP Health Care Management |
John Richter* |
Dir., CNS & Anti-Infective
Marketing, Health Care Mgmt. |
Ginny Ludwig |
Sr. Mgr., Health Care Mgmt. |
Ron Preblick, Pharm.D. |
Mgr., Health Care Economics |
Debra Schramm * |
Dir., Contracts and Pricing, Health
Care Management |
Lynne Fredericks |
Market Research |
Rick Wantees |
Market Research |
Lene Ulrich* |
VP, SC CBU |
John Howard* |
VP, NC CBU |
Daniel Green* |
VP, West CBU |
Les Slater* |
VP, SE CBU |
Laura Johnson* |
Marketing Mgr., NE CBU |
Andrew Purcell |
VP, West CBU |
Janice Hall |
Senior Product Manager |
Allison Fannon |
Product Manager |
Tim Amato |
Product Manager |
* These individuals are signing as to confidentiality only
Appendix X (public)
Key Employee Confidentiality
Agreement
I, ________________ , hereby acknowledge that I will
maintain all Celexa Know-how (as defined in the Consent Order, including, without
limitation, all field experience) regarding Celexa strictly confidential, including from
all other employees, executives, or other personnel of Warner-Lambert, its Affiliates and
successors.
I also hereby agree that I will not be involved in the
marketing, sale, or promotion of Zoloft or any SSRI/SNRI Product (as defined in the
Consent Order) other than Celexa through March 31, 2001.
Appendix XI (public)
Warner/Pfizer Notice
I.
Pursuant to a Consent Order entered into between
Warner-Lambert Company, Pfizer Inc. and the Federal Trade Commission on May 24, 2000,
members of the Warner-Lambert PC-2 salesforce, CNS, Hospital, Managed Care, and
Governmental salesforces, who directly participated in the marketing of Celexa within the
twelve month period immediately prior to the termination date of April 30, 2000, are
prohibited from performing services for Pfizer, or any affiliate of Pfizer, in connection
with the marketing or promotion of Zoloft through November 30, 2000. In addition, such
employees are prohibited from accompanying Pfizer personnel on Zoloft detailing calls.
In addition, these employees shall maintain all Celexa
Know-how (as defined in the Consent Order) in their possession strictly confidential from
any person or entity, including from all other employees, executives, or other personnel
of Warner-Lambert, its Affiliates and successors.
II.
Pursuant to a Consent Order entered into between
Warner-Lambert Company, Pfizer Inc. and the Federal Trade Commission on May 24, 2000,
Morris Plains New Jersey and Warner-Lambert Central Business Unit-based Warner-Lambert
marketing executives and personnel and administrative and sales personnel, who directly
participated in the marketing of Celexa within the twelve month period immediately prior
to the termination date of April 30, 2000, are prohibited from performing services for
Pfizer, or any affiliate of Pfizer, in connection with the marketing or promotion of
Zoloft through March 31, 2001. In addition, such employees are prohibited from
accompanying Pfizer personnel on Zoloft detailing calls.
In addition, such employees shall maintain all Celexa
Know-how (as defined in the Consent Order) strictly confidential from any person or
entity, including from all other employees, executives, or other personnel of
Warner-Lambert, its Affiliates and successors. |