Baxter International Inc

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IN THE MATTER OF BAXTER INTERNATIONAL INC., ET AL.

CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 7 OF THE CLAYTON ACT AND SEC. 5 OF THE FEDERAL TRADE COMMISSION ACT Docket C-4068; File No. 0210171 Complaint, December 20, 2002--Decision, February 3, 2003 This consent order addresses the acquisition by Respondent Baxter International Inc. from Wyeth of substantially all of the assets related to Respondent Wyeth’s generic injectable pharmaceutical business, operated by Wyeth and its ESI Lederle division. The order, among other things, requires the respondents to divest all of Wyeth’s assets relating to propofol – a general anesthetic commonly used for the induction and maintenance of anesthesia during surgical procedures and as a sedative for patients who are mechanically ventilated – to Faulding Pharmaceutical Company, or another Commissionapproved acquirer, no later than ten business days after the acquisition. The order also requires the respondents to terminate all rights and interests in GensiaSicor’s (1) pancuronium, (2) vecuronium, and (3) metoclopramide products – which are respectively (1) a rapid-onset, long-acting neuromuscular blocking agent used to temporarily freeze muscles during surgery or mechanical ventilation and to assist in the intubation process; (2) an intermediate-acting neuromuscular blocking agent that temporarily freezes muscles during surgery, mechanical ventilation, or intubation; and (3) an antiemetic used for the prevention and treatment of nausea and vomiting for patients undergoing certain types of chemotherapy and for post-operative treatment – and divest all of their pancuronium, vecuronium, and metoclopramide assets to GensiaSicor. In addition, the order requires the respondents to terminate Baxter’s comarketing agreement with Watson Pharmaceuticals, Inc., pursuant to which Baxter promotes Ferrlecit®, – an injectable iron gluconate product used to treat iron deficiency in patients undergoing hemodialysis – by March 14, 2004, in order to give Baxter the incentive to continue developing and ultimately launch the iron gluconate product it acquired from W yeth. Participants For the Commission: Yolanda R. Gruendel, Joanne C. Lewers, Stephanie C. Bovee, Jennifer Clarke-Smith, Sylvia M. Brooks, Ann Malester, Jeff Dahnke, Roberta S. Baruch, John Howell, and Mary T. Coleman.

VOLUME 135 Complaint For the Respondents: Michael Sennett and Pam Taylor, Bell Boyd & Lloyd LLC, and Charles E. Koob, and Ann Rappleye, Simpson, Thacher and Bartlett.

COMPLAINT The Federal Trade Commission (“Commission”), having reason to believe that Respondent Baxter International Inc. (“Baxter”), a corporation subject to the jurisdiction of the Commission, has agreed to acquire certain assets of Respondent Wyeth, a corporation subject to the jurisdiction of the Commission, in violation 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 it appearing to the Commission that a proceeding in respect thereof would be in the public interest, hereby issues its Complaint, stating its charges as follows:

I. DEFINITIONS 1. “Commission” means the Federal Trade Commission. 2. “FDA” means the United States Food and Drug Administration.

3. “ESI” means ESI Lederle, a division of Wyeth that, among other things, researches, develops, manufactures and sells human generic injectable pharmaceuticals. ESI is 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 Five Giralda Farms, Madison, New Jersey 07940. 4. “Respondents” means Baxter and Wyeth individually and collectively.

VOLUME 135 Complaint 5. “Metoclopramide” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as metoclopramide or metoclopramide hydrochloride.

6. “New Injectable Iron Replacement Therapies” or “NIIRTs” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as iron gluconate or iron sucrose.

7. “Pancuronium” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as pancuronium or pancuronium bromide.

8. “Propofol” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as propofol. 9. “Vecuronium” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as vecuronium or vecuronium bromide.

II. RESPONDENTS 10. Respondent Baxter 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 One Baxter Parkway, Deerfield, Illinois 60015. Baxter, among other things, is engaged in the research, development, manufacture and/or sale of generic injectable pharmaceuticals, including: Pancuronium, Vecuronium, Metoclopramide, Propofol and NIIRTs.

11. Respondent Wyeth 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 VOLUME 135 Complaint Five Giralda Farms, Madison, New Jersey 07940. Wyeth, through ESI, is engaged in the research, development, manufacture and/or sale of generic injectable pharmaceuticals, including: Pancuronium, Vecuronium, Metoclopramide, Propofol and NIIRTs.

12. Respondents are, and at all times relevant herein have been, engaged in commerce, as “commerce” is defined in Section 1 of the Clayton Act as amended, 15 U.S.C. § 12, and are corporations whose business is in or affects commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act, as amended, 15 U.S.C. § 44. III. THE PROPOSED ACQUISITION 13. On June 8, 2002, Baxter and Wyeth entered into an Asset Purchase Agreement whereby Baxter agreed to acquire substantially all of the assets relating to Wyeth’s human generic injectable pharmaceutical business, operated by Wyeth’s ESI Lederle division (hereinafter “Acquisition”). IV. THE RELEVANT MARKETS 14. For the purposes of this Complaint, the relevant lines of commerce in which to analyze the effects of the Acquisition are: 1. the manufacture and sale of Pancuronium; 2. the manufacture and sale of Vecuronium; 3. the manufacture and sale of Metoclopramide; 4. the manufacture and sale of Propofol; and 5. the manufacture and sale of NIIRTs. VOLUME 135 Complaint 15. For the purposes of this Complaint, the United States is the relevant geographic area in which to analyze the effects of the Acquisition in the relevant lines of commerce. V. THE STRUCTURE OF THE MARKETS 16. Baxter and ESI are the two leading U.S. suppliers of Pancuronium, a neuromuscular blocking agent. The Acquisition would create a duopoly in the market for the manufacture and sale of Pancuronium. After the acquisition, the combined company would account for 74% of annual sales of Pancuronium in the United States, and the post-acquisition Herfindahl-Hirschman Index (“HHI”) would be 6,152, representing a 2,496 point increase in the HHI.

17. The market for the manufacture and sale of Vecuronium is also highly concentrated. Baxter and ESI were the two leading suppliers of Vecuronium in the United States, with a combined market share of 53%, until ESI temporarily suspended sales of Vecuronium in 2001. The post-acquisition HHI would be 3,598, representing a 1,364 point increase in the HHI. Prior to the announcement of the Acquisition, ESI had planned to relaunch its Vecuronium product.

18. The market for the manufacture and sale of Metoclopramide is highly concentrated as measured by the HHI. Baxter and ESI are two of only four suppliers of Metoclopramide. Baxter and ESI, respectively, represent approximately 12% and 39% of the market. As a result of the Acquisition, Baxter would account for 51% of the market and the post-Acquisition HHI would be 3,852, an increase of 936 points above the pre- Acquisition HHI.

19. The market for the manufacture and sale of Propofol is highly concentrated. Currently, AstraZeneca Pharmaceuticals LP and Baxter market the only Propofol products in the United States. ESI is seeking FDA approval for its own Propofol product and is one of the two best-positioned firms to enter the market. Other VOLUME 135 Complaint firms that have undertaken efforts to develop Propofol have either failed in their efforts or lag well behind ESI. 20. The market for the manufacture and sale of NIIRTs is highly concentrated. Currently, Watson Pharmaceuticals, Inc. and Baxter jointly market one of only two NIIRT products approved for use in the United States. ESI has the most advanced development effort for a NIIRT and appears to be the bestpositioned firm to enter the market for the manufacture and sale of NIIRTs.

VI. ENTRY CONDITIONS 21. Entry into any of the relevant product markets described in Paragraph 14 would not be timely, likely, or sufficient in its magnitude, character, and scope to deter or counteract the anticompetitive effects of the Acquisition. Developing and obtaining approval for even the simplest generic injectable takes at least two years and significantly longer for more complex products. Additionally, patents and other intellectual property create large and potentially insurmountable barriers to entry in some of the product markets.

VII. EFFECTS OF THE ACQUISITION 22. The effects of the Acquisition, if consummated, may be to lessen competition and to tend to create a monopoly in the relevant markets in 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 following ways, among others: 1. by eliminating actual, direct, and substantial competition between Baxter and Wyeth, and reducing the number of competitors, in the market for the manufacture and sale of Pancuronium, thereby (a) increasing the likelihood of a unilateral exercise of market power in the market for the manufacture and sale of Pancuronium, or (b) increasing the likelihood of coordinated interaction, and VOLUME 135 Complaint (c) increasing the likelihood that Pancuronium customers would be forced to pay higher prices;

2. by eliminating potential competition between Baxter and Wyeth in the market for the manufacture and sale of Vecuronium, thereby (a) increasing the likelihood that the combined entity would forego or delay the relaunch of ESI’s Vecuronium and (b) increasing the likelihood that the combined entity would delay or eliminate the additional price competition that would have resulted from ESI’s re-entry into the market for the manufacture and sale of Vecuronium;

3. by eliminating actual, direct, and substantial competition between Baxter and Wyeth, and reducing the number of competitors, in the market for the manufacture and sale of Metoclopramide, thereby (a) increasing the likelihood of a unilateral exercise of market power in the market for the manufacture and sale of Metoclopramide, or (b) increasing the likelihood of coordinated interaction, and (c) increasing the likelihood that Metoclopramide customers would be forced to pay higher prices;

4. by eliminating potential competition between Baxter and Wyeth in the market for the manufacture and sale of Propofol, thereby (a) increasing the likelihood that the combined entity would forego or delay the launch of ESI’s Propofol and (b) increasing the likelihood that the combined entity would delay or eliminate the additional price competition that would have resulted from ESI’s entry into the market for the manufacture and sale of Propofol; and 5. by eliminating potential competition between Baxter and Wyeth in the market for the manufacture and sale of NIIRTs, thereby (a) increasing the likelihood that the combined entity would forego or delay the launch of ESI’s NIIRT and (b) increasing the likelihood that the VOLUME 135 Complaint combined entity would delay or eliminate the additional price competition that would have resulted from ESI’s entry into the market for the manufacture and sale of NIIRTs.

VIII. VIOLATIONS CHARGED 23. The Asset Purchase Agreement described in Paragraph 13 constitutes a violation of Section 5 of the FTC Act, as amended, 15 U.S.C. § 45.

24. The Acquisition described in Paragraph 13, 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.

WHEREFORE, THE PREMISES CONSIDERED, the Federal Trade Commission on this twentieth day of December, 2002, issues its Complaint against said Respondents. VOLUME 135 Decision and Order DECISION AND ORDER The Federal Trade Commission (“Commission”) having initiated an investigation of the proposed acquisition by Respondent Baxter International Inc. (“Baxter”) of certain assets of Respondent Wyeth, hereinafter referred to as “Respondents,” and Respondents having been furnished thereafter with a copy of a draft of Complaint that the Bureau of Competition proposed to present 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, and having duly considered the comment filed thereafter by an interested party pursuant to § 2.34 of the Commission Rules, the Commission hereby makes the following jurisdictional findings and issues the following Decision and Order (“Order”): VOLUME 135 Decision and Order 1. Respondent Baxter 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 One Baxter Parkway, Deerfield, Illinois 60015. 2. Respondent Wyeth 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 Five Giralda Farms, Madison, New Jersey 07940. 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. “Baxter” means Baxter International Inc., its directors, officers, employees, agents, representatives, predecessors, successors, and assigns; its joint ventures, subsidiaries, divisions, groups and affiliates controlled by Baxter International Inc. (including, but not limited to, Baxter Healthcare Corporation), and the respective directors, officers, employees, agents, representatives, successors, and assigns of each. B. “Wyeth” means Wyeth, its directors, officers, employees, agents, representatives, predecessors, successors, and assigns; its joint ventures, subsidiaries, divisions, groups and affiliates controlled by Wyeth (including, but not limited to, Wyeth Pharmaceuticals Inc.), and the respective directors, officers, employees, agents, representatives, successors, and assigns of each.

VOLUME 135 Decision and Order C. “Respondents” means Baxter and Wyeth individually and collectively.

D. “Acquisition” means the proposed acquisition by Baxter of certain assets of Wyeth’s human generic injectable pharmaceutical business, operated by Wyeth’s ESI Lederle division, pursuant to an Asset Purchase Agreement dated June 8, 2002, by and among Wyeth, Wyeth Pharmaceuticals Inc. and Baxter Healthcare Corporation.

E. “Commission” means the Federal Trade Commission. F. “Faulding” means Faulding Pharmaceutical Co., 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 650 From Road (Mack-Cali Centre II), 5th Floor South, Paramus, New Jersey, 07652. G. “Acquisition Date” means the date the Acquisition is consummated.

H. “Access Period” means the period described in Paragraph II.H. of this Order.

I. “Agency” means any governmental, legislative, regulatory, judicial or other authority in the world responsible for granting approvals, consents, licenses, registrations, permits, waivers or other authorizations for any aspect of the research, development, manufacture, finishing, packaging, validation, distribution, marketing or sale of any of Respondents’ products. The term “Agency” includes, but is not limited to, the FDA. J. “ANDA” means an Abbreviated New Drug Application filed or to be filed with the FDA pursuant to 21 C.F.R. 314, or its foreign Agency equivalent, and all supplements, amendments and revisions thereto.

VOLUME 135 Decision and Order K. “Anesthesia/Sedation Product” means any pharmaceutical product indicated for the induction or maintenance of general anesthesia or sedation in connection with a surgical procedure or an invasive non-surgical procedure (including, but not limited to, sedation of intubated, mechanically ventilated individuals), but excluding any product marketed by Wyeth on the day following the Divestiture Date.

L. “Business Day” means any day excluding Saturday, Sunday and any United States Federal holiday. M. “Confidential Propofol Information” means all information that is not in the public domain relating to Propofol that was obtained in any manner by Respondent Wyeth. “Confidential Propofol Information” does not include (1) any information that Respondent Baxter demonstrates it obtained without the assistance of Respondent Wyeth prior to the Acquisition Date or (2) the Propofol Licensed Intellectual Property.

N. “Confidential PV&M Information” means all information that is not in the public domain relating to Sicor’s Pancuronium, Vecuronium, and Metoclopramide that was obtained in any manner by Respondent Baxter.

O. “Copyrights” means all rights to all original works of authorship of any kind in any form related to any of Respondents’ products, and any registrations and applications for registrations thereof.

P. “Direct Cost” means the pro rata share of salary or wages and reasonable expenses.

Q. “Divestiture Agreement” means the Faulding Divestiture Agreement or any other agreement to divest the Propofol Assets that has been approved by the Commission to accomplish the requirements of this Order, between Respondents and a Propofol Acquirer (or between a trustee appointed pursuant to Paragraph VOLUME 135 Decision and Order VI. of this Order and a Propofol Acquirer) and all amendments, exhibits, attachments, agreements, and schedules thereto. R. “Divestiture Date” means the date on which Respondents and a Propofol Acquirer close on a transaction to divest, license, or otherwise convey relevant assets pursuant to this Order. S. “Divestiture Trustee” means the trustee appointed by the Commission pursuant to Paragraph VI.A. of this Order. T. “Drug Master Files” means the information required by the FDA as described in 21 C.F.R. Part 314.420 related to Propofol. U. “Faulding Divestiture Agreement” means the Asset Purchase Agreement (including all related agreements, amendments, schedules, exhibits, and appendices) by and between Respondent Baxter and Faulding dated November 20, 2002 that is attached hereto as Confidential Appendix I. V. “FDA” means the United Stated Food and Drug Administration.

W. “Iron Gluconate” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as iron gluconate or sodium ferric gluconate.

X. “Iron Gluconate Agreement” means the Ferrlecit® Co- Promotion Agreement dated June 28, 2002, between Baxter Healthcare Corporation and Watson Pharmaceuticals, Inc. relating to Watson’s product Ferrlecit®.

Y. “Know-how” means any product specifications, processes, product designs, plans, trade secrets, ideas, concepts, manufacturing, engineering, and other manuals and drawings, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, safety, quality control and clinical data, technical information, test results, data, research records, VOLUME 135 Decision and Order invention disclosures, literature, supplier lists and similar data and information and all other confidential and proprietary technical or business information in each case in whatever medium (electronic, magnetic or otherwise), and all rights in any jurisdiction to limit the use or disclosure thereof.

Z. “Metoclopramide” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as metoclopramide or metoclopramide hydrochloride.

AA. “NDA” means the New Drug Application filed or to be filed with the FDA pursuant to C.F.R. Part 314, or its foreign Agency equivalent, and all supplements, amendments and revisions thereto.

BB. “NDC Numbers” means the National Drug Code numbers(s) assigned by the FDA.

CC. “Pancuronium” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as pancuronium or pancuronium bromide.

DD. “Patents” means all patents, patent applications, and statutory invention registrations, including all reissues, renewals, divisions, continuations, continuations-in-part, supplementary protection certificates, extensions and reexaminations thereof, all inventions disclosed therein, all rights therein provided by international treaties and conventions, and all rights to obtain and file for patents and registrations thereto in the world, related to any of Respondents’ products.

EE. “Person” includes the company and means any natural person, incorporated or unincorporated entity, partnership, association, joint venture, government entity, non-profit organization, university, trust or other entity. VOLUME 135 Decision and Order FF. “Product Registrations” means all registrations, permits, licenses, consents, authorizations and other approvals, and pending applications and requests therefore, required by applicable Agencies related to the research, development, manufacture, finishing, packaging, distribution, marketing or sale of any of Respondents’ products, including all NDAs and ANDAs. “Product Registrations” includes all underlying information, data, filings, reports, correspondence or other materials used to obtain or apply for any of the foregoing, including, without limitation, all data submitted to and all correspondence with the FDA and other Agencies. GG. “Propofol” means any pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as propofol.

HH. “Propofol Acquirer” means an entity approved by the Commission to acquire the Propofol Assets. II. “Propofol Assets” means all of Respondent Wyeth’s rights, title and interest, in and to all assets, tangible or intangible, related to Propofol in any market anywhere in the world, in existence as of the Acquisition Date, including the research, development, registering, manufacture, packaging, distribution, marketing or sale of Propofol, including, without limitation, the following: 1. all personal property owned, leased or otherwise held by Wyeth;

2. all Propofol Intellectual Property; 3. all Confidential Propofol Information; 4. all Product Registrations;

5. at the Propofol Acquirer’s option, any of the Propofol Contracts;

VOLUME 135 Decision and Order 6. all Propofol Manufacturing Technology, Propofol Scientific and Regulatory Materials, and Propofol Marketing Materials;

7. a list of all of the NDC Numbers related to Propofol; 8. all Drug Master Files including all rights of reference to the Drug Master Files and rights of reference (if such rights exist) to information similar to the Drug Master Files submitted to any Agency other than the FDA; 9. all inventories, stores, and supplies held by, or under the control of, Wyeth, including, but not limited to, raw materials, goods in process, finished goods, and Propofol specific packaging and labels; and 10. all books, records and files.

Provided, however, that “Propofol Assets” does not include (i) any assets exclusively relating to Sicor’s Propofol that Baxter markets pursuant to an agreement dated September 30, 1993 between Baxter and Sicor, (ii) any real property relating to Wyeth’s Propofol Assets, and (iii) any Propofol Licensed Intellectual Property.

JJ. “Propofol Contracts” means all contracts and agreements relating to Propofol between Wyeth and any Person, including, but not limited to, contracts and agreements with manufacturers, raw material suppliers, customers, and group purchasing organizations.

KK. “Propofol Employees” means all of Respondent Wyeth’s employees who participated (irrespective of the portion of working time involved), within the eighteen (18) month period immediately prior to the Divestiture Date, in the following activities: (i) the regulatory approval process, including clinical, bioequivalence or stability studies of Propofol; (ii) the planning, engineering, procurement, or analysis of the means to produce VOLUME 135 Decision and Order Propofol; (iii) the manufacture of (or attempt to manufacture) Propofol, including, but not limited to, those involved in the quality assurance and quality control of Propofol; or (iv) legal work on Patents or litigation related to Propofol. “Propofol Employees” also includes all of Respondent Wyeth’s employees who participated (irrespective of the portion of working time involved), within the five (5) year period immediately prior to the Divestiture Date, in the research and development of Propofol. These employees are identified in Confidential Appendix II, attached hereto.

LL. “Propofol Intellectual Property” means all of each of the following that relate to Propofol:

1. inventions and discoveries related to Propofol that are or may be patentable, and rights to obtain or file for Patents and registrations thereof;

2. Patents, including, but not limited to (a) U.S. Patents 6,177,477 and 6,028,108 and (b) all pending applications in Brazil, Canada, and the European Patent Office, that are the counterparts to U.S. Patents 6,177,477 and 6,028,108, and any patents issuing therefrom; 3. Copyrights, including, without limitation, all such rights relating to Propofol Marketing Materials, Propofol Manufacturing Technology, and Propofol Scientific and Regulatory Materials;

4. Software;

5. Trademarks, Trade Dress, and mask works; 6. Know-how; and 7. rights to sue and recover damages or obtain injunctive relief for infringement, dilution, misappropriation, violation or breach of any of the foregoing. VOLUME 135 Decision and Order Provided, however, that “Propofol Intellectual Property” does not include any Propofol Licensed Intellectual Property. MM. “Propofol Launch Date” means the earliest date on which the Proposed Acquirer (1) obtains all final approvals from any Agency necessary to manufacture and sell 20 ml, 50 ml, and 100 ml dosage forms of Propofol, each as a finished good, in the United States and (2) is able to legally sell 20 ml, 50 ml, and 100 ml dosage forms of Propofol, each as a finished good, in the United States.

NN. “Propofol Licensed Intellectual Property” means all of Respondent Wyeth’s rights, title, and interest, in and to all Knowhow that relates to (but does not exclusively relate to) Propofol as of the Divestiture Date.

OO. “Propofol Manufacturing Technology” means all technology, trade secrets, know-how, techniques, processes, practices, methods, and proprietary information, materials, or data relating to the manufacture, engineering, safety, quality control, validation, packaging, finishing, release testing, stability or shelf life of Propofol, and any rights thereto, in all jurisdictions, including, but not limited to, all Propofol specifications, formulations, manufacturing and engineering records, manuals, and drawings, all sampling records, standard operating procedures, batch records, stability studies, supplier lists, and all specifications for commercial field equipment. PP. “Propofol Marketing Materials” means all marketing information, materials or data used (or that Wyeth planned for use) anywhere in the world relating to Propofol, including, but not limited to (i) all advertising, promotional, educational, training, display, and sales (e.g., forecasting models, detailing reports, sales force call activity reports) information, materials, or data, (ii) all vendor lists, price lists, and reimbursement data, (iii) all market, competitor, and customer information (e.g., customer lists, customer contact information, mailing lists, research data and market intelligence reports), (iv) all statistical programs (if any) VOLUME 135 Decision and Order used for marketing and sales research, (v) all artwork for packaging, and (vi) all marketing, strategic, sales or other plans. QQ. “Propofol Patent Litigation” means the action filed by AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd. against Wyeth for patent infringement in the United States District Court for the Southern District of New York (Case No. 02 CV 7936) relating to the Propofol Assets. RR. “Propofol Scientific and Regulatory Materials” means all technical, scientific, clinical, pharmaceutical, chemical, pharmacological, toxicological, physical, analytical, regulatory, process development, bioequivalence, and stability information, materials, or data relating to Propofol, and all rights thereto, in any and all jurisdictions, including, but not limited to, all information, data, and materials used in or relating to the research, development, registration, and Agency approval of Propofol, including (i) all raw data used to support any information submitted to an Agency (e.g., clinical or bioequivalence data), (ii) all case report forms, (iii) all statistical programs developed (or modified in a manner material to the use or function thereof (other than through user references)) to analyze data, (iv) all data contained in laboratory notebooks, and (v) all adverse experience reports, files, and underlying data (including source documentation).

SS. “Propofol Services” means the services described in Paragraph II.E. of this Order.

TT. “PV&M Assets” means all of Respondent Baxter’s right, title and interest, in and to all assets, tangible or intangible, related to Pancuronium, Vecuronium, and Metoclopramide, in existence as of the date Respondents sign the Consent Agreement, including, but not limited to:

1. all Confidential PV&M Information;

2. at Sicor’s option, any of the PV&M Contracts; VOLUME 135 Decision and Order 3. all Copyrights, including, without limitation, all such rights relating to the PV&M Marketing Materials; 4. all PV&M Marketing Materials;

5. all inventories, stores, and supplies held by, or under the control of, Respondent Baxter; and 6. all books, records and files.

UU. “PV&M Contracts” means all of the contracts and agreements relating to Pancuronium, Vecuronium, and Metoclopramide between Respondent Baxter and any Person, including, but not limited to, group purchasing organizations and hospitals.

VV. “PV&M Customers” means all of Baxter’s Pancuronium, Vecuronium, and Metoclopramide customers as of the date Respondents sign the Consent Agreement. WW. “PV&M Marketing Materials” means all marketing information, materials or data used anywhere in the world relating to Pancuronium, Vecuronium, and Metoclopramide, including, but not limited to (i) all advertising, promotional, educational, training, display, and sales (e.g., forecasting models, detailing reports, sales force call activity reports) information, materials, or data, (ii) all vendor lists, price lists, and reimbursement data, (iii) all market, competitor, and customer information (e.g., customer lists, customer contact information, mailing lists, research data and market intelligence reports), (iv) all statistical programs (if any) used for marketing and sales research, (v) all artwork for packaging, and (vi) all marketing, strategic, sales or other plans.

XX. “PV&M Services” means the term described in Paragraph III.D. of this Order.

VOLUME 135 Decision and Order YY. “PV&M Term” means the term described in Paragraph III.D. of this Order.

ZZ. “Restricted Period” means the period described in Paragraph III.E. of this Order.

AAA. “Sicor” means Sicor Inc. (including Gensia Sicor Pharmaceuticals, Inc. and Gensia Sicor Pharmaceuticals Sales, 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 19 Hughes Irvine, CA 92618.

BBB. “Software” means computer programs (including all software implementations of algorithms, models, and methodologies whether in source code or object code form), databases and compilations, including any and all data and collections of data, all documentation, including user manuals and training materials, related to any of the foregoing and the content and information contained on any website; provided, however, that “Software” does not include software that is readily purchasable or licensable and which has not been modified in a manner material to the use or function thereof (other than through user preference settings).

CCC. “Trade Dress” means any current or planned trade dress related to any of Respondents’ products, including, but not limited to, product packaging associated with the sale of the product worldwide and the lettering of the product’s trade name or brand name.

DDD. “Trademarks” means all (i) trademarks, trade names and brand names, including registrations and applications for registration therefor, (ii) all renewals, modifications, and extensions thereof, and (iii) all common law rights, and the goodwill symbolized thereby and associated therewith. VOLUME 135 Decision and Order EEE. “Vecuronium” means any injectable pharmaceutical composition containing any formulation or dosage of the active ingredient generically known as vecuronium or vecuronium bromide.

FFF. “Watson” means Watson Pharmaceuticals, Inc., a corporation organized, existing and doing business under and by virtue of the laws of the State of Nevada, with its corporate headquarters located at 311 Bonnie Circle, Corona, California, 92880.

II.

IT IS FURTHER ORDERED that:

A. No later than ten (10) Business Days after the Acquisition Date, Respondents shall divest the Propofol Assets, absolutely and in good faith, at no minimum price to Faulding. 1. To the extent that any of the Propofol Assets are conveyed to Respondent Baxter on the Acquisition Date, Respondent Baxter shall divest all such Propofol Assets to Faulding in accordance with Paragraph II.A. of this Order. The Faulding Divestiture Agreement is incorporated by reference into this Order and made a part hereof, and shall not be construed to vary or contradict the terms of this Order. Any failure to comply with the terms of the Faulding Divestiture Agreement shall constitute a violation of this Order by Respondent Baxter. 2. To the extent that any of the Propofol Assets are not conveyed to Respondent Baxter on the Acquisition Date, Respondent Wyeth shall divest all such Propofol Assets to Faulding in accordance with Paragraph II.A. of this Order.

VOLUME 135 Decision and Order B. Provided, however, that, if, at the time the Commission determines to make this Order final, the Commission notifies Respondent Baxter that Faulding is not an acceptable purchaser of the Propofol Assets or that the Faulding Divestiture Agreement is not an acceptable manner of divestiture: (i) Respondent Baxter shall immediately rescind the Faulding Divestiture Agreement; (ii) Respondents shall divest the Propofol Assets at no minimum price, absolutely and in good faith, no later than ninety (90) Business Days from the date this Order becomes final, to a Person that receives the prior approval of the Commission and only in a manner that receives the prior approval of the Commission; and (iii) Respondents shall comply with all terms of the Divestiture Agreement. The Divestiture Agreement shall not be construed to vary or contradict the terms of this Order, and any breach by Respondents of any term of the Divestiture Agreement shall constitute a violation of this Order.

C. No later than the date Respondents divest the Propofol Assets, Respondents shall grant to the Propofol Acquirer a worldwide, royalty-free, fully paid-up, perpetual, irrevocable, transferable, assignable license (with the right to grant sublicenses) to the Propofol Licensed Intellectual Property to make, distribute, offer for sale, promote, advertise, sell, import or export or have used, made, distributed, offered for sale, promoted, advertised, sold, imported or exported, any product anywhere in the world. Such license shall be (i) exclusive (even as to Respondents) for any Propofol product and (ii) non-exclusive for any other product; provided, however, that Respondents may require that the Propofol Acquirer not sublicense the Propofol Intellectual Property to any Person (other than third-party manufacturing contractor(s) or third-party developer(s) working on behalf of the Propofol Acquirer), to make, distribute, offer for sale, promote, advertise, sell, import or export or have used, made, distributed, offered for sale, promoted, advertised, sold, imported or exported, any non-Propofol or non-Anesthesia/Sedation product. Respondents shall disclose, provide or otherwise make available all of the Propofol Licensed Intellectual Property to the Propofol Acquirer no later than the Divestiture Date. VOLUME 135 Decision and Order D. Nothing in this Order shall prohibit the Propofol Acquirer from granting to Wyeth a non-exclusive license to any Know-how conveyed to the Propofol Acquirer pursuant to this Order; provided, however, that Respondent Wyeth shall not use any such Know-how licensed from the Propofol Acquirer for (1) any Propofol product or (2) any Anesthesia/Sedation Product. E. Upon request and reasonable notice from the Propofol Acquirer to Respondents, Respondents shall provide the following services (hereinafter “Propofol Services”) in a timely manner: 1. assistance and training from knowledgeable Propofol Employees to enable the Propofol Acquirer (or its designee) to obtain all necessary approvals from any Agency to manufacture and sell all formulations and dosages of Propofol, including, but not limited to, conducting stability studies, preparing filings, addressing FDA deficiency letters, and assisting with pre-approval inspections, until the Propofol Acquirer (or its designee) obtains all such necessary approvals; provided, however, that such assistance and training may be limited to applications for approvals that were filed, or requests for approvals that were made, on or before the Propofol Launch Date;

2. assistance and training from knowledgeable Propofol Employees at a facility chosen by the Propofol Acquirer, until the Propofol Acquirer or its designee is able to manufacture all formulations and dosages of Propofol for commercial sale, including, but not limited to, assistance with production batches, scale-up, commercial field equipment, and transferring Know-how related to Propofol; and 3. assistance from knowledgeable personnel to enable the Propofol Acquirer to defend against, respond to, or otherwise participate in any litigation (including the Propofol Patent Litigation), investigation, audit, process, VOLUME 135 Decision and Order subpoena or other proceeding relating to Propofol, until the litigation (including the Propofol Patent Litigation), investigation, audit, process, subpoena or other proceeding relating to Propofol is settled or finally disposed of without any right to appeal; provided, however, that such assistance may be limited to litigation, investigations, audits, processes, subpoenas or other proceedings relating to Propofol that are initiated on or before the Propofol Launch Date.

Provided, further, however, that Respondents shall not: (i) require the Propofol Acquirer to pay compensation for Propofol Services that exceeds the Direct Cost of providing such services; (ii) terminate its obligation to provide Propofol Services because of a material breach by the Propofol Acquirer of any agreement to provide such services, in the absence of a final order of a court of competent jurisdiction; or (iii) seek to limit the damages (such as indirect, special or consequential damages) that the Propofol Acquirer would be entitled to receive in the event of Respondents’ breach of any agreement to provide Propofol Services. F. At the time of divestiture, Respondents shall also divest any additional, incidental assets of Respondents and make any further arrangements for transitional services that may be reasonably necessary to ensure the marketability, viability and competitiveness of the Propofol Assets. G. Respondents shall secure, prior to the Divestiture Date, all consents and waivers from all Persons that are necessary for the divestiture of the Propofol Assets to the Propofol Acquirer, or for the continued research, development, manufacture, sale, marketing or distribution of Propofol by the Propofol Acquirer. H. For a period of six (6) months from the Divestiture Date (hereinafter “Access Period”), Respondents shall allow the Propofol Acquirer an opportunity to enter into an employment contract with any Propofol Employee, provided that such VOLUME 135 Decision and Order contracts are contingent upon the Commission’s approval of the Divestiture Agreement. Provided, further, that: 1. At the request of the Propofol Acquirer, any time during the Access Period, Respondents shall (i) allow the Propofol Acquirer an opportunity to interview any Propofol Employee, and (ii) allow the Propofol Acquirer to inspect the personnel files and other documentation relating to any Propofol Employee, to the extent permissible under applicable laws.

2. During the Access Period, Respondents shall (i) not interfere with the hiring or employing by the Propofol Acquirer of Propofol Employees, (ii) remove any impediments within the control of Respondents that may deter these employees from accepting employment with the Propofol Acquirer, 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 the Propofol Acquirer, and (iii) not make any counteroffer to a Propofol Employee who receives a written offer of employment from the Propofol Acquirer. Provided, however, that Paragraph II.H.2. does not prohibit Respondents from making offers of employment to or employing any Propofol Employee during the Access Period where the Propofol Acquirer has notified Respondents in writing that the Propofol Acquirer does not intend to make an offer of employment to that employee.

3. Respondents shall provide all Propofol Employees with reasonable financial incentives to continue in their positions until the Divestiture Date. Such incentives shall include a continuation of all employee benefits offered by Respondents until the Divestiture Date, including regularly scheduled raises and bonuses, and a vesting of all pension benefits (as permitted by law). VOLUME 135 Decision and Order 4. Respondents shall provide to each Propofol Employee incentives to accept employment with the Propofol Acquirer. Such incentives shall include a bonus equal to 10% of the employee’s current salary and commissions (including any annual bonuses), to any Propofol Employee as of the Divestiture Date, who accepts an offer of employment from the Propofol Acquirer during the Access Period, and remains employed by the Propofol Acquirer for a period of one (1) year, payable by Respondents one (1) year after the commencement of the employee’s employment with the Propofol Acquirer. 5. For a period of one (1) year following the Divestiture Date, Respondents shall not, directly or indirectly, hire or enter into any arrangement for the services of any employee employed by the Propofol Acquirer with any amount of responsibility related to Propofol, unless the individual’s employment has been terminated by the Propofol Acquirer.

I. Respondents shall take all necessary steps to maintain the confidentiality of the Confidential Propofol Information. Provided, further, that:

1. Except as permitted under the Divestiture Agreement or this Order, Respondents shall not (i) provide, disclose, or otherwise make available any Confidential Propofol Information to any Person or (ii) use any Confidential Propofol Information for any reason or purpose. 2. If use of any Confidential Propofol Information is permitted under this Order, Respondents shall provide, disclose, or otherwise make available such information (i) only to those Persons who require such information for the permitted purposes, (ii) only such part of the Confidential Propofol Information that is so required, and (iii) only to those Persons who agree in writing to maintain the confidentiality of such information. VOLUME 135 Decision and Order 3. Respondents shall (i) require that any Propofol Employee who continues his or her employment with either Respondent sign a confidentiality agreement pursuant to which such employee shall be required to maintain the confidentiality of all Confidential Propofol Information, including the obligation not to disclose such information to any other employee, executive, consultant, agent or other personnel of Respondents, and (ii) enforce the terms of this Paragraph II.I. as to any Person and take such action as is necessary to cause each such Person to comply with the terms of this Paragraph II.I., including notification and training of employees and all other actions that Respondents would take to protect their own trade secrets and proprietary information. 4. Nothing in this Order prohibits Respondents from disclosing Confidential Propofol Information if required by United States federal or state law, regulation, court order, or subpoena; provided, however, that Respondents shall use their best efforts to protect the confidentiality of such information, including, but not limited to, obtaining a protective order during an adjudication. J. The purpose of the divestiture of the Propofol Assets and of related obligations is to ensure the continued use of the Propofol Assets in the same business in which the Propofol Assets were used by Respondent Wyeth at the time of the announcement of the Acquisition, and to remedy the lessening of competition resulting from the Acquisition as alleged in the Commission’s Complaint. III.

IT IS FURTHER ORDERED that:

A. No later than five (5) Business Days after the Acquisition Date, Respondent Baxter shall (i) terminate all of its rights and interests in Sicor’s Pancuronium, Vecuronium, and Metoclopramide, and (ii) divest the PV&M Assets to Sicor. VOLUME 135 Decision and Order B. Respondent Baxter shall secure, prior to the Acquisition Date, all consents and waivers from all Persons that are necessary for the divestiture of the PV&M Assets to Sicor. C. No later than five (5) Business Days after the date Respondents sign the Consent Agreement, Respondent Baxter shall notify in writing all PV&M Customers that (i) Baxter intends to transfer all of its rights and interests in Pancuronium, Vecuronium, and Metoclopramide back to Sicor, (ii) Baxter intends to transfer all contracts relating to these products to Sicor, and (iii) following a transition period not to exceed ninety (90) Business Days, PV&M Customers will be able to purchase these products under the Sicor label. Respondent Baxter shall provide Sicor with a copy of such notification, together with a list of the names and addresses of all PV&M Customers to whom such notification was sent, no later than five (5) Business Days after the date Respondents sign the Consent Agreement. Prior to the date Respondent Baxter terminates all of its rights and interests in Sicor’s Pancuronium, Vecuronium, and Metoclopramide pursuant to Paragraph III.A. of this Order, Respondent Baxter shall permit Sicor to contact the PV&M Customers solely for the purpose of (i) introducing Sicor and its sales representatives to the PV&M Customers, (ii) informing such customers of how orders may be placed during the transition period, and (iii) addressing ways to ensure the uninterrupted supply of Pancuronium, Vecuronium, and Metoclopramide.

D. For a period not to exceed ninety (90) Business Days after the Acquisition date (hereinafter “PV&M Term”), at the request of Sicor, Respondent Baxter shall provide to Sicor at no cost and in a timely manner the following services (hereinafter “PV&M Services”):

1. Baxter shall continue to take customer orders, ship product, invoice customers, collect customer remittances, and provide any other additional services that are necessary to ensure an uninterrupted supply of Sicor’s VOLUME 135 Decision and Order Pancuronium, Vecuronium, and Metoclopramide (including any such Baxter-labeled products); provided, however, that for the term of the PV&M Services, Baxter may share a dual award on any group purchasing organization contracts for the sole purpose of performing its obligations under this Paragraph III.D.; provided further, however, that Respondent Baxter shall not market, distribute, sell or otherwise convey Pancuronium, Vecuronium, or Metoclopramide manufactured by Sicor after the PV&M Term.

2. Respondent Baxter shall not: (i) terminate its obligation to provide PV&M Services because of a material breach by Sicor of any agreement to provide such services, in the absence of a final order of a court of competent jurisdiction; or (ii) seek to limit the damages (such as indirect, special or consequential damages) that Sicor would be entitled to receive in the event of Respondent Baxter’s breach of any agreement to provide PV&M Services.

E. For a period of six (6) months from the Acquisition Date (hereinafter “Restricted Period”), Respondent Baxter shall not solicit, induce or attempt to induce any PV&M Customer to transfer to Respondent Baxter any business relating to Pancuronium, Vecuronium, or Metoclopramide; provided, however, that nothing in this paragraph shall prevent Respondent Baxter from responding to an unsolicited invitation to bid on a contract from any Person during the Restricted Period. F. For a period of ten (10) years beginning on the date this Order becomes final, Respondent Baxter shall not enter into any agreements with Sicor relating to Pancuronium, Vecuronium or Metoclopramide without the prior approval of the Commission. G. Respondent Baxter shall take all necessary steps to maintain the confidentiality of the Confidential PV&M - Information. Provided, further, that:

VOLUME 135 Decision and Order 1. Except as permitted under this Order, Respondent Baxter shall not (i) provide, disclose, or otherwise make available any Confidential PV&M Information to any Person or (ii) use any Confidential PV&M Information for any reason or purpose.

2. If use of any Confidential PV&M Information is permitted under this Order, Respondent Baxter shall provide, disclose, or otherwise make available such information (i) only to those Persons who require such information for the permitted purposes, (ii) only such part of the Confidential PV&M Information that is so required, and (iii) only to those Persons who agree in writing to maintain the confidentiality of such information.

3. Respondent Baxter shall (i) require that each of its employees with any responsibility for Pancuronium, Vecuronium, and Metoclopramide sign a confidentiality agreement pursuant to which such employee shall be required to maintain the confidentiality of all Confidential PV&M Information, including the obligation not to disclose such information to any other employee, executive, consultant, agent or other personnel of Respondent Baxter, and (ii) enforce the terms of this Paragraph III.G. as to any Person and take such action as is necessary to cause each such Person to comply with the terms of this Paragraph III.G., including notification and training of employees and all other actions that Respondent Baxter would take to protect its own trade secrets and proprietary information.

H. The purpose of the requirements in Paragraph III. is to ensure the continued use of the PV&M Assets and related obligations in the same business in which the PV&M Assets were used by Respondent Baxter at the time of the announcement of the proposed Acquisition, and to remedy the lessening of competition VOLUME 135 Decision and Order resulting from the Acquisition as alleged in the Commission’s Complaint.

IV.

IT IS FURTHER ORDERED that:

A. No later than ten (10) Business Days after the Acquisition Date, Respondent Baxter shall notify Watson in writing of Respondent Baxter’s intention to terminate the Iron Gluconate Agreement by March 14, 2004.

B. Respondent Baxter shall terminate the Iron Gluconate Agreement no later than March 14, 2004. C. For a period of ten (10) years beginning on the date this order becomes final, Respondent Baxter shall not enter into any agreement with Watson relating to Iron Gluconate without the prior approval of the Commission.

D. The purpose of the requirements in Paragraph IV. is to ensure the continued development of Respondent Wyeth’s Iron Gluconate in the market, and to remedy the lessening of competition resulting from the Acquisition as alleged in the Commission’s Complaint.

V.

IT IS FURTHER ORDERED that:

A. At any time after Respondents sign the Consent Agreement, the Commission may appoint one or more persons to serve as Monitor to ensure that Respondents expeditiously perform their obligations as required by this Order and the Order to Maintain Assets.

B. If a Monitor is appointed pursuant to this Paragraph, Respondents shall consent to the following terms and conditions VOLUME 135 Decision and Order regarding the powers, duties, authorities, and responsibilities of the Monitor:

1. The Commission shall select the Monitor, 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 Monitor within fourteen (14) days after notice by the staff of the Commission to Respondents of the identity of any proposed Monitor, Respondents shall be deemed to have consented to the selection of the proposed Monitor.

2. The Monitor shall have the power and authority to monitor Respondents’ compliance with the terms of this Order and the Order to Maintain Assets and shall exercise such power and authority and carry out the duties and responsibilities of the Monitor pursuant to the terms of this Order and in a manner consistent with the purposes of this Order and the Order to Maintain Assets. 3. Within fourteen (14) days after appointment of the Monitor, Respondents shall execute an agreement that, subject to the approval of the Commission, confers on the Monitor all the rights and powers necessary to permit the Monitor to monitor Respondents’ compliance with the terms of this Order and the Order to Maintain Assets in a manner consistent with the purposes of such Orders. Respondents may require the Monitor to sign a confidentiality agreement prohibiting the use, or disclosure to anyone other than the Commission, of any competitively sensitive or proprietary information gained as a result of his or her role as Monitor. VOLUME 135 Decision and Order 4. The Monitor’s power and duties under this Paragraph V. shall terminate sixty (60) days after the Monitor has completed his or her final report pursuant to Paragraph V.B.9., or at such other time as directed by the Commission.

5. The Monitor shall have full and complete access to Respondents’ books, records, documents, personnel, facilities, and technical information relating to compliance with this Order and the Order to Maintain Assets, or to any other relevant information, as the Monitor may reasonably request. Respondents shall cooperate with any reasonable request of the Monitor. Respondents shall take no action to interfere with or impede the Monitor’s ability to monitor Respondents’ compliance with this Order and the Order to Maintain Assets.

6. The Monitor 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 Monitor 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 Monitor's duties and responsibilities. The Monitor 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 Monitor and hold the Monitor harmless against any losses, claims, damages, liabilities, or expenses arising out of, or in connection with, the performance of the Monitor’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 the Monitor’s gross negligence or VOLUME 135 Decision and Order willful misconduct. For purposes of this Paragraph V.B.7., the term “Monitor” shall include all Persons retained by the Monitor pursuant to Paragraph V.B.6. of this Order.

8. If at any time the Commission determines that the Monitor has ceased to act or failed to act diligently, or is unwilling or unable to continue to serve, the Commission may appoint a substitute in the same manner as provided in this Paragraph V.

9. The Monitor shall report in writing to the Commission (i) every sixty (60) days from the date this Order becomes final, (ii) no later than thirty (30) days from the date Respondents have completed all obligations required by Paragraphs II. through IV. of this Order, and (iii) at any other time as requested by the staff of the Commission, concerning Respondents’ compliance with this Order. C. The Commission may on its own initiative or at the request of the Monitor issue such additional orders or directions as may be necessary or appropriate to assure compliance with the requirements of this Order.

VI.

IT IS FURTHER ORDERED that:

A. If Respondents have not divested, absolutely and in good faith, the Propofol Assets within the time and in the manner required by Paragraph II. of this Order, the Commission may at any time appoint one or more Persons as Divestiture Trustee to divest such assets to an acquirer and to execute a Divestiture Agreement that satisfies the requirements and purposes of this Order.

B. In the event that the Commission or the Attorney General brings an action pursuant to § 5(l) of the Federal Trade VOLUME 135 Decision and Order Commission Act, 15 U.S.C. § 45(l), or any other statute enforced by the Commission, Respondents shall consent to the appointment of a Divestiture Trustee in such action. Neither the appointment of a Divestiture Trustee nor a decision not to appoint a Divestiture 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 Divestiture 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. C. If a Divestiture Trustee is appointed by the Commission or a court pursuant to this Paragraph, Respondents shall consent to the following terms and conditions regarding the Divestiture Trustee's powers, duties, authority, and responsibilities: 1. The Commission shall select the Divestiture Trustee, subject to the consent of the Respondents, which consent shall not be unreasonably withheld. The Divestiture Trustee shall be a Person with experience and expertise in acquisitions and divestitures and may be the same Person as the Monitor appointed pursuant to Paragraph V. of this Order. If Respondents have not opposed, in writing, including the reasons for opposing, the selection of any proposed Divestiture Trustee within fourteen (14) days after receipt of written notice from the staff of the Commission to Respondents of the identity of any proposed Divestiture Trustee, Respondents shall be deemed to have consented to the selection of the proposed Divestiture Trustee.

2. Subject to the prior approval of the Commission, the Divestiture Trustee shall have the exclusive power and authority to accomplish the divestiture for which he or she has been appointed pursuant to the terms of this Order and in a manner consistent with the purposes of this Order and to enter into a Divestiture Agreement with another acquirer.

VOLUME 135 Decision and Order 3. Within ten (10) days after appointment of the Divestiture Trustee, Respondents shall execute an agreement that, subject to the prior approval of the Commission and, in the case of a court-appointed Divestiture Trustee, of the court, transfers to the Divestiture Trustee all rights and powers necessary to permit the Divestiture Trustee to accomplish the divestiture required by this Order. 4. The Divestiture Trustee shall have twelve (12) months from the date the Commission approves the agreement described in Paragraph VI.C.3. of this Order 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 Divestiture 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 Divestiture Trustee, by the court; provided, however, the Commission may extend this period only two (2) times.

5. The Divestiture Trustee shall have full and complete access to the personnel, books, records, and facilities related to the assets to be divested, or to any other relevant information, as the Divestiture Trustee may request. Respondents shall develop such financial or other information as the Divestiture Trustee may reasonably request and shall cooperate with the Divestiture Trustee. Respondents shall take no action to interfere with or impede the Divestiture 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 Divestiture Trustee, by the court. 6. The Divestiture Trustee shall use his or her best efforts to negotiate the most favorable price and terms available in VOLUME 135 Decision and Order each contract that is submitted to the Commission, but shall divest expeditiously at no minimum price. The divestiture shall be made only to an acquirer that receives the prior approval of the Commission, and the divestiture shall be accomplished only in a manner that receives the prior approval of the Commission; provided, however, if the Divestiture Trustee receives bona fide offers for the assets required to be divested from more than one acquiring entity, and if the Commission determines to approve more than one such acquiring entity, the Divestiture Trustee shall divest to the acquiring entity selected by Respondents from among those approved by the Commission; provided, further, that Respondents shall select such entity within five (5) Business Days of receiving written notification of the Commission’s approval.

7. The Divestiture 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 Divestiture 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 Divestiture Trustee's duties and responsibilities. The Divestiture 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 Divestiture Trustee, by the court, of the account of the Divestiture Trustee, including fees for his or her services, all remaining monies shall be paid at the direction of the Respondents, and the Divestiture Trustee's power shall be terminated. The Divestiture Trustee's compensation shall be based at least in significant part on a commission arrangement contingent on the Divestiture Trustee's divesting the assets required to be divested by this Order. VOLUME 135 Decision and Order 8. Respondents shall indemnify the Divestiture Trustee and hold the Divestiture Trustee harmless against any losses, claims, damages, liabilities, or expenses arising out of, or in connection with, the performance of the Divestiture 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 liabilities, losses, damages, claims, or expenses result from gross negligence or willful misconduct by the Divestiture Trustee. For purposes of this Paragraph VI.C.8., the term “Divestiture Trustee” shall include all Persons retained by the Divestiture Trustee pursuant to Paragraph VI.C.7. of this Order.

9. If the Divestiture Trustee ceases to act or fails to act diligently, the Commission may appoint a substitute Divestiture Trustee in the same manner as provided in Paragraph VI.A. for appointment of the initial Divestiture Trustee.

10. In the event that the Divestiture Trustee determines that he or she is unable to divest the relevant assets required to be divested in a manner that preserves their marketability, viability and competitiveness and ensures their continued use in the research, development, manufacture, distribution, marketing, promotion, sale, or after-sales support of Propofol, the Divestiture Trustee may divest such additional assets of Respondents and effect such arrangements as are necessary to satisfy the requirements of this Order.

11. The Commission or, in the case of a court-appointed Divestiture Trustee, the court, may on its own initiative or at the request of the Divestiture Trustee issue such additional orders or directions as may be necessary or appropriate to accomplish the divestiture required by this Order.

VOLUME 135 Decision and Order 12. The Divestiture Trustee shall have no obligation or authority to operate or maintain the assets required to be divested by this Order.

13. The Divestiture Trustee shall report in writing to the Commission every sixty (60) days concerning the Divestiture Trustee's efforts to accomplish the divestiture. VII.

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 Paragraphs II. through IV., 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 Monitor, if any Monitor 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 IV. of the Order, including a description of all substantive contacts or negotiations related to the divestiture of the Propofol Assets 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 nine (9) 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 VOLUME 135 Decision and Order the manner and form in which they have complied and are complying with this Order.

VIII.

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, or 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 this Order. IX.

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, Respondents shall permit any duly authorized representative of the Commission:

A. Access, during office hours and in the presence of counsel, to all facilities and access to inspect and copy all non-privileged books, ledgers, accounts, correspondence, memoranda, and other records and documents in the possession or under the control of Respondents relating to any matter contained in this Order; and B. Upon five (5) days’ notice to Respondents and without restraint or interference from them, to interview Respondents’ officers, directors, or employees, who may have counsel present, regarding any such matters. X.

IT IS FURTHER ORDERED that this Order will terminate on February 3, 2013.

VOLUME 135 Decision and Order APPENDIX I (non-public) Faulding Divestiture Agreement APPENDIX II (non-public) Propofol Employees VOLUME 135 Order ORDER TO MAINTAIN ASSETS The Federal Trade Commission (“Commission”) having initiated an investigation of the proposed acquisition by Respondent Baxter International Inc. (“Baxter”) of certain assets of Respondent Wyeth, hereinafter referred to as “Respondents,” and the Respondents having been furnished thereafter with a copy of a draft of Complaint that the Bureau of Competition proposed to present 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 the proposed Decision and Order, 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 determined to accept the executed Consent Agreement and to place 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 issues its Complaint, makes the following jurisdictional findings and issues this Order to Maintain Assets:

VOLUME 135 Order 1. Respondent Baxter 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 One Baxter Parkway, Deerfield, Illinois 60015. 2. Respondent Wyeth 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 Five Giralda Farms, Madison, New Jersey 07940. 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 to Maintain Assets, the definitions used in the Consent Agreement and the attached Decision and Order shall apply. II.

IT IS FURTHER ORDERED that from the date this Order to Maintain Assets becomes final:

A. With respect to the PV&M Assets Respondent Baxter shall: 1. Take such actions as are reasonably necessary to maintain the viability, marketability, and competitiveness of the PV&M Assets and to prevent the destruction, removal, wasting, deterioration, sale, disposition, transfer or impairment of any of the PV&M Assets, except for ordinary wear and tear and as would otherwise occur in the ordinary course of business.

VOLUME 135 Order 2. Preserve the PV&M Assets intact and not take any affirmative action, or fail to take any action within its control, as a result of which the viability, marketability, or competitiveness of the PV&M Assets would be diminished.

3. Maintain relations and good will with suppliers, distributors, customers, employees, Agencies, and others having relationships with the business relating to the PV&M Assets.

B. With respect to the Propofol Assets: 1. Respondents shall take such actions as are reasonably necessary to maintain the viability, marketability, and competitiveness of the Propofol Assets and to prevent the destruction, removal, wasting, deterioration, sale, disposition, transfer or impairment of any of the Propofol Assets, except for ordinary wear and tear and as would otherwise occur in the ordinary course of business. 2. Respondents shall preserve the Propofol Assets intact and not take any affirmative action, or fail to take any action within their control, as a result of which the viability, marketability, or competitiveness of the Propofol Assets would be diminished.

3. Respondents shall maintain relations and good will with suppliers, distributors, customers, employees, Agencies, and others having relationships with the business relating to the Propofol Assets.

4. Respondents shall provide all Propofol Employees with reasonable financial incentives to continue in their positions until the Divestiture Date, including, but not limited to, a continuation of all employee benefits offered by Respondents until the Divestiture Date, including VOLUME 135 Order regularly scheduled raises and bonuses, and a vesting of all pension benefits (as permitted by law). 5. Respondent Wyeth shall: (i) keep Faulding (or the Propofol Acquirer) timely and reasonably informed on an on-going basis as to the defense of the Propofol Patent Litigation; (ii) promptly provide Faulding (or the Propofol Acquirer) and its counsel copies of all court filings relating to the Propofol Patent Litigation; (iii) defend the Propofol Patent Litigation in a commercially reasonably manner until the Divestiture Date; (iv) not take any action or position in defending the Propofol Patent Litigation that would be prejudicial in any material respect to Faulding’s (or the Proposed Acquirer’s) ability to successfully defend the Propofol Patent Litigation after the Divestiture Date; (v) upon request of Faulding (or the Proposed Acquirer), discuss with Faulding (or the Proposed Acquirer) and its counsel proposed litigation strategy, proposed action, responses or replies; (vi) not settle or otherwise dispose of the Propofol Patent Litigation in a manner that would have a material adverse effect on Wyeth’s Propofol Assets after the Acquisition Date without the prior written consent of Faulding (or the Propofol Acquirer), which consent shall not be unreasonably withheld or delayed; (vii) pay any and all costs, damages, and expenses relating to the Propofol Patent Litigation prior to the Divestiture Date; and (viii) prior to the Divestiture Date, take reasonably appropriate and necessary action to assist in the transition to Faulding (or the Propofol Acquirer) and its counsel of the defense of the Propofol Patent Litigation. III.

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 VOLUME 135 Order corporation, or the creation or dissolution of subsidiaries or any other change in the corporation that may affect compliance obligations arising out of this Order to Maintain Assets. IV.

IT IS FURTHER ORDERED that for the purposes of determining or securing compliance with this Order to Maintain Assets, 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 representatives 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 to Maintain Assets; 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.

V.

IT IS FURTHER ORDERED that this Order to Maintain Assets shall terminate on the earlier of: A. Three (3) business days after the Commission withdraws its acceptance of the Consent Agreement pursuant to the provisions of Commission Rule 2.34, 16 C.F.R. § 2.34; or B. The day after all of the divestitures or transfers of the Assets, as described in and required by the Decision and Order, are completed.

VOLUME 135 Analysis Analysis of Agreement Containing Consent Orders to Aid Public Comment The Federal Trade Commission has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) from Baxter International Inc. and Wyeth. The Consent Agreement contains an Order to Maintain Assets to preserve, among other things, the viability, marketability, and competitiveness of the assets to be divested pending their divestiture. The Consent Agreement also contains a Decision and Order that is designed to remedy the anticompetitive effects of Baxter’s proposed acquisition of the generic injectable pharmaceutical business of Wyeth. Under the terms of the Consent Agreement, the companies will be required to: (1) divest all of Wyeth’s assets relating to propofol to a Commissionapproved acquirer; (2) terminate all of Baxter’s rights and interests in GensiaSicor’s pancuronium, vecuronium, and metoclopramide products, and divest all of its pancuronium, vecuronium, and metoclopramide assets to GensiaSicor; and (3) terminate Baxter’s co-marketing agreement with Watson Pharmaceuticals, Inc. by March 14, 2004. The proposed Consent Agreement has been placed on the public record for thirty days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will again review the agreement and any comments received and will decide whether it should withdraw from the agreement or make final the agreement’s proposed Consent Order.

Pursuant to an asset purchase agreement dated June 8, 2002 between Baxter and Wyeth, Baxter proposes to acquire from Wyeth substantially all of the assets related to Wyeth’s generic injectable pharmaceutical business operated by Wyeth’s ESI Lederle division for a total of $316 million in cash and assumed liabilities. The Commission’s 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. VOLUME 135 Analysis § 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. § 45, in the markets for the manufacture and sale of: (1) propofol; (2) pancuronium; (3) vecuronium; (4) metoclopramide; and (5) new injectable iron replacement therapies (“NIIRTs”). The proposed Consent Agreement would remedy the alleged violations by replacing in each of these markets the lost competition that would result from the merger. Propofol Propofol is a general anesthetic commonly used for the induction and maintenance of anesthesia during surgical procedures and as a sedative for patients who are mechanically ventilated. Although there are other anesthetic agents, there are many benefits associated with propofol including the ability to quickly adjust the amount of sedation and its superior safety profile. Because propofol has a short duration profile, it is the preferred anesthetic agent for out-patient surgery. Annual U.S. sales of propofol total between $375 and $400 million. The market for propofol is highly concentrated. AstraZeneca sells Diprivan®, the branded propofol product. Baxter markets the only generic propofol product, which is manufactured by GensiaSicor. Wyeth is seeking approval from the Food and Drug Administration (“FDA”) for its own propofol product, and it is one of the two best-positioned firms to enter the market. Entry into the propofol market requires lengthy development efforts because of the product’s unique characteristics. Propofol is considered to be one of the most difficult injectable products to develop. Indeed, only one company has been able to introduce a generic propofol product. Propofol is manufactured using a complex process, and it requires the use of a preservative. The preserved formulation used for Diprivan® and the preserved formulation used for the generic propofol marketed by Baxter are both protected by patents. For this reason, any new entrant would have to develop a propofol product using a different preservative that does not infringe existing patents. Once a company has VOLUME 135 Analysis developed a viable product, it is also required to conduct studies and obtain approval from the FDA to market propofol. Clinical development and FDA approval for this particular generic drug takes several years.

The proposed acquisition would cause significant anticompetitive harm in the U.S. market for the manufacture and sale of propofol by eliminating potential competition between Baxter and Wyeth. With only two firms currently supplying propofol to customers in this market (Baxter and AstraZeneca), entry by Wyeth and the one other firm well-positioned to enter would likely increase competition and reduce propofol prices. Accordingly, allowing Baxter to acquire Wyeth’s generic injectable business likely would reduce the number of rivals in the future from four to three and force customers to pay higher prices for propofol.

The proposed Consent Agreement preserves future competition in the market for propofol by requiring the parties to divest Wyeth’s propofol assets to Faulding Pharmaceutical Company no later than ten business days after the acquisition. Faulding is wellpositioned to continue Wyeth’s development efforts and poses no separate competitive concerns as the acquirer of the propofol assets. If the Commission determines that Faulding is not an acceptable purchaser, or that the manner of divestiture is not acceptable, Baxter and Wyeth must divest the propofol assets to a Commission-approved buyer no later than ninety business days from the date the Order becomes final. Should they fail to do so, the Commission may appoint a trustee to divest the propofol assets. The Consent Agreement also requires the parties to license certain additional know-how that relates, but does not exclusively relate, to propofol to the propofol acquirer. The Consent Agreement contains several provisions designed to ensure that the divestiture is successful. Baxter and Wyeth are required to provide transitional services to the propofol acquirer relating to regulatory approvals and manufacturing, and in responding to, and defending against, any lawsuit, investigation or VOLUME 135 Analysis proceeding relating to propofol. The Consent Agreement also requires Baxter and Wyeth to provide incentives to certain employees to continue in their positions until the divestiture is accomplished. For a period of six months from the date the assets are divested, Baxter and Wyeth will provide the propofol acquirer an opportunity to enter into employment contracts with individuals who have experience relating to Wyeth’s propofol product. Baxter and Wyeth are also required to provide incentives to these individuals to accept employment with the propofol acquirer. For a period of one year following the divestiture date, Baxter and Wyeth are prohibited from hiring any employees of the acquirer of the propofol assets who have responsibility related to propofol. Finally, Baxter and Wyeth must take steps to maintain the confidentiality of confidential information related to propofol. Pancuronium Pancuronium is a rapid-onset, long-acting neuromuscular blocking agent used to temporarily freeze muscles during surgery or mechanical ventilation and to assist in the intubation process. Although pancuronium is an older drug, doctors continue to use it because it is an effective and inexpensive product with a known side-effect profile. The market for pancuronium in the United States is approximately $2 million.

Pancuronium is a small and highly concentrated market. Baxter, Wyeth and Abbott are the only suppliers of generic injectable pancuronium in the United States. Currently, Baxter, which markets pancuronium pursuant to an exclusive agreement with GensiaSicor, accounts for almost half of U.S. sales of the drug. Post-acquisition, Baxter would account for 74% of the sales of pancuronium in the United States, and the post-acquisition Herfindahl-Hirschman Index (“HHI”) would be 6,152 points, representing a 2,496 point increase in the HHI. Post-acquisition, Abbott would be the only other supplier of pancuronium in the United States.

VOLUME 135 Analysis The market for the manufacture and sale of pancuronium is unlikely to attract new entrants because pancuronium is an older drug whose usage and price have declined over time. Although pancuronium is still an important drug, companies are unlikely to devote resources to developing an older drug with limited sales. Even if a supplier of other injectable drugs decided to develop pancuronium, it would be costly and time consuming to complete the necessary research and development, and to obtain the requisite approval from the FDA. Consequently, entry into the pancuronium market is not likely to occur in a timely manner, if at all.

The proposed acquisition would create a duopoly in the market for the manufacture and sale of pancuronium in the United States. Post-acquisition, Baxter and Abbott would be the only remaining suppliers of pancuronium. This is likely to lead to higher prices of pancuronium.

The proposed Consent Agreement preserves competition in the pancuronium market by requiring Baxter to terminate all of its rights and interests in GensiaSicor’s pancuronium product and divest all of its pancuronium assets to GensiaSicor no later than five days after the acquisition. GensiaSicor is capable of marketing and selling its own pancuronium. It is a well recognized and respected company in the injectable pharmaceutical industry, and will be an able competitor in the market for the manufacture and sale of pancuronium. Vecuronium Vecuronium is an intermediate-acting neuromuscular blocking agent that temporarily freezes muscles during surgery, mechanical ventilation, or intubation. Vecuronium is a popular neuromuscular blocking agent with a superior side effect profile. The market for the manufacture and sale of vecuronium in the United States is approximately $21 million. VOLUME 135 Analysis The market for the manufacture and sale of vecuronium is highly concentrated. Baxter markets vecuronium under an exclusive supply agreement with GensiaSicor. Baxter and Wyeth were the two leading suppliers of vecuronium in the United States, with a combined market share of 53%, until Wyeth temporarily suspended its vecuronium production in 2001. Prior to the announcement of the acquisition, Wyeth planned to re-enter the vecuronium market in the near future. Post-acquisition, the HHI would be 3,598 points, representing a 1,364 point increase in the HHI. There are only three other suppliers of vecuronium in the United States. Organon continues to market its branded vecuronium, and Abbott and Bedford supply generic vecuronium products.

Entry into the market for the manufacture and sale of vecuronium is unlikely because it is an older drug with established suppliers, and it is a difficult drug to manufacture. Although vecuronium continues to be an important drug, companies are unlikely to devote resources to entering this market because existing suppliers have become entrenched, making it difficult for new entrants to capture meaningful market share. In addition, vecuronium is a complicated drug to manufacture. Because of the unique manufacturing process involved in making vecuronium, entry would take longer than two years and cost hundreds of thousands of dollars.

The proposed acquisition is likely to result in anticompetitive harm in the U.S. market for the manufacture and sale of vecuronium. Absent the proposed acquisition, Wyeth would have re-entered this market. By acquiring Wyeth’s vecuronium, Baxter would likely delay or forego the re-launch of Wyeth’s vecuronium and eliminate any associated price competition. The proposed Consent Agreement preserves future competition in the market for vecuronium by requiring Baxter to terminate all of its rights and interests in GensiaSicor’s vecuronium product and divest all of its vecuronium assets to GensiaSicor no later than five days after the acquisition.

VOLUME 135 Analysis Metoclopramide Metoclopramide is an antiemetic used for the prevention and treatment of nausea and vomiting for patients undergoing certain types of chemotherapy and for post-operative treatment. Metoclopramide is an older antiemetic that continues to be used because it is effective, has a known safety profile, and is considerably cheaper than newer antiemetics. Annual U.S. sales of metoclopramide total approximately $13 million. The market for metoclopramide is highly concentrated. Wyeth developed the branded metoclopramide product, Reglan®. Baxter is the exclusive supplier of GensiaSicor’s metoclopramide product. Wyeth and Baxter together represent over half of the sales of metoclopramide in the United States. Post-acquisition, the HHI would be 3,852 points, an increase of 936 points above the pre-Acquisition HHI. Only two other companies supply metoclopramide in the United States: Abbott and Faulding. New entry into the market for the manufacture and sale of metoclopramide is difficult, expensive and unlikely to occur. Metoclopramide is an older drug with small sales relative to newer injectable anti-emetics. Therefore, firms do not consider the market for the manufacture and sale of metoclopramide to be an attractive entry opportunity. Several manufacturers have already exited the market and none are interested in re-entering. Even if firms that have exited were interested in re-launching their drugs, re-entry would likely take such firms an estimated two years or more.

The proposed acquisition would cause significant anticompetitive harm in the U.S. market for the manufacture and sale of metoclopramide by reducing the number of suppliers from four to three. The combined entity would account for over half of all sales of metoclopramide in the United States. The proposed acquisition is likely to lead to higher prices. VOLUME 135 Analysis The proposed Consent Agreement preserves competition in the metoclopramide market by requiring Baxter to terminate all of its interests in GensiaSicor’s metoclopramide and divest all of its metoclopramide assets to GensiaSicor no later than five days after the acquisition.

New Injectable Iron Replacement Therapies NIIRTs are used to treat iron deficiency in patients undergoing hemodialysis. NIIRTs include both injectable iron gluconate and iron sucrose. Annual U.S. sales of NIIRTs total approximately $225 million.

The market for the manufacture and sale of NIIRTs is highly concentrated. Watson markets Ferrlecit®, the only injectable iron gluconate product available in the United States. American Regent markets Venofer®, the only injectable iron sucrose product in the United States. Watson recently entered into a copromotional agreement with Baxter, pursuant to which Baxter promotes Ferrlecit®.

Entry into the market for the manufacture and sale of NIIRTs is very difficult and time consuming. Because of FDA-imposed New Chemical Entity exclusivity periods, the earliest that any company could file for regulatory approval of a generic iron gluconate product is February 2004. Similar provisions protect iron sucrose, though its exclusivity period expires in November 2003. Entry into the market for the manufacture and sale of NIIRTs is further complicated by a lack of raw material suppliers. Even if a new entrant were to locate a raw material supplier, both iron gluconate and iron sucrose are difficult products that would take more than two years to develop. Wyeth is the best-positioned firm to successfully develop a NIIRT product. The proposed acquisition is likely to have anticompetitive effects in the market for the manufacture and sale of NIIRTs in the United States because it would eliminate potential competition VOLUME 135 Analysis between Baxter and Wyeth. The proposed acquisition would remove Wyeth as the best-positioned independent entrant into this market and prevent all associated price competition. The proposed Consent Agreement preserves future competition in the market for the manufacture and sale of NIIRTs by requiring Baxter to terminate its co-marketing agreement with Watson within weeks of the expiration of Ferrlicit®’s New Chemical Entity exclusivity. This termination provides an incentive for Baxter to continue developing and ultimately launch the iron gluconate product that it will acquire from Wyeth. Pursuant to the terms of the Order, the Commission has appointed William E. Hall as a Monitor Trustee to ensure Baxter’s and Wyeth’s compliance with all of the requirements of the Order. Mr. Hall has over 30 years of experience in the pharmaceutical industry and is well-respected in the industry. In order to ensure that the Commission remains informed about the status of the proposed divestitures and the transfers of assets, the Consent Agreement requires Baxter and Wyeth to file reports with the Commission periodically until the divestitures are accomplished. The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Consent Agreement or to modify its terms in any way. VOLUME 135 Complaint