IN THE UNITED STATES DISTRICT COURT

                      FOR THE EASTERN DISTRICT OF TENNESSEE

                               KNOXVILLE DIVISION

UNITED STATES OF AMERICA,               )
                                        )
                     Plaintiff,         )        No. 3:00-CV-359
                                        )
                v.                      )
                                        )
VARIOUS ARTICLES OF DRUG                )
IDENTIFIED IN ATTACHMENT A,             )
which are located on the premises of    )
Wyeth-Ayerst Laboratories, 98 Excellence)
Way, Vonore, Tennessee,                 )
                                        )
                  Defendants-in-rem,    )
                                        )
                  and                   )
                                        )
WYETH-AYERST LABORATORIES               )
DIVISION OF AMERICAN HOME               )
PRODUCTS CORPORATION and                )
WYETH-AYERST PHARMACEUTICALS,           )
INC., corporations, and BERNARD J.      )
POUSSOT, JOHN V. BUCCERI, and           )
ROY J. STURGEON, PH.D., individuals,    )
                                        )
                  Defendants.           )
------------------------------------    )

                         CONSENT DECREE OF CONDEMNATION
                            AND PERMANENT INJUNCTION

     WHEREAS,  plaintiff  United States of America  ("Plaintiff"  or the "United
States"),  on behalf of the United States Food and Drug Administration ("FDA" or
the  "Agency"),  has filed a verified  complaint  for  forfeiture  in this Court
bearing the docket  number  3:00-CV-359  (the  "Tennessee  action")  against the
articles of drug  described in  Attachment A of the  complaint,  and has filed a
verified  complaint for  forfeiture in the United States  District Court for the
District of Puerto Rico bearing the docket number  00-1779(JP) (the "Puerto Rico
action")  against  the  articles  of  drug  described  in  Attachment  A of that
complaint,  both of which  allege  that the drugs  described  in the  respective
actions  are  adulterated  within the  meaning of the Federal  Food,  Drug,  and
Cosmetic Act (the "FD&C Act"), 21 U.S.C. ss. 35l(a)(2)(B),  while such drugs are
held for sale after shipment in interstate commerce, or after shipment of one or
more of their  components in interstate  commerce,  in that the methods used in,
and the  facilities  and  controls  used  for,  their  manufacture,  processing,
packing,  and holding did not conform to and were not operated and  administered
in conformity with current good  manufacturing  practice ("CGMP") to assure that
such drugs meet the safety  requirements  of the FD&C Act and have the  identity
and  strength,  and meet the  quality  and  purity  characteristics,  which they
purport and are represented to possess; and

     WHEREAS,  the United States Marshal for this District and the United States
Marshal  for the  District  of Puerto  Rico have  seized  the  articles  of drug
(collectively,  the  "Seized  Articles")  pursuant  to warrants of arrest in rem
issued by this Court and by the United States District Court for the District of
Puerto Rico; and

     WHEREAS,  Wyeth-Ayerst  Laboratories  Division  of American  Home  Products
Corporation  and  Wyeth-Ayerst   Laboratories  Puerto  Rico,  Inc.   (hereafter,
collectively  "Claimants")  affirm  that they are the sole  owners of the Seized
Articles in this action and the Puerto Rico action,  respectively,  and agree to
hold the United States  harmless  should any party or parties  hereafter file or
seek to file a claim to intervene  in this action or the Puerto Rico action,  or
seek to defend or obtain any part of the Seized Articles; and

     WHEREAS,  Claimants have intervened and filed claims to the Seized Articles
in each action and Wyeth-Ayerst  Laboratories Division of American Home Products
Corporation has filed an Answer in the Tennessee  action denying the allegations
in the complaint in that action; and

     WHEREAS, Claimants and the United States have agreed to transfer the Puerto
Rico action to this Court and consolidate that action with this action; and

     WHEREAS,  Wyeth-Ayerst  Laboratories  Division  of American  Home  Products
Corporation and  Wyeth-Ayerst  Pharmaceuticals,  Inc.  (hereafter,  collectively
"Wyeth")  operate  and manage  facilities  located  at Wasp and Biddle  Streets,
Marietta,  Pennsylvania  (hereafter,  "the  Marietta  facility")  and 401  North
Middletown Road, Pearl River, New York (hereafter,  "the Pearl River facility");
and

     WHEREAS,  Wyeth does not intend to manufacture at the Marietta facility any
currently  approved products other than FluShield(R)  (Influenza Virus Vaccine),
Antivenin  (Crotalidae)  Polyvalent,  Antivenin  (Micrurus  fulvius),  Dryvax(R)
(Smallpox Vaccine), and Wydase(R) (hyaluronidase); and

     WHEREAS,  Wyeth-Ayerst  Laboratories  Division  of American  Home  Products
Corporation,  Wyeth-Ayerst  Pharmaceuticals,   Inc.,  Wyeth-Ayerst  Laboratories
Puerto Rico, Inc., Bernard J. Poussot, President,  Wyeth-Ayerst Pharmaceuticals,
Inc.; John V. Bucceri, Senior Vice-President,  Global Supply Chain, Wyeth-Ayerst
Pharmaceuticals, Inc.; and Roy J. Sturgeon, Ph.D., Senior Vice-President, Global
Quality Assurance and Quality Control, Wyeth-Ayerst Pharmaceuticals,  Inc., have
appeared,  have  waived the filing of an amended  complaint  seeking  injunctive
relief,  and,  without  admitting the  allegations in this action and the Puerto
Rico action, and although denying any liability arising out of or related in any
way to this matter,  and before any testimony has been taken,  have consented to
the entry of this Consent Decree;

         THEREFORE, IT IS ORDERED, ADJUDGED, AND DECREED that:

I.       JURISDICTION

     1. This Court has subject matter jurisdiction over this action and personal
jurisdiction over all parties pursuant to 28 U.S.C.ss.  1345 and 21 U.S.C.ss.ss.
332 and 334. Venue is proper in this District under 28 U.S.C.ss.ss.  1391(b) and
1395.

     2. Both the  complaint  for  forfeiture  in the  Tennessee  action  and the
complaint  for  forfeiture  in the Puerto Rico  action  state a claim for relief
under the FD&C Act.

II.  THE SEIZED ARTICLES

     3. The Seized  Articles are hereby  condemned  and  forfeited to the United
States pursuant to 21 U.S.C.ss. 334(a).

     4. The United  States shall recover from  Claimants all court costs,  fees,
and  storage  and  other  proper  expenses,  and such  further  costs  for which
Claimants are liable pursuant to 21 U.S.C. ss. 334(e) with respect to the Seized
Articles.  Claimants  shall pay these  costs  within ten (10) days of  receiving
notice from FDA of such costs.

     5. Within twenty (20) days of the entry of this Consent  Decree,  Claimants
shall execute and file with the Clerk of this Court a good and sufficient  penal
bond with surety in the amount of $156,500.00. The penal bond shall be in a form
acceptable  to the  Clerk of this  Court and  payable  to the  United  States of
America,  and  conditioned  on Claimants'  abiding by and  performing all of the
terms and  conditions  of this  Consent  Decree and of such  further  orders and
decrees as may be entered in this proceeding relating to the Seized Articles.

     6. After the  filing of the penal  bond with this  Court and within  thirty
(30) days after the date of entry of this Decree,  Claimants  shall give written
notice  to the  District  Director  of the  Philadelphia  District  Office  that
Claimants,  at their own expense,  are  prepared to destroy the Seized  Articles
pursuant to 21 U.S.C. ss. 334(d) under FDA supervision.  Claimants' notification
shall specify the time frames for completing the proposed destruction.

         7. Upon receipt of the notice under paragraph 6, FDA will notify the
United States Marshal for this District and the United States Marshal for the
District of Puerto Rico to return the Seized Articles to Claimants' custody for
the sole purpose of destroying the Seized Articles. Claimants shall, at all
times until the Seized Articles have been destroyed, retain intact each lot of
Seized Articles for examination or inspection by FDA, in a place made known to
and subject to approval by FDA, and shall maintain the records or other proof
necessary to establish the identity of the Seized Articles to the satisfaction
of FDA. In addition, Claimants shall, within the time frames specified in their
notification under paragraph 6 and at their own expense, complete the process of
destroying the Seized Articles under the supervision of FDA, to the extent that
FDA deems such supervision to be necessary, and of the United States Marshal
Service. Claimants shall reimburse the United States for the costs of
supervising the destruction of the Seized Articles within ten (10) days of
receiving an invoice(s) for such costs.

         8. The United States Attorney for this District, on being advised by
FDA that the articles have been destroyed and that Claimants have paid the costs
of supervising such destruction pursuant to paragraph 7, shall transmit such
information to the Clerk of this Court, whereupon the penal bond(s) given in
this proceeding by Claimants shall be canceled and discharged.

         9. If Claimants fail to abide by and perform all the terms and
conditions of this Consent Decree or of such further order or decree as may be
entered in this proceeding concerning the Seized Articles, or of the penal bond,
then the penal bond shall, on motion of the Plaintiff in this proceeding, be
forfeited in its entirety and judgment be entered in favor of Plaintiff.

III.  INJUNCTIVE PROVISIONS

                              THE MARIETTA FACILITY

     10. Except as provided in paragraph 14, Wyeth-Ayerst  Laboratories Division
of American  Home  Products  Corporation,  Wyeth-Ayerst  Pharmaceuticals,  Inc.,
Bernard J. Poussot,  John V. Bucceri,  and Roy J. Sturgeon,  Ph.D., the Managing
Director  of  the  Marietta  facility  (hereafter,   subject  to  paragraph  45,
collectively "Defendants"), each and all of Wyeth's officers, agents, employees,
representatives, successors, assigns, and attorneys, and those persons in active
concert or participation with any of the Defendants who receive actual notice of
this Decree by personal  service or otherwise,  are  permanently  restrained and
enjoined  from  manufacturing,   processing,  packing,  labeling,  holding,  and
distributing any drug or biological product at the Marietta facility, other than
FluShield(R)  (Influenza  Virus  Vaccine),  Antivenin  (Crotalidae)  Polyvalent,
Antivenin (Micrurus  fulvius),  Wydase(R)  (hyaluronidase),  Dryvax(R) (Smallpox
Vaccine),  and  any  associated  diluents  or  agents  covered  by the  approved
applications for those products,  unless and until FDA so authorizes  Defendants
in writing.

     11.A.  Within ten (10) days after the date of entry of this  Decree,  Wyeth
shall select and retain one or more expert  consultant(s)  who are  qualified as
set forth in paragraph 36 (hereafter,  collectively "the expert  consultant") to
inspect the Marietta facility.

     B. Within fourteen (14) days after the date of entry of this Decree,  Wyeth
shall cause the expert consultant to commence a comprehensive  inspection of the
Marietta facility to ensure that the methods,  facilities, and controls used for
manufacturing,   processing,   packing,   holding,  and  distributing  drug  and
biological  products  comply with the FD&C Act,  the Public  Health  Service Act
("PHS Act"), CGMP, and applicable regulations relating to the safety,  identity,
strength,  quality,  and  purity of drugs and  biological  products  (hereafter,
"applicable laws and regulations"). (However, this inspection is not required to
address  validation  of those  manufacturing  processes  that  are  specifically
addressed in paragraph 25.) The inspection  shall be completed no later than one
hundred fifty (150) days after the date of entry of this Decree.  In preparation
for this inspection, the expert consultant shall review all Forms FDA 483 issued
to Wyeth  regarding  the  Marietta  facility  since  October  1998  and  Wyeth's
responses  thereto.  The expert  consultant's  inspection  shall  include,  at a
minimum, the following:

     (1) An evaluation of whether Wyeth has established a comprehensive  written
quality  assurance  ("QA") and quality control ("QC") program ("QA/QC  program")
that is  adequate  to ensure  continuous  compliance  with  applicable  laws and
regulations. The expert consultant shall determine whether the QA/QC program, at
a minimum:

     a.   Addresses  all facets of  compliance  monitoring  and trend  analyses;
          records   management   systems  for  those   records  that  relate  to
          in-process,  bulk, and finished  product safety,  identity,  strength,
          quality, and purity; and internal audit procedures;

     b.   Includes  procedures  to ensure  that  Wyeth  thoroughly  investigates
          product  deviations  subject  to 21  C.F.R.  ss.  600.14,  reports  of
          complaints regarding the use of Wyeth's products,  and any unexplained
          discrepancy or the failure of a batch of drug or biological product or
          its   components  to  meet  any  of  the   product's  or   component's
          specifications, including the extension of such investigation to other
          batches  of the same drug or  biological  product  and  other  drug or
          biological  products that may have been  associated  with the specific
          failure or discrepancy;

     c.   Includes written standard operating procedures ("SOPs") specifying the
          responsibilities  and procedures  applicable to QA or QC personnel and
          establishes mechanisms to ensure that such written SOPs are followed;

     d.   Includes   written  SOPs  necessary  to  ensure  that  all  facets  of
          compliance monitoring are reviewed and controlled by QA personnel; and

     e.   Includes  written  SOPs to ensure that (i) Wyeth's  division-level  QA
          personnel are notified of deviations and/or problems that could affect
          the  safety,  identity,  strength,  quality,  and  purity of drugs and
          biological products,  including,  but not limited to, those deviations
          and/or  problems  that the expert  consultant  identifies  pursuant to
          paragraphs  15, 19, and 22 of this  Decree;  (ii) Wyeth's QA personnel
          participate  in or monitor  the  implementation  and  verification  of
          corrective  actions to prevent future  occurrences of such  deviations
          and/or  problems;  and (iii)  there are  systems  to ensure  that such
          written SOPs are followed.

     (2) An evaluation of the adequacy of Wyeth's  system of written  production
and process  controls.  The expert  consultant  shall,  at a minimum,  determine
whether these production and process controls:

     a.   Include production and process controls necessary to ensure compliance
          with applicable laws and regulations;

     b.   Include written procedures to evaluate, implement, and control changes
          to any and all systems,  processes,  equipment,  and tests, including,
          but not limited to, sterilization processes, lyophilization processes,
          container and closure  cleaning and  preparation  processes,  critical
          in-process   specifications  and  controls,   and  release  tests  and
          criteria;

     c.   Include  adequate,  written  specifications  for controls,  tests, and
          organoleptic   examinations   to  monitor  the  performance  of  those
          manufacturing   processes  that  may  affect  the  characteristics  of
          in-process material, bulk, and finished drugs and biological products;

     d.   Are adequate to ensure that production and process control  procedures
          and protocols are continuously  followed;  that production and process
          control functions are accurately and completely documented at the time
          of  performance;  that  deviations  from  procedures,  protocols,  and
          established   production  and  process   controls  are  justified  and
          documented;  and  that  any  failure  to meet  established  acceptance
          criteria  (as  defined  in  21  C.F.R.   ss.   210.3(20))  or  process
          specifications is thoroughly investigated and documented; and

     e.   Include a system for reporting to the appropriate QA/QC unit instances
          in which:  production and process control procedures and protocols are
          not followed;  deviations from procedures,  protocols, and established
          production and process  controls occur; and there are failures to meet
          established criteria or process specifications.

     (3) An assessment of whether Wyeth has implemented a  scientifically  sound
and  appropriate  system of laboratory  controls  that,  at a minimum,  includes
specifications,  standards,  sampling plans,  and test  procedures  necessary to
ensure that components,  drug product containers,  closures (including container
closure  integrity),  in-process  materials,  labeling,  and drug and biological
products are in compliance with applicable laws and regulations. As part of this
assessment,  the expert  consultant  shall  determine  whether Wyeth's system of
laboratory controls adequately provides for:

     a.   Investigations and appropriate scientific analyses of laboratory tests
          that result in out-of-specification results;

     b.   Justification  of the specific basis for invalidation of test results,
          and plans for retesting of products or samples when indicated;

     c.   Analyses of trends in laboratory  failures and  maintenance of records
          showing investigations of such trends; and

     d.   Statistical  quality control  criteria and appropriate  acceptance and
          rejection levels.

     (4) An evaluation of whether Wyeth has  implemented an effective  buildings
and facility  control  system that describes in sufficient  detail  cleaning and
maintenance schedules,  methods, equipment, and materials. The expert consultant
shall determine whether the system ensures,  at minimum:  that the materials and
procedures used to clean and disinfect rooms and equipment in aseptic processing
areas  are  effective  to remove  microorganisms,  particularly  those  that are
typically  isolated in the aseptic  processing  environment;  that materials are
used in accordance  with written  procedures;  and that written  procedures  are
continuously followed and documented.

     (5) An  assessment of whether  Wyeth has  implemented a records  management
system that is adequate to  maintain  all records  relating to the  manufacture,
processing,  packing, holding, and distribution from or to the facility or other
disposition of drug and  biological  products that are required to be maintained
by  applicable  laws and  regulations,  SOPs,  and/or  this  Decree.  The expert
consultant shall determine whether the records management system, at a minimum:

     a.   Ensures  documentation of each significant step, recorded  completely,
          accurately,  and concurrently with the performance of the step, in the
          manufacture, processing, packing, holding, and distribution from or to
          the facility of drug and biological  products,  including the identity
          of the  person(s)  performing  such  steps and the dates on which each
          step was taken;

     b.   Includes procedures to ensure  documentation of all investigations and
          any steps  taken  to:  (i)  correct  failures  of drug and  biological
          products to meet  specifications,  (ii) prevent  future  recurrence of
          failures of drug and biological products to meet specifications, (iii)
          investigate  other  batches of drug and  biological  products that may
          have been affected by the same or similar failures,  and (iv) evaluate
          out-of-specification test results;

     c.   Includes  complete  data  derived  from all tests  necessary to assure
          compliance with established  specifications  and standards,  including
          organoleptic examinations and assays; and

     d.   Includes a mechanism to ensure that such procedures are followed.


     (6) An  evaluation  of  whether  the  equipment  used  in the  manufacture,
processing,  packing,  and  holding  of  drug  and  biological  products  is  of
appropriate  design for each of its intended uses. The evaluation shall include,
but not be limited to,  equipment  used to process drug and  biological  product
containers and closures.  The expert consultant  shall, at a minimum,  determine
whether controls exist to ensure that:

     a.   Such equipment is operating within  specifications  so as not to alter
          the safety,  identity,  strength,  quality,  or purity of the drug and
          biological products;

     b.   Such  equipment is cleaned,  is  maintained,  and,  where  applicable,
          performs processes adequately to prevent product contamination,  e.g.,
          microorganisms,  pyrogens, or other contaminants, that would alter the
          safety, identity,  strength, quality, or purity of drug and biological
          products beyond the official or other established requirements;

     c.   Such  equipment  produces drug and biological  product  containers and
          closures such that the resulting  container  closure  system  provides
          adequate  protection  against  foreseeable  external  factors that can
          cause  deterioration  or  contamination  of the  drug  and  biological
          products; and

     d.   Water systems used for rinsing, cleaning,  manufacturing,  and storage
          are adequately designed,  validated,  maintained, and routinely tested
          for compliance with all applicable specifications.

     (7) An assessment of whether the processes and systems used to  manufacture
the  finished  drug  products and finished  biological  products  that are being
manufactured  at the  facility  after the date of entry of the Decree  have been
adequately validated. As part of this assessment, for each such validation study
that was  completed  on or before the date of entry of this  Decree,  the expert
consultant shall: (i) determine  whether the validation  protocol clearly stated
how the validation  study was  conducted,  including  test  parameters,  product
characteristics,  production equipment,  and decision points on what constituted
acceptable  test  results;  (ii)  evaluate  whether the  protocol was adhered to
during its execution (and if not, what deviations  occurred and what effects the
deviations had on the results of the study), and (iii) review the results of the
study.  (Validation  studies  that  have not been  initiated  or that  have been
initiated but not completed are addressed separately in paragraph 26.)

     C.  Within  twenty  (20) days of  completing  the  inspection,  the  expert
consultant shall prepare a detailed written report of his/her inspection,  which
addresses, at a minimum, each of the matters described in paragraph 11.B.(1)-(7)
and whether the  aforementioned  Form FDA 483 observations  have been corrected,
and submit that report concurrently to the President and Senior  Vice-President,
Regulatory Affairs and Compliance of Wyeth-Ayerst  Pharmaceuticals,  Inc. and to
FDA.

     D.  Within  forty-five  (45) days of  receipt  of the  expert  consultant's
inspection  report,  Wyeth shall submit a written report to FDA that details the
specific  actions  Defendants  will take and a  timetable  to address the expert
consultant's  observations.  The  timetable  shall be subject  to FDA  approval.
Defendants  shall  ensure the  implementation  of the  actions  detailed  in the
report.

     E. As the actions  detailed in the report  described in  subparagraph D are
completed, Wyeth shall notify the expert consultant. The expert consultant shall
promptly  inspect and verify  whether  those  actions  have been  completed in a
manner  that  complies  with  applicable  laws and  regulations,  to the  expert
consultant's satisfaction (hereafter, "to the expert consultant's satisfaction")
and in accordance with the timetable  approved by FDA. If the expert  consultant
determines  that an action has not been  completed  to the  expert  consultant's
satisfaction,  he/she promptly will so notify Wyeth.  Beginning twenty (20) days
after the  submission of the plan and timetable to FDA under  subparagraph D and
thereafter on the first day of each month, the expert consultant shall submit to
FDA a table that succinctly  summarizes  his/her findings  regarding whether the
actions  have been  completed  to the expert  consultant's  satisfaction  and in
accordance  with the timetable  approved by FDA. FDA may, in its  discretion and
without prior notice,  periodically  inspect the Marietta facility and undertake
such additional  examinations,  reviews, and analyses (as provided in paragraphs
32 and 33) to verify whether the actions reported to have been completed have in
fact been completed in a satisfactory  manner.  In the event that FDA determines
that an action that has been  reported to be completed is  inadequate,  FDA will
notify  Defendants in writing,  and Defendants shall take appropriate  action in
accordance with a timetable that is subject to approval by FDA.

     F. When the expert consultant determines that all of the actions identified
in the timetable  approved by FDA pursuant to subparagraph D have been completed
to the expert  consultant's  satisfaction,  the expert  consultant shall provide
Defendants  with a  written  certification  that all of the  actions  have  been
completed  and that the Marietta  facility,  based on the  inspection  conducted
under  paragraph  11.B.  and  on the  satisfactory  completion  of  the  actions
identified  under  paragraph  11.D.,  is in conformity  with applicable laws and
regulations and this Decree. Once the certification has been issued, Wyeth shall
promptly submit the expert consultant's certification to FDA.

     G. Within forty-five (45) days of receipt of the certification, FDA may, in
its discretion and without prior notice,  commence an inspection of the Marietta
facility and undertake such additional  examinations,  reviews, and analyses (as
provided in paragraphs 32 and 33) as the Agency deems  appropriate  to determine
whether  the  Marietta  facility  is in  conformity  with  applicable  laws  and
regulations  (with  the  exception  of the  validation  of  those  manufacturing
processes that are specifically  addressed in paragraph 25) and this Decree.  If
FDA determines  that the Marietta  facility is not operating in conformity  with
applicable laws and regulations,  FDA will notify Defendants of the deficiencies
it observed and take such other action,  if any, as the Agency deems appropriate
(e.g., issuing an order pursuant to paragraph 29 or a notice under 21 C.F.R. ss.
601.5(b)).

     H. Within  thirty (30) days of receiving  the  notification  from FDA under
subparagraph G, Wyeth shall submit to FDA a plan of actions  Defendants  propose
to take and a timetable for correcting the deficiencies.  The timetable shall be
subject to FDA approval.  Defendants  shall  promptly  correct all  deficiencies
noted by FDA in accordance with the FDA-approved timetable, and cause the expert
consultant to reinspect and either (i) certify that the  deficiencies  have been
corrected  to assure  that the  manufacturing  facility  is in  conformity  with
applicable laws and regulations,  or (ii) notify Defendants that the one or more
deficiencies  remain  uncorrected.  If one or more  deficiencies  have  not been
corrected,  Defendants and the expert  consultant shall follow the procedures in
paragraph 37 until the expert consultant issues the  certification.  Wyeth shall
then  submit the  certification  to FDA.  Within  forty-five  (45) days of FDA's
receipt of the certification, FDA may reinspect as it deems necessary.

     I.  FDA's  Philadelphia   District  Office  will,  as  described  below  in
subparagraphs (1) and (2), notify Defendants in writing that the  manufacturing,
processing,  packing, holding, and distribution of drugs and biological products
at the Marietta  facility  appear to be in conformity  with  applicable laws and
regulations  (with  the  exception  of the  validation  of  those  manufacturing
processes that are  specifically  addressed in paragraph 25) and the portions of
this Decree relating to the Marietta facility.

          (1)  If FDA  conducts an  inspection  (or  re-inspection)  pursuant to
               subparagraphs  G  and/or  H and  finds  that  the  manufacturing,
               processing,  packing,  holding,  and  distribution  of drugs  and
               biological  products  at the  Marietta  facility  appear to be in
               conformity  with applicable laws and regulations and the portions
               of this Decree  relating to the  Marietta  facility,  this notice
               will be issued  within sixty (60) days after  completion  of such
               inspection.

          (2)  If  FDA  elects  not  to  conduct  an   inspection   pursuant  to
               subparagraph G or a reinspection pursuant to subparagraph H, this
               notice will be issued within  forty-five  (45) days after receipt
               of the expert consultant's certification under subparagraph F.

     12. In the event that Defendants  fail, as determined  either by the expert
consultant  or  FDA,  to  satisfactorily  complete  one or more  actions  in the
timetable  approved by FDA pursuant to paragraph  11.D.,  Wyeth shall pay to the
United States Treasury as liquidated  damages the sum of $15,000 per action, per
business  day,  until the action is fully  implemented  and  completed  to FDA's
satisfaction.

     13. No later than  January 15,  2001,  Wyeth shall  submit to FDA a written
report on the status of the  actions  undertaken  at the  Marietta  facility  to
respond to the Form FDA 483 issued  for that  facility  on  February  17,  2000,
including the Building 20 Restart  Protocol (Wyeth Protocol Number 00075P).  FDA
may, at its discretion and without prior notice,  inspect the Marietta  facility
as the Agency deems  appropriate  to verify the progress  made,  and the actions
completed,  as described in the report. In the event that FDA determines that an
action has not been completed or is not  progressing as described in the report,
FDA will notify  Defendants,  who shall cause Wyeth to take appropriate  actions
and submit a revised status report to FDA within thirty (30) days.

     14. The injunctive provisions of paragraph 10 do not apply to the following
activities at the Marietta facility:

          A.   Manufacturing,  processing,  packing,  holding,  or  distributing
               investigational drugs,  biologicals,  and medical devices for the
               sole purpose of conducting clinical trials under  investigational
               new  drug  applications  or  investigational  device  exemptions,
               provided  that   Defendants   comply  with  applicable  laws  and
               regulations  relating  to the  manufacture  and  distribution  of
               investigational products;

          B.   Manufacturing,  processing,  packing,  and holding  quantities of
               products  that are  necessary  for the  purpose of  preparing  or
               supporting  a  new  drug  application  or  a  biologics   license
               application,  but such  products may not be  distributed  without
               prior written authorization from FDA;

          C.   Manufacturing,   processing,   packing,  labeling,  holding,  and
               exporting  any drug or biological  product in compliance  with 21
               U.S.C.ss.ss. 381(e) or 382, 21 C.F.R.ss. 312.110, or 42 U.S.C.ss.
               262(h), as appropriate; and

          D.   Manufacturing,  processing,  packing,  holding,  or  distributing
               products  for the purpose of  conducting  nonclinical  laboratory
               studies  or other  research  and  testing  that does not  involve
               exposure of human research subjects.

     15.A.  With  respect  to  approved  finished  drug  products  and  finished
biological  products  manufactured at the Marietta  facility between the date of
entry of this Decree and the issuance of the notice under paragraph  11.I.,  the
expert  consultant  shall,  prior to the distribution of each batch,  review the
in-process,  bulk, and finished product batch production  records for that batch
and prepare and deliver a report to Wyeth's  Senior  Vice-President,  Regulatory
Affairs and Compliance. The written report shall include, but not be limited to,
a line list of deviations from written  procedures found in the batch production
records;  an evaluation of whether any atypical  environmental  conditions  were
present at the time of batch  manufacture;  an assessment of whether an adequate
investigation  was  conducted  with  respect  to the  deviations,  including  an
explanation of corrective actions with respect to the deviations;  an evaluation
of whether such  investigations were conducted in a timely manner; an assessment
of whether any  deviations  may have  adversely  affected the safety,  identity,
strength,  quality,  and purity of the batch; a review of glass vials acceptance
examinations to determine whether lots not meeting acceptance criteria were used
in production;  a review of records to determine whether adequate investigations
were  conducted  into  defects  and/or  process  deviations  that  could  affect
container-closure  integrity;  a report of  deviations  and/or  problems that QA
failed to note or address during the QA review of batch  production  records for
release of products;  and, if appropriate,  a certification  that all deviations
observed by the expert  consultant  have been resolved to his/her  satisfaction.
Upon a review of the expert  consultant's report and a recommendation by a Wyeth
Vice-President of Quality Assurance,  Wyeth's Senior Vice-President,  Regulatory
Affairs and Compliance shall determine  whether the batch should be released for
distribution.   If  Wyeth's  Senior   Vice-President,   Regulatory  Affairs  and
Compliance is unavailable,  a Wyeth  Vice-President  of Quality  Assurance shall
determine whether the batch should be released.

     B. Wyeth's Senior Vice-President,  Regulatory Affairs and Compliance shall,
on a monthly basis, update the President of Wyeth-Ayerst  Pharmaceuticals,  Inc.
on the results of the batch record review under subparagraph A.

     16.A.  In  recognition  of  the   government's   right  to  seek  equitable
disgorgement  in an  injunction  under the FD&C Act, but without  admitting  the
government's right to obtain such relief,  Wyeth agrees to pay the United States
Treasury,  within  fifteen (15) days after entry of this Decree,  thirty million
dollars ($30,000,000.00).

     B. In addition,  if one or more actions described in paragraph 11.D. remain
incomplete  as of the date that the last action is  scheduled to be completed in
the timetable  approved by FDA pursuant to paragraph 11.D., then Wyeth shall pay
to the United States  Treasury  18.5% of the net sales  generated by the sale of
those  products  that i) are  manufactured  and  distributed  from the  Marietta
facility  after that date and ii) may be affected by the  action(s)  that remain
incomplete. Payments under this paragraph shall continue until the date that all
of the actions  have been  completed  to FDA's  satisfaction.  In the event that
payments become due under this subparagraph,  then, as of the timetable date for
the last action,  no further  payments  shall be required  under  paragraph  12,
provided that Wyeth promptly makes the payments required by this subparagraph.

     C. The parties  acknowledge  that the payment(s)  made under this paragraph
are not a fine, penalty, forfeiture or payment in lieu thereof.

     17.  Within five (5)  business  days after the date of entry of this Decree
and for a period of no less than twelve  (12) months  after the date of entry of
this Decree,  Wyeth shall  assign an  individual  from or reporting  directly to
Wyeth's  division-level  QA/QC  department,   who  is  qualified  by  education,
training,  and experience to perform the functions  described in this paragraph,
to work on-site in the Marietta  facility.  This individual shall have full-time
responsibility  for monitoring  whether  employees in the Marietta  facility are
performing  their  functions  and the facility is operating in  accordance  with
applicable Wyeth SOPs relating to manufacturing,  processing,  packing, holding,
and distributing drug and biological  products,  including,  but not limited to,
quality  assurance and quality  control  functions.  Each month this  individual
shall  report  his/her   findings   directly  and  concurrently  to  the  Senior
Vice-President,  Regulatory Affairs and Compliance,  the Senior  Vice-President,
Global Supply Chain, and the Senior Vice-President, Global Quality Assurance and
Quality Control (all three of Wyeth-Ayerst Pharmaceuticals,  Inc.), the Director
of QA/QC of the Marietta  facility,  and the  Managing  Director of the Marietta
facility.  The employees  identified in the previous  sentence shall ensure that
any adverse  findings  included  in the report are  promptly  and  appropriately
addressed.

     18.  Within  forty-five  (45) days after the date of entry of this  Decree,
Wyeth shall submit to FDA an inventory and plan for retention or  disposition of
all  in-process,  bulk,  and finished  products  that were  manufactured  at the
Marietta  facility  before the date of entry of this  Decree and that are within
Wyeth's possession, custody, and control as of the date of entry of this Decree.
Wyeth  shall  also  propose  a  schedule  of  dates by  which  the plan  will be
completed. Wyeth's plan and schedule shall be subject to FDA's written approval.
This paragraph does not apply to the Seized  Articles,  FluShield(R)  (Influenza
Virus Vaccine), Antivenin (Crotalidae) Polyvalent, Antivenin (Micrurus fulvius),
Wydase(R)  (hyaluronidase),  and  Dryvax(R)  (Smallpox  Vaccine),  or  to  their
intermediates or associated diluents or agents covered by approved  applications
for these products.

     19.A.  Within one hundred  fifty (150) days after the date of entry of this
decree,  the expert  consultant shall complete a record review for all approved,
finished drug and  biological  products  (other than the Antivenin  (Crotalidae)
Polyvalent)  that  were  manufactured,  in  whole or in  part,  at the  Marietta
facility  before the date of entry of this  Decree and that will  remain  within
expiration date at the conclusion of the one hundred fifty (150) day period, and
have been distributed but not withdrawn or recalled from the market. The records
to be reviewed shall include batch production records,  protocols,  studies, and
reports,  including,  but not limited to,  General  Technical  Reports,  Product
Stability/Retained  Product Reports, and Service Request Records that contain or
reference information that potentially adversely affects the quality of the drug
and/or biological products. The expert consultant shall review these records and
shall  prepare and deliver a report  concurrently  to the  President  and Senior
Vice-President,    Regulatory    Affairs   and   Compliance   of    Wyeth-Ayerst
Pharmaceuticals,  Inc.,  and FDA's  Philadelphia  District  Office.  The written
report shall include,  at a minimum:  (1) a line list of deviations from written
procedures found in the records; (2) an assessment of the following:  whether an
adequate  investigation was conducted with respect to the deviations,  including
an explanation  of corrective  actions with respect to the  deviations;  whether
such  investigation was conducted in a timely manner;  whether required records,
including  in-process  monitoring  records,  are being  retained  as required by
Wyeth's SOPs; (3) a review of glass vial  acceptance  examinations  to determine
whether lots not meeting  acceptance  criteria  were used in  production;  (4) a
review of records to determine  whether adequate  investigations  were conducted
into  any   defects   and/or   process   deviations   that   could   affect   of
container-closure integrity; and (5) a report of deviations and/or problems that
QA failed to note or address  during the QA review of batch  production  records
for  release of product.  If the expert  consultant  identifies  any batches for
which the deviations,  in the judgment of the expert  consultant,  may adversely
affect  the  safety,  identity,  strength,  quality,  and  purity  of the of the
product, then he/she shall immediately notify Wyeth in writing.

     B. Within twenty (20) days of receiving  the report  described in the third
sentence of paragraph 19.A., Wyeth's Senior  Vice-President,  Regulatory Affairs
and Compliance shall prepare and submit to FDA's Philadelphia  District Office a
plan and a proposed timetable  detailing actions that Wyeth intends to take with
respect  to those  batches  the  quality  of which  the  expert  consultant  has
determined may have been  adversely  affected.  Wyeth's  Senior  Vice-President,
Regulatory  Affairs  and  Compliance  shall  also  send a copy of the  plan  and
timetable to the President of  Wyeth-Ayerst  Pharmaceuticals,  Inc. The plan and
timetable  are  subject  to FDA  approval.  Nothing in this  paragraph  modifies
Wyeth's obligations under 21 C.F.R. ss.ss. 314.81 and 600.14.

                            THE PEARL RIVER FACILITY

     20.A. Within ten (10) days of the date of entry of this Decree, Wyeth shall
retain an expert consultant to inspect the Pearl River facility.

     B. Within  twenty (20) days after the date of entry of this  Decree,  Wyeth
shall cause the expert consultant to commence a comprehensive  inspection of the
Pearl River facility to ensure that the methods,  facilities,  and controls used
for  manufacturing,  processing,  packing,  holding,  and distributing  drug and
biological products comply with applicable laws and regulations.  (However, this
inspection  is  not  required  to  address  validation  of  those  manufacturing
processes that are specifically addressed in paragraph 25.) The inspection shall
be completed no later than one hundred  fifty (150) days after the date of entry
of this Decree. In preparation for this inspection,  the expert consultant shall
review  all Forms FDA 483 issued to Wyeth  regarding  the Pearl  River  facility
since January 1997, and Wyeth's  actions taken in response  thereto.  The expert
consultant's  inspection  shall  include,  at a  minimum,  a review of the areas
described in paragraph 11.B.(1)-(7).

     C. Within twenty (20) days of the completion of the inspection,  the expert
consultant shall prepare a detailed written report of his/her inspection,  which
addresses each of the matters  described in paragraph  11.B.(1)-(7)  and whether
the aforementioned Form FDA 483 observations have been corrected, and submit the
inspection  report  concurrently  to the  President  and Senior  Vice-President,
Regulatory Affairs and Compliance of Wyeth-Ayerst Pharmaceuticals, Inc. and FDA.

     D. Within forty-five (45) days of receipt of the expert consultant's report
on the  inspection  of the Pearl River  facility,  Wyeth shall  submit a written
report to FDA that  details  the  specific  actions  Defendants  will take and a
timetable to address the expert consultant's  observations.  The timetable shall
be subject to FDA approval.  Defendants shall ensure the  implementation  of the
actions detailed in the report.

     E. As the actions  detailed in the report  described in  subparagraph D are
completed, Wyeth shall notify the expert consultant. The expert consultant shall
promptly  inspect and verify  whether those  actions have been  completed to the
expert  consultant's  satisfaction and in accordance with the timetable approved
by FDA.  If the  expert  consultant  determines  that  an  action  has not  been
completed  to the expert  consultant's  satisfaction,  he/she  promptly  will so
notify Wyeth.  Beginning  twenty (20) days after the  submission of the plan and
timetable to FDA under  subparagraph  D and  thereafter on the first day of each
month,  the  expert  consultant  shall  submit  to FDA a table  that  succinctly
summarizes his/her findings regarding whether the actions have been completed to
the  expert  consultant's  satisfaction  and in  accordance  with the  timetable
approved  by  FDA.  FDA  may,  in  its  discretion  and  without  prior  notice,
periodically  inspect the Pearl River  facility and  undertake  such  additional
examinations,  reviews,  and analyses (as provided in  paragraphs  32 and 33) to
verify  whether the actions  reported to have been  completed  have in fact been
completed in a satisfactory  manner.  In the event that FDA  determines  that an
action that has been  reported to be  completed is  inadequate,  FDA will notify
Defendants  in  writing,   and  Defendants  shall  take  appropriate  action  in
accordance with a timetable that is subject to approval by FDA.

     F. When the expert consultant determines that all of the actions identified
in the timetable  approved by FDA pursuant to subparagraph D have been completed
to the expert  consultant's  satisfaction,  the expert  consultant shall provide
Defendants  with a  written  certification  that all of the  actions  have  been
completed and that the Pearl River facility,  based on the inspection  conducted
under  paragraph  20.B.  and  on the  satisfactory  completion  of  the  actions
identified  under  paragraph  20.D.,  is in conformity  with applicable laws and
regulations and this Decree. Once the certification has been issued, Wyeth shall
promptly submit the expert consultant's certification to FDA.

     G. Within forty-five (45) days of receipt of the certification, FDA may, in
its  discretion  and without prior  notice,  commence an inspection of the Pearl
River facility and undertake such additional examinations, reviews, and analyses
(as  provided  in  paragraphs  32 and 33) as the  Agency  deems  appropriate  to
determine whether the Pearl River facility is in conformity with applicable laws
and  regulations  (with the exception of the  validation of those  manufacturing
processes that are specifically  addressed in paragraph 25) and this Decree.  If
FDA determines that the Pearl River facility is not operating in conformity with
applicable laws and regulations,  FDA will notify Defendants of the deficiencies
it observed and take such other action,  if any, as the Agency deems appropriate
(e.g., issuing an order pursuant to paragraph 29 or a notice under 21 C.F.R. ss.
601.5(b)).

     H. Within  thirty (30) days of receiving  the  notification  from FDA under
subparagraph G, Wyeth shall submit to FDA a plan of actions  Defendants  propose
to take and a timetable for correcting the deficiencies.  The timetable shall be
subject to FDA approval.  Defendants  shall  promptly  correct all  deficiencies
noted by FDA in accordance with the FDA-approved timetable, and cause the expert
consultant to reinspect and either (i) certify that the  deficiencies  have been
corrected  to assure  that the  manufacturing  facility  is in  conformity  with
applicable laws and regulations,  or (ii) notify Defendants that the one or more
deficiencies  remain  uncorrected.  If one or more  deficiencies  have  not been
corrected,  Defendants and the expert  consultant shall follow the procedures in
paragraph 37 until the expert consultant issues the  certification.  Wyeth shall
then  submit the  certification  to FDA.  Within  forty-five  (45) days of FDA's
receipt of the certification, FDA may reinspect as it deems necessary.

     I. FDA's New York District Office will, as described in  subparagraphs  (1)
and (2) below, notify Defendants in writing that the manufacturing,  processing,
packing, holding, and distribution of drugs and biological products at the Pearl
River facility  appear to be in conformity  with applicable laws and regulations
(with the exception of the validation of those manufacturing  processes that are
specifically addressed in paragraph 25) and the portions of this Decree relating
to the Pearl River facility.

          (1)  If FDA  conducts an  inspection  (or  re-inspection)  pursuant to
               subparagraphs  G  and/or  H and  finds  that  the  manufacturing,
               processing,  packing,  holding,  and  distribution  of drugs  and
               biological  products at the Pearl River facility  appear to be in
               conformity  with applicable laws and regulations and the portions
               of this Decree relating to the Pearl River facility,  this notice
               will be issued  within sixty (60) days after  completion  of such
               inspection.

          (2)  If  FDA  elects  not  to  conduct  an   inspection   pursuant  to
               subparagraph G or a reinspection pursuant to subparagraph H, this
               notice will be issued within  forty-five  (45) days after receipt
               of the expert consultant's certification under subparagraph F.


<PAGE>


     J. Wyeth may choose to satisfy the requirements of paragraph 20 on separate
schedules  for those Pearl River  facilities  in which  biological  products and
non-biological drug products, respectively, are manufactured, processed, packed,
and held. If Wyeth so chooses, FDA will act on the expert consultant's  separate
certifications in accordance with the time frames in subparagraphs G, H, and I.

     21. In the event that Defendants  fail, as determined  either by the expert
consultant  or  FDA,  to  satisfactorily  complete  one or more  actions  in the
timetable  approved by FDA  pursuant to paragraph  20.D,  Wyeth shall pay to the
United States Treasury as liquidated  damages the sum of $15,000 per action, per
business  day,  until the action is fully  implemented  and  completed  to FDA's
satisfaction.

     22.A.  Within fifteen (15) days of the date of entry of this Decree,  Wyeth
shall submit to FDA a proposed  statistical  sampling plan that will be used for
selecting batches of approved finished biological products produced at the Pearl
River  facility  for batch  record  review  prior to release,  as  described  in
subparagraph  B. The  statistical  sampling plan shall be prepared by the expert
consultant  and shall  describe the method of selection  and the number of batch
production  records  to be  reviewed.  The  statistical  sampling  plan shall be
subject to FDA  approval.  If FDA  notifies  Wyeth that it does not  approve the
statistical  sampling  plan as submitted by Wyeth,  Wyeth shall submit a revised
statistical  sampling  plan  within five (5)  business  days of receipt of FDA's
notice.

     B.  With  respect  to  approved  finished   biological  products  that  are
manufactured  at the  Pearl  River  facility  between  the date on  which  Wyeth
receives  written notice of FDA's approval of the statistical  sampling plan and
the date on which  Defendants  receive the  notification in paragraph 20.I., the
expert consultant shall review a sample of finished product  production  records
selected  pursuant to the approved  statistical  sampling plan and shall prepare
and  deliver a report for each batch  included  in the sample to Wyeth's  Senior
Vice President,  Regulatory  Affairs and Compliance and to the Director of QA/QC
of the Pearl River  facility.  The scope of the  records to be reviewed  and the
contents of the expert  consultant's  report  shall be the same as  described in
paragraph 15. After  reviewing the expert  consultant's  report for a particular
batch, the Director of QA/QC of the Pearl River facility shall determine whether
the batch should be released for distribution.

                               MANAGEMENT CONTROLS

     23.A. Wyeth shall retain an expert consultant to prepare a detailed written
report on management  controls at the Marietta and Pearl River  facilities.  The
report shall be delivered to the President of Wyeth-Ayerst Pharmaceuticals, Inc.
within one  hundred  twenty  (120) days after the date of entry of this  Decree.
This written report shall, at a minimum:

          (1)  Describe  Wyeth's  current   organizational   structure  and  the
               specific    responsibilities    of   each    Wyeth    department,
               division-level and site-level,  that is involved in manufacturing
               of drugs or  biological  products at the Marietta and Pearl River
               facilities;

          (2)  Assess the role and  personnel  resources of Wyeth's QA/QC units,
               division-level and site-level,  including the units' current role
               in detecting and/or correcting all deficiencies and noncompliance
               with Wyeth's SOPs at the Marietta and Pearl River facilities; and


<PAGE>


          (3)  Evaluate   whether   personnel   responsible  for  directing  and
               conducting  the  manufacture  and  quality  control  of drugs and
               biological  products at the Marietta  and Pearl River  facilities
               are adequate in number and qualifications  (education,  training,
               and experience,  or a combination  thereof) to ensure  compliance
               with applicable laws and regulations and this Decree.

     B. The President of Wyeth-Ayerst Pharmaceuticals, Inc. shall, within thirty
(30) days of receipt of the expert  consultant's  report under  subparagraph  A,
submit to FDA a copy of the report  together with a  description  of the actions
Wyeth  proposes to take in response to the report and a timetable for completing
those actions. The timetable is subject to approval by FDA.

                               WYETH QA/QC REVIEW

     24.A. Wyeth shall retain an expert  consultant to undertake a division-wide
assessment of Wyeth's QA/QC  program(s).  For each of the various  facilities at
which Wyeth  manufactures,  processes,  packs, and holds drugs and/or biological
products for  distribution in interstate  commerce,  as defined in 21 U.S.C. ss.
321(b),  the expert  consultant,  within one hundred eighty (180) days after the
date of entry of this Decree, shall: (i) assess the adequacy of Wyeth's proposed
QA/QC policies; (ii) determine whether Wyeth has a plan to prepare and implement
division-level  QA/QC  policies and to translate  them into written SOPs;  (iii)
evaluate Wyeth's  progress in implementing  that plan; (iv) audit an appropriate
sample  of  failure   investigations  at  each  of  the  facilities,   including
assessments of whether such investigations  include analysis of other batches of
the same  product,  other  products  that may have been  affected,  and  similar
previous occurrences,  to assess whether the failure investigations are adequate
in scope,  depth,  and  timeliness;  and (v) report to  Defendants in writing on
items (i)-(iv).  The expert consultant's report shall include a statement of the
methodology used to determine the appropriate sample size and selection for item
(iv).

     B. Within sixty (60) days of receipt of the expert consultant's  report(s),
Wyeth  shall  submit  a copy  of the  report(s)  and a  description  of  actions
Defendants  propose to take in response  to the  report(s)  and a timetable  for
completing  those  actions to the Director,  Office of Compliance  and Biologics
Quality ("OCBQ"),  Center for Biologics  Evaluation and Research  ("CBER");  the
Director,  Office of  Compliance,  Center  for  Drugs  Evaluation  and  Research
("CDER");  and to the  Director  of each FDA  District  Office  in  which  Wyeth
manufactures drug or biological products.  The timetable shall be subject to FDA
approval by the Director,  OCBQ,  CBER, and the Director,  Office of Compliance,
CDER.

                                   VALIDATION

     25.  Within sixty (60) days after the date of entry of this Decree,  Wyeth,
working with the expert  consultant,  shall submit to FDA a proposed  validation
plan for accomplishing  validation of Wyeth's bulk manufacturing  processes used
to manufacture  finished drugs and biological products at the Marietta and Pearl
River  facilities.  The validation plan submitted for each facility  shall:  (a)
identify the specific  manufacturing  processes  that remain to be validated and
the products  affected by such  processes,  with the  exception of protocols for
biological  products  already  submitted  to FDA,  and (b)  include  a  proposed
validation  schedule for each facility,  which shall be subject to FDA approval.
Wyeth then shall execute and complete  validation studies in accordance with the
FDA-approved  validation schedule.  Within forty-five (45) days of receipt of an
inspection  report under paragraph 11.C. or 20.C.,  Wyeth may propose an amended
validation  plan and  schedule  for the  applicable  facility,  together  with a
justification for the proposed  amendments.  The proposed amendments to the plan
and schedule are subject to FDA approval.

     26.  Until  notified  otherwise  by  FDA,  Wyeth  shall  retain  an  expert
consultant  to  review  on  an  on-going  basis  all  validation  protocols  for
validation studies at the Marietta and Pearl River facilities that have not been
initiated  as of the date of entry of this  Decree  and  those  that  have  been
initiated  but not  completed,  including,  but not  limited to,  those  studies
included in the validation schedule in paragraph 25.

     A. For each  validation  study that has not been initiated or that has been
initiated but not  completed on or before the date of entry of this Decree,  the
expert consultant shall determine whether the validation protocol clearly states
how the validation study is to be conducted,  including test parameters, product
characteristics,  production equipment,  and decision points on what constitutes
acceptable  test  results.  If the expert  consultant  finds the  protocol to be
inadequate, Wyeth shall revise the protocol.

     B. Within thirty (30) days of the completion of each validation  study, the
expert  consultant shall evaluate whether the protocol was adhered to during its
execution (and if not, what deviations  occurred and what effects the deviations
had on the results of the study), and review the results of the study. Depending
on the  results of the expert  consultant's  evaluation,  the expert  consultant
shall either i) provide Wyeth with a certification  that an adequate  validation
has been  completed,  or ii) if the expert  consultant  finds any  deficiencies,
submit a written  report of  findings  to Wyeth.  Wyeth  shall  investigate  the
deficiencies and revalidate as the expert consultant deems necessary.

     C. Once the expert  consultant has determined  that an adequate  validation
has been completed,  he/she shall issue a  certification,  including the date on
which  the  validation  was  completed,   and  Wyeth  shall  submit  the  expert
consultant's certification to FDA.

     D.  After  receiving  the  expert  consultant's  certification(s),  FDA may
request a copy of any completed validation package(s) (data and summary report),
including  the expert  consultant's  evaluation  of the  protocol  and the study
results,  for review and Wyeth  shall  submit the  requested  package(s)  to FDA
within  seven  (7)  days of  such  request.  If FDA  finds  deficiencies  in the
validation  package,  FDA shall so notify Wyeth,  and Wyeth shall revalidate (or
take  other  corrective  action) as FDA deems  necessary  in  accordance  with a
schedule approved by FDA.

     27. In the event  that  Wyeth  fails,  as  determined  by either the expert
consultant or FDA, to prepare an adequate  validation or  revalidation  protocol
(as  appropriate)  and to  properly  execute  and  complete  the  validation  or
revalidation  study in accordance with the schedules approved by FDA pursuant to
paragraphs  25 and  26,  Wyeth  shall  pay  to the  United  States  Treasury  as
liquidated damages the sum of $15,000 for each validation and revalidation study
that is not completed, per business day, until the study is completed.

                   YEARLY INSPECTIONS BY THE EXPERT CONSULTANT

     28.A.  Wyeth shall retain an expert  consultant to inspect the Marietta and
Pearl  River  facilities,  in  accordance  with the  schedule  set forth in this
paragraph,  to  ensure  that the  methods,  facilities,  and  controls  used for
manufacturing,   processing,   packing,  holding,  and  distributing  drugs  and
biological products comply with applicable laws and regulations and this Decree.
As part of these inspections,  the expert consultant shall assess the steps that
have been taken to ensure that the QA/QC  programs in place at the  Marietta and
Pearl River  facilities  comply with  applicable  laws and  regulations and this
Decree,  including  those  matters set forth in paragraph  11.B. of this Decree.
This assessment shall address the QA/QC failures,  if any, that are described in
the reports prepared  pursuant to paragraphs 15, 19, and 22 of this Decree.  The
expert consultant shall prepare reports of these  inspections  outlining his/her
inspectional  findings  and the state of  compliance  with  applicable  laws and
regulations  and shall submit these  reports to  Defendants no later than twenty
(20) days after the date the  inspection is completed.  Within  forty-five  (45)
days of receiving a copy of the expert  consultant's  inspection  report,  Wyeth
shall submit to FDA a copy of that report,  together with a  description  of the
actions  Wyeth  proposes to take in response to the report,  and a timetable for
completing  those  actions.  The  proposed  timetable  shall be  subject  to FDA
approval.

     B.  The  inspections  required  in this  paragraph  shall  commence  at the
Marietta  facility  within  one (1)  year  after  issuance  of the  notification
described in paragraph  11.I.,  and at the Pearl River  facility  within one (1)
year after the issuance of the  notification  described in paragraph  20.I., and
the  inspections  shall  thereafter  be  conducted  at  each  facility  no  less
frequently  than once a year for a period of three (3) years from  those  dates,
for a total of four (4) inspections at each facility.

IV.  GENERAL PROVISIONS

     29.A.  If at any time after this Decree has been  entered,  FDA  determines
that,  with respect to the Marietta  and/or Pearl River  facilities,  Defendants
have failed to comply  fully with or have  violated  the FD&C Act,  the PHS Act,
applicable   regulations,   Wyeth's  biological  products  licenses,   new  drug
applications, or any provision of this Decree; or that any report, plan, SOP, or
validation data prepared or submitted by Defendants  pursuant to this Decree, or
any measure  implemented by Defendants to comply with this Decree, is inadequate
to comply with the FD&C Act, the PHS Act, applicable regulations,  Wyeth's SOPs,
or the provisions of this Decree, FDA may, as and when it deems necessary, order
Defendants in writing to take appropriate corrective actions,  including but not
limited  to,  ordering  that  Defendants  immediately  take  one or  more of the
following  actions with respect to the Marietta and/or Pearl River facilities or
products manufactured,  processed,  packed,  labeled, or held in, or distributed
from, those facilities:

          (1)  Revise,  modify,  or expand any  report(s)  or  plan(s)  prepared
               pursuant to this Decree;

          (2)  Submit additional reports or information to FDA;

          (3)  Submit any  supplement to an existing drug or biological  product
               application to FDA;

          (4)  Cease  manufacturing,   processing,   packing,   holding,  and/or
               distributing drugs and/or biological products;

          (5)  Recall  drugs  and/or  biological  products  in  accordance  with
               procedures identified by FDA; or

          (6)  Take any other  corrective  action(s) as FDA, in its  discretion,
               deems  necessary  to bring  Defendants  and Wyeth's  drugs and/or
               biological  products into  compliance with the FD&C Act, PHS Act,
               applicable  regulations,   and  this  Decree.  Any  order  issued
               pursuant  to this  paragraph  shall  issue from the  Philadelphia
               District  Director  or  the  New  York  District   Director,   as
               appropriate,  in accordance with FDA's internal  procedures,  and
               shall specify the  deficiencies or violations  giving rise to the
               order.

     B. Unless a different  time frame is specified by FDA in its order,  within
ten (10)  business days after  receiving an order  pursuant to  subparagraph  A,
Defendants   shall  notify  FDA  in  writing  either  that  (1)  Defendants  are
undertaking or have undertaken corrective action, in which event Defendants also
shall  describe  the  specific  action taken or to be taken and the schedule for
completing  the action;  or (2)  Defendants  do not agree with FDA's  order.  If
Defendants notify FDA that they do not agree with FDA's order,  Defendants shall
explain in writing  the basis for their  disagreement;  in so doing,  Defendants
also may  propose  specific  alternative  actions and  specific  time frames for
achieving FDA's objectives.

     C. If  Defendants  notify FDA that they do not agree with FDA's order,  FDA
will review Defendants' notification and thereafter, in writing, affirm, modify,
or withdraw its order, as the Agency deems appropriate.

     D. If FDA affirms or modifies its order,  Defendants shall, upon receipt of
FDA's order, immediately implement the order (as modified, if applicable),  and,
if they so choose,  bring the matter  before this Court on an  expedited  basis.
Defendants shall continue to diligently  implement FDA's order, unless the Court
issues an order to the contrary.  Any matter  brought before this Court shall be
based  exclusively on the record before FDA at the time the order in dispute was
issued pursuant to subparagraph C. No discovery shall be taken by either party.

     30. After FDA issues the  notifications  pursuant to paragraphs  11.I.  and
20.I., Wyeth-Ayerst Laboratories Division of American Home Products Corporation,
Wyeth-Ayerst  Pharmaceuticals,  Inc.,  Bernard  Poussot,  John Bucceri,  and Roy
Sturgeon,  Ph.D., the Managing Director of the Marietta  facility,  and each and
all  of   Wyeth-Ayerst   Laboratories   Division  of  American   Home   Products
Corporation's  and  Wyeth-Ayerst   Pharmaceuticals,   Inc.'s  officers,  agents,
employees,  representatives,  successors,  assigns,  and  attorneys,  and  those
persons  in active  concert  or  participation  with any of the  Defendants  who
receive actual notice of this Decree by personal service or otherwise,  shall be
permanently  enjoined  under 21 U.S.C.  ss.  332(a) from  directly or indirectly
causing to be  introduced  or  delivered  into  interstate  commerce any drug or
biological  product  that is  adulterated  within the  meaning of 21 U.S.C.  ss.
351(a)(2)(B), or from causing the adulteration of any drug or biological product
while such drug or biological  product is held for sale after shipment of one or
more of its components in interstate commerce.

     31.A. All communications required to be sent to FDA under this Decree shall
be  prominently  marked  "Decree  Correspondence."  Unless  otherwise  specified
herein,  all reports  shall be sent to the Director,  Office of  Compliance  and
Biologics Quality,  HFM-600,  Center for Biologics Evaluation and Research, 1401
Rockville  Pike,  Suite 200 N,  Rockville,  MD  20852-1448  and to the Director,
Office of Compliance,  HFD-300, Center for Drugs Evaluation and Research,  MPN1,
7520 Standish  Place,  Rockville,  MD,  20855-2737.  Those  communications  that
pertain  in  whole  or in part  to the  Marietta  facility  also  shall  be sent
concurrently to the Director,  Philadelphia District Office, HFR-CE100, FDA, 900
U.S.  Customhouse,  2nd and  Chestnut  Streets,  Philadelphia,  PA 19106.  Those
communications  that  pertain  in whole or in part to the Pearl  River  facility
shall be sent concurrently to the Director, New York District Office, HFR-NE100,
300 Pearl Street, Suite 100, Buffalo, NY 14202.

     B. All notifications and other communications  required to be sent to Wyeth
under this Decree shall be marked "Decree  Correspondence"  and shall be sent by
U.S. mail and, if practicable,  by facsimile or electronic mail, to the Director
of the Consent Decree  Compliance Task Force at 555 East Lancaster  Avenue,  St.
Davids, PA 19087. All notifications and other communications required to be sent
to  Defendants  under this Decree shall be marked  "Decree  Correspondence"  and
shall be sent to Wyeth, and to Bernard Poussot, P.O. Box 8299, Philadelphia,  PA
19101 or 555 East Lancaster Avenue, St. Davids, PA 19087, John V. Bucceri,  P.O.
Box 8299,  Philadelphia,  PA 19101 or 555 East Lancaster Avenue,  St. Davids, PA
19087,  and Roy J. Sturgeon,  Ph.D.,  240 Radnor  Chester Road,  St. Davids,  PA
19087.

     32.  Wyeth  shall  reimburse  FDA for  the  costs  of all FDA  inspections,
examinations,  analytical  work,  and review  work that FDA deems  necessary  to
evaluate  Defendants'  compliance  with any part of this Decree with  respect to
drug and/or  biological  products  manufactured  at the Marietta and Pearl River
facilities  at the standard  rates  prevailing  at the time the  activities  are
accomplished.  As of the date that this Decree is signed by the  parties,  these
rates  are:  $59.90  per  hour  and  fraction  thereof  per  representative  for
inspection  work,  $71.79 per hour or fraction  thereof per  representative  for
analytical or review work,  $0.325 per mile for travel  expenses by  automobile,
government  rate  or the  equivalent  for  travel  by  air,  and  the  published
government  per  diem  rate  or the  equivalent  for  the  areas  in  which  the
inspections are performed per day per representative  for subsistence  expenses,
where necessary.  FDA shall submit a reasonably  detailed bill of costs to Wyeth
at the address specified in paragraph 31.B. In the event that the standard rates
applicable to FDA supervision of  court-ordered  compliance are modified,  these
rates shall be increased or decreased without further order of the Court.

     33.  Defendants shall, as and when FDA deems necessary to ensure compliance
with this  Decree,  and  without  prior  notice or  regard to  inspection  dates
specified  elsewhere in this Decree,  permit duly authorized FDA representatives
to make  inspections of the Marietta and Pearl River  facilities,  including all
drugs and  biological  products and equipment  therein,  finished and unfinished
materials,  containers,  labeling,  records (including,  but not limited to, all
computer hardware and software, computer printouts, raw data and laboratory data
generated in connection with the expert consultant's  reports identified above),
files, papers, SOPs, and processes and controls; to take photographs; to collect
samples of any drugs and biological  products;  and to copy any of the foregoing
records. FDA will provide Wyeth with a receipt for any samples taken pursuant to
21 U.S.C.  ss. 374(c) and with copies of any photographs  made. The costs of all
such inspections, record reviews, and sample analyses shall be borne by Wyeth at
the rates  specified  above in paragraph 32. The  inspections  described in this
Decree  shall  be  permitted  upon  presentation  of a copy of this  Decree  and
appropriate  credentials.  The inspection  authority described in this paragraph
shall be separate  and apart from,  and in addition to,  statutory  authority to
make inspections under the FD&C Act and the PHS Act.

     34.A.  Within  fifteen  (15) days  after the date of entry of this  Decree,
Wyeth shall deliver copies of this Decree to each of its officers,  and to those
employees and all other persons who are in active concert or participation  with
Wyeth's  CGMP-related  operations  in the  manufacture  of drugs and  biological
products at either of the Marietta or Pearl River  facilities.  Also, within ten
(10) days after the date of entry of this Decree, Wyeth shall prominently post a
copy of this Decree in the employee common areas in the Marietta and Pearl River
facilities  so that it is  accessible  to all employees who are involved in such
CGMP-related  operations.  Wyeth shall ensure that the Decree  remains posted in
the employee common areas for a period of no less than  twenty-four (24) months.
If any person  begins  employment  at the Marietta or Pearl River  facilities in
areas  involving  compliance  with  CGMP  at a time  subsequent  to the  periods
described above,  Wyeth shall,  within ten (10) days of the commencement of such
employment, deliver a copy of this Decree to such person.

     B. Within  thirty (30) days after the date of entry of this  Decree,  Wyeth
shall  provide  to the  District  Director,  Philadelphia  District  Office,  an
affidavit  stating the fact and manner of its  compliance  with this  paragraph,
identifying  the names and  positions  of all  persons  receiving  copies of the
Decree pursuant to the first sentence of subparagraph A. Thereafter,  within ten
(10) days of receiving a request from FDA for any  information or  documentation
that FDA deems necessary to evaluate compliance with this paragraph, Wyeth shall
provide such information or documentation to FDA.

     35.A.  Wyeth shall notify FDA in writing at least  fifteen (15) days before
any of the following  events,  if the event may affect  Defendants'  obligations
arising out of the Decree:

          (1)  reorganization,  bankruptcy,  dissolution,  or assignment or sale
               resulting in the emergence of a successor;

          (2)  the creation or dissolution of subsidiaries; or

          (3)  any other change of the corporate structure or function of Wyeth.

     B. Wyeth shall serve a copy of this Decree on any prospective  purchaser or
assignee at least  fifteen  (15) days prior to such an  assignment  or change in
ownership.  Wyeth shall  furnish FDA with an affidavit of  compliance  with this
paragraph  sworn to by the President of  Wyeth-Ayerst  Pharmaceuticals,  Inc. no
later than ten (10) days prior to such assignment or change in ownership.

     36. All expert consultants  required to be retained pursuant to this Decree
shall be  qualified  by  education,  training,  and  experience  to perform  the
functions  for which they are  retained  (e.g.,  to inspect  sterile and aseptic
manufacturing  processes,  to  conduct  investigations,  to  design  appropriate
procedures,  controls,  and SOPs, and to prepare reports) and shall otherwise be
knowledgeable  in CGMP.  In  addition,  all  such  expert  consultants  shall be
retained at Wyeth's  expense and shall be without  personal  or  financial  ties
(other than consulting  agreements  between the parties or indirect ownership of
American Home Products Corporation stock, e.g., through diversified mutual funds
or pension plans) to Defendants or their immediate families.

     37.  Whenever  this Decree  requires an expert  consultant  to certify to a
matter, and the expert consultant  determines that he/she is unable to make that
certification,  he/she will so notify  Wyeth and state the  reasons  therefor in
writing.  After Wyeth has addressed those reasons,  the expert  consultant shall
determine whether he/she may make the certification. This process shall continue
until the certification is made.

     38. All destruction of drugs or biological products pursuant to this Decree
shall be  conducted  in a manner  that  complies  with the  requirements  of the
National Environmental Policy Act of 1969.

     39. All decisions  conferred upon FDA in this Decree shall be vested in the
discretion  of FDA,  and,  in the  event  of a  decision  adverse  to any of the
Defendants,  shall include a written  explanation of FDA's  reasons.  Defendants
shall abide by the decisions of FDA, and FDA's decisions  shall be final.  FDA's
decisions  under this Decree shall be reviewed by this Court under the arbitrary
and capricious standard set forth in 5 U.S.C. ss. 706(2)(A).

     40.  Wyeth may at any time  petition FDA to extend any time frame or revise
any schedule  provided  for in this Decree,  and FDA may, in the exercise of its
discretion, grant such an extension without seeking leave of court. However, any
such  petitions  shall  not  become  effective  or stay the  impositions  of any
payments under this Decree unless granted by FDA in writing.

     41. FDA will  either  approve  or  disapprove  any  timetable  or  schedule
submitted to the Agency pursuant to paragraphs 11, 18-20,  23-26, and 28 of this
Decree  within  twenty (20) days of FDA's  receipt of the proposed  timetable or
schedule. FDA may, if it so chooses, approve a timetable or schedule in part and
disapprove it in part. If a timetable or schedule is  disapproved in whole or in
part, FDA will include a written  explanation  of its reasons.  Within seven (7)
business  days of  receipt  of  FDA's  disapproval  (in  whole  or in part) of a
timetable or schedule,  Wyeth may offer a modification of or  justification  for
the proposal.  Within seven (7) business days of receipt of Wyeth's modification
or  justification,  FDA will  notify  Wyeth in  writing  of the  Agency's  final
decision on the timetable or schedule.

     42.A.  For  purposes  of  paragraphs  12, 21, and 27, if Wyeth  submits the
expert  consultant's  certification  that (1) a deficiency has been corrected or
that a validation or revalidation study has been completed,  as applicable,  and
(2) such  correction  or validation  or  revalidation  study was completed on or
before the date in the timetable for that activity  approved by FDA, it shall be
assumed that the activity was completed by the timetable date,  unless and until
FDA notifies Wyeth to the contrary under  subparagraph B of this  paragraph.  If
the completion  date stated by the expert  consultant is after the date on which
the activity was  scheduled to be completed in the  timetable  for that activity
approved by FDA,  payment  shall be due for each  business day that the activity
was not completed,  commencing on the first business day after the date on which
the activity was to be completed  according to the timetable approved by FDA and
ending on (and including) the actual completion date.

     B. If after an inspection or review of information FDA notifies  Defendants
in writing that one or more activities were not satisfactorily  completed by the
timetable dates described in paragraphs 11.D.,  20.D., 25, and 26, payment shall
be due for each activity (i.e.,  correction or validation or revalidation study)
for each  business day  commencing  on the first  business day after  Defendants
receive  the  notice  and  ending  on  (and   including)  the  completion   date
re-certified to by the expert consultant.

     C. Duplicate payments under paragraphs 12 and 27 or under paragraphs 21 and
27 shall not be imposed for the identical validation study.

     D. The total payments under paragraphs 12, 21, and 27 shall not exceed five
million dollars ($5,000,000.00).

     43. Wyeth shall notify FDA in writing within three (3) business days of any
decision to suspend  manufacturing  for a period of more than fourteen (14) days
outside  of  the  usual  production   schedule  or  a  decision  to  discontinue
manufacturing  of any drug or biological  product at the Marietta or Pearl River
facilities.

     44.  Defendants'  obligations  under  this  Decree do not modify or absolve
Defendants  from any  obligation  to comply  with the FD&C Act,  PHS Act, or any
other federal  statute or regulation.  Nothing in this Decree shall affect FDA's
authority  to suspend or revoke  Wyeth's  biologicals  licenses  pursuant  to 21
C.F.R.  ss.ss.  601.5 and 601.6 or to withdraw Wyeth's new drug  applications or
abbreviated new drug applications pursuant to 21 C.F.R. ss. 314.150.

     45. The use of  "Defendants"  collectively  in this  Decree to include  the
Managing Director of the Marietta facility recognizes that the Managing Director
of the  Marietta  facility  is used in this  Decree  to refer to the  individual
holding that position and that such individual may change from time to time. For
purposes  of  paragraphs  20, 21, and 24 and for  reports  prepared  pursuant to
paragraph 28 regarding the Pearl River facility,  the term "Defendants" does not
apply to the Managing Director of the Marietta facility.

     46. The obligations under this Decree of each individual named herein shall
apply only to the extent of his authority,  responsibilities, and conduct within
a division or subsidiary of American Home Products  Corporation.  If, and for so
long as, an  individual  Defendant or an employee of Wyeth ceases to be employed
by or act on behalf of any  division or  subsidiary  of American  Home  Products
Corporation,  then that  Defendant or employee shall not be subject to the terms
of this Decree except as to such individual's  act(s) or failure(s) to act under
this Decree prior to the time such individual ceased to be employed by or to act
on behalf of any division or subsidiary of American Home Products Corporation.

     47. If  Defendants  petition  the Court for relief from this Decree and, at
the time of the petition,  in FDA's judgment,  Defendants have maintained at the
Marietta  and Pearl  River  facilities  a state of  continuous  compliance  with
applicable laws and regulations, Wyeth's SOPs, and this Decree for the preceding
sixty (60) months, Plaintiff will not oppose such petition.

     48. This Court shall retain  jurisdiction  over this action and the parties
hereto for the  purpose  of  enforcing  and  modifying  this  Decree and for the
purpose of granting such additional  relief as may be necessary and appropriate.
If any Defendant violates this Decree and is found in civil or criminal contempt
thereof,  that Defendant  shall,  in addition to other  remedies,  reimburse the
United States for its attorney's fees, investigational expenses, and court costs
relating to contempt proceedings related to that Defendant.

Dated this 3 day of Oct., 2000.

/s/ James H. Jarvis II
---------------------------------------
UNITED STATES DISTRICT JUDGE




<PAGE>


We hereby consent to the entry of the foregoing:


FOR DEFENDANTS:                                FOR PLAINTIFF:

_________________________                      David W. Ogden, Assistant
Bernard J. Poussot, individually               Attorney General
and on behalf of Wyeth-Ayerst                  Civil Division
Laboratories Division of                       U.S. Department of Justice
American Home Products Corporation
Wyeth-Ayerst Pharmaceuticals, Inc.,
and Wyeth-Ayerst Laboratories Puerto
Rico, Inc.
                                                Gerald C. Kell
                                                Senior Trial Counsel
                                                Office of Consumer Litigation
Richard Cooper                                  Civil Division
Williams & Connolly LLP                         U.S. Department of Justice
725 12th Street, N.W.                           P.O. Box 386
Washington, D.C. 20005                          Washington, D.C.  20044
(202) 434-5466                                  (202) 514-1586

Counsel for Bernard J. Poussot                  Carl K. Kirkpatrick
 as an individual                               United States Attorney

-------------------------                       ----------------------------
John V. Bucceri                                 Cynthia F. Davidson
                                                Assistant United States Attorney
                                                800 Market Street
_________________________                       Suite 211
Roy J. Sturgeon, Ph.D.                          Knoxville, TN 37902
                                               (865) 545-4167

_________________________                       Of Counsel:
Bruce N. Kuhlik
Covington & Burling                             Margaret Jane Porter
1201 Pennsylvania Avenue, N.W.                  Chief Counsel
P.O. Box 7566
Washington, D.C. 20044-7566                     Paige Harrison Taylor
(202) 662-6000                                  Associate Chief Counsel
                                                5600 Fishers Lane, Rm. 7-77
Counsel for John V. Bucceri                     Rockville, MD 20857
and Roy J. Sturgeon, Ph.D.                      (301) 827-1161
-------------------------
William W. Vodra
Arnold & Porter
555 Twelfth Street, N.W.
Washington, D.C. 20004-1206
(202) 942-5088

Attorney for Wyeth-Ayerst Laboratories
Division of American Home Products Corporation,
Wyeth-Ayerst Pharmaceuticals, Inc., and Wyeth-Ayerst
Laboratories Puerto Rico, Inc.