Document:

[VION LETTERHEAD]

                                  June 27, 2006

Dr. Terrence Doyle
Five Wellsweep Lane
Killingsworth, Connecticut 06419

Dear Terry:

Reference is made to the option agreements between you and Vion dated October
14, 1996, January 29, 1998, May 20, 1999, February 24, 2000, December 5, 2000
and December 6, 2001 (the "Option Agreements") evidencing certain outstanding
options (the "Options") granted to you under our Amended and Restated 1993 Stock
Option Plan (the "Plan"). Pursuant to Section 11(d) of the Plan, your Options
will cease to be exercisable three months following the termination of your
employment with Vion, unless the Option Agreements designate a longer exercise
period. Accordingly, as a further inducement for you to remain a consultant to
Vion following the termination of your employment with Vion, the Compensation
Committee desires to extend the period during which the Options shall remain
outstanding and exercisable until the earliest of (i) three months following the
termination of your employment or other relationship with the Company, (ii) the
term of the applicable Option as set forth in the applicable Option Agreement or
(iii) December 31, 2006, by amending Section 5 of each Option Agreement in its
entirety, subject to your consent, to read as follows:

      "5.   The Holder may exercise the Option (but only to the extent the
      Option is exercisable at the time of termination of the Holder's
      employment or other relationship with the Company) at any time until the
      earliest of (i) three months following the termination of the Holder's
      employment or other relationship with the Company or (ii) December 31,
      2006, but in no event later than the Expiration Date of the Option."

By returning a duly signed and dated copy of this letter to me, you hereby agree
and consent to the foregoing amendment of each Option Agreement and further
acknowledge and understand that any such Options that were designated as
"incentive stock options" in your Option Agreements within the meaning of
Section 422 of the Code will hereinafter cease to so qualify by virtue of the
modifications authorized herein.

                                    VION PHARMACEUTICALS, INC.

                                      /s/ Howard Johnson
                                    ----------------------------------------
                                    By: Howard Johnson

AGREED & CONSENTED TO
This 27 Day of June 2006:

  /s/ Terrence Doyle
---------------------------------------
Terrence Doyle

                                       5exv10w1

 

 
Exhibit 10.1

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF ILLINOIS

EASTERN DIVISION

	 	 	 	 	 	 	 
	UNITED STATES OF AMERICA,

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	Plaintiff,     

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	v.

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	7,140 boxes, more or less, of an article of device, each

	 	 	)	 	 	 
	boxes containing an infusion pump, labeled in part:

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	(box)

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	“*** Manufactured by an affiliate of Baxter Healthcare

	 	 	)	 	 	 
	Corporation Deerfield, IL *** Made in Singapore Baxter

	 	 	)	 	 	 
	*** ONE (1) 2L3113 *** SYNDEO PCA Syringe Pump

	 	 	)	 	 	 
	Voltage 6 VDC ***”

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	(pump)

	 	 	)	 	 	No. 05-C-5852
	 

	 	 	)	 	 	 
	“*** SYNDEO PCA Syringe Pump Baxter Healthcare

	 	 	)	 	 	Judge Wayne R. Andersen
	Corporation Medication Delivery Division Deerfield, IL ***

	 	 	)	 	 	 
	Made in Singapore ***”

	 	 	)	 	 	 
	 

	 	 	)	 	 	CONSENT DECREE FOR
	(box)

	 	 	)	 	 	CONDEMNATION AND
	 

	 	 	)	 	 	PERMANENT INJUNCTION
	“*** Manufactured by an affiliate of Baxter Healthcare

	 	 	)	 	 	 
	Corporation Deerfield, IL *** Made in Singapore Baxter

	 	 	)	 	 	 
	*** ONE (1) 2M8161 *** Colleague CX Volumetric

	 	 	)	 	 	 
	Infusion Pump Voltage 100-120V/220-240V ***”

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	(pump)

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	“*** Colleague CX Volumetric Infusion Pump Baxter

	 	 	)	 	 	 
	Healthcare Corporation Medication Delivery Division

	 	 	)	 	 	 
	Deerfield, IL *** Made in Singapore ***”

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	(box)

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	“*** Manufactured by an affiliate of Baxter Healthcare

	 	 	)	 	 	 
	Corporation Deerfield, IL *** Made in Singapore Baxter

	 	 	)	 	 	 
	*** ONE (1) 2M8163 *** Colleague 3 CX Volumetric

	 	 	)	 	 	 
	Infusion Pump Voltage 100-120V/220-240V ***”

	 	 	)	 	 	 

 

 

	 	 	 	 	 	 	 
	(pump)

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	“*** Colleague 3 CX Volumetric Infusion Pump Baxter

	 	 	)	 	 	 
	Healthcare Corporation Medication Delivery Division

	 	 	)	 	 	 
	Deerfield, IL *** Made in Singapore ***”

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	and

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	all other Baxter Colleague infusion pumps, including

	 	 	)	 	 	 
	2M8151 and 2M8153, and Baxter Syndeo PCA syringe

	 	 	)	 	 	 
	infusion pumps on the premises of Cardinal Health, Inc.,

	 	 	)	 	 	 
	2111 Waukegan Road, Waukegan, Illinois, and Baxter

	 	 	)	 	 	 
	Healthcare Corp., 900 Corporate Grove Drive, Buffalo

	 	 	)	 	 	 
	Grove, Illinois,

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	and

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	BAXTER HEALTHCARE CORPORATION, and

	 	 	)	 	 	 
	ROBERT L. PARKINSON, JR and PETER J.ARDUINI,

	 	 	)	 	 	 
	individuals,

	 	 	)	 	 	 
	 

	 	 	)	 	 	 
	Defendants.     

	 	 	)	 	 	 
	 

	 	 	)	 	 	 

     On October 12, 2005, plaintiff, the United States of America, by and through its attorneys,
filed a verified complaint for forfeiture against certain articles that were in the possession of
Baxter Healthcare Corporation (“Baxter”), located in Buffalo Grove, Illinois and Cardinal Health
Inc. (“Cardinal”), located in Waukegan, Illinois. The complaint alleged, among other things, that
the above-captioned articles (the “Seized Articles”) are adulterated and misbranded under the
Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. §§ 351(c), 351(h), and 352(t)(2). On
October 26, 2005, plaintiff filed an amended in rem complaint with substantially similar
allegations. Pursuant to each Warrant of Seizure and Monition issued by this court, the United
States Marshal for this district seized the articles of device at Cardinal’s and Baxter’s
facilities on October 12, 2005, and at Baxter’s facility on October 27, 2005. Baxter filed a
statement of interest for the Seized

2 

 

Articles on November 7, 2005, and its Answer on January 11, 2006, denying the allegations in
the amended complaint and asserting affirmative defenses.

     The amended complaint alleges, among other things, that certain of the Seized Articles are:
(1) adulterated within the meaning of the Act, 21 U.S.C. § 351(c), in that their quality falls
below that which they purport and are represented to possess; (2) adulterated within the meaning of
the Act, 21 U.S.C. § 351(h), in that the methods used in, and the facilities and controls used for,
their manufacture, packing, storage, and installation are not in conformity with current good
manufacturing practice (“CGMP”) and the Quality System regulation (“QS Regulation”) as promulgated
under 21 C.F.R. Part 820; and (3) misbranded within the meaning of the Act, 21 U.S.C. § 352(t)(2),
in that the firm failed or refused to furnish information required by the Act, 21 U.S.C. § 360(i).

     Defendants, Baxter, Robert L. Parkinson, Jr. (who assumed his position as Baxter’s Chief
Executive Officer on April 26, 2004), and Peter J. Arduini (who assumed his position as Corporate
Vice President and President of Baxter’s Medication Delivery Services on April 18, 2005)
(collectively, the “Defendants”), without admitting the allegations in the complaint and amended
complaint, and disclaiming any liability in connection therewith, having appeared, waived the
filing and service of a second amended complaint seeking injunctive relief, and, without contest
and before any testimony having been taken, agreed to the entry of this decree.

     IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows:

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

3

 

     2. The complaint and amended complaint state a claim for relief against the Seized Articles
under the Act, 21 U.S.C. §§ 301-397.

     3. Defendant Baxter affirms that it is the sole owner of the Seized Articles, and that no
other person has an interest in the Seized Articles. Defendant Baxter further affirms that it shall
indemnify and hold the United States harmless should any other party or parties hereafter file or
seek to file a statement of interest or right to intervene in this action, or seek to defend or
obtain any part of the Seized Articles.

SEIZURE
PROVISIONS

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

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

     6. A. Pursuant to 21 U.S.C. § 334(d)(1), within twenty (20) calendar days of the entry of this
decree, Defendant Baxter shall execute and file with the clerk of this court a good and sufficient
penal bond in the form of an irrevocable standby letter of credit (the “Penal Bond”) in the amount
of twenty million dollars ($20,000,000). The Penal Bond shall be obtained from a trust company or
commercial institution in good standing, payable to the United States, valid for at least one year
from the date said Penal Bond is approved by this court. The Penal Bond shall be in a form
acceptable to the clerk of this court and conditioned on Defendants abiding by and performing all

4

 

of the terms and conditions of this decree and of such further orders and decrees as may be entered
in this proceeding, and may be drawn upon by the presentation of a sight draft.

          B. If Defendant Baxter has not completed the process of destroying or attempting to bring the
Seized Articles into compliance with the law, as set forth in paragraph 7, prior to the expiration
of the original Penal Bond, or any subsequent Penal Bond, it shall be the responsibility of
Defendant Baxter to file with the clerk of this court a new Penal Bond, valid for at least an
additional one year, no later than sixty (60) calendar days before the expiration of the previous
Penal Bond, and to provide written notice of the posting of such new Penal Bond and a copy thereof
to both FDA and the United States Attorney assigned to this case. If, sixty (60) calendar days
before the expiration of the original Penal Bond, Defendant Baxter has not completed the process of
destroying or attempting to bring the Seized Articles into compliance with the law and has not
filed a new Penal Bond with the clerk of this court, the existing Penal Bond shall be immediately
payable to the United States of America prior to expiration of such Penal Bond.

     7. A. Within forty (40) calendar days of the entry of this decree, and after filing the Penal
Bond with this court as provided in paragraph 6 of this decree, Defendant Baxter shall give written
notice to FDA that Defendant Baxter, at its own expense, is prepared to attempt to bring the Seized
Articles into compliance with the law under FDA’s supervision. Defendant Baxter, also within forty
(40) calendar days of entry of this decree and filing of the Bond, shall submit to FDA a detailed
written plan describing its proposal to bring the Seized Articles into compliance with the Act. The
plan shall specifically identify which reconditioning measures apply to which Seized Articles.
Defendants shall not attempt to bring the Seized Articles into compliance until they have submitted
a written plan to FDA and FDA has provided them with written authorization to

5

 

commence attempting to bring the articles into compliance. FDA’s decision regarding the adequacy of
the reconditioning proposal shall be final.

          B. FDA shall notify Defendant Baxter in writing within forty-five (45) calendar days of FDA’s
receipt of Baxter’s reconditioning plan whether the reconditioning plan is acceptable in whole or
in part. If the reconditioning plan is
acceptable with regard to some of the Seized Articles and not others, FDA shall specify those
Seized Articles for which the reconditioning plan is acceptable. If FDA notifies Defendant Baxter
in writing that some or all of the reconditioning plan is unacceptable, FDA shall state the basis
for such determination. Defendant Baxter shall then submit, within twenty (20) calendar days of
receipt of FDA’s letter, either a revised reconditioning plan for those articles for which the
initial plan was unacceptable or a plan to destroy those articles as set forth below. FDA shall
respond in writing within thirty (30) calendar days of its receipt of Baxter’s revised
reconditioning plan to notify Defendants as to whether the revised plan is acceptable. If Defendant
Baxter has not submitted a revised reconditioning plan within twenty (20) calendar days of receipt
of FDA’s letter, or if FDA finds that the revised reconditioning plan is unacceptable, Defendant
Baxter shall cause that portion of the Seized Articles for which no revised reconditioning plan was
submitted or for which the revised reconditioning plan was deemed unacceptable, to be promptly
destroyed at Defendant Baxter’s expense and under the supervision of an FDA representative.
Destruction pursuant to this paragraph may take the form of a salvaging operation that permits
Defendant Baxter to dismantle specified Seized Articles for the purpose of salvaging and preserving
specified parts and components of the Seized Articles, provided that Defendant Baxter first submits
such salvaging plan to FDA in writing and receives FDA’s written authorization to implement the
salvaging plan. If FDA finds that Defendant Baxter’s revised

6

 

reconditioning plan and/or salvaging plan is unacceptable, in whole or in part, Defendants may
challenge that decision under the terms set forth in paragraph 26. Defendants may execute any
portion of the initial or revised reconditioning or salvaging plan that was found acceptable by FDA
in accordance with the applicable provisions in this decree.

          C. Defendants shall not dispose of the Seized Articles or any part of them in a manner
contrary to the provisions of the Act, or any other federal law, or of the laws of any state or
territory (as defined in the Act) in which they are disposed. All Seized Articles that are not
successfully reconditioned as provided in this decree shall be destroyed at Defendant Baxter’s
expense under the supervision of an FDA representative, and Defendant Baxter shall pay to the
United States all costs incurred in supervising the destruction of such articles, at rates
specified in paragraph 20 of this decree. If requested by FDA, Defendants shall furnish duplicate
copies of invoices of sale of any released devices, or other evidence of disposition as FDA may
request.

          D. Following Defendants’ receipt of written authorization to commence attempting to bring the
products into compliance with the Act and following the payment of costs pursuant to paragraph 5
and the posting of the Penal Bond by Defendant Baxter as required by paragraph 6 of this decree,
the United States Marshal for this district shall, upon receiving written notice from FDA, release
those articles that are specified in FDA’s notice to Defendants from his custody to the custody of
Defendants for the sole purpose of attempting to bring the articles into compliance with the law,
pursuant to the reconditioning proposal(s) approved by FDA as set forth in paragraph 7.

          E. Defendants shall at all times, until the Seized Articles have been brought into
compliance with the law as determined by FDA or destroyed under FDA supervision,
retain the

7

 

Seized Articles intact for examination or inspection by FDA in a place made known to and approved
by FDA, and shall retain the records or other proof necessary to establish the identity of the
Seized Articles.

          F. Within ninety (90) calendar days of receiving approval and/or rejection of the
reconditioning plan and/or salvaging plan pursuant to paragraph 7, Defendants shall either destroy
the Seized Articles at Defendant Baxter’s sole expense under the supervision of the FDA
representative or complete its attempt to bring the Seized Articles into compliance with the law in
the manner set forth in the reconditioning plan and/or salvaging plan found acceptable to FDA.
Defendant Baxter shall reimburse the United States for the costs of supervising the reconditioning
and/or destruction of the Seized Articles within twenty (20) calendar days of receiving an invoice
for such costs at the rates listed in paragraph 20. Defendant Baxter shall also bear all costs of
destruction and be responsible for ensuring that such destruction is carried out in a manner that
complies with the provisions of the Act, other federal law, and the laws of any state or territory
(as defined in the Act) in which they are disposed of. Within twenty-five (25) calendar days of
receiving Defendants’ written notice to FDA of its completion of its attempt to bring the Seized
Articles into compliance with the Act and/or destruction of the articles, FDA shall provide
Defendant Baxter with an invoice for the costs of supervising such attempt and/or destruction.
Defendant Baxter shall pay those costs within twenty (20) calendar days of receiving FDA’s invoice.
Upon receipt of such payment from Defendant Baxter, FDA will notify the United States Attorney for
this district that Defendants have brought the articles into compliance with the law and/or
destroyed the articles, and that Defendant Baxter has paid the costs set forth in FDA’s invoice.

8

 

          G. The United States Attorney for this district, upon being advised by FDA that the Seized
Articles have been destroyed or brought into compliance with the Act and its implementing
regulations, and that the foregoing conditions of this decree have been performed, shall transmit
such information to the clerk of this court, whereupon the Penal Bond given in this proceeding by
Defendant Baxter shall be canceled and discharged.

     8. If Defendants fail to abide by and perform all of the terms and conditions of this decree,
or of the Penal Bond, or of such further order or decree as may be entered in this proceeding
relating to the Seized Articles, then the Penal Bond posted as provided in paragraph 6 of this
decree shall, on motion of the United States in this proceeding, be forfeited in its entirety and
judgment entered in favor of plaintiff. In addition, if Defendants breach any term or condition of
this decree or such further order or decree as may be entered in this proceeding, then Defendant
Baxter shall, at its own expense, immediately return the Seized Articles to the United States
Marshal for this district or otherwise dispose of them pursuant to an order of this court.
Following return of the
articles to the United States, the Marshal shall destroy the Seized Articles and make due
return to this court. In the event that destruction of the Seized Articles by the Marshal becomes
necessary pursuant to this paragraph, Defendant Baxter shall be responsible for all costs of
storage and disposition that are incurred by the United States.

     9. Defendants shall at no time, and under no circumstances whatsoever, ship, sell, offer for
sale, or otherwise dispose of the Seized Articles, or any part thereof, until: (a) FDA has had free
access to the articles in order to take any samples or make any tests or examinations that FDA
deems necessary; (b) FDA has notified Defendants in writing that any reconditioning to be conducted
in accordance with the reconditioning proposal in paragraph 7 is complete and that the
reconditioned

9

 

products comply with the Act, its implementing regulations, and this decree; and (c) that FDA has
notified the United States Attorney for this district that Defendants have completed their attempt
to bring the articles into compliance with the law in accordance with paragraph 7(F).

INJUNCTION
PROVISIONS

     10. Upon entry of this decree, Defendants, and each and all of Baxter’s officers, directors,
agents, representatives, employees, successors, assigns, attorneys, and any and all persons in
active concert or participation with any of them (including franchisees, affiliates, and “doing
business as” entities), who have received actual notice of the contents of this decree by personal
service or otherwise, are permanently enjoined, pursuant to 21 U.S.C. § 332(a), subject to the
conditions set forth in paragraph 11, from manufacturing, processing, packing, repacking, labeling,
distributing, or importing into the United States of America any model or components for its
Colleague Volumetric Infusion Pumps (including, but not limited to, models 2M8151, 2M8151R, 2M8161,
2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R) (“Colleague Infusion Pumps”) and Syndeo Infusion
Pumps (including model 2L3113) (“Syndeo Infusion Pumps”) (collectively, the “Infusion Pumps”),
unless and until:

          A. Defendants’ methods, facilities, and controls used to manufacture, process, pack, repack,
label, hold, and distribute the Infusion Pumps are established, operated, and administered in
compliance with 21 U.S.C. § 351(h) and 21 C.F.R. Part 820;

          B. Defendants select and retain, at Defendants’ expense, an independent person or persons (the
“Expert”), who is qualified by education, training, and experience to conduct inspections at
Baxter’s facilities that manufacture, process, pack, repack, label, hold, or distribute the
Infusion Pumps, or any component thereof (hereafter, the “Infusion Pump Facilities”), and to

10

 

review procedures and methods for manufacturing, processing, packing, repacking, labeling, holding,
and distributing the Infusion Pumps, to determine whether their methods, facilities, and controls
are operated and administered in conformity with 21 U.S.C. § 351(h), 21 C.F.R. Part 820, 21 U.S.C.
§ 352(t)(2), and this decree. The Expert
shall be without personal or financial ties (other than a consulting agreement between the parties)
to any officer or employee of Baxter or their immediate families. Defendants shall notify FDA in
writing of the identity of the Expert within fifteen (15) calendar days of retaining such Expert;

          C. The Expert shall perform a comprehensive inspection of Baxter’s Infusion Pump Facilities and
their manner of operation and certify in writing to FDA: (1) that he or she has inspected Baxter’s
Infusion Pump Facilities, processes, and controls; and (2) whether Defendants’ operations are, in
the Expert’s opinion, in conformity with 21 U.S.C. § 351(h), 21 C.F.R. Part 820, 21 U.S.C. §
352(t)(2), and this decree. The Expert’s certification report shall include, but not be limited to,
the following:

               i. Steps taken by Defendants to comply with 21 U.S.C. §§ 351(h) and 352(t)(2);

               ii. Steps taken by Defendants to identify the root causes, or if not precisely known, the
most probable root causes, for the failures with the Infusion Pumps, and an evaluation
whether Defendants have implemented appropriate steps to correct and prevent such
failures;

               iii. Defendants’ procedures for properly and timely reporting adverse events under 21
C.F.R. Part 803;

11

 

               iv. Steps taken by management with executive responsibility to ensure continuous
implementation of an adequate and effective quality system, including specific written procedures
governing management review and quality audits;

               v. A detailed evaluation of Baxter’s current state of compliance with respect to the CGMP and
QS Regulation deviations brought to Baxter’s attention in writing by FDA and/or FDA investigators
since September 16, 1999;

               vi. Personnel training to perform product failure, and corrective and preventive action
assessment activities; and

               vii. Procedures for the Corrective and Preventive Action (“CAPA”) system, including, but not
limited to: implementing and verifying or validating corrective actions in accordance with 21
C.F.R. §§ 820.75 and 820.1(a)(3); establishing appropriate time frames; conducting and documenting
adequate failure investigations; implementing an effective complaint handling system; and properly
integrating international databases. The Expert may choose to conduct separate inspections for the
methods, processes, and controls for the Colleague and Syndeo Infusion Pumps, and provide separate
certification reports for each device.

          D. Defendants report to FDA in writing the actions they have taken to ensure that the methods
used in, and the facilities and controls used to manufacture, process, pack, repack, label, hold,
and distribute the Infusion Pumps are operated and administered and will be continuously operated
and administered in conformity with 21 U.S.C. § 351(h), 21 C.F.R. Part 820, 21 U.S.C. § 352(t)(2),
and this decree. This report shall include an evaluation of Baxter’s current state of compliance
with respect to the CGMP and QS Regulation deviations brought to Baxter’s attention in writing by
FDA and/or FDA investigators since September 16, 1999. Defendants may choose

12

 

to provide separate reports to FDA for the Colleague and Syndeo Infusion Pumps for purposes of
complying with this paragraph.

          E. Within thirty (30) calendar days of receipt of Defendants’ report(s) under paragraph 10(D),
FDA may, in its discretion and without prior notice, commence an inspection of Baxter’s Infusion
Pump Facilities to determine whether the requirements of this decree have been met, and whether
Baxter’s Infusion Pump Facilities are otherwise operated in conformity with 21 U.S.C. § 351(h), 21
C.F.R. Part 820, and 21 U.S.C. § 352(t)(2); and

          F. FDA notifies Defendants in writing that Defendants appear to be in compliance with the
requirements set forth in paragraphs 10(A)-(E).

          G. If Defendants have satisfied the criteria under paragraphs 10(A)-(F) for the resumption of
operations with respect to one infusion pump (e.g., Colleague), but not the other (e.g., Syndeo),
FDA shall issue the notice under subparagraph (F) to Defendants with respect to the infusion pump
satisfying the criteria set forth in this paragraph notwithstanding the fact that the other
infusion pump may not have satisfied such criteria.

     11. Paragraph 10 of this Decree shall not apply to the following:

          A. Any Infusion Pumps and components thereof manufactured, processed, packaged, labeled, or
held for sale at Defendants’ Infusion Pump facilities located in Singapore (“Singapore Infusion
Pump Facilities”) are excluded from paragraph 10, insofar and so long as the Singapore Infusion
Pump Facilities manufacture and distribute Infusion Pumps and components thereof only to countries
other than the United States or that are intended for export from the United States as set forth in
paragraph 11(B). However, Defendants’ Singapore Infusion Pump Facilities

13

 

are enjoined under paragraph 10 from, either directly or indirectly, causing the introduction into
interstate commerce of the Infusion Pumps, and/or components thereof.

          B. Any Infusion Pumps or components thereof manufactured, processed, packaged, labeled, held
for sale, or introduced into interstate commerce solely for export from the United States, provided
that the applicable requirements of 21 U.S.C. § 381(e) have been satisfied with respect to any such
device or component;

          C. Any Infusion Pumps, or components, parts, or accessories thereto, whose manufacture or
processing is not intended for human use and is undertaken for the sole purpose of developing,
testing, verifying, or validating design changes or modifications in accordance with 21 C.F.R. §§
820.75, 820.1(a)(3), and 820.30(f)-(g), and revised production and process controls, revised
manufacturing procedures, or the adequacy of corrective and preventive actions;

          D. Any Infusion Pump, component, part, or accessory that is manufactured, processed, packaged,
held for sale, or distributed solely for the purpose of responding to a written request or written
order to provide either routine service maintenance, or to replace components, parts, or
accessories for the Infusion Pumps that were already in the possession of customers of Baxter prior
to October 12, 2005 or otherwise placed in distribution pursuant to paragraphs 11(E) or 11(F);
provided, however, that: (a) Baxter shall send a copy of the notification letter attached hereto as
Exhibit A to customers upon providing such routine service maintenance or replacing components,
parts, or accessories as set forth herein; (b) any Infusion Pump furnished by Defendants to a
customer under this subparagraph shall be the identical device (same model and serial number) that
Defendants received from the customer and (c) that Baxter shall maintain a record, and shall allow
FDA access to such record upon request, of all such requests or orders and “ship to” records,

14

 

which records must include the following: (1) a detailed description of the requested service
maintenance; (2) the date of any such request or order; (3) the dates of service; (4) the names,
addresses, and telephone numbers of the persons/entities making any such request or order; and (5)
a description of Infusion Pump (model and serial number) the components, parts, or accessories used
to provide service maintenance. Provided further, however, Baxter shall not be required to provide
the notification letter (Exhibit A) to an entity or person with respect to any serviced or repaired
pump that has been previously upgraded or modified pursuant to the corrective action plan approved
pursuant to paragraph 14 below;

          E. Any Infusion Pumps or components thereof manufactured, imported, or distributed pursuant to, and
in conformity with a written authorization for medically necessary products as provided by FDA to
Baxter pursuant to this subparagraph. Baxter may submit a detailed written request to FDA seeking
authorization to distribute Infusion Pumps it believes are medically necessary products. A product
is considered to be medically necessary if it is used to treat or prevent a serious disease or
medical condition and there is no other available source of that product or alternative product
that is judged by FDA to be an adequate substitute. Baxter’s written request to FDA shall be signed
by senior Baxter officers, including at least one corporate medical officer, and include, at least,
the following information in its request: (a) the name of pump(s) and model number(s); (b) data
identifying Baxter’s market share and the market share for all alternative products used for the
potentially medically necessary use; (c) the number of pumps in distribution and available in the
market chain; (d) the name and contact information of appropriate medical personnel reporting
device shortages in their
facility; (e) supporting facts and documentation for Baxter’s claim that there is a bona fide
shortage, the cause and duration of the reported shortage, and that the

15

 

shortage product is medically necessary; (f) data identifying all other available sources of
alternative products that can be substituted for the Baxter device; (g) the medical risks posed by
the device shortage; and (h) whether the Baxter device has been cleared for marketing by FDA, and
for all such products that have manifested failures and/or defects, the supporting data documenting
Baxter’s corrective action(s) to remedy such failures and/or defects.

          F. Any Infusion Pumps or components thereof manufactured, imported, or distributed solely for
the purpose of complying with the requirements of paragraph 14 (the corrective action plan
provision as set forth in paragraph 14), provided that such Infusion Pumps comply with the
requirements set forth in Baxter’s corrective action plan after its approval by FDA under
paragraph 14.

          G. Any component for the Colleague and Syndeo Infusion Pumps whose manufacture, processing,
packaging, sale, or distribution has been requested by Baxter in writing to FDA pursuant to this
subparagraph and authorized by FDA in writing.

     12. Upon entry of this decree, Defendants and each and all of their officers, directors,
agents, representatives, employees, successors, assigns, attorneys, and any and all persons in
active concert or participation with any of them (including franchisees, subsidiaries, affiliates,
and “doing business as” entities), who have received actual notice of this decree by personal
service or otherwise, for so long as such persons are in positions of responsibility with Defendant
Baxter or any of Defendant Baxter’s franchisees, subsidiaries, affiliates, and/or “doing business
as” entities, are permanently enjoined under the provisions of 21 U.S.C. § 332(a) from directly or
indirectly: (a) causing the introduction or delivery for introduction into interstate commerce, of
any infusion pump device that is adulterated within the meaning of 21 U.S.C. §§ 351(c) and 351(h),
or misbranded

16

 

within the meaning of 21 U.S.C. § 352(t)(2); and (b) causing infusion pump devices that Defendants
hold for sale after shipment of one or more of their components in interstate commerce to become
adulterated within the meaning of 21 U.S.C. §§ 351(c) and 351(h), or misbranded within the meaning
of 21 U.S.C. § 352(t)(2).

     13. After Defendants receive written communication from FDA pursuant to paragraph 10(F),
Defendants shall retain an independent person or persons (the “Auditor”) to conduct audit
inspections of the operations at Baxter’s Infusion Pump Facilities located in the United States not
less than once every six (6) months for a period of one (1) year and not less than once every
twelve (12) months for a period of three (3) years thereafter, for a total of four (4) years. The
Auditor shall be qualified by education, training, and experience to conduct such inspections, and
shall be without personal or financial ties (other than a consulting agreement entered into by the
parties) to any of
Baxter’s officers or employees or their immediate families and may, if Baxter chooses, be the
same person or persons described as the Expert in paragraph 10(B).

          A. At the conclusion of each audit inspection, the Auditor shall prepare a written audit
report (the “Audit Report”) expressing in detail an opinion whether Defendants are in, or are not
in, compliance with 21 U.S.C. § 351(h), 21 C.F.R. Part 820, 21 U.S.C. § 352(t)(2), and this decree,
and identifying in detail any deviations from 21 U.S.C. § 351(h), 21 C.F.R. Part 820, 21 U.S.C. §
352(t)(2), and this decree (“Audit Report Observations”). As part of every Audit Report, except the
first Audit Report, the Auditor shall assess the adequacy of corrective actions taken by Defendants
to correct all previous Audit Report Observations, and report in writing the actions to correct
each item enumerated in the prior Audit Report(s), and which items have not been corrected, if any.
The Audit Reports shall be delivered contemporaneously to Defendants and FDA by courier

17

 

service or overnight delivery service, no later than twenty-five (25) calendar days after the date
the audit inspections are completed. If any Audit Reports identify deviations from 21 U.S.C. §
351(h), 21 C.F.R. Part 820, 21 U.S.C. § 352(t)(2), and/or this decree, FDA may, in its discretion,
require that the auditing cycle be extended for a length of time not to exceed four (4) years. In
addition, Defendants shall maintain the complete Audit Reports and all of their underlying data in
separate files at their facilities and shall promptly make the Audit Reports and underlying data
available to FDA upon request.

          B. If an Audit Report contains any adverse Audit Report Observations, Defendants shall, within
thirty-five (35) calendar days of receipt of the Audit Report, correct those observations, unless
FDA notifies Defendants that a shorter time period is necessary. If, after receiving the Audit
Report, Defendants believe that correction of an adverse Audit Report Observation will take longer
than thirty-five (35) calendar days, Defendants shall, within fifteen (15) calendar days of receipt
of the Audit Report, propose a schedule for completing corrections (“Correction Schedule”) and
provide justification describing why the additional time is necessary. That Correction Schedule
must be reviewed and approved by FDA in writing prior to implementation. Defendants shall complete
all corrections according to the approved Correction Schedule. Within thirty-five (35) calendar
days of Defendants’ receipt of an Audit Report, or within the time period provided in a Correction
Schedule approved by FDA, the Auditor shall review the actions taken by Defendants to correct the
adverse Audit Report Observations. Within ten (10) calendar days of the beginning of that review,
the Auditor shall report in writing to FDA whether each of the adverse observations has been
corrected and, if not, which Audit Report Observations remain uncorrected.

18

 

          C. The audit inspections and Audit Reports required by this paragraph shall encompass, but not
be limited to, the following:

               i. Steps taken by Defendants to identify the root causes, or if not precisely known, the most
probable root causes, for the failures with the Infusion Pumps, and an evaluation whether
Defendants have implemented appropriate steps to correct and
prevent such failures.

               ii. Defendants’ procedures for properly and timely reporting adverse events under 21 C.F.R.
Part 803;

               iii. Steps taken by management with executive responsibility to ensure continuous
implementation of an adequate and effective quality system, including specific written procedures
governing management review and quality audits;

               iv. Personnel training to perform product failure and corrective and preventive action
assessment activities; and

               v. Procedures for the CAPA system, including, but not limited to: implementing and verifying
or validating corrective actions in accordance with 21 C.F.R. §§ 820.75, 820.1(a)(3), and
820.30(f)-(g); establishing appropriate time frames; conducting and documenting adequate failure
investigations; and implementing an effective complaint handling system.

     14. Within twenty (20) calendar days after entry of this decree, Defendants shall submit to
FDA in writing a detailed Corrective Action Plan to bring the Infusion Pumps currently in use in
the United States by physicians, hospitals, pharmacies, and other users/facilities into compliance
with the Act, its implementing regulations, and this decree. The written Corrective Action Plan
shall include, among other things: (a) a description and the supporting documentation for each
upgrade,

19

 

modification, and/or action to be taken for the Infusion Pumps previously distributed; (b) the
testing conducted to verify and validate the upgrades and/or modifications in accordance with 21
C.F.R. §§ 820.75, 820.1(a)(3), and 820.30(f)-(g); (c) the projected date on which Defendants will
implement and complete the Corrective Action Plan; (d) the manner in which the upgrades and
modifications will be made to the Infusion Pumps; (e) whether Infusion Pumps will be recalled to
implement corrective actions; (f) identification of the root causes, or if not precisely known, the
most probable root causes, of the failures with the Infusion Pumps; and (g) a clear statement
whether Defendants’ believe the proposed upgrades and modifications to the Infusion Pumps proposed
in the Corrective Action Plan require premarket clearance from FDA, the reasons for that belief,
and whether premarket clearance has been sought and obtained by Defendants. Defendants shall not
initiate the Corrective Action Plan until FDA has first provided Defendants with written
authorization to do so.

     FDA shall respond in writing within forty-five (45) calendar days of FDA’s receipt of Baxter’s
Corrective Action Plan and notify Baxter in writing whether the proposed plan is acceptable. If FDA
finds the plan unacceptable, it shall state the basis for finding the proposed plan unacceptable in
writing, and Defendants shall submit a revised Corrective Action Plan in writing within twenty (20)
calendar days of receipt of FDA’s response. FDA’s decision regarding the adequacy of Defendants’
Corrective Action Plan shall be final.

     Defendants shall commence the implementation of the Corrective Action Plan within thirty (30)
calendar days of receiving FDA’s written authorization. Defendants shall, beginning one month after
the date on which implementation of the Corrective Action Plan has begun, and continuing until its
completion, submit to FDA monthly written progress reports updating the status of the Corrective
Action Plan. Defendants shall use their best efforts to locate all Infusion Pumps in use

20

 

by health care professionals in the United States and to obtain the cooperation of such users to
implement the corrective actions required by this paragraph. If Defendants have not obtained FDA
authorization for the Corrective Action Plan within twelve (12) months after the date this decree
is entered, then FDA may take any action(s) it deems appropriate under paragraph 15 of this decree.

     15. If, at any time after this decree has been entered, FDA determines, based on the results
of an inspection, sample analysis, a report or data prepared or submitted by Defendants, the
Expert, or the Auditor pursuant to this decree, or any other information, that Defendants have
failed to comply with any provision of this decree, or have violated the Act or its regulations, or
that additional corrective actions are necessary to achieve compliance with this decree or the Act,
FDA may, as and when it deems necessary, order Defendants in writing to take appropriate actions
with respect to the Infusion Pumps or components thereof located in or to be distributed into the
United States, including but not limited to, the following:

          A. With respect to Infusion Pump Facilities located in the United States, cease the
manufacture, processing, packing, repacking, labeling, holding, and interstate distribution of any
or all the Infusion Pumps or components thereof;

          B. Cease importing, directly or indirectly, any or all of the Infusion Pumps or components
thereof;

          C. Revise, modify, or expand any report(s) or plan(s) prepared pursuant to the decree;

          D. Submit additional reports or information to FDA;

21

 

          E. Recall, at Defendants’ sole expense, specified adulterated or misbranded Infusion Pumps
manufactured, distributed, or sold by Defendants or that are under the custody and control of
Defendants’ agents, distributors, customers, or consumers;

          F. Issue a safety alert; and/or

          G. Take any other corrective action(s) as FDA, in its discretion, deems necessary
to protect the public health or to bring Defendants into compliance with the Act,
its implementing regulations, and this decree.

     16. A. Any order issued by FDA pursuant to paragraph 15 shall be issued by the appropriate FDA
District Director, and shall specify the failures giving rise to the order. Unless a different time
frame is specified by FDA in its order, within fifteen (15) calendar days after receiving an order
pursuant to paragraph 15, 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 proposed 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.

          B. If Defendants notify FDA that they do not agree with FDA’s order, within fifteen (15)
calendar days after receiving Defendants’ response, FDA will review Defendants’ notification and
thereafter, in writing, affirm, modify, or withdraw its order, as the Agency deems appropriate. If
FDA affirms or modifies its order, it shall explain the basis for its decisions in writing. The
written notice of affirmance shall constitute final agency action.

22

 

          C. 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 reverses or modifies FDA’s order. Any review of FDA’s decision under
this paragraph shall be made in accordance with the terms set forth in paragraph 26.

     17. Any cessation of operations or other action described in paragraphs 15-16 shall continue
until Defendants receive written notification from FDA that Defendants appear to be in compliance
with this decree, the Act, and its implementing regulations. The costs of FDA inspections,
sampling, testing, travel time, and subsistence expenses to implement the remedies set forth in
this paragraph and paragraphs 15-16 shall be borne by Defendant Baxter at the rates specified in
paragraph 20.

     18. Defendants represent that they do not currently manufacture or distribute any other
infusion pumps that have any of the following components and device specifications in common with
the Colleague and Syndeo Infusion Pumps: software systems, computer motherboards, processors,
sensors, timing circuitry, power systems, and pumping mechanisms. If Defendant Baxter intends to
manufacture or distribute an infusion pump(s) with any of the above-listed components in common
with the Colleague and Syndeo Infusion Pumps, it shall notify FDA ninety (90) days prior to
distribution of the device and describe in detail the use of the same components.

     19. Representatives of FDA shall be permitted, without prior notice and as and when FDA deems
necessary, to make inspections of Baxter’s Infusion Pump Facilities, and take any other measures
necessary to monitor and to ensure continuing compliance
with the terms of this decree. During such inspections, FDA representatives shall be
permitted: access to buildings, equipment,

23

 

in-process and finished materials, containers, and labeling therein; to take photographs and make
video recordings; to take samples of Defendants’ materials and products, containers, and labeling;
and to examine and copy all records relating to the receipt, manufacture, processing, packing,
labeling, holding, and distribution of any and all devices. FDA will provide Defendants with a
receipt for any samples taken pursuant to 21 U.S.C. § 374 and upon Defendants request and at
Defendants’ own expense, with copies of any photographs or video recordings made. The inspections
shall be permitted upon presenting a copy of this decree and appropriate credentials. The
inspection authority granted by this decree is separate from, and in addition to, the authority to
make inspections under the Act, 21 U.S.C. § 374.

     20. Defendant Baxter shall reimburse FDA for the costs of all FDA inspections, investigations,
supervision, reviews, examinations, and analyses that FDA deems necessary to evaluate Defendants’
compliance with this decree. The costs of such inspections shall be borne by Defendant Baxter at
the prevailing rates in effect at the time the costs are incurred. As of the date that this decree
is signed by the parties, these rates are: $76.10 per hour and fraction thereof per representative
for inspection work; $91.18 per hour or fraction thereof per representative for analytical or
review work; $0.445 per mile for travel expenses by automobile; government rate or the equivalent
for travel by air or other means; 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 Baxter at the
address specified in paragraph 23. 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.

24

 

     21. Within ten (10) calendar days after the entry of this decree, Defendants shall provide a
copy of this decree, by personal service or certified mail (restricted delivery, return receipt
requested), to each and all of its directors, officers, agents, representatives, successors,
assigns, attorneys, and any and all persons in active concert or participation with any of them
(including individuals, directors, corporations, subsidiaries, franchisees, affiliates,
partnerships, and “doing business as” entities) with responsibilities for the manufacture and
quality of the Infusion Pumps (hereafter, collectively referred to as “Associated Persons”). In the
event that Defendant Baxter becomes associated, at any time after the entry of this decree, with
new Associated Persons, Defendants shall (a) within fifteen (15) calendar days of such association,
provide a copy of this decree to such person(s) by personal service or certified mail (restricted
delivery, return receipt requested) and (b) on a quarterly basis, notify FDA in writing when, how,
and to whom the decree was provided. Within twenty (20) calendar days after entry of this decree,
Defendants shall provide a copy of this decree to all of Defendants’ employees involved in the
manufacture, processing, packing, storage, or distribution of the Infusion Pumps, by posting a copy
of this decree on Baxter’s intranet Web site in such a manner to ensure that it will be viewed by
such employees, and shall
prominently post a copy of this decree in the employee common areas at all facilities where
such employees are located. Baxter shall ensure that the decree remains posted on Baxter’s intranet
and in the employee common areas for no less than twelve (12) months. Within thirty-five (35)
calendar days of the date of entry of this decree, Defendant Baxter shall provide to FDA an
affidavit of compliance, stating the fact and manner of compliance with the provisions of this
paragraph and identifying the names and positions of all persons who initially received a copy of
this decree and the manner of notification.

25

 

     22. Defendants shall notify the District Director, FDA Chicago District Office, in writing at
least fifteen (15) calendar days before any change in ownership, character, or name of its
business, such as dissolution, assignment, or sale resulting in the emergence of a successor
corporation, the creation or dissolution of subsidiaries, franchisees, affiliates, or “doing
business as” entities, or any other change in the corporate structure of the companies or in the
sale or assignment of any business assets, such as buildings, equipment, or inventory, that may
affect compliance with this decree. Defendants shall provide a copy of this decree to any potential
successor or assignee at least fifteen (15) calendar days before any sale or assignment. Defendants
shall furnish FDA with an affidavit of compliance with this paragraph no later than ten (10)
calendar days prior to such assignment or change in ownership.

     23. All notifications, correspondence, and communications required to be sent to FDA by the
terms of this decree shall be addressed to the District Director, FDA Chicago District Office, 550
West Jackson Boulevard, Chicago, Illinois 60661. All notifications, correspondence, and
communications required to be sent to Defendants by the terms of this decree shall be addressed to
the Director of the Consent Decree Compliance Task Force at One Baxter Parkway, Deerfield, IL
60015.

     24. If Defendants fail to comply with any of the provisions of this decree, including any time
frame imposed by this decree, then, on motion of the United States in this proceeding, Defendant
Baxter shall pay to the United States of America fifteen thousand dollars ($15,000) in liquidated
damages for each day such violation continues and an additional sum of fifteen thousand dollars
($15,000) in liquidated damages for each violation of the Act, its implementing regulations,

26

 

and/or this decree. The amount of liquidated damages in this paragraph shall not exceed ten million
dollars ($10,000,000) in any one calendar year.

     25. Should the United States bring, and prevail in, a contempt action to enforce the terms of
this decree, Defendants shall, in addition to other remedies, reimburse the United States for its
attorneys’ fees, investigational expenses, expert witness fees, travel expenses incurred by
attorneys and witnesses, and administrative court costs relating to such contempt proceedings.

     26. All decisions conferred upon FDA in this decree shall be vested in the sole discretion of
FDA, which discretion shall be reviewed, if contested, under the arbitrary and capricious standard
set forth in 5 U.S.C. § 706(2)(A) and shall be based exclusively upon the written record that was
before FDA at the time of the decision. No discovery may be had by either party.

     27. 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 Baxter’s Infusion Pump Facilities a
state of continuous compliance with applicable laws and regulations, and this decree for the sixty
(60) months preceding the petition and following entry of this decree, Plaintiff will not oppose
such petition.

     28. This court retains jurisdiction of this action for the purpose of enforcing or
modifying this decree and for the purpose of granting such additional relief as may be
necessary or appropriate.

	 	 	 	 	 	 	 	 	 
	 

	 	 	 	E N T E R:	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 

UNITED STATES DISTRICT JUDGE
	 	 
	 
	 	 	 	 	 	 	 	 
	Date:
	 	 	 	 	 	 	 	 
	 

	 	 

	 	 	 	 	 	 

27

 

     We hereby consent to the entry of the foregoing:

	 	 	 	 	 
	 

	 	Respectfully submitted,
	 	 
	 
	 	 	 	 
	 

	 	By Defendants:	 	 
	 
	 	 	 	 
	 

	 	 	 	 
	 

	 	ROBERT L. PARKINSON, JR.	 	 
	 

	 	individually and on behalf of	 	 
	 

	 	Baxter Healthcare Corporation as its	 	 
	 

	 	Chairman and Chief Executive Officer	 	 
	 
	 	 	 	 
	 

	 	 	 	 
	 

	 	PETER J. ARDUINI	 	 
	 

	 	individually and on behalf of Baxter Healthcare	 	 
	 

	 	Corporation as its Corporate Vice President and	 	 
	 

	 	President of Medication Delivery Services	 	 
	 
	 	 	 	 
	 

	 	 	 	 
	 

	 	MARK S. BROWN	 	 
	 

	 	KING & SPALDING LLP	 	 
	 

	 	1700 Pennsylvania, Avenue, N.W.	 	 
	 

	 	Washington, D.C. 20006	 	 
	 

	 	(202) 626-5443	 	 
	 

	 	Counsel for Baxter Healthcare Corporation	 	 
	 
	 	 	 	 
	 

	 	 	 	 
	 

	 	STEVEN M. KOWAL	 	 
	 

	 	BELL, BOYD & LLOYD, LLC	 	 
	 

	 	70 W. Madison Street, Suite 3100	 	 
	 

	 	Chicago, Illinois 60602	 	 
	 

	 	(312) 807-4430	 	 
	 

	 	Counsel for Baxter Healthcare Corporation	 	 
	 
	 	 	 	 
	 

	 	 	 	 
	 

	 	RICHARD M. COOPER	 	 
	 

	 	WILLIAMS & CONNOLLY LLP	 	 
	 

	 	725 Twelfth Street, NW	 	 
	 

	 	Washington, D.C. 20005	 	 
	 

	 	(202) 434-5466	 	 
	 

	 	Counsel for Robert L. Parkinson, Jr.,	 	 
	 

	 	and Peter J. Arduini	 	 

28

 

	 	 	 	 	 	 	 
	 	 	By The United States of America:  
	 
	 	 	 	 	 	 
	 	 	PATRICK J. FITZGERALD

United States Attorney
	 
	 	 	 	 	 	 
	 

	 	By:	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	DONALD R. LORENZEN	 	 
	 

	 	 	 	Assistant United States Attorney	 	 
	 

	 	 	 	219 South Dearborn Street	 	 
	 

	 	 	 	Chicago, Illinois 60604	 	 
	 

	 	 	 	(312) 353-5330	 	 

OF COUNSEL:

PAULA M. STANNARD

Acting General Counsel

SHELDON T. BRADSHAW

Chief Counsel

Food and Drug Division

ERIC M. BLUMBERG

Deputy Chief Counsel, Litigation

MARC L. CADEN

Associate Chief Counsel for Enforcement

U.S. Department of Health and Human Services

Office of the General Counsel

5600 Fishers Lane

Rockville, Maryland 20857

(301) 827-7141

29

 

EXHIBIT A

<BAXTER LETTERHEAD>

<DATE>

Subject: Colleague Volumetric Infusion Pump and Syndeo Infusion Pump

Dear Customer:

On ___2006, Baxter signed a Consent Decree for Condemnation and Permanent Injunction enjoining
the manufacture and distribution of Colleague Volumetric Infusion Pumps and Syndeo Infusion
Pumps. Under paragraph 11(D) of the consent decree, Baxter is authorized to: (a) continue
providing routine service maintenance, or (b) to replace components, parts, or accessories for
the Colleague and Syndeo infusion pumps that were already in the possession of customers of
Baxter prior to October 12, 2005. These pumps have been the subject of various recalls and
notices available at www.baxter.com, including Baxter’s July 20, 2005, Urgent Product Recall of
Colleague Volumetric Infusion Pumps (attached) asking you to remove from service any Colleague
infusion pump exhibiting the failure codes listed in that communication. Baxter also issued an
Important Product Information Letter dated July 6, 2005 (attached), for the Syndeo infusion pump
asking you to remove from service Syndeo pumps exhibiting certain failure codes or failing to
power on properly.

Baxter continues to pursue a permanent fix for these issues and will notify you once an
implementation schedule has been finalized in accordance with the terms set forth in the consent
decree. As part of servicing your pump, Baxter has reviewed the event history for all of the
failure codes in the July 20, 2005 letter, and replaced the PC Board on all pumps that have
demonstrated one of the failure codes. Baxter has also implemented a more rigorous inspection and
testing process for the pumps that have had a new PC Board installed.

While the Colleague and Syndeo Infusion Pumps serviced by Baxter have been inspected to reduce the
likelihood of future failures, this inspection will not completely eliminate the possibility of
future occurrences. It is recommended that users be vigilant in monitoring pump usage to ensure
that these failure codes do not occur on these or other pumps within your possession. If a pump is
found to have any of the stated failure codes, it should be taken out of service and returned to
Baxter for repair.

As stated in the July 6 and July 20, 2005 notices, the Colleague and Syndeo infusion pumps will
alarm, stop infusing, and display a failure code if they detect an abnormal situation. Because
this situation can occur during an infusion, it is imperative that institutions have a contingency
plan to mitigate any disruptions during infusion therapy (as discussed more fully in the
attachments). Additionally, you should consider not using these pumps in situations where a
replacement pump is not available or where a delay in therapy might adversely affect patient
health.

 

 

We apologize for any inconvenience caused to your institution.

<Insert Baxter contact information; telephone number>

	 	 	 	 	 
	 

	 	Sincerely,	 	 
	 
	 	 	 	 
	 

	 	 

<SIGNATURE BLOCK>

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00106-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00106-of-00352.parquet"}]]