Document:

exv10w9

 

Exhibit 10.9

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

	Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.

	SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMSOFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24 & 301.
REQUISITION NUMBERExhibit 10.9

	| | | | | | | | | | | | | | | | | | |
PAGE 1 OF
10
—
3. AWARD / EFFECTIVE 6 . SOLICITATION
2. CONTRACT NO. DATE 5. SOLICITATION NUMBER            ISSUE DATE
200-2005-11811 See Block 31c 4. ORDER NUMBER 2005-B-01697 01/05/2005
——  ——  ——  —
8. OFFER DUE DATE/
a . NAME            b. TELEPHONE NUMBER (no collect calls) LOCAL TIME
7. FOR SOLICITATION INFORMATION CALL: Linda Williams (770) 488-2692 02/01/2005
——  ——  ——  —
10. THIS ACQUISITION IS
UNRESTRICTED 12. DISCOUNT TERMS
9. ISSUED BY            SET ASIDE: % FOR            SEE SCHEDULE
Department of Health and Human Services            SMALL BUSINESS 13a. THIS CONTRACT IS A RATED ORDER
Office of Public Health Emergency Preparedness            SMALL DISADV. BUSINESS            UNDER DPAS (15 CFR 700)
Office of Research and Development Coordination 8(A) 13b. RATING
200 Independence Avenue, SW, Room 636G            SIC: 14. METHOD OF SOLICITATION
Washington, DC 20201 CODE            SIZE STANDARD: RFQ IFB X RFP
——  ——  ——  —
Williams
16. ADMINISTERED BY
Centers for Disease Control and Prevention (PGO)
15. DELIVER TO            Acquisition & Assistance Branch 8, Team 1
SEE C.1.1 2920 Brandywine Road, Room 3120
SMALL BUSINESS CODE            Atlanta, GA 30341-5539 CODE 2536
——  ——  —
CODE 18a. PAYMENT WILL BE MADE BY            CODE 434
——  Centers for Disease Control and Prevention (FMO) —
P.O. Box 15580 (404) 498-4050
Atlanta, GA 30333
BioPort Corporation
3500 North Martin Luther King, Jr. Blvd.
Lansing, MI 48906
TIN: 38-3412788
TELEPHONE NO. (301) 590-0129 ext. 518 Robert Shumate
ITEM            SUPPLIES / SERVICES            QTY
——  ——  —
18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18A UNLESS BLOCK BELOW
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER            SEE ADDENDUM
——  —
19. 20. 21. 22. 23. 24.
ITEM NO. SCHEDULE OF SUPPLIES/SERVICES            QUANTITY            UNIT            UNIT PRICE            AMOUNT
——  ——  ——  ——  ——  —
“See Continuation Page”
(Attach Additional Sheets as Necessary)

	25. ACCOUNTING AND APPROPRIATION DATA Appropriation: 7550140 CAN: 921Z02A            OCC: 2641 26. TOTAL AWARD AMOUNT (For Govt. Use Only)
Allowance: A2AYS            Amount: $122,737,000.00 $122,737,000.00

	——  —

	27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA            ARE            ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA            ARE            ARE NOT ATTACHED.
—
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN            COPIES 29. AWARD OF CONTRACT: REFERENCE OFFER
TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET            DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),
FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT            INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
TO THE TERMS AND CONDITIONS SPECIFIED HEREIN. HEREIN, IS ACCEPTED AS TO ITEMS:

	——  —

	30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a . UNITED STATES OF AMERICA (Signature of Contracting Officer)
/s/ Robert G. Kramer /s/ Lorenzo J. Falgiano
—
30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED 31b . NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED
Robert G. Kramer, President & CEO 5/5/05 Lorenzo J. Falgiano            May 05 2005
——  ——  ——  —

	32a. QUANTITY IN COLUMN 21 HAS BEEN 33. SHIP NUMBER
RECEIVED INSPECTED            PARTIAL            FINAL 34. VOUCHER NUMBER
——  ——  —

	32b. SIGNATURE OF AUTHORIZED GOV’T REPRESENTATIVE 32c. DATE
41a. I            CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT 36 . PAYMENT
41b. SIGNATURE AND TITLE OF CERTIFYING            OFFICER 41c. DATE            COMPLETE            PARTIAL            FINAL 37. CHECK NUMBER
——  ——  —

	38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY
42a. RECEIVED BY (Print) —

	42b. RECEIVED AT (Location )
42c. DATE REC’D 42d. TOTAL CONTAINERS
—
AUTHORIZED FOR LOCAL REPRODUCTION            SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT            STANDARD FORM 1449 (10-95)

 

 

TABLE OF CONTENTS

	 	 	 	 	 	 	 
	Section	 	Document/Clause/Provision
	 	 	Page No.	 
	A	 	Standard Form 1449
	 	 	1	 
	B	 	Continuation of SF1449 (Block 19 — 24)
	 	 	2	 
	C	 	Contract Clauses
	 	 	3	 
	D	 	Contract Documents, Exhibits or Attachments
	 	 	9	 

Page i

 

Contract No. 200-2005-11811

SECTION B — CONTINUATION OF SF1449

Contract Schedule

AVA available doses for the period May 2005 — December 2005, as projected in Table E.1 of
the final revised proposal dated March 8, 2005.

	 	 	 	 	 	 	 	 	 	 	 
	ITEM NO.	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0001
	 	BioThrax Vaccine	 	[**] Doses	 	$[**]	 	$	75,237,000.00	 
	 
	 	Anthrax Vaccine Adsorbed (AVA)	 	 	 	 	 	 	 	 
	 
	 	BioThrax®	 	 	 	 	 	 	 	 

AVA available doses for the period January 2006 — September 2006, as projected in Table
E.1 of the final revised proposal dated March 8, 2005.

	 	 	 	 	 	 	 	 	 	 	 
	ITEM NO.	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0002
	 	BioThrax Vaccine	 	[**]	 	$[**]	 	$	47,500,000.00	 
	 
	 	Anthrax Vaccine Adsorbed (AVA)	 	Doses	 	 	 	 	 	 
	 
	 	BioThrax®	 	 	 	 	 	 	 	 

OPTION I*

	 	 	 	 	 	 	 	 	 
	ITEM NO.	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0003
	 	BioThrax Vaccine	 	5,000,000	 	TBD	 	TBD*
	 
	 	Anthrax Vaccine Adsorbed (AVA)	 	Doses	 	 	 	 
	 
	 	BioThrax®	 	 	 	 	 	 

 

			
	*	 	Following execution of the contract, the government agrees to meet with
the contractor to discuss an option to procure 5 million additional doses of
AVA. Since the option price nor the performance period has been agreed upon at
contract execution the clauses found at FAR 52.217-7 and 52.217-9 are not
included.

	 	 	 	 	 
	TOTAL: 5,000,000 Doses
	 	$	122,737,000.00	 
	 
	 	 	 

There are no clauses/provisions included in this section.

Page 2

 

Contract No. 200-2005-11811

SECTION C — CONTRACT CLAUSES

	 	 	 
	FAR SOURCE

	 	TITLE AND DATE
	52.212-4

	 	Contract Terms and Conditions — Commercial Items (Oct 2003)
	52.243-1

	 	Changes — Fixed Price
	52.247-30

	 	F.O.B. Origin, Contractor’s Facility

Addendum to 52.212-4, Contract Terms and Conditions — Commercial Items (Oct 2003)

C.1.1 Method of Delivery

	 	a.	 	Delivery of the BioThrax Vaccine shall be F.O.B.Origin, Contractor’s Facility.
	 
	 	b.	 	The USG will receive and transport product from the manufacturer monthly, on or about
the 15th of each month or such mutually acceptable date, during the life of the
contract.
	 
	 	c.	 	Inspection/Acceptance: Prior to acceptance of the product by the Strategic National
Stockpile (SNS), the contractor shall provide approximately 2 week advanced notification of
the amount of product that will be available, so that the USG may plan for the necessary
logistics. Notice of availability of product with supporting documentation shall be
provided to the Project Officer, Walter Lange at (202)401-4848.
	 
	 	d.	 	Acceptance of the product shall be deemed to have occurred after USG inspection and in
accordance with C.1.2 below, and upon delivery of the FDA-released product to the USG
designated carrier on the monthly transport date as provided in (b.) above. Contractor
will invoice the USG immediately upon acceptance.

     (End of Clause)

C.1.2 Packing Requirements

The product will be delivered to the Government’s carrier in boxes, on pallets, at Contractor’s
facility on the designated pick up days. The pallets will be stacked according to the load plan
(Attachment D.2) and stretch wrapped on a pallet, after government inspection, to prevent
shifting/damage during transit. (Note: Attachment D.2 is based on theoretical 180,000 dose lot
size; actual loading may vary slightly based upon lot yield). Contractor is not required to
deliver the product in any other configuration under this contract. Contractor will store the
product in validated cold rooms at 2-8 degrees Celsius until turned over to the USG designated
carrier. In accordance with the FOB origin clause, the USG will be responsible for cold storage
conditions (i.e. — maintaining the product at 2-8 degrees Celsius) after pick up by the USG
designated carrier.

(End of Clause)

C.1.3 Excusable Delay

FAR 52.212-4 Contract Terms and Commercial Provisions, Part (f) is amended as follows:

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is
caused by an occurrence beyond the reasonable control of the Contractor and without its fault or
negligence such as, acts of God or the public enemy, acts of the Government in either its
sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes,
unusually severe weather, and delays of common carriers. Furthermore, the Contractor will not
be in default under this contract if it is unable to deliver AVA doses in accordance with any
delivery schedule because of the action or inaction of the FDA, except to the extent that such
action or inaction is a direct consequence of the negligence or willful misconduct of the
Contractor. Additionally, the Contractor will not be in default of this contract in the event
that deliveries are delayed as a result of another Government agency placing an order for AVA
doses that is determined to have priority over this contract under the Defense Priority
Allocation System or under any other reasonable legal justification. The Contractor shall
notify the Contracting Officer in writing as soon as it is reasonably possible after the
commencement or any excusable delay, setting forth the full particulars in connection therewith,
shall remedy
such occurrence with all reasonable dispatch and shall promptly give written notice to the
Contracting Officer of the cessation of such occurrence.

(End of Clause)

Page 3

 

Contract No. 200-2005-11811

C.2 FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders
— Commercial Items (May 2004)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clause,
which are incorporated in this contract by reference, to implement provisions of law or Executive
orders applicable to acquisitions of commercial items: 52.233-3, Protest after Award (Aug 1996)(31
U.S.C 3553).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting
officer has indicated as being incorporated in this contract by reference to implement provisions
of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer shall check as appropriate.]

þ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jul 1995), with Alternate I
(Oct 1995)(41 U.S.C. 253g and 10 U.S.C. 2402).

o (2) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999)(15 U.S.C. 657a).

o (3) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan
1999) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C.
657a).

o (4) (i) 52.219-5, Very Small Business Set-Aside (June 2003)(Pub. L. 103-403, section 304, Small
Business Reauthorization and Amendments Act of 1994).

o (ii) Alternate I (Mar 1999) of 52.219-5.

o (iii) Alternate II (June 2003) of 52.219-5.

o (5) (i) 52.219-6, Notice of Total Small Business Aside (June 2003) (15 U.S.C. 644).

o (ii) Alternate I (Oct 1995) of 52.219-6.

o (6) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003)(15 U.S.C. 644).

o (ii) Alternate I (Oct 1995) of 52.219-7.

o (7) 52.219-8, Utilization of Small Business Concerns (Oct 2000) (15 U.S.C. 637(d)(2) and (3)).

o (8) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2002)(15 U.S.C. 637 (d)(4)).

o (ii) Alternate 1 (Oct 2001) of 52.219-9.

o (iii) Alternate II (Oct 2001) of 52.219-9.

o (9) 52.219-14, Limitations on Subcontracting (Dec 1996)(15 U.S.C. 637(a)(14)).

o (10) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business
Concerns (June 2003)(Pub. L. 103-355, section 7102, and 10 U.S.C. 2323) (if the offeror elects to
waive the adjustment, it shall so indicate in its offer).

o (ii) Alternate I (June 2003) of 52.219-23.

o (11) 52.219-25, Small Disadvantaged Business Participation Program — Disadvantaged Status and
Reporting (Oct 1999)(Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

Page 4

 

Contract No. 200-2005-11811

o (12) 52.219-26, Small Disadvantaged Business Participation Program – Incentive Subcontracting
(Oct 2000)(Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

o (13) 52.222-3, Convict Labor (June 2003)(E.O. 11755).

Page 5

 

Contract No. 200-2005-11811

þ (14) 52.222-19, Child Labor — Cooperation with Authorities and Remedies (Jan 2004) (E.O. 13126).

þ (15) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

þ (16) 52.222-26, Equal Opportunity (Apr 2002)(E.O. 11246).

þ (17) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and
Other Eligible Veterans (Dec 2001)(38 U.S.C. 4212).

þ(18) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998)(29 U.S.C. 793).

þ (19) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and
Other Eligible Veterans (Dec 2001)(38 U.S.C. 4212).

o (20) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated
Products (Aug 2000)(42 U.S.C. 6962(c)(3)(A)(ii)).

o (ii) Alternate I (Aug 2000) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)).

o (21) 52.225-1, Buy American Act — Supplies (June 2003)(41 U.S.C. 10a-10d).

o (22) (i) 52.225-3, Buy American Act —Free Trade Agreement — Israeli Trade Act (Jan 2004)(41
U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, Pub. L. 108-77,108-78).

o (ii) Alternate I (Jan 2004) of 52.225-3.

o (iii) Alternate II (Jan 2004) of 52.225-3.

o (23) 52.225-5, Trade Agreements (Jan 2004)(19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

þ (24) 52.225-13, Restrictions on Certain Foreign Purchases (Oct 2003) (E.o.s, proclamations, and
statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

o (25) 52.225-15, Sanctioned European Union Country End Products (Feb 2000)(E.O. 12849).

o (26) 52.225-16, Sanctioned European Union Country Services (Feb 2000)(E.O. 12849).

o (27) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002)(41 U.S.C. 255(f),
10 U.S.C. 2307(f)).

o (28) 52.232.30, Installment Payments for Commercial Items (Oct 1995)(41 U.S.C. 255(f), 10 U.S.C.
2307(f)).

þ (29) 52.232-33, Payment by Electronic Funds Transfer — Central Contractor Registration (Oct.
2003)(31 U.S.C. 3332).

o (30) 52.232-34, Payment by Electronic Funds Transfer — Other Than Central Contractor Registration
(May 1999)(31 U.S.C. 3332).

o (31) 52.232-36, Payment by Third Party (May 1999)(31 U.S.C. 3332).

þ (32) 52.233-4, Applicable Law for Breach of Contract Claim.

o (33) 52.239-1, Privacy or Security Safeguards (Aug 1996)(5 U.S.C. 552a).

o (34) 52.244-2, Subcontracts

Page 6

 

Contract No. 200-2005-11811

o (35) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Apr 2003)(46
U.S.C. 1241 and 10 U.S.C. 2631).

o (ii) Alternate I (Apr 1984) of 52.247-64.

Page 7

 

Contract No. 200-2005-11811

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to
commercial services, that the Contracting Officer has indicated as being incorporated in this
contract by reference to implement provisions of law or executive orders applicable to acquisitions
of commercial items:

[Contracting Officer check as appropriate.]

o (1) 52.222-41, Service Contract Act of 1965, as Amended (May 1989)(41 U.S.C. 351, et seq.).

o (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989)(29 U.S.C. 206 and 41
U.S.C. 351, et seq.).

o (3) 52.222-43, Fair Labor Standards Act and Service Contract Act — Price Adjustment (Multiple
Year and Option Contracts) (May 1989)(29 U.S.C.206 and 41 U.S.C. 351, et seq.).

o (4) 52.222-44, Fair Labor Standards Act and Service Contract Act — Price Adjustment (Feb 2002)(29
U.S.C. 206 and 41 U.S.C. 351, et seq.).

o (5) 52.222-47, SCA Minimum Wages and Fringe Benefits Applicable to Successor Contract Pursuant to
Predecessor Contractor Collective Bargaining Agreements (CBA) (May 1989)(41 U.S.C. 351, et seq.).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records —
Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor’s directly
pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after final
payment under this contract or for any shorter period specified in FAR Subpart 4.7,

Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be made
available for 3 years after any resulting final termination settlement. Records relating to
appeals under the disputes clause or to litigation or the settlement of claims arising under or
relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices,
and other data, regardless of type and regardless of form. This does not require the Contractor to
create or maintain any record that the Contractor does not maintain in the ordinary course of
business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in paragraphs
(i) through (vi) of this paragraph in a subcontract for commercial items. Unless otherwise
indicated below, the extent of the flow down shall be as required by the clause —

(i) 52.219-8, Utilization of Small Business Concerns (Oct 2000)(15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds $500,000 ($1,000,000 for construction of any
public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer
subcontracting opportunities.

(ii) 52.222-26, Equal Opportunity (Apr 2002)(E.O. 11246).

(iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and
Other Eligible Veterans (Dec 2001)(38 U.S.C. 4212).

(iv) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998)(29 U.S.C. 793).

(v) 52.222-41, Service Contract Act of 1965, as Amended (May 1989), flow down required for all
subcontracts subject to the Service Contract Act of 1965 (41 U.S.C. 351, et seq.)

Page 8

 

Contract No. 200-2005-11811

(vi) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Apr 2003)(46 U.S.C.
Appx 1241 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause
52.247-64,

Page 9

 

Contract No. 200-2005-11811

(2) While not required, the contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its
contractual obligations.

(End of Clause)

C.3 FAR 52.212-5 Alternate I Contract Terms and Conditions Required to Implement Statutes or
Executive Orders — Commercial Items — Alternate I (Feb 2000)

As prescribed in 12.301(b)(4), delete paragraph (d) from the basic clause, redesignate paragraph
(e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause”
in the redesignated paragraph (d) to read “paragraphs (a),
(b), and (c) of this clause”.

(End of Alternate)

C.4 Indemnification

The United States Government agrees that vaccine delivered under this contract will not be used in
humans unless indemnification has been approved in accordance with FAR Subpart 50.4 that is
mutually agreeable to both parties. As a requirement of indemnification, the Contractor will apply
to the Department of Homeland Security (DHS) for liability protection under the terms of the SAFETY
ACT (6 U.S.C. 441 to 444; see also 6 C.F.R. part 25).

(End of Clause)

C.5 Insurance Related to SAFETY Act Application

Should the United States Government require the contractor to obtain additional insurance in
connection with making application under the SAFETY Act in accordance with C.4 of the contract, the
requirement to obtain additional insurance shall be deemed a change in accordance with FAR
52.243-1. FAR 52.243-1 is hereby incorporated for this purpose. All other changes will be
governed by FAR 52.212-4(c).

(End of Clause)

C.6 Dissemination of Information

No information related to the performance or content of this contract or the data obtained or
generated under this contract shall be released or otherwise publicized without prior written
approval of the Contracting Officer, which approval shall not be unreasonably withheld or delayed;
provided, however, that no such written approval shall be required for release of information
concerning this Contract to Contractor’s lenders in connection with Contractor’s financing
activities, to third parties performing due diligence on Contractor in connection with Contractor’s
capital raising activities or proposed mergers, acquisitions or other business combinations, or
disclosure as may be required by law, rule, regulation, court ruling or similar order. In any
event the Contractor shall notify the government prior to the release of any information associated
with this contract. Clearance for any press release related specifically to this contract must be
approved by the Office of Public Affairs, Office of the Secretary of
DHHS.

(End of Clause)

C.7 Prohibition on Contractor Involvement with Terrorist Activities

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to
Executive Order 13224 and Public Law 107-56, prohibit transactions with, and the provision of
resources and support to, individuals and organizations associated with terrorism. It is the legal
responsibility of the contractor to ensure compliance with these Executive Orders and Laws. This
clause must also be included in all subcontracts issued to support
performance under this contract.

(End of Clause)

C.8 Invoice Submission (July 1999)

	(a)	 	The Contractor shall submit an original and one (1) copy of contract invoices to the address
shown below:
	 
	 	 	Centers for Disease Control and Prevention

Procurement and Grants Office

Attn: Linda F. Williams, Contract Specialist

2920 Brandywine Road, Room 3120

Atlanta, Ga. 30341

Page 10

 

Contract No. 200-2005-11811

	(b)	 	The contractor shall submit one (1) copy of each invoice to our Financial Management
Office:
	 
	 	 	Centers for Disease Control and Prevention

FMO

PO Box 15580

Atlanta, GA 30333

	(c)	 	The Contractor agrees to include (as a minimum) the following information on each invoice:
	 
	 	 	(1) Contractor’s Name & Address
	 
	 	 	(2) Contractor’s Tax Identification Number (TIN)
	 
	 	 	(3) Contract Number
	 
	 	 	(4) Invoice Number
	 
	 	 	(5) Invoice Date
	 
	 	 	(6) Contract Line Item Number
	 
	 	 	(7) Quantity
	 
	 	 	(8) Unit Price & Extended Amount for each line item
	 
	 	 	(9) Total Amount of Invoice
	 
	 	 	(10) Name, title and telephone number of person to be notified in the event of a defective
invoice
	 
	 	 	(11) Payment Address or Electronic Funds Transfer (EFT) banking information.
	 
	 	 	(12) Material Receiving Report — Signed by USG Representative.

(End of Clause)

C.9 Government Assistance to Contractor in Litigation

In the event that a claim or suit for damages is brought against the Contractor by a third party
arising out of it’s performance of this contract, the Government will provide reasonable and timely
access to documents, potentially relevant to the Contractor’s assertion of defenses to any dispute
with a third party, including, but not limited to a claim for bodily injury or other damages
allegedly arising out of the use or ingestion of any product delivered to the Government under this
contract. In addition, the Government will consider any request from the Contractor, to assist the
Contractor in litigation, including a request to support the Contractor’s assertion of appropriate
defenses, including, but not limited to, the government contractor defense. If and when
appropriate, the Government will file papers in support of the Contractor’s assertion of its
defenses in such disputes. The USG will assist the Contractor in resolving the Contractor’s
liability concerns related to this contract and will not take any public position adversely
affecting the Contractor’s requirement for full indemnification before the vaccine may be used in
humans consistent with this Contract.

(End of Clause)

C.10 Data Rights

Data submitted by the Contractor, whether in this proposal, during negotiations, or after award
shall be solely for the purpose of negotiation of an award or, after award, administering the
contract. All data submitted shall be considered proprietary and confidential and shall not be
distributed outside of the Government or for use, other than specified above, without the advance
written consent of the Contractor.

(End of Clause)

C.11 Notification of Utilization

The USG agrees to notify the Contractor of any ultimate use of the Government owned vaccine
provided by the Contractor to the SNS. This information is necessary for the investigation of
adverse event claims and adverse event reporting

(End of Clause)

Page 11

 

Contract No. 200-2005-11811

SECTION D — CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

Section D — List Of Attachments

	 	 	 	 	 
	Item	 	Description	 	Attachment
	1
	 	Statement of Work	 	D.1
	 
	 	 	 	 
	2
	 	BioPort Load Plan	 	D.2
	 
	 	 	 	 
	3
	 	ACH Vendor/Miscellaneous Payment	 	D.3
	 
	 	Enrollment Form	 	 

Page 12

 

Attachment D.1, Contract No. 200-2005-11811

STATEMENT OF WORK

Acquisition of Licensed Anthrax Vaccine Adsorbed (BioThrax ®)

for the Strategic National Stockpile (SNS)

D.1 Background and Need

The Federal Response Plan of the Department of Homeland Security designates the Department of
Health and Human Services (HHS) as the lead agency for public health and medical response to
manmade or natural disasters. In 2002, HHS established the Office of Public Health Emergency
Preparedness (OPHEP). This office is responsible for the implementation of a comprehensive HHS
strategy to protect from, and be prepared to respond to, acts of bioterrorism and other public
health emergencies threatening the civilian population. The Office of Research and Development
Coordination (ORDC) in OPHEP has the primary responsibility within HHS to contract for large-scale
manufacturing and delivery of licensed and licensable products to the Strategic National Stockpile
(SNS) in preparation for response to a public health emergency.

Recent, significant changes in both the nature, regularity, and degree of the threat posed by the
use of infectious agents as weapons of biological warfare have generated increased concern for the
safety of the general American populace. Following the deliberate exposure of citizens of the
United States to Bacillus anthracis (B. anthracis) spores in 2001, there is an urgent need to
stockpile appropriate and effective medical countermeasures to safeguard against this potential
threat. The USG has established a requirement for the procurement of licensed Anthrax Vaccine
Adsorbed to meet this urgent need.

The Department of Health and Human Services intends to negotiate a sole source procurement with
BioPort Corporation under the authority of FAR 6.302-1, Only One Responsible Source and No Other
Supplies or Services will Satisfy Agency Requirements.

D.2 Project Identification and Purpose

Provide 5 million doses of U.S. licensed Anthrax Vaccine Adsorbed (BioThrax®) in multi-dose
vials to be delivered in appropriately packaged containers under controlled and secure
conditions to the SNS.

AVA SOW Page l of 3

 

 

Attachment D.1, Contract No. 200-2005-11811

D.3 Specific Technical Requirements

The Contractor shall provide the necessary qualified personnel, facilities, material, equipment
(except Government property) and services to produce, test, bottle, package, and prepare for pick
up in accordance with BioPort’s Standard Operating Procedures and BioPort’s Food and Drug
Administration Biologics License and all federal government, and statutory requirements applicable
to the manufacture, formulation, filling, and testing of BioThrax for the SNS in accordance with
requirements as outlined below:

Task 1 Vaccine Production and cGMP Compliance

a) The Contractor shall manufacture AVA in accordance with current GMP guidelines. The
Contractor shall deliver 5 million doses of Final Drug Product (FDP) in 5 mL multi-dose vials,
to the SNS within 18 months of contract award. AVA shall be made available for delivery not
more than 60 days after the date of the FDA release, with the exception of lots [**] and [**].

b) The Contractor shall provide primary and secondary points of contact who will be available
24 hours per day, seven days per week to be notified in case of a public health emergency.

Task 2 — Potency, Stability, and Container/Closure Integrity Testing of Finished Vaccine

The Contractor shall perform all requisite assays and release tests, including but not limited
to potency, identity, and stability testing in accordance with the FDA approved Biologic License
Application (BLA)(License Number 1260, BL 103821).

AVA SOW Page 2 of 3

 

 

Attachment D.1, Contract No. 200-2005-11811

D.4 Reporting Requirements

The Contractor shall submit to the Contracting Officer and to the Project Officer progress reports
covering the work accomplished during each reporting period. These reports are subject to the
technical inspection and requests for clarification by the Project Officer. These shall be brief
and factual and prepared in accordance with the following format:

	 	(1)	 	Monthly Progress Reports: On the fifteenth of each month for the previous calendar
month, the Contractor shall submit a Monthly Progress Report to the Project Officer and the
Contracting Officer. A monthly report will not be required for the period when the final
report is due. The Contractor shall submit one copy of the Monthly Progress Report
electronically via e-mail. Any attachments to the e-mail report shall be submitted in
Microsoft Word or WordPerfect 9 or compatible version. Such reports shall include the
following specific information:
	 
	 	a.	 	The contract number and title, the period of performance being reported, the
contractor’s name and address, the author(s), and the date of submission;
	 
	 	b.	 	Section I — An introduction covering the purpose and scope of the contract effort;
	 
	 	 	 	Section II — The report shall detail, document, and summarize the results of work done in
performance of requirements of this contract during the period covered, and include a
summary of work planned for the next reporting period. This shall include the information
listed below that is applicable for the performance period during the month being reported:
	 
	 	 	 	Production capacity assessment problems and recommendations to include:
	 
	 	 	 	1. Raw material procurement status;
	 
	 	 	 	2. Inventory report of product manufactured and delivered to the USG under this
contract.
	 
	 	 	 	3. Quality control testing and purity;
	 
	 	 	 	4. Quality control potency assessment;
	 
	 	 	 	5. FDA inspections and consultation results or recommendations;
	 
	 	 	 	6. Security assessment, problems and recommendations;
	 
	 	 	 	7. Physical storage monitoring and calibration reports for manufactured products.
	 
	 	 	 	8. Overall project assessment, problems encountered and recommended solutions,
etc.

Section III — An explanation of any difference between planned progress and actual progress, why
the differences have occurred, and, if behind planned progress, what corrective steps are planned.
The project plan and delivery schedule will be updated in each Monthly Report and compared to the
baseline plan and delivery schedule.

AVA SOW Page 3 of 3

 

 

[**]

 

 

			
	Attachment D.3, Contract No. 200-2005-11811
	 	OMB No. 1510-0056

ACH VENDOR/MISCELLANEOUS PAYMENT

ENROLLMENT FORM

This form is used for Automated Clearing House (ACH) payments with an addendum record that contains
payment-related information processed through the Vendor Express Program. Recipients of these
payments should bring this information to the attention of their financial institution when
presenting this form for completion. See reverse for additional instructions.

PRIVACY ACT STATEMENT

The following information is provided to comply with the Privacy Act of 1974
(P.L. 93-579). All information collected on this form is required under the
provisions of 31 U.S.C. 3322 and 31 CFR 210. This information will be used by
the Treasury Department to transmit payment data, by electronic means to
vendor’s financial institution. Failure to provide the requested information
may delay or prevent the receipt of payments through the Automated Clearing
House Payment System.

	 	 	 	 	 	 	 	 	 
	 	 	 
	 	AGENCY INFORMATION
	 
	 	 	 
	 	FEDERAL PROGRAM AGENCY

	 	 	 	 	 	 	 
	 	 
	 
	 	 	 
	 	AGENCY IDENTIFIER:

	 	AGENCY LOCATION CODE (ALC):
	 	ACH FORMAT:	 	 
	 	 

	 	 	 	o CCD+
o CTX	 	 
	 	 	 
	 	ADDRESS:
	 	 	 	 	 	 	 
	 	 
	 
	 	 	 
	 	 
	 	 	 	 	 	 	 
	 	 	 
	 	CONTACT PERSON NAME:

	 	 	 	 	 	TELEPHONE NUMBER:	 
	 	 

	 	 	 	 	 	(                    )	 
	 	 	 
	 	ADDITIONAL INFORMATION:
	 	 	 	 	 	 	 
	 	 
	 
	 	 	 

	 	 	 	 	 
	 	 	 
	 	PAYEE/COMPANY INFORMATION
	 
	 	 	 
	 	NAME

	 	SSN NO. OR TAXPAYER ID NO.

	 
	 	 	 
	 	ADDRESS
	 	 	 
	 	 
	 
	 	 	 
	 	 
	 	 	 
	 	 	 
	 	CONTACT PERSON NAME:

	 	TELEPHONE NUMBER:	 
	 	 

	 	(                    )	 
	 	 	 

	 	 	 	 	 	 	 
	 	 	 
	 	FINANCIAL INSTITUTION INFORMATION
	 
	 	 	 
	 	NAME:
	 	 	 	 	 
	 	 
	 
	 	 	 
	 	ADDRESS:
	 	 	 	 	 
	 	 
	 
	 	 	 
	 	 
	 	 	 	 	 
	 	 	 
	 	ACH COORDINATOR NAME:	 	TELEPHONE NUMBER:	 
	 	 	 	(                    )	 
	 	 	 
	 	NINE-DIGIT ROUTING TRANSIT NUMBER:
	 	 	 	 	 
	 	
--- --- --- --- --- --- --- --- ---
	 	 	 	 	 
	 	 	 
	 	DEPOSITOR ACCOUNT TITLE:
	 	 	 	 	 
	 	 
	 
	 	 	 
	 	DEPOSITOR ACCOUNT NUMBER:

	 	 	 	LOCKBOX NUMBER:	 
	 	 	 	 	 
	 
	 	 	 
	 	TYPE OF ACCOUNT:
	 	 	 	 	 
	 	 
	 
	 	                    o CHECKING                     o SAVINGS                     
o LOCKBOX	 
	 	 	 
	 	SIGNATURE AND TITLE OF AUTHORIZED OFFICIAL:	 	TELEPHONE NUMBER:	 
	 	(Could be the same as ACH Coordinator)	 	(                    )	 
	 	 	 
	 
	 	 	 

			
	     AUTHORIZED FOR LOCAL REPRODUCTION
	 	SF 3881 (Rev. 2/2003)
	 
	 	Prescribed by Department of Treasury
	 
	 	31 U S C 3322; 31 CFR 210

 

 

Attachment D.3, Contract No. 200-2005-11811

Instructions for Completing SF 3881 Form

Make three copies of form after completing. Copy 1 is the Agency Copy; copy 2 is the Payee/Company
Copy; and copy 3 is the Financial Institution Copy.

	1.	 	Agency Information Section - Federal agency prints or types the name and address of the
Federal program agency originating the vendor/miscellaneous payment, agency identifier, agency
location code, contact person name and telephone number of the agency. Also, the appropriate
box for ACH format is checked.

	2.	 	Payee/Company Information Section - Payee prints or types the name of the payee/company and
address that will receive ACH vendor/miscellaneous payments, social security or taxpayer ID
number, and contact person name and telephone number of the payee/company. Payee also
verifies depositor account number, account title, and type of account entered by your
financial institution in the Financial Institution Information Section.

	3.	 	Financial Institution Information Section - Financial institution prints or types the name
and address of the payee/company’s financial institution who will receive the ACH payment, ACH
coordinator name and telephone number, nine-digit routing transit number, depositor
(payee/company) account title and account number. Also, the box for type of account is
checked, and the signature, title, and telephone number of the appropriate financial
institution official are included.

Burden Estimate Statement

The estimated average burden associated with this collection of information is 15 minutes per
respondent or recordkeeper, depending on individual circumstances. Comments concerning the
accuracy of this burden estimate and suggestions for reducing this burden should be directed to the
Financial Management Service, Facilities Management Division, Property and Supply Branch, Room
B-101, 3700 East West Highway, Hyattsville, MD 20782 and the Office of Management and Budget,
Paperwork Reduction Project (1510-0056), Washington, DC 20503.

 

 

	PAGE            OF            PAGES
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE 1 1
2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE
00001 See Block 16c 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable)
6. ISSUED BY            CODE 2536 7. ADMINISTERED BY (If other than Item 8) CODE
Centers for Disease Control and Prevention (PGO)
Acquisition & Assistance Branch 8, Team 1
2920 Brandywine Road, Room 3120
Atlanta, GA 30341-5539
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and Zip Code) 9A. AMENDMENT OF SOLICITATION NO.
BIOPORT CORPORATION
3500 N. MARTIN LUTHER KING, JR. BLVD.
LANSING, MI 48906-2933 9B. DATED (See Item 11)
10A. MODIFICATION OF CONTRACT/ORDER NO.
200-2005-11811
X 10B. DATED (See Item 13)
CODE 026489018 FACILITY CODE 05/05/2005
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

	The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers ___is extended, ___is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in
the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and
amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an
offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

	12. ACCOUNTING AND APPROPRIATION DATA (If required)
N/A

	13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
X Contract Clause C.4 Indemnification

	D. OTHER (Specify type of modification and authority)

	E. IMPORTANT: Contractor is not, x is required to sign this document and return 1 copies to the issuing office.

	14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
The purpose of this modification is to:
(1) indemnify the contractor pursuant to the attached memorandum of decision, signed by the Secretary of Department of Health and Human Services.
(2) The indemnification agreement is hereby incorporated into the contract.
(3) As a result of items (1) and (2) above, the contract price and performance period remain unchanged.
(4) all other terms and conditions of the contract remain unchanged and in full force and effect.
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

	15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME OF CONTRACTING OFFICER
Robert G. Kramer Joe G. Little, Jr.

	15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA
/s/ Robert G. Kramer            BY /s/ Joe G. Little, Jr.
15C. DATE SIGNED 16C. DATE SIGNED
(signature of person authorized to sign) 2/23/06 (Signature of Contracting Officer) 02/23/2006

	NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)
PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GBA
FAR (48 CFR) 53.243

 

 

MEMORANDUM OF DECISION

SUBJECT: Authority under the residual powers provisions of Public Law 85-804 to include
Indemnification Clause in Contract No. 200-2005-11811, awarded May 5, 2005 to BioPort Corporation.

BioPort Corporation (BioPort) has requested that the Department of Health and Human Services (HHS)
indemnify it against risks associated with supplying anthrax vaccine adsorbed (AVA) pursuant to
Office of Public Health Emergency Preparedness Contract No. 200-2005-11811 (the Contract).

I adopt as applicable to the Contract the findings of former Acting Secretary of the Army Brownlee
with respect to unusually hazardous risks contained in the second, fourth, and fifth sentences of
the second paragraph of his September 28, 2004 memorandum of decision authorizing indemnification
of BioPort (attached). I note that the Food and Drug Administration affirmed the conclusion
referenced by former Acting Secretary Brownlee in a December 19, 2005 final order. I further
adopt, with respect to AVA acquired under the Contract, the definition of unusually hazardous risks
contained in TAB A, section a, appended to that memorandum. The use of this definition is for the
purposes of this contract indemnification matter only. It has no bearing on, and is unrelated to,
any determination by the Food and Drug Administration (FDA) concerning the safety or effectiveness
of AVA or any other product.

This indemnification shall include BioPort, its affiliates (including, but not limited to Emergent
BioSolutions Inc.), subsidiaries, divisions, and organizational units, together with their
officers, directors, employees, agents, successors and assigns; provided, that with respect to
successors or assigns responsible for the performance of any executory contract subject to this
memorandum, this indemnification shall include only those successors or assigns with whom BioPort
has entered into a Government-approved novation agreement, or, where appropriate, as to whom a
change-of-name-agreement has been executed in accordance with the Federal Acquisition Regulation
(FAR).

I adopt the findings of the Acting Secretary as to the availability, cost and terms of private
insurance to specifically cover these risks, as well as self-insurance. Based on this evaluation,
and except as otherwise provided herein, all liabilities of BioPort arising from the
above-described unusually hazardous risks with respect to AVA acquired under the Contract shall be
subject to indemnification. Accordingly, except with regard to BioPort’s workers’ compensation
insurance or as deemed necessary by the Department of Homeland Security should BioPort receive
certification under the SAFETY Act, the Government will not require that Contractor purchase or
maintain any insurance coverage as a condition of the indemnification hereby authorized.

 

 

Page 2 — BioPort Corp./Memorandum of Decision

Based on my findings that: (1) AVA serves as a significant bioterrorism countermeasure; and (2) the
Contract provides that the Government will not administer the vaccine to human subjects until I
have approved a request for indemnification; I further find that the use of an indemnification
clause in the contract to cover the unusually hazardous risks defined above will facilitate the
national defense. Because BioPort is licensed by the FDA to produce AVA, I further determine that
BioPort is in compliance with applicable Government safety requirements.

The Government retains the right to closely monitor any and all litigation of claims arising out of
the Contract between BioPort and HHS, including any and all dispute resolution proceedings or
settlement discussions involving claims. As a condition of indemnification, BioPort shall fully
cooperate with the Government’s efforts to effect such monitoring.

“Claim” or “claims” shall mean claims arising out of the Contract between BioPort and HHS for
relief of any sort relating to the unusually hazardous risks as defined above asserted in court,
arbitration or dispute resolution proceedings, and claims or demands presented to the Contractor
without the institution of formal proceedings. Reference to “claims,” “losses,” or “damages”
include all claims (as defined above), losses or damages that are identified on or after the date
of this memorandum.

“Contractor” means BioPort, its affiliates (including without limitation Emergent BioSolutions
Inc.), subsidiaries, divisions, and organizational units.

“Indemnify” means to indemnify and hold harmless.

Legal fees and expenses incurred by Contractor are subject to indemnification to the extent that
the Secretary determines these amounts to be just and reasonable. These legal fees and expenses
specifically include, but are not limited to, any and all costs (including reasonable legal fees
and expenses) relating to invoking the protections of the SAFETY Act and/or defending its
applicability, legality and/or constitutionality, to the extent that such costs (1) are not covered
by any insurance the contractor is required to obtain to meet SAFETY Act qualification
requirements, and (2) are incurred in connection with the defense of a claim or claims as defined
herein. Further, HHS agrees to consider and pay promptly all submissions for reimbursement by
Contractor for all reasonable legal fees and expenses that are incurred in connection with the
foregoing or otherwise subject to indemnification and to make prompt payment therefore consistent
with the requirement for HHS to obtain supplemental appropriations, if applicable, and the legal
standards on HHS under the Anti-Deficiency Act.

In view of the foregoing and pursuant to the authority vested in me by the residual power
provisions of Public Law 85-804 (50 U.S.C. §§ 1431-1433, 1435) and Executive Order 10789, as
amended, I hereby authorize the Contracting Officer to modify the Contract to include the
indemnification clause set forth at FAR § 52.250-1 in the Contract, provided that: (1) the Contract
defines unusually hazardous risks as set forth above, and (2) the indemnification clause shall be
so interpreted as to effectuate the policies set forth at FAR § 50.102.

 

 

Page 3 — BioPort Corp./Memorandum of Decision

As a condition of this indemnification, BioPort shall submit to the Secretary of Homeland Security
an application for the designation of AVA as a qualified anti-terrorism technology (QATT) under
section 862(b) of the Homeland Security Act of 2002 (6 U.S.C. § 442(b)). In the event that the
Secretary of Homeland Security designates AVA as a QATT, this indemnification shall remain
effective according to its terms with respect to such residual indemnified liabilities on the part
of BioPort as may remain or survive following application of the SAFETY Act, provided that BioPort
has complied with the SAFETY Act and its implementing regulations.

Should the Secretary of Homeland Security decline to designate AVA as a QATT, this indemnification
shall remain in effect according to its terms. See 68 Fed. Reg. 59684, 59694 (Oct. 16, 2003).

As permitted by FAR 50.403-2(d) and FAR 52.250-1(e), and when justified by the circumstances, I
authorize the Contracting Officer to permit BioPort to provide for indemnification of its first and
second-tier subcontractors, provided that the indemnification is limited to the unusually hazardous
risks defined in this Memorandum of Decision and that the Contracting Officer approves BioPort’s
request for subcontractor indemnification in writing.

It is not possible to determine the actual or estimated cost to the government as the result of the
use of this indemnification clause, inasmuch as the liability of the government, if any, will
depend upon the occurrence of incidents within the definition of unusually hazardous risks.

	 	 	 
	 

	 	/s/ Michael O. Leavitt
	 

	 	Michael O. Leavitt

 

 

TAB A

DEFINITION OF UNUSUALLY HAZARDOUS RISKS

AND LIMITATIONS ON COVERAGE

     a. Definition of Unusually Hazardous Risks.

     Release (or alleged release) of an infectious agent or toxic material into the environment in
connection with activities undertaken pursuant to the contract that results (or allegedly results),
either directly or indirectly, in human exposure to or environmental damage by an infectious
material or toxic material involved with the production or testing of vaccines pursuant to the
contract. Such activities may include, but are not limited to: (1) storage, use, testing, or
handling of the live vaccine products, their intermediate precursors or infectious agents or toxins
that are used as challenge materials for test of the products or intermediates; (2) transportation
of such substances; and (3) disposal of such substances.

     Adverse reaction (or alleged adverse reaction) in a human from administration of a vaccine or
other material used in the production or testing of the vaccine, in conjunction with or as a result
of the performance of the contract, or administration of a vaccine produced, tested, or delivered
under the contract.

     The term adverse reaction includes anaphylaxis and other foreseeable and unforeseeable adverse
reactions. Such reactions include, but are not limited to: (1) reactions directly attributable to
and resulting from the administration of the vaccine or other material involved with the vaccine
production or testing (to include challenge materials); (2) reactions that manifest long after
exposure, but which are directly attributable to and resulting from the administration of the
vaccine or other material involved with the production, or testing of the vaccine; (3) the failure
of the vaccine to perform as intended or otherwise confer immunity; or (4) performance by the
vaccine in a manner not intended.

     b. Limitations on Coverage.

     Notwithstanding any other provision in the indemnification clause or Memorandum of Decision,
BioPort Corporation and its subcontractors shall not be indemnified against grossly negligent or
criminal behavior on the part of BioPort Corporation’s or its subcontractors’ directors, officers,
or managers who have supervision over, or direction of, all or substantially all of the operations
at any one plant or separate locations where the contract or a subcontract is being performed.

Attachment No. 4 to

Contract W9113M-04-B-0002

3

 

	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE            PAGE OF PAGES 1 1

	2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE
00001 See Block 16c 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable)

	6. ISSUED BY            CODE 2536 7. ADMINISTERED BY (If other than Item 8) CODE

	Centers for Disease Control and Prevention (PGO)
Acquisition & Assistance Branch 8, Team 1
2920 Brandywine Road, Room 3120
Atlanta, GA 30341-5539
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and Zip Code) 9A. AMENDMENT OF SOLICITATION NO.
BIOPORT CORPORATION
3500 N. MARTIN LUTHER KING, JR. BLVD.
LANSING, MI 48906-2933 9B. DATED (See Item 11)
10A. MODIFICATION OF CONTRACT/ORDER NO.
200-2005-11811
X 10B. DATED (See Item 13)
CODE 026489018 FACILITY CODE 05/05/2005

	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

	The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers ___is extended, ___is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in
the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and
amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an
offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

	12. ACCOUNTING AND APPROPRIATION DATA (If required)
N/A

	13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
X Contract Clause C.4 Indemnification

	D. OTHER (Specify type of modification and authority)

	E. IMPORTANT: Contractor is not, x is required to sign this document and return 1 copies to the issuing office.

	14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
The purpose of this modification is to:
(1) indemnify the contractor pursuant to the attached memorandum of decision, signed by the Secretary of Department of Health and Human Services.
(2) The indemnification agreement is hereby incorporated into the contract.
(3) As a result of items (1) and (2) above, the contract price and performance period remain unchanged.
(4) all other terms and conditions of the contract remain unchanged and in full force and effect.
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

	15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME OF CONTRACTING OFFICER
Robert G. Kramer Joe G. Little, Jr.

	15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA
/s/ Robert G. Kramer            BY /s/ Joe G. Little, Jr.
16C. DATE SIGNED
(signature of person authorized to sign) 2/23/06 (Signature of Contracting Officer) 02/23/2006

	NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)
PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GBA
FAR (48 CFR) 53.243

 

 

	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE            PAGE OF            PAGES
1 3

2. AMENDMENT/MODIFICAITON NO.
Modification 00003 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicble)

	6. ISSUED BY            CODE 7. ADMINISTERED BY (If other than Item 6) CODE
Department of Health & Human Services
OS/OPHEP/ORDC
200 Independence Ave., S.W. Room 636G
Washington, D.C. 20201

	8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
BioPort Corporation
3500 N. Martin Luther King, Jr. Blvd.
Lansing, MI 48906-2933 (X) 9A. AMENDMENT OF SOLICIATION NO.

	9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.
HHSO100200600019C

10B. DATED (SEE ITEM 11)
05/05/05

CODE            FACILITY CODE

	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

	The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;
or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If
by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

	12. ACCOUNTING AND APPROPIRATION DATA (If required)
TIN: 383412788 CAN: 1991535 Appropriation: 7560140 O.C. 25.2A $120,000,000.00

	13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 .

	A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
CHECK ONE            NO. IN ITEM 10A.

	B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
X            FAR 52.243-1, Changes

	D. OTHER (Specify type of modification and authority)

	E. IMPORTANT: Contractor            is not, is required to sign this document and return 1 copies to the issuing office.

	14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
The purpose of this modification is to modify the statement of work, apply the indemnification to the modified contract number, and purchase an additional 5 million doses of AVA as reflected on page 2 through 3.
1. The total contract amount is increased by $120,000,000 from $122,737,000 to $242,737,000
2. The total allotted amount is increased by $120,000,000 from $122,737,000 to $242,737,000
3. The contract period of performance is extended from September 30, 2006 to September 30, 2007.
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

	15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
Robert G. Kramer, President & CEO            Brian K. Goodger

	15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED
/s/ Robert            G. Kramer 5/4/06 /s/ Brian K. Goodger 5/4/06

	(Signature of person authorized to sign) (Signature of Contracting Officer)

	NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)
Previous edition unusable            Prescribed by GSA FAR (48 CFR) 53.243

 

 

			
	HHSO100200600019C, modification 3
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The contract is hereby modified as follows:

SECTION B

Contract Schedule

AVA available doses for the period May 8, 2006 — May 5, 2007.

	 	 	 	 	 	 	 	 	 	 	 
	ITEM NO.	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0004
	 	BioThrax Vaccine

Anthrax Vaccine Adsorbed

(AVA) BioThrax®

	 	5,000,000
Doses
	 	$[**]

FFP
	 	$	120,000,000.00	 
	 	 	 
	 	 	 	 	 	 	 	 
	 	 	 	 	TOTAL: 5,000,000 Doses	 	$	120,000,000.00	 

SECTION C — CONTRACT CLAUSES

C.1.1 Method of Delivery

	 	b.	 	The USG will receive and transport product from the manufacturer approximately
bi-monthly. A first delivery of approximately [**] doses shall be available for inspection
and acceptance immediately after award of the contract modification. The contractor shall
invoice and be paid upon acceptance of the first delivery. Upon acceptance of the first
delivery at the manufacturer’s location, the manufacturer shall store the USG vaccine in
cGMP conditions in segregated storage until the first scheduled shipment on or about August
15. Subsequent deliveries and shipments shall occur as follows:

	 	 	 	 	 
	 	 	Target Quantities to be	 	Target Quantities to be
	 	 	Delivered (Inspection	 	Shipped to SNS
	Estimated
“Delivery Dates”	 	and Acceptance)	 	Location
	Immediately after Contract Award
	 	[**]	 	[**]
	August 15, 2006
	 	[**] — [**]	 	[**] — [**]
	October 15, 2006
	 	[**] — [**]	 	[**] — [**]
	December 16, 2006
	 	[**] — [**]	 	[**] — [**]
	February or March, 2007
(balance to be delivered by May
5, 2007 at the latest)
	 	[**] — [**]	 	[**] — [**]

	 	d.	 	Except for the acceptance of the first delivery, acceptance of the product shall be
deemed to have occurred after USG inspection and in accordance with C.1.2, and upon
delivery of the FDA-released product to the USG designated carrier on the periodic
transport dates as provided in (b.) above. Contractor will invoice the USG immediately
upon acceptance.
	 
	 	 	 	(End of Clause)

C.4 Indemnification

The indemnification granted under contract number 200-2005-11811, modification 0001, dated
2/23/2006, applies to this contract (HHSO100200600019C).

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C.8 Invoice Submission (July 1999)

	 	(a)	 	The Contractor shall submit an original and one (1) copy of contract invoices to the
address shown below:

Department of Health & Human Services

Office of Research & Development Coordination

Attn: Brian K. Goodger, Contracting Officer

200 Independence Ave. S.W.

Room 636-G

Washington, DC 20201

C.12 Risk of Loss

Under paragraph (j) of FAR clause 52.212-4, risk of loss of or damage to vaccine under Item 0004
shall pass to the Government upon acceptance by the Government, except to the extent provided in
FAR 52.212-4(a) regarding nonconforming items. The Contractor remains responsible for ensuring
that during the Contractor’s storage of the product that all doses shall remain in compliance with
FDA cGMP guidelines. In the event that the Contractor or its subcontractor fails to comply with
FDA cGMP guidelines for storage of the product, the Contractor shall replace those units of product
not stored in compliance with FDA guidelines.

SECTION D — CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

Section D — List Of Attachments

	 	 	 	 	 
	Item	 	Description	 	Attachment
	1
	 	Revised Statement of Work (modified on page 2,
Task 1)

	 	D.1, 3 pages

All Other Terms & Conditions of the Contract Remain Unchanged.

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	HHSO100200600019C, modification 3
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STATEMENT OF WORK

Acquisition of Licensed Anthrax Vaccine Adsorbed (BioThrax®)

for the Strategic National Stockpile (SNS)

D.1 Background and Need

The Federal Response Plan of the Department of Homeland Security designates the Department of
Health and Human Services (HHS) as the lead agency for public health and medical response to
manmade or natural disasters. In 2002, HHS established the Office of Public Health Emergency
Preparedness (OPHEP). This office is responsible for the implementation of a comprehensive HHS
strategy to protect from, and be prepared to respond to, acts of bioterrorism and other public
health emergencies threatening the civilian population. The Office of Research and Development
Coordination (ORDC) in OPHEP has the primary responsibility within HHS to contract for large-scale
manufacturing and delivery of licensed and licensable products to the Strategic National Stockpile
(SNS) in preparation for response to a public health emergency.

Recent, significant changes in both the nature, regularity, and degree of the threat posed by the
use of infectious agents as weapons of biological warfare have generated increased concern for the
safety of the general American populace. Following the deliberate exposure of citizens of the
United States to Bacillus anthracis (B. anthracis) spores in 2001, there is an urgent need to
stockpile appropriate and effective medical countermeasures to safeguard against this potential
threat. The USG has established a requirement for the procurement of licensed Anthrax Vaccine
Adsorbed to meet this urgent need.

The Department of Health and Human Services intends to negotiate a sole source procurement with
BioPort Corporation under the authority of FAR 6.302-1, Only One Responsible Source and No Other
Supplies or Services will Satisfy Agency Requirements.

D.2 Project Identification and Purpose

Provide 5 million doses of U.S. licensed Anthrax Vaccine Adsorbed (BioThrax®) in multi-dose vials
to be delivered in appropriately packaged containers under controlled and secure conditions to the
SNS.

1

 

			
	HHSO100200600019C, modification 3
	 	BioPort

D.3 Specific Technical Requirements

The Contractor shall provide the necessary qualified personnel, facilities, material, equipment
(except Government property) and services to produce, test, bottle, package, and prepare for pick
up in accordance with BioPort’s Standard Operating Procedures and BioPort’s Food and Drug
Administration Biologics License and all federal government, and statutory requirements applicable
to the manufacture, formulation, filling, and testing of BioThrax for the SNS in accordance with
requirements as outlined below:

Task 1 Vaccine Production and cGMP Compliance

	 	a)	 	The Contractor shall manufacture AVA in accordance with current GMP guidelines. The
Contractor shall deliver 5 million doses of Final Drug Product (FDP) in 5 mL multi-dose
vials, to the SNS by May 5, 2007. No lots shall be accepted that have an expiration date
before December 7, 2008.
	 
	 	b)	 	The Contractor shall provide primary and secondary points of contact who will be
available 24 hours per day, seven days per week to be notified in case of a public health
emergency.

Task 2 — Potency, Stability, and Container/Closure Integrity Testing of Finished Vaccine

The Contractor shall perform all requisite assays and release tests, including but not limited to
potency, identity, and stability testing in accordance with the FDA approved Biologic License
Application (BLA)(License Number 1260, BL 103821).

2

 

			
	HHSO100200600019C, modification 3
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D.4 Reporting Requirements

The Contractor shall submit to the Contracting Officer and to the Project Officer progress reports
covering the work accomplished during each reporting period. These reports are subject to the
technical inspection and requests for clarification by the Project Officer. These shall be brief
and factual and prepared in accordance with the following format:

	 	(1)	 	Monthly Progress Reports: On the fifteenth of each month for the previous calendar
month, the Contractor shall submit a Monthly Progress Report to the Project Officer and the
Contracting Officer. A monthly report will not be required for the period when the final
report is due. The Contractor shall submit one copy of the Monthly Progress Report
electronically via e-mail. Any attachments to the e-mail report shall be submitted in
Microsoft Word or WordPerfect 9 or compatible version. Such reports shall include the
following specific information:
	 
	 	a.	 	The contract number and title, the period of performance being reported, the
contractor’s name and address, the author(s), and the date of submission;
	 
	 	b.	 	Section I — An introduction covering the purpose and scope of the contract effort;
	 
	 	 	 	Section II — The report shall detail, document, and summarize the results of work done in
performance of requirements of this contract during the period covered, and include a
summary of work planned for the next reporting period. This shall include the information
listed below that is applicable for the performance period during the month being reported:
	 
	 	 	 	Production capacity assessment problems and recommendations to include:

	 	1.	 	Raw material procurement status;
	 
	 	2.	 	Inventory report of product manufactured and delivered to the USG under this
contract.
	 
	 	3.	 	Quality control testing and purity;

	 
	 	4.	 	Quality control potency assessment;
	 
	 	5.	 	FDA inspections and consultation results or recommendations;
	 
	 	6.	 	Security assessment, problems and recommendations;
	 
	 	7.	 	Physical storage monitoring and calibration reports for manufactured products.
	 
	 	8.	 	Overall project assessment, problems encountered and recommended solutions,
etc.

Section III — An explanation of any difference between planned progress and actual
progress, why the differences have occurred, and, if behind planned progress, what
corrective steps are planned. The project plan and delivery schedule will be updated in
each Monthly Report and compared to the baseline plan and delivery schedule.

3exv10w10

 

Exhibit 10.10

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

FILLING SERVICES AGREEMENT

This Agreement is made this 18th day of March, 2002 (the “Effective Date”), by and between
BioPort Corporation, a Michigan corporation having its principal office at 3500 North Martin Luther
King Jr. Blvd., Lansing, MI 48906 (“BIOPORT”) and HOLLISTER-STIER Laboratories LLC, a Delaware
limited liability company having its principal office at 3525 North Regal Street, Spokane, WA
99207 (“HOLLISTER-STIER”) (sometimes referred to in the singular as “Party” and collectively as the
“Parties”).

RECITALS

WHEREAS, BIOPORT is engaged in the production and sale of vaccines;

WHEREAS, HOLLISTER-STIER is a contract filler in the pharmaceutical industry and experienced in the
filling services of pharmaceuticals;

WHEREAS, BIOPORT has, as specified herein, several contracts with the United States Government for
the production, testing and maintenance of Anthrax Vaccine Adsorbed (“AVA”);

WHEREAS, BIOPORT produces AVA in bulk quantities and desires to fill this vaccine in vials at an
FDA-licensed location; and

WHEREAS, BIOPORT desires to engage HOLLISTER-STIER directly to provide filling services, and
HOLLISTER-STIER desires to be so engaged.

NOW, THEREFORE, the parties hereto agree as follows:

AGREEMENT

	1.0	 	Definitions: As used in this agreement, the following definitions shall apply:

	 	1.1	 	“Act” shall mean the US Food, Drug and Cosmetic Act of 1934, and the regulations
promulgated thereunder, as the same may be amended from time to time.
	 
	 	1.2	 	“Bulk Lot” shall mean each separate and distinct quantity of Bulk Product designated as a
single batch or lot by BIOPORT and designated by lot number.
	 
	 	1.3	 	“Bulk Product” shall mean AVA in bulk form as manufactured by BIOPORT and shipped to
HOLLISTER-STIER.
	 
	 	1.4	 	“Bulk Product Specification(s)” means the specifications for the composition, testing,
packaging and labeling of the Bulk Product.
	 
	 	1.5	 	“Certificate of Analysis” and “COA” shall mean a document prepared in accordance with
cGMP and certifying that a Filled Lot meets the Filling Process Specifications as
referenced, signed and dated by a duly authorized representative of the Quality Assurance
Department of HOLLISTER-STIER.
	 
	 	1.6	 	“cGMP” shall mean current Good Manufacturing Practices as such term is used in the Act.

HS Filling Services Agreement — Final — March 18, 2002

1

 

	 	1.7	 	“Confidential Information” shall mean any nonpublic information of BIOPORT that has been
or will be communicated to HOLLISTER-STIER or any nonpublic information of HOLLISTER-STIER
that has been or will be communicated to BIOPORT, including without limitation, trade
secrets, business methods, operating procedures, manufacturing methods and processes,
prices, product forecasts, actual orders, and customer information, whether in a written,
oral or visual format; provided, however, that “Confidential Information” will not include
any information that is: (a) already known to the receiving Party at the time of disclosure
hereunder, as demonstrated by its written records; (b) now or hereafter becomes publicly
known other than through acts or omissions of the receiving Party, or anyone to whom the
receiving Party disclosed such information; (c) disclosed to the receiving Party on a
nonconfidential basis by a third party under no obligation of confidentiality to the
disclosing Party; or (d) independently developed by the receiving Party without reliance on
the Confidential Information of the disclosing Party as shown by its written records.
	 
	 	1.8	 	“FDA” shall mean the United States Food and Drug Administration.
	 
	 	1.9	 	“Filled Lot” shall mean each separate and distinct quantity of Filled Product processed
under continuous conditions from a [**] Bulk Lot and that is designated as a single batch or
lot by HOLLISTER-STIER and designated by a lot number.
	 
	 	1.10	 	“Filled Product” shall mean vials filled by HOLLISTER-STIER with Bulk Product in
accordance with all Filling Process Specifications and other requirements of this Agreement.
	 
	 	1.11	 	“Filling Process Specification(s)” means the requirements and statement of procedures for
filling, testing, packaging, labeling, storage, and shipping Filled Product, as set forth in
[**], as altered or amended pursuant to Section 4.12. The Filling Process Specifications do
not include matters covered by the Bulk Product Specifications.
	 
	 	1.12	 	“Good Faith Annual Estimate” shall have the meaning described in Section 5.2.
	 
	 	1.13	 	“Health Authority” means a regulatory authority having jurisdiction over the manufacture
or sale of Bulk Product or Filled Product, including but not limited to the Canadian Health
Protection Branch, the European Medicines Evaluation Agency, the FDA and any other relevant
national regulatory agency in any nation, and “Health Authorities” shall mean collectively
all such regulatory authorities.
	 
	 	1.14	 	“Percentage Yield” means the ratio of the Yield to the Theoretical Yield with respect to
a particular Bulk Lot, expressed as a percentage.
	 
	 	1.15	 	“Term Year” means (a) the period between the Effective Date and the end of the calendar
year in which the Effective Date occurs (the “First Term Year”) and (b) any one of the four
next following calendar years.
	 
	 	1.16	 	“Theoretical Yield” means the number of vials of Filled Product that could be filled from
a particular Bulk Lot based on the total amount of Bulk Product in such Bulk Lot.
	 
	 	1.17	 	“Yield” means the number of acceptable vials of Filled Product available for shipment to
BIOPORT that were filled from a particular Bulk Lot.

	2.0	 	ENGAGEMENT AND LICENSE. BIOPORT hereby engages HOLLISTER-STIER, on a nonexclusive basis, and
HOLLISTER-STIER hereby accepts such engagement, to provide BIOPORT with filling services to
produce Filled Product in accordance with the Filling Process Specifications and the other
terms and conditions set forth in this Agreement, as ordered by BIOPORT in accordance with this Agreement. BIOPORT

HS Filling Services Agreement — Final — March 18, 2002

2

 

	 	 	hereby grants
HOLLISTER-STIER a nonexclusive, royalty-free right and license to practice any and all
patents, know-how, and other intellectual properties, proprietary rights and technologies
(including without limitation as to access to or use or modification of any tangible
materials) owned or controlled by BIOPORT that are necessary or useful in the performance
by HOLLISTER-STIER of its activities under, and in preparation for, this Agreement.
	 
	3.0	 	REPRESENTATIONS AND WARRANTIES. BIOPORT and HOLLISTER-STIER each represent and warrant to the
other as follows:

	 	3.1	 	It has full power and authority to enter into this Agreement and consummate the
transactions contemplated hereby.
	 
	 	3.2	 	Except as provided in Section 4.10, it has or shall obtain prior to performance hereunder
such permits, licenses and authorizations of government or regulatory authorities as are
necessary to own its respective properties, conduct its business and consummate the
transactions contemplated hereby.
	 
	 	3.3	 	It is not currently debarred, suspended, or otherwise excluded by the United States from
receiving Federal contracts.
	 
	 	3.4	 	All laboratory, scientific, technical and/or other data submitted by or on behalf of
BIOPORT relating to the Bulk Product or by or on behalf of HOLLISTER-STIER relating to the
Filled Product, shall, to the best of the submitter’s knowledge, be true and correct and
shall not contain any material falsification, misrepresentation or omission.
	 
	 	3.5	 	In performing its obligations or activities under or in connection with this Agreement,
it shall comply with all applicable existing and future laws, rules and regulations of the
United States and the States thereof; provided, however, that HOLLISTER-STIER may rely on
BIOPORT’s warranty that the Filling Process Specifications conform to all applicable laws,
rules and regulations.
	 
	 	3.6	 	Each Party represents and warrants that neither it nor its employees or agents has made
or will make any payments in connection with this Agreement or from funds paid or payable
hereunder directly or indirectly to any officials or employees of any governmental agency or
instrumentality.
	 
	 	3.7	 	HOLLISTER-STIER represents and warrants to BIOPORT as follows:

	 	3.7.1	 	HOLLISTER-STIER’s performance of the filling services will not violate or
misappropriate any patent, copyright, trademark, trade secret or other intellectual
property right of any third party (other than as may be due to HOLLISTER-STIER’s
compliance with BIOPORT’s instructions or other matters bearing on the Bulk Product or
its filling that are the responsibility of BIOPORT as provided herein).
	 
	 	3.7.2	 	The Filled Product shall when delivered to BIOPORT hereunder meet all
Filling Process Specifications, be of good, merchantable and usable quality, free of
defects in materials and workmanship, suitable for the purposes for which the Filled
Product is to be used, and shall not be adulterated or misbranded within the meaning
of the Act or other substantially similar laws and statutes; provided, however, that
the foregoing shall not apply to the extent that any defect or deficiency is caused by
the Bulk Product or any other materials or technologies provided by BIOPORT or is due
to HOLLISTER-STIER’s compliance with the
Filling Process Specifications or any other instructions provided by BIOPORT.

HS Filling Services Agreement — Final — March 18, 2002

3

 

	 	3.7.3	 	Subject to obtaining the rights and authorizations that are the
responsibility of BIOPORT pursuant to Section 4.10, HOLLISTER-STIER’s manufacturing
facilities for the Filled Product: (a) conform, and will conform throughout the term
of this Agreement, in all material respects with applicable laws, regulations and
approvals governing such facilities, including but not limited to the cGMP as defined
by 21 Code of Federal Regulations Sections 210, 211, et seq., (b) will be adequate to
produce at least [**] Filled Lots per annum; and (c) shall conform to FDA requirements
for a multiple product facility, including without limitation with respect to
prevention of cross contamination of products.
	 
	 	3.7.4	 	HOLLISTER-STIER shall not, during the term of this Agreement, fill any
penicillin-based products, beta-lactam-based products, live viral vaccines or spore
forming products in the same small volume parenteral facility used to fill any of the
Filled Products (the “Filling Suite”).
	 
	 	3.7.5	 	All product contact parts used to fill the Filled Product will be dedicated
solely to Filled Product or disposed after each use.

	3.8	 	BIOPORT represents and warrants to HOLLISTER-STIER as follows:

	 	3.8.1	 	BIOPORT has the full power and authority to grant the licenses it grants
under this Agreement and to engage HOLLISTER-STIER hereunder, and the granting of the
licenses granted to HOLLISTER-STIER hereunder, and the exercise by HOLLISTER-STIER of
the rights granted by BIOPORT under such engagement or licenses will not breach any
obligation to or right of any third party.
	 
	 	3.8.2	 	Neither the Bulk Product, the BIOPORT technology licensed hereunder, nor the
use thereof by HOLLISTER-STIER, nor HOLLISTER-STIER’s conduct of the filling services
in conformity with the Filling Process Specifications, shall cause HOLLISTER-STIER to
violate any law or infringe, violate or misappropriate any patent, copyright,
trademark, trade secret or other intellectual property right of any third party.
	 
	 	3.8.3	 	The Bulk Product shipped by BIOPORT to HOLLISTER-STIER shall be accompanied
by a complete and accurate AVA Bulk Formulation Lot Approval for Filling Form (the
“Approval for Filling Form”), duly signed by an authorized representative of BIOPORT’s
Quality Assurance Department, and be of good, merchantable and usable quality, free of
defects in materials and workmanship, suitable for the purposes for which the Bulk
Product is to be used, and shall not be adulterated or misbranded within the meaning
of the Act. The Bulk Product does not and will not contain any select agent as
defined in subsection (j) of 42 CFR section 72.6, unless the same is exempted under
subsection (h) of such section 72.6 or Appendix A of 42 CFR part 72, as such
provisions may be amended from time to time.
	 
	 	3.8.4	 	BIOPORT shall not release any Filled Product for distribution, sale or use
without conducting all testing and certifications thereof that are the responsibility
of BIOPORT hereunder or under current health, safety and environmental regulations,
laws, Health Authority rules and regulations, and industry standards.

	 	 	THE WARRANTIES SET FORTH HEREIN ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY EITHER PARTY
UNDER THIS AGREEMENT, AND NEITHER PARTY MAKES ANY OTHER WARRANTIES EXPRESS OR IMPLIED OR
ARISING BY
LAW, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY ARISING FROM THE COURSE OF
PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE.

HS Filling Services Agreement — Final — March 18, 2002

4

 

	 	 	EXCEPT FOR THE INDEMNITY OBLIGATIONS SET FORTH IN THIS AGREEMENT OR FOR BREACHES OF THE
CONFIDENTIALITY OBLIGATIONS SET FORTH IN THIS AGREEMENT, UNDER NO CIRCUMSTANCES WILL EITHER
PARTY BE LIABLE TO THE OTHER UNDER ANY CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE OR
OTHER LEGAL OR EQUITABLE THEORY, FOR COVER OR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES OR LOST PROFITS IN CONNECTION WITH THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING
WITHOUT LIMITATION THE BULK PRODUCT OR FILLED PRODUCT OR ANY SERVICES PROVIDED OR TO BE
PROVIDED IN CONNECTION WITH THE BULK PRODUCT OR FILLED PRODUCT.
	 
	4.0	 	COVENANTS

	 	4.1	 	The sterile Bulk Product and all vials, stoppers, seals and other materials to be
provided by BIOPORT pursuant to the Filling Process Specifications will be delivered to
HOLLISTER-STIER at BIOPORT’s expense and liability, along with BIOPORT’s Approval for
Filling Form for each Bulk Lot. BIOPORT shall deliver or cause to be delivered quantities
of Bulk Product and such other items, and shall do so in a timely manner, sufficient for
HOLLISTER-STIER to perform the filling services called for hereunder.
	 
	 	4.2	 	To the extent called for in the Filling Process Specifications, HOLLISTER-STIER shall
conduct materials tests of each Bulk Lot, but no such testing (or failure so to test) will
relieve BIOPORT of its responsibility hereunder to deliver the Bulk Product in conformity
with the requirements of the Approval for Filling Form, as based on the Bulk Product
Specifications. If such materials tests indicate that any of the Bulk Product does not meet
the requirements of the Approval for Filling Form, as based on the Bulk Product
Specifications, HOLLISTER-STIER will immediately so inform BIOPORT and BIOPORT will supply
replacement Bulk Product that does conform to the Bulk Product Specifications.
	 
	 	4.3	 	For each Filled Lot filled by HOLLISTER-STIER, HOLLISTER-STIER shall perform the
following testing for compliance with the Filling Process Specifications: final container
sterility and gross visual inspection. Upon completion of such testing and review of
manufacturing records, HOLLISTER-STIER shall submit to BIOPORT a COA listing the results of
such testing and copies of all agreed upon records. Subject to HOLLISTER-STIER’s prior
consent (such consent not to be unreasonably withheld if either the same does not add to the
costs of HOLLISTER-STIER’s performance hereunder or BIOPORT agrees to bear all additional
costs associated with the same), BIOPORT, may, from time to time, change the type of test(s)
or the form of the records to be provided by HOLLISTER-STIER to BIOPORT for each Filled Lot.
	 
	 	4.4	 	BIOPORT is responsible for the release of the Filled Product for sale or distribution.
	 
	 	4.5	 	BIOPORT is responsible for the Stability Testing Program for the Filled Product.
	 
	 	4.6	 	BIOPORT is responsible for maintaining Retention Samples of Filled Product.
	 
	 	4.7	 	BIOPORT is responsible for compliance with the requirements of all Health Authorities
concerning the reporting of any adverse reactions or other events (“Adverse Events”) that
may occur as the result of the manufacture, testing, sale or use of the Bulk Product or the
Filled Product. HOLLISTER-STIER shall advise BIOPORT promptly of any Adverse Event, safety
or toxicity problem reported to HOLLISTER-STIER regarding Filled Product.
	 
	 	4.8	 	Except as required by applicable law and/or regulations, or in order to seek approval of
any Health Authority, neither Party shall make any use of the other Party’s name,

HS Filling Services Agreement — Final — March 18, 2002

5

 

	 	 	 	whether in
a press release, company profile, promotional or advertising material or otherwise, without
the other Party’s prior written approval.
	 
	 	4.9	 	BIOPORT and HOLLISTER-STIER shall provide to each other copies of all correspondence from
Health Authorities related to the Bulk Product or Filled Product, including all inspection
reports issued by Health Authorities during the term of this Agreement, provided, however,
that BIOPORT shall only be required to provide such copies to the extent they relate to the
filling process or the filling services of HOLLISTER-STIER. HOLLISTER-STIER shall provide
informal notice within 24 hours by telephone of any such inquiry or inspection. All
documents provided by HOLLISTER-STIER to any Health Authority, with respect to Filled
Product or Bulk Product or its SVP facility, shall be provided to BIOPORT in advance for
review and comment if feasible, and in no case shall such documents be provided to BIOPORT
later than three (3) business days after such documents are provided to any Health
Authority. To the extent permitted by law or regulation: (a) HOLLISTER-STIER shall promptly
notify BIOPORT of all Health Authority inspections concerning the Filled Product or Bulk
Product, and (b) BIOPORT shall have the right to be present for such inspection, at
BIOPORT’s risk and expense.
	 
	 	4.10	 	While HOLLISTER-STIER shall be responsible to obtain and maintain any
generally-applicable FDA approvals of its facility as a licensed FDA facility (i.e., not
specific to the manufacture of Filled Product or to the receipt, storage, shipping or
handling of Bulk Product or Filled Product), BIOPORT shall be solely responsible at its risk
and expense for obtaining all permits, licenses, and authorizations necessary for
HOLLISTER-STIER to fill and ship the Filled Product under this Agreement. Filling
operations are to be performed using appropriate safety measures and containment techniques
as dictated by current health, safety and environmental regulations, laws, Health Authority
rules and regulations, and industry standards.
	 
	 	4.11	 	BIOPORT shall supply HOLLISTER-STIER with a Safety Sheet and the U.S. Department of
Transportation Hazard Classification for the Bulk Product and Filled Product.
HOLLISTER-STIER and BIOPORT shall cooperate reasonably to develop mutually-agreed safety
procedures as amendments to the Filling Process Specifications, for the handling of the Bulk
Product and Filled Product and treatment or disposal of wastes relating thereto that comply
with all federal, and state environmental and occupational safety and health requirements.
HOLLISTER-STIER shall, in accordance with BIOPORT’s instructions, ship rejected Bulk Product
or Filled Product to such destination as BIOPORT shall designate in writing. The expense for
disposal or reclamation of rejected Bulk Product or Filled Product and waste shall be borne
by BIOPORT, provided, however, that the expense for disposal of rejected Bulk Product or
Filled Product due to failure of HOLLISTER-STIER to perform its obligations under this
Agreement shall be borne by HOLLISTER-STIER. HOLLISTER-STIER will not dispose of rejects or
waste Bulk Product or Filled Product without prior written consent from BIOPORT.
	 
	 	4.12	 	No changes to the Filling Process Specifications shall be made without the mutual written
consent of BIOPORT and HOLLISTER-STIER. However, the Parties agree to amend the Filling
Process Specifications at the times, and in accordance with the procedures, set forth in the
Filling Process Specifications, in order, among other things, to alter the preliminary
Percentage Yield called for under the Filling Process Specifications to reasonably reflect
the Yields obtained by HOLLISTER-STIER in the initial Filled Lots during the term hereof.
	 
	 	4.13	 	HOLLISTER-STIER shall not make any changes or additions to or alter in any way its
Filling Suite, or the equipment, testing procedures, validation, suppliers of raw materials
and components, or documentation systems that relate to the Bulk Product or the Filled
Product without the prior written consent of BIOPORT, which consent shall not be
unreasonably withheld or delayed.

HS Filling Services Agreement — Final — March 18, 2002

6

 

	 	4.14	 	HOLLISTER-STIER shall provide BIOPORT with not less than thirty (30) days advance written
notice of HOLLISTER-STIER’s commencement of production or filling in the Filling Suite of
any product that is not within one or more of the Product Classifications specified in the
Filling Process Specifications. “Product Classifications” means those types and classes of
products any of which are or have been produced or filled in the Filling Suite, including
those as of or prior to the Effective Date and those of which HOLLISTER-STIER gives notice
under this Section (all of which shall be deemed from that point forward to be added to the
list of Prior Product Classifications in the Filling Process Specifications).
	 
	 	4.15	 	The Parties agree that the filling services under this Agreement shall be conducted at
the HOLLISTER-STIER facility in Spokane, Washington.
	 
	 	4.16	 	Subject to the confidentiality provisions of Section 8, BIOPORT shall have the right, at
its risk and expense, to have personnel on site (maximum of two people) observing operations
during filling and other related activities.

	5.0	 	ORDERING AND SUPPLY OF FILLED PRODUCT

	 	5.1	 	HOLLISTER-STIER agrees to meet all of BIOPORT’s firm purchase orders for Filled Product,
based on BIOPORT’s forecasts for Filled Product as set forth in Section 5.2 of this
Agreement.
	 
	 	5.2	 	BIOPORT and HOLLISTER-STIER shall cooperate in estimating and scheduling production of
commercial orders.

	 	5.2.1	 	BIOPORT shall annually provide a Good Faith Annual Estimate of the timing
and pace of its expected specific orders for Filled Product. The first such Good
Faith Annual Estimate shall be given upon execution of this Agreement and shall cover
orders during the remainder of the First Term Year, and subsequent Good Faith Annual
Estimates shall be delivered to HOLLISTER-STIER on or before each November 1, with
respect to the next following Term Year. The estimates in each Good Faith Annual
Estimate shall be good faith forecasts to assist HOLLISTER-STIER in planning its
production and shall be non-binding and without prejudice to BIOPORT’s subsequent firm
orders.
	 
	 	5.2.2	 	Subject to Section 5.2.4, on or before the first day of each calendar month,
BIOPORT shall provide a firm purchase order for the next following calendar month,
thereby constituting a rolling monthly firm purchase order; provided, however, that
during any Term Year in which BIOPORT is filling AVA itself (or is actively preparing
to do so), or is obtaining or has contracted to obtain AVA filling services from any
other source, BIOPORT shall, on or before the first day of each calendar month,
provide a firm purchase order for the next three following calendar months, thereby
constituting a rolling three-month firm purchase order.
	 
	 	5.2.3	 	To the extent that BIOPORT requests that HOLLISTER-STIER fill more lots than
are the subject of a firm purchase order, HOLLISTER-STIER shall accommodate such
additional fill requests subject to its then-available production capacity.
	 
	 	5.2.4	 	BIOPORT may, without charge or breach of this Agreement, cancel or delay any
firm order for a Filled Lot or Filled Lots, provided that it gives HOLLISTER-STIER
notice of such cancellation or delay prior to the acceptance of the Bulk Lot for such
Filled Lot(s) by HOLLISTER-STIER in accordance with the incoming
inspection requirements as set forth in the Filling Process Specifications. Where
BIOPORT gives such notice of a delay, rescheduling of the delayed Filled Lot

HS Filling Services Agreement — Final — March 18, 2002

7

 

shall
be accommodated into HOLLISTER-STIER’s schedule subject to its then-available
production capacity. Following such arrival of the Bulk Lot for a Filled Lot
covered by a firm order, BIOPORT may not cancel or delay such Filled Lot unless it
pays HOLLISTER-STIER a fee (the “Order Change Fee”) equal to [**]% of the aggregate
Lot Production Fee (determined under Article 6) for the Filled Lot(s) that are so
cancelled or delayed by BIOPORT. The parties agree that the Order Change Fee is a
reasonable fee (and not a penalty) to compensate HOLLISTER-STIER for disruptions in
its personnel planning and facilities usage.

	 	5.3	 	If BIOPORT believes that a Filled Lot as delivered to it by HOLLISTER-STIER does not
conform to the Filling Process Specifications, BIOPORT shall promptly so notify
HOLLISTER-STIER, specifying the grounds for BIOPORT’s belief in as much detail as is
available to BIOPORT. If HOLLISTER-STIER disagrees, the Parties shall use their best
efforts to resolve such disputes amicably. If the parties are unable to resolve the
dispute, the matter shall be referred for resolution to an independent laboratory or other
recognized expert, agreed to by the parties, whose decision shall be final and binding. Any
charges of such laboratory or expert shall be paid for by the party against whom the dispute
is decided. If BIOPORT does not give HOLLISTER-STIER such a notice of non-conformity prior
to the tenth (10th) business day following delivery of the COA for a given Filled
Lot and the batch record for such Filled Lot, BIOPORT will be deemed to have accepted such
Filled Lot.
	 
	 	5.4	 	Where volumes of Bulk Product in excess of those anticipated under the Percentage Yields
called for in the Filling Process Specifications do not meet the Filling Process
Specifications or are made unusable or are otherwise destroyed in the course of the filling
services for a Filled Lot, but the balance of such Filled Lot remains in conformity with
this Agreement, BIOPORT shall AS ITS SOLE REMEDY THEREFOR, be entitled to a prorata price
adjustment to reflect the shortfall (to the extent under such Percentage Yield) in the
anticipated volume in such Filled Lot. As an example, if the Percentage Yield called for in
the Filling Process Specifications for a Filled Lot is [**]% and the actual Percentage Yield
achieved for such Filled Lot is [**]%, then the price for such Filled Lot (as otherwise
determined under Article 6) would be reduced by [**]% (representing [**]% — [**]%).
	 
	 	5.5	 	If an entire Filled Lot is made unusable or is destroyed, either through the fault of
HOLLISTER-STIER or otherwise because it does not meet the Filling Process Specifications,
HOLLISTER-STIER shall promptly so inform BIOPORT or BIOPORT shall promptly so inform
HOLLISTER-STIER, as the case may be, together with an explanation of the circumstances and
HOLLISTER-STIER shall, AS BIOPORT’S SOLE REMEDY THEREFOR, (i) conduct the filling services
for the replacement Bulk Lot without charge, including bearing the cost of vials, stoppers,
seals and other costs associated with the filling and preparation for shipment of the Filled
Product, provided that BIOPORT at its risk and expense (other than shipping costs) supplies
the replacement Bulk Lot; (ii) conduct a non-conforming materials run without charge to
BIOPORT, if reasonably so requested by BIOPORT; (iii) conduct, without charge to BIOPORT,
appropriate additional training of personnel, development work and/or technical studies to
address the causes underlying the failed fill as BIOPORT and HOLLISTER-STIER agree in good
faith after consultation are called for under the circumstances; and (iv) pay for all
destruction costs associated with the rejected material, including any shipment related
expenses, any such destruction only to occur with BIOPORT’s prior written consent.

	6.0	 	PRICE — PAYMENT

	 	6.1	 	The initial price to be paid by BIOPORT for the filling services for each Filled Lot (the
“Lot Production Fee”) shall be [**] dollars ($[**]); provided, however, that effective for
Filled

HS Filling Services Agreement — Final — March 18, 2002

8

 

	 	 	 	Products shipped following the thirtieth day after the first and each subsequent
anniversary of the Effective Date, the initial Lot Production Fee set forth above shall be
increased to reflect increases (if any, but not decreases) since the Effective Date in the
“Producer Price Index — Pharmaceutical Preparations” (code PCU2834) published by the US
Bureau of Labor Statistics, or if the same is no longer published, the successor index
published by the US BLS that is most similar thereto (the “Index”).
	 
	 	6.2	 	All prices for Filled Product shall be on the basis of Filled Product being shipped
F.O.B. HOLLISTER-STIER’s plant in Spokane, Washington. Shipment of Filled Product shall be
arranged by BIOPORT and the cost and liability of such shipment shall be borne by BIOPORT.
	 
	 	6.3	 	In addition to the prices for Filled Product specified under Section 6.1, and the matters
described in Sections 4.3 and 4.10, certain additional costs specifically associated with
HOLLISTER-STIER’s performance and preparation for performance under this Agreement have been
borne by BIOPORT and/or the U.S. Government under separate agreements, either as one-time
costs or otherwise. Any future such additional costs shall be negotiated by the parties in
good faith, and where appropriate BIOPORT shall assist HOLLISTER-STIER to obtain
reimbursement therefor from the U.S. Government, either directly or through BIOPORT.
	 
	 	6.4	 	HOLLISTER-STIER will issue an invoice at such time as BIOPORT has accepted the Filled Lot
pursuant to Section 5.3.
	 
	 	6.5	 	BIOPORT will be required to pay HOLLISTER-STIER for all Filled Product ordered during any
period when Production and Testing Procedures have not been fully developed and validated,
either initially or due to any agreed changes or modifications thereto.
	 
	 	6.6	 	During periods when the cost for filling services is to be directly reimbursed by the
Government to BIOPORT: (a) BIOPORT will include HOLLISTER-STIER’s invoice amounts, with
respect to Filled Product to be provided to the U.S. Government, in its invoice to the
Government submitted on or before the 30th day of the month and shall pay
HOLLISTER-STIER within ten (10) days of receiving payment from the Government; and (b)
regardless of whether BIOPORT shall receive compensation from the Government, BIOPORT shall
pay HOLLISTER-STIER a minimum of [**]% of the invoiced amount within thirty (30) days of
receipt of HOLLISTER-STIER’s invoice and shall within 90 days of HOLLISTER-STIER’s issuance
of the invoice pay HOLLISTER-STIER the balance of the invoiced amounts if BIOPORT has not
received payment from the Government due to any fault or deficiency in BIOPORT’s
performance, billing or documentation under its contract with the Government. During
periods when the cost for filling services is to be included in the price of Filled Product
to be provided by BIOPORT to the Government, and at all times with respect to Filled Product
to be supplied to any BIOPORT customer other than the U.S. Government, BIOPORT shall pay
HOLLISTER-STIER’s invoices within thirty days of receipt of invoice.
	 
	 	6.7	 	The remittance address for payments to HOLLISTER-STIER hereunder is:

Hollister-Stier Laboratories LLC

P.O. 201236

Dallas, Texas 75320-1236

	7.0	 	AUDITS AND INSPECTIONS. HOLLISTER-STIER shall allow up to [**] of BIOPORT’s personnel (or
its authorized representatives as approved for such purpose by HOLLISTER-STIER, which approval
shall not be unreasonably withheld) access, during
normal business hours up to two (2) times per Term Year (and not more than three days per
time), to HOLLISTER-STIER’s facilities for the purpose of conducting a quality

HS Filling Services Agreement — Final — March 18, 2002

9

 

	 	 	systems
audit as such systems relate to the filling and packaging of the Filled Products.
HOLLISTER-STIER’s personnel shall provide such BIOPORT personnel or such approved
authorized representatives with all necessary assistance, including access to documents and
reports to the extent bearing on the filling services (including but not limited to
validation documents), during such inspections. The failure to inspect shall not be deemed
a waiver of any of BIOPORT’s rights or of HOLLISTER-STIER’s obligations under this
Agreement.
	 
	8.0	 	CONFIDENTIALITY. The parties acknowledge and agree that the terms and conditions of this
Agreement shall remain confidential. The Parties acknowledge and agree that all Confidential
Information of a Party shall be considered confidential and proprietary to such Party. Each
Party agrees not to use any Confidential Information of the other Party for any purpose other
than as permitted herein or required for the performance by such Party of its obligations
hereunder. Each Party also agrees, during and following the term of this Agreement, not to
disclose or provide any of the other Party’s Confidential Information except to its personnel,
contractors or consultants with a need to know the same for purposes of such Party’s
performance under this Agreement and to take reasonable precautions (at least as protective as
those such Party takes to protect its own, and in no event less than reasonable precautions,
to prevent the disclosure of the other Party’s Confidential Information to any other third
party or for any other purpose. Nothing herein shall prevent either Party from disclosing any
Confidential Information of the other Party to the extent such disclosure is required by
applicable law or regulation, or by order of any court or governmental body, provided that
such Party gives the other Party such advance notice of the disclosure as may be practicable
under the circumstances and assists with any reasonable attempts by such other Party to limit
or to restrict such disclosure in accordance with applicable law.
	 
	9.0	 	AUTHORIZED CONTACTS. The Parties will interact for purposes of this Agreement primarily
through their designated primary contacts. HOLLISTER-STIER’s primary contact for this
Agreement is [**], and BIOPORT’s primary contact for this Agreement is [**]. Either Party may
change its primary contact from time to time by written notice from either the out-going
primary contact or from such Party’s President.
	 
	10.0	 	TERM AND TERMINATION. This Agreement will become effective as of the Effective Date and
shall continue in effect until the end of the fifth Term Year (December 31, 2006), provided,
however, that either party may terminate this Agreement in the event of a material breach by
the other party of any one or more terms or obligations of this Agreement which is not
remedied within ninety (90) days after receipt of written notice of the breach from the
non-breaching party or, if such breach cannot reasonably be cured within such 90-day period,
if the breaching party has failed to commence such cure within the 90-day period or to proceed
diligently to prosecute such cure to completion within a reasonable time thereafter.
	 
	11.0	 	RELATIONSHIP OF PARTIES. With respect to the subject matter under this Agreement, the Parties
are and remain independent contractors. This Agreement shall not be deemed to create a joint
venture, partnership, association, or agency between the Parties. Neither Party hereunder is
authorized to incur or create any obligation, express or implied, on behalf of the other Party
or to bind the other Party in any manner whatsoever.
	 
	12.0	 	DISPUTES. All disputes arising under this Agreement that can not be settled amicably, shall
be finally resolved by arbitration in Chicago, Illinois, before a single arbitrator pursuant
to the Commercial Arbitration Rules of the American Arbitration Association then in effect,
and any arbitral award thereon may be enforced by any court of competent
jurisdiction. The prevailing Party in any arbitration shall be entitled to reimbursement
from the other Party for the prevailing Party’s attorneys fees and other costs and

HS Filling Services Agreement — Final — March 18, 2002

10

 

	 	 	expenses
incurred in, and in preparation for, the arbitration and the enforcement of any judgment
therefrom.
	 
	13.0	 	INSURANCE. BIOPORT and HOLLISTER-STIER each agree to maintain in force during the term of
this Agreement product liability and other insurance coverage commensurate with industry
standards and practices.
	 
	14.0	 	NO LIENS. HOLLISTER-STIER will not allow, directly or indirectly, create, incur, assume or
permit to exist any lien or encumbrance of any kind on the Bulk Product or Filled Product.
	 
	15.0	 	NO SOLICITATION OF EMPLOYEES OR CUSTOMERS. Both Parties agree that, during the term of this
Agreement, and for a period of twelve (12) consecutive months after termination of such
Agreement, neither of the Parties will (a) directly induce or attempt to induce or otherwise
counsel, advise, solicit or encourage any employee to leave the employ of the other Party or
to accept employment with any other person or entity, (b) employ any person who, as of the
time of such employment, had left the employ of the other Party within the previous six (6)
months, and (c) actively solicit any customer, client, or business partner of the other Party
to cease or reduce its relationship with that Party or induce or attempt to induce any such
customer, client, or business partner to breach any agreement that such customer, client, or
business partner may have with the other Party.
	 
	16.0	 	INDEMNIFICATION.

	 	16.1	 	Indemnification of BIOPORT. HOLLISTER-STIER shall indemnify, defend and hold BIOPORT and
its directors, personnel, owners, and agents harmless from and against any and all damages,
losses, obligations, deficiencies, liabilities, costs, expenses, penalties, claims and
encumbrances, including without limitation, attorneys’ fees and disbursements, resulting
from or arising out of any third party claim or demand, including but not limited to a claim
or demand for bodily injury or death, alleged to have arisen due to or in connection with
any breach of warranty by HOLLISTER-STIER hereunder or otherwise due to or in connection
with a manufacturing defect in any Filled Product manufactured by HOLLISTER-STIER otherwise
than in accordance with the Filling Process Specifications.
	 
	 	16.2	 	Indemnification of HOLLISTER-STIER. BIOPORT agrees to indemnify, defend, and hold
harmless HOLLISTER-STIER and its directors, personnel, owners, and agents from and against
any and all damages, losses, obligations, deficiencies, liabilities, costs, expenses,
penalties, claims and encumbrances, including, without limitation, attorneys’ fees and
disbursements, resulting from and arising out of any third party claim or demand, including
but not limited to a claim or demand for bodily injury or death, alleged to have arisen due
to or in connection with any breach of warranty by BIOPORT hereunder or otherwise due to or
in connection with the production, use, sale, distribution, advertising and/or marketing of
the Bulk Product or the Filled Product, except to the extent such claim or demand is the
result of HOLLISTER-STIER’s failure to manufacture Filled Product in accordance with the
Filling Process Specifications.
	 
	 	16.3	 	Procedures. Subject to the requirements and procedures specified in FAR 52.250-1, where
applicable, BIOPORT and HOLLISTER-STIER agree to give, and agree that their respective
directors, personnel, owners, and agents shall give, to the Party that is obligated to
indemnify pursuant to this Section 16: (a) prompt notice of any claim or suit coming within
the scope of the indemnities in this Section, (b) all relevant facts in its possession or
control, (c) the right to exclusively control the defense or settlement of any action unless
the Party or person being indemnified reasonably determines that a conflict
of interest exists with respect to such assumption of such control due to actual or

HS Filling Services Agreement — Final — March 18, 2002

11

 

	 	 	 	potential differing interests between the parties, and (d) its reasonable cooperation in
the defense or settlement of any such action.
	 
	 	16.4	 	Limitation of Indemnification Liability. Neither party shall have any liability under
this Section to the other or its directors, personnel, owners, and agents to the extent that
damages, losses, obligations, deficiencies, liabilities, costs, expenses, penalties, claims
and encumbrances result from the willful misconduct or gross negligence of the Party seeking
indemnification (or whose directors, personnel, owners, and agents are seeking
indemnification), or that of its officers directors, agents or employees.

	17.0	 	LIMITATION OF LIABILITY.
	 
	 	 	Neither party shall be responsible to the other for payment of consequential, special or
incidental damages. With the exception of a third party claim or demand for bodily injury
or death alleged to have arisen due to or in connection with the manufacture of Filled
Product by HOLLISTER-STIER otherwise than in accordance with the Filling Process
Specifications, in no event shall HOLLISTER-STIER’s liability under Section 16 hereof
exceed the Lot Production Fee and the other costs as described in Section 5.4 hereof to be
borne by HOLLISTER-STIER.
	 
	18.0	 	FORCE MAJEURE.
	 
	 	 	If either Party’s performance of its respective obligations hereunder is prevented or made
unprofitable to it by fire, strike, lockouts, war, civil disturbances, acts of God, altered
laws or regulations, or other similar or dissimilar events beyond the reasonable control of
the Party, the Party will not be liable to the other Party for damages or for breach of
this Agreement. The Party being able to perform may, at its sole option, either (a)
terminate this Agreement if the other Party is or reasonably appears likely to be so
prevented from performing for a period in excess of 120 days, (b) extend the term of this
Agreement by a period equal in length to the period during which the other Party was unable
to perform its obligations hereunder, or (c) waive such obligations.
	 
	19.0	 	SEVERABILITY.
	 
	 	 	In the event that any one or more of the agreements, covenants, provisions or terms
contained herein shall be declared invalid, illegal or unenforceable in any respect, the
validity of the remaining agreements, covenants, provisions or terms contained herein shall
in no way be affected, prejudiced or invalidated thereby.
	 
	20.0	 	PRIME CONTRACT FLOW DOWN
	 
	 	 	The following Federal Acquisition Regulations (“FAR”) clauses are incorporated herein by
reference:
	 
	 	 	The services being provided by HOLLISTER-STIER under this Filling and Packaging Agreement
represent subcontracted work under U.S. Army Medical Research and Material Command contract
DAMD17-98-C-8052. The following provisions in that contract are hereby incorporated by
reference into this subcontract and made a part thereof except that where not inappropriate
in the context of the clauses (e.g., it is agreed to be inappropriate to alter the meaning
of “Government” or of “Contracting Officer” in clause 52.249-2, “Termination for
Convenience of the Government” in this way, and clause 52.249-2 will only be applied to
this Agreement if and to the extent that the Government exercises that clause to terminate
BIOPORT’s agreements with the Government), “Government” shall mean “BIOPORT”, “Contracting
Officer” shall mean
“BIOPORT’s representative”, “Contractor” shall mean HOLLISTER-STIER, and other terms shall
be appropriately revised to reflect that this is a subcontract:

HS Filling Services Agreement — Final — March 18, 2002

12

 

     Federal Acquisition Regulation Clauses:

	 	 	 	 	 
	 

	 	52.202-3
	 	Gratuities (Apr 1984)
	 
	 	 	 	 
	 

	 	52.203-1
	 	Officials Not To Benefit (Apr 1984)
	 
	 	 	 	 
	 

	 	52.203-5
	 	Covenant Against Contingent Fees (Apr 1984)
	 
	 	 	 	 
	 

	 	52.203-6
	 	Restrictions on Subcontractor Sales to the Government (Jul 1995)
	 
	 	 	 	 
	 

	 	52.203-7
	 	Anti-Kickback Procedures (Jul 1995)
	 
	 	 	 	 
	 

	 	52.203-8
	 	Cancellation, Rescission, and Recovery of Funds for Illegal or
Improper Activity (Jan 1997)
	 
	 	 	 	 
	 

	 	52.203-12
	 	Limitation on Payments to Influence Certain Federal Transactions
(Jun 1997)
	 
	 	 	 	 
	 

	 	52.211-15
	 	Defense Priority and Allocation Requirements (Sep 1990)
	 
	 	 	 	 
	 

	 	52.215-2
	 	Audit and Records — Negotiation (Aug 1996)
	 
	 	 	 	 
	 

	 	52.215-13
	 	Subcontractor Cost or Pricing Data-Modifications (Oct 1997)
	 
	 	 	 	 
	 

	 	52.215-15
	 	Termination of Defined Benefit Pension Plans (Oct 1997)
	 
	 	 	 	 
	 

	 	52.215-18
	 	Reversion or Adjustment of Plans for Postretirement Benefits
(PRB) Other Than Pensions (Oct 1997)
	 
	 	 	 	 
	 

	 	52.215-19
	 	Notification of Ownership Changes (Oct 1997)
	 
	 	 	 	 
	 

	 	52.219-8
	 	Utilization of Small Business Concerns and Small Disadvantaged
Business Concerns (Feb 1990)
	 
	 	 	 	 
	 

	 	52.222-3
	 	Convict Labor (Aug 1996)
	 
	 	 	 	 
	 

	 	52.222-4
	 	Contract Work Hours and Safety Standards Act — Overtime
Compensation (Mar 1986)
	 
	 	 	 	 
	 

	 	52.222-20
	 	Walsh-Healey Public Contracts Act (Dec 1996)
	 
	 	 	 	 
	 

	 	52.222-26
	 	Equal Opportunity (Apr 1984)
	 
	 	 	 	 
	 

	 	52.222-35
	 	Affirmative Action for Disabled Veterans and Veterans of the
Vietnam Era (Apr 1998)
	 
	 	 	 	 
	 

	 	52.222-36
	 	Affirmative Action for Workers with Disabilities (Jun 1998)
	 
	 	 	 	 
	 

	 	52.222-37
	 	Employment Reports on Disabled Veterans and Veterans of the
Vietnam Era (Apr 1998)
	 
	 	 	 	 
	 

	 	52.223-2
	 	Clean Air and Water (Apr 1984)
	 
	 	 	 	 
	 

	 	52.223-6
	 	Drug-Free Workplace (Jan 1997)
	 
	 	 	 	 
	 

	 	52.223-14
	 	Toxic Chemical Release Reporting (Oct 1996)
	 
	 	 	 	 
	 

	 	52.225-10
	 	Duty-Free Entry (Apr 1984)
	 
	 	 	 	 
	 

	 	52.225-11
	 	Restrictions on Certain Foreign Purchases (Aug 1998)
	 
	 	 	 	 
	 

	 	52.226-2
	 	Notice and Assistance Regarding Patent and Copyright
Infringement (Aug 1996)

HS Filling Services Agreement — Final — March 18, 2002

13

 

	 	 	 	 	 
	 

	 	52.227-1
	 	Authorization and Consent (Jul 1995)
	 
	 	 	 	 
	 

	 	52.242-12
	 	Report of Shipment (REPSHIP) (Jul 1995)
	 
	 	 	 	 
	 

	 	52.243-1
	 	Changes — Fixed-Price (Aug 1987)
	 
	 	 	 	 
	 

	 	52.249-2
	 	Termination for Convenience of the Government (Fixed-Price) (Sep
1996)
	 
	 	 	 	 
	 

	 	52.249-8
	 	Default (Fixed-Price Supply and Service) (Apr 1984)
	 
	 	 	 	 
	 

	 	52.249-14
	 	Excusable Delays (Apr 1984)
	 
	 	 	 	 
	 

	 	52.250-1
	 	Indemnification under Public Law 85-804 (4/84)

	 	 	Copies of these clauses are available in applicable Government publications. Some clauses
are no longer set forth in the current FAR and must be obtained from prior versions of the
FAR.
	 
	21.0	 	CONDITION PRECEDENT TO AGREEMENT.
	 
	 	 	Except for the last sentence of this Section 21, this Agreement shall not be effective
until the Contracting Officer under the contract DAMD98-C-8052 between BIOPORT and the U.S.
Government (“8052”) shall consent in writing to this Agreement as a subcontract to 8052 and
shall approve pass-through indemnification to HOLLISTER-STIER under FAR clause 52.250-1 and
that certain Memorandum of Decision of the Secretary of the Army dated November 15, 2000
(“Authority under Public Law (PL) 85-804 to include an Indemnification Clause in ...
Contract No. DAMD17-98-C-8052 with BioPort Corporation (BioPort),” herein the “MOD”). The
MOD is hereby incorporated into this Agreement by this reference. BIOPORT shall exert its
continuing commercially reasonable best efforts to promptly secure such consent.
	 
	22.0	 	DEPARTMENT OF DEFENSE CONTRACTS.
	 
	 	 	The following contract clauses are incorporated by reference from the Department of Defense
(DOD) Federal Acquisition Regulations (DFARS) and apply with the same force and effect if
given in full text to contracts placed by BIOPORT in connection with DOD contracts. In
addition, all DFARS clauses required by the U.S. Government by statute, regulation or
otherwise to be flowed down are hereby incorporated into this Agreement by this reference.
In all the following clauses, “Contractor” and “Offeror” mean HOLLISTER-STIER and
“Government” and “Contracting Officer” mean BIOPORT and/or Government. Unless otherwise
provided, the clauses are those in effect as of the date of this Contract.
	 
	 	 	Defense Federal Acquisition Regulation Clauses:

	 	 	 	 	 
	 

	 	252.203-7000
	 	Statutory Prohibition on Compensation to Former Department of
Defense Employees (Dec 1991)
	 
	 	 	 	 
	 

	 	252.203-7001
	 	Special Prohibition on Employment (Jun 1997)
	 
	 	 	 	 
	 

	 	252.203-7002
	 	Display of DOD Hotline Poster (Dec 1991)
	 
	 	 	 	 
	 

	 	252.204-7000
	 	Disclosure of Information (Dec 1991)
	 
	 	 	 	 
	 

	 	252.223-7004
	 	Drug-Free Work Force (Sep 1988)
	 
	 	 	 	 
	 

	 	252.231-7000
	 	Supplemental Cost Principles (Dec 1991)
	 
	 	 	 	 
	 

	 	252.243-7001
	 	Pricing of Contract Modifications (Dec 1991)

HS Filling Services Agreement — Final — March 18, 2002

14

 

	 	 	Copies of these clauses are available in applicable Government publications. Some clauses
are no longer set forth in the current DFAR and must be obtained from prior versions of the
DFAR
	 
	23.0	 	NOTICES.
	 
	 	 	Subject to Section 6.7, all notices permitted or required by this Agreement or other
communications to either Party by the other shall be in writing and shall be deemed given
(a) upon personal delivery or (b) three (3) days after being deposited in the United States
mail (first class, postage prepaid) or (c) the day after being given to a reputable carrier
for overnight shipment, addressed as follows:

	 	 	 	 	 
	 

	 	To HOLLISTER-STIER:
	 	Hollister-Stier Laboratories LLC
	 

	 	 	 	P.O. Box 3145
	 

	 	 	 	Spokane, Washington, 99220-3145
	 

	 	 	 	Attn: Anthony Bonanzino, President
	 
	 	 	 	 
	 

	 	To BIOPORT:
	 	BioPort Corporation
	 

	 	 	 	3500 North Martin Luther King Blvd.
	 

	 	 	 	Lansing, MI 48906
	 

	 	 	 	Attn: Robert G. Kramer, President

	24.0	 	ENTIRE AGREEMENT.
	 
	 	 	This Agreement contains the entire agreement between the Parties with respect to the
subject matter hereof and supersedes any prior agreements between them with respect to that
subject matter, including without limitation the Filling and Packaging Services Agreement
dated December 21, 2000.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed effectively as of the
date first written above in two copies, each of which is deemed to be an original.

	 	 	 	 	 	 	 	 	 	 	 
	BIOPORT CORPORATION  	 	 	 	HOLLISTER-STIER	 	 
	 	 	 	 	 	 	LABORATORIES LLC	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By

	 	/s/ Robert G. Kramer
	 	 	 	By
	 	/s/ Anthony Bonanzino	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Its:

	 	President
	 	 	 	Its:
	 	President	 	 

15

 

AMENDMENT NO. 1

TO

FILLING SERVICES AGREEMENT

This Amendment No. 1 to the Filling Services Agreement dated March 18, 2002, by and between
Hollister-Stier Laboratories LLC, a Delaware limited liability company (“Hollister-Stier”), and
BioPort Corporation, a Michigan corporation (“BioPort”), is made effective this 18th day of April
2003.

RECITALS

Hollister-Stier and BioPort deem it desirable and to be in the best interests of the parties to
amend the Agreement as hereinafter described and, therefore, the parties agree as follows:

	A.	 	Amendment
	 
	 	 	Pursuant to Section 6.0 Price — Payment Paragraph 6.1 the price to be paid by BioPort for the
filling services for each Filled Lot (the “Lot Production Fee”) shall be [**] dollars ($[**]) as
of the effective date of this Amendment.
	 
	B.	 	Remaining Agreement
	 
	 	 	Except as set forth in Section A. hereof, all other terms, provisions and conditions of the
Agreement remain in full force and effect as of the date hereof.
	 
	 	 	In WITNESS WHEREOF, the parties have executed this Amendment No. 1 as of the date hereinabove
stated, to be effective as of the date hereinabove stated.

	 	 	 	 	 	 	 	 	 	 	 
	HOLLISTER-STIER LABORATORIES LLC  	 	BIOPORT CORPORATION
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Anthony D. Bonanzino
	 	 	 	By:
	 	/s/ Robert G. Kramer	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name: Anthony D. Bonanzino, Ph. D.	 	Name: Robert G. Kramer
	 
	 	 	 	 	 	 	 	 	 	 
	Title: President and CEO	 	Title: President & COO
	 
	 	 	 	 	 	 	 	 	 	 
	Date: March 13, 2003	 	Date: June 4, 2003

 

 

AMENDMENT NO. 2

TO

FILLING SERVICES AGREEMENT

This Amendment No. 2 to the Filling Services Agreement dated March 18, 2002, by and between
Hollister-Stier Laboratories LLC, a Delaware limited liability company (“Hollister-Stier”), and
BioPort Corporation, a Michigan corporation (“BioPort”), is made effective this 1st day of June
2004.

RECITALS

Hollister-Stier and BioPort deem it desirable and to be in the best interests of the parties to
amend the Agreement as hereinafter described and, therefore, the parties agree as follows:

	A.	 	Amendment
	 
	 	 	Pursuant to Section 6.0 Price — Payment Paragraph 6.1 the price to be paid by BioPort for the
filling services for each Filled Lot (the “Lot Production Fee”) shall be [**] dollars ($[**]) as
of the effective date of this Amendment. This pricing adjustment is based off the successor PPI
index series PCU3254 for Pharmaceutical Preparations Mfg. The new price is calculated by the
net change in the index between the Preliminary index for March of 2004 (355.1) and the base
year index of March 2002 (323.7). The net effective increase in successive years will be
calculated in this same manner, using the preliminary March index net increase over the base
year index of March 2002.
	 
	B.	 	Remaining Agreement
	 
	 	 	Except as set forth in Section A. hereof, all other terms, provisions and conditions of the
Agreement remain in full force and effect as of the date hereof.
	 
	 	 	In WITNESS WHEREOF, the parties have executed this Amendment No. 2 as of the date hereinabove
stated, to be effective as of the date hereinabove stated.

	 	 	 	 	 	 	 	 	 	 	 
	HOLLISTER-STIER LABORATORIES LLC  	 	BIOPORT CORPORATION
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Anthony D. Bonanzino
	 	 	 	By:
	 	/s/ Robert G. Kramer	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name: Anthony D. Bonanzino, Ph. D.	 	Name: Robert G. Kramer
	 
	 	 	 	 	 	 	 	 	 	 
	Title: President and CEO	 	Title: President
	 
	 	 	 	 	 	 	 	 	 	 
	Date: 05/17/2004	 	Date: 5/24/04

 

 

AMENDMENT No. 3

TO

FILLING SERVICES AGREEMENT

     This Amendment No. 3 to the Filling Services Agreement dated March 18, 2002, is made and
entered into this 1st day of September, 2004, by and between BIOPORT CORPORATION, a
Michigan corporation, having its principal place of business at 3500 North Martin Luther King Jr.
Blvd., Lansing, Michigan 48906 (“BIOPORT”), and HOLLISTER-STIER LABORATORIES, LLC, a Delaware
limited liability company, having its principal place of business at 3525 North Regal Street,
Spokane, Washington 99207 (“HOLLISTER-STIER”).

     WHEREAS, BIOPORT and HOLLISTER-STIER entered into a Filling Services Agreement dated March 18,
2002 (the “Agreement”), as modified by Amendments dated April 18, 2003 and June 1, 2004; and

     WHEREAS, pursuant to Modification P00065 to Contract DAMD17-91-C1139, the Department of
Defense reimbursed BIOPORT for the cost of security at HOLLISTER-STIER in the amount of [**]
Dollars ($[**]), which amount BIOPORT in turn paid to HOLLISTER STIER, to cover security for the
period of October 2003 through December 2003; and

     WHEREAS, the Department of Defense has since agreed to reimburse BIOPORT for that portion of
HOLLISTER-STIER’s security costs that are both related to the security of Bulk Product and Filled
Product, as those terms, are defined in the Filling Services Agreement, and only to the extent the
Bulk Product and Filled Product are allocated to a contract between BIOPORT and the Department of
Defense; and

     WHEREAS, the Department of Defense has agreed to reimburse BIOPORT in the amount of [**]
Dollars ($[**]) per month for security for the period of July 2004 through December 2004.

     NOW, THEREFORE, BIOPORT and HOLLISTER-STIER agree as follows:

     1. Definitions. The following definitions apply to this Amendment:

“Monthly Security Costs” shall mean the portion of HOLLISTER-STIER’s security costs each month that
is associated with the services provided by HOLLISTER-STIER pursuant to the Filling Services
Agreement.

“Product Security Guard” shall mean the security guard provided by HOLLISTER-STIER to provide
dedicated security directly in conjunction with the services provided by HOLLISTER-STIER pursuant
to the Filling Services Agreement.

“Timesharing Patrol” shall mean the use of security guards, other than Product Security Guards, to
temporarily substitute for the Product Security Guard for short term breaks.

     2. HOLLISTER-STIER agrees to employ adequate security for the Bulk Product and Filled
Product, as those terms are defined in the Filling Services Agreement, during all times in which
such Bulk Product and/or Filled Product are in the possession and/or control of HOLLISTER-STIER.
Such security shall consist of a Product Security Guard, with additional

 

 

Timesharing Patrols to cover officer breaks.

     3. HOLLISTER-STIER agrees that any personnel providing such security services, either as
Product Security Guard or Timesharing Patrol, shall be fully qualified to provide such services.

     4. BIOPORT agrees to reimburse HOLLISTER-STIER for the Monthly Security Costs. Both Parties
agree that, for the level of services now anticipated under the Filling Services Agreement, the
Monthly Security Costs shall amount to [**] Dollars ($[**]) per month for the time period of July
2004 through December 2004. This agreement creates no obligation for BIOPORT to pay for security
services after 12/31/04. Any compensation for security services after 12/31/04 is subject to
future agreement.

     5. If HOLLISTER-STIER experiences or anticipates an increase in the Monthly Security Costs,
it shall give such adequate advance written notice to allow BIOPORT to request an increase in
reimbursement from the Department of Defense as necessary.

     6. If, during the period of July 2004 through December 2004, BIOPORT determines that such
security services are no longer required, or that it requires a reduction in such services, BIOPORT
shall give HOLLISTER-STIER thirty (30) days written notice pursuant to pursuant to Paragraph 23.0
of the Filling Services Agreement, and BIOPORT shall not be required to reimburse HOLLISTER-STIER
for any security services provided in excess of the services described in such written notice.

     7. All other provisions of the Agreement, including all Exhibits or Addendums thereto, remain
in full force and effect, and this Amendment is subject to the terms thereof.

IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duly authorized
representatives as of the date and year first above written.

	 	 	 	 	 	 	 	 	 	 	 
	BIOPORT CORPORATION	 	HOLLISTER-STIER
	 	 	 	 	 	 	LABORATORIES, LLC
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Robert G. Kramer 9/3/04
	 	 	 	By:
	 	/s/ [Illegible] 9-4-04
	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	Title: President	 	Title: V.P. — ENG/VAL./PD.

 

 

AMENDMENT TO FILLING SERVICES AGREEMENT

     This Amendment is made and entered into this 10th day of February, 2003, by and between
BIOPORT CORPORATION, a Michigan corporation, having its principal place of business at 3500 North
Martin Luther King Jr. Blvd., Lansing, Michigan 48906 (“BIOPORT”), and HOLLISTER-STIER
LABORATORIES, LLC, a Delaware limited liability company, having its principal place of business at
3525 North Regal Street, Spokane, Washington 99207 (“HOLLISTER-STIER”).

     WHEREAS, BIOPORT and HOLLISTER-STIER entered into a Filling Services Agreement dated March 18,
2002 (the “Agreement”); and

     WHEREAS, pursuant to Section 21.0 of the Agreement, the Agreement did not become effective
until such date that the Contracting Officer under Contract DAMD17-98-C-8052 (“Contract 8052”)
between BIOPORT and the U.S. Government (the “Contracting Officer”) would consent in writing to the
Agreement as a subcontract to Contract 8052 and approve pass-through indemnification to
HOLLISTER-STIER under FAR Clause 52.250-1 and the Memorandum of Decision of the Secretary of the
Army dated November 15, 2000; and

     WHEREAS, the Contracting Officer provided such consent and approved such pass-through
indemnification to HOLLISTER-STIER by virtue of executing Modification P00036 to Contract 8052 on
December 27, 2002, a copy of which is attached hereto; and

     WHEREAS, BIOPORT and HOLLISTER-STIER now desire to acknowledge the Contracting Officer’s
actions as described above and desire to amend the Agreement.

     NOW, THEREFORE, BIOPORT and HOLLISTER-STIER agree as follows:

	 	1.	 	Pursuant to the provisions of Section 21.0 of the Agreement, the effective date of the
Agreement shall be December 27, 2002.
	 
	 	2.	 	FAR Clause 52.250-1 and the Modification P00036 to Contract 8052, each of which are
attached to this Amendment, are hereby incorporated by reference into the Agreement.
	 
	 	3.	 	Section 16.2 of the Agreement (entitled “Indemnification of HOLLISTER-STIER”) is
amended by inserting the following clause in front of the first sentence : “Except to the
extent Hollister-Stier is indemnified from and against liabilities by the United States
Government as a result of pass-through indemnification pursuant to FAR Clause 52.250-l,”.
	 
	 	4.	 	All other provisions of the Agreement, including all Exhibits or Addendums thereto,
remain in full force and effect, and this Amendment is subject to the terms thereof.

[signatures on following page]

 

 

IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duty authorized
representatives as of the date and year first above written.

	 	 	 	 	 	 	 	 	 	 	 
	BIOPORT CORPORATION	 	HOLLISTER-STIER
	 	 	 	 	 	 	LABORATORIES, LLC
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Robert G. Kramer
	 	 	 	By:
	 	/s/ [Illegible]	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	Title: President	 	Title: Vice President

 

 

	1. CONTRACT ID CODE
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT            J PAGE            OF PAGES

1 2
——  —
2. AMENDMENT/MODIFICATION NO. December 27, 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable)
P00036 2002 N/A N/A

	6. ISSUED BY            CODE DASG60 7. ADMINISTERED BY (If other than Item 8) CODE            S2303A
U.S. Army Space and Missile Defense Command
Attn: SMDC -CM-CH (L. Selfridge) DCMC Detroit-Grand Rapids
64 Thomas Johnson Drive, 3rd Floor 678 Front Avenue, NW
Frederick, MD 21702 Grand Rapids, Michigan 49504-5352

	8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and Zip Code) ( ) 9A. AMENDMENT OF SOLICITATION NO.
BIOPORT CORPORATION
3500 N. MARTIN LUTHER KING, JR. BLVD.
LANSING, MI 48906 9B. DATED (See Item 11)

	10A. MODIFICATION OF CONTRACT/ORDER NO.
X            DAMD17-98-C-8052

	10B. DATED (See Item 13)
CODE 025489018 FACILITY CODE September 17, 1998

	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
[ ] is extended [ ] is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and

	returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) by separate letter or telegram which includes a reference to the solicitation and amendment numbers.
FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer
already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
12. ACCOUNTING AND APPROPRIATION DATA (If required)
N/A
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF :

	D. OTHER (Specify type of modification and authority)
X            Public Law 85-804 and Memorandum of Decision dated November 15, 2000 signed by the SECARMY

	E. IMPORTANT: Contractor [X ] is not, [ ] is required to sign this document and return ___copies to the issuing office.
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
See Attached.
Except as provided herein, all terms and conditions of the document referenced in Items 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
Lynn M. Selfridge
Contracting Officer
16B. UNITED STATES OF AMERICA
BY /s/ Lynn M. Selfridge.
(Signature of person authorized to sign) 15C. DATE SIGNED (Signature of Contracting Officer) Dec 27, 2002

	NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)
PREVIOUS EDITION UNUSABLE            Prescribed by GSA

 

 

A. Pursuant to the authority granted by the Secretary of the Army to the Contracting Officer
to include indemnification clauses in certain first-tier subcontracts awarded by the BioPort
Corporation under contract DAMD17-98-C-8052, the following contract revisions is effected:

           Hollister-Stier Laboratories LLC, as a first-tier subcontractor to the BioPort Corporation
shall have FAR 52.250-1 incorporated into the subcontract. The Memorandum of Decision dated
November 15, 2000 containing the definition of “Unusually Hazardous Risk” pertinent, in part, to
the subcontract is delineated below and is added to Section J of the Contract.

Adverse Reaction (or alleged adverse reaction) in a human form from administration of a vaccine or
other material used in the production or testing of the vaccine, in conjunction with or as a result
of the performance of the Subcontract, or administration of a vaccine produced, tested, or
delivered under the Prime Contract.

The term “adverse reaction” (or “alleged adverse reaction”) includes anaphylaxis and other
foreseeable and unforeseeable adverse reactions. Such adverse reactions include, but are not
limited to: (1) reactions directly attributable to and resulting from the administration of the
vaccine, or other material involved with the vaccine, production or testing (to include challenge
materials); (2) reactions that manifest long after exposure, but which are directly attributable
and resulting from the administration of the vaccine or other material involved with the production
or testing of the vaccine; (3) failure of the vaccine to perform as intended or otherwise confer
immunity; or (4) performance by the vaccine in a manner not intended.

Notwithstanding any other provision in the indemnification clause or the Memorandum of Decision,
Hollister-Stier shall not be indemnified against grossly negligent or criminal behavior on the part
of Hollister-Stier’s directors, officers or managers who have supervision over or direction of, all
or substantially all of the operations at any one plant or separate locations where the subcontract
is being performed.

B. This modification is executed without cost to either party and is without effect to any other
contract terms or conditions.

Modification P00036 to

Contract DAMD17-98-C-8052

Page 2 of 2

 

 

52.250 — Extraordinary Contractual Actions Provisions and Clauses.

52.250-1 — Indemnification Under Public Law 85-804.

Indemnification Under Public Law 85-804 (Apr 1984)

(a) “Contractor’s principal officials,” as used in this clause, means directors, officers,
managers, superintendents, or other representatives supervising or directing —

(1) All or substantially all of the Contractor’s business;

(2) All or substantially all of the Contractor’s operations at any one plant or separate
location in which this contrast is being performed; or

(3) A separate and complete major industrial operation in connection with the performance of
this contract.

(b) Under Public Law 85-804 (50 U.S.C. 1431-1435) and Executive Order 10789, as amended,
regardless of any other provisions of this contract, the Government shall, subject to the
limitations contained in the other paragraphs of this clause, indemnify the Contractor against —

(1) Claims (including reasonable expenses of litigation or settlement) by third persons
(including employees of the Contractor) for death; personal injury; or loss of, damage to, or
loss of use of property;

(2) Loss of, damage to, or loss of use of Contactor property, excluding loss of profit; and

(3) Loss of, damage to, or loss of use of Government property, excluding loss of profit.

(c) This indemnification applies only to the extent that the claim, loss, or damage

(1) arises out of or results from a risk defined in this contract as unusually hazardous or
nuclear and

(2) is not compensated for by insurance or otherwise.
Any such claim, loss, or damage, to the extent that it is within the deductible amounts of the
Contractor’s insurance, is not covered under this clause. If insurance coverage or other
financial protection in effect on the date the approving official authorizes use of this clause
is reduced, the Government’s liability under this clause shall not increase as a result.

(d) When the claim, loss, or damage is caused by willful misconduct or lack of good faith on the
part of any of the Contractor’s principal officials, the Contractor shall not be indemnified for —

(1) Government claims against the Contractor (other than those arising through subrogation); or

(2) Loss or damage affecting the Contractor’s property.

(e) With the Contracting Officer’s prior written approval, the Contractor may, in any subcontract
under this contract, indemnify the subcontractor against any risk defined in this contract as
unusually hazardous or nuclear. This indemnification shall provide, between the Contractor and the
subcontractor, the same rights and duties, and the same provisions for notice, furnishing of
evidence or proof, and Government settlement or defense of claims as this clause provides. The
Contracting Officer may also approve indemnification of subcontractors at any lower tier, under the
same terms and conditions. The Government shall indemnify the Contractor against liability to
subcontractors incurred under subcontract provisions approved by the Contracting Officer.

(f) The rights and obligations of the parties under this clause shall survive this contract’s
termination, expiration, or completion. The Government shall make no payment under this clause
unless the agency head determines that the amount is just and reasonable. The Government may pay
the Contractor or subcontractors, or may directly pay parties to whom the Contractor or
subcontractors may be liable.

(g) The Contractor shall —

(1) Promptly notify the Contracting Officer of any claim or action against, or any loss by, the
Contractor or any subcontractors that may be reasonably be expected to involve indemnification
under this clause;

(2) Immediately furnish to the Government copies of all pertinent papers the Contractor
receives;

(3) Furnish evidence or proof of any claim, loss, or damage covered by this clause in the
manner and form the Government requires; and

(4) Comply with the Government’s directions and execute any authorizations required in
connection with settlement or defense of claims or actions.

(h) The Government may direct, control, or assist in settling or defending any claim or action
that may involve indemnification under this clause.

(End of Clause)

 

 

Amendment No. 4

To

Filling Services Agreement

This Amendment No. 4 to the Filling Services Agreement dated March 18, 2002 is made and
entered into this 17th day of May, 2006, by and between BioPort Corporation, a Michigan
corporation, having its principal place of business at 3500 North Martin Luther King Jr. Blvd.,
Lansing, Michigan 48906 (BioPort), and Hollister-Stier Laboratories LLC, a Delaware limited
liability corporation, having its principal place of business at 3525 North Regal Street, Spokane,
Washington 99207 (Hollister-Stier).

Recitals

Hollister-Stier and BioPort deem it desirable and to be in the best interests of the parties to
amend the Agreement as hereinafter described and, therefore, the parties agree as follows:

A. Amendment

Pursuant to Section 10.0 Term and Termination — It is the desire of BioPort and
Hollister-Stier to extend the term of this agreement from December 31, 2006 to December 31,
2007.

B. Remaining Agreement

Except as set forth in Section A. hereof, all other terms, provisions and conditions of the
Agreement remain in full force and effect as of the date hereof.

In WITNESS WHEREOF, the parties have executed this Amendment No. 4 as of the date hereinabove
stated, to be effective as of the date hereinabove stated.

	 	 	 	 	 	 	 	 	 	 	 
	Hollister-Stier Laboratories LLC	 	BioPort Corporation
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	/s/ A. Bonanzino
	 	 	 	By:
	/s/ Robert G. Kramer	 	 
	 

	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name:

	/s/ A. Bonanzino
	 	 	 	Name:
	 	 Robert G. Kramer	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	President, CEO
	 	 	 	Title:
	 	President & CEO	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date:

	 	05/19/2006
	 	 	 	Date:
	 	 May 23, 2006

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