Delaware
|
2834 | 14-1902018 | ||
(State or Other Jurisdiction
of
Incorporation or Organization) |
(Primary Standard Industrial
Classification Code No.) |
(I.R.S. Employer
Identification No.) |
David E. Redlick, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP 1875 Pennsylvania Avenue, NW Washington, DC 20006 (202) 663-6000 |
Daniel J.
Abdun-Nabi, Esq.
General Counsel Emergent BioSolutions Inc. 300 Professional Drive, Suite 250 Gaithersburg, Maryland 20879 (301) 944-0290 |
James A. Lebovitz, Esq.
Brian D. Short, Esq. Dechert LLP 2929 Arch Street Philadelphia, Pennsylvania 19104 (215) 994-4000 |
Proposed
Maximum
|
Amount of
|
|||||
Title of Each
Class of
|
Aggregate
Offering
|
Registration
|
||||
Securities to be Registered | Price(1) | Fee(2) | ||||
Common stock, $0.001 par value per
share
|
$86,250,000 | $9,229 | ||||
Series A junior participating
preferred stock purchase rights(3)
|
| | ||||
(1) | Estimated solely for the purpose of computing the registration fee pursuant to Rule 457(o) under the Securities Act. |
(2) | Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price. This amount has been paid previously. |
(3) | Each share of common stock includes one series A junior participating preferred stock purchase right pursuant to a rights agreement to be entered into between the Registrant and the rights agent. The series A junior participating preferred stock purchase rights will initially trade together with the common stock. The value attributable to the series A junior participating preferred stock purchase rights, if any, is reflected in the offering price of the common stock. |
The
information in this preliminary prospectus is not complete and
may be changed. We may not sell these securities until the
registration statement filed with the Securities and Exchange
Commission is effective. This preliminary prospectus is not an
offer to sell these securities, and we are not soliciting an
offer to buy these securities in any state where the offer or
sale is not permitted.
|
|
||||||||||||
Per share | Total | |||||||||||
|
||||||||||||
Initial public offering price
|
$ | $ | ||||||||||
Underwriting discounts and
commissions
|
$ | $ | ||||||||||
Proceeds to Emergent, before
expenses
|
$ | $ | ||||||||||
|
Page | ||||
Prospectus summary
|
1 | |||
Risk factors
|
9 | |||
Special note regarding
forward-looking statements
|
45 | |||
Use of proceeds
|
46 | |||
Dividend policy
|
47 | |||
Capitalization
|
48 | |||
Dilution
|
50 | |||
Selected consolidated financial
data
|
52 | |||
Managements discussion and
analysis of financial condition and results of operations
|
54 | |||
Business
|
80 | |||
Management
|
130 | |||
Certain relationships and related
party transactions
|
150 | |||
Principal and selling stockholders
|
156 | |||
Description of capital stock
|
163 | |||
Shares eligible for future
sale
|
171 | |||
Underwriting
|
174 | |||
Legal matters
|
178 | |||
Experts
|
178 | |||
Where you can find more information
|
178 | |||
Index to consolidated financial
statements
|
F-1 |
1
| Anthrax immune globulin for post-exposure treatment of anthrax infection, which we are developing in part with funding from NIAID; |
| Botulinum immune globulin for post-exposure treatment of illness caused by botulinum toxin, which we are developing based on a new botulinum toxoid vaccine that we are developing in collaboration with the U.K. Health Protection Agency, or HPA; and |
| Recombinant bivalent botulinum vaccine a prophylaxis for illness caused by botulinum toxin, which we also are developing in collaboration with HPA. |
| Typhoid vaccine a single dose, drinkable vaccine, for which we have completed a Phase I clinical program, including trials in the United States, the United Kingdom and Vietnam, and expect to initiate a Phase II clinical trial in Vietnam in the fourth quarter of 2006; |
| Hepatitis B therapeutic vaccine a multiple dose, drinkable vaccine for treatment of chronic carriers of hepatitis B infection, for which we have completed a Phase I clinical trial in the United Kingdom and expect to initiate a Phase II clinical trial in the United Kingdom in the fourth quarter of 2006; and |
2
| Group B streptococcus vaccine a multiple dose, injectable vaccine for administration to women of childbearing age for protection of the fetus and newborn babies, for which we have completed a Phase I clinical trial in the United Kingdom. |
| maximize the commercial potential of BioThrax; |
| continue to develop a balanced portfolio of immunobiotic products; |
| focus on core capabilities in product development and manufacturing; |
| build a large scale manufacturing infrastructure; |
| selectively establish collaborations; and |
| seek governmental and other third party grants and support. |
| We have derived substantially all of our revenue from sales of BioThrax under contracts with the DoD and HHS. |
| Our ongoing U.S. government contracts do not necessarily increase the likelihood that we will secure future comparable contracts with the U.S. government. |
| We expect that a significant portion of the business that we will seek in the near future, in particular for BioThrax, will be under government contracts that present a number of risks that are not typically present in the commercial contracting process. |
| Our U.S. government contracts for BioThrax require annual funding decisions by the government and are subject to unilateral termination and modification by the government. |
3
| We may fail to achieve significant sales of BioThrax to customers in addition to the U.S. government, which would harm our growth opportunities. |
| We may not be able to sustain or increase profitability. |
| We are spending significant amounts for the expansion of our manufacturing facilities. |
| We may not be able to manufacture BioThrax consistently in accordance with FDA specifications. |
| Other than BioThrax, all of our product candidates are undergoing clinical trials or are in early stages of development, and failure is common and can occur at any stage of development. |
| None of our product candidates other than BioThrax has received regulatory approval. |
4
Common stock offered by us | shares | |
Common stock offered by the selling stockholders | shares if the underwriters exercise their over-allotment option in full | |
Common stock to be outstanding after this offering | shares | |
Preferred stock purchase rights | Each share of common stock offered hereby will have associated with it one preferred stock purchase right under a rights agreement that we will enter into in connection with this offering. The preferred stock purchase rights will initially trade together with the common stock. See Description of capital stock Stockholder rights plan. |
Use of proceeds | We expect to use the net proceeds from this offering, together with our existing cash and cash equivalents, revenues from BioThrax product sales and other committed sources of funds, to fund development of our biodefense and commercial product candidates and a portion of the construction costs of our new manufacturing facility in Lansing, Michigan and the balance for general corporate purposes. See Use of proceeds. |
We will not receive any proceeds from the sale of shares of common stock by the selling stockholders as a result of the exercise by the underwriters of their over-allotment option. | ||
Risk factors | See Risk factors and other information in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our common stock. | |
Proposed NASDAQ Global Market symbol | EBSI |
| 1,091,779 shares of common stock issuable upon the exercise of stock options outstanding as of September 30, 2006 at a weighted average exercise price of $7.30 per share; |
| 128,206 additional shares of common stock reserved for issuance under our employee stock option plan as of September 30, 2006; and |
| 175,000 additional shares of common stock that will be reserved for issuance under our 2006 stock incentive plan immediately prior to completion of this offering. |
5
| no exercise of the outstanding options described above; and |
| no exercise by the underwriters of their option to purchase up to shares of common stock from the selling stockholders to cover over-allotments. |
6
|
||||||||||||||||||||
Year ended December 31, | Nine months ended September 30, | |||||||||||||||||||
(in thousands, except share and per share data) | 2003 | 2004 | 2005 | 2005 | 2006 | |||||||||||||||
|
||||||||||||||||||||
(unaudited) | ||||||||||||||||||||
Statements of operations
data:
|
||||||||||||||||||||
Revenues:
|
||||||||||||||||||||
Product sales
|
$ | 55,536 | $ | 81,014 | $ | 127,271 | $ | 85,807 | $ | 61,263 | ||||||||||
Collaborative research and grants
|
233 | 2,480 | 3,417 | 1,093 | 4,580 | |||||||||||||||
Total revenues
|
55,769 | 83,494 | 130,688 | 86,900 | 65,843 | |||||||||||||||
Operating expenses (income):
|
||||||||||||||||||||
Cost of product sales
|
22,342 | 30,102 | 31,603 | 23,147 | 11,645 | |||||||||||||||
Research and development
|
6,327 | 10,117 | 18,381 | 9,632 | 26,640 | |||||||||||||||
Selling, general &
administrative
|
19,547 | 30,323 | 42,793 | 28,924 | 32,952 | |||||||||||||||
Purchased in-process research and
development
|
1,824 | | 26,575 | 26,575 | 477 | |||||||||||||||
Settlement of State of Michigan
obligation
|
| (3,819 | ) | | | | ||||||||||||||
Litigation settlement
|
| | (10,000 | ) | (10,000 | ) | | |||||||||||||
Total operating expenses
|
50,040 | 66,723 | 109,352 | 78,278 | 71,714 | |||||||||||||||
Income (loss) from operations
|
5,729 | 16,771 | 21,336 | 8,622 | (5,871 | ) | ||||||||||||||
Other income (expense):
|
||||||||||||||||||||
Interest income
|
100 | 65 | 485 | 338 | 405 | |||||||||||||||
Interest expense
|
(293 | ) | (241 | ) | (767 | ) | (575 | ) | (778 | ) | ||||||||||
Other income (expense), net
|
168 | 6 | 55 | (24 | ) | 291 | ||||||||||||||
Total other income (expense)
|
(25 | ) | (170 | ) | (227 | ) | (261 | ) | (82 | ) | ||||||||||
Income (loss) before provision for
(benefit from) income taxes
|
5,704 | 16,601 | 21,109 | 8,361 | (5,953 | ) | ||||||||||||||
Provision for (benefit from) income
taxes
|
1,250 | 5,129 | 5,325 | 2,109 | (2,617 | ) | ||||||||||||||
Net income (loss)
|
$ | 4,454 | $ | 11,472 | $ | 15,784 | $ | 6,252 | $ | (3,336 | ) | |||||||||
|
||||||||||||||||||||
Earnings (loss) per
share basic
|
$ | 0.68 | $ | 1.74 | $ | 2.21 | $ | 0.90 | $ | (0.43 | ) | |||||||||
Earnings (loss) per
share diluted
|
$ | 0.63 | $ | 1.61 | $ | 2.00 | $ | 0.82 | $ | (0.43 | ) | |||||||||
Weighted average number of
shares basic
|
6,570,856 | 6,576,019 | 7,136,866 | 6,927,289 | 7,775,263 | |||||||||||||||
Weighted average number of
shares diluted
|
7,061,537 | 7,104,172 | 7,908,023 | 7,663,468 | 7,775,263 | |||||||||||||||
7
|
||||||||
As of September 30, 2006 | ||||||||
(in thousands) | Actual | As adjusted | ||||||
|
||||||||
(unaudited) | ||||||||
Balance sheet data:
|
||||||||
Cash and cash equivalents
|
$ | 19,906 | $ | |||||
Working capital
|
18,726 | |||||||
Total assets
|
130,831 | |||||||
Total long-term liabilities
|
35,606 | |||||||
Total stockholders equity
|
56,759 | |||||||
8
| the need to devote substantial time and attention of management and key employees to the preparation of bids and proposals for contracts that may not be awarded to us; |
| the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded; and |
| the expenses that we might incur and the delays that we might suffer if our competitors protest or challenge contract awards made to us pursuant to competitive bidding, and the risk that any such |
9
protest or challenge could result in the resubmission of bids based on modified specifications, or in termination, reduction or modification of the awarded contract. |
| procurement integrity; |
| export control; |
10
| government security regulations; |
| employment practices; |
| protection of the environment; |
| accuracy of records and the recording of costs; and |
| foreign corrupt practices. |
| terminate existing contracts, in whole or in part, for any reason or no reason; |
| reduce or modify contracts or subcontracts; |
| cancel multi-year contracts and related orders if funds for contract performance for any subsequent year become unavailable; |
| decline to exercise an option to renew a contract; |
| exercise an option to purchase only the minimum amount specified in a contract; |
| decline to exercise an option to purchase the maximum amount specified in a contract; |
| claim rights in products, including intellectual property, developed under the contract; |
| suspend or debar the contractor from doing business with the government or a specific government agency; |
11
| pursue criminal or civil remedies under the False Claims Act and False Statements Act; and |
| control or prohibit the export of products. |
12
| requiring us to dedicate a substantial portion of any cash flow from operations to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes; |
| increasing the amount of interest that we have to pay on debt with variable interest rates if market rates of interest increase; |
| increasing our vulnerability to general adverse economic and industry conditions; |
| limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and |
| placing us at a competitive disadvantage compared to our competitors that have less debt. |
13
| the level and timing of BioThrax product sales and cost of product sales; |
| the timing of, and the costs involved in, constructing our new manufacturing facility in Lansing, Michigan and the build out of our manufacturing facilities in Frederick, Maryland; |
| the scope, progress, results and costs of our preclinical and clinical development activities; |
| the costs, timing and outcome of regulatory review of our product candidates; |
| the number of, and development requirements for, other product candidates that we may pursue; |
| the costs of commercialization activities, including product marketing, sales and distribution; |
| the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other patent-related costs, including litigation costs and the results of such litigation; |
| the extent to which we acquire or invest in businesses, products and technologies; |
| our ability to obtain development funding from government entities and non-government and philanthropic organizations; and |
| our ability to establish and maintain collaborations, such as our collaboration with Sanofi Pasteur. |
14
15
| equipment malfunctions or failures; |
| technology malfunctions; |
| work stoppages; |
| damage to or destruction of the facility due to natural disasters; |
| regional power shortages; |
| product tampering; or |
| terrorist activities. |
16
17
| fines, injunctions and civil penalties; |
| refusal by regulatory authorities to grant marketing approval of our product candidates; |
| delays, suspension or withdrawal of regulatory approvals, including license revocation; |
| seizures or recalls of product candidates or products; |
| operating restrictions; and |
| criminal prosecutions. |
18
| successful completion of preclinical development; |
| successful completion of clinical trials; |
| receipt of marketing approvals from the FDA and similar foreign regulatory authorities; |
| a determination by the Secretary of HHS that our biodefense product candidates should be purchased for the strategic national stockpile prior to FDA approval; |
| establishing commercial manufacturing processes or arrangements; |
| launching commercial sales of the product, whether alone or in collaboration with others; and |
| acceptance of the product by potential government customers, physicians, patients, healthcare payors and others in the medical community. |
19
| regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
| we may decide, or regulators may require us, to conduct additional preclinical testing or clinical trials, or we may abandon projects that we expect to be promising, if our preclinical tests, clinical trials or animal efficacy studies produce negative or inconclusive results; |
| we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks; |
| regulators or institutional review boards may require that we hold, suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements; |
| the cost of our clinical trials may be greater than we currently anticipate; |
| any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable; and |
| the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics. |
| be delayed in obtaining marketing approval for our product candidates; |
| not be able to obtain marketing approval; or |
| obtain approval for indications that are not as broad as intended. |
20
21
22
| the prevalence and severity of any side effects; |
| the efficacy and potential advantages over alternative treatments; |
| the ability to offer our product candidates for sale at competitive prices; |
| relative convenience and ease of administration; |
| the willingness of the target patient population to try new products and of physicians to prescribe these products; |
| the strength of marketing and distribution support; and |
| sufficient third party coverage or reimbursement. |
23
24
25
26
| decreased demand for any product candidates or products that we may develop; |
| injury to our reputation; |
| withdrawal of clinical trial participants; |
| withdrawal of a product from the market; |
| costs to defend the related litigation; |
| substantial monetary awards to trial participants or patients; |
| loss of revenue; and |
| the inability to commercialize any products that we may develop. |
27
| a covered benefit under its health plan; |
| safe, effective and medically necessary; |
| appropriate for the specific patient; |
| cost-effective; and |
| neither experimental nor investigational. |
28
29
| termination of contracts; |
| forfeiture of profits; |
| suspension of payments; |
| fines; and |
| suspension or prohibition from doing business with the U.S. government. |
| the Federal Acquisition Regulations, and agency-specific regulations supplemental to the Federal Acquisition Regulations, which comprehensively regulate the procurement, formation, administration and performance of government contracts; |
| the business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and Foreign Corrupt Practices Act; |
| export and import control laws and regulations; and |
| laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data. |
30
31
32
| restrictions on the marketing or manufacturing of a product; |
| warning letters; |
| withdrawal of the product from the market; |
| refusal to approve pending applications or supplements to approved applications; |
| voluntary or mandatory product recall; |
| fines or disgorgement of profits or revenue; |
| suspension or withdrawal of regulatory approvals, including license revocation; |
| refusal to permit the import or export of products; |
| product seizure; and |
| injunctions or the imposition of civil or criminal penalties. |
33
34
| our collaboration agreements are likely to be for fixed terms and subject to termination by our collaborators in the event of a material breach by us; |
| our collaborators may have the first right to maintain or defend our intellectual property rights and, although we would have the right to assume the maintenance and defense of our intellectual property rights if our collaborators do not do so, our ability to maintain and defend our intellectual property rights may be compromised by our collaborators acts or omissions; and |
| our collaborators may utilize our intellectual property rights in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential liability. |
35
36
37
38
| we may be unable to license or acquire the relevant technology on terms that would allow us to make an appropriate return on the product; |
| companies that perceive us to be their competitor may be unwilling to assign or license their product rights to us; or |
| we may be unable to identify suitable products or product candidates within our areas of expertise. |
| use of cash resources; |
| higher than anticipated acquisition costs and expenses; |
39
| potentially dilutive issuances of equity securities; |
| the incurrence of debt and contingent liabilities, impairment losses or restructuring charges; |
| large write-offs and difficulties in assessing the relative percentages of in-process research and development expense that can be immediately written off as compared to the amount that must be amortized over the appropriate life of the asset; and |
| amortization expenses related to other intangible assets. |
| challenges associated with managing an increasingly diversified business; |
| disruption of our ongoing business; |
| difficulty and expense in assimilating the operations, products, technology, information systems or personnel of the acquired company; |
| diversion of managements time and attention from other business concerns; |
| inability to maintain uniform standards, controls, procedures and policies; |
| the assumption of known and unknown liabilities of the acquired company, including intellectual property claims; and |
| subsequent loss of key personnel. |
40
| the classification of our directors; |
| limitations on changing the number of directors then in office; |
| limitations on the removal of directors; |
| limitations on filling vacancies on the board; |
| limitations on the removal and appointment of the chairman of our board of directors; |
| following the second anniversary of the completion of this offering, advance notice requirements for stockholder nominations for election of directors and other proposals; |
| the inability of stockholders to act by written consent; |
| the inability of stockholders to call special meetings; and |
| the ability of our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval. |
41
| the success of competitive products or technologies; |
| results of clinical trials of our product candidates or those of our competitors; |
42
| decisions and procurement policies by the U.S. government affecting BioThrax and our biodefense product candidates; |
| regulatory developments in the United States and foreign countries; |
| developments or disputes concerning patents or other proprietary rights; |
| the recruitment or departure of key personnel; |
| variations in our financial results or those of companies that are perceived to be similar to us; |
| market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts reports or recommendations; |
| general economic, industry and market conditions; and |
| the other factors described in this Risk factors section. |
43
44
| our performance under existing BioThrax sales contracts with HHS and DoD, including the timing of deliveries under these contracts; |
| our plans for future sales of BioThrax; |
| our plans to pursue label expansions and improvements for BioThrax; |
| our plans to expand our manufacturing facilities and capabilities; |
| the rate and degree of market acceptance and clinical utility of our products; |
| our ongoing and planned development programs, preclinical studies and clinical trials; |
| our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; |
| the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; |
| the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; |
| our commercialization, marketing and manufacturing capabilities and strategy; |
| our intellectual property portfolio; and |
| our estimates regarding expenses, future revenues, capital requirements and needs for additional financing. |
45
| approximately $13 million of these net proceeds to fund development of our biodefense product candidates, comprised of approximately $3 million for label expansions and improvements for BioThrax, approximately $5 million for a next generation anthrax vaccine candidate and approximately $5 million for our anthrax immune globulin candidate; |
| approximately $19 million of these net proceeds to fund clinical development of our commercial product candidates, comprised of approximately $6 million for our typhoid vaccine candidate and approximately $13 million for our hepatitis B therapeutic vaccine candidate; |
| approximately $20 million of these net proceeds to fund a portion of the construction costs of our new manufacturing facility in Lansing, Michigan; and |
| the balance of these net proceeds for general corporate purposes, which may include the build out of our manufacturing facilities in Frederick, Maryland, the expansion of our sales and marketing organization, the acquisition or in license of technologies, products or businesses, working capital and capital expenditures. |
| for our biodefense product candidates, the work necessary to support our applications to the FDA to further extend the shelf life and reduce the number of required doses for BioThrax, stability testing of a next generation anthrax vaccine candidate, including manufacture of bulk drug substance, and animal efficacy studies and a Phase I safety and pharmacokinetic trial of our anthrax immune globulin candidate; and |
46
| for our commercial product candidates, a Phase II clinical trial, a disease surveillance study to prepare for a Phase III clinical trial and the manufacture of initial clinical material for such Phase III clinical trial of our typhoid vaccine candidate and a Phase II clinical trial of our hepatitis B therapeutic vaccine candidate. |
47
on an actual basis; and
on an as adjusted basis to give effect to:
the reclassification of our class A common stock, $0.01 par
value per share, as common stock, $0.001 par value per share,
and the conversion of each outstanding share of our class B
common stock into one share of common stock prior to the
completion of this offering; and
the sale
of shares
of common stock that we are offering at an assumed initial
public offering price of
$ per share, which is the
midpoint of the price range set forth on the cover page of this
prospectus, after deducting estimated underwriting discounts and
commissions and offering expenses payable by us.
(1)
A $1.00 increase (decrease) in the assumed initial public
offering price of $ per share
would increase (decrease) each of additional paid-in capital,
total stockholders equity and total capitalization by
approximately $ million,
assuming that the number of shares offered by us, as
48
set forth on the cover page of this prospectus, remains the same
and after deducting estimated underwriting discounts and
commissions.
1,091,779 shares of common stock issuable upon the exercise
of stock options outstanding as of September 30, 2006 at a
weighted average exercise price of $7.30 per share;
128,206 additional shares of common stock reserved for
issuance under our employee stock option plan as of
September 30, 2006; and
175,000 additional shares of common stock that will be reserved
for issuance under our 2006 stock incentive plan immediately
prior to completion of this offering.
49
$
$
7.29
$
Shares
purchased
Total
consideration
Average price
Number
Percentage
Amount
Percentage
per
share
7,782,016
%
$
35,102,225
%
$
4.51
100%
$
100%
$
50
1,091,779 shares of common stock issuable upon the exercise
of stock options outstanding as of September 30, 2006 at a
weighted average exercise price of $7.30 per share;
128,206 additional shares of common stock reserved for issuance
under our employee stock option plan as of September 30,
2006; and
175,000 additional shares of common stock that will be reserved
for issuance under our 2006 stock incentive plan immediately
prior to completion of this offering.
the number of shares of common stock held by existing
stockholders will decrease
to ,
or approximately % of the total number of shares of
our common stock outstanding after this offering; and
the number of shares of common stock held by new investors will
increase
to ,
or approximately % of the total number of shares of
our common stock outstanding after this offering.
51
Year ended
December 31,
Nine months ended
September 30,
(in thousands,
except share and per share data)
2001
2002
2003
2004
2005
2005
2006
(unaudited)
$
45,309
$
78,541
$
55,536
$
81,014
$
127,271
$
85,807
$
61,263
233
2,480
3,417
1,093
4,580
45,309
78,541
55,769
83,494
130,688
86,900
65,843
34,367
24,569
22,342
30,102
31,603
23,147
11,645
382
2,808
6,327
10,117
18,381
9,632
26,640
10,924
13,397
19,547
30,323
42,793
28,924
32,952
1,824
26,575
26,575
477
(3,819
)
(10,000
)
(10,000
)
45,673
40,774
50,040
66,723
109,352
78,278
71,714
(364
)
37,767
5,729
16,771
21,336
8,622
(5,871
)
122
80
100
65
485
338
405
(193
)
(451
)
(293
)
(241
)
(767
)
(575
)
(778
)
(119
)
(271
)
168
6
55
(24
)
291
(190
)
(642
)
(25
)
(170
)
(227
)
(261
)
(82
)
(554
)
37,125
5,704
16,601
21,109
8,361
(5,953
)
733
1,250
5,129
5,325
2,109
(2,617
)
$
(554
)
$
36,392
$
4,454
$
11,472
$
15,784
$
6,252
$
(3,336
)
$
(0.10
)
$
5.68
$
0.68
$
1.74
$
2.21
$
0.90
$
(0.43
)
$
(0.10
)
$
5.05
$
0.63
$
1.61
$
2.00
$
0.82
$
(0.43
)
5,651,192
6,409,661
6,570,856
6,576,019
7,136,866
6,927,289
7,775,263
5,561,192
7,212,903
7,061,537
7,104,172
7,908,023
7,663,468
7,775,263
52
As of
As of
December 31,
September 30,
(in
thousands)
2001
2002
2003
2004
2005
2006
(unaudited)
$
5,854
$
4,891
$
7,119
$
6,821
$
36,294
$
19,906
(35,299
)
1,130
(3,147
)
7,509
29,023
18,726
25,423
22,790
37,127
69,056
100,332
130,831
4,857
4,592
1,228
11,921
10,502
35,606
(32,295
)
4,155
8,448
22,949
59,737
56,759
53
issued 6,487,950 shares of class A common stock in
exchange for 6,262,554 shares of BioPort class A
common stock and 225,396 shares of BioPort class B
common stock;
repurchased and retired all other issued and outstanding shares
of BioPort class B common stock; and
assumed all outstanding stock options to purchase BioPort
class B common stock and granted option holders replacement
stock options to purchase an equal number of shares of our
class B common stock.
54
55
there is persuasive evidence of an arrangement;
delivery has occurred or title has passed to our customer based
on contract terms;
the fee is fixed and determinable and no further obligation
exists; and
collectibility is reasonably assured.
56
57
fees payable to contract research organizations in conjunction
with clinical trials;
fees payable to third party manufacturers in conjunction with
the production of clinical trial materials; and
professional service fees.
58
59
the history and nature of our business and results of operations;
our prospects for growth, including potential contracts for
BioThrax product sales;
our available cash, assets and financial condition;
prior determinations of the fair value of the common stock
underlying stock options granted and the effect of corporate
developments, including the progress of our product candidates,
that have occurred between the time of the grants;
rights and preferences of the security being granted compared to
the rights and preferences of our other outstanding equity;
values of public companies that we believe are comparable to us,
adjusted for the risks related to and the lack of a liquid
market for the shares;
the time frame in which a liquid market would likely be
available for the shares;
business developments involving our direct competitors; and
general economic trends and the economic outlook and market
conditions for our industry.
60
61
62
salaries and related expenses for personnel;
fees to professional service providers for, among other things,
independently monitoring our clinical trials and acquiring and
evaluating data from our clinical trials;
costs of contract manufacturing services;
costs of materials used in clinical trials and research and
development;
depreciation of capital assets used to develop our
products; and
operating costs, such as the cost of facilities and the legal
costs of pursuing patent protection of our intellectual property.
the scope, rate of progress and expense of our clinical trials
and other research and development activities;
our ability to obtain adequate supplies of our product
candidates required for later stage clinical trials, including
from third party manufacturers;
the potential benefits of our product candidates over other
products;
our ability to market, commercialize and achieve market
acceptance for any of our product candidates that we are
developing or may develop in the future;
future clinical trial results;
the terms and timing of regulatory approvals; and
the expense of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights.
63
64
65
Nine months ended
September 30,
(in thousands)
2005
2006
$
1,815
$
2,678
2,154
6,947
718
1,323
180
3,032
4,867
13,980
897
4,483
727
2,508
411
1,764
431
1,225
670
1,943
3,136
11,923
1,629
737
$
9,632
$
26,640
66
67
68
Year ended
December 31,
(in
thousands)
2004
2005
$
5,929
$
2,883
350
5,309
1,708
427
6,279
10,327
1,477
1,558
2,433
1,136
837
656
1,136
6,961
2,702
1,093
$
10,117
$
18,381
69
70
71
Year ended
December 31,
Nine months ended
September 30,
(in
thousands)
2003
2004
2005
2005
2006
$
11,072
$
9,196
$
41,974
$
21,581
$
(8,032
)
(7,917
)
(18,175
)
(5,841
)
(2,317
)
(32,741
)
(927
)
8,681
(6,660
)
(6,574
)
24,385
$
2,228
$
(298
)
$
29,473
$
12,690
$
(16,388
)
(1)
72
73
Payments due by
period
(in
thousands)
Total
2006
2007
2008
2009
2010
After 2010
$
49,707
$
3,504
$
5,627
$
5,297
$
5,287
$
5,286
$
24,707
15,919
422
1,699
1,801
686
647
10,664
200
100
100
$
65,826
$
4,026
$
7,426
$
7,098
$
5,973
$
5,933
$
35,371
(1)
Includes scheduled interest payments.
74
$2.5 million outstanding under a forgivable loan from the
Department of Business and Economic Development of the State of
Maryland used to finance eligible costs incurred to purchase one
of our facilities in Frederick, Maryland;
$7.0 million outstanding under a mortgage loan from
Mercantile Potomac Bank used to finance the remaining portion of
the purchase price for the Frederick facility;
$8.4 million outstanding under a mortgage loan from HSBC
Realty Credit Corporation used to finance the purchase price for
a second facility on the Frederick site;
$1.3 million outstanding under a term loan from Fifth Third
Bank used to finance the purchase of an enterprise resource
planning system;
$2.2 million outstanding under a $10.0 million
revolving line of credit with Fifth Third Bank;
$10.0 million outstanding under a term loan from HSBC
Realty Credit Corporation used to finance a portion of the costs
of our facility expansion in Lansing, Michigan; and
$5.0 million outstanding under a $5.0 million
revolving line of credit with HSBC Realty Credit Corporation.
Under our mortgage loan from Mercantile Potomac Bank for our
Frederick facility, we are required to maintain at all times a
minimum tangible net worth of not less than $5.0 million.
In addition, we are required to maintain at all times a ratio of
earnings before interest, taxes, depreciation and amortization
to the sum of current obligations under capital leases and
principal obligations and interest expenses for borrowed money,
in each case due and payable within the following
12 months, of not less than 1.1 to 1.0.
Under our forgivable loan from the State of Maryland, we are not
required to repay the principal amount of the loan if beginning
December 31, 2009 and through 2012 we maintain a specified
number of employees at the Frederick site, by December 31,
2009 we have invested at least $42.9 million in total funds
toward financing the purchase of the buildings on the site and
for related improvements and operation of the facility and we
occupy the facility through 2012.
Under our term loan and revolving line of credit with HSBC
Realty Credit Corporation, we are required to maintain on an
annual basis a minimum tangible net worth of not less than the
sum of 85% of our tangible net worth for the most recently
completed fiscal year plus 25% of current net operating profit
after taxes. In addition, we are required to maintain on a
quarterly basis a ratio of earnings before interest, taxes,
depreciation and amortization for the most recent four quarters
to the sum of current obligations under capital leases and
principal obligations and interest expenses for borrowed money,
in each case due and payable for the following four quarters, of
not less than 1.25 to 1.00.
75
Under our line of credit with Fifth Third Bank, our wholly owned
subsidiary, Emergent BioDefense Operations, is required to
maintain at all times a ratio of total liabilities to tangible
net worth of not more than 2.5 to 1.0.
76
the level and timing of BioThrax product sales and cost of
product sales;
the timing of, and the costs involved in, constructing our new
manufacturing facility in Lansing, Michigan and the build out of
our manufacturing facilities in Frederick, Maryland;
the scope, progress, results and costs of our preclinical and
clinical development activities;
the costs, timing and outcome of regulatory review of our
product candidates;
the number of, and development requirements for, other product
candidates that we may pursue;
the costs of commercialization activities, including product
marketing, sales and distribution;
the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims and other patent-related
costs, including litigation costs and the results of such
litigation;
77
the extent to which we acquire or invest in businesses, products
and technologies;
our ability to obtain development funding from government
entities and non-government and philanthropic organizations; and
our ability to establish and maintain collaborations, such as
our collaboration with Sanofi Pasteur.
78
79
80
Anthrax immune globulin
for post-exposure
treatment of anthrax infection, which we are developing in part
with funding from NIAID;
Botulinum immune globulin
for post-exposure
treatment of illness caused by botulinum toxin, which we are
developing based on a new botulinum toxoid vaccine that we are
developing in collaboration with the U.K. Health Protection
Agency, or HPA; and
Recombinant bivalent botulinum vaccine
a
prophylaxis for illness caused by botulinum toxin, which we also
are developing in collaboration with HPA.
Typhoid vaccine
a single dose, drinkable
vaccine, for which we have completed a Phase I clinical
program, including trials in the United States, the United
Kingdom and Vietnam, and expect to initiate a Phase II
clinical trial in Vietnam in the fourth quarter of 2006;
Hepatitis B therapeutic vaccine
a multiple
dose, drinkable vaccine for treatment of chronic carriers of
hepatitis B infection, for which we have completed a
Phase I clinical trial in the United Kingdom and expect to
initiate a Phase II clinical trial in the United Kingdom in
the fourth quarter of 2006; and
Group B streptococcus vaccine
a multiple
dose, injectable vaccine for administration to women of
childbearing age for protection of the fetus and newborn babies,
for which we have completed a Phase I clinical trial in the
United Kingdom.
81
82
83
the U.S. Postal Service;
foreign governments;
state and local governments, which we expect will be interested
in these products to protect first responders, such as police,
fire and emergency medical personnel;
multinational companies and non-governmental
organizations; and
hospitals.
84
85
86
87
Therapeutic/
Stage of
Collaboration/external
Immunobiotic
prophylactic
development
Status
relationship
Prophylactic
FDA approved
Commercially marketed six dose
regimen
Prophylactic
Post-approval label expansion
BLA supplement submitted for five
dose regimen and intramuscular injection; CDC clinical trial
ongoing
CDC independent
clinical trial
Prophylactic
Post-approval label expansion
Single dose syringe development
program initiated
Post-exposure prophylactic
Post-approval label expansion
Phase I clinical trial
ongoing; two
proof-of-concept
animal studies completed
Pre-exposure and post-exposure
prophylactic
Phase I and preclinical
Responses submitted to NIAID
request for proposals
Therapeutic
Preclinical
Plasma donor stimulation program
ongoing; animal efficacy studies planned; plan to file IND in
late 2006 or early 2007
NIAID funding for animal
efficacy studies in rabbits
Prophylactic
Preclinical
Proof-of-concept
animal study completed
HPA collaboration
Therapeutic
Preclinical
Proof-of-concept
animal studies planned
HPA collaboration for
development of a new botulinum toxoid vaccine
Prophylactic
Phase II
Phase I clinical trial in
Vietnam completed; plan to initiate Phase II clinical trial
in Vietnam in the fourth quarter of 2006
Wellcome Trust funding
for Phase I and Phase II clinical trials in Vietnam
Therapeutic
Phase II
Phase I clinical trial in the
United Kingdom completed; clinical trial application approved in
the United Kingdom for a Phase II clinical trial
Prophylactic
Phase I
One Phase I clinical trial in
the United Kingdom completed; two additional Phase I
clinical trials planned
Prophylactic
Preclinical
Proof-of-concept
animal study completed
Prophylactic
Preclinical
Antigen identification completed
Sanofi Pasteur
collaboration
*
We currently intend to rely on the
FDA animal rule in seeking marketing approval for these product
candidates. Under the animal rule, if human efficacy trials are
not ethical or feasible, the FDA can approve drugs or biologics
used to treat or prevent serious or life threatening conditions
caused by exposure to lethal or permanently disabling toxic
chemical, biological, radiological or nuclear substances based
on human clinical data demonstrating safety and immunogenicity
and evidence of efficacy from appropriate non-clinical animal
studies and any additional supporting data. For more information
about the FDA animal rule, see Government
regulation Clinical trials.
88
89
90
BioThrax is safe and effective;
the study used to support the original marketing approval of
BioThrax constituted a well controlled human efficacy study in
which BioThrax was 92.5% effective in preventing inhalational
and cutaneous anthrax;
as reported by the Institute of Medicine, studies in humans and
animal models support the conclusion that BioThrax is effective
against anthrax strains that are dependent upon the anthrax
toxin as a mechanism of virulence by all routes of exposure,
including inhalation;
periodic evaluations of reports in the vaccine adverse event
reporting system database maintained by the CDC and the FDA
confirm that BioThrax continues to be safe for its intended use;
and
as reported by an independent advisory panel to the FDA, CDC
data suggest that BioThrax is fairly well tolerated with severe
local reactions and systemic reactions being relatively rare.
Extend shelf life.
In 2005, the FDA approved an
extension of BioThrax shelf life from two to three years, which
will allow BioThrax to be stockpiled for a longer period of
time. We are conducting ongoing stability testing of BioThrax,
and, depending on the outcome of these tests, we may apply for a
further extension of BioThrax shelf life in late 2006.
Reduce doses for pre-exposure prophylaxis.
We have
applied to the FDA to reduce the number of required doses of
BioThrax for pre-exposure prophylaxis from six to five, with an
annual booster dose thereafter. Our application is based on an
interim analysis of data from an ongoing clinical trial being
conducted by the CDC to evaluate whether as few as three doses
of BioThrax, administered over six months, will confer adequate
immune response over as long as 42 months. In April 2006, the
FDA issued a complete response letter to our application,
requesting clarification and requiring additional analysis of
the data that we submitted. We are in the process of responding
to this letter and amending our application. If the final data
from the CDC trial, which we expect at the end of 2007,
91
are favorable, we plan to apply to the FDA in 2008 for approval
of a three dose regimen of BioThrax for pre-exposure
prophylaxis, with a booster dose once every three years
thereafter.
Add second route of administration.
We have applied
to the FDA to add a second route of administration of BioThrax
to include intramuscular injection in addition to subcutaneous
injection. We believe that intramuscular injection will result
in fewer injection site reactions than subcutaneous injection.
Single dose syringe.
We believe that products that
are administered in a single dose syringe are of significant
interest to HHS for inclusion in the strategic national
stockpile. As a result, we have initiated a development program
to make BioThrax available in single dose syringes.
92
shelf life of three years or longer at room temperature;
the ability to generate protective immune response in one or two
doses; and
the ability to be safely self administered or rapidly inoculated
into large numbers of people.
93
94
95
96
97
In
in vitro
tests in which human cells were exposed
to our vaccine candidate, the live attenuated bacteria contained
in the vaccine did not multiply.
In pharmacology studies in mice, our vaccine candidate was
immunogenic and had higher relative immunogenicity when
delivered subcutaneously than the currently approved oral
typhoid vaccine.
In safety and toxicity studies in mice, a strain of
Salmonella
that causes a disease similar to typhoid in
mice, which contained deletions of the genes that are also
deleted in our vaccine candidate, did not cause disease.
98
An open-label, non-placebo controlled, pilot study conducted in
the United Kingdom in nine healthy adult volunteers. The purpose
of this study was to evaluate the safety and immunogenicity of
our vaccine candidate. In this study, our vaccine candidate was
immunogenic, eliciting both cell mediated and humoral
immunogenicity, and well tolerated.
A double-blind, placebo controlled, single dose escalating
Phase I clinical trial conducted in the United States in 60
healthy adult volunteers. The purpose of this trial was to
evaluate the safety, tolerability and immunogenicity of three
dose levels of our vaccine candidate. In this trial, our vaccine
candidate was immunogenic and well tolerated at all dose levels.
The immunogenicity parameter for this trial was the proportion
of trial participants with an immune response to the product
candidate on day seven after dosing or day 28 after dosing. To
be considered adequately immunogenic, 50% of the participants
receiving a vaccine dose had to satisfy the primary
immunogenicity endpoint. We performed analyses on both an intent
to treat and a per protocol basis. An intent to treat analysis
is based on the participants who receive a dose of vaccine. A
per protocol analysis is based on the participants who complete
a trial and substantially comply with the trial protocol. In
both the intent to treat population and the per protocol
population, 100% of the trial participants in the highest dose
group and 56% of the participants in the lowest dose group had
an immune response on day seven or day 28. The immune
response rate for the highest dose group was statistically
significantly greater than the immune response rate for the
lowest dose group, with a p-value of 0.0068 in the intent to
treat population and 0.0073 in the per protocol population.
An open-label, non-placebo controlled, single dose Phase I
clinical trial conducted in the United States in 32 healthy
adult volunteers. The purpose of this trial was to evaluate the
safety and immunogenicity of two different presentations of the
vaccine candidate, one using bottled water and another using tap
water. We vaccinated 16 subjects with each presentation. Because
one subject who received the tap water presentation of the
vaccine candidate was excluded from the trial results due to a
lack of post-baseline immunology data, the tap water
presentation data reflected data from only 15 subjects. The
immunogenicity parameter for this trial was the proportion of
trial participants with a humoral antibody response to
S.
typhi
following administration of a single dose of the
vaccine candidate. The immune response rate was 94% for the
participants who received the bottled water presentation and 93%
for the participants who received the tap water presentation.
The response rate for both groups was statistically
significantly higher than the assumed response rate of 50%. The
p-value was 0.0005 for the participants who received the bottled
water presentation and 0.0010 for the participants who received
the tap water presentation. Because the two presentations were
equally immunogenic and both were well tolerated by trial
participants, we selected the tap water presentation for further
development based on its relative convenience.
99
Phase II clinical trial.
In the fourth quarter
of 2006, we plan to initiate a single-blind, placebo controlled
Phase II clinical trial in Vietnamese children between five
and 14 years of age. The Wellcome Trust has agreed to
provide funding for this trial. The purpose of this trial will
be to evaluate the safety and immunogenicity of our vaccine
candidate. The trial design calls for 100 subjects to receive
vaccine and 50 to receive placebo, with at least 70% of the
subjects being between five and ten years of age. We will assess
safety and immunogenicity up to 28 days after vaccination.
Disease surveillance study.
Concurrently with the
planned Phase II clinical trial, we plan to conduct a
disease surveillance study in the areas where we are considering
conducting a Phase III clinical trial of our vaccine
candidate in order to confirm that a sufficient number of
subjects will be included in the Phase III trial.
Phase III clinical trial.
We plan to conduct a
single-blind Phase III clinical trial in an area where
typhoid is endemic. The purpose of this trial will be to
evaluate the efficacy of our vaccine candidate in children who
are likely to be exposed to the typhoid bacterium. We expect to
undertake an interim analysis of the data from the trial after
approximately one year, which, if the results are favorable, we
plan to use to support the filing with the FDA of a BLA for
marketing approval of our vaccine candidate. We plan to continue
to monitor the incidence of typhoid in the trial participants
for several years after vaccination.
Tolerability and immunogenicity study.
Concurrently
with our Phase III clinical trial, we plan to conduct a
Phase III clinical trial in the United States or Europe in
healthy volunteers. The purpose of this trial will be to
evaluate the safety and immunogenicity of our vaccine candidate
in the target population to support marketing approval in the
United Sates and Europe.
100
101
102
In studies in rabbits and mice, the three protein components of
our vaccine candidate were immunogenic.
In a passive immunization study in which we administered rabbit
antibody to rat pups, the rat pups were protected against
challenge with disease.
Antibodies elicited by one of the protein components of our
vaccine candidate recognized a number of group B streptococcus
types, indicating that the protein component has potential to
generate immune responses with broad coverage.
In a toxicology study in mice with one of the protein components
of our vaccine candidate, the protein was non-toxic.
103
104
105
Approximate
Location
Use
Segment
square
feet
Owned/leased
Manufacturing operations facilities
and office space
Biodefense
214,000
Owned
Future manufacturing facilities
Biodefense/
Commercial
290,000
Owned
Office and laboratory space
Biodefense/
36,000
Leases expire 2008
Commercial
Office space
Biodefense/
Commercial
23,000
Lease expires 2016
Office and laboratory space
Commercial
16,000
Leases expire 2016
106
107
108
the need for significant, long-term investment in research and
development;
the importance of manufacturing capacity, capability and
specialty know-how, such as techniques, processes and biological
starting materials; and
the high regulatory burden for prophylactic products, which
generally are administered to healthy people.
109
Next generation anthrax vaccine.
We expect that
NIAID will issue multiple contracts to fund future development
and testing of a next generation anthrax vaccine pursuant to its
request for proposals issued in June 2006. We face significant
competition for NIAID funding from other companies that have
responded to this NIAID request for proposals. If we continue to
pursue the development of a next generation anthrax vaccine, we
also expect that we will face significant competition for the
supply of our product candidate to the U.S. government.
Anthrax immune globulin.
Cangene, in collaboration
with the CDC, is currently developing an anthrax immune globulin
using plasma collected from military personnel who have been
vaccinated with
110
BioThrax. In July 2006, HHS exercised an option under a
modification to an existing development and supply contract for
Cangene to supply 10,000 doses of anthrax immune globulin for
the strategic national stockpile. In June 2006, HHS awarded a
contract to Human Genome Sciences to supply 20,000 treatment
courses of a monoclonal antibody to
Bacillus anthracis
,
referred to as ABthrax, for the strategic national stockpile.
Recombinant bivalent botulinum vaccine.
DynPort
Vaccine Company has a recombinant bivalent botulinum vaccine in
Phase I clinical development with funding from the DoD.
Botulinum immune globulin.
The current recommended
therapy for clinical symptoms of botulism following exposure
consists of passive immunization with an immune globulin derived
from equine plasma. In June 2006, HHS awarded a five-year
development and supply contract to Cangene for a heptavalent
botulinum immune globulin derived from equine plasma. The
contract provides for the supply of 200,000 doses of a botulinum
immune globulin for the strategic national stockpile.
Typhoid vaccine.
One oral typhoid vaccine and one
injectable typhoid vaccine are currently approved and
administered in the United States and Europe. In addition,
combination vaccines are available for the prevention of
hepatitis A and typhoid infections. Antibiotics typically are
used to treat typhoid after infection. For more information, see
Products Commercial
business Typhoid vaccine. We believe that
Avant Immunotherapeutics Inc. has an oral, single dose, live
attenuated typhoid vaccine candidate in Phase I clinical
development with funding from NIAID.
Hepatitis B therapeutic vaccine.
There is no vaccine
currently on the market that is licensed for therapeutic use for
hepatitis B infection. Currently available therapies for this
patient population consist mainly of antiviral drugs, such as an
immunotherapy with interferons. For more information, see
Products Commercial
business Hepatitis B therapeutic vaccine.
Several other companies have vaccine candidates in clinical
development, including Enzo Biochem, Oxxon Therapeutics and
Genencor International.
Group B streptococcus vaccine.
The existing method
of prevention of group B streptococcus infection in neonates is
the targeted administration of intravenous antibiotics to women
during labor. A number of competitors have passive immune
vaccines in preclinical development.
Chlamydia vaccine.
There is no vaccine currently on
the market for chlamydia, and we are not aware of any competing
chlamydia vaccine candidate in clinical development. Several
competitors may have chlamydia vaccine candidates in preclinical
development. Screening tests and effective antibiotic treatments
have been effective at containing chlamydia in the United States
and Europe.
Meningitis B vaccine.
Currently, there is no
meningitis vaccine on the market that is protective against
group B meningococcal infection. Novartis markets a meningitis B
vaccine in New Zealand to people under the age of 20 and is also
developing a broad coverage protein subunit vaccine candidate.
Current meningitis B treatment strategies include antibiotics
and clinical support.
111
Typhoid vaccine.
We hold five U.S. patents
relating to our typhoid vaccine candidate. Some of these patents
have claims to the composition of matter of the vaccine
candidate and methods of use of attenuated
Salmonella typhi
bacteria as vaccines for the treatment and prevention of
typhoid and for the delivery of vaccine antigens. In addition,
we have two pending U.S. patent applications with claims to
additional compositions and methods of therapy that are
generally related to our typhoid vaccine candidate. Our issued
U.S. patents expire, and, if issued, our U.S. patent
applications would expire, between 2015 and 2020. We hold 28
foreign counterparts to our issued U.S. patents relating to our
typhoid vaccine candidate, including counterparts under the
European Patent Convention and in Japan, that expire, and 34
foreign patent applications that, if issued, would expire,
between 2015 and 2020.
Hepatitis B therapeutic vaccine.
Our hepatitis B
therapeutic vaccine candidate uses our proprietary
spi
-VEC oral delivery system technology to deliver
hepatitis B core antigen to the human immune system.
Spi
-VEC is based on our live attenuated typhoid vaccine
candidate and employs recombinant technology to insert the gene
for hepatitis B core into the live attenuated S
almonella
bacteria. As a result, the patents relating to our typhoid
vaccine candidate also protect our hepatitis B therapeutic
vaccine candidate. We also hold one U.S. patent with claims
to the use of attenuated
Salmonella
organisms for the
delivery of hepatitis B vaccine antigens, which expires in 2019.
In addition, we have one pending U.S. patent application
relating to our hepatitis B therapeutic vaccine candidate, which
if issued also would expire in 2019. We have four foreign patent
applications relating to our hepatitis B therapeutic vaccine
candidate that, if issued, would expire in 2019.
Group B streptococcus vaccine.
We hold two
U.S. patents relating to our group B streptococcus vaccine
candidate with claims to the composition of matter of the
vaccine candidate and methods of use for the prevention or
treatment of infection caused by
Streptococcus
agalactiae
. In addition, we have four pending
U.S. patent applications with claims to additional
compositions and methods of therapy relating to our group B
streptococcus vaccine candidate. Our issued U.S. patents expire,
and, if issued, our U.S. patent applications would expire,
between 2019 and 2022. We hold 19 foreign counterparts to our
issued U.S. patents relating to our group B streptococcus
vaccine candidate, including counterparts under the European
Patent Convention and in Japan, that expire, and 40 foreign
patent applications that, if issued, would expire, in 2019.
112
STM technology.
We jointly own with Imperial College
Innovations Limited patents with claims to methods for the
identification of virulence genes using our signature tagged
mutagenesis, or STM, technology, which we used to identify and
develop the gene mutations that form the basis of our typhoid
vaccine and hepatitis B therapeutic vaccine candidates. We also
jointly own with Imperial Innovations the composition of matter
patents covering these gene mutations. We have exclusive rights,
even as to Imperial Innovations, under these jointly owned
patents in all fields of use, except in the field of diagnosis,
prevention, treatment, or palliation of microbial diseases,
disorders and infections in humans and animals where our rights
are generally non-exclusive and are subject to existing license
agreements with third parties. Because our typhoid vaccine and
hepatitis B therapeutic vaccine candidates are outside of this
non-exclusive field of use, we have exclusive rights with
respect to these vaccine candidates. We exclusively own the
composition of matter patents covering the specific combination
of mutations employed in our typhoid vaccine and hepatitis B
therapeutic vaccine candidates.
113
114
a percentage of the net revenue or license fees, as applicable,
that we receive from products developed using MVA that are used
for research or other purposes; and
a percentage of the license fees that we receive from products
developed using MVA that are licensed as starting material for
the production of a smallpox vaccine.
115
116
preclinical laboratory and animal tests;
submission to the FDA of an IND, which must become effective
before clinical trials may begin;
completion of human clinical trials and other studies to
establish the safety and efficacy of the proposed product for
each intended use;
FDA review of whether the facility in which the product is
manufactured, processed, packed or held complies with cGMP
requirements designed to assure the products continued
quality; and
submission to the FDA and approval of an NDA in the case of a
drug, or a BLA in the case of a biologic, containing preclinical
and clinical data, proposed labeling and information to
demonstrate that the product will be manufactured to appropriate
standards of identity, purity and quality.
In a Phase I clinical trial, the drug or biologic is
initially administered into healthy human subjects or subjects
with the target condition and tested for safety, dosage
tolerance, absorption, metabolism, distribution and excretion.
In a Phase II clinical trial, the drug or biologic is
administered to a limited subject population to identify
possible adverse effects and safety risks, the efficacy of the
product for specific targeted diseases and dosage tolerance and
optimal dosage.
A Phase III clinical trial is undertaken if a Phase II
clinical trial demonstrates that a dosage range of the drug or
biologic is effective and has an acceptable safety profile. In a
Phase III clinical trial, the drug or
117
biologic is administered to an expanded population, often at
geographically dispersed clinical trial sites, to further
evaluate dosage and clinical efficacy and to further test for
safety.
118
recordkeeping requirements;
periodic reporting requirements;
cGMP requirements related to all stages of manufacturing,
testing, storage, packaging, labeling and distribution of
finished dosage forms of the product;
reporting of adverse experiences with the drug or
biologic; and
advertising and promotion restrictions.
119
restrictions on the marketing or manufacturing of a product;
warning letters;
withdrawal of the product from the market;
refusal to approve pending applications or supplements to
approved applications;
voluntary or mandatory product recall;
fines or disgorgement of profits or revenue;
suspension or withdrawal of regulatory approvals;
refusal to permit the import or export of products;
product seizure; and
injunctions or the imposition of civil or criminal penalties.
120
121
the agent for which the countermeasure is designed can cause
serious or life-threatening disease;
the product may reasonably be believed to be effective in
detecting, diagnosing, treating or preventing the disease;
the known and potential benefits of the product outweigh its
known and potential risks;
there is no adequate alternative to the product that is approved
and available; and
any other criteria prescribed in regulations are met.
122
123
124
125
126
develop and implement biosafety, security and emergency response
plans;
restrict access to select agents and toxins;
provide appropriate training to our employees for safety,
security and emergency response;
comply with strict requirements governing transfer of select
agents and toxins;
provide timely notice to the government of any theft, loss or
release of a select agent or toxin; and
maintain detailed records of information necessary to give a
complete accounting of all activities related to select agents
and toxins.
127
128
129
157
Name
Age
Position
48
55
49
49
52
44
50
53
55
62
54
39
50
72
(1)
Member of the Audit Committee.
(2)
Member of the Compensation Committee.
(3)
Member of the Nominating and Corporate Governance Committee.
130
131
132
133
Mr. El-Hibri, Mr. Hauer and Mr. Richard will
serve as class I directors, and their terms will expire at our
2007 annual meeting;
Dr. Harsanyi and Dr. Sullivan will serve as
class II directors, and their terms will expire at our 2008
annual meeting; and
Mr. Allbaugh and Dr. Malik will serve as
class III directors, and their terms will expire at our
2009 annual meeting.
appointing, approving the compensation of, and assessing the
independence of our independent registered public accounting
firm;
overseeing the work of our independent registered public
accounting firm, including through the receipt and consideration
of reports from our independent registered public accounting
firm;
134
reviewing and discussing with management and the independent
registered public accounting firm our annual and quarterly
financial statements and related disclosures;
coordinating our board of directors oversight of internal
control over financial reporting, disclosure controls and
procedures and code of business conduct and ethics;
establishing procedures for the receipt and retention of
accounting related complaints and concerns;
meeting independently with our independent registered public
accounting firm and management; and
preparing the audit committee report required by Securities and
Exchange Commission rules.
reviewing and approving, or making recommendations to the board
of directors with respect to, the compensation of our chief
executive officer and our other executive officers;
overseeing the evaluation of the performance of our senior
executives;
overseeing and administering, and making recommendations to the
board of directors with respect to, our broad-based compensation
programs and our cash and equity incentive plans;
reviewing and making recommendations to the board of directors
with respect to director compensation; and
preparing the compensation committee report required by
Securities and Exchange Commission rules.
recommending to the board of directors the persons to be
nominated for election as directors or to fill vacancies and to
be appointed to each of the boards committees;
overseeing an annual review by the board of directors with
respect to management succession planning;
135
developing and recommending to the board of directors corporate
governance principles and guidelines; and
overseeing periodic evaluations of the board of directors.
On December 1, 2004, we granted a stock option to purchase
15,000 shares at an exercise price of $7.89 per share
to Dr. Harsanyi.
On January 26, 2005, we granted a stock option to purchase
15,000 shares at an exercise price of $7.89 per share
to Mr. Richard.
On June 15, 2005, we granted a stock option to purchase
15,000 shares at an exercise price of $10.06 per share
to Mr. Hauer.
136
On June 30, 2006, we granted a stock option to purchase
15,000 shares at an exercise price of $29.58 per share
to Dr. Sullivan.
On June 30, 2006, we granted a stock option to purchase
15,000 shares at an exercise price of $29.58 per share
to Mr. Allbaugh.
7,500 shares of common stock upon commencement of service
on our board of directors;
5,000 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six
months; and
if the non-employee director is serving as the chair of one or
more committees of our board of directors, an additional
2,500 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six months.
137
Long-term
compensation
Annual
compensation
Shares
Other annual
underlying
All other
Name and
principal position
Salary
Bonus
compensation
options
compensation(1)
President, Chief Executive Officer and Chairman of the Board of
Directors
$
490,818
$
237,215
$
75,000
$
7,000
Executive Vice President and Chief Operating Officer
280,192
94,517
40,000
President and Chief Executive Officer, Emergent BioDefense
Operations Lansing Inc.
371,192
140,816
40,000
7,000
President, Emergent Product Development UK Limited and Chief
Scientific Officer
225,162
82,250
38,752
(2)
20,000
Senior Vice President Corporate Affairs, General Counsel and
Secretary
272,631
110,400
7,000
(1)
Represents the value of our contributions on behalf of the named
executive officer to our 401(k) savings plan.
(2)
Represents a relocation payment of $15,000 and a living
allowance of $23,752.
138
Potential
realizable
value at
assumed
Percentage of
annual rates
of
Number of
total options
stock price
shares
granted to
Exercise
appreciation
for
underlying
employees in
price per
Expiration
option
term(1)
Name
options
granted
fiscal
year
share
date
5% ($)
10% ($)
75,000
(2)
30.0
%
$
10.06
5/25/10
40,000
(3)
16.0
7.89
2/9/10
40,000
(2)
16.0
10.06
5/25/10
20,000
(3)
8.0
7.89
2/9/10
(1)
The dollar amounts under these columns are the result of
calculations at rates set by the Securities and Exchange
Commission and, therefore, are not intended to forecast possible
future appreciation, if any, in the price of the underlying
common stock.
(2)
These options vest in three annual installments, with 40% of the
original number of shares having vested on December 31,
2005 and 30% of the original number of shares vesting on each of
December 31, 2006 and December 31, 2007.
(3)
These options vest in three equal annual installments beginning
on December 31, 2005.
139
fiscal year-end option values
Number of
securities
underlying
unexercised
Value of
unexercised
Number of
shares
options at
in-the-money
options at
acquired on
Value
December 31,
2005
December 31,
2005
Name
exercise
realized
Exercisable
Unexercisable
Exercisable
Unexercisable
30,000
45,000
13,334
26,666
178,500
24,000
6,667
13,333
25,900
11,100
140
any unpaid base salary and accrued paid time-off through the
date of termination;
a pro rata target annual bonus in respect of the year of
termination;
any bonus earned but unpaid as of the date of termination for
any previously completed year;
reimbursement for any unreimbursed expenses incurred by the
participant prior to the date of termination;
an amount equal to a specified percentage of the
participants annual base salary;
141
employee and fringe benefits and perquisites, if any, to which
the participant may be entitled as of the date of termination
under our relevant plans, policies and programs; and
continued eligibility for the participant and his or her
eligible dependents to receive employee benefits, for a stated
period following the participants date of termination,
except when the provision of employee benefits would result in a
duplication of benefits provided by any subsequent employer.
Stated period
Percentage of
for continued
annual base
employee
Name
salary
benefits
150
%
18 months
100
12 months
100
12 months
100
12 months
100
12 months
75
9 months
75
9 months
for the same stated period during which we have agreed to
provide continued employee benefits to the terminated employee,
not to:
induce, counsel, advise, solicit or encourage our employees to
leave our employ or to accept employment with any other person
or entity,
induce, counsel, advise, solicit or encourage any person who we
employed within six months prior to that time to accept
employment with any person or entity besides us or hire or
engage that person as an independent contractor,
solicit, interfere with or endeavor to cause any of our
customers, clients or business partners to cease or reduce its
relationship with us or induce any such customer, client or
business partner to breach any agreement that such customer,
client or business partner may have with us, and
engage in or have a financial interest in any business competing
with us within any state, region or locality in which we are
then doing business or marketing products;
upon reasonable notice and at our expense, to cooperate fully
with any reasonable request that may be made by us in connection
with any investigation, litigation or other similar activity to
which we are or may be a party or may otherwise be involved and
for which the participant may have relevant information; and
142
to sign and deliver a suitable waiver and release under which
the participant will release and discharge us from and on
account of any and all claims that relate to or arise out of our
employment relationship.
Mr. El-Hibris service as chairman of Digicel
Holdings, chairman of East West Resources, general manager of
Intervac, L.L.C. and Intervac Management, L.L.C., a member of
the board of trustees of American University, a member of the
board of directors of the International Biomedical Research
Alliance and director and treasurer of El-Hibri Charitable
Foundation and his management of his personal investments at
levels of time and attention comparable to those that
Mr. El-Hibri provided to such entities within the preceding
twelve months, do not violate his contractual obligations to us
or interfere with his ability to perform his duties to us;
it is not a violation of
Mr. El-Hibris
contractual obligations to us if he pursues a business
transaction or opportunity where such transaction or opportunity
was first presented to
Mr. El-Hibri
in his capacity as an officer or director of the entities listed
above or where such transaction or opportunity was first
presented to us and our board of directors declined to pursue
such transaction or opportunity; and
with respect to three employees who, at
Mr. El-Hibris
invitation, left their employment with East West Resources to
accept employment with us, it is not a violation of
Mr. El-Hibris
non-solicitation agreement to induce, counsel, advise, solicit
or encourage, or attempt to induce, counsel, advise, solicit or
encourage those employees to return to employment with East West
Resources.
a lump sum amount, payable within 30 days following the
date of termination, equal to the sum of:
any unpaid base salary and accrued paid time-off through the
date of termination,
a pro rata target annual bonus in respect of the year of
termination,
any bonus earned but unpaid as of the date of termination for
any previously completed year,
any unreimbursed expenses incurred by the participant prior to
the date of termination, and
an amount equal to a specified percentage of the sum of the
participants base salary and the greater of the annual
bonus that was paid to the participant in respect of the most
recently completed year or the maximum annual bonus that could
have been paid to the participant under an established bonus
plan for the most recently completed year;
employee and fringe benefits and perquisites, if any, to which
the participant may be entitled as of the date of termination of
employment under our relevant plans, policies and programs;
143
any unvested stock options held by the participant that are
outstanding on the date of termination will become fully vested
as of that date, and the period, during which any stock options
held by the participant that are outstanding on that date may be
exercised, shall be extended to a date that is the later of the
15th day of the third month following the termination date,
or December 31 of the calendar year in which the stock
option would otherwise have expired if the exercise period had
not been extended, but not beyond the final date the stock
option could have been exercised if the participants
employment had not terminated, in each case based on the term of
the option at the original grant date;
continued eligibility for the participant and his or her
eligible dependents to receive employee benefits, for a stated
period following the participants date of termination,
except when the provision of employee benefits would result in a
duplication of benefits provided by any subsequent employer;
a
gross-up
payment with respect to applicable taxes on any payment to the
participant;
the retention for the maximum period permitted by applicable law
of all rights the participant has to indemnification from us
immediately prior to the change of control and the continuation
throughout the period of any applicable statute of limitations
of any directors and officers liability insurance
covering the participant immediately prior to the change of
control; and
the advancement to the participant of all costs and expenses,
including attorneys fees and disbursements, incurred by
the participant in connection with any legal proceedings that
relate to the termination of employment or the interpretation or
enforcement of any provision of the severance plan, for which
the participant will have no obligation to reimburse us if the
participant prevails in the proceeding with respect to at least
one material issue or the proceeding is settled.
Stated period
Percentage of
for continued
annual base
employee
Name
salary
benefits
250
%
30 months
200
24 months
200
24 months
150
18 months
100
12 months
75
9 months
75
9 months
144
for any breach of their duty of loyalty to us or our
stockholders;
for acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law;
for voting or assenting to unlawful payments of dividends or
other distributions; or
for any transaction from which the director derived an improper
personal benefit.
145
146
Maximum
Maximum
specified
specified
percentage of
number of
outstanding
shares
shares
149,000
1.5
%
161,000
1.5
322,000
3.0
162,000
1.5
326,000
3.0
164,000
1.5
the number of shares of common stock covered by options and the
dates upon which the options become exercisable;
the exercise price of options, which may not be less than 100%
of the fair market value of the stock on the date of grant;
the duration of options, which may not be in excess of
10 years;
the method of payment of the exercise price; and
the number of shares of common stock subject to any stock
appreciation right, restricted stock, restricted stock units or
other stock-unit awards and the terms and conditions of such
awards, including conditions for exercise, repurchase, issue
price and repurchase price.
147
7,500 shares of common stock, upon the commencement of
service on our board of directors;
5,000 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six
months; and
if the non-employee director is serving as the chair of one or
more committees of our board of directors, an additional
2,500 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six months.
have an exercise price equal to the closing sale price of the
common stock on the Nasdaq Stock Market or the national
securities exchange on which the common stock is then traded on
the trading date immediately prior to the date of grant, or the
fair market value of the common stock on such date as determined
by our board of directors, if the common stock is not then
traded on The Nasdaq Stock Market or on a national securities
exchange;
vest in three equal annual installments beginning on the
anniversary of the date of grant provided that the individual is
serving on our board of directors on such date, or, with respect
to annual grants, on the date which is one business day prior to
the date of our next annual meeting, if earlier, provided that
no additional vesting will take place after the individual
ceases to serve as a director and that our board of directors
may provide for accelerated vesting in the case of death,
disability, attainment of mandatory retirement age or retirement
following at least 10 years of service;
expire on the earlier of 10 years from the date of grant or
three months following cessation of service on our board of
directors; and
contain other terms and conditions as our board of directors
determines.
148
149
Emergent BioSolutions Inc., a newly formed Delaware corporation,
issued 6,487,950 shares of class A common stock to
stockholders of BioPort Corporation in exchange for
6,262,554 shares of BioPort class A common stock and
225,396 shares of BioPort class B common stock;
we repurchased and retired all other issued and outstanding
shares of BioPort class B common stock; and
we assumed all outstanding stock options to purchase BioPort
class B common stock and granted option holders replacement
stock options to purchase an equal number of shares of our
class B common stock under our employee stock option plan.
Number of shares
of
Name
class A
common stock
2,890,000
1,412,896
672,500
555,822
477,941
250,000
228,791
150
Number of shares
of
class B
common stock
underlying
options
Name
granted
162,500
37,000
15,000
Amount of
special
Name
cash
dividend
$
2,402,864
1,174,739
559,144
462,133
397,380
207,860
190,226
151
Number of shares
of
Name
common
stock
2,890,000
1,412,896
1,264,051
672,500
555,822
477,941
250,000
228,791
152
153
154
payment of any previously unpaid base salary and accrued paid
time off and other benefits through the date of termination;
payment of any unpaid, pro-rated bonus through the date of
termination; and
a lump sum payment in the amount of $100,000, less applicable
withholding and related taxes.
155
each of our named executive officers;
each of our directors;
all of our executive officers and directors as a group; and
each person, or group of affiliated persons, who is known by us
to beneficially own more than 5% of our common stock.
156
Percentage of
shares
Number of
shares
beneficially
owned
Name of
beneficial owner
beneficially
owned
Before
offering
After
offering
7,782,001
99.6
%
13,334
*
178,500
2.2
6,667
*
25,900
*
10,000
*
5,000
*
5,000
*
8,038,902
99.6
7,752,001
99.6
1,264,051
16.2
832,104
10.5
502,941
6.4
*
Less than 1%.
(1)
Consists of the following shares of our common stock:
If the underwriters exercise their over-allotment option in
full, Mr. El-Hibri will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Robert Myers has the power to direct the disposition of all
shares of our capital stock held by Michigan Biologics Products.
Mauro and Yasmine Gibellini, as tenants by the entirety, have
the power to dispose of all shares of our capital stock held by
Biologika.
Janice Mugrditchian has the power to dispose of all shares of
our capital stock held by ARPI.
The holders of series B preferred ordinary shares of
Microscience Investments have the power to dispose of all shares
of our capital stock held by Microscience Investments and share
the power to vote these shares with BioPharm, L.L.C.
For more information regarding the beneficial ownership of these
shares, see Stockholder arrangements
below.
(2)
Consists of 13,334 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(3)
Consists of 178,500 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(4)
Consists of 6,667 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(5)
Consists of 25,900 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(6)
Consists of 10,000 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(7)
Consists of 5,000 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(8)
Consists of 5,000 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(9)
Consists of 286,901 shares of common stock subject to stock
options exercisable within 60 days of September 30,
2006.
(10)
Consists of the following shares of our common stock:
158
If the underwriters exercise their over-allotment option in
full, these stockholders will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Intervac, BioPharm, Michigan Biologics Products, Biovac,
Biologika, Intervac Management and ARPI are parties to a voting
agreement dated June 30, 2004. BioPharm also is a party to
separate voting agreements with Michigan Biologics Products,
Biologika and Microscience Investments.
Robert Myers has the power to direct the disposition of all
shares of our capital stock held by Michigan Biologics Products.
Mauro and Yasmine Gibellini, as tenants by the entirety, have
the power to dispose of all shares of our capital stock held by
Biologika.
Janice Mugrditchian has the power to dispose of all shares of
our capital stock held by ARPI.
The holders of series B preferred ordinary shares of
Microscience Investments have the power to dispose of all shares
of our capital stock held by Microscience Investments.
For more information regarding the beneficial ownership of these
shares, see Stockholder arrangements
below.
(11)
The holders of series B preferred ordinary shares of
Microscience Investments have the power to dispose of all shares
of our capital stock held by Microscience Investments and share
the power to vote these shares with BioPharm, L.L.C. Investment
funds affiliated with Apax Funds Nominees Limited, Advent
Private Equity Funds, JP Morgan Partners LLC and The Merlin
Biosciences Funds are the holders of the Microscience
Investments series B preferred ordinary shares. No holder
or group of affiliated holders of series B preferred
ordinary shares of Microscience Investments alone has the power
to direct the disposition of the shares of our capital stock
held by Microscience Investments. Microscience Investments is a
party to a voting agreement with BioPharm. For more information
regarding this voting agreement, see
Stockholder arrangements below.
(12)
Consists of the following shares of our common stock:
159
If the underwriters exercise their over-allotment option in
full, Dr. Myers will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Dr. Myers has the power to direct the disposition of all
shares of our capital stock held by Michigan Biologics Products.
Mr. El-Hibri has the power to direct the voting of all
shares of our capital stock held by Michigan Biologics Products.
For more information regarding the beneficial ownership of these
shares, see Stockholder arrangements
below.
(13)
Consists of the following shares of our common stock:
If the underwriters exercise their over-allotment option in
full, Mr. and Mrs. Gibellini will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Mr. and Mrs. Gibellini, as tenants by the entirety, have
the power to dispose of all shares of our capital stock held by
Biologika. Mr. El-Hibri has the power to direct the voting
of all shares of our capital stock held by Biologika. For more
information regarding the beneficial ownership of these shares,
see Stockholder arrangements below.
Number of shares
of
Name
common
stock
160
161
162
our class A common stock will be reclassified as common
stock and each outstanding share of our class B common
stock will be converted into one share of common stock; and
each outstanding option to purchase shares of our class B
common stock will automatically become an option to purchase an
equal number of shares of common stock at the same exercise
price per share.
163
164
165
the rights are evidenced by our common stock certificates and
will be transferred with and only with such common stock
certificates; and
the surrender for transfer of any certificates of our common
stock will also constitute the transfer of the rights associated
with our common stock represented by such certificate.
166
10 business days following the later of (1) a public
announcement that a person or group, other than an exempted
person, has acquired, or obtained the right to acquire
beneficial ownership of 15% or more of the outstanding shares of
our common stock or (2) the first date on which one of our
executive officers has actual knowledge of such an
event; and
10 business days following the start of a tender offer or
exchange offer that would result in a person or group, other
than an exempted person, beneficially owning 15% or more of the
outstanding shares of our common stock.
Fuad El-Hibri and his wife, Nancy
El-Hibri,
and any entity controlled by Fuad
El-Hibri
or
Nancy
El-Hibri;
Microscience Investments Limited, unless and until such time as
Microscience Investments, together with its affiliates and
associates, directly or indirectly, becomes the beneficial owner
of any additional shares of common stock, except under certain
specified circumstances, and disregarding any shares
Microscience Investments is or becomes the beneficial owner of
solely as a result of the fact that it is a party to any of the
voting agreements described under Principal and selling
stockholders Stockholder arrangements; and
each other holder of our common stock immediately prior to this
offering to the extent such persons beneficial ownership
exceeds 15% solely as a result of the fact that the person is a
party to any of the voting agreements described under
Principal and selling stockholders Stockholder
arrangements.
rights will not be exercisable until the rights are no longer
redeemable by us as set forth below; and
all rights that are, or were, under the circumstances specified
in the rights agreement, beneficially owned by any acquiring
person will be null and void.
167
we are acquired in a merger or other business combination
transaction in which we are not the surviving corporation;
we are the surviving entity in a merger of other business
combination transaction but our common stock is changed or
exchanged for stock or securities of any other person or for
cash or any other property; or
more than 50% of our assets or earning power is sold or
transferred,
168
169
170
1% of the number of shares of our common stock then outstanding,
which will equal
approximately shares
immediately after this offering; and
the average weekly trading volume in our common stock on The
NASDAQ Global Market during the four calendar weeks preceding
the date of filing of a Notice of Proposed Sale of Securities
Pursuant to Rule 144 with respect to the sale.
171
the person is not our affiliate and has not been our affiliate
at any time during the three months preceding the sale; and
the person has beneficially owned the shares proposed to be sold
for at least two years, including the holding period of any
prior owner other than an affiliate.
172
173
F-30
Number of
Name
shares
Without over-
With full
over-
Underwriting
discounts and commissions
allotment
exercise
allotment
exercise
$
$
$
$
174
175
176
the information set forth in this prospectus and otherwise
available to the representatives;
our prospects and the history and prospects for the industry in
which we compete;
an assessment of our management;
our prospects for future earnings;
the general condition of the securities markets at the time of
this offering;
the recent market prices of, and demand for, publicly traded
common stock of generally comparable companies; and
other factors deemed relevant by the underwriters and us.
177
178
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-1
F-2
Consolidated balance sheets
F-3
Consolidated statements of operations
Nine months
ended
September 30,
(in
thousands, except
Year
ended December 31,
(unaudited)
share and per
share data)
2003
2004
2005
2005
2006
$
55,536
$
81,014
$
127,271
$
85,807
$
61,263
233
2,480
3,417
1,093
4,580
55,769
83,494
130,688
86,900
65,843
22,342
30,102
31,603
23,147
11,645
6,327
10,117
18,381
9,632
26,640
19,547
30,323
42,793
28,924
32,952
1,824
26,575
26,575
477
(3,819
)
(10,000
)
(10,000
)
5,729
16,771
21,336
8,622
(5,871
)
100
65
485
338
405
(293
)
(241
)
(767
)
(575
)
(778
)
168
6
55
(24
)
291
(25
)
(170
)
(227
)
(261
)
(82
)
5,704
16,601
21,109
8,361
(5,953
)
1,250
5,129
5,325
2,109
(2,617
)
$
4,454
$
11,472
$
15,784
$
6,252
$
(3,336
)
$
0.68
$
1.74
$
2.21
$
0.90
$
(0.43
)
$
0.63
$
1.61
$
2.00
$
0.82
$
(0.43
)
6,570,856
6,576,019
7,136,866
6,927,289
7,775,263
7,061,537
7,104,172
7,908,023
7,663,468
7,775,263
$
$
$
0.76
$
0.78
$
F-4
Consolidated statement of changes in
stockholders equity
Class A
Class B
Accumulated
no-par
no-par
Class A
Class B
Additional
other
Total
(in thousands,
except
common
stock
common stock
$0.01 par
value common stock
$0.01 par
value common stock
paid-in
comprehensive
Retained
stockholders
share and per
share data)
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
capital
loss
earnings
equity
6,262,554
$
2,940
$
254,384
$
69
$
$
$
$
$
1,146
$
4,155
(25,000
)
(7
)
(193
)
(200
)
152,676
39
39
4,454
4,454
6,262,554
2,940
382,060
101
5,407
8,448
(199,271
)
(53
)
(1,559
)
(1,612
)
42,607
12
12
(6,262,554
)
(2,940
)
6,262,554
63
2,877
(225,396
)
(60
)
225,396
2
58
4,310
4,310
319
319
11,472
11,472
6,487,950
65
7,564
15,320
22,949
1,264,051
13
26,988
27,001
46,384
33
33
(38,984
)
(29
)
(308
)
(337
)
(17
)
(17
)
(5,400
)
(5,400
)
15,784
15,784
(276
)
(276
)
15,508
7,752,001
78
7,400
34,539
(276
)
25,396
59,737
(221
)
(221
)
22,615
43
43
442
442
(3,336
)
(3,336
)
94
94
(3,242
)
$
$
7,752,001
$
78
30,015
$
$
35,024
$
(182
)
$
21,839
$
56,759
F-5
Consolidated statements of cash flows
Nine months
ended
September 30,
Year ended
December 31,
(unaudited)
(in
thousands)
2003
2004
2005
2005
2006
$
4,454
$
11,472
$
15,784
$
6,252
$
(3,336
)
4,310
(17
)
442
(3,819
)
1,214
1,867
3,549
2,495
3,265
(467
)
(418
)
(10,968
)
(10,313
)
933
200
13
43
32
31
82
1,824
26,575
26,575
477
540
(528
)
(15,664
)
16,107
16,299
(744
)
(4,656
)
(1,609
)
(3,189
)
(3,009
)
(11,627
)
(1,713
)
5,794
(2,390
)
(2,509
)
(4,913
)
(244
)
50
(865
)
(939
)
(3,653
)
983
2,472
5,463
(1,275
)
6,146
(583
)
585
2,466
(1,163
)
(1,279
)
(1,617
)
44
619
103
1,442
11,852
3,869
(10,916
)
(10,916
)
4,639
11,072
9,196
42,250
21,631
(8,126
)
(4,123
)
(17,072
)
(6,532
)
(2,300
)
(32,333
)
(3,794
)
(559
)
(218
)
(1,250
)
1,250
(17
)
(190
)
147
(7,917
)
(18,175
)
(5,841
)
(2,317
)
(32,741
)
172
10,992
31
35,853
947
123
123
(900
)
(2,351
)
39
12
33
43
(200
)
(665
)
(337
)
(339
)
(221
)
(38
)
(184
)
(1,110
)
(958
)
(11,290
)
(70
)
(5,400
)
(5,400
)
(927
)
8,681
(6,660
)
(6,574
)
24,385
(276
)
(50
)
94
2,228
(298
)
29,473
12,690
(16,388
)
4,891
7,119
6,821
6,821
36,294
$
7,119
$
6,821
$
36,294
$
19,511
$
19,906
$
99
$
170
$
696
$
501
$
665
$
4,280
$
$
17,985
$
3,835
$
1,470
$
$
$
27,001
$
27,001
$
F-6
Notes to consolidated financial statements
(dollars in thousands, except per
share data)
1.
Nature of the
business and organization
Emergent issued 6,487,950 shares of Class A Common
Stock in exchange for 6,262,554 shares of BioPort
class A common stock and 225,396 shares of BioPort
class B common stock;
all other issued and outstanding shares of BioPort class B
common stock were repurchased and retired; and
all outstanding stock options to purchase BioPort class B
common stock were assumed by Emergent and option holders were
granted replacement stock options to purchase an equal number of
shares of Class B Common Stock of Emergent.
2.
Summary of
significant accounting policies
F-7
F-8
39 years
3-7 years
Lesser of 3 years or product life
Lesser of the asset life or life of lease
F-9
there is persuasive evidence of an arrangement;
delivery has occurred and title has passed to the Companys
customer;
the fee is fixed and determinable and no further obligation
exists; and
collectibility is reasonably assured.
F-10
F-11
F-12
Nine months
ended
Year ended
December 31,
September 30,
2003
2004
2005
2005
2006
$
4,454
$
11,472
$
15,784
$
6,252
$
(3,336
)
6,570,856
6,576,019
7,136,866
6,927,289
7,775,263
490,681
528,152
771,157
736,179
7,061,537
7,104,172
7,908,023
7,663,468
7,775,263
$
0.68
$
1.74
$
2.21
$
0.90
$
(0.43
)
$
0.63
$
1.61
$
2.00
$
0.82
$
(0.43
)
F-13
Year ended
December 31,
Nine months ended
September 30,
2003
2004
2005
2005
2006
0
%
0
%
0
%
0
%
0
%
100
%
52
%
50
%
50
%
50
%
3.15
%
2.93
%
3.68
%
4.18
%
4.69
%
2.7
2.5
2.9
2.7
2.9
0
%
0
%
0
%
0
%
5
%
Expected dividend yield
The Company does not
pay regular dividends on its common stock and does not
anticipate paying any dividends in the foreseeable future.
Expected volatility
Volatility is a measure
of the amount by which a financial variable, such as share
price, has fluctuated (historical volatility) or is expected to
fluctuate (expected volatility) during a period. The Company
uses the historical volatility of similar companies over the
preceding three-year period to estimate expected volatility.
Since 2003, the annual volatility of these similar companies has
ranged from 18.4% to 29.4%, with an average of 23.4%.
Risk-free interest rate
This is the average
U.S. Treasury rate with a term that most closely resembles
the expected life of the option for the quarter in which the
option was granted.
Expected average life of options
This is the
period of time that the options granted are expected to remain
outstanding. This estimate is based primarily on the employee
position profile of option holders and the trading lock out
periods that result from the employees access to stock price
sensitive information.
Forfeiture rate
This is the estimated
percentage of options granted that are expected to be forfeited
or cancelled on an annual basis before becoming fully vested.
The Company estimates the forfeiture rate based on past turnover
data with further consideration given to the level of the
employees to whom the options were granted.
F-14
Year ended
December 31,
Nine months ended
September 30,
2003
2004
2005
2005
2006
$
4,454
$
11,472
$
15,784
$
6,252
$
(3,336
)
2,801
248
(133
)
(3,185
)
(258
)
(161
)
(248
)
$
4,321
$
11,088
$
15,526
$
6,091
$
(3,336
)
$
0.68
$
1.74
$
2.21
$
0.90
$
(0.43
)
$
0.63
$
1.61
$
2.00
$
0.82
$
(0.43
)
$
0.66
$
1.69
$
2.18
$
0.88
$
(0.43
)
$
0.61
$
1.56
$
1.96
$
0.77
$
(0.43
)
F-15
3.
Acquisitions
$
250
180
$
430
F-16
$
153
97
(297
)
47
477
$
430
$
27,001
1,194
$
28,195
$
1,441
863
(684
)
1,620
26,575
$
28,195
F-17
$
3,400
394
$
3,794
$
279
1,691
1,824
$
3,794
4.
Accounts
receivable
December 31,
September 30,
2004
2005
2006
$
14,865
$
1,112
$
3,166
3,772
1,418
107
$
18,637
$
2,530
$
3,273
F-18
5.
Inventories
December 31,
September 30,
2004
2005
2006
$
1,947
$
2,229
$
2,165
6,674
9,547
24,195
4,632
4,665
1,708
$
13,253
$
16,441
$
28,068
6.
Property, plant
and equipment
December 31,
September 30,
2004
2005
2006
$
2,963
$
2,995
$
5,124
13,496
14,143
22,569
10,563
12,520
14,597
3,818
3,937
3,937
2,086
6,197
25,506
32,925
39,792
71,733
(5,657
)
(9,147
)
(12,101
)
$
27,269
$
30,645
$
59,632
7.
Other
assets
F-19
8.
Other current
liabilities
December 31,
September 30,
2004
2005
2006
$
3
$
445
$
1,948
1,462
1,390
1,056
71
146
259
357
628
838
$
1,893
$
2,609
$
4,101
9.
Long-term debt
and related party notes payable
2004
2005
2006
$
$
$
10,000
5,000
7,000
7,000
7,000
2,500
2,500
2,500
2,280
1,760
1,280
8,428
947
537
63
140
113
34
12,867
11,909
34,305
(1,046
)
(1,408
)
(1,750
)
$
11,821
$
10,502
$
32,555
F-20
F-21
$
1,408
1,302
317
2,838
6,045
$
11,910
10.
Stockholders
equity
F-22
F-23
BioPort
Plan
Emergent
Plan
Weighted
Weighted
average
average
Aggregate
Number
exercise
Number
exercise
intrinsic
of
shares
price
of
shares
price
value
Outstanding at December 31,
2002
803,242
$
0.25
$
103,500
13.05
(152,676
)
0.26
(77,235
)
0.80
676,831
2.17
458,696
0.58
47,391
3.11
281,898
7.89
(42,607
)
0.27
(677,381
)
1.24
677,381
1.24
(4,234
)
1.36
(57,784
)
3.44
901,495
$
3.27
860,279
2.95
280,000
11.19
(46,384
)
0.91
(43,032
)
7.57
1,092,079
$
5.11
F-24
BioPort
Plan
Emergent
Plan
Weighted
Weighted
average
average
Aggregate
Number
exercise
Number
exercise
intrinsic
of
shares
price
of
shares
price
value
852,481
$
3.50
90,000
32.68
(22,615
)
1.86
(67,685
)
7.62
1,091,779
$
7.30
$
33,692,300
811,347
$
3.81
$
27,869,769
Options
outstanding
Options
exercisable
Weighted
average
Weighted
Weighted
remaining
average
average
Range
of
Number
contractual
exercise
Number
exercise
exercise
prices
outstanding
life
(years)
price
exercisable
price
$ 0.25
342,879
1.50
$
0.25
342,879
$
0.25
162,500
1.50
0.28
162,500
0.28
16,100
1.50
4.43
16,100
4.43
400,600
2.69
7.89
279,002
7.89
135,000
4.96
10.06
48,000
10.06
35,000
4.65
24.52
4,000
24.52
1,092,079
2.46
$
5.11
852,481
$
3.50
Weighted
Weighted
Weighted
Number of
average
average
average
options
exercise
fair value of
intrinsic
Month
of grant
granted
price
common stock
value(1)
10,000
24.52
24.52
57,500
29.58
29.58
32,500
38.16
38.16
(1)
Intrinsic value reflects the amount by which the value of the
shares as of the grant date exceeds the exercise price of the
options.
F-25
11.
Income
taxes
Nine months
Year ended
December 31,
ended
September 30,
2003
2004
2005
2005
2006
Current
$
1,717
$
5,547
$
16,093
$
12,222
$
(3,650
)
200
200
100
1,717
5,547
16,293
12,422
(3,550
)
(416
)
(372
)
(9,769
)
(9,177
)
833
(51
)
(46
)
(1,199
)
(1,136
)
100
(467
)
(418
)
(10,968
)
(10,313
)
933
$
1,250
$
5,129
$
5,325
$
2,109
$
(2,617
)
December 31,
September 30,
2004
2005
2006
Net operating loss carryforward
$
666
$
2,242
$
4,180
645
721
703
1,457
1,696
1,393
27,797
30,343
883
1,219
1,245
3,651
33,675
37,864
(1,859
)
(1,387
)
(941
)
(124
)
(393
)
(673
)
(1,983
)
(1,780
)
(1,614
)
(666
)
(19,925
)
(25,213
)
$
1,002
$
11,970
$
11,037
F-26
Year ended
December 31,
Nine months ended
September 30,
2003
2004
2005
2005
2006
Federal tax at statutory rates
$
1,996
$
5,863
$
7,388
$
2,926
(1,794
)
(230
)
(714
)
(2,329
)
(1,864
)
(962
)
Impact of foreign operations
(17,982
)
(17,368
)
(3,599
)
Change in valuation allowance
187
479
19,259
17,712
5,288
Tax credits
(441
)
(492
)
(474
)
(474
)
Other differences
(255
)
11
(211
)
1,198
(1,840
)
Permanent differences
(7
)
(18
)
(326
)
(21
)
290
Federal tax at statutory rates
$
1,250
$
5,129
$
5,325
$
2,109
$
(2,617
)
12.
401(k) savings
plan
13.
Commitments and
settlement gains
$
1,689
2007
1,249
2008
1,188
2009
56
Total minimum lease payments
$
4,182
F-27
F-28
15.
Segment
information
Reportable
segments
Biodefense
Commercial
All
other
Total
$
128,219
$
2,469
$
$
130,688
10,327
6,962
1,092
18,381
485
485
(767
)
(767
)
2,911
411
226
3,548
58,632
(40,325
)
2,523
15,784
40,502
5,489
54,341
100,332
$
3,286
$
3,052
$
194
$
6,532
$
82,585
$
909
$
$
83,494
6,279
1,136
2,702
10,117
65
65
(241
)
(241
)
1,685
169
10
1,867
21,776
(5,428
)
(4,876
)
11,472
51,626
3,491
13,939
69,056
$
8,320
$
668
$
8,084
$
17,072
F-29
Reportable
segments
Biodefense
Commercial
All
other
Total
$
55,536
$
233
$
$
55,769
4,352
477
1,498
6,327
100
100
(293
)
(293
)
1,153
61
6,106
(1,459
)
(193
)
(4,454
)
28,266
2,462
7,119
37,847
$
4,020
$
103
$
$
4,123
16.
Quarterly
financial data (unaudited)
Three months
ended
March 31
June 30
September 30
December 31
$
15,261
$
44,058
$
27,581
$
43,788
425
3,699
4,498
12,714
225
2,616
3,410
9,533
0.03
0.40
0.44
1.23
0.03
0.37
0.40
1.11
$
20,360
$
13,044
$
22,241
$
27,848
3,758
(7,632
)
8,063
12,582
2,582
(5,271
)
5,580
8,560
0.39
(0.79
)
0.86
1.32
0.37
(0.79
)
0.79
1.22
Cowen and Company
HSBC
Item 13.
Other
Expenses of Issuance and Distribution
Amount
$
9,229
9,125
*
*
*
*
*
*
*
$
*
*
To be filed
by amendment.
Item 14.
Indemnification
of Directors and Officers
Item 15.
Recent
Sales of Unregistered Securities
(1)
On
June 30, 2004, the Registrant issued an aggregate of
6,487,950 shares of class A common stock to
stockholders of BioPort Corporation in exchange for an equal
number of outstanding shares of common stock of BioPort. All
other issued and outstanding shares of common stock of BioPort
were repurchased and retired. As a result of this exchange,
BioPort became a wholly owned subsidiary of the Registrant. The
Registrant subsequently renamed BioPort as Emergent BioDefense
Operations Lansing Inc.
(2)
On
June 23, 2005, the Registrant issued an aggregate of
1,264,051 shares of class A common stock to
Microscience Investments Limited, formerly Microscience Holdings
plc, in connection with the acquisition of all the outstanding
shares of capital stock of Microscience Limited.
Item 16.
Exhibits
Item 17.
Undertakings
(a)
The
undersigned registrant hereby undertakes to provide to the
underwriters at the closing specified in the underwriting
agreement, certificates in such denominations and registered in
such names as required by the underwriters to permit prompt
delivery to each purchaser.
(b)
Insofar as
indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions,
or otherwise, the registrant has been advised that, in the
opinion of the Securities and Exchange Commission, such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other
than the payment by the registrant of expenses incurred or paid
by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final
adjudication of such issue.
(c)
The
undersigned registrant hereby undertakes that:
(i)
For purposes
of determining any liability under the Securities Act of 1933,
the information omitted from the form of prospectus filed as
part of this registration statement in reliance upon
Rule 430A and contained in the form of prospectus filed by
the registrant pursuant to Rule 424(b)(1) or (4) or
497(h) under the Securities Act shall be deemed to be part of
the registration statement as of the time it was declared
effective.
(ii)
For purposes
of determining any liability under the Securities Act, each
post-effective amendment that contains a form of prospectus
shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona
fide offering thereof.
By:
President, Chief Executive Officer
and Chairman of the Board of Directors
(Principal Executive Officer)
October 20, 2006
Vice President Finance, Chief
Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
October 20, 2006
Director
October 20, 2006
Director
October 20, 2006
Director
October 20, 2006
Director
October 20, 2006
Director
October 20, 2006
Director
October 20, 2006
*By:
Attorney-in-fact
Exhibit
1
.1**
Form of Underwriting Agreement
3
.1*
Amended and Restated Certificate
of Incorporation of the Registrant
3
.2*
Form of Restated Certificate of
Incorporation of the Registrant to be effective upon completion
of the offering
3
.3*
Bylaws of the Registrant
3
.4*
Form of Amended and Restated
By-laws of the Registrant to be effective upon the completion of
the offering
4
.1
Specimen certificate evidencing
shares of common stock
4
.2*
Registration Rights Agreement,
dated June 23, 2005, between the Registrant and
Microscience Investments Limited, formerly Microscience Holdings
plc
4
.3*
Registration Rights Agreement,
dated September 22, 2006, among the Registrant and the entities
listed on Schedule 1 thereto
4
.4**
Rights Agreement, to be entered
into between the Registrant and the Rights Agent
5
.1*
Form of Opinion of Wilmer Cutler
Pickering Hale and Dorr LLP to be issued prior to effectiveness
9
.1*
Voting and Right of First Refusal
Agreement, dated October 21, 2005 between the William J.
Crowe, Jr. Revocable Living Trust and Fuad El-Hibri
9
.2*
Voting Agreement, dated
June 30, 2004, between BioPharm, L.L.C. and Michigan
Biologics Products, Inc.
9
.3*
Voting Agreement, dated
June 30, 2004, between BioPharm, L.L.C. and Biologika,
L.L.C.
9
.4*
Voting Agreement, dated
June 30, 2004, by and among the stockholders named therein
9
.5*
Voting Agreement, dated August 11,
2006, between BioPharm, L.L.C. and Microscience Investments
Limited
10
.1*
Employee Stock Option Plan, as
amended and restated
10
.2*
Form of Director Stock Option
Agreement
10
.3**
2006 Stock Incentive Plan
10
.4**
Form of Incentive Stock Option
Agreement under 2006 Stock Incentive Plan
10
.5**
Form of Nonstatutory Stock Option
Agreement under 2006 Stock Incentive Plan
10
.6
Severance Plan and Termination
Protection Program
10
.7*
Form of Indemnity Agreement
10
.8
Contract
No. W9113M-04-D-0002,
dated January 3, 2004, between Emergent BioDefense
Operations Lansing Inc., formerly BioPort Corporation, and
U.S. Army Space and Missile Defense Command, as amended
10
.9*
Contract
No. 200-2005-11811,
dated May 5, 2005, between Emergent BioDefense Operations
Lansing Inc., formerly BioPort Corporation, and Department of
Health and Human Services, Office of Public Health Emergency
Preparedness and Office of Research and Development
Coordination, as amended
10
.10*
Filling Services Agreement, dated
March 18, 2002, between Emergent BioDefense Operations
Lansing Inc., formerly BioPort Corporation, and Hollister-Stier
Laboratories LLC, as amended
10
.11*
BT Vaccine License Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
10
.12*
BT Vaccine Development Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
10
.13*
rBot Vaccine License Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
10
.14*
rBot Vaccine Development
Agreement, dated November 23, 2004, between the Registrant
and the Health Protection Agency
10
.15*
Exclusive Distribution Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
Exhibit
10
.16*
Investment Agreement relating to
Microscience Holdings plc, dated March 18, 2005, among the
Wellcome Trust, Microscience Investments Limited, formerly
Microscience Holdings plc, and Emergent Product Development
UK Limited, formerly Microscience Limited, as amended
10
.17*
Standard Employment Contract,
dated September 22, 2006, between Emergent Product
Development UK Limited, formerly Emergent Europe Limited, and
Steven N. Chatfield
10
.18*
Letter Agreement, dated
July 11, 2006, between the Registrant and Steven N.
Chatfield
10
.19*
Consulting Services Agreement,
dated March 1, 2006, between the Registrant and The Hauer
Group
10
.20*
Amended and Restated Marketing
Agreement, dated January 1, 2000, between Emergent
BioDefense Operations Lansing Inc., formerly BioPort
Corporation, and Intergen N.V., as amended
10
.21*
Lease, dated December 1,
1998, between ARE-QRS, Corp. and Antex Biologics Inc., as amended
10
.22*
Lease (540 Eskdale Road, Winnersh
Triangle, Wokingham, Berkshire), dated December 13, 1996,
between Slough Properties Limited and Azur Environmental
Limited, as assigned to Emergent Product Development UK Limited,
formerly Microscience Limited
10
.23*
Lease (545 Eskdale Road, Winnersh
Triangle, Wokingham, Berkshire), dated December 13, 1996,
between Slough Properties Limited and Azur Environmental
Limited, as assigned to Emergent Product Development UK Limited,
formerly Microscience Limited
10
.24*
Lease Agreement, dated
June 27, 2006, between Brandywine Research LLC and the
Registrant
10
.25
Amended and Restated Loan
Agreement, dated July 29, 2005, between Emergent BioDefense
Operations Lansing Inc., formerly BioPort Corporation, and Fifth
Third Bank, as amended
10
.26*
Loan and Security Agreement, dated
October 14, 2004, among the Registrant, Emergent Commercial
Operations Frederick Inc., formerly Advanced BioSolutions, Inc.,
Antex Biologics Inc., Emergent BioDefense Operations Lansing
Inc., formerly BioPort Corporation, and Mercantile Potomac Bank
10
.27*
Promissory Note, dated
October 14, 2004, from Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., to
Mercantile Potomac Bank
10
.28*
Loan Agreement, dated
October 15, 2004, between Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., and the
Department of Business and Economic Development
10
.29*
Deed of Trust Note, dated
October 14, 2004, between Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., and the
Department of Business and Economic Development
10
.30*
Term Note, dated August 10,
2004, from Emergent BioDefense Operations Lansing Inc., formerly
BioPort Corporation, to Fifth Third Bank
10
.31*
Loan Agreement, dated
April 25, 2006, among the Registrant, Emergent Frederick
LLC and HSBC Realty Credit Corporation (USA)
10
.32*
Bond Purchase Agreement, dated
March 31, 2005, between the County Commissioners of
Frederick County, Emergent Commercial Operations Frederick Inc.,
formerly Emergent Biologics Inc., and Mercantile Potomac Bank
10
.33*
License and Co-development
Agreement, dated May 6, 2006, between Emergent Product
Development UK Limited, formerly Emergent Europe Limited, and
Sanofi Pasteur, S.A.
10
.34
Product Supply Agreement, dated
June 12, 2006, between Emergent Product Development
Gaithersburg Inc. and Talecris Biotherapeutics, Inc.
10
.35*
Election of Fuad El-Hibri to
Participate in the Severance Plan and Termination Protection
Program
10
.36*
Services Agreement, dated August
1, 2006, between East West Resources Corporation and the
Registrant
10
.37*
Director Compensation Program
10
.38*
Revolving Credit Note, dated July
29, 2005, from Emergent BioDefense Operations Lansing Inc.,
formerly BioPort Corporation, to Fifth Third Bank
10
.39*
Promissory Note, dated April 25,
2006, from Emergent Frederick LLC to HSBC Realty Credit
Corporation (USA)
Exhibit
10
.40*
Loan Agreement, dated August 25,
2006, among the Registrant, Emergent BioDefense Operations
Lansing Inc., formerly BioPort Corporation, and HSBC Realty
Credit Corporation (USA)
10
.41*
Promissory Note (Term Note), dated
August 25, 2006, from Emergent BioDefense Operations Lansing
Inc., formerly BioPort Corporation, to HSBC Realty Credit
Corporation (USA)
10
.42*
Promissory Note (Revolving Credit
Loan), dated August 25, 2006, from Emergent BioDefense
Operations Lansing Inc., formerly, BioPort Corporation to HSBC
Realty Credit Corporation (USA)
10
.43
Agreement, dated June 16,
2005, between the Free State of Bavaria and Emergent Product
Development UK, formerly ViVacs GmbH
21
.1
Subsidiaries of the Registrant
23
.1
Consent of Independent Registered
Public Accounting Firm
23
.2**
Consent of Wilmer Cutler Pickering
Hale and Dorr LLP (included in Exhibit 5.1)
24
.1*
Powers of Attorney (included on
signature page)
*
Previously
filed.
**
To be filed
by amendment.
Confidential
treatment requested. Confidential materials omitted and filed
separately with the Securities and Exchange Commission.
TEN COM
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| as tenants in common | ||||||||||||
TEN ENT
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| as tenants by the entireties | UNIF GIFT MIN ACT | Custodian | ||||||||||
JT TEN | | as joint tenants with right of |
(Cust)
|
(Minor) | ||||||||||
survivorship and not as tenants in common | under Uniform Gifts to Minors | |||||||||||||
|
Act | |||||||||||||
|
(State) |
PLEASE INSERT SOCIAL SECURITY OR OTHER
|
||
IDENTIFYING NUMBER OF ASSIGNEE
|
||
|
||
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|
X | |||
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|
X | |||
|
NOTICE: | THE SIGNATURE(S) TO THIS ASSIGNMENT MUST CORRESPOND WITH THE NAME(S)AS WRITTEN UPON THE FACE OF THE CERTIFICATE IN EVERY PARTICULAR, WITHOUT ALTERATION OR ENLARGEMENT OR ANY CHANGE WHATEVER. |
By
|
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|
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THE SIGNATURE(S) SHOULD BE GUARANTEED BY AN ELIGIBLE GUARANTOR INSTITUTION (BANKS, STOCKBROKERS, SAVINGS AND LOAN ASSOCIATIONS AND CREDIT UNIONS WITH MEMBERSHIP IN AN APPROVED SIGNATURE GUARANTEE MEDALLION PROGRAM), PURSUANT TO S.E.C. RULE 17Ad-15. |
- 2 -
- 3 -
(i) | any unpaid Base Salary and accrued paid-time-off through the date of termination; | ||
(ii) | pro rata target annual bonus in respect of the year of termination; | ||
(iii) | any bonus earned but unpaid as of the date of termination for any previously completed year; | ||
(iv) | reimbursement for any unreimbursed expenses incurred by such Participant prior to the date of termination; | ||
(v) | an amount equal to 50% of such Participants Base Salary (or for Participants identified on Appendix C the greater percentage specified therein); | ||
(vi) | employee and fringe benefits and perquisites, if any, to which such Participant may be entitled as of the date of termination under the relevant plans, policies and programs of the Company; and | ||
(vii) | continued eligibility for such Participant and his/her eligible dependents to receive Employee Benefits, for a period of 6 months following such Participants date of termination (or for Participants identified on Appendix C the greater period specified therein), except where the provision of such Employee Benefits would result in a duplication of benefits provided by any subsequent employer. |
- 4 -
(i) | shall not, for a period of six (6) consecutive months after termination of employment (or for Participants who are listed on Appendix C on the date of termination, the period specified therein), directly or indirectly, either alone or in association with others, (A) induce, counsel, advise, solicit or encourage, or attempt to induce, counsel, advise, solicit or encourage any employee to leave the employ of the Company, or any of its Affiliates, or accept employment with any other person or entity, (B) induce counsel, advise, solicit or encourage, or attempt to induce, counsel, advise, solicit or encourage any person who at the time of such inducement, counseling, advice, solicitation or encouragement had left the employ of the Company, or any of its Affiliates, within the previous six (6) months to accept employment with any person or entity besides the Company, or any of its Affiliates, or hire or engage such person as an independent contractor, and (C) solicit, interfere with, or endeavor to cause any customer, client, or business partner of the Company, or any of its Affiliates, to cease or reduce its relationship with the Company, or any of its Affiliates, 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 Company, or any of its Affiliates; | ||
(ii) | shall not, for a period of six (6) consecutive months after termination of employment (or for Participants who are listed on Appendix C on the date of termination, the period specified therein), directly or indirectly, whether or not for compensation, and whether or not as an employee, be engaged in or have a financial interest in any business, competing with the business of the Company or of any Affiliate within any state, region or locality in which the Company or such Affiliate is then doing business or marketing products, as the business of the Company or such Affiliates may then be constituted. With respect to this sub-section, however, it is understood and agreed that a business is not competing with the business of the Company or any Affiliate if (A) Participants duties with respect to such business relate solely to discrete business units which do not compete with the business of the Company or any Affiliate; or (B) the competitive activity is limited to geographical markets or products in which the Company or Affiliate was not engaged (whether by manufacture, distribution, sale, or development for manufacture, distribution, or sale) during the two (2) years immediately preceding the termination of Participants employment with the Company. | ||
(iii) | shall, upon reasonable notice and at the Companys expense, cooperate fully with any reasonable request that may be made by the Company (giving due consideration for Participants obligations with respect to any new employment or business activity) in connection with any investigation, |
- 5 -
litigation, or other similar activity to which the Company or any Affiliate is or may be a party or otherwise involved and for which Participant may have relevant information. | |||
(iv) | shall sign and deliver a suitable waiver and release under which the Participant shall release and discharge the Company and its Affiliates from and on account of any and all claims that relate to or arise out of the employment relationship between the Company and the Participant. |
(i) | such Participants pro rata target annual bonus in respect of the year of termination; | ||
(ii) | any unpaid Base Salary and accrued paid-time-off through the date of termination; | ||
(iii) | any bonus earned but unpaid as of the date of termination for any previously completed year; | ||
(iv) | reimbursement for any unreimbursed expenses incurred by such Participant prior to the date of termination; | ||
(v) | an amount equal to 50% of such Participants Compensation (or for Participants identified on Appendix C the greater percentage specified therein). |
- 6 -
- 7 -
- 8 -
- 9 -
- 10 -
- 11 -
Emergent BioSolutions - Gaithersburg | ||
Name of Participant
|
Title of Participant | |
Fuad El-Hibri
|
Chief Executive Officer | |
Ed Arcuri
|
Executive VP, Chief Operating Officer | |
Dan Abdun-Nabi
|
Senior VP, Corporate Affairs & General Counsel | |
Kyle Keese
|
Senior VP, Marketing & Communications | |
Thomas Zink
|
Senior VP, Medical Affairs & Chief Medical Officer | |
Don Elsey
|
VP, Chief Financial Officer | |
[**]
|
[**] | |
[**]
|
[**] | |
[**]
|
[**] | |
[**]
|
[**] | |
[**]
|
[**] | |
[**]
|
[**] |
Emergent BioSolutions - BioDefense Operations - Lansing | ||
Name of Participant
|
Title of Participant | |
Robert Kramer
|
President, BioDefense Operations Lansing | |
[**]
|
[**] | |
[**]
|
[**] |
Emergent BioSolutions - Product Development - Gaithersburg | ||
Name of Participant
|
Title of Participant | |
[**]
|
[**] | |
[**]
|
[**] | |
[**]
|
[**] | |
[**]
|
[**] | |
[**]
|
[**] |
Emergent BioSolutions - Product Development - Reading | ||
Name of Participant
|
Title of Participant | |
Steven Chatfield
|
Chief Scientific Officer & President, Emergent Product Development Reading | |
[**]
|
[**] |
Emergent BioSolutions - Sales & Marketing - Germany | ||
Name of Participant
|
Title of Participant | |
[**]
|
[**] |
Name of Participant | Applicable Percentage | Severance Payment and | ||||||
of Base Salary | Continuation Benefit | |||||||
Fuad El-Hibri
|
150 | % | 18 months | |||||
Edward Arcuri
|
100 | % | 12 months | |||||
Robert Kramer
|
100 | % | 12 months | |||||
Daniel Abdun-Nabi
|
100 | % | 12 months | |||||
Kyle Keese
|
100 | % | 12 months | |||||
*Steve Chatfield
|
75 | % | 9 months | |||||
(Chatfields current
employment contract
includes language re:
|
||||||||
the Severance Plan and
Termination Protection
Program)
|
||||||||
[**]
|
[**] | % | [**] | |||||
Don Elsey
|
75 | % | 9 months | |||||
Tom Zink
|
75 | % | 9 months |
Applicable Percentage
Severance Payment and
Name of Participant
of Base Salary
Continuation Benefit
250
%
30 months
200
%
24 months
200
%
24 months
150
%
18 months
100
%
12 months
100
%
12 months
[**]
%
[**]
75
%
9 months
75
%
9 months
SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDERUNDER DPAS (15 CFR 700)RATING DO-C9 |
PAGE OF PAGES 1 26 2. CONTRACT NUMBER 3. SOLICITATION NUMBER 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER W9113M-04-D-0002 W9113M-0R-4-0004 4. TYPE OF SOLICITATION 11/18/2003 W90GXK33010005 ¨ SEALED BID (IFB) ¨ NEGOTIATED (RFP) 7. ISSUED BY CODE W9113M 8. ADDRESS OFFER TO ( if other than Item 7 ) Same US Army Space and Missile Defense Command, 64 Thomas Johnson Drive Frederick, MD 21702 NOTE: In sealed bid solicitations offer and offeror mean bid and bidder. SOLICITATION 9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until local time (Hour) (Date) CAUTION LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation. 10. FOR INFORMATION A. NAME C. E-MAIL ADDRESS CALL: Lynn M. Selfridge B. TELEPHONE (NO COLLECT CALLS) Lynne.Selfridge@SMCC.A AREA CODE NUMBER EXT. 301 619-2707 11. TABLE OF CONTENTS (X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S) - - PART I THE SCHEDULE PART II CONTRACT CLAUSES X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 12-26 X B SUPPLIES OR SERVICES AND PRICES/COSTS 2-3 PART III LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. - X C DESCRIPTION/SPECS./WORK STATEMENT 4-6 X J LIST OF ATTACHMENTS 26 - D PACKAGING AND MARKING PART IV REPRESENTATIONS AND INSTRUCTIONS REPRESENTATIONS, CERTIFICATIONS AND OTHER X E INSPECTION AND ACCEPTANCE 7 K STATEMENTS OF OFFERORS X F DELIVERIES OR PERFORMANCE 8 - X G CONTRACT ADMINISTRATION DATA 9 L INSTRS., CONDS., AND NOTICES TO OFFERORS X H SPECIAL CONTRACT REQUIREMENTS 10-11 M EVALUATION FACTORS FOR AWARD OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period. |
12. In compliance with the above, the undersigned agrees, if this offer is accepted within 60 calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule. 13. DISCOUNT FOR PROMPT PAYMENT (See Section I, Clause No. 52.232-8) 10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%) |
14. ACKNOWLEDGEMENT OF AMEND- MENTS (The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated) : AMENDMENT NO. DATE AMENDMENT NO. DATE |
15A. NAME AND ADDRESS 16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER OF OFFER- (Type or print) OR CODE 1H0B6 FACILITY Robert G. Kramer, President BioPort Corporation 3500 N. Martin Luther King JR., Blvd. Lansing, Michigan 48906 15C. CHECK IF REMITTANCE ADDRESS IS DIFFERENT FROM ABOVE ENTER SUCH 17. SIGNATURE 18. OFFER DATE 15B. TELEPHONE NUMBER ¨ ADDRESS IN SCHEDULE. /s/ Robert G. Kramer Jan. 3, 2004 |
AREA CODE NUMBER 517 327 1579 EXT. - |
AWARD (To be completed by Government) |
19. ACCEPTED AS TO ITEMS NUMBERED 21. ACCOUNTING AND APPROPRIATION 0001-0003 20. AMOUNT To be cited on individual delivery orders 22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 23. SUBMIT INVOICES TO ADDRESS ITEM SHOWN IN (4 copies unless otherwise specified) ý 10 U.S.C. 2304(c) (1) ¨ 41 U.S.C. 253(c) ( ) |
24. ADMINISTERED BY (If other than Item 7) CODE S2303A 25. PAYMENT WILL BE MADE BY CODE DCMA Detroit-Grand Rapids DFAS-Columbus 678 Front Avenue, NW ATTN: DFAS-CO/Chesapeake, PO Box 182264 Grand Rapids, MI 49504-5352 Columbus, Ohio 43218-2264 |
26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE Lynn M. Selfridge (Signature of Contracting Officer) 01/02/2004 |
IMPORTANT Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice. AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97) Previous edition is unusable Prohibited by GSA FAR (48 CFR) 53.214(c) |
MAX | ||||||||||||||||||
ITEM NO | SUPPLIES/SERVICES | QUANTITY | UNIT | UNIT PRICE | MAX AMOUNT | |||||||||||||
0002 |
|
[**] | $ | [**] | $ | 95,950,567.80 | ||||||||||||
OPTION |
|
|||||||||||||||||
|
||||||||||||||||||
Doses of Vaccine
FFP as identified in Section C, during the period of January 1, 2005 through December 31, 2005. PURCHASE REQUEST NUMBER: W90GXK33010005 |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
MAX NET AMT | $ | 95,950,567.80 | |||||||||||||||
|
||||||||||||||||||
Funded Amount | $ | 0.00 |
MINIMUM
MINIMUM
MAXIMUM
MAXIMUM
CLIN
QUANTITY
AMOUNT
QUANTITY
AMOUNT
1,297,380
[**]
[**]
71,248,954
1,533,090
[**]
[**]
$
95,950,568
1,034,930
[**]
[**]
$
78,340,434
1. | Manufacture | ||
2. | Formulation | ||
3. | Filling | ||
4. | FDA Release |
CLIN
INSPECT AT
INSPECT BY
ACCEPT AT
ACCEPT BY
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
0001
|
IAW Attachment No. 1 in Section J of the Contract | 1,297,380 | To be determined | TBD | ||||
0002
|
Will be provided at time of exercising option. | 1,533,090 | To be determined | TBD | ||||
0003
|
Will be provided at time of exercising option. | 1,034,930 | To be determined | TBD |
52.232-25
|
Prompt Payment | OCT 2003 | ||
52.242-13
|
Bankruptcy | JUL 1995 | ||
52.245-4
|
Government-Furnished Property (Short Form) | JUN 2003 | ||
252.204-7004
|
Required Central Contractor Registration | NOV 2001 | ||
252.245-7001
|
Reports Of Government Property | MAY 1994 |
Attachment Number
Description
No. of Pages
1
1
2
22
3
1
Attachment 1
Page 1 of 1
50
%
30
%
10
%
10
%
Attachment 2
ent Owned Equipment
Page 1
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
R
Bu
9/1/93
Warehouse modular facility
264,674.00
DAMD17-91-C-1139
R
Bu
9/1/93
BL-3 Modular Facility
1,484,553.00
Bu
Sub Total:
1,749,227.00
DAMD17-91-C-1139
P
Co
9/1/93
Thermal Transfer Printer
7,128.00
DAMD17-91-C-1139
P
Co
9/1/93
Security room console, power panel, conduit and wi
20,000.00
DAMD17-91-C-1139
P
Co
9/1/93
door alarms, motion detectors, card readers, card ac
50,000.00
DAMD17-91-C-1139
P
Co
9/1/93
Intercom system to gates central control, remote an
60,000.00
DAMD17-91-C-1139
P
Co
9/1/93
Host computer, remote processors, conduit and wiri
80,000.00
DAMD17-91-C-1139
P
Co
9/1/93
Cameras, Video control, re corders, multiplexers, n
120,000.00
DAMD17-91-C-1139
P
Co
9/1/98
Printer Hewlitt Packard
300.00
DAMD17-91-C-1139
P
Co
9/1/98
Printer Epson
387.00
DAMD17-91-C-1139
P
Co
2/1/00
Compaq Proliant ML570 Server and Rack Mounts I
15,497.00
DAMD17-91-C-1139
P
Co
3/1/00
HP Laserjet Printer 4050N
1,360.00
DAMD17-91-C-1139
P
Co
3/1/00
Computer
1,499.97
DAMD17-91-C-1139
P
Co
3/1/00
Computer
1,699.97
DAMD17-91-C-1139
P
Co
3/1/00
Computer System
2,128.98
DAMD17-91-C-1139
P
Co
3/1/00
Z505R Laptop Computers
2,538.24
DAMD17-91-C-1139
P
Co
3/1/00
Mail server
3,624.61
DAMD17-91-C-1139
P
Co
3/1/00
Laptop Computers
3,711.24
DAMD17-91-C-1139
P
Co
4/1/00
Computer System
633.32
DAMD17-91-C-1139
P
Co
4/1/00
Computer System
633.32
DAMD17-91-C-1139
P
Co
4/1/00
Computer System
633.32
DAMD17-91-C-1139
P
Co
4/1/00
Laptop Computers
1,660.00
DAMD17-91-C-1139
P
Co
4/1/00
Laptop Computers F420
1,660.00
DAMD17-91-C-1139
P
Co
4/1/00
Laptop Computers F420
1,660.00
DAMD17-91-C-1139
P
Co
4/1/00
Bar Code Scanners
2,605.50
DAMD17-91-C-1139
P
Co
4/1/00
Bar Code Scanners
2,605.50
DAMD17-91-C-1139
P
Co
4/1/00
Compaq Proliant ML370
3,400.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Proliant 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
17 P793 Monitor
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.14
DAMD17-91-C-1139
P
Co
8/1/00
Monitors
221.43
DAMD17-91-C-1139
P
Co
8/1/00
Computers
651.43
DAMD17-91-C-1139
P
Co
8/1/00
Laptop Computers F420
1,660.00
DAMD17-91-C-1139
P
Co
8/1/00
Epson Projector
5,322.00
DAMD17-91-C-1139
P
Co
8/1/00
Compaq Proliant Server and Rack
5,908.74
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.26
DAMD17-91-C-1139
P
Co
9/1/00
Monitor
296.78
DAMD17-91-C-1139
P
Co
9/1/00
Printer
690.00
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.06
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.08
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.08
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.08
DAMD17-91-C-1139
P
Co
9/1/00
CPU
1,383.52
DAMD17-91-C-1139
P
Co
9/1/00
Compaq Deskpro En NT Workstation
1,878.91
DAMD17-91-C-1139
P
Co
9/1/00
Compaq Proliant ML530 Server and Parts
10,842.00
DAMD17-91-C-1139
P
Co
10/1/00
HP Brio BA410 Computer
1,019.35
DAMD17-91-C-1139
P
Co
10/1/00
Compaq Deskpro En Workstation
1,440.00
DAMD17-91-C-1139
P
Co
11/1/00
Viewsonic 17 Color Monitor
228.87
DAMD17-91-C-1139
P
Co
11/1/00
Compaq Deskpro EN Pen III 733 mhz
1,318.87
DAMD17-91-C-1139
P
Co
11/1/00
Compaq Deskpro EN Pen III 733 mhz and Viewsoni
1,318.87
DAMD17-91-C-1139
P
Co
11/1/00
Compaq Deskpro EN Pen III 733 mhz and Viewsonic
1,318.87
DAMD17-91-C-1139
P
Co
11/1/00
Datafile Diskette for VAERS
1,344.00
DAMD17-91-C-1139
P
Co
12/1/00
Elron Software Server
3,669.46
DAMD17-91-C-1139
P
Co
12/1/00
Security System Upgrade, Camera and wiring neces
128,502.20
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro Workstation Ap250
1,887.00
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro Workstation Ap250
1,887.00
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro Workstation Ap250
1,887.00
DAMD17-91-C-1139
P
Co
2/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
2/1/01
Computer System Okidata 14E printer
371.04
DAMD17-91-C-1139
P
Co
2/1/01
Computer System
1,853.40
DAMD17-91-C-1139
P
Co
2/1/01
Compaq Proliant ML570 Server and Rack Mounts
20,376.50
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Viewsonic E70
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
3/1/01
Computer System
1,220.00
DAMD17-91-C-1139
P
Co
3/1/01
Computer System
1,220.00
DAMD17-91-C-1139
P
Co
3/1/01
Computer Deskpro
1,220.00
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Compaq PC
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Compaq Deskpro EN
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computer
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computer
1,263.91
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
4/1/01
Server-Snap for PAI Workroom
2,405.00
DAMD17-91-C-1139
P
Co
4/1/01
Server-Snap for PAI Workroom
2,405.00
DAMD17-91-C-1139
P
Co
5/1/01
All in one Printer Fax Copier
784.00
DAMD17-91-C-1139
P
Co
6/1/01
UPS for Domain Controller
16,075.32
DAMD17-91-C-1139
P
Co
6/1/01
UPS for Domain Controller
16,075.32
DAMD17-91-C-1139
P
Co
7/1/01
IS Monitor
897.23
DAMD17-91-C-1139
P
Co
8/24/01
Developer Server
4,024.41
DAMD17-91-C-1139
P
Co
8/29/01
PowerEdge 700MHZ
10,310.28
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/2/01
Security System Multiplexer
2,313.18
DAMD17-91-C-1139
P
Co
11/26/01
Dell Optiplex GX 240 Small Mini Tower
1,213.91
DAMD17-91-C-1139
P
Co
11/28/01
Closed Circuit TV System
157,025.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 1700 Router
1,066.36
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Pix Firewall 515 FO-Bun
2,552.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 6509 Switch
10,005.27
DAMD17-91-C-1139
P
Co
1/11/02
Pix Firewall 515UR
10,212.90
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/11/02
URT Policy Server 100Series
10,636.37
DAMD17-91-C-1139
P
Co
1/11/02
URT Policy Server 1100Series
10,636.37
DAMD17-91-C-1139
P
Co
1/11/02
Cisco Intrusion Detection System 4210
12,416.38
DAMD17-91-C-1139
P
Co
1/24/02
Flat Panel 340 Minitower Monitor 1702FD
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
17 P793 Monitor
296.64
DAMD17-91-C-1139
P
Co
1/24/02
17 P793 Monitor
296.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Precision 340 Minitower Workstation-Labwatch Sy
1,629.21
DAMD17-91-C-1139
P
Co
1/31/02
Exchange Bundle Media Kin
20.00
DAMD17-91-C-1139
P
Co
1/31/02
Server
4,837.49
DAMD17-91-C-1139
P
Co
2/28/02
Security System Workstation (CPU)
4,274.89
DAMD17-91-C-1139
P
Co
2/28/02
Security System Workstation (Monitor)
4,274.90
DAMD17-91-C-1139
P
Co
3/29/02
Plain-paper Impact printer
448.88
DAMD17-91-C-1139
P
Co
3/29/02
Maintenance Agreement
25,725.70
DAMD17-91-C-1139
P
Co
3/29/02
Computer Services
31,225.24
DAMD17-91-C-1139
P
Co
3/29/02
Computer Supplies
134,486.81
DAMD17-91-C-1139
P
Co
4/12/02
Dell Optiplex GX 240 Small Mini Tower
1,786.09
DAMD17-91-C-1139
P
Co
4/12/02
Profile 3 SE
1,934.00
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.30
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.30
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
9/1/02
Staging Server-Sandbox
4,091.61
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
9/1/02
Network Back Up
4,516.82
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.09
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.09
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.09
Co
127,357.24
(40,000.00
)
(6,528.00
)
1,225.98
1,408,629.95
DAMD17-91-C-1139
P
Eq
9/1/93
Refrigerator
530.00
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Incubator
2,600.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
9/1/93
Radios
3,375.00
DAMD17-91-C-1139
P
Eq
9/1/93
6 Biological Safety Cabinet
9,800.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cages and racks
12,750.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cages and racks
12,750.00
DAMD17-91-C-1139
P
Eq
9/1/93
Biocontainment Hood - 8 Biological Safety Cabine
18,500.00
DAMD17-91-C-1139
P
Eq
9/1/93
Wire security carts
19,681.00
DAMD17-91-C-1139
P
Eq
9/1/93
Labeler
27,415.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cagewasher
41,600.00
DAMD17-91-C-1139
P
Eq
9/1/93
Small Autoclave
61,300.00
DAMD17-91-C-1139
P
Eq
9/1/93
Large Autoclave
124,400.00
DAMD17-91-C-1139
P
Eq
9/1/93
5 Animal Cubicles
130,000.00
DAMD17-91-C-1139
P
Eq
9/1/93
Vial Capper
132,977.00
DAMD17-91-C-1139
P
Eq
9/1/93
Tray Loader
132,977.00
DAMD17-91-C-1139
P
Eq
9/1/93
Diesel generator, fuel tank, conduit and wiring
175,000.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cartoner
242,260.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Heat Exchanger
3,715.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Pump
4,405.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Pump
4,405.00
DAMD17-91-C-1139
P
Eq
9/1/97
Air Handling Unit
7,012.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Heat Exchanger
10,890.00
DAMD17-91-C-1139
P
Eq
9/1/97
Vertical Conveyor
14,000.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Storage Tanks
17,933.00
DAMD17-91-C-1139
P
Eq
9/1/97
Air Handling (Condensing) Unit
17,950.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean in place piping
18,750.00
DAMD17-91-C-1139
P
Eq
9/1/97
SIP Station and Piping
20,000.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean Steam Distribution Piping
25,000.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Cooling System
26,122.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean Steam Generator
78,628.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean Steam Generator
125,875.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean in Place Skid (Pump, Heat Exchanger, Electri
174,066.00
DAMD17-91-C-1139
P
Eq
9/1/97
eGMP Autoclave
186,900.00
DAMD17-91-C-1139
P
Eq
9/1/98
Water closet
150.00
DAMD17-91-C-1139
P
Eq
9/1/98
Lavatory (2)
300.00
DAMD17-91-C-1139
P
Eq
9/1/98
sinks (2)
300.00
DAMD17-91-C-1139
P
Eq
9/1/98
Hot water heater
450.00
DAMD17-91-C-1139
P
Eq
9/1/98
Mop Receptor
500.00
DAMD17-91-C-1139
P
Eq
9/1/98
heat water pump
700.00
DAMD17-91-C-1139
P
Eq
9/1/98
air separator
800.00
DAMD17-91-C-1139
P
Eq
9/1/98
Emergency Shower/Eyebath
900.00
DAMD17-91-C-1139
P
Eq
9/1/98
hot water reticulator
1,300.00
DAMD17-91-C-1139
P
Eq
9/1/98
Expansion tank
1,500.00
DAMD17-91-C-1139
P
Eq
9/1/98
by-pass chemical feeder
1,800.00
DAMD17-91-C-1139
P
Eq
9/1/98
Glove extenders for rigid and flex wall systems
1,800.00
DAMD17-91-C-1139
P
Eq
9/1/98
steam condensate pump
2,200.00
DAMD17-91-C-1139
P
Eq
9/1/98
2 Undercounter Refrigerators
2,848.00
DAMD17-91-C-1139
P
Eq
9/1/98
Heat Exchangers (3)
3,000.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
9/1/98
Nitrogen regulator
3,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
CO2 regulator
3,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Double Sink (Stainless)
3,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Folding Lockable Carts
3,580.00
DAMD17-91-C-1139
P
Eq
9/1/98
Horizontal Laminat Flow Hood
4,870.00
DAMD17-91-C-1139
P
Eq
9/1/98
Sterility Isolator Air Handling System
5,573.00
DAMD17-91-C-1139
P
Eq
9/1/98
Biosafety Cabinet
6,709.00
DAMD17-91-C-1139
P
Eq
9/1/98
Jacket Water reservoir
8,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Reach-in refrigerators (2)
9,784.00
DAMD17-91-C-1139
P
Eq
9/1/98
New panel for EMS, Honeywell
10,133.00
DAMD17-91-C-1139
P
Eq
9/1/98
AHU 4
11,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Stainless steel benchwork, racks and tables
17,670.00
DAMD17-91-C-1139
P
Eq
9/1/98
Bag-in/Bag-out filters
18,395.00
DAMD17-91-C-1139
P
Eq
9/1/98
Laboratory Casework (Stainless Steel)
18,950.00
DAMD17-91-C-1139
P
Eq
9/1/98
AHU 5 Air Handling Unit
19,787.50
DAMD17-91-C-1139
P
Eq
9/1/98
AHU 7 Air Handling Unit
19,787.50
DAMD17-91-C-1139
P
Eq
9/1/98
Standard Guinea Pig Unit
20,100.00
DAMD17-91-C-1139
P
Eq
9/1/98
Standard Guinea Pig Unit
20,100.00
DAMD17-91-C-1139
P
Eq
9/1/98
Process Chiller
23,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Holding tank
26,468.00
DAMD17-91-C-1139
P
Eq
9/1/98
Carbon Filter, Building 16, Penthouse
26,700.00
DAMD17-91-C-1139
P
Eq
9/1/98
AHU-3
28,875.00
DAMD17-91-C-1139
P
Eq
9/1/98
SE Recruiting Water System
34,825.43
DAMD17-91-C-1139
P
Eq
9/1/98
5 tanks retrofit old tanks
72,677.54
DAMD17-91-C-1139
P
Eq
9/1/98
Glassware washer/dryer
76,656.00
DAMD17-91-C-1139
P
Eq
9/1/98
GMP autoclave
136,225.00
DAMD17-91-C-1139
P
Eq
9/1/98
Barrior Isolation Units and VHP Generator
189,000.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Sterility Isolator Parts
6,702.55
DAMD17-91-C-1139
P
Eq
9/1/99
6 SS difuseable pans
8,820.00
DAMD17-91-C-1139
P
Eq
9/1/99
hood and bench laminar flow
9,224,35
DAMD17-91-C-1139
P
Eq
9/1/99
Redundant HVAC BL-3
31,919.00
DAMD17-91-C-1139
P
Eq
3/1/00
Eppendorf CH-500 Column Heater
2,225.36
DAMD17-91-C-1139
P
Eq
3/1/00
Eppendorf Centrifuge 5417R w/rotor
5,357.00
DAMD17-91-C-1139
P
Eq
3/1/00
Eppendorf Centrifuge 5417R w/rotor
5,357.00
DAMD17-91-C-1139
P
Eq
3/1/00
96 Well Plate Washer
7,229.16
DAMD17-91-C-1139
P
Eq
3/1/00
Imaging Densiometer
11,500.09
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
4/1/00
BioChemistry Analyzer
11,865.00
DAMD17-91-C-1139
P
Eq
6/1/00
Control Box & Digital Display for Steinmixer
1,504.93
DAMD17-91-C-1139
P
Eq
6/1/00
Control Box & Digital Display for Steinmixer
1,504.94
DAMD17-91-C-1139
P
Eq
6/1/00
Control Box & Digital Display for Steinmixer
1,504.94
DAMD17-91-C-1139
P
Eq
7/1/00
SL Stainless Pressure Vessel
1,226.65
DAMD17-91-C-1139
P
Eq
7/1/00
SL Stainless Pressure Vessel
1,226.65
DAMD17-91-C-1139
P
Eq
7/1/00
SL Stainless Pressure Vessel
1,226.65
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
8/1/00
Pen & Multichannel Recorder & Enclosure
1,940.00
DAMD17-91-C-1139
P
Eq
8/1/00
Pen & Multichannel Recorder & Enclosure
2,950.00
DAMD17-91-C-1139
P
Eq
8/1/00
150L Holding Tank
26,434.44
DAMD17-91-C-1139
P
Eq
8/1/00
150L Holding Tank
26,434.44
DAMD17-91-C-1139
P
Eq
8/1/00
SIP Lead Equipment
45,257.61
DAMD17-91-C-1139
P
Eq
8/1/00
Vial Washer GW24
64,434.00
DAMD17-91-C-1139
P
Eq
9/1/00
SAIP Filling & Packaging Project
59,759.13
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
11/1/00
Heat Exchange Redesign
28,533.31
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.26
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
1/1/01
Kjeldahl digestion apparatus, rotary base
1,810.00
DAMD17-91-C-1139
P
Eq
3/1/01
Rapid Still 1, Labonco
2,850.00
DAMD17-91-C-1139
P
Eq
4/1/01
Trash Pump
1,088.57
DAMD17-91-C-1139
P
Eq
4/1/01
Mini Neph Unit and Printer
3,357.50
DAMD17-91-C-1139
P
Eq
4/1/01
Fermentor Datalogger
5,870.85
DAMD17-91-C-1139
P
Eq
4/1/01
ExMark Mower
8,914.54
DAMD17-91-C-1139
P
Eq
5/1/01
Honeywell Chart Recorder
2,114.89
DAMD17-91-C-1139
P
Eq
5/1/01
Honeywell Chart Recorder
2,114.90
DAMD17-91-C-1139
P
Eq
5/1/01
Flange Fitness Gauge
4,129.00
DAMD17-91-C-1139
P
Eq
5/1/01
Centrifuge with Rotor and Microplus Carriers
7,908.25
DAMD17-91-C-1139
P
Eq
5/1/01
Machining of Formulation Tanks Project 211
32,138.82
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
5/1/01
TOC Analyzer
33,621.26
DAMD17-91-C-1139
P
Eq
5/1/01
Building 1 Air Conditioning Unit
92,633.24
DAMD17-91-C-1139
P
Eq
6/1/01
Chryo Freezer
13,962.33
DAMD17-91-C-1139
P
Eq
6/1/01
Stability Chamber
17,906.00
DAMD17-91-C-1139
P
Eq
6/1/01
Stability Chamber
17,906.00
DAMD17-91-C-1139
P
Eq
7/1/01
Fuel Tank
2,236.81
DAMD17-91-C-1139
P
Eq
7/1/01
Stainless Steel Carts
7,248.00
DAMD17-91-C-1139
P
Eq
7/1/01
RO System Move to Bld 30
199,603.53
DAMD17-91-C-1139
P
Eq
8/15/01
Undercounter Refrigerator
747.00
DAMD17-91-C-1139
P
Eq
8/21/01
Automatic Polarimeter
19,465.00
DAMD17-91-C-1139
P
Eq
8/30/01
Sanitary Conical Tank
2,838.68
DAMD17-91-C-1139
P
Eq
9/1/01
Clean Steam Generators Outlet Piping Modification
12,260.00
DAMD17-91-C-1139
P
Eq
9/10/01
Compressor for Building 45
4,067.00
DAMD17-91-C-1139
P
Eq
9/25/01
Ice Flaker
2,180.00
DAMD17-91-C-1139
P
Eq
10/1/01
Repair to Forklift Mast System
1,245.49
DAMD17-91-C-1139
P
Eq
10/1/01
GPS System for contract filler truck
2,212.00
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Vial Rinser
5,300.00
DAMD17-91-C-1139
P
Eq
10/1/01
Security Related Equipment
22,809.97
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Filling Pumps
35,000.00
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Ultrasonic Bath
44,343.00
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Cold Room
136,740.00
DAMD17-91-C-1139
P
Eq
10/25/01
Refrigerator
2,986.90
DAMD17-91-C-1139
P
Eq
10/25/01
Haske Bath
3,017.71
DAMD17-91-C-1139
P
Eq
10/25/01
Incubator
3,987.00
DAMD17-91-C-1139
P
Eq
11/7/01
Condensate Tanks
11,780.00
DAMD17-91-C-1139
P
Eq
11/8/01
Tube Bender
5,275.08
DAMD17-91-C-1139
P
Eq
11/20/01
AVA Kill Tank System
5,763.03
DAMD17-91-C-1139
P
Eq
12/1/01
Pipe Rack Modifications
29,728.12
DAMD17-91-C-1139
P
Eq
12/1/01
Modifications to Trains 2, 3, 4
77,813.20
DAMD17-91-C-1139
P
Eq
12/3/01
Micro Kheldahl
1,349.92
DAMD17-91-C-1139
P
Eq
12/3/01
Micro Kjeldahl
1,349.92
DAMD17-91-C-1139
P
Eq
12/3/01
Micro Kjeldahl
2,091.18
DAMD17-91-C-1139
P
Eq
12/18/01
Micro Kjeldahl Distillation
2,035.97
DAMD17-91-C-1139
P
Eq
12/18/01
Micro Kjeldahl Distillation
2,035.97
DAMD17-91-C-1139
P
Eq
12/18/01
Micro Kjeldahl Distillation
2,035.97
DAMD17-91-C-1139
P
Eq
12/31/01
Nikon Eclipse E400
7,245.26
DAMD17-91-C-1139
P
Eq
1/1/02
Building #12 Fermentation Room Camera
8,642.00
DAMD17-91-C-1139
P
Eq
1/8/02
Undercounter Continental Refrigerator 7.4cft
1,727.26
DAMD17-91-C-1139
P
Eq
1/8/02
Bench Top Incubator Shaker
5,160.00
DAMD17-91-C-1139
P
Eq
1/8/02
Artel Pipette Calibration System
8,105.62
DAMD17-91-C-1139
P
Eq
1/8/02
Incubator Shaker
8,930.00
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 SCP Printer Kit
1,189.06
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 SCP Printer Kit
1,189.06
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 Spectrophotometer
5,371.56
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 Spectrophotometer
5,371.56
DAMD17-91-C-1139
P
Eq
1/31/02
Tunnel Camera and Motion Units
66,109.02
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
1/31/02
Trailer for Contract Filler
85,145.82
DAMD17-91-C-1139
P
Eq
1/31/02
Fire Alarm System Upgrade
273,375.00
DAMD17-91-C-1139
P
Eq
2/28/02
Locknetics Prox Cipher Locks
8,000.00
DAMD17-91-C-1139
P
Eq
2/28/02
EMS System Upgrade (1of3 Stations)
9,623.32
DAMD17-91-C-1139
P
Eq
2/28/02
EMS System Upgrade (2of3 Stations)
9,623.34
DAMD17-91-C-1139
P
Eq
2/28/02
EMS System Upgrade (3of3 Stations)
9,623.34
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.24
DAMD17-91-C-1139
P
Eq
3/1/02
Water for Injection (WFI) Capacity Improvement P
115,000.00
DAMD17-91-C-1139
P
Eq
3/29/02
SMA Portable Compressed Air Sampler
1,126.95
DAMD17-91-C-1139
P
Eq
3/29/02
Benchtop pH/temp/MV Meter (model 390)
1,221.57
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Spot Insight Color C Mount Camera
3,877.43
DAMD17-91-C-1139
P
Eq
3/29/02
1240 Spectrophotometer
5,258.25
DAMD17-91-C-1139
P
Eq
3/29/02
Nikon E400 Microscope
6,541.78
DAMD17-91-C-1139
P
Eq
3/29/02
PR Wire/elx 405 VR Plate Washer & Reader
28,571.25
DAMD17-91-C-1139
P
Eq
3/29/02
D1 Water Skid
114,375.11
DAMD17-91-C-1139
P
Eq
3/29/02
PBX Telephone System
160,000.00
DAMD17-91-C-1139
P
Eq
3/29/02
Housing for Water for Injection Capacity PART B
1,110,980.00
DAMD17-91-C-1139
P
Eq
4/1/02
Security Gates in Tunnels
5,460.00
DAMD17-91-C-1139
P
Eq
4/1/02
Hollister Stier - Security System - Security Equipme
245,098.00
DAMD17-91-C-1139
P
Eq
4/12/02
Greenlee Bender
5,905.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
X6000-Validation Reference Manual
750.00
DAMD17-91-C-1139
P
Eq
5/1/02
X6005-IQ/OQ Validation Protocols for Validator 2
1,500.00
DAMD17-91-C-1139
P
Eq
5/1/02
X2020-ICAL Kit
1,600.00
DAMD17-91-C-1139
P
Eq
5/1/02
X0855-IRTD 400 High Accuracy Probe
3,730.00
DAMD17-91-C-1139
P
Eq
5/1/02
Sublot Transfer Cart
4,905.00
DAMD17-91-C-1139
P
Eq
5/1/02
Sublot Transfer Cart
4,905.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
5/1/02
Building #29 Camera
8,105.00
DAMD17-91-C-1139
P
Eq
5/1/02
X200 Validator 2000 High Accuracy Validation Sy
13,360.00
DAMD17-91-C-1139
P
Eq
5/1/02
X2000 Validator 2000-High Accuracy Validation S
13,360.00
DAMD17-91-C-1139
P
Eq
5/1/02
X2000 Validator 2000-High Accuracy Validation S
13,360.00
DAMD17-91-C-1139
P
Eq
5/1/02
Guardhouse
58,750.00
DAMD17-91-C-1139
P
Eq
6/1/02
Honeywell Minitrend Data Recorder
7,250.20
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.52
Eq
7,009,192.12
DAMD17-91-C-1139
P
Fu
9/1/93
Shelving
9,600.00
DAMD17-91-C-1139
P
Fu
4/1/00
Server Racks
3,814.04
DAMD17-91-C-1139
P
Fu
5/1/00
Tables & Chairs for Meeting Rooms
2,787.06
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
546.00
DAMD17-91-C-1139
P
Fu
8/1/00
Table and Chairs
636.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,678.28
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,949.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,953.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,983.05
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
2,077.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
2,543.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
4,302.20
DAMD17-91-C-1139
P
Fu
8/1/00
Furniture
7,341.31
DAMD17-91-C-1139
P
Fu
8/1/00
Furniture
21,390.75
DAMD17-91-C-1139
P
Fu
10/1/00
Management Chair
541.87
DAMD17-91-C-1139
P
Fu
10/1/00
Office Furniture
2,120.00
DAMD17-91-C-1139
P
Fu
10/1/00
Office Furniture
2,120.00
DAMD17-91-C-1139
P
Fu
10/1/00
(13) Task Chairs, Paint and Carpet Squares
2,535.58
DAMD17-91-C-1139
P
Fu
12/1/00
10 Chairs
2,039.99
DAMD17-91-C-1139
P
Fu
12/1/00
Office Furniture
2,231.50
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
75.34
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
75.34
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
150.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
150.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
150.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.60
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Furniture for AVA Trailer Project 178
9,487.82
DAMD17-91-C-1139
P
Fu
3/1/01
Cubicles for Workroom
13,141.98
DAMD17-91-C-1139
P
Fu
4/1/01
Building 29 Cubicles
25,383.55
DAMD17-91-C-1139
P
Fu
6/1/01
Marker Board
33.57
DAMD17-91-C-1139
P
Fu
6/1/01
Light Walnut Low Coffee Table
38.57
DAMD17-91-C-1139
P
Fu
6/1/01
Cherry Laminate Table
50.00
DAMD17-91-C-1139
P
Fu
6/1/01
Cherry Wood Guest Chair
54.28
DAMD17-91-C-1139
P
Fu
6/1/01
Cherry Wood Guest Chair
55.29
DAMD17-91-C-1139
P
Fu
6/1/01
Guest Chair
58.57
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Big Man Chair
108.57
DAMD17-91-C-1139
P
Fu
6/1/01
Blue Superior Chair
158.57
DAMD17-91-C-1139
P
Fu
6/1/01
Desk National 30x60
258.58
DAMD17-91-C-1139
P
Fu
6/1/01
Conference Table
300.00
DAMD17-91-C-1139
P
Fu
6/1/01
Dark Walnut Desk
589.68
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
162.83
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
162.83
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
162.84
DAMD17-91-C-1139
P
Fu
7/1/01
Heather Blue Chair
223.60
DAMD17-91-C-1139
P
Fu
7/1/01
Heather Blue Chair
223.60
DAMD17-91-C-1139
P
Fu
7/1/01
Heather Blue Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Executive Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Executive Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Executive Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
271.25
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
271.25
DAMD17-91-C-1139
P
Fu
7/1/01
36 Bookcase
278.00
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
424.48
DAMD17-91-C-1139
P
Fu
7/1/01
4 Drawer Lateral File
620.00
DAMD17-91-C-1139
P
Fu
7/1/01
IS Storage Shelves
790.04
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.74
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
3,000.97
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
3,000.97
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
3,000.98
DAMD17-91-C-1139
P
Fu
7/1/01
Building 29 Cubicles
15,622.62
DAMD17-91-C-1139
P
Fu
7/1/01
Document Control Fire Suppression System #1
48,321.30
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Wild Cherry Laminate Table
868.95
DAMD17-91-C-1139
P
Fu
9/1/01
System Wall w/Locking Doors
2,450.34
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
12/1/01
Stainless Steel Cabinets
5,034.28
DAMD17-91-C-1139
P
Fu
12/1/01
Lockers
6,450.50
DAMD17-91-C-1139
P
Fu
12/1/01
Scientific Tables
7,167.15
DAMD17-91-C-1139
P
Fu
12/1/01
Security Office Storage
11,674.08
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
60 Bookcase
418.60
DAMD17-91-C-1139
P
Fu
1/31/02
60 Bookcase
418.61
DAMD17-91-C-1139
P
Fu
1/31/02
60 Bookcase
418.61
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Equipment Stand
328.40
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Utility Cart
370.30
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Utility Cart
370.30
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Insurance Table
444.00
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Insurance Table
444.00
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.89
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
7/1/02
Lateral Fireproof File Cabinet
2,024.00
DAMD17-91-C-1139
P
Fu
7/1/02
Lateral Fireproof File Cabinet
2,024.00
Fu
280,532.20
DAMD17-91-C-1139
R
Im
9/1/93
Security Doors
24,800.00
DAMD17-91-C-1139
R
Im
9/1/93
Coldroom Modular Facility
112,681.00
DAMD17-91-C-1139
R
Im
9/1/98
Backup generator
227,200.00
DAMD17-91-C-1139
R
Im
9/1/98
coldrooms (3A, 3B, 4)
230,000.00
DAMD17-91-C-1139
R
Im
8/1/00
Lab Renovations
8,108.00
DAMD17-91-C-1139
R
Im
10/1/00
Building 30 & Building 6 Roof
63,965.41
DAMD17-91-C-1139
R
Im
4/1/01
Building 29 Renovations
5,176.55
DAMD17-91-C-1139
R
Im
9/1/01
Fire Suppression IS
18,054.97
DAMD17-91-C-1139
R
Im
11/1/01
Paving Project
48,885.00
DAMD17-91-C-1139
R
Im
11/28/01
Perimeter Fence Building 15
1,749.00
DAMD17-91-C-1139
R
Im
11/28/01
Sheridan Rd Mechanical Slide Gate
35,196.00
DAMD17-91-C-1139
R
Im
12/1/01
Bullet Resistant Windows
30,845.00
DAMD17-91-C-1139
R
Im
12/1/01
Repairs to Domestic Water and Gas
92,349.00
DAMD17-91-C-1139
R
Im
1/1/02
Intercom System for Security Gates
17,600.00
DAMD17-91-C-1139
R
Im
1/1/02
Perimeter Fence Detection System
100,200.00
DAMD17-91-C-1139
R
Im
2/28/02
Coldroom 150 Temporary Loading Platform
83,881.22
DAMD17-91-C-1139
R
Im
4/1/02
Hollister Stier - Security System - Fiber Cabling in :
2,730.00
DAMD17-91-C-1139
R
Im
4/1/02
Hollister Stier-Security System - Reception Area Gh :
6,480.00
DAMD17-91-C-1139
R
Im
4/1/02
Hollister Stier-Security System - Campus Modific
24,868.00
DAMD17-91-C-1139
R
Im
5/1/02
Stainless Steel Razor Wire
20,978.00
DAMD17-91-C-1139
R
Im
6/1/02
Campus Lighting
4,923.00
DAMD17-91-C-1139
R
Im
6/1/02
Coldroom 150 Modifications
21,441.00
Im
1,182,111.15
DAMD17-91-C-1139
R
La
9/1/93
Tunnel Barricade
9,570.00
DAMD17-91-C-1139
R
La
9/1/93
Light pole lights, poles, conduit and wiring
20,000.00
DAMD17-91-C-1139
R
La
9/1/93
Pipe access covers
72,600.00
DAMD17-91-C-1139
R
La
9/1/93
Security fence
101,000.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
R
La
9/1/98
Wooden fencing
8,413.00
DAMD17-91-C-1139
R
La
7/1/01
Tunnel Renovation
20,480.98
DAMD17-91-C-1139
R
La
9/1/01
Tunnel Barricade
14,361.35
La
246,425.33
DAMD17-91-C-1139
P
So
9/1/98
Date Acquisition System (Software and net packs)
36,765.00
DAMD17-91-C-1139
P
So
9/1/98
MRP-Fourth Shift Software Package
99,421.00
DAMD17-91-C-1139
P
So
3/1/00
Calhoun Computer System
1,699.96
DAMD17-91-C-1139
P
So
7/1/00
Seal Force Tester & Interface Software
12,675.00
DAMD17-91-C-1139
P
So
9/1/00
SAIP Compliance Software
212,153.00
DAMD17-91-C-1139
P
So
10/1/00
ABRA Suite Payroll Software
50,786.42
DAMD17-91-C-1139
P
So
9/1/01
Statistical Software
1,052.00
DAMD17-91-C-1139
P
So
10/9/01
STAT View Software
5,560.00
DAMD17-91-C-1139
P
So
10/12/01
Affirmative Action Plan (HR)
3,990.00
DAMD17-91-C-1139
P
So
1/31/02
Norton, Anti Virus Desk Server
7,653.75
DAMD17-91-C-1139
P
So
2/28/02
STAT View Software
6,500.00
DAMD17-91-C-1139
P
So
7/1/02
Office XP Property Licenses (60)
25,018.20
DAMD17-91-C-1139
P
So
8/1/02
Ghost Media Pack
2,884.00
DAMD17-91-C-1139
P
So
8/1/02
Office XP Property Licenses
20,875.00
DAMD17-91-C-1139
P
So
11/1/02
Network/Backup Archive System
99,232.59
So
586,265.92
DAMD17-91-C-1139
12,462,383.67
DAMD17-97-E-0004
P
Eq
9/1/89
Balance, Bench Top Model
1,503.00
DAMD17-97-E-0004
P
Eq
9/1/89
Bright Field Microscope
2,819.00
DAMD17-97-E-0004
P
Eq
9/1/89
Automated Kjeldahl Apparatus
24,400.00
DAMD17-97-E-0004
P
Eq
9/1/90
Holding Tank B, Train 2
67,883.66
DAMD17-97-E-0004
P
Eq
9/1/90
10 Liter Fermenter, Train 2
67,883.67
DAMD17-97-E-0004
P
Eq
9/1/90
100 Liter Fermenter, Train 2
67,883.67
DAMD17-97-E-0004
P
Eq
9/1/91
pH Meter
1,895.00
DAMD17-97-E-0004
P
Eq
9/1/91
Balance
2,625.50
DAMD17-97-E-0004
P
Eq
9/1/91
Balance
2,625.50
DAMD17-97-E-0004
P
Eq
9/1/91
CO2 Incubator
2,767.00
DAMD17-97-E-0004
P
Eq
9/1/91
Refrigerated Low Speed Centrifuge
17,113.00
DAMD17-97-E-0004
P
Eq
9/1/91
Autoclave
30,000.00
DAMD17-97-E-0004
P
Eq
9/1/91
100 Liter Fermenter, Train 1
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/91
10 Liter Fermenter, Train 3
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/91
100 Liter Fermenter, Train 4
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/91
10 Liter Fermenter, Train 4
102,900.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-97-E-0004
P
Eq
9/1/91
Autoclave, Double-door
128,350.00
DAMD17-97-E-0004
P
Eq
9/1/92
Holding Tank A, Train 3
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/92
Holding Tank A, Train 4
102,500.00
DAMD17-97-E-0004
P
Eq
9/1/94
Hoist
575.00
DAMD17-97-E-0004
P
Eq
9/1/94
Hoist
575.00
DAMD17-97-E-0004
P
Eq
9/1/94
10 Liter Fermenter, Train 1
71,610.00
DAMD17-97-E-0004
P
Eq
9/1/94
Holding Tank A, Train 2
71,610.00
DAMD17-97-E-0004
P
Eq
9/1/94
100 Liter Fermenter, Train 3
71,610.00
DAMD17-97-E-0004
P
Eq
9/1/95
Two-Chart Recorder for Freezer #2
1,349.00
Eq
1,252,478.00
DAMD17-97-E-0004
R
Im
9/1/94
Stairs
1,000.00
Im
1,000.00
DAMD17-97-E-0004
1,253,478.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
Eq
250,000.00
DAMD17-98-C-8052
250,000.00
13,965,861.67
Attachment 3
Page 1 of 1
Jan
Feb
Mar
Apr
May
June
July
Aug
Sep
Oct
Nov
Dec
Total
0
0
0
108,120
108,120
108,120
108,120
108,120
108,120
108,120
108,120
108,120
973,080
235,880
235,880
235,820
127,760
127,760
127,760
127,760
127,760
127,760
127,760
127,760
127,730
1,857,390
115,000
115,000
115,000
115,000
115,000
115,000
115,000
115,000
114,930
1,034,930
3,865,400
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. P00001 20-Jan-2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCMA GRAND RAPIDS RIVERVIEW CENTER BUILDING 678 FRONT STREET, NW GRAND RAPIDS, MI 49504-5352 US ARMY SPACE & MISSILE DEFENSE COMMAND SMDC-CM-CB / MS. OCONNELL 301-819-2895 64 THOMAS JOHNSON DRIVE FREDERICK, MD 21702 8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and ZIP Code) BIOPORT CORPORATION 3400 N. MARTIN LUTHER KING JR. BLVD LANSING, MI 48906 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MOD OF CONTRACT/ORDER NO. W9113M-04-D-0002 X 10B. DATED (SEE ITEM 13) 08-Jan-2004 CODE 1H086 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 APPROPRIATION DATA (If required) 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 NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, X 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) E. IMPORTANT: Contractor 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 Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) LYNN M. SELFRIDGE//CONTRACTING OFFICER 15A. NAME AND TITLE OF SIGNER (Type or print) TEL: 301-619-2707 EMAIL: lynn.selfridge@DET.AMEDO.ARMY.MIL 15B. CONTRACTOR/OFFEROR 1 6B. UNITED STATES OF AMERICA BY /s/ Lynn M. Selfridge 16C. DATE SIGNED 15C. DATE SIGNED 22-JAN-2004 (Signature of person authorized to sign) (Signature of Contracting Officer) STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES - 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. P00002 2-Sep-2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCM GRAND RAPIDS RIVERVIEW CENTER BUILDING 678 FRONT STREET, NW GRAND RAPIDS, MI 49504-5352 US ARMY SPACE & MISSILE DEFENSE COMMAND SMDC-CM-CB / MS. SELFRIDGE 301-619-2707 64 THOMAS JOHNSON DRIVE FREDERICK, MD 21702 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 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 X 10B. DATED (SEE ITEM 13) 06-Jan-2004 CODE 1HDB6 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 1 5, 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 APPROPRIATION DATA (If required) 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 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 FAR52.217-9 E. IMPORTANT: Contractor 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.) Exercise Option 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. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) LYNN SELFRIDGE, / CONTRACTING OFFICER 15A. NAME AND TITLE OF SIGNER (Type or print) TEL: 301-619-2707 EMAIL: lynn.selfridge@DET.AMEDD.ARMY.MIL 15B. CONTRACTOR/OFFEROR 1 6B. UNITED STATES OF AMERICA BY /s/ Lynn M. Selfridge 16C. DATE SIGNED (Signature of person authorized to sign) 15C. DATE SIGNED (Signature of Contracting Officer) 2-Sep-2004 STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES - 1 4 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) P00003 09/28/04 N/A N/A - 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A U.S. Army Space and Missile Defense Command Attn: SMDC-CM-CB DCMA Detroit-Grand Rapids 64 Thomas Johnson Drive 678 Front Avenue, NW Fredrick, MD 21702 Grand Rapids, MI 49504-5352 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) BioPort Corporation, Inc. 3500 Martin Luther King Jr., Blvd. Lansing, MI 48906 (X) 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. X W9113M-04-D-0002 10B. DATED (SEE ITEM 11) 01/04/04 CODE 1H0B6 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 1 5, 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 APPROPRIATION DATA (If required) N/A 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: D. OTHER (Specify type of modification and authority) X PL 85-804, Implemented by FAR 50.403-2(b) and MoD dated Sep. 28, 2004 E. IMPORTANT: Contractor 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 Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) 15A. NAME AND TITLE OF SIGNER (Type or print) LYNN M. SELFRIDGE 15B. CONTRACTOR/OFFEROR 1 6B. UNITED STATES OF AMERICA /s/ Lynn M. Selfridge 16C. DATE SIGNED (Signature of person authorized to sign) 15C. DATE SIGNED (Signature of Contracting Officer) 09/28/04 NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243 |
A. | This modification incorporates the full text FAR clause 50.250-1 entitled Indemnification under Public Law 85-804 into contract number W9113M-04-D-0002 and is added to Section I. |
B. | The Memorandum of Decision signed by the Acting Secretary of the Army on September 28, 2004, is incorporated into Section J of the contract as Attachment Number 4, 3 pages. The definition of unusually hazardous risk applicable to this contract is delineated in TAB A to the Memorandum of Decision. |
C. | This modification is executed without cost to either party and is without effect to any other contract terms or conditions comprising contract W9113M-04-D-0002. |
(1) | All or substantially all of the Contractors business; | ||
(2) | All or substantially all of the Contractors operations at any one plant or separate location in which this contract is being performed; or | ||
(3) | A separate and complete major industrial operation in connection with the performance of this contract. |
(1) | Claims (including reasonable expenses of litigation or settlement) by third persons (including employees 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 Contractor property, excluding loss of profit; and | ||
(3) | Loss of, damage to, or loss of use of Government property, excluding loss of profit. |
(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 Contractors 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 Governments liability under this clause shall not increase as a result. |
(1) | Government claims against the Contractor (other than those arising through subrogation); or | ||
(2) | Loss or damage affecting the Contractors property. |
(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 Governments directions and execute any authorizations required in connection with settlement or defense of claims or actions. |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES J 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. POOOO4 26-Oct-2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W90GXK 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCM GRAND RAPIDS CHEMICAL-BIOLOGICAL-MEDICAL SYSTEMS PMO RIVERVIEW CENTER BUILDING 64 THOMAS JOHNSON DRIVE 678 FRONT STREET, NW FREDERICK MD 21702 GRAND RAPIDS MI 49504-5352 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 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) (X) 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 (X) 10B. DATED (SEE ITEM 13) 06-Jan-2004 CODE 1HOB6 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 1 5, 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 APPROPRIATION DATA (If required) 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 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 Mutual Agreement - D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return 2 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Add new contract line items for Pentavalent Bot annual testing. 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 a nd effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) 15A. NAME AND TITLE OF SIGNER (Type or print) LYNN M. SELFRIDGE / CONTRACTING OFFICER Robert Kramer, President & CEO TEL: 301-619-2707 EMAIL: Lynn.Selfridge@DET.AMEDO.ARMY.MIL 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert Kramer BY /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 11/12/04 (Signature of Contracting Officer) 03-Nov-2004 STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
ITEM NO | SUPPLIES/SERVICES | QUANTITY | UNIT | UNIT PRICE | MAX AMOUNT | |||||||||||||||
0004 |
|
1 | $ | 52,324.00 | $ | 52,324.00 | ||||||||||||||
Pentavalent Botulinum Testing
FFP Conduct Pentavalent Botulinum Long-Term Interval Testing for lots PBP003 and PBP0004 using Protocol Numbers LTIT2003-001 and LTIT2003-002 |
||||||||||||||||||||
|
||||||||||||||||||||
NET AMT
|
$ | 52,324.00 | ||||||||||||||||||
Funded Amount
|
$ | 0.00 |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY | |||
N/A
|
N/A | N/A | Government |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES 1 5 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. P00005 Nov 16 2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W90GXK 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCM GRAND RAPIDS CHEMICAL-BIOLOGICAL-MEDICAL SYSTEMS PMO RIVERVIEW CENTER BUILDING 64 THOMAS JOHNSON DRIVE 678 FRONT STREET, NW FREDERICK MD 21702 GRAND RAPIDS MI 49504-5352 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 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 X 10B. DATED (SEE ITEM 13) 06-Jan-2004 CODE 1HOB6 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 APPROPRIATION DATA (If required) 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 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 Mutual Agreement - 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.) Revise quantity of CLIN 0004 in P00004 dated November 3, 2004 from 1 test to 2 tests, and to increase the total value of CLIN 0004 to $104,648. The Statement of Work Paragr aph C.1.4.b. is revised to read: All testing other than Pentavalent Botulinum Vaccine.... as included on the attached SOW. FAR 52.216-19 and FAR 52.232-32 of the contract are not applicable to CLIN 0004. Funding will be provided on individual delivery orders. 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. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) 15A. NAME AND TITLE OF SIGNER (Type or print) LYNN M. SELFRIDGE Robert Kramer, President & CEO TEL: EMAIL: 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA By /s/ Robert Kramer BY_/s/ Lynn M. Selfridge___ 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 11/12/04 (Signature of Contracting Officer) Nov 16, 2004 STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES - 1. CONTRACT ID CODE 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) P00006 01/04/04 N/A N/A 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2101A U.S. Army Space and Missile Defense Command ATTN: SMDC-CM-CB DCMA Detroit-Grand Rapids 64 Thomas Johnson Drive 678 Front Street, NW Frederick, MD 21702 Grand Rapids, MI 49504 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 (X) 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 10B. DATED (SEE ITEM 11) 01/02/04 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 1 5, 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 APPROPRIATION DATA (If required) Not applicable 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 52.212-4 (c) 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.) See Page 2. 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 Lynn M. Selfridge 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 2/3/05 (Signature of Contracting Officer) 2/8/05 NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243 |
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(1) | Maintain current level of security at BioPorts production facility in Lansing, MI that is used to produce and store the Governments purchase of Anthrax Vaccine Adsorbed. | ||
(2) | Printing labels, labeling of vials and packaging for shipment of AVA produced under this contract. | ||
(3) | Potency testing on stability lots produced under this contract. | ||
(4) | Stability test consisting of chemistry, sterility, and safety, on the doses produced under this contract: |
Contract Line Item No. | Old Price/dose | Adjusted Price/dose | ||||||
0001
|
$ | [**] | $ | [**] | ||||
0002
|
$ | [**] | $ | [**] | ||||
0003
|
$ | [**] | $ | [**] |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) 01 02/16/05 N/A N/A 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A U.S. Army Space and Missile Defense Command DCMA Grand Rapids ATTN: SMDC-CM-CB Riverview Center Building 64 Thomas Johnson Drive 678 Front Street, NW Frederick, MD 21702 Grand Rapids, MI 49504-5352 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 (X) 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. X W9113M-04-D-0002-0001 10B. DATED (SEE ITEM 11) 01/02/04 CODE 1HNOB6 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 1 5, 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 APPROPRIATION DATA (If required) See Block 14, below. 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 52.212-4 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.) This instrument modifies delivery order number 0001 issued under the provisions of contract W9113M-04-D-0002, as a result of contract modification P00006 dated February 8, 2005. The price per dose of the commercially available anthrax vaccine (the DoDs Anthrax Vaccine Adsorbed) is increased to cover the additional expense for labels, labeling, packaging for shipment, stability testing, potency testing, and the provision of security at the BioPort Lansing, MI facility. The revised dose price is $[**]. 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 Lynn M. Selfridge 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 2/17/05 (Signature of Contracting Officer) 2/17/05 NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243 |
ITEM NO | SUPPLIES | MIN QTY | UNIT | UNIT PRICE | AMOUNT | |||||||||||||||
0001
|
AVA Vaccine | [**] | Dose | $ | [**] | $ | 32,408,552.40 |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES |
1 2 |
2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) 01 02/16/05 N/A N/A |
6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A U.S. Army Space and Missile Defense Command DCMA Grand Rapids ATTN: SMDC-CM-CB Riverview Center Building 64 Thomas Johnson Drive 678 Front Street, NW Frederick, MD 21702 Grand Rapids, MI 49504-5352 |
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 (X) 9A. AMENDMENT OF SOLICITATION NO. |
9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. X W9113M-04-D-0002-0002 10B. DATED (SEE ITEM 11) 01/02/04 CODE 1HOB6 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 1 5, 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 APPROPRIATION DATA (If required) See Block 14, below. 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 52.212-4 |
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.) This instrument modifies delivery order number 0002 issued under the provisions of contract W9113M-04-D-0002, as a result of contract modification P00006 dated February 8, 2005. The price per dose of the commercially available anthrax vaccine (the DoDs Anthrax Vaccine Adsorbed) is increased to cover the additional expense for labels, labeling, packaging for shipment, stability testing, potency testing, and the provision of security at the BioPort Lansing, MI facility. The revised dose price is $[**]. 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 Lynn M. Selfridge |
15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 2/17/05 (Signature of Contracting Officer) 2/17/05 |
NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)
Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243
|
ITEM NO | SUPPLIES | MIN QTY | UNIT | UNIT PRICE | AMOUNT | |||||||||||||||
0002
|
AVA Vaccine | [**] | Dose | $ | [**] | $ | 36,870,814.50 |
|
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. | |||
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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). | |||
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|||||
X
|
C. |
THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
Mutual Agreement of Both Parties |
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|||||
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|||||
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D. | OTHER (Specify type of modification and authority) | |||
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|||||
|
|||||
14.
|
DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) | |
Modification Control Number: oconnels0767
See Attached |
||
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||
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||
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||
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15A. NAME AND TITLE OF SIGNER (Type or print) | 16A. | NAME AND TITLE OF CONTRACTING OFFICER (Type or print) | ||||||
Robert G. Kramer, President & CEO |
Lynn M. Selfridge | |||||||
TEL: | EMAIL: | |||||||
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED | 16B. | UNITED STATES OF AMERICA | 16C. DATE SIGNED | ||||
|
||||||||
|
October 12, 2006 | |||||||
/s/ Robert G. Kramer | 10/12/06 | By /s/ Lynn M. Selfridge | ||||||
(Signature of person authorized to sign) | (Signature of Contracting Officer) | |||||||
EXCEPTION TO SF 30 | 30-105-04 | STANDARD FORM 30 (REV. 10-83) | ||||||
APPROVED BY OIRM 11-84 | Prescribed by GSA | |||||||
FAR (48 CFR) 53.243 |
FROM: | ||||||||
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
|
||||||||
0001
|
30-SEP-2006 | 1,297,380 | Contractors Facility | |||||
|
FOB: Origin |
TO: | ||||||||
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
|
||||||||
0001
|
30-SEP-2006 | [**] | Contractors Facility | |||||
|
31-DEC-2006 | [**] | FOB: Origin |
|
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). | |||
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û
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C. |
THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
Mutual Agreement of Both Parties |
|||
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|||||
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|||||
|
D. | OTHER (Specify type of modification and authority) | |||
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|||||
|
|||||
14.
|
DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) | |
Modification Control Number: oconnels0768
See Attached |
||
|
||
|
||
|
||
|
15A. NAME AND TITLE OF SIGNER (Type or print) | 16A. | NAME AND TITLE OF CONTRACTING OFFICER (Type or print) | ||||||
Robert G. Kramer, President & CEO |
||||||||
TEL: | EMAIL: | |||||||
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED | 16B. | UNITED STATES OF AMERICA | 16C. DATE SIGNED | ||||
|
||||||||
|
October 12, 2006 | |||||||
/s/ Robert G. Kramer | 10/12/06 | By /s/ Lynn M. Selfridge | ||||||
(Signature of person authorized to sign) | (Signature of Contracting Officer) | |||||||
EXCEPTION TO SF 30 | 30-105-04 | STANDARD FORM 30 (REV. 10-83) | ||||||
APPROVED BY OIRM 11-84 | Prescribed by GSA | |||||||
FAR (48 CFR) 53.243 |
FROM: | ||||||||
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
|
||||||||
0003
|
30 SEP 06 | 1,034,930 | BioPort Corporation | |||||
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3500 N. Martin Luther King Jr., Blvd | |||||||
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Lansing, MI 48906 | |||||||
0004
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30 SEP 06 | [**] | Same as Above |
TO: | ||||||||
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
|
||||||||
0003
|
30 SEP 06 | [**] | BioPort Corporation | |||||
|
31 DEC 06 | [**] | 3500 N. Martin Luther King Jr., Blvd | |||||
|
Lansing, MI 48906 | |||||||
0004
|
31 DEC 06 | [**] | Same as Above |
|
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). | |||
|
|||||
X | C. |
THIS SUPPLEMENTAL AGREEMENT IS
ENTERED INTO PURSUANT TO AUTHORITY OF:
Mutual Agreement of both Parties |
|||
|
|||||
|
|||||
|
D. | OTHER (Specify type of modification and authority) | |||
|
|||||
|
|||||
14.
|
DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section heading, including solicitation/contract subject matter where feasible.) | |
Modification Control Number: oconnels082517 | ||
See Attached. | ||
|
||
|
||
|
||
|
15A. NAME AND TITLE OF SIGNER (Type or print) | 16A. | NAME AND TITLE OF CONTRACTING OFFICER (Type or print) | ||||||
Robert G. Kramer, President & CEO |
||||||||
TEL: | EMAIL: | |||||||
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED | 16B. | UNITED STATES OF AMERICA | 16C. DATE SIGNED | ||||
|
||||||||
|
October 12, 2006 | |||||||
/s/ Robert G. Kramer | 10/12/06 | By /s/ Lynn M. Selfridge | ||||||
(Signature of person authorized to sign) | (Signature of Contracting Officer) | |||||||
EXCEPTION TO SF 30 | 30-105-04 | STANDARD FORM 30 (REV. 10-83) | ||||||
APPROVED BY OIRM 11-84 | Prescribed by GSA | |||||||
FAR (48 CFR) 53.243 |
|
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). | |||
|
|||||
X
|
C. |
THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
Mutual Agreement of Both parties |
|||
|
|||||
|
|||||
|
D. | OTHER (Specify type of modification and authority) | |||
|
|||||
|
|||||
14.
|
DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) | |
Modification Control Number: oconnels0770
See Attached |
||
|
||
|
||
|
||
|
15A. NAME AND TITLE OF SIGNER (Type or print) | 16A. | NAME AND TITLE OF CONTRACTING OFFICER (Type or print) | ||||||
Robert G. Kramer, President & CEO |
Lyan M. selfridge | |||||||
TEL: | EMAIL: | |||||||
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED | 16B. | UNITED STATES OF AMERICA | 16C. DATE SIGNED | ||||
|
||||||||
|
Oct 12, 2006 | |||||||
/s/ Robert G. Kramer | 10/12/06 | By /s/ Lynn M. Selfridge | ||||||
(Signature of person authorized to sign) | (Signature of Contracting Officer) | |||||||
EXCEPTION TO SF 30 | 30-105-04 | STANDARD FORM 30 (REV. 10-83) | ||||||
APPROVED BY OIRM 11-84 | Prescribed by GSA | |||||||
FAR (48 CFR) 53.243 |
FROM: | ||||||||
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
|
||||||||
0005
|
30-SEP-2006 | [**] | Contractors Facility | |||||
|
FOB: Origin |
TO: | ||||||||
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
|
||||||||
0005
|
31-DEC-2006 | [**] | Contractors Facility | |||||
|
FOB: Origin |
|
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). | |||
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|||||
X
|
C. |
THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
Mutual Agreement of Both Parties |
|||
|
|||||
|
|||||
|
D. | OTHER (Specify type of modification and authority) | |||
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|||||
|
|||||
14.
|
DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract, subject matter where feasible.) | |
Modification Control Number: oconnels076B
See Attached |
||
|
||
|
||
|
||
|
15A. NAME AND TITLE OF SIGNER (Type or print) | 16A. | NAME AND TITLE OF CONTRACTING OFFICER (Type or print) | ||||||
Robert G. Kramer, President & CEO |
Lyan M. selfridge | |||||||
TEL: | EMAIL: | |||||||
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED | 16B. | UNITED STATES OF AMERICA | 16C. DATE SIGNED | ||||
|
||||||||
|
October 12, 2006 | |||||||
/s/ Robert G. Kramer | 10/12/06 | By /s/ Lynn M. Selfridge | ||||||
(Signature of person authorized to sign) | (Signature of Contracting Officer) | |||||||
EXCEPTION TO SF 30 | 30-105-04 | STANDARD FORM 30 (REV. 10-83) | ||||||
APPROVED BY OIRM 11-84 | Prescribed by GSA | |||||||
FAR (48 CFR) 53.243 |
FROM: | ||||||||
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
|
||||||||
0003
|
30 Jun 07 | [**] | BioPort Corporation | |||||
|
3500 N. Martin Luther King Jr., Blvd | |||||||
|
Lansing, MI 48906 | |||||||
|
31 Jul 07 | [**] | Same as above | |||||
|
31 Aug 07 | [**] | Same as above | |||||
0004
|
31 Aug 07 | [**] | Same as above | |||||
|
30 Sep 07 | [**] | Same as above | |||||
|
31 Oct 07 | [**] | Same as above | |||||
|
30 Nov 07 | [**] | Same as above | |||||
|
31 Dec 07 | [**] | Same as above |
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- 13 -
- 14 -
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- 16 -
- 17 -
ATTEST: | BIOPORT CORPORATION | |||||||||
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||||||||||
By | /s/ Robert G. Kramer | |||||||||
|
||||||||||
|
Its | President & CEO | ||||||||
|
||||||||||
|
||||||||||
And by | /s/ Ronald S. Huben | |||||||||
|
||||||||||
|
Its | Associate Director of Finance | ||||||||
|
||||||||||
|
||||||||||
FIFTH THIRD BANK | ||||||||||
|
||||||||||
By | /s/ Michael Debri | |||||||||
Michael Debri | ||||||||||
|
Its | Vice President | ||||||||
|
- 18 -
BIOPORT CORPORATION | ||||||||
|
||||||||
By | /s/ Robert G. Kramer | |||||||
|
||||||||
|
Its | President and CEO | ||||||
|
||||||||
|
||||||||
And by Patrick D. Saam | ||||||||
|
||||||||
|
Its | Controller | ||||||
|
||||||||
|
||||||||
FIFTH THIRD BANK | ||||||||
|
||||||||
By | /s/ Mark Conn | |||||||
|
||||||||
|
Its | Vice President | ||||||
|
2
2
3
4
5
6
BIOPORT CORPORATION | ||||||||
|
||||||||
By | /s/ R. Don Elsey | |||||||
|
||||||||
|
Its | Treasurer | ||||||
|
||||||||
|
||||||||
And by | /s/ Daniel J. Abdun-Nabi | |||||||
|
Its | Secretary | ||||||
|
||||||||
|
||||||||
FIFTH THIRD BANK | ||||||||
|
||||||||
By | /s/ Mark D. Conn | |||||||
|
||||||||
|
Its | Vice President | ||||||
|
7
1. | Adamus v. BioPort Corp., Emergent BioSolutions, Inc., and Antex Corp. (sic), No. 05-CV-6759 (N.D. Ill.) (filed October 14, 2005) (BioPorts MTD/to transfer pending.) |
2. | Emery v. BioPort Corp. , No. CV-06-0008-AAM (E.D. Wash.) (filed January 9, 2006) (BioPorts MTD/to transfer pending.) |
3. | Savage v. BioPort, Inc. (sic), No. 1:06CV00081 (D.D.C.) (filed January 17, 2006) (BioPorts MTD/to transfer pending.) |
1. | Allen v. Abbott Laboratories, et al., No. 02CC00108 (filed April 26, 2002) (BioPort has not been served.) |
2. |
Mays v. Abbott Laboratories, et. al. No. 266529 (BioPort has not been served.)
|
3. | Schmuck v. Abbott Laboratories, et al., No. BC 2552268 (filed August 1, 2001) |
4. | Werley v. Abbott Laboratories, et al., No. 787422 (filed April 25, 2002) (BioPort has not been served.) |
8
37. | Reilly v. Laboratories , et al., No. 02-L-14697 (Cook County) (filed November 20, 2002) (dismissed April 2006; appeal pending) |
1. | Pandey v. Giri , et al., United States District Court for the District of Massachusetts, Civil Case No. HDCV2006-00529 (Emergent BioSolutions named as a defendant in action where plaintiff alleges that employee of Emergent and his wife misled him in connection with potential marriage of individual defendants niece to son of plaintiff.) |
9
UNPAID PRINCIPAL & | ||||||
INTEREST | ||||||
CREDITOR | DESCRIPTION | AS OF JULY 31, 2006 | COLLATERAL | |||
GMAC
|
2002 CHEVROLET VENTURE MINIVAN | $6,741 | 2002 CHEVROLET VENTURE MINIVAN | |||
LEXUS FINANCIAL SERVICES
|
2004 LEXUS E330 | $24,990 | 2004 LEXUS E330 | |||
BOBCAT FINANCIAL
|
||||||
SERVICES
|
INGERSOL BOBCAT | $546 | INGERSOL BOBCAT | |||
IMAGISTICS
|
||||||
(rolled up of Pitney
Bowes operating leases)
|
COPIERS & FAX MACHINES | $225,500 | COPIERS & FAX MACHINES | |||
|
||||||
|
||||||
|
TOTAL DEBT | $257,777 | ||||
|
2
BIOPORT CORPORATION | FIFTH THIRD BANK | |||||||||||
|
||||||||||||
By | /s/ Robert G. Kramer | By | /s/ Mark Conn | |||||||||
|
||||||||||||
Its President & CEO | Its | /s/ Vice President | ||||||||||
|
|
|||||||||||
|
||||||||||||
And by
|
/s/ Patrick D. Saam
|
|||||||||||
|
||||||||||||
Its Controller |
(1) | Emergent Product Development Gaithersburg Inc., a Delaware corporation having offices at 300 Professional Drive, Gaithersburg, MD 20879 (Emergent); and | ||
(2) | Talecris Biotherapeutics, Inc., a Delaware corporation having offices at 4101 Research Commons, 79 T.W. Alexander Drive, Research Triangle Park, NC 27709 (Talecris) |
1.01 | Adverse Events shall mean, with respect to the Finished Product, any adverse event associated with the use of the Finished Product in a patient or clinical investigation, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of the Finished Product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any significant and consistent failure of expected pharmacological action. Adverse Events shall include, without limitation, any unfavorable and unintended sign (including, without limitation, an abnormal laboratory finding), exacerbation of a pre-existing condition, intercurrent illness, drug interaction, significant worsening of a disease under investigation or treatment, significant failure of expected pharmacological or biological action, and/or symptom or disease temporally associated with the use of the Finished Product, whether or not considered related to the Finished Product. Notwithstanding anything foregoing to the contrary, with respect to the Territory in which the Finished Product is marketed, Adverse Events shall include any experience required to be reported to a relevant authority in any such country. | |
1.02 | Affiliate shall mean, with respect to a Party, any business entity which directly or indirectly controls, is controlled by, or is under common control with such Party. A business entity shall be deemed to control another business entity if (a) it owns, directly or indirectly, at least fifty percent (50%) of the issued and outstanding voting securities, capital stock, or other comparable equity or ownership interest of such business entity, or (b) it has the de facto ability to control or direct the management of such business entity. If the laws of the jurisdiction in which such entity operates prohibit ownership by a Party of fifty percent (50%) or more, control shall be deemed to exist at the maximum level |
of ownership allowed by such jurisdiction, provided, however, that there is a de facto ability to direct or control its management. |
1.03 | Agreement shall mean this Product Supply Agreement, including any exhibits or schedules hereto, as such may be amended from time to time, in writing, by mutual agreement of the Parties. | |
1.04 | AIG shall mean Anthrax Immune Globulin derived from AIG Source Plasma. | |
1.05 | AIG specific IgG Yield shall mean the total volume of AIG contained in AIG Source Plasma or Processed Product (as applicable) expressed in grams per liter. | |
1.06 | AIG specific IgG Target Yield shall have the meaning set forth in Section 4.01(c)(i). | |
1.07 | AIG Source Plasma shall mean anthrax immune human plasma, as defined under Applicable Law, collected by or on behalf of Emergent. AIG Source Plasma shall exclude By-Products. | |
1.08 | AIG Source Plasma Specifications shall mean the quality and other specifications for Source Plasma, as set forth on Exhibit C attached hereto, which specifications may be amended from time to time by mutual agreement of the Parties. | |
1.09 | Applicable Law shall mean any statute, law, treaty, rule, code, ordinance, regulation, permit, interpretation, certificate or order of a government authority, or any judgment, decision, decree, injunction, writ, order, subpoena, or like action of any court, arbitrator or other government entity (including without limitation, requirements of the FDA and cGMP) to the extent applicable and in each case as amended from time to time. | |
1.10 | Batch Production Record shall mean a copy of the Master Batch Record for AIG and Finished Product, which shall include, without limitation, instructions for manufacturing, packaging, in-process testing and release testing for the AIG and Finished Product, as well as the actual record of the performance of such work. | |
1.11 | BLA shall mean a Biologics License Application filed with the FDA and/or any other application required for the purpose of marketing or selling or using a therapeutic or prophylactic product to be filed with a governmental agency in a non-U.S. country or group of countries, including, without limitation, a Product License Application or Marketing Authorization in the European Union. | |
1.12 | Business Day shall mean Monday, Tuesday, Wednesday, Thursday or Friday of any week other than such days on which banking institutions located in Washington, D.C. and/or Raleigh, North Carolina are permitted or required by law, executive order or governmental decree to remain closed. | |
1.13 | By-Products shall mean products or materials, other than the Finished Product, that are processed from derivative materials resulting from Talecris Processing of the AIG Source Plasma into Finished Product at the Facilities hereunder. |
1.14
Certificate of Analysis shall mean a document or documents provided by Talecris to Emergent
for a batch of the Finished Product, that (a) bears the results of in-process or release
analytical testing and their respective specifications, and (b) states whether such Finished
Product was Processed in accordance with cGMP.
1.15
Certificate of Conformance shall mean a document or documents provided by Talecris to
Emergent that attests that a specific Lot of Finished Product was Processed in accordance with
cGMP.
1.16
cGMP shall mean current good manufacturing practices as set forth in Title 21, Parts 210
and 211 of the C.F.R. and 21 C.F.R. Part 312 (IND), and 21 C.F.R. Part 600, 606, 610, 630 and
640 (Biologics and Blood Products), as established and amended by the FDA, and any comparable
requirement of law in a country or group of countries other than the United States.
1.17
Claim shall mean any charge, complaint, action, suit, proceeding, hearing, investigation,
claim, controversy, dispute, demand, judgment, order, decree, stipulation, injunction, or
similar matters.
1.18
Commercial Product shall mean Finished Product for commercial use or use other than for
Pre-Commercial Product.
1.19
Commercial Target Yield shall have the meaning set forth in Section 4.01(d).
1.20
Commercial Term shall have the meaning set forth in Section 10.01(b).
1.21
Commercial Volume Commitment shall have the meaning set forth in Section 4.02(a).
1.22
Commercially Reasonable Efforts shall mean that degree of skill, effort, expertise, and
resources which a Person of ordinary skill, ability, and experience, under similar
circumstances, in the matters addressed herein would reasonably utilize and otherwise apply
with respect to fulfilling the obligations assumed hereunder.
1.23
Conforming AIG Source Plasma shall have the meaning set forth in Section 11.02(a).
1.24
Contract Year shall mean each twelve (12) month period during the Commercial Term or any
Extension Period hereunder, commencing on the effective date of the Commercial Term.
1.25
Dedicated Equipment shall consist of the equipment and associated fixtures which are used
by Talecris during the Term of this Agreement for the purpose of manufacturing the Finished
Product for Emergent hereunder.
1.26
Dollar shall mean the United States dollar.
1.27
Emergent Indemnitee shall mean Emergent, its Affiliates, its Sublicensees, and their
respective directors, officers, employees and agents.
1.28
Emergent Specifications shall mean the specifications concerning [**] Product hereunder,
established by Emergent in its sole discretion from time to time pursuant to Section 5.04.
The initial Emergent Specifications shall be completed by Emergent as soon as practicable
following the Effective Date and attached hereto as
Exhibit A-1
.
1.29
Evaluation Lot shall have the meaning set forth in Section 4.01(a).
1.30
Exclusivity Agreement shall mean the exclusivity agreement between the Parties dated as of
the Effective Date, in the form attached hereto as
Exhibit G
.
1.31
Extension Period shall have the meaning set forth in Section 10.01(c).
1.32
Facilities shall mean the Melville, New York Precision Pharma or Clayton, North Carolina
location where fractionation shall take place, and the manufacturing facility in Clayton,
North Carolina where purification shall take place, and the real property underlying such
manufacturing facilities used by Talecris to practice the Process, together with all of the
Dedicated Equipment, but not including equipment which is not used in the Process.
1.33
Facility Goods shall mean any products manufactured at the Facilities other than the
Finished Product, including without limitation Gamunex.
1.34
FDA shall mean the United States Food and Drug Administration.
1.35
Field shall mean the prevention, treatment or therapy of anthrax infection in humans.
1.36
Fill/Finish Specifications shall mean such manufacturing specifications concerning the
[**], as the Parties may mutually agree.
1.37
Finished Product shall mean any [**] as an active ingredient.
1.38
Firm Commitment shall have the meaning set forth in Section 4.02(d).
1.39
Force Majeure shall have the meaning set forth in Section 15.11.
1.40
Foreign Currency Sales shall mean Sales which are invoiced by Emergent in a currency other
than the Dollar.
1.41
Gamunex shall mean Talecris immunology product marketed as Gamunex
®
.
1.42
Gamunex Specifications shall mean the specifications for Gamunex attached hereto as
Exhibit A
, as amended by Talecris from time to time in accordance with Section 5.01.
1.43
Generally Accepted Accounting Principles shall mean generally accepted accounting
principles as set forth in opinions and pronouncements of the Accounting Principles Board of
the American Institute of Certified Public Accountants and statements and pronouncements of
the Financial Accounting Standards Board as consistently applied per usual accounting
practices.
1.44
Gross Price shall mean, with respect to a Finished Product, the unit price, without
deduction, actually invoiced by Emergent, its Affiliates and Sublicensees for the Sale of such
Finished Product.
1.45
IgG Yields shall have the meaning set forth in Section 4.01(c)(iv).
1.46
INCOTERMS 2000 shall mean the specifications of the obligations for delivering goods in
international contracts, as issued by the International Chamber of Commerce.
1.47
IND shall mean an investigational new drug application filed with the FDA and/or any other
similar application to be filed with a governmental agency in a country or group of countries
other than the United States.
1.48
Initial AIG Source Plasma shall have the meaning set forth in Section 3.01(a).
1.49
Insolvency Event shall mean the commencement of any action, whether voluntarily or
involuntarily (provided, that such involuntary action is not dismissed within ninety (90) days
of commencement thereof), seeking any relief by liquidation, reorganization (other than for
corporate reorganization), dissolution or similar act under any bankruptcy, insolvency or
similar law or otherwise any action seeking any arrangement between or with its creditors or
any commencement of a proceeding or receipt of an order, judgment or decree seeking the
liquidation, reorganization or dissolution of a Party or any other relief under any
bankruptcy, insolvency or similar law or an arrangement is made with respect to such Partys
debts or business by its creditors.
1.50
Losses shall mean losses, deficiencies, defaults, assessments, dues, penalties, fines,
amounts paid in settlement, liabilities, obligations, taxes, liens, damages, costs and actual
out-of-pocket expenses (including interest, penalties, court costs, attorneys fees,
accountants and other experts, or other expenses of any Claim), including all damages
awardable pursuant to statute and treble damages.
1.51
Lot shall mean a lot of between [**] liters to [**] liters of AIG Source Plasma to be
Processed by Talecris in accordance with Product Specifications and cGMP (or as otherwise may
be mutually agreed by the Parties).
1.52
Major Markets shall mean the United States and Canada.
1.53
Master Batch Record shall mean the master batch record for AIG and Finished Product, which
shall include, without limitation, instructions for manufacturing, packaging, and in-process
testing and release testing for the AIG and Finished Product.
1.54
Minimum Commitment Fee shall have the meaning set forth in Section 7.05(a).
1.55
Negotiation Period shall have the meaning set forth in Section 2.03.
1.56
Net Sales shall mean the Gross Price of Finished Products multiplied by the quantity of
Finished Products Sold in the Territory, less (a) trade and quantity discounts actually
allowed and taken, (b) sales, value added, or other excise taxes paid, absorbed or allowed,
(c) import and export taxes and such other amounts paid by Emergent, its Affiliates or Sublicensees to a governmental entity as a result of the importing or exporting of Finished Product, (d) amounts repaid or credited by reason of purchase chargebacks, rebates (including rebates in kind), rejections, defects or returns (including, without limitation, rebates pursuant to governmental and managed care programs), and (e) charges actually incurred for insurance, handling, distribution, freight and transportation, provided that the aggregate amount of such charges shall not exceed two percent (2%) of the total invoiced price. All of the items set forth in (a) through (e) above shall be calculated according to Emergents standard method of accounting consistently applied in accordance with Generally Accepted Accounting Principles, and shall not in aggregate exceed fifteen percent (15%) of the aggregate Gross Price of any Finished Product. |
1.58
Non-Conforming AIG Source Plasma shall mean AIG Source Plasma which does not comply with
the AIG Source Plasma Specifications as of the time of delivery of such AIG Source Plasma to
Talecris.
1.59
Nonspecific IgG Target Yield shall have the meaning set forth in Section 4.01(c)(i).
1.60
Nonspecific IgG Yield shall mean the total volume of all immune globulins present in AIG
Source Plasma or Processed Product (as applicable) expressed in grams per liter.
1.61
Notice shall have the meaning set forth in Section 15.01 of this Agreement; Notify or any
variation thereof shall mean to provide Notice or other corresponding meaning.
1.62
Order shall mean a written order for either Pre-Commercial Product or Commercial Product.
1.63
Person shall mean any natural person or any corporation, company, sole proprietorship,
partnership, joint venture, firm or other business entity.
1.64
Pre-Commercial Product shall mean Finished Product (a) for pre-clinical or animal studies,
(b) for clinical use or for non-clinical testing required for clinical trials in preparation
for submission, approval or maintenance of a regulatory filing, including without limitation
any INDs and/or BLAs, and/or (c) necessary for Emergent to secure the first contractual
commitment for Finished Product from a Third Party and/or to obtain government funding for
Finished Product.
1.65
Pre-Commercial Target Yield shall have the meaning set forth in Section 4.01(c)(iv).
1.66
Pre-Commercial Term shall have the meaning set forth in Section 10.01(a).
1.67
Process, Processed, or Processing shall mean the act of fractionation, purification,
sterilization, virus inactivation/removal, testing, filling, finishing and any other
pharmaceutical manufacturing procedures, or any part thereof, for manufacturing the Finished
Product hereunder, consisting of activities which are required to meet the Gamunex
Specifications and, with respect to Finished Product, such other activities required to meet
the Fill/Finish Specifications.
1.68
Processing Fee shall have the meaning set forth in Section 7.03(a).
1.69
Processed Product shall mean AIG Source Plasma that has been Processed in compliance with
Gamunex Specifications but has not yet met Fill/Finish Specifications.
1.70
Product Liability Claim shall mean, with respect to any Finished Product or By-Product, as
applicable, a Claim of a Third Party (other than a Claim arising out of use of Finished
Product in a clinical trial) that (a) arises as a result of the use of such product that
results in personal injury or death or (b) is in anticipation of or intended to prevent or
forestall personal injury or death as a result of the use of such product.
1.71
Product Specifications shall mean the (a) Gamunex Specifications, and (b) the Fill/Finish
Specifications.
1.72
Quality Agreement shall mean the agreement attached hereto as
Exhibit F.
1.73
Regulatory Authority shall mean, with respect to the United States, the FDA or, in the case
of a country in the Territory other than the United States, such other appropriate regulatory
authority with similar responsibilities.
1.74
Rolling Forecast shall have the meaning specified in Section 4.02(c).
1.75
Sale(s), Sold and Sell shall mean the sale, transfer or disposition of the Finished
Product for commercial purposes for value to a Third Party (whether an end user, wholesaler or
otherwise), whether by Emergent, its Affiliates or Sublicensees, but excluding the sale,
transfer or disposition of any Validation Lots or Pre-Commercial Product.
1.76
Sublicensee shall mean any third party (including Affiliates) to whom a sublicense has been
granted pursuant to this Agreement.
1.77
Supply Failure shall be deemed to exist with respect to any Lot of AIG Source Plasma
Processed under this Agreement to provide Finished Product to Emergent if either of the
following has occurred:
(a)
a Lot of AIG Source Plasma Processed hereunder has a Yield of less than [**]
percent ([**]%) of the Commercial Target Yield on [**] occasions within any given
rolling twelve (12) month period.
(b)
over any given rolling (12) month period, the Lots of AIG Source Plasma
Processed hereunder have an average Yield of less than the Commercial Target Yield,
provided that any Lot described in clause (a) shall be excluded from the computation of
average Yield.
1.78
Talecris BLA sections shall have the meaning set forth in Section 8.01(a).
1.79
Talecris Gamunex Activities shall mean those activities as defined in Section 8.01(a), as
such activities are related to Finished Product hereunder. The list of such activities under
Section 8.01 is provided for illustrative purposes only and is not intended to be a
comprehensive list.
1.80
Talecris Patent Rights shall mean Talecriss rights in inventions and discoveries which are
related to AIG or the Finished Product and/or the Process and covered by a patent or patent
application listed on
Exhibit B
, all provisionals, divisions, continuations,
continuations-in-part, reissues, reexaminations or extensions thereof, and any corresponding
foreign counterparts and equivalents thereof.
1.81
Term shall have the meaning set forth in Section 10.01(c).
1.82 | Territory shall mean each country in the world. | |
1.83 | Third Party shall mean any Person which is not a Party, an Affiliate or a Sublicensee under this Agreement. | |
1.84 | Third Party Customer shall mean a Third Party that is a customer of Talecris for Facility Goods. | |
1.85 | US CPI shall mean the U.S. consumer price index medical care commodities index for similar goods and services published by the United States Department of Labor, Bureau of Labor Statistics, as reported by the Wall Street Journal (Eastern Edition), or such other index as may be mutually agreed upon by the Parties. | |
1.86 | Validation shall mean successful validation of the Facilities, Dedicated Equipment and critical Process steps in compliance with cGMP, including (a) the successful completion of all validation protocols established by the Parties for the Facility and Designated Equipment, and (b) ensuring and providing documentary evidence that the Process used by Talecris to manufacture Finished Product is capable of consistently producing Finished Product of the required quality as determined by the Product Specifications. | |
1.87 | Validation Lot(s) shall mean the consistency Lot(s) necessary to obtain Validation hereunder and that meets the Pre-Commercial Target Yield. | |
1.88 | Yield shall mean, with respect to any Lot of AIG Source Plasma Processed under this Agreement to provide Finished Product to Emergent, in the case of AIG specific IgG, (i) the quantity of AIG specific IgG from Processed Product exhibited following Processing divided by (ii) the quantity of AIG specific IgG from Source Plasma exhibited prior to Processing (AIG specific IgG Yield), and, in the case of Nonspecific IgG, (i) the quantity of Nonspecific IgG from Processed Product exhibited following Processing divided by (ii) the quantity of Nonspecific IgG from Source Plasma exhibited prior to Processing (Nonspecific IgG Yield); provided, however, that Non-Conforming Product shall not be included in the computation of Yield. |
2.01 | Emergent Obligations . Emergent shall provide AIG Source Plasma meeting the AIG Source Plasma Specifications to Talecris for Processing. Emergent shall pursue all necessary regulatory approvals with regard to Finished Products with the assistance of Talecris as each is further described in Article 8 below. | |
2.02 | Scope of Talecris Services . Talecris shall, in accordance with the terms of this Agreement: |
(a) | perform Processing services at the Facilities in accordance with the Product Specifications and cGMP, provided, however, that during the Pre-Commercial Term the purification and fill and finish shall be performed at the Facility in Clayton, North Carolina; |
(b) | perform quality assurance review of the Finished Product and of the Processing in accordance with the Product Specifications and cGMP; and | ||
(c) | permit Emergent to perform quality assurance review of the Finished Product and of the Processing in accordance with the Product Specifications and cGMP. |
2.03 | Emergent [**] . If at any time during the Term Talecris [**] Centers for Disease Control (CDC) category A, B and/or C bioterrorism agents which are listed on Exhibit J attached hereto (the Proposal), then Talecris [**] Emergent [**]. If Emergent [**] Talecris [**], the Parties shall [**] in good faith for up to [**] days (or longer, upon mutual agreement of the Parties) (Negotiation Period) [**]. If the Parties are [**] Negotiation Period, Talecris shall be [**]. | |
2.04 | Exclusivity . Each Partys noncompete and/or exclusivity obligations under this Agreement with respect to Finished Product shall be governed by the terms of the Exclusivity Agreement. |
3.01 | Supply and Use . |
(a) | Delivery of AIG Source Plasma; Use of AIG Source Plasma . Emergent shall (or shall cause one of its Affiliates or a designee to) deliver to Talecris (by or on a date mutually scheduled by Talecris and Emergent) such quantity of AIG Source Plasma which meets the AIG Source Plasma Specifications as is reasonably necessary for Talecris to manufacture Finished Product hereunder, including without limitation an initial pool of [**] liters (or such other amount as the Parties may mutually agree) of AIG Source Plasma (Initial AIG Source Plasma). Talecris shall not procure human plasma from sources other than Emergent, its designee(s) or Affiliates for use in Finished Product. Talecris shall not use AIG Source Plasma, except as set forth in Section 2.02, Section 3.04 and 4.01(e) below, for any purpose other than to supply Finished Product to Emergent. Except as specifically set forth in Article 4 below, Talecris shall handle, store, use and dispose of all such AIG Source Plasma at the Facilities in compliance with Applicable Law in the Major Markets. | ||
(b) | Processing of AIG Source Plasma . Talecris shall Process the AIG Source Plasma in compliance with the Product Specifications and, except as set forth in Section 4.01(e) below (Macrobench-Scale Purification), cGMP. |
3.02
Delivery
. Within fifteen (15) Business Days following Talecris receipt from
Emergent of each Order for Finished Product pursuant to Article 4, Talecris shall Notify
Emergent of the scheduled date(s) for commencement of the Processing of the Finished Product
covered by such Order. Emergent shall use Commercially Reasonable Efforts to deliver or have
delivered to Talecris a sufficient quantity of AIG Source Plasma to meet Processing of the
Finished Product covered by such Order at least [**] days prior to each of Talecris scheduled
run date(s) for Processing of such Finished Product. Emergent acknowledges and agrees that its
failure to provide sufficient quantity of AIG Source Plasma meeting the AIG Source Plasma
Specifications on a timely basis may negatively affect Talecris ability to Process and
deliver the Finished Product by the delivery dates requested by Emergent.
3.03
Ownership of AIG Source Plasma
. Emergent shall retain ownership of all right, title
and interest in and to any AIG Source Plasma.
3.04
By-Products
. Subject to the terms and conditions of this Agreement, Talecris shall
have the right to dispose of, further manufacture, or sell any By-Products, provided that
Talecris shall not, by itself or in collaboration with or on behalf of a Third Party, develop,
manufacture, produce, promote, market, offer to sell, sell or otherwise dispose of any
By-Product for use in the Field, and By-Products shall not be generated from any unprocessed
Lot of AIG Source Plasma or portion thereof nor from any II/III paste generated therefrom.
Furthermore, Talecris shall not undertake any changes to the Process with the purpose of
increasing the quantity of By-Products at the expense of the Finished Product.
AND ORDERS
4.01
Pre-Commercial Product.
(a)
Evaluation Lot
.
During the Pre-Commercial Term, Emergent shall submit to Talecris an Order for [**]
(Evaluation Lot). Emergent shall pay Talecris the Processing Fee for such
Evaluation Lot.
(b)
Validation Lots
.
For purposes of calculating the Commercial Target Yield in order to determine
whether a Supply Failure has arisen pursuant to Section 4.04(a) below, Emergent
shall order at least [**] Validation Lots. The Evaluation Lot may constitute a
Validation Lot for the purposes of this Section 4.01(b). Emergent shall pay
Talecris the Processing Fee for each Validation Lot provided by Talecris.
(c)
Pre-Commercial Target Yield
.
(i)
During the Pre-Commercial Term, Talecris shall provide a
Nonspecific IgG Yield of no less than [**] percent ([**]%) (Nonspecific IgG
Target
Yield) and a AIG specific IgG Yield of no less than [**] percent ([**]%) (AIG specific IgG Target Yield). |
(ii) | In conjunction with the Processing of each Lot of Pre-Commercial Product, Talecris shall determine the Nonspecific IgG Yield in a manner consistent with Talecris customary practices. | ||
(iii) | In conjunction with the Processing of each Lot of Pre-Commercial Product, Emergent shall determine the AIG specific IgG Yield, with the use of testing procedures reviewed and approved by Talecris, which approval shall not be unreasonably withheld, delayed or conditioned. | ||
(iv) | The Nonspecific IgG Yield and the AIG specific IgG Yield shall collectively be referred to as the IgG Yields. The Nonspecific IgG Target Yield and the AIG specific IgG Target Yields shall collectively be referred to as the Pre-Commercial Target Yield. | ||
(v) | In the event that Talecris determines that the Nonspecific IgG Yield is less than the Nonspecific IgG Target Yield, Talecris shall Notify Emergent of such determination and provide reasonable documentation supporting such determination, which shall be reflective of its usual manufacturing process and procedures. In the event that Emergent determines that the AIG specific IgG Yield is less than the AIG specific IgG Target Yield, Emergent shall Notify Talecris of such determination and provide reasonable documentation supporting such determination, which shall be reflective of its usual process and procedures. | ||
(A) | If the Parties agree with the determination that either the Nonspecific IgG Yield or the AIG specific IgG Yield is less than the respective Pre-Commercial Target Yield, Emergent shall have the right, but not the obligation, to utilize the services of a Third Party to process another Evaluation Lot. | ||
(1) | In the event that such Third Party achieves an AIG IgG specific Yield of at least [**] percent ([**]%) greater than Talecris AIG specific IgG Yield, Emergent may terminate this Agreement pursuant to Section 10.02(i) and the Exclusivity Agreement shall terminate in accordance with the terms set forth therein. | ||
(2) | In the event that such Third Party does not achieve an AIG IgG specific Yield of at least [**] percent ([**]%) greater than Talecris AIG IgG specific Yield, Emergent may not sell any pharmaceutical product processed on its behalf that contains AIG as an active ingredient from any Third Party in accordance with the terms of the Exclusivity Agreement, and the terms and conditions of the Exclusivity Agreement shall remain in full force and effect. |
(B) | If either Party disagrees with the determination of the other Party whether or not the IgG Yield is less than the Pre-Commercial Target Yield, such Party shall Notify the other Party of such disagreement and the Parties shall engage a mutually selected independent laboratory to make such determination. |
(d) | Commercial Target Yield . | ||
If the Parties mutually determine that the IgG Yields are equal to or greater than the Pre-Commercial Target Yield for the Evaluation Lot (if applicable) and each of the [**] Validation Lots, the Commercial Target Yield for the Commercial Term shall be computed and determined as follows: | |||
With respect to Nonspecific IgG: |
(i) | the average final quantity of Nonspecific IgG exhibited after Processing all of the Validation Lots ordered pursuant to Section 4.01(b), divided by | ||
(ii) | the average initial quantity of Nonspecific IgG from the AIG Source Plasma exhibited prior to Processing all of the Validation Lots ordered pursuant to Section 4.01(b); and | ||
(iii) | the quotient of which is multiplied by [**] percent ([**]%). |
With respect to AIG specific IgG: |
(i) | the average final quantity of AIG specific IgG exhibited after Processing all of the Validation Lots ordered pursuant to Section 4.01(b), divided by | ||
(ii) | the average initial quantity of AIG specific IgG from the AIG Source Plasma exhibited prior to Processing all of the Validation Lots ordered pursuant to Section 4.01(b); and | ||
(iii) | the quotient of which is multiplied by [**] percent ([**]%). |
Upon the completion of the Pre-Commercial Term and at the completion of each twelve (12) month period during the Commercial Term, the Parties shall recompute the Commercial Target Yield to include the additional Processed Lots which were not included in the original computation set forth above. Such computation shall be based on Yield results provided by each respective Party to the other at the end of each period. In the event that the recomputed Commercial Target Yield more closely resembles the historical average yields experienced by Talecris in processing Gamunex, the Parties agree to negotiate in good faith an adjustment to the Commercial Target Yield to reflect the processing information provided by the additional Lots. | |||
(e) | Macrobench-Scale Purification . Talecris shall Process a non-cGMP macrobench-scale purification of [**] liters (or such other amount as the Parties may mutually |
agree) of the Initial AIG Source Plasma Processed by Talecris hereunder, which may be used by Emergent for proof-of-concept studies, validation of the potency release assay for Finished Product, development activities, pre-clinical studies, and otherwise in support of Emergents development efforts in connection with Finished Product. For purposes of clarity, such macrobench-scale purification process shall be sterile and endotoxin-free and otherwise be the same as the purification process used in the Process, except that Talecris shall not be required to conduct such purification under cGMP conditions. |
(f) | Additional Lots of Pre-Commercial Product . During the Pre-Commercial Term, Emergent shall have the right, in its sole discretion, to submit to Talecris Orders for additional Lots of Pre-Commercial Product in excess of those Ordered pursuant to Sections 4.01(a) through 4.01(c), including without limitation Validation Lots. Talecris shall conduct the Processing of any Lots of Pre-Commercial Product ordered by Emergent pursuant to Sections 4.01(a) through 4.01(c) at such times as the Parties may mutually agree; provided, however, that Talecris shall use Commercially Reasonable Efforts to schedule the Processing of such Lots on dates which are as close as practicable to the dates requested by Emergent in the Order(s) for such Lots. Emergent shall pay the Processing Fee for any additional Lots of Pre-Commercial Product ordered pursuant to this Section 4.01(f). | ||
(g) | Non-Binding Forecast for Pre-Commercial Product . As soon as practicable following the Effective Date of this Agreement and from time to time thereafter during the Pre-Commercial Term, Emergent shall submit to Talecris a non-binding, good faith forecast that sets forth the total quantity of Pre-Commercial Product which Emergent expects to order from Talecris within the time period set forth in such forecast. Emergent shall update such forecast from time to time but not less frequently than annually, unless otherwise agreed by the Parties in writing, based on its reasonable expectations and/or need for Pre-Commercial Product. | ||
(h) | Orders for Pre-Commercial Product . Each Order for Pre-Commercial Product shall specify the Pre-Commercial Product ordered, the quantities of the Pre-Commercial Product ordered, the requested manner and address of delivery, and the requested delivery date, which shall be no earlier than [**] days from the date of the Order (unless otherwise agreed to by Talecris in writing), all of which shall be subject to Article 6. Emergent shall submit its initial Order for Pre-Commercial Product on the Effective Date and may submit additional Orders for Pre-Commercial Product at any time thereafter during the Pre-Commercial Term. |
4.02 | Commercial Product . |
(a) | Commercial Volume Commitment . Unless otherwise mutually agreed by the Parties, the minimum annual volume commitment by Emergent (Commercial Volume Commitment) for each Contract Year shall be (a) [**] liters of AIG Source Plasma per annum to be Processed into Finished Product during the |
Commercial Term, and (b) [**] liters of AIG Source Plasma per annum to be Processed into Finished Product during any Extension Period. The Commercial Volume Commitment shall be reduced, upon the occurrence of a Supply Failure, on a prorated basis with respect to each month in which Emergent is able to use an alternative supplier pursuant to Section 4.04(a) below and Emergent has elected to use such an alternative supplier. |
(b) | Process Initiation . Subject to the provisions of Section 3.02 above, Talecris shall use Commercially Reasonable Efforts to initiate the Processing of the Commercial Product on the date which is as close as practicable to the initial fill date set forth in the initial Rolling Forecast submitted by Emergent under Section 4.02(c) below, but in no event later than twelve (12) months from the date of Emergents Notice of its intent to initiate the Commercial Term as set forth in Section 10.01(b). | ||
(c) | Rolling Forecast for Commercial Product . No later than thirty (30) days following the commencement of the Commercial Term, Emergent shall submit to Talecris an initial twelve (12) month rolling forecast (Rolling Forecast) that sets forth the total quantity of Finished Product which Emergent expects to order from Talecris within such twelve (12) month period (Annual Forecast Amount), with a breakdown of the total quantity of Finished Product by month and the delivery schedule for such Finished Product. Without Talecris prior written approval, the initial Annual Forecast Amount for the first Contract Year shall not exceed [**] liters of Finished Product, and the Annual Forecast Amount for any other given Contract Year shall not exceed [**] liters. The initial Annual Forecast Amount shall include an initial delivery date for Finished Product which is not earlier than [**] days from Emergents submission of the initial Rolling Forecast to Talecris. Following Emergents submission of the initial Rolling Forecast, Emergent shall submit to Talecris on a monthly basis on or before the first Business Day of each month, an updated Rolling Forecast, provided that (i) the monthly forecast amount shall not exceed [**] Lots for any given month without Talecris prior written approval, and (ii) the Annual Forecast Amount shall be updated on an annual basis only. | ||
(d) | Firm Commitments for Commercial Product . The Rolling Forecast shall be binding on Emergent for the first [**] months (i.e., months [**]) (each, a Firm Commitment), each of which Firm Commitment shall be the subject of an Order delivered in accordance with Section 4.02(e). | ||
(e) | Orders for Commercial Product . Emergent shall, together with its monthly Rolling Forecast, deliver to Talecris an Order for each new Firm Commitment that was only a forecasted amount in the previous months Rolling Forecast. Each Order shall specify the Commercial Product ordered, the quantities of the Commercial Product ordered, the requested manner and address of delivery, and the requested delivery date, which shall be no earlier than [**] days from the date of the Order (unless otherwise agreed to by Talecris), all of which shall be subject |
to Article 6. Emergent may submit its initial Order for Commercial Product at any time on or after the commencement of the Commercial Term. |
(f) | Amending Forecasts for Commercial Product . Any Rolling Forecast that is not a Firm Commitment is to be considered an estimated forecast to be used for planning purposes, shall not be construed as a Firm Commitment by Emergent to Talecris, and may be increased or reduced by Emergent from time to time. Notwithstanding anything in the foregoing to the contrary, in the event of a Supply Failure as set forth in Section 4.04(a) below, the Rolling Forecast for each month during which the Supply Failure persists shall not be considered a Firm Commitment until such time that Talecris is capable of resuming the Processing of Finished Products under this Agreement. | ||
(g) | Fulfillment of Orders for Commercial Product . Talecris shall diligently fulfill Emergents Orders in accordance with their terms and the terms of this Agreement, provided that Talecris shall not be obligated to fulfill any Orders during any Contract Year to the extent that the quantity of Commercial Product covered by such Orders exceeds in the aggregate [**] percent ([**]%) of the Annual Forecast Amount for such Contract Year. Talecris shall promptly Notify Emergent if it becomes aware or believes that it will not be able to fulfill a particular Order that was included in a Firm Commitment on time, in full or at all, which Notice shall include an explanation in reasonable detail of the reason for Talecris failure to comply with a particular Order and its proposed course of action for remedying such failure. |
4.03 | Bona Fide Forecasts . Emergent shall make its Rolling Forecasts under Section 4.02(c) acting reasonably, in good faith, based on its reasonable expectations for Sales of the Finished Product (having due regard to any sales over the previous twelve (12) months). Emergent shall use Commercially Reasonable Efforts to give accurate Rolling Forecasts. | |
4.04 | Alternative Supplier . Emergent shall be required to obtain all of its Finished Product requirements from Talecris, provided, however, that: |
(a) | Supply Failure . In the event of a Supply Failure, Emergent shall have the right to purchase from one or more alternative suppliers its Finished Product requirements, to the extent necessary to replace Finished Product not provided by Talecris due to the Supply Failure, until Talecris reasonably demonstrates that Talecris is able to resume Processing of Finished Product, provided that Emergent shall [**] Finished Product [**] of the Supply Failure. In any case, Emergent shall [**] to the Supply Failure. Emergent shall purchase all other Finished Product requirements from Talecris as soon as Emergent has fulfilled all obligations or commitments, if any, undertaken by Emergent in connection with Emergents arrangement(s) with the alternative supplier(s). |
(b) | Redundant Supply . Emergent shall have the right to purchase from one or more alternative suppliers such portion of its Finished Product requirements as Emergent may reasonably establish, if, and for so long as, any Regulatory Authority, governmental agency or Applicable Law (relevant to the Major Markets) requires Emergent to obtain and/or maintain a redundant supply of Finished Product from one or more alternative suppliers. In such event, to the extent not otherwise prohibited by any Regulatory Authority, governmental agency or Applicable Law (in the Major Markets), Emergent shall give priority to selling Finished Product provided by Talecris and Emergent shall not sell products supplied by a Third Party until the inventory of Finished Product Processed by Talecris has been exhausted. Emergent shall notify the appropriate Regulatory Authority or governmental agency in the United States that Talecris shall act as Emergents sole commercial supplier with respect to Finished Product pursuant to the terms of this Agreement. Emergent shall promptly Notify Talecris in the event that any Regulatory Authority, governmental agency or Applicable Law (relevant to the Major Markets) requires Emergent to obtain and/or maintain a redundant supply of Finished Product from one or more alternative suppliers. Emergent shall not advocate to any Regulatory Authority that a redundant supply from alternate suppliers should be required with respect to the Finished Product. |
5.01 | Process Changes . |
(a) | Prior Approval of Emergent Required . Talecris shall have the right to make any change to the manufacturing process for Gamunex or other Facility Goods, or to the Facilities, as such change applies to Gamunex or other Facility Goods, provided, however, that Talecris shall not make any change to the Process or any Facility (other than routine maintenance, reconditioning and/or replacement of the equipment) that would reasonably be expected to have a material negative impact on the AIG or the Finished Product or require submissions to or approvals from any Regulatory Authority specific to the Finished Product, except by prior written approval of Emergent for such change, which approval shall not be unreasonably conditioned, withheld or delayed, and, in any event, which costs shall be borne by Talecris. | ||
(b) | Process Changes Based on cGMP . Talecris shall make such changes to the Process or any Facility as may be required pursuant to cGMP, provided that (i) changes to the Process or any Facility which affect the Finished Product, but do not affect Gamunex or another Facility Good, shall be at Emergents cost, and (ii) the cost of any changes to the Process or any Facility which affect both the Finished Product and Gamunex or another Facility Good shall be shared between the Parties, taking into consideration various factors, including without limitation, improvements in Yields for Finished Product, historical volumes, and other measures mutually agreed upon by the Parties. If the Parties are not able to reach |
consensus on the allocation of such costs, such allocation shall be determined in accordance with the dispute resolution mechanism set forth in Article 14. |
(c) | Changes Made at the Request of Emergent . From time to time, Emergent may request that Talecris make certain changes (other than those required pursuant to Section 5.01(b) above) to the Process; provided, however, that (i) Emergent shall seek to minimize such changes, (ii) Talecris shall not be required to make any changes which may have a negative impact on any Facility Good, on Talecris ability to manufacture such Facility Good at the Facilities, or on Talecris business, including without limitation the production of Gamunex, or which require submissions to or approvals from any Regulatory Authority specific to Gamunex or any other Facility Goods, (iii) Emergent and Talecris shall enter into good faith negotiations with each other regarding the assessment of the implications and costs arising from a change to the Process, and (iv) after the Parties have agreed upon the implications and costs related to a change to the Process, Talecris may, at its sole discretion, implement such change. Costs incurred by Talecris in connection with such changes shall be fully reimbursed by Emergent. |
5.02 | Quality Assurance . |
(a) | Testing by Talecris . Talecris shall perform quality testing using assays proposed by Emergent and acceptable to Talecris (which acceptance shall not be unreasonably withheld, conditioned or delayed), in order to assure that the Finished Product complies with the Product Specifications and cGMP, and shall retain samples of the Finished Product produced and records of the tests made on each such batch of Finished Product. In addition, no Finished Product shall be delivered until such Finished Product has been released in accordance with the tests, inspections and controls required under the Product Specifications and cGMP, and such other tests as the Parties may mutually agree upon; provided, however, that the foregoing shall not relieve Talecris of its obligations under Section 4.02(g). Talecris shall maintain records with respect to the quality testing and shall make such records available to Emergent during normal business hours, upon prior written request. Without limiting Talecris obligations under Sections 4.01 and 4.02, Talecris shall run, complete and record such number of qualification batches of the Finished Product as are required by Regulatory Authorities in the Major Markets pursuant to the BLA submission and ordered by Emergent pursuant to Sections 4.01(a)-(b), at Emergents expense. | ||
(b) | Notice of Non-Conforming Products . Talecris shall promptly Notify Emergent of any Non-Conforming Product of which it becomes aware, specifying the Finished Products release testing and Batch Production Record for the completed Lot. | ||
(c) | Testing by Emergent . At Emergents election, the Finished Product may be subjected to testing by Emergent at Emergents facilities in order to verify conformance of the Finished Product with the Product Specifications, Emergent Specifications and Applicable Law in the Major Markets. Such testing |
procedures shall be reviewed by Talecris in advance of their implementation. Emergent shall maintain records with respect to the scope and nature of any such testing and shall disclose such records to Talecris in a timely fashion. |
(d) | Notice of Delivery of Non-Conforming Products . Emergent shall Notify Talecris of any Non-Conforming Product within (i) [**] days of Emergents receipt of such Non-Conforming Product if a defect is discovered by Emergent through the use of reasonable testing methods and procedures or (ii) in the event of a defect (hidden or otherwise) which was not discovered through the use of such testing methods and procedures, the earlier of (A) [**] Business Days following Emergents confirmation of the Non-Conforming status of the Finished Product, and (B) [**] months after delivery of the Non-Conforming Product. Talecris shall have the right to examine and test any Finished Product in Emergents possession that Emergent claims is Non-Conforming, provided that such re-testing is conducted in accordance with applicable regulatory guidelines and other Applicable Law in the Major Markets. The Parties shall cooperate to determine the point at which the Finished Product became Non-Conforming. In the event that the Parties cannot agree as to whether any Finished Product is Non-Conforming, the Parties shall engage a mutually selected independent laboratory to make such determination in accordance with applicable regulatory guidelines and other Applicable Law in the Major Markets. If the dispute between the Parties relates to Talecriss ability to manufacture and deliver Finished Product that is not Non-Conforming, which is not attributable to any negligence or willful misconduct of Emergent, the Parties shall resolve their dispute in accordance with the procedures in Article 14. This Section shall not relieve Talecris of its obligations to deliver Finished Products in accordance with Sections 4.02(g) and 6.01. | ||
(e) | Responsibilities of the Quality Units . A summary of the responsibilities of the quality units of each Party related to the Process shall be set forth on Exhibit E , which responsibilities shall be further described in Exhibit F . Such responsibilities shall include, without limitation, (i) the specific content of the Certificate of Analysis, (ii) the specific content of the Certificate of Conformance, (iii) the nature of the Batch Production Record and/or Master Batch Record review process, including notification of deviations associated with the Process, and (iv) a table of key contacts associated with the manufacturing, regulatory, quality control and quality assurance functions; (v) establishing the process by which it can be determined whether a particular Lot of Finished Product is Non-Conforming. | ||
(f) | Quality Assurance Audits by Emergent . During the Term, Emergent shall have the right, at Emergents sole cost and expense, during normal business hours and upon reasonable Notice, to (i) have an Emergent employee present at the Facility(ies) during Processing and (ii) inspect the Facility(ies) in order to ensure that the Processing complies with the Product Specifications and cGMP. Such inspections shall not interfere with Talecriss operations and shall not exceed one (1) occurrence in any year; provided, however, that if any such inspection reveals |
any noncompliance with the Product Specifications or cGMP, Emergent shall have the right to conduct a reasonable number of follow-on inspections as necessary in order to confirm that compliance with such Product Specifications and cGMP has been re-established. |
(g) | Recalls and Voluntary Withdrawals . If either Party becomes aware of information about [**] indicating that they may be Non-Conforming or that there is potential adulteration, misbranding and/or any potential issues regarding safety or effectiveness, it shall promptly serve Notice to that effect on the other Party. The Party initiating an investigation and assessment of such circumstances shall promptly Notify the other Party of its findings and any proposed course of action. The Parties shall meet to discuss such circumstances and to consider appropriate courses of action; provided, however, that if Emergent determines that a recall or withdrawal of the [**] is necessary or advisable, Emergent shall have final decision-making authority concerning the course of action to be taken with respect to the affected [**]. Emergent shall bear all costs associated with such a recall or withdrawal of the [**], unless such recall or withdrawal is caused by Talecris gross negligence or willful misconduct. |
5.03 | Labeling and Packaging . Talecris shall be responsible for labeling and packaging the Finished Product for shipment to Emergent or to its designee(s), in accordance with Emergents directions, provided that Emergent shall be responsible for developing the design and content for the final label and package inserts. Upon Emergents request, Talecris shall assist Emergent in developing the design and content for such final label and package inserts at Emergents cost and Talecris standard consulting rates set forth in Exhibit D , and shall provide regulatory support pursuant to Section 8.09. | |
5.04 | Emergent Specifications; Fill/Finish Specifications . Emergent shall have the right, from time to time, at its cost, to amend the (a) Emergent Specifications, but only to the extent such revisions do not affect the Product Specifications, and (b) the Fill/Finish Specifications, but only to the extent that such revisions are agreed to in writing by Talecris, provided, that Emergent shall use Commercially Reasonable Efforts to minimize the frequency of such changes and shall provide Talecris with reasonable advance Notice of any changes to such portions of the Fill/Finish Specifications. Without limiting the foregoing, any modifications to the Fill/Finish Specifications required by any Regulatory Authority with jurisdiction to require such modifications shall be made in accordance therewith. Emergent shall reimburse Talecris for any additional charges incurred by Talecris as a result of changes made by Emergent to the Emergent Specifications or the Fill/Finish Specifications. |
6.01 | Delivery . Subject to the provisions of Sections 3.01 and 3.02, Talecris shall use Commercially Reasonable Efforts to deliver Finished Product in accordance with the delivery dates specified in the Orders. All shipments shall be made by Talecris (FCA) in accordance with INCOTERMS 2000 at a Talecris Facility (NY or NC as Talecris may |
designate during the Commercial Term from time to time). The delivery of any Finished Product to Emergent hereunder shall be deemed to occur when such Finished Product is delivered into the custody of Emergents carrier at such designated location. Talecris shall bear all expense and risk of shipping the AIG, Finished Product, AIG Source Plasma and/or other materials between its Facilities. |
6.02 | Certificates of Analysis . Each Finished Product batch delivered to Emergent shall be accompanied by an appropriate Certificate of Analysis and Certificate of Conformance. Talecris shall, for customs purposes, upon delivery of Finished Product, provide Emergent with a valid declaration of origin, in a form reasonably acceptable to Emergent, in respect of all Finished Products supplied to Emergent under this Agreement, together with such other supporting documents relating to the origin of such Finished Product as Emergent may reasonably require. |
7.01 | Deposit . Within thirty (30) days following the Effective Date, Emergent shall pay Talecris a deposit of [**] Dollars (US$[**]), which shall be fully creditable against the cost of Lot(s) of Finished Product manufactured by Talecris hereunder and any other amounts payable by Emergent to Talecris hereunder, including without limitation, the amount payable by Emergent under Section 7.02 for Start-Up Preparations (as defined below). | |
7.02 | Fees Associated With Certain Pre-Commercial Activities . |
(a) | Start-Up Preparations . Within thirty (30) days following the Effective Date, Emergent shall pay Talecris a one-time fee of [**] Dollars (US$[**]) for Talecris performance of reasonable start-up preparations related to the Processing of Finished Product hereunder, including without limitation preparation of SOPs, Master Batch Production Records, assay transfers, equipment validation, and product-specific cleaning validation (Start-Up Preparations). Talecris shall provide Emergent with documentation of such Start-Up Preparations in form and substance reasonably satisfactory to Emergent within thirty (30) days following the Effective Date (or such other time as may be mutually agreed by the Parties) and upon completion thereof. If, within one-hundred eighty (180) days of the Effective Date, Talecris has failed to complete the preparation of SOPs, Batch Production Records and assay transfers and/or to use Commercially Reasonable Efforts to conduct equipment validation and product-specific cleaning validation, and such failure can not be attributed in any way to the acts or omissions of Emergent, and Talecris has not provided to Emergent a reasonable plan of action for completing such Start-Up Preparations in a reasonable time period, Emergent shall have the right to terminate this Agreement pursuant to Section 10.02(i). | ||
(b) | Stability Testing . Emergent shall pay Talecris a one-time fee of [**] Dollars (US$[**]) following Talecris performance of the stability testing and related activities set forth in Section 9.07 hereof. |
(c) | Container Closure Study . [**], Talecris shall conduct a container closure study, as further described on Exhibit K attached hereto. | ||
(d) | Process Validation Study . Emergent shall pay Talecris a one-time fee not to exceed [**] Dollars (US$[**]) for Talecris conduct of the process validation study, as further described on Exhibit K attached hereto. |
7.03 | Processing Fee . |
(a) | Processing Fee . Subject to any price adjustments set forth in this Article 7 and the method of payment set forth in Section 7.07, the Parties agree that the price of the Finished Product to be charged to Emergent (the Processing Fee) shall be at a rate equal to [**] Dollars ($[**]) per liter . Such Processing Fee shall include final fill and finish, but shall not include the cost of labels or packaging. | ||
(b) | Annual Price Adjustments . During the Commercial Term, upon commencement of each Contract Year following the first Contract Year, the Processing Fee and any relevant hourly billable rates of Talecris personnel shall be adjusted prospectively by a percentage equal to the percentage increase in the US CPI reported from the commencement of the prior Contract Year, beginning with the calendar quarter following the publication of the US CPI. For clarity, such adjustment shall take place only once per Contract Year on a calendar-year basis. |
7.04 | Royalty . |
(a) | Commercialization License . Talecris hereby grants to Emergent, under the Talecris Patent Rights, the rights, which shall be exclusive within the Field, to commercialize Finished Product, including to use, have used, offer for sale, sell, have sold, import, and have imported the Finished Product in the Territory . | ||
(b) | Royalty Rate . In addition to the Processing Fee set forth in Section 7.03(a), Emergent shall pay Talecris a royalty equal to [**] percent ([**]%) of Net Sales on a country-by-country basis for Commercial Product manufactured by Talecris hereunder. | ||
(c) | Royalty Term . The royalty payable under Section 7.04(b) shall be paid on a country-by-country basis on Finished Product Processed by Talecris hereunder (the Royalty Term). | ||
(d) | Obligation to Pay . The obligation to pay royalties hereunder is imposed only once with respect to the same unit of Finished Product. | ||
(e) | Royalty Report . Emergent shall deliver to Talecris, within sixty (60) days after the end of each calendar quarter during the Royalty Term reasonably detailed written accountings of Net Sales of Finished Product that are subject to royalty payments due to Talecris for such calendar quarter. When Emergent delivers such accountings to Talecris, Emergent shall also deliver any royalty payments due under this Section 7.04 to Talecris for the calendar quarter. |
7.05
Minimum Commitment Fee
.
(a)
Minimum Commitment Fee
. If, during the Commercial Term or any
Extension Period, Emergent fails to submit Orders (other than as a result of any Supply
Failure) for the greater of (i) the total quantity of the [**] or (ii) the total quantity of [**],
Emergent shall be responsible for an amount which is equal to the
difference between the [**] and [**], as applicable (Minimum Commitment
Fee). Emergent shall make a payment in cash of the Minimum Commitment Fee within
[**] days of the end of the Contract Year or month, as applicable, during which
the failure occurs.
(b)
Exclusive Remedy
. Emergents payment of fees or submission of Orders,
as applicable, as set forth under this Section 7.05, shall be Talecris exclusive
remedy and Emergents sole liability, solely with respect to any failure to submit
Orders as set forth herein.
7.06
Method of Invoicing for Orders
. All Orders under this Agreement shall be invoiced at
the time of Finished Product release by Talecris.
7.07
Remittance of Payments
. Payments due by Emergent under this Article 7 shall be
payable by Emergent no later than thirty (30) days after the invoice date; provided, however,
that the Finished Product associated with such payment was actually delivered in compliance
with Section 6.01. Emergent shall make payment by wire transfer of Dollars to a bank account
designated by Talecris or by such other payment method as the Parties may agree upon from time
to time.
7.08
Foreign Currency
. Payments made under this Agreement shall be payable in United
States Dollars. With respect to foreign exchange rate conversion, Net Sales calculated under
this Agreement shall be computed for each quarter with Foreign Currency Sales converted into
United States Dollars using the average exchange rate for such period, which average exchange
rate shall be the actual rate as utilized by Emergent for its standard financial reporting,
provided that such rate shall be consistent with other generally available, publicly reported
exchange rates.
7.09
Talecris Right to Audit
. Emergent shall maintain and keep (and shall cause its
Affiliates and Sublicensees to maintain and keep) for three (3) years after payment is made or
should have been made by Emergent under this Agreement complete and accurate books and records
in sufficient detail to calculate all sums falling due or which should fall due for payment by
Emergent under this Agreement. No more than once during each calendar year during the Term,
Emergent shall permit Talecris independent auditors, to
whom Emergent has no reasonable objection and with reasonable Notice at any time during Emergents normal business hours, to inspect, audit and copy relevant accounts and records of Emergent, its Affiliates and Sublicensees, for the sole purpose of verifying the accuracy of the calculation of payments to Talecris based on Net Sales and the reports which accompanied them. Talecris independent auditors shall not disclose to Talecris any information other than information relating solely to the accuracy of the accounting and payments made by Emergent. If such audit determines that payments are due to Talecris, Emergent shall pay to Talecris any such additional amounts within thirty (30) days of the date on which such auditors written report is delivered to Emergent, unless such audit report is disputed, in which case the dispute shall be resolved in accordance with Article 14. If the auditor determines that Emergents payments are in excess of those required under this Agreement, Talecris shall credit the amount of such overpayment towards any amounts payable by Emergent to Talecris under this Agreement within ninety (90) days following the date of the auditors determination of such overpayment, and shall promptly remit to Emergent any portion of such overpayment which has not been credited within such ninety (90) day period, unless such audit report is disputed, in which case the dispute shall be resolved in accordance with Article 14. Any such inspection of records shall be at Talecriss expense unless such audit discloses a deficiency in the payments made by Emergent of more than five percent (5%), in which case Emergent shall bear the cost of such audit. |
7.10 | Deductions from Payments . Any income or other taxes which Emergent is required by Applicable Law to pay or withhold on behalf of Talecris with respect to payments and any other monies payable to Talecris under this Agreement shall be deducted from the amount of such payments and other monies due and paid to the relevant competent taxing authority. Emergent shall furnish Talecris with proof of such payments. Any such tax required to be paid or withheld shall be an expense of and borne solely by Talecris. Emergent shall promptly provide Talecris with a certificate or other documentary evidence and provide reasonable assistance to enable Talecris to support a claim for a refund or a foreign tax credit with respect to any such tax so withheld or deducted by Emergent. Emergent and Talecris will reasonably cooperate in completing and filing documents required under the provisions of any applicable tax treaty or under any other Applicable Law, in order to enable Emergent to make such payments to Talecris without any deduction or withholding, if possible. |
8.01 | Preparation of INDs and BLAs . |
(a) | Drafting . Emergent shall prepare and submit all necessary regulatory approvals for the AIG and/or Finished Product other than the Talecris BLA sections (as defined below), including without limitation INDs and the BLAs in the United States for the production of Initial AIG Source Plasma and for the Processing of Finished Product (including, without limitation, the filling and finishing of Finished Product, but excluding those activities set forth on Exhibit I attached hereto (Talecris Gamunex Activities), including any amendments or supplements thereto (Emergent BLAs). Emergent shall reasonably determine, |
upon consultation with Talecris and taking into account in good faith Talecris concerns and proposed timetable for submission of the Talecris BLA sections, the timing of the submission of the Emergent BLAs to the Regulatory Authorities. Talecris shall, at Talecris expense, diligently and timely prepare and submit in compliance with Applicable Law in the Major Markets the portions of the BLA that cover the Talecris Gamunex Activities, including any amendments or supplements thereto (Talecris BLA sections), in the United States and in any other country or group of countries where such separate submission by Talecris is required, in accordance with the submission date(s) established by Emergent, which shall take into account in good faith Talecriss concerns and proposed timetable for submission of the Talecris BLA sections. |
(b) | Assistance by Talecris . Talecris hereby agrees to provide (i) to Emergent all information and regulatory support which is reasonably necessary in the preparation of comprehensive and complete INDs for Finished Product and the Emergent BLAs, and any amendments and supplements thereto, including, without limitation, the Talecris BLA sections (including without limitation the Chemistry Manufacturing and Controls (CMC) section), and (ii) access to the Facilities and pertinent information to Emergent and to FDA inspectors conducting the pre-approval inspection. Talecris shall provide such regulatory support pursuant to the provisions of Section 8.09. | ||
(c) | Changes . Subject to Section 5.01 and Section 8.06, each Party shall be responsible for timely notifying the applicable Regulatory Authority regarding proposed changes to the portion of the Process or Product Specifications or Emergent Specifications, as the case may be, covered by such Partys relevant sections of the Emergent BLAs in accordance with Applicable Law in the Major Markets. |
8.02 | Ownership . The Parties agree that all INDs arising under this Agreement related to AIG and/or Finished Product will be owned solely by Emergent, that Emergent BLAs arising under this Agreement, except for the Talecris BLA sections, will be owned solely by Emergent and held in the name of Emergent, in compliance with Applicable Law in the Major Markets. | |
8.03 | Right of Cross-Reference . Emergent shall have the right to cross-reference all Talecris regulatory documents related to the Finished Product and/or the Process which are on file with applicable Regulatory Authorities as necessary in order to obtain all applicable regulatory approvals for Finished Product. During the term of the Agreement (excluding any suspensions of performance thereunder), Talecris shall have the right to cross-reference all Emergent regulatory documents related to the Finished Product and/or the Process which are on file with applicable Regulatory Authorities, solely as necessary for Talecris to Process Finished Product for Emergent under this Agreement or to exercise the rights granted to Talecris with respect to By-Products pursuant to Section 3.04 above. Talecris shall provide Emergent with regulatory support as reasonably necessary for each Party to obtain and maintain all necessary regulatory approvals for Finished Product |
hereunder. Talecris shall provide such regulatory support pursuant to the provisions of Section 8.09. |
8.04 | Subsequent Filings or Applications . Talecris hereby agrees to provide to Emergent, regulatory support, data and other information which is reasonably necessary for the preparation of IND annual reports and/or any subsequent filings or applications Emergent may submit to the FDA pursuant to the provisions of Section 8.09. | |
8.05 | Record and Files . Talecris shall maintain those documents required by applicable cGMP regulations. Emergent shall have the right to audit such Talecris documents and records related to the Processing of Finished Product upon reasonable advance Notice to Talecris and at reasonable intervals during the Term (but not more frequently than once every twelve (12) month period) to verify Talecris compliance with such requirements. | |
8.06 | Communications with Regulatory Authorities . Talecris shall not, without the consent of Emergent or unless so required by Applicable Law in the Major Markets, correspond or communicate with any Regulatory Authority specifically regarding the Finished Product. Furthermore, Talecris shall, as soon as practicable after any contact with or receipt of any communication from any Regulatory Authority relating to the Finished Product, forward a copy or description of the same to Emergent and respond to all inquiries by Emergent relating thereto. If Talecris is advised by its counsel that it must communicate with any Regulatory Authority specifically regarding the Finished Product, then Talecris shall so advise Emergent as soon as practicable and, unless prohibited by Applicable Law in the Major Markets, provide Emergent in advance with a copy of any proposed written communication with any Regulatory Authority and comply with any and all reasonable direction of Emergent concerning any meeting or written or oral communication with any Regulatory Authority. To the extent permitted by the Regulatory Authority, Emergent shall have the right to participate in any planned oral communications or meetings between Talecris and any Regulatory Authority relating to Finished Product, including without limitation periodic reporting sessions. For purposes of clarification, the obligations imposed on Talecris pursuant to this Section 8.06 shall not apply with respect to communications with Regulatory Authorities that are focused primarily on Gamunex and not on the Finished Product. | |
8.07 | Governmental Inspections . Talecris shall immediately Notify Emergent in the event that any Regulatory Authority carries out or gives notice of its intention to carry out any inspection or investigation in connection with the Finished Product. To the extent permitted by the Regulatory Authority, Emergent shall have the right to be present at and observe any such inspection. | |
8.08 | Post-Approval Obligations . Unless otherwise set forth in this Agreement, Emergent shall be responsible, at its own cost, for post-approval regulatory obligations associated with the Finished Product, including without limitation post-marketing clinical trials, additional product stability studies, drug safety monitoring, complaint handling, recalls, error and accident reporting, and adverse experience reporting, as each may be further described in Article 9. Emergent may procure regulatory support services from Talecris pursuant to the provisions of Section 8.09. |
8.09 | Regulatory Support; Investigations; Reports; Data . Talecris shall provide regulatory support, investigative support and reports or data to Emergent in support of filings to the Regulatory Authorities of the Major Markets only up to a maximum of [**] hours at no cost to Emergent, and, subject to Talecris agreement, at Talecris standard consulting rates set forth on Exhibit D for Talecris personnel time in excess of the cap set forth herein. For other markets, Talecris shall use Commercially Reasonable Efforts to support Emergent at the consulting rates set forth on Exhibit D . Talecris shall use diligent efforts to provide the regulatory, advisory and related services under this Agreement in a professional manner; provided, however, that in no event does Talecris guarantee the outcome of such services. |
9.01 | Exchange of Drug Safety Information . Each Party shall, and shall require that its Affiliates, (a) adhere to all Applicable Laws in the Major Markets which relate to the reporting and investigation of Adverse Events and biological product deviations as defined in 21 C.F.R. Part 600.14, and (b) keep the other Party informed of such experiences related to the Finished Product. | |
9.02 | Adverse Events and Biological Product Deviations . |
(a) | Regulatory Reporting . Emergent shall have sole and exclusive responsibility for worldwide regulatory reporting of all Adverse Events and biological product deviations with respect to the Finished Product. In order that Emergent may be fully informed, Talecris shall, and shall require that its Affiliates and Sublicensees, provide Notice to Emergent of all Adverse Events and biological product deviations with respect to the Finished Product anywhere in the world in accordance with the timelines specified herein. Notwithstanding the foregoing, all Adverse Events and biological product deviations with respect to the Finished Product shall be reported by Talecris to Emergent promptly enough to allow Emergent sufficient time to evaluate, process and comply with worldwide regulatory reporting. Talecris shall have sole and exclusive responsibility for worldwide regulatory reporting of all Adverse Events and biological product deviations with respect to Gamunex, activities required to meet the Gamunex Specifications, or By-Products. In order that Talecris may be fully informed, Emergent shall, and shall require that its Affiliates, provide Notice to Talecris of all Adverse Events and biological product deviations with respect to the Finished Product anywhere in the world that may affect Gamunex, activities required to meet the Gamunex Specifications or By-Products, in accordance with the timelines specified herein. Notwithstanding the foregoing, to the extent practicable, all such Adverse Events and biological product deviations with respect to the Finished Product shall be reported by Emergent to Talecris promptly enough to allow Talecris sufficient time to evaluate, process and comply with worldwide regulatory reporting. | ||
(b) | Complaints . [**] all complaints, as defined in 21 C.F.R. Part 211.198 or any analogous |
regulations or requirements in jurisdictions outside the United States, regarding the Finished Product. [**] shall Notify [**] within [**] hours of becoming aware of a complaint, including [**]. Talecris shall timely cooperate in [**], including providing information applicable to each, and shall timely initiate and complete corrective and preventive actions related to such investigations and identified product and quality system nonconformities that are the responsibility of Talecris under this Agreement. Talecris shall make [**] accessible to Emergent for purposes of FDA inspection in accordance with FDA regulations or pursuant to applicable regulations and requirements in jurisdictions outside the United States. [**] shall Notify [**] within [**] hours of becoming aware of a complaint pertaining to the [**] which may affect Gamunex or the Process, and shall timely share information pertaining to the investigation of such complaint with Talecris. |
(c) | Reports . Talecris shall provide to Emergent, within [**] hours of becoming aware thereof, information from any source that suggests an Adverse Event related to the [**] occurred. Emergent shall provide to Talecris, within [**] hours of becoming aware thereof, information from any source that suggests an Adverse Event related to the [**] occurred. This information shall include any adverse drug experience or reaction reports or any other reports or information, from whatever source derived, indicating that the [**] has any toxicity, sensitivity reactions, or is otherwise alleged to cause illness or injury of any kind due to a possible product quality problem, or is adulterated or misbranded. | ||
(d) | Investigations and Inquiries . With respect to information received regarding [**] complaints, Adverse Events and biological product deviations, Talecris shall thereafter reasonably cooperate with Emergent and the Regulatory Authority regarding an investigation or inquiry directed at the [**] that may be initiated by a Regulatory Authority or otherwise required in response to a [**] with respect thereto (which investigation or inquiry [**] shall have the right to direct and control) and shall further provide Emergent with all data or other information related solely to the [**] and excluding data or other information related to Gamunex that Emergent may reasonably require in connection with any reports or correspondence that Emergent provides to the Regulatory Authority, the [**] relative to any such adverse drug reaction [**] complaint. |
9.03 | Exchange of Drug Safety Requests . The Parties shall immediately provide each other with copies of all drug safety requests from all governmental agencies and Regulatory Authorities directed solely toward the Finished Product. Proposed answers materially affecting the Finished Product will be exchanged between the Parties before submission and the Parties shall cooperate with respect to such answers; provided, however, that |
Emergent shall have ultimate decision-making authority with respect to answers relating solely to the Finished Product, unless Applicable Law in the Major Markets requires otherwise. The Parties shall exchange decisions from applicable health authorities immediately. |
9.04 | Regulatory Actions . Each Party shall advise the other Party of any regulatory action of which it is aware, which would affect the Finished Product in any country in the Major Markets. | |
9.05 | Events Affecting Integrity or Reputation . During the Term, the Parties shall Notify each other immediately of any circumstances of which they are aware which arise whereby the integrity and reputation of the Finished Product or of the Parties are threatened by the unlawful activity of any Third Party in relation to the Finished Product. | |
9.06 | Retention of Product Samples . Talecris shall, or shall cause one of its Affiliates to, retain all records and samples with respect to the Finished Product supplied by Talecris in accordance with Applicable Law in the Major Markets. | |
9.07 | Stability . Talecris will perform stability testing, data interpretation, reporting and updating of stability information to regulatory documents for the Finished Product. Talecris shall perform such stability testing and related activities in accordance with the stability protocols, Talecris procedures, timing and other terms as set forth on Exhibit H , from the date of commencement of Processing of Finished Product from each Lot. | |
9.08 | Annual Product Reviews . On a calendar-year basis, Talecris will prepare summary data for Finished Product Processed within the prior calendar year. Such data will be prepared and sent to Emergent within one calendar month (unless otherwise agreed by Talecris and Emergent) of the end of the applicable calendar year during which the Finished Product was Processed hereunder. This data will include [**]. Such data shall be prepared pursuant to the provisions of Section 8.09. | |
9.09 | Quality Assurance Investigations . Upon Notice to Talecris that Emergent has received an Adverse Event, product complaint or inquiry regarding Finished Product supplied by Talecris to Emergent hereunder, Talecris shall (or shall cause one of its Affiliates to) within a reasonable period, conduct a quality assurance investigation to determine if any process or testing deviations or events may have contributed to such Adverse Event, complaint or inquiry. Quality assurance investigations may include a review of Batch Production Records and the evaluation of returned or retained samples of Finished Product. Talecris shall, or shall cause one of its Affiliates to, supply Emergent with the outcome of the investigation within thirty (30) days of Emergents notice. In cases where a more comprehensive investigation might be required, the Parties will jointly develop an investigational plan. Talecris shall conduct such quality assurance investigations pursuant to the provisions of Section 8.09. |
10.01
Pre-Commercial Term; Commercial Term; Term
.
(a)
Pre-Commercial Term
. Pre-Commercial Term shall mean the period
commencing on the Effective Date and ending on the earlier of (i) January 1, 2009, or
January 1, 2010 if Emergent gives Notice to Talecris by at least December 31, 2008 that
it desires to extend the Pre-Commercial Term until January 1, 2010 and (A) the
aggregate amount paid by Emergent to Talecris under this Agreement prior to December
31, 2008 plus the aggregate amount committed to be paid by Emergent during the first
six (6) months of 2009 for (1) Pre-Commercial Product based on the forecasts and orders
for such period and (2) other services to be provided hereunder during such period,
equals or exceeds [**] Dollars (US$[**]), or (B) Emergent pays Talecris on or before
December 31, 2008 a non-refundable deposit of [**] Dollars (US$[**]) less all amounts
already paid or committed to be paid as described in the immediately preceding clause
(i) (the Extension Deposit); and (ii) such date that is twelve (12) months following
the date on which Emergent provides Notice to Talecris of its desire to commence the
Commercial Term. The Extension Deposit, if any, shall be fully creditable against any
amounts payable thereafter by Emergent to Talecris hereunder.
(b)
Commercial Term
. Commercial Term shall mean a five (5) year period
commencing on the earlier of (i) either January 1, 2009 or, if the Pre-Commercial Term
was extended pursuant to the terms of Section 10.01(a) above, January 1, 2010, or (ii)
such earlier date that is twelve (12) months following the date on which Emergent
provides Notice to Talecris of its desire to commence the Commercial Term.
(c)
Term
. Unless earlier terminated as set forth below, this Agreement
shall be in effect from the Effective Date until the end of the Commercial Term (the
Initial Term), which Commercial Term may be extended by Emergent for an additional
five (5) year period (Extension Period) upon Notice to Talecris at least twelve (12)
months prior the expiration of such Initial Term; provided, however, that Emergent
shall have no right to extend the Commercial Term if Talecris has provided to Emergent
a Notice of termination pursuant to Section 10.02(b) (Elective Termination by
Talecris). The Term shall consist of the Initial Term and any Extension Period.
10.02
Termination
. This Agreement may be terminated in accordance with the following
sections.
(a)
Elective Termination by Emergent
. Emergent may terminate this
Agreement by giving at least two (2) years advance Notice (Emergent Elective
Termination Notice) to Talecris, which Emergent Elective Termination Notice may not be
given prior to the completion of the third (3
rd
) Contract Year during the
Commercial Term but may be given at any time thereafter (including without
limitation during any Extension Period). Upon the second (2 nd ) anniversary of the Emergent Elective Termination Notice, this Agreement shall terminate. | |||
(b) | Elective Termination by Talecris . Talecris may terminate this Agreement by giving at least two (2) years advance Notice (Talecris Elective Termination Notice) to Emergent, which Talecris Elective Termination Notice may not be given prior to the completion of the third (3 rd ) Contract Year during the Commercial Term but may be given at any time thereafter (including without limitation during any Extension Period). If, despite good faith efforts, Emergent is unable to obtain regulatory approval for the manufacture and sale of any alternative Finished Product during the two (2) year notice period commencing upon the date of the Talecris Elective Termination Notice (Termination Notice Period), Emergent may Notify Talecris that Emergent desires for Talecris to continue to Process Finished Product for Emergent. Upon receipt of such Notice, Talecris shall continue to Process Finished Product for Emergent at a price per liter equal to [**] percent ([**]%) of the then-current Processing Fee until such time as Emergent obtains regulatory approval for such alternative Finished Product, provided that (a) Emergent shall continue to use good faith efforts to obtain such regulatory approval during such period of extension of the Termination Notice Period (Termination Extension Period), and (b) the Termination Extension Period shall be no longer than an additional twelve (12) months following the end of the Termination Notice Period. This Agreement shall terminate upon the later of the end of the Termination Notice Period or any Termination Extension Period. | ||
(c) | Mutual Agreement . This Agreement may be terminated by mutual written agreement of the Parties. | ||
(d) | Force Majeure . In the event a Party (Affected Party) continues to experience a Force Majeure condition for a period of at least twelve (12) consecutive months after Notice of the Force Majeure was given pursuant to Section 15.11, the other Party shall be entitled to terminate this Agreement by giving a Notice of termination to the Affected Party at any time while such Force Majeure persists thereafter. | ||
(e) | Supply Failure . Upon the occurrence of a Supply Failure that has not been corrected within [**] from the triggering of the Supply Failure, Emergent shall have the right to terminate this Agreement by giving a Notice of termination to Talecris, such termination to take effect upon delivery of the Notice of termination. | ||
(f) | Material Breach by Emergent . In the event Emergent commits a material breach of this Agreement, Talecris shall be entitled to terminate this Agreement if such breach is not cured within sixty (60) days of Notice from Talecris, in which case the termination shall be effective sixty (60) days after receipt of the Notice; provided, however, that if such breach is incapable of cure within such sixty (60) |
day period, the termination shall be effective upon delivery of the Notice of material breach. | |||
(g) | Material Breach by Talecris . In the event Talecris commits a material breach of this Agreement, Emergent shall be entitled to terminate this Agreement if such breach is not cured within sixty (60) days of Notice from Emergent, in which case the termination shall be effective sixty (60) days after receipt of the Notice; provided, however, that if such breach is incapable of cure within such sixty (60) day period, the termination shall be effective upon delivery of the Notice of material breach. | ||
(h) | Insolvency . Either Party shall be entitled to terminate this Agreement, by giving Notice to the other Party (Insolvent Party), in the event of an Insolvency Event occurring in relation to the Insolvent Party, such termination to take effect upon delivery of the Notice of termination to the Insolvent Party. | ||
(i) | Pre-Commercial Failure . During the Pre-Commercial Term, Emergent shall have the right to terminate this Agreement by Notice to Talecris if Talecris has failed to meet its obligations (i) to perform Start-Up Preparations as set forth in Section 7.02 above; or, (ii) pursuant to Pre-Commercial Target Yield provisions as set forth in Section 4.01(c). Such Notice of termination shall take effect upon delivery of such Notice to Talecris. | ||
(j) | Termination of AIG Program . Emergent shall have the right to terminate this Agreement by Notice to Talecris if (i) Emergents production of AIG Source Plasma or development of AIG or Finished Product is discontinued or terminated for any reason other than for safety concerns, or (ii) Emergent determines in good faith not to file an IND for Finished Product, or the FDA rejects an IND or BLA for Finished Product. Such Notice of termination shall take effect upon delivery of such Notice to Talecris. | ||
(k) | Safety Concerns . Emergent shall have the right to terminate this Agreement by Notice to Talecris if Emergent determines in good faith that the development or commercialization of AIG or Finished Product should be discontinued for safety reasons and the safety problem cannot be resolved by modification of the Product Specifications. Such Notice of termination shall be accompanied by a written statement explaining in reasonable detail such safety concerns, and the basis thereof, and shall take effect upon delivery of such Notice to Talecris. |
10.03 | [Section Intentionally Left Blank] | |
10.04 | Talecris Rights Upon Termination of AIG Program . |
(a) | Termination During Pre-Commercial Term . In the event Emergent terminates this Agreement pursuant to Section 10.02(j) (Termination of AIG Program) or Section 10.02(k) (Safety Concerns) during the Pre-Commercial Term, within thirty (30) days following such termination, Emergent shall pay Talecris the aggregate Processing Fees which would have been payable to Talecris for the |
total amount of Finished Product covered by all Orders that are submitted to Talecris prior to such termination had such termination not occurred. | |||
(b) | Termination During Commercial Term . In the event Emergent terminates this Agreement pursuant to Section 10.02(j) (Termination of AIG Program) or Section 10.02(k) (Safety Concerns) during the Commercial Term, within thirty (30) days following such termination, Emergent shall pay Talecris twice (X2) the aggregate Processing Fees for the Commercial Volume Commitment in effect for the current Contract Year. |
10.05 | Effect of Termination . Except as specifically set forth in this Agreement, all rights and obligations of the Parties shall terminate upon the expiration or termination of this Agreement, provided that such expiration or termination is without prejudice to any accrued rights of the Parties and shall not be construed to release either Party of any obligation matured prior to the effective date of such termination or expiration. | |
10.06 | Survival . Sections 2.04, 3.03, 3.04, 7.09 (and the remainder of Article 7 to the extent any amounts are owed but unpaid), 8.02 and 10.04-10.06, and Articles 1, 11, 12, 13, 14, and 15 shall survive the expiration or termination of this Agreement in accordance with their terms. |
11.01 | Warranty by Talecris . Talecris hereby represents and warrants to Emergent the following: |
(a) | Compliance with Product Specifications . The Finished Product shall have been Processed in accordance with the Product Specifications and cGMP, shall comply with the Product Specifications and cGMP, and shall not be adulterated or misbranded within the meaning of any applicable food and/or drug law or regulation in the Major Markets, all at time of delivery. | ||
(b) | Rights . Talecris has all rights necessary to undertake the activities contemplated under this Agreement. | ||
(c) | Ownership of Talecris Patent Rights . Talecris holds good title to and is the legal and beneficial owner of the Talecris Patent Rights, free and clear of all liens, security interests and other recorded encumbrances of any kind. | ||
(d) | Validity and Enforceability; Non-Infringement . To Talecris knowledge, (i) the Talecris Patent Rights are valid and enforceable, (ii) the Processing of Gamunex to the extent that such Processing is applicable to the Finished Product would not infringe the patent rights or misappropriate the trade secrets of any Third Party, and (iii) no Third Party is infringing any Talecris Patent Rights. | ||
(e) | Investigations . There are no inquiries, actions, investigations or other proceedings pending before or, to the best of Talecris knowledge, threatened by any Regulatory Authority or other governmental agency with respect to any |
Facility or with respect to Gamunex, and Talecris has not received written notice threatening any such inquiry, action or other proceeding. |
11.02 | Warranty by Emergent . Emergent hereby represents and warrants to Talecris the following: |
(a) | AIG Source Plasma . As of the time of delivery of AIG Source Plasma to Talecris hereunder, such AIG Source Plasma shall comply with the AIG Source Plasma Specifications and Applicable Laws (Conforming AIG Source Plasma) and shall not be adulterated or misbranded within the meaning of any applicable food and/or drug law or regulation. If any Non-Conforming AIG Source Plasma is delivered to Talecris hereunder, Emergent shall replace or have replaced such Non-Conforming AIG Source Plasma with Conforming AIG Source Plasma, as reasonably necessary for Talecris to manufacture Finished Product hereunder. For the avoidance of doubt, if any Non-Conforming AIG Source Plasma is delivered to Talecris hereunder and Talecris Processes or has Processed such Non-Conforming AIG Source Plasma in accordance with the terms of this Agreement prior to Talecris becoming aware of such non-conformity, Emergent shall pay for the Processing of such Lot(s) of Non-Conforming AIG Source Plasma. Talecris shall, at Emergents option and cost, either destroy or return to Emergent any unprocessed Non-Conforming AIG Source Plasma. | ||
(b) | Rights . Emergent has all rights to undertake the activities contemplated under this Agreement. | ||
(c) | Investigations . There are no inquiries, actions, investigations or other proceedings pending before or, to the best of Emergents knowledge, threatened by any Regulatory Authority or other governmental agency with respect to Finished Product, and Emergent has not received written notice threatening any such inquiry, action or other proceeding. |
11.03 | Disclaimer of Warranties . The warranties set forth in Sections 11.01 and 11.02 are exclusive and are in lieu of all other warranties, whether written or oral express, implied or statutory. EXCEPT WITH RESPECT TO THE FOREGOING WARRANTY, THERE IS NO WARRANTY OF MERCHANTABILITY, SATISFACTORY QUALITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE GIVEN BY TALECRIS WITH RESPECT TO THE FINISHED PRODUCT OR BY EMERGENT WITH RESPECT TO THE AIG SOURCE PLASMA. | |
11.04 | Remedies for Delivery of Non-Conforming Products or Spoiled AIG Source Plasma . |
(a) | General . In the event that Talecris Processes Non-Conforming Products it shall refund or credit any Processing Fees associated with such Non-Conforming Product resulting from the failure to follow the Process, negligence or willful misconduct in Processing the AIG Source Plasma. For the purpose of this Agreement, failure to follow the Process shall deemed to be negligence. In addition, Emergent shall, at Talecriss option and cost, either return or destroy any |
Non-Conforming Products. Any Non-Conforming Products returned by Emergent pursuant to this Section shall be delivered to Talecris at its Facility. | |||
(b) | Damages for Spoiled AIG Source Plasma . Talecris shall pay Emergent an amount equal to (i) [**] Dollars ($[**]) for each liter of Spoiled AIG Source Plasma resulting from the [**] of Talecris, and (ii) [**] Dollars ($[**]) for each liter of Spoiled AIG Source Plasma resulting from the [**] of Talecris. Spoiled AIG Source Plasma shall mean Conforming AIG Source Plasma which (i) has been Processed but results in Non-Conforming Product, (ii) cannot reasonably be Processed in accordance with Product Specifications and cGMP to produce Finished Product which conforms to the Product Specifications and cGMP, or (iii) is otherwise lost or destroyed. | ||
(c) | Non-Conformance with Emergent Specifications . Notwithstanding anything in the foregoing to the contrary, if Finished Product does not meet the Emergent Specifications, upon receipt of Notification by Emergent of such variance or non-conformance, Talecris shall use Commercially Reasonable Efforts (i) to assist Emergent in investigating the cause of any such variance or non-conformance and (ii) to cure such variance or non-conformance, pursuant to the provisions of Section 8.09. For the avoidance of doubt, in no event shall Talecris be obligated to effect, or undertake efforts to effect a cure under this Section 11.04(c) that would adversely affect the Gamunex Specifications or require the implementation of any changes to Talecris production of Gamunex. | ||
(d) | Remedies Exclusive . Except for Product Liability claims for Finished Product governed by Section 12.03(a), the payments provided for under this Section 11.04 shall be Emergents exclusive remedy, and Talecris sole liability, in connection with Talecris delivery of Non-Conforming Products. |
12.01 | Indemnification In Favor of Emergent . Subject to Section 12.02, Talecris shall defend, indemnify and hold harmless each Emergent Indemnitee from and against any and all Losses for (a) any Claims of Third Parties that arise as a result of a material breach of any covenant, agreement, warranty or representation made by Talecris or any of its Affiliates under this Agreement which causes the Finished Product to not be Processed in accordance with Product Specifications, (b) any Third Party Claims of patent infringement or trade secret misappropriation involving the Processing of the Finished Product, but only to the extent such Third Party Claim is specifically directed to the activities required to meet the Gamunex Specifications, (c) any Claims of Third Parties (including, without limitation, any Product Liability Claims) that arise as a result of the development, manufacture, marketing, promotion, sale, disposition, distribution or other use of By-Products, (d) any Product Liability Claims, or such portion of Product Liability Claims, with respect to Finished Product as are allocated to Talecris pursuant to Section 12.03(a), and (e) any Claims arising from the regulatory, advisory and related services provided by Talecris in connection with this Agreement. Talecris shall not be obligated under this Section 12.01 to the extent it is shown that the Loss was the direct result of a |
material breach of any covenant, warranty or representation made by Emergent under this
Agreement. Except with respect to the indemnification of any Claim covered by clause (b) or
(c) above, the indemnity in this Section 12.01 shall be limited to the greater of the (i)
Processing Fees paid by Emergent during the twelve (12) months prior to the date the Claim
arose, (ii) the Commercial Volume Commitment for the Contract Year during which such Claim
arose, or (iii) the Firm Commitment for the Contract Year during which such Claim arose.
12.02
Indemnification In Favor of Talecris
. Emergent shall defend, indemnify and hold
harmless each Talecris Indemnitee from and against any and all Losses for (a) any Claims of
Third Parties that arise as a result of a material breach of any covenant, agreement, warranty
or representation made by Emergent under this Agreement, (b) any Claims of Third Parties of
patent infringement or trade secret misappropriation involving the Processing or Sale of the
Finished Product and which is not specifically directed to the activities required to meet the
Gamunex Specifications, and (c) any Product Liability Claims, or such portion of Product
Liability Claims, with respect to Finished Product as are allocated to Emergent pursuant to
Section 12.03(b). Emergent shall not be obligated under this Section 12.02 to the extent it
is shown that the Loss was the direct result of a material breach of any covenant, warranty or
representation made by Talecris under this Agreement.
12.03
Product Liability Claims
. Notwithstanding the foregoing Sections 12.01 and 12.02,
the Parties responsibilities with respect to Product Liability Claims for Finished Product
shall be governed by this Section 12.03.
(a)
Talecris Liability
. Talecris shall be solely responsible for all
Product Liability Claims that arise out of Non-Conforming Product where such
nonconformance (i) arose from Talecris failure to Process Finished Product in
accordance with Product Specifications or cGMP, and (ii) existed at the time the
Finished Product was delivered by Talecris; provided, however, that Talecris liability
for such Product Liability Claims shall be limited to the greater of the (A) Processing
Fees paid by Emergent during the twelve (12) months prior to the date the Claim arose,
(B) the Commercial Volume Commitment for the Contract Year during which such Claim
arose, or (C) the Firm Commitment for the Contract Year during which such Claim arose.
(b)
Emergents Liability
. Emergent shall be solely responsible for all
Product Liability Claims other than those for which responsibility was allocated to
Talecris pursuant to Section 12.03(a).
(c)
Responsibility for Settlement and Defense
. The Parties shall jointly
defend and settle any Product Liability Claim with respect to the Finished Product.
Notwithstanding the foregoing, at such time that Talecris reasonably determines in good
faith that there is a reasonable likelihood that a Product Liability Claim could have a
material negative affect on Gamunex, then Talecris, shall have the right, but not the
obligation, to assume the sole defense of such Product Liability Claim.
(d) | Procedure . Each Party shall consult with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, and the Parties shall cooperate fully with each other in connection therewith. To facilitate the defense of any Product Liability Claim, the Parties shall mutually select a law firm to represent them in the joint defense of such claim as soon as practicable following the Effective Date of this Agreement. In furtherance of the Parties cooperation, the Parties will consult with each other regarding strategic decisions, including without limitation the changing of counsel and defense of each Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably conditioned, withheld or delayed. All damages and expenses (including attorneys fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Sections 12.03(a) and 12.03(b). |
12.04 | Notice . Should any claim arise which could reasonably be expected to lead to a claim for indemnification, the Party seeking indemnification (the Indemnified Party) shall promptly Notify the other Party (the Indemnifying Party) of the claim and the facts constituting the basis for such claim. The omission of such Notice shall not relieve either Party from its indemnification obligations under this Article 12, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. | |
12.05 | Indemnification Not Sole Remedy . Each Party hereby acknowledges that the indemnification provided for under this Article 12 shall in no manner limit, restrict or prohibit (unless liability is otherwise expressly limited by the terms of this Agreement) either Party from seeking any recovery or remedy provided at law or in equity from the other Party in connection with any breach or default by such other Party of any representation, warranty or covenant hereunder. | |
12.06 | Guarantor . Parent agrees to act as a third party guarantor (Guarantor) of Emergent for the indemnities provided by Emergent to Talecris under this Article 12 and the payment obligations of Emergent set forth in Section 7.05(a). Upon Emergents default of its indemnity obligations hereunder or its payment obligations set forth in Section 7.05(a), Guarantor agrees to guarantee such obligation as its own. Guarantor agrees that no amendment, termination or other release, other than Talecris expressly releasing Guarantor in writing, shall in any way alleviate its obligations under this Section 12.06 and Guarantor hereby waives any notice of any such amendment, termination or other release. Guarantor hereby agrees to give written notice to Talecris within ten (10) days of: (i) any notice received or action filed alleging the insolvency or bankruptcy of Guarantor; (ii) any notice received or action filed alleging the insolvency or bankruptcy of Emergent; or (iii) any other event which would otherwise reasonably prevent Guarantor from fulfilling its obligations under this Section 12.06. |
14.01 | Dispute Resolution Procedures . Except for matters to be resolved pursuant to Sections 4.01(c)(v)(B), 5.02(d) or 9.03, any dispute arising out of, relating to, or having any connection with this Agreement (including any question relating to its existence, validity, interpretation, performance, or termination) (Dispute) shall be resolved pursuant to the procedures set forth in this Article. If either Party fails to observe the procedures of this Article, as may be modified by the written agreement of the Parties, the other Party may bring an action for specific performance. |
(a) | Negotiation . In the event of a Dispute, the affected Party shall notify the other Party of the Dispute in writing, and the Parties shall negotiate in good faith, for a period of thirty (30) days (or such longer period as may be agreed by the Parties) from the issuance of the Notice (the Notice Date), to resolve the Dispute without the intervention of a neutral party or a court. |
(b) | Mediation . If the Dispute remains unresolved within sixty (60) days after the Notice Date, either Party may request that the Parties submit the Dispute to non-binding mediation before a mutually acceptable neutral mediator by sending written Notice to the other Party. If the other Party agrees to mediate, the Parties shall attempt to resolve the Dispute through mediation until one of the following occurs: (i) the Parties reach a written settlement; (ii) the mediator notifies the Parties in writing that they have reached an impasse; (iii) the Parties agree in writing that they have reached an impasse; or (iv) the Parties have not reached a settlement within one hundred twenty (120) days after the Notice Date. | ||
(c) | Litigation . If the Parties fail to resolve the Dispute through mediation, or if the Dispute is, in any event, not resolved within one hundred eighty (180) days after the Notice Date, each Party shall have the right to pursue any other remedies legally available to resolve the Dispute. | ||
(d) | Statute of Limitations . The Parties agree that all applicable statutes of limitation and time-based defenses (such as estoppel and laches) shall be tolled while the procedures set forth in Sections 14.01(a) and 14.01(b) are pending. The Parties shall take any actions necessary to effectuate this result. |
14.02 | Other Rights . |
(a) | Exception for Additional Disputes . In the event that the Parties are involved in ongoing litigation of one or more Disputes that already have been through the dispute resolution process set forth in Sections 14.01(a)(c), the Parties are not required to submit additional Disputes to negotiations pursuant to Section 14.01(b), as long as that litigation remains pending. | ||
(b) | Provisional Remedies . Notwithstanding the dispute resolution procedures described above, either Party may seek a preliminary injunction or other provisional equitable relief if, in its reasonable judgment, such action is necessary to avoid irreparable harm. | ||
(c) | Termination . For the avoidance of doubt, nothing in this Article shall preclude, interfere with or modify either Partys rights under Article 10 with respect to the termination of this Agreement. |
14.03 | Governing Law . This Agreement and any and all matters arising directly or indirectly herefrom shall be governed by and construed and enforced in accordance with the laws of the United States and the internal laws of the State of New York, without regard to conflicts of law principles. |
15.01 | Notice . Notices and other communications (each, a Notice) provided herein shall be in writing and shall be delivered by hand or overnight courier service, mailed or sent by facsimile (with receipt confirmed) as follows: |
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If to Emergent , to: | |
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Emergent Product Development Gaithersburg Inc. | |
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300 Professional Drive | |
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Gaithersburg, MD 20879 | |
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Attn: General Counsel | |
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or | |
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Attn: Accounts Payable (for invoices only) | |
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with copies (except as to invoices), which shall not constitute notice hereunder, sent to: | |
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Wilmer Cutler Pickering Hale and Dorr LLP | |
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1899 Pennsylvania Avenue, NW | |
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Washington, DC 20006 | |
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Facsimile: (202) 663-6363 | |
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Attn: Van W. Ellis | |
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If to Talecris , to: | |
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Talecris BioTherapeutics, Inc. | |
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79 T.W. Alexander Drive | |
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4101 Research Commons | |
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PO Box 13887 | |
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Research Triangle Park | |
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North Carolina 27709 | |
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Attn: VP of Law, General Counsel |
All Notices and other communications given to any Party in accordance with the provisions of this Agreement shall be deemed to have been given on the date of receipt if delivered by hand or overnight courier services or sent by facsimile (with receipt confirmed by telephone or by facsimile machine), or on the date five (5) Business Days after dispatch by certified or registered mail (postage prepaid) if mailed, in each case delivered, sent or mailed (property addressed) to such Party at its address as set forth in this Section 15.01, or to such other address that such Party may have Notified to the other Party from time to time. | ||
15.02 | Entire Agreement . This Agreement and the Exclusivity Agreement (including all attachments hereto and thereto) constitute the entire agreement among the Parties with respect to the matters set forth herein, and supersede all prior agreements and understandings, both written and oral, among the Parties with respect thereto, including without limitation the Letter of Intent, dated as of April 5, 2006 (as amended), between the Parties. In the event of any conflict or discrepancy between the terms of the Quality Agreement or the Exclusivity Agreement and this Agreement, the terms of this Agreement shall control. |
15.03
Covenant of Further Assurances
. The Parties covenant and agree that, subsequent to
the execution and delivery of this Agreement and without any additional consideration, each of
the Parties shall execute and deliver any further legal instruments and perform such acts
which are or may become reasonably necessary to effectuate the purposes of this Agreement.
15.04
Waivers; Amendment
. The failure of either Party to insist, in any one or more
instances, upon the performance of any of the terms, covenants or conditions of this Agreement
or to exercise any right hereunder, shall not be construed as a waiver or relinquishment of
the future performance of any such term, covenant or conditions or the future exercise of such
right, and the obligation of the other Party with respect to such future performance shall
continue in full force and effect. No item or provision of this Agreement may be altered,
amended or waived except by a writing signed by both Parties.
15.05
Relationship
. Talecris is an independent contractor engaged by Emergent for the
provision of the Finished Product. Nothing in this Agreement shall constitute Talecris as an
employee, agent or general representative of Emergent. This Agreement shall not constitute
either Party as the legal representative or agent of the other, nor shall either Party have
the right or authority to assume, create or incur any liability or any obligation of any kind,
express or implied, against, or in the name of or on behalf of, the other Party. This
Agreement shall not constitute, create or in any way be interpreted as a joint venture,
partnership or formal business organization of any kind.
15.06
Publicity
. Except as otherwise required by Applicable Law, neither Party shall use
the others name or refer to it directly or indirectly in an advertisement, news release or
release to any professional or trade publication or issue any news release relating to this
Agreement, without the prior written approval from such Party for such use or release, which
approval shall not be unreasonably withheld, conditioned or delayed. The Parties agree that a
news release with respect to the consummation of this transaction and the details thereof will
be made, the content, form and timing of which shall be reasonably agreed between the Parties.
15.07
Severability
. If, under Applicable Law, any provision of this Agreement is invalid
or unenforceable, or otherwise directly or indirectly affects the validity of any other
material provision(s) of this Agreement (such invalid or unenforceable provision, a Severed
Clause), this Agreement shall endure except for the Severed Clause. The Parties shall
consult one another and use Commercially Reasonable Efforts to agree upon a valid and
enforceable provision that is a reasonable substitute for the Severed Clause in view of the
intent of this Agreement.
15.08
Assignment
. This Agreement may not be assigned by either Party without the prior
written consent of the other Party; provided, however, that either Party may assign its right
to receive payment hereunder without prior consent of the other Party, but provided it
Notifies such other Party of such assignment within three (3) Business Days. In addition,
either Party may assign this Agreement, without the other Partys prior written consent, to
any Affiliate or in connection with an acquisition, merger or sale of all or substantially all
of the stock, assets or business to which this Agreement pertains.
15.09
Subcontracting
. Talecris shall not subcontract or otherwise delegate any of its
obligations under this Agreement, either to an Affiliate or a Third Party, if such
subcontracting or delegation would require the manufacturing of additional Validation Lots for
Finished Product. If such subcontracting or delegation would not require the manufacturing of
additional Validation Lots of Finished Product, Talecris may subcontract or delegate any of
its obligations hereunder to an Affiliate or Third Party, provided, that (a) Talecris Notifies
Emergent of such proposed subcontracting arrangement, including without limitation the
identity of the proposed subcontractor, the location of such proposed subcontractors
facilities, and a reasonably detailed description of the terms of such proposed subcontracting
arrangement as it relates to the Finished Product, (b) Talecris procures for Emergent a
reasonable opportunity to conduct a quality audit of the facilities proposed to be used by
such proposed subcontractor in performing its obligations with respect to Finished Product, at
a time reasonably satisfactory to Emergent, (c) Talecris guarantees to Emergent the
performance of any of its obligations which it fulfills through such subcontracting and
remains primarily liable for the performance of such obligations, and (d) Talecris obtains
Emergents prior written consent, which shall not be unreasonably withheld, conditioned or
delayed. Talecris shall bear all costs associated with or arising as a result of any such
permitted subcontracting by Talecris (including, without limitation, costs associated with any
regulatory filings which may be required to be submitted to any Regulatory Authorities with
respect to Finished Product), and shall reimburse Emergent for such costs to the extent
incurred by Emergent.
15.10
Headings
. The headings used in this Agreement are included for convenience only and
are not to be used in construing or interpreting this Agreement.
15.11
Force Majeure
. Subject to Section 10.02(d), if either Party is impeded in
fulfilling its undertakings in accordance with this Agreement by circumstances beyond its
reasonable control, such as, but not limited to, labor conflict, lightening striking, acts of
God, fire, war, mobilization or unforeseen military call-up of a large magnitude, requisition,
confiscation, commandeering, public decrees, riots, insurrections, terrorism, general shortage
of transport, goods or energy, and faults or delays in deliveries from subcontractor or
suppliers caused by any circumstances referred to in this Section 15.11, the impediment shall
be considered a Force Majeure condition and the Party shall be exempted from liability for
delays due to such reasons; provided, however, that it Notifies the other Party thereof
without undue delay after such a circumstance has occurred. Upon such Notice, the Parties
shall agree upon a reasonable extension of the time for performance, not to exceed an
extension equal to the period the Force Majeure condition continues to exist.
15.12
Counterparts
. This Agreement may be executed in any number of counterparts, each of
which will be deemed an original, but all of which together will constitute one and same
instrument.
15.13
LIMITATION OF DAMAGES
. EXCEPT WITH RESPECT TO A PARTYS INDEMNIFICATION OBLIGATIONS
UNDER ARTICLE 12 HEREUNDER OR A BREACH OF A PARTYS CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE
13, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY, AND EACH PARTY SHALL PROCURE THAT NONE OF ITS AFFILIATES SHALL MAKE ANY CLAIM AGAINST THE OTHER PARTY (OR ITS AFFILIATES) FOR ANY LOST PROFITS, LOSS OF BUSINESS, LOSS OF CONTRACTS, DIMINISHED GOODWILL, DIMINISHED REPUTATION, OR CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE OR OTHER INDIRECT DAMAGES ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT, THE AIG, THE FINISHED PRODUCT AND/OR THE PROCESSING OF FINISHED PRODUCT. | ||
15.14 | Talecris Limitation on Liability . To the fullest extent permitted by law, and except as otherwise expressly provided in this Agreement in Section 12.01 (b) and (c) and Third Party Claims relating to Gamunex ® Products, Talecris aggregate liability for any and all Claims, losses, costs or damages whatsoever arising out of or resulting from or in any way related to the Processing or this Agreement from any cause or causes, including but not limited to the negligence, strict liability, breach of contract or warranty (express or implied) of Talecris or Talecris officers, directors, employees, agents or consultants shall be limited to the greater of the (i) Processing Fees paid by Emergent during the twelve (12) months prior to the date the Claim, loss, cost, or damage arose, (ii) the Commercial Volume Commitment for the Contract Year during which such Claim, loss, cost or damage arose, or (iii) the Firm Commitment for the Contract Year during which such Claim, loss, cost or damage arose. | |
15.15 | Exhibits . In the event that an Exhibit referenced herein is not completed by the Effective Date, such Exhibit shall be completed as soon as practicable following the Effective Date, but no later than forty-five (45) days thereafter, and upon approval in writing by both Parties, shall be attached hereto. |
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By:
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/s/ R. Don Elsey
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Name: R. Don Elsey | |||
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Title: Treasurer |
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By:
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/s/ Alberto Martinez
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Name: Alberto Martinez | |||
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Title: President and CEO |
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By:
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/s/ Daniel J. Abdun-Nabi
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Name: Daniel J. Abdun-Nabi | |||
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Title: Sr. V.P. and General Counsel |
Test | Specification | |
Protein concentration
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[**] | |
Appearance: color
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[**] | |
Appearance: clarity
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[**] | |
Caprylate concentration
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[**] | |
Anticomplement Activity
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[**] | |
Anti-A
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[**] | |
Anti-B
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[**] | |
pH (1% protein solution)
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[**] | |
Glycine concentration
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[**] | |
Protein composition (CZE)
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[**] | |
MW Distribution: Aggregate
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[**] | |
MW Distribution: Monomer + Dimer
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[**] | |
MW Distribution: Fragment
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[**] | |
Prekallikrein activator
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[**] | |
Sterility USP
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[**] | |
Pyrogen USP
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[**] | |
General Safety Testing
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[**] |
Test
Specification
[**]
[**]
Inventors:
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Alred; Patricia (Fredrick, MD); Cook; Scott A. | |
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(Apex, NC); Lebing; Wytold R. (Clayton, NC); Lee; | |
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Douglas C. (Raleigh, NC); Paul; Hanns-Ingolf | |
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(Leverkusen, DE); Radtke; Klaus-Peter (Apex, NC) | |
Assignee:
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Bayer Healthcare LLC (Tarrytown, NY) | |
Appl. No.:
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270918 | |
Filed:
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October 15, 2002 |
Inventors:
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Lebing; Wytold (Clayton, NC); Alred; Patricia (New Market, MD); | |
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Lee; Douglas C. (Apex, NC); Paul; Hanns-Ingolf (Cary, NC) | |
Assignee:
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Bayer Corporation Incorporated (Indiana, PA) | |
Appl. No.:
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270724 | |
Filed:
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March 17, 1999 |
Inventors:
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Lebing; Wytold R. (1304 Pine Trail, Clayton, NC 27520-9324); | |
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Alred; Patricia (9890 Washington Blvd. Apt. 404, Gaithersberg, | |
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MD 20878); Lee; Doug C. (116 Altair Cir., Apex, NC 27502); Paul; | |
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Hanns-Ingolf (1107 Queenferry Rd., Cary, NC 27511) | |
Assignee:
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[ ] | |
Appl. No.:
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879362 | |
Filed:
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June 20, 1997 |
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8368 U.S. 70 West | |
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Clayton, NC 27520 | |
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David Sorrell | |
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Senior Contract Manager | |
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Tel: 919.359.7094 | |
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Fax: 919.359.7174 | |
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david.sorrell@talecris.com |
1. | Purchase Specification Source Plasma Anthrax (AX), Revision New, SAP # 08937351, Effective Date: 6/14/2006 | ||
2. | SOP Plasma Supplier Supplemental Directions, Revision 12, SOP # CS-000-BE-053, Effective Date: 03/31/2006 | ||
3. | Purchase Specification General Specification Source Plasma, Revision 23, Effective Date: 03/31/2006 |
/s/ David M. Sorrell
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Contract Manager
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Talecris
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PURCHASE SPECIFICATION | SAP MATERIAL #: 08937351 | ||
BIOTHERAPEUTICS
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REVISION: NEW | |||
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TITLE: SOURCE PLASMA ANTHRAX (AX) | PAGE 1 of 2 |
/s/ Amy W. Durham | 6-12-06 | /s/ John W. Parrish | 6-12-2006 | |||
Document Owner | Date | Quality Approver | Date |
Supercedes:
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N/A | Date Effective: | JUN 14 2006 | |||
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1. | PURPOSE |
1.1. | To describe specific requirements, in addition to those described in the Source Plasma, General Specification, for Source Plasma Anthrax. |
2. | REFERENCE(S) |
2.1. | Source Plasma General Specification | ||
2.2. | CS-000-BE-053, Plasma Supplier Supplemental Directions | ||
2.3. | CS-000-BH-010, Supplier Quality Notification, Evaluation and Approval of Plasma Suppliers and Service Providers |
3. | DEFINITIONS |
3.1. | Source Plasma Type Anthrax (AX) - Refers to plasma collected by approved plasmapheresis method from donors with naturally occurring or artificially stimulated antibody levels for Anthrax. | ||
3.2. | SQID Supplier Quality Information Database - Database maintained by Talecris Supplier Quality that contains pertinent information and current status of each collection facility, test laboratory, and plasma transportation carriers. |
4. | GENERAL REQUIREMENTS |
4.1. | Plasma collection must be in approved bottles only. | ||
4.2. | Plasma collection is non-EU approved only. |
5. | SPECIAL REQUIREMENTS |
5.1. | Emergent BioSolutions is the purchaser of the [**] Anthrax (AX) plasma. Emergent is responsible for contracts with the individual plasma suppliers of the AX plasma and ensuring that these plasma centers and product meet the requirements listed in this specification and in the Source Plasma, General Specification for Source Plasma. Moreover, Emergent is responsible for the transport of the plasma to Talecris receiving dock. | ||
5.2. | The plasma donor centers supplying the AX plasma must also be on the Talecris approved centers listing in the SQID, as well as the testing labs associated with the plasma testing. | ||
5.3. | The AX plasma under this material number will be processed together to form a manufacturing pool, as modeled by Talecris. Only [**] will be further processed from an AX pool. The [**] will be further manufactured into IGIV-C product. |
Talecris
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PURCHASE SPECIFICATION | SAP MATERIAL #: 08937351 | ||
BIOTHERAPEUTICS
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REVISION: NEW | |||
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TITLE: SOURCE PLASMA ANTHRAX (AX) | PAGE 2 of 2 |
5.4. | Plasma from donors identified with [**] Anthrax or AX antibodies (as judged by Emergent) may be designated as AX plasma. |
6. | NAT TESTING REQUIREMENTS |
6.1. | The following chart lists the required NAT testing and the material numbers for Anthrax high titer plasma. Note: Only plasma tested for HCV, HIV-1, HBV and Parvo B19 by NAT is acceptable to ship to Talecris. |
SAP (Required) | ||||||||||||||||||||||||
Material | EU | HCV by | HIV-1 by | Parvo B-19 by | ||||||||||||||||||||
Numbers | ELIGIBLE | NAT | NAT | HBV by NAT | NAT | Bottles | ||||||||||||||||||
08937351
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X | X | X | X | Bottles |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 1 of 13 |
/s/ Amy W. Durham | 2-28-06 | /s/ John W. Parrish | 2-28-2006 | |||
Document Owner | Date | Quality Approver | Date |
Supercedes:
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CS-000-AR-107 | Effective Date: | MAR 31 2006 | |||
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1. | PURPOSE |
1.1. | This document outlines specific directions that supplement the minimum requirements listed in the Talecris General Specification Source Plasma. |
2. | SCOPE |
2.1. | These directions are applicable to all plasma that is procured and designated for shipment to Talecris. | ||
2.2. | This document is to be used by plasma suppliers that sell plasma to Talecris. | ||
2.3. | This SOP is distributed by Clayton QO-Plasma to all Talecris Plasma Operations Account Managers. | ||
2.4. | This SOP contains Talecris-required NDP and Packing List Summary forms that are completed by plasma centers for shipments to Talecris. Changes to these forms must be documented through a revision of this SOP. |
3. | RESPONSIBILITY |
3.1. | Talecris QO-Plasma: |
3.1.1. | Communicates to plasma suppliers and appropriate Talecris departments (e.g., Plasma Ops, QO Compliance) any quality issues (discrepancies) with received product. |
3.2. | Talecris Plasma Operations Account Manager monitors plasma suppliers compliance and adherence to regulatory agency requirements and to the Talecris General Specification Source Plasma. |
3.2.1. | Provides supplier with most current revisions of this document, associated forms, and other SOPs/specifications. | ||
3.2.2. | May initiate changes to this SOP and other plasma supplier documents and participates in the review process of revisions. |
3.3. | Plasma Supplier assures that all conditions of the General Specification - Source Plasma and supply contract are met. | ||
3.4. | Talecris Plasma Operations Technical Services Manager approves the use of specific plasma collection materials and supplies, all packaging and shipping materials, samples tubes, labels and bar code systems used by suppliers. Successful completion of materials clearance testing is required prior to approval for all specific plasma collection and supply materials. These functions may be performed by the Talecris Plasma Operations Account Managers in the absence of the Technical Services Manager. |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 2 of 13 |
3.5. | Talecris QO Manager, Supplier Quality determines and communicates all changes in plasma supplier status and/or services to Talecris, and maintains the appropriate documentation files for status of suppliers, collection and testing facilities. | ||
3.6. | Talecris, Regulatory Affairs coordinates implementation of any new regulatory requirements. | ||
3.7. | Talecris Plasma Receiving receives all incoming plasma shipments and handles all correspondence related to inventory control. | ||
3.8. | QO Document Management, Clayton, maintains and revises the NDP and PLS forms as requested. |
4. | REFERENCES |
4.1. | CS-000-BE-057 Supplier Quality Method For Evaluating The Suitability Of Source Plasma Collection Facilities And Test Laboratories | ||
4.2. | Talecris General Specification Source Plasma |
5. | DEFINITIONS |
5.1. | ITS: Incident Tracking System. Used by Talecris to track discrepancy reports for plasma not yet processed (RMRs) and only impacting processed material (ITS). | ||
5.2. | NDP: Notification for Destruction of Plasma form. Submitted to Talecris in the event plasma unit removal or disposition is required. | ||
5.3. | NDDR: National Donor Deferral Registry | ||
5.4. | QO-Plasma: Quality Operations Plasma Business Unit | ||
5.5. | PPL: Plasma Packing List for individual plasma cases | ||
5.6. | PLS: Packing List Summary form. Separate PLS forms are submitted for each vendor batch number. | ||
5.7. | RMR: Raw Material Report. A report used to document discrepancies against plasma not yet processed (pooled). | ||
5.8. | RTL: Talecris Raleigh Test Lab | ||
5.9. | SAP Material Number: The SAP material number replaces the plasma item number. The SAP material number (referred to as plasma material number) identifies the plasma type, collection in bottles, level of testing, and whether or not the plasma is EU eligible. | ||
5.10. | Vendor Batch Number: Identifies the shipment, to Talecris. The vendor batch number is a unique identifier that is NEVER duplicated at the same center. Whenever a shipment comprises more than one plasma type, a unique vendor batch number must be assigned to each plasma type within the shipment. The first four (4) characters of the Vendor Batch Number must be the donor centers NDDR number. | ||
5.11. | Working Day: Any scheduled workday. |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 3 of 13 |
6. | REQUIREMENTS |
6.1. | Materials/Reagents Refer to Talecris General Specification | ||
6.2. | Equipment Refer to Talecris General Specification | ||
6.3. | Frequency |
6.3.1. | This procedure is to be used to verify each shipment of plasma sent to Talecris complies with all applicable regulatory requirements, Talecris General Specification Source Plasma, and any plasma material-number-specific Talecris plasma specifications. | ||
6.3.2. | Copies of this SOP are sent to Plasma Operations Account Managers each time this SOP is revised. From the date this SOP is approved, the effective date will be stamped one month in advance and sent to plasma suppliers to conduct training. | ||
6.3.3. | Master copies of NDP and PLS forms are sent to Plasma Operations Account Managers each time the forms are modified. |
7. | PROCEDURE |
7.1. | Vendor Approval |
7.1.1. | Talecris must approve each plasma collection, testing, storage and transport establishment prior to shipment of plasma. This approval is documented internally at Talecris in accordance with CS-000-BE-057 and externally in written correspondence to the plasma supplier. |
7.2. | Plasma Identification |
7.2.1. | A Talecris-approved bar code labeling system must be used to generate all labels used for plasma donor, unit, sample, and case identification. Talecris provides appropriate scan sheets for use with the Sigma Bar Code Printer System. Alternate bar-coding systems are acceptable for use if approved, in writing, by Talecris Plasma Operations Technical Services Manager. | ||
7.2.2. | Correct plasma material number assignment is critical to Talecris receipt and manufacturing operations. Usage decisions and traceability of plasma is dependent on plasma material numbers. The plasma material number identifies the plasma type, that the plasma is collected in bottles, the testing level of the plasma, and EU approval status. Refer to Talecris General Specification - Source Plasma for required plasma material number legend. | ||
7.2.3. | A unique vendor batch number must be assigned to each plasma type within the shipment. |
a. | The unique vendor batch number for the shipment must be for only one center (combining plasma units from different centers in one case is unacceptable). |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 4 of 13 |
7.3. | Plasma Unit Documentation and Error Correction of PPL |
7.3.1. | Record Keeping | ||
Adhere to the following instructions when making entries or correcting errors on packing lists and other records that are sent to Talecris: |
a. | Make all entries on all documents in permanent, indelible black or blue ink. | ||
b. | It is unacceptable to use felt-tipped or gel pens on documents sent to Talecris. | ||
c. | All entries on all documents and photocopies must be legible. | ||
d. | If a space is inappropriate for a given step, enter N/A (Not Applicable). If a space becomes inappropriate due to special circumstances, enter N/A and a brief explanation. A diagonal line may be used across unused spaces. All entries must be initialed and dated. | ||
e. | When a copy is sent as documentation, it must bear the statement, This is a true and accurate copy of the original. The statement must be initialed and dated by center management. |
NOTE : | If the entire packing list is a copy, one stamp on the PLS is adequate. If subsequent changes are made on plasma units or cases, the affected pages must be stamped, initialed, and dated. |
f. | Use of liquid paper, white out, or any similar material that obliterates errors is unacceptable. | ||
g. | Application of one plasma unit control number label over another is unacceptable. |
7.3.2. | Removal of a Plasma Unit |
a. | When a plasma unit is removed from a case, two initials and the date of action are required on the PPL to verify that the unit has been removed. Talecris QO Plasma may approve, in writing, an alternate documentation method for unit removal. |
7.3.3. | Error Correction |
a. | Draw a single line through the error so that the words (or figures, etc.) can still be read. Initial and date line out. Rewrite correct information. | ||
b. | If a plasma unit is lined out in error, it is not acceptable to Talecris. For Talecris to accept such a plasma unit, all correct unit information must be re-entered on the PPL with a detailed explanation of why the line out occurred. Comment must also be initialed and dated. |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 5 of 13 |
7.4. | Unacceptable Plasma Units |
7.4.1. | Plasma units that test positive, reactive, or elevated for any of the required tests must not be shipped to Talecris. Actions to be taken and lookback requirements must be followed as outlined in Talecris General Specification Source Plasma, Appendix A, Table of Actions. | ||
7.4.2. | If in error, a viral marker reactive or NAT reactive unit is shipped to Talecris or unit from a donor diagnosed with CJD/vCJD is shipped to Talecris, immediately forward the NDP by fax to 919-359-4428. Additionally, phone the Talecris QO Plasma Supervisor at 919-359-4581 to initiate unit trace. | ||
7.4.3. | Plasma units with unacceptably high hemoglobin concentrations must not be shipped to Talecris. Evaluate hemoglobin concentration at time of collection using the Talecris Hemoglobin Comparator by following the instructions for use printed on the card. Note that the color comparison must be performed against the well-mixed, liquid contents of the plasma collection bottle prior to freezing. |
7.5. | Notification for Destruction of Plasma (NDP) |
7.5.1. | As detailed in the Talecris General Specification- Source Plasma, Appendix A Table of Actions, following receipt of a repeat reactive test result or valid post-donation information, complete the plasma center entries on the NDP form for notification to Talecris of needed unit destruction. It is critical for unit traceability at Talecris that all Plasma Item or SAP material numbers reported on the NDP form reflect the actual Plasma Item or SAP material numbers under which the plasma was shipped. Due to added NAT level testing, Plasma Item and SAP material numbers have changed over time. | ||
7.5.2. | Concerning instances of owner transfer of plasma centers, the NDDR and Talecris center code reported on the NDP sent to Talecris must reflect the NDDR/center code at the time of unit collection (not at time of reporting). | ||
7.5.3. | The NDP must be faxed to Clayton Plasma Receiving within 3 working days upon receipt of a reactive or positive test result for a donor from whom prior or subsequent units have been shipped to Talecris (lookbacks). Reference the Talecris fax number on the NDP form. | ||
7.5.4. | The NDP must be faxed to Clayton Plasma Receiving within 1 working day of notification of Post Donation Information resulting in product recalls or seizure concerning units shipped to Talecris. Reference the Talecris fax number on the NDP form. | ||
7.5.5. | The NDP must be faxed to Clayton Plasma Receiving within a timely manner for Post Donation Information (PDI) not resulting in a seizure or recall (example: tattoo, body piercing, high risk). Reference the Talecris fax number on the NDP form. |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 6 of 13 |
7.5.6. | For any reason other than viral marker lookback, record reason as Other status in Section 3 of the NDP form and provide a detailed explanation. An example of Other unacceptable plasma is plasma from donors with valid post-donation information that would make them unacceptable donors; Public Health Notifications; plasma involved in plasma shipping errors, etc. Complete information is needed by Talecris to evaluate the status of plasma pools that contain units with any post-donation information except lookback plasma units. If necessary, use an additional sheet of paper identified by Center Code/NDDR and Donor Number. | ||
7.5.7. | Enter date the reactive test result, or other information, was received by the plasma center in Section 4 of the NDP form. | ||
7.5.8. | Complete only one NDP per donor, even if the donor is reactive for more than one test. Use the longest lookback period as defined in the Table of Actions. | ||
7.5.9. | Within one working day of receipt of a NDP, Clayton will fax a partially completed copy of the NDP, confirming receipt of NDP, to the fax number (plasma center or corporate office) entered in Step 6 of the form. If the fax is not received, contact Plasma Receiving, Talecris, Clayton (919-359-4444). | ||
Clayton will only fax a completed dispositioned copy of the NDP for notifications marked Recall. It may take several months for plasma suppliers to receive the completed, dispositioned copy of the NDP from Talecris due to the plasma inventory hold periods. | |||
7.5.10. | In the event that a change has to be made to an original NDP that has already been sent to Clayton Lookback, the plasma supplier must stamp or write Revision and clearly indicate by circling the change(s) and/or addition(s) made that differ from the data reported on the original NDP before re-sending to Clayton Lookback. A date and initials must accompany these changes, additions, and/or comments. Any alternative method for error correction to original NDPs must be pre-approved by Talecris (example: brackets). |
7.6. | Plasma Packaging |
7.6.1. | Talecris requires all U.S. source plasma to be collected and shipped in approved bottles for receipt. |
a. | Remove all rubber bands or tape prior to placing unfrozen plasma units in freezer. | ||
b. | Store filled cases in a freezer operating at -20°C or colder until time of shipment. | ||
c. | The plasma case must be pre-approved, in writing, by Talecris Manager of Technical Services or designated Talecris Plasma Operations Account Managers with input from Talecris QO and Supply Chain groups. | ||
d. | The plasma case must have any softgoods labeling information either crossed out or only the plasma case label visible. |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 7 of 13 |
e. | Line the case with a polyethylene liner of at least 1.3 mil thickness that has been inspected for tears prior to placing into the case. The liner selected must permit closure of the filled case without bulging or tearing. Do not use twist ties to close the liner. | ||
f. | The maximum acceptable volume of Normal plasma to be shipped to Talecris in a vendor batch number is 3,700 Liters. | ||
g. | Targeted volume of plasma to be shipped to Talecris in a vendor batch number is 1,840 Liters. | ||
h. | Targeted minimum volume of plasma to be shipped to Talecris in a vendor batch number is 90 liters. Talecris Plasma Operations Account Manager must be notified for any vendor batch number less than 90 liters prior to shipment. | ||
i. | Plasma units with less than 200 mL are unacceptable to Talecris. | ||
j. | Plasma units from individual donors must not be shipped to Talecris out of collection sequence. |
7.6.2. | Two plasma supplier employees must participate in packing plasma units into the case, one employee performing the task and the other verifying the correct units are being packed and the correct labels have been applied. Each participating employees initials are required on the Plasma Packing List. |
a. | Alternatively, automated electronic verification may be used; in which case one persons initials must appear on the Plasma Packing List verifying correct packing and labeling. | ||
b. | Only if a Plasma Center has one employee can packing and manual verification be performed and initialed by one person. |
7.6.3. | When using the Sigma Bar Code Printer System apply a vendor batch number sticker and a SAP case number sticker on the plasma shipper label, in spaces adjacent to each hand-written entry. | ||
7.6.4. | Prior to use each day, verify the Sigma label printer/scanner against the Daily Start up Label Set. Create all three donation labels from the Daily Start up Label Set scan menu, and compare to the sample labels provided on the menu. Document results on a Daily Start up Scanner/Printer Test Record or equivalent. Deface and discard test labels. |
a. | Alignment of the label stock should be monitored throughout the day to ensure that the white spaces (quiet zones) on each side of the barcode are no less than 1/8. |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 8 of 13 |
7.7. | Storage Temperature Certification |
7.7.1. | Using the Packing List Summary (PLS) form, the plasma supplier will record the temperature status of the plasma shipment while it has been in storage. | ||
7.7.2. | There are three options for plasma temperature storage disposition: |
a. | The first option for temperature storage certification is applicable if all storage temperature recordings for associated plasma have been -20°C or colder. | ||
b. | The second option for temperature storage certification is applicable if only one temperature storage excursion has occurred for associated plasma and it still meets the maximum temperature requirements for Source Plasma in 21 CFR 640.76. Option 2 requires copies of all applicable temperature records (freezer graph(s), freezer logs and any associated investigation and/or CAPA documents) to be attached to Page 2 of the PLS forms. | ||
c. | The third option for temperature storage certification is applicable if all storage temperature recordings for associated plasma meet the requirements for Source Plasma, Salvaged as defined in 21 CFR 640.76. Option 3 also requires copies of all applicable temperature records to be attached to Page 2 of the PLS forms. Additionally, since pre-approval from Talecris is required for shipment, the Request/Approval Form for Source Plasma, Salvaged must be initiated and forwarded to the Talecris Account Manager. Full instructions for shipment of Source Plasma, Salvaged is listed in Section 7.8. |
7.8. | Source Plasma, Salvaged |
7.8.1. | Because Talecris is limited in the timeframe in which plasma must be processed (greater than 60 days but less than 3 years from date of collection) and because of the limited markets that will accept product manufactured from source plasma, salvaged, receipt of this material is not desirable. | ||
7.8.2. | Source Plasma, Salvaged is defined in 21 CFR 640.76. | ||
7.8.3. | Prior to shipment of any Source Plasma, Salvaged, written approval must be received from Talecris Plasma Operations Account Manager with Clayton QO Plasma concurrence. |
a. | Complete Talecris Shipment Request/Approval Form for Salvaged Plasma. | ||
b. | Submit completed form with required documentation to Talecris Account Manager for approval. |
7.8.4. | Each case of plasma, the Packing List Summary Sheet and Bill of Lading must be clearly marked: Source Plasma Salvaged. | ||
7.8.5. | Source plasma, salvaged, is not used for products going to EU and, therefore, cannot be labeled with German/EU plasma material numbers. |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 9 of 13 |
7.8.6. | Talecris will not accept any salvaged hyperimmune plasma. If hyperimmune plasma, other than Anti-D plasma, is re-classified as Source Plasma Salvaged, it must be relabeled as Normal X plasma. Anti-D plasma may not be re-labeled as Normal X plasma nor shipped as salvaged. | ||
7.8.7. | A copy of the freezer temperature chart(s) and a report containing the following information must accompany any shipment of source plasma, salvaged: |
a. | The vendor batch number | ||
b. | Prior written Talecris approval to ship source plasma, salvaged | ||
c. | The maximum temperature reached by the freezer | ||
d. | The time span during which the temperature was warmer than -20°C | ||
e. | The number of times the plasma was exposed to temperatures warmer than -20°C during the entire freezing and storage period of the product. | ||
f. | The cause of the incident and corrective action taken |
7.9. | Shipment Documentation Requirements |
7.9.1. | A documentation packet must accompany each shipment of plasma, and must include the plasma packing list(s), the Packing List Summary Sheet(s), and the Bill of Lading(s). This packet must be given to the driver of the Talecris designated-carrier when plasma is shipped. |
a. | The plasma center address provided on the plasma packing list(s), the Packing List Summary Sheet(s), and the Bill of Lading(s) must match the address listed on the Form FDA 2830, Blood Establishment Registration and Product Listing. The Form FDA 2830 is updated annually and validated by FDA. Any and all changes in plasma center address regardless of reason must be noted in the annual update of the Form FDA 2830. The most current Form 2830 must be provided immediately to the Talecris Plasma Operations Account Manager following validation by FDA and receipt by plasma supplier. This applies to the initial registration and each annual registration for every plasma center. |
1.) | A letter from the corporate office of the plasma supplier on company letterhead must be provided to the appropriate Plasma Operations Account Manager immediately for each address change. The letter must include the following information: |
1.a) The reason for the address changes (e.g., Zip code change, street extension, correction, etc.) | |||
1.b) Verification that the plasma center has not relocated. |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 10 of 13 |
1.c) | Commitment to include the change in the Form FDA 2830 annual registration to FDA and provide the validated form to the Talecris Plasma Operations Account Manager immediately after receipt. |
b. | Any address changes which have not been previously communicated to Talecris that are discovered by upon receipt of plasma at the Clayton facility will be addressed with the plasma supplier corporate office by the Plasma Operations Account Manager. | ||
c. | The volume entries must be carried out to three decimal places for all manual entries. It is permissible to carry out to two decimal places when a document is system generated and the ending zero is dropped. | ||
d. | The plasma packing lists must be the original documents or, if copies, stamped with This is a true and accurate copy of the original or similar verbiage. Any copies must be signed and dated by the responsible individual at the collection facility. If the entire packing list is a copy, one stamp, initialed and dated is adequate with total number of pages of PPL indicated at stamp site. |
7.9.2. | The plasma packing list and Packing List Summary Sheet information may be alternatively sent to Talecris via electronic data interchange (EDI) with prior written approval by Talecris. The same information is required. | ||
7.9.3. | The plasma packing list must contain the following information: |
a. | Name, address, and Talecris assigned center code of the collection facility or, minimally, the corporate office address of the plasma supplier | ||
b. | Name and address of each testing facility used for all required tests | ||
c. | Individual test results per plasma unit. Only with prior written approval by Talecris QO Plasma may the supplier certify that all Source Plasma units are negative by approved tests for all required tests as detailed in the Talecris General Specification. | ||
d. | A statement that all donors have tested negative for syphilis as required by the Code of Federal Regulations. This statement may be documented on the Packing List Summary form. | ||
e. | Plasma material number | ||
f. | Case numbers | ||
g. | Unique bleed number/control number for each unit | ||
h. | Unique donor number for each unit or unique traceability system of units to donors |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 11 of 13 |
i. | Plasma volume (mL) for each unit | ||
j. | Total number of units in each case | ||
k. | Total volume of plasma in each case | ||
l. | Vendor batch number | ||
m. | Initials and dates as required |
7.9.4. | The Packing List Summary must contain the following identifying information: |
a. | Plasma center name and address | ||
b. | Talecris-assigned center code | ||
c. | NDDR number | ||
d. | Vendor batch number | ||
e. | Talecris P.O. number | ||
f. | Talecris plasma material number | ||
g. | Number of shippers | ||
h. | List of case numbers | ||
i. | Liters | ||
j. | Earliest bleed date | ||
k. | Latest bleed date | ||
l. | Certifications as appropriate |
7.9.5. | The Bill of Lading must contain the following information: |
a. | Carriers Name | ||
b. | Center name and address | ||
c. | Addressed to: | ||
Talecris Biotherapeutics
c/o Nordic Warehouse 2400 Hodges Chapel Road Benson, NC 27504 |
|||
d. | Number of cases of plasma per vendor batch | ||
e. | Plasma type | ||
f. | Plasma material number | ||
g. | Vendor batch number |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 12 of 13 |
h. | Total cases shipped | ||
i. | The statement Maintain -20°C or colder in transit | ||
j. | The statement Load at -25°C or colder | ||
k. | Truck loading temperature | ||
l. | Shippers signature | ||
m. | Date and time (military or AM/PM designation). Indicate time zone. | ||
n. | Drivers signature and date | ||
o. | Trailer Number |
7.9.6. | Plasma cases to be shipped should not be removed from the freezer until the transport truck is at the center and the trailer temperature has been checked and found to be at -25°C or colder. | ||
7.9.7. | The Sipper Label must, minimally, contain the following information: |
a. | Ship from and ship to addresses | ||
b. | The complete vendor batch number | ||
c. | The case number | ||
d. | The product description | ||
Reference Appendix G, Example Of Talecris Shipper Label, for preferred format and other preferred label information. |
8. | DATA/INFORMATION MANAGEMENT, NOTIFICATION REQUIREMENTS |
8.1. | Detail all plasma shipment information on the accompanying plasma packing lists, Packing List Summary (PLS) form, and Bill of Lading (BOL). | ||
8.2. | Plasma suppliers must notify Talecris by the Notification for Destruction of Plasma (NDP) form of any lookback, recall, or other situations in which plasma would be deemed unacceptable to process. | ||
8.3. | During the normal course of business operations, Talecris RTL preferred method of test result data reporting will be an electronic method (Electronic Data Interface). An alternate method of test result data reporting will be by printed, hard copy data result sent by the most expedient method. | ||
8.4. | Revision numbers or revised date listed in Section 9 to track individual revisions to forms. |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 13 of 13 |
9. | ATTACHMENTS |
9.1. | Appendix A, Example Of Notification For Destruction Of Plasma Form, 2 pages, Rev. 12 | ||
9.2. | Appendix B, Example Of Packing List Summary Form, 2 pages, Rev. 11 | ||
9.3. | Appendix C, Example Of Bill Of Lading, 1 page, Rev. 12 | ||
9.4. | Appendix D, Example Of Daily Startup Scanner/Printer Test Record, 1 page, Rev. 10 | ||
9.5. | Appendix E, Example Of Talecris Hemoglobin Comparator, 1 page, Revised 4/1/05, Rev. 11 | ||
9.6. | Appendix F, Example Of Talecris Shipment Request/Approval Form For Source Plasma, Salvaged, 2 pages, Rev. 11 | ||
9.7. | Appendix G, Example Of Talecris Shipper Label, 1 page, Rev. 00 |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 12 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 1 of 2 | ||
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APPENDIX A |
Collection
|
Control | Plasma Item or | Ship Doc # | Case Number | Disp. | 3. | Disposition Codes | |||||||||||||||||
Date
|
Number | Material Number | or Vendor | Code | #1 Pooled prior to notification | |||||||||||||||||||
|
Batch # | #2 Unit received; to be destroyed | ||||||||||||||||||||||
|
Reactive Unit for | N/A | N/A | N/A | #3 Unit in transit/off-site storage; to be destroyed | |||||||||||||||||||
|
Viral or by NAT | #4 Unit shipped to contract fractionator | ||||||||||||||||||||||
|
#6 Unit shipped back to plasma supplier | |||||||||||||||||||||||
|
#7 Unit used for research purposes | |||||||||||||||||||||||
|
#8 Unit removed for reason other than NDP |
Explanation for Other : | Collection date of last negative Unit: | 4. | Contract Fractionation Section : | ||||||||||||
|
Contract fractionator notified by fax (Code #4): | Date/Initials: | |||||||||||||
5.
|
Information verified: | Fractionators acknowledgement of fax received: | Date/Initials: | ||||||||||||
Date: Initials (2) / | Fractionators disposition report received: | Date/Initials: | |||||||||||||
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|||||||||||||||
Phone Clayton of intent to fax (919) 359-4444 Initials: | |||||||||||||||
|
|||||||||||||||
6.
|
Plasma Supplier fax: | 5. | Completion and Final Review of NDP : | ||||||||||||
Reference attached Work Complete print screen from the
NDP Database for the following: |
|||||||||||||||
- Pool Number | |||||||||||||||
7. | Fax this form to Clayton: (919) 359-4428 | - Unit Removed/Destruction Date | |||||||||||||
Lookback Coordinator: Attach a Work Complete Print Screen to this NDP form. Verify each unit is reconciled and matches disposition on Work Complete Printout. | |||||||||||||||
|
|||||||||||||||
Date faxed: Initials: | Date: Time: Initials | ||||||||||||||
Lookback Coordinator Work Complete approval: Date/Initials: | |||||||||||||||
QO Plasma Close review and approval: Date/Initials: | |||||||||||||||
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Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 2 of 2 | ||
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APPENDIX A |
NOTIFICATION FOR DESTRUCTION OF PLASMA |
CS-000-BE-053, NDP Form; Revision 12, March 2006
(Supercedes CS-000-AR-107, NDP Form; Revision 00) Page ___ of ___ |
|
This side to be completed by plasma supplier : | This side to be completed by Talecris Biotherapeutics, Clayton: | |||||||||||
Plasma Supplier Reference # (optional): | Log #: | |||||||||||
Center Code:
|
NDDR #: | Donor #: | ||||||||||
|
||||||||||||
Collection
Date |
Control Number |
Plasma Item or
Material Number |
Ship Doc #
or Vendor Batch # |
Case Number | Disp. Code | |||||||||||||
|
||||||||||||||||||
|
Disposition Codes | |||||||||||||||||
|
||||||||||||||||||
|
#1 Pooled prior to notification | |||||||||||||||||
|
#2 Unit received; to be destroyed | |||||||||||||||||
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#3 Unit in transit/off-site storage; to be destroyed | |||||||||||||||||
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#4 Unit shipped to contract fractionator | |||||||||||||||||
|
#6 Unit shipped back to plasma supplier | |||||||||||||||||
|
# 7 Unit used for research purposes | |||||||||||||||||
|
#8 Unit removed for reason other than NDP | |||||||||||||||||
|
||||||||||||||||||
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Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
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REVISION: 11 | |||
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TITLE: Plasma Supplier Supplemental Directions | PAGE 1 of 2 | ||
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APPENDIX B |
Center Code:
|
||
|
||
|
||
NDDR #:
|
||
|
||
|
||
Vendor Batch #
|
||
|
||
|
||
Talecris P.O. #:
|
||
|
Plasma Material | ||||||||
Number | # of Units | # of Shippers | Case Numbers | Liters | ||||
This shipment: |
Earliest Bleed Date:
Latest Bleed Date: |
| All plasma units in this shipment are negative/non-reactive for the following tests: | |
HBsAg, Anti-HCV, Anti-HlV-1/2, HCV / HIV-1 / HBV by NAT, and ALT values less than or equal to 2X the upper limit of normal. | ||
| Applicant Donor units in this shipment have been qualified by the receipt of acceptable test results obtained on a second unit within six months of the first unit. | |
| Applicant Donor units in this shipment, with the exception of Anti-D specialty plasma donors, are negative for Anti-D. | |
| Entire Anti-D shipment has an Anti-C titer of less than or equal to 1:8. |
| Donors participating in an Anti-D stimulation program have not contributed to this shipment unless it is an Anti-D plasma shipment. |
| All donors have tested negative for syphilis as required by the Code of Federal Regulations. | |
| Hyperimmune Anti-D, Rabies, Tetanus, and Hepatitis plasma have been pre-qualified by the Raleigh Test Lab. | |
| All plasma units in this shipment have been collected and stored in compliance with all regulatory requirements and Talecris specifications. |
o | The plasma in this shipment was stored at -20°C or colder, and is designated Source Plasma. | |
o | The plasma in this shipment was stored at -20°C or colder, with an allowable temperature excursion (See PLS page 2 attached along with required temperature records), and is designated Source Plasma. | |
o | The plasma in this shipment is designated Source Plasma, Salvaged (temperature records required). |
|
/ | / | ||||||||||
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Quality
|
Date | Management | Date |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 11 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 2 of 2 | ||
|
APPENDIX B |
Center Code:
|
||||
|
|
|||
NDDR #:
|
||||
|
|
|||
Vendor Batch #:
|
||||
|
|
|||
Material Number:
|
||||
|
|
Maximum | Duration of | |||||
Date of | Temperature | Temperature | ||||
Excursion(s) | Reached | Excursion(s) | Reason for Excursion(s) | |||
Note: | If temperature excursions warrant plasma to be classified as salvaged, reference Talecris Plasma Supplier Supplemental Directions 7.8, requiring pre-approval from Talecris before shipment. |
|
/ | / | ||||||||||
|
||||||||||||
Management
|
Date | Quality | Date |
Talecris
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STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 12 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 1 of 1 | ||
|
APPENDIX C |
TO: |
TALECRIS
c/o Nordic Warehouse 2400 Hodges Chapel Road Benson, NC 27504 |
FROM: |
Plasma Center
1234 Main Street Any Where, USA 11111 |
Plasma Type | ||||||
Vendor Batch # | # Of Cases | (NX, TX, CX, etc) | SAP Material # | |||
MAINTAIN -20ºC OR COLDER IN TRANSIT | LOAD AT -25ºC OR COLDER |
|
||||||||
|
Truck Temperature | Shippers Signature | Date |
Time (military)
E C M P (Circle Time Zone) |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 10 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 1 of 1 | ||
|
APPENDIX D |
Printed Labels | ||||||
Same As Sample? | COMMENTS | |||||
Date | Yes No | (Explain any NO responses and corrective action taken) | Initials | |||
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 11 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 1 of 1 | ||
|
APPENDIX E |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 11 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 1 of 2 | ||
|
APPENDIX F |
Plasma Center Name
|
Talecris Center Code | |||||
|
||||||
|
||||||
Plasma Material Number
|
||||||
|
||||||
Bill of Lading Number(s)
|
||||||
|
||||||
Vendor Batch Number(s)
|
||||||
|
Plasma Center Information/Action | Info/Action | Initials/Date | ||
Number of units of Source Plasma, Salvaged
|
||||
|
||||
Number of cases of Source Plasma, Salvaged
|
||||
|
||||
Earliest collection date of Source Plasma, Salvaged
|
||||
|
||||
Latest collection date of Source Plasma, Salvaged
|
||||
|
||||
Total time which the temperature was warmer than -20°C (recorded in hours)
|
||||
|
||||
Warmest temperature reached by freezer
|
||||
|
||||
Number of times plasma was exposed to temperatures warmer than -20°C
during the entire freezing and storage period of the product.
|
||||
|
||||
Incident Report detailing the cause of the incident and CAPA taken (circle
yes or no)
|
Y / N | |||
|
||||
All cases marked Source Plasma Salvaged (circle yes or no)
|
Y / N | |||
|
||||
BOL marked Source Plasma Salvaged (circle yes or no)
|
Y / N | |||
|
||||
Packing List Summary marked Source Plasma Salvaged (circle yes or no)
|
Y / N | |||
|
||||
Plasma re-classified/relabeled as Normal plasma if originally hyperimmune
plasma (Anti-D plasma cannot be relabeled as Normal plasma nor shipped as salvaged plasma) (circle yes, no or N/A) |
Y / N /
N/A |
|||
|
||||
Freezer temperature charts included with submission of Talecris Shipment
Request/Approval Form of Source Plasma, Salvaged accounting for the
date
plasma was placed in freezer until date of this request (include period
temperature of freezer was warmer than -20°C)
(circle yes or no)
|
Y / N |
Talecris
|
STANDARD OPERATING PROCEDURE | SOP #: CS-000-BE-053 | ||
BIOTHERAPEUTICS
|
REVISION: 11 | |||
|
TITLE: Plasma Supplier Supplemental Directions | PAGE 2 of 2 | ||
|
APPENDIX F |
Talecris Account Manager reviewed suppliers Incident Report and
found complete and acceptable
|
Y / N |
Number of times plasma was exposed to temperature warmer than
-20°C during the
entire freezing and storage period
|
||||
|
||||
Freezer temperature charts included in shipping document packet
accounting for the entire storage period (circle yes or no) |
Y / N |
Plasma Center Manager
|
Signature/Date | |||
|
Disposition of Request:
|
(Circle One) |
|
/ | Approve | Reject | |||||
|
||||||||
Talecris Account Manager
|
/ Date |
|
/ | Approve | Reject | |||||
|
||||||||
Talecris Clayton Quality Operations Manager
|
/ Date |
Talecris
BIOTHERAPEUTIC
|
STANDARD OPERATING PROCEDURE |
SOP #: CS-000-BE-053
REVISION: 00 |
||
|
TITLE: Plasma Supplier Supplemental Directions |
PAGE 1 of 1
APPENDIX G |
Talecris
|
||||
BIOTHERAPEUTICS | FINAL CONTROLLED DOCUMENT ROUTING FORM (REV 06) | Page 1 of 1 |
Document Type:
|
þ SOP | o BPR | o Other (Specify) | |||
|
||||||
Document #
|
CS-000-BE-053 | Rev # 12 | Prev. Doc. # N/A | |||
|
||||||
Document Title: | Plasma Supplier Supplemental Directions | |||||
|
||||||
Authored By:
|
Amy Durham | o Author Check/Sign/Date for Training Credit | ||||
|
||||||
Owners Dept. Name: | QO Plasma / Zone 1 | Date Requested: 02/20/2006 | ||||
|
||||||
Document Owner:
|
Amy Durham | |||||
|
||||||
EFFECTIVE DATE
|
MAR 31 2006 | FINAL DATE USED |
Document processed by: | ||||||||||
|
||||||||||
Signature:
|
/s/ Christy Pychinka | Print Name: | Christy Pychinka | Date: | 2/21/06 | |||||
|
||||||||||
Document reviewed in
accordance with current requirements:
o
Check for Training
Credit
|
||||||||||
|
||||||||||
Signature:
|
/s/ Susan Dixon | Print Name: | Susan Dixon | Date: | 2/21/06 |
1. | Sections 3.4. and 7.6.1.c. Indicate that the functions usually performed by the Talecris Plasma Operations Technical Services Manager may be performed by the Talecris Plasma Operations Account Mangers in the absence of the Technical Services Manager. Clarification by Plasma Operations of technical services functions performed in the absence of this position. |
2. | Add new Section 7.5.2. and re-number remaining sections Add section defining lookback and post donation information (PDI) notification requirements for listed plasma bleeds collected under prior NDDR and center code references. Clarify what NDDR and center code is required on the notification form for bleeds collected under prior ownership or previous NDDR number. |
3. | Add new Section 7.6.1.d. and re-number remaining sections Added for clarity of shipper information. |
4. | Section 7.7.2.b. and Appendix B List specific documentation that is required for review if there is more than 1 temperature excursion. Clarification and consistency of needed documentation to review in cases of more than one storage temperature excursion (>20C). |
5. | Section 7.9.5.C. and Appendix C Correct Benson address. It should be 2400 Hodges Chapel Road. |
7. | New Section 7.9.7. List minimum information that is required on the plasma shipper label. Added for clarification and consistency for shipper label information. |
9. | New Appendix G Example of shipper label. As with NDP and the packing list summary form, include an example template for suppliers to reference for consistency. |
As Document Owner, I state that the proposed changes and the entire document are consistent with all systems, documents, and
current requirements.
þ
Check for Training
Credit
|
||||
|
||||
Signature: /s/ Amy W. Durham
|
Print Name: Amy W. Durham | Date: 2/28/06 | ||
|
||||
As Quality Approver, I have found the proposed changes and the entire document to be compliant with cGMPs and appropriate for
the intended purpose of producing safe, pure and effective products.
o
Check for Training
Credit
|
||||
|
||||
Signature: /s/ John W. Parrish
|
Print Name: John W. Parrish | Date: 2/28/2006 |
Collection
|
Control | Plasma Item or | Ship Doc # | Case Number | Disp. | 3. | Disposition Codes | ||||||||||||||
Date
|
Number | Material Number | or Vendor Batch # | Code | #1 Pooled prior to notification | ||||||||||||||||
|
#2 Unit received; to be destroyed | ||||||||||||||||||||
|
Reactive Unit for | N/A | N/A | N/A | #3 Unit in transit/off-site storage; to be destroyed | ||||||||||||||||
|
Viral or by NAT | #4 Unit shipped to contract fractionator | |||||||||||||||||||
|
#6 Unit shipped back to plasma supplier | ||||||||||||||||||||
|
#7 Unit used for research purposes | ||||||||||||||||||||
|
#8 Unit removed for reason other than NDP | ||||||||||||||||||||
Explanation for Other : | Collection date of last negative Unit: | 4. | Contract Fractionation Section : | ||||||||||||
|
Contract fractionator notified by fax (Code #4): | Date/Initials: | |||||||||||||
5.
|
Information verified: | Fractionators acknowledgement of fax received: | Date/Initials: | ||||||||||||
Date: Initials (2) / | Fractionators disposition report received: | Date/Initials: | |||||||||||||
Phone Clayton of intent to fax (919) 359-4444 Initials: | |||||||||||||||
|
|||||||||||||||
6.
|
Plasma Supplier fax: | 5. | Completion and Final Review of NDP : | ||||||||||||
Reference attached Work Complete print screen from the NDP Database for the following: | |||||||||||||||
- Pool Number | |||||||||||||||
7. | Fax this form to Clayton: (919) 359-4428 | - Unit Removed/Destruction Date | |||||||||||||
Lookback Coordinator: Attach a Work Complete Print Screen to this NDP form. Verify each unit is reconciled and matches disposition on Work Complete Printout. | |||||||||||||||
Date faxed: Initials: | Date: Time: Initials | ||||||||||||||
Lookback Coordinator Work Complete approval: Date/Initials: | |||||||||||||||
QO Plasma Close review and approval: Date/Initials: | |||||||||||||||
|
|||||||||||||||
NOTIFICATION FOR DESTRUCTION OF PLASMA |
CS-000-BE-053, NDP Form: Revision 12, March 2006
(Supercedes CS-000-AR-107, NDP Form: Revision 00) Page ___ of ___ |
|
Center Name & Address:
|
Center Code:
NDDR #: Vendor Batch: Talecris P.O. #: |
||||
Plasma Material | ||||||||
Number | # of Units | # of Shippers | Case Numbers | Liters | ||||
|
||||||||
|
||||||||
|
||||||||
|
This Shipment: |
Earliest Bleed Date:
Latest Bleed Date: |
| All plasma units in this shipment are negative/non-reactive for the following tests: HBsAg, Anti-HCV, Anti-HlV-1/2, HCV / HIV-1 / HBV by NAT, and ALT values less than or equal to 2X the upper limit of normal. | |
| Applicant Donor units in this shipment have been qualified by the receipt of acceptable test results obtained on a second unit within six months of the first unit. | |
| Applicant Donor units in this shipment, with the exception of Anti-D specialty plasma donors, are negative for Anti-D. | |
| Entire Anti-D shipment has an Anti-C titer of less than or equal to 1:8. |
| All donors have tested negative for syphilis as required by the Code of Federal Regulations. | |
| Hyperimmune Anti-D, Rabies, Tetanus, and Hepatitis plasma have been pre-qualified by the Raleigh Test Lab. | |
| All plasma units in this shipment have been collected and stored in compliance with all regulatory requirements and Talecris specifications. |
o | The plasma in this shipment was stored at -20°C or colder, and is designated Source Plasma. | |
o | The plasma in this shipment was stored at -20°C or colder, with an allowable temperature excursion (See PLS page 2 attached along with required temperature records), and is designated Source Plasma. | |
o | The plasma in this shipment is designated Source Plasma, Salvaged (temperature records required). |
Total number of storage temperature excursions warmer than -20ºC from
earliest bleed date to shipping date:
(If answer is other than zero complete PLS page 2 and attached to this form.) |
|||||
|
/ | / | ||||||||||
|
||||||||||||
Quality
|
Date | Management | Date |
Maximum | Duration of | |||||
Date of | Temperature | Temperature | ||||
Excursion(s) | Reached | Excursion(s) | Reason for Excursion(s) | |||
|
||||||
|
||||||
|
||||||
|
||||||
|
Note: | If temperature excursions warrant plasma to be classified as salvaged, reference Talecris Plasma Supplier Supplemental Directions 7.8, requiring pre-approval from Talecris before shipment. |
|
/ | / | ||||||||||
|
||||||||||||
Management
|
Date | Quality | Date |
|
Talecris Center | |||||
Plasma Center Name
|
Code | |||||
|
||||||
Plasma Material Number
|
||||||
Bill of Lading Number(s)
|
||||||
Vendor Batch Number(s)
|
||||||
|
||||||
/
|
Approve | Reject | ||
Talecris Account Manager / Date
|
||||
|
||||
/
|
Approve | Reject | ||
Talecris Clayton Quality Operations Manager / Date
|
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 1 of 12 |
/s/ Amy W. Durham | 2/28/06 | /s/ John W. Parrish | 2/28/2006 | |||
Document Owner | Date | Quality Approver | Date |
Supercedes: 19-71XX-XXX | Date Effective: MAR 31 2006 |
1. | PURPOSE |
1.1. | To provide and describe the requirements specified by Talecris Biotherapeutics for the procurement of Source Plasma intended for manufacture of therapeutic biological products, both domestic and foreign. This specification is intended to assure that incoming plasma meets all Talecris requirements, in addition to established domestic and international regulations and standards for Source Plasma. |
2. | SCOPE |
2.1. | These requirements are applicable to all Source Plasma purchased by Talecris. |
3. | REFERENCE(S) |
3.1. | 21 CFR 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General | ||
3.2. | 21 CFR 211 Good Manufacturing Practice for Finished Pharmaceuticals | ||
3.3. | 21 CFR 606 Current Good Manufacturing Practice for Blood and Blood Components | ||
3.4. | 21 CFR 610 General Biological Products Standards | ||
3.5. | 21 CFR 640 Additional Standards for Human Blood and Blood Products, Plasma and Source Plasma | ||
3.6. | 42 CFR 493 CLIA regulations | ||
3.7. | FDA approved Standard Operating Procedures Manuals | ||
3.8. | EU Pharmacopoeia monograph for Human Plasma for Fractionation, Revision to Annex 14 to EU Guide to GMP: Manufacture of products derived from human blood or plasma. | ||
3.9. | All current FDA guidance documents relating to collecting, testing, processing, storing or transporting Source Plasma | ||
3.10. | RS-000-AA-011 Protocol for Submission of Plasma Samples to Talecris RTL | ||
3.11. | PPTA Viral Marker Standard, Revised October 26, 2004 and PPTA Viral Marker Data Collection Form Instructions with attached samples | ||
3.12. | PPTA Qualified Donor Standard | ||
3.13. | PPTA NAT Testing Standard and NAT Technical Standard | ||
3.14. | CS-000-AR-027 Auditing of Plasma Suppliers and Associated Test Laboratories |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 2 of 12 |
3.15. | CS-000-BE-053 Plasma Supplier Supplemental Directions | ||
3.16. | CS-000-BE-057 Method for Evaluating the Suitability of Source Plasma Collection Facilities and Test Laboratories | ||
3.17. | EMEA/CHMP/BWP/3794/03 Guideline on the Scientific Data Requirements for A Plasma Master File (PMF) | ||
3.18. | EMEA/CHMP/BWP/125/04 Guideline on Epidemiological Data on Blood Transmissible Infections |
4. | RESPONSIBILITIES |
4.1. | Plasma supplier |
4.1.1. | Assures that all conditions of this specification and supply contract are met. |
4.2. | Talecris Plasma Operations, Account Manager |
4.2.1. | Serves as point of contact for all communication with the Plasma Supplier and is responsible for disseminating information to and from the Plasma Supplier and appropriate departments within Talecris. | ||
4.2.2. | Assists Plasma Supplier in developing and implementing training programs relevant to new Talecris requirements. | ||
4.2.3. | Assists Plasma Supplier in developing and implementing corrective action plans in response to deficiencies identified in relation to Talecris specifications and regulatory agency requirements and recommendations. | ||
4.2.4. | Conducts periodic review of suppliers contractual issues, delivery schedules and any proposed changes in center operations. | ||
4.2.5. | Coordinates the evaluation process for all proposed plasma suppliers, collection and/or testing facilities. | ||
4.2.6. | Communicates to the plasma supplier any quality issues (discrepancies) with product received. | ||
4.2.7. | Coordinates communications between supplier and Talecris concerning investigations, CAPA and final resolution of product quality issues. |
4.3. | Talecris Plasma Operations Technical Services Manager |
4.3.1. | Approves use of specific plasma collection materials and supplies, all packaging and shipping materials, sample tubes, labels and bar code systems used by plasma suppliers. These functions may be performed by the Talecris Plasma Operations Account Managers in the absence of the Technical Services Manager. |
4.4. | QO Compliance |
4.4.1. | Maintains Supplier Information Database. | ||
4.4.2. | Maintains current files for all plasma suppliers, collection and testing facilities, storage and transport facilities. | ||
4.4.3. | Determines, communicates and has final approval of all changes in plasma supplier status and plasma testing facilities. |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 3 of 12 |
4.4.4. | Receives, evaluates and distributes viral marker data in accordance with current regulation requirements. |
4.5. | Talecris Regulatory Affairs |
4.5.1. | Maintains and updates Plasma Master File. | ||
4.5.2. | Coordinates implementation of any new regulatory requirements. | ||
4.5.3. | Files any necessary BPDRs. |
4.6. | Talecris Quality Operations Plasma |
4.6.1. | Communicates to the plasma supplier and appropriate Talecris departments (e.g. Plasma Ops, QO Compliance) any quality issues (discrepancies) with product received. | ||
4.6.2. | Approves final assessment and disposition of quality issues (discrepancies) arising at collection facilities. | ||
4.6.3. | Reviews and dispositions all incoming plasma and modeled manufacturing pools. |
4.7. | Talecris Plasma Receiving |
4.7.1. | Receives all incoming plasma shipments. | ||
4.7.2. | Receives all plasma notifications regarding the status of units shipped. | ||
4.7.3. | Communicates to Talecris QO Plasma and Plasma Operations any discrepancies noted during plasma receipt. |
5. | GENERAL REQUIREMENTS |
5.1. | QO Compliance |
5.1.1. | Plasma Supplier Approval All plasma intended for use by Talecris must be collected by approved suppliers and collection facilities, and tested by approved laboratories using approved test kits, and stored and transported using approved establishments. | ||
5.1.2. | Supplier Files All supplier information is maintained by QO Compliance. Copies of the following documents must be current and updates provided by the supplier, when applicable: |
a. | FDA approved ELA, PLA or BLA | ||
b. | CLIA registration certificate for the facility | ||
c. | Individual state licenses, as required | ||
d. | iQPP certification for the collection facility | ||
e. | FDA approved SOP manual | ||
f. | Epidemiology Data provided no less than quarterly (compiled monthly) using the Talecris form (Appendix C). | ||
g. | FDA written approval to collect hyperimmune plasma, if shipped to Talecris. |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 4 of 12 |
h. | The supplier must notify the Talecris Plasma Operations Account Manager of any changes in the following, at the corporate level, or at an individual facility: |
1). | Facility address or location, phone and fax numbers. | ||
2). | Hours of operation. | ||
3). | Management or medical supervisory personnel: |
Lab Director
Medical Director Physician Substitute Center Director, Manager or Assistant Manager Quality Assurance Specialist Regional Manager |
i. | The supplier must notify Talecris Plasma Operations Account Manager prior to any changes in the following: |
1). | Tests performed | ||
2). | Methods/reagents/equipment or procedures used | ||
3). | Plasma types collected | ||
4). | Facility address | ||
5). | Plasma collection materials |
j. | For all collection, testing, storage and transport establishments, the following documentation is required to be provided to Talecris as soon as it becomes available: |
1). | Copy of EU competent authority certificate, inspection observations and follow-up/corrective actions. | ||
2). | U.S. FDA Form 483, inspection observations and follow-up/corrective actions. |
k. | For all testing establishments, the following documentation is required to be provided to Talecris upon request: |
1). | Copies of viral marker tests and NAT validation reports/data. | ||
2). | Results of proficiency testing programs. |
5.1.3. | Compliance Audits QO Compliance group will conduct audits of all facilities on a periodic basis, not less than once every 24 months. |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 5 of 12 |
5.1.4. | Epidemiology Data In accordance with current regulatory requirements and with some consideration given to the PPTA Viral Marker Standard, epidemiology data (viral marker serological and NAT), compiled monthly, must be provided for each facility collecting Source Plasma. The data is required to be reported to Talecris monthly for the entire year (Jan. 1 through Dec. 31) for each collection center supplying plasma to Talecris at any point in a given year regardless of duration of supply during the year. This is necessary to meet regulatory requirements for an epidemiological profile to be established and reported for each individual center supplying plasma to the manufacturing facility. |
a. | Failure on the part of any collection facility to meet PPTA (iQPP) Standards will result in the removal of the collection facility from the approved supplier list. | ||
b. | Data must be submitted using the attached form, Appendix C, by the end of the month following the close of each quarter (i.e.- Q1 due by 4/30, Q2 due by 7/31, Q3 due by 10/31 and Q4 due by 1/31). An alternate format may be used if requested in writing by the collection organization stating that the definitions as listed in Appendix C would be adhered to and the request is subsequently approved in writing by Plasma Operations, Quality Operations and Regulatory Affairs. | ||
c. | Complete the form for each month and follow the instructions as indicated on the form, Appendix C. Definitions are provided below: |
1). | First time tested donor person whose blood/plasma is tested for the first time for viral markers without evidence of prior testing. The first time tested donor population represents a subset of applicant donors (applicant donors that are tested for the first time in the given system). | ||
2). | Repeat tested donor person whose blood/plasma has been tested previously for viral markers in the given system. This includes applicant donors tested for the second time, applicant donors re-qualifying after 6 months or more, and qualified donors. | ||
3). | Qualified donor an individual who has provided a plasma sample at a specified plasma center, at least twice in a six month period, and all screening requirements have been met for both a) questions and tests and for b) the donor and the plasma sample, according to the iQPP Qualified Donor Standard. | ||
4). | Total number First time tested donors the total number of unique/individual donors presenting at a center at any time during the entire reporting calendar year (January 1 to December 31) who are tested for the first time for viral markers without evidence of prior testing. Do not count the same donor as identified by the unique donor ID more than once in a given year. These data should be provided when the December epidemiology data are reported and is to be a |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 6 of 12 |
comprehensive annual count. When reporting Jan. through Nov. epidemiology data, simply N/A this box for each center. | |||
5). | Total number Repeat tested donors the total number of unique/individual donors presenting at a center at any time during the entire reporting calendar year (January 1 to December 31) who have been tested previously for viral markers in the given system. Do not count the same donor as identified by the unique donor ID more than once in a given year. These data should be provided when the December epidemiology data are reported and is to be a comprehensive annual count. When reporting Jan. through Nov. epidemiology data, simply N/A this box for each center. | ||
6). | Total number donations from Repeat tested Donors the total number of donations collected from Repeat tested Donors during the entire reporting calendar year (January 1 to December 31). These data should be provided when the December epidemiology data are reported and is to be a comprehensive annual count. When reporting Jan. through Nov. epidemiology data, simply N/A this box for each center. | ||
7). | Donation frequency applies only to the Repeat tested donors. This should be calculated as the total number of donations from Repeat tested donors divided by the total number of Repeat tested donors for the entire reporting calendar year (January 1 through December 31) for each center. These data should be provided when the December epidemiology data are reported. When reporting January through November epidemiology data, simply N/A this box for each center. | ||
8). | Confirmed seropositive: donors testing repeat reactive with a serological screening test (HBsAg, anti-HIV-1/2, anti-HCV)and who are subsequently confirmed positive by a supplementary method (Western Blot, RIBA, etc.). Do not count the same donor more than once in a given year. | ||
9). | NAT only positive: confirmed positive in a NAT assay for a specific virus (HIV-1, HCV or HBV), and not found repeat reactive for that virus in serological screening i.e., window period cases. NAT only positives may or may not be subsequently confirmed by serological testing. Do not count the same donor more than once in a given year. |
5.1.5. | All plasma suppliers must have a QA program in place, which is consistent with the current CBER document entitled Guideline for Quality Assurance in Blood Establishments. | ||
5.1.6. | Deviations from Talecris Specifications |
a. | Any proposed deviation to Talecris specification must be submitted in writing to the Talecris Plasma Operations Account Manager prior to implementation. Plasma Operations will initiate any required change control, on which QO disposition will |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 7 of 12 |
be documented. |
5.2. | Regulatory Affairs |
5.2.1. | The supplier must notify the Talecris Plasma Operations Account Manager, no longer than 72 hours/3 working days from discovery , in the event that any of the following occur, at the corporate level, or at an individual facility: |
a. | Any fatal donor reaction, as defined in 21 CFR 640.73. | ||
b. | Any FDA or other regulatory inspection results that may affect the approval status of any facility. | ||
c. | Any regulatory action (i.e., warning letter, injunction, suspension) that would adversely affect, or bring into question, the quality of product produced for Talecris. |
5.2.2. | The supplier must notify the Talecris Plasma Operations Account Manager and Clayton Plasma Receiving, and QO within [**] of notification for product seizure or recall. | ||
5.2.3. | The supplier must notify Talecris Plasma Receiving within 72 hours/3 working days of any lookback notification as detailed in the Table of Actions. Reference section 5.2.2 for product seizure or recall. | ||
5.2.4. | The supplier must notify Talecris Plasma Receiving in a timely manner (e.g. as soon as investigation and unit trace are completed) of any Post Donation Information notifications (examples, but not limited to, are tattoos, body piercings, high risk, etc.) as detailed in the Table of Actions. Reference section 5.2.2 for product seizure or recall. | ||
5.2.5. | Regulatory actions may result in the removal of a facility from Talecris approved supplier list. |
5.3. | Plasma Operations |
5.3.1. | Supplier agreements Each supplier group will sign a written statement agreeing to meet the Talecris specifications. | ||
5.3.2. | The Supplier will communicate directly all concerns, questions and changes to the Talecris Plasma Operations Account Manager assigned to the supplier group, and in turn, the Account Manager will disseminate, within Talecris, all communications to and from the Supplier. |
5.4. | Documents and Records, requirements as defined in 21 CFR 640.72, and in addition: |
5.4.1. | Copies of this specification are sent to Plasma Operations Account Managers with each revision. From the date the specification is approved, the effectivity date will be stamped one month in advance and sent to plasma suppliers to conduct training. | ||
5.4.2. | All facility documents and records pertaining to the collection, processing, QA/QC, storage, shipment and testing of plasma intended for manufacture by Talecris must be available for review for a minimum of 33 years . | ||
5.4.3. | Each facility collecting or testing Source Plasma will be assigned a unique four-digit facility identification code. All documentation and records accompanying plasma units shipped to Talecris must be clearly identified with the facility identification code. |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 8 of 12 |
5.4.4. | If original documents are required, but are unavailable, a copy may be substituted as long as it is stamped with the statement This is a true and accurate copy of the original. Verification must be provided to assure that all copies are accurate, legible and accounted for. |
5.5. | European Product |
5.5.1. | Product intended for shipment to Europe must be collected and tested by EU approved facilities. | ||
5.5.2. | EU Requirements are as follows: |
a. | Inspection and approval by a European Competent Authority. | ||
b. | Listed on the Talecris GMP certificate. |
6. | DONOR SUITABILITY |
6.1. | Requirements as defined in 21 CFR 640.61, 640.62, 640.63, 640.65(b), and 640.71 must be met, and in addition: |
6.1.1. | Applicant donor procedures and policies must be in effect in accordance with the iQPP Qualified Donor Standard. | ||
6.1.2. | Donors must be at least 18 years old. Donors older than 65 may donate if an acceptable physical examination and medical history is acquired annually. | ||
6.1.3. | Normal Source Plasma, collected from donors who have been re-entered through FDA approved re-entry programs, is not acceptable for delivery to or use by Talecris (except Anti-D plasma, refer to Talecris Anti-D plasma specification for requirements. No other plasma type, including NX, may be shipped to Talecris from re-entered donors). | ||
6.1.4. | Donors participating in an Anti-D stimulation program are not allowed to contribute to any other plasma type (NX, TX, HX, CX, RX) shipped to Talecris. Only Anti-D plasma may be shipped from donors participating in an Anti-D stimulation program. |
7. | PLASMA COLLECTION |
7.1. | Requirements defined in 21 CFR 640.62, 640.64, 640.65, 640.66, and 640.71 must be met, and in addition: |
7.1.1. | Plasma identification systems and labels, plasma collection containers, anticoagulant, supplies and equipment, sample tubes, and all packaging and shipping materials used must be approved in writing, prior to use, by Talecris Plasma Operations, Technical Services (Appendix D). | ||
7.1.2. | Only plasma collected in approved bottles using approved anticoagulant solutions (ref. Appendix D) are allowed to ship to Talecris. | ||
7.1.3. | Each collection facility must adhere to PPTA (iQPP) and PPTA voluntary standards. | ||
7.1.4. | A FDA approved nomogram must be used. |
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7.1.5. | Plasma Identification: |
a. | A unique Control Number/Bleed Number must be assigned to one specific unit of plasma and all associated samples, which must be traceable to an individual donor and donation. | ||
b. | The Source Plasma Label applied to the unit of plasma must also contain the facility identification code, name, address and US license number of the collection facility, or minimally, the address of the plasma supplier corporate office. | ||
c. | Material Numbers: |
1). | Talecris will determine and provide the appropriate material number(s) for use by the collection facility. | ||
2). | In the event that it is ever necessary to change a material number on plasma already received or in transit to Talecris, the plasma supplier will communicate this change to the Talecris Plasma Operations Account Manager. | ||
3). | In the event that it is necessary to change a material number on plasma that is in storage at a suppliers facility, the supplier will be notified by the Talecris Plasma Operations Account Manager and requested to correct the shipping documents for the affected plasma, prior to shipment. |
d. | The case shipper label must minimally contain the ship from and ship to address, the complete vendor batch number, the case number, and the product description. Reference the example label in CS-000-BE-053, Plasma Supplier Supplemental Directions, for preferred format and other preferred label information. |
8. | PLASMA PROCESSING |
8.1. | Requirements defined in 21 CFR 640.68, 640.69(d), 640.70, 640.71 and 640.72 must be met, and in addition: |
8.1.1. | All plasma units must be placed in the freezer within one hour of collection and maintained at -20°C or colder. | ||
8.1.2. | All plasma units must be evaluated for unacceptably high hemoglobin concentration using the Talecris Hemoglobin Comparator (reference CS-000-BE-053), following the instructions for use printed on the card. Plasma units with unacceptably high hemoglobin concentrations must not be shipped to Talecris. |
9. | PLASMA PACKING |
9.1. | Plasma must remain frozen during packing procedures. |
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10. | PLASMA STORAGE |
10.1. | Requirements defined in 21 CFR 640.71, 640.76 and the EP Monograph for Human Plasma for Fractionation must be met, and in addition: |
10.1.1. | Hyperimmune plasma, designated as Salvaged Plasma, must be relabeled as Normal X plasma. Talecris will not accept salvaged hyperimmune plasma. |
Note: Anti-D plasma cannot be relabeled as Normal X plasma nor shipped as salvaged. |
11. | PLASMA SHIPPING |
11.1. | Requirements defined in 21 CFR 640.71 and 640.76, and in addition: |
11.1.1. | Maximum volume of normal plasma to be shipped in a vendor batch is 3700 liters. | ||
11.1.2. | Plasma Aging Plasma must not be older than 24 months when shipped to Talecris. | ||
11.1.3. | Plasma that falls into one of the following categories is unacceptable for shipment to Talecris: |
a. | units with reactive or positive test results refer to Appendix A-Table of Actions | ||
b. | prior and/or subsequent units from TMR or PMR donors refer to Appendix A- Table of Actions | ||
c. | hemolyzed units, units with red spots in or on the plasma containers | ||
d. | lipemic units | ||
e. | units with frozen plasma on the outside of the container | ||
f. | broken, cracked or contaminated units | ||
g. | untested, or units with incomplete testing | ||
h. | orphan units | ||
i. | units collected from donors re-entered through a FDA approved donor re-entry program (except Anti-D plasma, refer to Talecris Anti-D plasma specification for requirements). | ||
j. | recovered plasma | ||
k. | unlabeled or mislabeled units, or units with torn or unreadable labels | ||
l. | units tested by a non-approved laboratory, or by non-approved test methods, reagents or equipment | ||
m. | units collected at non-approved facilities or by non approved owner groups | ||
n. | units having errors that breech traceability, such as units that cannot be traced back to an individual donor | ||
o. | parvo elevated units | ||
p. | units with ALT greater than 2 times the upper limit of normal | ||
q. | units with < 200 mL / bottle | ||
r. | plasma shipped to Talecris out of collection sequence |
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s. | unit(s) with prior notification to supplier of unacceptable status by Talecris |
11.1.4. | Quarantine Plasma Shipments |
a. | Quarantined plasma shipments must be pre-approved by CBER. | ||
b. | Quarantined plasma shipments must be pre-approved by Talecris. Notification, in writing, including documentation of CBER approval, must be provided to the Talecris Plasma Operations Account Manager and written approval received from Talecris prior to shipment. |
11.1.5. | Source Plasma Salvaged |
a. | Salvaged Plasma shipments must be pre-approved by Talecris. Notification, in writing, must be provided to the Talecris Plasma Operations Account Manager and written approval received from Talecris prior to shipment. |
11.1.6. | A documentation packet must accompany each shipment of plasma and must be QA approved. | ||
11.1.7. | Transport/Carriers and Off-Site Storage |
a. | All carriers used to transport Source Plasma and off-site storage facilities must be pre-approved by Talecris. | ||
b. | The temperature of the transport trailer must be -25°C or colder prior to loading the plasma shipment. |
12. | TESTING REQUIREMENTS |
12.1. | Testing requirements as described in 21 CFR 640.67 and 640.71 must be met, and in addition all plasma units intended for use by Talecris must meet the following criteria prior to shipment: |
Test Type | Test Requirements | |
HBsAG
1, 4
|
Non-reactive 3 | |
Anti-HIV-1/2
1, 4
|
Non-reactive 3 | |
Anti-HCV
1, 4
|
Non-reactive 3 | |
ALT
4
|
Less than or equal to 2X the upper limit of normal | |
Syphilis
4, 7
|
Negative or Non-reactive 3 for donor | |
Atypical Antibody
2,4,5,6
|
Negative or Non-detectable (<1:1) | |
HCV NAT
1,4
|
Negative 3 | |
HIV NAT
1,4
|
Negative 3 | |
HBV NAT
1,4
|
Negative 3 | |
Parvo, B-19 NAT
8
|
Non-Elevated |
Notes: | ||
1. | Most current version or generation available of a FDA approved test method must be used. | |
2. | Test reagents for atypical antibody screening tests must include specific anti-D antibody. Detection of other atypical antibodies is not required, except anti-C for Rho-D plasma. | |
3. | Some manufacturers package inserts use the terms negative and non-reactive interchangeably. |
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4. | Prior to use, the test kit manufacturer, test kit methodology and testing facility must be approved by Talecris. | |
5. | Test not performed on anti-D specialty plasma. | |
6. | Test applicant or qualified donors. Testing must be performed and acceptable prior to sending units from donor. | |
7. | Donor test performed every 4 months. | |
8. | Parvo elevated units are unacceptable to ship to Talecris. |
12.2. | Testing must be performed by a testing facility that meets all regulatory and licensing requirements and has been pre-approved by Talecris . The Talecris Director of Plasma Operations will approve one of the Talecris eligible viral marker testing labs for each plasma supplier. The Talecris Director will also approve any switch of viral marker testing laboratories prior to change. | ||
12.3. | Notification for Destruction of Plasma |
12.3.1. | Notification to Talecris Plasma Receiving must be made |
a. | within three working days/72 hours upon receipt of a reactive or positive test result for a donor from whom prior or subsequent units have been shipped to Talecris (lookbacks). | ||
b. | within one working day/24 hours of notification of Post Donation Information resulting in product recalls or seizure concerning units shipped to Talecris. | ||
c. | within a timely manner for Post Donation Information not resulting in a seizure or recall (example: tattoo, body piercing, high risk). |
12.3.2. | Concerning instances of owner transfer of plasma centers, the NDDR and Talecris center code reported on the NDP sent to Talecris must reflect the NDDR / center code at the time of unit collection (not at time of reporting). |
13. | ATTACHMENTS |
13.1. | Appendix A Table of Actions Unacceptable Plasma and Donors | ||
13.2. | Appendix B Glossary of Terms | ||
13.3. | Appendix C Epidemiology Data Form | ||
13.4. | Appendix D List of Approved Materials, Supplies and Vendors |
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Action on | ||||||||
Action on This | Subsequent | Action on Prior | Action on | |||||
Test Results or Behavior or Circumstances | Donation | Donations | Donations | Donor | ||||
ALT
Elevated (greater than 2 x the upper
limit of normal)
|
Destroy (1) | No Action | No Action | No Action | ||||
|
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Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
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ATYA
Positive (Atypical Antibody)
|
Destroy (1) | Destroy (1) | No Action, unless the positive unit was the second donation from an applicant donor. In this case, the first donation is also unacceptable for Talecris. |
Not acceptable for
Talecris |
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|
||||||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Parvo, B-19 by NAT
Elevated
|
Destroy (1) | No Action | No Action | No Action |
Footnotes: | (1) The option to divert plasma units from Talecris is allowed at those plasma centers that have approved SOPs to do so. |
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Action on | ||||||||
Action on This | Subsequent | Action on Prior | ||||||
Test Results or Behavior or circumstances | Donation | Donations | Donations | Action on Donor | ||||
vCJD:
Information or Post Donation Information (PDI) from a donor who has been diagnosed with vCJD, suspected vCJD, or CJD diagnosis and Age < 55 years. |
Destroy (1) | Destroy (1) | Destroy (1) LB to include all in-date Source Plasma units | PMR | ||||
|
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Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
CJD:
Information or Post Donation Information (PDI) from a donor who has been diagnosed with CJD and Age ³ 55 years |
Destroy (1) | Destroy (1) | Destroy (1) LB not to exceed 3 years from date of center notification | PMR | ||||
|
||||||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
CJD/vCJD Increased Risk:
Information or Post Donation Information (PDI) from a donor who has received a dura mater graft, or human pituitary growth hormone (HPGH). |
Destroy (1) | Destroy (1) | Destroy (1) LB to date of event | PMR | ||||
|
||||||||
Sexual Partner
|
No Action | No Action | No Action | No Action |
Footnotes:
|
(1) | The option to divert plasma units from Talecris is allowed at those plasma centers that have approved SOPs to do so. | ||
|
(2) | UK Countries include: England, Scotland, Wales, Northern Ireland, Isle of Man, the Channel Islands, Gilbraltar or the Falkland Islands. |
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Action on | Action on | |||||||
This | Subsequent | Action on Prior | ||||||
Test Results or Behavior or Circumstances | Donation | Donations | Donations | Action on Donor | ||||
CJD/vCJD Potential Risk:
Donor with a family history of one or more blood relatives diagnosed with CJD/vCJD, recipient of bovine-derived insulin since 1980, or who has accumulated travel or residence in the UK of 3 months or more between 1980 and 1996,* (2) This information may be received as PDI. |
Destroy (1) | Destroy (1) | Destroy (1) LB not to exceed 3 years from date of center notification for familial risk |
PMR for
familial risk |
||||
|
||||||||
|
Destroy (1) LB not to exceed 3 years from date of center notification | Indefinite deferral for travel risk and bovine insulin | ||||||
|
for travel risk and bovine insulin. | |||||||
|
||||||||
Sexual Partner
|
No Action | No Action | No Action | No Action |
Footnotes:
|
(1) | The option to divert plasma units from Talecris is allowed at those plasma centers that have approved SOPs to do so. | ||
|
(2) | UK Countries include: England, Scotland, Wales, Northern Ireland, Isle of Man, the Channel Islands, Gilbraltar or the Falkland Islands. |
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Test Results or Behavior | Action on This | Action on Subsequent | ||||||
or Circumstances | Donation | Donations | Action on Prior Donations | Action on Donor | ||||
Diagnosed Acute West
Nile Virus Illness or Infection (3) |
Destroy (1) | Destroy (1) Time period to cover 14 days prior to the onset of symptoms and 28 days subsequent to the onset of illness. | Destroy (1) Time period to cover 14 days prior to the onset of symptoms and 120 days subsequent to the onset of illness. | TMR 120 days following diagnosis or onset of illness, whichever is the later date | ||||
|
||||||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Suspected Acute West Nile
Virus Illness or Infection (2) |
Destroy (1) (if quarantine and retrieval is decided by the center Medical Director) | N/A | Destroy (1) (if quarantine and retrieval is decided by the center Medical Director) LB to 14 days prior to and 120 days subsequent to the onset of symptoms. | TMR 120 days following diagnosis or onset of illness, whichever is the later date | ||||
|
||||||||
Sexual Partner
|
No Action | No Action | No Action | No Action |
Footnotes:
|
(1) | The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. | ||
|
(2) | According to CBER guidance, the minimum time frame to ask questions regarding suspected acute WNV infection is from May 1st to November 30th each year. If the plasma center medical directors suspects a case of acute WNV infection, at any time of year, the plasma units and plasma donor should be managed as stated in the table of actions. | ||
|
(3) | In the absence of current or recent symptoms, an IgM positive antibody test result alone should not be grounds for deferral. |
\
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Action on | ||||||||
Action on This | Subsequent | |||||||
Test Results or Behavior or Circumstances | Donation | Donations | Action on Prior Donations | Action on Donor | ||||
HBsAg (EIA repeat reactive) or HBV by NAT
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months from last negative donation, not to exceed 3 years |
PMR
(NDDR) |
||||
|
||||||||
Household Contact or Sexual Partner
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months from date of center notification | TMR 12 months from date of last household or sexual contact. | ||||
|
||||||||
Anti-HCV (EIA repeat reactive) or HCV by NAT
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months from last negative donation, not to exceed 3 years |
PMR
(NDDR) |
||||
|
||||||||
Household Contact or Sexual Partner
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months from date of center notification | TMR 12 months from date of last household or sexual contact. | ||||
|
||||||||
Hepatitis Risk/Behavior
: Pre-donation
History, Clinical Signs or Symptoms |
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months from date of center notification, not to exceed 3 years | PMR | ||||
|
||||||||
Household Contact or Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
IV Drug User:
Past or present
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months from date of center notification | PMR | ||||
|
||||||||
Sexual Partner
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months from date of center notification | TMR 12 months from date of last sexual contact |
Footnotes: | (1) The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. |
Talecris
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Action on | ||||||||
Action on This | Subsequent | |||||||
Test Results or Behavior or Circumstances | Donation | Donations | Action on Prior Donations | Action on Donor | ||||
PDI-Post Donation Information received
describing possible exposure to Hepatitis or
HIV
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 12 months to date of exposure, not to exceed 12 months | TMR for 12 months from date of exposure | ||||
|
||||||||
Household Contact (2) or Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Anti-HCV-1/2 (EIA repeat reactive), AIDS or HIV
risk |
Destroy (1) | Destroy (1) | Destroy (1) LB units 6 months from last negative donation, not to exceed 3 years |
PMR
(NDDR) (3) |
||||
|
||||||||
Sexual Partner
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 6 months from date of center notification | TMR 12 months from date of last sexual contact | ||||
|
||||||||
HIV-1 NAT
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 3 months from last negative donation, not to exceed 3 years |
PMR
(NDDR) |
||||
|
||||||||
Sexual Partner
|
Destroy (1) | Destroy (1) | Destroy (1) LB units 3 months from date of center notification | TMR 12 months from date of last sexual contact |
Footnotes:
|
(1) | The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. | ||
|
(2) | Applies to exposure to Hepatitis only. | ||
|
(3) | NDDR notification is for reactive results only; not for high risk. |
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Action on | Action on | |||||||
This | Subsequent | |||||||
Test Results or Behavior or Circumstances | Donation | Donations | Action on Prior Donations | Action on Donor | ||||
Syphilis, confirmatory positive or confirmatory not performed
|
Destroy (1) | Destroy (1) | No Action |
Not acceptable for
Talecris |
||||
|
||||||||
Sexual Partner
|
No Action | No Action | No Action | TMR 12 months from date of last sexual contact | ||||
|
||||||||
Syphilis positive, confirmatory negative
|
No Action | No Action | No Action |
No action if
approved for further donations by the Medical Supervisor (2) |
||||
|
||||||||
Sexual Partner
|
No Action | No Action | No Action | No Action |
Footnotes:
|
(1) | The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. | ||
|
(2) | FDA requires a licensed physician to approve donor for further donations. |
Talecris
|
PURCHASE SPECIFICATION | SAP MATERIAL #: N/A | ||||
BIOTHERAPEUTICS
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Test Results or | ||||||||
Behavior | Action on this | Action on subsequent | Action on prior | |||||
or Circumstances | donation | donations | donations | Action on the Donor | ||||
Donors reporting a
history of SARS or
suspected SARS
|
Destroy (1) |
Destroy (1)
Time period to cover 28 days after complete symptom resolution AND the cessation of any treatment |
Destroy (1)
LB to date of exposure |
TMR until 28 days after complete symptom resolution AND the cessation of any treatment | ||||
Close Contact (2)
OR Travel / Residence Exposure |
Destroy (1)(3) |
Destroy (1)(3)
Time period to cover NLT 14 days after last exposure OR 14 days after arrival in the US if travel/residence exposure |
Destroy (1)(3)
LB to date of exposure |
TMR for NLT 14 days after last exposure OR for 14 days after arrival in the US if travel/residence exposure |
Footnotes:
|
(1 | ) | | The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. | ||||
|
(2 | ) | | Close contact is defined as having cared for, having lived with, or having had direct contact with respiratory secretions and/or body fluids of a patient known to be a suspect. SARS case. | ||||
|
(3 | ) | | If the donor is symptom-free more than 14 days post-exposure, product retrieval and quarantine are not necessary. |
Talecris
|
PURCHASE SPECIFICATION | SAP MATERIAL #: N/A | ||||
BIOTHERAPEUTICS
|
REVISION: 023 | |||||
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TITLE: | GENERAL SPECIFICATION SOURCE PLASMA | PAGE 9 of 12 |
Test Results or | Action on | |||||||
Behavior | this | Action on subsequent | ||||||
or Circumstances | donation | donations | Action on prior donations | Action on the Donor | ||||
Recipient of
Smallpox
Vaccine
WITHOUT
Vaccine
Complications
|
Destroy (1) |
A) Destroy Time Period to
Cover Date of Smallpox
Vaccination and date the scab
spontaneously separated or 21 days
whichever is longer.
B) Destroy Time Period to Cover Date of Smallpox Vaccination and 2 months after Vaccination. |
A) Destroy Time Period to Cover Date
of Smallpox Vaccination and date the
scab spontaneously separated or 21 days
whichever is longer.
B) Destroy Time Period to Cover Date of Smallpox Vaccination and 2 months after vaccination. |
A) TMR until the vaccination
scab has separated
spontaneously, or for 21 days
post-vaccination, whichever is
the later date.
B) If scab was removed prior to separating spontaneously, TMR for 2 months after vaccination. |
||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Recipient of
Smallpox
Vaccine With
Vaccine
Complications
|
Destroy (1) | Destroy Time Period to Cover Date of Smallpox Vaccination and 14 days after all vaccine complications have completely resolved. | Destroy Time Period to Cover Date of Smallpox Vaccination and 14 days after all vaccine complications have completely resolved. | TMR until 14 days after all vaccine complications have completely resolved. | ||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Recipient of
Antrax
Vaccine
|
No Action | No Action | No Action | TMR 48 hours from time of vaccination. |
Footnotes:
|
(1 | ) | | The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. |
Talecris
|
PURCHASE SPECIFICATION | SAP MATERIAL #: N/A | ||||
BIOTHERAPEUTICS
|
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Test Results or | Action on | |||||||
Behavior | this | Action on subsequent | ||||||
or Circumstances | donation | donations | Action on prior donations | Action on the Donor | ||||
Symptomatic
Contacts (of Smallpox Vaccinees) Exhibiting Localized Skin Lesions with No Other Complications |
Destroy (1) |
A) Destroy Time Period to
Cover Date of Contact with
Smallpox Vaccinee (if known) and
date the scab spontaneously
separated.
B) Destroy Time Period to Cover Date of Contact with Smallpox Vaccinee (if known) and 3 months from the date of vaccination of the vaccine recipient with whom contact occurred or for 2 months from the present if the vaccination date is not known. |
A) Destroy Time Period to Cover Date
of Contact with Smallpox Vaccinee (if
known) and date the scab spontaneously
separated.
B) Destroy Time Period to Cover Date of Contact with Smallpox Vaccinee (if known) and 3 months from the date of vaccination of the vaccine recipient with whom contact occurred or for 2 months from the present if the vaccination date is not known. |
A) If the scab separated
spontaneously, no action
is taken.
B) If the scab was removed prior to separating spontaneously, TMR for 3 months from the date or vaccination of the vaccine recipient with whom contact occurred or for 2 months from the present if the vaccination date is not known. |
||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Symptomatic
Contacts (of Smallpox Vaccinees) Exhibiting Vaccine Complications |
Destroy (1) | Destroy Time Period to Cover Date of Contact with Smallpox Vaccinee (if known) and 14 days after all vaccine complications have completely resolved. | Destroy Time Period to Cover Date of Contact with Smallpox Vaccinee (if known) and 14 days after all vaccine complications have completely resolved. | TMR until 14 days after all vaccine complications have completely resolved. | ||||
Sexual Partner
|
No Action | No Action | No Action | No Action |
Footnotes:
|
(1 | ) | | The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. |
Talecris
|
PURCHASE SPECIFICATION | SAP MATERIAL #: N/A | ||||
BIOTHERAPEUTICS
|
REVISION: 023 | |||||
|
TITLE: | GENERAL SPECIFICATION SOURCE PLASMA | PAGE 11 of 12 |
Test Results or | Action on | |||||||
Behavior or | this | Action on subsequent | ||||||
Circumstances | donation | donations | Action on prior donations | Action on the Donor | ||||
Vaccines with
killed /inactivated viruses or bacteria recombinant, OR Toxoids |
No Action | No Action | No Action | No Action if donor is acceptable according to the center medical director or supervisor. | ||||
|
||||||||
Vaccines with
attenuated bacteria or viruses |
No Action | No Action | No Action | TMR for 4 weeks from vaccination date. | ||||
|
||||||||
Other Vaccines:
Rabies, tick- borne encephalitis |
No Action | No Action | No Action |
No Action
if donor is acceptable
according to the center
medical director or supervisor.
OR TMR for 1 year if vaccine was administered post-exposure. Deferral period is from last exposure to rabies. |
Talecris
|
PURCHASE SPECIFICATION | SAP MATERIAL #: N/A | ||||
BIOTHERAPEUTICS
|
REVISION: 023 | |||||
|
TITLE: | GENERAL SPECIFICATION SOURCE PLASMA | PAGE 12 of 12 |
Test Results or | ||||||||
Behavior or | Action on this | Action on subsequent | ||||||
Circumstances | donation | donations | Action on prior donations | Action on the Donor | ||||
Confirmed
Medical Diagnosis
of Anthrax of Any
Form
|
Destroy (1)
|
Destroy (1)
Time period to cover known date of exposure to Anthrax or 60 days prior to the onset of illness until the condition is considered resolved |
Destroy (1)
Time period to cover known date of exposure to Anthrax or 60 days prior to the onset of illness, whichever is the shorter period |
TMR until donor completes a full course of appropriate treatment and condition is considered resolved. | ||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Proven Anthrax
Bacterial Colonization |
No Action | No Action | No Action | TMR until donor completes a full course of prophylaxis with an appropriate antibiotic. | ||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Undiagnosed
Skin Lesions
Expected to be
Anthrax
|
No Action | No Action | No Action | TMR until either donor lesion is proven not to be Anthrax or donor completes full course of appropriate treatment and condition is considered resolved. | ||||
Sexual Partner
|
No Action | No Action | No Action | No Action | ||||
|
||||||||
Undiagnosed
Post-Donation
Illness in
Individuals
Potentially Exposed
to Anthrax
|
Destroy (1)
(if quarantine and retrieval is decided by the center Medical Director) |
N/A |
Destroy (1)
(if quarantine and retrieval is decided by the center Medical Director) Time period to cover known date of exposure to Anthrax or 60 days prior to the onset of illness, whichever is the shorter period |
TMR until condition is considered resolved. | ||||
Sexual Partner
|
No Action | No Action | No Action | No Action |
Footnotes:
|
(1 | ) | | The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so. |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 1 of 3 |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 2 of 3 |
PLASMA DESCRIPTION | PLASMA MATERIAL # | LEGACY ITEM # | ||||||
Normal, EU approved, bottles
|
08634958 | 19-7100-110 | ||||||
Normal, non-EU approved, bottles
|
08634966 | 19-7100-111 | ||||||
Normal, EU Flash Frozen approved, all products, bottles
|
08754430 | N/A | ||||||
Normal, EU approved from Configured Pools (ZLB)
|
08936601 | N/A | ||||||
CMV, EU approved, bottles
|
08635318 | 19-7122-110 | ||||||
CMV, non-EU approved, bottles
|
08635326 | 19-7122-111 | ||||||
Tetanus, non-EU approved, bottles
|
08635024 | 19-7103-111 | ||||||
Rabies, non-EU approved, bottles
|
08635083 | 19-7106-111 | ||||||
Anti-D, non-EU approved, bottles
|
08635156 | 19-7108-111 | ||||||
Hepatitis, non-EU approved, bottles
|
08635458 | 19-7145-111 |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 3 of 3 |
a. | Single Shipment : refers to a shipment from a single plasma center that meets all requirements stated in the general specification. | ||
b. | Combined Shipment or Master Ship Documents : expands the definition of shipment to include hyperimmune plasma shipped from multiple locations, all belonging to the same owner group. All centers are to be listed on Talecris approved suppliers list. Combined shipments must not exceed 500 liters and must be pooled together. |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 1 of 1 |
|
To: | QO Compliance/Audits & Systems Epidemiology Data | ||
|
Fax: (919) 359-7195 |
Month (1 only):
|
||||||||||
|
||||||||||
Owner Group:
|
||||||||||
|
||||||||||
Submitted By:
|
Phone: | Date: | ||||||||
|
||||||||||
Signature:
|
||||||||||
|
Total # | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total # | Donations | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
First | Total # | from | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Time | Repeat | Repeat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Center | tested | tested | tested | Donation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Code | NDDR # | Donors | Donors | Donors | Frequency 4 | Anti-HIV-1/2 | Anti-HCV | HBsAg | HIV-1 NAT | HCV NAT | HBV NAT | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FTD 2 | RD 3 | QD 5 | FTD 2 | RD 3 | QD 5 | FTD 2 | RD 3 | QD 5 | FTD 2 | RD 3 | QD 5 | FTD 2 | RD 3 | QD 5 | FTD 2 | RD 3 | QD 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
1 | Follow the definitions provided in section 5.1.4 of the General Specification Source Plasma. | |
2 | In all cases, FTD is to be representative of the number of confirmed positive First time tested donors (not donations). | |
3 | In all cases, RD is to be representative of the number of confirmed positive Repeat tested donors (not donations). | |
4 | In all cases, NAT refers to NAT only positives (donors testing NAT positive but not repeat reactive by EIA). | |
5 | In all cases, QD is to be representative of the number of confirmed positive Qualified donors for the entire calendar year. |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 1 of 2 |
Product | Part Number/Description | Purpose | Acceptable Materials | |||
|
Both Medisystems and JMS are included in the Talecris Plasma Master File | |||||
Apheresis Needle Set:
|
||||||
15g
|
Medisystems/P9-9115MGLB (Medisystems code) | |||||
16g
|
Medisystems/P9-9116MGLB (Medisystems code)/Baxter number 4R2440 | Access donors vein | ||||
175
|
Medisystems/P9-9117MGLB (Medisystems code)/Baxter number 4R2441 | |||||
15g
|
JMS/820-1504 | |||||
16g
|
JMS/820-1609 | |||||
17g
|
JMS/820-1702 | |||||
|
Two automated systems are licensed in the U.S. for collecting Source Plasma: Haemonetics PCS/PCS2 and Baxter Autopheresis-C (Plasmacell-C disposable) | |||||
|
||||||
Plasma Separation Device:
|
Separate plasma from whole blood | |||||
Apheresis bowl
|
Haemonetics/L/N: 625B | |||||
PCS2 harness
|
Haemonetics/L/N: 620 | |||||
or Plasmacell-C kit
|
Baxter/Fenwal/4R2256 | |||||
|
Baxter and Haemonetics both make comparable FDA- licensed USP solutions, which are listed in the PMF. | |||||
|
||||||
Anticoagulant:
|
||||||
|
Prevent plasma from clotting | |||||
4% Citrate, USP, 250 mL
|
Haemonetics/L/N: 420A (US) | |||||
4% Citrate, USP, 250 mL
|
Baxter/Fenwal/4B7867Q | |||||
4% Citrate, USP, 500 mL
|
Baxter/Fenwal/4B7889Q | |||||
|
Plasma Collection/Storage Container | - Baxter plasma bottles | ||||
|
||||||
Plasma Container:
|
- Haemonetics plasma bottles | |||||
Plasma Bottle (PlasmaLink)
|
Baxter/Fenwal/4R2067, 4R2068 | |||||
Plasma Bottle
|
Haemonetics 694, 694S, 694D |
Talecris
BIOTHERAPEUTICS |
PURCHASE SPECIFICATION
|
SAP MATERIAL #: N/A
REVISION: 023 |
||
|
TITLE: GENERAL SPECIFICATION SOURCE PLASMA | PAGE 2 of 2 |
Product | Part Number/Description | Purpose | Acceptable Materials | |||
NAT Sample tray:
|
All-Pak/HMS-Zero | NAT Sample Submission to RTL | MUST be manufacturer and P/N specified | |||
NAT Sample Shipper:
|
All-Pak/HMS-69100 | NAT Sample Submission to RTL | MUST be manufacturer and P/N specified | |||
Gel Packs:
|
Tech Pak/ Frigid 15, All-Pak/SturdeeSeal | NAT Sample Submission to RTL | MUST be manufacturer and P/N specified | |||
Sigma Printing System:
|
Allegro printer, BLS memory module, media kits | labeling documents for NAT samples and plasma cases | All centers NAT tested by Talecris RTL (Raleigh Test Lab) are furnished this equipment by Talecris | |||
Plasma Shipper:
|
Corrugated plasma shipping carton | Plasma Shipments to Clayton | Prior approval by Manager of Technical Services of Plasma Operations. | |||
Shipper Label:
|
various Talecris catalog #s/(81-9999 series) Teslin material | Plasma Shipments to Clayton | Printed by Universal Graphics. Alternates acceptable if pre-approved by Manager of Technical Service, Plasma Operations. |
Month
|
Date | Talecris Employee | Hours | Task/Subproject | Description | Dept | ||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
0 | Total Hours | ||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
$[**] per hour | Rate | ||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
Invoice | |||||||||||||||||||||||||||
|
RESPONSIBILITY | ||||||||||||
Stage(s) of Manufacturing | ||||||||||||
[**] | [**] | |||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||
SPECIFICATIONS | [**] | [**] | [**] | [**] | ||||||||
|
a. | Product Specifications, [**] | ||||||||||
|
b. | Product Specification [**] | ||||||||||
|
c. | Labeling and packaging components | ||||||||||
|
d. | Packaging inserts | ||||||||||
|
e. | Compatibility with equipment | ||||||||||
|
||||||||||||
STABILITY Finished Product | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
|
a. | Writing stability protocol | ||||||||||
|
b. | Approving stability protocol | ||||||||||
|
c. | Collection / storage of stability samples | ||||||||||
|
d. | Testing [**] | ||||||||||
|
e. | Stability data interpretation [**] | ||||||||||
|
f. | Testing [**] | ||||||||||
|
g. | Writing stability report | ||||||||||
|
h. | Approving stability report | ||||||||||
|
i. | Establish expiration date/shelf life | ||||||||||
|
||||||||||||
PRODUCT RETAINS | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
|
a. | Identification of samples to be retained | ||||||||||
|
b. | Approval of samples to be retained | ||||||||||
|
c. | Retention / storage of samples at appropriate storage conditions | ||||||||||
|
d. | Final disposition of retain samples | ||||||||||
|
||||||||||||
PRODUCT RELEASE | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
|
a. | Initial review of completed Batch Record | ||||||||||
|
b. | Final review / approval of completed Batch Record | ||||||||||
|
c. | Issuance/Approval of Certificate of Conformance | ||||||||||
|
d. | Issuance/Approval of Certificate of Analysis [**] | ||||||||||
PRODUCT RELEASE continued | ||||||||||||
|
||||||||||||
|
e. | Issuance of Certificate of Analysis [**] | ||||||||||
|
f. | Lot Release |
RESPONSIBILITY | ||||||||||||
Stage(s) of Manufacturing | ||||||||||||
[**] | [**] | |||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||
NON-CONFORMANCE EVENTS | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
Deviations | ||||||||||||
|
a. | Documentation of non-conformance event per established SOPs | ||||||||||
|
b. | Notification to Emergent of non-conforming event [**] | ||||||||||
|
c. | Investigation of non-conforming event and identifying appropriate CAPAs | ||||||||||
|
d. | Approval of non-conforming event [**] | ||||||||||
|
||||||||||||
OOS Assays performed by Talecris [**] | ||||||||||||
|
e. | Documentation of OOS per established SOPs | ||||||||||
|
f. | Notification to Emergent of confirmed OOS event with established root cause | ||||||||||
|
g. | Review of confirmed OOS and retest plan with established root cause | ||||||||||
|
h. | Investigation of OOS event and identification of appropriate CAPAs including proposed re-test plans | ||||||||||
|
i. | Review of confirmed OOS event and re-test plan where no assignable root cause is established | ||||||||||
|
j. | Approval of confirmed OOS event and re-test plan where no assignable root cause is established | ||||||||||
|
||||||||||||
OOS Assays performed by Emergent [**] | ||||||||||||
|
k. | Documentation of OOS per established SOPs | ||||||||||
|
l. | Notification to Talecris of confirmed OOS event | ||||||||||
|
m. | Investigation of OOS event and identification of appropriate CAPAs including proposed re-test plans |
RESPONSIBILITY | ||||||||||||
Stage(s) of Manufacturing | ||||||||||||
[**] | [**] | |||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||
|
n. | Approval of OOS event and re-test plan | ||||||||||
|
||||||||||||
AUDITING / MAN-IN-PLANT | [**] | [**] | [**] | |||||||||
|
||||||||||||
|
a. | Right to conduct scheduled routine audits of facility and quality systems not to exceed one (1) occurrence per year | ||||||||||
|
b. | Right to conduct for cause audits of facility and quality systems as needed in response to specific noncompliance events [**] | ||||||||||
|
c. | Right to maintain man-in-plant presence during process start up and execution of validation lots | ||||||||||
|
||||||||||||
ADVERSE EVENTS / PRODUCT COMPLAINTS | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
|
a. | Regulatory notification of AEs Complaints as required by regulations | ||||||||||
|
b. | Lead in AE / Complaint investigations | ||||||||||
|
c. | Assistance in conducting AE / Complaint investigations, including manufacturing investigation | ||||||||||
|
d. | Final written report for AE / Complaints | ||||||||||
|
e. | Approval of report |
RESPONSIBILITY | ||||||||||||
Stage(s) of Manufacturing | ||||||||||||
[**] | [**] | |||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||
PRODUCT RECALL | [**] | [**] | [**] | [**] | ||||||||
|
a. | Final Decision [**] | ||||||||||
|
b. | Notification of other Company regarding recall decision | ||||||||||
|
c. | Notification of potential event that may initiate recall | ||||||||||
|
d. | Impact of recall on Talecris filings | ||||||||||
|
e. | Impact of recall on Emergent filings | ||||||||||
|
f. | FDA notification of recall | ||||||||||
|
g. | Management of recall event | ||||||||||
|
||||||||||||
LOOK BACK PROCESS | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
|
a. |
Plasma collection center notification
for look backs involving units at Talecris |
||||||||||
|
b. | Tracing of plasma units effected by look back | ||||||||||
|
c. | Destruction of plasma units not yet processed and documentation of destruction | ||||||||||
|
d. | Supplying documentation of plasma unit destruction to Emergent | ||||||||||
|
e. | Product impact assessment involving plasma units that have been processed | ||||||||||
|
f. | Supply copies of documentation to include plasma pool date and product lot number(s) for processed/pooled plasma | ||||||||||
|
||||||||||||
REGULATORY | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
|
a. | Single IND Submission by Emergent for AIG Product | ||||||||||
|
b. | BLA Submission | ||||||||||
|
c. | Notification of any regulatory action which could affect finished product | ||||||||||
|
d. | Providing regulatory advice as needed related to process related to Emergent filings | ||||||||||
|
e. | Communications to Regulatory Authorities concerning Finished Product | ||||||||||
|
RESPONSIBILITY | ||||||||||||
Stage(s) of Manufacturing | ||||||||||||
[**] | [**] | |||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||
REGULATORY INSPECTIONS | [**] | [**] | [**] | [**] | ||||||||
|
a. | Notification of regulatory inspection by FDA, EU Regulatory agency or other governmental agency in conjunction with the facilities, processes or quality systems used to manufacture or support Emergent finished product. | ||||||||||
|
b. | Ability to maintain site presence during inspection [**] | ||||||||||
|
c. | Approval of corrective actions associated with identified deficiencies or observations resulting from inspections [**] | ||||||||||
|
d. | Review and approval of corrective actions associated with identified deficiencies or observations resulting from inspections [**] | ||||||||||
|
e. | Submission of corrective actions to inspecting Authority | ||||||||||
|
||||||||||||
BIOLOGICAL PRODUCT DEVIATIONS | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
|
a. | Final Decision submission of BPDR related to distributed product | ||||||||||
|
b. | Submission of BPDR | ||||||||||
|
c. | Lead investigation for BPDR | ||||||||||
|
d. | Assistance investigation including manufacturing investigation |
RESPONSIBILITY | ||||||||||||
Stage(s) of Manufacturing | ||||||||||||
[**] | [**] | |||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||
CHANGE MANAGEMENT | [**] | [**] | [**] | [**] | ||||||||
|
||||||||||||
Talecris Initiated | ||||||||||||
|
a. | Approval of changes to facility or Gamunex process, including testing and specifications , that do not impact [**] | ||||||||||
|
b. | Notification of non-routine changes to facility or Gamunex process, including testing and specifications, that have the potential to impact [**] | ||||||||||
|
c. | Review and approval of non-routine changes to facility or Gamunex process, including testing and specifications, that have the potential to impact [**] | ||||||||||
|
d. | Review of changes to facility or Gamunex process, including testing and specifications, required to maintain compliance to GMP during audit(s) | ||||||||||
|
e. | Approval of changes to facility or Gamunex process, including testing and specifications, required to maintain GMP | ||||||||||
|
||||||||||||
Emergent Initiated | ||||||||||||
|
f. | Approval of changes to process including specifications that do not impact facilities or Gamunex process | ||||||||||
|
g. | Notification of changes to process including specifications that have the potential to impact facilities or Gamunex process | ||||||||||
|
h. | Approval of changes to process including specifications that have the potential to impact facilities or Gamunex process |
RESPONSIBILITY | ||||||||||||
Stage(s) of Manufacturing | ||||||||||||
[**] | [**] | |||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||
VALIDATION | [**] | [**] | [**] | [**] | ||||||||
|
a. | Maintaining validated state of facility and equipment used for Gamunex [**] | ||||||||||
|
b. | Writing Process Validation Protocol | ||||||||||
|
c. | Approval of Process Validation Protocol | ||||||||||
|
d. | Writing Process Validation Report | ||||||||||
|
e. | Approving Process Validation Report | ||||||||||
|
||||||||||||
ANNUAL PRODUCT REVIEW / ANNUAL REPORT | [**] | [**] | [**] | |||||||||
|
||||||||||||
|
a. | Preparation of summary data for Emergent Annual Product Review Report | ||||||||||
|
b. | Annual Product Review final report | ||||||||||
|
c. | Submission of Annual Report to FDA |
protected by
|
Approved by:
|
Date: | |||
|
||||
/s/ Edward Arcuri
|
7/31/06 | |||
Emergent BioSolutions Inc.
|
||||
Edward Arcuri
|
||||
Executive Vice President, Corporate Operations
|
||||
Chief Operating Officer
|
||||
|
||||
/s/ Barbara Sneade
|
7/31/06 | |||
Talecris Biotherapeutics Inc.
|
||||
Barbara Sneade
|
||||
Senior Quality Manager, Quality Operations
|
Version | Date | Revised By | Description | |||
01
|
July 27 2006 | D. Bland | New | |||
|
Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.
Quality Agreement |
Emergent BioSolutions | |||
CONFIDENTIAL | Version 01 | Page 2 of 27 |
Page | ||||
1. DEFINITIONS
|
4 | |||
2. SCOPE / GENERAL REGULATORY COMPLIANCE
|
4 | |||
3. PURPOSE
|
5 | |||
4. CONTACT INFORMATION
|
5 | |||
5. DURATION OF AGREEMENT
|
5 | |||
6. MANUFACTURING cGMP COMPLIANCE
|
5 | |||
7. QUALITY CONTROL
|
9 | |||
8. QUALITY ASSURANCE
|
11 | |||
9. REGULATORY COMPLIANCE
|
14 | |||
10. DISPUTE RESOLUTION
|
16 | |||
11. CHANGE MANAGEMENT
|
17 | |||
12. PRODUCT AND PROCESS VALIDATION
|
17 | |||
13. NOTIFICATION OF NEW PRODUCT CLASSIFICATION
|
18 | |||
14. ANNUAL PRODUCT REVIEW, ANNUAL REPORT AND DRUG LISTING
|
18 | |||
APPENDIX I List of Contacts
|
19 | |||
APPENDIX II Summary of Responsibilities
|
21 |
Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.
Quality Agreement |
Emergent BioSolutions | |||
CONFIDENTIAL | Version 01 | Page 3 of 27 |
1.1 | The definitions set forth in the Product Supply Agreement are applicable to this Quality Agreement. |
2.1 | This Quality Agreement is between Emergent and Talecris and applies to Finished Product manufactured with the intent to support Investigational New Drug (IND) applications, Biological License Applications (BLA) and Commercial Product as set forth in the Product Supply Agreement. |
2.1.1. | [**]. | ||
2.1.2. | [**]. |
2.2 | In the event of amendments or changes to the Product Supply Agreement, or at intervals not to exceed 1 (one) year, the Quality Agreement will be reviewed by Emergent and Talecris to ensure that the roles and responsibilities reflect current practice and can be modified as needed with the written approval of both parties. | ||
2.3 | For the avoidance of doubt the arrangements relating to the manufacture of Finished Product are governed by the Product Supply Agreement and subsequent amendments. In the event of any inconsistency between the terms and conditions of this Quality Agreement and the terms and conditions of the Product Supply Agreement and possible subsequent amendments between the parties, the terms and conditions of the Product Supply Agreement and the subsequent amendments shall prevail. | ||
2.4 | Emergent and Talecris shall conduct operations in compliance with cGMP as defined in applicable sections of 21 CFR (see definitions). Both parties agree to work together in good faith to resolve differences in interpretation of current issues of these regulations and guidelines. | ||
2.5 | Emergent and Talecris shall ensure that the receipt, manufacture, labeling, packaging, testing, release, storage and shipping of the Finished Product are in compliance with the above noted regulations and associated guidelines or equivalent standards. |
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3.1 | This Quality Agreement further defines the roles and responsibilities for the Emergent and Talecris Quality Departments for the services defined in the Product Supply Agreement. A summary of responsibilities is presented in Appendix II of this Quality Agreement. | ||
3.2 | This Quality Agreement also defines how Talecris Quality Departments and Emergent Quality Departments will interact during conduct of contracted services. | ||
3.3 | This Quality Agreement shall be considered an Exhibit to the Product Supply Agreement. Refer to Section 2.3 in the event of discrepancies between the Quality Agreement and Product Supply Agreement. |
4.1 | Emergent contact names: refer to Appendix I | ||
4.2 | Talecris contact names: refer to Appendix I |
5.1 | The Quality Agreement will be effective once representatives of Emergent and Talecris approve the document as designated by the signatures and date on the cover page of the Quality Agreement and will expire with termination or expiration of the Product Supply Agreement and any subsequent amendments except for provisions which, by their nature, are intended to survive. |
6.1 | General |
6.1.1. | The manufacturing operations for the Finished Product to be performed by Talecris are defined in the Product Supply Agreement. |
6.2 | Premises |
6.2.1. | Talecris will manufacture the Finished Product at the Clayton facility. The floor plans of the manufacturing areas and corresponding room classifications will be made available by Talecris for review by Emergent during annual audits of the facility by Emergent. | ||
6.2.2. | The premises and equipment used to manufacture Finished Product will be maintained according to current regulatory requirements and in accordance with the approved procedures. The production of the Finished Product will be conducted in a suitably controlled environment and such facilities will be regularly monitored for parameters critical to the process to demonstrate compliance with appropriate cGMP and Regulatory Guidelines. | ||
6.2.3. | Talecris will maintain controlled access to the premises. |
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6.3.1. | The principles detailed in the referenced documents in Section 2 of this Quality Agreement will cover the standards of manufacture of the Finished Product. Applicable cGMP guidelines will cover the standards of quality assurance for the Finished Product. |
6.4.1. | For pooling of [**] plasma (source plasma), purification, and manufacture of the [**], Talecris will use only raw materials and components listed in the Bill of Materials or Master Production Records. | ||
6.4.2. | For manufacture of the [**] and Finished Product, packaging, and labeling activities, Talecris will use only packaging materials and labeling components listed in the Bill of Materials or Master Production Records, which have been reviewed and approved by Emergent. | ||
6.4.3. | Materials Procured by Talecris |
6.4.3.1. | Talecris is responsible for ensuring that all materials and components procured by Talecris for use in the manufacture of Finished Product are in full compliance with the approved specifications. | ||
6.4.3.2. | Talecris is responsible for ensuring that all materials are appropriately sampled, tested, and stored upon receipt, and that only released raw materials are used in the manufacture of Finished Product, as well as for holding the relevant Certificates of Analysis for the raw materials. | ||
6.4.3.3. | Talecris is responsible for ensuring all Finished Product related vendors and suppliers for materials procured by Talecris for the manufacture of Finished Product are approved for use by Talecris Quality. |
6.4.4. | Materials Provided by Emergent for Talecris AIG Source Plasma |
6.4.4.1. | Emergent is responsible for ensuring that the AIG Source Plasma collected on behalf of Emergent and provided to Talecris by Emergent for use in the manufacture of Finished Product meets the requirements of the AIG Source Plasma Specifications, Talecris General Plasma Specification, and Plasma Supplier Supplemental Directions current revision. | ||
6.4.4.2. | Emergent Quality is responsible for ensuring all vendors and suppliers related to the supply of AIG Source Plasma are approved for use by Emergent Quality. | ||
6.4.4.3. | Talecris Quality is responsible for ensuring that all plasma centers supplying AIG Source Plasma are approved and are listed on the Talecris approved sources list. |
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6.5 | Master Production Records |
6.5.1. | Talecris will create and maintain the manufacturing information in the form of a Master Production Record (MPR) in accordance with their established procedures and policies. |
6.5.1.1. | MPRs for the manufacture of the [**] will be reviewed by Emergent [**] prior to initiation of the first production campaign. | ||
6.5.1.2. | MPRs for manufacture of the [**] and Finished Product (filled, packaged, labeled) will be reviewed and approved by Emergent [**] prior to the first manufacture of the [**] and Finished Product. |
6.5.2. | Changes to approved MPRs will be documented and justified according to established [**] as outlined in the Change Management section of this Agreement (refer to Section 11). |
6.6 | Standard Operating Procedures |
6.6.1. | Talecris shall maintain the Standard Operating Procedures (SOPs) and/or Test Methods required to manufacture, test, and store the Finished Product [**] with the exception of the testing of the [**]. |
6.6.1.1. | Emergent will review Standard Operating Procedures and/or Test Methods created exclusively for the manufacture of Finished Product. |
6.6.2. | Changes to approved SOPs and/or Test Methods will be documented and justified according to established [**] as outlined in the Change Management section of this Agreement (see Section 11). |
6.7 | Batch Numbers |
6.7.1. | Talecris will determine the manufacturing batch numbering system for raw materials and components used in the manufacture of Finished Product in accordance to their established procedures and policies. Each lot of Bulk Drug Substance and Final Drug Product will have unique identifiers assigned and recorded. | ||
6.7.2. | Talecris will be responsible for maintaining forward and backward lot traceability for all components and raw materials used in the manufacture of Finished Product. |
6.8 | Dates of Manufacture and Expiration |
6.8.1. | Date of Manufacture- Talecris will assign the Date of Manufacture in accordance to their established procedures and policies. Dates of Manufacture will be assigned to the Bulk Drug Substance and Final Drug Product. Date of Manufacture will not be assigned to in-process hold steps. | ||
6.8.2. | Expiration Date: Talecris will assign an Expiration Date for the Bulk Drug Substance in accordance with established procedures and policies. |
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Expiration dates will be assigned to in-process hold steps per Talecris. Expiration dating and/or shelf-life period for Final Drug Product will be established by Emergent. |
6.9 | Manufacturing and Equipment Data |
6.9.1. | Talecris is responsible for keeping records of equipment usage, cleaning, and any maintenance and calibration performed according to cGMP requirements. | ||
6.9.2. | As applicable, Talecris is responsible for labeling all non-disposable Finished Product dedicated equipment and storing this equipment appropriately to prevent its use and or cross contamination with other products. | ||
6.9.3. | Talecris is responsible for having adequate cleaning validation for all non-disposable non-dedicated equipment used in the manufacture of Finished Product. | ||
6.9.4. | Talecris is responsible for having adequate room clearance procedures, including decontamination procedures appropriate for the degree of exposure of the Finished Product for all non-dedicated rooms in which the Finished Product is manufactured. |
6.10 | Reprocessing and Rework |
6.10.1. | Reprocessing and rework at any stage of the manufacture of Finished Product, including re-labeling, will be according to Talecris and Emergent license and process validation. | ||
6.10.2. | Documentation of re-labeling or re-inspection will be included in the production batch record documentation submitted to Emergent. |
6.11 | Storage and Shipment |
6.11.1. | Talecris will store Finished Product under conditions as specified in approved specifications and the Product Supply Agreement. | ||
6.11.2. | Talecris will ensure that during storage of the Finished Product at Talecris appropriate cGMP controls are in place to prevent interference, theft, product contamination, or admixture with any other materials. |
6.12 | Finished Product will be suitably packaged and labeled for transit. Emergent shall specify the design and content of the package insert and labels in accordance with Talecris equipment limitations. At the request of Emergent, Talecris shall work with Emergent to specify the design of the labels and insert. |
6.12.1. | Emergent will authorize Talecris to ship Finished Product in writing. Samples associated with the manufacture of Finished Product required for testing or other purposes may be shipped prior to the Finished Product. | ||
6.12.2. | Talecris will prepare shipments of Finished Product as directed by Emergent using shipping containers, temperature controls and recorders as determined appropriate by Emergent. |
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7.1 | General |
7.1.1. | The testing activities for Finished Product that are to be performed by Talecris are to be performed in accordance with approved Test Methods and SOPs and according to established specifications. | ||
7.1.2. | Talecris will notify Emergent and obtain prior approval for the sub-contract of any analytical testing related to the manufacture of Finished Product. |
7.2 | Materials supplied by Talecris |
7.2.1. | Quality control of materials supplied by Talecris will be performed by Talecris. | ||
7.2.2. | Talecris will notify Emergent of any significant Quality Assurance non-conformance investigations related to the testing, storage and handling of any raw materials used to manufacture Finished Product as defined in Section 8.2. |
7.3 | In-Process and Final Drug Product Testing |
7.3.1. | Talecris will perform testing on in-process samples, [**] plasma, bulk drug substance and final drug product as agreed upon by Talecris and Emergent, using approved specifications, SOPs and/or Test methods. | ||
7.3.2. | Emergent will perform product-specific testing on in-process samples, [**] plasma, bulk drug substance and final drug product as agreed upon by Talecris and Emergent, using approved specifications, SOPs and/or Test methods. | ||
7.3.3. | In-Process and [**] plasma test results generated by Talecris and Emergent will be documented either in the executed MPR or separately on a document that will be included with the MPR. | ||
7.3.4. | For each lot of [**] manufactured for and Final Drug Product delivered to Emergent, Talecris will provide to Emergent a Certificate of Conformance (CofC) to confirm each lot has been manufactured per approved procedures and in conformance with appropriate cGMP requirements. At a minimum, the CofC will contain the following information: |
Ø | Product/Lot description/name | ||
Ø | Lot number | ||
Ø | Date of Manufacture | ||
Ø | Expiration Date | ||
Ø | Quantity/Dose/Volume | ||
Ø | Storage conditions | ||
Ø | Declaration that the product was manufactured in compliance with GMP regulations | ||
Ø | Signature/Date of a responsible Quality representative |
7.3.5. | For each lot of [**] and Final Drug Product delivered to Emergent, Talecris will provide a Certificate of Analysis (CofA) to confirm each lot has been |
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tested in accordance with and has met the approved Specifications. At a minimum, the CofA will contain the following information: |
Ø | Product/Lot description/name | ||
Ø | Lot number | ||
Ø | Test method name | ||
Ø | Corresponding test method procedure number | ||
Ø | Test method acceptance criteria as applicable (e.g. specific value(s), range of values, or pass/fail) | ||
Ø | Actual test result | ||
Ø | An indication of whether the actual test result represents a Pass or Fail result when compared to the test method acceptance criteria. | ||
Ø | Attestation of lot conformance to release specifications | ||
Ø | Signature/Date of a responsible Quality representative |
7.3.6. | All In-Process and Release Testing results are to be reviewed and approved by the appropriate Talecris Quality Management. |
7.4 | Retain Samples |
7.4.1. | Talecris is responsible for storing retain samples of the Bulk Drug Substance and Final Drug Product per 21 CFR Part 211.170. |
7.5 | Stability Testing |
7.5.1. | Talecris is responsible for conducting stability studies on the Finished Product, and identifying the batch number and quantity of samples for the lots to be tested. | ||
7.5.2. | Stability protocols will be generated by Talecris and approved by Talecris and Emergent. | ||
7.5.3. | Stability reports will be generated by Talecris and approved by Talecris and Emergent. Emergent will be responsible for any required action as a result of the stability data. |
7.6 | Out-of-Specification (OOS) Investigations |
7.6.1. | Talecris is responsible for investigating any in-process or Finished Product testing performed by Talecris that fails to meet approved specifications. Talecris will notify a designated Emergent Quality representative per the requirements for notification of deviations as outlined in Section 8.1. |
7.6.1.1. | Each OOS investigation will be reviewed by Talecris designated Quality representative(s), and will follow the procedures defined in appropriate Talecris SOPs for OOS Investigations. | ||
7.6.1.2. | For each confirmed Finished Product OOS result in which the investigation has not determined a root cause, Emergent will be allowed to review the investigation and approve the proposed re-test plan prior to any re-testing being performed. | ||
7.6.1.3. | For each OOS result in which the investigation has determined a root cause, Emergent reserves the right to review the |
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investigation and will be notified by Talecris of the intent to re-test prior to any re-testing being performed. |
7.6.2. | Emergent is responsible for investigating any in-process or Finished Product testing performed by Emergent that fails to meet approved specifications. Emergent will notify a designated Talecris Quality representative per the requirements for notification of deviations as outlined in Section 8.1. |
7.6.2.1. | Each OOS investigation will be reviewed by Emergent designated Quality representative(s), and will follow the procedures defined in appropriate Emergent SOPs for OOS Investigations. |
7.6.3. | Talecris shall retain final authority for the content of investigation reports for testing performed by Talecris and directly related to the [**] manufacture. | ||
7.6.4. | Emergent shall retain final authority for the content of investigation reports for product-specific testing performed by Emergent for all stages of manufacture. | ||
7.6.5. | Copies of all completed investigation reports will be included in the released, executed production batch record documentation provided to Emergent. |
8.1 | Deviations and Investigations |
8.1.1. | Deviation and Investigation Reports Any deviation from the process during manufacture, including but not limited to, batch record execution, environmental monitoring excursions or aseptic processing procedures, must be documented and investigated per Talecris approved procedures for conducting non-conformance investigations. |
8.1.1.1. | All non-conformance investigations will include an explanation of the non-conformance event, root cause analysis, impact assessment and corrective/preventive actions. | ||
8.1.1.2. | All non-conformance investigations directly related to the manufacture of Finished Product must be approved by Talecris Quality and the affected area management, and be included in the released, executed production batch record. | ||
8.1.1.3. | Any non-conformance event which has the potential to impact the safety, identity, strength, purity, or quality of the Finished Product will be communicated to Emergent Quality not more than [**] working days after discovery. | ||
8.1.1.4. | Emergent Quality will have the right to participate in and approve any investigation associated with a non-conformance event which has the potential to impact the safety, identity, strength, purity, or quality of the Finished Product. |
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8.1.2. | Talecris will provide notification to Emergent and investigate any adverse trends, including review of media fills and environmental monitoring data, which may directly impact Finished Product, either in process or that has previously shipped to Emergent, within [**] working days of initiation of the investigation. |
8.2 | Batch Disposition Documentation |
8.2.1. | Talecris is responsible for the review and final approval of the executed batch record(s) associated with [**]. | ||
8.2.2. | For each lot of [**] manufactured by Talecris for Emergent, Talecris will provide Emergent with the following documentation: |
Ø | Certificate of Conformance | ||
Ø | Certificate of Analysis (excluding testing performed by Emergent) | ||
Ø | A summary of non-conformances (i.e. deviation and/or OOS) | ||
Ø | Copies of any non-conformances that have been determined to have potential impact on the safety, identity, strength, purity, or quality of the [**] | ||
Ø | Lot Release Certificate signed by Talecris Quality |
8.2.3. | Prior to shipment, Talecris is responsible for the review and approval of the executed batch production record(s) associated with each lot of Finished Product manufactured for Emergent. | ||
8.2.4. | For each lot of Finished Product manufactured for Emergent, Talecris will provide Emergent with the following documentation: |
Ø | A copy of the product-specific executed production batch record(s), from the [**] forward, reviewed and approved by Talecris Quality | ||
Ø | Certificate of Conformance | ||
Ø | Certificate of Analysis (excluding testing performed by [**]) | ||
Ø | A summary of non-conformances (i.e., deviation and/or OOS) | ||
Ø | Copies of any non-conformances which have been determined to have potential impact on the safety, identity, strength, purity, or quality of the Finished Product |
8.2.5. | Emergent must authorize in writing [**] any lot of Finished Product [**] by Talecris prior to its disposition. |
8.3 | Product [**] |
8.3.1. | [**] is the sole responsibility of Talecris. | ||
8.3.2. | [**] is the sole responsibility of Emergent. | ||
8.3.3. | Any issue(s) discovered by Emergent associated with production batch record documentation, disposition documentation or samples provided to Emergent by Talecris that may impact or prevent the final release of the Finished Product, or that has the potential to cause the rejection of Finished Product by Emergent, will be communicated to Talecris by Emergent within [**] of discovery. Talecris is responsible for working with |
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Emergent in the conduct of any additional investigations that may be warranted to resolve the issue(s). |
8.4 | Records Retention |
8.4.1. | Talecris will retain production batch records for all stages of the manufacture of Finished Product for a minimum of at least one (1) year after the expiration date of corresponding lot of Finished Product or for such longer period as may be required by applicable law. | ||
8.4.2. | Talecris will not destroy any batch production records or associated documentation without obtaining written approval from Emergent prior to destruction. |
8.5 | Manufacturing and Quality Presence in the Manufacturing Facility |
8.5.1. | Talecris will maintain adequate, qualified Manufacturing and Quality personnel to ensure compliance with cGMP and the consistent manufacture of Finished Product. | ||
8.5.2. | Talecris will permit Emergent representatives to be present at the facility during the manufacture of Finished Product for observational purposes only. This presence will be limited to the manufacture of the initial Validation Lots. These visits will be pre-arranged by mutual consent. |
8.6 | Product Complaints |
8.6.1. | Emergent is responsible for receiving and [**]. | ||
8.6.2. | Emergent will notify Talecris within [**] of discovery of any complaints potentially associated with [**]. This notification may include a request for Talecris to initiate [**]. | ||
8.6.3. | In the event [**] becomes aware of a complaint [**], including [**] will notify [**] within [**] hours of becoming aware of the complaint. | ||
8.6.4. | Talecris will initiate an [**] within [**] of an Emergent request, for any complaint associated with [**] will be forwarded to Emergent Talecris within thirty (30) calendar days of [**]. Extensions for the completion of the [**] Talecris, along with justification for the extension and a proposed completion date, within the initial thirty (30) calendar day period. |
8.7 | Product Recalls |
8.7.1. | Emergent retains final decision making authority for product recalls associated with [**]. | ||
8.7.2. | Each party will notify the other party within [**] of (a) receipt of notification, written or otherwise, if any lot of [**] is alleged or proven to be the subject of a recall, market withdrawal or correction or (b) either partys determination that a recall may be warranted. | ||
8.7.3. | Emergent is responsible for instituting a recall of [**]. Emergent will notify Talecris of any recall decision within [**] of initiation if the recall is associated with the manufacture of the [**]. |
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8.7.4. | [**] issued by Talecris associated with the [**] of the recall [**] will be forwarded to Emergent within [**] after receipt of request. Extensions may be requested by Talecris, with justification and a proposed completion date, within the initial [**] period. |
8.8 | Adverse Events |
8.8.1. | Emergent shall advise Talecris of any adverse medical event or adverse drug event within [**] of Emergent receipt of notice thereof if thought to be due to manufacture of Finished Product. | ||
8.8.2. | Talecris will initiate an internal investigation within [**] of an Emergent notification of any adverse medical event or adverse drug event potentially associated with the manufacture of the Finished Product. | ||
8.8.3. | Investigation reports will be forwarded to Emergent by Talecris within [**] of initiation of the Talecris investigation. Extensions for the completion of the investigation may be requested by Talecris, along with justification for the extension and a proposed completion date, within the initial [**] period. |
8.9 | Look-Back Process for AIG source plasma provided by Emergent to Talecris under contract. |
8.9.1. | Emergent will arrange for the Plasma Collection Centers to notify Talecris and Emergent directly in the event a look-back notification occurs. | ||
8.9.2. | Talecris will investigate and act upon look-back notifications per approved procedures and policies. | ||
8.9.3. | For look back events affecting non-pooled [**], Talecris will provide Emergent documentation of destruction of the units identified on the notification (unit number/volume, donor number, date of destruction). | ||
8.9.4. | For look back events affecting pooled/processed plasma, Talecris will provide documentation to include the plasma pool date, associated product lot number(s), and the corresponding product impact assessment. |
9.1 | Regulatory Inspections |
9.1.1. | Talecris will permit access by the Regulatory Authorities, as defined in the Product Supply Agreement, to Talecris premises. Talecris will inform Emergent of any announced regulatory inspections that involve the Finished Product within [**], to permit Emergent to be present on site during the inspection. | ||
9.1.2. | Talecris will immediately inform Emergent of any unannounced regulatory inspections that involve the Finished Product. Talecris will permit an Emergent representative to be present on site during the inspection involving Finished Product. | ||
9.1.3. | Talecris will secure the agreement of Emergent prior to making any commitment to a Regulatory Authority specifically regarding Finished |
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Product. Emergent shall be provided with draft responses to regulatory observations that directly involve the Finished Product and may provide comments to the responses and corrective actions within [**]. Emergent shall retain the final authority and responsibility for the content of responses directly related to Finished Product. | |||
9.1.4. | Talecris will forward to Emergent any observations and associated responses from a routine regulatory inspection directly related to Finished Product. Talecris reserves the right to appropriately redact this documentation to preserve client confidential information. | ||
9.1.5. | Emergent will inform Talecris in writing of any regulatory issues that impact Talecris ability to manufacture the Finished Product. |
9.2 | Regulatory Actions |
9.2.1. | Talecris will notify Emergent in writing of any regulatory actions received by Talecris related to the Finished Product or regulatory actions received by Talecris that impact Talecris ability to manufacture the Finished Product. | ||
9.2.2. | Emergent will notify Talecris in writing of any regulatory actions received by Emergent related to the Finished Product or regulatory actions received by Emergent that impact Talecris ability to manufacture the Finished Product. | ||
9.2.3. | Talecris is responsible for supporting all investigations associated with regulatory actions related to the manufacture of the Finished Product. |
9.3 | Right to Audit |
9.3.1. | Talecris will permit Emergent to perform one standard cGMP compliance audit per year. |
9.3.1.1. | Talecris will allow representatives from Emergent to have access to Talecris manufacturing, warehousing, laboratory premises, records, regulatory filings and communications (i.e., FDA Form 483) directly associated with the manufacture of Finished Product for audit purposes provided, however, that Talecris has the obligation to protect the confidential information of its clients. |
9.3.2. | Talecris will permit Emergent to conduct for cause audits to address significant Finished Product quality or safety issues as discovered through Finished Product failures or complaints and determined to be potentially related to the manufacture of the Finished Product. |
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9.4 | Emergent may audit with the presence of Talecris any subcontractors that are utilized by Talecris in the manufacture of the Finished Product. Talecris will use reasonable efforts to cause such vendors, contractors or subcontractors to allow such audits. | ||
9.5 | Audit Closeout |
9.5.1. | For audits of Talecris conducted by Emergent, an exit meeting will be held with representatives from Talecris and Emergent to discuss audit observations. | ||
9.5.2. | Emergent will provide a written report of all observations within thirty (30) calendar days to Talecris. Within thirty (30) calendar days of the audit report receipt, Talecris will provide a written response to all findings that details corrective action to be implemented. Talecris will follow up to ensure that all corrective actions are implemented. |
10.1 | Non-Conformity of [**] |
10.1.1. | In the event that a dispute arises between Talecris and Emergent regarding the conformity of a lot of [**], the resolution will proceed as follows: |
10.1.1.1. | Direct communication between the Quality units from both parties will occur who will in good faith promptly attempt to reach an agreement. | ||
10.1.1.2. | If direct communication between the Quality units from both parties does not resolve the dispute and Talecris Quality Unit considers the disputed lot to be in conformance, Talecris Quality retains sole authority over final disposition of the [**] lot; however Emergent retains the right to reject the lot. |
10.2 | Test Result Conflict |
10.2.1. | In the event that a dispute arises between Talecris and Emergent regarding test results obtained during the manufacture and release of product lots, the resolution will proceed as follows: |
10.2.1.1. | Talecris and Emergent will determine that the methods of analysis are the same and are being executed in the same manner at both sites. | ||
10.2.1.2. | If the investigation dictates, carefully controlled and split samples shall be sent from one site to another in an attempt to reach agreement. | ||
10.2.1.3. | Analysts from both Talecris and Emergent shall be required to work side by side through the analysis of a mutually agreeable sample. | ||
10.2.1.4. | If resolution is not achieved after following the foregoing procedure, the samples shall be sent to an independent, |
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qualified testing laboratory agreed upon by both Talecris and Emergent. Talecris and Emergent shall agree to be bound by the results obtained by the independent laboratory. |
11.1 | Changes to the Process, Documents or Facility are to be processed using Talecris approved Change Control procedures. |
11.1.1. | All proposed changes must document, at a minimum, the proposed change, the reason/justification for the proposed change, the target date for implementation of the proposed change, an impact assessment, and documentation of pre- and post- validation or qualification requirements. The assessment of impact must include an impact of the proposed change on any regulatory filings and any required notification to regulatory authorities. |
11.2 | Talecris shall not make any change to the Process, Documents or any Facility (other than routine maintenance, reconditioning and/or replacement of the equipment) that would reasonably be expected to have a negative impact on [**] or Finished Product or require submissions to or approvals from any Regulatory Authority with respect to the source plasma or Finished Product, except by prior written approval of Emergent. |
11.2.1. | Emergent will assess proposed changes requiring Emergent signature within [**] and those changes marked urgent within [**]. | ||
11.2.2. | Completed change control documentation requiring Emergent approval shall be included as part of the Production Batch Record documentation forwarded to Emergent. | ||
11.2.3. | Proposed changes initiated by Emergent must be approved by Talecris and Emergent. |
12.1 | Equipment and Process Validation Talecris is responsible for ensuring that all necessary equipment and process validations are conducted as required by cGMP and other Regulatory Guidance Documents for the manufacture of Finished Product. | ||
12.2 | Cleaning Verification/Validation Talecris is responsible for ensuring that adequate cleaning of product contact parts used in the manufacture of Finished Product is carried out between batches of different product to prevent cross contamination. | ||
12.3 | Sterilization and Depyrogenation Validation Talecris is responsible for ensuring that sterilization processes are validated and that adequate sterilization and depyrogenation, as applicable, is carried out on the components and appropriate equipment prior to the manufacture of each batch of Finished Product. | ||
12.4 | Equipment, Computer, Facility, and Utilities Qualification Talecris is responsible for ensuring that any equipment, computer, facility, utility and support system used for the manufacture of Finished Product are qualified according to applicable regulatory requirements. |
Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.
Quality Agreement |
Emergent BioSolutions | |||
CONFIDENTIAL | Version 01 | Page 17 of 27 |
12.5 | Assay Validation Talecris is responsible for ensuring that all testing performed by Talecris related to Finished Product is conducted using appropriately validated assays. Emergent is responsible for ensuring that all testing performed by Emergent related to Finished Product is conducted using appropriately validated assays. | ||
12.6 | For any test methods specifically for Finished Product conducted by a Third Party laboratory contracted by Talecris, and approved by Emergent, Talecris is responsible for ensuring the required validation work is performed. | ||
12.7 | For any test methods conducted by a Third Party laboratory contracted by Emergent, Emergent is responsible for ensuring the required validation work is performed. Talecris will have the right to audit such labs jointly with Emergent upon request. | ||
12.8 | Packaging/Labeling/Shipping Qualification Emergent is responsible for the packaging configuration and shipping validation for Finished Product. |
13.1 | Talecris will notify Emergent [**] prior to introduction of a new product classification into the production areas used for the manufacture of Finished Product. |
14.1 | Talecris will be responsible for providing reports as requested by Regulatory Authorities under the shared license agreement. |
14.1.1. | Annual Product Review On an annual calendar-year basis, Talecris will prepare summary data for Finished Product processed within the prior calendar year. Such data will be prepared and sent to Emergent within [**] (unless otherwise agreed by Talecris and Emergent) of the end of the applicable calendar year during which the Finished Product was Processed hereunder. This data will include [**]. | ||
14.1.2. | Annual Report Emergent is responsible for preparing any Annual Reports for Investigational New Drugs and Licensed Product as required by applicable regulations. At least [**] before the Annual Report due date, Emergent shall request in writing from Talecris any information required by the regulations that must be provided by Talecris, including but not limited to a summary of any significant manufacturing or microbiological changes made during the past reporting year. Talecris will provide the requested information to Emergent within [**]. |
Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.
Quality Agreement |
Emergent BioSolutions | |||
CONFIDENTIAL | Version 01 | Page 18 of 27 |
AREA OF RESPONSIBILITY
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Emergent BioSolutions Inc. | Talecris Biotherapeutics, Inc. | ||
Product Development
|
James McIver | Deborah Barnette | ||
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Ph: (301) 944-0149 | Ph: (919)359-4601 | ||
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Fax: (301) 590-1251 | Fax: (919)359-4280 | ||
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McIverJ@ebsi.com | deborah.barnette@talecris.com | ||
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Manufacturing
|
James McIver | Jerry Sellers | ||
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Ph: (301) 944-0149 | Ph: (919)359-4533 | ||
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Fax: (301) 590-1251 | Fax: (919)359-5462 | ||
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MciverJ@ebsi.com | jerry.sellers@talecris.com | ||
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Quality Control
|
Edward Arcuri | Wayne Zunic | ||
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Ph: (301) 944-0109 | Ph: (919)359-4601 | ||
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Fax: (301) 944-0173 | Fax: ( 919)359-4431 | ||
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ArcuriE@ebsi.com | wayne.zunic@talecris.com | ||
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Audits
|
Joy Dumont | Barbara Sneade | ||
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Ph: (517) 327-1655 | Ph: (919)359-4415 | ||
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Fax: (517) 327-7207 | Fax: (919)359-4677 | ||
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DumontJ@ebsi.com | barbara.sneade@talecris.com | ||
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Validation
|
Edward Arcuri | Frank Highsmith | ||
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Ph: (301) 944-0109 | Ph: (919)359-7251 | ||
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Fax: (301) 944-0173 | Fax: (919)359-4000 | ||
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ArcuriE@ebsi.com | frank.highsmith@talecris.com | ||
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Regulatory
|
Virginia Johnson | Joan Robertson | ||
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Ph: (301) 944-0139 | Ph: (919)359-7128 | ||
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Fax: (301) 590-1252 | Fax: (919)359-7154 | ||
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JohnsonV@ebsi.com | joan.robertson@talecris.com | ||
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Product Complaints / Adverse Events
|
Robert Hopkins | Mary Ann Lamb | ||
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Ph: (301) 944-0136 | Ph: (919)359-7143 | ||
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Fax: (301) 944-1252 | Fax: (919)359-7304 | ||
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HopkinsR@ebsi.com | maryann.lamb@talecris.com | ||
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Quality Assurance
|
Edward Arcuri | John Parrish | ||
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Ph: (301) 944-0109 | Ph: (919)359-4592 | ||
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Fax: (301) 944-0173 | Fax: (919)550-4886 | ||
|
ArcuriE@ebsi.com | john.parrish@talecris.com |
* | All correspondence should be directed to David Sorrell of Talecris and Nili Leffers of Emergent |
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CONFIDENTIAL
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Summary of Responsibilities
RESPONSIBILITY
Stage(s) of Manufacturing
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Topic
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Talecris
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Talecris
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Summary of Responsibilities
RESPONSIBILITY
Stage(s) of Manufacturing
[**]
[**]
Topic
Emergent
Talecris
Emergent
Talecris
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Summary of Responsibilities
RESPONSIBILITY
Stage(s) of Manufacturing
[**]
[**]
Topic
Emergent
Talecris
Emergent
Talecris
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CONFIDENTIAL
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Summary of Responsibilities
RESPONSIBILITY
Stage(s) of Manufacturing
[**]
[**]
Topic
Emergent
Talecris
Emergent
Talecris
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Page 25 of 27
RESPONSIBILITY | ||||||||||||||||
Stage(s) of Manufacturing | ||||||||||||||||
[**] | [**] | |||||||||||||||
Topic | Emergent | Talecris | Emergent | Talecris | ||||||||||||
CHANGE MANAGEMENT
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[**] | [**] | [**] | [**] | ||||||||||||
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Talecris Initiated
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a. Approval of changes to facility
or Gamunex process, including
testing and specifications , that do
not impact [**]
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b. Notification of non-routine
changes to facility or Gamunex
process, including testing and
specifications, that have the
potential to impact [**]
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c. Review and approval of
non-routine changes to facility or
Gamunex process, including testing
and specifications, that have the
potential to impact [**]
|
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d. Review of changes to facility or
Gamunex process, including testing
and specifications, required to
maintain compliance to GMP during
audit(s)
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e. Approval of changes to facility
or Gamunex process, including
testing and specifications, required
to maintain GMP
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Emergent Initiated
|
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f. Approval of changes to process
including specifications that do not
impact facilities or Gamunex process
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g. Notification of changes to
process including specifications
that have the potential to impact
facilities or Gamunex process
|
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h. Approval of changes to process
including specifications that have
the potential to impact facilities
or Gamunex process
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CONFIDENTIAL
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Summary of Responsibilities
RESPONSIBILITY
Stage(s) of Manufacturing
[**]
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Topic
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Talecris
Emergent
Talecris
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2
EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.
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By /s/ R. Don Elsey | ||||
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Name: | R. Don Elsey | |||
Title: | Treasurer | |||
By /s/ [Illegible]
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Name:
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Title:
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Date:
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06/16/06 | Agreed and accepted by: |
EMERGENT BIOSOLUTIONS INC.
|
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By: | /s/ Daniel J. Abdun-Nabi | |||
Name: Daniel J. Abdun-Nabi | ||||
Title: SVP, Corporate Affairs, General Counsel | ||||
Date: June 20, 2006 | ||||
3
Test Interval [**] | ||||||||||||||||||||||||||||||||||||
Test | Initial | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | |||||||||||||||||||||||||||
Appearance: color, clarity
|
X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||||
pH (diluted)
|
X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||||
Molecular Weight Distribution
|
X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||||
Anticomplement Activity
|
X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||||
Prekallikrein Activator (PKA)
|
X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||||
[**]
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X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||||
[**]
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X | X | X | X | X | X | X | X | X | |||||||||||||||||||||||||||
[**]
|
X | X |
Test Interval, [**] | ||||||||||||||||||||
Test | Initial | [**] | [**] | [**] | [**] | |||||||||||||||
Appearance: color, clarity
|
X | X | X | X | X | |||||||||||||||
pH (diluted)
|
X | X | X | X | X | |||||||||||||||
Molecular Weight Distribution
|
X | X | X | X | X | |||||||||||||||
Anticomplement Activity
|
X | X | X | X | X | |||||||||||||||
Prekallikrein Activator (PKA)
|
X | X | X | X | X | |||||||||||||||
[**]
|
X | X | X | X | X | |||||||||||||||
[**]
|
X | X | X | X | X |
Note: | Protocols, procedures, timing and other terms to be further defined and agreed upon by the parties in advance of implementation. |
| Anthrax ( Bacillus anthracis ) | ||
| Botulism ( Clostridium botulinum toxin) | ||
| Plague ( Yersinia pestis ) | ||
| Smallpox (variola major) | ||
| Tularemia ( Francisella tularensis ) | ||
| Viral hemorrhagic fevers (filoviruses [e.g., Ebola, Marburg] and arenaviruses [e.g., Lassa, Machupo]) |
| Brucellosis ( Brucella species) | ||
| Epsilon toxin of Clostridium perfringens | ||
| Food safety threats (e.g., Salmonella species, Escherichia coli O157:H7, Shigella ) | ||
| Glanders ( Burkholderia mallei ) | ||
| Melioidosis ( Burkholderia pseudomallei ) | ||
| Psittacosis ( Chlamydia psittaci ) | ||
| Q fever ( Coxiella burnetii ) | ||
| Ricin toxin from Ricinus communis (castor beans) | ||
| Staphylococcal enterotoxin B | ||
| Typhus fever ( Rickettsia prowazekii ) | ||
| Viral encephalitis (alphaviruses [e.g., Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis]) | ||
| Water safety threats (e.g., Vibrio cholerae , Cryptosporidium parvum ) |
| Emerging infectious diseases such as Nipah virus and hantavirus |
| can be easily disseminated or transmitted from person to person; | ||
| result in high mortality rates and have the potential for major public health impact; |
| might cause public panic and social disruption; and | ||
| require special action for public health preparedness. |
| are moderately easy to disseminate; | ||
| result in moderate morbidity rates and low mortality rates; and | ||
| require specific enhancements of CDCs diagnostic capacity and enhanced disease surveillance. |
| availability; | ||
| ease of production and dissemination; and | ||
| potential for high morbidity and mortality rates and major health impact. |
1. | The Container Closure Study is no longer applicable. | |
2. | Details of the Process Validation Study is attached. |
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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Page 2 of 27
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Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For Emergent Product Development Gaithersburg Inc |
[**] Page 3 of 27 |
Author
|
Date | |
/s/ Erin Sorrell
|
7-21-06 | |
Print Name and Title: Erin Sorrell, Validation Specialist
|
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|
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Reviewer:
|
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Regulatory Affairs
|
Date | |
/s/ Joan Robertson
|
7/21/06 | |
Print Name and Title: Joan Robertson, Deputy Director, Regulatory Affairs
|
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|
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Talecris Approvers:
|
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Qualification and Validation Engineering
|
Date | |
/s/ Jeff Crane
|
7/21/06 | |
Print Name and Title: Jeff Crane, Validation Manager
|
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|
||
Technical Operations - Fractionation
|
Date | |
/s/ Joe Barbour
|
07/24/06 | |
Print Name and Title: Joe Barbour, Manager Production II
|
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|
||
Technical Operations - Gamunex
|
Date | |
/s/ Jonathan Kent
|
07/24/06 | |
Print Name and Title: Jonathan Kent, Technical Support Manager
|
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Technology
|
Date | |
/s/ Douglas B. Burns
|
7/24/06 | |
Print Name and Title: Doug Burns, Sr. Process Development Engineer II
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||
Quality Operations - Fractionation
|
Date | |
/s/ Amy W. Durham
|
7-24-06 | |
Print Name and Title: Amy Durham, Manager Quality
|
||
|
||
Quality Operations - Gamunex
|
Date | |
/s/ Cherilyn Metzler for Clara Schreiner
|
7-24-06 | |
Print Name and Title: Clara Schreiner, Manager Quality
|
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
[**]
Page 4 of 27
Representative
|
Date | |
/s/ Jim Molver
|
24 July 2006 | |
Print Name and Title: Jim Molver, Project Leader
|
||
|
||
Representative
|
Date | |
/s/ [illegible]
|
24 July 2006 | |
Print Name and Title: Mike Cowan, VP of Quality
|
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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Page 5 of 27
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Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For Emergent Product Development Gaithersburg Inc |
[**] Page 6 of 27 |
1. | PURPOSE |
1.1. | The purpose of this Process Verification (PV) protocol is to document the ability to manufacture Anthrax Immune Globulin (AIG) for Emergent Product Development Gaithersburg Inc (hereafter referred to as Emergent) from Source Plasma obtained from immunized donors in the Fractionation Facility, Building [**] and the IGIV Chromatography Facility, Building [**], at the Talecris Biotherapeutics Division in Clayton, NC. |
2. | SCOPE AND RATIONALE |
2.1. | The scope of this study is to verify that the [**] are capable of [**]. Emergent will [**] and will provide the plasma to Talecris. The source plasma must meet all FDA and Talecris requirements. The protocol requires samples at various points throughout the production process from plasma pool to final container. Additionally, all Batch Production Record (BPR) requirements must be met. The rationale for this approach is based on the following documents used to validate the existing fractionation and purification processes: |
2.1.1 | [**]. | ||
2.1.2 | [**]. |
2.2. | Study Design |
2.2.1. | [**]. | ||
2.2.2. | [**]. | ||
2.2.3. | [**]. | ||
2.2.4. | [**]. |
3. | REFERENCES |
3.1. | Validation Procedures and Documents | ||
[**] [**] | |||
[**] [**] | |||
[**] [**] | |||
[**] [**] | |||
[**] [**] | |||
[**] [**] |
3.2. | Standard Operating Procedures | ||
[**] [**] | |||
[**] [**] | |||
[**] [**] |
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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Page 7 of 27
3.3.
Manufacturing Procedures - Batch Production Records
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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Page 8 of 27
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[**] | [**] | ||
|
[**] | [**] | ||
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[**] | [**] | ||
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[**] | [**] | ||
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[**] | [**] | ||
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[**] | [**] | ||
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[**] | [**] | ||
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[**] | [**] | ||
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4. | ACRONYMS AND DEFINITIONS |
|
Acronym | Definition | ||
|
AIG | Anthrax Immune Globulin | ||
|
AIGIV | Anthrax Immune Globuiin Intravenous | ||
|
BPR | Batch Production Record | ||
|
C | Celsius | ||
|
CV | Column Volumes | ||
|
CWFI | Cold Water For Injection | ||
|
CZE | Capillary Zone Electrophoresis | ||
|
EIA | Enzyme Immunoassay | ||
|
HPLC | High Performance Liquid Chromatography | ||
|
IGIV-C | Immunoglobulin Intravenous Chromatography | ||
|
[**] | [**] | ||
|
ITS | Incident Tracking System | ||
|
kg | Kilograms | ||
|
NLT | Not Less Than | ||
|
NMT | Not More Than |
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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OOS
Out Of Specification
PKA
Prekallikrein Activator
PV
Process Verification
QOPQM
Quality Operations Product Quality Management
QOSCL
Quality Operations Supply Chain Laboratory
QVE
Qualification and Validation Engineering
[**]
[**]
[**]
[**]
SOP
Standard Operating Procedure
[**]
[**]
[**]
[**]
5.
RESPONSIBILITIES
5.1. | Qualification and Validation Engineering. |
5.1.1. | Prepares protocol, final report and final report packet. | ||
5.1.2. | Coordinates the execution of the protocol including non-routine sampling with all involved groups. | ||
5.1.3. | Reviews all data collected during the execution for completeness and compliance with acceptance criteria. | ||
5.1.4. | Verifies that any incidents encountered during execution are documented and resolved in accordance with [**]. | ||
5.1.5. | Reviews and approves the verification protocol, interim reports, and final |
report for quality, accuracy, and completeness. 5.2. Regulatory Affairs |
5.2.1. | Reviews the process verification protocol, interim reports, and final report for quality, accuracy, and completeness. |
5.3. | Technical Operations |
5.3.1. | Reviews and approves the process verification protocol, interim reports, and final report for quality, accuracy, and completeness. | ||
5.3.2. | Assists QVE in the execution of the protocol, including scheduling the lots and collecting samples, |
5.4. | Supply Chain / Materials Management |
5.4.1. | Schedules PV runs. |
5.5. | Engineering |
5.5.1. | Maintains all associated instruments in a calibrated state during the execution of this protocol. |
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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Page 10 of 27
5.5.2. | Assists QVE in obtaining documentation required for the completion of the protocol execution. |
5.6. | Quality Operations Product Quality Management |
5.6.1. | Approves the process verification protocol, any incidents, interim reports, and the final report. |
5.7. | Quality Operations Supply Chain Laboratory / Bioanalytics |
5.7.1. | Completes all laboratory testing requirements stated in the protocol. | ||
5.7.2. | Provides a detailed report of the laboratory test results to be included in the final process verification report packet. |
5.8. | Emergent Representatives |
5.8.1. | Approves the process verification protocol, interim reports, and final report. |
5.9. | Technology |
5.9.1. | Approves the process verification protocol and final report. |
6. | EQUIPMENT/PROCESS FUNCTIONAL REQUIREMENTS |
6.1. | Plasma will be pooled in volumes of approximately [**] liters and fractionated by the Cohn- Oncley method of cold ethanol fractionation to [**] according to approved BPRs and SOPs at Talecris Biotherapeutics in Clayton, NC. Fractions will be held in cGMP condition at [**]°C or below until a combined paste equivalent to approximately [**] liters of plasma is collected. At that time, purification, formulation, fill and finish of the final AIG product will be completed by the licensed process used by Talecris to manufacture Gamunex®. |
7. | EQUIPMENT SYSTEM DESCRIPTION |
7.1. | The same equipment licensed for use in the fractionation ([**]), purification ([**]), filling ([**]) and packaging ([**]) of Gamunex® will be used for AIG manufacture. |
8. | REQUIRED DOCUMENTATION |
8.1. | All production data will be documented in approved BPRs at the time of execution. Talecris Quality Operations will review the BPRs to verify that all license parameters are met. | ||
8.2. | The original data in support of the verification lots will be maintained by the respective departments where testing is conducted. Copies of the original data will be included in the final report package. QOSCL data will be maintained in Quality Operations Release in lot packets. | ||
8.3. | Incidents will be documented on an Incident Tracking System Notification Form and recorded on the Incident Log sheet. Incident Reports will be included in the final report package. |
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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Page 11 of 27
9. | TEST PROCEDURE |
9.1. | Processing will occur according to approved BPRs, Sample Tables and Standard Operating Procedures (SOPs). | ||
9.2. | All operators involved in this PV must be trained on the approved documentation prior to the execution of this protocol. | ||
9.3. | Execution |
9.3.1. | Routine samples will be collected concurrent with production according to the processing BPRs and approved sampling tables. | ||
9.3.2. | Non-routine samples will be collected as described in this protocol. | ||
9.3.3. | All routine samples will be submitted to Quality Operations Supply Chain Laboratory or Bioanalytics for testing following sample collection. Non-routine samples to be tested by Emergent will be collected and stored as specified in this protocol prior to shipment. | ||
9.3.4. | The Run Number recorded on Test Function data sheets may be recorded as number and alphabet (1a and 1b) for pooled lots that will be combined. | ||
9.3.5. | Any results obtained outside of the specified test conditions or acceptance criteria will be documented on an Incident Tracking System Notification Form and recorded on the Incident Log sheet. |
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Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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10. | SAMPLING PLAN |
10.1. | The following table outlines samples for this process verification. Samples for In-Process Testing Routinely Performed by Talecris column will be pulled by the Sample Tables specified in each test function. (Qualification samples referred to in the Sample Tables are not required for this verification protocol.) Samples for In-Process Testing Routinely Performed by Emergent will be considered non-routine samples in this protocol. Non-routine samples will be collected according to the test functions in this protocol. |
Sampling for | ||||||||||||||||
In-Process Testing | In-Process Testing | Reference | ||||||||||||||
Routinely | Routinely | Standard | ||||||||||||||
Performed by | Performed by | Preparation by | ||||||||||||||
Sampling Point / Sample Description | Assays | Talecris | Emergent | Emergent | ||||||||||||
[**]
|
[**] | [**] | [**] | [**] | ||||||||||||
[**]
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[**] | [**] | [**] |
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Anthrax Immune Globulin Intravenous (AIGIV) For
Emergent Product Development Gaithersburg Inc
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Sampling for
In-Process Testing
In-Process Testing
Reference
Routinely
Routinely
Standard
Performed by
Performed by
Preparation by
Sampling Point / Sample Description
Assays
Talecris
Emergent
Emergent
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
Process Verification Protocol
Anthrax Immune Globulin Intravenous (AIGIV) For
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11. | TEST FUNCTION 1 PLASMA TESTING |
11.1. | Purpose |
11.1.1. | To provide test Instructions to verify that the plasma used for the AIG meets predetermined acceptance criteria. |
11.2. | Rationale |
11.2.1. | The plasma must be acceptable to be used in this process verification. |
11.3. | Procedure |
11.3.1.1. | [**]. | ||
11.3.1.2. | [**]. | ||
11.3.1.3. | [**]. | ||
11.3.1.4. | [**]. |
11.3.4.1 | [**]. | ||
11.3.4.2 | [**]. | ||
11.3.4.3 | [**]. |
Verified by | ||||
Sample progress | and Date | |||
Samples collected
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Samples stored at [**]C
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Samples sent to Emergent
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11.4. | Acceptance Criteria |
11.4.1. | [**]. | ||
11.4.2. | [**]. |
Acceptance | Verified | |||||||
Critical Parameters | Acceptance Criteria | Criteria Source | Actual Result | By/Date | ||||
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12.1. | Purpose |
12.1.1. | To provide test instructions to verify non-clarified pools can be successfully processed to [**]. |
12.2. | Rationale |
12.2.1. | The [**] must meet specifications and quality attributes in accordance with Talecris requirements to be used in this process verification. |
12.3. | Procedure |
12.3.1. | [**]. |
12.4. | Acceptance Criteria |
12.4.1 | [**]. |
13.1. | Purpose |
13.1.1. | To provide test instructions to verify [**] can be successfully processed to [**]. |
13.2. | Rationale |
13.2.1. | [**] must meet specifications and quality attributes to be used in this process verification. |
13.3. | Procedure |
13.3.1 | [**]. |
13.4. | Acceptance Criteria |
13.4.1 | [**]. |
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14.1. | Purpose |
14.1.1. | To provide test instructions to verify [**] can be successfully processed to [**]. |
14.2. | Rationale |
14.2.1. | [**] suspension and [**] must meet specifications and quality attributes to be used in this process verification. |
14.3. | Procedure |
14.3.1 | [**]. |
14.4. | Acceptance Criteria |
14.4.1 | [**]. |
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15.1. | Purpose |
15.1.1. | To provide test instructions to verify [**] can be successfully processed to [**]. |
15.2. | Rationale |
15.2.1. | Caprylate treatment and [**] must meet specifications and quality attributes to be used in this process verification. |
15.3. | Procedure |
15.3.1 | [**]. |
15.4. | Acceptance Criterion |
15.4.1. | [**]. | ||
15.4.2. | [**]. |
Acceptance | Verified | |||||||
Critical Parameters | Acceptance Criterion | Criterion Source | Actual Result | By/Date | ||||
Caprylate Treatment 2 | ||||||||
Caprylate
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[**] | [**] |
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16.1. | Purpose |
16.1.1. | To provide test instructions to verify [**] can be successfully processed through the Chromatography Columns. |
16.2. | Rationale |
16.2.1. | Chromatography flow-through must meet specifications and quality attributes to be used in this process verification. |
16.3. | Procedure |
16.3.1. | [**]. |
16.4. | Acceptance Criteria |
16.4.1 | [**]. |
17.1. | Purpose |
17.1.1. | To provide test instructions to verify column flowthrough material can be successfully processed by [**]. |
17.2. | Rationale |
17.2.1. | The [**] and formulation process must meet specifications and quality attributes to be used in this process verification. |
17.3. | Procedure |
17.3.1 | [**]. |
17.4. | Acceptance Criteria |
17.4.1 | [**]. |
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18.1. | Purpose |
18.1.1. | To provide test instructions to verify that the formulated bulk can be successfully prepared and processed to [**]. |
18.2. | Rationale |
18.2.1. | The [**] must meet specifications and quality attributes to be used in this process verification. |
18.3. | Procedure |
18.3.1. | [**]. | ||
18.3.2. | Collect non-routine TNA concentration [**]sample for Emergent. |
18.3.2.1. | [**]. | ||
18.3.2.2. | [**]. | ||
18.3.2.3. | [**]. |
Verified by | ||
Sample progress | and Date | |
Samples collected
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Samples stored at [**]°C
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Samples sent to Emergent
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18.4. | Acceptance Criteria |
18.4.1. | [**]. | ||
18.4.2. | [**]. |
Acceptance | Verified | |||||||
Critical Parameters | Acceptance Criteria | Criteria Source | Actual Result | By/Date | ||||
[**]
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Total Protein
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[**] | [**] | ||||||
pH, diluted
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[**] | [**] | ||||||
Glycine
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IgA
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[**] | [**] | ||||||
IgM
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Anti-PA IgG ELISA
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[**] | [**] | ||||||
TNA Assay
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(Potency)
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[**] | [**] | ||||||
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Sterility
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[**] | [**] |
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19.1. | Purpose |
19.1.1. | To provide test instructions to verify the [**] can be successfully processed to final container. |
19.2. | Rationale |
19.2.1. | Final containers must meet specifications and quality attributes to be used in this process verification. |
19.3. | Procedure |
19.3.1 | Fill the [**]. | ||
19.3.2 | [**]. | ||
19.3.3 | [**]. |
19.3.3.1 | [**]. | ||
19.3.3.2 | [**]. | ||
19.3.3.3 | [**]. |
Verified by | ||
Sample progress | and Date | |
Samples collected
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Samples stored at [**]°C to [**]°C
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Samples sent to Emergent
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19.4. | Acceptance Criteria | ||||
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19.4.1. [**]. |
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19.4.2. [**]. |
Critical | Acceptance | Verified | ||||||||||
Parameters | Acceptance Criteria | Criteria Source | Actual Result | By/Date | ||||||||
Final Container
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Appearance
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[**] | [**] | ||||||||||
Volumetric fill
check
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[**] | [**] | ||||||||||
Protein
concentration
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[**] | [**] | ||||||||||
Protein composition
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[**] | [**] | ||||||||||
Glycine
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Sodium Caprylate
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Prekallikrein
Activator
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Anticomplement Assay
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IgA
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Acceptance | Verified | |||||||||||||
Critical Parameters | Acceptance Criteria | Criteria Source | Actual Result | By/Date | ||||||||||
IgM
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[**] | [**] | ||||||||||||
Sterility, USP
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[**] | [**] | ||||||||||||
Pyrogen, USP
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Safety
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Isoagglutinin Titer
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Molecular [**]
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Weight [**]
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pH of 1% protein solution
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Turbidity
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Anti-D
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Acceptance Criteria | Verified | |||||||
Critical Parameters | Acceptance Criteria | Source | Actual Result | By/Date | ||||
Osmolatity
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[**] | [**] | ||||||
Identity: [**]
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[**] | [**] | ||||||
[**] (Potency)
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Anti-PA IgG ELISA
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20. | INCIDENT LOG |
20.1. | An Incident Tracking System Notification Form shall be completed for any incident encountered during the execution of the protocol as according to [**]. The table below will document the Incident number and the protocol section to which it applies as well as ensure that each Incidents Batch Disposition record has been satisfactorily resolved before final approval. |
ITS or Batch | ||||||
Disposition | ||||||
Incident Number | Protocol Reference Section | Approval Date | Verified By/Date | |||
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Qualification and Validation Engineering
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Print Name and Title:
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Qualification Operations Product Quality Management Fractionation
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Print Name and Title:
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Qualification Operations Product Quality Management Gamunex
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1.a) | The StMUGV intends and is obliged to strengthen Bavaria as development and research location. Thus the StMUGV is particularly interested in encouraging and supporting young innovative enterprises in the region. | |
b) | The Free State of Bavaria owns a pre-vaccine for small pox that was approved between 1977 and 1987. The pre-vaccine contains the Modified Vacciniavirus Ankara (MVA) as active live vaccine. The Bavarian institute for vaccination had developed this vaccine and had documented its preparation. | |
2.a) | VIVACS is a biotech company, located in the Gründerzentrum IZB (Founders Center) in Munich that specializes in the development and production of viral vectors and recombinant viral vectors that may be used as vaccines against infectious diseases or cancer. | |
b) | VIVACS works primarily with MVA as vector system. The employees of VIVACS are all experienced with the treatment, the breeding, the reproduction and the preparation of recombinants from MVA and from other orto pox viruses. | |
c) | It is VIVACS declared goal to harmonize the standards in the field of Vaccinavirus technology and to make the promising MVA technology available to a broad scientific and industrial community. | |
d) | Based on this goal VIVACS considers itself a service provider that not only develops recombinant virus vectors by order of third parties but wishes to produce and offer standardized reference material, for example control vectors. | |
e) | In order to reach the goals described under d) VIVACS prefers to work with standardized and well-documented starting materials ( Ausgangsmaterialien ) and executes all works according to a standard similar to GLP. Within medium term VIVACS aims for a GLP certification. |
f) | VIVACS is interested in using and marketing the pre-vaccine owned by StMUGV as starting material ( Ausgangsmaterial ) for the production of standardized control vectors, reference materials and for the production of recombinant virus vectors. | |
3. | In order to realize their respective goals and in accordance with the following definitions the parties agree as follows: |
1. | StMUGV makes available to VIVACS Material according to Schedule 1 to be used as Starting Material for the production of recombinant virus vectors for research purposes and for the development of vaccines. In addition StMUGV hands over to VIVACS a copy of the relevant documentation and all existing information on clinical vaccination trials that were conducted with the small pox pre-vaccine. |
2. | StMUGV permits VIVACS to win an isolate from the provided Materials that may be then used and marketed as MVA Starting Material for further Products. | |
3. | StMUGV undertakes to inform VIVACS in case MVA Starting Material is made available to a third party under generally similar but better conditions than the conditions agreed on under Section 3.6.1 of this agreement in connection with schedule 2 and agrees to amend Section 3.6.1 of this agreement in connection with schedule 2 based on such better conditions. |
1. | VIVACS does use the provided Materials and the Documentation exclusively for the development of standardized Reference Materials, control vectors and for the production of recombinant virus vectors in Bavaria. | |
2. | VIVACS undertakes not to give the provided Materials in their starting form ( überlassene Materialien in ihrer Ausgangsform ) to third parties and to secure them against being taken away by third parties. | |
3. | Any remaining Materials in their starting form must be returned to StMUGV in case VIVACS is liquidated and in case of termination of this agreement. | |
4. | VIVACS is the sole producer of the Products. | |
5. | VIVACS is the owner of the Products and is entitled to market or license them worldwide. | |
6.1 | VIVACS undertakes to allow StMUGV a share in the marketing of the Products according to the breakdown in Schedule 2. Such share is to be paid in Euro. | |
6.2 | VIVACS undertakes to transfer the due payments once a year and with effect of September 1 of each year respectively to the account of the Staatsoberkasse Bayern, Buchungsstelle München, account no. 24592 at the Bayer.Landesbank München, bank identification code 700 500 00. | |
6.3 | VIVACS undertakes to forward StMUGV a report on its marketing activities, the marketing success that have been achieved according to Schedule 2 and the payments due to StMUGV by August 31, of each year respectively. | |
7.1 | VIVACS undertakes to keep the most precise account on the development, the production and the marketing of Products that are based on the provided Materials. Such books must be retained for at least 10 years. | |
7.2 | VIVACS undertakes to allow inspection of the books named in Section 7.1 during normal business hours and in VIVACS premises upon request of StMUGV or an independent auditor or other expert named by StMUGV. StMUGV shall bear the costs of such audit. | |
7.3 | In case the audit reveals that the paid sum deviates from the sum payable to StMUGV by more than EUR 1,000, VIVACS shall bear the costs of the audit. | |
8. | VIVACS may use the Materials history for own marketing purposes. |
1. | To the extent that new inventions are made in the course of VIVACS development and production of Products, VIVACS is solely entitled to apply for patents and to effect Trademark Rights. | |
2. | VIVACS shall bear all costs for the application and enforcement of Property Rights. |
1. | StMUGV does not warrant and is not liable for the quality and the security profile for the handed over Materials. | |
2. | StMUGV does not warrant and is not liable for the applicability of the handed over Materials for the contractual purposes, in particular that the handed over Materials are viable and augmentable. | |
3. | StMUGV does not warrant and is not liable for the completeness and correctness of the handed over documentation. | |
4. | StMUGV is furthermore not liable for any damages whatsoever that may arise from the handed over Materials, particularly from the contact and the use of the handed over Materials. | |
5. | VIVACS undertakes to indemnify StMUGV or its employees from all claims for damages of third parties that may arise from the use or marketing of Products from the originally handed over Materials. | |
6. | VIVACS further undertakes to effect relevant liability insurances and to exclude any claims for damages of third parties in all marketing or licensing agreements with third parties. |
1. | VIVACS may assign this agreement and possible Property Rights including all rights and obligations to a legal successor/assignee or contribute it to a trading company or other legal entity only upon StMUGVs consent. | |
2.1 | VIVACS undertakes to pay a contractual penalty of up to EUR 50,000 in case it breaches the obligations provided for in Sections: |
2.2 | StMUGV is entitled to define the actual amount of the contractual penalty within the given frame of EUR 50,000 in each case. |
2.3 | In case VIVACS does not fulfill a contractual obligation at all or not in a proper manner, the contractual penalty becomes due if VIVACS is in breach according to the provisions of the German Civil Code ( BGB ). In case of a default the penalty becomes due with the default. | |
2.4 | StMUGV reserves the right to claim further damages. In case StMUGV claims damages in addition to the contractual penalty, the forfeited contractual penalty shall be credited against the claim for damage. |
1. | Any party is entitled to terminate the agreement for cause without a notice period. Cause for termination is given if the other party has willfully breached one of its contractual obligations and such breach is not cured within a reasonable time limit, set by the other party. | |
2. | Cause for a termination by StMUGV is given, in case of VIVACS repeated default of payment or if VIVACS becomes insolvent or is liquidated. | |
3. | Any rights and obligations related to marketing agreements that have at the time of the termination already been entered into by VIVACS shall not be affected by the termination. New marketing agreements may not be entered into. |
1. | This agreement is subject to German law. | |
2. | The relevant court of Jurisdiction for any possible disputes shall be the Munich County Court I ( Landgericht München I ). | |
3. | There are no side agreements. Any amendments to this agreement shall only be valid if they are made in written form and executed by the parties. | |
4. | In case any of the provisions of this agreement is or becomes void or in case the agreement is unintentionally silent, the other provisions shall not be affected. Instead of the void provision a valid provision that comes closest to the parties intention shall be deemed agreed on. The same applies in case the agreement is unintentionally silent. |
MVA pre-vaccine:
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approval | January 31, 1977 | ||
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approval expired | December 31, 1987 |
Handed over to VIVACS: | Charge MVA 470 MG | |||
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(Including the copies of the production documentation of MVA 470 MG and the seed virus MVA 460 MG) | ||||
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Release of Charge: | December 12, 1977 | ||
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Amount: | 5 containers of 0.5 ml each | ||
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(before Lyophilisation) |
1. | From the marketing of Products that are given away for research purposes, the StMUGV receives: |
2. | From the marketing of Products that are given away or licensed for other purposes, particularly for medical and diagnostic use, the StMUGV receives: |
3. | From the marketing of Products that are licensed as Starting Material for the production of a small pox vaccine, the StMUGV receives: |
Name of Subsidiary | Jurisdiction of | |
Incorporation or Organization | ||
Emergent BioSolutions Inc.
|
Delaware | |
*Emergent BioDefense Operations Lansing Inc.
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Michigan | |
Emergent Product Development Gaithersburg Inc.
|
Delaware | |
Emergent Commercial Operations Frederick Inc.
|
Maryland | |
Emergent Frederick LLC
|
Maryland | |
Emergent Sales and Marketing US LLC
|
Delaware | |
Emergent International Inc.
|
Delaware | |
Emergent Europe Inc.
|
Delaware | |
Emergent Product Development UK Limited
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England and Wales | |
Emergent Sales and Marketing Germany GmbH
|
Germany | |
Emergent Product Development Germany GmbH
|
Germany | |
Emergent BioSolutions Malaysia SDN BHD
|
Malaysia | |
Emergent Sales and Marketing Singapore Pte. Ltd.
|
Singapore |