(Mark One)
|
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended September 30, 2016
|
|
OR
|
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from
to
|
Delaware
|
14-1902018
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
|
400 Professional Drive, Suite 400
|
|
Gaithersburg, Maryland
|
20879
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Part I. Financial Information
|
|
Item 1.
|
Unaudited Financial Statements
|
Item 2.
|
|
Item 3.
|
|
Item 4.
|
|
Part II. Other Information
|
|
Item 1.
|
|
Item 1A.
|
|
Item 2.
|
|
Item 3.
|
|
Item 4.
|
|
Item 5.
|
|
Item 6.
|
|
|
appropriations for the procurement of BioThrax
®
(Anthrax Vaccine Adsorbed) and our other countermeasure products;
|
|
our ability to perform under our contracts with the U.S. government related to BioThrax, including the timing of deliveries;
|
|
our ability to obtain a new procurement contract for BioThrax on favorable terms;
|
§ |
our ability to obtain Emergency Use Authorization pre-approval for NuThrax from the FDA;
|
|
the availability of funding for our U.S. government grants and contracts;
|
|
our ability to successfully execute our growth strategy and achieve our financial and operational goals;
|
|
our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities or businesses that we acquire;
|
|
our ability to utilize the full manufacturing capacity of Building 55, our large-scale vaccine manufacturing facility in Lansing, Michigan;
|
§ |
whether the operational, marketing and strategic benefits of the spin-off of our biosciences business can be achieved and the timing of any such benefits;
|
|
our ability to identify and acquire companies or in-license products or late-stage product candidates that satisfy our selection criteria;
|
|
our ability to realize synergies and benefits from acquisitions or in-licenses within expected time periods or at all;
|
|
our ability to successfully identify and respond to new development contracts with the U.S. government, as well as successfully maintain, through achievement of development milestones, current development contracts with the U.S. government;
|
|
our ability to obtain and maintain intellectual property protection for our products and product candidates;
|
|
our ability and plans to expand our manufacturing facilities and capabilities;
|
|
our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations;
|
|
the results of regulatory inspections;
|
|
the operating and financial restrictions placed on us and our subsidiaries under our senior secured credit facility;
|
§ |
the outcome of the purported class action lawsuit filed against us and possible other future material legal proceedings;
|
|
the rate and degree of market acceptance and clinical utility of our products;
|
|
the success of our ongoing and planned development programs, non-clinical activities and clinical trials of our product candidates;
|
|
our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals;
|
|
the success of our commercialization, marketing and manufacturing capabilities and strategy; and
|
|
the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.
|
Consolidated Balance Sheets
|
||||||||
(in thousands, except share and per share data)
|
||||||||
September 30, 2016
|
December 31, 2015
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
298,932
|
$
|
308,304
|
||||
Accounts receivable, net
|
69,633
|
113,906
|
||||||
Inventories
|
81,160
|
60,887
|
||||||
Income tax receivable, net
|
11,831
|
6,573
|
||||||
Prepaid expenses and other current assets
|
18,439
|
18,458
|
||||||
Current assets of discontinued operations
|
-
|
29,282
|
||||||
Total current assets
|
479,995
|
537,410
|
||||||
Property, plant and equipment, net
|
362,544
|
327,808
|
||||||
In-process research and development
|
-
|
701
|
||||||
Intangible assets, net
|
35,419
|
40,758
|
||||||
Goodwill
|
41,001
|
41,001
|
||||||
Deferred tax assets, net
|
11,286
|
11,286
|
||||||
Other assets
|
1,781
|
2,155
|
||||||
Non-current assets of discontinued operations
|
-
|
76,365
|
||||||
Total assets
|
$
|
932,026
|
$
|
1,037,484
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
46,342
|
$
|
37,970
|
||||
Accrued expenses and other current liabilities
|
4,279
|
6,207
|
||||||
Accrued compensation
|
32,102
|
31,998
|
||||||
Notes payable
|
20,000
|
-
|
||||||
Contingent consideration, current portion
|
2,759
|
2,109
|
||||||
Deferred revenue, current portion
|
4,824
|
3,979
|
||||||
Current liabilities of discontinued operations
|
-
|
17,348
|
||||||
Total current liabilities
|
110,306
|
99,611
|
||||||
Contingent consideration, net of current portion
|
20,169
|
23,046
|
||||||
Long-term indebtedness
|
247,793
|
246,892
|
||||||
Deferred revenue, net of current portion
|
4,695
|
3,426
|
||||||
Other liabilities
|
1,440
|
1,258
|
||||||
Non-current liabilities of discontinued operations
|
-
|
3,234
|
||||||
Total liabilities
|
384,403
|
377,467
|
||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both September 30, 2016 and December 31, 2015
|
-
|
-
|
||||||
Common stock, $0.001 par value; 200,000,000 shares authorized, 40,910,479 shares issued and 40,487,649 shares outstanding at September 30, 2016; 100,000,000 shares authorized, 39,829,408 shares issued and 39,406,578 shares outstanding at December 31, 2015
|
41
|
40
|
||||||
Treasury stock, at cost, 422,830 common shares at both September 30, 2016 and December 31, 2015
|
(6,420
|
)
|
(6,420
|
)
|
||||
Additional paid-in capital
|
342,888
|
317,971
|
||||||
Accumulated other comprehensive loss
|
(3,572
|
)
|
(2,713
|
)
|
||||
Retained earnings
|
214,686
|
351,139
|
||||||
Total stockholders' equity
|
547,623
|
660,017
|
||||||
Total liabilities and stockholders' equity
|
$
|
932,026
|
$
|
1,037,484
|
(in thousands, except share and per share data)
|
||||||||||||||||
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Revenues:
|
||||||||||||||||
Product sales
|
$
|
96,698
|
$
|
117,512
|
$
|
208,785
|
$
|
204,563
|
||||||||
Contract manufacturing
|
14,712
|
11,341
|
32,455
|
32,443
|
||||||||||||
Contracts and grants
|
31,504
|
29,525
|
95,879
|
92,541
|
||||||||||||
Total revenues
|
142,914
|
158,378
|
337,119
|
329,547
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of product sales and contract manufacturing
|
39,560
|
35,240
|
93,025
|
73,083
|
||||||||||||
Research and development
|
27,188
|
34,179
|
81,173
|
93,833
|
||||||||||||
Selling, general and administrative
|
40,688
|
25,800
|
108,328
|
86,263
|
||||||||||||
Income from operations
|
35,478
|
63,159
|
54,593
|
76,368
|
||||||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
358
|
104
|
764
|
459
|
||||||||||||
Interest expense
|
(2,049
|
)
|
(1,635
|
)
|
(5,082
|
)
|
(4,923
|
)
|
||||||||
Other income (expense), net
|
(234
|
)
|
519
|
(176
|
)
|
669
|
||||||||||
Total other expense, net
|
(1,925
|
)
|
(1,012
|
)
|
(4,494
|
)
|
(3,795
|
)
|
||||||||
Income from continuing operations before provision for income taxes
|
33,553
|
62,147
|
50,099
|
72,573
|
||||||||||||
Provision for income taxes
|
13,165
|
20,059
|
19,861
|
23,648
|
||||||||||||
Net income from continuing operations
|
20,388
|
42,088
|
30,238
|
48,925
|
||||||||||||
Income (loss) from discontinued operations (net of tax)
|
952
|
(5,145
|
)
|
(15,854
|
)
|
(19,402
|
)
|
|||||||||
Net income
|
$
|
21,340
|
$
|
36,943
|
$
|
14,384
|
$
|
29,523
|
||||||||
Net income per share - basic:
|
||||||||||||||||
Income from continuing operations
|
$
|
0.50
|
$
|
1.08
|
$
|
0.75
|
$
|
1.28
|
||||||||
Income (loss) from discontinued operations
|
0.02
|
(0.14
|
)
|
(0.40
|
)
|
(0.51
|
)
|
|||||||||
Net income per share - basic
|
$
|
0.52
|
$
|
0.94
|
$
|
0.35
|
$
|
0.77
|
||||||||
Net income per share - diluted (1):
|
||||||||||||||||
Income from continuing operations
|
$
|
0.43
|
$
|
0.90
|
$
|
0.68
|
$
|
1.11
|
||||||||
Income (loss) from discontinued operations
|
0.02
|
(0.11
|
)
|
(0.32
|
)
|
(0.42
|
)
|
|||||||||
Net income per share - diluted
|
$
|
0.45
|
$
|
0.79
|
$
|
0.36
|
$
|
0.69
|
||||||||
Weighted-average number of shares - basic
|
40,465,423
|
38,831,341
|
40,071,730
|
38,423,715
|
||||||||||||
Weighted-average number of shares - diluted
|
49,440,313
|
47,784,550
|
48,826,597
|
46,958,179
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||||||
(in thousands)
|
||||||||||||||||
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Net income
|
$
|
21,340
|
$
|
36,943
|
$
|
14,384
|
$
|
29,523
|
||||||||
Foreign currency translations, net of tax
|
(492
|
)
|
(495
|
)
|
(859
|
)
|
(1,144
|
)
|
||||||||
Comprehensive income
|
$
|
20,848
|
$
|
36,448
|
$
|
13,525
|
$
|
28,379
|
(in thousands)
|
August 1, 2016
|
|||
Assets:
|
||||
Cash and cash equivalents
|
$
|
45,000
|
||
Accounts receivable, net
|
4,465
|
|||
Inventories
|
11,959
|
|||
Other current assets
|
4,870
|
|||
Current assets of discontinued operations
|
66,294
|
|||
Property, plant and equipment, net
|
6,128
|
|||
In-process research and development
|
41,800
|
|||
Intangible assets, net
|
15,402
|
|||
Goodwill
|
13,902
|
|||
Non-current assets of discontinued operations
|
77,232
|
|||
Total assets of discontinued operations
|
$
|
143,526
|
||
Liabilities:
|
||||
Accounts payable
|
$
|
6,285
|
||
Accrued expenses and other current liabilities
|
64
|
|||
Accrued compensation
|
2,456
|
|||
Contingent consideration
|
191
|
|||
Provisions for chargebacks
|
2,341
|
|||
Deferred revenue, current portion
|
433
|
|||
Current liabilities of discontinued operations
|
11,770
|
|||
Deferred revenue, net of current portion
|
3,232
|
|||
Other liabilities
|
91
|
|||
Non-current liabilities of discontinued operations
|
3,323
|
|||
Total liabilities of discontinued operations
|
$
|
15,093
|
(in thousands)
|
December 31, 2015
|
|||
Assets:
|
||||
Cash and cash equivalents
|
$
|
4,492
|
||
Accounts receivable, net
|
6,861
|
|||
Inventories
|
16,049
|
|||
Prepaid expenses and other current assets
|
1,880
|
|||
Current assets of discontinued operations
|
29,282
|
|||
Property, plant and equipment, net
|
4,046
|
|||
In-process research and development
|
41,800
|
|||
Intangible assets, net
|
16,617
|
|||
Goodwill
|
13,902
|
|||
Non-current assets of discontinued operations
|
76,365
|
|||
Total assets of discontinued operations
|
$
|
105,647
|
||
Liabilities:
|
||||
Accounts payable
|
$
|
8,134
|
||
Accrued expenses and other current liabilities
|
22
|
|||
Accrued compensation
|
2,684
|
|||
Contingent consideration, current portion
|
306
|
|||
Provisions for chargebacks
|
2,238
|
|||
Deferred revenue, current portion
|
3,964
|
|||
Current liabilities of discontinued operations
|
17,348
|
|||
Deferred revenue, net of current portion
|
3,163
|
|||
Other liabilities
|
71
|
|||
Non-current liabilities of discontinued operations
|
3,234
|
|||
Total liabilities of discontinued operations
|
$
|
20,582
|
||
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
Revenues:
|
||||||||||||||||
Product sales
|
$
|
3,019
|
$
|
6,441
|
$
|
21,183
|
$
|
19,704
|
||||||||
Collaborations
|
68
|
121
|
187
|
5,434
|
||||||||||||
Total revenues
|
3,087
|
6,562
|
21,370
|
25,138
|
||||||||||||
Operating expense:
|
||||||||||||||||
Cost of product sales
|
907
|
3,270
|
11,556
|
11,442
|
||||||||||||
Research and development
|
2,509
|
7,689
|
18,024
|
27,678
|
||||||||||||
Selling, general and administrative
|
7,499
|
5,756
|
23,792
|
16,239
|
||||||||||||
Loss from operations
|
(7,828
|
)
|
(10,153
|
)
|
(32,002
|
)
|
(30,221
|
)
|
||||||||
Other income (expense), net:
|
(116
|
)
|
83
|
(41
|
)
|
(464
|
)
|
|||||||||
Loss from discontinued operations before benefit from income taxes
|
(7,944
|
)
|
(10,070
|
)
|
(32,043
|
)
|
(30,685
|
)
|
||||||||
Benefit from income taxes
|
(8,896
|
)
|
(4,925
|
)
|
(16,189
|
)
|
(11,283
|
)
|
||||||||
Net loss from discontinued operations
|
$
|
952
|
$
|
(5,145
|
)
|
$
|
(15,854
|
)
|
$
|
(19,402
|
)
|
Nine Months Ended September 30,
|
||||||||
(in thousands)
|
2016
|
2015
|
||||||
Net cash (used in) provided by operating activities
|
$
|
(17,813
|
)
|
$
|
1,414
|
|||
Net cash used in investing activities
|
(1,925
|
)
|
(970
|
)
|
||||
Net cash provided by (used in) financing activities
|
15,247
|
(679
|
)
|
|||||
Net increase (decrease) in cash and cash equivalents
|
$
|
(4,491
|
)
|
$
|
(235
|
)
|
September 30, 2016
|
||||||||||||||||
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Assets:
|
||||||||||||||||
Investment in money market funds (1)
|
$
|
10
|
$
|
-
|
$
|
-
|
$
|
10
|
||||||||
Total assets
|
$
|
10
|
$
|
-
|
$
|
-
|
$
|
10
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent consideration
|
$
|
-
|
$
|
-
|
$
|
22,928
|
$
|
22,928
|
||||||||
Total liabilities
|
$
|
-
|
$
|
-
|
$
|
22,928
|
$
|
22,928
|
||||||||
December 31, 2015
|
||||||||||||||||
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Assets:
|
||||||||||||||||
Investment in money market funds (1)
|
$
|
3,323
|
$
|
-
|
$
|
-
|
$
|
3,323
|
||||||||
Total assets
|
$
|
3,323
|
$
|
-
|
$
|
-
|
$
|
3,323
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent consideration
|
$
|
-
|
$
|
-
|
$
|
25,155
|
$
|
25,155
|
||||||||
Total liabilities
|
$
|
-
|
$
|
-
|
$
|
25,155
|
$
|
25,155
|
(in thousands)
|
||||
Balance at December 31, 2015
|
$
|
25,155
|
||
Income included in earnings
|
1,263
|
|||
Settlements
|
(964
|
)
|
||
Purchases, sales and issuances
|
-
|
|||
Transfers in/(out) of Level 3
|
-
|
|||
Balance at September 30, 2016
|
$
|
22,928
|
September 30,
|
December 31,
|
|||||||
(in thousands)
|
2016
|
2015
|
||||||
Raw materials and supplies
|
$
|
31,239
|
$
|
21,275
|
||||
Work-in-process
|
24,459
|
32,709
|
||||||
Finished goods
|
25,462
|
6,903
|
||||||
Total inventories
|
$
|
81,160
|
$
|
60,887
|
September 30,
|
December 31,
|
|||||||
(in thousands)
|
2016
|
2015
|
||||||
Land and improvements
|
$
|
20,391
|
$
|
16,520
|
||||
Buildings, building improvements and leasehold improvements
|
141,322
|
108,908
|
||||||
Furniture and equipment
|
191,529
|
129,933
|
||||||
Software
|
52,744
|
39,683
|
||||||
Construction-in-progress
|
64,885
|
126,531
|
||||||
Property, plant and equipment, gross
|
470,871
|
421,575
|
||||||
Less: Accumulated depreciation and amortization
|
(108,327
|
)
|
(93,767
|
)
|
||||
Total property, plant and equipment, net
|
$
|
362,544
|
$
|
327,808
|
(in thousands)
|
||||
Cost basis
|
||||
Balance at December 31, 2015
|
$
|
57,099
|
||
Additions
|
-
|
|||
Balance at September 30, 2016
|
$
|
57,099
|
||
Accumulated amortization
|
||||
Balance at December 31, 2015
|
$
|
(16,343
|
)
|
|
Amortization
|
(5,337
|
)
|
||
Balance at September 30, 2016
|
$
|
(21,680
|
)
|
|
Net balance at September 30, 2016
|
$
|
35,419
|
2006 Plan
|
2004 Plan
|
|||||||||||||||||||
Number of Shares
|
Weighted-Average Exercise Price
|
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||||||||
Outstanding at December 31, 2015
|
2,964,237
|
$
|
22.73
|
29,699
|
$
|
10.28
|
$
|
52,119,607
|
||||||||||||
Granted
|
403,978
|
33.70
|
-
|
-
|
||||||||||||||||
Exercised
|
(750,293
|
)
|
19.56
|
(29,699
|
)
|
10.28
|
||||||||||||||
Forfeited
|
(62,441
|
)
|
27.48
|
-
|
-
|
|||||||||||||||
Canceled
|
(146,986
|
)
|
28.33
|
-
|
-
|
|||||||||||||||
Equitable adjustment
|
236,313
|
22.90
|
-
|
-
|
||||||||||||||||
Outstanding at September 30, 2016
|
2,644,808
|
22.84
|
-
|
-
|
22,976,804
|
|||||||||||||||
Exercisable at September 30, 2016
|
1,558,840
|
$
|
19.51
|
-
|
$
|
-
|
$
|
18,732,937
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2015
|
889,004
|
$
|
26.86
|
$
|
35,569,048
|
|||||||
Granted
|
488,738
|
34.36
|
||||||||||
Vested
|
(416,289
|
)
|
24.68
|
|||||||||
Forfeited
|
(46,994
|
)
|
29.84
|
|||||||||
Canceled
|
(107,514
|
)
|
30.90
|
|||||||||
Equitable adjustment
|
79,339
|
28.86
|
||||||||||
Outstanding at September 30, 2016
|
886,284
|
$
|
28.95
|
$
|
24,922,306
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
(in thousands, except share and per share data)
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
Numerator:
|
||||||||||||||||
Net income from continuing operations
|
$
|
20,388
|
$
|
42,088
|
$
|
30,238
|
$
|
48,925
|
||||||||
Interest expense, net of tax
|
934
|
786
|
2,234
|
2,378
|
||||||||||||
Amortization of debt issuance costs, net of tax
|
183
|
215
|
569
|
671
|
||||||||||||
Net income, adjusted from continuing operations
|
21,505
|
43,089
|
33,041
|
51,974
|
||||||||||||
Income (loss) from discontinued operations
|
952
|
(5,145
|
)
|
(15,854
|
)
|
(19,402
|
)
|
|||||||||
Net income, adjusted
|
$
|
22,457
|
$
|
37,944
|
$
|
17,187
|
$
|
32,572
|
||||||||
Denominator:
|
||||||||||||||||
Weighted-average number of shares—basic
|
40,465,423
|
38,831,341
|
40,071,730
|
38,423,715
|
||||||||||||
Dilutive securities—equity awards
|
878,390
|
1,232,684
|
658,367
|
813,939
|
||||||||||||
Dilutive securities—convertible debt
|
8,096,500
|
7,720,525
|
8,096,500
|
7,720,525
|
||||||||||||
Weighted-average number of shares—diluted
|
49,440,313
|
47,784,550
|
48,826,597
|
46,958,179
|
||||||||||||
Net income per share-basic from continuing operations
|
$
|
0.50
|
$
|
1.08
|
$
|
0.75
|
$
|
1.28
|
||||||||
Income (loss) per share-basic from discontinued operations
|
0.02
|
(0.14
|
)
|
(0.40
|
)
|
(0.51
|
)
|
|||||||||
Net income per share-basic
|
$
|
0.52
|
$
|
0.94
|
$
|
0.35
|
$
|
0.77
|
||||||||
Net income per share-diluted from continuing operations
|
$
|
0.43
|
$
|
0.90
|
$
|
0.68
|
$
|
1.11
|
||||||||
Income (loss) per share-diluted from discontinued operations
|
0.02
|
(0.11
|
)
|
(0.32
|
)
|
(0.42
|
)
|
|||||||||
Net income per share-diluted
|
$
|
0.45
|
$
|
0.79
|
$
|
0.36
|
$
|
0.69
|
Incurred in
|
Inception to Date
|
Total Expected
|
||||||||||
(in thousands)
|
2016
|
Costs Incurred
|
to be Incurred
|
|||||||||
Termination benefits
|
$
|
2,488
|
$
|
2,488
|
$
|
5,264
|
||||||
Abandonment of equipment
|
3,749
|
3,749
|
3,749
|
|||||||||
Other costs
|
691
|
691
|
691
|
|||||||||
Total
|
$
|
6,928
|
$
|
6,928
|
$
|
9,704
|
Termination
|
||||
(in thousands)
|
Benefits
|
|||
Balance at December 31, 2015
|
$
|
-
|
||
Expenses incurred
|
2,488
|
|||
Amount paid
|
-
|
|||
Other adjustments
|
-
|
|||
Balance at September 30, 2016
|
$
|
2,488
|
|
BioThrax
®
(Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration, or the FDA, for the general use prophylaxis and post-exposure prophylaxis of anthrax disease;
|
|
Anthrasil™ (Anthrax Immune Globulin Intravenous (Human)), the only polyclonal antibody therapeutic licensed by the FDA for the treatment of inhalational anthrax;
|
|
BAT™ (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-Equine), the only heptavalent therapeutic licensed by the FDA for the treatment of botulinum disease;
|
|
VIGIV (Vaccinia Immune Globulin Intravenous (Human)), the only therapeutic licensed by the FDA to address adverse events from smallpox vaccination; and
|
|
RSDL
®
(Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA for the removal or neutralization of chemical agents, T-2 toxin and many pesticide-related chemicals from the skin.
|
|
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), a next generation anthrax vaccine;
|
|
UV-4B, a novel antiviral being developed for dengue and influenza infections;
|
|
GC-072, the lead compound in the EV-035 series of broad spectrum antibiotics, being developed for
Burkholderia pseudomallei
;
|
|
VAX161C, a recombinant pandemic influenza vaccine candidate being developed by VaxInnate, Inc. and for which we have an exclusive license agreement to manufacture and sell in the event of a surge order from the Biomedical Advanced Research and Development Authority, or BARDA; and
|
|
Other product candidates that are focused on public health threats and emerging infectious diseases.
|
Development Programs
|
Funding Source
|
Award Date
|
Performance Period
|
Anthrasil
|
BARDA
|
Sep-05
|
9/2005 — 4/2021
|
BARDA
|
Sep-13
|
9/2013 — 9/2018
|
|
BAT
|
BARDA
|
May-06
|
5/2006 — 5/2026
|
CIADM
|
BARDA
|
Jun-12
|
6/2012 — 6/2037
|
GC-072
|
DTRA
|
Aug-14
|
8/2014 — 8/2017
|
Large-scale manufacturing for BioThrax
|
BARDA
|
Jul-10
|
7/2010 — 7/2016
|
NuThrax
|
NIAID
|
Aug-14
|
8/2014 — 10/2019
|
BARDA
|
Mar-15
|
3/2015 — 8/2017
|
|
BARDA
|
Sep-16
|
9/2016 — 9/2021
|
|
VIGIV
|
CDC
|
Aug-12
|
8/2012 — 8/2017
|
Zika
|
BARDA
|
Jun-16
|
6/2016 — 12/2018
|
|
personnel-related expenses;
|
|
fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies;
|
|
costs of contract manufacturing services for clinical trial material; and
|
|
costs of materials used in clinical trials and research and development.
|
|
Three Months Ended September 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
94,116
|
$
|
109,785
|
$
|
(15,669
|
)
|
(14
|
%)
|
|||||||
Other
|
2,582
|
7,727
|
(5,145
|
)
|
(67
|
%)
|
||||||||||
Total product sales
|
96,698
|
117,512
|
(20,814
|
)
|
(18
|
%)
|
||||||||||
Contract manufacturing
|
14,712
|
11,341
|
3,371
|
30
|
%
|
|||||||||||
Contracts and grants
|
31,504
|
29,525
|
1,979
|
7
|
%
|
|||||||||||
Total revenues
|
$
|
142,914
|
$
|
158,378
|
$
|
(15,464
|
)
|
(10
|
%)
|
§ |
increased development funding of $6.9 million related to our CIADM program, including $3.2 million from new CIADM task orders;
|
§ |
increased development funding of $3.8 million for NuThrax related to non-clinical studies and manufacturing activities; and
|
§ |
increased development funding of $3.3 million for VIGIV related to plasma collection.
|
§ |
decreased development funding of $5.7 million for Anthrasil related to the timing of plasma collection; and
|
§ |
decreased development funding of $5.2 million for large scale manufacturing of BioThrax due to our Building 55 facility receiving FDA approval in August 2016.
|
Three Months Ended
|
||||||||||||||||
September 30,
|
||||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Biodefense:
|
||||||||||||||||
Large-scale manufacturing for BioThrax
|
$
|
1,491
|
$
|
3,577
|
$
|
(2,086
|
)
|
(58
|
%)
|
|||||||
BioThrax related programs
|
1,012
|
1,449
|
(437
|
)
|
(30
|
%)
|
||||||||||
PreviThrax
|
294
|
1,972
|
(1,678
|
)
|
(85
|
%)
|
||||||||||
NuThrax
|
6,182
|
3,764
|
2,418
|
64
|
%
|
|||||||||||
Pandemic influenza
|
201
|
5,243
|
(5,042
|
)
|
(96
|
%)
|
||||||||||
Anthrasil
|
178
|
3,923
|
(3,745
|
)
|
(95
|
%)
|
||||||||||
BAT
|
814
|
578
|
236
|
41
|
%
|
|||||||||||
EV-035 series of molecules
|
1,331
|
4,357
|
(3,026
|
)
|
(69
|
%)
|
||||||||||
CIADM task orders
|
2,600
|
375
|
2,225
|
593
|
%
|
|||||||||||
VIGIV
|
1,475
|
(828
|
)
|
2,303
|
278
|
%
|
||||||||||
Emergard
|
2,475
|
1,207
|
1,268
|
105
|
%
|
|||||||||||
Other
|
9,135
|
8,562
|
573
|
7
|
%
|
|||||||||||
Total
|
$
|
27,188
|
$
|
34,179
|
$
|
(6,991
|
)
|
(20
|
%)
|
|
Nine Months Ended September 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
193,255
|
$
|
182,026
|
$
|
11,229
|
6
|
%
|
||||||||
Other
|
15,530
|
22,537
|
(7,007
|
)
|
(31
|
%)
|
||||||||||
Total product sales
|
208,785
|
204,563
|
4,222
|
2
|
%
|
|||||||||||
Contract manufacturing
|
32,455
|
32,443
|
12
|
0
|
%
|
|||||||||||
Contracts and grants
|
95,879
|
92,541
|
3,338
|
4
|
%
|
|||||||||||
Total revenues
|
$
|
337,119
|
$
|
329,547
|
$
|
7,572
|
2
|
%
|
§ |
increased development funding of $25.5 million related to our CIADM program, including $13.0 million from new CIADM task orders;
|
§ |
increased development funding of $7.2 million for NuThrax related to non-clinical animal studies and manufacturing activities;and
|
§ |
increased development funding of $18.8 million for VIGIV related to plasma collection.
|
§ |
decreased development funding of $36.9 million for Anthrasil related to the timing of plasma collection; and
|
§ |
decreased development funding of $8.5 million for large scale manufacturing of BioThrax due to our Building 55 facility receiving FDA approval in August 2016.
|
Nine Months Ended
|
||||||||||||||||
September 30,
|
||||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Biodefense:
|
||||||||||||||||
Large-scale manufacturing for BioThrax
|
$
|
4,870
|
$
|
8,526
|
$
|
(3,656
|
)
|
(43
|
%)
|
|||||||
BioThrax related programs
|
2,701
|
2,732
|
(31
|
)
|
(1
|
%)
|
||||||||||
PreviThrax
|
1,369
|
5,772
|
(4,403
|
)
|
(76
|
%)
|
||||||||||
NuThrax
|
15,847
|
9,098
|
6,749
|
0
|
%
|
|||||||||||
Pandemic influenza
|
1,260
|
6,469
|
(5,209
|
)
|
(81
|
%)
|
||||||||||
Anthrasil
|
626
|
25,533
|
(24,907
|
)
|
(98
|
%)
|
||||||||||
BAT
|
2,964
|
4,277
|
(1,313
|
)
|
(31
|
%)
|
||||||||||
EV-035 series of molecules
|
2,973
|
6,076
|
(3,103
|
)
|
(51
|
%)
|
||||||||||
CIADM task orders
|
7,899
|
375
|
7,524
|
2,006
|
%
|
|||||||||||
VIGIV
|
7,428
|
(106
|
)
|
7,534
|
7,108
|
%
|
||||||||||
Emergard
|
7,645
|
2,405
|
5,240
|
218
|
%
|
|||||||||||
Other
|
25,591
|
22,676
|
2,915
|
13
|
%
|
|||||||||||
Total
|
$
|
81,173
|
$
|
93,833
|
$
|
(12,660
|
)
|
(13
|
%)
|
|
Nine Months Ended
|
|||||||
September 30,
|
||||||||
(in thousands)
|
2016
|
2015
|
||||||
Net cash provided by (used in):
|
||||||||
Operating activities(i)
|
$
|
62,800
|
$
|
41,373
|
||||
Investing activities
|
(56,243
|
)
|
(33,631
|
)
|
||||
Financing activities
|
(20,420
|
)
|
20,477
|
|||||
Net increase in cash and cash equivalents
|
$
|
(13,863
|
)
|
$
|
28,219
|
|
our ability to secure a new BioThrax procurement contract on favorable terms;
|
§ |
the level, timing and cost of product sales;
|
|
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
|
the acquisition of new facilities and capital improvements to new or existing facilities;
|
|
the payment obligations under our indebtedness;
|
|
the scope, progress, results and costs of our development activities;
|
|
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
§ |
the extent to which we repurchase our common stock under our share repurchase program; and
|
|
the costs of commercialization activities, including product marketing, sales and distribution.
|
|
the commitment of 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;
|
|
the possibility that we may be ineligible to respond to a request for proposal issued by the government;
|
|
the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal; and
|
|
in the event our competitors protest or challenge contract or grant awards made to us pursuant to competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge would result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract.
|
|
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;
|
|
the Defense Federal Acquisition Regulations, or DFARs, and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of U.S. Department of Defense, or DoD, government contracts;
|
|
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, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act;
|
|
export and import control laws and regulations, including but not limited to ITAR (International Traffic in Arms 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.
|
|
terminate existing contracts, in whole or in part, for any reason or no reason;
|
|
unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;
|
|
cancel multi-year contracts and related orders, if funds for contract performance for any subsequent year become unavailable;
|
|
decline, in whole or in part, to exercise an option to purchase product under a procurement contract or to fund additional development under a development contract;
|
|
decline to renew a procurement contract;
|
§ |
claim rights to facilities or to products, including intellectual property, developed under the contract;
|
|
require repayment of contract funds spent on construction of facilities in the event of contract default;
|
|
take actions that result in a longer development timeline than expected;
|
|
direct the course of a development program in a manner not chosen by the government contractor;
|
|
suspend or debar the contractor from doing business with the government or a specific government agency;
|
|
pursue civil or criminal remedies under acts such as the False Claims Act and False Statements Act; and
|
|
control or prohibit the export of products.
|
|
warning letters and other communications;
|
|
product seizure or withdrawal of the product from the market;
|
|
restrictions on the marketing or manufacturing of a product;
|
|
suspension or withdrawal of regulatory approvals or refusal to approve pending applications or supplements to approved applications;
|
|
fines or disgorgement of profits or revenue; and
|
|
injunctions or the imposition of civil or criminal penalties.
|
§ |
equipment malfunctions or failures;
|
§ |
technology malfunctions;
|
§ |
cyber-attacks;
|
§ |
work stoppages or slow-downs;
|
§ |
protests, including by animal rights activists;
|
§ |
injunctions or the imposition of civil or criminal penalties.
|
§ |
damage to or destruction of the facility; or
|
§ |
product contamination or tampering.
|
|
successful development, formulation and cGMP scale-up of manufacturing that meets FDA requirements;
|
|
successful program partnering;
|
|
successful completion of clinical or non-clinical development, including toxicology studies and studies in approved animal models;
|
|
receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;
|
|
establishment of commercial manufacturing processes and product supply arrangements;
|
|
training of a commercial sales force for the product, whether alone or in collaboration with others;
|
|
successful registration and maintenance of relevant patent and/or other proprietary protection; and
|
|
acceptance of the product by potential government customers.
|
|
our inability to manufacture sufficient quantities of materials for use in trials;
|
|
the unavailability or variability in the number and types of subjects for each study;
|
|
safety issues or inconclusive or incomplete testing, trial or study results;
|
|
drug immunogenicity;
|
|
lack of efficacy of product candidates during the trials;
|
|
government or regulatory restrictions or delays; and
|
|
greater than anticipated costs of trials.
|
|
retaining existing customers and attracting new customers;
|
|
retaining key employees;
|
|
diversion of management attention and resources;
|
|
conforming internal controls, policies and procedures, business cultures and compensation programs;
|
|
consolidating corporate and administrative infrastructures;
|
|
consolidating sales and marketing operations;
|
|
identifying and eliminating redundant and underperforming operations and assets;
|
|
assumption of known and unknown liabilities;
|
|
coordinating geographically dispersed organizations; and
|
|
managing tax costs or inefficiencies associated with integrating operations.
|
|
requiring us to dedicate a substantial portion of any cash flow from operations to payment on our debt, which would reduce the amounts available to fund other corporate initiatives;
|
|
increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase;
|
|
subjecting us, as under our senior secured revolving credit facility, to restrictive covenants that may reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing;
|
|
requiring us to pledge our assets as collateral, which could limit our ability to obtain additional debt financing;
|
|
limiting our flexibility in planning for, or reacting to, general adverse economic and industry conditions; and
|
|
placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
|
|
the level, timing and cost of product sales;
|
|
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
|
the acquisition of new facilities and capital improvements to new or existing facilities;
|
|
the payment obligations under our indebtedness;
|
|
the scope, progress, results and costs of our development activities;
|
|
our ability to obtain funding from government entities for our development programs; and
|
|
the costs of commercialization activities, including product marketing, sales and distribution.
|
|
decreased demand or withdrawal of a product;
|
|
injury to our reputation;
|
|
withdrawal of clinical trial participants;
|
|
costs to defend the related litigation;
|
|
substantial monetary awards to trial participants or patients;
|
|
loss of revenue; and
|
|
an inability to commercialize products that we may develop.
|
|
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;
|
|
advance notice requirements for stockholder nominations of candidates for election to the Board 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 a new series of preferred stock without stockholder approval.
|
|
contracts, decisions and procurement policies by the U.S. government affecting BioThrax and our other biodefense products and product candidates;
|
|
the success of competitive products or technologies;
|
|
results of clinical and non-clinical trials of our product candidates;
|
|
announcements of acquisitions, financings or other transactions by us;
|
§ |
announcements relating to litigation or legal proceedings;
|
|
public concern as to the safety of our products;
|
|
termination or delay of a development program;
|
|
the recruitment or departure of key personnel;
|
|
variations in our product revenue and profitability; and
|
|
the other factors described in this "Risk Factors" section.
|
Exhibit
Number
|
Description
|
2.1
|
Contribution Agreement, dated July 29, 2016, by and among Emergent BioSolutions Inc., Aptevo Therapeutics Inc., Aptevo Research and Development LLC and Aptevo BioTherapeutics LLC (incorporated by reference to Exhibit 2.1 to the Company's Quarterly Report on Form 10-Q, filed on August 5, 2016).
|
2.2
|
Separation and Distribution Agreement, dated July 29, 2016, by and between Emergent BioSolutions Inc. and Aptevo Therapeutics Inc. (incorporated by reference to Exhibit 2.2 to the Company's Quarterly Report on Form 10-Q, filed on August 5, 2016).
|
10.1
|
Promissory Note, dated July 29, 2016, made by Emergent BioSolutions Inc. in favor of Aptevo Therapeutics Inc. (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q, filed on August 5, 2016).
|
10.2#††
|
Award/Contract, effective September 30, 2016, from the BioMedical Advanced Research and Development Authority to Emergent Product Development Gaithersburg Inc.
|
10.3#††
|
Modification No. 16 to the Solicitation, Offer and Award, effective September 30, 2011, from the Centers for Disease Control and Prevention to Emergent Biodefense Operations Lansing LLC (the "CDC BioThrax Procurement Contract"), effective March 22, 2016, between Emergent Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
|
10.4#
|
Modification No. 17 to the CDC BioThrax Procurement Contract, effective April 19, 2016, between Emergent Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
|
10.5#††
|
Modification No. 18 to the CDC BioThrax Procurement Contract, effective May 6, 2016, between Emergent Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
|
10.6#††
|
Modification No. 19 to the CDC BioThrax Procurement Contract, effective August 11, 2016, between Emergent Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
|
10.7#††
|
Modification No. 20 to the CDC BioThrax Procurement Contract, effective September 7, 2016, between Emergent Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
|
10.8#††
|
Modification No. 21 to the CDC BioThrax Procurement Contract, effective September 8, 2016, between Emergent Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
|
10.9#
|
Modification No. 22 to the CDC BioThrax Procurement Contract, effective September 20, 2016, between Emergent Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
|
12#
|
Ratio of Earnings to Fixed Charges.
|
31.1
#
|
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
|
31.2
#
|
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
|
32.1
#
|
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2
#
|
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101. INS
|
XBRL Instance Document.
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
XBRL Taxonomy Calculation Linksbase Document.
|
101.DEF
|
XBRL Taxonomy Definition Linksbase Document.
|
101.LAB
|
XBRL Taxonomy Label Linksbase Document.
|
101.PRE
|
XBRL Taxonomy Presentation Linksbase Document.
|
†† |
Confidential treatment requested with the Securities and Exchange Commission as to certain portions. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
Ratio of Earnings to Fixed Charges
|
|||||||||||||||||||||||
Year to Date
|
|||||||||||||||||||||||
|
September 30,
|
Year Ended December 31,
|
|||||||||||||||||||||
(in thousands)
|
2016
|
2015
|
2014
|
2013
|
2012
|
2011
|
|||||||||||||||||
|
|||||||||||||||||||||||
Pretax income (loss) from continuing operations (1)
|
$
|
50,099
|
|
$
|
89,769
|
$
|
53,062
|
$
|
44,243
|
$
|
37,446
|
$
|
38,849
|
||||||||||
Fixed charges
|
|||||||||||||||||||||||
Interest expense
|
5,787
|
7,834
|
7,480
|
1,973
|
2,177
|
1,719
|
|||||||||||||||||
Debt issuance cost
|
1,145
|
1,564
|
3,290
|
319
|
67
|
135
|
|||||||||||||||||
Total fixed charges (2)
|
6,932
|
9,398
|
10,770
|
2,292
|
2,244
|
1,854
|
|||||||||||||||||
Noncontrolling interest in pretax income (3)
|
-
|
-
|
-
|
876
|
5,381
|
6,906
|
|||||||||||||||||
Capitalized interest (4)
|
1,850
|
2,875
|
2,530
|
1,973
|
2,177
|
1,713
|
|||||||||||||||||
Earnings ((1) + (2) -(3) -(4))
|
55,181
|
|
96,292
|
61,302
|
43,686
|
32,132
|
32,084
|
||||||||||||||||
Fixed charges
|
6,932
|
9,398
|
10,770
|
2,292
|
2,244
|
1,854
|
|||||||||||||||||
Ratio of earnings to fixed charges
|
8.0
|
10.2
|
5.7
|
19.1
|
14.3
|
17.3
|
|||||||||||||||||
Coverage deficiency | - | - | - | - | - | - |
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Double asterisks denote omissions.
|
1.
THIS CONTRACT IS A RATED ORDER
UNDER OPAS (15 CFR 700) |
RATING
|
PAGE OF PAGE
1 46
|
|||||||||||||||||||||||||||
2. CONTRACT
(Proc Inst Ident.)
NO.
HHSO100201600030C
|
3. EFFECTIVE DATE
See Block 20C
|
4. ACQUISITION (PURCHASE REQUES
T NO.
OS165547
|
||||||||||||||||||||||||||||
5. ISSUED BY CODE
|
ASPR-BARDA
|
6. ADMINISTERED BY
(If other ______ by)
CODE
|
ASPR BARDA
|
|||||||||||||||||||||||||||
ASPR-BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201
|
ASPR-BARDA
200 Independence Ave., S.W.
Room 638-G
Washington DC 20201
|
|||||||||||||||||||||||||||||
7. NAME AND ADDRESS OF CONTRACTOR
(No., Street, City Country, State and ZIP Code)
EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. 1365869
EMERGENT PRODUCT DEVELOPMENT GAITHE
300 PROFESSIONAL DR # 100
GAITHERSBURG MD 208793419
|
8. DELIVERY
FOB ORIGIN
|
x OTHER
(See below)
|
||||||||||||||||||||||||||||
9. DISCOUNT(FOR PROMPT PAYMENT
|
||||||||||||||||||||||||||||||
10. SUBMIT INVOICES
(4 copies unless otherwise specified)
TO THE ADDRESS SHOWN IN
|
}
|
ITEM
|
||||||||||||||||||||||||||||
CODE
|
1365869
|
FACILITY CODE
|
||||||||||||||||||||||||||||
11. SHIP TO/MARK FORCODE
|
HHS/OS/ASPR
|
12. PAYMENT WILL BE MADE BY CODE
|
PSC
|
|||||||||||||||||||||||||||
HHS/OS/ASPR
200 C St SW
WASHINGTON DC 20201
|
Program Support Center
330 Independence Avenue SW
Washington DC 20201
|
|||||||||||||||||||||||||||||
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION
10 USC 2304(c)( ) 41 USC 253(c) ( )
|
14. ACCOUNTING AND APPROPRIATION DATA
2016.1990007.26201
|
|||||||||||||||||||||||||||||
15A. ITEM NO
|
15B. SUPPLIES/SERVICES
|
15C.
QUANTITY
|
15D.
UNIT
|
15E. UNIT PRICE
|
15F. AMOUNT
|
|||||||||||||||||||||||||
Continued
|
||||||||||||||||||||||||||||||
15G. TOTAL AMOUNT OF CONTRACT
|
}
|
$
|
198,705,042.00
|
|||||||||||||||||||||||||||
16. TABLE OF CONTENTS
|
||||||||||||||||||||||||||||||
(X)
|
SEC
|
DESCRIPTION
|
PAGE(S)
|
(X)
|
SEC.
|
DESCRIPTION
|
||||||||||||||||||||||||
PART 1 – THE SCHEDULE
|
PART II –
CONTRACT CLAUSES
|
|||||||||||||||||||||||||||||
X
|
A
|
SOLICITATION/CONTRACT FORM
|
1
|
X
|
I
|
CONTRACT CLAUSES
|
42
|
|||||||||||||||||||||||
X
|
B
|
SUPPLIES OR SERVICES AND PRICES/COSTS
|
3
|
PART III –LIST OF DOCUMEMTS, EXHIBITS AND OTHER ATTACH
|
||||||||||||||||||||||||||
X
|
C
|
DESCRIPTION/SPECS/WORK STATEMENT
|
10
|
X
|
J
|
LIST OF ATTACHMENTS
|
46
|
|||||||||||||||||||||||
X
|
D
|
PACKAGING AND MARKING
|
11
|
PART IV –
REPRESENTATIONS AND INSTRUCTIONS
|
||||||||||||||||||||||||||
X
|
E
|
INSPECTION AND ACCEPTANCE
|
12
|
K
|
REPRESENTATIONS, CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORS
|
|||||||||||||||||||||||||
X
|
F
|
DELIVERIES OR PERFORMANCE
|
13
|
|||||||||||||||||||||||||||
X
|
G
|
CONTRACT ADMINISTRATION DATA
|
22
|
L
|
INSTRS., CONDS., AND NOTICES TO OFFERORS
|
|||||||||||||||||||||||||
X
|
H
|
SPECIAL CONTRACT REQUIREMENTS
|
26
|
M
|
EVALUATION FACTORS FOR AWARD
|
|||||||||||||||||||||||||
CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED BID PROCUREMENT) AS APPLICABLE
|
||||||||||||||||||||||||||||||
17. X CONTRACTOR'S NEGOTIATED AGREEMENT
(Contractor is required to sign this document and return
2
copies to issuing office.)
Contractor agrees to
furnish and deliver all items to perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.) |
18. SEALED BID AWARD
(Contractor is not required to sign this document.) Your bid on
Solicitation Number
including the additions or changes made by you which additions or changes are set forth
in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents (a) the Government's solicitation and your bid, and (b) this award/contract. No further contractual document is necessary. (Block 18 should be checked only when awarding a sealed-bid contract.) |
|||||||||||||||||||||||||||||
19A. NAME AND TITLE OF SIGNER
(Type or print)
Adam Havey
|
Adam Havey
|
20A. NAME OR CONTRACTING OFFICER
BROOKE T. BERNOLD
|
||||||||||||||||||||||||||||
19B. NAME OF CONTRACTOR
Emergent BioSolutions
BY
/s/ Adam Havey
(Signature of person authorized to sign)
|
19C. DATE SIGNED
Sep 28, 2016
|
20B. UNITED STATES OF AMERICA
BY
/s
/ Brooke Bernold
(Signature of the Contracting Officer)
|
20C. DATE SIGNED
9/30/2016
|
|||||||||||||||||||||||||||
AUTHORIZED FOR LOCAL REPRODUCTION
Previous edition is NOT usable.
|
STANDARD FORM 26 (Rev. 5/2011)
Prescribed by GSA
Ÿ
FAR (48 CFR) 53.214(a)
|
CLIN
|
Period of
Performance
|
Supplies/ Services
|
Total Est.
Cost
|
Fixed Fee
(7%)
|
Total Cost
Plus Fixed Fee
|
|||||||||
COST REIMBURSEMENT
|
||||||||||||||
0001
(Base)
|
09/30/2016 –
09/29/2021
|
Licensure, approval, and clearance of product through the FDA
|
[
|
**]
|
[
|
**]
|
[
|
**]
|
||||||
FIRM FIXED PRICE
|
||||||||||||||
CLIN
|
Period of
Performance
|
Supplies/ Services
|
Units (# of
Doses)
|
Unit Price
($)
|
Total ($)
|
|||||||||
0002
(Base)
|
09/30/2016 –
09/29/2021
|
Initial Purchase, Storage, and Delivery of Product
|
2,000,000
|
[
|
**]
|
[
|
**]
|
|||||||
Total CLINS
1&2
|
09/30/2016 –
09/29/2021
|
See Above Descriptions
|
$198,705,042
(Funded)
|
CLIN
|
Period of
Performance
|
Supplies/ Services
|
Total Est. Cost
|
Fixed Fee
|
Total Cost
Plus Fixed
Fee ($)
|
COST REIMBURSEMENT
|
|||||
0001A
(Option Quantity)
|
[**]
|
Phase II [**] Study or studies required by the FDA [**]
|
[**]
|
[**]
|
[**]
|
CLIN
|
Period of
Performance
|
Supplies/ Services
|
Total Est. Cost
|
Fixed Fee
|
Total Cost
Plus Fixed
Fee ($)
|
FIXED PRICE
|
|||||
0003
(Option Quantity)
|
[**]
|
Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)
|
N/A
|
N/A
|
[**]
|
CLIN
|
Period of
Performance
|
Supplies/ Services
|
Units (# of
Product)
|
FY 2018
Unit Price
($)
|
Total ($)
|
0004A
(Option Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
7,500,000 to
[**]
|
[**]
|
[**]
|
0004B
(Option Quantity)
|
[**]
|
Additional Surge Capacity (Licensure)
|
7,500,000 to
[**]
|
[**]
|
[**]
|
0004C
(Option Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
[**]
|
[**]
|
[**]
|
0004D
(Option Quantity)
|
[**]
|
Additional Surge Capacity (Licensure)
|
[**]
|
[**]
|
[**]
|
0004E
(Option Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
[**]
|
[**]
|
[**]
|
0004F
(Option Quantity)
|
[**]
|
Additional Surge Capacity (Licensure)
|
[**]
|
[**]
|
[**]
|
0004G
(Option Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
[**]
|
[**]
|
[**]
|
0004H
(Option Quantity)
|
[**]
|
Additional Surge Capacity (Licensure)
|
[**]
|
[**]
|
[**]
|
a.
|
Items Unallowable Unless Otherwise Provided
|
1.
|
Acquisition, by purchase or lease, of any interest in real property;
|
2.
|
Special rearrangement or alteration of facilities;
|
3.
|
Purchase or lease of
any
item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of
|
4.
|
Travel to attend general scientific meetings;
|
5.
|
Unapproved foreign travel;
|
6.
|
Consultant costs;
|
7.
|
Subcontracts;
|
8.
|
Patient care costs;
|
9.
|
Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and "sensitive items" (defined as items of personal property, supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value.
|
10.
|
Printing Costs (as defined in the Government Printing and Binding Regulations).
|
11.
|
Light Refreshment and Meal Expenditures
-
Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to "HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meeting, Food and Promotional Items and Printing and Publications." The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility.
|
12.
|
Meeting room or conference space used for face to face meetings with USG staff in the performance of this contract. Justification for why the meeting cannot be held at a government facility must be provided. COA requests must be made at least (2) two weeks prior to meeting date.
|
13.
|
Clinical Trial Insurance
|
b.
|
Travel Costs
|
1.
|
During the Base Period total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred by the Prime Contractor in direct performance of this contract shall not exceed
$
[**]
without prior advance written approval by the Contracting Officer. Costs must be consistent with FAR 52.247-63 – Preference for U.S.- Flag Air Carriers.
|
2.
|
The Contactor shall invoice and be reimbursed for all travel costs in accordance with FAR 31.205-46, Contracts with Commercial Organizations, Travel Costs.
|
3.
|
Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following:
|
(i)
|
Meeting(s) and place(s) to be visited, with costs and dates;
|
(ii)
|
Names(s) and title(s) of Contractor personnel to travel and their functions in the contract project;
|
(iii)
|
Contract purpose to be served by the travel;
|
(iv)
|
How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of AMCG contract funds;
|
(v)
|
How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and
|
(vi)
|
What additional functions may be performed by the travelers to accomplish other purpose of the contact and thus further benefit the project.
|
a.
|
Subcontracts and Consultants
|
b.
|
Site Visits, Inspections and General Audits
|
·
|
If issues are identified during the audit, Contractor shall submit an issue report to the CO and COR within 10 business days detailing the finding and corrective action(s) of the audit.
|
·
|
COR and CO will review the issues report and provide a response to the Contractor within 10 business days.
|
·
|
Once corrective action is completed, the Contractor will provide a final report to the CO and COR within a time frame negotiated with the COR in writing after review of the issues report.
|
c.
|
QA Audits
|
·
|
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications.
|
·
|
Contractor shall notify the COR and CO within 5 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings.
|
d.
|
Man-in-Plant
|
e.
|
Emergency Use Authorization (EUA)
|
(2)
|
criteria listed below may be considered for procurement at the discretion of the USG. The Contractor would be required to demonstrate the two (2) essential criteria listed below for consideration of procurement of any unapproved products by seeking a COA. The COA shall include a product delivery schedule for consideration and documentation of the following:
|
·
|
Substantial evidence, including a validated process, of the Contractor's ability to manufacture a product that would be identical to the commercial scale as required for product approval or licensure. A clear understanding of the outstanding risks, if any, for approval or licensure must be demonstrated.
|
·
|
Completion of non-clinical and clinical studies with substantial evidence of safety and efficacy for the indicated use. A list of outstanding activities and targets for completion, adverse events/safety profile which do not pose unusual risks or challenges for FDA approval or licensure shall be provided.
|
f.
|
Sharing of contract deliverables within United States Government (USG)
|
g.
|
Overtime Compensation
|
h.
|
Option CLINS
|
Units (# of Doses)
|
FY 2019 Unit Price ($)
|
FY 2020 Unit Price ($)
|
FY 2021 Unit Price ($)
|
7,500,000 to
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
i.
|
Contract Number Designation
|
j.
|
Quality Agreement
|
U.S.
|
Department of Health and Human Services 200 C St. SW
|
A.
|
Monthly Progress Report
|
B.
|
Annual Progress Report
|
C.
|
Draft Final Report and Final Report
|
D.
|
FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions.
|
a.
|
Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available.
|
b.
|
Within five business days of any informal meeting with the FDA or other regulatory agency, the Contractor shall provide a formal contact report to BARDA. The Contractor shall forward the final minutes when available and if applicable.
|
c.
|
The Contractor shall forward the dates and times of any formal meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.
|
d.
|
The Contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor's submission to the FDA.
|
e.
|
The Contractor shall make Standard Operating Procedures (SOPs) available upon request from COR.
|
f.
|
The Contractor shall provide raw data and/or specific analysis of data generated with USG funds upon request from the COR.
|
g.
|
The Contractor shall notify the Contracting Officer's Representative and Contracting Officer within 24 hours of all site visits/audits conducted by the FDA or any other regulatory agency. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer's
|
E.
|
Other Requirements/Deliverables
|
a.
|
Integrated Master Project Plan
|
i.
|
Critical Path Milestones
|
ii.
|
Work Breakdown Structure
|
iii.
|
Risk Mitigation Plan/Matrix
|
b.
|
Technology Packages
|
c.
|
Experimental Protocols
|
d.
|
Annual/Final Invention Report
|
e.
|
Publications
|
f.
|
Press Releases
|
g.
|
Incident Security Report
|
h.
|
Security Plan
|
F.
|
Earned Value Management System Plan
|
a.
|
Earned Value Management System Plan:
|
I.
|
Plan all work scope for the program to completion.
|
II.
|
Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.
|
III.
|
Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control changes to the baseline.
|
IV.
|
Use actual cost incurred and recorded in accomplishing the work performed.
|
V.
|
Objectively assess accomplishments at the work performance level.
|
VI.
|
Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.
|
VII.
|
Use earned value information in the company's management processes.
|
VIII.
|
Elements of EVMS shall be applied to all CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements.
|
b.
|
Performance Measurement Baseline Review (PMBR):
|
I.
|
Jointly assess areas such as the Contractor's planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks.
|
II.
|
Confirm the integrity of the Performance Measurement Baseline (PMB).
|
III.
|
Foster the use of EVM as a means of communication.
|
IV.
|
Provide confidence in the validity of Contractor reporting
|
V.
|
Identify risks associated with the PMB.
|
VI.
|
Present any revised PMBs for approval.
|
VII.
|
Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI- MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/).
|
VIII.
|
Present the Risk Management Plan.
|
c.
|
Integrated Master Schedule
|
d.
|
Earned Value Contract Performance Report (EV-CPR)
|
a.
|
The Offeror shall deliver an Earned Value Contract Performance Report (CPR) on a monthly basis per the instruction in DI-MGMT-81466A (see
http://www.acq.osd.mil/pm/
). The Contractor shall provide Format 1, Format 3, and Format 5 only. Format 1 will be reported at the Work Breakdown Structure level 3 agreed to by BARDA and the Contractor.
|
b.
|
EV Variance thresholds will be negotiated with the Contractor post-award but for planning purposes will likely be (+/- 10% and $30,000). In conjunction with the CPR, the Contractor shall provide a monthly update to the IMS with up to date performance data and shall include actual start/finish and projected start / finish dates.
|
c.
|
The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)), and actual costs of work performed (ACWP) as captured in the Contractor's EVM systems.
|
d.
|
The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the COR. Such meetings may include, but are not limited to, site visits to the Contractor's and/or
|
e.
|
The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, to be notified in case of a public health emergency.
|
Item No.
|
Description
|
Addresses
|
Deliverable Schedule
|
1
|
Monthly Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due on or before the 15
th
of each month following the end of each reporting period.
|
2
|
Annual Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due on or before the 30
th
calendar day following the end of each reporting period.
|
3
|
Draft Final Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Report is due 45 Calendar days prior to the expiration date of the contract.
|
4
|
Final Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Report is due on or before the expiration date of the contract.
|
5
|
FDA/ Regulatory Agency Correspondence and Meeting Summaries
|
COR: (1) electronic copy
|
Reports are due within 5 business days of each meeting for Contractor's minutes, upon receipt of minutes from FDA/ regulatory agency, and upon request from the COR or Alternate COR.
|
6
|
Integrated Master Project Plan
-Critical Path Milestones
-
Work Breakdown Structure
-
Risk Mitigation Plan/Matrix
|
COR: (1) electronic copy
|
Report is due within 90 days of contract award. Updates are due as requested by the COR or Alternate COR.
|
7
|
Technology Packages
|
COR: (1) electronic copy
|
Upon request from the COR or Alternate COR.
|
8
|
Experimental Protocols for non- clinical animal studies or clinical studies
|
COR: (1) electronic copy
|
Upon request from the COR or Alternate COR. Written approval from the COR or Alternate COR is required prior to the execution of the study.
|
9
|
Annual/Final Invention Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
An Annual Invention Report is due on or before the 30
th
calendar day after the
completion of each reporting period. A Final Invention Report is due on or before the expiration date of the
|
contract.
|
|||
10
|
Publications
|
COR: (1) electronic copy
|
Reports are due within 10 business days for manuscripts and 5 business days for abstracts.
|
11
|
Press Releases
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports/Notices are due for approval to the CO not less than five (5) business days prior to the issuance of any potential press release.
|
12
|
Incident Security Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due within 24 hours after occurrence of an activity or incident.
|
13
|
Security Plan
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Draft report is due within 90 days of contract award.
Updates are due at least 3 months prior to product procurement or as requested by the COR or Alternate COR.
|
14
|
Earned Value Management Requirements
|
CO: (1) electronic copy
COR: (1) electronic copy
|
As detailed in Section F.2 Reporting Requirements, subpart -F.
|
a.
|
The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions, specifications or other requirements of this contract.
|
b.
|
The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the CO has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.
|
c.
|
No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, shall be considered grounds for deviation from this contract.
|
d.
|
The Government may unilaterally change its CO designation.
|
a.
|
Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;
|
b.
|
Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;
|
c.
|
Performing technical evaluation as required;
|
d.
|
Performing technical inspections and assisting the Contracting Officer in acceptances of deliverables required by this contract; and
|
e.
|
Assisting in the resolution of technical problems encountered during performance.
|
f.
|
The Government may unilaterally change its COR designation(s).
|
Name
|
Title
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
a.
|
The Contractor shall submit an electronic copy of contract monthly invoices/financial reports to the Contracting Officer as defined above, in ARTICLE G of this contract.
|
b.
|
Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests made a part of the contract at Section J, Attachments 2 & 3.
|
c.
|
Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.
|
d.
|
The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any options for additional quantities (See estimated costs under Articles B.2 and B.3) and the reasons for the variance. Also refer to the requirements of FAR Clause 52.232-20, Limitation of Cost.
|
e.
|
The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord,
|
f.
|
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment.
|
g.
|
Invoices shall be delivered electronically to the Contracting Officer (CO), the Contracting Officer's Representative (COR), PSC, and e-Room electronically. Unless otherwise specified by the Contracting Officer, all deliverables, invoices, and reports furnished to the Government under the resultant contract shall be addressed as follows:
|
[**]
Contracting Officer HHS/ASPR/AMCG
200 C Street, S.W. Washington, DC 20024
Email: [**]
|
[**]
Contracting Officer Representative HHS/ASPR/BARDA
200 C Street, S.W. Washington, DC 20024
Email:
[**]
|
Email invoices to:
PSC_Invoices@psc.hhs.gov
e-Room
|
(a)
|
Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.
|
(b)
|
The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.
|
(c)
|
Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.
|
1.
|
Contractor Performance Evaluations
|
2.
|
Electronic Access to Contractor Performance Evaluations
|
1.
|
In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at:
|
2.
|
Notwithstanding the provisions outlined in the HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated in this contract in paragraph 1 above, the Contractor shall use the form entitled, "Report of Government Owned, Contractor Held Property" for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.
|
3.
|
Title will vest in the Government for equipment purchased as a direct cost.
|
a.
|
The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.
|
b.
|
The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.
|
c.
|
Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP website at:
http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf
).
|
d.
|
If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those Contractors with approved Human Subject Assurances.
|
a)
|
All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.
|
b)
|
All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if applicable)
|
c)
|
Termination or temporary suspension of the study(ies) for regulatory issues
|
d)
|
Termination or temporary suspension of the protocol.
|
e)
|
Any change that is made in the specific IACUC approval for the indicated study(ies).
|
f)
|
Any other problems or issues that could affect the scientific integrity of the study(ies), i.e. fraud, misrepresentation, misappropriation of funds, etc.
|
1.
|
Non-clinical research protocol to be submitted for IACUC approval identified by version number, date, or both, including details of study design, euthanasia criteria, proposed interventions, and exclusion criteria. Contractor should reduce the number of animals required for a study using power of statistics
|
2.
|
Plans for the management of side effects, rules for interventions and euthanasia criteria
|
3.
|
Procedures for assessing and collecting safety data
|
4.
|
If a study is contracted through CRO(s), work orders and service agreements the Contractor shall assure that an integrated safety documentation plan is in place for
|
5.
|
Documentation that the Contractor or CRO and all staff responsible for the conduct of the research have received required training in the protection and handling of animals
|
6.
|
Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval by the Contracting Officer. The Contractor must have the ability to return/re-sell animals, at purchase price, to distributor or a third party, in the event that the protocols do not obtain approval
|
7.
|
Provide justification for whether studies require good laboratory practice (GLP) conditions
|
H.3.1
|
Safety and Monitoring Issues
|
1.
|
All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.
|
2.
|
All changes in informed consent documents, identified by version number, date, or both and dates it is valid.
|
3.
|
Termination or temporary suspension of patient accrual.
|
4.
|
Termination or temporary suspension of the protocol.
|
5.
|
Any change in IRB approval.
|
6.
|
Any other problems or issues that could affect the participants in the studies.
|
H.3.2.
|
Data and Safety Monitoring Requirements
|
1.
|
Independent Safety Monitor
– a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.
|
2.
|
Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC)
– a small group of independent investigators and biostatisticians who review data from a particular study.
|
3.
|
Data and Safety Monitoring Board
– an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB.
|
H.3.3.
|
BARDA Protocol Review Process Before Patient Enrollment Begins
|
1.
|
Clinical research protocol to be submitted for approval by the IRB or IEC, identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria;
|
2.
|
Informed consent document, identified by version number, date, or both and date it is valid;
|
3.
|
Plans for the management of side effects;
|
4.
|
Procedures for assessing and reporting adverse events;
|
5.
|
Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory;
|
6.
|
Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects.
|
H.3.4.
|
Required Time-Sensitive Notification
|
1.
|
Expedited safety report of unexpected or life-threatening experience or death –
A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor's receipt of the information, must be submitted to the BARDA program officer or the Contracting Officer's Representative within 24 hours of FDA notification.
|
2.
|
Expedited safety reports of serious and unexpected adverse experiences –
A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor's receipt of the information, must be submitted to the BARDA Contracting Officer's Representative within 24 hours of FDA notification.
|
3.
|
IDE reports of unanticipated adverse device effect –
A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the BARDA Contracting Officer's Representative within 24 hours of FDA notification.
|
4.
|
Expedited safety reports –
shall be sent to the BARDA COR concurrently with the report to FDA.
|
5.
|
Other adverse events documented during the course of the trial shall be included in the annual IND report and reported to the BARDA annually.
|
a.
|
Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.
|
b.
|
The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1- 2.11, or from a source that is exempt from licensing under those sections.
|
c.
|
The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.
|
d.
|
If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Assurances.
|
ARTICLE H.8. |
REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS
|
a.
|
The Contractor shall not use any funds obligated under this contract for any abortion.
|
b.
|
The Contractor shall not use any funds obligated under this contract for the following:
|
1.
|
The creation of a human embryo or embryos for research purposes; or
|
2.
|
Research in which a human embryo or embryos are destroyed,
|
c.
|
The term "human embryo or embryos'" includes any organism,
|
d.
|
The Contractor shall not use any Federal funds for the cloning of human beings.
|
E.O.
|
13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.
|
a.
|
Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.
|
b.
|
Accordingly, any Offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at
http://www.hhs.gov/web/508
.
The complete text of the Section 508 Final Provisions can be accessed at
http://www.access-board.gov/sec508/standards.htm
.
|
c.
|
The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.
|
d.
|
Respondents to this solicitation must identify any exception to Section 508 requirements. If a Offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.
|
a.
|
The Contractor shall use an Earned Value Management System (EVMS) that is compliant with the guidelines in ANSI/EIA Standard-748 (current version at the time of award) to manage this contract. If the Contractor's current EVMS is not compliant at the time of award, see paragraph (b) of this clause. The Contractor shall submit EVM reports in accordance with the requirements of this contract.
|
b.
|
If, at the time of award, the Contractor's EVM system is not in compliance with the EVMS guidelines in ANSI/EIA Standard-748 (current version at time of award), the Contractor shall:
|
a.
|
Apply the current system to the contract; and
|
b.
|
Take necessary and timely actions to meet the milestones in the Contractor's EVMS plan approved by the Contracting Officer.
|
c.
|
HHS will not formally validate or accept the Contractor's EVMS with respect to this contract. The use of the Contractor's EVMS for this contract does not imply HHS acceptance of the Contractor's EVMS for application to future contracts. The Contracting Officer or designee will conduct a Compliance Review to assess the Contractor's compliance with its approved plan. If the Contractor does not follow the approved implementation schedule or correct all resulting system deficiencies noted during the Compliance Review within a reasonable time, the Contracting Officer may take remedial action that may include, but is not limited to, suspension of or reduction in progress payments, or a reduction in fee.
|
d.
|
HHS will conduct a Performance Measurement Baseline Review (PMBR). If a pre-award PMBR has not been conducted, a post-award PMBR will be conducted by HHS as early as practicable, but no later than ninety (90) days after contract award. The Contracting Officer may also require a PMBR as part of the exercise of an option or the incorporation of a major modification.
|
e.
|
Unless a waiver is granted by the CFA, Contractor-proposed EVMS changes require approval of the CFA prior to implementation. The CFA will advise the Contractor of the acceptability of such changes within 30 calendar days after receipt of the notice of proposed changes from the Contractor. If the advance approval requirements are waived by the CFA, the Contractor shall disclose EVMS changes to the CFA at least 14 calendar days prior to the effective date of implementation.
|
f.
|
Unless a waiver is granted by the CFA, Contractor-proposed EVMS changes require approval of the CFA prior to implementation. The CFA will advise the Contractor of the acceptability of such changes within 30 calendar days after receipt of the notice of proposed changes from the Contractor. If the advance approval requirements are waived by the CFA, the Contractor shall disclose EVMS changes to the CFA at least 14 calendar days prior to the effective date of implementation.
|
g.
|
The Contractor shall provide access to all pertinent records and data requested by the Contracting Officer or a duly authorized representative as necessary to permit Government surveillance to ensure that the EVMS conforms, and continues to conform to the requirements referenced in paragraph (a) of this clause.
|
a.
|
Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.
|
b.
|
The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.
|
c.
|
If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.
|
d.
|
Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.
|
e.
|
Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor shall obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
|
f.
|
Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.
|
g.
|
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.
|
a.
|
Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:
|
1.
|
With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;
|
2.
|
With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest; or
|
3.
|
Intellectual property rights and interests, upon receipt of income related to such rights and interest.
|
1.
|
Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and
|
2.
|
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions
|
b.
|
Require each Investigator to complete training regarding the Institution's financial conflicts of interest policy prior to engaging in research related to any BARDA funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.
|
c.
|
Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the BARDA funded research.
|
d.
|
Require that each Investigator who is planning to participate in the BARDA funded research disclose to the Institution's designated official(s) the Investigator's significant financial interest (and those of the Investigator's spouse and dependent children) no later than the date of submission of the Institution's proposal for BARDA funded research. Require that each Investigator who is participating in the BARDA funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest.
|
e.
|
Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator's significant financial interest is related to BARDA funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related to BARDA funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the BARDA funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the BARDA funded research.
|
f.
|
Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).
|
g.
|
Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).
|
h.
|
Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such disclosures, and all actions under the Institution's policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.
|
i.
|
Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.
|
j.
|
Complete the certification in Section K
-
Representations, Certifications, and Other Statements of Contractors titled "Certification of Institutional Policy on Financial Conflicts of Interest".
|
1)
|
Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at
http://www.gpoaccess.gov/cfr/index.html
|
2)
|
The Project Officer/COR is hereby designated as the official who is responsible for monitoring Contractor compliance with the Privacy Act.
|
3)
|
The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link:
http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm
|
·
|
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications. The Contractor shall notify the CO and COR reasonably in advance of upcoming QA audit so that Government personnel may participate in person at BARDA's discretion.
|
·
|
Contractor shall notify the COR and CO within 5 business days of report completion.
|
·
|
If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit.
|
·
|
COR and CO will review the report and provide a response to the Contractor with 10 business days.
|
·
|
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
|
(1)
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
|
Reg
|
Clause
|
Date
|
Clause Title
|
FAR
|
52.202-1
|
Nov 2013
|
Definitions
|
FAR
|
52.203-3
|
Apr 1984
|
Gratuities
|
FAR
|
52.203-5
|
May 2014
|
Covenant Against Contingent Fees
|
FAR
|
52.203-6
|
Sep 2006
|
Restrictions on Subcontractor Sales to the Government
|
FAR
|
52.203-7
|
May 2014
|
Anti-Kickback Procedures
|
FAR
|
52.203-8
|
May 2014
|
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
|
FAR
|
52.203-10
|
May 2014
|
Price or Fee Adjustment for Illegal or Improper Activity
|
FAR
|
52.203-12
|
Oct 2010
|
Limitation on Payments to Influence Certain Federal Transactions
|
FAR
|
52.203-13
|
Oct 2015
|
Contractor Code of Business Ethics and Conduct
|
FAR
|
52.203-14
|
Oct 2015
|
Display of Hotline Poster(s)
|
FAR
|
52.203-17
|
Apr 2014
|
Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights
|
FAR
|
52.204-4
|
May 2011
|
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
|
FAR
|
52.204-7
|
Jul 2013
|
System for Award Management
|
FAR
|
52.204-10
|
Oct 2015
|
Reporting Executive Compensation and First-Tier Subcontract Awards
|
FAR
|
52.204-13
|
Jul 2013
|
System for Award Management Maintenance
|
FAR
|
52.209-6
|
Oct 2015
|
Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment
|
FAR
|
52.209-10
|
Nov 2015
|
Prohibition on Contracting with Inverted Domestic Corporations
|
FAR
|
52.210-1
|
Apr 2011
|
Market Research
|
FAR
|
52.215-2
|
Oct 2010
|
Audit and Records – Negotiation
|
FAR
|
52.215-8
|
Oct 1997
|
Order of Precedence - Uniform Contract Format
|
FAR
|
52.215-10
|
Aug 2011
|
Price Reduction for Defective Cost or Pricing Data
|
FAR
|
52.215-11
|
Aug 2011
|
Price Reduction for Defective Certified Cost or Pricing Data—Modifications.
|
FAR
|
52.215-12
|
Oct 2010
|
Subcontractor Certified Cost or Pricing Data
|
FAR
|
52.215-13
|
Oct 2010
|
Subcontractor Certified Cost or Pricing Data—Modifications
|
FAR
|
52.215-15
|
Oct 2010
|
Pension Adjustments and Asset Reversions
|
FAR
|
52.215-17
|
Oct 1997
|
Waiver of Facilities Capital Cost of Money
|
FAR
|
52.215-18
|
Jul 2005
|
Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than Pensions
|
FAR
|
52.215-19
|
Oct 1997
|
Notification of Ownership Changes
|
FAR
|
52.215-21
|
Oct 2010
|
Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data -Modifications
|
FAR
|
52.215-23
|
Oct 2009
|
Limitations on Pass-Through Charges
|
FAR
|
52.216-7
|
Jun 2013
|
Allowable Cost and Payment
|
FAR
|
52.216-8
|
Jun 2011
|
Fixed Fee
|
FAR
|
52.219-8
|
Oct 2014
|
Utilization of Small Business Concerns
|
FAR
|
52.219-28
|
July 2013
|
Post-Award Small Business Program Representation
|
FAR
|
52.222-1
|
Feb 1997
|
Notice to the Government of Labor Disputes
|
FAR
|
52.222-2
|
Jul 1990
|
Payment for Overtime Premiums
|
FAR
|
52.222-3
|
Jun2003
|
Convict Labor
|
FAR
|
52.222-21
|
Apr 2015
|
Prohibition of Segregated Facilities
|
FAR
|
52.222-26
|
Apr 2015
|
Equal Opportunity
|
FAR
|
52.222-35
|
Oct 2015
|
Equal Opportunity for Veterans
|
FAR
|
52.222-36
|
Jul 2014
|
Equal Opportunity for Workers with Disabilities
|
FAR
|
52.222-37
|
Feb 2016
|
Employment Reports on Veterans
|
FAR
|
52.222-40
|
Dec 2010
|
Notification of Employee Rights Under the National Labor Relations Act
|
FAR
|
52.222-43
|
May 2014
|
Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts)
|
FAR
|
52.222-50
|
Mar 2015
|
Combating Trafficking in Persons
|
FAR
|
52.222-54
|
Oct 2015
|
Employment Eligibility Verification
|
FAR
|
52.223-6
|
May 2001
|
Drug-Free Workplace
|
FAR
|
52.223-18
|
Aug 2011
|
Encouraging Contractor Policy to Ban Text Messaging While Driving
|
FAR
|
52.224-1
|
April 1984
|
Privacy Act Notification
|
FAR
|
52.224-2
|
April 1984
|
Privacy Act
|
FAR
|
52.225-13
|
Jun 2008
|
Restrictions on Certain Foreign Purchases
|
FAR
|
52.227-1
|
Dec 2007
|
Authorization and Consent, Alternate 1 (APR 1984)
|
FAR
|
52.227-2
|
Dec 2007
|
Notice and Assistance Regarding Patent and Copyright Infringement
|
FAR
|
52.227-3
|
Apr 1984
|
Patent Indemnity
|
FAR
|
52.227-11
|
May 2014
|
Patent Rights – Ownership by the Contractor
|
FAR
|
52.227-14
|
May 2014
|
Rights in Data - General
|
FAR
|
52.227-16
|
Jun 1987
|
Additional Data Requirements
|
FAR
|
52.228-7
|
Mar 1996
|
Insurance – Liability to Third Persons
|
FAR
|
52.229-3
|
Feb 2013
|
Federal, State and Local Taxes
|
FAR
|
52.230-2
|
Oct 2015
|
Cost Accounting Standards
|
FAR
|
52.230-6
|
June 2010
|
Administration of Cost Accounting Standards
|
FAR
|
52.232-1
|
Apr 1984
|
Payments
|
FAR
|
52.232-2
|
Apr 1984
|
Payments under Fixed-Price Research and Development Contracts
|
FAR
|
52.232-8
|
Feb 2002
|
Discounts for Prompt Payment
|
FAR
|
52.232-9
|
Apr 1984
|
Limitation on Withholding of Payments
|
FAR
|
52.232-11
|
Apr 1984
|
Extras
|
FAR
|
52.232-17
|
May 2014
|
Interest
|
FAR
|
52.232-20
|
Apr 1984
|
Limitation of Cost
|
FAR
|
52.232-23
|
May 2014
|
Assignment of Claims
|
FAR
|
52.232-25
|
Jul 2013
|
Prompt Payment
|
FAR
|
52.232-33
|
Jul 2013
|
Payment by Electronic Funds Transfer--System for Award Management
|
FAR
|
52.233-1
|
May 2014
|
Disputes
|
FAR
|
52.233-3
|
Aug 1996
|
Protest After Award, Alternate I
|
FAR
|
52.233-4
|
Oct 2004
|
Applicable Law for Breach of Contract Claim
|
FAR
|
52.242-1
|
Apr 1984
|
Notice of Intent to Disallow Costs
|
FAR
|
52.242-3
|
May 2014
|
Penalties for Unallowable Costs
|
FAR
|
52.242-4
|
Jan 1997
|
Certification of Final Indirect Costs
|
FAR
|
52.242-13
|
Jul 1995
|
Bankruptcy
|
FAR
|
52.243-1
|
Aug 1987
|
Changes - Fixed-Price Alternate V (Apr 1984).
|
FAR
|
52.243-2
|
Aug 1987
|
Changes—Cost-Reimbursement Alternate V (Apr 1984).
|
FAR
|
52.243.6
|
Apr 1984
|
Change Order Accounting
|
FAR
|
52.243-7
|
Apr 1984
|
Notification of Changes
|
FAR
|
52.244-2
|
Oct 2010
|
Subcontracts, Alternate 1 (Jun 2007)
|
FAR
|
52.244-5
|
Dec 1996
|
Competition in Subcontracting
|
FAR
|
52.244-6
|
Apr 2015
|
Subcontracts for Commercial Items
|
FAR
|
52.245-1
|
Apr 2012
|
Government Property
|
FAR
|
52.245-9
|
Apr 2012
|
Use and Charges
|
FAR
|
52.246-7
|
Apr 1996
|
Inspection of Research and Development – Fixed-Price
|
FAR
|
52.246-8
|
May 2001
|
Inspection of Research and Development – Cost-Reimbursement
|
FAR
|
52.246-23
|
Feb 1997
|
Limitation of Liability.
|
FAR
|
52.246-25
|
Feb 1997
|
Limitation of Liability—Services
|
FAR
|
52.248-1
|
Oct 2010
|
Value Engineering
|
FAR
|
52.249-2
|
Apr 2012
|
Termination for the Convenience of the Government (Fixed-Price)
|
FAR
|
52.249-6
|
May 2004
|
Termination (Cost-Reimbursement)
|
FAR
|
52.249-8
|
Apr 1984
|
Default (Fixed-Price Supply and Service)
|
FAR
|
52.249-9
|
Apr 1984
|
Default (Fixed-Price Research and Development)
|
FAR
|
52.249-14
|
Apr 1984
|
Excusable Delays
|
FAR
|
52.253-1
|
Jan 1991
|
Computer Generated Forms
|
(2)
|
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:
|
HHSAR
|
352.203-70
|
Dec 2015
|
Anti-Lobbying
|
HHSAR
|
352.211-3
|
Dec 2015
|
Paperwork Reduction Act
|
HHSAR
|
352.222-70
|
Dec 2015
|
Contractor Cooperation in Equal Employment Opportunity Investigations
|
HHSAR
|
352.223-70
|
Dec 2015
|
Safety and Health
|
HHSAR
|
352.224-70
|
Dec 2015
|
Privacy Act
|
HHSAR
|
352.227-70
|
Dec 2015
|
Publications and Publicity
|
HHSAR
|
352.233-71
|
Dec 2015
|
Litigation and Claims
|
HHSAR
|
352.237-75
|
Dec 2015
|
Key Personnel
|
HHSAR
|
352.270-4a
|
Dec 2015
|
Protection of Human Subjects
|
HHSAR
|
352.270-5b
|
Dec 2015
|
Care of Live Vertebrate Animals
|
HHSAR
|
352.270-6
|
Dec 2015
|
Restriction on use of Human Subjects
|
(a)
|
The Government may extend the term of this contract by written notice to the Contractor within 30 Days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least
30 days
before the contract expires. The preliminary notice does not commit the Government to an extension.
|
(b)
|
If the Government exercises this option, the extended contract shall be considered to include this option clause.
|
(c)
|
The total duration of this contract, including the exercise of any options under this clause, shall not exceed 8 years.
|
(a)
|
The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.
|
(b)
|
For purposes of the salary rate limitation, the terms "direct salary," "salary," and "institutional base salary," have the same meaning and are collectively referred to as "direct salary," in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract. Direct salary excludes any income that
|
(c)
|
The salary rate limitation also applies to individuals under subcontracts.
|
(d)
|
If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract.
|
(e)
|
See the salaries and wages pay tables on the Office of Personnel Management website for Federal Executive Schedule salary levels.
|
1.
|
Statement of Work, dated September 30, 2016, 10 pages
|
2.
|
Invoice/Financing Instructions for Cost-Reimbursement Type Contracts
|
3.
|
Invoice Instructions for Fixed-Priced Type Contracts
|
4.
|
Sample Invoice Form
|
5.
|
Research Patient Care Costs
|
6.
|
Report of Government Owned, Contractor Held Property, 1 page.
|
7.
|
Form SF-LLL, Disclosure of Lobbying Activities,
2 pages
|
1.1
|
Contractual Statement of Work
|
Preamble to the Statement of Work
Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work submitted in response to RFP 16-100-SOL- 00015.
|
1.2
|
Scope
|
1.3
|
Objective
|
·
|
CLIN 0001
-
Approval of Emergency Use Authorization (EUA), licensure, approval, and clearance of product through the FDA (Base)
|
·
|
CLIN 0001A – Conduct of a Phase 2 clinical [**] study or other studies required by the FDA [**] (Option)
|
·
|
CLIN 0002
-
Initial purchase, storage, and delivery of product (Base)
|
·
|
CLIN 0003 – Phase 4 post marketing requirements (Option)
|
·
|
CLIN 0004 - Surge Capacity – Additional procurement of product (Option)
|
1.
|
3 CLIN 0001 - Approval of Emergency Use Authorization (EUA), licensure, approval, and clearance of product through the FDA (Base)
|
·
|
Identification of and management to, distinct stages of the product development pathway that are gates for Go/No Go decisions for advancing to the next stage of the Integrated Product Development Plan.
|
·
|
Establishment of and tracking of milestones and timelines for the initiation conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage.
|
·
|
Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development.
|
·
|
Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work.
|
·
|
Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract.
|
·
|
Conducting performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; their approach in providing a detailed schedule that generates a critical path for the project; and a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both Emergent and subcontractors on a real time basis.
|
·
|
Manage contract activities in accordance with Earned Value Management. In this regard, Emergent shall:
|
o
|
Provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The Integrated Master Project Plan shall outline key, critical path milestones, with "Go/No-Go" decision criteria and a contract Work Breakdown Structure (due within 90 days of contract award with updates as requested by the Contracting Officer's Representative (COR).
|
o
|
Submit an updated Integrated Master Schedule in an approved format.
|
o
|
Use principles of Earned Value Management System (EVMS) in the management of this contract.
|
o
|
Submit a plan for a Performance Measurement Baseline Review (PMBR) electronically via email to the Contracting Officer (CO) and COR for a PBMR to occur within 90 days of contract award.
|
·
|
Develop and maintain a risk management plan.
|
·
|
Participate in regular meetings to coordinate and oversee the contracting effort.
|
1.4
|
CLIN 0001A - Conduct of a Phase 2 clinical [**] study or other studies required by the FDA [**] (Option)
|
·
|
Identification of and management to, distinct stages of the product development pathway that are gates for Go/No Go decisions for advancing to the next stage of the Integrated Product Development Plan.
|
·
|
Establishment of and tracking of milestones and timelines for the initiation conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage.
|
·
|
Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development.
|
·
|
Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work.
|
·
|
Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract.
|
·
|
Conducting performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; their approach in providing a detailed schedule that generates a critical path for the project; and a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both Emergent and subcontractors on a real time basis.
|
·
|
Manage contract activities in accordance with Earned Value Management. In this regard, Emergent shall:
|
o
|
Provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The Integrated Master Project Plan shall outline key, critical path milestones, with "Go/ No Go" decision
|
o
|
Submit an updated Integrated Master Schedule in an approved format.
|
o
|
Use principles of Earned Value Management System (EVMS) in the management of this contract.
|
o
|
Submit a plan for a Performance Measurement Baseline Review (PMBR) electronically via email to the Contracting Officer (CO) and COR for a PBMR to occur within 90 days of contract award.
|
·
|
Develop and maintain a risk management plan.
|
·
|
Participate in regular meetings to coordinate and oversee the contracting effort.
|
·
|
[**] - AVA.214 Phase 2 [**] Study
|
1.5
|
CLIN 0002 - Initial purchase, storage, and delivery of product (Base)
|
1.
|
6 CLIN 0003
-
Phase 4 post marketing requirements (Option)
|
·
|
Identification of and management to, distinct stages of the product development pathway that are gates for Go/No Go decisions for advancing to the next stage of the Integrated Product Development Plan.
|
·
|
Establishment of and tracking of milestones and timelines for the initiation conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage.
|
·
|
Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development.
|
·
|
Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work.
|
·
|
Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract.
|
·
|
Conducting performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; their approach in providing a detailed schedule that generates a critical path for the project; and a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both Emergent and subcontractors on a real time basis.
|
·
|
Manage contract activities in accordance with Earned Value Management. In this regard, Emergent shall:
|
o
|
Provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The Integrated Master Project Plan shall outline key, critical path milestones, with "Go/No Go" decision criteria and a contract Work Breakdown Structure (due within 90 days of contract award with updates as requested by the Contracting Officer's Representative (COR).
|
o
|
Submit an updated Integrated Master Schedule in an approved format.
|
o
|
Use principles of Earned Value Management System (EVMS) in the management of this contract.
|
o
|
Submit a plan for a Performance Measurement Baseline Review (PMBR) electronically via email to the Contracting Officer (CO) and COR for a PBMR to occur within 90 days of contract award.
|
·
|
Develop and maintain a risk management plan.
|
·
|
Participate in regular meetings to coordinate and oversee the contracting effort.
|
1.7
|
CLIN 0004 - Surge Capacity – Additional procurement of product (Option)
|
1.8
|
Reporting Requirements and Deliverables Reports
|
·
|
Forward the initial draft minutes to BARDA within five business days of any formal meeting with the FDA or other regulatory agency, and forward the final minutes when available.
|
·
|
Forward the initial draft minutes to BARDA within five business days of any informal meeting with the FDA or other regulatory agency, and forward the final minutes when available and if applicable.
|
·
|
Forward the dates and times of any meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.
|
·
|
Provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. Emergent will provide BARDA with five (5) business days in which to review and provide comments prior to Emergent's submission to the FDA.
|
Milestone
#
|
WBS
#
|
Milestone
|
Deliverables Summary (Details as specified in the Deliverables)
|
Quantity
|
Estimated
Completion Date
|
|
CLIN 0001
|
1
|
[**]
|
[**]
|
[**]
|
1 Electronic Copy to Contract Officer Representative (COR);
1 Electronic Copy to Contracting Officer (CO)
|
[**]
|
2
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
3
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
4
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
5
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
6
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
7
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
8
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
9
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
10
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
11
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
12
|
[**]
|
[**]
|
[**]
|
See Above
|
[**]
|
|
CLIN 0002
|
16
|
-
|
Completion of delivery of 2 million doses of AV7909
|
Delivery of 2 million doses of AV7909
|
See Above
|
[**]
|
(a)
|
Interim Invoice/Contract Financing Request:
These are interim payment requests submitted during the contract performance period.
|
(b)
|
Completion Invoice:
The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.
|
(c)
|
Final Invoice:
A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).
|
(a)
|
Designated Billing Office Name and Address:
Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(b)
|
Contractor's Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:
Show the Contractor's name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide the Contractor's Vendor Identification Number (VIN), and Data Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor's name and address exactly as stated on the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS).
|
(c)
|
Invoice/Financing Request Number:
Insert the appropriate serial number of the payment request.
|
(d)
|
Date Invoice/Financing Request Prepared:
Insert the date the payment request is prepared.
|
(e)
|
Contract Number and Order Number (if applicable):
Insert the contract number and order number (if applicable).
|
(f)
|
Effective Date:
Insert the effective date of the contract or if billing under an order, the effective date of the order.
|
(g)
|
Total Estimated Cost of Contract/Order:
Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed- fee. For incrementally funded contracts/orders, enter the amount currently obligated and available for payment.
|
(h)
|
Total Fixed-Fee:
Insert the total fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice as defined in the contract.
|
(i)
|
Two-Way/Three-Way Match:
Identify whether payment is to be made using a two-way or three- way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(j)
|
Office of Acquisitions:
Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(k)
|
Central Point of Distribution:
Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(l)
|
Billing Period:
Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.
|
(m)
|
Amount Billed
-
Current Period:
Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately
|
(n)
|
Amount Billed
-
Cumulative:
Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
|
(o)
|
Direct Costs:
Insert the major cost elements. For each element, consider the application of the paragraph entitled "Costs Requiring Prior Approval" on page 1 of these instructions.
|
(1)
|
Direct Labor:
Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.
|
(2)
|
Fringe Benefits:
List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs.
|
(3)
|
Accountable Personal Property:
Include any property having a unit acquisition cost of
|
-
|
Item number for the specific piece of equipment listed in the Property Schedule, and
|
-
|
COA number, if the equipment is not covered by the Property Schedule.
|
(4)
|
Materials and Supplies:
Include all consumable material and supplies regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.) is required.
|
(5)
|
Premium Pay:
List remuneration in excess of the basic hourly rate.
|
(6)
|
Consultant Fee:
List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.
|
(7)
|
Travel:
Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.
|
(8)
|
Subcontract Costs:
List subcontractor(s) by name and amount billed. Provide subcontract invoices/receipts as backup documentation. If subcontract is of the cost-reimbursement variety, detailed breakdown will be required. Regardless, include backup documentation (e.g. subcontractor invoices, quotes, etc.).
|
(9)
|
Other:
Include all other direct costs not fitting into an aforementioned category. If over
|
(p)
|
Cost of Money (COM):
Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed, if applicable.
|
(q)
|
Indirect Costs:
Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.
|
(r)
|
Fixed-Fee:
Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.
|
(s)
|
Total Amounts Claimed:
Insert the total amounts claimed for the current and cumulative periods.
|
(t)
|
Adjustments:
Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.
|
(u)
|
Grand Totals
|
(v)
|
Certification of Salary Rate Limitation:
If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:
|
(a)
|
Designated Billing Office and address: HHS/ASPR/BARDA
|
(b)
|
Invoice Number
|
(c)
|
Date of Invoice
|
(d)
|
Contract number and date
|
(e)
|
Payee's name and address. Show the Contractor's name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the Contractor, or a different payee has been designated, then insert the name and address of the payee instead of the Contractor.
|
(f)
|
Description of goods or services, quantity, unit price, (where appropriate), and total amount.
|
(g)
|
Charges for freight or express shipments other than F.O.B. destination. (If shipped by freight or express and charges are more than $25, attach prepaid bill.)
|
(h)
|
Equipment
-
If there is a contract clause authorizing the purchase of any item of equipment, the final invoice must contain a statement indicating that no item of equipment was purchased or include a completed form HHS-565, Report of Capitalized Nonexpendable Equipment.
|
Amount Billed
|
|||||||
Expenditure Category
|
Current
|
Cumulative
|
Contract Value
|
||||
Direct Costs:
|
|||||||
Direct Labor
|
|||||||
Fringe Benefits
|
0.00
|
%
|
|||||
Total Labor Costs:
|
|||||||
Overhead
|
0.00
|
%
|
|||||
Travel
|
|||||||
Subcontracts
|
|||||||
Consultant Fees
|
|||||||
Materials and Supplies
|
|||||||
Other
|
|||||||
Total Direct Costs
|
|||||||
G&A Rate
|
0.00
|
%
|
|||||
Subtotal:
|
|||||||
Fixed Fee
|
0.0
|
||||||
Total Amount Claimed
|
|||||||
Adjustments
|
|||||||
Grand Total
|
$-
|
(a)
|
Research patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract.
|
(b)
|
Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient care rates or amounts shall be established by the Secretary of HHS or his duly authorized representative.
|
(c)
|
Prior to submitting an invoice for patient care costs under this contract, the Contractor must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care.
|
(d)
|
The Contractor must maintain adequate procedures to identify those research patients participating in this contract who are eligible for third party reimbursement.
|
(e)
|
Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions of the contract are chargeable to this contract.
|
REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY
|
|||||||||||||
CONTRACTOR:
|
CONTRACT NUMBER:
|
||||||||||||
ADDRESS:
|
REPORT DATE:
|
||||||||||||
ADDRESS1:
|
|||||||||||||
ADDRESS2:
|
FISCAL YEAR:
|
||||||||||||
CITY:
|
|||||||||||||
STATE:
|
|||||||||||||
ZIP:
|
|||||||||||||
CLASSIFICATION
|
BEGINNING OF PERIOD
|
ADJUSTMENTS
|
END OF PERIOD
|
||||||||||
#ITEMS
|
VALUE
|
GFP ADDED
|
CAP ADDED
|
DELETIONS
|
#ITEMS
|
VALUE
|
|||||||
LAND >=$25K
|
|||||||||||||
LAND <$25K
|
|||||||||||||
OTHER REAL >=$25K
|
|||||||||||||
OTHER REAL <$25K
|
|||||||||||||
PROPERTY UNDER CONST
>=$25K
|
|||||||||||||
PROPERTY UNDER CONST
<$25K
|
|||||||||||||
PLANT EQUIP >=$25K
|
|||||||||||||
PLANT EQUIP <$25K
|
|||||||||||||
SPECIAL TOOLING >=$25K
|
|||||||||||||
SPECIAL TOOLING <$25K
|
|||||||||||||
SPECIAL TEST EQUIP >=$25K
|
|||||||||||||
SPECIAL TEST EQUIP <$25K
|
|||||||||||||
AGENCY PECULIAR >=$25K
|
|||||||||||||
AGENCY PECULIAR <$25K
|
|||||||||||||
MATERIAL >=$25K (CUMULATIVE)
|
|||||||||||||
PROPERTY UNDER MFR
>=$25K
|
|||||||||||||
PROPERTY UNDER MFR
<$25K
|
|||||||||||||
SIGNED BY:
|
|||||||||||||
SIGNATURE
|
DATE SIGNED:
|
||||||||||||
NAME PRINTED
|
Email
|
||||||||||||
TITLE
|
TELEPHONE
|
_____________
|
_______________________
|
_________
|
_________
|
______________
|
PRINT
|
1.
|
Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.
|
2.
|
Identify the status of the covered Federal action.
|
3.
|
Identify the appropriate classification of this report. If this is a follow up report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.
|
4.
|
Enter the full name, address, city, State and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.
|
5.
|
If the organization filing the report in item 4 checks "Subawardee," then enter the full name, address, city, State and zip code of the prime Federal recipient. Include Congressional District, if known.
|
6.
|
Enter the name of the Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For example, Department of Transportation, United States Coast Guard.
|
7.
|
Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.
|
8.
|
Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal control number assigned by the Federal agency). Include prefixes, e.g., "RFP-DE-90-001."
|
9.
|
For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.
|
10.
|
(a) Enter the full name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action.
|
11.
|
The certifying official shall sign and date the form, print his/her name, title, and telephone number.
|
According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid OMB Control Number. The valid OMB control number for this information collection is OMB No. 0348-0046. Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC 20503.
|
Racial Categories
|
Ethnic Categories
|
Total
|
||||||||
Not Hispanic or Latino
|
Hispanic or Latino
|
Unknown/Not Reported Ethnicity
|
||||||||
Female
|
Male
|
Unknown/ Not Reported
|
Female
|
Male
|
Unknown/ Not Reported
|
Female
|
Male
|
Unknown/ Not Reported
|
||
American Indian/ Alaska Native
|
0
|
|||||||||
Asian
|
0
|
|||||||||
Native Hawaiian or Other Pacific Islander
|
0
|
|||||||||
Black or African American
|
0
|
|||||||||
White
|
0
|
|||||||||
More Than One Race
|
0
|
|||||||||
Unknown or Not Reported
|
0
|
|||||||||
Total
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
EXTENDED PRICE
|
||||||||
0005
|
BioThrax [**] product
BioThrax [**] product [**] upon date of delivery [**]
To be delivered in accordance with the delivery schedule below (attached per SOW)
|
[**]
Doses |
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
939ZWUX 2642 2016 75-X-0956 5664711101 $17,906,329.32 |
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
EXTENDED PRICE
|
||||||||
0005
|
BioThrax [**] product
[**] upon date of delivery
[**]
To be delivered in accordance with the delivery schedule below (attached per SOW)
POP: 05/06/16 to 09/30/16.
|
[**]Doses
|
$
|
[
|
**]
|
$
|
143,740,431.60
|
|||||
Line(s) Of Accounting:
939ZWUX 2642 2016 75-X-0956
5664711101 $39,999,996.00
|
ActiveUS 158180924v.1
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
EXTENDED PRICE
|
||||||||
0005
|
BioThrax [**] product
[**] upon date of delivery [**]
To be delivered in accordance with
the delivery schedule below (attached per SOW)
Delivery Peiod – 08/10/16 - 09/30/16
|
[**]
Doses |
$
|
[
|
**]
|
$
|
168,170,916
|
|||||
Line(s) Of Accounting:
939ZQPD 2642 2016 75-X-0956 5664711101 $[**] 939ZWUX 2642 2016 75-X-0956 5664711101 $[**] 939ZXXW 2642 2016 75-X-0956 5664711101 $[**] |
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
EXTENDED PRICE
|
||||||||
0005
|
BioThrax [**] product
[**] upon date of delivery
[**]
To be delivered in accordance with
the delivery schedule below (attached per SOW)
POP: 09/07/16 to 09/30/16.
Delivery Peiod – 09/07/2016 -
09/30/16 |
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
939062V 2642 2016 75-16-0943
5623RF1101 $[**]
93907BF 2642 2016 75-16-0943
5623RF1101 $[**]
93907BF 2642 2016 75-16-0943
5623RF1101 $[**]
93907EW 2642 2016 75-16-0943
5623RF1101 $[**]
939ZWUX 2642 2016 75-X-0956
5664711101 $[**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
EXTENDED PRICE
|
||||||||
000502
|
BioThrax [**] product
[**] upon date of delivery
[**]
Corresponds to Line Item 0005B in
the contract.
To be delivered in accordance with
the delivery schedule schedule below (attached per SOW)
Delivery Peiod – 09/07/2016 -09/30/16
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
939ZWUX 2642 2016 75-X-0956
5664711101 $[**]
|