(Mark One)
|
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended March 31, 2017
|
|
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
|
|
|
|
Part II. Other Information
|
|
§ |
appropriations for the procurement of BioThrax
®
(Anthrax Vaccine Adsorbed) and our other countermeasures addressing public health threats;
|
§ |
our ability to perform under our contracts with the U.S. government related to BioThrax, including the timing of deliveries;
|
§ |
our ability to obtain Emergency Use Authorization pre-approval for NuThrax from the U.S. Food and Drug Administration;
|
§ |
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 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 and utilize our manufacturing facilities and capabilities;
|
§ |
our ability and the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices 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 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.
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
(in thousands, except share and per share data)
|
||||||||
March 31, 2017
|
December 31, 2016
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
270,170
|
$
|
271,513
|
||||
Accounts receivable, net
|
128,082
|
138,478
|
||||||
Inventories
|
70,732
|
74,002
|
||||||
Income tax receivable, net
|
6,771
|
9,996
|
||||||
Prepaid expenses and other current assets
|
13,411
|
16,229
|
||||||
Total current assets
|
489,166
|
510,218
|
||||||
Property, plant and equipment, net
|
381,102
|
376,448
|
||||||
Intangible assets, net
|
32,311
|
33,865
|
||||||
Goodwill
|
41,001
|
41,001
|
||||||
Deferred tax assets, net
|
5,022
|
6,096
|
||||||
Other assets
|
3,037
|
2,483
|
||||||
Total assets
|
$
|
951,639
|
$
|
970,111
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
27,179
|
$
|
34,649
|
||||
Accrued expenses and other current liabilities
|
4,346
|
6,368
|
||||||
Accrued compensation
|
23,318
|
34,537
|
||||||
Notes payable
|
-
|
20,000
|
||||||
Contingent consideration, current portion
|
2,216
|
3,266
|
||||||
Deferred revenue, current portion
|
10,647
|
7,036
|
||||||
Total current liabilities
|
67,706
|
105,856
|
||||||
Contingent consideration, net of current portion
|
9,601
|
9,919
|
||||||
Long-term indebtedness
|
248,394
|
248,094
|
||||||
Deferred revenue, net of current portion
|
13,887
|
8,433
|
||||||
Other liabilities
|
1,632
|
1,604
|
||||||
Total liabilities
|
341,220
|
373,906
|
||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both March 31, 2017 and December 31, 2016
|
-
|
-
|
||||||
Common stock, $0.001 par value; 200,000,000 shares authorized, 41,380,108 shares issued and 40,954,615 shares outstanding at March 31, 2017; 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016
|
41
|
41
|
||||||
Treasury stock, at cost, 425,493 and 422,830 common shares at March 31, 2017 and December 31, 2016, respectively
|
(6,501
|
)
|
(6,420
|
)
|
||||
Additional paid-in capital
|
355,661
|
352,435
|
||||||
Accumulated other comprehensive loss
|
(3,747
|
)
|
(4,331
|
)
|
||||
Retained earnings
|
264,965
|
254,480
|
||||||
Total stockholders' equity
|
610,419
|
596,205
|
||||||
Total liabilities and stockholders' equity
|
$
|
951,639
|
$
|
970,111
|
|
Three Months Ended March 31,
|
|||||||
|
2017
|
2016
|
||||||
|
(Unaudited)
|
|||||||
Revenues:
|
||||||||
Product sales
|
$
|
81,969
|
$
|
63,753
|
||||
Contract manufacturing
|
17,628
|
7,587
|
||||||
Contracts and grants
|
17,261
|
31,624
|
||||||
Total revenues
|
116,858
|
102,964
|
||||||
|
||||||||
Operating expenses:
|
||||||||
Cost of product sales and contract manufacturing
|
46,322
|
24,001
|
||||||
Research and development
|
20,476
|
26,093
|
||||||
Selling, general and administrative
|
35,150
|
31,713
|
||||||
Income from operations
|
14,910
|
21,157
|
||||||
|
||||||||
Other income (expense):
|
||||||||
Interest income
|
373
|
186
|
||||||
Interest expense
|
(1,938
|
)
|
(1,524
|
)
|
||||
Other income (expense), net
|
300
|
35
|
||||||
Total other expense, net
|
(1,265
|
)
|
(1,303
|
)
|
||||
|
||||||||
Income from continuing operations before provision for income taxes
|
13,645
|
19,854
|
||||||
Provision for income taxes
|
3,160
|
7,965
|
||||||
Net income from continuing operations
|
10,485
|
11,889
|
||||||
Net loss from discontinued operations
|
-
|
(7,898
|
)
|
|||||
Net income
|
$
|
10,485
|
$
|
3,991
|
||||
Net income from continuing operations - basic
|
$
|
0.26
|
$
|
0.30
|
||||
Net loss from discontinued operations - basic
|
-
|
(0.20
|
)
|
|||||
Net income per share - basic
|
$
|
0.26
|
$
|
0.10
|
||||
Net income from continuing operations - diluted
|
$
|
0.23
|
$
|
0.27
|
||||
Net loss from discontinued operations - diluted
|
-
|
(0.17
|
)
|
|||||
Net income per share - diluted (1)
|
$
|
0.23
|
$
|
0.10
|
||||
|
||||||||
Weighted-average number of shares - basic
|
40,727,755
|
39,542,656
|
||||||
Weighted-average number of shares - diluted
|
49,718,426
|
48,359,892
|
|
Three Months Ended March 31,
|
|||||||
|
2017
|
2016
|
||||||
|
(Unaudited)
|
|||||||
|
||||||||
Net income
|
$
|
10,485
|
$
|
3,991
|
||||
Foreign currency translations, net of tax
|
584
|
(1,439
|
)
|
|||||
Comprehensive income
|
$
|
11,069
|
$
|
2,552
|
(in thousands)
|
||||||||
Three Months Ended March 31,
|
||||||||
2017
|
2016
|
|||||||
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
Net Income
|
$
|
10,485
|
$
|
3,991
|
||||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
Stock-based compensation expense
|
4,284
|
5,197
|
||||||
Depreciation and amortization
|
10,166
|
8,840
|
||||||
Income taxes
|
4,299
|
2,964
|
||||||
Change in fair value of contingent obligations
|
200
|
847
|
||||||
Excess tax benefits from stock-based compensation
|
-
|
(5,786
|
)
|
|||||
Other
|
87
|
71
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
10,561
|
51,207
|
||||||
Inventories
|
3,270
|
(11,264
|
)
|
|||||
Prepaid expenses and other assets
|
2,338
|
(5,555
|
)
|
|||||
Accounts payable
|
81
|
385
|
||||||
Accrued expenses and other liabilities
|
(1,962
|
)
|
(2,045
|
)
|
||||
Accrued compensation
|
(11,203
|
)
|
(8,277
|
)
|
||||
Provision for chargebacks
|
-
|
(278
|
)
|
|||||
Deferred revenue
|
9,065
|
1,874
|
||||||
Net cash provided by operating activities
|
41,671
|
42,171
|
||||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment
|
(20,304
|
)
|
(18,214
|
)
|
||||
Net cash used in investing activities
|
(20,304
|
)
|
(18,214
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Issuance of common stock upon exercise of stock options
|
2,957
|
3,595
|
||||||
Excess tax benefits from stock-based compensation
|
-
|
5,786
|
||||||
Taxes paid on behalf of employees for equity activity
|
(4,015
|
)
|
(4,377
|
)
|
||||
Payments of notes payable
|
(20,000
|
)
|
-
|
|||||
Contingent obligation payments
|
(1,568
|
)
|
(752
|
)
|
||||
Purchase of treasury stock
|
(81
|
)
|
-
|
|||||
Net cash (used in) provided by financing activities
|
(22,707
|
)
|
4,252
|
|||||
Effect of exchange rate changes on cash and cash equivalents
|
(3
|
)
|
11
|
|||||
Net (decrease) increase in cash and cash equivalents
|
(1,343
|
)
|
28,220
|
|||||
Cash and cash equivalents at beginning of period
|
271,513
|
312,795
|
||||||
Cash and cash equivalents at end of period
|
$
|
270,170
|
$
|
341,015
|
Three Months Ended March 31,
|
||||
(in thousands)
|
2016
|
|||
Revenues:
|
||||
Product sales
|
$
|
7,952
|
||
Collaborations
|
85
|
|||
Total revenues
|
8,037
|
|||
Operating expense:
|
||||
Cost of product sales
|
4,502
|
|||
Research and development
|
8,061
|
|||
Selling, general and administrative
|
8,070
|
|||
Loss from operations
|
(12,596
|
)
|
||
Other income (expense), net:
|
81
|
|||
Loss from discontinued operations before benefit from income taxes
|
(12,515
|
)
|
||
Benefit from income taxes
|
(4,617
|
)
|
||
Net loss from discontinued operations
|
$
|
(7,898
|
)
|
Three Months Ended March 31,
|
||||
(in thousands)
|
2016
|
|||
Net cash used in operating activities
|
$
|
(6,021
|
)
|
|
Net cash used in investing activities
|
(1,087
|
)
|
||
Net cash provided by financing activities
|
5,689
|
|||
Net decrease in cash and cash equivalents
|
$
|
(1,419
|
)
|
(in thousands)
|
||||
Balance at December 31, 2016
|
$
|
13,185
|
||
Expense included in earnings
|
200
|
|||
Settlements
|
(1,568
|
)
|
||
Purchases, sales and issuances
|
-
|
|||
Transfers in/(out) of Level 3
|
-
|
|||
Balance at March 31, 2017
|
$
|
11,817
|
March 31,
|
December 31,
|
|||||||
(in thousands)
|
2017
|
2016
|
||||||
Raw materials and supplies
|
$
|
33,264
|
$
|
30,687
|
||||
Work-in-process
|
27,326
|
19,821
|
||||||
Finished goods
|
10,142
|
23,494
|
||||||
Total inventories
|
$
|
70,732
|
$
|
74,002
|
March 31,
|
December 31,
|
|||||||
(in thousands)
|
2017
|
2016
|
||||||
Land and improvements
|
$
|
20,376
|
$
|
20,340
|
||||
Buildings, building improvements and leasehold improvements
|
147,481
|
147,130
|
||||||
Furniture and equipment
|
192,828
|
190,157
|
||||||
Software
|
53,059
|
52,564
|
||||||
Construction-in-progress
|
87,330
|
77,813
|
||||||
Property, plant and equipment, gross
|
501,074
|
488,004
|
||||||
Less: Accumulated depreciation and amortization
|
(119,972
|
)
|
(111,556
|
)
|
||||
Total property, plant and equipment, net
|
$
|
381,102
|
$
|
376,448
|
(in thousands)
|
||||
Cost basis
|
||||
Balance at December 31, 2016
|
$
|
57,099
|
||
Additions
|
-
|
|||
Balance at March 31, 2017
|
$
|
57,099
|
||
Accumulated amortization
|
||||
Balance at December 31, 2016
|
$
|
(23,234
|
)
|
|
Amortization
|
(1,554
|
)
|
||
Balance at March 31, 2017
|
$
|
(24,788
|
)
|
|
Net balance at March 31, 2017
|
$
|
32,311
|
2006 Plan
|
||||||||||||
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2016
|
2,559,331
|
$
|
22.94
|
$
|
25,348,245
|
|||||||
Granted
|
376,798
|
30.63
|
||||||||||
Exercised
|
(162,642
|
)
|
18.00
|
|||||||||
Forfeited
|
(10,225
|
)
|
27.38
|
|||||||||
Outstanding at March 31, 2017
|
2,763,262
|
$
|
24.17
|
$
|
14,763,038
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2016
|
875,584
|
$
|
28.94
|
$
|
28,754,179
|
|||||||
Granted
|
353,681
|
30.63
|
||||||||||
Vested
|
(350,617
|
)
|
30.39
|
|||||||||
Forfeited
|
(13,989
|
)
|
28.09
|
|||||||||
Outstanding at March 31, 2017
|
864,659
|
$
|
30.13
|
$
|
25,109,698
|
|
Three Months Ended March 31,
|
|||||||
(in thousands, except share and per share data)
|
2017
|
2016
|
||||||
Numerator:
|
||||||||
Net income from continuing operations
|
$
|
10,485
|
$
|
11,889
|
||||
Interest expense, net of tax
|
907
|
716
|
||||||
Amortization of debt issuance costs, net of tax
|
195
|
215
|
||||||
Net income, adjusted from continuing operations
|
11,587
|
12,820
|
||||||
Income (loss) from discontinued operations
|
-
|
(7,898
|
)
|
|||||
Net income, adjusted
|
$
|
11,587
|
$
|
4,922
|
||||
|
||||||||
Denominator:
|
||||||||
Weighted-average number of shares—basic
|
40,727,755
|
39,542,656
|
||||||
Dilutive securities—equity awards
|
894,171
|
1,096,711
|
||||||
Dilutive securities—convertible debt
|
8,096,500
|
7,720,525
|
||||||
Weighted-average number of shares—diluted
|
49,718,426
|
48,359,892
|
||||||
|
||||||||
Net income per share-basic from continuing operations
|
$
|
0.26
|
$
|
0.30
|
||||
Income (loss) per share-basic from discontinued operations
|
-
|
(0.20
|
)
|
|||||
Net income per share-basic
|
0.26
|
0.10
|
||||||
Net income per share-diluted from continuing operations
|
$
|
0.23
|
$
|
0.27
|
||||
Income (loss) per share-diluted from discontinued operations
|
-
|
(0.17
|
)
|
|||||
Net income per share-diluted
|
0.23
|
0.10
|
Incurred in
|
Inception to Date
|
Total Expected
|
||||||||||
(in thousands)
|
2017
|
Costs Incurred
|
to be Incurred
|
|||||||||
Termination benefits
|
$
|
20
|
$
|
5,266
|
$
|
5,286
|
||||||
Abandonment of equipment
|
-
|
3,749
|
3,749
|
|||||||||
Other costs
|
-
|
691
|
691
|
|||||||||
Total
|
$
|
20
|
$
|
9,706
|
$
|
9,726
|
Termination
|
||||
(in thousands)
|
Benefits
|
|||
Balance at December 31, 2016
|
$
|
4,357
|
||
Expenses incurred
|
20
|
|||
Amount paid
|
(2,122
|
)
|
||
Other adjustments
|
-
|
|||
Balance at March 31, 2017
|
$
|
2,255
|
§ |
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. BioThrax is also licensed by the Paul-Ehrlich-Institut of the German Federal Ministry of Health for general use 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 and Health Canada for the treatment of botulinum disease;
|
§ |
VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only therapeutic licensed by the FDA to address certain complications from smallpox vaccination;
|
§ |
RSDL
®
(Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin; and
|
§ |
Tro
bigard™ (atropine sulfate, obidoxime chloride),
an auto-injector device designed for intramuscular self-injection
of atropine sulfate and obidoxime chloride, a nerve agent countermeasure. This product has not been approved by the FDA or any other regulatory agency, is not promoted or distributed in the U.S., and is only sold to non-U.S. authorized government buyers.
|
§ |
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
;
|
§ |
FLU-IG (NP025), a human polyclonal antibody therapeutic being developed to treat seasonal influenza;
|
§ |
ZIKA-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis for Zika infections; and
|
§ |
FILOV (NP026), an equine polyclonal antibody therapeutic being developed to treat Ebola infections.
|
Development Programs
|
Funding Source
|
Award Date
|
Performance Period
|
Anthrasil
|
BARDA
|
09/2005
|
9/2005 — 4/2021
|
BARDA
|
09/2013
|
9/2013 — 9/2018
|
|
BAT
|
BARDA
|
05/2006
|
5/2006 — 5/2026
|
CIADM
|
BARDA
|
06/2012
|
6/2012 — 6/2037
|
GC-072
|
DTRA
|
08/2014
|
8/2014 — 8/2017
|
Large-scale manufacturing for BioThrax
|
BARDA
|
07/2010
|
7/2010 — 7/2017
|
NuThrax
|
NIAID
|
08/2014
|
8/2014 — 10/2019
|
BARDA
|
03/2015
|
3/2015 — 8/2017
|
|
BARDA
|
09/2016
|
9/2016 — 9/2021
|
|
UV-4B
|
NIAID
|
09/2011
|
9/2011 — 9/2017
|
VIGIV
|
CDC
|
08/2012
|
8/2012 — 8/2017
|
Zika
|
BARDA
|
06/2016
|
6/2016 — 12/2018
|
|
Three Months Ended March 31,
|
|||||||||||||||
(in thousands)
|
2017
|
2016
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
43,815
|
$
|
59,100
|
$
|
(15,285
|
)
|
(26
|
%)
|
|||||||
Other
|
38,154
|
4,653
|
33,501
|
720
|
%
|
|||||||||||
Total product sales
|
81,969
|
63,753
|
18,216
|
29
|
%
|
|||||||||||
Contract manufacturing
|
17,628
|
7,587
|
10,041
|
132
|
%
|
|||||||||||
Contracts and grants
|
17,261
|
31,624
|
(14,363
|
)
|
(45
|
%)
|
||||||||||
Total revenues
|
$
|
116,858
|
$
|
102,964
|
$
|
13,894
|
13
|
%
|
§ |
decreased development funding of $8.2 million for VIGIV related to the timing of plasma collection;
|
§ |
decreased development funding of $3.9 million related to our CIADM program, which includes a decrease of $2.4 million for CIADM task orders; and
|
§ |
decreased development funding of $2.2 million for large-scale manufacturing of BioThrax due to our Building 55 facility receiving FDA approval in August 2016.
|
Three Months Ended
|
||||||||||||||||
March 31,
|
||||||||||||||||
(in thousands)
|
2017
|
2016
|
Change
|
% Change
|
||||||||||||
NuThrax
|
$
|
6,403
|
$
|
4,386
|
$
|
2,017
|
46
|
%
|
||||||||
UV-4B
|
1,849
|
1,153
|
696
|
60
|
%
|
|||||||||||
CIADM task orders
|
1,115
|
2,824
|
(1,709
|
)
|
(61
|
%)
|
||||||||||
FLU-IG (NP025)
|
1,028
|
-
|
1,028
|
N/A
|
||||||||||||
BAT
|
934
|
1,055
|
(121
|
)
|
(11
|
%)
|
||||||||||
Auto-injector platform
|
658
|
2,672
|
(2,014
|
)
|
(75
|
%)
|
||||||||||
Large-scale manufacturing for BioThrax
|
626
|
2,380
|
(1,754
|
)
|
(74
|
%)
|
||||||||||
Pandemic influenza
|
621
|
741
|
(120
|
)
|
(16
|
%)
|
||||||||||
VIGIV
|
610
|
2,587
|
(1,977
|
)
|
76
|
%
|
||||||||||
EV-035 series of molecules
|
606
|
802
|
(196
|
)
|
24
|
%
|
||||||||||
Anthrasil
|
212
|
283
|
(71
|
)
|
-25
|
%
|
||||||||||
BioThrax related programs
|
9
|
791
|
(782
|
)
|
(99
|
%)
|
||||||||||
Other
|
5,805
|
6,419
|
(614
|
)
|
(10
|
%)
|
||||||||||
Total
|
$
|
20,476
|
$
|
26,093
|
$
|
(5,617
|
)
|
(22
|
%)
|
|
Three Months Ended
|
|||||||
March 31,
|
||||||||
(in thousands)
|
2017
|
2016
|
||||||
Net cash provided by (used in):
|
||||||||
Operating activities(i)
|
$
|
41,668
|
$
|
42,182
|
||||
Investing activities
|
(20,304
|
)
|
(18,214
|
)
|
||||
Financing activities
|
(22,707
|
)
|
4,252
|
|||||
Net (decrease) increase in cash and cash equivalents
|
$
|
(1,343
|
)
|
$
|
28,220
|
|
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 possibility that we may be ineligible to respond to a request for proposal issued by the government;
|
§ |
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 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 could 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 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;
|
§ |
damage to or destruction of the facility; and
|
§ |
product contamination or tampering.
|
§ |
successful development, formulation and cGMP scale-up of manufacturing that meets FDA or other foreign regulatory 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 and other 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 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.
|
§ |
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;
|
§ |
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 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
|
10.1*
|
Form of Performance-Based Stock Unit Award Agreement (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on February 21, 2017).
|
10.2#††
|
Modification No. 1 to the Award/Contract (the "BARDA NuThrax Contract"), effective March 16, 2017, between the BioMedical Advanced Research and Development Authority and Emergent Product Development Gaithersburg Inc.
|
10.3#††
|
Award/Contract (the "BARDA BioThrax Contract"), effective March 16, 2017, between the BioMedical Advanced Research and Development Authority and Emergent Biodefense Operations Lansing LLC.
|
10.4#
|
Sixth Amendment to Credit Agreement, dated as of April 4, 2017, among the Company, as borrower, certain of its subsidiaries party thereto, as guarantors, Bank of America, N.A., as administrative agent, and certain financial institutions party thereto as lenders.
|
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.
|
* |
Management contract or compensatory plan or arrangement filed herewith in response to Item 15(c) of Form 10-Q.
|
Ratio of Earnings to Fixed Charges
|
|||||||||||||||||||||||
Year to Date
|
|||||||||||||||||||||||
|
March 30,
|
Year Ended December 31,
|
|||||||||||||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
2014
|
2013
|
2012
|
|||||||||||||||||
|
|||||||||||||||||||||||
Pretax income from continuing operations (1)
|
$
|
13,645
|
|
$
|
99,221
|
$
|
135,716
|
$
|
84,194
|
$
|
83,439
|
$
|
68,011
|
||||||||||
Fixed charges
|
|||||||||||||||||||||||
Interest expense
|
1,957
|
8,270
|
7,834
|
7,480
|
1,973
|
2,177
|
|||||||||||||||||
Debt issuance cost
|
382
|
1,526
|
1,564
|
3,290
|
319
|
67
|
|||||||||||||||||
Total fixed charges (2)
|
2,339
|
9,796
|
9,398
|
10,770
|
2,292
|
2,244
|
|||||||||||||||||
Noncontrolling interest in pretax income (3)
|
-
|
-
|
-
|
-
|
876
|
5,381
|
|||||||||||||||||
Capitalized interest (4)
|
401
|
2,179
|
2,875
|
2,530
|
1,973
|
2,177
|
|||||||||||||||||
Earnings ((1) + (2) -(3) -(4))
|
15,583
|
|
106,838
|
142,239
|
92,434
|
82,882
|
62,697
|
||||||||||||||||
Fixed charges
|
2,339
|
9,796
|
9,398
|
10,770
|
2,292
|
2,244
|
|||||||||||||||||
Ratio of earnings to fixed charges
|
6.7
|
10.9
|
15.1
|
8.6
|
36.2
|
27.9
|
|||||||||||||||||
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.
|
(i)
|
a fully-executed and effective Amendment executed by the Borrower, the Guarantors, the Administrative Agent and the Required Lenders; and
|
(ii)
|
such additional documents, instruments and information as Administrative Agent may reasonably request in connection with the transactions contemplated hereby.
|
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
|
3,000,000
|
[
|
**]
|
[
|
**]
|
|||||||
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 ($)
|
0004A
(Option
Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
7,500,000 to
[**]
|
[**]
|
[**]
|
0004B
(Option
Quantity)
|
[**]
|
Additional Surge Capacity
(Licensure)
|
7,500,000 to
[**]
|
[**]
|
[**]
|
0004C
(Option
Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
[**]
|
[**]
|
[**]
|
0004D
(Option
Quantity)
|
[**]
|
Additional Surge Capacity
(Licensure)
|
[**]
|
[**]
|
[**]
|
0004E
(Option
Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
[**]
|
[**]
|
[**]
|
0004F
(Option
Quantity)
|
[**]
|
Additional Surge Capacity
(Licensure)
|
[**]
|
[**]
|
[**]
|
0004G
(Option
Quantity)
|
[**]
|
Additional Surge Capacity (EUA)
|
[**]
|
[**]
|
[**]
|
0004H
(Option
Quantity)
|
[**]
|
Additional Surge Capacity
(Licensure)
|
[**]
|
[**]
|
[**]
|
Units (# of Doses)
|
FY 2019 Unit
Price ($)
|
FY 2020 Unit
Price ($)
|
FY 2021 Unit
Price ($)
|
7,500,000 to
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
1998)
|
is hereby modified to add FAR 52.219-9 as follows:
|
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
|
52.219-9
|
Nov 2016
|
Small Business Subcontracting Plan
|
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
|
AWARD/CONTRACT
|
1.
THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 700)
|
RATING
|
PAGE OF PAGES
1
42
|
|||||||||||||||||||||||||
2.
CONTRACT (
Proc. Inst. Indent.
) NO.
HHSO100201700007C
|
3.
EFFECTIVE DATE
See Block 20C
|
4.
REQUISITION/PURCHASE REQUEST/PROJECT NO.
OS194860
|
||||||||||||||||||||||||||
5.
ISSUED BY CODE
|
HHS/OS/ASPR/BARDA
|
6.
ADMINISTERED BY
(if other than Item 5)
|
CODE
|
ASPR-BARDA01
|
||||||||||||||||||||||||
HHS/OS/ASPR/BARDA
330 Independence Ave., SW
Room 640-G
Washington, DC 20201
|
ASPR-BARDA
330 Independence Ave, SW, Rm G644
Washington DC 20201
|
|||||||||||||||||||||||||||
7.
NAME AND ADDRESS OF CONTRACTOR
(No., street, county, State and ZIP Code)
EMERGENT BIODEFENSE OPERATIONS LANSING LLC 330303
EMERGENT BIODEFENSE OPERATIONS LANS
3500 N MARTIN LUTHER KING, JR BLVD #
LANSING, MI 489062933
|
8.
DELIVERY
FOB ORIGIN
Other
(See below)
|
|||||||||||||||||||||||||||
9.
DISCOUNT FOR PROMPT PAYMENT
|
||||||||||||||||||||||||||||
CODE 330303
|
FACILITY CODE
|
|||||||||||||||||||||||||||
11.
SHIP TO/MARK FOR CODE
|
HHS/OS/ASPR
|
12.
PAYMENT WILL BE MADE BY
|
CODE
|
PSC
|
||||||||||||||||||||||||
HHS/OS/ASPR
200 C St SW
WASHINGTON DC 20201
|
PSC
330 Independence Ave, SW, Rm G644
Washington DC 20201
|
|||||||||||||||||||||||||||
13.
AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:
10 U.S.C. 2304(c) ( )
41 U.S.C. 253(c) ( )
|
14.
ACCOUNTING AND APPROPRIATION DATA
2017.1990008.26402
|
|||||||||||||||||||||||||||
15A. ITEM NO.
|
15B. SUPPLIES/SERVICES
|
15C. QUANTITY
|
15D. UNIT
|
15E. UNIT PRICE
|
15F. AMOUNT
|
|||||||||||||||||||||||
TITLE: AVA FOR THE SNS
Continued
|
||||||||||||||||||||||||||||
15G. TOTAL AMOUNT OF
|
$
|
99,941,719.80
|
||||||||||||||||||||||||||
16. TABLE OF CONTENTS
|
||||||||||||||||||||||||||||
(X)
|
SEC.
|
DESCRIPTION
|
PAGE(S)
|
(X)
|
SEC.
|
DESCRIPTION
|
PAGE(S)
|
|||||||||||||||||||||
PART I – THE SCHEDULE
|
PART II – CONTRACT CLAUSES
|
|||||||||||||||||||||||||||
X
|
A
|
SOLICITATION/CONTRACT FORM
|
1
|
X
|
I
|
CONTRACT CLAUSES
|
31
|
|||||||||||||||||||||
X
|
B
|
SUPPLIES OR SERVICES AND PRICES/COSTS
|
4
|
PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
|
||||||||||||||||||||||||
X
|
C
|
DESCRIPTION/SPECS./WORK STATEMENT
|
7
|
X
|
J
|
LIST OF ATTACHMENTS
|
42
|
|||||||||||||||||||||
X
|
D
|
PACKAGING AND MARKING
|
15
|
PART IV – REPRESENTATIONS AND INSTRUCTIONS
|
||||||||||||||||||||||||
X
|
E
|
INSPECTION AND ACCEPTANCE
|
16
|
K
|
REPRESENTATIONS, CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORS
|
|||||||||||||||||||||||
X
|
F
|
DELIVERIES OR PERFORMANCE
|
17
|
|||||||||||||||||||||||||
X
|
G
|
CONTRACT ADMINISTRATION DATA
|
21
|
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. 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 or 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. AWARD
(Contractor is required to sign this document.)
Your bid on
Solicitation Number ________
17-100-SOL-00010
______________,
including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the terms listed above and on any continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government's soliciation 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)
|
20A. NAME OF CONTRACTING OFFICER
[**]
|
|||||||||||||||||||||||||||
19B. NAME OF CONTRACTOR
|
19C. DATE SIGNED
|
20B. UNITED STATES OF AMERICA
|
20C. DATE SIGNED
3/16/2017
|
|||||||||||||||||||||||||
BY
|
BY
|
|||||||||||||||||||||||||||
(Signature of person authorized to sign)
|
(Signature of Contracting Officer)
|
|||||||||||||||||||||||||||
AUTHORIZED FOR LOCAL REPRODUCTION
Previous edition is NOT usable
|
STANDARD FORM 26
(REV. 5/2011)
Prescribed by GSA – FAR (48 CFR) 53.214(a)
|
B.1.
|
BRIEF DESCRIPTION OF SUPPLIES
|
B.2.
|
PRICES/COSTS
|
B.2.1.
|
BASE PERIOD OF PERFORMANCE: The base period is 24 months from date of award.
|
B.2.2.
|
FIRM FIXED PRICE
|
ITEM
|
SUPPLIES/SERVICES
|
QTY/UNIT
|
UNIT PRICE
|
Total Fixed Price
|
||||||||
0001
|
BioThrax
®
/AVA
BioThrax ® [**] product [**] upon date of delivery [**] |
[**] Dose
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
0002
|
Logistics – Safe and secure shipment of product to SNS
Delivery Address: TBD
|
[**] Trucks
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
TOTAL
|
$
|
99,941,719.80
|
B.2.3.
|
OPTION PERIODS
|
B.2.4.
|
RESERVED
|
B.2.5.
|
PRICE PROTECTIONS
|
B.2.6.
|
COSTS UNALLOWABLE UNLESS AUTHORIZED BY THE CONTRACTING OFFICER
|
(a)
|
Acquisition, by purchase or lease, of any interest in real property;
|
(b)
|
Rearrangement or alteration of facilities;
|
(c)
|
Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar value;
|
(d)
|
Accountable Government Property;
|
(e)
|
Overtime;
|
(f)
|
General scientific meetings/conferences;
|
(g)
|
Travel costs including foreign travel;
|
(h)
|
Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);
|
(i)
|
Costs to be paid for the performance of a fixed-price subcontract that exceeds $150,000.00;
|
(j)
|
Refreshments and Meal Expenditures;
|
(k)
|
Promotional Items
|
(l)
|
Printing
|
B.2.7.
|
SUBCONTRACTS AND CONSULTANTS
|
B.2.8.
|
CONFIDENTIAL TREATMENT OF SENSITIVE INFORMATION
|
B.2.9.
|
SHARING OF CONTRACT DELIVERABLES WITHIN THE UNITED STATES GOVERNMENT
|
B.2.10.
|
CONTRACT NUMBER DESIGNATION
|
B.2.11.
|
DEFINITION OF DAYS
|
C.1.
|
VACCINE PRODUCTION AND CGMP COMPLIANCE:
|
1.
|
The Contractor shall manufacture BioThrax
®
in accordance with current Good Manufacturing Practices (cGMP) guidelines
|
2.
|
BioThrax
®
must be delivered on any business day, except Federal holidays, within the scheduled month in accordance with the targeted delivery schedule. The Contractor shall notify the Government promptly upon becoming aware of any deviations from the targeted delivery schedule. All changes to the targeted delivery schedule must be approved by the Contracting Officer and/or the Contracting Officer's Representative (COR).
|
3.
|
Quantities for each scheduled delivery shall be of a specific quantity.
|
4.
|
The Contractor shall perform all requisite assays and release tests, including but not limited to potency, identity, and stability testing in accordance with the Food Drug Administration (FDA) approved Biologic License Application (BLA-License Number 1755, STN 103821, and any approved change).
|
5.
|
All BioThrax
®
delivered under this contract must be labeled with an expiration date consistent with its current product license at the time of manufacture.
|
6.
|
The Contractor shall provide primary and secondary points of contact that shall be available 24 hours per day, seven days per week to be notified in case of a public health emergency.
|
7.
|
The Contractor shall report to the Government material correspondence from the FDA regarding the quality, safety, or efficacy of BioThrax
®
.
|
8.
|
The Contractor shall provide the Government with access to and/or provide copies of the following documents: (1) Form 483s form FDA inspections of Contractor's Lansing facility, (2) Establishment Inspection Reports (EIRs) from FDA inspections of Contractor's Lansing facility; (3) W arning Letters relating to BioThrax
®
; and Contractor's Annual Safety Report to FDA regarding BioThrax
®
. These documents will be provided to the Contracting Officer within 2 business days of receipt.
|
9.
|
The Contractor shall notify the Government of any issues with the safety and efficacy of BioThrax
®
and/or manufacturing or quality of the FDA-licensed production lines at the Contractor's Lansing facility within [**] business days of the determination of potential to be reported to FDA.
|
10.
|
The Government will have the option to conduct site inspections of the Contractor's Lansing facility during the period of performance of the contract. Such inspections will be performed by the COR or the COR's designee(s).
|
11.
|
If the contractor should obtain FDA approval for the manufacture and production of BioThrax
®
having [**] while under this contract, the Government will accept delivery of those doses with the [**] in addition to doses with a [**]. The Contractor may invoice only for those doses actually delivered under this contract in accordance with Section B.
|
12.
|
The product must be delivered in accordance with cGMP guidelines.
|
13.
|
The Contractor shall notify BARDA at least [**] days' prior of estimated shipment of product. At least [**] business days prior to the product being ready for shipment to DSNS, the Contractor shall obtain delivery address from the Contracting Officer and provide to the Contracting Officer and COR the following:
|
(a)
|
The date the product will be ready for loading on the truck(s) and the intended delivery date of product to the DSNS
|
(b)
|
Number of pallets, vials, and doses to be loaded and delivered to DSNS
|
14.
|
At least [**] hours before each scheduled delivery, the Contractor shall provide the following to the Contracting Officer and COR:
|
(a)
|
Packing Slip
|
(b)
|
Certificate(s) of Analysis c. FDA Lot Release(s)
|
(c)
|
Actual number of pallets, vials and doses to be loaded
|
(d)
|
Diagram of product shipment pallet (how many vials per box, per pallet)
|
15.
|
TempTale monitors supplied with each delivery must be returned to Contractor per instructions provided with each shipment within [**] business days after product delivery. Within [**] hours of receipt of TempTale monitors, the Contractor shall provide to the Contracting Officer and COR a letter for each delivered lot from the Contractor's Quality Department containing the following information:
|
(a)
|
The remaining ambient exposure time letter disclosing accumulated ambient temperature exposure until the point that BARDA (or DSNS-designated personnel) assumed responsibility for temperature control, per Section F, for each lot from the Contractor's Quality Department. The letter must indicate that the product was manufactured and released in accordance with cGMP and has met all acceptance criteria to allow for Government distribution.
|
16.
|
Funds provided shall be paid on a price per doses basis only on those products delivered and accepted to DSNS under contract.
|
17.
|
Under CLIN 0001 of this contract the products shall have an [**] product. The Contractor shall target ≥[**] of the total [**] remaining when the Government takes delivery of the product.
|
C.2.
|
RESERVED
|
C.3.
|
MEETINGS/SITE VISITS/AUDITS
|
C.4.
|
PRODUCT DELIVERIES
|
C.4.1.
|
TEMPERATURE CONTROL AND MONITORING
|
C.4.2.
|
DSNS QUALITY CONTROL UNIT (QCU) ACCEPTANCE PROCEDURE FOR BIOTHRAX (AVA)
|
1.
|
Notification of practices that may impact DSNS shipping procedures, if applicable
|
2.
|
All items outlined for delivery of product.
|
C.4.3.
|
ACCEPTANCE PROCESS AND TIMEFRAME (FOB DESTINATION DELIVERY)
|
1.
|
Contractor shall deliver to the Government, via e-mail or facsimile:
|
(a)
|
All required documentation outlined for delivery of product
|
(b)
|
Notification of the date and time that the product was delivered.
|
2.
|
Acceptance Timeframe: The Government will have [**] full business days, after receipt of all documentation required to establish that the requirements have been satisfied and provide Contractor notice that DSNS accepts the lot(s).
|
(a)
|
For purposes of this acceptance timeframe, business days are defined as 9:00AM to 5:00PM Eastern Time, Monday through Friday, excluding U.S. Government Holidays.
|
(b)
|
For the avoidance of doubt, BARDA will provide the Contractor with a written acceptance or refusal of BioThrax
®
lot(s) no later than 5:00PM on the [**] business day after receipt of the documentation.
|
C.4.4.
|
BARDA RELEASE FOR BioThrax
|
Temperature Range
|
Action
|
< [**]°C
|
☐
AVA Pallet will be placed into DSNS quarantine pending further disposition
|
[**]°C – [**]°C
|
☐
Acceptable for use by the SNS
|
≥[**]°C – [**]°C
|
☐
AVA Pallet will be placed into DSNS quarantine
☐
Release of product by BARDA will be pending quality disposition investigation, and remaining ambient exposure for the lot
|
>[**]°C
|
☐
AVA Pallet will be placed into DSNS quarantine pending further disposition
|
C.5.
|
REPORTING REQUIREMENTS
|
A.
|
MONTHLY PROGRESS REPORT
|
B.
|
ANNUAL PROGRESS REPORT
|
C.
|
DRAFT FINAL REPORT AND FINAL REPORT
|
D.
|
FDA REGULATORY AGENCY CORRESPONDENCE, MEETING SUMMARIES, AND SUBMISSIONS
|
E.
|
OTHER REQUIREMENTS/DELIVERABLES
|
(a)
|
ANNUAL/FINAL INVENTION REPORT
All reports and documentation required by FAR Clause 52.227-11, Patent Rights- Ownership by the Contractor, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. An Annual Invention Report shall be due on or before the [**] calendar day after the completion of each reporting period. A Final Invention Report (see FAR 27.303 (b)(2)(ii)) shall be due on or before the expiration date of the contract. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer. |
(b)
|
PRESS RELEASES
The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than [**] business days prior to the issuance of any potential press release. |
(c)
|
SECURITY REPORT
The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products. Reports shall be due within [**] hours after occurrence of an activity or incident. |
D.1.
|
METHOD OF DELIVERY
|
E.1.
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR Chapter 1) CLAUSES
|
Reg
|
Clause
|
Date
|
Clause Title
|
FAR
|
52.246-2
|
Aug 1996
|
Inspection of Supplies - Fixed Price
|
FAR
|
52.246-16
|
Apr 1984
|
Responsibility for Supplies
|
E.2.
|
INSPECTION AND ACCEPTANCE (NON-PRODUCT DELIVERABLES)
|
E.3.
|
INSPECTION AND ACCEPTANCE (PRODUCT DELIVERABLES)
|
FAR 52.252-2 |
Clauses Incorporated by Reference (Feb 1998)
|
F.1.
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR Chapter 1) CLAUSES
|
Reg
|
Clause
|
Date
|
Clause Title
|
FAR
|
52.246-15
|
Aug 1989
|
Stop Work Order
|
FAR
|
52.246-15, Alternate 1
|
Apr 1984
|
Alternate 1
|
F.2.
|
PERIOD OF PERFORMANCE
|
F.3.
|
DELIVERIES
|
F.4.
|
CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS
|
F.4.1.
|
SUBMISSION OF CONTRACT DELIVERABLES (NON-PRODUCT DELIVERABLES)
|
UPS/FedEx/Courier
|
USPS Mail Packages
|
[**]
Contracting Officer HHS/ASPR/AMCG 200 C St. SW Washington, DC 20024 Email: [**] |
[**]
Contracting Officer HHS/ASPR/AMCG 200 C St. SW Washington, DC 20024 |
UPS/FedEx/Courier
|
USPS Mail Packages
|
[**]
Contracting Officer Representative HHS/ASPR/BARDA 200 C St. SW Washington, DC 20024 Email: [**] |
[**]
Contracting Officer Representative HHS/ASPR/BARDA 200 C St. SW Washington, DC 20024 |
F.4.2.
|
DELIVERABLE SCHEDULE
|
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 [**] 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 [**] 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 [**] 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
|
CO: (1) electronic copy
COR: (1) electronic copy |
Reports are due with the next applicable report from Items 1 through 4 above.
|
6
|
Annual/Final Invention Report
|
CO: (1) electronic copy
COR: (1) electronic copy |
An Annual Invention Report is due on or before the [**] calendar day after the completion of each reporting period. A Final Invention Report is due on or before the expiration date of the contract.
|
7
|
Press Releases
|
CO: (1) electronic copy COR: (1) electronic copy
|
Reports/Notices are due for approval to the CO not less than [**] business days prior to the issuance of any potential press release.
|
8
|
Security Report
|
CO: (1) electronic copy
COR: (1) electronic copy |
Reports are due within [**] hours after occurrence of an activity or incident.
|
F.5.
|
PRODUCT DELIVERIES
|
F.5.1.
|
USE OF PRODUCT BY THE U.S. GOVERNMENT
|
F.5.2.
|
CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS
|
(a)
|
The delivery of BioThrax
®
product shall be F.O.B Destination at the USG designated drop off location.
|
(b)
|
At least [**] days prior to an estimated shipment vendor will provide the COR with the notices required under Section C.1.13 above and F.5.2.3 below.
|
(c)
|
The place of product drop off by the Contractor will be provided by the USG to the Contractor at least [**] business days prior to scheduled pick up by the designated carrier.
|
(a)
|
At least [**] days prior to an estimated shipment the contractor shall notify the COR and receive the DSNS shipment delivery address from the COR.
|
(b)
|
At least [**] business days prior to each product shipment by the Contractor, the Contractor shall provide to the Contracting Officer and COR:
|
(i)
|
The delivery date: For FOB Destination deliveries, shall be the date the product will be scheduled for delivery by the Contractor
|
(ii)
|
Actual number of 40"x48" pallets, number of vials, and doses to be loaded
|
(c)
|
At least [**] hours before each scheduled shipment by the Contractor, the Contractor shall provide the following to the Contracting Officer and COR:
|
(i)
|
Packing Slip
|
(ii)
|
Certificate(s) of Analysis iii. FDA Lot Release(s)
|
(iii)
|
Confirm the number of pallets, vials and doses to be loaded
|
(iv)
|
Diagram of product shipment pallet (how many vials per box, per pallet)
|
(d)
|
On the shipment date, the Contractor shall provide a shipment confirmation including the TempTale ID#(s) associated with each pallet being delivered.
|
(e)
|
TempTale monitors supplied with each delivery must be returned to Contractor per instructions provided with each shipment within [**] business days upon product receipt. Within [**] hours of receipt of TempTale monitors, the Contractor shall provide to the Contracting Officer and COR a letter for each delivered lot from the Contractor's Quality Department containing the following information:
|
(i)
|
The remaining ambient temperature exposure time for the lot until the point that BARDA (or DSNS-designated personnel) assumed responsibility for temperature control, per Section C.4.1.
|
(ii)
|
This letter shall also indicate that the product was manufactured and released in accordance with cGMP and has met acceptance criteria to allow for Government distribution.
|
G.1.
|
CONTRACTING OFFICER (CO)
|
1.
|
direct or negotiate any changes in the statement of objectives;
|
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;
|
5.
|
obligate or de-obligate funds into the contract;
|
6.
|
sign written licensing agreements; or
|
7.
|
otherwise change any terms and conditions of this contract.
|
G.2.
|
CONTRACTING OFFICER'S REPRESENTATIVE (COR)
|
1.
|
monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;
|
2.
|
assisting the CO in interpreting the statement of work and any other technical performance requirements;
|
3.
|
performing technical evaluation as required;
|
4.
|
performing technical inspections required by this contract; and
|
5.
|
assisting in the resolution of technical problems encountered during performance.
|
G.3.
|
CONTRACTOR'S POINTS OF CONTACT
|
G.4.
|
KEY PERSONNEL, HHSAR 352.237-75 (December 2015)
|
·
|
[**]
|
G.5.
|
INVOICE SUBMISSION
|
(a) |
The Contractor shall submit invoices electronically to the Contracting Officer (CO), the Contract Specialist (CS), the Contracting Officer's Representative (COR), and PSC (PSC_Invoices@psc.hhs.gov). The payment request shall be transmitted as an attachment via email. Invoice composition instructions are provided in Attachment #2 (Fixed Price Type Contracts). A sample invoice form is provided as Attachment #3.
|
(b) |
The Contractor agrees to include (as a minimum) the following information on each invoice:
|
1. |
Contractor's Name & Address
|
2. |
Contractor's Tax Identification Number (TIN)
|
3. |
Contract Number
|
4. |
Invoice Number
|
5. |
Invoice Date
|
6. |
Contract Line Item Number
|
7. |
Quantity
|
8. |
Unit Price & Extended Amount for each line item
|
9. |
Total Amount of Invoice
|
10. |
Name, title and telephone number of person to be notified in the event of a defective invoice
|
11. |
Payment Address, if different from the information in (b)(1).
|
(c) |
The invoice shall be signed by a person authorized to bind the Contractor.
|
(d) |
The Contractor shall not submit an invoice prior to delivery of goods or services.
|
(e) |
The Contractor shall include the following certification at the bottom of the payment request: "I hereby certify that the salaries billed in this payment request are in compliance with the current HHS Salary Rate Limitation Provisions in Section I of the contract."
|
G.6.
|
PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (DEC 2013)
|
(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.
|
G.7.
|
CONTRACT COMMUNICATIONS/CORRESPONDENCE
|
G.8.
|
POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
|
(a)
|
Purpose
: In accordance with FAR Subpart 42.15, the Contractor's performance will be periodically evaluated by the government in order to provide current information for source selection purposes. These evaluations will therefore be marked "Source Selection Information."
|
(b)
|
Performance Evaluation Period
: The Contractor's performance will be evaluated at least [**].
|
(c)
|
Evaluators
: The performance evaluation will be completed jointly by the Contracting Officer's Representative and the Contracting Officer.
|
(d)
|
Performance Evaluation Factors
: The Contractor's performance will be evaluated in accordance with FAR Subpart 42.15.
|
(e)
|
Contractor Review
: A copy of the evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within [**] calendar days after receipt of the evaluation.
|
(f)
|
Resolving Disagreements between the Government and the Contractor
: Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, Contractor's response, and review comments, if any, will be retained as part of the evaluation.
|
(g)
|
Release of Contractor Performance Evaluation Information
: The completed evaluation will not be released to other than Government personnel and the Contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the Contractor being evaluated, as well as impede the efficiency of Government operations.
|
(h)
|
Source Selection Information
: Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.
|
(i)
|
Retention Period
: The agency will retain past performance information for a maximum period of [**] years after completion of contract performance for the purpose of providing source selection
|
H.1.
|
NEEDLE DISTRIBUTION
|
H.2.
|
ACKNOWLEDGEMENT OF FEDERAL FUNDING
|
H.3.
|
RESTRICTIONS ON ABORTIONS
|
H.4.
|
GUN CONTROL
|
H.5.
|
DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
|
H.6.
|
CARE OF LIVE VERTEBRATE ANIMALS
|
(a)
|
Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (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 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 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 Animal Welfare Assurances.
|
H.7.
|
ANIMAL WELFARE
|
H.8.
|
OMB CLEARANCE
|
H.9.
|
RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS
|
H.10.
|
CERTIFICATION OF FILING AND PAYMENT OF TAXES
|
H.11.
|
SUBCONTRACTING PROVISIONS
|
A.
|
SMALL BUSINESS SUBCONTRACTING PLAN
|
1.
|
The Small Business Subcontracting Plan, dated February 1, 2017 is attached hereto and made a part of this contract.
|
2.
|
The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."
|
B.
|
SUBCONTRACTING REPORTS
|
1.
|
Individual Subcontract Reports (ISR)
|
·
|
[**]
|
·
|
[**]
|
·
|
Expiration Date of Contract
|
2.
|
Summary Subcontract Report (SSR)
|
·
|
[**]
|
H.12.
|
CONFIDENTIALITY OF INFORMATION
|
(a)
|
Confidential information, as used in this article, means information or data of a personal nature about 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. (See HHSAR Clause 352.224-70).
|
(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.
|
H.13.
|
PUBLICATION AND PUBLICITY
|
H.14.
|
REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE
|
H.15.
|
PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES
|
H.16.
|
ACCESS TO DOCUMENTATION/DATA
|
H.17.
|
IDENTIFICATION AND DISPOSITION OF DATA
|
H.18.
|
DISSEMINATION OF INFORMATION
|
H.19.
|
D
ISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
|
H.20.
|
INCORPORATION OF TECHNICAL PROPOSAL
|
B.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
|
52.203-7
|
May 2014
|
Anti-Kickback Procedures
|
FAR
|
52.203-8
|
May 2014
|
Cancellation, Recession, and Recovery of Funds for Illegal or Improper Activity
|
FAR
|
25.203-10
|
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
|
52.203-14
|
Oct 2015
|
Display of Hotline Poster(s)
|
FAR
|
52.203-17
|
Apr 2014
|
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
|
52.204-13
|
Jul 2013
|
System for Award Management Maintenance
|
FAR
|
52.209-10
|
Nov 2015
|
Prohibition on Contracting with Inverted Domestic Corporations
|
FAR
|
52.211-5
|
Aug 2000
|
Material Requirements
|
FAR
|
52.212-1
|
Oct 2016
|
Instructions to Offerors – Commercial Items
|
FAR
|
52.215-8
|
Oct 1997
|
Order of Precedence – Uniform Contract Format
|
FAR
|
52.218-23
|
Oct 2009
|
Limitations on Pass-Through Charges
|
FAR
|
52.219-8
|
Oct 2015
|
Utilization of Small Business Concerns
|
FAR
|
52.219-9
|
Oct 2015
|
Small Business Subcontracting Plan
|
FAR
|
52.222-1
|
Feb 1997
|
Notice to the Government of Labor Disputes
|
FAR
|
52.222-2
|
July 1990
|
Payment for Overtime Premiums
|
FAR
|
52.222-29
|
Apr 2015
|
Notification of Visa Denial
|
FAR
|
52.223-6
|
May 2001
|
Drug-Free Workplace
|
FAR
|
52.224-1
|
Apr 1984
|
Privacy Act Notification
|
FAR
|
52.224-2
|
Apr 1984
|
Privacy Act
|
FAR
|
52.225-13
|
Jun 2008
|
Restrictions on Certain Foreign Purchases
|
FAR
|
52.226-1
|
Jun 2000
|
Utilization of Indian Organizations and Indian-Owned Economic Enterprises
|
FAR
|
52.227-1
|
Dec 2007
|
Authorization and Consent
|
FAR
|
52.227-2
|
Dec 2007
|
Notice and Assistance Regarding Patent and Copyright Infringement
|
FAR
|
52.227-14
|
May 2014
|
Rights in Data – General
|
FAR
|
52.229-3
|
Feb 2013
|
Federal, State, and Local Taxes
|
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
|
52.232-25
|
Jan 2017
|
Prompt Payment
|
FAR
|
52.232-39
|
June 2013
|
Unenforceability of Unauthorized Obligations
|
FAR
|
52.233-3
|
Aug 1996
|
Protest after Award
|
FAR
|
52.233-4
|
Oct 2004
|
Applicable Law for Breach of Contract Claim
|
FAR
|
52.242-13
|
Jul 1995
|
Bankruptcy
|
FAR
|
52.243-1
|
Aug 1987
|
Changes—Fixed Price
|
FAR
|
52.244-6
|
Jan 2017
|
Subcontracts for Commercial Items
|
FAR
|
52.246-23
|
Feb 1997
|
Limitation of Liability
|
FAR
|
52.248-1
|
Oct 2010
|
Value Engineering
|
B.2.
|
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR Chapter 3) CLAUSES
|
HHSAR
|
352.203-70
|
December 2015
|
Anti-Lobbying
|
HHSAR
|
352.208-70
|
December 2015
|
Printing and Duplication
|
HHSAR
|
352.215-70
|
December 2015
|
Late Proposals and Revisions
|
HHSAR
|
352.216-70
|
December 2015
|
Additional Cost Principles
|
HHSAR
|
352.222-70
|
December 2015
|
Contractor Cooperation in Equal Employment Opportunity Investigations
|
HHSAR
|
352.223-70
|
December 2015
|
Safety and Health
|
HHSAR
|
352.224-70
|
December 2015
|
Privacy Act
|
HHSAR
|
352.224-71
|
December 2015
|
Confidential Information
|
HHSAR
|
352.227-70
|
December 2015
|
Publications and Publicity
|
HHSAR
|
352.233-71
|
December 2015
|
Litigation and Claims
|
HHSAR
|
352-239.73
|
December 2015
|
Electronic Information and Technology Accessibility Notice
|
HHSAR
|
352.270-9
|
December 2015
|
Non-Discrimination for Conscience
|
B.3.
|
ADDITIONAL CONTRACT CLAUSES
|
B.3.1.
|
ADDITIONAL HHS ACQUISITION REGULATION (HHSAR) CLAUSES – IN FULL TEXT
|
(a)
|
This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (
44 U.S.C 3501
et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer's Technical Representative shall be guided by the provisions of
5 CFR Part 1320
, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance.
|
(b)
|
The Contractor shall not expend any funds or begin any data collection until OMB Clearance is received. Once OMB Clearance is received from the Contracting Officer's Technical Representative, the Contracting Officer shall provide the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract.
|
B.3.2.
|
ADDITIONAL FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES – IN FULL TEXT
|
(a)
|
In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), Government agencies are not permitted to use funds appropriated (or otherwise made available) under that or any other Act for contracts with an entity that requires employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
|
(b)
|
The prohibition in paragraph (a) of this provision does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.
|
(c)
|
Representation. By submission of its offer, the Contractor represents that it does not require employees or subcontractors of such entity seeking to report fraud, waste or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
|
1.
|
Security Plan
|
2.
|
Technical Proposal
|
3.
|
Invoice Instructions for Fixed Price Contracts
|
4.
|
Sample Invoice Form
|
5.
|
SF-LLL, Disclosure of Lobbying Activities
|
6.
|
ACH Vendor/ Miscellaneous Payment Enrollment Form
|
7.
|
Small Business Subcontracting Plan
|
8.
|
Responses to Negotiation Questions
|
·
|
management responsibility and review
|
·
|
personnel qualification and training
|
·
|
document and data control
|
·
|
validation
|
·
|
equipment and facilities control
|
·
|
supplier quality and materials management control
|
·
|
production and in-process controls
|
·
|
non-conformance handling
|
·
|
change control
|
·
|
corrective and preventive action
|
Volume I – Technical Proposal Original
|
Administrative Business Contact:
[**]
Phone: [**]
E-Mail· [**]
|
Prepared for:
[**], Contracting Officer
Phone: [**]
HHS/OS/ASPR/AMCG
330 Independence AV, SW, RM G-460 Washington, DC 20024
Email: [**]
|
/s/ [**]
|
|
[**]
This proposal is predicated upon all the terms and conditions contained in the above referenced solicitation.
|
|
Technical Contacts:
[**]
Phone: [**]
E-Mail· [**]
[**]
Phone: [**]
E-Mail· [**]
|
Cognizant Audit Office:
The National Institutes of Health Office of Acquisition Mgmt. and Policy Division of Financial Advisory Services
6100 Executive Blvd., Room 6805
Rockville, MD 20892
|
C.1.
VACCINE PRODUCTION AND CGMP COMPLIANCE
|
|
C.1.1
The Contractor shall manufacture BioThrax in accordance with current Good Manufacturing Practices (cGMP) guidelines
|
Sect IV.A
|
C.1.2
BioThrax
®
must be delivered on any business day, except Federal holidays, within the scheduled month in accordance with the targeted delivery schedule. The Contractor shall notify the Government promptly upon becoming aware of any deviations from the targeted delivery schedule. All changes to the targeted delivery schedule must be approved by the Contracting Officer and/or the Contracting Officer's Representative (COR).
|
Appendix B
|
C.1.3
Quantities for each scheduled delivery shall be of a specific quantity
|
Appendix B
|
C.1.4.
The Contractor shall perform all requisite assays and release tests, including but not limited to potency, identity, and stability testing in accordance with the Food Drug Administration (FDA) approved Biologic License Application (BLA-License Number 1755, STN 103821, and any approved change).
|
Section IV.A
|
C.1.5.
All BioThrax
®
delivered under this contract must be labeled with an expiration date consistent with its current product license at the time of manufacture.
|
Sections IV.A, V.E
|
C.1.6.
The Contractor shall provide primary and secondary points of contact that shall be available 24 hours per day, seven days per week to be notified in case of a public health emergency.
|
Section VI.C
|
C.1.7.
The Contractor shall report to the Government material correspondence from the FDA regarding the quality, safety, or efficacy of BioThrax
®
.
|
Section VI.A
|
C.1.8.
The Contractor shall provide the Government with access to and/or provide copies of the following documents: (1) Form 483s form FDA inspections of Contractor's Lansing facility, (2) Establishment Inspection Reports (EIRs) from FDA inspections of Contractor's Lansing facility; (3) Warning Letters relating to BioThrax
®
; and Contractor's Annual Safety Report to FDA regarding BioThrax
®
. These documents will be provided to the Contracting Officer within 2 business days of receipt.
|
Section VI.A
|
C.1.9.
The Contractor shall notify the Government of any issues with the safety and efficacy of BioThrax
®
and/or manufacturing or quality of the FDA-licensed production lines at the Contractor's Lansing facility within two business days of the determination of potential to be reported to FDA.
|
Section VI.A
|
C.1.10.
The Government will have the option to conduct site inspections of the Contractor's Lansing facility during the period of performance of the contract. Such inspections will be performed by the COR or the COR's designee(s).
|
Section VI.A
|
C.1.11.
If the contractor should obtain FDA approval for the manufacture and production of BioThrax
®
having [**] while under this contract, the Government will accept delivery of those doses with the [**] in addition to doses with a [**]. The Contractor may invoice only for those doses actually delivered under this contract in accordance with Section B.
|
Section IV.A
|
C.1.12.
The product must be delivered in accordance with cGMP guidelines.
|
Section IV.B
|
C.1.13.
The Contractor shall notify BARDA at least [**] days' prior of estimated shipment of product. At least [**] business days prior to the product being ready for shipment to DSNS, the Contractor shall obtain delivery address from the Contracting Officer and provide to the Contracting Officer and COR the following:
a. The date the product will be ready for loading on the truck(s) and the intended delivery date of product to the DSNS
b. Certificate(s) of Analysis d. FDA Lot Release(s)
c. Number of pallets, vials, and doses to be loaded and delivered to DSNS
|
Sections IV.B, VI.A
|
C.1.14.
At least [**] hours before each scheduled delivery, the Contractor shall provide the following to the Contracting Officer and COR:
a. Packing Slip
b. Actual number of pallets, vials and doses to be loaded
c. Diagram of product shipment pallet (how many vials per box, per pallet)
|
Sections IV.B, VI.A
|
C.1.15.
Within [**] hours after the product has been delivered to the DSNS, the Contractor shall provide to the Contracting Officer and COR:
a. The remaining ambient exposure time letter disclosing accumulated ambient temperature exposure until the point that BARDA (or DSNS-designated personnel) assumed responsibility for temperature control, per Section F, for each lot from the Contractor's Quality Department. The letter must indicate that the product was manufactured and released in accordance with cGMP and has met all acceptance criteria to allow for Government distribution.
|
Section VI.A
|
C.1.16.
Funds provided shall be paid on a price per doses basis only on those products delivered and accepted to DSNS under contract.
|
See Business Vol. II
|
C.1.17.
Under CLIN 0001 of this contract, the products shall have an [**] product. The Contractor shall target [**] of the [**] remaining when the Government takes delivery of the product.
|
Section IV.B
|
C.2.
PROJECT MANAGEMENT & RISK MITIGATION OBJECTIVES
|
|
C.2.1
INTEGRATED MASTER PLAN AND EARNED VALUE MANAGEMENT
|
|
C.2.1.1
The Offeror shall 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 [**] days of contract award with updates as requested by the COR).
|
Section VII
|
C.2.1.2
The Offeror shall submit an updated Integrated Master Schedule in an approved format.
|
Section VII
|
C.2.1.3
The Offeror shall submit a plan for a Performance measurement Baseline Review (PMBR). Section VII
|
|
C.2.2
RISK MANAGEMENT OBJECTIVES
|
|
C.2.2.1
The Offeror shall develop and maintain an acceptable risk management plan. If changes are needed to the risk management plan during the execution of the contract, the Offeror shall submit draft changes to risk management plan to USG for approval prior to implementation.
|
Sections VI.D,VII
|
C.2.2.2
The Offeror shall participate in regular meetings to coordinate and oversee the work performed.
|
Section VI.A
|
C.2.2.3
The Offeror 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.
|
Section VI.C
|
C.2.2.4
The Offeror shall provide a security plan, which is associated with all aspects of manufacture of product, process, storage, and inventory of the FDP including when procured for use under EUA and intended for delivery to the CDC/SNS.
|
Section VI.F
|
C.3.
MEETING/SITE VISITS/AUDITS
|
Section VI.A
|
C.4.
PRODUCT DELIVERIES
|
|
C.4.1
TEMPERATURE CONTROL AND MONITORING, FOB Destination Deliveries
|
Section IV.B
|
C.4.2
DSNS QUALITY CONTROL UNIT (QCU) ACCEPTANCE PROCEDURE FOR BIOTHRAX (AVA)
|
Section IV.B
|
C.4.3
ACCEPTANCE PROCESS AND TIMEFRAME (FOB DESTINATION DELIVERY)
|
Section IV.B
|
C.4.4
BARDA RELEASE FOR BioThrax
|
Section IV.B
|
C.5.
REPORTING REQUIREMENTS
|
Section VI.A
|
M.1
FAR 52.212-2 EVALUATION – COMMERCIAL ITEMS (OCT 2014)
|
|
M.1.(a)1.
The ability to manufacture BioThrax
®
vaccine in accordance with current Good Manufacturing Practices (cGMP) guidelines
|
Section IV.A
|
M.1.(a)2.
The ability to manufacture and deliver [**] doses of Final Drug Product (FDP) with an acceptable delivery schedule.
|
Section V.E
|
M.1.(a)3.
The ability to perform all requisite assays and release testing in accordance with the FDA approved Biologic License Application (BLA).
|
Section IV.A
|
M.1.(a)4.
The ability to package doses according to FDA approved labeling and packaging requirements and ship doses to SNS facilities for USG acceptance
|
Section V.D
|
M.1(a)5.
The product dose price shall be consistent with current dose prices under active USG procurement mechanisms
|
See Business Vol. II
|
·
|
A state-of-the-art current Good Manufacturing Practices (cGMP) high capacity manufacturing facility at its Lansing, Michigan campus
|
·
|
Available manufacturing capacity
|
·
|
Sufficient inventory and supply lines for required raw materials
|
·
|
Decades of experience and know-how in the manufacturing of BioThrax
|
·
|
Significant experience managing large and small business subcontractors currently utilized for fill-finish and logistics functions
|
·
|
Singapore - Health Sciences Authority (HSA) approved 2011
|
·
|
Germany – Paul-Ehrlich Institut (PEI) approved 2013
|
·
|
The requirement of ≥[**] months remaining expiry dating upon date of delivery was modified in the Scope of Work according to ACMG's response to Emergent's Question 3, received February 1, 2017. As a consequence of this Emergent will deliver product with ≥[**] months remaining expiry dating upon date of delivery.
|
·
|
A Kickoff meeting
|
·
|
Status update meetings/teleconferences as required ([**] frequency is preferred given the scope of work)
|
·
|
Site visits and other meetings to discuss technical, regulatory and ethical aspects of performance of a contract awarded under this Solicitation
|
·
|
The Monthly progress report frequency be revised to Quarterly
|
·
|
Submission of the Contract Final Report be tied to the last accepted delivery of goods under this contract, and formally mark the end of the period of performance under the contract
|
·
|
Earned Value Management (EVM) requirements were removed from the Scope of Work according to ACMG's response to Emergent's Question 1, received February 1, 2017. As a consequence of this Emergent will not submit an EVM plan or associated reports per section C.5.E.a in the Solicitation.
|
·
|
Emergent proposes sharing all such relevant material information as it does with all commercial customers related to FDA communications for BioThrax.
|
·
|
Emergent proposes that this reporting requirement be covered by the modifications to Section C.1.7 above.
|
·
|
Emergent proposes notifying the Government within [**] days after a Biologic Process Deviation Report (BPDR) is submitted and including these notifications in periodic reports.
|
·
|
These communication requirements were modified in the Scope of Work according to ACMG's response to Emergent's Question 4, received February 1, 2017. As a consequence of this Emergent will provide Certificates of Analysis and FDA Lot Releases at least [**] prior to delivery.
|
·
|
These Regulatory communication requirements were modified in the Scope of Work according to ACMG's response to Emergent's Question 2, received February 1, 2017. As a consequence of this Emergent shall provide a copy of any regulatory communications (e.g. meeting minutes, submissions, etc.) that occur during the contract period of performance pertaining to the product being procured (i.e. BioThrax). Any pertinent regulatory communications or issues that may impact the product or ability of Emergent to complete delivery of the product on this particular contract shall be made known to BARDA/AMCG until delivery of all [**] doses are completed.
|
Year
|
Agency
|
Purpose
|
Outcome/Classification
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
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[**]
|
[**]
|
[**]
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[**]
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[**]
|
[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
|
[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
|
[**]
|
[**]
|
Name
|
Position
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
·
|
Reduction: Reduction of risk wherever possible
|
·
|
Transfer: Determination that the risk is outside control of the functional team and the PD identifies the team responsible for mitigation
|
·
|
Retention: Determination that the risk to project cost, schedule, and performance can continue without action
|
·
|
Avoidance: Decision to avoid the risk by not implementing the task involving the risk
|
·
|
management responsibility and review
|
·
|
personnel qualification and training
|
·
|
document and data control
|
·
|
validation
|
·
|
equipment and facilities control
|
·
|
supplier quality and materials management control
|
·
|
production and in-process controls
|
·
|
non-conformance handling
|
·
|
change control
|
·
|
corrective and preventive action
|
1.1
|
BioThrax is approved for pre-exposure prophylaxis of disease in persons whose occupation or other activities place them at high risk of exposure.
|
1.2
|
BioThrax is approved for post-exposure prophylaxis of disease following suspected or confirmed
Bacillus anthracis
exposure, when administered in conjunction with recommended antibacterial drugs.
|
2.1
|
Dose
|
Schedule
|
Route of Administration
|
Dosing Schedule
|
Primary Series
|
Intramuscular
|
0, 1, and 6 months
|
Booster Series
|
Intramuscular
|
6 and 12 months after completion of the primary series and at 12-month intervals thereafter
|
Post-Exposure Prophylaxis:
|
||
Schedule
|
Route of Administration
|
Dosing Schedule
|
Primary Series
|
Subcutaneous
|
0, 2, and 4 weeks post-exposure combined with antimicrobial therapy
|
2.2
|
Administration
|
5.1
|
Hypersensitivity Reactions
|
5.2
|
Latex
|
5.3
|
Pregnancy
|
5.4
|
History of Anthrax Disease
|
5.5
|
Altered Immunocompetence
|
5.6
|
Limitations of Vaccine Effectiveness
|
6.1
|
Clinical Trials Experience
|
6.2
|
Postmarketing Experience
|
·
|
Blood and lymphatic system disorders
|
·
|
Gastrointestinal Disorders
|
·
|
Immune system disorders
|
·
|
Nervous system disorders
|
·
|
Musculoskeletal, connective tissue, and bone disorders
|
·
|
General disorders and administration site conditions
|
·
|
Psychiatric disorders
|
·
|
Skin and Subcutaneous disorders
|
·
|
Vascular disorders
|
7.1
|
Ciprofloxacin
|
7.2
|
Concomitant Administration with Other Vaccines
|
7.3
|
Immunosuppressive Therapies
|
8.1
|
Pregnancy
|
14.3 |
Non-Interference of Post-Exposure Prophylaxis Vaccination and Antimicrobials When Used Concurrently
|
1. |
Ryan MA, Smith TC, Sevick CJ, Honner WK, Loach RA, Moore CA, Erickson JD. 2008. Birth defects among infants born to women who received anthrax vaccine in pregnancy. Am J Epidemiol, 168:434-442.
|
2. |
Catherino WH, Levi A, Kao TC, Leondires MP, McKeeby J, Segars JH. 2005. The anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcome in couples with a vaccinated male military service member. Fertility and Sterility, 83:480-483
|
3. |
Brachman P, Friedlander A, Grabenstein J. 2008. Anthrax Vaccine. In: Vaccines, Fifth Edition, Plotkin, S.A.: Orenstein W.A. and Offit P.A. (eds.), 111-126
|
4. |
Brachman, PS, Gold H, Plotkin SA, Fekety FR, Werrin M, Ingraham NR. 1962. Field evaluation of a human anthrax vaccine. Amer. J. Public Health, 52:632-645.
|
5. |
Food and Drug Administration, 2005, Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order. FDA Federal Register 2005; 70(242): 75180-75198.
|
6. |
Food and Drug Administration. Biological Products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register (December 13, 1985), 50(240):51002-51117.
|
·
|
BioThrax is a vaccine licensed by the FDA to protect against anthrax disease in persons 18 through 65 years of age:
|
o
|
It can be used
before
exposure to anthrax to protect people at high risk of getting the disease.
|
o
|
It can be used
after
exposure to anthrax, along with antibiotics, to protect people from getting the disease.
|
·
|
BioThrax may not protect all people who get the vaccine.
|
·
|
How well BioThrax works when given after exposure to anthrax has been studied only in animals. It has not been studied in humans because there are not enough people who get the disease naturally, and it is not ethical to expose people to anthrax on purpose to find out how well BioThrax works.
|
·
|
The safety of BioThrax was studied in healthy adults.
|
·
|
If you may be pregnant, plan to get pregnant soon, or are nursing a baby.
|
·
|
About medicines that you take, including over-the-counter medicines and supplements.
|
·
|
About immune problems you have, including steroid treatments and cancer treatments.
|
·
|
About blood clotting problems or if you have "blood thinners."
|
·
|
If you are allergic to latex.
|
·
|
Inform your healthcare provider
|
·
|
You can enroll in the BioThrax (Anthrax) Vaccine in Pregnancy Registry (Phone: 1-619-553-9255), if eligible
|
·
|
Pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot
|
·
|
Muscle aches
|
·
|
Headaches
|
·
|
Fatigue
|
·
|
Fainting
|
Lot
|
CLIN
|
Delivery #
|
Shipment Date
|
Delivery Date
|
Expiry Date*
|
Remaining Expiry (Months)*
|
Expected Doses
|
Cum Expected Doses
|
[**]
|
[**]
|
[**]
|
[**]
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[**]
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[**]
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·
|
Delivery Date is dependent upon delivery destination provided by Government at least [**] business days prior to Shipment Date
|
·
|
For planning purposes, typical transit time between Shipment Date and Delivery Date is [**] days
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·
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Actual delivery dates and quantities subject to available FDA-released lots of BioThrax on hand for shipment
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Company Name
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||||
Designated Billing Office Name and Address:
DHHS/OS/ASPR/AMCG
Attn: Contracting Officer 330 Independence Avenue., S.W. Room G640 Washington, D.C. 20201
Contractor's Address and Contact Information:
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Invoice/Finance Number:
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Date Invoice Prepared:
|
||||
Contract No.
|
||||
Effective Date:
|
||||
Total Estimated Cost of Order:
|
||||
Office of Acquisitions:
Contracting Officer (insert name here) Office of Acquisitions Management, Contracts, and Grants (AMCG)
Central Point of Distribution:
|
||||
POC: Name of accountant or COO or signatory authority for invoice
|
||||
TIN:
DUNS #: |
Amount Billed
|
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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
|
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Other
|
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Total Direct Costs
|
|||
G&A Rate
0.00%
|
|||
Subtotal:
|
|||
Fixed Fee
0.0%
|
|||
Total Amount Claimed
|
|||
Adjustments
|
|||
Grand Total
|
$
‐
|
X
|
|||||
Federal Employee:
|
Contractor:
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Vendor:
|
Name:
|
Emergent BioSolutions, Inc.
|
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Business
Address: |
400 Professional Drive, Suite 400
|
|
Gaithersburg, MD 20879
|
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Remit To
|
||
(If same as above, leave blank. Must match address on invoice for internal control purposes.)
|
||
Address:
|
||
2. |
Name of Financial Institution:
|
3. |
Address of Financial Institution:
|
5. |
Depositor Account Title: Emergent BioSolutions, Inc.
|
6.
Depositor Account Number:
|
[**]
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[**]
|
[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
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[**]
|
X
|
||||
7.
Type of Account
|
Checking
|
Savings
|
8. |
Signature and Title of Authorized Official of Financial Institution:
|
************The following must be signed by the payee************
|
|
I have verified the information on this form.
|
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Signature
|
Date
|
1. |
Type of Plan (check one)
|
2. |
Goals
|
Products and/or
Services
|
Other
|
Small Business
|
SDB
|
WOSB
|
Hubz
|
VOSB
|
SDVOSB
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
3. |
Program Administrator:
|
a. |
Developing and promoting company-wide policy initiatives that demonstrate the company's support for awarding contracts and subcontracts to SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns; and for assuring that these concerns are included on the source lists for solicitations for products and services they are capable of providing;
X
yes __ no
|
b. |
Developing and maintaining bidder source lists of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns from all possible sources;
X
yes __ no
|
c. |
Ensuring periodic rotation of potential subcontractors on bidder's lists;
X
yes __ no
|
d. |
Assuring that SB, SDB, WOSB, HUBZone, VOSB and SDVOSB businesses are included on the bidders' list for every subcontract solicitation for products and services that they are capable of providing.
X
yes __ no
|
e. |
Ensuring that Requests for Proposals (RFPs) are designed to permit the maximum practicable participation of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns.
X
yes __ no
|
f. |
Reviewing subcontract solicitations to remove statements, clauses, etc., which might tend to restrict or prohibit small, 8(a), SDB, WOSB, HUBZone, VOSB and SDVOSB small business participation.
X
yes __ no
|
g. |
Accessing various sources for the identification of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns to include the Central Contractor Registration (
http://www.ccr.gov/
), local small business and minority associations, local chambers of commerce and Federal Agencies' Small Business Offices;
X
yes __ no
|
h. |
Establishing and maintaining contract and subcontract award records;
X
yes __ no
|
i. |
Participating in Business Opportunity Workshops, Minority Business Enterprise Seminars, Trade Fairs, Procurement Conferences, etc.;
X
yes __ no
|
j. |
Ensuring that SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns are made aware of subcontracting opportunities and assisting concerns in preparing responsive bids to the company;
X
yes __ no
|
k. |
Conducting or arranging for the conduct of training for purchasing personnel regarding the intent and impact of Section 8(d) of the Small Business Act, as amended;
X
yes __ no
|
l. |
Monitoring the company's subcontracting program performance and making any adjustments necessary to achieve the subcontract plan goals;
X
yes __ no
|
m. |
Preparing and submitting timely, required subcontract reports;
X
yes __ no
|
n. |
Conducting or arranging training for purchasing personnel regarding the intent and impact of 8(d) of the Small Business Act on purchasing procedures;
X
yes __ no
|
o. |
Coordinating the company's activities during the conduct of compliance reviews by Federal agencies; and
X
yes __ no
|
p. | Other duties: |
4. |
Equitable Opportunity
|
1. |
Contact minority and small business trade associations; 2) contact business development organizations and local chambers of commerce; 3) attend SB, SDB, WOSB, HUBZone, VOSB and SDVOSB procurement conferences and trade fairs; 4) review sources from the Central Contractor Registration (
http://www.ccr.gov/
); 5) review sources from the Small Business Administration (SBA), Central Contractor Registration (CCR); 6) Consider using other sources such as the National Institutes of Health (NIH) e-Portals in Commerce, (e-PIC), (http://epic.od.nih.gov/). The NIH e-PIC is not a mandatory source; however, it may be used at the offeror's discretion; and 7) Utilize newspaper and magazine ads to encourage new sources.
|
1. |
Conduct workshops, seminars and training programs;
|
2. |
Establish, maintain, and utilize SB, SDB, WOSB, HUBZone, VOSB and SDVOSB source lists, guides, and other data for soliciting subcontractors; and
|
3. |
Monitor activities to evaluate compliance with the subcontracting plan.
|
5. |
Flow Down Clause
|
6. |
Reporting and Cooperation
|
Reporting Period
|
Report Due
|
Due Date
|
Oct 1 - Mar 31
|
ISR
|
4/30
|
Apr 1 - Sept 30
|
ISR
|
10/30
|
Oct 1 - Sept 30
|
SSR
|
10/30
|
Contract Completion
|
Year End SDB Report
|
30 days after completion
|
a. |
Submit ISR (bi-annually) for the awarding Contracting Officer's review and acceptance via the eSRS website.
|
b. |
Currently, SSR (annually) must be submitted for the HHS eSRS Agency Coordinator review and acceptance via the eSRS website. (
Note
: Log onto the OSDBU website to view the HHS Agency Coordinator contact information (
http://www.hhs.gov/about/smallbusiness/osdbustaff.html
).
|
7. |
Record keeping
|
a. |
SB, SDB, WOSB, HUBZone, VOSB and SDVOSB source lists, guides and other data identifying such vendors;
|
b. |
Organizations contacted in an attempt to locate SB, SDB, WOSB, HUBZone, VOSB and SDVOSB sources;
|
c. |
On a contract-by-contract basis, records on all subcontract solicitations over $100,000, which indicate for each solicitation (1) whether SB, SDB, WOSB, HUBZone, VOSB and/or SDVOSB concerns were solicited, if not, why not and the reasons solicited concerns did not receive subcontract awards;
|
d. |
Records to support other outreach efforts, e.g., contacts with minority and small business trade associations, attendance at small and minority business procurement conferences and trade fairs;
|
e. |
Records to support internal guidance and encouragement provided to buyers through (1) workshops, seminars, training programs, incentive awards; and (2) monitoring performance to evaluate compliance with the program and requirements; and
|
f. |
On a contract-by-contract basis, records to support subcontract award data including the name, address, and business type and size of each subcontractor. (This is not required on a contract–by–contract basis for commercial plans.)
|
g. |
Other records to support your compliance with the subcontracting plan: (Please describe)
|
8. |
Timely Payments to Subcontractors
|
9. |
Description of Good Faith Effort
|
SUBCO
NT
RACT P
L
A
N
REQU
I
R
EMEN
TS (con't)
|
C.O.
|
SBS
|
SB
A/
PCR
|
|||
(A=Acceptable
;
U=Unacceptab
l
e)
|
A
|
U
|
A
|
U
|
A
|
U
|
3. Subcontracting Plan Administrator's Name (Contractor): [**]
|
X
|
X
|
||||
4. Description of efforts to ensure the Small Businesses (incl. SDB, WOSB, HUBZone, SDVOSB) entities have equitable opportunity to compete for subcontracts.
|
X
|
X
|
||||
5. Required flow-down clause(s) to be included in prime contractor's subcontracts (i.e., FAR Clause 52.219-8, 52-219-9, 52.212-5(e)):
|
X
|
X
|
||||
6. Reporting and Cooperation:
|
||||||
a. Agreement to submit required reports
|
X
|
X
|
||||
b. Agreement to cooperate in studies and surveys
|
X
|
X
|
||||
7. Record keeping
|
X
|
X
|
||||
8. Timely Payment to Subcontractos
|
X
|
X
|
||||
9. Description of Good Faith Effort
|
X
|
X
|
||||
CONTRACTING OFFICER DETERMINATION, OSDBU SMALL BUSINESS SPECIALIST AND SBA PCR RECOMMENDATION
|
C.O.
|
SBS
|
SB
A/
PCR
|
|||
Yes
|
No
|
Yes
|
No
|
Yes
|
No
|
|
1. The proposed plan meets the requirements of FAR 19.704.
|
X
|
X
|
X
|
|||
2. In accordance with 19.705-4, past performance has been considered when determining acceptability of this plan.
|
X
|
X
|
||||
3. The proposed plan requires an additional pre-award review.
|
X
|
X
|
X
|
|||
HHS OPDIV Contracting Officer Signature
|
||||||
Contracting Officer:
/s/ [**]
Date:
2/21/17
Additional Comments:
Though the contractor did not meet most of HHS's SB subcontracting goals, per the justification from the contractor as to the reason why, the proposed SB plan is deemed acceptable.
|
||||||
HHS OSDBU SBS Signature
|
||||||
Small Business Specialist:
Date:
2/23/17
COMMENTS: If any elements are determined to be unacceptable, summarize below:
|
||||||
SBA PCR Signature
|
||||||
SBA PCR:
COMMENTS: If any elements are determined to be unacceptable, summarize below:
Justification accepted for goals below agency-established minimums.
|
Attn: |
[**]
|