DELAWARE
|
62-1413174
|
|
(State of other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
4505 Emperor Blvd., Suite 200
Durham, North Carolina
|
27703
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Large accelerated filer
|
x
|
|
Accelerated filer
|
¨
|
||
Non-accelerated filer
|
¨
(Do not check if a smaller reporting company)
|
|
Smaller reporting company
|
¨
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Page No.
|
|
Part I. Financial Information
|
|
Part II. Other Information
|
|
EX-10.1
|
|
EX-10.2
|
|
EX-31.1
|
|
EX-31.2
|
|
EX-32.1
|
|
EX-32.2
|
|
2015
(Unaudited)
|
2014
(Note 1)
|
||||||
Assets
|
|
|||||||
Cash and cash equivalents
|
|
$
|
48,367
|
|
$
|
54,54
0
|
|
|
Restricted cash
|
|
2,637
|
|
15
0
|
|
|||
Investments
|
|
19,160
|
|
18,232
|
|
|||
Receivables from collaborations
|
|
5,594
|
|
3,849
|
|
|||
Receivables from product sales
|
—
|
5,641
|
||||||
Inventory
|
|
1,21
0
|
|
683
|
|
|||
Prepaid expenses and other current assets
|
|
4,322
|
|
6,172
|
|
|||
Deferred collaboration expense
|
|
76
|
|
76
|
|
|||
|
||||||||
Total current assets
|
|
81,366
|
|
89,343
|
|
|||
Investments
|
|
41,116
|
|
41,116
|
|
|||
Furniture and equipment, net
|
|
727
|
|
207
|
|
|||
Deferred collaboration expense
|
|
163
|
|
177
|
|
|||
Other assets
|
|
6,495
|
|
6,031
|
|
|||
|
||||||||
Total assets
|
|
$
|
129,867
|
|
$
|
136,874
|
|
|
|
||||||||
Liabilities and Stockholders’ Equity
|
|
|||||||
Accounts payable
|
|
$
|
5,307
|
|
$
|
2,849
|
|
|
Accrued expenses
|
|
12,291
|
|
11,329
|
|
|||
Interest payable
|
|
7,241
|
|
6,029
|
|
|||
Deferred collaboration revenue
|
|
1,490
|
|
1,481
|
|
|||
Deferred product sales revenue
|
|
5,533
|
|
5,605
|
|
|||
Non-recourse notes payable
|
|
30,00
0
|
|
30,000
|
|
|||
|
||||||||
Total current liabilities
|
|
61,862
|
|
57,293
|
|
|||
Deferred collaboration revenue
|
|
3,256
|
|
3,552
|
|
|||
Deferred rent
|
|
378
|
|
394
|
|
|||
Stockholders’ equity:
|
|
|||||||
Preferred stock, $0.001 par value; shares authorized — 5,000; no shares issued and outstanding
|
|
—
|
—
|
|||||
Common stock, $0.01 par value: shares authorized — 200,000; shares issued and outstanding — 72,474 in 2015 and 71,955 in 2014
|
|
725
|
|
72
0
|
|
|||
Additional paid-in capital
|
|
546,698
|
|
542,943
|
|
|||
Accumulated other comprehensive income (loss)
|
|
1
0
|
|
(13
0
|
)
|
|||
Accumulated deficit
|
|
(483,062
|
)
|
(467,898
|
)
|
|||
|
||||||||
Total stockholders’ equity
|
|
64,371
|
75,635
|
|||||
|
||||||||
Total liabilities and stockholders’ equity
|
|
$
|
129,867
|
|
$
|
136,874
|
|
|
2015
|
2014
|
||||||
Revenues
|
|
|||||||
Product sales, net
|
$
|
537
|
$
|
—
|
||||
Royalty revenue
|
|
1,518
|
|
1,821
|
|
|||
Collaborative and other research and development
|
|
4,771
|
|
1,637
|
|
|||
|
||||||||
Total revenues
|
|
6,826
|
|
3,458
|
|
|||
Expenses
|
|
|||||||
Cost of products sold
|
15
|
—
|
||||||
Research and development
|
|
17,12
0
|
|
9,183
|
|
|||
General and administrative
|
|
4,061
|
|
1,588
|
|
|||
Royalty
|
|
6
0
|
|
73
|
|
|||
|
||||||||
Total operating expenses
|
|
21,256
|
|
10,844
|
|
|||
Loss from operations
|
|
(14,43
0
|
)
|
(7,386
|
)
|
|||
Interest and other income
|
|
117
|
|
17
|
|
|||
Interest expense
|
|
(1,315
|
)
|
(1,242
|
)
|
|||
Gain (loss) on foreign currency derivative
|
|
464
|
(1,526
|
)
|
||||
|
||||||||
Net loss
|
|
$
|
(15,164
|
)
|
$
|
(10,137
|
)
|
|
|
||||||||
Basic and diluted net loss per common share
|
|
$
|
(0.21
|
)
|
$
|
(0.17
|
)
|
|
Weighted average shares outstanding
|
|
72,341
|
|
59,589
|
|
|||
Unrealized gain (loss) on available for sale investments
|
|
14
0
|
(2
|
)
|
||||
|
||||||||
Comprehensive loss
|
|
$
|
(15,024
|
)
|
$
|
(10,139
|
)
|
|
2015
|
2014
|
||||||
Operating activities
|
|
|||||||
Net loss
|
|
$
|
(15,164
|
)
|
$
|
(10,137
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|||||||
Depreciation and amortization
|
|
45
|
|
53
|
|
|||
Stock-based compensation expense
|
|
2,259
|
|
1,610
|
|
|||
Amortization of debt issuance costs
|
|
11
0
|
|
110
|
|
|||
Change in fair value of foreign currency derivative
|
|
(464
|
)
|
1,526
|
||||
Changes in operating assets and liabilities:
|
|
|||||||
Receivables
|
|
3,896
|
(1,165
|
)
|
||||
Inventory
|
(527
|
)
|
—
|
|||||
Prepaid expenses and other assets
|
|
1,848
|
|
892
|
||||
Deferred collaboration expense
|
|
14
|
|
15
|
|
|||
Accounts payable and accrued expenses
|
|
3,404
|
(2,252
|
)
|
||||
Interest payable
|
|
1,212
|
|
685
|
|
|||
Deferred revenue
|
|
(359
|
)
|
(296
|
)
|
|||
|
||||||||
Net cash used in operating activities
|
|
(3,726
|
)
|
(8,959
|
)
|
|||
Investing activities
|
|
|||||||
Acquisitions of furniture and equipment
|
|
(565
|
)
|
(7
|
)
|
|||
Change in restricted cash
|
|
(2,487
|
)
|
1
|
||||
Purchases of investments
|
|
(3,378
|
)
|
(9,367
|
)
|
|||
Sales and maturities of investments
|
2,482
|
8,350
|
||||||
|
||||||||
Net cash used in investing activities
|
|
(3,948
|
)
|
(1,023
|
)
|
|||
Financing activities
|
|
|||||||
Sale of common stock, net
|
|
1,175
|
|
—
|
|
|||
Exercise of stock options
|
|
155
|
|
3,804
|
|
|||
Employee stock purchase plan sales
|
|
171
|
|
128
|
|
|||
Payment of foreign currency derivative collateral
|
|
—
|
(1,530
|
)
|
||||
|
||||||||
Net cash provided by financing activities
|
|
1,501
|
|
2,402
|
|
|||
|
||||||||
Decrease in cash and cash equivalents
|
|
(6,173
|
)
|
(7,580
|
)
|
|||
Cash and cash equivalents at beginning of period
|
|
54,540
|
|
21,164
|
|
|||
|
||||||||
Cash and cash equivalents at end of period
|
|
$
|
48,367
|
|
$
|
13,584
|
|
|
March 31, 2015
|
|||||||||||||||||||
|
Amortized
Cost
|
|
Accrued
Interest
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|||||||||||
Obligations of U.S. Government and its agencies
|
|
$
|
20,302
|
|
|
$
|
42
|
|
|
$
|
3
|
|
|
$
|
(2
|
)
|
|
$
|
20,345
|
|
Corporate debt securities
|
|
28,139
|
|
|
144
|
|
|
27
|
|
|
(13
|
)
|
|
28,297
|
|
|||||
Certificates of deposit
|
|
11,625
|
|
|
15
|
|
|
6
|
|
|
(12
|
)
|
|
11,634
|
|
|||||
|
|
|
|
|
||||||||||||||||
Total investments
|
|
$
|
60,066
|
|
|
$
|
201
|
|
|
$
|
36
|
|
|
$
|
(27
|
)
|
|
$
|
60,276
|
|
|
|
|
|
|
||||||||||||||||
|
December 31, 2014
|
|||||||||||||||||||
|
Amortized
Cost
|
|
Accrued
Interest
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|||||||||||
Obligations of U.S. Government and its agencies
|
|
$
|
20,307
|
|
|
$
|
22
|
|
|
$
|
—
|
|
|
$
|
(23
|
)
|
|
$
|
23,306
|
|
Corporate debt securities
|
|
27,152
|
|
|
151
|
|
|
5
|
|
|
(47
|
)
|
|
27,261
|
|
|||||
Certificates of deposit
|
|
11,838
|
|
|
6
|
|
—
|
|
|
(63
|
)
|
|
11,781
|
|
||||||
|
|
|
|
|
||||||||||||||||
Total investments
|
|
$
|
59,297
|
|
|
$
|
179
|
|
|
$
|
5
|
|
|
$
|
(133
|
)
|
|
$
|
59,348
|
|
|
2015
|
|
2014
|
|||||
Maturing in one year or less
|
|
$
|
19,16
0
|
|
|
$
|
18,232
|
|
Maturing after one year through two years
|
|
29,656
|
|
|
25,459
|
|
||
Maturing after two years
|
|
11,46
0
|
|
|
15,657
|
|
||
|
|
|||||||
Total investments
|
|
$
|
60,276
|
|
|
$
|
59,348
|
|
|
March 31, 2015
|
|||||||||||
|
Billed
|
|
Unbilled
|
|
Total
|
|||||||
U.S. Department of Health and Human Services
|
|
$
|
—
|
|
|
$
|
4,087
|
|
|
$
|
4,087
|
|
Shionogi & Co. Ltd.
|
|
1,507
|
|
|
—
|
|
|
1,507
|
|
|||
|
|
|
||||||||||
Total receivables
|
|
$
|
1,507
|
|
|
$
|
4,087
|
|
|
$
|
5,594
|
|
|
December 31, 2014
|
|||||||||||
|
Billed
|
|
Unbilled
|
|
Total
|
|||||||
U.S. Department of Health and Human Services
|
|
$
|
—
|
|
|
$
|
2,778
|
|
|
$
|
2,778
|
|
Shionogi & Co. Ltd.
|
|
1,071
|
|
|
—
|
|
|
1,071
|
|
|||
|
|
|
||||||||||
Total receivables
|
|
$
|
1,071
|
|
|
$
|
2,778
|
|
|
$
|
3,849
|
|
|
2015
|
|
2014
|
|||||
Work in process
|
|
$
|
—
|
|
|
$
|
267
|
|
Finished Goods
|
|
1,210
|
|
|
416
|
|
||
|
|
|||||||
Net inventories
|
|
$
|
1,210
|
|
|
$
|
683
|
|
•
|
fees paid to Clinical Research Organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials;
|
•
|
fees paid to investigative sites in connection with clinical trials;
|
•
|
fees paid to contract manufacturers in connection with the production of our raw materials, drug substance and drug products; and
|
•
|
professional fees.
|
|
2015
|
|
2014
|
|||||
Product sales, net
|
$
|
537
|
$
|
—
|
||||
Royalty revenue
|
|
1,518
|
|
|
1,821
|
|
||
Collaborative and other research and development revenues:
|
|
|
||||||
U.S. Department of Health and Human Services
|
|
4,475
|
|
|
1,341
|
|
||
Shionogi (Japan)
|
|
296
|
|
|
296
|
|
||
Total collaborative and other research and development revenues
|
4,771
|
1,637
|
||||||
|
|
|||||||
Total revenues
|
|
$
|
6,826
|
|
|
$
|
3,458
|
|
|
Awards
Available
|
Options
Outstanding
|
Weighted
Average
Exercise
Price
|
|||||||||
Balance December 31, 2014
|
|
2,362
|
|
9,605
|
|
$
|
6.21
|
|
||||
Restricted stock unit awards granted
|
|
(133
|
)
|
—
|
|
—
|
|
|||||
Restricted stock unit awards cancelled
|
|
1
|
|
—
|
|
—
|
|
|||||
Stock option awards granted
|
|
(917
|
)
|
917
|
|
11.83
|
|
|||||
Stock option awards exercised
|
|
—
|
|
(240
|
)
|
3.07
|
|
|||||
Stock option awards cancelled
|
|
28
|
|
(28
|
)
|
9.05
|
|
|||||
|
||||||||||||
Balance March 31, 2015
|
|
1,341
|
|
10,254
|
|
$
|
6.78
|
|
|
2015
|
2014
|
||||||
Expected Life in Years
|
|
5.5
|
|
5.5
|
|
|||
Expected Volatility
|
|
83
|
%
|
87
|
%
|
|||
Expected Dividend Yield
|
|
0.0
|
%
|
0.0
|
%
|
|||
Risk-Free Interest Rate
|
|
1.5
|
%
|
1.6
|
%
|
|
Three Months Ended
March 31,
|
|||||||
|
2015
|
|
2014
|
|||||
R&D expenses by program:
|
|
|
||||||
BCX4161
|
|
$
|
6,246
|
|
|
$
|
4,335
|
|
BCX4430
|
|
2,674
|
|
|
1,750
|
|
||
2nd generation HAE compounds
|
|
5,881
|
|
|
1,360
|
|
||
Peramivir
|
|
1,146
|
|
|
695
|
|
||
Other research, preclinical and development costs
|
|
1,173
|
|
|
1,043
|
|
||
|
|
|||||||
Total R&D expenses
|
|
$
|
17,120
|
|
|
$
|
9,183
|
|
•
|
lease or loan financing and future public or private equity financing;
|
•
|
our existing capital resources and interest earned on that capital;
|
•
|
payments under existing and executing new contracts with the U.S. Government; and
|
•
|
payments under collaborative and licensing agreements with corporate partners.
|
•
|
our ability to perform under our government contracts and receive reimbursement, and receive stockpiling procurement contracts;
|
•
|
the magnitude of work under our government contracts;
|
•
|
the progress and magnitude of our research, drug discovery and development programs;
|
•
|
changes in existing collaborative relationships or government contracts;
|
•
|
our ability to establish additional collaborative relationships with academic institutions, biotechnology or pharmaceutical companies and governmental agencies or other third parties;
|
•
|
the extent to which our partners, including governmental agencies, will share in the costs associated with the development of our programs or run the development programs themselves;
|
•
|
our ability to negotiate favorable development and marketing strategic alliances for certain product candidates or a decision to build or expand internal development and commercial capabilities;
|
•
|
successful commercialization of marketed products by either us or a partner;
|
•
|
the scope and results of preclinical studies and clinical trials to identify and develop product candidates;
|
•
|
our ability to engage sites and enroll subjects in our clinical trials;
|
•
|
the scope of manufacturing of our product candidates to support our preclinical research and clinical trials;
|
•
|
increases in personnel and related costs to support the development and commercialization of our product candidates;
|
•
|
the scope of manufacturing of our drug substance and product candidates required for future NDA filings;
|
•
|
competitive and technological advances;
|
•
|
the time and costs involved in obtaining regulatory approvals;
|
•
|
post-approval commitments for RAPIVAB and other products that receive regulatory approval; and
|
||
•
|
the costs involved in all aspects of intellectual property strategy and protection including the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims.
|
•
|
fees paid to Clinical Research Organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials;
|
•
|
fees paid to investigative sites in connection with clinical trials;
|
•
|
fees paid to contract manufacturers in connection with the production of our raw materials, drug substance and product candidates; and
|
•
|
professional fees.
|
•
|
the initiation, timing, progress and results of our preclinical testing, clinical trials, and other research and development efforts;
|
•
|
the potential funding from our contracts with BARDA/HHS for the development and support of the NDA filing for RAPIVAB and the potential funding from our contracts with NIAID/HHS and BARDA/HHS for the development of BCX4430;
|
•
|
the potential for a government stockpiling order or profit from commercial sales of RAPIVAB;
|
•
|
the potential use of RAPIVAB as a treatment for H1N1, H5N1, and H7N9 or other strains of influenza;
|
•
|
the further preclinical or clinical development and commercialization of our product candidates, including our HAE program, RAPIVAB, BCX4430, early stage discovery programs, forodesine, and other PNP inhibitor development programs;
|
•
|
the implementation of our business model, strategic plans for our business, product candidates and technology;
|
•
|
our ability to establish and maintain collaborations or out-license rights to our drug candidates;
|
•
|
plans, programs, progress and potential success of our collaborations, including Mundipharma for forodesine and Shionogi and Green Cross for peramivir in their territories;
|
•
|
Royalty Sub’s ability to service its payment obligations in respect of the PhaRMA Notes, and our ability to benefit from our equity interest in Royalty Sub;
|
•
|
the foreign currency hedge agreement entered into by us in connection with the issuance by Royalty Sub of the PhaRMA Notes;
|
•
|
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
|
•
|
our ability to operate our business without infringing the intellectual property rights of others;
|
•
|
estimates of our expenses, revenues, capital requirements and our needs for additional financing;
|
•
|
the timing or likelihood of regulatory filings and approvals;
|
•
|
our ability to raise additional capital to fund our operations;
|
•
|
our financial performance; and
|
•
|
competitive companies, technologies and our industry.
|
•
|
our ability to find suitable clinical sites and investigators to enroll patients;
|
•
|
the availability of and willingness of patients to participate in our clinical trials;
|
•
|
the ability to maintain contact with patients to provide complete data after treatment;
|
•
|
our product candidates may not prove to be either safe or effective;
|
•
|
clinical protocols or study procedures may not be adequately designed or followed by the investigators;
|
•
|
manufacturing or quality control problems could affect the supply of product candidates for our trials; and
|
•
|
delays or changes in requirements by governmental agencies.
|
•
|
terminate or reduce the scope of our contract; and
|
•
|
audit and object to our contract-related costs and fees, including allocated indirect costs.
|
•
|
our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, a change in business strategy, a change of control or other reasons;
|
•
|
our contracts for collaborative arrangements may expire;
|
•
|
our partners may choose to pursue alternative technologies, including those of our competitors;
|
•
|
we may have disputes with a partner that could lead to litigation or arbitration;
|
•
|
we do not have day to day control over the activities of our partners and have limited control over their decisions;
|
•
|
our ability to generate future event payments and royalties from our partners depends upon their abilities to establish the safety and efficacy of our product candidates, obtain regulatory approvals and achieve market acceptance of products developed from our product candidates;
|
•
|
we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may utilize our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability;
|
•
|
our partners may not devote sufficient capital or resources towards our product candidates; and
|
•
|
our partners may not comply with applicable government regulatory requirements.
|
•
|
we or our collaborators may fail to successfully complete clinical trials sufficient to obtain FDA marketing approval;
|
•
|
many competitors are more experienced and have significantly more resources, and their products could reach the market faster, be more cost effective or have a better efficacy or tolerability profile than our product candidates;
|
•
|
we may fail to employ a comprehensive and effective intellectual property strategy, which could result in decreased commercial value of our Company and our products;
|
•
|
we may fail to employ a comprehensive and effective regulatory strategy, which could result in a delay or failure in commercialization of our products;
|
•
|
our ability to successfully commercialize our products is affected by the competitive landscape, which cannot be fully known at this time;
|
•
|
reimbursement is constantly changing, which could greatly affect usage of our products; and
|
•
|
future revenue from product sales would depend on our ability to successfully complete clinical studies, obtain regulatory approvals, and manufacture, market and commercialize our approved drugs.
|
•
|
discovery of compounds that cause or enable biological reactions necessary for the progression of the disease or disorder, called enzyme targets;
|
•
|
licensing or designing of enzyme inhibitors for development as product candidates;
|
•
|
execution of some preclinical studies and late-stage development for our compounds and product candidates;
|
•
|
management of our clinical trials, including medical monitoring and data management;
|
•
|
execution of additional toxicology studies that may be required to obtain approval for our product candidates; and
|
•
|
manufacturing the starting materials and drug substance required to formulate our products and the product candidates to be used in our clinical trials, toxicology studies and any potential commercial product.
|
•
|
RAPIVAB may not prove to be adequately safe and effective for market approval in markets other than the United States;
|
•
|
necessary funding for post marketing commitments and further development of RAPIVAB may not be available timely, at all, or in sufficient amounts;
|
•
|
flu prevention or pandemic treatment concerns may not materialize at all, or in the near future;
|
•
|
advances in flu vaccines or other antivirals, including competitive i.v. antivirals, could substantially replace potential demand for RAPIVAB;
|
•
|
regulatory authorities may not make needed accommodations to accelerate the drug testing and approval process for RAPIVAB outside the United States;
|
•
|
a limited number of governmental entities are expected to be the primary potential stockpiling customers for RAPIVAB and if we are not successful at marketing RAPIVAB to these entities for any reason, we will not receive substantial revenues from stockpiling orders;
|
•
|
government and third party payors may not provide sufficient coverage or reimbursement which would negatively impact the demand for RAPIVAB;
|
•
|
we may not be able to maintain sufficient and acceptable commercial manufacturing ourselves or through third-party manufacturers;
|
•
|
the commercial demand and acceptance for RAPIVAB by healthcare providers and by patients may not be sufficient to result in substantial revenues of RAPIVAB;
|
•
|
effectiveness of our marketing efforts, especially since we have no sales force for RAPIVAB and we have devoted limited resources to its commercialization;
|
•
|
market satisfaction with existing alternative therapies;
|
•
|
perceived efficacy relative to other available therapies;
|
•
|
disease prevalence;
|
•
|
cost of treatment;
|
•
|
pricing and availability of alternative products;
|
•
|
marketing and sales activities of competitors;
|
•
|
shifts in the medical community to new treatment paradigms or standards of care; and
|
•
|
relative convenience and ease of administration.
|
•
|
inconsistent production yields;
|
•
|
product liability claims;
|
•
|
difficulties in scaling production to commercial and validation sizes;
|
•
|
interruption of the delivery of materials required for the manufacturing process;
|
•
|
scheduling of plant time with other vendors or unexpected equipment failure;
|
•
|
potential catastrophes that could strike their facilities or have an effect on infrastructure;
|
•
|
potential impurities in our drug substance or products that could affect availability of product for our clinical trials or future commercialization;
|
•
|
poor quality control and assurance or inadequate process controls; and
|
•
|
lack of compliance or cooperation with regulations and specifications or requests set forth by the FDA or other foreign regulatory agencies, particularly associated with RAPIVAB and planned studies for BCX4161, BCX7353 and BCX4430.
|
•
|
adverse drug experience reporting regulations;
|
•
|
product promotion;
|
•
|
product manufacturing, including good manufacturing practice requirements; and
|
•
|
product changes or modifications.
|
•
|
other drug development technologies;
|
•
|
methods of preventing or reducing the incidence of disease, including vaccines; and
|
•
|
new small molecule or other classes of therapeutic agents.
|
•
|
capital resources;
|
•
|
research and development resources, including personnel and technology;
|
•
|
regulatory experience;
|
•
|
preclinical study and clinical testing experience;
|
•
|
manufacturing and marketing experience; and
|
•
|
production facilities.
|
•
|
the degree and range of protection any patents will afford against competitors with similar products;
|
•
|
if and when patents will issue;
|
•
|
if patents do issue we cannot be sure that we will be able to adequately defend such patents and whether or not we will be able to adequately enforce such patents; or
|
•
|
whether or not others will obtain patents claiming aspects similar to those covered by our patent applications.
|
•
|
obtain licenses or redesign our products or processes to avoid infringement;
|
•
|
stop using the subject matter claimed in those patents; or
|
•
|
pay damages.
|
•
|
liabilities that substantially exceed our product liability insurance, which we would then be required to pay from other sources, if available;
|
•
|
an increase of our product liability insurance rates or the inability to maintain insurance coverage in the future on acceptable terms, or at all;
|
•
|
withdrawal of clinical trial volunteers or patients;
|
•
|
damage to our reputation and the reputation of our products, resulting in lower sales;
|
•
|
regulatory investigations that could require costly recalls or product modifications;
|
•
|
litigation costs; and
|
•
|
the diversion of management’s attention from managing our business.
|
•
|
announcements of technological innovations or new products by us or our competitors;
|
•
|
developments or disputes concerning patents or proprietary rights;
|
•
|
additional dilution through sales of our common stock or other derivative securities;
|
•
|
status of new or existing licensing or collaborative agreements and government contracts;
|
•
|
announcements relating to the status of our programs;
|
•
|
developments and announcements regarding new and virulent strains of influenza;
|
•
|
we or our partners achieving or failing to achieve development milestones;
|
•
|
publicity regarding actual or potential medical results relating to products under development by us or our competitors;
|
•
|
publicity regarding certain public health concerns for which we are or may be developing treatments;
|
•
|
regulatory developments in both the United States and foreign countries;
|
•
|
public concern as to the safety of pharmaceutical products;
|
•
|
actual or anticipated fluctuations in our operating results;
|
•
|
changes in financial estimates or recommendations by securities analysts;
|
•
|
changes in the structure of healthcare payment systems, including developments in price control legislation;
|
•
|
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
|
•
|
additions or departures of key personnel or members of our board of directors;
|
•
|
purchases or sales of substantial amounts of our stock by existing stockholders, including officers or directors;
|
•
|
economic and other external factors or other disasters or crises; and
|
•
|
period-to-period fluctuations in our financial results.
|
BIOCRYST PHARMACEUTICALS, INC.
|
|
/s/ Jon P. Stonehouse
|
|
Jon P. Stonehouse
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
/s/ Thomas R. Staab, II
|
|
Thomas R. Staab, II
|
|
Senior Vice President, Chief Financial Officer
and Treasurer
|
|
(Principal Financial and Principal Accounting Officer)
|
( )
|
Filed or furnished herewith.
|
†
|
Confidential treatment requested.
|
( ü ) | SEC. | DESCRIPTION | PAGE(S) | ( ü ) | SEC. | DESCRIPTION | PAGE(S) |
PART I - THE SCHEDULE
|
PART II
-
CONTRACT CLAUSES
|
||||||
x | A |
SOLICITATION/CONTRACT FORM
|
01 | x | I | CONTRACT CLAUSES | 47 |
x | B |
SUPPLIES OR SERVICES AND PRICE/COST
|
03 |
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
|
|||
x | C |
DESCRIPTION / SPECS / WORK STATEMENT
|
10 | x | J | LIST OF ATTACHMENTS | 54 |
x | D |
PACKAGING AND MARKING
|
11 |
PART IV - REPRESENTATIONS AND INSTRUCTIONS
|
|||
x | E |
INSPECTION AND ACCEPTANCE
|
11 | x | K | REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS | 55 |
x | F |
DELIVERIES OR PERFORMANCE
|
12 | ||||
x | G |
CONTRACT ADMINISTRATION DATA
|
22 | o | |||
x | H |
SPECIAL CONTRACT REQUIREMENTS
|
29 | o |
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
|
||||||
1
7.
X
CONTRACTOR’S NEGOTIATED AGREEMENT
(
Contractor
is
required
to
sign
this
document
and
return
2
copies
to
issuing
office.)
Contractor
agrees
to
furnish
and
deliver
all
items
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.
o
AWARD
(Contractor is not required to sign this document.) Your offer on Solicitation Number __________________, including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document is necessary.
|
|||||
19A. NAME AND TITLE OF SIGNER
(Type
or
print)
|
20A. NAME OF CONTRACTING OFFICER
|
|||||
Jon P. Stonehouse |
Thomas P. Hastings
|
|||||
19B. NAME OF CONTRACTOR
|
19C. DATE SIGNED
|
20B. UNITED STATES OF AMERICA
|
20C. DATE SIGNED
|
|||
BY | ||||||
(Signature of person authorized to sign)
|
(Signature of person authorized to sign)
|
Contents
|
||
PART I – THE SCHEDULE
|
||
SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS
|
3
|
|
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
|
10
|
|
SECTION D – PACKAGING, MARKING AND SHIPPING
|
11
|
|
SECTION E – INSPECTION AND ACCEPTANCE
|
11
|
|
SECTION F – DELIVERIES OR PERFORMANCE
|
12
|
|
SECTION G - CONTRACT ADMINISTRATION DATA
|
22
|
|
SECTION H - SPECIAL CONTRACT REQUIREMENTS
|
29
|
|
PART II - CONTRACT CLAUSES
|
||
SECTION I - CONTRACT CLAUSES
|
47
|
|
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
|
||
SECTION J - LIST OF ATTACHMENTS
|
54
|
|
PART IV - REPRESENTATIONS AND INSTRUCTIONS
|
||
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
|
55
|
a.
|
The total estimated cost of the base period of the contract excluding fee is
|
b.
|
The total fixed fee for the base period of performance is
$ * * *
|
c.
|
The fixed fee for the base period of performance (CLIN 0001) and any exercised cost- reimbursement contract options shall be paid at a rate equal to * * * % of actual costs incurred per invoicing period, with the balance of fee payable upon successful completion of all work under each CLIN, subject to the following limitations:
|
·
|
The government shall withhold the payment of a portion of the fee to protect the government’s interest as set forth in Federal Acquisition Regulation (FAR) 52.216-8, Fixed Fee (June 2011). The government shall withhold 15 percent of the total fixed fee or $100,000, whichever is less, until after government review and acceptance of the Final Technical Progress Report.
|
d.
|
The total estimated cost of the base period of the contract, CLIN 0001, represented by the sum of the total estimated cost plus fixed fee is
$12,133,606
.
The government will not be responsible for any Contractor-incurred costs that exceed this amount unless a modification to the contract is signed by the Contracting Officer which expressly increases this amount.
|
e.
|
The Contractor shall maintain records of all contract costs and such records shall be subject to FAR 52.215-2 (Oct 2010), Audit and Records-Negotiation, and Health and Human Services Acquisition Regulation (HHSAR) 352.242-74, Final Decisions on Audit Findings, incorporated by reference into this contract in SECTION I.
|
CLIN
|
Estimated Period of Performance
|
Supplies/Services
|
Total Estimated Cost
|
Fixed Fee
|
Total Estimated Cost Plus Fixed Fee
|
|||
0001
|
03/31/2015 –
09/30/2016
|
Manufacture of Clinical Trial Material and Process Improvements
|
* * *
|
* * *
|
$12,133,606
|
|
Pursuant to FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000), set forth in full in ARTICLE I.3 of this contract, the government may, by unilateral contract modification, require the Contractor to perform discrete portions of additional work as specified in the Statement of Work.
Unless the government exercises one or more optional CLINs, the contract consists
only
of the base work specified in the Statement of Work as defined in SECTIONS C and F, with estimated costs set forth in ARTICLE B.2 of the contract.
|
CLIN
|
Option
|
Estimated Period of Performa nce
|
Supplies/ Services
|
Total Estimated Cost
|
Fixed Fee
|
Total Estimated Cost Plus Fixed Fee
|
0002
|
1
|
*** |
Commercial Scale-up and NDA
Registration batches
|
$ ***
|
$ ***
|
$ ***
|
0003
|
2
|
*** |
Nonclinical NDA-
enabling Toxicology IM
|
$ ***
|
$ ***
|
$ ***
|
0004
|
3
|
*** |
In Vitro Experiments
|
$ ***
|
$ ***
|
$ ***
|
0005
|
4
|
*** |
Nonclinical NDA-
enabling Toxicology IV
|
$ ***
|
$ ***
|
$ ***
|
a.
|
Items Unallowable Unless Otherwise Provided
|
1.
|
Acquisition, by purchase or lease, of any interest in real property;
|
2.
|
Special rearrangement or alteration of facilities;
|
3.
|
Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);
|
4.
|
Travel to attend general scientific meetings, subject to limitation under Article B.4.b.1;
|
5.
|
Foreign travel;
|
6.
|
Subcontractor and/or Consultant costs;
|
7.
|
Patient care costs;
|
8.
|
Accountable government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” regardless of acquisition value (Section J, Attachment 6).
|
9.
|
Printing Costs (as defined in the government Printing and Binding Regulations).
|
10.
|
Light Refreshment and Meal Expenditures are not authorized.
|
11.
|
Costs for meeting room or conference space used for face to face meetings with United States government (USG) staff in the performance of this contract at Government or Contractor facilities are not authorized.
|
b.
|
Travel Costs
|
1.
|
Total expenditures for all travel (transportation, lodging, subsistence, and incidental expenses) incurred by the Prime Contractor in direct performance of this contract during the base period shall not exceed
$40,000
without the prior written approval of the Contracting Officer. Cost must be consistent with FAR 52.247-63 – Preference for U.S.
-
Flag Air Carriers.
|
2.
|
The Contactor shall invoice and be reimbursed for all travel costs in accordance with F A R 31
.
20 5
-
4 6, T r a v el C os t s a nd GSA Per Diem Rates (www.gsa.gov/perdiem).
|
3.
|
Requests for foreign travel must be submitted at least four weeks in advance and shall contain the following:
|
|
Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Article.
|
c.
|
Services Performed under Contract with NIAID
|
d.
|
Security
|
|
Information Security Policies and Procedures including but not limited to: Identification of sensitive information; Access control/determination; Secured storage infrastructure; Document control; Retention/destruction requirements.
|
e.
|
Confidential Treatment of Sensitive Information
|
f.
|
Sharing of contract deliverables within United States Government (USG)
|
|
performance as well as the government’s rights to data contained within those deliverables.
|
g.
|
Approval of Protocols
|
h.
|
Rights in Data
|
|
A conference call between the Contracting Officer’s Representative and designees and the Contractor’s Project Leader/delegate and designees shall occur bi-weekly or as otherwise mutually agreed upon by the USG and the Contractor or determined by the Contracting Officer. During this call the Contractor’s Project Leader/delegate and designees will discuss the activities since the last call, any problems that have arisen and the activities planned until the next call takes place. The Contractor’s Project Leader/delegate may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting Officer’s Representative. Electronic copy of conference call meeting minutes/summaries shall be provided via e-mail to the CO, COR, and uploaded in e-room by the Contractor within five (5) business days after the conference call is held.
|
a.
|
Kickoff Meeting
|
b.
|
Quarterly and Ad-Hoc Meetings
|
c.
|
F
ace-to-Face
Project
Review
Meetings
|
|
Unless otherwise specified by the Contracting Officer, delivery of reports to be furnished to the USG under this contract (including invoices) shall be delivered to AMCG and BARDA electronically along with a concurrent email notification to the Contracting Officer, Contract Specialist, and COR (as defined in SECTION F.3. ELECTRONIC SUBMISSION) summarizing the electronic delivery.
|
|
This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:
https://www.acquisition.gov/FAR/
.
HHSAR Clauses at:
http://www.hhs.gov/policies/hhsar/subpart352.html
.
|
FAR Clause | Title and Date | |
52.246-9 | Inspection of Research and Development (Short Form) (Apr 1984) |
|
U.S. Department of Health and Human Services 330 Independence Avenue, S.W., Room G640 Washington, D.C. 20201
|
a.
|
Site Visits and Inspections
|
·
|
If issues are identified during the audit, the Contractor shall submit a report to the CO and COR within five (5) business days detailing the finding and corrective action(s) of the audit.
|
·
|
COR and CO will review the report and provide a response to the Contractor within ten (10) business days.
|
·
|
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
|
|
Under CLIN 0001, the estimated period of performance for the base performance segment of this contract shall be from March 31, 2015 through September 30, 2016 (18 months).
|
CLIN
|
Option
|
Estimated Period of Performance
|
Supplies/Services
|
0002
|
1
|
* * * |
Commercial Scale-up and NDA Registration batches
|
0003
|
2
|
* * * |
Nonclinical NDA-enabling Toxicology IM
|
0004
|
3
|
* * * |
In Vitro Experiments
|
0004
|
4
|
* * * |
Nonclinical NDA-enabling Toxicology IV
|
|
Officer, of each of the deliverables described in SECTION C, SECTION F, and SECTION J, Attachment 2, “Contract WBS Milestones and Related Deliverables”.
|
|
All deliverables and reporting documents listed within this section shall be delivered electronically (as defined in SECTION F.3. ELECTRONIC SUBMISSION) to the CO, CS, and the COR unless otherwise specified by the Contracting Officer.
|
a.
|
Summary of Contract Deliverables
|
|
HHS/ASPR/AMCG
ATTN: Thomas P. Hastings, Contracting Officer 330 Independence Avenue, S.W., Room G640
Washington, DC 20201
* * *
|
|
HHS/ASPR/BARDA
ATTN: Kimberly Sciarretta, Contracting Officer’s Representative 330 Independence Avenue, S.W., Room G640
Washington, DC 20201
* * *
|
14
|
FDA/Regulatory Agency Submissions
|
BARDA shall provide comment within five (5) business days after receipt. BARDA reserves the right to request more than 5 business days for review of any regulatory submission that is of significant length.
The Contractor shall inform BARDA of the anticipated submission length so BARDA can make a determination if more than 5 business days will be needed to complete its review of the document.
|
15
|
Supplemental Technical Documents
|
Upon request. Contractor shall provide CO and COR with deliverables from the following contract funded activities: Process Development Reports; Stability Assay Reports; Assay Qualification Plan/Report; Assay Validation Plan/Report; Assay Technology Transfer Report; Batch Records; Contractor/
Subcontractor Standard Operating Procedures (SOPs); Master Production Records; Certificate of Analysis; Clinical Studies Data or Reports. The CO and COR reserve the right to request within the PoP a nonproprietary technical document for distribution within the USG.
Contractor shall provide technical document within 5 business days of CO or COR request.
Contractor can request additional time on an as-needed basis.
*If corrective action is recommended, the Contractor must address, in writing, concerns raised by BARDA.
|
16
|
Invention Report
Annual Utilization Report
|
Due on or before the 30
th
of the month following each 12-month period of performance.
|
17
|
Final Invention Report
|
Due on or before the completion date of the contract.
|
18
|
Kickoff Meeting
|
Within thirty (30) calendar days of contract award.
|
b.
|
Detailed Description of Select Contract Deliverables
|
1.
|
Monthly Progress Report
|
|
The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:
|
|
SECTION I
-
An introduction covering the purpose and scope of the contract effort; SECTION II – PROGRESS
|
|
SECTION II Part D: PROPOSED WORK
-
A summary of work proposed for the next reporting period and preprints/reprints of papers and abstracts, and a current/updated Gantt chart.
|
|
A Monthly Progress Report will not be required in the same month that the Annual or Final Technical Progress Reports are submitted.
|
2.
|
Annual Progress Reporting Requirement
|
|
SECTION I-EXECUTIVE SUMMARY
-
A brief overview of the work completed and major accomplishments achieved during the reporting period.
|
|
SECTION II Part D: PROPOSED WORK
-
A summary of work proposed for the next reporting period; and preprints/reprints of papers, abstracts and a current Gantt chart.
|
|
Technical Progress Report and provide the Contractor with comments within fifteen (15) calendar days after receipt.
|
3.
|
Summary of Salient Results
|
4.
|
Audit Reports
|
5.
|
Copies of FDA/Regulatory Agency Correspondence and Meeting Summaries
|
·
|
Within five business days of any formal meeting with the FDA or other regulatory agency, the contractor shall forward the initial draft minutes to BARDA. The contractor shall forward final draft minutes when available.
|
·
|
Within five business days of any informal meeting with the FDA or other regulatory agency, the contractor shall forward the final draft minutes to BARDA.
|
·
|
The contractor shall forward the dates and times of any meeting with the FDA and other regulatory agencies to BARDA and make arrangements for appropriate BARDA staff to attend the meetings.
|
·
|
The contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the contractor prior to the contractor’s submission to the FDA.
|
·
|
The contractor shall forward Standard Operating Procedures (SOPs) upon request from Project Officer/Contracting Officer.
|
·
|
The contractor shall provide upon request animal study and/or other technology packages developed under this contract. Packages shall include complete protocols and critical reagents for animal models developed and/or improved with contract funding.
|
·
|
The contractor shall provide upon request raw data and/or specific analysis of data generated with USG funds.
|
6.
|
Other Reports/Deliverables
|
·
|
Government Rights in Data and Inventions
|
·
|
Institutional Biosafety Approval
|
·
|
Experimental Protocols
|
7.
|
Data
|
i.
|
Earned Value Management (EVM) / Contract Performance Report (CPR)
|
·
|
Contractor shall provide EVM/CPR as part of the Monthly Progress Report (this requirement begins only as set forth in the Contract Milestones & Related Deliverables table)
|
·
|
Contractor shall provide top level or key changes in baseline cost as a result of anticipated cost savings or risks
|
·
|
In accordance with FAR 52.215-2, Audit and Records-Negotiation (Oct 2010), the USG may request, on a monthly or ad hoc basis that the Contractor provide raw data at a reporting level or lower level as ASPR deems necessary.
|
·
|
Contractor must address, in writing, all concerns raised by the USG.
|
·
|
Reporting will commence after the EVM system has been implemented but no later than six (6) months after start of base period.
|
ii.
|
Integrated Master Plan (IMP)
|
|
The Contractor shall provide an IMP including WBS, critical path milestones, and Earned Value Management Plan
|
·
|
Contractor shall provide the draft IMP within 180 days of contract award with final due 8 months after award and updated monthly as part of the Monthly Progress Report
|
·
|
Contractor must address, in writing, all concerns raised by the USG.
|
iii.
|
Performance Measurement Baseline Review (PMBR)
|
·
|
Contractor provides baseline proposal
|
·
|
Responsibility Assignment Matrix
|
·
|
A description of the work scope through control account Work Authorization Documents and/or WBS Dictionary down to the agreed upon control account level.
|
·
|
Template for work packages
|
·
|
Integrated Master Schedule (IMS) with the inclusion of agreed major milestones and control account plans for all control accounts
|
·
|
Baseline revision documentation and program log(s) risk management plan
|
·
|
PMBR is due within one year of contract award
|
·
|
Contractor shall provide baseline proposal .ppt briefing 10 business days prior to meeting
|
·
|
Contractor provides agenda to COR 2 business days in advance of meeting
|
·
|
COR approves (with CO concurrence) and distributes agenda
|
·
|
COR approves (with CO concurrence) all meeting material
|
·
|
Contactor provides minutes with 2 business days of the meeting
|
·
|
COR reviews and approves (with CO concurrence) minutes
|
·
|
ASPR will review documentation and provide written comments and questions to Contractor
|
·
|
Contractor shall address BARDA’s comments and resubmit PMBR report for BARDA approval within 10 business days.
|
iv.
|
Risk Management Plan
|
§
|
Due within 180 days of contract award
|
§
|
Contractor provides updated Risk Management Plan in Monthly Progress Report
|
§
|
ASPR shall provide Contractor with a written list of concerns in response plan submitted
|
§
|
Contractor must address, in writing, all concerns raised by ASPR within 20 business days of Contractor’s receipt of ASPR’s concerns.
|
v.
|
Requirement for Notification of Deviation and Mitigation Strategy
|
|
Reports and documentation submitted to the Contracting Officer shall be sent to the address set forth in SECTION G – CONTRACT ADMINISTRATION DATA.
|
|
The following Contracting Officer (CO) will represent the USG for the purpose of this contract:
|
|
Thomas P. Hastings
Contracting Officer
DHHS/OS/ASPR/AMCG
330 Independence Avenue, S.W. Room G644 Washington, D.C. 20201
(571) 221-2978
* * *
|
1)
|
The Contracting Officer (CO) is the only individual who can legally commit the USG to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.
|
2)
|
The Contracting Officer is the only person with the authority to act as agent of the USG under this contract. Only the Contracting Officer has authority to (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor of any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract.
|
3)
|
No information other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the US government, other otherwise, shall be considered grounds for deviation from any stipulation of this contract.
|
4)
|
The USG may unilaterally change the CO or CS designation.
|
|
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR) and ALTERNATE CONTRACTING OFFICER'S REPRESENTATIVE (COR)
|
|
The following COR and Alternate COR will represent the government for the purpose of this contract:
|
|
COR:
Kimberly Sciarretta
Biomedical Advanced Research and Development Authority (BARDA) Office of the
Assistant Secretary for Preparedness and Response Department of Health and Human Services
|
|
Email:* * *
* * *
|
Alternate COR:
Chia-Wei Tsai
Biomedical Advanced Research and Development Authority (BARDA) Office of the
Assistant Secretary for Preparedness and Response Department of Health and Human Services
* * *
* * *
|
|
Mailing Address:
330 Independence Avenue, SW G644 Washington, D.C. 20201 The COR is responsible for:
|
1)
|
Recommending to the Contracting Officer changes in requirements;
|
2)
|
Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;
|
3)
|
Performing technical evaluation as required;
|
4)
|
Performing technical inspections and acceptances required by this contract; and
|
5)
|
Assisting in the resolution of technical problems encountered during performance. The USG may unilaterally change the COR designation.
|
Name
|
Title
|
William Sheridan
|
SVP and Chief Medical Officer and Principal Investigator
|
Ray Taylor
|
VP Project Management and Project Team Leader
|
Elliott Berger
|
SVP Regulatory Affairs
|
a.
|
Financial reports on the attached Financial Report of Individual Project/Contract shall be submitted by the Contractor to the CO with a copy to the COR in accordance with the instructions for completing this form, which accompany the form, in an original and one electronic copy, not later than the 30th business day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories), which shall be reported within the total contract, are discussed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.
|
b.
|
Unless otherwise stated in the instructions for completing this form, all columns A through J, shall be completed for each report submitted.
|
c.
|
The first financial report shall cover the period consisting of the first full three calendar months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a quarterly basis.
|
d.
|
The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.
|
e.
|
The listing of expenditure categories to be reported is incorporated as a part of this contract and can be found under SECTION J Attachment 4 entitled, "Financial Report of Individual Project/Contract,".
|
f.
|
The USG may unilaterally revise the “Financial Report of Individual Project/Contract” to reflect the allotment of additional funds.
|
Thomas P. Hastings Contracting Officer HHS/ASPR/AMCG
330 Independence Ave., S.W., Room G640
Washington, DC 20201 Email:
* * *
|
Kimberly Sciarretta Contracting Officer Representative HHS/ASPR/BARDA
330 Independence Ave., S.W., Room G640 Washington, DC 20201 Email:
* * *
|
* * *
|
a.
|
Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests and Contract Financial Reporting.
|
b.
|
Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the USG.
|
c.
|
The Contractor agrees to immediately notify the CO in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any option period(s) (See estimated costs under Articles B.2) and the reasons for the variance. These requirements are in addition to the specified requirements of FAR Clause 52.232-20, Limitation of Cost
|
|
that is incorporated by reference under Article I.1 which states;
Limitation of Cost (Apr 1984)
|
(a)
|
The parties estimate that performance of this contract, exclusive of any fee, will not cost the Government more than (1) the estimated cost specified in the Schedule or, (2) if this is a cost-sharing contract, the Government’s share of the estimated cost specified in the Schedule. The Contractor agrees to use its best efforts to perform the work specified in the Schedule and all obligations under this contract within the estimated cost, which, if this is a cost-sharing contract, includes both the Government’s and the Contractor’s share of the cost.
|
(b)
|
The Contractor shall notify the Contracting Officer in writing whenever it has reason to believe that—
|
(1)
|
The costs the Contractor expects to incur under this contract in the next 60 days, when added to all costs previously incurred, will exceed 75 percent of the estimated cost specified in the Schedule; or
|
(2)
|
The total cost for the performance of this contract, exclusive of any fee, will be either greater or substantially less than had been previously estimated.
|
(c)
|
As part of the notification, the Contractor shall provide the Contracting Officer a revised estimate of the total cost of performing this contract.
|
(d)
|
Except as required by other provisions of this contract, specifically citing and stated to be an exception to this clause—
|
(1)
|
The Government is not obligated to reimburse the Contractor for costs incurred in excess of (i) the estimated cost specified in the Schedule or, (ii) if this is a cost-sharing contract, the estimated cost to the Government specified in the Schedule; and |
(2)
|
The Contractor is not obligated to continue performance under this contract (including actions under the Termination clause of this contract) or otherwise incur costs in excess of the estimated cost specified in the Schedule, until the Contracting Officer (i) notifies the Contractor in writing that the estimated cost has been increased and (ii) provides a revised estimated total cost of performing this contract. If this is a cost-sharing contract, the increase shall be allocated in accordance with the formula specified in the Schedule.
|
(e)
|
No notice, communication, or representation in any form other than that specified in paragraph (d)(2) of this clause, or from any person other than the Contracting Officer, shall affect this contract’s estimated cost to the Government. In the absence of the specified notice, the Government is not obligated to reimburse the Contractor for any costs in excess of the estimated cost or, if this is a cost- sharing contract, for any costs in excess of the estimated cost to the Government specified in the Schedule, whether those excess costs were incurred during the course of the contract or as a result of termination. |
(f)
|
If the estimated cost specified in the Schedule is increased, any costs the Contractor incurs before the increase that are in excess of the previously estimated cost shall be allowable to the same extent as if incurred afterward, unless the Contracting Officer issues a termination or other notice directing that the increase is solely to cover termination or other specified expenses.
|
(g)
|
Change orders shall not be considered an authorization to exceed the estimated cost to the Government specified in the Schedule, unless they contain a statement increasing the estimated cost.
|
(h)
|
If this contract is terminated or the estimated cost is not increased, the Government and the Contractor shall negotiate an equitable distribution of all property produced or purchased under the contract, based upon the share of costs incurred by each.
|
d.
|
The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.
|
e.
|
An electronic copy of the payment request shall be uploaded into the designated eRoom (as defined in SECTION F.3 ELECTRONIC SUBMISSION) and an e-mail notification of the upload will be provided to the CO and COR.
|
f.
|
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment (Oct 2008).
|
g.
|
Invoices
-
Cost and Personnel Reporting, and Variances from the Negotiated Budget
|
a.
|
Direct Labor
-
List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), and amount claimed.
|
b.
|
Fringe Benefits
-
Cite rate and amount
|
c.
|
Overhead
-
Cite rate and amount
|
d.
|
Materials & Supplies
-
Include detailed breakdown when total amount is over $1,000.
|
e.
|
Travel
-
Identify travelers, dates, destination, purpose of trip, and total breaking out amounts for transportation (plane, car etc), lodging, M&IE. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.
|
f.
|
Consultant Fees
-
Identify individuals, amounts and activities. Cite appropriate COA
|
g.
|
Subcontracts
-
Attach subcontractor invoice(s). Cite appropriate COA
|
h.
|
Equipment
-
Cite authorization and amount. Cite appropriate COA
|
i.
|
Other Direct Costs
-
Include detailed breakdown when total amount is over $1,000.
|
j.
|
G&A
-
Cite rate and amount.
|
k.
|
Total Cost
|
l.
|
Fee
|
m.
|
Total Cost Plus Fixed Fee
|
|
The following contractor established provisional billing rates are incorporated into the contract, and will be utilized for billing purposes during both the base and contract option periods pending the establishment of final indirect cost rates for each fiscal year or until revised by the contracting officer in accordance with the provisions of FAR 42.705-1. See FAR Clause 52.216-7.
|
BioCryst Pharmaceuticals
|
||||
Rate Type
|
Rate | Allocation Base | ||
Fringe Benefits
|
* * * % | * * * | ||
Overhead
|
* * * % | * * * | ||
G&A
|
* * * % | * * * |
1)
|
The USG shall reimburse the Contractor those costs determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following:
|
a)
|
All direct materials and supplies that are used in the performing of the work provided for under the contract, including those purchased for subcontracts and purchase orders.
|
b)
|
All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.
|
c)
|
All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.
|
d)
|
Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the restrictions under Article B.4. b. and the following:
|
i.
|
Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections) and must comply with the Fly America Act (49 U.S.C. 40118).
|
ii.
|
Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.
|
iii.
|
Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).
|
iv.
|
Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.
|
1.
|
Contractor Performance Evaluations
|
2.
|
Electronic Access to Contractor Performance Evaluations
|
|
Important information regarding performing human subject research is available at
http://www3.niaid.nih.gov/healthscience/clinicalstudies/
.
|
1.
|
Non-Clinical Terms of Award
|
a.
|
Safety and Monitoring Issues
|
i.
|
PHS Policy on Humane Care and use of Laboratory Animals
|
·
|
All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.
|
·
|
All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if applicable).
|
·
|
Termination or temporary suspension of the study(ies) for regulatory issues.
|
·
|
Termination or temporary suspension of the protocol.
|
·
|
Any change that is made in the specific IACUC approval for the indicated study(ies).
|
·
|
Any other problems or issues that could affect the scientific integrity of the study(ies), i.e., fraud, misrepresentation, misappropriation of funds, etc.
|
|
Contractor must notify BARDA of any of the above changes within five (5) working days from the time the Contractor becomes aware of such changes by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IACUC and a copy of any responses from the IACUC.
If a non-clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and
|
|
ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
|
b.
|
BARDA Review Process before Non-Clinical study Execution Begins
|
|
Therefore, before study execution, the Contractor must provide the following (as applicable) for review and comment by BARDA:
|
·
|
IACUC approved (signed) non-clinical research protocol identified by version number, date, or both, including details of study design, euthanasia criteria, proposed interventions, and exclusion criteria.
|
·
|
For non-pivotal mouse studies, the Contractor will provide an annual animal care and use protocol.
|
·
|
Documentation of IACUC approval, including OLAW federal wide number, IACUC registration number, and IACUC name.
|
·
|
Contractor should reduce the number of animals required for a study using power of statistics.
|
·
|
Plans for the management of side effects, rules for interventions and euthanasia criteria.
|
·
|
Procedures for assessing and collecting safety data were appropriate.
|
·
|
If a study is contracted through Contract Research Organizations (CROs), work orders and service agreements the Contractor shall assure an integrated safety documentation plan is in place for the study site, pharmacy service records on the dosing material to be used and excipients, and laboratory services (including histopathology).
|
·
|
Documentation that the Contractor and all required staff responsible for the conduct of the research have received training in the protection and handling of animals, or that the CRO has the required documentation.
|
·
|
Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval by the Contracting Officer in accordance with the contract. The Contractor must have the ability to return/re-sell animals, at purchase price, to distributor or a third part, in the event that the Contracting Officer Authorization is not granted.
|
·
|
Provide justification for whether studies require good laboratory practice (GLP) conditions.
|
·
|
Provide justification for whether studies will be classified as non- pivotal or pivotal studies.
|
|
Documentation of each of the above items shall be submitted to BARDA for evaluation and comment in conjunction with the protocol. Execution of non- clinical studies requires written authorization from the Contracting Officer in accordance with this section of the contract.
|
c.
|
References
|
|
USDA Animal Welfare Act:
|
2.
|
Clinical Terms of Award
|
i.
|
Safety and Monitoring Issues
|
a.
|
Institutional Review Board or Independent Ethics Committee Approval
|
·
|
All amendments or changes to the protocol, identified by protocol version number, date, or both and dates it is valid.
|
·
|
All changes in informed consent documents, identified by version number, dates, or both and dates it is valid.
|
·
|
Termination or temporary suspension of patient accrual.
|
·
|
Termination or temporary suspension of the protocol.
|
·
|
Any change in IRB approval.
|
·
|
Any other problems or issues that could affect the participants in the studies.
|
b.
|
Data and Safety Monitoring Requirements
|
|
BARDA reserves the right to accompany the Contractor on site visits and/or audits of CROs as BARDA deems necessary.
|
·
|
Independent
Safety
Monitor
– a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.
|
·
|
Independent
Monitoring
Committee
(IMC)
or
Safety
Monitoring
Committee
(SMC)
– a small group of independent investigators and biostatisticians who review data from a particular study.
|
·
|
Data
and
Safety
Monitoring
Board
– an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy
|
·
|
IRB- or IEC-approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria.
|
·
|
Documentation of IRB or IEC approval, including OHRP federal wide number, IRB or IEC registration number, and IRB and IEC name.
|
·
|
IRB- or IEC- approved informed consent document, identified by version number, date, or both and dates it is valid.
|
·
|
Plans for the management of side effects.
|
·
|
Procedures for assessing and reporting adverse events.
|
·
|
Plans for data and safety monitoring (see above) and monitoring of the clinical study site, pharmacy, and laboratory.
|
·
|
Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received training in the protection of human subjects.
|
|
Exceptions must be granted in writing by FDA. If the proposed clinical trial will be performed under an IND or IDE, the Contractor must provide BARDA with the name and institution of the IND or IDE sponsor, the date the IND or IDE was filed with FDA, the FDA IND or IDE number, any written comments from FDA, and the written responses to those comments.
|
v.
|
Required Time-Sensitive Notification
|
|
Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s Representative (COR) as follows:
|
ii.
|
Expedited safety report of unexpected or life-threatening experience or death:
|
iii.
|
Expedited safety reports of serious and unexpected adverse experiences:
|
iv.
|
IDE reports of unanticipated adverse device effect:
|
v.
|
Expedited safety reports:
|
vi.
|
Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to BARDA annually.
|
|
In case of problems or issues, the Contracting Officer’s Representative will contact the Contractor within ten (10) working days by email or fax, followed within thirty (30) calendar days by an official letter to the Contractor’s Project Manager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed.
|
vii.
|
Safety reporting for research not performed under an IND or IDE.
|
a.
|
Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through
|
b.
|
The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.
|
c.
|
The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.
|
d.
|
If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Assurances.
|
|
ARTICLE H.5. REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS
|
|
ARTICLE H.8. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES
|
|
The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data determined by DHHS to be relevant to this contract. The contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.
|
|
The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
|
|
The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.
|
a.
|
Confidential information, as used in this article, means information or data of a personal nature about an individual or proprietary information or data submitted by or pertaining to an institution or organization.
|
b.
|
The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the USG will furnish to the Contractor or that the Contractor is expected to generate which is confidential and providing further that the government is not entitled to unlimited rights to that information pursuant to FAR 52.227-14. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.
|
c.
|
If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.
|
d.
|
Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.
|
e.
|
Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
|
f.
|
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.
|
A.
|
Publication and Publicity
|
|
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract, Section 507 of
P.L. 104-208 mandates that Contractors funded with Federal dollars, in whole or in part, acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents. Contractors are required to state:
|
(1)
|
the percentage and dollar amounts of the total program or project costs financed with Federal money and;
|
(2)
|
the percentage and dollar amount of the total costs financed by nongovernmental sources
|
|
"This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500007C.”
|
B.
|
Press Releases
|
|
IPRs may be scheduled at the discretion of the USG to discuss progression of the contract. The Contractor shall provide a presentation following a prescribed template which will be provided by the USG at least 30 business days prior to the IPR. Subsequently, the contractor will be requested to provide a revised/final presentation to the Contracting Officer at least 10 business days prior to the IPR.
|
1)
|
Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the USG. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act.
|
2)
|
The Project Officer is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.
|
3)
|
The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link:
http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm
|
|
The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended) (42 U.S.C. 263a and 42 CFR Part 493). This requirement shall also be included in any subcontract for services under the contract.
|
|
BARDA reserves the right to participate in QA audits. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.
|
·
|
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications
|
·
|
Contractor shall notify the COR and CO within 5 business days of report completion.
|
|
Contractor shall accommodate periodic or ad hoc site visits by the USG. If the USG, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the USG.
|
·
|
If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit.
|
·
|
COR and CO will review the report and provide a response to the Contractor with 10 business days.
|
·
|
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
|
|
Violations of established security protocols shall be reported to the Contracting Officer (CO) and Contracting Officer’s Representative (COR) upon discovery and within 24 hours of any compromise, intrusion, loss or interference of its security processes and procedures. The Contractor shall ensure that all software components that are not required for the operation and maintenance of the database/control system has been removed and/or disabled. The Contractor shall provide to the CO and the COR information appropriate to Information and Information Technology software and service updates and/or workarounds to mitigate all vulnerabilities associated with the data and shall maintain the required level of system security.
|
|
ARTICLE H.29. NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISKS, OR POTENTIAL RISKS
|
·
|
Within 48 hours of activity or incident or within 24 hours for a security related activity or incident, Contractor must notify BARDA.
|
·
|
Additional updates due to COR and CO within 48 hours of additional developments.
|
·
|
Contractor shall submit within 5 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.
|
|
If corrective action is deemed necessary, Contractor must address in writing, its consideration of concerns raised by BARDA within 5 business days.
|
|
ARTICLE H.30. PUBLIC READINESS AND EMERGENCY PREPARDENESS ACT (“PREP ACT”)
|
(1)
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
|
FAR
CL
AUSE
|
DATE
|
CLAUSE
TITLE
|
52.202-1
|
Nov 2013
|
Definitions
|
52.203-3
|
Apr 1984
|
Gratuities
|
52.203-5
|
May 2014
|
Covenant Against Contingent Fees
|
52.203-6
|
Sep 2006
|
Restrictions on Subcontractor Sales to the government
|
52.203-7
|
May 2014
|
Anti-Kickback Procedures
|
52.203-8
|
May 2014
|
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
|
52.203-10
|
May 2014
|
Price or Fee Adjustment for Illegal or Improper Activity
|
52.203-12
|
Oct 2010
|
Limitation on Payments to Influence Certain Federal Transactions
|
52.203-13
|
Apr 2010
|
Contractor Code of Business Ethics and Conduct
|
52.203-17
|
April 2014
|
Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower rights
|
52.204-4
|
May 2011
|
Printed or Copied Double-Sided on Recycled Paper
|
52.204-7
|
Jul 2013
|
System for Award Management
|
52.204-10
|
Jul 2013
|
Reporting Executive Compensation and First-Tier Subcontract Awards
|
52.204-13
|
Jul 2013
|
System for Award Management Maintenance
|
52.209-6
|
Aug 2013
|
Protecting the government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment
|
52.209-9
|
Jul 2013
|
Updates of Publicly Available Information Regarding Responsibility Matters
|
52.210-1
|
Apr 2011
|
Market Research
|
52.215-2
|
Oct 2010
|
Audit and Records – Negotiation
|
52.215-8
|
Oct 1997
|
Order of Precedence - Uniform Contract Format
|
52.215-10
|
Aug 2011
|
Price Reduction for Defective Certified Cost or Pricing Data
|
52.215-12
|
Oct 2010
|
Subcontractor Certified Cost or Pricing Data
|
52.215-15
|
Oct 2010
|
Pension Adjustments and Asset Reversions
|
52.215-17
|
Oct 1997
|
Facilities Capital Cost of Money
|
52.215-18
|
Jul 2005
|
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
|
52.215-19
|
Oct 1997
|
Notification of Ownership Changes
|
52.215-21
|
Oct 2010
|
Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data – Modifications
|
52.215-23
|
Oct 2009
|
Limitations on Pass-Through Charges
|
52.216-7
|
Jun 2013
|
Allowable Cost and Payment
|
52.216-8
|
Jun 2011
|
Fixed Fee
|
52.217-8
|
Nov 1999
|
Option to Extend Services
|
52.219-8
|
May 2014
|
Utilization of Small Business Concerns
|
52.222-2
|
Jan 2011
|
Payment for Overtime Premiums
|
52.222-3
|
Jun 2003
|
Convict Labor
|
52.222-21
|
Feb 1999
|
Prohibition of Segregated Facilities
|
52.222-26
|
Mar 2007
|
Equal Opportunity
|
52.222-35
|
Jul 2014
|
Equal Opportunity for Veterans
|
52.222-36
|
Jul 2014
|
Equal Opportunities for Workers with Disabilities
|
52.222-37
|
Jul 2014
|
Employment Reports on Veterans
|
52.222-40
|
Dec 2010
|
Notification of Employee Rights Under the National Labor Relations Act
|
52.222-50
|
Feb 2009
|
Combating Trafficking in Persons
|
52.222-54
|
Aug 2013
|
Employment Eligibility Verification
|
52.223-6
|
May 2001
|
Drug-Free Workplace
|
52.223-18
|
Aug 2011
|
Encouraging Contractor Policies to Ban Text Messaging While Driving
|
52.224-1
|
April 1984
|
Privacy Act Notification
|
52.224-2
|
April 1984
|
Privacy Act
|
52.225-13
|
Jun 2008
|
Restrictions on Certain Foreign Purchases
|
52.227-1
|
Dec 2007
|
Authorization and Consent, Alternate I
|
52.227-2
|
Dec 2007
|
Notice and Assistance Regarding Patent and Copyright Infringement
|
52.227-3
|
April 1984
|
Patent Indemnity
|
52.227-11
|
May 2014
|
Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.)
|
52.227-14
|
May 2014
|
Rights in Data – General
|
52.227-16
|
Jun 1987
|
Additional Data Requirements
|
52.232-9
|
Apr 1984
|
Limitation on Withholding of Payments
|
52.232-17
|
May 2014
|
Interest
|
52.232-20
|
Apr 1984
|
Limitation of Cost
|
52.232-23
|
May 2014
|
Assignment of Claims
|
52.232-25
|
Jun 2013
|
Prompt Payment Alternate I (Feb 2002)
|
52.232-33
|
Jul 2013
|
Payment by Electronic Funds Transfer--System for Award Management
|
52.233-1
|
Jul 2002
|
Disputes
|
52.233-3
|
Aug 1996
|
Protest After Award, Alternate I (June 1985)
|
52.233-4
|
Oct 2004
|
Applicable Law for Breach of Contract Claim
|
52.242-1
|
Apr 1984
|
Notice of Intent to Disallow Costs
|
52.242-3
|
May 2014
|
Penalties for Unallowable Costs
|
2.242-4
|
Jan 1997
|
Certification of Final Indirect Costs
|
52.242-13
|
Jul 1995
|
Bankruptcy
|
52.243-2
|
Aug 1987
|
Changes - Cost Reimbursement, Alternate V (Apr 1984)
|
52.244-2
|
Oct 2010
|
Subcontracts, Alternate I (Jun 2007)
|
52.244-5
|
Dec 1996
|
Competition in Subcontracting
|
52.244-6
|
Oct 2014
|
Subcontracts for Commercial Items
|
52.245-1
|
Apr 2012
|
Government Property
|
52.245-9
|
Apr 2012
|
Use and Charges
|
52.246-9
|
May 2001
|
Inspection of Research and Development (Short Form)
|
52.246-23
|
Feb 1997
|
Limitation of Liability
|
52.246-25
|
Feb 1997
|
Limitation of Liability – Services
|
52.247-63
|
Jun 2003
|
Preference for U.S.-Flag Air Carriers
|
52.247-67
|
Feb 2006
|
Submission of Transportation Documents for Audit
|
52.249-6
|
May 2004
|
Termination (Cost-Reimbursement)
|
52-249-14
|
Apr 1984
|
Excusable Delays
|
52.251-1
|
Apr 2012
|
Government Supply Sources
|
52.253-1
|
Jan 1991
|
Computer Generated Forms
|
(2)
|
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:
|
HHSAR
CLA
USE
NO.
|
DATE
|
TITLE
|
352.201-70
|
Jan 2006
|
Paperwork Reduction Act
|
352.202-1
|
Jan 2006
|
Definitions, with Alternate paragraph (h)
|
352.203-70
|
Mar 2012
|
Anti-Lobbying
|
352.216-70
|
Jan 2006
|
Additional Cost Principles
|
352.222-70
|
Jan 2010
|
Contractor Cooperation in Equal Employment Opportunity Investigations
|
352.223-70
|
Jan 2006
|
Safety and Health
|
352.224-70
|
Jan 2006
|
Privacy Act
|
352.227-70
|
Jan 2006
|
Publications and Publicity
|
352.228-7
|
Dec 1991
|
Insurance - Liability to Third Persons
|
352.231-70
|
Aug 2012
|
Salary Rate Limitation
|
352.231-71
|
Jan 2001
|
Pricing of Adjustments
|
352.233-71
|
Jan 2006
|
Litigation and Claims
|
352.242-70
|
Jan 2006
|
Key Personnel
|
352.242-73
|
Jan 2006
|
Withholding of Contract Payments
|
352.242-74
|
Apr 1984
|
Final Decisions on Audit Findings
|
352.270-4
|
Jan 2006
|
Protection of Human Subjects
|
|
This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
|
a.
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
|
(b)
|
(1) The North American Industry Classification System (NAICS) code for this acquisition is
541711
.
(2)
The small business size standard is
500
employees.
(3)
The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.
|
(c)
|
Representations
.
|
(1)
|
The offeror represents as part of its offer that it [X] is, [ ] is not a small business concern.
|
(2)
|
The offeror represents as part of its offer that it [ ] is, [X] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.
|
(3)
|
The offeror represents as part of its offer that it [ ] is, [X] is not a woman-owned small business concern.
|
|
FAR 52.232-40, Providing Accelerated Payment to Small Business Subcontractors
|
1.
|
Statement of Work, dated March 27, 2015 (16 pages).
|
2.
|
Milestones and Deliverables Chart (4 pages)
|
3.
|
Manufacturing Chart (1 page)
|
4.
|
High-level Gantt Chart (2 pages)
|
5.
|
Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for Cost-Reimbursement Type Contracts (5 pages).
|
6.
|
Financial Report of Individual Project/Contract (1 page)
|
7.
|
Instructions for Completing Financial Report of Individual Project/Contract (3 pages)
|
8.
|
7 Principles of Earned Value Management Tier 2 System Implementation Intent Guide (26 pages)
|
1.
|
Annual Representations and Certifications completed and located at the System for Award Management website (SAM.gov).
|
2.
|
Animal Welfare Assurance – No Animal Studies will be conducted at BioCryst facilities. Animal Welfare Assurance Numbers will be procured from any subcontractors.
|
·
|
Drug substance (DS) and drug product (DP) manufacturing process development activities that will be conducted at US based facilities, which will result in the ability to consistently produce high quality, cGMP compliant material and deliver drug supply that could be available for deployment as a medical countermeasure during the Ebola crisis and support future clinical and non-clinical studies
|
·
|
Nonclinical development activities to advance the intramuscular (IM) and intravenous (IV) formulation through NDA-enabling toxicology including * * * and * * * studies in the * * *
|
·
|
Produce * * * batches of BCX4430 drug substance following * * *.
|
·
|
Conduct drug product process improvements that will be focused on validation of analytical methods, stress testing, stability studies, and process design space optimization
|
1.1.
|
Procurement of Starting Materials
|
1.1.1.
|
Procurement of Starting Materials to produce * * * batches of * * *
|
1.2.
|
Further Process Improvements of * * *
|
1.2.1
|
Conduct Process Improvements
|
1.2.2
|
Determination that Process is Sufficient to move to Commercial Scale up
|
1.3.
|
Manufacture of * * * at * * *
|
1.3.1.
|
Manufacture of * * * of * * * (Batch * * * )
|
1.3.2.
|
Manufacture of * * * of * * * (Batch * * * )
|
1.4.
|
Manufacturing Campaign of BCX4430
|
1.4.1.
|
Manufacturing of * * * of cGMP BCX4430 (DS Batch * * * )
|
1.4.2.
|
Manufacturing of * * * of cGMP BCX4430 (DS Batch * * * )
|
1.4.3.
|
Prepare a Campaign Summary Report
|
1.4.4.
|
Drug Substance Stability Studies
|
Test
ID
|
Months
|
|||||||||
0
|
1
|
3
|
6
|
9
|
12
|
18
|
24
|
48
|
60
|
|
A
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
B
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
C
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
D
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
E
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
F
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
||
G
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
Test ID
|
Test
|
A
|
* * *
|
B
|
* * *
|
C
|
* * *
|
D
|
* * *
|
E
|
* * *
|
F
|
* * *
|
G
|
* * *
|
1.5.
|
Drug Product Development
|
1.5.1.
|
Stress Conditions Studies
|
1.5.2.
|
Design Space Studies
|
1.5.3.
|
Analytical Method Validation
|
Te
st
|
Method and Objective
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
1.5.4.
|
Prepare Process Development Report for DP
|
1.5.5.
|
Pre-formulation and Physicochemical Properties Studies
|
1.5.6.
|
Feasibility Runs
|
1.5.7.
|
Extractable/Leachable Study
|
1.5.8.
|
Excipient Compatibility Studies for IV Formulation from IM
|
1.6.
|
Manufacturing of Drug Product to Support Clinical Trials
|
1.6.1.
|
Manufacture of Clinical Trial Material (CTM Batch * * * )
|
1.6.2.
|
Manufacture of Clinical Trial Material (CTM Batch * * * )
|
1.6.3.
|
Prepare a Campaign Summary Reports
|
1.6.4.
|
Drug Product Stability Studies
|
Stability Conditions
|
Configuration
|
Test Points
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
Test
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
1.6.5.
|
Comparability Study
|
1.7.
|
Manufacture of Additional Supply
|
1.7.1.
|
Manufacturing of * * * cGMP BCX4430 (DS Batch * * * )
|
1.7.2.
|
Prepare a Campaign Summary Report
|
1.7.3.
|
Manufacturing of approximately * * * (CTM Batch * * * )
|
1.7.4.
|
Prepare a Campaign Summary Report
|
1.7.5.
|
Stability Studies for DS and DP
|
1.7.6.
|
Comparability Studies
|
2
|
OPTION 1: COMMERCIAL SCALE UP AND NDA REGISTRATION BATCHES
|
2.1.
|
Procurement
|
2.1.1.
|
Procurement of * * *
|
2.1.2.
|
Procurement of * * *
|
2.2.
|
Drug Substance Process Scale-up
|
2.2.1
|
Further Process Improvements of Final Route
|
*
|
to be scaled up. The * * * will be based either * * *
.
|
2.2.2
|
Process Hazard Evaluation
|
2.2.3
|
Scale-up Technical Run
|
2.2.4
|
Analytical Method Development and Qualification
|
2.2.5
|
Prepare Process Development Report
|
2.3
|
Manufacture of cGMP Drug Substance Registration Batches
|
2.3.1
|
Manufacture of DS Batch (DS Batch * * * )
|
2.3.2
|
Manufacture of DS Batch (DS Batch * * * )
|
2.3.3
|
Manufacture of DS Batch (DS Batch * * * )
|
2.3.4
|
Prepare Campaign Summary Report
|
2.4
|
Drug Product Registration Batches
|
2.4.1
|
Manufacture of DP Registration (DPR Batch * * * )
|
*
|
* * the estimated commercial scale.
|
2.4.2
|
Manufacture of DP Registration (DPR Batch * * * )
|
*
|
* * the estimated commercial scale.
|
2.4.3
|
Manufacture of DP Registration (DPR Batch * * * )
|
*
|
* * the estimated commercial scale.
|
2.4.4
|
Prepare campaign summary report
|
2.5
|
Stability studies for DS and DP
|
2.6
|
Comparability study
|
3
|
OPTION 2: NONCLINICAL NDA-ENABLING TOXICOLOGY
-
IM
|
3.1.
|
GLP * * * Toxicology – IM
|
3.1.1.
|
Conduct GLP * * * IM toxicology study
-
* * *
|
3.1.2.
|
Conduct GLP * * * IM general toxicology study
-
* * *
|
3.2.
|
* * * toxicology
-
IM
|
3.2.1.
|
Conduct * * * assessment in * * *
|
3.2.2.
|
Conduct * * * Dose Range Finding Studies in the * * *
|
3.2.3.
|
Conduct Definitive * * * toxicology in the * * *
|
3.2.4.
|
Conduct * * * toxicology * * *
|
3.3.
|
Nonclinical ADME
-
IM
|
3.3.1.
|
Conduct Radiolabeled ADME study
-
* * *
|
3.3.2.
|
Conduct Radiolabeled ADME – * * *
|
Study #
|
Description
|
Objective(s)
|
Species (N)
|
GLP * * * IM general toxicology
|
* * *
|
* * *
|
|
GLP * * * IM general toxicology
|
* * *
|
* * *
|
|
* * *
assessment
|
* * *
|
* * *
|
|
* * *
Dose
Range
Finding
|
* * *
|
* * *
|
|
* * *
Dose
Range
Finding
|
* * *
|
* * *
|
|
Definitive
* * *
toxicology
|
* * *
|
* * *
|
|
Definitive
* * *
toxicology
|
* * *
|
* * *
|
|
* * *
toxicology
|
* * *
|
* * *
|
|
Radiolabeled ADME
|
Determine the absorption, distribution, metabolism and excretion of the test article following IM dosing
|
* * *
|
|
Radiolabeled ADME
|
Determine the absorption, metabolism and excretion of the test article following IM dosing
|
* * *
|
4
|
OPTION 3:
IN
VITRO
EXPERIMENTS – IV
|
Study #
|
Description
|
Objective(s)
|
Species (N)
|
* * *
|
* * *
|
* * *
|
|
* * *
|
* * *
|
* * *
|
5
|
OPTION 4: NONCLINICAL NDA-ENABLING TOXICOLOGY
-
IV
|
5.1.
|
GLP * * * Toxicology – IV
|
5.1.1.
|
Conduct GLP * * * IV general toxicology study
-
* * *
|
5.1.2.
|
Conduct GLP * * * IV toxicology study
-
* * *
|
5.2.
|
* * * toxicology
-
IV
|
5.2.1.
|
Conduct * * * assessment in * * *
|
5.2.2.
|
Conduct * * * Dose Range Finding Studies in the * * *
|
5.2.3.
|
Conduct Definitive * * * toxicology in the * * *
|
5.2.4.
|
Conduct * * * Developmental toxicology * * *
|
Study #
|
Description
|
Objective(s)
|
Species (N)
|
GLP * * * IV general toxicology
|
* * *
|
* * *
|
|
GLP * * * IV general toxicology
|
* * *
|
* * *
|
|
* * *
assessment
|
* * *
|
* * *
|
|
* * *
Dose
Range
Finding
|
* * *
|
* * *
|
|
* * *
Dose
Range
Finding
|
* * *
|
* * *
|
Definitive
* * *
toxicology
|
* * *
|
* * *
|
|
Definitive
* * *
toxicology
|
* * *
|
* * *
|
|
* * *
Developmental
toxicology
|
* * *
|
* * *
|
6
|
PROGRAM MANAGEMENT
|
6.1.
|
Technical and Project Management Support
|
6.2.
|
Subcontractor Management
|
6.3.
|
Risk Management
|
6.4.
|
Earned Value Management (EVM)
|
6.5.
|
Project Communications
|
7
|
REGULATORY
|
7.1.
|
Regulatory Authority Interactions
|
7.2.
|
Quality Assurance
|
7.3.
|
Expert Collaborations
|
WBS
|
Milestone
|
Deliverable
|
Success Criteria
|
Timing
|
Go/No-Go for initiation
|
|
CLIN 0001 - MANUFACTURE OF CLINICAL TRIAL MATERIAL
|
||||||
1.2.1
|
Process Improvements Report
|
Report on Process
Development
|
Process Developed
|
* * *
|
||
1.2.2
|
Determination of Sufficient Process for Commercial Scale up
|
Evaluation report
|
BARDA
approval of developed process
|
* * *
|
N/A
|
|
1.3.2
|
Manufacture * * * (Batch * * *)
|
* * *
|
Acceptable quality and yield
|
* * *
|
N/A
|
|
1.4.1
|
Manufacture cGMP BCX4430 (* * *
campaign DS Batch *
* *)
|
BCX4430 DS
CofA,
|
Acceptable quality and yield
|
* * *
|
N/A
|
|
1.4.2
|
Manufacture cGMP BCX4430 (* * *
campaign DS Batch *
* *)
|
BCX4430 DS
CofA,
|
Acceptable quality and yield
|
* * *
|
N/A
|
|
1.4.3
|
Prepare a Campaign Summary Reports
|
Campaign Reports (DS Batches * * *)
|
Completion of DS Campaigns
|
* * *
|
N/A
|
|
1.4.4
|
Drug substance stability study
|
Initial Report on stability activities
|
Stability data
|
* * *
|
||
1.5
|
Drug Product Development
|
DP Process Development
Report (WBS 1.5.4)
Pre-formulation and
Physicochemical Report (WBS1.5.5)
Extractable/Leachable Report (WBS 1.5.7)
|
Completion of Studies
|
* * *
|
N/A
|
|
1.5.8
|
Excipient Compatibility Report for IV Formulation
|
Compatibility Report
|
IV formulation completed
|
* * *
|
||
1.6.1
|
Manufacture cGMP DP (CTM Batch * * *)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
* * *
|
Accepted GMP DS
|
|
1.6.2
|
Manufacture cGMP DP (CTM Batch * * *)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
* * *
|
Accepted GMP DS
|
|
1.6.3
|
Prepare a Campaign Summary Reports
|
Campaign Reports (CTM Batches * * *)
|
Completion of DP Campaigns
|
* * *
|
N/A
|
5.1.1
|
Complete GLP * * *IV Tox Study - * * *
|
Study Report
|
Established NOAEL
|
* * *
|
Drug Substance confirming to release criteria
|
5.1.2
|
Complete GLP * * * IV Tox Study - * * *
|
Study Report
|
Established NOAEL
|
* * *
|
Drug Substance confirming to release criteria
|
5.2.1
|
Conduct * * * assessment in * * *
|
Study Report
|
No significant findings
|
* * *
|
N/A
|
5.2.2
|
Conduct * * * Dose Range Finding Studies in the * * *
|
Study Report
|
No significant findings
|
* * *
|
N/A
|
5.2.3
|
Conduct Definitive * * * toxicology in the * * *
|
Study Report
|
No significant findings
|
* * *
|
N/A
|
5.2.4
|
Conduct * * * toxicology * * *
|
Study Report
|
No significant findings
|
* * *
|
N/A
|
Starting Material
|
DS
Campaign
|
CMO
|
DS Process Desc
|
DS
Timing
|
DP
Campaign
|
DP
Timing
|
Use
|
Funding
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
|||
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
||
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
||
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
||
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
* * *
|
||
* * *
|
1.
|
Trigger 1 (for start of Option 1): Further optimization processes for manufacturing will be developed under the WBS 1.2.1 and then BioCryst will evaluate the processes developed and provide sufficient information through deliverable WBS 1.2.2 that will enable BARDA to determine that the processes are sufficient to move to commercial scale –up activities (milestone WBS1.2.2, July 2015), and then Option 1 can begin. In Option 1, the process developed in WBS 1.2 and other processes being developed to manufacture the BCX4430 compound will be evaluated, such that BioCryst can select a process of most value to the Government to generate * * * drug substance registration batches that will then be used to make * * * drug product registration batches at a scale at least * * * the estimated commercial scale which is a regulatory requirement for qualifying a GMP process for manufacturing.
|
2.
|
Trigger 2 (for start of Option 3): In preparation for manufacturing clinical trial (drug product)
|
3.
|
Trigger 3 (for start of Option 2): In order to conduct further regulatory activities to support NDA activities, toxicology experiments will need to be conducted with the IM formulation in
|
4.
|
Trigger 4 (for start of Option 4): In order to proceed with conducting further regulatory activities to support NDA activities for the IV formulation, toxicology experiments will need to be conducted in animals. However, this can only proceed if the preliminary toxicology studies performed
in
vitro,
as evaluated in the
in
vitro
study report (WBS 4.3, March 2016), demonstrate that the IV formulation is safe.
|
(a)
|
Interim
Invoice/Contract
Financing
Request:
These are interim payment requests submitted during the contract performance period.
|
(b)
|
Completion
Invoice:
The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.
|
(c)
|
Final
Invoice:
A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).
|
(a)
|
Designated
Billing
Office
Name
and
Address:
Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section B and F of the Contract Schedule.
|
(b)
|
Contractor's
Name,
Address,
Point
of
Contact,
VIN,
and
DUNS
or
DUNS+4
Number:
Show the Contractor's name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds
|
(c)
|
Invoice/Financing
Request
Number:
Insert the appropriate serial number of the payment request.
|
(d)
|
Date
Invoice/Financing
Request
Prepared:
Insert the date the payment request is prepared.
|
(e)
|
Contract
Number
and
Order
Number
(if
applicable):
Insert the contract number and order number (if applicable).
|
(f)
|
Effective
Date:
Insert the effective date of the contract or if billing under an order, the effective date of the order.
|
(g)
|
Total
Estimated
Cost
of
Contract/Order:
Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee.
|
(h)
|
Total
Fixed-Fee:
Insert the total fixed-fee (where applicable).
|
(i)
|
Two-Way/Three-Way
Match:
Identify payment to be made using a three-way match.
|
(j)
|
Office
of
Acquisitions:
Insert the name of the Office of Acquisitions, as identified in Section G of the Contract Schedule.
|
(k)
|
Central
Point
of
Distribution:
Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(l)
|
Billing
Period:
Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.
|
(m)
|
Amount
Billed
-
Current
Period:
Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
|
(n)
|
Amount
Billed
-
Cumulative:
Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
|
(o)
|
Direct
Costs:
Insert the major cost elements. For each element, consider the application of the paragraph entitled "Costs Requiring Prior Approval" on page 1 of these instructions.
|
(1)
|
|
(2)
|
Direct
Labor:
Include salaries and wages paid (or accrued) for direct performance of the contract.
|
(3)
|
Fringe
Benefits:
List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs.
|
(4)
|
Accountable
Personal
Property:
Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS
Contractor's
Guide
for
Control
of
Government
Property
). Show permanent research equipment separate from general purpose equipment.
|
-
|
item number for the specific piece of equipment listed in the Property Schedule, and
|
-
|
COA number, if the equipment is not covered by the Property Schedule.
|
(5)
|
Materials
and
Supplies:
Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.
|
(6)
|
Premium
Pay:
List remuneration in excess of the basic hourly rate.
|
(7)
|
Consultant
Fee:
List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.
|
(8)
|
Travel:
Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.
|
(9)
|
Subcontract
Costs:
List subcontractor(s) by name and amount billed. Cite applicable COA or notification.
|
(10)
|
Other:
List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.
|
(p)
|
Cost
of
Money
(COM):
Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed.
|
(q)
|
Indirect
Costs:
Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.
|
(r)
|
Fixed-Fee:
Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.
|
(s)
|
Total
Amounts
Claimed:
Insert the total amounts claimed for the current and cumulative periods.
|
(t)
|
Adjustments:
Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.
|
(u)
|
Grand Totals
|
(v)
|
Certification
of
Salary
Rate
Limitation:
If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:
|
(w)
|
Signature
|
|
The Contracting Officer may require the Contractor to submit detailed support for costs claimed on one or more interim payment requests.
|
(a)
(b)
|
Designated Billing Office Name and Address:
DHHS/OS/ASPR/BARDA
Attn: Contracting Officer
330 Independence Ave., S.W. Room G644
Washington, D.C. 20201
Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:
ABC CORPORATION
100 Main Street Anywhere, USA Zip Code
Name, Title, Phone Number, and E-mail Address of person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent.
VIN:
DUNS or DUNS+4:
|
|
(c) Invoice/Financing Request No.:
(d) Date Invoice Prepared:
(e) Contract No. and Order No. (if applicable):
(f)
Effective Date:
(g)
Total Estimated Cost of Contract/Order:
(h) Total Fixed-Fee (if applicable):
[ ]
Two-Way Match:
[ ] Three-Way Match:
(i) Office of Acquisitions:
(j) Central Point of Distribution:
|
||||||
(l) This invoice/financing request represents reimbursable costs for the period from to
|
|||||||||
■
Expenditure Category*
A
|
Cumulative Percentage of Effort/Hrs.
|
Amount Billed
|
Cost at
Completion
F
|
Contract
Amount
G
|
Variance
H
|
||||
Negotiated
B
|
Actual
C
|
(m)
Current
D
|
(n)
Cumulative
E
|
||||||
(o) Direct Costs:
|
|||||||||
(1) Direct Labor
|
|||||||||
(2) Fringe Benefits
|
|||||||||
(3) Accountable Property
|
|||||||||
(4) Materials & Supplies
|
|||||||||
(5) Premium Pay
|
|||||||||
(6) Consultant Fees
|
|||||||||
(7) Travel
|
|||||||||
(8) Subcontracts
|
|||||||||
(9) Other
|
|||||||||
Total Direct Costs
|
|||||||||
(p) Cost of Money
|
|||||||||
(q) Indirect Costs
|
|||||||||
(r) Fixed Fee
|
|||||||||
(s) Total Amount Claimed
|
|||||||||
(t) Adjustments
|
|||||||||
(u) Grand Totals
|
|||||||||
I certify that all payments are for appropriate purposes and in accordance with the contract.
(Name of Official) (Title)
* Attach details as specified in the contract
|
FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT
Note: Complete this Form in Accordance with Accompanying Instructions.
|
Project Task:
|
Contract No.:
|
Date of Report:
|
0990-0134
0990-0131
|
|||||||||
Reporting Period:
|
Contractor Name and Address:
|
||||||||||||
Expenditure Category
|
Percentage of Effort/Hours
|
Cumulative
Incurred Cost
at End of Prior
Period
|
Incurred Cost--
Current
Period
|
Cumulative
Cost to Date
(D + E)
|
Estimated
Cost to
Complete
|
Estimated Cost at Completion
(F + G)
|
Negotiated Contract Amount
|
Variance (Over or Under) (I - H)
|
|||||
Negotiated
|
Actual
|
||||||||||||
A
|
B
|
C
|
D
|
E
|
F
|
G
|
H
|
I
|
J
|
||||
|
Purpose
.
This Quarterly Financial Report is designed to: (1) provide a management tool for use by be BARDA in monitoring the application of financial and personnel resources to the BARDA contracts; (2) provide contractors with financial and personnel management data which is usable in their management processes; (3) promptly indicate potential areas of contract underruns or overruns by making possible comparisons of actual performance and projections with prior estimates on individual elements of cost and personnel; and (4) obtain contractor's analyses of cause and effect of significant variations between actual and prior estimates of financial and personnel performance.
|
(1)
|
Key
Personnel.
Include key personnel regardless of annual salary rates. All such individuals should be listed by names and job titles on a separate line including those whose salary is not directly charged to the contract but whose effort is directly associated with the contract. The listing must be kept up to date.
|
(2)
|
Personnel--Other.
List as one amount unless otherwise required by the contract.
|
(3)
|
Fringe
Benefits.
Include allowances and services provided by the contractor to employees as compensation in addition to regular salaries and wages. If a fringe benefit rate(s) has been established, identify the base, rate, and amount billed for each category. If a rate has not been established, the various fringe benefit costs may be required to be shown separately. Fringe benefits which are included in the indirect cost rate should not be shown here.
|
(4)
|
Accountable
Personal
Property.
Include nonexpendable personal property with an acquisition cost of $1,000 or more and with an expected useful life of two or more years, and sensitive items regardless of cost. Form HHS 565, "Report of Accountable Property," must accompany the contractor's public voucher (SF 1034/SF 1035) or this report if not previously submitted. See "Contractor's Guide for Control of Government Property."
|
(5)
|
Supplies.
Include the cost of supplies and material and equipment charged directly to the contract, but excludes the cost of nonexpendable equipment as defined in (4) above.
|
(6)
|
Inpatient
Care.
Include costs associated with a subject while occupying a bed in a patient care setting. It normally includes both routine and ancillary costs.
|
(7)
|
Outpatient
Care.
Include costs associated with a subject while not occupying a bed. It normally includes ancillary costs only.
|
(8)
|
Travel.
Include all direct costs of travel, including transportation, subsistence and miscellaneous expenses. Travel for staff and consultants shall be shown separately. Identify foreign and domestic travel separately. If required by the contract, the following information shall be submitted: (i) Name of traveler and purpose of trip; (ii)
|
(9)
|
Consultant
Fee.
Include fees paid to consultant(s). Identify each consultant with effort expended, billing rate, and amount billed.
|
(10)
|
Premium
Pay.
Include the amount of salaries and wages over and above the basic rate of pay.
|
(11)
|
Subcontracts.
List each subcontract by name and amount billed.
|
(12)
|
Other
Costs.
Include any expenditure categories for which the Government does not require individual line item reporting. It may include some of the above categories.
|
(13)
|
Overhead/Indirect
Costs.
Identify the cost base, indirect cost rate, and amount billed for each indirect cost category.
|
(14)
|
General
and
Administrative
Expense.
Cite the rate and the base. In the case of nonprofit organizations, this item will usually be included in the indirect cost.
|
(15)
|
Fee.
Cite the fee earned, if any.
|
(16)
|
Total Costs to the Government.
|
2.
|
3.
|
6.
|
|
In order to meet this Principle, the scheduling of the scope of work in work packages or activities need to incorporate measurable units or milestones in order to objectively assess accomplishments or obtain what we call “earned value”. These units or milestones are given a value based on labor resources needed to accomplish the work (which becomes the Budgeted Cost of Work Scheduled or BCWS). When they are accomplished (known as Budgeted Cost of Work Performed or BCWP) they receive the value associated with the budget which measures progress.
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Schedule status to measure progress needs to be on at least on a monthly basis although it is preferred on a bi-weekly basis. As part of the status process progress dates, such as actual start/complete and forecast start/complete need to be updated.
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Since Microsoft Project seems to be the schedule tool of choice by most contractors, there are four types of earned value methodologies utilized by Microsoft Project of which two assess progress by the completion of milestones and they are the 50/50 and 0/100 methodologies. In both cases, progress is reported for completion milestones and in the 50/50 methodology fifty percent of the value of the work package/activity is credited for starting the work. The other two earned value methodologies are assessed percent complete (also know as Supervisor’s Estimate) and level of effort (LOE). All four methodologies are legitimate earn value measurement techniques.
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Additional earned value methodologies, such as the weighted milestone methodology and percent complete with milestone gates may be utilized. The weighted milestone method allows value to be earned based on the resource value in each month, which eliminates artificial schedule variances.
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For subcontractors that have a fixed price contract with the prime contractor, the expectation is that there will be no cost variance. The ACWP reported on the CPR will equal the BCWP earned, regardless of the payment schedule with subcontractor.
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It is also recommended that the To-Complete Performance Index (TCPI) be included in the Control Account Manager performance report. The TCPI is a valuable index that calculates the cost performance the control account needs to perform at in order to complete the work within the current reported EAC. When the TCPI is compared against the cumulative CPI it gives a good indication whether or not the current EAC is reasonable. For example, if a cumulative CPI is .85 and the TCPI calculates to equal 1.15 that is the performance factor that work would need to perform at in order to meet the current EAC. If the cumulative CPI is .85 then it can be determined that the current EAC might not be reasonable. It allows management and Project Controls the opportunity to question the Control Account Manager as to the validity of the current EAC. As a rule in thumb if the deviation between the CPI and the TCPI is greater than .2 then the CAM should reassess the control account EAC.
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These reports, which should be provided monthly, should also include the current Budget at Completion (BAC) and the current Estimate at Completion (EAC). In addition, it would be a
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For all variances that exceed the contractual variance threshold will include a description of what caused the variance, impact to the control account and the program, and a corrective action.
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Providing an updated EAC is a prime concern of the customer and the contractor. Therefore a robust EAC process should be in place whether the program is ANSI compliant or not.
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Based on the performance to date the Estimates at Completion can be updated on a monthly basis by the Control Account Manager in the scheduling tool during the status process or in the cost/EVM tool at the end of the month’s process prior to submittal of the EVM report. The EAC is an element of the performance measurement system that needs to accurately reflect the contractor’s best estimate of what it will cost to complete the project.
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Program management should be able to validate control account manager’s EACs by looking at performance indices, such as the To-Complete Performance Index, as well as independent statistical EACs.
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One of the key areas that concerns government Program Management Offices (PMO) is the level of importance that contractor’s place on EVM as a management tool. During a site visit, such as conducting an Integrated Baseline Review, the PMO gauges what the interest, knowledge, and most importantly, the usage of the performance measurement data in managing the program.
They want to know that the managers on the program, including the program manager, have received some earned value training. The level of involvement and use of the EVM data to manage their schedule, cost and technical issues is ascertained by questions. The PMO can also tell by how robust the EACs are and if the variance narratives are being written with impacts to the program and corrective actions being monitored by the contractor. It is important that the contractor’s management team, including the Program Manager, utilize the data from the performance measurement system as a management tool. They should be knowledgeable and understand the data. They should know what is causing the variances and ensure that the variance narratives are written properly and answer what the issues, impacts and corrective actions are. They should be able to demonstrate that they use the information to assist them in the management decision process.
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Actual Cost of Work Performed (ACWP)
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The costs actually applied and recorded in accomplishing the work performed within a specified period.
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Actual Direct Cost
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Those costs identified specifically with a contract, based upon the contractor's cost identification and accumulation system as accepted by the cognizant DCAA representatives. (See Direct Costs).
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Advance Agreement (AA)
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An agreement between the contractor and the Contract Administration Office concerning the application of an approved earned value management system to contracts within the affected facility.
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Authorized Work
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That effort which has been authorized and is on contract, or that for which authorized contract costs have not been agreed to but for which written authorization has been received.
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Cost Performance Index (CPI)
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An efficiency rating reflecting a project's budget performance - either over or under. Measured as a ratio of the budgeted value of work accomplished versus the actual costs expended for a given project time period. The formula for CPI is BCWP/ACWP.
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Discrete Effort
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Program effort that has a measurable output, product or service.
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Direct Costs
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Those costs (labor, material, etc.) that can be reasonably and consistently related directly to service performed on a unit of work, and are charged directly to the contract, without distribution to an overhead unit.
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Earned Value
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See Budgeted Cost for Work Performed (BCWP)
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Earned Value Management System (EVMS)
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A project management system utilized for measuring project progress in an objective manner. Combines measurements of scope, schedule, and cost in a single integrated system.
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Estimate at Completion (EAC)
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A value (expressed in dollars and/or hours) developed to represent a realistic appraisal of the final cost of tasks when accomplished. It’s the sum of direct & indirect costs to date plus the estimate of costs for all authorized Work remaining. The EAC = ACWP + the Estimate-to-Complete.
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Estimate to Completion (ETC)
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A value (expressed in dollar and/or hours) developed to represent a realistic appraisal of the cost of the work still required to be accomplished in completing a task.
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Indirect Costs
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Represents those costs, because they are incurred for common or joint objectives, are not readily subject to
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product process result. It is measured only in terms of resources actually consumed within a given time period.
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Management Reserve (MR)
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An amount of the total Contract Budget Base (CBB) withheld for management control purposes rather than designated for the accomplishment of a specific task or set of tasks. It is not a part of the Performance Measurement Baseline.
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Negotiated Contract Target Cost
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The estimated cost negotiated in a Cost Plus Award Fee (CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive Fee (CPIF) or Fixed Price Incentive Fee (FPIF) contract.
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Original Budget
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The budget established at, or near, the time the contract was signed, based on the negotiated contract cost.
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Overhead
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Indirect labor and material, supplies and services costs and other charges, which cannot be consistently identified with individual programs.
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Other Direct Costs
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A group of accounting elements which can be isolated to specific tasks, other than labor and material. Included in ODC are such items as travel, computer time, and services
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Performance Measurement Baseline (PMB)
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The time-phased budget plan against which contract performance is measured. It is formed by the budgets assigned to scheduled Control Accounts and the allocation of overhead costs. For future effort, not planned to the Control Account level, the performance measurement baseline also includes budgets assigned to higher level WBS elements, and undistributed budgets. It equals the total assigned budget less management reserve.
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Performing Organization
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A defined unit within the program organization structure, which applies the resources to performs the authorized scope
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of work.
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Planning Package
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A logical aggregation of far term work within a Control Account that can be identified and budgeted but not yet defined into Work Packages.
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Reprogramming
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Replanning of the effort remaining in the contract, resulting in a new budget allocation which exceeds the contract budget base. The resulting baseline is called an Over Target Baseline (OTB).
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Responsible Organization
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A defined unit within program’s organization structure that is assigned responsibility for accomplishing specific tasks.
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Risk Register
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Is a tool commonly used in project planning and organizational risk assessments. It is often referred to as a Risk Log. It is used for identifying, analyzing and managing risks.
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Schedule Performance Index (SPI)
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An efficiency rating reflecting how quickly or slowly project work is progressing. Measured as a ratio of work accomplished versus work planned for a given period of time. The formula for SPI is BCWP/BCWS.
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Significant Variances
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Those differences between planned and actual cost and schedule performance which require further review, analysis, or action. Appropriate thresholds are established as to the magnitude of variances which will require variance analysis.
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Statistical Estimate at Completion
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Is a single point estimate that can be quickly prepared and used to test the reasonableness of the current cost estimates and budget and to indicate when a comprehensive EAC should be prepared
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·
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Implementation costs should range $75K-$125K
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Implementation costs should range ($50K - $100K)
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We will conduct a thorough evaluation of the cardiac effect of Panaceomycin Injection via a randomized, double-blind crossover study. A total of 100 participants (18-22 per arm) will randomize to one of five study arms to receive in a double-blind fashion a single IV infusion of either Panaceomycin Injection 10 mg/kg, Panaceomycin Injection at a supra-therapeutic dose, ciprofloxacin (positive control), or placebo. 12-Lead digital ECGs will be collected in triplicate via Holter monitor from each participant during dosing. Seven days after dosing, participants will be re-randomized to receive another treatment. ECGs will be collected and analyzed. A full statistical analysis and expert ECG report will be generated. Serum PK samples will also be collected at ECG collection time points and analyzed to confirm exposure.
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1.
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I have reviewed this quarterly report on Form 10-Q of BioCryst Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b)
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 8, 2015
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/s/ JON P. STONEHOUSE
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Jon P. Stonehouse
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President and Chief Executive Officer
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1.
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I have reviewed this quarterly report on Form 10-Q of BioCryst Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 8, 2015
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/s/ THOMAS R. STAAB, II
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Thomas R. Staab, II
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Senior Vice President, Chief Financial Officer and Treasurer
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
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/s/ Jon P. Stonehouse
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Jon P. Stonehouse
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President and Chief Executive Officer
Date: May 8, 2015
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
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/s/ Thomas R. Staab, II
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Thomas R. Staab, II
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Senior Vice President, Chief Financial Officer and Treasurer
Date: May 8, 2015
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