þ | Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
o | Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. |
DELAWARE | 62-1413174 | |
(State of other jurisdiction of
incorporation or organization) |
(I.R.S. employer identification no.) |
Title of each class | Name of each exchange on which registered | |
Common Stock, $.01 Par Value | The NASDAQ Global Market |
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Develop or License Inhibitors that are Promising Candidates for Commercialization.
We test
multiple compounds to identify those that are most promising for clinical development. We base
our selection of promising development candidates on desirable product characteristics, such
as initial indications of safety and efficacy. We believe that this focused strategy allows us
to eliminate unpromising candidates from consideration sooner without incurring substantial
clinical costs. In addition, our preference is to select drug candidates on the basis of their
potential for relatively efficient Phase I and Phase II clinical trials that require fewer
patients to initially indicate safety and efficacy. We will consider, however, more complex
candidates with longer development cycles if we believe that they offer promising commercial
opportunities.
Select and License Promising Enzyme Targets for the Discovery of Small-Molecule
Pharmaceuticals.
We use our technical expertise and network of academic and industry contacts
to evaluate and select promising enzyme targets to license for the discovery of small-molecule
pharmaceuticals. We choose enzyme targets that meet as many of the following criteria as
possible:
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serve important functions in disease pathways;
have known animal or cell-based models that would be indicative of results in humans;
address large potential markets or niche areas with significant unmet medical need; and
have multiple potential clinical applications.
Focus on High Value-Added Structure-Based Drug Design Technologies.
We focus our drug
discovery activities and expenditures on applications of structure-based drug design
technologies to design and develop drug candidates. Structure-based drug design is a process
by which we design a drug candidate through detailed analysis of the enzyme target, which the
drug candidate must inhibit in order to stop the progression of the disease or disorder. We
believe that structure-based drug design is a powerful tool for efficient development of
small-molecule drug candidates that have the potential to be safe, effective and relatively
inexpensive to manufacture. Our structure-based drug design technologies typically allow us to
design and synthesize multiple drug candidates that inhibit the same enzyme target. We believe
this strategy can lead to broad patent protection and enhance the competitive advantages of
our compounds.
Entering Into Relationships with Academic Institutions.
Many academic institutions perform
extensive research on the molecular and structural biology of potential drug development
targets. When we believe that an opportunity is beneficial for BioCryst we may enter into
relationships with academic institutions. We will consider each opportunity and whether or
not the relationship will significantly reduce the time, cost and risks involved in drug
development. An example of such a collaborative relationship is the arrangement that we have
with Albert Einstein College of Medicine of Yeshiva University (AECOM) and Industrial
Research Limited (IRL) who are the licensors of our PNP inhibitor programs.
Developing Drug Candidates or Licensing Them to Other Parties.
We generally plan to advance
drug candidates through initial and/or early-stage drug development. We prefer to retain full
product rights to our drug candidates within specialty markets, while relying on collaborative
arrangements with third parties or drug candidates within larger markets or outside our area
of expertise. For larger disease indications or those outside our area of expertise, our
strategy is to license drug candidates to pharmaceutical or biotechnology partners for
collaborative development and global marketing. We believe partnerships are a good source of
development payments, license fees, future event payments and royalties. They also reduce the
costs and risks, and increase the effectiveness, of late-stage product development, regulatory
approval, manufacturing and marketing. We are willing to license a drug candidate to a partner
during any stage of the development process we determine to be beneficial to us and to the
ultimate development and commercialization of that drug candidate.
Program and Candidate Disease
Category/Indication
Delivery Form
Development Stage
Rights
BioCryst (U.S.)/Mundipharma
Oral
Pivotal
(EU, Australia, Asia)
Oral
Phase II
i.v.
Pivotal
BioCryst (U.S.)
i.v.
Filed
Shionogi
(East Asia)/Green Cross (Korea)
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Program and Candidate Disease
Category/Indication
Delivery Form
Development Stage
Rights
Oral
Phase II
BioCryst
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delays;
warning letters;
fines;
product recalls or seizures;
injunctions;
penalties;
refusal of the FDA to review pending market approval applications or supplements to
approval applications;
total or partial suspension of production;
civil penalties;
withdrawals of previously approved marketing applications; and
criminal prosecutions.
willingness of investigators to participate in a study;
ability of clinical sites to obtain approval from their IRB;
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the availability of the required number of eligible subjects to be enrolled in a given
trial;
the availability of existing or other experimental drugs for the disease we intend to
treat;
the willingness of patients to participate; and
the patients meeting the eligibility criteria.
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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;
difficulty in maintaining 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 drug product for
our trials; and
delays or changes in requirements by governmental agencies.
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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;
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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 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 are 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
any future revenue directly from product sales would depend on our ability to
successfully complete clinical studies, obtain regulatory approvals, manufacture, market
and commercialize any approved drugs.
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discovery of compounds that cause or enable biological reactions necessary for the
progression of the disease or disorder, called enzyme targets;
licensing or design of enzyme inhibitors for development as drug 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 drug
products and the drug products to be used in both our clinical trials and toxicology
studies.
the peramivir i.v. currently in clinical development may not prove to be safe and
sufficiently effective for market approval in the United States or other major markets;
necessary government or other third party funding and clinical testing for further
development of peramivir may not be available timely, at all, or in sufficient amounts;
the flu prevention or pandemic treatment concerns may not materialize at all, or in the
near future;
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advances in flu vaccines or other antivirals, including competitive i.v. antivirals,
could substantially replace potential demand for peramivir;
any substantial demand for pandemic or seasonal flu treatments may occur before
peramivir can be adequately developed and tested in clinical trials;
peramivir may not prove to be accepted by patients and physicians as a treatment for
seasonal influenza compared to the other currently marketed antiviral drugs, which would
limit revenue from non-governmental entities;
numerous large and well-established pharmaceutical and biotech companies will be
competing to meet the market demand for flu drugs and vaccines;
the only major markets in which patents relating to peramivir have issued or been
allowed are the United States, Canada, Japan, Australia and many contracting and extension
states of the European Union, while no patent applications or issued patents for peramivir
exist in other potentially significant markets;
regulatory authorities may not make needed accommodations to accelerate the drug
testing and approval process for peramivir; and
in the next few years, it is expected that a limited number of governmental entities
will be the primary potential customers for peramivir and if we are not successful at
marketing peramivir to these entities for any reason, we will not receive substantial
revenues from stockpiling orders from these entities.
inconsistent production yields;
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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;
potential impurities in our drug substance or drug 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 with regulations and specifications set forth by the FDA or other
foreign regulatory agencies.
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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.
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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;
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if and when patents will issue;
if patents do issue we can not 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
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the diversion of managements 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;
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;
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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.
the initiation, timing, progress and results of our preclinical testing, clinical
trials, and other research and development efforts;
the potential funding from our contract with HHS for the development of peramivir;
the potential for a stockpiling order or profit from any order for peramivir;
the potential use of peramivir as a treatment for H1N1 flu (or other strains of flu);
the further preclinical or clinical development and commercialization of our product
candidates, including peramivir, forodesine and other PNP inhibitor and hepatitis C
development programs;
the implementation of our business model, strategic plans for our business, product
candidates and technology;
our ability to establish and maintain collaborations;
plans, programs, progress and potential success of our collaborations, including
Mundipharma for forodesine and Shionogi and Green Cross for peramivir;
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, future revenues, capital requirements and our needs for
additional financing;
the timing or likelihood of regulatory filings and approvals;
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our financial performance; and
competitive companies, technologies and our industry.
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36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
2009
2008
Low
High
Low
High
$
1.15
$
2.37
$
2.81
$
6.53
1.65
4.99
2.58
4.98
3.65
13.47
2.40
3.60
5.55
12.70
.85
3.18
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Indexed Comparison Since 2004
Beginning
Investment
Investment
Investment
Investment
Investment
Investment
12/31/04
at 12/31/05
at 12/31/06
at 12/31/07
at 12/31/08
at 12/31/09
$
100.00
$
289.79
$
200.00
$
106.92
$
23.70
$
111.76
100.00
102.13
112.20
121.67
58.64
84.28
100.00
110.12
107.79
113.35
105.47
118.52
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Approximate
Dollar Value
of Shares
Total Number of
That May
Total
Shares Purchased
Yet Be
Number of
Average
as Part of Publicly
Purchased Under
Shares
Price Paid
Announced Plans
the Plans or
Purchased
(1)
Per Share
or Programs
Programs
$
24,072
6.46
24,072
(1)
Amounts represent shares of common stock delivered to us as payment of withholding
taxes due on the vesting of restricted stock issued under our Stock Incentive Plan.
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Years Ended December 31,
(In thousands, except per share data)
2009
2008
2007
2006
2005
$
74,589
$
56,561
$
71,238
$
6,212
$
152
72,301
73,327
94,052
47,083
23,642
(13,452
)
(24,732
)
(29,055
)
(43,618
)
(26,099
)
$
(0.35
)
$
(0.65
)
$
(0.89
)
$
(1.50
)
$
(1.01
)
38,926
38,062
32,771
29,147
25,721
As of December 31,
(In thousands)
2009
2008
2007
2006
2005
$
94,259
$
63,314
$
85,009
$
46,236
$
59,988
142,190
84,692
142,717
68,485
99,248
18,441
20,937
49,694
36,596
29,426
(262,719
)
(249,268
)
(224,536
)
(195,481
)
(151,863
)
86,266
46,426
64,905
21,155
58,440
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FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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other collaborative and other research and development agreements;
government grants;
equipment lease financing;
facility leases;
research grants; and
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interest income.
payments under our contract with HHS;
our existing capital resources and interest earned on that capital;
payments under collaborative and licensing agreements with corporate partners; and
lease or loan financing and future public or private financing.
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our ability to perform under the contract with HHS and receive reimbursement;
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 drug 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
evaluate drug candidates;
our ability to engage sites and enroll subjects in our clinical trials;
the scope of manufacturing of our drug candidates to support our preclinical research
and clinical trials;
increases in personnel and related costs to support the development of our drug
candidates;
the scope of manufacturing of our drug substance and drug products required for future
NDA filings;
competitive and technological advances;
the time and costs involved in obtaining regulatory approvals; 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.
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Payments due by period
Less than
More than
Contractual Obligations
Total
1 year
1-3 years
3-5 years
5 years
$
4,349,863
$
565,357
$
1,725,003
$
1,771,073
$
288,430
36,856,315
36,856,315
$
41,206,178
$
37,421,672
$
1,725,003
$
1,771,073
$
288,430
(1)
Purchase obligations include commitments related to clinical development, manufacturing and
research operations and other purchase commitments.
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fees paid to contract research organizations 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 service fees.
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Year ended December 31,
2009
2008
2007
$
10.3
$
15.9
$
19.4
36.8
21.5
50.3
2.5
9.0
0.2
2.1
3.5
12.3
12.9
11.4
1.2
2.9
1.9
2.0
2.2
1.4
7.2
6.8
6.0
$
72.3
$
73.3
$
94.1
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ABOUT MARKET RISK.
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December 31,
2009
2008
$
41,124,937
$
22,342,058
625,000
27,838,812
39,186,404
33,722,207
11,982,430
6,281,263
1,055,712
1,136,842
374,221
376,972
111,022,152
75,024,706
24,670,060
1,786,034
3,871,653
4,880,475
2,626,241
3,000,462
$
142,190,106
$
84,691,677
$
18,069,767
$
5,265,947
15,794,800
8,442,398
839,362
794,375
52,537
40,000
2,496,534
2,565,285
37,253,000
17,108,005
230,145
220,000
18,440,911
20,937,445
439,068
382,751
348,571,914
295,207,583
(25,783
)
103,507
(262,719,149
)
(249,267,614
)
86,266,050
46,426,227
$
142,190,106
$
84,691,677
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Years Ended December 31,
2009
2008
2007
$
22,922,508
$
$
51,666,811
56,561,369
71,237,901
74,589,319
56,561,369
71,237,901
4,543,914
72,301,442
73,326,634
94,051,996
11,481,187
10,399,227
9,465,962
88,326,543
83,725,861
103,517,958
(13,737,224
)
(27,164,492
)
(32,280,057
)
285,689
2,432,922
3,224,533
$
(13,451,535
)
$
(24,731,570
)
$
(29,055,524
)
$
(0.35
)
$
(0.65
)
$
(0.89
)
38,925,525
38,062,131
32,770,923
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Accumulated
Additional
Other
Total Stock-
Common
Paid-in
Comprehensive
Accumulated
holders
Comprehensive
Stock
Capital
(Loss) Income
Deficit
Equity
Loss
$
292,488
$
216,310,578
$
32,463
$
(195,480,520
)
$
21,155,009
(29,055,524
)
(29,055,524
)
$
(29,055,524
)
345,594
345,594
345,594
$
(28,709,930
)
600
(600
)
83,155
65,034,937
65,118,092
3,080
1,378,098
1,381,178
349
269,328
269,677
5,691,028
5,691,028
379,672
288,683,369
378,057
(224,536,044
)
64,905,054
(24,731,570
)
(24,731,570
)
$
(24,731,570
)
(274,550
)
(274,550
)
(274,550
)
$
(25,006,120
)
765
(765
)
1,465
397,634
399,099
849
266,691
267,540
5,860,654
5,860,654
382,751
295,207,583
103,507
(249,267,614
)
46,426,227
(13,451,535
)
(13,451,535
)
$
(13,451,535
)
(129,290
)
(129,290
)
(129,290
)
$
(13,580,825
)
5,324
2,111,676
2,117,000
50,000
45,690,190
45,740,190
1,234
192,846
194,080
(241
)
(155,264
)
(155,505
)
5,524,883
5,524,883
$
439,068
$
348,571,914
$
(25,783
)
$
(262,719,149
)
$
86,266,050
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Years Ended December 31,
2009
2008
2007
$
(13,451,535
)
$
(24,731,570
)
$
(29,055,524
)
1,612,514
1,625,878
1,369,713
5,524,883
5,860,654
5,691,028
(21,739,777
)
27,145,246
(34,571,531
)
(6,281,263
)
81,130
(188,402
)
(274,682
)
376,972
8,960,709
1,361,824
20,201,209
(8,956,613
)
15,424,180
22,682
260,000
(2,565,285
)
(30,849,722
)
15,057,193
(16,218,470
)
(20,873,820
)
(24,997,799
)
(603,692
)
(1,212,274
)
(3,343,827
)
(625,000
)
(54,103,222
)
(124,459,834
)
(62,907,146
)
42,437,498
137,066,027
51,217,617
(12,894,416
)
11,393,919
(15,033,356
)
45,740,190
65,118,092
2,117,000
399,099
1,381,178
194,080
267,540
269,677
(155,505
)
47,895,765
666,639
66,768,947
18,782,879
(8,813,262
)
26,737,792
22,342,058
31,155,320
4,417,528
$
41,124,937
$
22,342,058
$
31,155,320
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Gross
Gross
Unrealized
Unrealized
Estimated Fair
Amortized Cost
Accrued Interest
Gains
Losses
Value
$
21,757,640
$
35,603
$
19,103
$
(17,500
)
$
21,794,846
14,544,257
67,919
9,755
(9,915
)
14,612,016
10,635,360
106,851
7,852
(35,361
)
10,714,702
4,090,727
1,285
(455
)
4,091,557
1,293,956
2,342
(547
)
1,295,751
$
52,321,940
$
212,715
$
37,995
$
(63,778
)
$
52,508,872
2009
2008
$
27,838,812
$
39,186,404
19,819,148
1,786,034
4,850,912
$
52,508,872
$
40,972,438
Billed
Unbilled
Total
$
11,521,378
$
18,673,947
$
30,195,325
1,344,040
1,344,040
1,065,000
692,824
1,757,824
425,018
425,018
$
14,355,436
$
19,366,771
$
33,722,207
Table of Contents
$
1,187,415
5,093,848
3,968,406
(3,968,406
)
$
6,281,263
Table of Contents
2009
2008
2007
$
22,500,000
$
$
397,508
25,000
22,922,508
37,866,792
21,779,745
55,449,095
10,415,490
2,007,924
8,515,714
3,142,818
4,615,448
5,298,271
27,783,252
1,898,403
241,711
375,000
76,418
51,666,811
56,561,369
71,237,901
$
74,589,319
$
56,561,369
$
71,237,901
Table of Contents
Table of Contents
2009
2008
$
588,407
$
535,994
1,383,829
1,126,282
1,318,409
1,116,661
6,989,960
6,973,158
62,712
62,712
6,175,698
6,100,516
16,519,015
15,915,323
(12,647,362
)
(11,034,848
)
$
3,871,653
$
4,880,475
2009
2008
$
12,471,204
$
6,479,546
470,703
486,047
162,265
138,237
2,111,073
1,011,739
579,555
326,829
$
15,794,800
$
8,442,398
$
565,357
853,672
871,331
872,729
898,344
288,430
$
4,349,863
Table of Contents
2009
2008
$
76,907,534
$
68,863,295
32,115,994
32,972,811
1,224,636
1,101,002
1,606,813
997,073
813,383
7,262,703
8,097,958
3,953,281
3,079,952
124,068,034
114,928,401
(124,068,034
)
(114,928,401
)
$
$
Table of Contents
Table of Contents
Weighted
Awards
Options
Average
Available
Outstanding
Exercise Price
820,754
3,952,568
$
8.94
1,200,000
(1,721,706
)
1,721,706
9.51
(50,000
)
(308,037
)
4.48
342,979
(342,979
)
12.02
592,027
5,023,258
9.20
1,200,000
(1,060,005
)
1,060,005
3.38
(76,536
)
(146,470
)
2.72
459,144
(459,144
)
8.53
1,114,630
5,477,649
8.30
1,540,000
(1,559,233
)
1,559,233
2.02
(532,379
)
3.98
677,975
(677,975
)
12.04
1,773,372
5,826,528
6.58
Table of Contents
2009
2008
2007
5.6
5.5
5.7
104.2
%
78.4
%
74.5
%
0.0
%
0.0
%
0.0
%
2.1
%
2.8
%
4.6
%
Outstanding
Exercisable
Weighted
Weighted
Weighted
Average
Average
Average
Remaining
Exercise
Exercise
Range
Number
Life
Price
Number
Price
1,660,746
8.4
$
1.38
232,674
$
1.30
1,072,554
7.0
3.65
746,015
3.79
1,326,091
5.7
8.09
1,060,760
8.21
882,570
7.1
11.37
621,284
11.37
860,280
6.7
12.53
713,787
12.53
5,167
6.0
15.58
5,062
15.57
2,000
6.1
18.99
1,958
18.99
5,000
0.3
23.75
5,000
23.75
6,120
0.2
26.05
6,120
26.05
6,000
0.4
29.29
6,000
29.29
5,826,528
7.0
6.58
3,398,660
8.36
Table of Contents
Table of Contents
Table of Contents
Table of Contents
First
Second
Third
Fourth
$
4,359
$
4,787
$
10,548
$
54,895
(9,292
)
(8,684
)
(10,627
)
15,151
(.24
)
(.23
)
(.28
)
.37
$
10,768
$
2,659
$
8,894
$
34,240
(13,098
)
(12,709
)
(8,995
)
10,070
(.34
)
(.33
)
(.24
)
.26
Table of Contents
Table of Contents
BioCryst Pharmaceuticals, Inc.
March 9, 2010
Table of Contents
BioCryst Pharmaceuticals, Inc.
March 9, 2010
Table of Contents
ON ACCOUNTING AND FINANCIAL DISCLOSURE
Table of Contents
OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Table of Contents
Page in
Form 10-K
51
52
53
54
55
70
71
(b)
Exhibits.
See Index of Exhibits.
Table of Contents
BIOCRYST PHARMACEUTICALS, INC.
By:
/s/ Jon P. Stonehouse
Jon P. Stonehouse
Chief Executive Officer
Signature
Title(s)
President, Chief Executive Officer and Director
Senior Vice President and Chief Financial Officer and Treasurer
Controller and Principal Accounting Officer
Director
Director
Director
Director
Director
Director
Director
Table of Contents
Number
Description
Third Restated Certificate of Incorporation of Registrant. Incorporated
by reference to Exhibit 3.1 to the Companys Form 8-K filed December
22, 2006.
Certificate of Amendment to the Third Restated Certificate of
Incorporation of Registrant. Incorporated by reference to Exhibit 3.1
to the Companys Form 8-K filed July 24, 2007.
Certificate of Increase of Authorized Number of Shares of Series B
Junior Participating Preferred Stock. Incorporated by reference to
Exhibit 3.1 to the Companys Form 8-K filed November 4, 2008.
Amended and Restated Bylaws of Registrant effective October 29, 2008.
Incorporated by reference to Exhibit 3.2 to the Companys Form 8-K
filed November 4, 2008.
Rights Agreement, dated as of June 17, 2002, by and between the Company
and American Stock Transfer & Trust Company, as Rights Agent, which
includes the Certificate of Designation for the Series B Junior
Participating Preferred Stock as Exhibit A and the form of Rights
Certificate as Exhibit B. Incorporated by reference to Exhibit 4.1 to
the Companys Form 8-A filed June 17, 2002.
Amendment to Rights Agreement, dated as of August 5, 2007. Incorporated
by reference to Exhibit 4.2 of the Companys Form 10-Q filed August 9,
2007.
Stock Incentive Plan, as amended and restated effective February 28,
2008. Incorporated by reference to Appendix A to the Companys
Definitive Proxy Statement, filed April 16, 2008.
Employee Stock Purchase Plan, as amended and restated effective
February 28, 2008. Incorporated by reference to Appendix B to the
Companys Definitive Proxy Statement, filed April 16, 2008.
Retention Bonus Agreement between BioCryst Pharmaceuticals, Inc. and
Stuart Grant dated May 21, 2008. Incorporated by reference to Exhibit
10.25 of the Companys Form 10-Q filed August 8, 2008.
Retention Bonus Agreement between BioCryst Pharmaceuticals, Inc. and
David McCullough dated May 21, 2008. Incorporated by reference to
Exhibit 10.26 of the Companys Form 10-Q filed August 8, 2008.
Employment Letter Agreement between BioCryst Pharmaceuticals, Inc. and
William P. Sheridan dated June 12, 2008. Incorporated by reference to
Exhibit 10.27 of the Companys Form 10-Q filed August 8, 2008.
Consulting Agreement between BioCryst Pharmaceuticals, Inc. and J.
Claude Bennett, M.D. dated June 13, 2008. Incorporated by reference to
Exhibit 10.28 of the Companys Form 10-Q filed August 8, 2008.
Agreement dated January 3, 2007, between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services, as amended by
Amendment number 1 dated January 3, 2007 and Amendment number 2 dated
May 11, 2007. (Portions omitted pursuant to request for confidential
treatment.) Incorporated by reference to Exhibit 10.3 to the Companys
Form 10-Q filed August 9, 2007.
Amendment #3 to the Agreement between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services, dated October 2, 2007.
Incorporated by reference to Exhibit 10.6 of the Companys Form 10-K
filed March 4, 2008.
Amendment #4 to the Agreement between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services dated April 3, 2008.
Incorporated by reference to Exhibit 10.29 of the Companys Form 10-Q
filed August 8, 2008.
Amendment #5 to the Agreement between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services dated July 2, 2008.
Incorporated by reference to Exhibit 10.30 of the Companys Form 10-Q
filed August 8, 2008.
Amendment #6 to the Agreement between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services dated August 18, 2008.
Incorporated by reference to Exhibit 10.1 of the
Table of Contents
Number
Description
Companys Form 8-K
filed November 7, 2008.
Amendment #7 to the Agreement between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services dated November 17,
2008. Incorporated by reference to Exhibit 10.12 of the Companys Form
10-K filed March 6, 2009.
Amendment #8 to the Agreement between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services dated March 13, 2009.
Amendment #9 to the Agreement between BioCryst Pharmaceuticals, Inc.
and the Department of Health and Human Services dated September 18,
2009. Incorporated by reference to Exhibit 10.1 of the Companys Form
10-Q filed November 6, 2009.
Amendment #10 to the Agreement between the Company and the U.S.
Department of Health & Human Services, dated October 15, 2009.
Incorporated by reference to Exhibit 10.2 of the Companys Form 10-Q
filed November 6, 2009.
Order for Supplies or Services from the U.S. Department of Health &
Human Services, dated November 4, 2009.
Annual Incentive Plan. Incorporated by reference to Exhibit 10.1 of the
Companys Form 10-K filed March 4, 2008.
Executive Relocation Policy. Incorporated by reference to Exhibit 10.2
of the Companys Form 10-K filed March 4, 2008.
Amendment to Employment Letter Agreement for Stuart Grant Dated July
23, 2007. Incorporated by reference to Exhibit 10.3 of the Companys
Form 10-K filed March 4, 2008.
Form of Notice of Grant of Non-Employee Director Automatic Stock Option
and Stock Option Agreement. Incorporated by reference to Exhibit 10.4
of the Companys Form 10-K filed March 4, 2008.
Form of Notice of Grant of Stock Option and Stock Option Agreement.
Incorporated by reference to Exhibit 10.5 of the Companys Form 10-K
filed March 4, 2008.
License, Development and Commercialization Agreement dated as of
February 28, 2007, by and between the Company and Shionogi & Co., Ltd.
Incorporated by reference to Exhibit 10.4 to the Companys Form 10-Q
filed May 10, 2007. (Portions omitted pursuant to request for
confidential treatment.)
First Amendment to License, Development and Commercialization
Agreement, effective as of September 30, 2008, between the Company and
Shionogi & Co., Ltd. Incorporated by reference to Exhibit 10.19 to the
Companys Form 10-K filed March 6, 2009. (Portions omitted pursuant to
request for confidential treatment.)
Employment Letter Agreement dated April 2, 2007, by and between the
Company and David McCullough. Incorporated by reference to Exhibit 10.5
to the Companys Form 10-Q filed May 10, 2007.
Amended and Restated Employment Letter Agreement dated February 14,
2007, by and between the Company and Jon P. Stonehouse. Incorporated by
reference to Exhibit 10.12 to the Companys Form 10-K for the year
ended December 31, 2006, filed March 14, 2007.
Warehouse Lease dated July 12, 2000 between RBP, LLC an Alabama Limited
Liability Company and the Registrant for office/warehouse space.
Incorporated by reference to Exhibit 10.8 to the Companys Form 10-Q
for the second quarter ending June 30, 2000 filed August 8, 2000.
Third Amendment to Lease Agreement dated August 7, 2007, by and between
Riverchase Capital LLC, a Florida limited liability company, Stow
Riverchase, LLC, a Florida limited liability company, as successor
landlord to RBP, LLC and the Company. Incorporated by reference to
Exhibit 10.4 of the
Table of Contents
Number
Description
Companys Form 10-Q filed August 9, 2007.
Stock and Warrant Purchase Agreement dated as of August 6, 2007, by and
among BioCryst Pharmaceuticals, Inc. and each of the Investors
identified on the signature pages thereto. Incorporated by reference to
Exhibit 4.1 of the Companys Form 8-K filed August 7, 2007.
Employment letter agreement between BioCryst Pharmaceuticals, Inc. and
Stuart Grant dated July 23, 2007. Incorporated by reference to Exhibit
10.1 of the Companys Form 8-K filed July 26, 2007.
Stock Purchase Agreement, dated as of February 17, 2005, by and among
BioCryst Pharmaceuticals, Inc., Baker Bros. Investments, L.P., Baker
Biotech Fund II, L.P., Baker Bros. Investments II, L.P., Baker Biotech
Fund II (Z), L.P., Baker/Tisch Investments, L.P., Baker Biotech Fund
III, L.P., Baker Biotech Fund I, L.P., Baker Biotech Fund III (Z), L.P.
and 14159, L.P. Incorporated by reference to Exhibit 4.1 to the
Companys Form 8-K filed February 17, 2005.
Development and License Agreement dated as of February 1, 2006, by and
between BioCryst Pharmaceuticals, Inc. and Mundipharma International
Holdings Limited (Portions omitted pursuant to request for confidential
treatment.) Incorporated by reference to Exhibit 10.2 to the Companys
Form 8-K/A filed May 2, 2006. (Portions omitted pursuant to request for
confidential treatment.)
License Agreement dated as of June 27, 2000, by and among Albert
Einstein College of Medicine, Industrial Research, Ltd. and BioCryst
Pharmaceuticals, Inc., as amended by the First Amendment Agreement
dated as of July 26, 2002 and the Second Amendment Agreement dated as
of April 15, 2005. Incorporated by reference to Exhibit 10.1 to the
Companys Form 8-K filed November 30, 2005. (Portions omitted pursuant
to request for confidential treatment.)
Third Amendment Agreement by and among Albert Einstein College of
Medicine, Industrial Research, Ltd. and BioCryst Pharmaceuticals, Inc.,
dated as of December 11, 2009. (Portions omitted pursuant to request
for confidential treatment.)
Development and License Agreement dated as of November 29, 2005, by and
between BioCryst Pharmaceuticals, Inc. and F.Hoffmann-La Roche Ltd and
Hoffmann-La Roche Inc. (Portions omitted pursuant to request for
confidential treatment.) Incorporated by reference to Exhibit 10.2 to
the Companys Form 8-K/A filed December 22, 2005. (Portions omitted
pursuant to request for confidential treatment.)
Stock Purchase Agreement, dated as of December 14, 2005, by and among
BioCryst Pharmaceuticals, Inc., Kleiner Perkins Caufield & Byers, Texas
Pacific Group Ventures and KPTV, LLC. Incorporated by reference to
Exhibit 4.1 to the Companys Form 8-K filed December 16, 2005.
Nomination and Observer Agreement, dated as of December 16, 2005, by
and between BioCryst Pharmaceuticals, Inc. and Kleiner Perkins Caufield
& Byers. Incorporated by reference to Exhibit 4.2 to the Companys Form
8-K filed December 16, 2005.
Severance Agreement and General Release between Michael Darwin and
BioCryst Pharmaceuticals, Inc., dated December 31, 2008. Incorporated
by reference to Exhibit 10.32 to the Companys Form 10-K filed March 6,
2009.
Consent of Ernst & Young, Independent Registered Public Accounting Firm.
Certification of the Chief Executive Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002.
Certification of the Chief Financial Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002.
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
Table of Contents
*
Confidential treatment requested.
#
Confidential treatment granted.
&
Management contracts.
( )
Filed herewith.
AMENDMENT OF SOLICITATIONMODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 1 2. AMENDMENT/MODIFICATION NO: 3. EFFECTIVE DATE 5. PROJECT NO. (lf applícable) Elght (8) See block 16C N/A 6. ISSUED BY CODE 7. ADMINI STERED BY (lf other than ltem 6l CODE Biomedlcal Advanced Research and Development Authority U.S. Oepartment of Health and Human Services 330 IndeÞendence Avenue. SW Room G640 Washlngton, OC20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) 9A. AMENDMENT OF SOLICITATION NO BioCryst Pharmaceuticals, Inc. 98. DATED (SEE \TEM 11) 21 90 Parkwây Lake Drive Birmingham, lL35244 DUNs 61-819-4609 TIN 62-1413174. I OA.MODIFICATION OF CONTRACT/ ORDER HHSOI 00200700032C The above numbered sollcatalíon ¡s amended a8 set forth ln Item 14. The hour and date specified for recelpt of Offers d is extended, is not extended. offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which Includes a reference lo the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE REOEIVED AT THE PLACE DESIGNATE0 FOR THE RECETPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. lf Þy virtue of this amendment, you desire to change an offer already submiited, such change may by telegram or letter,provided each telegram or letter makes reference to the sollaction and this amendment, and is recived prior to the opening hour and the date specifed. 12.ACCOUNTING AND APPRORIATION DATA(if required) SOGG: DOC# TIN# LOC# CAN# 13. THIS ITEM APPLIES ONLY TO MODIFIGATIONS OF CONTRACTS,ORDERS; lT MODIFIES THE CONTRACT/ORDER NO. AS DESGRIEED lN ITEM 14. A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:(specifed authority)THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT /ORDER IS MODIFIED TO REFELCT THE ADMINISTRATIVE CHANGES (suchas changes paying office, appropriation date ,etc.)SET FORTH IN ITEM 14,PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO THE AUTHROTY OF FAR 52.243.2 changes-cost Reimbursement D. OTHER (specify type of modification and authorty) E. IMPORTÁNt: Côntractor [] ls not, þ ls requlred to sign this document and return 2 copies to the issuing office. 14. DESCRIPTION OF MODIFICATION (oganízed by UCF section headings, lnclud¡ng sollcitation/contract subject metter where feasible PURPOSE: Extond the due date for the Feasibility Plan. This modification extends the due date forMilestone 3 Feasibility Plan listed on page 10 of the contract in Article F.3. Contract Deliverables to March 31, 2009. The total contratl amounl romalns unchanged. ($102,661,429) The contract completion date remains unchanged. (Oecember 31, 2010) Except as provided hereln, all tems and conditions referenced in item 9A or l0A, remain in full force and effect. 154. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING CONTRACTOR/OFFEROR (Type or print) 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED (SIgnature of person authorized to sign) (Signature of Contncting Officer) NSN 7540-01-l 52-8070 OMB No. 099H1 15 STANDARD FORM 30 (REV.1o-83I |
ORDER FOR SUPPLIES OR SERVICES PAGE OF PAGES 1 2 IMPORTANT: [Mark ell packages and papers with contract and/or order numbers.] I. DATEOFORDER r. CONTRACT NO. (IF ANY) 6, SHIP TO: November 4.2009 HHSO1 00201 000001 |a. NAME OF CONSIGNEE REQUISITION/REFERENCE NO TBD }. ORDER NO. 001 os23204 b. STREETADDRESS ISSUING OFFICE (Address correspondence to) HHS\OS\ASPR\BARDAc. CITYI. STATE e. ZIP CODE .TO: f. SHIP VIA NAME OF CONTRACTOR BioCryst Pharmaceuticals, Inc.8. TYPE OF ORDER COMPANY NAME fl a. PURCHASE! b. DELIVERY Except for billing REFERENCE YOUR:instructions on the reverse, this STREETADDRESS Please furnish the following!on thedelivery order is subject to 2190 Parkway Lake Drive on this side terms and conditions specified on both instructions contained d. CITY STATE ZIP rides of this order and on the attached only of this form and ¡s issued subject le. STATE if any, including delivery as to the terms and conditions of the indicated above-numbered contract. Birmingham AL 35244-1879 9.ACCOUNTING AND APPROPRIATION DATA 10.. REQUISITIONING OFFICE Appr.: 75X0140; F.Y.: 2010; HHS\OS\ASPR\BARDA CAN: 1994009: O,C,: 26201; Value: $22,500,000.00 11. BUSINESS CLASSFICATION (Check appropriate box(es)) 12. F,O.B. POINT a. SMALL b. OTHER THAN SMALL c. DISADVANTAGED g. service- Destination d. WOMEN-OWNED e. HUBZone f. EMERGING SMALL DISABLED BUSINESS VETERAN-OWNED 13. PLACE OF: 14. GOVERNMENT B/L NO. 15. DELIVER TO F.O.B. POINT ON 16. DISCOUNT TERMS a. INSPECTION b. ACCEPTANCE N/A OR BEFORE (Date) N/A See Schedule 17. SCHEDULE (See Reverse for Rejections) ITEM NO. SUPPLIES OR SERVICES QUANTITY UNIT UNIT AMOUNT QUANTITY . ORDERED PRICE ACCEPTED (a).(b) (c)(d)(e)(f) (g) Treatment Courses (TC) of IV peramivir 10,00 TC $2250.00 $22,500,000.00 (Shipping information will be provided in the Quality Agreement to be provided to the contractor in accordance with the contract specified in Item 2 above) [Remainder of this block intentionally left blank] 18.SHIPPING POINT I9. GROSS SHIPPINGWEIGHT 20. INVOICE No. SEE BILLING 17(h)TOT. 21. MAIL INVOICE TO: N/A a. NAME ¡Cont. INSTRUCIION s pages) RoseMary Mann ON b. STREETADDRESS (or P.O. Box) 17(rl 330 Independence Ave. SW, Room G640 REYERSE c. GITY d. STATE e. ZIP CODE GRANT 022,500,000.00 Washington DC 20201 TOTAL 23. NAME (Typed) |
22.UNITED STATES OF RoseMary Mann AMERICA BY (Signature) TITLE: CONTRACTING/ORDERING OFFICER AUTHORIZD FOR LOCAL REPRODUCTION OPTIONAL FORM 347 ( REV . 4/2006) PREVIOUS EDITIONS NOT USABLE Prescribed by GSA/FAR 48 CFR 53.213(f) |
|
|||
Signature
|
Date |
AuwADrv/-*r>MTDA<~T I 1- THIS CONTRACT IS A RATED ORDER \ IRATING Ipage of pages AWARD/CONTRACT UNDER DPAS (15 CFR 700) \> j | 17 2. CONTRACT (Proc. Inst. Indent.) NO. 3. EFFECTIVE DATE |4. REQUISITION/PURCHASEREQUEST/PROJECT NO.HHSO100201000001I | 11-04-2009 |5. ISSUED BY CODE| HHS/OS/ASPR/BAR | 6 - ADMINISTERED BY (If other than Item 5) CODE |HHS/OS/ASPR/BARDA 330 INDEPENDENCE AVE. SW ROOM G640 WASHINGTON DC 202017. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) |8. DELIVERYBIOCRYST PHARMACEUTICALS, INC D fob origin Pother (See below)2190 PARKWAY LAKE DRIVE 9- discount for prompt payment BIRMINGHAM AL 35244-187910. SUBMIT INVOICES I ITEM(4copies unless othe rwise ^\, . ¦ ^___specified) TO THE ^sCODE FACILITY CODE ADDRESS SHOWN IN ^11. SHIP TO/MARK FOR CODeT 112. PAYMENT WILL BE MADE BY CODE~SAME AS ITEM 713. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 14. ACCOUNTING ANDAPPROPRIATION DATAI 110 U.S.C. 2304(c) ( ) | | 41 U.S.C. 253(c) ( )15A. ITEMNOT 15B. SUPPLIES/SERVICES ?5C. QUANTITY |15D.UNIT|15E. UNIT PRI CS 15F. AMOUNTINTRAVENOUS ANTIVIRAL DRUGPlease see Schedule for additional information 15G. TOTAL AMOUNT OF CONTRACT~T> $___^^ 16. TABLE OF CONTENTS(X) I SEC. I DESCRIPTION I PAGE(S)| (X) f SEC. f DESCRIPTION I PAGE(S)PART I THE SCHEDULE PART II CONTRACT CLAUSESX| A | SOLICITATION/CONTRACT FORM | X| I CONTRACT CLAUSES jX B SUPPLIES OR SERVICES AND PRICES/COSTS PART III LIST OF DOCUMENTS, EXHIBITS AN DOTHER ATTACH.X C DESCRIPTION/SPECS./WORK STATEMENT X| J | LIST OF ATTACHMENTSX D PACKAGING AND MARKING PART IV REPRESENTATIONS AND INSTRUCTIONS X E INSPECTION AND ACCEPTANCE ^ REPRESENTATIONS, CERTIFICATIONS AND OTHER X F DELIVERIES OR PERFORMANCE ,, STATEMENTS OF OFFERORSX G CONTRACT ADMINISTRATION DATA L INSTRS., CONDS., AND NOTICES TO OFFERORSX H SPECIAL CONTRACT REQUIREMENTS M EVALUATION FACTORS FOR AWARD CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE17. þ CONTRACTORS NEGOTIATED AGREEMENT (Contractor is required to 18. | | AWARD (Contractoris not required to sign this document.) Yourofferonsign this document and return ___copies to issuing office.) Contractor Solicitation Number ,agrees to furnish and deliver all items or perform all the services set forth or otherwiseincluding the additions or changes made by yo u which additions or changes are set forth inidentified above and on any continuation sheets for the consideration stated herein. The fullabove, is hereby accepted as to the terms listed above and on any continuation sheets, rights andobligations of the parties to this contract shall be subject to and governed by the This awardconsummates the contract which consists of the following documents: (a) the following documents:(a) this award/contract, (b) the solicitation, if any, and (c) such Gove rnments solicitation andyour offer, and (b) this award/contract. No further contractualprovisions, representations, certifications, and specifications, as are attached or document isnecessary.incorporated by reference herein. Attachments are listed herein.)19A. NAME AND TITLE OF SIGNER (Type or Print) 20A. NAME OF CONTRACTING OFFICER^___ROSEMARY MANN19B. NAME OF CONTRACTOR |19C. DATE SIGNED 20B. UNITED STATES OF AMERICA |20C. DATE SIGNED BY BY(Signature of person au thorized to sign) (Signature of Contracting Officer)AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 26 (REV. 4/2008)Previous edition is usable Prescribed by GSA FAR (48 CFR) 53.214(a) |
a. | The prices set forth in this contract will cover the contract period of 24 months from the date of award. |
b. | Upon delivery and acceptance of the item(s) described in SECTION C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below in ARTICLE B.3. |
CLIN | Quantity | Unit Price | Total | |||||||
0001
- Antiviral Drug
|
1,000 (treatment courses) | $ | 2,250.00 | $ | 2,250,000.00 | |||||
OPTIONAL CLIN*
|
||||||||||
0002
- Maximum Order
Antiviral Drug
|
40,000 (treatment courses) | $ | 2,250.00 | $ | 90,000,000.00 |
* | The USG may order up to a maximum of 40,000 treatment courses if optional CLIN is exercised. |
a. | Manufacture treatment courses of antiviral drugs for delivery to the site requested. |
b. | Maintain ability to manufacture additional treatment courses dependent on the volume and size of antiviral orders received from HHS for additional needs for either treatment or prophylaxis. |
c. | Provide antiviral product and package labeling and packaging for finished product that is consistent with CDC guidelines for stockpiled countermeasures. |
d. | Maintain integrity of antivirals while they are being transported from manufacturer to the delivery sites pre-identified per order. |
e. | Provide report on product shipped to reflect delivery location, date of delivery, treatment courses delivered, and lot numbers for full delivery. |
f. | Product will be accepted up to 6 months from the date of manufacture provided stability testing data is supportive. |
FAR SOURCE | Title and Date | |
FAR Clause 52.246-1
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Contractor Inspection Requirements (Apr 1984) | |
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FAR Clause 52.246-2
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Inspection of Supplies Fixed Price ( Aug 1996) | |
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FAR Clause 52.246-16
|
Responsibility for Supplies ( Apr 1984) |
FAR Source | Title and Date | |
FAR Clause 52.211-17
|
Delivery of Excess Quantities ( Sept 1989) | |
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FAR Clause 52.242-15
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Stop Work Order (Aug 1989) | |
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FAR Clause 52.242-15, Alt 1
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Stop Work Order, Alternate 1 (April 1984) | |
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FAR Clause 52.242-17
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Government Delay of Work (Apr 1984) | |
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FAR Clause 52.247-34
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FOB Destination (Nov 1991) |
a. | The delivery of the antiviral drugs and related supplies shall be F.O.B. Destination. | |
b. | The place of delivery will be provided to the Contractor no less than 24 hours prior to shipping. | |
c. | Order Fulfillment and Delivery Criteria (from the Contractors proposal) | |
Through February 2010, if the government places an order(s) for up to 40,000 treatment courses, the contractor can deliver these treatment courses in one to two weeks ONLY IF the contractor has the inventory on-hand. If treatment courses are unavailable, up to 40,000 treatment courses can be delivered in 12-16 weeks following an order | ||
Beyond February 2010, if the government places an order, the contractor can deliver treatment courses manufactured in August 2009 IF ON-HAND within one to two weeks if the government chooses to accept product manufactured more than six months prior. If the government opts not to take treatments manufactured in August 2009, it will take 12-16 weeks to manufacture and deliver treatment courses. |
1. | If product does not meet any criterion outlined in this contract. | ||
2. | If product is deemed to be recalled for any reason, as outlined in the Product Recalls, Including Removal and corrections published by U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs; or based upon Chapter 7 of the Regulatory Procedures Manual of March 2007. |
For prime or subcontract awards to domestic institutions that possess, use, and/or transfer Select Agents under this contract, the institution must comply with the provisions of 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 ( http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf ) as required, before using HHS funds for work involving a Select Agent or Toxin . No HHS funds can be used for research involving a Select Agent or Toxin at a domestic institution without a valid registration certificate. | |||
For prime or subcontract awards to foreign institutions that possess, use, and/or transfer a Select Agent or Toxin , before using HHS funds for any work directly involving a Select Agent or Toxin , the foreign institution must provide information satisfactory to the HHS that safety, security, and training standards equivalent to those described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 are in place and will be administered on behalf of all Select Agent or Toxin work supported by these funds. The process for making this determination includes inspection of the foreign laboratory facility by a HHS representative. During this inspection, the foreign institution must provide the following information: concise summaries of safety, security, and training plans; names of individuals at the foreign institution who will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals, in accordance with institution procedures, will have access to the Select Agents under the contract; and copies of or links to any applicable laws, regulations, policies, and procedures applicable to that institution for the safe and secure possession, use, and/or transfer of select agents. No HHS funds can be used for work involving a Select Agent or Toxin at a foreign institution without written approval from the Contracting Officer. |
Listings of HHS select agents and toxins, and overlap select agents or toxins as well as information about the registration process for domestic institutions, are available on the Select Agent Program Web site at http:// www.cdc.gov/od/sap/ and http://www.cdc.gov/od/sap/docs/salist.pdf . |
Listings of USDA select agents and toxins as well as information about the registration process
for domestic institutions are available on the APHIS/USDA website at:
http://www.aphis.usda.gov/programs/ag_selectagent/index.html and: http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html |
For foreign institutions, see the HHS Select Agent Award information:
( http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm ). |
A. | 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 requirement is in addition to the continuing requirement to provide an acknowledgment of support and disclaimer on any publication reporting the results of a contract funded activity. | ||
B. | Publication and Publicity | |
The Contractor shall acknowledge the support of the Department of Health and Human Service,
Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and
Development Authority whenever publicizing the work under this contract in any media by including
an acknowledgment substantially as follows:
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C. | Press Releases | |
Pursuant to Section 508 of Public Law 105-78, the contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money that: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources. |
1. | Pursuant to Public Law(s) cited in paragraph (2), below, the contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: the percentage of the total costs of the program or project which will be financed with Federal money; the dollar amount of Federal funds for the project or program; and the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources. |
2. | Public Law and Section No. | Fiscal Year | Period Covered | |||||||
P.L. 109-149, Title V, section 506, as
Directed by P.L. 110-5, Div. B, title I,
Section 104
|
2009 | 10/1/2009 - 9/30/2010 |
a. | FEDERAL ACQUISITION REGULATION (FAR) (48 CHAPTER 1) CLAUSES |
Reg | Clause | Date | Clause Title | |||
FAR | 52.202-1 | Jul-04 |
Definitions (Over $100,000)
|
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FAR | 52.203-3 | Apr-84 |
Gratuities (Over $100,000)
|
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FAR | 52.203-5 | Apr-84 |
Covenant Against Contingent Fees (Over $100,000)
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FAR | 52.203-6 | Sep-06 |
Restrictions on Subcontractor Sales to the Government (Over $100,000)
|
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FAR | 52.203-7 | Jul-95 |
Anti-Kickback Procedures (Over $100,000)
|
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FAR | 52.203-8 | Jan-97 |
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)
|
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FAR | 52.203-10 | Jan-97 |
Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
|
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FAR | 52.203-12 | Sep-07 |
Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
|
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FAR | 52.204-4 | Aug-00 |
Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
|
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FAR | 52.204-7 | Apr-08 |
Central Contractor Registration
|
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FAR | 52.204-10 | Sep-07 |
Reporting Subcontract Awards ($500,000,000 or more)
|
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FAR | 52.209-6 | Sep-06 |
Protecting the Governments Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
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FAR | 52.211-5 | Aug-00 |
Material Requirements
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FAR | 52.215-2 | Mar-09 |
Audit and Records Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over $100,000 funded exclusively with non-Recovery Act funds.]
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FAR | 52.215-8 | Oct-97 |
Order of Precedence Uniform Contract Format
|
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FAR | 52.215-10 | Oct-97 |
Price Reduction for Defective Cost or Pricing Data (Over $650,000)
|
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FAR | 52.215-12 | Oct-97 |
Subcontractor Cost or Pricing Data (Over $650,000)
|
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FAR | 52.215-14 | Oct-97 |
Integrity of Unit Prices (Over $100,000)
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FAR | 52.215-15 | Oct-04 |
Pension Adjustments and Asset Reversions
|
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FAR | 52.215-18 | Jul-05 |
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
|
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FAR | 52.215-19 | Oct-97 |
Notification of Ownership Changes
|
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FAR | 52.215-21 | Oct-97 |
Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data Modifications
|
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FAR | 52.219-8 | May-04 |
Utilization of Small Business Concerns (Over $100,000)
|
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FAR | 52.219-9 | Apr-08 |
Small Business Subcontracting Plan (Over $550,000, $1,000,000 for Construction)
|
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FAR | 52.219-16 | Jan-99 |
Liquidated Damages Subcontracting Plan (Over $550,000, $1,000,000 for Construction)
|
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FAR | 52.222-19 | Feb-08 |
Child LaborCooperation with Authorities and Remedies
|
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FAR | 52.222-20 | Dec-96 |
Walsh-Healey Public Contracts Act
|
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FAR | 52.222-21 | Feb-99 |
Prohibition of Segregated Facilities
|
Reg | Clause | Date | Clause Title | |||||
FAR | 52.222-26 | Mar-07 |
Equal Opportunity
|
|||||
FAR | 52.222-35 | Sep-06 |
Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000)
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FAR | 52.222-36 | Jun-98 |
Affirmative Action for Workers with Disabilities
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|||||
FAR | 52.222-37 | Sep-06 |
Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000)
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|||||
FAR | 52.222-50 | Feb-09 |
Combating Trafficking in Persons
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|||||
FAR | 52.222-54 | Jan-09 |
Employment Eligibility Verification (Over $100,000)
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|||||
FAR | 52.223-6 | May-01 |
Drug-Free Workplace
|
|||||
FAR | 52.223-14 | Aug-03 |
Toxic Chemical Release Reporting (Over $100,000)
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|||||
FAR | 52.225-1 | Feb-09 |
Buy American Act Supplies
|
|||||
FAR | 52.225-13 | Jun-08 |
Restrictions on Certain Foreign Purchases
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|||||
FAR | 52.227-1 | Dec-07 |
Authorization and Consent
|
|||||
FAR | 52.227-2 | Dec-07 |
Notice and Assistance Regarding Patent and Copyright Infringement
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|||||
FAR | 52.229-3 | Apr-03 |
Federal, State and Local Taxes (Over $100,000)
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|||||
FAR | 52.232-1 | Apr-84 |
Payments
|
|||||
FAR | 52.232-8 | Feb-02 |
Discounts for Prompt Payment
|
|||||
FAR | 52.232-9 | Apr-84 |
Limitation on Withholding of Payments
|
|||||
FAR | 52.232-11 | Apr-84 |
Extras
|
|||||
FAR | 52.232-17 | Oct-08 |
Interest (Over $100,000)
|
|||||
FAR | 52.232-23 | Jan-86 |
Assignment of Claims
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FAR | 52.232-25 | Oct-08 |
Prompt Payment
|
|||||
FAR | 52.232-33 | Oct-03 |
Payment by Electronic Funds TransferCentral Contractor Registration
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FAR | 52.233-1 | Jul-02 |
Disputes
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FAR | 52.233-3 | Aug-96 |
Protest After Award
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FAR | 52.233-4 | Oct-04 |
Applicable Law for Breach of Contract Claim
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FAR | 52.242-13 | Jul-95 |
Bankruptcy (Over $100,000)
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|||||
FAR | 52.243-1 | Aug-87 |
Changes Fixed-Price
|
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FAR | 52.244-6 | Mar-09 |
Subcontracts for Commercial Items
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FAR | 52.249-2 | May-04 |
Termination for the Convenience of the Government (Fixed-Price)
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FAR | 52.249-8 | Apr-84 |
Default (Fixed-Price Supply and Service)(Over $100,000)
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FAR | 52.253-1 | Jan-91 |
Computer Generated Forms
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HHSAR | 352.202-1 | Jan-06 |
Definitions
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|||||
HHSAR | 352.232-9 | Jan-06 |
Withholding of Contract Payments
|
|||||
HHSAR | 352.270-4 | Jan-01 |
Pricing of Adjustments
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|||||
HHSAR | 352.270-5 | Jan-06 |
Key Personnel
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|||||
HHSAR | 352.270-6 | Jan-06 |
Publications and Publicity
|
|||||
HHSAR | 352.270-10 | Jan-06 |
Anti-Lobbying (Over $100,000)
|
FAR | 52.216-18 | Oct-95 |
Ordering
|
|||||
FAR | 52.216-19 | Oct-95 |
Order Limitations
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|||||
FAR | 52.216-22 | Oct-95 |
Indefinite Quantity
|
|||||
FAR | 52.216-27 | Oct-95 |
Single or Multiple Awards
|
|||||
FAR | 52.227-14 | Dec-07 |
Rights in Data General
|
|||||
FAR | 52.232-20 | Apr-84 |
Limitation of Cost
|
|||||
FAR | 52.232-32 | Jan-08 |
Performance-based Payments
|
|||||
FAR | 52.242-1 | Apr-84 |
Notice of Intent to Disallow Costs
|
|||||
FAR | 52.245-1 | Jun-07 |
Government Property
|
|||||
FAR | 52.245-2 | Jun-07 |
Government Property Fixed Price Contracts
|
|||||
FAR | 52.249-2 | May-04 |
Termination for the Convenience of the Government (Fixed-Price)
|
|||||
FAR | 52.249-8 | Apr-84 |
Default (Fixed-Price Supply and Service) (Over $100,000)
|
|||||
FAR | 52.249-14 | Apr-84 |
Excusable Delays
|
(1) | 52.217-7 Option for Increased Quantity Separately Priced Line Item (Reserved) (Mar 1989). | |
....The Contracting Officer may exercise the option by written notice to the Contractor within 24 hours of issuance of the contract .... | ||
(2) | 52.215-17 Waiver of Facilities Capital Cost of Money (October 1997) | |
(3) | 52.227-14, Rights in Data General (Dec 2007) |
(a) | Except as specified below, upon the filing by Licensee (or an Affiliate) of each IND for a Licensed Product (or each indication for a Licensed Product), Licensee shall pay to Licensors ***, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. Upon the filing by Licensee (or an Affiliate) of each IND for a Licensed Product for a *** indication, Licensee shall pay to Licensors only *** pursuant to this Subparagraph for such filing, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. Upon the filing by Licensee (or an Affiliate) of an IND for a Licensed Product that is not, on its face, directly associated with any indication (i.e. a generic IND), Licensee shall owe *** to Licensors pursuant to this Subparagraph for such filing. |
*** | shall be due under this Subparagraph for a Licensed Product solely for a *** indication. |
(b) | Except as specified below, upon the initiation by Licensee (or an Affiliate) of Phase II clinical trials (i.e. the administration of a Licensed Product to a patient for the primary purpose of assessing clinical efficacy; and not Phase I clinical trials for the primary purpose of assessing safety or pharmacokinetics) for each Licensed Product (or each indication for a Licensed Product), Licensee shall pay to Licensors ***, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. Upon the initiation by Licensee (or an Affiliate) of Phase II clinical trials for each Licensed Product for a *** indication, Licensee shall pay to Licensors only ***, pursuant to this Subparagraph for the initiation of such trials, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. No payment shall be due under this paragraph for any Phase II clinical trial initiated by a third party Investigator, even if the trial is supported by Licensee (an Investigator Initiated Trial). However, if the |
-2-
*** | shall be due under this Subparagraph for a Licensed Product solely for a *** indication. |
(c) | Except as specified below, upon the initiation by Licensee (or an Affiliate) of Phase III clinical trials for each Licensed Product (or each indication for a Licensed Product), Licensee shall pay to Licensors ***, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. Upon the initiation by Licensee (or an Affiliate) of Phase III clinical trials for each Licensed Product for a *** Indication, Licensee shall pay to Licensors only ***, pursuant to this Subparagraph for the initiation of such trials, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. |
*** | shall be due under this Subparagraph for a Licensed Product solely for a *** indication. |
(d) | Except as specified below, upon Licensees (or an Affiliates) first receipt of governmental approval (FDA or equivalent approval in a European country or Japan) to market each Licensed Product (or each Indication for a Licensed Product), Licensee shall pay to Licensors ***, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. Upon Licensees (or an Affiliates) first receipt of governmental approval (FDA or equivalent approval in a European country or Japan) to market each Licensed Product for a *** indication, Licensee shall pay to Licensors only *** pursuant to this Subparagraph for such FDA approval, which payments are non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. |
-3-
*** | shall be due under this Subparagraph for a Licensed Product solely for a *** indication. |
(e) | The first time the aggregate Net Sales of Licensed Products for a *** indication in a consecutive twelve month period total ***, Licensee shall pay to Licensors ***, which payment is non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. | ||
(f) | The first time the aggregate Net Sales of Licensed Products in a consecutive (12) twelve month period total ***, Licensee shall pay to Licensors ***, which payment is non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. | ||
(g) | The first time the aggregate Net Sales of Licensed Products in a consecutive twelve (12) month period total ***, Licensee shall pay to Licensors ***, which payment is non-refundable and not creditable against any other payment due to Licensors pursuant to this Agreement. | ||
(h) | The calculation of Net Sales pursuant to Subparagraphs (f) and (g) above shall exclude: (i) Net Sales of Licensed Products for a *** indication; and (ii) Net Sales of Licensed Products solely for a *** indication. |
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ALBERT EINSTEIN COLLEGE | BIOCRYST | |||||||||
OF MEDICINE OF YESHIVA | PHARMACEUTICALS, INC. | |||||||||
UNIVERSITY | ||||||||||
By:
|
/s/ John L. Harb | By: | /s/ Alane Barnes | |||||||
|
||||||||||
|
Name: John L. Harb | Name: Alane Barnes | ||||||||
|
Title: Assistant Dean
Scientific Operations |
Title: General Counsel |
INDUSTRIAL RESEARCH LTD.
|
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By: | /s/ Jeff Lycett | |||
Name: | Jeff Lycett | |||
Title: | Board Secretary | |||
-5-
| Registration Statements (Form S-8 Nos. 333-120345, 333-39484 and 333-30751) pertaining to the BioCryst Pharmaceuticals, Inc. 1991 Stock Option Plan, as amended and restated as of March 8, 2004; | ||
| Registration Statement (Form S-8 No. 333-90582) pertaining to the BioCryst Pharmaceuticals, Inc. Employee Stock Purchase Plan; | ||
| Registration Statement (Form S-8 No. 333-136703) pertaining to the BioCryst Pharmaceuticals, Inc. Stock Incentive Plan, which amended and restated the BioCryst Pharmaceuticals, Inc. 1991 Stock Option Plan as of May 17, 2006; | ||
| Registration Statement (Form S-3 No. 333-145638) pertaining to the registration of up to 8,140,000 shares of common stock; | ||
| Registration Statement (Form S-8 No. 333-145627) pertaining to the BioCryst Pharmaceuticals, Inc. Stock Incentive Plan as amended and restated effective March 2007 and Employment Letter Agreement dated April 2, 2007 between BioCryst Pharmaceuticals, Inc. and David McCullough; | ||
| Registration Statement (Form S-3 No. 333-155783) for the registration of up to $70 million of BioCryst Pharmaceuticals, Inc. common stock, preferred stock, depositary shares, stock purchase contracts, warrants or units; and | ||
| Registration Statement (Form S-3 No. 333-153084) for the registration of 3,335,408 shares of BioCryst Pharmaceuticals, Inc. common stock and 3,159,895 warrants to purchase common stock of BioCryst Pharmaceuticals, Inc. |
1. | I have reviewed this annual report on Form 10-K of BioCryst Pharmaceuticals, Inc.; | ||
2. | 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; | ||
3. | 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; | ||
4. | The registrants 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; | ||
c) | evaluated the effectiveness of the registrants 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 | ||
d) | disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants ability to record, process, summarize and report financial information; and | ||
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: March 9, 2010 | /s/ Jon P. Stonehouse | |||
Jon P. Stonehouse | ||||
Chief Executive Officer |
1. | I have reviewed this annual report on Form 10-K of BioCryst Pharmaceuticals, Inc.; | ||
2. | 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; | ||
3. | 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; | ||
4. | The registrants 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; | ||
c. | evaluated the effectiveness of the registrants 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 | ||
d. | disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants ability to record, process, summarize and report financial information; and | ||
b. | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: March 9, 2010 | /s/ Stuart Grant | |||
Stuart Grant | ||||
Chief Financial Officer |
/s/ Jon P. Stonehouse | ||||
Jon P. Stonehouse | ||||
Chief Executive Officer
March 9, 2010 |
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/s/ Stuart Grant | ||||
Stuart Grant | ||||
Chief Financial Officer
March 9, 2010 |
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