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o | TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
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Exhibit 32.1 |
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7
8
9
10
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18
19
There are also a number of chemotherapies and cancer therapies approved today and in various stages of clinical
development for ovarian, breast and cervical cancers including but not limited to: Avastin® (bevacizumab), Camptosar®
(irinotecan), Ellence® (epirubicin), Gemzar® (gemcitabine), Herceptin® (trastuzumab), Hycamtin® (topotecan),
Paraplatin® (carboplatin), and Taxol® (paclitaxel). These therapies are only partially effective in treating ovarian,
breast or cervical cancers. Major pharmaceutical or biotechnology companies with approved drugs or drugs in
development for these cancers include Bristol-Meyers Squibb, Genentech, Inc., GlaxoSmithKline plc, Pfizer, Inc., Eli
Lilly & Co., and many others.
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
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
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
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improve efficacy or safety in certain instances as a result of better pharmacokinetics,
pharmacodynamics, longer half-life and sustained exposure of the drug;
improve targeting or binding affinity of a drug to its target receptors with the
potential to improve efficacy and reduce toxicity or drug resistance;
enable oral administration of parenterally-administered drugs, or drugs that must be
administered intravenously or subcutaneously, and increase oral bioavailability of small
molecules;
prevent drugs from crossing the blood-brain barrier and limiting undesirable central
nervous system effects;
reduce first-pass metabolism effects of certain drug classes with the potential to
improve efficacy, which could reduce the need for other medicines and reduce toxicity;
reduce rate of drug absorption and of elimination or metabolism by improving stability
of the drug in the body and providing it with more sufficient time to act on its target;
and
reduce immune response to certain macromolecules with the potential to prolong their
effectiveness with repeated doses.
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Drug
Primary or Target Indications
Licensing Partner and Drug Marketer
Status(1)
Neutropenia
Amgen Inc.
Approved
Hepatitis-C
F. Hoffmann-La Roche Ltd
Approved
Acromegaly
Pfizer Inc.
Approved
Hepatitis-C
Schering-Plough Corporation
Approved
Age-related macular degeneration
OSI Pharmaceuticals (formerly Eyetech)
Approved
Crohns disease
UCB Pharma
Approved in U.S. and Switzerland
Anemia associated with chronic
kidney disease in patients on
dialysis and patients not on
dialysis
F. Hoffmann-La Roche Ltd
Approved in U.S. and EU
(Launched only in the EU)*
Rheumatoid arthritis
UCB Pharma
Filed in the U.S. and EU
Anemia
Affymax, Inc.
Phase 3
Migraine
MAP Pharmaceuticals
Phase 3
Cystic fibrosis lung infections
Bayer Schering Pharma AG
Phase 2**
Psoriasis
UCB Pharma
Phase 2
Non-small cell lung cancer
UCB Pharma
Phase 2
Hemophilia
Baxter
Preclinical
(1)
Status definitions are:
*
Amgen Inc. prevailed in a patent lawsuit against F. Hoffmann-La Roche Ltd and as a result of this
legal ruling Roche is currently prevented from marketing MIRCERA
®
in the U.S.
**
This product candidate was developed using our proprietary pulmonary delivery technology that was
transferred to Novartis in an asset sale transaction that closed on December 31, 2008. As part of
the transaction, Novartis assumed our rights and obligations for our Cipro Inhale agreements with
Bayer Schering PharmaAG; however, we maintained the rights to receive certain royalties on
commercial sales of Cipro Inhale if the product candidate is approved.
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Drug Candidate
Target Indications
Status (1)
Gram-negative pneumonias
Phase 2 (Partnered with Bayer Healthcare LLC)*
Second-line colorectal cancer in
patients with the KRAS gene
mutation
Phase 2
Metastatic breast cancer
Phase 2
Metastatic ovarian cancer
Phase 2
Metastatic cervical cancer
Phase 2
Opioid-induced constipation (OIC)
Phase 2
Solid tumors
Phase 1
Gram-positive pneumonias
Phase 1*
HIV
Research/Preclinical
Neuropathic pain
Research/Preclinical
Allergic rhinitis
Research/Preclinical
(1)
Status definitions are:
*
This product candidate uses a liquid aerosol technology platform that was transferred to Novartis
in the pulmonary asset sale transaction that was completed on December 31, 2008. As part of that
transaction, we retained an exclusive license to this technology for the development and
commercialization of this drug candidate originally developed by Nektar.
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dry powder and liquid pulmonary technology platform including but not limited to our
pulmonary inhalation devices, formulation technology, manufacturing technology and related
intellectual property;
capital equipment, information systems and facility lease obligations for our pulmonary
development and manufacturing facility in San Carlos, California;
manufacturing and associated development services payments for the Cipro Inhale program;
manufacturing and royalty rights to the Tobramycin Inhalation Powder (TIP) program
through the termination of our collaboration agreement with Novartis;
certain other interests that we had in two private companies; and
approximately 140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing operations.
Years ended December 31,
2008
2007
2006
$
58.4
$
70.7
$
69.9
4.6
6.3
9.7
25.9
33.9
31.0
40.2
26.8
24.1
19.0
10.8
8.9
3.3
2.2
2.4
3.0
2.9
3.4
$
154.4
$
153.6
$
149.4
Table of Contents
extensive preclinical laboratory and animal testing;
submission of an Investigational New Drug application (IND) prior to commencing
clinical trials;
adequate and well-controlled human clinical trials to establish the safety and
efficacy of the drug for the intended indication; and
submission to the FDA of a New Drug Application (NDA) for approval of a drug, a
Biologic License Application (BLA) for approval of a biological product or a Premarket
Approval Application (PMA) or Premarket Notification 510(k) for a medical device product
(a 510(k)).
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determine the preliminary efficacy of the product for specific targeted indications;
determine dosage and regimen of administration; and
identify possible adverse effects and safety risks.
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Name
Age
Position
56
Director, President and Chief Executive Officer
57
Senior Vice President and Chief Financial Officer
43
Senior Vice President and Chief Operating Officer
55
Senior Vice President, Drug Development and Chief Development Officer
37
Senior Vice President, General Counsel and Secretary
43
Vice President and Chief Accounting Officer
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design and conduct large scale clinical studies;
prepare and file documents necessary to obtain government approvals to sell a given
product candidate; and/or
market and sell our products when and if they are approved.
we may be unable to control whether, and the extent to which, our partners devote
sufficient resources to the development programs or commercial efforts;
disputes may arise in the future with respect to the ownership of rights to
technology or intellectual property developed with partners;
disagreements with partners could lead to delays in, or termination of, the research,
development or commercialization of product candidates or to litigation or arbitration;
contracts with our partners may fail to provide us with significant protection, or to
be effectively enforced, in the event one of our partners fails to perform;
partners have considerable discretion in electing whether to pursue the development
of any additional product candidates and may pursue alternative technologies or products
either on their own or in collaboration with our competitors;
partners with marketing rights may choose to devote fewer resources to the marketing
of our partnered products than they do to products of their own development;
the timing and level of resources that our partners dedicate to the development
program will affect the timing and amount of revenue we receive;
partners may be unable to pay us as expected; and
partners may terminate their agreements with us unilaterally for any or no reason, in
some cases with the payment of a termination fee penalty and in other cases with no
termination fee penalty.
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research and development performance and reimbursement obligations for our personnel
and other resources allocated to partnered product development programs;
clinical and commercial manufacturing agreements, some of which are priced on an
actual cost basis for products supplied by us to our partners with complicated cost
allocation formulas and methodologies;
intellectual property ownership allocation between us and our partners for
improvements and new inventions developed during the course of the partnership;
royalties on end product sales based on a number of complex variables, including net
sales calculations, geography, patent life and other financial metrics; and
indemnity obligations for third-party intellectual property infringement, product
liability and certain other claims.
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develop products utilizing our technologies, either independently or in collaboration
with other pharmaceutical or biotech companies;
receive necessary regulatory and marketing approvals;
maintain or expand manufacturing at necessary levels;
achieve market acceptance of our partnered products;
receive royalties on products that have been approved, marketed or submitted for
marketing approval with regulatory authorities; and
maintain sufficient funds to finance our activities.
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making it more difficult to obtain additional financing;
constraining our ability to react quickly in an unfavorable economic climate;
constraining our stock price; and
constraining our ability to invest in our proprietary product development programs.
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establishment of a classified board of directors such that not all members of the
board may be elected at one time;
lack of a provision for cumulative voting in the election of directors, which would
otherwise allow less than a majority of stockholders to elect director candidates;
the ability of our board to authorize the issuance of blank check preferred stock
to increase the number of outstanding shares and thwart a takeover attempt;
prohibition on stockholder action by written consent, thereby requiring all
stockholder actions to be taken at a meeting of stockholders;
establishment of advance notice requirements for nominations for election to the
board of directors or for proposing matters that can be acted upon by stockholders at
stockholder meetings; and
limitations on who may call a special meeting of stockholders.
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announcements of data from, or material developments in, our clinical trials or those
of our competitors, including delays in clinical development, approval or launch;
announcements by collaboration partners as to their plans or expectations related to
products using our technologies;
announcements or terminations of collaborative relationships by us or our
competitors;
fluctuations in our results of operations;
developments in patent or other proprietary rights, including intellectual property
litigation or entering into intellectual property license agreements and the costs
associated with those arrangements;
announcements of technological innovations or new therapeutic products that may
compete with our approved products or products under development;
announcements of changes in governmental regulation affecting us or our competitors;
hedging activities by purchasers of our convertible senior notes;
litigation brought against us or third parties to whom we have indemnification
obligations;
public concern as to the safety of drug formulations developed by us or others; and
general market conditions.
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Item 5.
Market for Registrants Common Equity Related Stockholder Matters and Issuer Purchases of
Equity Securities
High
Low
$
15.24
$
11.20
13.58
9.32
9.75
7.63
8.98
5.22
$
7.50
$
6.12
7.35
3.35
5.36
3.10
5.97
2.83
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(In thousands, except per share information)
Years ended December 31,
2008
2007
2006
2005
2004
$
41,255
$
180,755
$
153,556
$
29,366
$
25,085
48,930
92,272
64,162
96,913
89,185
90,185
273,027
217, 718
126,279
114,270
172,837
309,175
376,948
308,912
188,212
(82,652
)
(36,148
)
(159,230
)
(182,633
)
(73,942
)
50,149
(303
)
(9,258
)
(2,639
)
4,696
5,297
(2,312
)
(18,849
)
(806
)
1,309
828
(137
)
(163
)
$
(34,336
)
$
(32,761
)
$
(154,761
)
$
(185,111
)
$
(101,886
)
$
(.37
)
$
(0.36
)
$
(1.72
)
$
(2.15
)
$
(1.30
)
92,407
91,876
89,789
85,915
78,461
As of December 31,
2008
2007
2006
2005
2004
$
378,994
$
482,353
$
466,977
$
566,423
$
418,740
$
337,846
$
425,191
$
369,457
$
450,248
$
223,880
$
560,536
$
725,103
$
768,177
$
858,554
$
744,921
$
65,577
$
80,969
$
40,106
$
23,861
$
31,021
$
214,955
$
315,000
$
417,653
$
417,653
$
173,949
$
25,585
$
27,543
$
29,189
$
27,598
$
36,250
$
(1,124,090
)
$
(1,089,754
)
$
(1,056,993
)
$
(902,232
)
$
(717,121
)
$
190,154
$
214,439
$
227, 060
$
326,811
$
467,342
(1)
2006 and 2007 product sales and royalties include commercial manufacturing revenue from
Exubera bulk dry powder insulin and Exubera inhalers.
(2)
2007, 2006, and 2005 collaboration and other revenue included Exubera commercialization
readiness revenue.
(3)
We changed our method of accounting for stock based compensation on January 1, 2006 in
connection with the adoption of SFAS No. 123R,
Share-Based Payment.
(4)
Operating costs and expenses includes the Gain on sale of pulmonary assets of $69.6 million
in 2008 and the Gain on termination of collaborative agreements, net of $79.2 million in 2007.
(5)
Basic and diluted net loss per share is based upon the weighted average number of common
shares outstanding.
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Percentage
Percentage
Increase/
Increase/
Increase/
Increase/
Years ended December 31,
(Decrease)
(Decrease)
(Decrease)
(Decrease)
2008
2007
2006
2008 vs. 2007
2007 vs. 2006
2008 vs. 2007
2007 vs. 2006
$
41,255
$
180,755
$
153,556
$
(139,500
)
$
27,199
(77
)%
18
%
48,930
92,272
64,162
(43,342
)
28,110
(47
)%
44
%
$
90,185
$
273,027
$
217,718
$
(182,842
)
$
55,309
(67
)%
25
%
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Years ended December 31,
2008
2007
2006
$
30,800
$
212,990
$
182,959
59,385
60,037
33,471
1,288
$
90,185
$
273,027
$
217,718
Percentage
Percentage
Increase/
Increase/
Increase/
Increase/
Years ended December 31,
(Decrease)
(Decrease)
(Decrease)
(Decrease)
2008
2007
2006
2008 vs. 2007
2007 vs. 2006
2008 vs. 2007
2007 vs. 2006
$
28,216
$
137,696
$
113,921
$
(109,480
)
$
23,775
(80
)%
21
%
13,039
43,059
39,635
(30,020
)
3,424
(70
)%
9
%
32
%
24
%
26
%
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Percentage
Percentage
Increase/
Increase/
Increase/
Increase/
Years ended December 31,
(Decrease)
(Decrease)
(Decrease)
(Decrease)
2008
2007
2006
2008 vs. 2007
2007 vs. 2006
2008 vs. 2007
2007 vs. 2006
$
148
$
974
$
$
(826
)
$
974
(85
%)
n/a
1,221
1,221
n/a
n/a
3,087
5,791
(2,704
)
5,791
(47
%)
n/a
517
1,617
(1,100
)
1,617
(68
%)
n/a
$
4,973
$
8,382
$
$
(3,409
)
$
8,382
(41
%)
n/a
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Clinical
Years ended December 31,
Study
Status
(1)
2008
2007
2006
Phase 2
$
24.2
$
12.7
$
2.7
Phase 2
24.6
12.9
5.5
Phase 2
19.7
16.3
12.8
Phase 2
17.7
15.2
13.6
Phase 2
11.4
8.3
5.9
Phase 1
8.4
0.4
Discontinued
3.5
37.6
39.5
Phase 1
2.3
Various
21.0
16.2
12.4
Various
15.7
28.2
54.0
5.9
5.8
3.0
$
154.4
$
153.6
$
149.4
(1)
Clinical Study Status definitions are provided in the chart found in Part I, Item 1. Business
(2)
The collaboration agreement with Novartis Vaccines and Diagnostics, Inc. was terminated on December 31, 2008 in connection
with the Novartis Pulmonary Asset Sale.
(3)
Partnered with Bayer Healthcare LLC since August 2007. As part of the Novartis Pulmonary Asset Sale , we retained an exclusive
license to this technology for the development and commercialization of this product originally developed by Nektar.
(4)
The collaboration agreement with Bayer Schering Pharma AG was assigned to Novartis on December 31, 2008 in connection with
the Novartis Pulmonary Asset Sale.
(5)
Partnership for the collaboration and development of Exubera inhalation powder and the next generation inhaled insulin with
Pfizer was terminated on November 9, 2007. Inhaled insulin programs were terminated in April 2008.
(6)
Certain proprietary pulmonary intellectual property was transferred to Novartis as part of the Novartis Pulmonary Asset Sale.
(7)
Other includes additional costs related Novartis Pulmonary Asset Sale in 2008, workforce reduction charges in 2008 and 2007, and
research and development costs related to our ceased super-critical fluids business in 2006.
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Percentage
Percentage
Increase/
Increase/
Increase/
Increase/
Years ended December 31,
(Decrease)
(Decrease)
(Decrease)
(Decrease)
2008
2007
2006
2008 vs. 2007
2007 vs. 2006
2008 vs. 2007
2007 vs. 2006
$
1,458
$
28,396
$
9,410
$
(26,938
)
$
18,986
(95
%)
>100
%
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Percentage
Percentage
Increase/
Increase/
Increase/
Increase/
Years ended December 31,
(Decrease)
(Decrease)
(Decrease)
(Decrease)
2008
2007
2006
2008 vs. 2007
2007 vs. 2006
2008 vs. 2007
2007 vs. 2006
$
(69,572
)
$
$
$
69,572
$
n/a
n/a
Percentage
Percentage
Increase/
Increase/
Increase/
Increase/
Years ended December 31,
(Decrease)
(Decrease)
(Decrease)
(Decrease)
2008
2007
2006
2008 vs. 2007
2007 vs. 2006
2008 vs. 2007
2007 vs. 2006
$
$
(79,178
)
$
$
(79,178
)
$
79,178
n/a
n/a
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Payments due by period
<=1 yr
2-3 yrs
4-5 yrs
Total
2009
2010-2011
2012-2013
2014+
$
241,153
$
6,986
$
13,972
$
220,195
$
38,822
4,717
9,659
10,022
14,424
17,042
17,042
8,000
1,000
2,000
2,000
3,000
$
305,017
$
29,745
$
25,631
$
232,217
$
17,424
(1)
The above table does not include certain commitments and contingencies which are discussed in
Note 8 of Item 8. Financial Statements and Supplementary Data.
(2)
Substantially all of this amount was subject to open purchase orders as of December 31, 2008
that were issued under existing contracts. This amount does not represent minimum contract
termination liability.
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Page
53
55
56
57
58
59
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March 4, 2009
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March 4, 2009
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(In thousands, except per share information)
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(in thousands, except per share information)
Years ended December 31,
2008
2007
2006
$
41,255
$
180,755
$
153,556
48,930
92,272
64,162
$
90,185
$
273,027
$
217,718
28,216
137,696
113,921
6,821
9,821
4,168
154,417
153,575
149,381
51,497
57,282
82,358
1,458
28,396
9,410
(69,572
)
(79,178
)
1,583
17,710
$
172,837
$
309,175
$
376,948
(82,652
)
(36,148
)
(159,230
)
12,495
22,201
23,646
(15,192
)
(18,638
)
(20,793
)
58
1,133
2,444
50,149
47,510
4,696
5,297
$
(35,142
)
$
(31,452
)
$
(153,933
)
(806
)
1,309
828
$
(34,336
)
$
(32,761
)
$
(154,761
)
$
(0.37
)
$
(0.36
)
$
(1.72
)
92,407
91,876
89,789
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(in thousands)
Accumulated
Preferred Shares
Common Shares
Capital In
Other
Total
Amount
Excess of
Deferred
Comprehensive
Accumulated
Stockholders
Shares
Paid In
Shares
Par Value
Par Value
Compensation
Income/(Loss)
Deficit
Equity
20
87,707
$
9
$
1,233,690
$
(2,949
)
$
(1,707
)
$
(902,232
)
$
326,811
2,326
20,642
20,642
29,143
29,143
(2,949
)
2,949
(20
)
1,023
12
212
3,425
3,425
31
31
1,769
1,769
(154,761
)
(154,761
)
(152,992
)
91,280
$
9
$
1,283,982
$
$
62
$
(1,056,993
)
$
227,060
761
2,915
2,915
13,193
13,193
260
2,451
2,451
1,581
1,581
(32,761
)
(32,761
)
(31,180
)
92,301
$
9
$
1,302,541
$
$
1,643
$
(1,089,754
)
$
214,439
146
122
122
9,871
9,871
56
262
262
(204
)
(204
)
(34,336
)
(34,336
)
(34,540
)
92,503
$
9
$
1,312,796
$
$
1,439
$
(1,124,090
)
$
190,154
(1)
Employee plans include Employee Stock Purchase Plan (ESPP) and 401K Plan
Table of Contents
(in thousands)
Years ended December 31,
2008
2007
2006
$
(34,336
)
$
(32,761
)
$
(154,761
)
(69,572
)
(50,149
)
22,489
29,028
33,509
9,871
14,779
30,982
1,458
28,396
9,410
1,251
109
(3,003
)
10,476
24,318
(34,654
)
2,868
1,503
3,971
1,166
7,443
1,095
6,181
(3,147
)
(8,926
)
(3,382
)
986
3,581
14,727
907
1,322
(40,444
)
40,444
(1,332
)
(5,200
)
4,181
(15,392
)
40,863
16,245
(1,662
)
(1,366
)
4,333
$
(145,782
)
$
146,302
$
(92,715
)
114,831
(4,236
)
(18,855
)
(32,796
)
(22,524
)
588,168
591,202
405,622
70,060
2,057
2,252
(475,316
)
(593,118
)
(502,230
)
$
274,652
$
(32,655
)
$
(116,880
)
384
3,780
22,259
(2,368
)
(2,895
)
(10,488
)
(47,757
)
(102,653
)
$
(49,741
)
$
(101,768
)
$
11,771
162
654
311
$
79,291
$
12,533
$
(197,513
)
76,293
63,760
261,273
$
155,584
$
76,293
$
63,760
$
14,706
$
17,389
$
17,751
$
812
$
801
$
$
$
4,445
$
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Years ended December 31,
2008
2007
2006
13,804
15,781
16,896
14,147
11,108
8,901
13
27,951
26,889
25,810
Table of Contents
Estimated Fair Value at
December 31, 2008
December 31, 2007
$
155,584
$
76,293
223,410
406,060
$
378,994
$
482,353
Estimated Fair Value at
December 31, 2008
December 31, 2007
$
115,658
$
293,866
26,275
100,727
91,667
37,333
145,394
50,427
$
378,994
$
482,353
Table of Contents
Level 1
Level 2
Level 3
Total
$
134,686
$
$
$
134,686
115,658
115,658
26,275
26,275
91,667
91,667
$
134,686
$
233,600
$
$
368,286
10,708
$
378,994
December 31,
2008
2007
$
6,964
$
9,522
1,743
1,749
612
916
$
9,319
$
12,187
December 31,
2008
2007
$
62,260
$
114,210
24,549
48,425
8,682
18,493
14,717
21,169
6,875
18,374
$
117,083
$
220,671
( 43,505
)
(106,251
)
$
73,578
$
114,420
Table of Contents
Semi-Annual
December 31,
Interest Payment Dates
2008
2007
March 28, September 28
$
214,955
$
315,000
Table of Contents
December 31,
2008
2007
$
23,962
$
23,962
261
591
1,602
$
24,223
$
26,155
(8,050
)
(6,124
)
$
16,173
$
20,031
$
4,717
4,752
4,907
4,958
5,064
14,424
$
38,822
(17,190
)
$
21,632
(1,285
)
$
20,347
Table of Contents
Table of Contents
Table of Contents
As of December 31, 2008
9,989
28,922
161
220
39,292
Number of securities remaining
available for issuance under
Number of securities to be
Weighted-average
equity compensation plans
issued upon exercise of
exercise price of
(excluding securities reflected
outstanding options
outstanding options
in column(a))
Plan Category
(a) (1)
(b)
(c)
7,833
$
12.53
12,443
5,948
$
11.66
2,827
13,781
$
12.16
15,270
(1)
Does not include options 31,738 shares we assumed in connection with the acquisition of
Shearwater Corporation (with a weighted-average exercise price of $0.03 per share).
(2)
Includes shares of common stock available for future issuance under our ESPP as of December
31, 2008.
Table of Contents
Table of Contents
Table of Contents
Years ended December 31,
Partner
Agreement
2008
2007
2006
Tobramycin inhalation powder (TIP)
$
13,723
$
17,036
$
8,516
Cipro Inhale
11,653
8,116
4,884
BAY41-6651 (NKTR-061, Amikacin Inhale)
10,054
1,306
Exubera
®
inhalation powder
49,490
33,674
Next-generation inhaled insulin (NGI)
13,500
16,324
17,088
$
48,930
$
92,272
$
64,162
Table of Contents
dry powder and liquid pulmonary technology platform including but not limited to our
pulmonary inhalation devices, formulation technology, manufacturing technology and related
intellectual property;
manufacturing and associated development services payments for the Cipro Inhale program;
manufacturing and royalty rights to the TIP program;
capital equipment, information systems and facility lease obligations for our pulmonary
development and manufacturing facility in San Carlos, California;
certain other interests that we had in two private companies, Pearl Therapeutics Inc. and
Stamford Devices Limited; and
approximately 140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing operations, whom Novartis hired immediately
following the closing of the transaction.
Table of Contents
Year ended December 31, 2008
$
115,000
(4,609
)
(37,291
)
(2,658
)
(1,930
)
1,060
$
69,572
Table of Contents
Year ended December 31, 2007
$
135,000
(13,765
)
(18,598
)
102,637
(23,459
)
$
79,178
Years ended December 31,
2008
2007
2006
$
1,458
$
$
28,396
1,156
2,757
5,497
$
1,458
$
28,396
$
9,410
Table of Contents
Years ended December 31,
2008
2007
$
148
$
974
1,221
3,087
5,791
517
1,617
$
4,973
$
8,382
Table of Contents
2007 Plan
2008 Plan
Total
$
580
$
$
580
4,973
4,973
(580
)
(4,868
)
(5,448
)
$
$
105
$
105
Years ended December 31,
2008
2007
2006
$
269
$
1,003
$
1,614
4,642
6,275
9,692
4,960
5,915
17,837
$
9,871
$
13,193
$
29,143
As of
December 31,
Fiscal Year
2008
$
8,080
6,845
5,662
966
$
21,553
Year ended December 31, 2008
Year ended December 31, 2007
Year ended December 31, 2006
Employee
Employee
Employee
Stock Options
ESPP
Stock Options
ESPP
Stock Options
ESPP
2.5
%
2.00
%
4.2
%
4.8
%
4.8
%
5.2
%
0.0
%
0.0
%
0.0
%
0.0
%
0.0
%
0.0
%
51.58
%
72.34
%
53.3
%
38.4
%
63.1
%
33.3
%
4.97 years
0.5 years
5.09 years
0.5 years
5.20 years
0.5 years
Table of Contents
Weighted-
Weighted-
Average
Average
Options Outstanding
Exercise
Remaining
Aggregate
Number of
Exercise Price
Price
Contractual
Intrinsic
Shares
Per Share
Per Share
Life (in years)
Value (1)
13,253
$
0.0161.63
$
17.85
5.38
$
37,678
1,115
14.3621.51
17.88
(2,160
)
0.0520.41
9.51
$
18,651
(1,501
)
4.6252.16
21.86
10,707
$
0.0161.63
$
18.97
4.78
$
15,348
5,257
5.9815.24
9.87
(429
)
0.0114.25
6.80
$
1,770
(3,323
)
4.5055.19
18.47
12,212
$
0.0161.63
$
15.62
5.20
$
643
6,180
2.837.13
6.02
(39
)
0.037.33
5.72
$
42
(4,802
)
0.0161.63
12.93
13,551
$
0.0160.88
$
12.13
4.84
$
2,032
7,144
$
16.57
2.89
$
276
7,023
$
19.15
3.64
$
584
8,185
$
19.88
4.09
$
12,229
(1)
Aggregate Intrinsic Value represents the difference between the exercise price of the option
and the closing market price of our common stock on the exercise date or December 31, as
applicable.
Options Outstanding
Options Exercisable
Range of
Weighted-Average
Weighted-Average
Weighted-Average
Exercise
Exercise Price Per
Remaining Contractual
Exercise Price Per
Prices
Number of Shares
Share
Life (in years)
Number of Shares
Share
1,505
$
4.34
7.40
38
$
0.20
1,376
$
5.99
6.24
521
$
5.97
2,590
$
6.65
5.99
499
$
6.65
1,463
$
7.01
5.99
568
$
7.04
1,423
$
9.86
4.64
970
$
9.88
1,626
$
13.97
3.74
1,162
$
13.90
1,373
$
17.55
3.47
1,216
$
17.62
1,864
$
26.16
1.99
1,839
$
26.24
331
$
37.91
1.12
331
$
37.91
13,551
$
12.13
4.84
7,144
$
16.57
Table of Contents
Weighted-Average
Remaining
Weighted-Average
Aggregate
contractual Life
Grant-Date
Intrinsic
Units Issued
(in years)
Fair value(1)
Value
284
1.14
$
4,676
1,088
$
19.55
(178
)
$
3,184
(110
)
1,084
1.52
$
16,479
345
$
11.01
(334
)
$
3,808
(360
)
735
2.03
$
4,925
48
$
5.26
(107
)
$
487
(411
)
265
2.48
$
1,472
(1)
Fair value represents the difference between the exercise price of the award and the closing
market price of our common stock on the release date or the year ended December 31, 2008 as
applicable.
Table of Contents
Years ended December 31,
2008
2007
2006
$
(69,350
)
$
(30,143
)
$
(147,059
)
34,208
(1,309
)
(6,874
)
$
(35,142
)
$
(31,452
)
$
(153,933
)
Years ended December 31,
2008
2007
2006
$
(970
)
$
194
$
(69
)
782
6
519
333
(520
)
1,309
6
822
(286
)
(286
)
822
$
(806
)
$
1,309
$
828
Table of Contents
Years ended December 31,
2008
2007
2006
$
(12,300
)
$
(10,998
)
$
(52,337
)
(69
)
782
6
29,768
27,829
50,385
(11,754
)
(4,777
)
(2,366
)
(13,109
)
(1,431
)
1,508
14
210
2,138
(3,604
)
636
601
199
$
(806
)
$
1,309
$
828
December 31,
2008
2007
$
289,631
$
254,419
50,350
47,274
4,563
6,670
28,659
11,050
7,423
9,629
24,495
20,315
16,375
3,918
5,163
6,170
408,310
377,794
(402,907
)
(375,318
)
$
5,403
$
2,476
(1,479
)
(3,352
)
(2,476
)
(286
)
$
(5,117
)
$
(2,476
)
$
286
$
Table of Contents
December 31,
2008
2007
$
9,222
$
7,176
2,438
2,046
$
11,660
$
9,222
Table of Contents
Years ended December 31,
2008
2007
2006
$
30,800
$
212,990
$
182,959
59,385
60,037
33,471
1,288
$
90,185
$
273,027
$
217,718
Fiscal Year 2008
Fiscal Year 2007
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
$
10,371
$
9,010
$
9,474
$
12,400
$
71,355
$
47,001
$
35,697
$
26,702
$
9,621
$
11,392
$
11,965
$
15,952
$
13,661
$
18,916
$
20,624
$
39,071
$
3,144
$
3,566
$
4,125
$
2,204
$
15,727
$
8,626
$
9,391
$
9,315
$
37,373
$
33,500
$
38,265
$
45,279
$
37,492
$
41,000
$
35,773
$
39,310
$
11,947
$
13,329
$
12,386
$
13,835
$
16,971
$
13,415
$
12,663
$
14,233
$
$
$
$
1,458
$
$
$
$
28,396
$
$
$
$
(69,572
)
$
$
$
$
$
$
$
$
$
$
$
$
(79,178
)
$
(41,889
)
$
(33,358
)
$
(34,561
)
$
27,156
$
(25,969
)
$
(27,988
)
$
(19,572
)
$
37,381
$
3,918
$
3,929
$
3,988
$
3,357
$
4,933
$
4,702
$
4,773
$
4,230
$
$
$
$
50,149
$
$
$
$
$
(40,705
)
$
(33,375
)
$
(37,038
)
$
76,782
$
(25,673
)
$
(27,510
)
$
(18,620
)
$
39,042
$
(0.44
)
$
(0.36
)
$
(0.40
)
$
0.83
$
(0.28
)
$
(0.30
)
$
(0.20
)
$
0.42
(1)
Exubera commercialization readiness revenue was reclassified from Product sales and royalties
to Collaboration and other revenue.
(2)
Amortization of other intangible assets was previously separately disclosed, but has been
combined with General and administrative expenses for the years ended December 31, 2008, 2007,
and 2006.
(3)
Quarterly loss per share amounts may not total the year-to-date loss per share due to
rounding.
(4)
During the fourth quarter of 2008 and 2007, there were approximately 81 dilutive shares and
578 dilutive shares, respectively, outstanding which did not change earnings per share.
Table of Contents
Charged to
Balance at
Costs and
Balance At
Beginning
Expenses,
End
Description
of Year
Net of Reversals
Utilizations
of Year
(In thousands)
$
33
$
61
$
(2
)
$
92
$
5,772
$
2,668
$
(3,451
)
$
4,989
$
357
$
(16
)
$
(308
)
$
33
$
4,160
$
4,670
$
(3,058
)
$
5,772
$
70
$
380
$
(93
)
$
357
$
3,068
$
2,592
$
(1,500
)
$
4,160
Table of Contents
Table of Contents
Table of Contents
Page
53
55
56
57
58
59
Exhibit
Number
Description of Documents
2.1
(23
)
3.1
(1
)
3.2
(2
)
3.3
(3
)
3.4
(4
)
3.5
(5
)
3.6
(6
)
4.1
4.2
(5
)
4.3
(3
)
4.4
(3
)
4.5
(7
)
4.6
(7
)
Table of Contents
Exhibit
Number
Description of Documents
10.1
(8
)
10.2
(9
)
10.3
(10
)
10.4
(11
)
10.5
(11
)
10.6
(12
)
10.7
(13
)
10.8
(14
)
10.9
(12
)
10.10
(15
)
10.11
(15
)
10.12
(15
)
10.13
(15
)
10.14
(22
)
10.15
(10
)
10.16
(22
)
10.17
(23
)
10.18
(17
)
10.19
(18
)
10.20
(23
)
10.21
(23
)
10.22
(23
)
10.23
(19
)
10.24
(20
)
10.25
(15
)
10.26
(23
)
10.27
(23
)
10.28
(23
)
Table of Contents
Exhibit
Number
Description of Documents
10.29
(23
)
10.30
(15
)
10.31
(21
)
10.32
(15
)
10.33
(16
)
10.34
(23
)
10.35
(23
)
21.1
(23
)
23.1
(23
)
24
31.1
(23
)
31.2
(23
)
32.1
*
(23
)
+
Confidential treatment with respect to specific portions of this
Exhibit has been requested, and such portions are omitted and have
been filed separately with the SEC.
++
Management contract or compensatory plan or arrangement.
*
Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing.
(1)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1998.
(2)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2000.
(3)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 4, 2001.
(4)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 8, 2002.
(5)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 23, 2003.
(6)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on December 12, 2007.
(7)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on September 28, 2005.
Table of Contents
(8)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1996.
(9)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-98321), filed on August 19, 2002.
(10)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2004.
(11)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended.
(12)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on
Form 10-K, as amended, for the year ended December 31, 2005.
(13)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 7, 2006.
(14)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2000.
(15)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2007.
(16)
Incorporated by reference to the indicated exhibit in Nektar
Therapeutics Annual Report on
Form 10-K for the year ended December 31, 2007.
(17)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K/A, filed on March 16, 2006.
(18)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006.
(19)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on November 21, 2008.
(20)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 2, 2009.
(21)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2006.
(22)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended March 31, 2008.
(23)
Filed herewith.
Table of Contents
By:
/s/
John Nicholson
John Nicholson
Senior Vice President and Chief Financial Officer
By:
/s/
Jillian B. Thomsen
Jillian B. Thomsen
Vice President and Chief Accounting Officer
Table of Contents
SIGNATURE
TITLE
DATE
/s/
Howard W. Robin
Chief Executive Officer, President and Director (Principal
Executive Officer)
March 6, 2009
/s/
John Nicholson
Senior Vice President and Chief Financial Officer (Principal
Financial Officer)
March 6, 2009
/s/
Jillian B, Thomsen
Vice President Finance and Chief Accounting Officer (Principal
Accounting Officer)
March 6, 2009
/s/
Robert B. Chess
Director, Chairman of the Board of Directors
March 6, 2009
/s/
Michael A. Brown
Director
March 6, 2009
/s/
Hoyoung Huh
Director
March 6, 2009
/s/
Joseph J. Krivulka
Director
March 6, 2009
/s/
Christopher A. Kuebler
Director
March 6, 2009
/s/
Lutz Lingnau
Director
March 6, 2009
/s/
Susan Wang
Director
March 6, 2009
/s/
Roy A. Whitfield
Director
March 6, 2009
Table of Contents
Exhibit
Number
Description of Documents
2.1
(23
)
3.1
(1
)
3.2
(2
)
3.3
(3
)
3.4
(4
)
3.5
(5
)
3.6
(6
)
4.1
4.2
(5
)
4.3
(3
)
4.4
(3
)
4.5
(7
)
4.6
(7
)
10.1
(8
)
10.2
(9
)
10.3
(10
)
10.4
(11
)
10.5
(11
)
10.6
(12
)
10.7
(13
)
10.8
(14
)
10.9
(12
)
10.10
(15
)
10.11
(15
)
10.12
(15
)
10.13
(15
)
Table of Contents
Exhibit
Number
Description of Documents
10.14
(22
)
10.15
(10
)
10.16
(22
)
10.17
(23
)
10.18
(17
)
10.19
(18
)
10.20
(23
)
10.21
(23
)
10.22
(23
)
10.23
(19
)
10.24
(20
)
10.25
(15
)
10.26
(23
)
10.27
(23
)
10.28
(23
)
10.29
(23
)
10.30
(15
)
10.31
(21
)
10.32
(15
)
10.33
(16
)
10.34
(23
)
10.35
(23
)
21.1
(23
)
23.1
(23
)
Table of Contents
Exhibit
Number
Description of Documents
24
31.1
(23
)
31.2
(23
)
32.1
*
(23
)
+
Confidential treatment with respect to specific portions of this
Exhibit has been requested, and such portions are omitted and have
been filed separately with the SEC.
++
Management contract or compensatory plan or arrangement.
*
Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing.
(1)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1998.
(2)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2000.
(3)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 4, 2001.
(4)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 8, 2002.
(5)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 23, 2003.
(6)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on December 12, 2007.
(7)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on September 28, 2005.
(8)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1996.
(9)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-98321), filed on August 19, 2002.
(10)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2004.
(11)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended.
(12)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on
Form 10-K, as amended, for the year ended December 31, 2005.
(13)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 7, 2006.
(14)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2000.
(15)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2007.
(16)
Incorporated by reference to the indicated exhibit in
Nektar Therapeutics Annual Report on Form 10-K for the year ended December 31, 2007.
(17)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K/A, filed on March 16, 2006.
(18)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006.
(19)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on November 21, 2008.
(20)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 2, 2009.
(21)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2006.
(22)
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended March 31, 2008.
(23)
Filed herewith.
2
3
4
5
6
7
8
Defined Term | Section | |
401(k) Plan
|
5.7(c) | |
1060 Forms
|
3.2(a) | |
Acquisition
|
Recitals | |
Acquisition Proposal
|
5.3 | |
Adjustment
|
2.5(c) | |
Agreement
|
Preamble | |
Applicable Period
|
5.3 | |
ARC
|
5.5(b) | |
Assignment and Assumption Agreement
|
8.2(d) | |
Assumed Liabilities
|
2.2(a) | |
[***]
|
[***] | |
Building
|
4.1(e) | |
Business
|
Recitals | |
Buyer
|
Preamble | |
Buyers 401(k) Plan
|
5.7(c) | |
[***]
|
[***] |
9
Defined Term | Section | |
CIP Royalties
|
2.1(b)(vii) | |
Closing
|
7.1 | |
Closing Date
|
7.1 | |
COBRA
|
5.7(h) | |
Company
|
Preamble | |
Company Plan
|
4.1(k)(i) | |
Consents
|
2.4(a) | |
Corporate Records
|
2.1(b)(v) | |
Direct Claim
|
10.4(b) | |
DOJ
|
5.5(b) | |
ERISA Affiliate
|
4.1(k)(iii) | |
Excluded Contracts
|
2.1(b)(xii) | |
FTC
|
5.5(b) | |
GFCO
|
5.5(b) | |
Identified Employee
|
5.7(a) | |
indemnified party
|
10.3 | |
indemnifying party
|
10.3 | |
Intangibles Purchaser
|
Preamble | |
Material Contracts
|
4.1(p)(2) | |
Nonassignable Asset
|
2.4 | |
Option
|
4.1(e) | |
Pearl
|
2.1(a)(ix) | |
Purchase Price
|
3.1 | |
Related Person
|
4.1(o) | |
Retained Assets
|
2.1(b) | |
Retained Liabilities
|
2.2(b) | |
[***]
|
[***] | |
SEDS Contracts
|
4.1(q)(x) | |
SEDS Option Period
|
5.15(a) | |
SEDS Notice
|
5.15(a) | |
Seller Parties
|
5.1(c) | |
Severance Costs
|
5.7(a) | |
Stamford
|
2.1(a)(ix) | |
Termination Date
|
9.1(b) | |
Third Party Claim
|
10.4(a) | |
[***]
|
[***] | |
Transfer Costs
|
2.2(b)(v) | |
Transferred 201 Assets
|
2.1(a)(iii) | |
Transferred Assets
|
2.1(a) | |
Transferred Licenses
|
2.1(a)(v) | |
Transferred Employees
|
5.7(a) | |
Transferred Share Agreements
|
2.1(a)(ix) | |
Transferred Shares
|
2.1(a)(ix) | |
Transferring Subsidiary
|
Preamble | |
Violation
|
4.1(c) | |
WARN
|
5.2(a)(xi) |
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
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
COMPANY
NEKTAR THERAPEUTICS |
||||
By: | /s/ Gil M. Labrucherie | |||
Name: | Gil M. Labrucherie | |||
Title: | General Counsel |
TRANSFERRING SUBSIDIARY
AEROGEN, INC. |
||||
By: | /s/ Gil M. Labrucherie | |||
Name: | Gil M. Labrucherie | |||
Title: | Secretary | |||
BUYER
NOVARTIS PHARMACEUTICALS CORPORATION |
||||
By: | /s/ Ludwig Hantson | |||
Name: | Ludwig Hantson | |||
Title: | Chief Executive Officer | |||
INTANGIBLES PURCHASER
NOVARTIS PHARMA AG |
||||
By: | /s/ Joseph Jimenez | |||
Name: | Joseph Jimenez | |||
Title: | Chief Executive Officer | |||
By: | /s/ Jörg Walther | |||
Name: | Jörg Walther | |||
Title: | Authorized Signatory | |||
NEKTAR UK
NEKTAR THERAPEUTICS UK LIMITED |
|||
By: | /s/ Gil M. Labrucherie | ||
Name: | Gil M. Labrucherie | ||
Title: | Director | ||
|
The participant must execute and deliver to the Company a Separation and General Release
Agreement in substantially the form attached hereto as
Exhibit A
and must not revoke
such agreement within any revocation period provided under applicable law.
|
|
If the participant is notified by the Company or Successor Company that his or her
employment will be terminated following a Change of Control in advance of his or her
termination date, the participant must not voluntarily terminate his or her employment or fail
to perform his or her assigned duties prior to the termination date established by the Company
or Successor Company.
|
|
The participant must not at any time have engaged in conduct that would be Cause for
termination, as defined in Section 3.3 below, as determined by the Plan Administrator in its
sole discretion. The Plan Administrator shall have the discretion to terminate any and all
severance benefits provided under this Plan to a participant who is discovered to have engaged
in such conduct, regardless of when such discovery occurs.
|
|
Officer Participants
. For a participant who is an officer holding a position of
Executive Chairman, Chief Executive Officer, President, Chief Operating Officer, Business Unit
Head, Chief Scientific Officer, Chief Development Officer, Chief Technical Officer, Chief
Financial Officer, Senior Vice President, Vice President or Principal Fellow (an Officer
Participant), a Covered Termination is the involuntary termination of the participants
employment by the Company or Successor Company without Cause, other than on account of the
participants death or disability, or the participants Good Reason Resignation, which (i)
termination occurs at the request of a third party in the context of discussions regarding a
Change of Control or (ii) termination or resignation occurs within the period beginning with
the execution of an agreement providing for a Change of Control (and such Change of Control is
consummated) and ending 12 months following the Change of Control.
|
|
Non-Officer Participants
. For any other participant (a Non-Officer Participant),
a Covered Termination is the involuntary termination of the participants employment by the
Company or Successor Company without Cause, other than on account of the participants death
or disability, which termination occurs within the period beginning on the date of the Change
of Control and ending 12 months following the Change of Control.
|
2
|
Termination of Employment Asset Sale
. Notwithstanding anything else contained in
this Plan to the contrary, a participant shall not be entitled to benefits under this Plan as
a result of a termination of the participants employment with the Company or Successor
Company if such termination of employment occurs in connection with a sale of assets by the
Company or Successor Company and each of the following conditions is satisfied in connection
with such sale: (1) the participant becomes employed by the purchaser (which term shall
include
for these purposes a parent, subsidiary, or other affiliated entity of such purchaser) of such
assets upon or within sixty (60) days following such sale or such purchaser offers the
participant employment effective upon or within sixty (60) days following such sale (regardless
of whether the participant actually accepts or commences such employment) on substantially the
same terms; and (2) such purchaser adopts this Plan (or a substantially similar severance plan)
to provide the participant with substantially the same severance protections afforded by this
Plan had this Plan continued in effect as to the participant after such sale on its terms
(subject, without limitation, to any such entitys right to terminate this Plan as provided
herein). Whether employment is on substantially the same terms for this purpose shall be
determined by comparing the relevant aspects of the terms of the participants employment before
giving effect to such asset sale to the relevant aspects of the terms of the participants
employment (or offer of employment, as the case may be) with the purchaser after giving effect
to such asset sale (in each case relative to the Company and its subsidiaries, or the purchaser
and its parent, subsidiary, and other affiliated entities, as the case may be, on a consolidated
basis, not simply with reference to the participants employer).
|
|
An employees conviction of any felony or any crime involving fraud, dishonesty or moral
turpitude;
|
|
An employees commission of, or participation in, a fraud or act of dishonesty against the
Company or Successor Company that materially benefits the employee;
|
|
An employees intentional, material violation of any contract or agreement between the
employee and the Company or Successor Company or of any statutory or fiduciary duty owed to
the Company or Successor Company;
|
|
An employees intentional unauthorized use of Company or Successor Company property that
materially benefits the employee or intentional unauthorized use or disclosure of Company or
Successor Company confidential information or trade secrets;
|
|
An employees intentional gross misconduct or intentional material failure to comply with
the Companys or Successor Companys written policies; or
|
|
An employees intentional material failure or refusal to perform his or her position
responsibilities, other than on account of a mental or physical disability.
|
3
|
Assignment of any authority, duties or responsibilities that results in a material
diminution in the participants authority, duties or responsibilities as in effect immediately
prior to the Change of Control.
|
|
Assignment to a work location more than 50 miles from the participants immediately
previous work location, unless such reassignment of work location decreases the participants
commuting distance from his or her residence to his or her assigned work location.
|
|
A material diminution in the participants monthly base salary as in effect on the date of
the Change of Control or as increased thereafter.
|
|
Notice to the participant by the Company or Successor Company during the 12-month period
following the Change of Control that the participants employment will be terminated under
circumstances that would be a Covered Termination but for the designation of a date for
termination that is greater than 12 months following the Change of Control (provided that such
participant does in fact terminate his or her employment within the time period prescribed
below).
|
|
In the case of the Chief Executive Officer and President, such individual does not serve in
that position in the Successor Company (as defined below) and/or is not appointed to the board
of directors of the Successor Company.
|
|
The sale, lease or other disposition of all or substantially all of the Companys assets;
|
|
The acquisition of securities of the Company representing more than 50% of the combined
voting power of the Companys then outstanding securities, other than by virtue of a merger,
consolidation or similar transaction;
|
4
|
The merger, consolidation or similar transaction involving the Company, immediately after
which the stockholders of the Company immediately prior thereto do not own either
(i) outstanding voting securities representing more than 50% of the combined outstanding
voting power of the surviving entity in such merger, consolidation or similar transaction or
(ii) more than 50% of the combined outstanding voting power of the parent of the surviving
entity in such merger, consolidation or similar transaction, in each case in substantially the
same proportions as their ownership of the outstanding voting securities of the Company
immediately prior to such transaction; or
|
|
Individuals who, on the date the Plan is adopted by the Board, are members of the Board
(the Incumbent Board) cease for any reason to constitute at least a majority of the members
of the Board, provided, however, that if the appointment or election of any new Board member
was approved or recommended by a majority vote of the members of the Incumbent Board then
still in office, such new member will, for purposes of the Plan, be considered as a member of
the Incumbent Board.
|
|
Executive Chairman: Cash Severance Pay shall equal 24 months of monthly base salary plus
annual target incentive pay as in effect immediately prior to the Covered Termination or for
the immediately preceding calendar year, whichever is greater.
|
|
Chief Executive Officer and President: Cash Severance Pay shall equal 24 months of monthly
base salary plus annual target incentive pay as in effect immediately prior to the Covered
Termination or for the immediately preceding calendar year, whichever is greater.
|
|
Chief Scientific Officer, Chief Development Officer, Chief Financial Officer, Chief
Technical Officer, Chief Operating Officer and Business Unit Head: Cash Severance Pay shall
equal 12 months of monthly base salary plus annual target incentive pay as in effect
immediately prior to the Covered Termination or for the immediately preceding calendar year,
whichever is greater.
|
|
Senior Vice Presidents, Vice Presidents and Principal Fellows: Cash Severance Pay shall
equal 12 months of monthly base salary plus annual target incentive pay as in effect
immediately prior to the Covered Termination or for the immediately preceding calendar year,
whichever is greater.
|
5
|
All Other Participants: Cash Severance Pay shall equal 6 months of monthly base salary
plus annual target incentive pay as in effect immediately prior to the Covered Termination or
for the immediately preceding calendar year, whichever is greater.
|
|
any severance benefits (including, without limitation, any other change-in-control
severance benefits and any other severance benefits generally) that the participant may be
entitled to under any other plan or program with the Company. For purposes of the foregoing,
any cash severance benefits payable to the participant under any other plan or program with
the Company (including, without limitation, the Companys Severance Benefit Plan or any
similar successor plan) shall offset the Cash Severance Pay otherwise payable to the
participant under this Plan on a dollar-for-dollar basis. For purposes of the foregoing,
non-cash severance benefits to be provided to the participant under any other plan or program
with the Company shall offset any corresponding benefits otherwise to be provided to the
participant under this Plan or, if there are no corresponding benefits otherwise to be
provided to the participant under this Plan, the value of such benefits shall offset the cash
severance benefits otherwise payable to the participant under this Plan on a dollar-for-dollar
basis. If the amount of other benefits to be offset against the Cash Severance Pay otherwise
payable to the participant under this Plan in accordance with the preceding two sentences
exceeds the amount of Cash Severance Pay otherwise payable to the participant under this Plan,
then the excess may be used to offset other non-cash severance benefits otherwise to be
provided to the participant under this Plan on a dollar-for-dollar basis. For purposes of
this paragraph, the Plan Administrator shall reasonably determine the value of any non-cash
benefits;
|
|
any wages or wage replacement benefits paid or payable to the participant with respect to
any applicable notice period (including any pay in lieu of notice) in connection with the
participants termination of employment, whether such notice period is required under the
Worker Adjustment and Retraining Notification Act or any state law with respect to notice, if
applicable, or any Company policy, or any written agreement between the participant and the
Company;
|
|
the amount of any wages or other compensation the participant has received during a leave
of absence in excess of his or her accrued paid time off (other than disability plan income
replacement benefits); and
|
|
to the extent permitted by law, by any debt that the participant owes the Company at the
time the Cash Severance Pay becomes payable.
|
6
7
(i) |
If a reduction in the amount of the Payments by an amount up to but not in excess of ten
percent (10%) of the amount of the Payments would avoid the imputation of any Excise Tax on
the remaining Payments (after such reduction), then the Payments shall be reduced (but not
below zero) if and to the extent that such a reduction in the Payments would result in the
participant retaining a larger amount, on an after-tax basis (taking into account federal,
state and local income taxes and the Excise Tax), than if the participant received the entire
amount of the Payments. The Company shall reduce or eliminate the Payments by first reducing
or eliminating any Cash Severance Pay, then by reducing or eliminating any accelerated vesting
of equity awards, then by reducing or eliminating any other remaining Payments.
|
(ii) |
If a reduction in the amount of the Payments by 10% of the amount of the Payments would not
avoid the imputation of any Excise Tax on the remaining Payments (after such reduction), then
the Company shall pay to the participant (or to the applicable taxing authority on
participants behalf) an additional cash payment (the Gross-Up Payment) equal to an amount
such that after payment by the participant of all taxes, interest, penalties, additions to tax
and costs imposed or incurred with respect to the Gross-Up Payment (including, without
limitation, any income and excise taxes imposed upon the Gross-Up Payment), the participant
retains an amount of the Gross-Up Payment equal to the Excise Tax imposed upon such Payment or
Payments. The Gross-Up Payment, if triggered pursuant to this Section 4.7(ii), is intended to
put the participant in the same position as the participant would have been had no Excise Tax
been imposed upon or incurred as a result of any Payment. Any such Gross-Up Payment shall be
paid as soon as practicable and in all events no later than the end of the calendar year
following the year in which the participant remits the related taxes.
|
8
9
10
11
12
13
Sponsors Name and Address
:
|
Nektar Therapeutics
150 Industrial Road San Carlos, CA 94070 |
|
|
||
Plan Number
:
|
503 | |
|
||
Employer Identification Number
:
|
94-3134940 | |
|
||
Plan Administrator
:
|
Nektar Therapeutics
150 Industrial Road San Carlos, CA 94070 Tel: 650-631-3100 |
|
|
||
|
The Plan Administrator has delegated day-to-day | |
|
administration of the Plan to the following person: | |
|
Vice President, Human Resources | |
|
||
Agent to Receive Process
:
|
Nektar Therapeutics
150 Industrial Road San Carlos, CA 94070 Attn: General Counsel |
|
|
||
Type of Plan
:
|
The Plan is an unfunded employee welfare benefit plan. Benefits under the Plan are paid from the
general assets of Nektar Therapeutics. Benefits under the Plan are not insured by the Pension
Benefit Guaranty Corporation.
|
|
|
||
Effective Date
:
|
January 1, 2007 | |
|
||
Plan Year
:
|
The calendar year, from January 1 to December 31. |
14
1.
2.
3.
1 |
Section 12 will be included if the Employee is age 40
or older as of the date that the Employees employment with the Company
terminates or in such other circumstances (if any) as the Employee may have
claims under the ADEA. In the event Section 12 is included, whether the
Employee has 21 days, 45 days, or some other period in which to consider the
Release Agreement will be determined with reference to the requirements of the
ADEA in order for such waiver to be valid in the circumstances. The
determinations referred to in the preceding two sentences shall be made by the
Company in its sole discretion.
|
4.
5.
6.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Optionholder:
|
||||
Date of Grant:
|
|
|||
Vesting Commencement Date:
|
|
|||
Number of Shares Subject to Option:
|
|
|||
Exercise Price Per Share:
|
|
|||
Expiration Date:
|
|
|||
|
|
Exercise Schedule : | Same as Vesting Schedule | |||||||
Vesting Schedule : | of the shares vest one year after the Vesting Commencement Date. | |||||||
|
||||||||
of the shares vest monthly thereafter over the next | years. | |||||||
|
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|
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other agreements: | |||||||
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|||||||
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1
2
3
4
5
6
7
8
Participant:
|
||||
|
|
|||
Date of Grant:
|
||||
|
|
|||
Number of Restricted Stock Units:
|
||||
|
|
Vesting Schedule:
|
Subject to the limitations contained herein, the
Restricted Stock Units subject to this Award shall vest
as follows: (i)
_____% of the Restricted Stock Units
shall vest on [date], (ii)
_____% of the Restricted Stock
Units shall vest on [date], (iii)
_____% of the Restricted
Stock Units shall vest on [date], and (iv)
_____% of the
Restricted Stock Units shall vest on [date].
|
|
Other Agreements: |
|
||||||
|
|
Nektar Therapeutics: | Participant: | |||||||
|
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|||||||
By:
|
||||||||
|
Signature | Signature | ||||||
|
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|||||||
Name:
|
Date: | |||||||
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||||||||
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||||||||
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|||||||
Title:
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||||||||
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|||||||
Date:
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||||||||
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|
2
Sincerely,
|
||
|
||
/s/ Michael A. Brown
|
||
Michael A. Brown
|
||
Chairman, Organization and Compensation Committee of the Board of Directors
|
AGREED AND ACCEPTED:
|
||
|
||
/s/ Howard W. Robin
|
||
|
3
(1) |
Reimbursement for normal and customary closing costs actually incurred on the
sale of your New Jersey Home including but not limited to up to a 6% real estate sales
commission. Closing costs not considered deductible by you for tax purposes will be
grossed up and added to those costs that are considered deductible (which will be
subject to standard withholding).
|
(2) |
Reimbursement for normal and customary closing costs actually incurred in
connection with the purchase of a home in the San Francisco Bay Area (
California
Home
) including but not limited to up to 3% of the loan amount for
points/commission etc. Closing costs not considered deductible by you for tax purposes
will be grossed up and added to those costs that are considered deductible (which
will be subject to standard withholding).
|
(3) |
Reimbursement for shipment of your household goods from your New Jersey Home to
your California Home.
|
(4) |
Reimbursement for temporary housing for you in the San Francisco Bay Area and
reasonable expenses incurred in connection therewith through December 31, 2009, and
this benefit will be provided to you on a grossed up basis if determined to be
taxable to you.
|
(5) |
Nektar will reimburse you for your reasonable travel expenses to and from
Northern California and your New Jersey Home prior to your familys relocation to your
California Home.
|
(6) |
Following your relocation to California, you will then be entitled to a
one-time relocation bonus of $75,000 on grossed up basis (i.e. the total you receive
after applicable withholding will be $75,000).
|
2
3
Sincerely,
|
||||
/s/ Howard W. Robin | ||||
Howard W. Robin | ||||
President and Chief Executive Officer |
/s/ John Nicholson
|
4
2
Sincerely,
|
||||
/s/ Howard W. Robin | ||||
Howard W. Robin | ||||
President and Chief Executive Officer |
/s/ Bharatt M. Chowrira
|
3
|
Shipment of your household goods from Solano Beach, California to the San Francisco Bay
Area.
|
||
|
Subject to your continued employment through the first anniversary of your Start Date,
we will pay you $5,000 per month (subject to applicable tax withholdings) for the first 12
months of your employment to cover the cost of housing in the San Francisco Bay Area, such
amount to be paid to you each pay period (15
th
and 30
th
of the month)
on a prorata basis. (The cost of this housing is taxable to you and will be included in
your total W-2 income).
|
||
|
Travel expenses for you to the San Francisco Bay Area.
|
||
|
Use of a rental car for up to 14 days after your Start Date or until your car arrives.
|
2
|
Provide normal and customary closing costs on the sale of your home. Those items
considered not deductible for income tax purposes will be grossed up and added to those
costs considered deductible (this portion is subject to standard payroll withholding and
deductions). In no event will we reimburse you for more than 6% of the sale price.
|
||
|
Provide normal and customary single-family home purchase closing costs and loan discount
points (not to exceed 1%). Those items considered not deductible for income tax purposes
will be grossed up and added to those costs considered deductible (this portion is
subject to standard payroll withholding and deductions). In no event will we reimburse you
for more than 3% of the purchase price.
|
3
4
Sincerely,
|
||||
/s/ Howard W. Robin | ||||
Howard W. Robin | ||||
President and Chief Executive Officer |
/s/ Randall W. Moreadith
|
5
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
Page | ||||
|
||||
1. DEFINITIONS
|
2 | |||
|
||||
2. RESEARCH AND DEVELOPMENT ACTIVITIES
|
16 | |||
|
||||
2.1 OVERVIEW
|
16 | |||
|
||||
2.2 NEKTAR AL PAYMENTS
|
17 | |||
|
||||
2.3 MARKETING AUTHORIZATION
|
18 | |||
|
||||
2.4 MATERIALS
|
18 | |||
|
||||
2.5 HANDLING
|
20 | |||
|
||||
2.6 SELECTION OF POTENTIAL PRODUCTS AND [***]
|
20 | |||
|
||||
2.7 DISCLAIMER OF WARRANTY WITH RESPECT TO BAXTER MATERIALS
|
20 | |||
|
||||
3. GOVERNANCE
|
21 | |||
|
||||
3.1 JOINT STEERING COMMITTEE
|
21 | |||
|
||||
3.2 RESEARCH COMMITTEE
|
23 | |||
|
||||
3.3 DEVELOPMENT AND PRODUCTION COMMITTEE
|
25 | |||
|
||||
3.4 AMENDMENT; WAIVER
|
25 |
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-ii-
Page | ||||
|
||||
4. LICENSES TO NEKTAR AL LICENSED TECHNOLOGY AND BAXTER TECHNOLOGY
|
26 | |||
|
||||
4.1 LICENSE TO BAXTER
|
26 | |||
|
||||
4.2 TERMS OF SUBLICENSE
|
26 | |||
|
||||
4.3 NEKTAR AL RESEARCH RIGHTS AND LIMITATIONS
|
27 | |||
|
||||
4.4 NO IMPLIED RIGHTS OR LICENSES
|
28 | |||
|
||||
4.5 LICENSE TO NEKTAR AL
|
28 | |||
|
||||
4.6 MUTUAL COVENANT
|
28 | |||
|
||||
5. MANUFACTURE AND SUPPLY OF SELECTED REAGENTS
|
29 | |||
|
||||
5.1 [***]
|
29 | |||
|
||||
5.2 SUPPLY PRIOR TO PIVOTAL TRIAL/SUPPLY AGREEMENT
|
29 | |||
|
||||
5.3 PIVOTAL TRIAL AND COMMERCIAL PRODUCT SUPPLY AGREEMENT
|
30 | |||
|
||||
6. SPECIFICATIONS AND MANUFACTURING WARRANTY FOR SELECTED REAGENTS
|
31 | |||
|
||||
6.1 SPECIFICATIONS
|
31 | |||
|
||||
6.2 COMPLIANCE AUDITS
|
31 | |||
|
||||
6.3 WARRANTY
|
31 | |||
|
||||
6.4 DISCLAIMER OF WARRANTY
|
32 |
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-iii-
Page | ||||
|
||||
7. EXCLUSIVITY; [***]
|
33 | |||
|
||||
7.1 NEKTAR AL
|
33 | |||
|
||||
7.2 BAXTER
|
33 | |||
|
||||
8. QUALITY AND COMPLAINTS
|
34 | |||
|
||||
8.1 ANALYSIS
|
34 | |||
|
||||
8.2 ACCEPTANCE AND REJECTION
|
35 | |||
|
||||
8.3 REPLACEMENT OF NONCONFORMING REAGENT
|
36 | |||
|
||||
8.4 LIABILITY TO BAXTER FOR NONCONFORMING REAGENT
|
36 | |||
|
||||
8.5 [INTENTIONALLY OMITTED]
|
37 | |||
|
||||
8.6 FEES FOR MANUFACTURING AND SUPPLY OF SELECTED REAGENTS PRIOR TO PIVOTAL TRIAL
|
37 | |||
|
||||
9. MILESTONES; ROYALTY PAYMENTS; ROYALTY REPORTS
|
39 | |||
|
||||
9.1 MILESTONE PAYMENTS
|
39 | |||
|
||||
9.2 ROYALTIES
|
42 | |||
|
||||
9.3 SEPARATE COMPONENTS
|
45 | |||
|
||||
9.4 COMMERCIAL DILIGENCE
|
45 | |||
|
||||
9.5 REPORTS, EXCHANGE RATES
|
46 | |||
|
||||
9.6 THIRD PARTY ROYALTIES, ETC
|
47 |
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-iv-
Page | ||||
|
||||
10. RECORDS; AUDITS; SHIPMENT TERMS; PAYMENT TERMS
|
47 | |||
|
||||
10.1 RECORDS
|
47 | |||
|
||||
10.2 AUDITS
|
48 | |||
|
||||
10.3 INVOICING; PAYMENT TERMS
|
49 | |||
|
||||
10.4 PAYMENT METHOD
|
49 | |||
|
||||
10.5 TAXES
|
49 | |||
|
||||
11. CONFIDENTIALITY
|
50 | |||
|
||||
11.1 TERMINATION OF NON-DISCLOSURE AGREEMENT
|
50 | |||
|
||||
11.2 IN GENERAL
|
50 | |||
|
||||
11.3 ADDITIONAL PROTECTIONS
|
52 | |||
|
||||
11.4 PERMITTED DISCLOSURES
|
52 | |||
|
||||
11.5 IRREPARABLE INJURY
|
53 | |||
|
||||
12. REGULATORY MATTERS
|
53 | |||
|
||||
12.1 COMPLAINTS/ADVERSE EVENTS
|
53 | |||
|
||||
12.2 SPECIFIC REQUIREMENTS
|
53 | |||
|
||||
13. REPRESENTATIONS & WARRANTIES; COVENANTS
|
54 | |||
|
||||
13.1 REPRESENTATIONS AND WARRANTIES
|
54 | |||
|
||||
13.2 COMPLIANCE WITH LAWS
|
54 |
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-v-
Page | ||||
|
||||
14. LIMITATION OF LIABILITY; EXCLUSION OF DAMAGES
|
55 | |||
|
||||
14.1 LIMITATION OF LIABILITY
|
55 | |||
|
||||
14.2 REMEDIES
|
55 | |||
|
||||
14.3 APPLICABILITY, EXCLUSIVITY OF REMEDIES
|
56 | |||
|
||||
15. INDEMNIFICATION; INSURANCE
|
56 | |||
|
||||
15.1 INDEMNITY
|
56 | |||
|
||||
15.2 INSURANCE
|
57 | |||
|
||||
15.3 PROCEDURES
|
57 | |||
|
||||
16. INVENTIONS, KNOW-HOW AND PATENTS
|
59 | |||
|
||||
16.1 EXISTING INTELLECTUAL PROPERTY
|
59 | |||
|
||||
16.2 DISCLOSURE
|
59 | |||
|
||||
16.3 OWNERSHIP OF INVENTIONS
|
59 | |||
|
||||
16.4 NEKTAR AL CORE TECHNOLOGY INVENTIONS
|
60 | |||
|
||||
16.5 BAXTER CORE TECHNOLOGY INVENTIONS
|
61 | |||
|
||||
16.6 INDIVIDUAL PATENT FILINGS
|
61 | |||
|
||||
16.7 JOINT PATENT FILINGS
|
62 | |||
|
||||
16.8 DISPOSITION OF INVENTIONS
|
62 | |||
|
||||
16.9 FURTHER ACTIONS
|
63 | |||
|
||||
16.10 PATENT MARKING AND POTENTIAL PRODUCT AND
COMMERCIAL PRODUCT MARKING
|
63 | |||
|
||||
16.11 SUPPLEMENTAL PATENT PROTECTION
|
63 |
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-vi-
Page | ||||
|
||||
17. INFRINGEMENT
|
64 | |||
|
||||
17.1 INFRINGEMENT OF THIRD PARTY RIGHTS
|
64 | |||
|
||||
17.2 INFRINGEMENT BY THIRD PARTIES
|
65 | |||
|
||||
18. [INTENTIONALLY OMITTED]
|
67 | |||
|
||||
19. TERM AND TERMINATION
|
67 | |||
|
||||
19.1 EXPIRATION
|
67 | |||
|
||||
19.2 DISCRETIONARY TERMINATION
|
67 | |||
|
||||
19.3 TERMINATION FOR CAUSE
|
68 | |||
|
||||
19.4 TERMINATION FOR INSOLVENCY
|
68 | |||
|
||||
19.5 TERMINATION/[***] FOR LACK OF
DILIGENCE
|
68 | |||
|
||||
19.6 TERMINATION ON CHALLENGE
|
71 | |||
|
||||
19.7 EFFECT OF TERMINATION
|
71 |
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-vii-
Page | ||||
|
||||
20. ASSIGNMENT
|
74 | |||
|
||||
21. NOTICES
|
74 | |||
|
||||
22. MISCELLANEOUS
|
76 | |||
|
||||
22.1 FORCE MAJEURE
|
76 | |||
|
||||
22.2 SEVERABILITY
|
77 | |||
|
||||
22.3 VARIATION
|
77 | |||
|
||||
22.4 FORBEARANCE AND WAIVER
|
77 | |||
|
||||
22.5 COUNTERPARTS; FACSIMILE
|
77 | |||
|
||||
22.6 NO PARTNERSHIP
|
78 | |||
|
||||
22.7 CONSTRUCTION
|
78 | |||
|
||||
22.8 ENTIRE AGREEMENT
|
78 | |||
|
||||
22.9 GOVERNING LAW
|
79 | |||
|
||||
22.10 PUBLICITY
|
79 |
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-viii-
SCHEDULE I RESEARCH PLAN
|
|
SCHEDULE II MILESTONES
|
|
SCHEDULE III QUALITY AGREEMENT
|
|
SCHEDULE IV BAXTER DE ELOPMENT DILIGENCE TIMELINES
|
|
SCHEDULE V TERMS AND CONDITIONS OF SUPPLY AGREEMENT
|
|
SCHEDULE VI MANUFACTURING COST
|
|
SCHEDULE VII PERMITTED ACTIVITIES
|
|
EXHIBIT 1 BAXTER RESEARCH PLAN
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
-ix-
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
1
1.1 |
AFFILIATE means, with respect to any person or entity, any other person or
entity that directly or indirectly controls, is controlled by, or is under common
control with, such person or entity. For purposes of this definition only, control,
controlled by and under common control with shall mean the possession of the power
to direct or
cause the direction of the management and policies of an entity, whether through
the ownership of voting stock or partnership interest, by contract or otherwise. In
the case of a corporation, the direct or indirect ownership of fifty percent (50%)
or more of its outstanding voting shares or the ability otherwise to elect a
majority of the board of directors or other managing authority of the entity shall
in any event be deemed to confer control, it being understood that the direct or
indirect ownership of a lesser percentage of such shares shall not necessarily
preclude the existence of control.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
2
1.2 |
BAXTER CORE TECHNOLOGY means:
|
(i) |
[***];
|
||
(ii) |
a composition of a [***] as disclosed in any of the examples of
the [***] on the EFFECTIVE DATE, or [***] shall not fall within the BAXTER CORE
TECHNOLOGY and shall instead be considered JOINTLY OWNED TECHNOLOGY;
|
||
(iii) |
a method of: (a) [***]; provided that in each case none of
such methods employs a NEKTAR PROPRIETARY METHOD on the EFFECTIVE DATE.
|
||
(iv) |
methods of [***];
|
||
(v) |
methods of [***];
|
||
(vi) |
methods of [***];
|
||
(vii) |
[***];
|
||
(viii) |
methods of [***];
|
||
(ix) |
the methods [***];
|
||
(x) |
[***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
3
1.3 |
BAXTER CORE TECHNOLOGY INVENTIONS has the meaning set forth in Section 16.5.
|
||
1.4 |
BAXTER INDEMNITEE has the meaning set forth in Section 15.1.1.
|
1.5 |
BAXTER KNOW-HOW means all KNOW-HOW [***]. For the avoidance of doubt, [***]
are excluded from the definition of BAXTER KNOW-HOW.
|
||
1.6 |
BAXTER MATERIALS has the meaning set forth in Section 2.4.2.
|
1.7 |
BAXTER PATENT RIGHTS means all claims in those PATENTS and PATENT
APPLICATIONS (i) [***] and (ii) that [***].
|
1.8 |
BAXTER PROPRIETARY CONJUGATE means a CONJUGATE, the composition of matter,
manufacture, use, offer for sale, sale or import of which is covered by a claim of the
[***].
|
1.9 |
[***] means BAXTERs provisional patent applications [***] (the
PROVISIONALS), and any U.S. or other patent applications claiming priority therefrom,
including any continuation, divisional, reissue, reexamination or substitution (and in
each case any foreign counterpart thereto), and any extension, renewal or supplemental
protection certificate; provided that the only additional information that may be added
after the EFFECTIVE DATE to the disclosure of the PROVISIONALS (ADDITIONAL
INFORMATION) in the preparation of a U.S. or other patent application claiming
priority from the PROVISIONALS shall be [***]. For avoidance of doubt, BAXTER agrees
that (a) [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
4
1.10 |
BLA means a Biologics License Application filed with the FDA pursuant to 21
C.F.R. § 601.2 et seq., or any foreign equivalent filed with the regulatory
authorities in a country or territory to obtain MARKETING AUTHORIZATION for a
COMMERCIAL PRODUCT in such country or territory.
|
||
1.11 |
CLAIMS has the meaning set forth in Section 15.1.1.
|
||
1.12 |
COMMERCIAL DILIGENCE THRESHOLD has the meaning set forth in Section 9.4.
|
1.13 |
COMMERCIAL PRODUCT means any POTENTIAL PRODUCT that has received MARKETING
AUTHORIZATION which BAXTER, its AFFILIATES and/or SUBLICENSEES market and/or sell for
administration to or use by humans or animals.
|
||
1.14 |
CONFIDENTIAL INFORMATION has the meaning set forth in Section 11.2.
|
1.15 |
CONJUGATE(S) means any chemical entity obtained by the PEGYLATION of a
REAGENT to a therapeutic agent (including a THERAPEUTIC AGENT).
|
1.16 |
CONTRACT MANUFACTURER means a THIRD PARTY who (a) manufactures POTENTIAL
PRODUCT or COMMERCIAL PRODUCT on behalf of BAXTER as permitted herein, or (b)
manufactures SELECTED REAGENT as permitted under and pursuant to Schedule V.
|
1.17 |
CONTROL(LED) means the ability to grant a license or sublicense as provided
for herein without violating the terms of any agreement or other arrangement with any
THIRD PARTY and, with respect to KNOW-HOW, also means that which is not known to the
other PARTY prior to disclosure thereto (whether under this AGREEMENT or the
NON-DISCLOSURE AGREEMENT), nor freely available from the public domain or THIRD
PARTIES.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
5
1.18 |
DEVELOPMENT AND PRODUCTION COMMITTEE means the committee described in Section
3.3.
|
1.19 |
DISCLOSING PARTY means the PARTY disclosing CONFIDENTIAL INFORMATION to the
other PARTY hereunder.
|
1.20 |
DOLLAR(S) means United States dollars.
|
1.21 |
EMEA means the European Medicines Evaluation Agency, and any successor agency
thereto having the administrative authority to regulate the marketing of human
pharmaceutical products, biological therapeutic products and delivery systems in the
European Union.
|
1.22 |
ESTIMATED COST has the meaning set forth in Schedule VI.
|
1.23 |
[***] means a compound that is a [***]. For clarity, [***].
|
1.24 |
FACTOR VIII means a compound that is a Factor VIII molecule [***]. For
clarity, [***].
|
1.25 |
FDA means the United States Food and Drug Administration or any successor
entity that may be established hereafter which has substantially the same authority or
responsibility currently vested in the United States Food and Drug Administration.
|
1.26 |
FIELD means [***], either for use alone for the treatment of [***], in the
treatment of Hemophilia A, or PEGYLATED FACTOR VIII or [***] for the treatment of
Hemophilia A.
|
1.27 |
FIRST COMMERCIAL SALE means, with respect to a COMMERCIAL PRODUCT, the first
sale by BAXTER or its AFFILIATES or SUBLICENSEES to a THIRD PARTY following receipt of
MARKETING AUTHORIZATION for such
COMMERCIAL PRODUCT in the country of sale.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
6
1.28 |
FTE means the equivalent of an employee working [***] labor hours per year.
|
1.29 |
FTE RATE has the meaning set forth in Section 2.2. 1.30 GAAP has the
meaning set forth in Schedule VI.
|
1.31 |
INITIAL ROYALTY TERM has the meaning set forth in Section 9.2.
|
1.32 |
INVENTIONS means any and all ideas, concepts, methods, procedures, processes,
improvements, inventions and discoveries, whether or not patentable, that are conceived
or first reduced to practice during and in the course of the performance of activities
conducted in connection with this AGREEMENT, including the development or manufacture
of a POTENTIAL PRODUCT or a COMMERCIAL PRODUCT.
|
||
1.33 |
JOINT INVENTION has the meaning set forth in Section 16.3.
|
1.34 |
JOINT PATENT APPLICATIONS and JOINT PATENT have the meanings set forth in
Section 16.7.
|
||
1.35 |
JOINT STEERING COMMITTEE means the committee described in Section 3.1.
|
1.36 |
JOINTLY OWNED TECHNOLOGY means an INVENTION covering the composition of
[***].
|
1.37 |
KNOW-HOW means all technical, scientific and other know-how, data, materials,
information, trade secrets, ideas, formulae, inventions, discoveries, processes,
machines, compositions of matter, improvements, protocols, techniques, works of
authorship, and results of experimentation and testing (whether or not patentable) in
written, electronic, oral or any other form that is not known to the other PARTY prior
to disclosure thereto (whether under this AGREEMENT or the NON-DISCLOSURE
AGREEMENT), nor freely available from the public domain or from THIRD PARTIES.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
7
1.38 |
LAW(S) means any local, state or federal rule, regulation, statute or law in
any jurisdiction relevant to the activities undertaken pursuant to this AGREEMENT or
applicable to either of the PARTIES with respect to any matters set forth herein.
|
1.39 |
MAJOR MARKETS has the meaning set forth in Section 9.2.1.
|
||
1.40 |
MANUFACTURING COST has the meaning set forth in Schedule VI.
|
1.41 |
MARKETING AUTHORIZATION means the requisite governmental approval for the
marketing and sale of a COMMERCIAL PRODUCT in a given country.
|
||
1.42 |
MILESTONE means the milestone payments set forth in Schedule II.
|
||
1.43 |
NEKTAR AL CORE TECHNOLOGY means:
|
(i) |
[***];
|
||
(ii) |
methods of [***];
|
||
(iii) |
methods of [***];
|
||
(iv) |
methods of [***];
|
||
(v) |
methods of [***];
|
||
(vi) |
[***];
|
||
(vii) |
methods of [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
8
1.44 |
NEKTAR AL CORE TECHNOLOGY INVENTIONS has the meaning set forth in
Section 16.4.
|
||
1.45 |
NEKTAR AL INDEMNITEE has the meaning set forth in Section 15.1.2.
|
||
1.46 |
NEKTAR AL KNOW-HOW means all KNOW-HOW [***].
|
1.47 |
NEKTAR AL LICENSED TECHNOLOGY means, collectively, the NEKTAR AL PATENT
RIGHTS and NEKTAR AL KNOW-HOW.
|
||
1.48 |
NEKTAR AL MATERIALS has the meaning set forth in Section 2.4.1.
|
1.49 |
NEKTAR AL PATENT RIGHTS means all of the claims in those PATENTS and PATENT
APPLICATIONS CONTROLLED by NEKTAR AL which (i) pertain to [***].
|
||
1.50 |
NEKTAR PROPRIETARY METHODS means (i) [***].
|
1.51 |
NEKTAR PROPRIETARY REAGENT means a REAGENT, the composition of matter,
manufacture, use, offer for sale, sale or import of which is covered by [***].
|
1.52 |
NET SALES means the amount invoiced by BAXTER, its AFFILIATES or SUBLICENSEES
for the sale to THIRD PARTIES of COMMERCIAL PRODUCT commencing with the FIRST
COMMERCIAL SALE. [***]:
|
(i) |
[***];
|
||
(ii) |
[***];
|
||
(iii) |
[***];
|
||
(iv) |
[***];
|
||
(v) |
[***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
9
(A) |
[***];
|
||
(B) |
[***];
|
||
(C) |
[***].
|
1.53 |
NONCONFORMING REAGENTS has the meaning set forth in Section 6.3.
|
||
1.54 |
NON-DISCLOSURE AGREEMENT means that agreement entered into between the
PARTIES on [***], providing for confidential treatment of the PARTIES information.
|
1.55 |
PATENT means any claim in a patent including any extension, substitution,
registration, confirmation, reissue, supplemental protection certificate,
re-examination or renewal of such patent, to the extent valid and enforceable rights
are granted by a governmental authority thereunder (and in each case any foreign
counterpart thereto).
|
1.56 |
PATENT APPLICATION means any claim in an application for letters patent,
including a provisional application, converted provisional application, continuation
application, a continued prosecution application, a continuation-in-part application, a
divisional application, a re-examination application, and a reissue application (and
in each case any foreign counterpart thereto).
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
10
1.57 |
PEG means poly(ethylene) glycol.
|
1.58 |
PEGYLATION, with correlative meanings PEGYLATED or to PEGYLATE, means
covalent chemical bonding of any REAGENT (including a SELECTED REAGENT and including
covalent chemical bonding through linking groups), with or to another material or
materials. Such materials include, without limitation, proteins, peptides, polymers,
oligomers, oligonucleotides, other biomolecules, small molecules, therapeutic agents
(including a THERAPEUTIC AGENT), diagnostic agents, imaging agents and detectable
labels. Additional materials that may be PEGYLATED include, without limitation,
polymers, liposomes, films, chemical separation and purification surfaces, solid
supports, metal/metal oxide surfaces and other surfaces such as, by way of example but
not limitation, those on implanted devices, and equipment, where a REAGENT is
covalently chemically bonded to one or more reactive molecules on the surface of such
device or equipment. PEGYLATION shall include the synthesis, derivatization,
characterization, and modification of PEG for such purposes, together with the
synthesis, derivatization, characterization, and modification of the raw materials and
intermediates for the manufacture of REAGENTS (including SELECTED REAGENTS) or products
(including POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS) incorporating such REAGENT by
means of covalent chemical bonding, and all methods of making and using each and all of
the foregoing.
|
1.59 |
PHASE 1 CLINICAL TRIAL means the first lawful study in humans, conducted in
accordance with 21 C.F.R. §312.21(a) (or the equivalent LAWS and regulations in
jurisdictions outside the United States).
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
11
1.60 |
PHASE 2 CLINICAL TRIAL means a controlled clinical trial, conducted in
accordance with 21 C.F.R. §312.21(b) (or the equivalent LAWS and regulations in
jurisdictions outside the United States).
|
1.61 |
PIVOTAL TRIAL, also known as a Phase 3 clinical trial, means a controlled or
uncontrolled clinical trial, conducted in accordance with § 21 C.F.R. 312.21(c) (or the
equivalent LAWS and regulations in jurisdictions outside the United States).
|
1.62 |
POTENTIAL PRODUCT means (i) any chemical entity resulting from attachment of
any THERAPEUTIC AGENT to a SELECTED REAGENT by means of PEGYLATION that is selected by
the RESEARCH COMMITTEE or (ii) any product using PEGYLATION to extend or otherwise
improve the half-life of [***] FACTOR VIII, whether by using PEGYLATION technology
directly with [***] FACTOR VIII, or by means of the PEGYLATION of [***].
|
1.63 |
PURCHASE PRICE has the meaning set forth in Section 8.6.1
|
||
1.64 |
QUALITY AGREEMENT(S) shall include:
|
(i) |
the quality agreement governing the manufacture and supply of
[***], which shall be negotiated by the PARTIES [***]; and
|
(ii) |
the quality agreement governing the manufacture and supply of
[***], which shall be negotiated by the PARTIES [***].
|
1.65 |
REAGENT means a PEG derivative used in the manufacture of a pharmaceutical
or diagnostic product or medical device, including a SELECTED REAGENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
12
1.66 |
RECIPIENT means the PARTY receiving CONFIDENTIAL INFORMATION hereunder.
|
||
1.67 |
RESEARCH COMMITTEE means the committee described in Section 3.2.
|
1.68 |
RESEARCH PLAN means the PARTIES respective activities and responsibilities
as set forth in the RESEARCH PLAN attached hereto as Schedule I, as amended and
revised by the RESEARCH COMMITTEE from time to time.
|
1.69 |
RESPONSIBLE PARTY has the meaning set forth in Section 16.7.
|
1.70 |
ROYALTY RATE means the following:
|
(i) |
[***] NET SALES of all COMMERCIAL PRODUCTS sold in a calendar
year;
|
(ii) |
[***] NET SALES of all COMMERCIAL PRODUCTS sold in such
calendar year; and
|
(iii) |
[***] NET SALES of all COMMERCIAL PRODUCTS sold in such
calendar year [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
13
1.71 |
SCIENTIFIC ADVISORS has the meaning set forth in Section 3.1.
|
1.72 |
SCIENTIFIC AND TECHNICAL ADVISORY BOARD means the board described in Section
3.1.
|
1.73 |
SELECTED REAGENT means a REAGENT that is attached to a THERAPEUTIC AGENT by
means of PEGYLATION in a POTENTIAL PRODUCT or COMMERCIAL PRODUCT, as selected by the
RESEARCH COMMITTEE.
|
||
1.74 |
SOLE INVENTION has the meaning set forth in Section 16.3.
|
1.75 |
SPECIFICATIONS means the specifications for a SELECTED REAGENT to be used in
a POTENTIAL PRODUCT or COMMERCIAL PRODUCT determined based upon definitive testing
criteria that are agreed in writing by the DEVELOPMENT AND PRODUCTION COMMITTEE and
which will be set forth in the applicable QUALITY AGREEMENT.
|
1.76 |
SUBLICENSEE means any person or entity, including AFFILIATES, to which BAXTER
grants a sublicense (i) to research and/or develop POTENTIAL PRODUCTS or COMMERCIAL
PRODUCTS or (ii) to make, have made, use, sell, have sold, offer for sale and/or import
POTENTIAL PRODUCTS or COMMERCIAL PRODUCTS (which for the purposes hereof will include
the right to
distribute, market or promote).
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
14
1.77 |
SUPPLY AGREEMENT means the supply agreement to be entered into by the PARTIES
in accordance with Section 5.3.
|
||
1.78 |
TERM has the meaning set forth in Section 19.1.
|
||
1.79 |
TERRITORY means the world.
|
1.80 |
THERAPEUTIC AGENT means [***] FACTOR VIII [***] of each of the foregoing. For
clarity, THERAPEUTIC AGENT does not include [***].
|
1.81 |
THIRD PARTY means any entity other than NEKTAR AL, BAXTER, a SUBLICENSEE of
BAXTER or their respective AFFILIATES, whether such THIRD PARTY is a person, company,
corporation, limited liability company, partnership or other such legal entity, or a
division or operating or business unit of such legal entity.
|
1.82 |
VALID PATENT CLAIM means a claim of an issued and unexpired PATENT within the
[***] covering the manufacture, use, sale, offer for sale or import of a SELECTED
REAGENT or a COMMERCIAL PRODUCT, which PATENT is owned or CONTROLLED by NEKTAR AL or
jointly by the PARTIES and has not (a) expired or been canceled, (b) been declared
invalid by an unreversed and unappealable decision of a court or other appropriate body
of competent jurisdiction, (c) been admitted to be invalid or unenforceable through
reissue, disclaimer, or otherwise or (d) been abandoned.
|
1.83 |
[***] means the [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
15
2. |
RESEARCH AND DEVELOPMENT ACTIVITIES
|
2.1 |
OVERVIEW.
The PARTIES research and development responsibilities are
set forth in the RESEARCH PLAN, which shall be an evolving document that is updated and
revised from time to time in writing by the RESEARCH COMMITTEE.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
16
2.2 |
NEKTAR AL PAYMENTS.
In addition to the MILESTONES and royalties to be
paid by BAXTER to NEKTAR AL hereunder, BAXTER shall pay NEKTAR AL for all [***]
directly incurred and solely associated with the development and manufacture of such
CONJUGATES and REAGENTS (including SELECTED REAGENTS). NEKTAR ALs [***], subject to
the following increases: NEKTAR AL shall adjust the [***] for each calendar year
commencing with the year 2006 to reflect any year-to-year increase in the Consumer
Price Index (CPI) (based on a cumulative index of CPI numbers starting on the EFFECTIVE
DATE to the date of the calculation of such [***]).
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
17
2.3 |
MARKETING AUTHORIZATION.
As between the PARTIES, BAXTER shall be
responsible for all development activities under the RESEARCH PLAN, all manufacturing
activities associated with the manufacture of POTENTIAL PRODUCTS and COMMERCIAL
PRODUCTS, all activities associated with the [***], and for the [***] for COMMERCIAL
PRODUCTS. [***].
|
2.4 |
MATERIALS.
|
2.4.1 |
NEKTAR AL MATERIALS.
Any samples of SELECTED REAGENTS
or CONJUGATES that are provided by NEKTAR AL to BAXTER in the course of the
RESEARCH PLAN (collectively, the NEKTAR AL MATERIALS) are owned exclusively
by NEKTAR AL and provided solely for the performance of the RESEARCH PLAN, or
to otherwise extend the half-life of a THERAPEUTIC AGENT, and for no other
purpose. Without limitation, BAXTER will not:
|
(i) |
[***];
|
||
(ii) |
[***];
|
||
(iii) |
[***];
|
||
(iv) |
[***];
|
(v) |
[***],
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
18
2.4.2 |
BAXTER MATERIALS.
Any samples of [***] FACTOR VIII
[***] provided by BAXTER to NEKTAR AL (collectively, the BAXTER MATERIALS)
are owned exclusively by BAXTER and provided solely for the development of
CONJUGATES and REAGENTS to extend the half-life of a THERAPEUTIC AGENT in
conjunction with the RESEARCH PLAN, and for no other purpose. Without
limitation, NEKTAR AL will not:
|
(i) |
[***];
|
||
(ii) |
[***];
|
||
(iii) |
[***];
|
||
(iv) |
[***]; or
|
(v) |
[***],
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
19
2.5 |
HANDLING.
The PARTIES understand and agree the BAXTER MATERIALS and
NEKTAR AL MATERIALS may have unpredictable and unknown biological and/or chemical
properties and that they are to be handled and used with caution. The
PARTIES will handle and use such materials and conduct their respective activities
under the RESEARCH PLAN in compliance with all applicable LAWS. Each PARTY will
maintain reasonable security measures, no less strict than it maintains to protect
its own valuable tangible property, to protect the other PARTYS materials against
loss, theft or destruction. Other than in connection with the performance of its
obligations under this AGREEMENT, neither PARTY will sell, lease, license, copy,
transfer, disclose or otherwise provide access to the other PARTYs materials to
any person, entity or location without the prior written consent of the other
PARTY, such consent not to be unreasonably withheld or delayed. This provision
shall not prevent BAXTER from sublicensing (to the extent provided for in Article
4) or outsourcing some or all if its research or development activities. In such
case, BAXTER shall require any SUBLICENSEE or THIRD PARTY performing such
obligations to be bound by similar security, handling, confidentiality and
assignment of INVENTIONS obligations as are set forth in this AGREEMENT, including
without limitation, under Sections 2.4.1, 2.5 and 4.4 and Articles 11 and 16.
|
2.6 |
SELECTION OF POTENTIAL PRODUCTS AND [***].
The RESEARCH COMMITTEE shall
select POTENTIAL PRODUCT(S) from the CONJUGATES and SELECTED REAGENTS provided by
NEKTAR AL and, following such selection, [***].
|
2.7 |
DISCLAIMER OF WARRANTY WITH RESPECT TO BAXTER MATERIALS.
BAXTER HEREBY
ACKNOWLEDGES THE EXPERIMENTAL NATURE OF THE RESEARCH AND THAT NEKTAR AL CANNOT
GUARANTEE OR PROVIDE ANY WARRANTIES REGARDING THE QUANTITY OF BAXTER MATERIALS
REQUIRED TO CONDUCT THE RESEARCH OR TO BE CONSUMED IN THE PERFORMANCE OF THE RESEARCH.
EXCEPT IN THE CASE OF NEKTAR ALS NEGLIGENCE OR WILLFUL MISCONDUCT,
NEKTAR AL SHALL NOT BE LIABLE FOR ANY DAMAGES OR LOSSES SUFFERED BY BAXTER ARISING
FROM THE USE, CONSUMPTION OR LOSS OF BAXTER MATERIALS IN THE PERFORMANCE OF THE
RESEARCH PURSUANT TO THIS AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
20
3. |
GOVERNANCE
|
3.1 |
JOINT STEERING COMMITTEE.
To facilitate communication between the
PARTIES, implement the RESEARCH PLAN and oversee development of POTENTIAL PRODUCTS and
COMMERCIAL PRODUCTS (all during the TERM), the PARTIES shall appoint a JOINT STEERING
COMMITTEE consisting of [***] representatives from each of NEKTAR AL and BAXTER. The
initial representatives are:
|
BAXTER: [***]
|
|||
NEKTAR AL: [***]
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
21
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
22
3.2 |
RESEARCH COMMITTEE.
The RESEARCH COMMITTEE shall be comprised of
appropriate representatives of both PARTIES, initially consisting of [***]
representatives from each of NEKTAR AL and BAXTER. Each PARTY shall appoint a RESEARCH
PLAN team leader (and other key contacts, as necessary) to serve as principal RESEARCH
COMMITTEE liaisons for the PARTIES. Employees of each PARTY who are not on the
RESEARCH COMMITTEE may attend meetings of the RESEARCH COMMITTEE, as required to
further the research and development of POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS.
The initial team leader and PARTY representatives are:
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
23
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
24
3.3 |
DEVELOPMENT AND PRODUCTION COMMITTEE.
Within [***] after a POTENTIAL PRODUCT has been
selected by the RESEARCH COMMITTEE, the JOINT STEERING COMMITTEE shall appoint a DEVELOPMENT AND
PRODUCTION COMMITTEE to plan and manage the manufacturing and supply activities to be performed
under this AGREEMENT with respect to the SELECTED REAGENT for such POTENTIAL PRODUCT, and
facilitate communication between the PARTIES during such time as NEKTAR AL supplies BAXTER with
such SELECTED REAGENT hereunder. The
DEVELOPMENT AND PRODUCTION COMMITTEE shall be responsible for discussing in good faith and
agreeing on issues relating to forecasting and contingency planning. The DEVELOPMENT
AND PRODUCTION COMMITTEE shall operate by consensus with representatives of NEKTAR AL
having [***] and representatives of BAXTER having [***]. In the event of any
disagreements between the PARTIES representatives at the DEVELOPMENT AND PRODUCTION
COMMITTEE level, the disagreement shall first be referred to the JOINT STEERING
COMMITTEE for resolution. If the disagreement is not resolved by the JOINT STEERING
COMMITTEE within [***] after the matter is referred to it for resolution, then the
matter shall be referred to the senior management representatives of each PARTY for
resolution, which senior management representatives shall be for Baxter [***] and for
Nektar AL [***].
|
3.4 |
AMENDMENT; WAIVER.
Notwithstanding anything to the contrary herein,
neither the JOINT STEERING COMMITTEE, the RESEARCH COMMITTEE nor the DEVELOPMENT AND
PRODUCTION COMMITTEE shall have the right or
power to amend the terms of this AGREEMENT or waive rights or obligations of the
PARTIES hereunder, or take any action that would conflict with any provision of
this AGREEMENT, the SUPPLY AGREEMENT or a QUALITY AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
25
4. |
LICENSES TO NEKTAR AL LICENSED TECHNOLOGY AND BAXTER
TECHNOLOGY
|
4.1 |
LICENSE TO BAXTER.
Subject to the terms and conditions of this
AGREEMENT, NEKTAR AL hereby grants to BAXTER a worldwide, exclusive, royalty-bearing
license, with the right to grant sublicenses as provided in Section 4.2, under the
NEKTAR AL LICENSED TECHNOLOGY to develop, make, have made, import, export, use, sell,
offer for sale and have sold POTENTIAL PRODUCTS and COMMERCIAL PRODUCT(S) in the
FIELD. For clarity, [***].
|
4.2 |
TERMS OF SUBLICENSE.
The terms of each sublicense under the license
granted to BAXTER in Section 4.1 of this AGREEMENT shall provide that any SUBLICENSEE
shall be subject to and consistent with the terms and conditions of this AGREEMENT;
provided, however, that:
|
(i) |
All royalties or other amounts due to NEKTAR AL with respect
to such SUBLICENSEES development and/or commercialization of POTENTIAL
PRODUCT or COMMERCIAL PRODUCT shall be collected by BAXTER and transmitted to
NEKTAR AL in accordance with the payment terms set forth in Article 9;
|
(ii) |
BAXTERS grant of any sublicense shall not relieve BAXTER from
any of its obligations under this AGREEMENT; and
|
(iii) |
BAXTER shall remain jointly and severally liable for any
breach of a
sublicense by a SUBLICENSEE.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
26
4.3 |
NEKTAR AL RESEARCH RIGHTS AND LIMITATIONS.
Notwithstanding anything to
the contrary in this AGREEMENT and without limiting any other retained rights, the
license granted under Section 4.1 shall be subject to the retained right of NEKTAR AL
and its AFFILIATES:
|
(i) |
to practice the NEKTAR AL LICENSED TECHNOLOGY for the conduct
of research and development of products that it is developing itself;
|
(ii) |
to practice the NEKTAR AL LICENSED TECHNOLOGY for any
purposes, including the research, development, manufacture and
commercialization of products, whether itself or with or for others, outside
of the FIELD;
|
(iii) |
to sell REAGENTS (including SELECTED REAGENTS) through NEKTAR
ALS catalog for research purposes (subject to the limitations set forth
below); and
|
(iv) |
to perform their respective obligations to THIRD PARTIES set
forth in agreements existing as of the EFFECTIVE DATE, [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
27
4.4 |
NO IMPLIED RIGHTS OR LICENSES.
Neither PARTY grants to the other any
rights or licenses, including to any BAXTER PATENT RIGHTS or BAXTER KNOW HOW, or NEKTAR
AL PATENT RIGHTS or NEKTAR AL KNOW HOW or other intellectual property rights, whether
by implication, estoppel or otherwise, except to the extent expressly provided for
under this AGREEMENT. Other than as expressly provided for herein, neither BAXTER nor
its AFFILIATES, SUBLICENSEES or its or their contractors, may [***].
|
4.5 |
LICENSE TO NEKTAR AL.
BAXTER hereby grants to NEKTAR AL a
non-exclusive, non-sublicensable, non-assignable, non-transferable, worldwide,
royalty-free license, under BAXTER KNOW-HOW and BAXTER PATENT RIGHTS, and the NEKTAR AL
LICENSED TECHNOLOGY that is licensed exclusively to BAXTER hereunder, for the sole
purpose of performing NEKTAR ALs obligations under this AGREEMENT, including the
RESEARCH PLAN. This provision shall not prevent NEKTAR AL from [***]. BAXTER shall
respond within [***] of receipt of such a request by NEKTAR AL. [***].
|
4.6 |
MUTUAL COVENANT.
Each PARTY covenants and agrees that it and its
AFFILIATES shall not use or practice the intellectual property rights licensed under
this AGREEMENT except as expressly permitted by this AGREEMENT. Any use or practice of
the intellectual property rights licensed under this AGREEMENT except
as expressly permitted by this AGREEMENT that results in material harm to the other
PARTY shall constitute a material breach of this AGREEMENT. Each PARTY covenants and
agrees to cease any non-permitted use and to take all actions necessary to assign to
the other PARTY any inventions made through use or practice of such PARTYS
intellectual property rights outside the scope of the license rights granted
hereunder.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
28
5. |
MANUFACTURE AND SUPPLY OF SELECTED REAGENTS
|
5.1 |
[***]. NEKTAR AL shall manufacture and supply and BAXTER shall purchase from
NEKTAR AL, [***] of BAXTERS and BAXTERS AFFILIATES and SUBLICENSEES requirements
of SELECTED REAGENTS, for the sole purpose of developing and manufacturing POTENTIAL
PRODUCTS and COMMERCIAL PRODUCTS pursuant to the license granted hereunder.
|
5.2 |
SUPPLY PRIOR TO PIVOTAL TRIAL/SUPPLY AGREEMENT.
|
(i) |
FORECAST.
No later than [***] after selection of a
POTENTIAL PRODUCT by the RESEARCH COMMITTEE, BAXTER shall provide NEKTAR AL
with a [***] rolling forecast of its estimated requirements of the SELECTED
REAGENT for such POTENTIAL PRODUCT for research, pre-clinical development and
clinical development. BAXTER shall update such estimated forecast within
thirty (30) days following the start of each calendar quarter. BAXTER shall
issue purchase orders to NEKTAR AL [***] prior to the start of the calendar
quarter (such time period to be negotiated by the PARTIES in good faith after
the applicable SELECTED REAGENT is selected by the RESEARCH COMMITTEE) during
which BAXTER wishes to receive supplies of SELECTED REAGENT for use in
pre-clinical and Phase 1 and Phase 2 clinical development, until such time as
the PARTIES execute the SUPPLY AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
29
(ii) |
PRICE.
The price of each SELECTED REAGENT shall be the
PURCHASE PRICE, as set forth in Section 8.6.1.
|
(iii) |
DELIVERY AND SHIPMENT; TITLE AND RISK OF LOSS.
NEKTAR
AL shall deliver all SELECTED REAGENT to BAXTER, and [***].
|
5.3 |
PIVOTAL TRIAL AND COMMERCIAL PRODUCT SUPPLY AGREEMENT.
At least [***]
prior to the anticipated date of commencement of the first PIVOTAL TRIAL for a
POTENTIAL PRODUCT, the parties shall negotiate and execute a SUPPLY AGREEMENT for the
manufacture and supply of SELECTED REAGENT for such POTENTIAL PRODUCT. The SUPPLY
AGREEMENT shall be negotiated in good faith after the PARTIES have gained insight into
the attributes of the SELECTED REAGENT, including quality requirements, testing
requirements, production cycles and production costs. For purposes of this AGREEMENT,
commencement of a clinical trial shall be deemed to occur on the date on which
POTENTIAL PRODUCT is first administered to the first patient or subject in such trial.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
30
6. |
SPECIFICATIONS AND MANUFACTURING WARRANTY FOR SELECTED REAGENTS
|
6.1 |
SPECIFICATIONS.
The SPECIFICATIONS for SELECTED REAGENTS to be supplied
pursuant to Article 5 will be set forth in the applicable QUALITY
AGREEMENT. Any modifications of the SPECIFICATIONS shall require prior written
approval of BAXTER and NEKTAR AL, not to be unreasonably withheld or delayed. Prior
to entering into the SUPPLY AGREEMENT, BAXTER shall reimburse NEKTAR AL for its
reasonable costs associated with implementing any agreed upon modifications to the
SPECIFICATIONS, including without limitation any increases in MANUFACTURING COSTS.
NEKTAR AL shall be responsible for any changes to SPECIFICATIONS initiated by NEKTAR
AL to accommodate its business needs that do not directly relate to the development
or improvement of SELECTED REAGENTS. For clarity, a change in regulatory
requirements that is unique to a SELECTED REAGENT is not a NEKTAR AL business need.
For example, if NEKTAR AL requests relocating the SELECTED REAGENT manufacturing
operations from Alabama to California to accommodate the closure of its Alabama
facility, NEKTAR AL shall be responsible for all costs related to such relocation.
|
6.2 |
COMPLIANCE AUDITS.
BAXTER will have the right to perform
compliance/quality audits, as set forth in the QUALITY AGREEMENTS.
|
6.3 |
WARRANTY.
NEKTAR AL warrants that each shipment of SELECTED REAGENT
shall, upon delivery, be in compliance/conformity with:
|
(i) |
All applicable SPECIFICATIONS,
|
||
(ii) |
The applicable QUALITY AGREEMENT, and
|
(iii) |
ICH Q7A GUIDELINES and LAWS, as they apply to critical raw
materials, in each case with respect to those SELECTED REAGENTS used in the
manufacture of (a) POTENTIAL PRODUCTS for human clinical trials and (b) for
COMMERCIAL PRODUCTS.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
31
6.4 |
DISCLAIMER OF WARRANTY.
|
6.4.1 |
EXCEPT AS PROVIDED IN SECTION 6.3, NEKTAR AL PROVIDES NO
WARRANTIES, EXPRESS OR IMPLIED, REGARDING ANY SELECTED REAGENT, POTENTIAL
PRODUCT OR COMMERCIAL PRODUCT, OR NEKTAR AL LICENSED TECHNOLOGY, AND HEREBY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, INCLUDING WITHOUT
LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NON-INFRINGEMENT. BAXTER ACKNOWLEDGES THAT NEKTAR AL CANNOT
GUARANTEE THE SAFETY, NON-TOXICITY, FITNESS OR EFFICACY OF SELECTED REAGENTS,
POTENTIAL PRODUCTS OR COMMERCIAL PRODUCTS, AND BAXTER ACCEPTS ANY AND ALL RISK
RESULTING FROM ITS USE OF CONJUGATES, REAGENTS, SELECTED REAGENTS, POTENTIAL
PRODUCTS OR COMMERCIAL PRODUCTS.
|
6.4.2 |
EXCEPT AS PROVIDED IN SECTION 6.3, NEITHER PARTY PROVIDES ANY
WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE RESEARCH PLAN OR ANY REAGENT,
CONJUGATE, PRODUCT (INCLUDING THE SUCCESSFUL DEVELOPMENT, REGISTRATION,
MANUFACTURE OR COMMERCIALIZATION OF ANY POTENTIAL PRODUCT) OR DELIVERABLE
PROVIDED PURSUANT TO THE RESEARCH PLAN, AND EACH PARTY DISCLAIMS ALL EXPRESS
AND IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION
THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE
AND NON-INFRINGEMENT. FOR CLARITY, THE FOREGOING SHALL NOT DIMINISH NEKTAR
ALS OBLIGATIONS PURSUANT TO SECTION 15.1.1.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
32
7. |
EXCLUSIVITY; [***]
|
7.1 |
NEKTAR AL.
In consideration of the MILESTONES, royalties and other
consideration set forth herein, NEKTAR AL agrees to partner exclusively with BAXTER in
the FIELD. Specifically, during the TERM, other than as provided for in this AGREEMENT
or under the RESEARCH PLAN, [***].
|
7.2 |
BAXTER.
For good and valuable consideration (the receipt and
sufficiency of which is hereby acknowledged by BAXTER), BAXTER agrees to partner
exclusively with NEKTAR AL in the FIELD. Specifically, during the TERM, [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
33
8. |
QUALITY AND COMPLAINTS
|
8.1 |
ANALYSIS.
After the RESEARCH COMMITTEES designation of a POTENTIAL
PRODUCT or a SELECTED REAGENT, the PARTIES shall cooperate and work in good faith to
establish written evaluation procedures and evaluation time lines in which to analyze
shipments of SELECTED REAGENTS and verify SELECTED REAGENT quality (including meeting
SPECIFICATIONS) using methods consistent with test procedures set forth in the
applicable QUALITY AGREEMENT. In the event the PARTIES are not able to agree upon such
procedures and timelines within [***] prior to the first PHASE 1 CLINICAL TRIAL of such
POTENTIAL PRODUCT, (i) the matter shall first be referred to the DEVELOPMENT AND
PRODUCTION COMMITTEE for resolution in accordance with Section 3.3; (ii) if within
[***] the DEVELOPMENT AND PRODUCTION COMMITTEE is unable to reach resolution, either
PARTY may elect to have a mutually acceptable laboratory or consultant establish such
procedures and time lines, whose determination thereof shall be binding; and (iii) if
within [***] the PARTIES are unable to select a mutually acceptable laboratory or
consultant, each PARTY shall select an independent consultant within [***] and such
consultants shall within [***] thereof select a mutually acceptable laboratory or
consultant to establish such time lines and procedures, whose determination thereof
shall be binding.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
34
8.2 |
ACCEPTANCE AND REJECTION.
BAXTER shall notify NEKTAR AL in writing if
BAXTER believes that a shipment of SELECTED REAGENT does not comply with the testing
criteria identified pursuant to Section 8.1 above within [***] after BAXTERS receipt
of the relevant shipment of SELECTED REAGENT at BAXTERS designated destination
facility (NOTICE OF NON-CONFORMITY),
which notice shall include the basis for its assertion of such noncompliance
(including, at NEKTAR ALS request, supporting data) for purposes of consideration
and verification by NEKTAR AL. Unless otherwise set forth in the SUPPLY AGREEMENT
for the applicable SELECTED REAGENT, if no such written NOTICE OF NON-CONFORMITY is
received by NEKTAR AL within the above [***] period, BAXTER shall be deemed to have
accepted the applicable shipment of SELECTED REAGENT as meeting SPECIFICATIONS and
any other quality requirements which were verified using the agreed-upon evaluation
procedures set forth in the QUALITY AGREEMENT, which shall thereafter conclusively
be presumed to meet the SPECIFICATIONS and such quality requirements. If NEKTAR AL
receives such NOTICE OF NON-CONFORMITY within such [***] period, then NEKTAR AL will
evaluate BAXTERS NOTICE OF NON-CONFORMITY within [***] of receipt thereof and
provide a written response (RESPONSE TO NOTICE OF NON-CONFORMITY). If NEKTAR AL
fails to provide to BAXTER a RESPONSE TO NOTICE OF NON-CONFORMITY within the [***]
period, then NEKTAR AL shall be deemed to have accepted BAXTERS conclusion that the
SELECTED REAGENTS are non-conforming and waived its right to object to such
conclusion.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
35
8.3 |
REPLACEMENT OF NONCONFORMING REAGENT.
NEKTAR AL shall [***], supply
BAXTER with a replacement quantity of SELECTED REAGENT in an amount equal to that
which, pursuant to the agreed upon procedures set forth herein and in the applicable
QUALITY AGREEMENT, is determined to be NONCONFORMING REAGENT. [***], BAXTER shall
promptly return all NONCONFORMING REAGENT to NEKTAR AL. Unless otherwise specified in
the applicable SUPPLY AGREEMENT, such replacement shipment shall be made within a
reasonable period of time not to exceed [***], which period of time shall be agreed
upon once the production cycle time for the applicable SELECTED REAGENT has been
established.
|
8.4 |
LIABILITY TO BAXTER FOR NONCONFORMING REAGENT.
|
8.4.1 |
NONCONFORMING REAGENT DETECTABLE BY TESTING.
With
respect to SELECTED REAGENT that was determined to be NONCONFORMING REAGENT
through testing in accordance with the agreed-upon evaluation procedures for
the applicable SELECTED REAGENT established pursuant to Section 8.1 and the
applicable QUALITY AGREEMENT and for which BAXTER gave to NEKTAR AL a NOTICE
OF NONCONFORMITY in accordance with the requirements of Section 8.2, [***].
For clarity, if BAXTER does not comply with the procedures set forth in
Section 8.2 with respect to SELECTED REAGENT and BAXTER could
reasonably have detected that such SELECTED REAGENT was NONCONFORMING
REAGENT through testing in accordance with the agreed-upon evaluation
procedures for the applicable SELECTED REAGENT established pursuant to
Section 8.1 and the applicable QUALITY AGREEMENT, or if BAXTER otherwise
failed to comply with the notice requirements in Section 8.2 for
NONCONFORMING REAGENT, [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
36
8.4.2 |
NONCONFORMING REAGENT NOT DETECTABLE BY TESTING.
With
respect to (a) NEKTAR ALS negligence or willful misconduct regarding SELECTED
REAGENT or (b) SELECTED REAGENT that is NONCONFORMING REAGENT because of
breaches of the warranties set forth in Sections 6.3(ii) or (iii) that could
not reasonably have been detected through testing in accordance with the
agreed-upon evaluation procedures for the applicable SELECTED REAGENT
established pursuant to Section 8.1 and the applicable QUALITY AGREEMENT,
[***].
|
8.5 |
[INTENTIONALLY OMITTED.]
|
8.6 |
FEES FOR MANUFACTURING AND SUPPLY OF SELECTED REAGENTS
PRIOR TO
PIVOTAL TRIAL.
|
8.6.1 |
From the date of selection of SELECTED REAGENT until the
earlier of the date of commencement of a PIVOTAL TRIAL or the date on which
the PARTIES enter into the SUPPLY AGREEMENT, BAXTER shall pay NEKTAR AL its
MANUFACTURING COST plus [***] for each SELECTED REAGENT supplied to BAXTER,
[***] (PURCHASE PRICE). BAXTER shall be entitled to audit such MANUFACTURING
COST pursuant to Section 10.2.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
37
8.6.2 |
In addition to the PURCHASE PRICE, BAXTER shall [***] as
described herein. [***]. To the extent available, NEKTAR AL shall [***]:
|
A. |
[***];
|
B. |
[***];
|
C. |
[***];
|
D. |
[***].
|
BAXTER [***] and NEKTAR AL shall provide invoices for such fees and
services, as incurred. BAXTER shall also reimburse NEKTAR AL for NEKTAR ALS
reasonable pre-approved expenses incurred in connection with travel at
BAXTERS request.
|
BAXTER shall be entitled to audit such fees pursuant to Section 10.2.
However, NEKTAR AL shall not be required to produce records that are not
maintained in the normal course of business. For example, if NEKTAR AL
[***].
|
8.6.3 |
BAXTER shall pay for or reimburse NEKTAR AL (as the case may
be) for such [***] services or expenses within [***] after the date of NEKTAR
ALS invoice therefor. For clarity, BAXTER shall not be responsible for any
fees, services, or travel that: (i) expand NEKTAR ALs capacity to develop or
produce PEG reagents for other customers; or (ii) do not directly or uniquely
relate to this AGREEMENT or otherwise directly benefit BAXTER.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
38
9. |
MILESTONES; ROYALTY PAYMENTS; ROYALTY REPORTS
|
9.1 |
MILESTONE PAYMENTS.
BAXTER shall pay to NEKTAR AL MILESTONES in
accordance with and pursuant to the events described in Schedule II hereto for
POTENTIAL PRODUCT and/or COMMERCIAL PRODUCT, as the case may be. Each such MILESTONE
shall be payable at the time the corresponding event occurs, and due within [***] of
the event triggering such MILESTONE. All milestones payments shall not be advance
payments against any royalties or other payments due and payable hereunder, but
shall be in addition to any royalty or other payments due under this AGREEMENT. In
the event BAXTER [***].
|
(i) |
SKIPPED MILESTONE EVENT.
If, for whatever reason, a
particular milestone activity or event for which a MILESTONE is due is not
carried out, then in such case the MILESTONE that NEKTAR AL would have received
upon the occurrence of such milestone event for the POTENTIAL PRODUCT or
COMMERCIAL PRODUCT had the particular milestone event been carried out shall be
paid [***]. For example, [***].
|
||
(ii) |
[***].
|
(iii) |
NON-REFUNDABLE.
Once a MILESTONE is due and payable
hereunder or once a MILESTONE is paid, BAXTER shall not have any basis for
claiming that such MILESTONE is not to be paid or is to be refunded (as the
case may be). This provision shall not preclude BAXTER from seeking to recover
damages from NEKTAR AL for the breach of this AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
39
(iv) |
MARKETING AUTHORIZATION OUTSIDE OF THE FIELD.
For
clarity BAXTER shall have no rights whatsoever with respect to the development,
manufacture, use, sale or importation of POTENTIAL PRODUCTS or COMMERCIAL
PRODUCTS outside of the FIELD. For clarification, BAXTER [***]. If BAXTER
desires to develop, manufacture, have manufactured, use, sell, offer for sale
or import any POTENTIAL
PRODUCT or COMMERCIAL PRODUCT outside of the
FIELD, including without limitation obtaining MARKETING AUTHORIZATION for the
addition of label claims that are outside of the FIELD for then-existing
COMMERCIAL PRODUCT(S), BAXTER shall discuss the matter with NEKTAR AL. If
NEKTAR AL (in its discretion) wishes to grant such additional rights to
BAXTER, the PARTIES shall negotiate in good faith the terms and conditions
(which may include, among other things, the payment of additional milestone
payments) applicable to the grant of such rights.
|
9.1.1 |
[***] MILESTONES FOR THE DEVELOPMENT AND
COMMERCIALIZATION OF ONE COMMERCIAL PRODUCT FOR THE TREATMENT OF
HEMOPHILIA A.
The MILESTONES that are provided for under Schedule II shall
apply with respect to the first POTENTIAL PRODUCT being developed for the
treatment of Hemophilia A that achieves each such MILESTONE, and the first
COMMERCIAL PRODUCT receiving MARKETING AUTHORIZATION having a label indication
for the treatment of Hemophilia A. Such POTENTIAL PRODUCT and COMMERCIAL
PRODUCT may be the same, but in the event they are not, [***].
|
||
For clarity, BAXTER or its AFFILIATE or SUBLICENSEE, at BAXTERS discretion,
shall be [***]. In the event BAXTER or its AFFILIATE or SUBLICENSEE [***].
|
|||
For example, [***], BAXTER shall [***].
|
|||
NEKTAR AL shall not be entitled to additional MILESTONES for additional label claims that are obtained by BAXTER or its AFFILIATE or SUBLICENSEE for
then-existing COMMERCIAL PRODUCT(S) for the treatment of Hemophilia A. For
example, [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
40
9.1.2 |
ADDITIONAL MILESTONES FOR THE COMMERCIALIZATION OF
MORE THAN ONE COMMERCIAL PRODUCT FOR THE TREATMENT
OF HEMOPHILIA
A.
After the receipt of MARKETING AUTHORIZATION for the first COMMERCIAL
PRODUCT, NEKTAR AL shall be entitled to receive milestone payments in addition
to the MILESTONES provided for in Schedule II, for each additional POTENTIAL
PRODUCT with a label indication for the treatment of Hemophilia A, for which
BAXTER or its AFFILIATE or SUBLICENSEE receives a new MARKETING AUTHORIZATION
in the United States and/or European Union. With respect to any additional
POTENTIAL PRODUCTS [***]. The amounts of such payments will be negotiated by
the PARTIES in good faith and agreed upon in a formal written amendment hereto
[***], provided that the additional milestone payments for each such additional
POTENTIAL PRODUCT [***].
|
||
For clarity, [***].
|
9.1.3 |
POTENTIAL PRODUCTS FOR [***].
If BAXTER elects to
develop a POTENTIAL PRODUCT to treat [***], BAXTER shall pay to NEKTAR AL
milestone payments in addition to the MILESTONES that are set forth in
Schedule II, which additional milestone payments will be negotiated by the
PARTIES in good faith and agreed upon in a formal written amendment hereto.
The additional milestone payments for such POTENTIAL PRODUCT to treat [***]
shall be agreed upon in advance but no later than
[***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
41
9.1.4 |
INDICATIONS FOR [***].
While NEKTAR AL shall not be
entitled to additional milestone payments for additional label claims that are
obtained by BAXTER or its AFFILIATE or SUBLICENSEE for then-existing COMMERCIAL
PRODUCT(S) within the FIELD, if BAXTER or its AFFILIATE or SUBLICENSEE seeks to
obtain [***] are for a then-existing COMMERCIAL PRODUCT with a label indication
for the [***], then in such case, additional milestone payments shall be due.
The provisions of Section 9.1.2, as they pertain to [***], shall apply such
that clinical development of COMMERCIAL PRODUCT(S) associated with obtaining
label claims for the treatment of [***] shall be deemed to constitute
development of an additional POTENTIAL PRODUCT.
|
9.2 |
ROYALTIES.
BAXTER shall pay NEKTAR AL royalties in an amount equal to
the product of the ROYALTY RATE and the annual aggregate NET SALES of all COMMERCIAL
PRODUCTS on a COMMERCIAL PRODUCT-by-COMMERCIAL PRODUCT and country-by-country basis for
an initial period of ten (10) years from the FIRST COMMERCIAL SALE of the applicable
COMMERCIAL PRODUCT in the applicable country (the INITIAL ROYALTY TERM). Royalties
shall be paid during the INITIAL ROYALTY TERM in each and every country where
COMMERCIAL PRODUCT is sold, without regard to whether a VALID PATENT CLAIM covers the
manufacture, use, sale, offer for sale or import of the COMMERCIAL PRODUCT or the
SELECTED REAGENT contained in such COMMERCIAL PRODUCT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
42
9.2.1 |
After the expiration of the INITIAL ROYALTY TERM for a
particular COMMERCIAL PRODUCT in a particular country, BAXTER shall
continue to pay such royalties on NET SALES of such COMMERCIAL PRODUCT on a
world-wide basis provided that there exists, in each of the following major
markets in which MARKETING AUTHORIZATION is received for such COMMERCIAL
PRODUCT, a VALID PATENT CLAIM which would be infringed by the making, using,
having made, offering for sale, sale or importation of such COMMERCIAL
PRODUCT or the SELECTED REAGENT contained in such COMMERCIAL PRODUCT: [***]
(collectively, MAJOR MARKETS). Such royalties shall be paid on NET SALES
of COMMERCIAL PRODUCTS in those countries where the manufacture, import,
use, offer for sale or sale of the applicable COMMERCIAL PRODUCT or the
SELECTED REAGENT contained in such COMMERCIAL PRODUCT is not covered by a
VALID PATENT CLAIM, provided that the manufacture, import, use, offer for
sale or sale of such applicable COMMERCIAL PRODUCT or such SELECTED REAGENT
is covered by a VALID PATENT CLAIM in each of the MAJOR MARKETS. [***].
|
9.2.2 |
If, at the time of sale of a COMMERCIAL PRODUCT in a
particular country after the expiration of the INITIAL ROYALTY TERM in such
country, there is no VALID PATENT CLAIM covering the manufacture, use, import,
offer for sale or sale of such COMMERCIAL PRODUCT or the SELECTED REAGENT
contained in such COMMERCIAL PRODUCT in each of the MAJOR MARKETS, then BAXTER
shall only owe royalties with respect to NET SALES of COMMERCIAL PRODUCTS in
those countries in which a VALID PATENT CLAIM covers the manufacture, use,
import, offer for sale or sale of such COMMERCIAL PRODUCTS or the SELECTED
REAGENT contained in such COMMERCIAL PRODUCTS in such countries. For
example, after the expiration of the INITIAL ROYALTY TERM [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
43
9.2.3 |
The PARTIES agree that a VALID PATENT CLAIM exists, for
purposes of determining whether royalties are payable after the expiration of
the INITIAL ROYALTY TERM, even if components of a COMMERCIAL PRODUCT are sold
separately as more fully described in Section 9.3 below, and the only VALID
PATENT CLAIM covers the manufacture, use, sale, offer for sale or import of
only one component of such COMMERCIAL PRODUCT ([***]).
|
||
9.2.4 |
BAXTER shall [***].
|
9.2.5 |
Neither PARTY shall contest the accuracy of any royalty,
including the overpayment or underpayment of any royalty, after [***] from the
end of the calendar year in which such royalties are due and payable. For
clarity, prior to the expiration of such [***] period, BAXTER may allege the
overpayment of such royalties (and if determined that overpayment was made, be
entitled to a refund payable within [***] of NEKTAR ALS receipt of an invoice
for the overpaid amount) and NEKTAR AL may allege the underpayment of
royalties (and if determined that underpayment was made, be entitled to such
shortfall). Thereafter, the accuracy of the payment of such royalties shall be
deemed conclusively binding.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
44
9.3 |
SEPARATE COMPONENTS.
If components of a COMMERCIAL PRODUCT are sold
separately, the NET SALES of such COMMERCIAL PRODUCT shall be calculated as if the
components of the COMMERCIAL PRODUCT were not sold separately; provided that no
provision of this AGREEMENT shall be construed as [***]. For example, if a COMMERCIAL
PRODUCT consists of [***] which is intended to be used with and to improve the
half-life of FACTOR VIII, the NET
SALES of such COMMERCIAL PRODUCT shall be deemed to include the amount invoiced
([***]) by BAXTER, its SUBLICENSEES and/or their respective AFFILIATES for the
FACTOR VIII with which such product is intended to be used and the [***], it being
understood and agreed that, for purposes of calculating royalties, the [***] and
the FACTOR VIII are the COMMERCIAL PRODUCT.
|
9.4 |
COMMERCIAL DILIGENCE.
If, during the TERM, BAXTER sells or markets
another FACTOR VIII extended half-life product using a non-PEGYLATION technology which
is used to treat Hemophilia A, then BAXTER must meet the COMMERCIAL DILIGENCE
THRESHOLD, as set forth below. No later than [***] after the FIRST COMMERCIAL SALE of a
COMMERCIAL PRODUCT in each MAJOR MARKET in which MARKETING AUTHORIZATION has been
obtained, the sales of all COMMERCIAL PRODUCTS in the aggregate shall constitute at
least [***] of the total sales of all FACTOR VIII extended half-life products used to
treat Hemophilia A in such MAJOR MARKET (the COMMERCIAL DILIGENCE THRESHOLD). If
sales of such COMMERCIAL PRODUCTS, in the aggregate, do not meet the COMMERCIAL
DILIGENCE THRESHOLD in such MAJOR MARKET within such timeframe, then [***]. In the
event [***], the ROYALTY RATE to which NEKTAR AL is otherwise entitled shall be [***].
For example, [***]. The terms of any such [***] shall be negotiated in good faith by
the PARTIES, and shall include minimum [***] and shall provide that [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
45
9.5 |
REPORTS, EXCHANGE RATES.
BAXTER shall notify NEKTAR AL in writing
promptly upon the FIRST COMMERCIAL SALE of each COMMERCIAL PRODUCT in each country in
which BAXTER elects to pursue commercialization. Commencing upon the FIRST COMMERCIAL
SALE of a COMMERCIAL PRODUCT, BAXTER shall furnish to NEKTAR AL a [***] showing, on a
country-by-country basis, according to the volume of units of such COMMERCIAL
PRODUCT sold in each such country (by SKU) during the reporting period: (a) the
gross invoiced sales of the COMMERCIAL PRODUCT sold in each country during the
reporting period, and the amounts deducted therefrom to determine NET SALES from
such gross invoiced sales detailed in accordance with those deductions provided for
in the definition of NET SALES; (b) the royalties payable in DOLLARS, if any, which
shall have accrued hereunder based upon the NET SALES of the COMMERCIAL PRODUCT; (c)
the withholding taxes, if any, required by LAW to be deducted in respect of such
sales; and (d) the date of the FIRST COMMERCIAL SALE of the COMMERCIAL PRODUCT in
each country during the reporting period. With respect to sales of COMMERCIAL
PRODUCT invoiced in DOLLARS, the gross invoiced sales, NET SALES, and royalties
payable shall be expressed in the report in DOLLARS. With respect to sales of
COMMERCIAL PRODUCT invoiced in a currency other than DOLLARS, the gross invoiced
sales, NET SALES and royalties payable shall be expressed in the report provided
hereunder in the domestic currency of the PARTY making the sale as well as in the
DOLLAR equivalent of the royalty payable and the exchange rate used in determining
the amount of DOLLARS. The DOLLAR equivalent shall be calculated using the average
exchange rate (local currency per DOLLAR) published in The Wall Street Journal,
Western Edition, under the heading Currency Trading, on the last business day of
each month during the applicable calendar quarter. Reports shall be due hereunder on
the forty-fifth (45
th
) day following the close of each calendar quarter.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
46
9.6 |
THIRD PARTY ROYALTIES, ETC.
If either PARTY is required to pay
royalties or any other payments to a THIRD PARTY because the composition of matter or
method of manufacture of a SELECTED REAGENT contained in a POTENTIAL PRODUCT or
COMMERCIAL PRODUCT used, manufactured, imported, sold or offered for sale in a
particular country infringes a PATENT of such THIRD PARTY
in that country or misappropriates know-how of such THIRD PARTY in that country,
then [***] for a license under such PATENT or know-how necessary to use,
manufacture, import, sell or offer for sale such POTENTIAL PRODUCT or COMMERCIAL
PRODUCT in such country. In such event, BAXTER [***]. For example, [***] as a result
of the manufacture, use, import, export, offer for sale or sale of a SELECTED
REAGENT, POTENTIAL PRODUCT or COMMERCIAL PRODUCT, and shall be in addition to
BAXTERs obligations under Sections 15.1.2 and 17.1. In no event shall the royalties
due to NEKTAR AL on the NET SALES of COMMERCIAL PRODUCT in a country on account of
[***] pursuant to this Section 9.6 [***], except in the case where BAXTER is [***],
in which event the royalties due to NEKTAR AL on the NET SALES of COMMERCIAL PRODUCT
may be [***].
|
10. |
RECORDS; AUDITS; SHIPMENT TERMS; PAYMENT TERMS
|
10.1 |
RECORDS.
The PARTIES shall keep complete and accurate records in
sufficient detail to make the reports required hereunder, to confirm their respective
compliance with the provisions of this AGREEMENT, to properly reflect all amounts
billed, owed or reported and to verify the determination of all amounts payable
hereunder. Without limiting the foregoing, BAXTER shall include in each sublicense
granted by it pursuant to this AGREEMENT a provision requiring the SUBLICENSEE to make
reports to BAXTER consistent with those BAXTER is required to provide hereunder, to
keep and maintain records of sales made and deductions taken in calculating royalties
due to NEKTAR AL with respect to such sublicense, and to grant access to such records
by NEKTAR ALS independent accountant pursuant to Section 10.2 below to the same extent
required of BAXTER under this AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
47
10.2 |
AUDITS.
Upon the written request of a PARTY, the other PARTY shall
permit an independent certified public accounting firm of recognized national standing
in the
United States, selected by the requesting PARTY and reasonably acceptable to the
other PARTY, at the requesting PARTYS expense, to have access to such PARTYS
records as may be reasonably necessary to verify (i) the accuracy of any amounts
reported, actually paid or payable under this AGREEMENT, and (ii) in the case of
NEKTAR AL, BAXTERs compliance with Section 5.1, for any year ending not more than
[***] prior to the date of such request. Such audits shall be conducted under
conditions of confidentiality and may be made no more than once each calendar year,
during normal business hours at reasonable times mutually agreed by the PARTIES, and
shall not be conducted on a contingent fee basis.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
48
10.3 |
INVOICING; PAYMENT TERMS.
NEKTAR AL shall send invoices to BAXTER for
any SELECTED REAGENT shipped to BAXTER no earlier than the date of shipment. All
invoices shall be in DOLLARS. Other than as provided for in Section 9.5 with respect to
royalty payments, which shall be made within [***] after the end of each calendar
quarter as provided for therein, all payments due under this AGREEMENT shall be due and
payable [***] from date of invoice. Royalties shown to have accrued to NEKTAR AL as set
forth in each royalty report to be provided under Section 9.5 shall be due and payable
on the date such royalty report is due. Any and all amounts past due under this
AGREEMENT shall [***].
|
10.4 |
PAYMENT METHOD.
Except as otherwise provided for herein, all payments
by BAXTER under this AGREEMENT shall be paid in DOLLARS, and all such payments shall be
made by electronic funds transfer in immediately available funds to such account as
NEKTAR AL shall designate before such payment is due. If at any time legal restrictions
prevent the prompt remittance of part or all royalties due with respect to sales of any
COMMERCIAL PRODUCT in any country where such COMMERCIAL PRODUCT is sold, payment shall
be made through such lawful means or methods as BAXTER shall reasonably determine.
|
10.5 |
TAXES.
All amounts due hereunder shall be paid net of any deduction for
withholding for any taxes or similar governmental charges imposed by any applicable
jurisdiction, and BAXTER shall provide NEKTAR AL evidence of its payment of any such
withholdings that may be required. BAXTER agrees to cooperate with and
provide reasonable assistance to NEKTAR AL in order to facilitate NEKTAR ALs
recovery of any withholdings that NEKTAR AL is due.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
49
11. |
CONFIDENTIALITY
|
11.1 |
TERMINATION OF NON-DISCLOSURE AGREEMENT.
All provisions of, rights
granted and covenants made in the NON-DISCLOSURE AGREEMENT are hereby terminated and of
no further force and effect and are superseded in their entirety by the provisions of,
rights granted and covenants made in this AGREEMENT. The PARTIES acknowledge and agree
that any disclosure made pursuant to the NON-DISCLOSURE AGREEMENT shall be subject to
and governed by the terms and conditions of this Article 11.
|
11.2 |
IN GENERAL.
For the TERM and for a period of [***] thereafter, each
PARTY shall maintain in confidence all information and materials of the other PARTY
(including, but not limited to, KNOW-HOW and samples of THERAPEUTIC AGENT, CONJUGATES,
REAGENT, SELECTED REAGENT, POTENTIAL PRODUCT and COMMERCIAL PRODUCT) disclosed or
provided to it by the other PARTY (either pursuant to this AGREEMENT or the
NON-DISCLOSURE AGREEMENT). CONFIDENTIAL INFORMATION shall be identified as
confidential in writing or, if disclosed verbally or by observation, summarized in
writing and submitted to RECIPIENT within [***] of the oral or visual disclosure
thereof (together with all embodiments thereof, the CONFIDENTIAL INFORMATION).
CONFIDENTIAL INFORMATION shall include both BAXTER MATERIALS and NEKTAR AL MATERIALS.
It may also include information regarding intellectual property and confidential or
proprietary information of AFFILIATES and THIRD PARTIES. The terms and conditions of
this AGREEMENT and the NON-DISCLOSURE AGREEMENT also shall be
deemed CONFIDENTIAL INFORMATION of both PARTIES.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
50
(i) |
known to the general public at the time of its
disclosure to the RECIPIENT, or thereafter became generally known to
the general public, other than as a result of actions or omissions of
the RECIPIENT in violation of this AGREEMENT or the NONDISCLOSURE
AGREEMENT;
|
(ii) |
known by the RECIPIENT prior to the date of
disclosure by the DISCLOSING PARTY;
|
(iii) |
disclosed to the RECIPIENT on an unrestricted
basis from a source unrelated to the DISCLOSING PARTY and not known to
be under a duty of confidentiality to the DISCLOSING PARTY; or
|
(iv) |
independently developed by the RECIPIENT without
the use of CONFIDENTIAL INFORMATION of the DISCLOSING PARTY.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
51
11.3 |
ADDITIONAL PROTECTIONS.
Each PARTY shall take reasonable steps to
maintain the confidentiality of the CONFIDENTIAL INFORMATION of the other
PARTY, which steps shall be no less protective than those that such PARTY takes to
protect its own information and materials of a similar nature, but in no event less
than a reasonable degree of care. Neither PARTY shall use or permit the use of any
CONFIDENTIAL INFORMATION of the other PARTY except for the purposes of carrying out
its obligations or exercising its rights under this AGREEMENT. All CONFIDENTIAL
INFORMATION of a PARTY, including all copies and derivations thereof, is and shall
remain the sole and exclusive property of the DISCLOSING PARTY and subject to the
restrictions provided for herein. Neither PARTY shall disclose any CONFIDENTIAL
INFORMATION of the other PARTY other than to those of its directors, officers,
AFFILIATES, employees, licensors, independent contractors (including CONTRACT
MANUFACTURERS), SUBLICENSEES, assignees, agents and external advisors directly
concerned with the carrying out of this AGREEMENT, on a strictly applied need to
know basis. Other than as expressly permitted herein, RECIPIENT may not use
CONFIDENTIAL INFORMATION of the DISCLOSING PARTY in applying for PATENTS or securing
other intellectual property rights.
|
11.4 |
PERMITTED DISCLOSURES.
The obligations of Sections 11.1 and 11.2 shall
not apply to the extent that RECIPIENT is required to disclose information by LAW,
judicial order by a court of competent jurisdiction, or rules of a securities exchange
or requirement of a governmental agency for purposes of obtaining approval to test or
market POTENTIAL PRODUCT or COMMERCIAL PRODUCT (provided that the RECIPIENT shall
provide prior written notice thereof to the DISCLOSING PARTY and sufficient opportunity
for the DISCLOSING PARTY to review and comment on such required disclosure and request
confidential treatment thereof or a protective order therefor), or discloses
information to a patent office for the purposes of filing or maintaining a PATENT
APPLICATION or PATENT as permitted in this
AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
52
11.5 |
IRREPARABLE INJURY.
The PARTIES acknowledge that either PARTYS breach
of this Article 11 would cause the other PARTY irreparable injury for which it would
not have an adequate remedy at LAW. In the event of a breach, the nonbreaching PARTY
shall be entitled to injunctive relief in addition to any other remedies it may have at
LAW or in equity, without necessity of posting a bond.
|
12. |
REGULATORY MATTERS
|
12.1 |
COMPLAINTS/ADVERSE EVENTS.
Each PARTY shall promptly notify the other
in writing of any information that comes to its attention concerning the safety or
efficacy of any SELECTED REAGENT, POTENTIAL PRODUCT and/or COMMERCIAL PRODUCT,
including, without limitation, any threatened or pending action by any regulatory
authority with respect thereto, in accordance with the applicable QUALITY AGREEMENT.
|
12.2 |
SPECIFIC REQUIREMENTS.
Without limiting the generality of Section 12.1,
BAXTER shall [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
53
13. |
REPRESENTATIONS & WARRANTIES; COVENANTS
|
13.1 |
REPRESENTATIONS AND WARRANTIES.
Each PARTY represents and warrants to
the other that as of the EFFECTIVE DATE to the best of its knowledge and belief: (a)
it has the full corporate power to enter into and perform this AGREEMENT; (b) this
AGREEMENT constitutes its legal, valid and binding obligation; (c) it has sufficient
legal and/or beneficial title or other rights under its intellectual property rights
to grant the licenses contained in this AGREEMENT; (d) each PARTYS professional
employees, officers, contractors (including any
CONTRACT MANUFACTURERS) and consultants that will be involved with this AGREEMENT
and the RESEARCH PLAN (and in the case of BAXTER, its AFFILIATES and SUBLICENSEES),
has executed or will execute an agreement that requires such person or entity, to
the extent permitted by LAW, to assign all INVENTIONS, PATENTS, and KNOW-HOW made
during the course of and as a result of the performance of such PARTYS obligations
under this AGREEMENT, to such PARTY; and (e) each of such PARTYS employees,
officers, contractors (including any CONTRACT MANUFACTURERS) and consultants (and
in the case of BAXTER, its AFFILIATES and SUBLICENSEES) are or will be subject to
written confidentiality obligations no less restrictive than those provided for in
this AGREEMENT. If the obligation to assign under subsection 13.1(d) is not
permitted in a particular country, then such person or entity will be required to
grant an exclusive, worldwide, perpetual, royalty-free license to all such
INVENTIONS, PATENTS, and KNOW-HOW to the PARTY to whom such assignment was to be
made, with the right to sublicense.
|
13.2 |
COMPLIANCE WITH LAWS.
Each PARTY will comply with all LAWS in
performing its obligations and exercising its rights hereunder. Nothing in this
AGREEMENT shall be deemed to permit BAXTER or its SUBLICENSEES to export, re-export or
otherwise transfer any information or materials (including SELECTED REAGENT or
CONJUGATES) transferred hereunder or POTENTIAL PRODUCT or COMMERCIAL PRODUCT
manufactured therefrom without complying with LAWS.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
54
14. |
LIMITATION OF LIABILITY; EXCLUSION OF DAMAGES
|
14.1 |
LIMITATION OF LIABILITY.
EXCEPT (I) FOR THE PARTIES OBLIGATIONS FOR
THIRD PARTY CLAIMS UNDER ARTICLE 15 AND (II) IN THE CASE OF A BREACH OF ARTICLE 7 OR 11:
|
14.1.1 |
IN NO EVENT SHALL NEKTAR ALS LIABILITY ARISING OUT OF THIS AGREEMENT,
INCLUDING WITHOUT LIMITATION AS A RESULT OF THE RESEARCH, DEVELOPMENT,
MANUFACTURE, SUPPLY, USE OR SALE OF CONJUGATES, SELECTED REAGENTS, POTENTIAL
PRODUCTS OR COMMERCIAL PRODUCTS, EXCEED IN THE AGGREGATE, AN AMOUNT THAT IS
[***]. FOR CLARITY, [***] ARE NOT SUBJECT TO THE FOREGOING.
|
14.1.2 |
IN NO EVENT SHALL A PARTY OR ITS AFFILIATES BE LIABLE TO THE OTHER PARTY OR
ITS AFFILIATES OR SUBLICENSEES FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE
OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION, DAMAGES RESULTING FROM
LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF BUSINESS OR OTHER
ECONOMIC LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTYS
PERFORMANCE OR NON-PERFORMANCE HEREUNDER. THIS REPRESENTS AN EXPRESS
ALLOCATION OF RISK BETWEEN THE PARTIES.
|
14.2 |
REMEDIES.
Notwithstanding anything herein to the contrary, the PARTIES
acknowledge that either PARTYS breach of Articles 7 and 11 would cause the other PARTY
irreparable injury for which it would not have an adequate remedy at LAW. In the event
of a breach, the nonbreaching PARTY shall be entitled to injunctive relief in addition
to any other remedies it may have at LAW or in equity, without necessity of posting a
bond.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
55
14.3 |
APPLICABILITY, EXCLUSIVITY OF REMEDIES.
The limitations on liability
and exclusion of damages under this AGREEMENT: (i) apply even if a PARTY had or should
have had knowledge, actual or constructive, of the possibility of such damages; (ii)
are a fundamental element of the basis of the bargain between the PARTIES and this
AGREEMENT would not be entered into without such limitations and exclusions and
(iii) other than as set forth in this Article 14, shall apply whether a claim is
based on breach of contract, breach of warranty, tort (including negligence),
product liability, strict liability or otherwise, and notwithstanding any failure of
essential purpose of any limited remedy herein. Moreover, the remedies under this
AGREEMENT are intended to be exclusive, and, other than as set forth in this Article
14, the limitations on liability and exclusion of damages under this AGREEMENT are
intended to apply even if there is a total and fundamental breach of this AGREEMENT,
and the essential purpose of these provisions is to limit the PARTIES respective
liabilities hereunder.
|
15. |
INDEMNIFICATION; INSURANCE
|
15.1 |
INDEMNITY.
|
15.1.1 |
BY NEKTAR AL.
NEKTAR AL shall defend, indemnify and hold BAXTER,
BAXTERS SUBLICENSEES and their respective shareholders, directors, officers,
employees and agents (each, a BAXTER INDEMNITEE) harmless from and against
all losses, liabilities, damages, costs and expenses (including reasonable
attorneys fees and costs of investigation and litigation, regardless of
outcome) resulting from all claims, demands, actions and other proceedings by
or on behalf of any THIRD PARTY (including any governmental authority)
(collectively, CLAIMS) to the extent arising from: (a) the breach of any
representation, warranty, covenant or material
obligation of NEKTAR AL under this AGREEMENT; [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
56
15.1.2 |
BY BAXTER.
BAXTER shall defend, indemnify and hold NEKTAR AL, NEKTAR
AL AFFILIATES, and their respective shareholders, directors, officers,
employees and agents (each, a NEKTAR AL INDEMNITEE) harmless from and
against all CLAIMS to the extent arising from: (a) the breach of any
representation, warranty, covenant or material obligation of BAXTER under this
AGREEMENT; [***].
|
15.2 |
INSURANCE.
Each PARTY shall, at its own expense, maintain comprehensive
general liability insurance, including product liability insurance, in the minimum
amount of [***] per occurrence, and [***] in the aggregate. BAXTER has the right to
self-insure. Any independent insurance carriers must be rated A-, VII or better by A.M.
Best Company. The PARTIES shall maintain such insurance for so long as they continue to
research or develop or manufacture or commercialize POTENTIAL PRODUCTS or COMMERCIAL
PRODUCTS, and shall from time to time provide copies of certificates of such insurance
to each other upon request. If the insurance policy is written on a claims-made basis,
then the coverage must be kept in place for at least [***] after the termination of
this AGREEMENT.
|
15.3 |
PROCEDURES.
If any CLAIM covered by Section 15.1 is brought, the
indemnifying PARTYS obligations are conditioned upon the following:
|
(i) |
the indemnified PARTY shall promptly notify the indemnifying
PARTY in writing of such CLAIM, provided, however, the failure to provide such
notice within a reasonable period of time shall not relieve the indemnifying
PARTY of any of its obligations hereunder except if the indemnifying PARTY is
prejudiced by such failure or delay;
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
57
(ii) |
the indemnifying PARTY shall assume, at its cost and expense,
the sole defense of such CLAIM through counsel selected by the indemnifying
PARTY, except that those indemnified may at their option and expense select and
be represented by separate counsel;
|
(iii) |
the indemnifying PARTY shall maintain control of such defense
and/or the settlement of such CLAIM, and the indemnified PARTY shall cooperate
with the indemnifying PARTY;
|
(iv) |
those indemnified may, at their option and expense, participate
in such defense, and if they so participate, the indemnifying PARTY and those
indemnified shall cooperate with one another in such defense;
|
(v) |
the indemnifying PARTY will have authority to consent to the
entry of any monetary judgment, to enter into any settlement or otherwise to
dispose of such CLAIM (provided and only to the extent that an indemnified
PARTY does not have to admit liability and such judgment does not involve
equitable relief), and an indemnified PARTY may not consent to the entry of any
judgment, enter into any settlement or otherwise to dispose of such CLAIM
without the prior written consent of the indemnifying PARTY; and
|
(vi) |
the indemnifying PARTY shall pay the full amount of any
judgment, award or settlement with respect to such CLAIM and all other costs,
fees and expenses related to the resolution thereof; provided that such other
costs, fees and expenses have been incurred or agreed, as the case may be, by
the indemnifying PARTY in its defense or settlement of the CLAIM.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
58
16. |
INVENTIONS, KNOW-HOW and PATENTS
|
16.1 |
EXISTING INTELLECTUAL PROPERTY.
Other than as expressly provided in
this AGREEMENT, neither PARTY grants nor shall be deemed to grant any right, title or
interest to the other PARTY in any PATENT, PATENT APPLICATION, KNOW-HOW or other
intellectual property right CONTROLLED by such PARTY as of the EFFECTIVE DATE.
|
16.2 |
DISCLOSURE.
Each PARTY shall promptly disclose in writing to the other
all INVENTIONS arising from the joint or separate activities (including any INVENTIONS
conceived or first reduced to practice as a result of such activities) of the PARTIES
or their agents, employees, SUBLICENSEES or independent contractors (including CONTRACT
MANUFACTURERS) during and in connection with the performance of their obligations or
activities under this AGREEMENT (including in carrying out its activities under the
RESEARCH PLAN and the development or manufacture of POTENTIAL PRODUCT or COMMERCIAL
PRODUCT); provided, however, that [***].
|
16.3 |
OWNERSHIP OF INVENTIONS.
Except as otherwise set forth in Sections 16.4
or 16.5, all INVENTIONS conceived or first reduced to practice solely by employees,
agents, SUBLICENSEES or independent contractors (including CONTRACT MANUFACTURERS) of a
PARTY during the course and in the performance of this AGREEMENT (including in carrying
out its activities under the RESEARCH PLAN and the development or manufacture of
POTENTIAL PRODUCT or COMMERCIAL PRODUCT) (each, a SOLE INVENTION) shall be the
exclusive property of such PARTY. Except as otherwise set forth in Sections 16.4 or
16.5, if employees, agents, SUBLICENSEES or independent contractors (including CONTRACT
MANUFACTURERS) of each of NEKTAR AL and BAXTER jointly, conceive or first reduce to
practice any INVENTION during the course and in the performance of activities conducted
in connection with this AGREEMENT (including in carrying out its activities
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
59
16.4 |
NEKTAR AL CORE TECHNOLOGY INVENTIONS.
Any and all rights, title and
interest in and to all SOLE INVENTIONS and JOINT INVENTIONS (except those JOINT
INVENTIONS that are JOINTLY OWNED TECHNOLOGY), which fall solely within the scope of
NEKTAR AL CORE TECHNOLOGY, shall belong solely to NEKTAR AL (NEKTAR AL CORE TECHNOLOGY
INVENTIONS). BAXTER hereby agrees to and hereby does, and shall, without additional
consideration transfer and assign to NEKTAR AL all of its right, title and interest in
and to such NEKTAR AL CORE TECHNOLOGY INVENTIONS and all intellectual property rights
therein including enforcement rights, and shall require its employees, agents,
SUBLICENSEES and independent contractors (including CONTRACT MANUFACTURERS) to so
assign their right, title and interest therein to NEKTAR
AL. NEKTAR AL shall be responsible, [***], for the filing, prosecution and
maintenance of foreign and domestic PATENT APPLICATIONS and PATENTS covering such
NEKTAR AL CORE TECHNOLOGY INVENTIONS.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
60
16.5 |
BAXTER CORE TECHNOLOGY INVENTIONS.
Any and all rights, title and
interest in and to all SOLE INVENTIONS and JOINT INVENTIONS (except those JOINT
INVENTIONS that are JOINTLY OWNED TECHNOLOGY), which fall solely within the scope of
BAXTER CORE TECHNOLOGY, shall belong solely to BAXTER (BAXTER CORE TECHNOLOGY
INVENTIONS). NEKTAR AL hereby agrees to and hereby does, and shall, without additional
consideration assign to BAXTER all of its right, title and interest in and to any
BAXTER CORE TECHNOLOGY INVENTIONS and all intellectual property rights therein
including enforcement rights, and shall require its employees, agents or independent
contractors (including CONTRACT MANUFACTURERS) to so assign their right, title and
interest therein to BAXTER. BAXTER shall be responsible, [***], for the filing,
prosecution and maintenance of foreign and domestic PATENT APPLICATIONS and PATENTS
covering such BAXTER CORE TECHNOLOGY INVENTIONS.
|
16.6 |
INDIVIDUAL PATENT FILINGS.
Each PARTY shall have sole discretion and
right to prepare, file, prosecute, maintain and defend PATENT APPLICATIONS or PATENTS
for INVENTIONS it solely owns under this AGREEMENT, and shall be responsible for
related interference proceedings. [***]. Costs incurred with respect to PATENT
APPLICATIONS shall be borne by the PARTY with the right to prosecute each such PATENT
APPLICATION.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
61
16.7 |
JOINT PATENT FILINGS.
With respect to all PATENT APPLICATIONS on JOINT
INVENTIONS that are jointly owned by the PARTIES (i.e., JOINT INVENTIONS that have not
been assigned nor are assignable to the other PARTY
pursuant to Sections 16.4 and 16.5) (the JOINT PATENT APPLICATIONS), the PARTIES
shall determine which PARTY shall be responsible for filing, prosecuting and
maintaining PATENT APPLICATIONS and PATENTS on behalf of both PARTIES (the
RESPONSIBLE PARTY) [***]. All PATENTS issuing from such PATENT APPLICATIONS shall
be defined as JOINT PATENTS. It is understood that BAXTER shall have the
preferential right to prosecute those JOINT INVENTIONS directed solely at POTENTIAL
or COMMERCIAL PRODUCTS. At least [***] prior to the contemplated filing of such
PATENT APPLICATION, the RESPONSIBLE PARTY shall submit a substantially completed
draft of the JOINT PATENT APPLICATION to the other PARTYs patent attorneys only for
its approval, which shall not be unreasonably withheld or delayed. Except as set
forth below, [***] of the preparation, filing, prosecution and maintenance of all
JOINT PATENT APPLICATIONS. [***] of preparing, filing, prosecuting and maintaining
all of the foreign and domestic JOINT PATENT APPLICATIONS that cover INVENTIONS
within the scope of JOINTLY OWNED TECHNOLOGY, and the JOINT PATENTS that issue
therefrom.
|
16.8 |
DISPOSITION OF INVENTIONS.
It is understood and agreed that for the
purposes of this AGREEMENT, even if an employee, agent, SUBLICENSEE or contractor of a
PARTY is an inventor of an INVENTION that is claimed in a PATENT or PATENT APPLICATION,
the PARTY who owns said INVENTION as a result of the operation of Article 16 shall not
assign, transfer, license or otherwise dispose of any other claim in such PATENT or
PATENT APPLICATION, unless such PARTY solely or jointly owns or otherwise has the right
to license rights with respect to said other claim (in each case as expressly provided
for in this AGREEMENT).
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
62
16.9 |
FURTHER ACTIONS.
Each PARTY shall cooperate with the other PARTY to
execute all documents and take all reasonable actions to effect the intent of this
Article 16.
|
16.10 |
PATENT MARKING AND POTENTIAL PRODUCT AND COMMERCIAL PRODUCT MARKING.
|
(i) |
BAXTER shall place appropriate NEKTAR AL patent and/or patent
pending markings on each POTENTIAL PRODUCT and COMMERCIAL PRODUCT or the
packaging therefor. The content, form, size, location and language of such
markings shall be in accordance with the LAWS and practices of the country in
which the applicable units of each POTENTIAL PRODUCT or COMMERCIAL PRODUCT are
distributed.
|
(ii) |
BAXTER shall be responsible for all packaging (non-commercial
and commercial) and labeling of POTENTIAL PRODUCT or COMMERCIAL PRODUCT. To the
extent allowed by LAWS, all POTENTIAL PRODUCT or COMMERCIAL PRODUCT labeling,
packaging and package inserts and any promotional materials associated with the
POTENTIAL PRODUCT or COMMERCIAL PRODUCT shall carry, in a conspicuous location,
the trademark of NEKTAR AL, the identity and style of which shall be at NEKTAR
ALS sole discretion. NEKTAR AL authorizes the use of its trademark pursuant to
this Section 16.10(ii).
|
16.11 |
SUPPLEMENTAL PATENT PROTECTION.
[***]. Such protection shall include
the listing of any requested [***] in any book, or book equivalent, of any country
necessary for extending the term of such [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
63
17. |
INFRINGEMENT
|
17.1 |
INFRINGEMENT OF THIRD PARTY RIGHTS.
|
17.1.1 |
NOTICE.
If the development, manufacture, use, import, sale or offer
for sale of a POTENTIAL PRODUCT or a COMMERCIAL PRODUCT results in a claim for
PATENT infringement by a THIRD PARTY, the PARTY to this AGREEMENT first having
notice shall promptly notify the other PARTY in writing. The notice shall set
forth the facts of the claim in reasonable detail.
|
17.1.2 |
LITIGATION UNRELATED TO SELECTED REAGENT.
Except to the extent any
infringement of patents or misappropriation of know-how results solely from
the composition of matter or the method of manufacture of a SELECTED REAGENT,
[***] from and against all losses, liabilities, damages, costs and expenses
(including reasonable attorneys fees and costs of investigation and
litigation, regardless of outcome) resulting from any claim that the
development, manufacture, use, import, offer for sale or sale of a POTENTIAL
PRODUCT or a COMMERCIAL PRODUCT infringes a THIRD PARTY patent or
misappropriates THIRD PARTY know-how, and the provisions of Sections 15.1.2
and 15.3 shall apply with respect to any such claim to the same extent as
though it were a CLAIM [***]. In the event of a conflict between the
provisions of Article 15 and this Section 17.1.2, [***].
|
17.1.3 |
LITIGATION RELATED TO SELECTED REAGENT.
If infringement of a THIRD
PARTY patent or misappropriation of THIRD PARTY know-how is alleged solely
because the composition of the SELECTED REAGENT or the method of making the
same, is used in the development, manufacture, use, offer for sale, sale, or
import of a POTENTIAL PRODUCT or COMMERCIAL PRODUCT, [***], any such action
taken by such THIRD PARTY against either PARTY or both PARTIES, including the
costs and expenses (including reasonable attorneys fees and costs of
investigation and
litigation, regardless of outcome) resulting from such defense. [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
64
17.2 |
INFRINGEMENT BY THIRD PARTIES.
|
17.2.1 |
NOTICE OF INFRINGEMENT.
If any VALID PATENT CLAIM is infringed by a
THIRD PARTY, or any KNOW-HOW utilized in the manufacture, use, import, offer
for sale or sale of SELECTED REAGENT or POTENTIAL PRODUCT or COMMERCIAL
PRODUCT is misappropriated by a THIRD PARTY, the PARTY first having knowledge
of such infringement or misappropriation shall promptly notify the other PARTY
in writing. The notice shall set forth the facts of such infringement or
misappropriation in reasonable detail.
|
||
17.2.2 |
PROSECUTION OF ACTIONS RELATED TO SELECTED REAGENT.
|
A. |
NEKTAR AL shall have the right, but not the
obligation, to carry out actions against THIRD PARTIES arising from such
THIRD PARTIES infringement or misappropriation of NEKTAR AL LICENSED
TECHNOLOGY covering the manufacture, use, import, offer for sale or sale
of a SELECTED REAGENT. [***].
|
B. |
If NEKTAR AL fails to bring an action or
proceeding within a period of [***] after receiving written notice from
BAXTER of the possibility of a claim, or otherwise having knowledge of a
claim described in Section 17.2.2(A), BAXTER shall have the right, but
not the obligation, to bring and control any such action using counsel
of its own choice, [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
65
C. |
AWARDS.
If either PARTY brings an action
for infringement or
misappropriation by a THIRD PARTY under this Section 17.2.2 any
damages or other monetary awards or payments in settlement recovered
by such PARTY shall be applied first to defray the costs and
expenses incurred by both PARTIES in the action. Any remainder shall
be shared by the PARTIES as follows: [***], when the action for
infringement or misappropriation relates to a COMMERCIAL PRODUCT;
and [***].
|
17.2.3 |
PROSECUTION OF ACTIONS RELATED TO THE FIELD.
|
A. |
Except as set forth in Section 17.2.2, BAXTER
shall have the primary right, but not the obligation, to carry out
actions against THIRD PARTIES arising from such THIRD PARTIES
infringement or misappropriation of NEKTAR AL LICENSED TECHNOLOGY in
the FIELD, including the manufacture, use, import, offer for sale or
sale of a POTENTIAL PRODUCT or COMMERCIAL PRODUCT. [***].
|
B. |
If BAXTER fails to bring an action or proceeding
within a period of sixty (60) days after receiving written notice from
NEKTAR AL of the possibility of a claim, or otherwise having knowledge
of a claim described in Section 17.2.3(A), NEKTAR AL shall have the
right, but not the obligation, to bring and control any such action
using counsel of its own choice, [***].
|
C. |
AWARDS.
If either PARTY brings an action
for infringement or misappropriation by a THIRD PARTY under this
Section 17.2.3 any damages or other monetary awards or payments in
settlement recovered by such PARTY shall be applied first to defray the
costs and
expenses incurred by both PARTIES in the action. Any remainder shall
be shared by the PARTIES as follows: [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
66
18. |
[INTENTIONALLY OMITTED]
|
|
19. |
TERM AND TERMINATION
|
19.1 |
EXPIRATION.
The term of this AGREEMENT (the TERM) shall commence on
the EFFECTIVE DATE and shall continue until terminated as set forth herein. Once a
POTENTIAL PRODUCT is a COMMERCIAL PRODUCT and has been commercialized, this AGREEMENT
shall expire on a country-by-country basis upon the expiration of all royalty
obligations with respect to such COMMERCIAL PRODUCT in the applicable country, unless
earlier terminated as provided herein. Upon the expiration of royalty obligations with
respect to a COMMERCIAL PRODUCT in any applicable country, BAXTER is hereby granted by
NEKTAR AL a paid-up, exclusive, royalty-free, perpetual, non-cancelable, license, with
rights to sublicense, in the FIELD under the NEKTAR AL LICENSED TECHNOLOGY to make,
have made, use, sell, offer for sale and import such COMMERCIAL PRODUCT in such
country, [***]. The terms and conditions of such manufacture and supply of SELECTED
REAGENT shall be negotiated in good faith by the PARTIES.
|
19.2 |
DISCRETIONARY TERMINATION.
[***], other than pursuant to any other
provision of this AGREEMENT, [***], payable in accordance with Section 19.7.5, upon
[***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
67
19.3 |
TERMINATION FOR CAUSE.
Each PARTY shall have the right to terminate
this AGREEMENT by written notice to the other PARTY for a failure to comply with the
material terms of this AGREEMENT by the other PARTY, provided such failure to
comply is not corrected by the failing PARTY within: (i) [***] of written notice of
any failure to make timely payment of royalties or any other amount that is not in
dispute, when due hereunder, or (ii) [***] of receipt of written notice of any other
failure from the non-failing PARTY.
|
19.4 |
TERMINATION FOR INSOLVENCY.
Either PARTY may terminate this AGREEMENT
immediately by written notice in the event: (i) the other PARTY voluntarily enters into
bankruptcy proceedings; (ii) the other PARTY makes an assignment for the benefit of
creditors; (iii) a petition is filed against the other party under a bankruptcy law, a
corporate reorganization law, or any other law for relief of debtors or similar law
analogous in purpose or effect, which petition is not stayed or dismissed within [***]
of filing thereof; or (iv) the other PARTY enters into liquidation or dissolution
proceedings or a receiver is appointed with respect to any assets of the other PARTY,
which appointment is not vacated within [***] (herein a BANKRUPTCY PROCEEDING).
|
19.5 |
TERMINATION/[***] FOR LACK OF DILIGENCE.
In the event [***]. In the
event [***] provided for herein shall continue to apply, except as otherwise set forth
in Section 19.5.2. Notwithstanding the foregoing, before [***] may provide notice of
termination of the AGREEMENT or termination of [***] shall call a special meeting of
the JOINT STEERING COMMITTEE for the sole purpose of discussing the reasons for [***].
Such special meeting of the JOINT STEERING COMMITTEE shall be held [***]. At any time
during the period commencing on the conclusion of such meeting up through the date that
is [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
68
19.5.1 |
An ACCEPTABLE DELAY shall be the failure to meet a Development Diligence
milestone event due to:
|
A. |
an event of force majeure as described in Section 22.1;
|
B. |
any breach by NEKTAR AL, or NEKTAR AL delay,
that materially adversely affects BAXTERs ability to meet a relevant
Development Diligence milestone event;
|
C. |
a dispute or disagreement in one or more of the
governance committees (JOINT STEERING COMMITTEE, RESEARCH COMMITTEE,
DEVELOPMENT AND PRODUCTION COMMITTEE) which is [***];
|
D. |
a regulatory requirement that comes into effect
after the EFFECTIVE DATE;
|
E. |
a development issue involving safety, toxicity,
efficacy or pharmacokinetics, or the ability to scale up to commercial
manufacturing (including the inability to obtain commercially viable
yields);
|
F. |
any other delay deemed to be an ACCEPTABLE DELAY
by both PARTIES in writing, the intent of which is to be inclusive of
unanticipated delays outside of the control of BAXTER; or
|
G. |
[***] in accordance with the timelines set forth
in the RESEARCH PLAN, [***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
69
(i) |
[***];
|
||
(ii) |
[***];
|
||
(iii) |
[***];
|
||
(iv) |
[***].
|
19.5.2 |
If, at the time that [***] elects to exercise its rights to terminate this
AGREEMENT [***] solely for the treatment of [***]. In such event, the following
shall occur:
|
(i) |
The definition of FIELD in Section 1.26 shall automatically be
narrowed to consist only of [***] for use alone for the treatment of
[***];
|
(ii) |
The definition of THERAPEUTIC AGENT shall
automatically be limited to [***];
|
(iii) |
[***]; and
|
(iv) |
All royalty and milestone provisions applicable
to such POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS shall remain in
effect.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
70
19.6 |
TERMINATION ON CHALLENGE.
[***] may terminate this AGREEMENT by giving
written notice to [***] challenging the validity of any of the [***]; provided that
[***] may not exercise such termination rights if [***] (whether under contract or
other legal theory) [***] allege in defense of such claim or action that the COMMERCIAL
PRODUCT does not infringe a VALID PATENT CLAIM.
|
19.7 |
EFFECT OF TERMINATION.
|
19.7.1 |
The provisions of Articles [***] (and in each case together with any defined
terms applicable to such provisions) shall survive expiration or termination
of this AGREEMENT for any reason whatsoever.
|
19.7.2 |
Notwithstanding anything in this AGREEMENT to the contrary, if this AGREEMENT
is terminated for any reason other than for cause [***]:
|
A. |
[***];
|
||
B. |
[***];
|
||
C. |
BAXTER shall pay NEKTAR AL all
earned milestone payments and accrued royalties in accordance
with the terms of this AGREEMENT;
|
||
D. |
[***] Subject to the foregoing,
if this AGREEMENT is terminated for any reason whatsoever, any
licenses and sublicenses granted under this AGREEMENT shall
automatically terminate and all licensed rights shall revert
in their entirety to the respective licensor; and
|
||
E. |
Termination of this AGREEMENT by
a PARTY shall not be an exclusive remedy and all other remedies
will be available to the terminating PARTY, in equity and at
LAW, subject to the limitations and exclusions that are
provided for in this AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
71
19.7.3 |
If this AGREEMENT is terminated by [***], then on the effective date of such
termination, [***], including any of the intellectual property rights therein,
including any JOINT PATENT APPLICATIONS and JOINT PATENTS covering such
JOINTLY OWNED TECHNOLOGY. As of the effective date of such termination, [***]
shall have the sole right, as between NEKTAR AL and BAXTER, to bring actions
against THIRD PARTIES arising from such THIRD PARTIES infringement or
misappropriation of JOINTLY OWNED TECHNOLOGY. [***].
|
19.7.4 |
In the event of a BANKRUPTCY PROCEEDING, NEKTAR AL hereby agrees to grant
and hereby grants to BAXTER and its AFFILIATES, and the PARTIES agree that
this AGREEMENT shall be deemed an executory contract and that BAXTER and its
AFFILIATES shall be deemed to retain, an exclusive, perpetual, non-cancelable,
license, with rights to sublicense as provided for herein, in the FIELD under
the NEKTAR AL LICENSED TECHNOLOGY to develop, make, have made, import, export,
use, sell and have sold POTENTIAL PRODUCTS and COMMERCIAL PRODUCT(S) in the
FIELD; provided that BAXTER shall continue to fulfill its MILESTONES and
royalty payment obligations under this AGREEMENT.
BAXTER agrees to pay NEKTAR AL, or any trustee, in such BANKRUPTCY
PROCEEDING a royalty for such a license equivalent to the license royalty
provision provided in this AGREEMENT. In addition to the surviving Sections
in Section 19.7.1, Sections 9.2, 9.3, 9.5 and 9.6 shall survive termination
or expiration of this Agreement.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
72
19.7.5 |
TERMINATION FEE.
If this AGREEMENT is terminated by BAXTER under
Section 19.2, BAXTER shall pay to NEKTAR AL a termination fee (TERMINATION
FEE) within [***] after the effective date of such termination as follows:
(i) if such termination occurs prior to the payment to NEKTAR AL of all of the
[***], then the TERMINATION FEE shall be equal to [***], (ii) if such
termination occurs after payment to NEKTAR AL of all of the [***], then the
TERMINATION FEE shall be [***]; (iii) if such termination occurs after the
successful completion of the [***], then the TERMINATION FEE shall be [***];
and (iv) if such termination occurs after the successful completion of the
[***], then the TERMINATION FEE shall be [***]. In addition to the foregoing
and, if applicable, if a COMMERCIAL PRODUCT is not launched within [***] after
the date on which [***]. Notwithstanding the foregoing, if BAXTER terminates
the AGREEMENT under Section 19.2 due to a COMMERCIAL FAILURE, the TERMINATION
FEE [***]. COMMERCIAL FAILURE means:
|
(i) |
[***];
|
||
(ii) |
[***];
|
||
(iii) |
[***];
|
||
(iv) |
[***];
|
||
(v) |
[***];
|
||
(vi) |
[***].
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
73
20. |
ASSIGNMENT
|
|
Unless otherwise expressly permitted hereunder, neither PARTY may assign any of its rights
or delegate any of its duties under this AGREEMENT without the prior written consent of the
other PARTY, except that either PARTY may assign any or all of its rights and/or
responsibilities hereunder without the other PARTYS consent as part of: (i) the sale of all
or substantially all of the assets or the entire business to which this AGREEMENT relates,
(ii) a merger, consolidation, reorganization or other combination with or into another
person or entity; or (iii) the transfer or assignment to an AFFILIATE, in each case,
pursuant to which the surviving entity or assignee assumes the assigning or merging PARTYS
obligations hereunder. Any assignment made in violation of this Article 20 shall be null and
void.
|
||
21. |
NOTICES
|
|
Wherever notice is required or permitted hereunder, it shall be by personal delivery, first
class mail, overnight delivery service, or sent by facsimile transmission, with electronic
confirmation, properly directed to the PARTY at its address and contact information listed
below. Said address and contact information may be changed from time to time by similar
written notice.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
74
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
75
22. |
MISCELLANEOUS
|
22.1 |
FORCE MAJEURE.
Except for each PARTYs confidentiality and indemnity
obligations, the obligations of either PARTY under this AGREEMENT shall be excused
during each period of delay caused by matters such as acts of God, strikes, supplier
delays, failure of utilities or common carriers, shortages of raw materials,
government orders, sufferance of or voluntary compliance with acts of government or
governmental regulation, or acts of war or terrorism, which are reasonably beyond the
control of the PARTY obligated to perform. Force majeure shall not include a lack of
funds, bankruptcy or other financial cause or disadvantage, and force majeure shall
not excuse or delay any PARTYS payment obligations under this AGREEMENT. Nothing
contained in this AGREEMENT shall affect either PARTYs ability or discretion
regarding any strike or other employee dispute or disturbance and all such strikes,
disputes or disturbances shall be deemed to be beyond the control of such PARTY. A
condition of force majeure shall be deemed to continue only so long as the affected
PARTY shall be taking all reasonable actions necessary to overcome such condition. If
either PARTY shall be affected by a condition of force majeure, such PARTY shall give
the other PARTY prompt notice thereof, which notice shall contain the affected PARTYS
estimate of the duration of such condition and a description of the steps being taken
or proposed to be taken to overcome such condition of force majeure. Any delay
occasioned by any such cause shall not constitute a default, breach or failure under
this AGREEMENT, and the obligations of the PARTIES shall be suspended during the
period of delay so occasioned. During any period of force majeure, the PARTY that is
not directly affected by such condition of force majeure may take any reasonable
action
necessary to mitigate the effects of such condition of force majeure.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
76
22.2 |
SEVERABILITY.
All the terms and provisions of this AGREEMENT are
distinct and severable, and if any term or provision is held unenforceable, illegal or
void in whole or in part by any court, regulatory authority or other competent
authority it shall to that extent be deemed not to form part of this AGREEMENT, and the
enforceability, legality and validity of the remainder of this AGREEMENT shall not be
affected thereby.
|
22.3 |
VARIATION.
This AGREEMENT may not be amended, varied or modified in any
manner except by an instrument in writing signed by a duly authorized officer or
representative of each PARTY hereto.
|
22.4 |
FORBEARANCE AND WAIVER.
No waiver by a PARTY in respect of any breach
shall operate as a waiver in respect of any subsequent breach. No forbearance, failure
or delay by a PARTY in exercising any right or remedy shall operate as a waiver
thereof, nor shall any single or partial forbearance, exercise or waiver of any right
or remedy prejudice its further exercise of any right or remedy under this AGREEMENT or
at LAW.
|
22.5 |
COUNTERPARTS; FACSIMILE.
This AGREEMENT may be executed in more than
one counterpart, each of which constitutes an original and all of which together shall
constitute one enforceable agreement. For purposes of this AGREEMENT and any other
document required to be delivered pursuant to this AGREEMENT, facsimiles of signatures
shall be deemed to be original signatures. In addition, if any of the PARTIES sign
facsimile copies of this AGREEMENT, such copies shall be deemed originals.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
77
22.6 |
NO PARTNERSHIP.
The relationship of the PARTIES is that of independent
contractors and this AGREEMENT shall not operate so as to create a partnership or
joint venture of any kind between the PARTIES.
|
22.7 |
CONSTRUCTION.
The PARTIES have participated jointly in the negotiation
and drafting of this AGREEMENT. In the event that an ambiguity or question of intent or
interpretation arises, this AGREEMENT shall be construed as if drafted jointly by the
PARTIES and no presumption or burden of proof shall arise favoring or disfavoring any
PARTY by virtue of the authorship of any of the provisions of this AGREEMENT. Except
where the context otherwise requires, where used, the singular shall include the
plural, the plural the singular, the use of any gender shall be applicable to all
genders and the word or is used in the inclusive sense (and/or). The captions of this
AGREEMENT are for convenience of reference only and in no way define, describe, extend
or limit the scope or intent of this AGREEMENT or the intent of any provision contained
in this AGREEMENT. The term includes and including as used herein means including,
but not limited to.
|
22.8 |
ENTIRE AGREEMENT.
This AGREEMENT and the Schedules and Exhibit attached
hereto constitute the entire understanding between the PARTIES and supersedes any prior
or contemporaneous written or oral understanding, negotiations or agreements between
and among them respecting the subject matter hereof. This AGREEMENT may not be modified
or amended other than by a writing signed by both PARTIES duly authorized officers.
This AGREEMENT shall be binding upon, and inure to the benefit of, the PARTIES and
their respective successors and assigns.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
78
22.9 |
GOVERNING LAW.
This AGREEMENT shall be governed by and construed in
accordance with the LAWS of the State of California without regard to its or any other
jurisdictions choice of law rules. Any disputes under this AGREEMENT shall be brought
in the state or federal courts located in California. The PARTIES submit to
the personal jurisdiction of such courts for any such action, agree that such courts
provide a convenient forum for any such action, and waive any objections or
challenges to venue with respect to such courts.
|
22.10 |
PUBLICITY.
Neither PARTY shall make any public announcement concerning
this AGREEMENT without the prior written consent of the other PARTY, unless counsel to
such PARTY advises that such announcement or statement may be required by LAW
(including applicable stock exchange rule). In the case of an announcement required by
LAW, the other PARTY shall be advised in advance and both PARTIES shall use good faith
efforts to cause a mutually agreeable announcement to be issued in a timely basis.
Notwithstanding the foregoing, NEKTAR AL and BAXTER shall prepare and issue a joint
press release acceptable to both PARTIES announcing the relationship created under this
AGREEMENT.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
79
Signed:
|
||
For and on behalf of:
|
For and on behalf of: | |
NEKTAR Therapeutics AL, Corporation
|
Baxter Healthcare Corporation | |
|
||
Signature [***]
|
Signature [***] | |
Name: [***]
|
Name: [***] | |
Title: [***]
|
Title: [***] | |
|
||
For and on behalf of:
|
||
Baxter Healthcare SA
|
||
|
||
Signature [***]
|
||
Name: [***]
|
||
Title: [***]
|
[***] |
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
80
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
1
a. |
Full Force and Effect.
Except as expressly amended by this Amendment, the
Agreement shall remain unchanged and continue in full force and effect as provided
therein.
|
b. |
Entire Agreement of the Parties.
This Amendment and the Agreement constitute
the complete final and exclusive understanding and agreement of the Parties with
respect to the subject matter of the Agreement, and supersede any and all prior or
contemporaneous negotiations, correspondence, understandings and agreements, whether
oral or written, between the Parties respecting the subject matter of the Agreement.
|
c. |
Counterparts.
This Amendment may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one
and the same instrument.
|
NEKTAR THERAPEUTICS AL, CORPORATION
|
BAXTER HEALTHCARE CORPORATION | |
|
||
By: [***]
|
By: [***] | |
|
||
Name: [***]
|
Name: [***] | |
|
||
Title: [***]
|
Title: [***] | |
|
||
BAXTER HEALTHCARE SA
|
||
|
||
By: [***]
|
||
|
||
Name: [***]
|
||
|
||
Title: [***]
|
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
2
1. |
A new Section 2.8 is hereby added to the Agreement as follows:
|
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
3
(a) |
[***] under the Agreement;
|
||
(b) |
[***] of the Agreement; and
|
||
(c) |
[***] as of the EFFECTIVE DATE of the Agreement.
|
2. |
Miscellaneous
|
a. |
Full Force and Effect.
Except as expressly amended by this Amendment, the
Agreement shall remain unchanged and continue in full force and effect as provided
therein.
|
b. |
Entire Agreement of the Parties.
This Amendment and the Agreement constitute
the complete final and exclusive understanding and agreement of the Parties with
respect to the subject matter of the Agreement, and supersede any and all prior or
contemporaneous negotiations, correspondence, understandings and agreements, whether
oral or written, between the Parties respecting the subject matter of the Agreement.
|
c. |
Counterparts.
This Amendment may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one
and the same instrument.
|
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
4
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
5
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
6
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
7
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
8
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
9
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
10
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
11
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
12
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
13
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
14
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
15
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
16
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
17
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
18
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
19
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
20
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
21
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
22
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
23
[***] |
indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
1. |
All references to the Agreement contained in any Section or subsection of the
Agreement shall mean the Agreement (as amended).
|
2. |
New Section 1.86 is added to the Agreement, as follows:
|
3. |
The Parties agree to add a new Section 2.2.2 to the Agreement, as follows;
|
4. |
The Parties agree to amend Section 36 of Amendment No. 3 of the Agreement, amending
Section 19.2(ii) of the Agreement by deleting the present Section 19.2(ii) in its entirety
and replacing it with the following:
|
5. |
The Parties agree to amend Section 36 of Amendment No. 3 of the Agreement to add the
following Subsection (iv) to Section 19.2 of the Agreement:
|
6. |
The Parties agree to add a new Section 23 to the Agreement, as follows:
|
a. |
Mediation
. The PARTIES agree that any and all disputes, claims or
controversies arising out of or relating to this AGREEMENT shall be submitted to [***]
for mediation, and if the matter is not resolved through mediation, then it shall be
submitted to [***] for final and binding arbitration pursuant to the arbitration clause
set forth in Section 23(b) below; provided, however, that either PARTY may apply to any
court of appropriate jurisdiction to seek equitable relief without the requirement of
pursuing arbitration pursuant to Section 23(b).
|
b. |
Arbitration
.
|
i. |
The PARTIES shall attempt to resolve any and all disputes, claims or
controversies arising out of or relating to this AGREEMENT promptly by
negotiation between executives who have authority to settle the controversy.
If such disputes, claims or controversies are not resolved through such
negotiation, then they shall be submitted for final and binding arbitration
pursuant to the arbitration clause set forth below. Either PARTY may
initiate arbitration with respect to the matters
submitted to negotiation by filing a written demand for arbitration at any
time following the initial negotiation session.
|
ii. |
To the extent not resolved by mediation, any dispute, claim or
controversy arising out of or relating to this AGREEMENT or the breach,
termination, enforcement, interpretation or validity thereof, including the
determination of the scope or applicability of this AGREEMENT to arbitrate,
shall be determined by arbitration conducted in the English language. The
arbitration shall take place in [***]. The arbitration shall be
administered by [***] pursuant to its Arbitration Rules and Procedures.
References herein to any arbitration rules or procedures mean such rules or
procedures as amended from time to time, including any successor rules or
procedures, and references herein to the [***] include any successor
thereto. The arbitration shall be before [***] arbitrators. [***]. All
[***] arbitrators shall have experience in the area under dispute. This
arbitration provision, and the arbitration itself, shall be governed by the
laws of the [***], and [***] the Federal Arbitration Act, 9 U.S.C. §§ 1-16.
|
iii. |
Consistent with the expedited nature of arbitration, each PARTY will,
upon the written request of the other PARTY, promptly provide the other with
copies of documents on which the producing PARTY may rely in support of or
in opposition to any claim or defense. At the request of a PARTY, the
arbitrators shall have the discretion to order examination by deposition of
witnesses to the extent the arbitrator deems such additional discovery
relevant and appropriate. Depositions shall be limited to a maximum of [***]
per PARTY and shall be held within [***] days of the grant of a request.
Additional depositions may be scheduled only with the permission of the
arbitrators, and for good cause shown. Each deposition shall be limited to a
maximum of [***] duration. All objections are reserved for the arbitration
hearing except for objections based on privilege and proprietary or
confidential information. The PARTIES shall not utilize any other discovery
mechanisms, including international processes and U.S. federal statutes, to
obtain additional evidence for use in the arbitration. Any dispute regarding
discovery, or the relevance or scope thereof, shall be determined by the
arbitrators, which determination shall be conclusive. All discovery shall be
completed within [***] days following the appointment of the arbitrators.
All costs and/or fees relating to the retrieval, review and production of
electronic discovery shall be paid by the PARTY requesting such discovery.
|
iv. |
The panel of arbitrators shall have no power to award non-monetary or
equitable relief of any sort. [***]. The arbitrators shall have no power
or authority, under the [***] or otherwise, to relieve the PARTIES from
their agreement hereunder to arbitrate or otherwise to amend or disregard
any provision of this AGREEMENT. Subject to the provisions set forth in
Section 23(b)(v) below, the award of the arbitrators shall be final, binding
and the sole and exclusive remedy to the PARTIES. Either PARTY may seek to
confirm and enforce any final award entered in arbitration, in any court of
competent jurisdiction. The cost of the
arbitration, including the fees of the arbitrators, shall be borne by the
PARTY the arbitrator determines has not prevailed in the arbitration.
|
v. |
If an arbitral award does not contain an award of money damages in excess
of [***], then the arbitral award shall not be appealable and shall only be
subject to such challenges as would otherwise be permissible under the
Federal Arbitration Act, 9 U.S.C. §§ 1-16. In the event that the
arbitration results in an arbitral award, which imposes a monetary award in
excess of [***], such award may be appealed to a tribunal of appellate
arbitrators via the [***] Appeal Procedure.
|
vi. |
Except as may be required by law, and except to the extent necessary for
either PARTY to seek to confirm and enforce any final award entered in
arbitration in a court of competent jurisdiction, neither a PARTY nor an
arbitrator may disclose the existence, content, or results of any
arbitration hereunder without the prior written consent of both PARTIES.
|
a. |
Full Force and Effect.
Except as expressly amended by this Amendment, the
AGREEMENT shall remain unchanged and continue in full force and effect as provided
therein.
|
b. |
Entire Agreement of the Parties.
This Amendment and the AGREEMENT constitute
the complete final and exclusive understanding and agreement of the PARTIES with
respect to the subject matter of the AGREEMENT, and supersede any and all prior or
contemporaneous negotiations, correspondence, understandings and agreements, whether
oral or written, between the PARTIES respecting the subject matter of the AGREEMENT.
|
c. |
Counterparts.
This Amendment may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one
and the same instrument. One or more counterparts of this Amendment may be executed by
facsimile, electronic reproductions of signatures or other electronic means, all of
which shall be deemed originals.
|
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NEKTAR THERAPEUTICS | ||||
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||||
|
By: | /s/ Gil M. Labrucherie | ||
|
||||
|
Name: | Gil M. Labrucherie | ||
|
Title: | SVP & General Counsel | ||
|
||||
NOVARTIS PHARMA AG | ||||
|
||||
|
By: | /s/ Jörg Walther | ||
|
||||
|
Name: | Jörg Walther | ||
|
Title: | Authorized Signatory | ||
|
||||
|
By: | /s/ Cristina Ruggeberg | ||
|
||||
|
Name: | Cristina Ruggeberg | ||
|
Title: | Authorized Signatory |
Name | Jurisdiction of Incorporation or Organization | |
Nektar Therapeutics AL, Corporation
|
Alabama | |
Nektar Therapeutics UK, Ltd.
|
United Kingdom | |
Inhale Therapeutic Systems Deutschland GmbH
|
Germany | |
Nektar Therapeutics (India) Pvt. Ltd
|
India | |
Aerogen, Inc.
|
Delaware |
* | Includes subsidiaries that do not fall under the definition of Significant Subsidiary as defined under Rule 1-02(w) of Regulation S-X. |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements (Form S-8 Nos. 333-07969, 333-59735,
333-65919, 333-74669, 333-32788, 333-54078, 333-55032, 333-67342, 333-71936, 333-76638, 333-98321, 333-103040,
333-117975, 333-136498, 333-145259 and 333-153106) pertaining to the amended and restated 1994 Equity
Incentive Plan, the 1998 Non-Officer Equity Incentive Plan, the 2000 Non-Officer Equity Incentive Plan, the 401(k)
Retirement Plan, the Employee Stock Purchase Plan, the 2000 Equity Incentive Plan, the 2008 Equity Incentive Plan, the
Bradford Particle Design plc Share Option Schemes, the Shearwater Corporation 1996 Nonqualified Stock Option Plan, and
in the Registration Statements (Form S-3 Nos. 333-54080, 333-108859, 333-120009, 333-67340, 333-130591) of Nektar
Therapeutics, and in the related Prospectuses, of our reports dated
March 4, 2009, with respect to the consolidated
financial statements and schedule of Nektar Therapeutics, and the effectiveness of internal control over financial
reporting of Nektar Therapeutics included in this Annual Report Form 10-K for the year ended December 31, 2008.
/s/ Ernst & Young LLP
San Jose, California
March 4, 2009
/s/ Howard W. Robin | ||||
Howard W. Robin | ||||
Chief Executive Officer, President and Director |
/s/ John Nicholson | ||||
John Nicholson | ||||
Senior Vice President and
Chief Financial Officer |
/s/
Howard W. Robin
|
/s/
John Nicholson
|
|||||
Chief Executive Officer, President and Director
|
Senior Vice President and Chief Financial Officer |
* | This certification accompanies the Annual Report on Form 10-K, to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. |