Washington | 2834 | 91-1663741 | ||
(State or other jurisdiction
of
incorporation or organization) |
(Primary Standard Industrial
Classification Code Number) |
(I.R.S. Employer
Identification Number) |
Craig E. Sherman, Esq.
Mark J. Handfelt, Esq. Wilson Sonsini Goodrich & Rosati Professional Corporation 701 Fifth Avenue, Suite 5100 Seattle, Washington 98104 (206) 883-2500 |
Marcia S. Kelbon, Esq.
Alex F. Sutter, Esq. Omeros Corporation 1420 Fifth Avenue, Suite 2600 Seattle, Washington 98101 (206) 676-5000 |
James R. Tanenbaum, Esq.
Morrison & Foerster LLP 1290 Avenue of the Americas New York, New York 10104 (212) 468-8000 |
o
Large
accelerated filer
|
o Accelerated filer | þ Non-accelerated filer | o Smaller reporting company | |||
(Do not check if a
smaller reporting company) |
The
information in this preliminary prospectus is not complete and
may be changed. We may not sell these securities until the
registration statement filed with the Securities and Exchange
Commission is declared effective. This preliminary prospectus is
not an offer to sell these securities and it is not soliciting
an offer to buy these securities in any state where the offer or
sale is not permitted.
|
Per Share | Total | |||
Public offering price
|
$ | $ | ||
Underwriting discounts and commissions(1)
|
$ | $ | ||
Proceeds, before expenses, to Omeros Corporation
|
$ | $ |
Canaccord Adams Inc. | Needham & Company, LLC |
Chicago Investment Group | National Securities |
(1) | These amounts do not include warrants held by Chicago Investment Group, LLC and selling group members, which may constitute compensation. See Underwriters. |
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EX-23.1 |
i
1
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2
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3
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obtain regulatory approval for our PharmacoSurgery product
candidates OMS103HP, OMS302 and OMS201;
maximize commercial opportunity for our PharmacoSurgery product
candidates OMS103HP, OMS302 and OMS201;
continue to leverage our business model to mitigate risk by
combining our multiple late-stage PharmacoSurgery product
candidates with our deep and diverse pipeline of preclinical
development programs;
further expand our broad patent portfolio; and
manage our business with continued efficiency and discipline,
while continuing to evaluate opportunities and acquire
technologies that meet our business objectives.
5
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We are largely dependent on the success of our PharmacoSurgery
product candidates, particularly our lead product candidate,
OMS103HP, and our clinical trials may fail to adequately
demonstrate the safety and efficacy of OMS103HP or our other
PharmacoSurgery product candidates. If a clinical trial fails,
if regulatory approval is delayed or if additional clinical
trials are required, our development costs may increase and we
will not have the anticipated revenue from that product
candidate to fund our operations.
We are a clinical-stage company with no product revenue and no
products approved for marketing. The regulatory approval process
is expensive, time-consuming and uncertain, and our product
candidates have not been, and may not be, approved for sale by
regulatory authorities. Even if approved for sale by the
appropriate regulatory authorities, our products may not achieve
market acceptance and we may never achieve profitability.
Our preclinical development programs may not generate product
candidates that are suitable for clinical testing or that can be
successfully commercialized.
Our patents may not adequately protect our present and future
product candidates or permit us to gain or keep a competitive
advantage. Our pending patents for our present and future
product candidates may not be issued.
6
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Shares of common stock offered by us
6,820,000 shares
Shares of common stock to be outstanding after this offering
21,287,580 shares
Use of proceeds
We plan to use the net proceeds of this offering to fund
(1) the completion of our Phase 3 clinical trials for
OMS103HP and the submission of the related NDA(s) to the FDA,
(2) the launch and commercialization of OMS103HP,
(3) the clinical development of OMS302 and OMS201,
(4) the development of our pipeline of preclinical programs
and (5) working capital, capital expenditures, repayment of
debt, potential acquisitions of products or technologies and
general corporate purposes. See Use of Proceeds.
Proposed NASDAQ Global Market symbol
OMER
2,819,594 shares of common stock issuable upon the exercise
of options outstanding at June 30, 2009 at a
weighted-average exercise price of $1.82 per share;
209,017 shares of common stock issuable upon exercise of
warrants outstanding at June 30, 2009 at a weighted-average
exercise price of $12.08 per share; and
1,039,211 shares of common stock available for future
issuance under our 2008 Equity Incentive Plan.
a
1-for-1.96
reverse stock split of our outstanding common stock and
convertible preferred stock to be effective prior to the closing
of this offering;
the automatic conversion of all outstanding shares of our
convertible preferred stock into 11,514,506 shares of
common stock, effective upon the closing of this offering;
the conversion of all outstanding warrants to purchase shares
of our convertible preferred stock into warrants to purchase
208,983 shares of common stock, effective upon the closing
of this offering; and
no exercise by the underwriters of their right to purchase
additional shares of common stock to cover over-allotments, if
any.
8
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Period from
Period from
June 16, 1994
June 16, 1994
Six Months Ended
(Inception) to
(Inception) to
June 30,
June 30,
Year Ended December 31,
December 31,
2009
2008
2009
2008
2007
2006
2008
(in thousands, except share and per share data)
$
568
$
488
$
3,961
$
1,170
$
1,923
$
200
$
3,393
8,599
8,018
70,833
17,850
15,922
9,637
62,234
10,891
10,891
10,891
2,885
2,899
35,368
7,845
10,398
3,625
32,483
11,484
10,917
117,092
25,695
26,320
24,153
105,608
(10,916
)
(10,429
)
(113,131
)
(24,525
)
(24,397
)
(23,953
)
(102,215
)
142
460
5,305
661
1,582
1,088
5,163
(1,165
)
(38
)
(1,794
)
(335
)
(151
)
(91
)
(629
)
348
(57
)
782
372
(125
)
179
434
$
(11,591
)
$
(10,064
)
$
(108,838
)
$
(23,827
)
$
(23,091
)
$
(22,777
)
$
(97,247
)
$
(3.96
)
$
(3.53
)
$
(8.26
)
$
(10.65
)
$
(12.08
)
2,929,397
2,852,616
2,883,522
2,167,500
1,884,925
$
(0.80
)
$
(1.65
)
14,411,430
14,275,579
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As of June 30, 2009
Pro Forma
Pro
As
Actual
Forma
Adjusted (1)
(in thousands)
$
10,363
$
10,363
$
79,353
(12,101
)
(12,101
)
56,889
12,682
12,682
81,115
15,192
15,192
15,192
1,820
91,019
(108,838
)
(108,838
)
(108,838
)
(101,648
)
(8,809
)
59,624
(1)
A $1.00 increase (decrease) in the
assumed public offering price of $11.00 would increase
(decrease) each of cash, cash equivalents and short-term
investments, working capital, total assets and total
shareholders equity (deficit) by $6.3 million,
assuming that the number of shares offered by us, as set forth
on the cover page of this prospectus, remains the same, and
after deducting estimated underwriting discounts and commissions
and estimated offering expenses payable by us.
10
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discussions with the FDA or comparable foreign authorities
regarding the scope or design of our clinical trials;
delays or the inability to obtain required approvals from
institutional review boards or other governing entities at
clinical sites selected for participation in our clinical trials;
delays in enrolling patients into clinical trials;
lower than anticipated retention rates of patients in clinical
trials;
the need to repeat or conduct additional clinical trials as a
result of problems such as inconclusive or negative results,
poorly executed testing or unacceptable design;
an insufficient supply of product candidate materials or other
materials necessary to conduct our clinical trials;
13
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the need to qualify new suppliers of product candidate materials
for FDA and foreign regulatory approval;
an unfavorable FDA inspection or review of a clinical trial site
or records of any clinical investigation;
the occurrence of drug-related side effects or adverse events
experienced by participants in our clinical trials; or
the placement of a clinical hold on a trial.
failure to conduct the clinical trial in accordance with
regulatory requirements or our clinical protocols;
inspection of the clinical trial operations or trial sites by
the FDA or other regulatory authorities resulting in the
imposition of a clinical hold;
unforeseen safety issues or any determination that a trial
presents unacceptable health risks; or
lack of adequate funding to continue the clinical trial,
including the incurrence of unforeseen costs due to enrollment
delays, requirements to conduct additional trials and studies
and increased expenses associated with the services of our
contract research organizations, or CROs, and other third
parties.
complete the Phase 3 clinical trials of OMS103HP for use in
arthroscopic ACL reconstruction surgery;
initiate, conduct and complete the Phase 3 clinical trials of
OMS103HP for use in arthroscopic meniscectomy surgery;
conduct and complete the clinical trials of OMS302 for use
during lens replacement surgery;
conduct and complete the clinical trials of OMS201 for use in
endoscopic surgery of the urological tract;
14
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continue our research and development;
make milestone payments to our collaborators;
make principal and interest payments due under our debt facility
with BlueCrest Venture Finance Master Fund Limited, or BlueCrest;
initiate and conduct clinical trials for other product
candidates; and
launch and commercialize any product candidates for which we
receive regulatory approval.
15
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our ability to provide acceptable evidence of safety and
efficacy;
availability, relative cost and relative efficacy of alternative
and competing treatments;
the effectiveness of our marketing and distribution strategy to,
among others, hospitals, surgery centers, physicians
and/or
pharmacists;
prevalence of the surgical procedure or condition for which the
product is approved;
acceptance by physicians of each product as a safe
and effective treatment;
perceived advantages over alternative treatments;
relative convenience and ease of administration;
the availability of adequate reimbursement by third parties;
the prevalence and severity of adverse side effects;
publicity concerning our products or competing products and
treatments; and
our ability to obtain sufficient third-party insurance coverage.
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our inability to recruit and retain adequate numbers of
effective sales and marketing personnel;
the inability of sales personnel to obtain access to or persuade
adequate numbers of hospitals, surgery centers, physicians
and/or
pharmacists to purchase, use or prescribe our approved product
candidates;
the lack of complementary products to be offered by sales
personnel, which may put us at a competitive disadvantage
relative to companies with more extensive product lines; and
unforeseen costs and expenses associated with creating an
independent sales and marketing organization.
17
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we might not have been the first to make the inventions covered
by any of our patents, if issued, or our pending patent
applications;
we might not have been the first to file patent applications for
these inventions;
others may independently develop similar or alternative
technologies or products or duplicate any of our technologies or
products;
it is possible that none of our pending patent applications will
result in issued patents or, if issued, these patents may not be
sufficient to protect our technology or provide us with a basis
for commercially viable products and may not provide us with any
competitive advantages;
if our pending applications issue as patents, they may be
challenged by third parties as not infringed, invalid or
unenforceable under U.S. or foreign laws;
if issued, the patents under which we hold rights may not be
valid or enforceable; or
we may develop additional proprietary technologies or products
that are not patentable and which are unlikely to be adequately
protected through trade secrets if, for example, a competitor
were to independently develop duplicative, similar or
alternative technologies or products.
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develop and market products that are less expensive or more
effective than any future products developed from our product
candidates;
commercialize competing products before we can launch any
products developed from our product candidates;
operate larger research and development programs, possess
commercial-scale manufacturing operations or have substantially
greater financial resources than we do;
initiate or withstand substantial price competition more
successfully than we can;
have greater success in recruiting skilled technical and
scientific workers from the limited pool of available talent;
more effectively negotiate third-party licenses and strategic
relationships; and
take advantage of acquisition or other opportunities more
readily than we can.
restrictions on such product candidates or manufacturing
processes;
withdrawal of the product candidates from the market;
voluntary or mandatory recalls;
fines;
suspension of regulatory approvals;
product seizures; or
injunctions or the imposition of civil or criminal penalties.
27
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a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
28
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results from our clinical trial programs, including our ongoing
Phase 3 clinical trials for OMS103HP for use in ACL
reconstruction surgery, our Phase 2 clinical trial for
OMS103HP for use in meniscectomy surgery, our ongoing
Phase 2 clinical trial for OMS302, and our ongoing
Phase 1/Phase 2 clinical trial for OMS201;
FDA or international regulatory actions, including failure to
receive regulatory approval for any of our product candidates;
failure of any of our product candidates, if approved, to
achieve commercial success;
quarterly variations in our results of operations or those of
our competitors;
our ability to develop and market new and enhanced product
candidates on a timely basis;
announcements by us or our competitors of acquisitions,
regulatory approvals, clinical milestones, new products,
significant contracts, commercial relationships or capital
commitments;
third-party coverage and reimbursement policies;
29
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additions or departures of key personnel;
commencement of, or our involvement in, litigation;
our ability to meet our repayment and other obligations under
our debt facility with BlueCrest, pursuant to which we have
borrowed $17.0 million;
changes in governmental regulations or in the status of our
regulatory approvals;
changes in earnings estimates or recommendations by securities
analysts;
any major change in our board or management;
general economic conditions and slow or negative growth of our
markets; and
political instability, natural disasters, war
and/or
events of terrorism.
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31
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32
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assuming that we receive positive results from our ongoing Phase
3 clinical trials of OMS103HP in patients undergoing ACL
reconstruction surgery, our ability to submit a related NDA to
the FDA during the second half of 2010;
our ability to review the data from our first Phase 2 trial
of OMS103HP in patients undergoing arthroscopic meniscectomy
surgery in the second half of 2009;
our ability to market OMS103HP by 2011;
our ability to complete the ongoing Phase 2 clinical trial,
and initiate a second Phase 2 clinical trial, for OMS302 in
patients undergoing cataract surgery in the second half of 2009;
our ability to complete the Phase 1/Phase 2 clinical
trial of OMS201 in patients undergoing ureteroscopic removal or
ureteral or renal stones in the first half of 2010;
our ability to achieve the expected near-term milestones in our
pipeline of preclinical development programs, including the
selection of a clinical product candidate for our MASP-2 program
in the second half of 2009, submission of an IND to the FDA for
our Addiction program in the second half of 2009, the selection
of one or more clinical candidates for our PDE10 program in the
second half of 2009 and the selection of a clinical candidate
for our PDE7 program in the first half of 2010, and the size of
target markets;
our expectations regarding the growth in the number of
arthroscopic, cataract and uroendoscopic operations, the rates
at which each of our PharmacoSurgery product candidates will be
reimbursed to the surgical facility for its utilization and to
the surgeon for its use, the size of the markets for our
PharmacoSurgery product candidates, in particular, the market
opportunity for OMS103HP, and the rate and degree of adoption
and market penetration of our PharmacoSurgery product candidates;
our ability to obtain commercial supplies of our PharmacoSurgery
product candidates, our competition and, if approved, our
ability to successfully commercialize our PharmacoSurgery
product candidates with a limited, hospital-based marketing and
sales force;
our expectations regarding the clinical benefits of our
PharmacoSurgery product candidates;
the extent of protection that our patents provide and our
pending patent applications may provide, if patents issue from
such applications, to our technologies and programs;
33
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our estimate regarding how long our existing cash, cash
equivalents and short-term investments, along with the net
proceeds from this offering, will be sufficient to fund our
anticipated operating expenses and capital expenditures, the
factors impacting our future capital expenditures and our
expected number of full-time employees by the end of 2009;
our expectations regarding our ability to de-orphanize orphan
GPCRs and the number of druggable targets among the orphan GPCRs;
our ability to meet our repayment and other obligations under
our debt facility with BlueCrest, pursuant to which we have
borrowed $17.0 million; and
our estimates regarding the use of the net proceeds from this
offering and our future net losses, revenues, expenses and net
operating loss carryforwards and research and development tax
credit carryforwards.
34
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42
F-7
F-28
F-31
II-3
II-4
II-5
approximately $5.5 million to fund the completion of our
clinical trials and our submission of the related NDA(s) to the
FDA for our lead PharmacoSurgery product candidate, OMS103HP;
approximately $30.5 million to fund the launch and
commercialization of OMS103HP;
approximately $11.0 million to fund the clinical
development of our other PharmacoSurgery product candidates,
OMS302 and OMS201, through Phase 2 clinical trials; and
the remainder to continue to fund our pipeline of preclinical
product development programs focused on inflammation and CNS
disorders, and to fund working capital, capital expenditures,
potential acquisitions of products or technologies and general
corporate purposes.
35
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36
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on an actual basis;
on a pro forma basis reflecting (a) the automatic
conversion of all outstanding shares of our convertible
preferred stock into 11,514,506 shares of our common stock
upon the closing of this offering and (b) the automatic
conversion of all outstanding warrants to purchase convertible
preferred stock into warrants to purchase 208,983 shares of
our common stock upon the closing of this offering, resulting in
the reclassification of $1.8 million from preferred stock
warrant liability to additional paid-in capital;
on a pro forma as adjusted basis to give effect to the issuance
and sale by us of 6,820,000 shares of common stock in this
offering and the receipt of the net proceeds from our sale of
these shares at an assumed initial public offering price of
$11.00 per share (the mid-point of the range set forth on
the cover page of this prospectus), after deducting estimated
underwriting discounts and commissions and estimated offering
expenses payable by us.
As of June 30, 2009
Pro Forma
Actual
Pro Forma
As Adjusted
(in thousands, except share
and per share data)
$
10,363
$
10,363
$
79,353
$
15,192
$
15,192
$
15,192
1,820
91,019
30
145
213
7,104
99,828
168,193
56
56
56
(108,838
)
(108,838
)
(108,838
)
(101,648
)
(8,809
)
59,624
$
6,383
$
6,383
$
74,816
37
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2,819,594 shares of common stock issuable upon the exercise
of options outstanding at June 30, 2009 at a
weighted-average exercise price of $1.82 per share;
209,017 shares of common stock issuable upon exercise of
warrants outstanding at June 30, 2009 at a weighted-average
exercise price of $12.08 per share; and
1,039,211 shares of common stock available for future
issuance under our 2008 Equity Incentive Plan.
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$
11.00
$
(34.42
)
33.81
(0.61
)
3.41
2.80
$
8.20
39
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Average
Shares Purchased
Total Consideration
Price Per
Number
Percent
Amount
Percent
Share
14,467,580
68
%
$
92,051,000
55
%
$
6.36
6,820,000
32
75,020,000
45
11.00
21,287,580
100
%
$
167,071,000
100
%
$
7.85
2,819,594 shares of common stock issuable upon the exercise
of options outstanding at June 30, 2009 at a
weighted-average exercise price of $1.82 per share;
209,017 shares of common stock issuable upon exercise of
warrants outstanding at June 30, 2009 at a weighted-average
exercise price of $12.08 per share; and
1,039,211 shares of common stock available for future
issuance under our 2008 Equity Incentive Plan.
40
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Period from
Period from
Six Months
June 16, 1994
June 16, 1994
Ended
(inception) to
(inception) to
June 30,
June 30,
Years Ended December 31,
December 31,
2009
2008
2009
2008
2007
2006
2005
2004
2008
(in thousands, except share and per share data)
$
568
$
488
$
3,961
$
1,170
$
1,923
$
200
$
$
$
3,393
8,599
8,018
70,833
17,850
15,922
9,637
5,803
2,670
62,234
10,891
10,891
10,891
2,885
2,899
35,368
7,845
10,398
3,625
1,904
2,079
32,483
11,484
10,917
117,092
25,695
26,320
24,153
7,707
4,749
105,608
(10,916
)
(10,429
)
(113,131
)
(24,525
)
(24,397
)
(23,953
)
(7,707
)
(4,749
)
(102,215
)
142
460
5,305
661
1,582
1,088
333
171
5,163
(1,165
)
(38
)
(1,794
)
(335
)
(151
)
(91
)
(629
)
348
(57
)
782
372
(125
)
179
8
434
$
(11,591
)
$
(10,064
)
$
(108,838
)
$
(23,827
)
$
(23,091
)
$
(22,777
)
$
(7,366
)
$
(4,578
)
$
(97,247
)
$
(3.96
)
$
(3.53
)
$
(8.26
)
$
(10.65
)
$
(12.08
)
$
(4.16
)
$
(2.63
)
2,929,397
2,852,616
2,883,522
2,167,500
1,884,925
1,769,830
1,742,958
$
(0.80
)
$
(1.65
)
14,411,430
14,275,579
41
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As of
June 30,
As of December 31,
2009
2008
2007
2006
2005
2004
(in thousands)
$
10,363
$
19,982
$
24,082
$
35,885
$
12,372
$
14,008
(12,101
)
(3,083
)
16,526
32,277
10,672
13,664
12,682
21,681
27,162
38,432
13,109
14,600
15,192
16,674
1,010
2,015
1,820
1,780
1,562
1,037
483
91,019
89,168
89,168
85,742
40,888
35,203
(108,838
)
(97,247
)
(73,420
)
(50,329
)
(27,553
)
(20,187
)
(101,648
)
(91,166
)
(69,941
)
(53,363
)
(29,743
)
(21,114
)
Table of Contents
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
43
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44
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employee and consultant-related expenses, which include salaries
and benefits;
external research and development expenses incurred pursuant to
agreements with third-party manufacturing organizations,
contract research organizations and clinical trial sites;
facilities, depreciation and other allocated expenses, which
include direct and allocated expenses for rent and maintenance
of facilities and depreciation of leasehold improvements and
equipment; and
third-party supplier expenses including laboratory and other
supplies.
Development
Expected Near-
Project
Status
Term Milestone (1)
Phase 3
Complete Phase 3 trials; submit NDA in second half of 2010
Phase 2
Review data from Phase 2 trial in second half of 2009
Phase 2
Complete first/initiate second Phase 2 trial
in second half of 2009
Phase 1/
Phase 2
Complete Phase 1/ Phase 2 trial
in first half of 2010
Preclinical
Select clinical
candidate in second half of 2009
Preclinical
File IND in second half of 2009
Preclinical
Select clinical
candidate in second half of 2009
Preclinical
Select clinical candidate
in first half of 2010
Preclinical
Surrogate de-orphanization of orphan GPCR(s)
(1)
Following selection of a clinical
candidate, we must conduct additional studies, including in vivo
toxicity studies of the clinical candidate. We must submit the
results of these studies, together with manufacturing
information and analytical results related to the clinical
candidate, to the FDA as part of an IND, which must become
effective before we may commence clinical trials. Submission of
an IND does not always result in the FDA allowing clinical
trials to commence. Depending on the nature of information that
we must obtain and include in an IND, it may take from 12 to
24 months from selection of the clinical candidate to IND
submission, if it occurs at all. All of these expected near-term
milestones are subject to a number of risks, uncertainties and
assumptions, including those described in Risk
Factors, and may not occur in the timelines set forth
above or at all.
45
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Six Months Ended
June 30,
Years Ended December 31,
2009
2008
2008
2007
2006
(In thousands)
$
1,911
$
1,796
$
3,521
$
2,944
$
1,849
1,162
1,584
3,525
3,630
2,116
712
920
2,080
1,943
825
576
486
1,049
633
152
259
301
590
280
181
4,620
5,087
10,765
9,430
5,123
1,331
1,236
2,572
2,315
1,848
1,711
868
2,774
2,566
1,604
759
643
1,346
1,412
934
178
184
393
199
128
3,979
2,931
7,085
6,492
4,514
$
8,599
$
8,018
$
17,850
$
15,922
$
9,637
$
$
$
$
$
10,891
46
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47
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revenue recognition;
research and development expenses, primarily clinical trial
expenses;
stock-based compensation;
preferred stock warrant liability; and
fair value measurement of financial instruments.
48
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Six Months
Ended June 30,
Years Ended December 31,
2009
2008
2008
2007
2006
71% - 75%
60%
60%
60%
60%
6.08
6.08
6.08
6.00-6.08
5.00-6.08
2.13% - 2.64%
2.80% - 3.40%
2.80% - 3.40%
3.78% - 4.78%
4.57% - 5.04%
0%
0%
0%
0%
0%
the prices of our convertible preferred stock sold to outside
investors in arms-length transactions, and the rights,
preferences and privileges of our convertible preferred stock
relative to those of our common stock including the liquidation
preference of our preferred stock;
our results of operations, financial position, and the status of
our research and product development efforts, including
continued enrollment in our Phase 3 clinical trials
evaluating OMS103HPs safety and ability to improve
postoperative joint function and reduce pain following ACL
reconstruction surgery, continued enrollment in our clinical
trials for OMS302 and OMS201, and advancement of our preclinical
development programs;
our stage of development and business strategy;
the composition of and changes to our management team;
the market value of a comparison group of publicly traded
pharmaceutical and biotechnology companies that are in a similar
stage of development to us;
the lack of liquidity of our common stock as a private company;
49
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contemporaneous valuations performed by an unrelated valuation
specialist prepared in accordance with methodologies not
outlined in the
AICPA Practice Aid Valuation of
Privately-Held-Company Equity Securities Issued as
Compensation;
and
the likelihood of achieving a liquidity event for the shares of
our common stock and underlying stock options, such as an
initial public offering, or IPO, given prevailing market
conditions.
50
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51
Table of Contents
Estimated
Number of
Fair Value of
Shares
Common
Subject to
Exercise
Stock per
Intrinsic
Options
Price per
Share at
Value per Share
Granted
Share
Date of Grant
at Date of Grant
11,733
$
0.98
$
1.74
$
0.76
14,285
0.98
1.74
0.76
2,181,037
0.98
1.74
0.76
157,393
1.96
2.06
0.10
178,571
1.96
7.11
5.15
140,671
2.45
12.21
9.76
266,558
2.45
12.39
9.94
22,959
2.45
12.39
9.94
612
12.39
12.39
13,775
12.39
13.48
1.09
11,224
13.49
13.47
7,906
12.47
12.41
104,590
12.41
13.29
0.88
52
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continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study and
advancement of additional product candidates through preclinical
development;
expanded activities in preparation for an IPO; and
progress towards an IPO.
positive efficacy data in a preclinical study evaluating OMS302,
our PharmacoSurgery product candidate for use during
ophthalmological surgery, and its components in a primate model
of lens replacement surgery;
filing of an IND for OMS201, our PharmacoSurgery product
candidate being developed for use during urological surgery;
continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study; and
continued progress toward an IPO.
initiation of sites for the Phase 2 clinical trial of OMS103HP
evaluating the safety and efficacy of the product candidate in
patients undergoing meniscectomy surgery;
initiation of sites for the OMS201 Phase 1 clinical trial; and
continued progress toward an IPO together with an extension in
the estimated completion date of the IPO compared to our
estimate at September 30, 2007.
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continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study and Phase
1 study for OMS201;
advancement of our preclinical development programs;
filing of an IND for OMS302, our PharmacoSurgery product
candidate being developed for use during cataract surgery; and
continued progress toward an IPO together with an extension in
the estimated completion date of the IPO compared to our
estimate at December 31, 2007.
continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study, Phase 1
study for OMS201, and Phase 1/Phase 2 Study for OMS302;
advancement of our preclinical development programs; and
continued progress toward an IPO together with an extension in
the estimated completion date of the IPO compared to our
estimate at March 31, 2008.
continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study and Phase
1/Phase 2 Study for OMS302;
completion of enrollment in our Phase 1 study for OMS201;
advancement of our preclinical development programs;
establishment of debt facility providing up to
$20.0 million in borrowings;
extension of an estimated date for an IPO; and
weakness of the equity capital markets.
54
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extension of an estimated date for an IPO;
weakness of the equity capital markets;
continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study and Phase
1/Phase 2 study for OMS302;
initiation of a Phase 1/Phase 2 study for OMS201;
advancement of our preclinical development programs; and
draw down of additional $12.0 million of debt under our
debt facility.
extension of an estimated date for an IPO;
weakness of the equity capital markets;
continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study, and
completed enrollment in our Phase 1/Phase 2 study for OMS302;
initiation of sites for a Phase 1/Phase 2 study for
OMS201; and
advancement of our preclinical development programs.
continued progress toward an IPO;
continued advancement in our development programs, including
additional patient enrollment in our Phase 3 ACL study, Phase
1/Phase 2 study for OMS201 and Phase 2 study for OMS302; and
advancement of our preclinical development programs.
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Six Months
Ended June 30,
Years Ended December 31,
2009
2008
2008
2007
2006
(in thousands)
$
437
$
485
$
983
$
482
$
309
502
681
1,332
5,574
1,130
$
939
$
1,166
$
2,315
$
6,056
$
1,439
56
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57
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58
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Period from
January 1,
2006
to August 11,
2006
(in thousands)
$
200
2,394
957
3,219
59
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60
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in 1994, we issued and sold a total of 446,446 shares of
Series A convertible preferred stock for aggregate net
proceeds of $868,000;
in 1998, we issued and sold a total of 1,358,840 shares of
Series B convertible preferred stock for aggregate net
proceeds of $4.4 million;
in 2000, we issued and sold a total of 1,441,539 shares of
Series C convertible preferred stock for aggregate net
proceeds of $7.2 million;
in 2002, we issued and sold a total of 496,258 shares of
Series D convertible preferred stock for aggregate net
proceeds of $3.7 million; and
from 2004 through 2009, we issued and sold a total of
6,579,519 shares of Series E convertible preferred
stock for aggregate net proceeds of $61.2 million.
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62
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63
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the progress and results of our clinical trials for OMS103HP,
OMS302 and OMS201;
costs related to manufacturing services;
whether the hiring of a number of new employees to support our
continued growth during this period will occur at salary levels
consistent with our estimates;
the scope, rate of progress, results and costs of our
preclinical testing, clinical trials and other research and
development activities for additional product candidates;
the terms and timing of payments of any collaborative or
licensing agreements that we have or may establish, including
pursuant to our agreements with Affitech AS and North Coast
Biologics;
market acceptance of our approved product candidates;
the cost, timing and outcomes of the regulatory processes for
our product candidates;
the costs of commercialization activities, including product
manufacturing, marketing, sales and distribution;
the number and characteristics of product candidates that we
pursue;
the cost of establishing clinical and commercial supplies of our
product candidates;
the cost of preparing, filing, prosecuting, defending and
enforcing patent claims and other intellectual property rights;
the extent to which we acquire or invest in businesses, products
or technologies, although we currently have no commitments or
agreements relating to any of these types of transactions other
than our right to acquire assets for our GPCR program from
Patobios Limited for $10.8 million CAD in cash and stock;
whether we receive grant funding for our programs; and
our degree of success in commercializing OMS103HP and other
product candidates.
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Payments Due Within
1 Year
2-3 Years
4-5 Years
More Than 5 Years
Total
(in thousands)
$
1,560
$
2,697
$
38
$
$
4,295
5
10
10
40
65
3,704
11,759
1,730
17,193
$
5,269
$
14,466
$
1,778
$
40
$
21,553
(1)
We are contracted to receive
sublease income of $603,000 and $240,000 in 2009 and 2010,
respectively, which is excluded from operating lease payment
amounts.
Pursuant to our agreement with SMRI, beginning the first
calendar year after commencement of commercial sales of a
product candidate from our PDE10 program, we will be obligated
to pay royalties to SMRI based on net income, as defined in the
agreement, not to exceed a set multiple of total grant funding
received. Based on the amount of grant funding that we have
received as of June 30, 2009, the maximum amount of
royalties payable to SMRI is $12.8 million.
If we select a clinical product candidate for our PDE10 program
that is a compound synthesized for us by ComGenex, Inc.
(subsequently acquired by Albany Medical Research, Inc.), we may
be required to pay ComGenex a low single-digit percentage
royalty on sales of a PDE10 inhibitor product candidate that
includes the compound and make milestones payments of up to
$3.4 million upon the occurrence of certain development
events, such as the filing of an IND, the initiation of clinical
trials and the receipt of marketing approval.
If we select a clinical product candidate for our PDE10 program
that is a compound synthesized for us by Scottish Biomedical
Research, Inc., we may be required to pay Scottish Biomedical a
low single-digit percentage royalty on sales of a PDE10
inhibitor product candidate that includes the compound and make
milestones payments of up to $178,000 per selected compound upon
the occurrence of certain development events, such as the filing
of an IND, the initiation of clinical trials and the receipt of
marketing approval. The first event that triggered a milestone
payment to Scottish Biomedical was its provision of a compound
library.
Pursuant to our MASP-2 antibody discovery and development
agreement with Affitech AS, we may be required to pay a low
single-digit percentage royalty on any net sales of a product
containing a MASP-2 antibody developed by Affitech under the
agreement. We also may be required to make additional milestone
payments to Affitech of up to $10.1 million upon the
achievement of certain development events related to an
Affitech-generated MASP-2 antibody, such as the filing of an
IND, initiation of clinical trials and the receipt of marketing
approval.
Under our antibody discovery and development agreement with
North Coast Biologics, LLC, we may be required to pay a low
single-digit percentage royalty on any net sales of a product
containing an antibody developed by North Coast under the
agreement. Upon the achievement of certain development events,
such as the filing of an IND, initiation of
65
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clinical trials and the receipt of marketing approval, we also
may be required to make additional milestone payments to North
Coast of up to $4.0 million for a MASP-2 antibody and
$4.1 million per additional target antibody that we may
select under the agreement.
Pursuant to our patent assignment agreement with Roberto
Ciccocioppo, Ph.D. under which we acquired assets for our
Addiction program, we may be required to pay a low single-digit
percentage royalty on any net sales of a product from our
Addiction program that is covered by any patents that issue from
the patent application we acquired from Dr. Ciccocioppo. In
addition, if we grant any third parties rights to manufacture,
sell or distribute any such products, we must pay to
Dr. Ciccocioppo a percentage of any associated fees we
receive from such third parties in the range of low
single-digits to low double-digits depending on stage of
development at which such rights are granted. We also may be
required to make milestone payments of up to $2.3 million
upon the achievement of certain development events, such as the
initiation of clinical trials and receipt of marketing approval.
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67
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68
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69
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70
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Product
Targeted
Development
Expected Near-
Worldwide
Procedure/Disease
Status
Term Milestone (1)
Rights
Arthroscopic ACL reconstruction
Phase 3
Complete Phase 3 trials; submit NDA in second half of 2010
Omeros
Arthroscopic meniscectomy
Phase 2
Review data from Phase 2 trial in second half of 2009
Omeros
Cataract surgery
Phase 2
Complete first/initiate second Phase 2 trial in
second half of 2009
Omeros
Ureteroscopy
Phase 1/
Phase 2
Complete Phase 1/
Phase 2 trial
in first half of 2010
Omeros
Macular degeneration, ischemia-reperfusion injury,
transplant surgery
Preclinical
Select clinical candidate
in second half of 2009
In-licensed(2)
Addiction and other compulsive behaviors
Preclinical
File IND in
second half of 2009
Omeros
Schizophrenia
Preclinical
Select clinical
candidate in second half of 2009
Omeros
Parkinsons disease, Restless Legs Syndrome
Preclinical
Select clinical candidate
in first half of 2010
Omeros
Multiple CNS Disorders
Preclinical
Surrogate de-orphanization of orphan GPCR(s)
Omeros
(1)
Following selection of a clinical
candidate, we must conduct additional studies, including in vivo
toxicity studies of the clinical candidate. We must submit the
results of these studies, together with manufacturing
information and analytical results related to the clinical
candidate, to the FDA as part of an IND, which must become
effective before we may commence clinical trials. Submission of
an IND does not always result in the FDA allowing clinical
trials to commence. Depending on the nature of information that
we must obtain and include in an IND, it may take from 12 to
24 months from selection of the clinical candidate to IND
submission, if it occurs at all. All of these expected near-term
milestones are subject to a number of risks, uncertainties and
assumptions, including those described in Risk
Factors, and may not occur in the timelines set forth
above or at all.
(2)
We hold worldwide exclusive
licenses to rights in connection with MASP-2, the antibodies
targeting MASP-2 and the therapeutic applications for those
antibodies from the University of Leicester and from its
collaborator, Medical Research Council at Oxford University.
Obtain regulatory approval for our PharmacoSurgery product
candidates OMS103HP, OMS302 and OMS201.
We are conducting
Phase 3 and Phase 2 clinical trials for OMS103HP and we
plan to submit an NDA for OMS103HP in the second half of 2010.
In addition, we are conducting a Phase 2 clinical trial for
OMS302 and a Phase 1/Phase 2 clinical trial for
OMS201. Each of these PharmacoSurgery product candidates are
specifically comprised of APIs contained in generic,
FDA-approved drugs with established safety and pharmacological
profiles, and are delivered to the surgical site in low
concentrations with minimal systemic uptake and reduced risk of
adverse side effects. All of these product candidates are
eligible for submission under the potentially less-costly and
time-consuming Section 505(b)(2) NDA process.
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Maximize commercial opportunity for our PharmacoSurgery
product candidates OMS103HP, OMS302 and OMS201.
Our
PharmacoSurgery product candidates target large surgical markets
with significant unmet medical needs. For each of our product
candidates, we have retained all manufacturing, marketing and
distribution rights and have not entered into any partnerships
granting any of these rights to any third party. Our product
candidates do not require a surgeon to change his or her
operating procedure. In addition to ease of use, we believe that
the clinical benefits of our product candidates could provide
surgeons a competitive marketing advantage and may facilitate
third-party payor acceptance, all of which we expect will drive
adoption and market penetration. Because accessing the surgeons
who perform the procedures targeted by our PharmacoSurgery
product candidates requires a limited, hospital-based marketing
and sales force, we believe that we are well positioned to
successfully commercialize these product candidates
independently or through third-party partnerships.
Continue to leverage our business model to mitigate risk by
combining our multiple late-stage PharmacoSurgery product
candidates with our deep and diverse pipeline of preclinical
development programs.
Our lead PharmacoSurgery product is in
clinical trials for two distinct therapeutic indications,
providing two potential paths for commercialization. We are also
advancing two additional PharmacoSurgery product candidates
through clinical trials, and from our intellectual property
estate we are able to develop a series of proprietary follow-on
product candidates. Further, all of these current product
candidates consist of generic APIs and are eligible for
submission under the potentially less-costly and time-consuming
Section 505(b)(2) NDA process. We believe that these
attributes collectively mitigate the typical risks of late-stage
clinical programs. Leveraging our clinical development
experience and our expertise in inflammation and the CNS, we
have built multiple development programs, including our
PharmacoSurgery and
MASP-2
programs targeting large markets focused on inflammation, and
our Addiction, PDE10, PDE7 and GPCR programs targeting large
markets in disorders of the CNS. By combining our late-stage
PharmacoSurgery product candidates with this deep and diverse
pipeline of preclinical development programs, we believe that
our business model mitigates risk by creating multiple
opportunities for commercial success.
Further expand our broad patent portfolio.
We
have made a significant investment in the development of our
patent portfolio to protect our technologies and programs, and
will continue to do so. We own a total of 21 issued or
allowed patents and 29 pending patent applications in the
United States, 83 issued or allowed patents and
85 pending patent applications in commercially significant
foreign markets, and we also hold worldwide exclusive licenses
to two pending United States patent applications, an issued
foreign patent and two pending foreign patent applications. Our
patent portfolio for our PharmacoSurgery platform is directed to
locally delivered compositions and treatment methods using
agents selected from broad therapeutic classes such as pain and
inflammation inhibitory agents, spasm inhibitory agents,
restenosis inhibitory agents, tumor cell adhesion inhibitory
agents, mydriatic agents and agents that reduce intraocular
pressure. We intend to continue to maintain an aggressive
intellectual property strategy in the United States and other
commercially significant markets and plan to seek additional
patent protection for our existing programs as they advance, for
our new inventions and for new products that we develop or
acquire.
Manage our business with continued efficiency and
discipline.
We have efficiently utilized our
capital and human resources to develop and acquire our product
candidates and programs, build a modern research facility and
vivarium and create a broad intellectual property portfolio. We
operate cross-functionally and are led by an experienced
management team with backgrounds in developing and
commercializing product candidates. We use rigorous project
management techniques to assist us in making disciplined
strategic program decisions and to limit the risk profile of our
product pipeline.
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In addition, we plan to continue to seek and access external
sources of grant funding to support the development of our
pipeline programs. We will continue to evaluate opportunities
and, as appropriate, acquire technologies that meet our business
objectives. We successfully implemented this strategy with our
acquisition of nura in 2006, which expanded and diversified our
CNS pipeline and strengthened our discovery research
capabilities. In addition, we will also consider strategic
partnerships to maximize commercial opportunities for our
product candidates.
alterations in vascular caliber, or vasodilation, that lead to
an increase in blood flow;
structural changes in the microvasculature that permit plasma
proteins to leave the circulation, or plasma
extravasation; and
white cell migration from the microcirculation to the site of
tissue injury.
Ketoprofen
, a non-steroidal anti-inflammatory drug, or
NSAID, is a non-selective inhibitor of the pro-inflammatory
mediators COX-1 and COX-2, with potent anti-inflammatory and
analgesic actions that result from inhibiting the synthesis of
the pro-inflammatory mediator
PGE
2
,
and antagonizing the effects of bradykinin, another inflammatory
mediator;
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Amitriptyline
is a compound with analgesic activity that
inhibits the pro-inflammatory actions of histamine and serotonin
released locally at the site of tissue trauma; and
Oxymetazoline
is a vasoconstrictor and also activates
serotonin receptors, located on a group of nerve fibers called
primary afferents, that can inhibit the release of
pro-inflammatory mediators such as substance P and calcitonin
gene-related peptide, or CGRP.
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If approved, OMS103HP will be the first commercially available
drug product for the improvement of function following
arthroscopic surgery.
OMS103HP will provide additional postoperative clinical
benefits, including improved range of motion, reduced pain and
earlier return to work.
OMS103HP selectively targets multiple and discrete
pro-inflammatory mediators and pathways within the inflammatory
and pain cascade.
By delivering OMS103HP to the joint at the initiation of
surgical trauma, the inflammatory and pain cascade will be
preemptively inhibited.
Intra-operative delivery to the joint creates a constant
concentration of OMS103HP, bathing and replenishing the joint
with drug throughout the duration of the surgical procedure.
Because OMS103HP is delivered locally to, and acts directly at,
the site of tissue injury, it can be delivered in low
concentration, and will not be subject to the substantial
interpatient variability in metabolism that is associated with
systemic delivery.
By delivering low-concentration OMS103HP locally and only during
the arthroscopic procedure, systemic absorption of the APIs will
be minimized or avoided, thereby reducing the risk of adverse
side effects.
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Figure 2: Median Last Day of Continuous Passive Motion
Machine Use was Earlier for OMS103HP-Treated Patients
*p = 0.007, log rank
Figure 1 depicts the median number
of days to maximum passive flexion
³
90° without pain, which
is a knee range of motion test, as measured in the clinic.
Figure 2 depicts the number of days
until the continuous passive motion, or CPM, machine was
discontinued. CPM machines are often used postoperatively to
move the knee through a range of motion. CPM usage, recorded in
the patient diary, was discontinued at the direction of either
the surgeon or rehabilitation therapist based on the
patients progress, usually at the time the patient
reproducibly attained at least 90° of flexion of the
operated knee. CPM machine usage was significantly less for
OMS103HP.
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Figure 6: A Greater Percentage of OMS103HP-Treated
Patients Demonstrated Very Good
and Good Ratings on the Knee Function
CompositeStraight-Leg Raise
*p = 0.009, Wilcoxon rank sum test
Figure 5 depicts the studys
primary endpoint, the Knee Function Composite, or KFC. The KFC
is composed of the straight-leg raise, one-leg stance, shuttle
press, and two-leg squat. Each test is a direct measure of knee
function, and all four are routinely used by orthopedic surgeons
and rehabilitation therapists to measure improvement in knee
function during the early postoperative period following ACL
reconstruction surgery. Success on the KFC requires success on
all four of the component tests by the end of the
30-day
evaluation period.
Very
Good
: Achievement
of the KFC by the end of the 30-day evaluation period and
achievement of the highest level of straight-leg raise, or SLR,
by the 13th day after surgery
Good:
Achievement of the KFC by the end of the
30-day evaluation period without achievement of the highest
level of SLR by the 13th day after surgery
Poor
: Failure to achieve the KFC by the end of the
30-day evaluation period
Figure 6 depicts the Knee Function
Composite Straight-Leg Raise, or KFC-SLR, which
combines the successful achievement of the KFC with a second key
rehabilitation milestone, the ability to perform the highest
level of the straight-leg raise by the 13th day after
surgery following ACL reconstruction surgery. While the KFC
accurately assesses knee function throughout the first 30-day
period of postoperative rehabilitation therapy, an evaluation of
postoperative function within the first two weeks also is
important because early functional return is considered a key
driver in successful post-arthroscopy outcomes. Of the four
tests comprising the KFC, the straight-leg raise is the most
important in the first two weeks following ACL reconstruction
because it is used to determine the pace to progress
exercises.
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Figure 8: OMS103HP-Treated Patients Demonstrated a Lower
Median Number of Days to Return to Work
*p = 0.031, FET
*p = 0.048; log-rank test
Figure 7 depicts the percentage of
patients achieving Successful Pain Management, or SPM, which is
a composite of pain assessment and narcotic usage based on data
from clinic visits and the patient diary. The SPM composite sets
two criteria that the patient must meet in order to be
considered a responder. During the first postoperative week, at
all clinic visits, the VAS pain score must be not greater than
20 mm with the operated knee at rest. A maximum of two narcotic
tablets could be self-administered on each day during the first
postoperative week. VAS pain scores of 20 mm or less are
considered to be indicative of good to excellent pain control
not requiring analgesic medication. The SPM allows pain
assessments and narcotic use to be evaluated together, and
provides a more complete evaluation of pain management than
either VAS pain scores or narcotic usage considered individually
because a low VAS pain score recorded by a patient taking high
doses of opioid pain medications does not reflect the same level
of pain management as that same low VAS pain score recorded in
the absence of narcotic pain medications.
Figure 8 depicts results related to
patients ability to return to work following ACL
reconstruction surgery. Patients were considered to have
returned to work if they reported in the patient diary that they
had gone to work outside of the home on two consecutive work
days excluding weekends and holidays. Return to work was
considered to have begun on the first of the two consecutive
days. Patients who were unemployed or not working for pay were
excluded from the analysis.
As published in
Arthroscopy: The
Journal of Arthroscopic and Related Surgery, Vol. 24, No. 6
(June), 2008: pp. 625-636.
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The anti-inflammatory API in OMS302 inhibits miosis by blocking
the synthesis of prostaglandins caused by surgical trauma.
By delivering OMS302 intra-operatively, inflammation and
discomfort will be reduced during the first 24 hours
following surgery, the time during which anti-inflammatory
topical drops are not commonly administered, as well as after
this initial postoperative period.
Intra-operative delivery of the mydriatic API in OMS302 will
maintain pupil dilation throughout the surgical procedure,
decreasing the risk of surgical damage to structures within the
eye.
Because the mydriatic API in OMS302 maintains pupil dilation,
OMS302 will increase the ease of the surgical procedure, thereby
increasing patient throughput for both the surgeon and the
surgical facility.
The mydriatic API in OMS302 prevents intra-operative floppy iris
syndrome in many patients taking alpha adrenergic antagonists,
such as
FLOMAX
®
.
Because OMS302 is delivered intracamerally in standard
irrigation solution at a constant, defined concentration,
maintaining a more consistent local tissue exposure during the
surgical procedure, it will provide superior efficacy relative
to topical drug products containing either API.
OMS302 is delivered locally to, and acts directly at, the site
of tissue injury and, therefore, can be delivered in low
concentrations, and will not be subject to the substantial
interpatient variability in pharmacokinetics that is associated
with systemic delivery.
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By delivering OMS201 intra-operatively, it will reduce
inflammation, pain, smooth muscle spasm and lower urinary tract
symptoms including frequency, urgency and painful urination, and
improve patient outcomes.
OMS201 will save health care costs and increase patient comfort
by reducing the incidence of ureteral occlusion and the routine
need for ureteral stents.
By targeting inflammation and smooth muscle spasm, OMS201 will
permit surgeons to more frequently place a standard larger-sized
UAS, decreasing intra-operative trauma and shortening operative
time, thereby saving costs.
OMS201 is delivered locally to, and acts directly at, the site
of tissue injury and, therefore, can be delivered in low
concentrations, and will not be subject to the substantial
interpatient variability in pharmacokinetics that is associated
with systemic delivery.
By delivering OMS201 locally and only during the uroendoscopic
procedure, systemic absorption of the APIs will be minimized or
avoided, thereby reducing the risk of adverse side effects.
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develop and market products that are less expensive, more
effective or safer than our future products;
commercialize competing products before we can launch any
products developed from our product candidates;
operate larger research and development programs, possess
greater manufacturing capabilities or have substantially greater
financial resources than we do;
initiate or withstand substantial price competition more
successfully than we can;
have greater success in recruiting skilled technical and
scientific workers from the limited pool of available talent;
more effectively negotiate third-party licenses and strategic
relationships; and
take advantage of acquisition or other opportunities more
readily than we can.
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OMS103HP Arthroscopy.
OMS103HP is
protected by our PharmacoSurgery patent portfolio. The relevant
patents and patent applications in this portfolio cover
combinations of agents, generic
and/or
proprietary to us or others, drawn from therapeutic classes such
as pain and inflammation inhibitory agents and vasoconstrictive
agents, delivered locally and intra-operatively to the site of
medical or surgical procedures, including arthroscopy. We
currently own four issued U.S. Patents, two pending
U.S. Patent Applications, and 12 issued patents and
8 pending patent applications in foreign markets
(Australia, Brazil, Canada, China, Europe, Hong Kong, Japan,
Mexico, Norway, Russia, Singapore and South Korea) that cover
OMS103HP.
OMS302 Ophthalmology.
OMS302 is
protected by our PharmacoSurgery patent portfolio. The relevant
patents and patent applications in this portfolio cover
combinations of agents, generic
and/or
proprietary to us or others, drawn from therapeutic classes such
as pain and inflammation inhibitory agents, mydriatic agents and
agents that reduce intraocular pressure, delivered locally and
intra-operatively to the site of ophthalmological procedures,
including cataract and lens replacement surgery. We currently
own two pending U.S. Patent Applications and eight pending
patent applications in foreign markets (Australia, Canada,
China, Europe, Hong Kong and Japan) that cover OMS302.
OMS201 Urology.
OMS201 is
protected by our PharmacoSurgery patent portfolio. The relevant
patents and patent applications in this portfolio cover
combinations of agents, generic
and/or
proprietary to us or others, drawn from therapeutic classes such
as pain and inflammation inhibitory agents and spasm inhibitory
agents, delivered locally and intra-operatively to the site of
medical or surgical procedures, including uroendoscopy. We
currently own three issued U.S. Patents, two pending
U.S. Patent
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Applications, and an additional 10 issued patents and
15 pending patent applications in foreign markets
(Australia, Brazil, Canada, China, Europe, Hong Kong, India,
Japan, Mexico, Norway, Russia, Singapore and South Korea) that
cover OMS201.
MASP-2 Program.
We hold worldwide exclusive
licenses to rights in connection with MASP-2, the antibodies
targeting MASP-2 and the therapeutic applications for those
antibodies from the University of Leicester and from its
collaborator, Medical Research Council at Oxford University.
These licenses include what we believe to be each
institutions joint ownership rights in patent applications
and patents related to MASP-2 antibodies initially filed by
researchers at Aarhus Universitet, Denmark. We currently
exclusively control four pending U.S. Patent Applications
and 21 pending patent applications in foreign markets
(Australia, Brazil, Canada, China, Hong Kong, Europe, India,
Indonesia, Japan, Mexico, New Zealand, Russia and South Korea)
related to our MASP-2 program.
Addiction Program.
We own three pending U.S.
Patent Applications and a pending International Patent
Cooperation Treaty, or PCT, Patent Application directed to the
previously unknown link between PPARγ and addictive
disorders.
PDE10 Program.
Medicinal chemistry
developments in our PDE10 program have resulted in two pending
U.S., one pending European and two pending PCT Patent
Applications that claim what we believe to be novel chemical
structures, as well as claiming the use of a broader set, or
genus, of chemical structures as inhibitors of PDE10 for the
treatment of schizophrenia and other psychotic disorders.
PDE7 Program.
We own two pending U.S. Patent
Applications and a pending international PCT Patent Application
directed to the previously unknown link between PDE7 and
movement disorders.
GPCR Program.
We own one issued
U.S. Patent, three pending U.S. Patent Applications,
and two issued patents and two pending patent applications in
foreign markets (Australia, Europe and Japan), which are
directed to previously unknown links between specific molecular
targets in the brain and a series of CNS disorders, and to
research tools that are used in our GPCR program.
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PharmacoSurgery Platform.
Our scientific
co-founders, Gregory A. Demopulos, M.D. and Pamela Pierce
Palmer, M.D., Ph.D., conceived the initial invention
underlying our PharmacoSurgery platform and transferred all of
their related intellectual property rights to us in 1994. Other
than their rights as shareholders, our co-founders have not
retained any rights to our PharmacoSurgery platform, except that
if we file for liquidation under Chapter 7 of the
U.S. Bankruptcy Act or voluntarily liquidate or dissolve,
other than in connection with a merger, reorganization,
consolidation or sale of assets, our
co-founders
have the right to repurchase the initial PharmacoSurgery
intellectual property at the then-current fair market value.
Subsequent developments of the PharmacoSurgery intellectual
property were assigned to us by Dr. Demopulos,
Dr. Palmer and other of our employees and consultants,
without restriction.
MASP-2 Program.
We hold worldwide exclusive
licenses to rights related to MASP-2, the antibodies targeting
MASP-2 and the therapeutic applications for the antibodies from
the University of Leicester and from its collaborator, Medical
Research Council at Oxford University, or MRC. Concurrent with
execution of the license agreement with the University of
Leicester, two provisional US Patent Applications directed to
methods of treating conditions associated with complement
activation by inhibiting MASP-2 or a related protein, and a
British application directed to MASP-2 knock-out mice, were
filed. Exclusive licenses to these three initial patent
applications were conveyed to us by the University of Leicester
license agreement. Under the terms of the University of
Leicester and MRC license agreements, we have agreed to pay
royalties to each of the University of Leicester and MRC based
on a percentage of any proceeds we receive from the licensed
technology during the terms of the agreements. We must pay low
single-digit percentage royalties with respect to proceeds that
we receive from products incorporating the licensed technology
that are used, manufactured, directly sold or directly
distributed by us, and we must pay royalties, in the range of a
low single-digit percentage to a low double-digit percentage,
with respect to proceeds we receive from sublicense royalties or
fees that we receive from third parties to which we grant
sublicenses to the licensed technology. We may also sponsor
research of MASP-2 by these institutions and retain worldwide
exclusive licenses from these institutions to develop and
commercialize any intellectual property rights developed in the
sponsored research. The term of each license agreement ends when
there are no longer any pending patent applications,
applications in preparation or unexpired issued patents related
to any of the intellectual property rights we are licensing
under the agreement. Both of these license agreements may be
terminated prior to the end of their terms by us for convenience
or by a party if the other party (1) breaches any material
obligation under the agreement and does not cure such breach
after notice and an opportunity to cure or (2) is declared
or adjudged to be insolvent, bankrupt or in receivership and
materially limited from performing its obligations under the
agreement. Each license agreement can also be terminated by us
if the University of Leicester or MRC, as applicable, is unable
to establish title to joint ownership rights to patents and
patent applications obtained or filed by researchers at Aarhus
Universitet related to MASP-2 that are based in part on the
results of research conducted by the University of Leicester,
MRC and these researchers.
Addiction Program.
We acquired the patent
applications and related intellectual property rights for our
Addiction program in 2009 from Roberto Ciccocioppo, Ph.D. of the
Università di Camerino, Italy, pursuant to a Patent
Assignment Agreement. We have
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agreed to pay Dr. Ciccocioppo royalties and milestone
payments related to any products that are covered by the patents
we acquired from him. For a more detailed description of this
agreement, see Business Our Product Candidates
and Development Programs Addiction Program.
PDE10, PDE7 and GPCR Programs.
We acquired our
PDE10, PDE7 and GPCR programs and some of our related patents
and other intellectual property rights as a result of our
acquisition of nura, inc. in August 2006 for an aggregate
purchase price of $14.4 million. We hold an exclusive
option to purchase the CRA for our GPCR program from Patobios
Limited for approximately $10.8 million CAD. Our exclusive
option with Patobios ends on December 4, 2009, provided
that we have the right to extend our option for one additional
six-month period ending June 4, 2010 by paying Patobios $650,000
CAD.
preclinical laboratory and animal tests, and formulation studies;
submission to the FDA of an Investigational New Drug
Application, or IND, for human clinical testing, which must
become effective before human clinical trials may begin in the
United States;
adequate and well-controlled human clinical trials to establish
the efficacy and safety of the product candidate for each
indication for which approval is sought;
submission to the FDA of a New Drug Application, or NDA;
satisfactory completion of an FDA inspection of the
manufacturing facility or facilities at which the drug is
produced to assess compliance with cGMP; and
FDA review and approval of an NDA.
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Phase 1 usually involves the initial administration of the
investigational drug product to human subjects to evaluate its
safety, dosage tolerance, pharmacodynamics and, if possible, to
gain an early indication of its effectiveness.
Phase 2 usually involves trials in a limited patient population,
with the disease or condition for which the product candidate is
being developed, to evaluate dosage tolerance and appropriate
dosage, identify possible adverse side effects and safety risks,
and preliminarily evaluate the effectiveness of the drug for
specific indications.
Phase 3 trials usually further evaluate effectiveness and test
further for safety by administering the drug in its final form
in an expanded patient population.
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Name
Position(s)
50
President, Chief Executive Officer, Chief Medical Officer and
Chairman of the Board of Directors
50
Vice President, Patent and General Counsel and Secretary
52
Vice President, Science
50
Vice President, Pharmaceutical Operations
47
Vice President, Clinical Development
65
Vice President, Regulatory Affairs and Quality Systems
50
Vice President, Research
41
Director of Finance and Controller
73
Director
69
Director
55
Director
70
Director
46
Director
(1)
Member of our audit committee.
(2)
Member of our compensation
committee.
(3)
Member of our nominating and
corporate governance committee.
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Class I, which will consist of Ray Aspiri and Jean-Philippe
Tripet, and whose term will expire at our first annual meeting
of shareholders to be held following the completion of this
offering;
Class II, which will consist of Thomas J. Cable and Peter
A. Demopulos, M.D., and whose term will expire at our second
annual meeting of shareholders to be held following the
completion of this offering; and
Class III, which will consist of Gregory A. Demopulos, M.D.
and Leroy E. Hood, M.D., Ph.D., and whose term will expire at
our third annual meeting of shareholders to be held following
the completion of this offering.
selecting and hiring our independent auditors, and approving the
audit and non-audit services to be performed by our independent
registered public accounting firm;
evaluating the qualifications, performance and independence of
our independent registered public accounting firm;
monitoring the integrity of our financial statements and our
compliance with legal and regulatory requirements as they relate
to financial statements or accounting matters;
reviewing with our independent registered public accounting firm
and management significant issues that arise regarding
accounting principles and financial statement presentation, and
matters concerning the scope, adequacy and effectiveness of our
financial controls;
reviewing the adequacy and effectiveness of our internal control
policies and procedures;
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establishing procedures for the receipt, retention and treatment
of complaints received by us regarding accounting, internal
accounting controls or auditing matters;
reviewing and approving in advance any proposed related-party
transactions and monitoring compliance with our code of business
conduct and ethics; and
preparing the audit committee report that the SEC requires in
our annual proxy statement.
evaluating and recommending to our board of directors the
compensation and other terms of employment of our executive
officers and reviewing and approving corporate performance goals
and objectives relevant to such compensation;
evaluating and recommending to our board of directors the type
and amount of compensation to be paid or awarded to board
members;
evaluating and recommending to our board of directors the equity
incentive plans, compensation plans and similar programs
advisable for us;
administering our equity incentive plans;
reviewing and approving the terms of any employment agreements,
severance arrangements, change in control protections and any
other compensatory arrangements for our executive
officers; and
preparing the compensation committee report that the SEC
requires in our annual proxy statement.
assisting the board in identifying prospective director nominees
and recommending director nominees to our board for each annual
meeting of shareholders;
evaluating nominations by shareholders of candidates for
election to our board;
recommending governance principles to our board;
overseeing the evaluation of our board of directors and
management;
reviewing shareholder proposals for our annual meetings;
evaluating proposed changes to our charter documents and board
committee charters;
reviewing and assessing our senior management succession
plan; and
recommending to our board the members for each board committee.
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Option Awards
Total
($)(1) (2)(3)
($)
45,599
45,599
(1)
Our directors did not receive any
cash compensation during 2008. Amounts shown in this column
represent the compensation cost for the year ended
December 31, 2008 of option awards granted to each of our
non-employee directors as determined in accordance with
Statement of Financial Accounting Standards
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No. 123(revised), or
SFAS 123R, using the Black-Scholes option valuation model.
The assumptions used to calculate the value of option awards are
set forth in Note 11 to our consolidated financial
statements included elsewhere in this prospectus. Pursuant to
SEC rules, the amounts shown exclude the impact of estimated
forfeiture related to service-based vesting conditions.
(2)
As of December 31, 2008,
Mr. Mann held an option award to purchase
12,755 shares of our common stock with an exercise price of
$2.45 per share that vested over a three-year period in equal
annual installments. Mr. Mann exercised this option award
for 4,252 shares of our common stock in January 2009. Mr.
Mann resigned from our board of directors in March 2009.
(3)
As of December 31, 2008,
Mr. Aspiri, Mr. Cable and Dr. Hood held option
awards to purchase 15,306, 22,959 and 25,510 shares of our
common stock, respectively. All of these option awards were
fully vested and exercisable as of December 31, 2008.
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Option
All Other
Salary
Awards
Compensation
Total
Year
($)
($) (1)
($)
($)
2008
475,000
594,203
25,225
(2)
1,094,428
2008
285,000
67,706
3,049
355,755
2008
250,000
202,577
4,092
456,669
(1)
Amounts shown do not reflect
compensation actually received by the named executive officers.
Instead, the dollar amounts shown in this column represent the
compensation cost for the year ended December 31, 2008 of
option awards granted to each of our named executive officers as
determined pursuant to SFAS 123R using the Black-Scholes
option valuation model. The assumptions used to calculate the
value of option awards are set forth in Note 11 to our
consolidated financial statements included elsewhere in this
prospectus. Pursuant to SEC rules, the amounts shown exclude the
impact of estimated forfeiture related to service-based vesting
conditions.
(2)
Represents $25,088 in
perquisites and other personal benefits, which included payments
for medical malpractice insurance, parking expenses, legal fees,
medical practice fees and travel expenses, and $137 in life
insurance premiums.
(3)
Mr. Kleins employment
with us ended in January 2009.
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the annual base salary he was receiving as of his termination,
provided that if he terminates his employment for good reason
because of a reduction in his annual base salary, then the
annual base salary we will be obligated to pay him will be his
annual base salary in effect prior to such reduction; plus
the greater of (1) the average annual bonus he received in
the preceding two calendar years and (2) any bonus he would
have been entitled to in the year of his termination as
determined by our board of directors in good faith.
his willful misconduct or gross negligence in performance of his
duties, including his refusal to comply in any material respect
with the legal directives of our board of directors so long as
such directives are not inconsistent with his position and
duties, and such refusal to comply is not remedied within ten
working days after written notice from the board of directors;
dishonest or fraudulent conduct that materially discredits us, a
deliberate attempt to do an injury to us, or conduct that
materially discredits us or is materially detrimental to the
reputation of us, including conviction of a felony; or
his material breach, if incurable, of any element of his
confidential information and invention assignment agreement with
us, including without limitation, his theft or other
misappropriation of our proprietary information.
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any material diminution in his authority, duties or
responsibilities;
any material diminution in his base salary;
we relocate his principal work location to a place that is more
than 50 miles from our current location; or
we materially breach his employment agreement, which may
include, for example, our failure to enter into a new employment
agreement by May 1, 2009 because of our actions or
omissions.
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a change in control means proposed sale of all or
substantially all of the assets of us, or the merger of us with
or into another corporation, or other change in control;
a termination for cause means a termination of an
employee for any of the following reasons: (1) his or her
willful failure to substantially perform his or her duties and
responsibilities to us or a deliberate violation of a company
policy; (2) his or her commission of any act of fraud,
embezzlement, dishonesty or any other willful misconduct that
has caused or is reasonably expected to result in material
injury to us; (3) unauthorized use or disclosure by him or
her of any proprietary information or trade secrets of ours or
any other party to whom he or she owes an obligation of
nondisclosure as a result of his or her relationship with us; or
(4) his or her willful breach of any of his or her
obligations under any written agreement or covenant with
us; and
a constructive termination means the occurrence of
any of the following events: (1) there is a material
adverse change in an employees position causing such
position to be of materially reduced stature or responsibility;
(2) a reduction of more than 30% of an employees base
compensation unless in connection with similar decreases of
other similarly situated employees; or (3) an
employees refusal to comply with our request to relocate
to a facility or location more than 50 miles from our
current location; provided that in order for an employee to be
constructively terminated, he or she must voluntarily terminate
his or her employment within 30 days of the applicable
material change or reduction.
Successor in
Successor in
Employee is Terminated
Change in Control
Change in Control
Without Cause or
Assumes or
does not Assume
Constructively Terminated
Replaces Option
or Replace Option
within Twelve Months of
Awards ($)
Awards ($)
Change in Control ($)
540,181
1,080,362
1,080,362
218,724
437,449
437,449
364,685
729,370
729,370
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five percent of the outstanding shares of our common stock on
the last day of the immediately preceding fiscal year;
1,785,714 shares; and
such other amount as our board of directors may determine.
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Option Awards
Stock Awards
Number of
Number of
Securities
Securities
Underlying
Number of
Market Value of
Underlying
Unexercised
Option
Shares or Units
Shares or Units
Unexercised
Options
Exercise
Option
of Stock That
of Stock That
Options
(#)
Price
Expiration
Have Not
Have Not
(#) Exercisable
Unexercisable(1)
($)
Date
Vested (#)
Vested ($)(2)
1,542
0.52
12/10/11
391,156
17,007
(3)
0.98
12/11/16
586,733
25,511
(3)
0.98
12/11/16
25,510
76,530
(4)
2.45
12/29/17
153,485
40,392
(5)
0.98
12/11/16
1,275
3,827
(4)
2.45
12/29/17
51,021
(6)
1.96
05/13/17
26,044
(6)
286,484
1,275
3,827
(4)
2.45
12/29/17
(1)
These option awards were granted
pursuant to the 1998 Stock Plan, which provides for the
automatic vesting of at least a portion of any unvested options
upon a change of control transaction as described under the
section of this prospectus entitled Management
Employee Benefit Plans Second Amended and Restated
1998 Stock Option Plan.
(2)
The market value of shares of stock
that have not vested has been calculated using the assumed
initial public offering price of $11.00 per share (the mid-point
of the range set forth on the cover page of this prospectus).
(3)
The shares subject to the option
award vest on a monthly basis in equal amounts over a four-year
period that began on February 28, 2005.
(4)
1/4th of the shares subject to the
option award vest on December 30, 2008 and 1/48th of the
shares subject to the option award vest each month thereafter.
(5)
The shares subject to the option
award vest on a monthly basis in equal amounts over a four-year
period that began on October 1, 2005.
(6)
A total of 127,551 shares
were subject to this option award. 1/4th of the shares
subject to the option vested on May 14, 2008 and
1/48th of the shares vested each month thereafter. Pursuant
to the terms of the option award, Mr. Klein had the right
to purchase unvested shares, provided that if his employment
terminated for any reason prior to him vesting into any shares
that he exercised, we had the right, but not the obligation, to
repurchase at the original purchase price any shares that he
exercised and was not vested in as of the date of his
termination. As of December 31, 2008, Mr. Klein had
purchased 76,530 of these shares, 50,488 of which were vested.
Mr. Kleins employment with us ended in
January 2009, at which time 53,146 of these shares were
vested. We repurchased the unvested shares in August 2009.
Stock Vested
Number of
Shares Acquired
Value Realized
on Vesting
on Vesting
(#)
(#)(1)
50,488
555,368
(1)
The value realized on vesting has
been calculated using the assumed initial public offering price
of $11.00 per share (the mid-point of the range set forth on the
cover page of this prospectus).
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acts or omissions that involve intentional misconduct or a
knowing violation of law;
unlawful distributions; or
any transaction from which the director will personally receive
a benefit in money, property or services to which the director
is not legally entitled.
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Series E Convertible
Preferred Stock
Common Stock
(#)
(#)
285,486
3,534
428,230
3,951
(1)
Jean-Philippe Tripet, a member of
our board of directors, is managing partner of Aravis
Venture I, L.P. Mr. Tripet holds the title of Director
of Aravis General Partner Ltd., which serves as general partner
of Aravis Venture I, L.P. Mr. Tripet disclaims
beneficial ownership of the shares held by Aravis
Venture I, L.P., except to the extent of his proportionate
pecuniary interest therein.
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(2)
Represents (a) 425,403 and
3,924 shares of Series E convertible preferred stock
and common stock, respectively, held by ARCH Venture
Fund V, L.P. and (b) 2,827 and 27 shares of
Series E convertible preferred stock and common stock,
respectively, held by ARCH V Entrepreneurs Fund, L.P. These two
associated partnerships together hold more than five percent of
our capital stock.
Series E Convertible
Aggregate Purchase
Preferred Stock
Price
(#)
($)
204,082
2,000,000
306,123
3,000,000
(1)
Represents 304,074 and
2,049 shares of Series E convertible preferred stock
that we issued and sold to ARCH Venture Fund V, L.P. and
ARCH V Entrepreneurs Fund, L.P., respectively.
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each person who we know beneficially owns more than five percent
of our common stock;
each of our directors;
each of our named executive officers; and
all of our directors and executive officers as a group.
Number of
Percentage of Shares
Shares
Beneficially Owned
Beneficially
Before
Owned
Offering
After Offering
738,304
5.1
%
3.5
%
2,537,619
16.3
%
11.4
%
294,964
2.0
%
1.4
%
76,530
*
*
162,178
1.1
%
*
99,067
*
*
263,803
1.8
%
1.2
%
54,390
*
*
493,102
3.4
%
2.3
%
3,981,653
25.2
%
17.6
%
*
Less than one percent
(1)
Represents
(a) 733,401 shares of common stock held by ARCH
Venture Fund V, L.P., or ARCH V, and
(b) 4,903 shares of common stock held by ARCH V
Entrepreneurs Fund, L.P., or the Entrepreneurs Fund. ARCH
Venture Partners V, L.P., or the GPLP, as the sole general
partner of ARCH V and the Entrepreneurs Fund, has the
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power to vote and dispose of the
shares held of record by ARCH V and the Entrepreneurs Fund and
may be deemed to beneficially own certain of the shares held of
record by ARCH V and the Entrepreneurs Fund. The GPLP disclaims
beneficial ownership of all shares held of record by ARCH V and
the Entrepreneurs Fund in which the GPLP does not have an actual
pecuniary interest. ARCH Venture Partners V, LLC, or the
GPLLC, as the sole general partner of the GPLP, has the power to
vote and dispose of the shares held of record by ARCH V and the
Entrepreneurs Fund and may be deemed to beneficially own certain
of the shares held of record by ARCH V and the Entrepreneurs
Fund. The GPLLC disclaims beneficial ownership of all shares
held of record by ARCH V and the Entrepreneurs Fund in which it
does not have an actual pecuniary interest. Keith Crandell,
Steven Lazarus, Clinton Bybee and Robert Nelsen are the managing
directors of the GPLLC, share the power to vote and dispose of
the shares held of record by ARCH V and the Entrepreneurs Fund
and may be deemed to beneficially own certain of the shares held
of record by ARCH V and the Entrepreneurs Fund. The managing
directors disclaim beneficial ownership of all shares held of
record by ARCH V and the Entrepreneurs Fund in which they do not
have an actual pecuniary interest. The address of all filing
persons is 8725 W. Higgins Road, Suite 290,
Chicago, IL 60631.
(2)
Includes 1,062,339 shares of
common stock that Dr. Demopulos has the right to acquire
from us within 60 days of June 30, 2009 pursuant to
the exercise of option awards.
(3)
Includes 187,817 shares of
common stock that Ms. Kelbon has the right to acquire from
us within 60 days of June 30, 2009 pursuant to the
exercise of option awards.
(4)
Includes 23,384 shares of
common stock that we repurchased from Mr. Klein in August
2009. Mr. Kleins employment ended with us in January
2009. See Management Executive
Compensation Executive Employment
Agreements Richard J. Klein for a description
of our repurchase of these shares.
(5)
Represents
(a) 15,306 shares of common stock that Mr. Aspiri
has the right to acquire from us within 60 days of
June 30, 2009 pursuant to the exercise of option awards and
(b) 146,872 shares of common stock held by Aspiri
Enterprises LLC. Mr. Aspiri is the managing partner and a
member of Aspiri Enterprises LLC.
(6)
Includes 22,959 shares of
common stock that Mr. Cable has the right to acquire from
us within 60 days of June 30, 2009 pursuant to the
exercise of option awards.
(7)
Includes 164,382 shares of
common stock held by the Demopulos Family Trust, of which
Dr. Peter A. Demopulos is the trustee and a beneficiary
along with his mother and sister. Dr. Peter A. Demopulos
disclaims beneficial ownership of the shares held by the
Demopulos Family Trust except to the extent of his pecuniary
interest therein.
(8)
Includes 25,510 shares of
common stock that Dr. Hood has the right to acquire from us
within 60 days of June 30, 2009 pursuant to the
exercise of option awards.
(9)
Represents 493,102 shares of
common stock held by Aravis Venture I, L.P. Mr. Tripet
holds the title of director of Aravis General Partner Ltd.,
which serves as general partner of Aravis Venture I, L.P.
Mr. Tripet disclaims beneficial ownership of the shares
held by Aravis Venture I, L.P., except to the extent of his
proportionate pecuniary interest therein.
(10)
Includes 1,313,931 shares of
common stock that our executive officers and directors have the
right to acquire from us within 60 days of June 30,
2009 pursuant to the exercise of option awards.
134
Table of Contents
150,000,000 shares will be designated as common
stock; and
20,000,000 shares will be designated as preferred stock.
135
Table of Contents
A warrant that we assumed in connection with our acquisition of
nura on August 11, 2006 to purchase 11,539 shares of
our common stock with an exercise price of $9.13 per share. This
warrant will terminate upon the earlier of
(a) April 26, 2015 and (b) certain acquisitions
of us as described in the warrant.
Warrants issued on March 29, 2007 to purchase an aggregate
of 197,478 shares of our common stock with an exercise
price of $12.25 per share. These warrants will terminate on the
earlier of (a) a change of control as defined in the
warrants and (b) March 29, 2012.
Warrants that we issued on September 12, 2008 to purchase
up to an aggregate of 29,662 shares of our common stock
with an exercise price of $13.48 per share in connection with
loans we received from BlueCrest Venture Finance Master Fund
Limited. As of June 30, 2009, 25,213 shares of common
stock subject to these warrants were vested and the remaining
4,449 shares were not vested. The 4,449 shares of
common stock would have vested only if we borrowed additional
amounts from Blue Crest on or before March 31, 2009.
Because we did not borrow those additional amounts on or before
March 31, 2009, these 4,449 shares will not vest. If
not exercised, the warrants will terminate on the earlier of
(a) completion of this offering, (b) a change of
control as defined in the warrants and
(c) September 12, 2018.
136
Table of Contents
137
Table of Contents
138
Table of Contents
a merger or share exchange with, disposition of assets to, or
issuance or redemption of stock to or from, the acquiring person;
a termination of five percent or more of the employees of the
target corporation as a result of the acquiring persons
acquisition of 10% or more of the shares; or
a transaction in which the acquiring person is allowed to
receive a disproportionate benefit as a shareholder.
139
Table of Contents
Number of Shares
14,467,580
one percent of the number of shares of common stock then
outstanding, which will equal approximately 213,000 shares
immediately after the offering; and
the average weekly trading volume of the common stock during the
four calendar weeks preceding the filing of a notice on
Form 144 with respect to such sale.
140
Table of Contents
during the last 17 days of the 180-day restricted period we
issue an earnings release or material news, or a material event
relating to us occurs; or
prior to the expiration of the 180-day restricted period we
announce that we will release earnings results during the 16-day
period following the last day of the 180-day period,
141
Table of Contents
142
Table of Contents
Deutsche Bank Securities Inc.
Total Fees
Without Exercise of
With Full Exercise
Fee per
Over-Allotment
of Over-Allotment
share
Option
Option
$
$
$
143
Table of Contents
during the last 17 days of the 180-day restricted period we
issue an earnings release or material news, or a material event
relating to us occurs; or
prior to the expiration of the 180-day restricted period we
announce that we will release earnings results during the 16-day
period following the last day of the 180-day period,
144
Table of Contents
145
Table of Contents
prevailing market conditions;
our results of operations in recent periods;
the present stage of our development;
the market capitalizations and stages of development of other
companies that we and the representative of the underwriters
believe to be comparable to our business; and
estimates of our business potential.
to any legal entity that is authorized or regulated to operate
in the financial markets or, if not so authorized or regulated,
whose corporate purpose is solely to invest in securities;
to any legal entity that has two or more of (1) an average
of at least 250 employees during the last financial year;
(2) a total balance sheet of more than 43,000,000 and
(3) an annual net turnover of more than 50,000,000,
as shown in its last annual or consolidated accounts;
146
Table of Contents
to fewer than 100 natural or legal persons (other than qualified
investors as defined in the Prospectus Directive) subject to
obtaining the prior consent of the representative of the
underwriters; or
in any other circumstances that do not require the publication
of a prospectus pursuant to Article 3 of the Prospectus
Directive;
147
Table of Contents
148
Table of Contents
FOR
NON-UNITED
STATES HOLDERS OF COMMON STOCK
149
Table of Contents
the gain is effectively connected with the conduct by the
non-United
States holder of a U.S. trade or business (in which case the
special rules described below apply);
the
non-U.S. holder
is an individual who is present in the United States for
183 days or more in the taxable year of the sale, exchange
or other disposition of our common stock, and certain other
requirements are met;
the
non-United
States holder was a citizen or resident of the United States and
thus is subject to special rules that apply to
expatriates; or
the rules of the Foreign Investment in Real Property Tax Act, or
FIRPTA, treat the gain as effectively connected with a U.S.
trade or business.
150
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151
Table of Contents
152
Table of Contents
Page
F-2
F-3
F-5
F-7
F-14
F-16
F-1
Table of Contents
Omeros Corporation
September , 2009
F-2
Table of Contents
(A Development Stage Company)
June 30,
December 31,
2009
2008
2007
Assets
(unaudited)
$
1,283
$
12,726
$
5,925
9,080
7,256
18,157
570
207
190
183
289
189
11,116
20,478
24,461
557
1,462
775
918
839
9
60
164
193
193
209
32
32
27
$
12,682
$
21,681
$
27,162
F-3
Table of Contents
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS(Continued)
(In thousands, except share and per share data)
Pro Forma
Shareholders
Equity at
June 30,
December 31,
June 30,
2009
2008
2007
2009
(unaudited)
(Unaudited)
(Note 1)
$
1,475
$
1,229
$
2,567
3,555
3,764
2,296
1,820
1,780
1,562
1,269
232
500
15,098
16,556
1,010
23,217
23,561
7,935
94
118
91,019
89,168
89,168
30
30
29
$
145
7,104
6,150
3,466
99,828
56
(99
)
(4
)
56
(12
)
(108,838
)
(97,247
)
(73,420
)
(108,838
)
(101,648
)
(91,166
)
(69,941
)
$
(8,809
)
$
12,682
$
21,681
$
27,162
F-4
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Period from
June 16,
1994
(Inception)
through
Year Ended December 31,
December 31,
2008
2007
2006
2008
$
1,170
$
1,923
$
200
$
3,393
17,850
15,922
9,637
62,234
10,891
10,891
7,845
10,398
3,625
32,483
25,695
26,320
24,153
105,608
(24,525
)
(24,397
)
(23,953
)
(102,215
)
661
1,582
1,088
5,163
(335
)
(151
)
(91
)
(629
)
372
(125
)
179
434
$
(23,827
)
$
(23,091
)
$
(22,777
)
$
(97,247
)
$
(8.26
)
$
(10.65
)
$
(12.08
)
2,883,522
2,167,500
1,884,925
$
(1.65
)
14,275,579
F-5
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS(Continued)
(In thousands, except share and per share data)
(unaudited)
Period from
June 16,
1994
(Inception)
through
Six Months Ended June 30,
June 30,
2009
2008
2009
$
568
$
488
$
3,961
8,599
8,018
70,833
10,891
2,885
2,899
35,368
11,484
10,917
117,092
(10,916
)
(10,429
)
(113,131
)
142
460
5,305
(1,165
)
(38
)
(1,794
)
348
(57
)
782
$
(11,591
)
$
(10,064
)
$
(108,838
)
$
(3.96
)
$
(3.53
)
2,929,397
2,852,616
$
(0.80
)
14,411,430
F-6
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS EQUITY (DEFICIT)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
$
$
$
$
$
$
$
$
1,785,725
18
17
35
446,446
875
(7
)
(7
)
(140
)
(140
)
446,446
875
1,785,725
18
10
(140
)
(112
)
(327
)
(327
)
446,446
875
1,785,725
18
10
(467
)
(439
)
(495
)
(495
)
446,446
875
1,785,725
18
10
(962
)
(934
)
(787
)
(787
)
446,446
875
1,785,725
18
10
(1,749
)
(1,721
)
1,358,840
4,661
(302
)
(302
)
6
6
(22
)
(22
)
(930
)
(930
)
(952
)
1,805,286
$
5,536
1,785,725
$
18
$
(286
)
$
(22
)
$
$
$
(2,679
)
$
(2,969
)
(189,733
)
(2
)
(63
)
(65
)
613
8,948
3
3
4
4
3
3
(1,801
)
(1,801
)
(1,798
)
1,805,286
5,536
1,605,553
16
(342
)
(19
)
(4,480
)
(4,825
)
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND
SHAREHOLDERS EQUITY (DEFICIT)(Continued)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
1,805,286
$
5,536
1,605,553
$
16
$
(342
)
$
(19
)
$
$
$
(4,480
)
$
(4,825
)
1,441,539
7,487
(262
)
(262
)
12
4,813
25
25,827
10
10
4,728
2
2
8
8
18
18
(1,363
)
(1,363
)
(1,345
)
3,251,638
13,060
1,636,108
16
(584
)
(1
)
(5,843
)
(6,412
)
24,554
1
8
9
6,260
3
3
20
20
33
33
(2,554
)
(2,554
)
(2,521
)
3,251,638
$
13,060
1,666,922
$
17
$
(553
)
$
32
$
$
$
(8,397
)
$
(8,901
)
F-8
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND
SHAREHOLDERS EQUITY (DEFICIT)(Continued)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
3,251,638
$
13,060
1,666,922
$
17
$
(553
)
$
32
$
$
$
(8,397
)
$
(8,901
)
496,258
3,861
(124
)
(124
)
216,157
2
86
88
9
(9
)
2
2
121
(65
)
56
16
16
(3,152
)
(3,152
)
(3,136
)
3,747,896
16,921
1,883,079
19
(461
)
48
(7
)
(65
)
(11,549
)
(12,015
)
6,038
21
(51,021
)
(100
)
178,096
2
93
95
4
4
406
(9
)
(86
)
311
(37
)
(37
)
(4,060
)
(4,060
)
(4,097
)
3,702,913
16,842
2,061,175
21
38
11
(12
)
(151
)
(15,609
)
(15,702
)
1,873,764
18,361
(1,119
)
(1,119
)
28,413
10
11
77
(77
)
263
10
273
1
1
(4,578
)
(4,578
)
(4,577
)
5,576,677
$
35,203
2,089,588
$
21
$
(731
)
$
12
$
(79
)
$
(151
)
$
(20,187
)
$
(21,114
)
F-9
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND
SHAREHOLDERS EQUITY (DEFICIT)(Continued)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
5,576,677
$
35,203
2,089,588
$
21
$
(731
)
$
12
$
(79
)
$
(151
)
$
(20,187
)
$
(21,114
)
571,581
5,601
(278
)
(278
)
197,503
2
104
106
16,329
84
23
23
(530
)
(88
)
(618
)
(490
)
(490
)
(6
)
(6
)
(7,366
)
(7,366
)
(7,372
)
6,164,587
40,888
2,287,091
23
(1,925
)
6
(56
)
(239
)
(27,553
)
(29,743
)
3,141,304
30,784
(1,821
)
(1,821
)
(607
)
(607
)
1,733,914
14,070
18,498
1
231,493
2
123
126
23
23
1,416
1,416
20
20
(22,777
)
(22,777
)
(22,757
)
11,039,805
$
85,742
2,537,082
$
26
$
(2,814
)
$
26
$
(33
)
$
(239
)
$
(50,329
)
$
(53,363
)
F-10
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND
SHAREHOLDERS EQUITY (DEFICIT)(Continued)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
11,039,805
$
85,742
2,537,082
$
26
$
(2,814
)
$
26
$
(33
)
$
(239
)
$
(50,329
)
$
(53,363
)
12,445
96
339,807
3,330
(90
)
(90
)
(22
)
(22
)
54,666
1
186
187
208,611
2
171
173
81,156
1
154
155
(1
)
(154
)
(155
)
(4
)
21
17
336
6,039
6,039
239
239
(30
)
(30
)
(23,091
)
(23,091
)
(23,121
)
11,392,057
$
89,168
2,881,851
$
29
$
3,466
$
(4
)
$
(12
)
$
$
(73,420
)
$
(69,941
)
F-11
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND
SHAREHOLDERS EQUITY (DEFICIT)(Continued)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Additional
Other
Deferred
Receivable
During the
Total
Convertible Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
11,392,057
$
89,168
2,881,851
$
29
$
3,466
$
(4
)
$
(12
)
$
$
(73,420
)
$
(69,941
)
69,555
1
39
40
241
241
101
101
2,303
2,303
12
12
(95
)
(95
)
(23,827
)
(23,827
)
(23,922
)
11,392,057
$
89,168
2,951,406
$
30
$
6,150
$
(99
)
$
$
$
(97,247
)
$
(91,166
)
F-12
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND
SHAREHOLDERS EQUITY (DEFICIT)(Continued)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Additional
Other
Deferred
Receivable
During the
Total
Convertible Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
11,392,057
$
89,168
2,951,406
$
30
$
6,150
$
(99
)
$
$
$
(97,247
)
$
(91,166
)
122,449
1,851
4,252
10
10
5
5
(2,584
)
939
939
155
155
(11,591
)
(11,591
)
(11,436
)
11,514,506
$
91,019
2,953,074
$
30
$
7,104
$
56
$
$
$
(108,838
)
$
(101,648
)
F-13
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Period from
June 16, 1994
(Inception)
Year Ended
through
December 31,
December 31,
2008
2007
2006
2008
$
(23,827
)
$
(23,091
)
$
(22,777
)
$
(97,247
)
434
375
232
1,551
2,315
6,056
1,439
10,158
218
503
(117
)
595
55
55
76
(145
)
(145
)
45
1,948
1,948
10,891
10,891
163
(17
)
1,110
1,093
19
(22
)
150
(172
)
(486
)
(1,462
)
(1,948
)
(140
)
3,162
155
4,658
(268
)
(800
)
(1,068
)
(19,673
)
(14,314
)
(10,172
)
(69,278
)
(164
)
(534
)
(166
)
(1,793
)
(30,562
)
(9,541
)
(83,897
)
5,572
11,450
2,007
32,671
5,158
13,555
7,333
43,664
(212
)
(212
)
10,566
(6,091
)
(579
)
(9,567
)
16,878
16,928
(1,010
)
(1,005
)
(391
)
(2,456
)
40
360
126
642
239
239
3,336
28,963
71,183
5,200
5,200
(165
)
15,908
2,930
33,898
91,571
6,801
(17,475
)
23,147
12,726
5,925
23,400
253
$
12,726
$
5,925
$
23,400
$
12,726
$
222
$
151
$
91
$
516
$
52
$
$
$
52
$
193
$
$
$
193
$
101
$
$
$
101
$
241
$
$
$
241
$
$
$
$
239
$
$
$
14,070
$
14,070
F-14
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS(Continued)
(In thousands)
(unaudited)
Period from
June 16,1994
Six Months
(Inception)
Ended
through
June 30,
June 30,
2009
2008
2009
$
(11,591
)
$
(10,064
)
$
(108,838
)
245
207
1,796
939
1,166
11,097
55
285
650
125
180
8
55
53
1,948
10,891
163
(363
)
70
730
80
(48
)
(92
)
(557
)
(486
)
(2,505
)
30
(796
)
4,688
1,037
(378
)
(31
)
(9,992
)
(9,989
)
(79,270
)
(51
)
(80
)
(1,844
)
(3,200
)
(87,097
)
950
3,924
33,621
573
3,650
44,237
(212
)
(1,728
)
7,494
(11,295
)
16,928
(1,581
)
(540
)
(4,037
)
10
38
652
239
1,851
73,034
5,200
(3
)
(168
)
277
(502
)
91,848
(11,443
)
(2,997
)
1,283
12,726
5,925
$
1,283
$
2,928
$
1,283
$
1,041
$
38
$
1,577
$
$
100
$
7
$
$
$
159
$
5
$
$
106
$
$
$
253
$
$
$
239
$
$
$
14,070
F-15
Table of Contents
(A Development Stage Company)
F-16
Table of Contents
(A Development Stage Company)
F-17
Table of Contents
(A Development Stage Company)
June 30,
December 31,
2009
2008
2007
(in thousands)
$
535
$
180
$
143
35
27
47
$
570
$
207
$
190
F-18
Table of Contents
(A Development Stage Company)
June 30,
December 31,
2009
2008
2007
(in thousands)
$
1,768
$
1,644
$
906
95
423
11
335
319
463
325
310
480
345
252
552
723
664
$
3,555
$
3,764
$
2,296
F-19
Table of Contents
(A Development Stage Company)
F-20
Table of Contents
(A Development Stage Company)
F-21
Table of Contents
(A Development Stage Company)
Six Months Ended June 30,
Year Ended December 31,
2009
2008
2008
2007
2006
(in thousands)
$
(11,591
)
$
(10,064
)
$
(23,827
)
$
(23,091
)
$
(22,777
)
155
3
(95
)
(30
)
20
$
(11,436
)
$
(10,061
)
$
(23,922
)
$
(23,121
)
$
(22,757
)
F-22
Table of Contents
(A Development Stage Company)
Six Months Ended June 30,
Year Ended December 31,
2009
2008
2008
2007
2006
Numerator:
$
(11,591
)
$
(10,064
)
$
(23,827
)
$
(23,091
)
$
(22,777
)
2,953,494
2,924,410
2,937,789
2,684,162
2,358,359
(24,097
)
(71,794
)
(54,267
)
(43,228
)
(473,434
)
(473,434
)
2,929,397
2,852,616
2,883,522
2,167,500
1,884,925
$
(3.96
)
$
(3.53
)
$
(8.26
)
$
(10.65
)
$
(12.08
)
F-23
Table of Contents
(A Development Stage Company)
Six Months Ended June 30,
December 31,
2009
2008
2008
2007
2006
11,514,506
11,392,057
11,392,057
11,392,057
11,038,996
2,819,594
2,938,901
2,839,851
3,014,309
2,588,528
473,434
473,434
234,230
209,017
234,230
209,017
281,135
23,385
45,522
28,762
80,882
14,591,715
14,585,497
14,494,900
15,169,699
14,382,093
Six Months
Ended
Year Ended
June 30,
December 31,
2009
2008
$
(11,591
)
$
(23,827
)
40
218
$
(11,551
)
$
(23,609
)
2,929,397
2,883,522
11,482,033
11,392,057
14,411,430
14,275,579
$
(0.80
)
$
(1.65
)
F-24
Table of Contents
(A Development Stage Company)
F-25
Table of Contents
(A Development Stage Company)
F-26
Table of Contents
(A Development Stage Company)
June 30, 2009
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
(in thousands)
$
1,476
$
$
$
1,476
2,250
2,250
6,774
60
(4
)
6,830
$
10,500
$
60
$
(4
)
$
10,556
$
1,283
193
9,080
$
10,556
December 31, 2008
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
(in thousands)
$
12,919
$
$
$
12,919
7,355
3
(102
)
7,256
$
20,274
$
3
$
(102
)
$
20,175
$
12,726
193
7,256
$
20,175
F-27
Table of Contents
(A Development Stage Company)
December 31, 2007
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
(in thousands)
$
1,135
$
$
$
1,135
4,995
4
4,999
18,165
32
(40
)
18,157
$
24,295
$
36
$
(40
)
$
24,291
$
5,925
209
18,157
$
24,291
June 30, 2009
Less than 12 Months
12 Months or Greater
Total
Unrealized
Unrealized
Unrealized
Fair Value
Losses
Fair Value
Losses
Fair Value
Losses
(in thousands)
$
831
$
(3
)
$
37
$
(1
)
$
868
$
(4
)
December 31, 2008
Less than 12 Months
12 Months or Greater
Total
Unrealized
Unrealized
Unrealized
Fair Value
Losses
Fair Value
Losses
Fair Value
Losses
(in thousands)
$
4,512
$
(59
)
$
2,123
$
(43
)
$
6,635
$
(102
)
Table of Contents
(A Development Stage Company)
Six Months Ended
June 30,
Year Ended December 31,
2009
2008
2008
2007
2006
(in thousands)
$
150
$
515
$
737
$
1,437
$
943
9
16
310
270
(8
)
(64
)
(92
)
(165
)
(125
)
$
142
$
460
$
661
$
1,582
$
1,088
F-29
Table of Contents
(A Development Stage Company)
June 30, 2009
Level 1
Level 2
Level 3
Total
(in thousands)
$
1,163
$
2,250
$
$
3,413
6,830
6,830
$
1,163
$
9,080
$
$
10,243
$
$
$
1,820
$
1,820
325
325
$
$
$
2,145
$
2,145
F-30
Table of Contents
(A Development Stage Company)
December 31, 2008
Level 1
Level 2
Level 3
Total
(in thousands)
$
12,783
$
$
$
12,783
7,256
7,256
$
12,783
$
7,256
$
$
20,039
$
$
$
1,780
$
1,780
310
310
$
$
$
2,090
$
2,090
Notes Payable
Preferred Stock
Success Fee
Warrant Liability
Liability
(in thousands)
$
1,562
$
319
218
(9
)
$
1,780
$
310
40
15
$
1,820
$
325
Table of Contents
(A Development Stage Company)
June 30,
December 31,
2009
2008
2007
(in thousands)
$
277
$
266
$
267
359
319
46
284
284
268
278
278
276
1,016
1,016
953
2,214
2,163
1,810
(1,439
)
(1,245
)
(971
)
$
775
$
918
$
839
F-32
Table of Contents
(A Development Stage Company)
F-33
Table of Contents
(A Development Stage Company)
F-34
Table of Contents
(A Development Stage Company)
Loan and Security
Software Financing
Agreement
Arrangement
Total
$
3,629
$
75
$
3,704
5,459
64
5,523
6,182
54
6,236
1,730
1,730
17,000
193
17,193
(17,000
)
(75
)
(17,075
)
$
$
118
$
118
F-35
Table of Contents
(A Development Stage Company)
$
87
233
5,200
182
(2,535
)
3,167
310
10,891
$
14,368
F-36
Table of Contents
(A Development Stage Company)
Lease
Sublease
Net Lease
Payments
Income
Payments
(in thousands)
$
1,560
$
603
$
957
1,563
240
1,323
1,134
1,134
23
23
15
15
$
4,295
$
843
$
3,452
F-37
Table of Contents
(A Development Stage Company)
F-38
Table of Contents
(A Development Stage Company)
F-39
Table of Contents
(A Development Stage Company)
F-40
Table of Contents
(A Development Stage Company)
June 30, 2009
December 31, 2008
Weighted-
Weighted-
Warrants
Fair
Average
Warrants
Fair
Average
Outstanding
Value
Exercise Price
Outstanding
Value
Exercise Price
25,246
$
$
13.47
25,246
$
$
13.47
208,983
1,820
12.08
208,983
1,780
12.08
234,229
$
1,820
$
12.23
234,229
$
1,780
$
12.23
June 30,
December 31,
2009
2008
2007
2006
1.64%-2.64%
2.3%
3.78%
4.57%
2.75-5.00
3.25-5.00
4.25-5.00
5.00-6.08
75%
71%
60%
60%
F-41
Table of Contents
(A Development Stage Company)
June 30, 2009
Shares
Issued
Authorized
Issued and
Aggregate
Price per
and
Outstanding
Liquidation
Carrying
Share
Designated
Shares
Preference
Value
$
1.96
395,430
395,425
$
775
$
775
$
3.43
1,364,885
1,364,878
4,682
4,682
$
5.19
1,462,685
1,462,681
7,597
7,608
$
7.78
509,041
508,703
3,958
3,957
$
9.80
9,693,878
7,782,819
76,272
73,997
13,425,919
11,514,506
$
93,284
$
91,019
(*)
Shares issued in conjunction with
nura acquisition totaled 1,733,914 at a price of $8.11 per share.
December 31, 2008 and 2007
Shares
Issued
Authorized
Issued and
Aggregate
Price per
and
Outstanding
Liquidation
Carrying
Share
Designated
Shares
Preference
Value
$
1.96
395,430
395,425
$ 775
$ 775
$
3.43
1,364,885
1,364,878
4,682
4,682
$
5.19
1,462,685
1,462,681
7,597
7,608
$
7.78
509,041
508,703
3,958
3,957
$
9.80
9,693,878
7,660,370
75,072
72,146
13,425,919
11,392,057
$
92,084
$
89,168
(*)
Shares issued in conjunction with
the nura acquisition totaled 1,733,914 at a price of $8.11 per
share.
F-42
Table of Contents
(A Development Stage Company)
F-43
Table of Contents
(A Development Stage Company)
June 30,
December 31,
2009
2008
138,107
25,611
1,039,211
1,020,728
2,648,505
2,781,152
30,001
30,001
2,981
3,086
11,514,506
11,392,057
208,983
208,983
25,247
25,247
15,607,541
15,486,865
F-44
Table of Contents
(A Development Stage Company)
five percent of the outstanding shares of the Companys
common stock on the last day of the immediately preceding fiscal
year;
1,785,714 shares; or
such other amount as the Companys board of directors may
determine.
F-45
Table of Contents
(A Development Stage Company)
Weighted-
Average
Shares
Exercise
Available for
Options
Price per
Grant
Outstanding
Share
101,455
635,763
$
0.69
2,908,163
7,729
10.63
(2,207,055
)
2,207,055
0.98
(231,493
)
0.54
(4,165
)
10.63
26,346
(26,346
)
0.74
828,909
2,588,543
0.96
(743,193
)
743,193
2.36
(289,765
)
1.14
(324
)
10.63
27,333
(27,333
)
1.07
113,049
3,014,314
1.29
1,046,336
(243,566
)
(48,570
)
48,570
7.95
(69,555
)
0.58
153,479
(153,479
)
1.74
1,020,728
2,839,850
1.40
130,979
(128,500
)
(112,496
)
112,496
12.41
(4,252
)
2.45
128,500
(128,500
)
1.68
1,039,211
2,819,594
$
1.82
F-46
Table of Contents
(A Development Stage Company)
June 30, 2009
Options Outstanding
Options Exercisable
Weighted-
Average
Remaining
Weighted-
Weighted-
Range of
Number of
Contractual
Average
Number of
Average
Options
Life (Years)
Exercise Price
Options
Exercise Price
73,111
1.94
$
0.50
73,111
$
0.50
2,091,913
7.04
$
0.98
1,968,706
$
0.98
500,727
8.07
$
2.32
240,503
$
2.30
153,843
9.50
$
12.24
8,885
$
11.97
2,819,594
7.22
$
1.82
2,291,205
$
1.15
December 31, 2008
Options Outstanding
Options Exercisable
Weighted-
Average
Remaining
Weighted-
Weighted-
Range of
Number of
Contractual
Average
Number of
Average
Options
Life (Years)
Exercise Price
Options
Exercise Price
85,866
2.66
$
0.54
85,866
$
0.54
2,124,566
7.78
$
0.98
1,828,699
$
0.98
587,966
8.71
$
2.29
179,917
$
2.28
41,452
8.83
$
11.76
3,195
$
10.77
2,839,850
7.83
$
1.40
2,097,677
$
1.09
F-47
Table of Contents
(A Development Stage Company)
Six Months Ended
June 30,
Years Ended December 31,
2009
2008
2008
2007
2006
71%-75%
60%
60%
60%
60%
6.08
6.08
6.08
6.00-6.08
5.00-6.08
2.13%-2.64%
2.80%-3.40%
2.80%-3.40%
3.78%-4.78%
4.57% - 5.04%
0%
0%
0%
0%
0%
F-48
Table of Contents
(A Development Stage Company)
Estimated
Number of
Fair Value of
Shares
Common
Subject to
Exercise
Stock per
Intrinsic
Options
Price per
Share at
Value per Share
Granted
Share
Date of Grant
at Date of Grant
11,733
$
0.98
$
1.74
$
0.76
14,285
0.98
1.74
0.76
2,181,037
0.98
1.74
0.76
157,393
1.96
2.06
0.10
178,571
1.96
7.11
5.15
140,671
2.45
12.21
9.76
266,558
2.45
12.39
9.94
22,959
2.45
12.39
9.94
612
12.39
12.39
13,775
12.39
13.48
1.09
11,224
13.49
13.47
7,906
12.47
12.41
104,590
12.41
13.29
0.88
F-49
Table of Contents
(A Development Stage Company)
Six Months
Ended June 30,
Years Ended December 31,
2009
2008
2008
2007
2006
(in thousands)
$
437
$
485
$
983
$
482
$
309
502
681
1,332
5,574
1,130
$
939
$
1,166
$
2,315
$
6,056
$
1,439
F-50
Table of Contents
(A Development Stage Company)
December 31,
2008
2007
(in thousands)
$
24,658
$
18,105
79
170
120
41
2,281
1,580
133
138
27,271
20,034
(27,271
)
(20,034
)
$
$
December 31,
2008
2007
2006
(in thousands)
(34
%)
(34
%)
(34
)%
6
9
19
21
20
14
7
5
1
F-51
Table of Contents
(A Development Stage Company)
F-52
Table of Contents
(A Development Stage Company)
F-53
Table of Contents
Page
1
11
33
35
36
37
39
41
43
68
108
114
129
132
134
139
142
150
150
150
F-1
Table of Contents
ITEM 13.
OTHER EXPENSES
OF ISSUANCE AND DISTRIBUTION.
$
5,000
125,000
12,000
489,000
944,000
1,398,000
23,000
358,000
$
3,354,000
ITEM 14.
INDEMNIFICATION
OF DIRECTORS AND OFFICERS.
II-1
Table of Contents
ITEM 15.
RECENT SALES
OF UNREGISTERED SECURITIES.
ITEM 16.
EXHIBITS AND
FINANCIAL STATEMENT SCHEDULES.
Exhibit
Form of Underwriting Agreement.
Agreement and Plan of Reorganization among the registrant,
Epsilon Acquisition Corporation, nura, inc. and ARCH Venture
Corporation dated August 4, 2006
II-2
Table of Contents
Exhibit
Form of Amended and Restated Articles of Incorporation of the
registrant, to be in effect upon the completion of this offering.
Form of Amended and Restated Bylaws of the registrant, to be in
effect upon the completion of this offering.
Form of registrants common stock certificate.
Stock Purchase Warrant issued by nura, inc. to Oxford Finance
Corporation dated April 26, 2005 (assumed by the registrant
on August 11, 2006).
Amended and Restated Investors Rights Agreement among the
registrant and holders of capital stock dated October 15,
2004.
Form of Series E Preferred Stock Purchase Warrant (as of
June 30, 2009, 10 registered holders held warrants in this
form to purchase up to a total of 329,044 shares of
Series E Preferred Stock).
Form of Series E Preferred Stock Purchase Warrant (as of
June 30, 2009, 14 registered holders held warrants in
this form to purchase up to a total of 57,986 shares of
Series E Preferred Stock).
Form of Notice of Waiver of Warrant Termination (applicable to
Series E Preferred Stock Purchase Warrants filed as
Exhibits 4.4 and 4.5).
Opinion of Wilson Sonsini Goodrich & Rosati,
Professional Corporation.
Form of Indemnification Agreement to be entered into between the
registrant and its directors and officers.
Second Amended and Restated 1998 Stock Option Plan.
Form of Stock Option Agreement under the Second Amended and
Restated 1998 Stock Option Plan (that does not permit early
exercise).
Form of Amendment to Stock Option Agreement under the Second
Amended and Restated 1998 Stock Option Plan (to permit early
exercise).
Form of Stock Option Agreement under the Second Amended and
Restated 1998 Stock Option Plan (that permits early exercise).
nura, inc. 2003 Stock Plan.
Form of Stock Option Agreement under the nura, inc. 2003 Stock
Plan.
2008 Equity Incentive Plan.
Form of Stock Option Award Agreement under the 2008 Equity
Incentive Plan (to be used following the completion of this
offering).
Second Amended and Restated Employment Agreement between the
registrant and Gregory A. Demopulos, M.D. dated
December 30, 2007.
Non-Plan Stock Option Agreement between the registrant and
Gregory A. Demopulos, M.D. dated December 11, 2001.
Offer Letter between the registrant and Marcia S.
Kelbon, Esq. dated August 16, 2001.
Offer Letter between the registrant and Richard J. Klein dated
May 11, 2007.
Technology Transfer Agreement between the registrant and Gregory
A. Demopulos, M.D. dated June 16, 1994.
Technology Transfer Agreement between the registrant and Pamela
A. Pierce, M.D., Ph.D. dated June 16, 1994.
Second Technology Transfer Agreement between the registrant and
Gregory A. Demopulos, M.D. dated December 11, 2001.
Second Technology Transfer Agreement between the registrant and
Pamela Pierce, M.D., Ph.D. dated March 22, 2002.
Technology Transfer Agreement between the registrant and Gregory
A. Demopulos, M.D. dated June 16, 1994 (related to
tendon splice technology).
Table of Contents
Exhibit
Master Security Agreement between the nura, inc. and Oxford
Finance Corporation dated April 26, 2005.
Guaranty from the registrant to Oxford Finance Corporation dated
August 11, 2006.
U.S. Bank Centre Office Lease Agreement between Bentall City
Centre LLC and Scope International, Inc. dated
September 28, 1998.
Assignment and Amendment of Lease among the registrant, City
Centre Associates and Navigant Consulting, Inc. dated
August 1, 2002.
Second Amendment to Office Lease Agreement between the
registrant and City Centre Associates dated January 4, 2006.
Lease Agreement between Alexandria Real Estate Equities, Inc.
and Primal, Inc. dated April 6, 2000.
Lease Agreement between Alexandria Real Estate Equities, Inc.
and Primal, Inc. dated September 28, 2001.
Assignment and Assumption and Modification of Lease Documents
among Alexandria Real Estate Equities, Inc., Primal, Inc., and
nura, inc. dated October 23, 2003.
Assignment and Assumption and Modification of Lease Documents
among Alexandria Real Estate Equities, Inc., nura, inc., and the
registrant dated September 26, 2007.
Commercial Supply Agreement between the registrant and Hospira
Worldwide, Inc. dated October 9, 2007.
Exclusive License and Sponsored Research Agreement between the
registrant and the University of Leicester dated June 10,
2004.
Research and Development Agreement First Amendment between the
registrant and the University of Leicester dated October 1,
2005.
Exclusive License and Sponsored Research Agreement between the
registrant and the Medical Research Council dated
October 31, 2005.
Amendment dated May 8, 2007 to Exclusive License and
Sponsored Research Agreement between the registrant and the
Medical Research Council dated October 31, 2005.
Funding Agreement between the registrant and The Stanley Medical
Research Institute dated December 18, 2006.
Services and Materials Agreement between the registrant and
Scottish Biomedical Limited dated April 20, 2007.
Amendment dated April 30, 2007 of the Services and
Materials Agreement between the registrant and Scottish
Biomedical Limited dated April 20, 2007.
Drug Product Development and Clinical Supply Agreement between
the registrant and Althea Technologies, Inc. dated
January 20, 2006.
Project Plan for Non-GMP and cGPM Fill and Finish of OMS302
between the registrant and Althea Technologies, Inc. dated
May 31, 2007.
Master Services Agreement between nura, inc. and ComGenex, Inc.
dated January 27, 2005.
Landlord Consent to Sublease among Christensen OConnor
Johnson Kindness PLLC, City Centre Associates and the registrant
dated January 29, 2008.
Form of Stock Option Award Agreement under the 2008 Equity
Incentive Plan (used prior to the completion of this offering).
Agreement for Antibody Discovery and Development between the
registrant and Affitech AS dated July 25, 2008.
Table of Contents
Exhibit
Exclusive Technology Option Agreement between the registrant,
Patobios Limited, Susan R. George, M.D., Brian F.
ODowd, Ph.D. and U.S. Bank National Association as
escrow agent dated September 4, 2008.
Loan and Security Agreement between the registrant and BlueCrest
Capital Finance, L.P. dated September 12, 2008.
Promissory Note issued by the registrant to BlueCrest Capital
Finance, L.P. dated September 12, 2008.
Promissory Note issued by the registrant to BlueCrest Capital
Finance, L.P. dated December 23, 2008.
Agreement for Antibody Development between the registrant and
North Coast Biologics LLC dated October 31, 2008.
Patent Assignment Agreement between the registrant and Roberto
Ciccocioppo, Ph.D. dated February 23, 2009.
Amendment to Exercise Notice and Restricted Stock Purchase
Agreements between the registrant and Richard J. Klein dated
April 29, 2009.
Second Amendment to Exercise Notice and Restricted Stock
Purchase Agreements between the registrant and Richard
J. Klein dated July 28, 2009.
Omeros Corporation Non-Employee Director Compensation Policy.
List of significant subsidiaries of the registrant.
Consent of Independent Registered Public Accounting Firm.
Consent of Wilson Sonsini Goodrich & Rosati,
Professional Corporation (included in Exhibit 5.1).
Power of Attorney.
Consent of The Reimbursement Group.
*
Previously Filed.
**
To be filed by amendment.
Confidential treatment will be
requested for portions of this exhibit. These portions will be
omitted from this Registration Statement and will be filed
separately with the Securities and Exchange Commission.
ITEM 17.
UNDERTAKINGS.
Table of Contents
II-6
Table of Contents
By:
President, Chief Executive Officer,
Chief Medical Officer
and
Chairman of the Board of Directors
(Principal Executive, Financial and Accounting Officer)
September 16, 2009
Director
September 16, 2009
Director
September 16, 2009
Director
September 16, 2009
Director
September 16, 2009
Director
September 16, 2009
Attorney-in-Fact
II-7
Table of Contents
Exhibit
1
.1*
Form of Underwriting Agreement.
2
.1*
Agreement and Plan of Reorganization among the registrant,
Epsilon Acquisition Corporation, nura, inc. and ARCH Venture
Corporation dated August 4, 2006
3
.1*
Form of Amended and Restated Articles of Incorporation of the
registrant, to be in effect upon the completion of this offering.
3
.2*
Form of Amended and Restated Bylaws of the registrant, to be in
effect upon the completion of this offering.
4
.1**
Form of registrants common stock certificate.
4
.2*
Stock Purchase Warrant issued by nura, inc. to Oxford Finance
Corporation dated April 26, 2005 (assumed by the registrant
on August 11, 2006).
4
.3*
Amended and Restated Investors Rights Agreement among the
registrant and holders of capital stock dated October 15,
2004.
4
.4
Form of Series E Preferred Stock Purchase Warrant (as of
June 30, 2009, 10 registered holders held warrants in this
form to purchase up to a total of 329,044 shares of
Series E Preferred Stock).
4
.5
Form of Series E Preferred Stock Purchase Warrant (as of
June 30, 2009, 14 registered holders held warrants in
this form to purchase up to a total of 57,986 shares of
Series E Preferred Stock).
4
.6
Form of Notice of Waiver of Warrant Termination (applicable to
Series E Preferred Stock Purchase Warrants filed as
Exhibits 4.4 and 4.5).
5
.1*
Opinion of Wilson Sonsini Goodrich & Rosati,
Professional Corporation.
10
.1*
Form of Indemnification Agreement to be entered into between the
registrant and its directors and officers.
10
.2*
Second Amended and Restated 1998 Stock Option Plan.
10
.3*
Form of Stock Option Agreement under the Second Amended and
Restated 1998 Stock Option Plan (that does not permit early
exercise).
10
.4*
Form of Amendment to Stock Option Agreement under the Second
Amended and Restated 1998 Stock Option Plan (to permit early
exercise).
10
.5*
Form of Stock Option Agreement under the Second Amended and
Restated 1998 Stock Option Plan (that permits early exercise).
10
.6*
nura, inc. 2003 Stock Plan.
10
.7*
Form of Stock Option Agreement under the nura, inc. 2003 Stock
Plan.
10
.8*
2008 Equity Incentive Plan.
10
.9*
Form of Stock Option Award Agreement under the 2008 Equity
Incentive Plan (to be used following the completion of this
offering).
10
.10*
Second Amended and Restated Employment Agreement between the
registrant and Gregory A. Demopulos, M.D. dated
December 30, 2007.
10
.11*
Non-Plan Stock Option Agreement between the registrant and
Gregory A. Demopulos, M.D. dated December 11, 2001.
10
.12*
Offer Letter between the registrant and Marcia S.
Kelbon, Esq. dated August 16, 2001.
10
.13*
Offer Letter between the registrant and Richard J. Klein dated
May 11, 2007.
10
.14*
Technology Transfer Agreement between the registrant and Gregory
A. Demopulos, M.D. dated June 16, 1994.
10
.15*
Technology Transfer Agreement between the registrant and Pamela
Pierce, M.D., Ph.D. dated June 16, 1994.
10
.16*
Second Technology Transfer Agreement between the registrant and
Gregory A. Demopulos, M.D. dated December 11, 2001.
10
.17*
Second Technology Transfer Agreement between the registrant and
Pamela Pierce, M.D., Ph.D. dated March 22, 2002.
Table of Contents
Exhibit
10
.18*
Technology Transfer Agreement between the registrant and Gregory
A. Demopulos, M.D. dated June 16, 1994 (related to
tendon splice technology).
10
.19*
Master Security Agreement between the nura, inc. and Oxford
Finance Corporation dated April 26, 2005.
10
.20*
Guaranty from the registrant to Oxford Finance Corporation dated
August 11, 2006.
10
.21*
U.S. Bank Centre Office Lease Agreement between Bentall City
Centre LLC and Scope International, Inc. dated
September 28, 1998.
10
.22*
Assignment and Amendment of Lease among the registrant, City
Centre Associates and Navigant Consulting, Inc. dated
August 1, 2002.
10
.23*
Second Amendment to Office Lease Agreement between the
registrant and City Centre Associates dated January 4, 2006.
10
.24*
Lease Agreement between Alexandria Real Estate Equities, Inc.
and Primal, Inc. dated April 6, 2000.
10
.25*
Lease Agreement between Alexandria Real Estate Equities, Inc.
and Primal, Inc. dated September 28, 2001.
10
.26*
Assignment and Assumption and Modification of Lease Documents
among Alexandria Real Estate Equities, Inc., Primal, Inc., and
nura, inc. dated October 23, 2003.
10
.27*
Assignment and Assumption and Modification of Lease Documents
among Alexandria Real Estate Equities, Inc., nura, inc., and the
registrant dated September 26, 2007.
10
.28
Commercial Supply Agreement between the registrant and Hospira
Worldwide, Inc. dated October 9, 2007.
10
.29
Exclusive License and Sponsored Research Agreement between the
registrant and the University of Leicester dated June 10,
2004.
10
.30*
Research and Development Agreement First Amendment between the
registrant and the University of Leicester dated October 1,
2005.
10
.31
Exclusive License and Sponsored Research Agreement between the
registrant and the Medical Research Council dated
October 31, 2005.
10
.32*
Amendment dated May 8, 2007 to Exclusive License and
Sponsored Research Agreement between the registrant and the
Medical Research Council dated October 31, 2005.
10
.33*
Funding Agreement between the registrant and The Stanley Medical
Research Institute dated December 18, 2006.
10
.34*
Services and Materials Agreement between the registrant and
Scottish Biomedical Limited dated April 20, 2007.
10
.35*
Amendment dated April 30, 2007 of the Services and
Materials Agreement between the registrant and Scottish
Biomedical Limited dated April 20, 2007.
10
.36*
Drug Product Development and Clinical Supply Agreement between
the registrant and Althea Technologies, Inc. dated
January 20, 2006.
10
.37
Project Plan for Non-GMP and cGMP Fill and Finish of OMS302
between the registrant and Althea Technologies, Inc. dated
May 31, 2007.
10
.38*
Master Services Agreement between nura, inc. and ComGenex, Inc.
dated January 27, 2005
10
.39*
Landlord Consent to Sublease among Christensen OConnor
Johnson Kindness PLLC, City Centre Associates and the registrant
dated January 29, 2008.
10
.40*
Form of Stock Option Award Agreement under the 2008 Equity
Incentive Plan (used prior to the completion of this offering).
10
.41
Agreement for Antibody Discovery and Development between the
registrant and Affitech AS dated July 25, 2008.
Table of Contents
Exhibit
10
.42*
Exclusive Technology Option Agreement between the registrant,
Patobios Limited, Susan R. George, M.D., Brian F.
ODowd, Ph.D. and U.S. Bank National Association as
escrow agent dated September 4, 2008.
10
.43*
Loan and Security Agreement between the registrant and BlueCrest
Capital Finance, L.P. dated September 12, 2008.
10
.44*
Promissory Note issued by the registrant to BlueCrest Capital
Finance, L.P. dated September 12, 2008.
10
.45*
Promissory Note issued by the registrant to BlueCrest Capital
Finance, L.P. dated December 23, 2008.
10
.46
Agreement for Antibody Development between the registrant and
North Coast Biologics LLC dated October 31, 2008.
10
.47
Patent Assignment Agreement between the registrant and Roberto
Ciccocioppo, Ph.D. dated February 23, 2009.
10
.48*
Amendment to Exercise Notice and Restricted Stock Purchase
Agreements between the registrant and Richard J. Klein dated
April 29, 2009.
10
.49
Second Amendment to Exercise Notice and Restricted Stock
Purchase Agreements between the registrant and Richard J. Klein
dated July 28, 2009.
10
.50
Omeros Corporation Non-Employee Director Compensation Policy.
21
.1*
List of significant subsidiaries of the registrant.
23
.1
Consent of Independent Registered Public Accounting Firm.
23
.4
Consent of Wilson Sonsini Goodrich & Rosati,
Professional Corporation (included in Exhibit 5.1).
24
.1*
Power of Attorney.
99
.1*
Consent of The Reimbursement Group.
*
Previously Filed.
**
To be filed by amendment.
Confidential treatment will be
requested for portions of this exhibit. These portions will be
omitted from this Registration Statement and will be filed
separately with the Securities and Exchange Commission.
Warrant No. _________
Date of Issuance: _________ |
Number of Shares: _________
(subject to adjustment) |
|
X = |
Y (AB)
|
Where
|
X = | The number of shares of Warrant Stock to be issued to the Registered Holder. | ||
|
Y = | The number of shares of Warrant Stock purchasable under this Warrant (at the date of such calculation). | ||
|
A = | The fair market value of one share of Warrant Stock (at the date of such calculation). | ||
|
B = | The Purchase Price (as adjusted to the date of such calculation). |
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|
OMEROS CORPORATION | |
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By: _________________________________ | |
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Name: _______________________________ | |
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Its: _________________________________ |
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Address: |
1420 Fifth Avenue, Suite 2600
Seattle, Washington 98101 |
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Fax Number: | (206) 264-7856 |
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To: Omeros Corporation | Dated: |
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Signature: | |||||
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Name (print): | |||||
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Title (if applic.) | |||||
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Company (if applic.): | |||||
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Name of Assignee | Address/Fax Number | No. of Shares |
Dated:
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Signature: | ||||||
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Witness: | ||||||
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3
Warrant No. _________
Date of Issuance: _________ |
Number of Shares: _________
(subject to adjustment) |
- -
|
X = |
Y (AB)
|
Where
|
X = The number of shares of Warrant Stock to be issued to the Registered Holder. | |
|
Y = The number of shares of Warrant Stock purchasable under this Warrant (at the date of such calculation). | |
|
A = The fair market value of one share of Warrant Stock (at the date of such calculation). | |
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B = The Purchase Price (as adjusted to the date of such calculation). |
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|
OMEROS CORPORATION | |
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By: _________________________________ | |
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Name: _______________________________ | |
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Its: _________________________________ |
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Address: |
1420 Fifth Avenue, Suite 2600
Seattle, Washington 98101 |
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Fax Number: | (206) 264-7856 |
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To: Omeros Corporation
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Dated: |
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Signature: | |||||
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Name (print): | |||||
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Title (if applic.) | |||||
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Company (if applic.): | |||||
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Name of Assignee | Address/Fax Number | No. of Shares |
Dated:
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Signature: | ||||||
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Witness: | ||||||
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OMEROS CORPORATION | ||||||
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By: | |||||
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Its: | |||||
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Name: | |||||
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
4
Defined Term | Section in which Defined | |
Agreement
|
Preamble | |
[]
|
10.4 | |
[]
|
10.4 | |
Change Order
|
2.4 | |
Damages
|
9.2 | |
Development Agreement
|
Recitals | |
DMF
|
5.2 | |
Effective Date
|
Preamble | |
Executives
|
12.2 | |
Firm Commitment
|
3.9.2 | |
Firm Purchase Order
|
3.10.1 | |
General SOPs
|
1.33 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
5
Defined Term | Section in which Defined | |
Hospira
|
Preamble | |
Hospira Indemnitees
|
9.2 | |
ICH
|
1.4 | |
Indemnified Party
|
9.4 | |
Indemnifying Party
|
9.4 | |
Initial Term
|
10.1 | |
Launch
|
10.4 | |
Minimum Purchase Requirement
|
3.10.5 | |
NDA
|
3.9.2 | |
Omeros
|
Preamble | |
Omeros Indemnitees
|
9.3 | |
Party
and/or
Parties
|
Preamble | |
Product and Equivalents
|
7.1 | |
Product Specific SOPs
|
1.33 | |
Purchase Order
|
3.10.1 | |
Quality Agreement
|
3.2 | |
Representative
|
2.5 | |
Rolling
[]
Estimate
|
3.9.1 | |
Rolling Forecast
|
3.9.2 | |
Stability Lot Price
|
3.7 | |
Submission
|
10.4 | |
Supply Period
|
10.4 | |
[]
|
10.6.2 | |
Term
|
10.1 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
6
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
7
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
8
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
9
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
10
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
18
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
19
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
20
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
21
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
22
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
23
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
24
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
25
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
26
Date of Termination Notice | Supply Period | Break-Up Fee | ||
(a) Prior to Submission
|
None | [] | ||
|
||||
(b) Between Submission* and
6-months prior to Launch
|
None | [] | ||
|
||||
(c) Between 6-months prior to
Launch* and Launch
|
First two (2) years of Initial Term | [] | ||
|
||||
(d) Between Launch* and one
(1) year following Launch
|
Two (2) years from date of termination notice | [] | ||
|
||||
(e) Between one (1)* and two
(2) years following Launch
|
Two (2) years from date of termination notice | [] | ||
|
||||
(f) Between two (2)* and three
(3) years following Launch
|
Two (2) years from date of termination notice | [] |
* | The start event in each period (a)-(f) set forth in the table above includes the first day of such event (e.g., (e) covers the period of time between the 1st year anniversary of Launch and the day prior to the 2nd year anniversary of Launch). |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
27
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
28
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
29
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
30
OMEROS CORPORATION | ||||||
|
||||||
|
By: |
/s/ Gregory A. Demopulos
|
||||
Gregory A. Demopulos, M.D. | ||||||
Chairman & CEO | ||||||
|
||||||
|
||||||
HOSPIRA WORLDWIDE, INC. | ||||||
|
||||||
|
By: |
/s/ Thomas Moore
|
||||
Thomas Moore | ||||||
President, Global Pharmaceuticals |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
31
§ | Manufactured at Hospiras McPherson, Kansas facility [] | ||
§ | [] | ||
§ | [] | ||
§ | [] | ||
§ | [] | ||
§ | Bulk APIs to be supplied by Omeros, [] | ||
§ | [] | ||
§ | Release testing to be performed by Hospira with issuance of a Certificate of Analysis | ||
§ | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
|
[] | [] | ||||
|
[] | [] | ||||
|
[] | [] | ||||
[]
|
[] | [] | [] |
| [] | ||
| [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
1 | Definitions | |
1.1 | Reference to Leicester and Omeros in regards to any intellectual property right developed by the respective party shall be construed to refer to the respective party as well as the respective partys employees, officers, directors, consultants and agents. | |
1.2 | Intellectual Property Rights shall mean all inventions, ideas, discoveries, issued, reissued or reexamined patents, pending and future patent applications, continuation, continuation-in-part and divisional patent applications, utility models, inventors certificates, trade secrets, know-how, copyrights and trademarks. | |
1.3 | Sponsored Research shall mean all research activities carried out by Leicester and/or its employees (as may be agreed by Leicester and Omeros) with the financial sponsorship, in whole or in part, by Omeros in accordance with Section 2 herein below or as otherwise agreed. |
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1.4 | Leicester IP shall mean all Intellectual Property Rights owned or held by Leicester, including without limitation all such Intellectual Property Rights arising from the work of Dr. Schwaeble, Dr. Stover, and/or other Leicester employees as well as that acquired under an assignment agreement from Dr. Fujita, prior to the Effective Date of this Agreement, or developed or obtained by Leicester after the Effective Date of this Agreement both (a) independently of Omeros (as determined by inventorship under US law with respect to any patents and patent applications) and (b) independently of the Sponsored Research, provided however that in the event and to the extent that such independently developed Intellectual Property Rights arise as the direct result of sponsorship by a not-for-profit enterprise in accordance with Section 4.3 herein, such independently developed Intellectual Property Rights shall be included within the scope of the license granted herein only if Leicester or Leicester employee(s) obtain an assignment or release of such independently developed Intellectual Property Rights from such not-for-profit enterprise, which assignment or release Leicester shall exert all reasonable efforts to obtain or to cause its employees to obtain, provided always that any of the Intellectual Property Rights described above in this section 1.4 are directly related to compositions, antibodies and/or methods for the inhibition of MASP-2 and/or MAp19 and/or the diagnosis and/or treatment of MASP-2 or MAp19 mediated disorders and/or deficiency syndromes, as well as methods, polynucleotides, polypeptides, sequences and tools related to the development and production of MASP-2 or MAp19 antibodies including without limitation murine, human, humanized and recombinant antibodies, murine lines in which MASP-2 or MAp19 genes have been knocked-out or knocked-in, and all Intellectual Property Rights in the subject matter disclosed or claimed in the draft patent application entitled Genetically modified non-human mammals and cells filed in the British Patent Office on 10 June 2004 and attached hereto as Exhibit A [] . | |
1.5 | Omeros IP shall mean all Intellectual Property Rights owned or held by Omeros prior to the Effective Date of this Agreement, or developed or obtained by Omeros after the Effective Date of this Agreement independently of Leicester (as determined by inventorship under US law with respect to any patents and patent applications), including without limitation all such Intellectual Property Rights related to methods and pharmaceuticals or other agents to inhibit pain, inflammation, cartilage loss, vasospasm, smooth muscle spasm, restenosis, or tumor cell adhesion, and/or to accelerate recovery of joint motion and function, for use in surgical procedures (including without limitation arthroscopic, cardiovascular, urologic and general surgical procedures), other medical procedures, and/or for treatment of cartilaginous disorders, and drug delivery methods and systems. | |
1.6 | Joint IP shall mean (a) all Intellectual Property Rights in technology that is developed jointly (as determined by inventorship with respect to any patents and patent applications) by Omeros and Leicester (as may be agreed by Leicester and Omeros) during the Sponsored Research Term (as that term is defined in Section 2.2 herein), and (b) all Intellectual Property Rights arising from and as the direct result of the Sponsored Research. Should Dr. Schwaeble or other Leicester employees enter into a consulting agreement with Omeros for general scientific consulting such as in the field of |
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inflammation, then to the extent that such scientific consulting services may pertain to MASP-2 and MAp19, the results of such scientific consulting services will be treated as part of the Joint IP. However, the parties acknowledge herein that research by Dr. Schwaeble and other Leicester employees on behalf of Omeros related to MASP-2 and MAp19 will be carried out in major part through the Sponsored Research. | ||
1.7 | [] | |
1.8 | Licensed Products shall mean all antibodies, inhibitors and all other products that, were it not for the license granted to Omeros under this Agreement, infringe, or the use, manufacture, offer for sale or sale of which infringe any valid and subsisting claim(s) of any issued patent or any patentable claim(s) of any pending patent application included within the Leicester IP in the country or countries in which such products are offered for sale, sold, manufactured or used, excluding all products that would be included within the Licensed Products in accordance with the above definition only because they are products that infringe any claim(s) within the [] . | |
1.9 | Licensed Research Products shall mean any antibodies that are not Licensed Products and which are produced or developed as the direct result of use of murine line(s) that, were it not for the license granted to Omeros under this Agreement, infringe, or the use of which infringe, any valid and subsisting claim(s) of any issued patent or any patentable claim(s) of any pending patent application for such murine line(s) included within the Leicester IP in the country or countries in which such lines are propagated or used. | |
1.10 | Net License Proceeds shall mean the total of the gross monetary amounts invoiced and collected by Omeros for Licensed Products and Licensed Research Products (or that portion of the value of any combination product attributed to a Licensed Product or a Licensed Research Product included therein) used, manufactured, directly sold or directly distributed by Omeros, less (a) the sum of the following actual and customary deductions where applicable: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes, and any other governmental taxes imposed on particular sales; transportation charges and allowances; commissions to third party sales agents; and credits to customers because of rejections or returns and (b) any accrued Omeros IP Legal Fees (as defined below) not previously deducted. For purposes of this paragraph, the acquisition of Licensed Products and Licensed Research Products from Omeros as part of an acquisition of all or a substantial part of the assets of Omeros business to which this Agreement pertains shall not be considered a manufacture, sale or distribution. | |
1.11 | Net Sublicense Proceeds shall mean the total of all sublicense royalties or sublicense fees received by Omeros from third parties to which Omeros grants a sublicense under the Leicester IP for the manufacture, sale or distribution of Licensed Products or Licensed Research Products, and which were not included in the Net License Proceeds, less any accrued Omeros IP Legal Fees not previously deducted, provided however that the Net Sublicense Proceeds shall not include any fees or payments from such third parties to Omeros to support research and development efforts, to purchase equity in Omeros, or for any other purpose other than as compensation for sublicense rights. |
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1.12 | Omeros IP Legal Fees shall mean the sum of all legal fees and costs incurred by Omeros to (a) evaluate, apply for, prosecute and maintain any Intellectual Property Rights included within the Leicester IP, including without limitation any such fees and costs paid by Omeros as reimbursement to Leicester for such fees and costs incurred by Leicester, and (b) obtain or assist Leicester in obtaining or attempting to obtain clear, defensible, lawful and uncontested title to the Leicester IP, including without limitation all such fees and costs incurred in [] . | |
1.13 | Third Party License Fees shall mean all royalties or other fees paid by Omeros to third parties for a license from such third parties under Intellectual Property Rights owned or held by such third parties for the manufacture, use, offer for sale, sale or distribution of Licensed Products or Licensed Research Products, but shall exclude that portion of any such third party royalties or other fees paid by Omeros attributed to items sold in combination with the Licensed Products or the Licensed Research products, which items are not Licensed Products or Licensed Research products. | |
2 | Sponsored Research | |
2.1 | Leicester shall perform research to be conducted by or under the direction of the Principal Investigator (as may be agreed between Leicester and Omeros), directed to advancing the technology included in the Leicester IP or related technology concerning the characterization and inhibition of MASP-2 or MAp19, supported by the financial sponsorship of Omeros, and without the use of third party sponsorship that would provide any intellectual property rights in the results of the Sponsored Research to such third party, in accordance with one or more research plans (Research Plans) agreed to in advance in writing between Leicester and Omeros. An initial Research Plan is attached hereto as Exhibit B. No Research Plan or any amendment thereto shall be effective until executed by Leicester and Omeros, and upon mutual execution shall be automatically incorporated into this Agreement. Each Research Plan shall define scientific aims, objectives and activities, a budget and a timeline for performance of Sponsored Research during the corresponding time period. | |
2.2 | The Sponsored Research shall be completed over a term (the Sponsored Research Term) that will initially run for a period of one (1) year from the appointment or designation of appropriate and mutually acceptable staff at Leicester, and that is extendable annually upon mutual written agreement for a total term of three (3) years from the Effective Date of this Agreement or as may otherwise be mutually agreed in writing. If Omeros or Leicester does not wish to extend the Sponsored Research Term for the second or the third year, such party shall provide the other party notice of non-extension at least ninety (90) days prior to the end of the preceding year. The Sponsored Research Term shall run independently of the License Term (as defined herein below) of this Agreement. Termination of this Agreement shall result in termination of the Sponsored Research Term, but termination of the Sponsored Research Term, such as in accordance with Section 14.4 herein, shall not affect the overall status of this Agreement or the License Term. |
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2.3 | Leicester shall supply all necessary personnel, administrative management, facilities, equipment and supplies to enable timely completion of the Sponsored Research. Reimbursement for Leicesters costs and expenses for the Sponsored Research shall be provided only to the extent agreed to in writing in the applicable Research Plan. Each Research Plan will be completed diligently by Leicester using best efforts in accordance with prevailing professional standards and all applicable laws, regulations and Leicesters official policies. Should the Principal Investigator become unavailable to complete any Research Plan, Leicester and Omeros may agree on a substitute investigator, and in the event that a mutually acceptable substitute is not available, either party may terminate the Sponsored Research Term. | |
2.4 | Within thirty (30) days of the end of each quarter of the Sponsored Research Term, Leicester shall submit a status report in written and electronic form (Status Report) summarizing the results of the research completed during that quarter, except that annually within thirty (30) days of the end of each year of the Sponsored Research Term or at such other point in time as may be mutually agreed in writing, Leicester shall submit a final status report in written and electronic form (Final Report) detailing the results of the research completed during such year of the Sponsored Research Term. Upon Omeros request, Leicester shall complete all requested corrections and make reasonable revisions to each Status Report and/or Final Report to place it into a form suitable to meet Omeros objectives, including potential use of any Status Report and/or any Final Report as part of any regulatory submissions. | |
2.5 | In full and complete consideration for the Sponsored Research completed by Leicester during the Sponsored Research Term in accordance with the Research Plan(s), Omeros shall pay Leicester [] for the first year, and unless a change in the level of Sponsored Research work is agreed to in writing in subsequent Research Plans, this amount shall be increased by [] per year plus, in the event of continued use of a Leicester laboratory technician in performing Sponsored Research activities after the first year of the Sponsored Research Term, any increase in fees due to British national standard pay scale changes applicable on a pro rata basis to such Leicester laboratory technicians Sponsored Research activities, for each mutually agreed subsequent year of the Sponsored Research Term throughout which Sponsored Research is carried out (i.e., a total of [] if the Sponsored Research Term is extended for a total three-year period and the level of Sponsored Research work during each year remains constant), payable at the rate of [] of the annual amount per quarter within thirty (30) days of the end of each quarter within the Sponsored Research Term, provided however that no payment shall be due for any quarter prior to the receipt and acceptance by Omeros of a Status Report or any Final Report, as appropriate, for the respective quarter or year. | |
2.6 | Omeros and the Principal Investigator shall collaborate on any proposed scientific publications of Sponsored Research data and results, including a discussion of authorship and contents. Leicester shall furnish Omeros with copies of any publication or written or oral disclosure that is proposed by Leicester, including, without limitation, disclosures in papers or abstracts or at research seminars, lectures, professional meetings, or poster sessions, at least sixty (60) days prior to the proposed date for submission for publication |
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3 | Ownership of Intellectual Property | |
3.1 | All Leicester IP shall remain owned or held by Leicester to the same extent as would be the case were it not for this Agreement. | |
3.2 | All Omeros IP shall remain owned or held by Omeros to the same extent as would be the case were it not for this Agreement. | |
3.3 | All Joint IP shall be jointly owned by Omeros and Leicester, i.e., Omeros and Leicester each shall hold a 50% undivided joint ownership interest in all Joint IP. | |
4 | Grant Of License | |
4.1 | Leicester hereby grants to Omeros for the term of this Agreement a royalty-bearing, world-wide exclusive license in the Leicester IP for the research, development, manufacture, use, sale, offering for sale, distribution, exportation and importation of any and all products and the practice of all methods within the Leicester IP, including without limitation the exclusive right to develop, manufacture, use, sell, offer for sale, distribute, export and import the Licensed Products and the Licensed Research Products and to use all murine lines within the Leicester IP for all purposes including without limitation the research, development and production of antibody products . | |
4.2 | Leicester hereby grants to Omeros a fully-paid up, irrevocable, world-wide exclusive license in and to Leicesters joint ownership interest in the Joint IP, for the manufacture, use, sale, offering for sale, distribution, exportation and importation of any and all products and the practice of all methods encompassed by the Joint IP . | |
4.3 | Subject to publication approval and timing procedures consistent with Section 2.6 herein, Leicester shall retain the right to use the Leicester IP and the Joint IP for the purpose of conducting non-commercial, academic research, including research sponsored by not-for-profit entities, which shall not include the performance of research sponsored (directly or |
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4.4 | Omeros shall have the right to grant sublicenses in the Leicester IP and the Joint IP under this Agreement subject, with respect to the Leicester IP, to Omeros obligations to share sublicense revenues as set forth in Section 5. | |
4.5 | As part of the licenses granted to Omeros under Sections 4.1 and 4.2, Leicester agrees to transfer and provide and/or make available to Omeros upon request progeny from the licensed murine lines, cell lines, biological materials and any other research materials encompassed by or included within the Leicester IP and/or the Joint IP to which Leicester has appropriate rights and access, all such materials being provided on the basis of Omeros reimbursing Leicester for Leicesters actual cost in providing such materials but for no additional consideration. | |
4.6 | Leicester also grants to Omeros a right of first refusal for an exclusive license in all of Leicesters Intellectual Property Rights, for which Omeros has not already been granted a license hereunder, and for which Leicester has all necessary rights to offer such first refusal, and Leicester shall exert reasonable efforts to obtain such necessary rights, in (1) any commercially applicable technology that arises during the Term of this Agreement and is directly related to MASP-2 and/or MAp19 as more fully defined in the Leicester IP and the Joint IP, and (2) any technology that has been developed through the contribution of both Omeros and Leicester after the Sponsored Research Term. | |
5 | Royalties and Sublicense Revenue | |
5.1 | Omeros shall pay Leicester on a quarterly basis a royalty for Licensed Products of [] of the that portion of the Net License Proceeds realized during each respective quarter from Licensed Products (the Licensed Product Royalty), provided however that Omeros shall be entitled to deduct from the Licensed Product Royalty any accrued Third Party License Fees paid by Omeros on the Licensed Products not already deducted, but in no event shall Third Party License Fees be permitted to be deducted to an extent that such Third Party License Fees would reduce the Licensed Product Royalty by greater than [] for any given quarter. | |
5.2 | Omeros shall pay Leicester on a quarterly basis a royalty for Licensed Research Products (the Licensed Research Products Royalty) of (a) [] of that portion of the Net License Proceeds realized from Licensed Research Products during each respective quarter during and only during the first three (3)-year period following initial introduction of the relevant product to a commercial market, and (b) [] of that portion of the Net License Proceeds realized from Licensed Research Products during each respective quarter after the first three-year period until such time that any third party should introduce into a commercial market a competing product that does not infringe the Leicester IP, after which third-party introduction no further Licensed Research Products Royalty shall be payable for the relevant product, provided however that Omeros shall be entitled to |
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deduct from the Licensed Research Products Royalty any accrued Third-Party License Fees paid by Omeros on Licensed Research Products not already deducted, but in no event shall Third-Party License Fees be permitted to be deducted to an extent that such Third Party License Fees would reduce the Licensed Research Products Royalty by greater than [] for any given quarter. | ||
5.3 | Omeros shall pay Leicester on a quarterly basis a share of that portion of the Net Sublicense Proceeds collected by Omeros on Licensed Products and collected by Omeros (Sublicensed Product Revenue Share) from sublicensed third parties during each respective quarter, such Sublicensed Product Revenue Share being either (a) [] for any sublicenses in connection with the Licensed Products granted hereunder prior to the earlier of (i) [] , or (ii) the second year anniversary of the Effective Date of this Agreement, or (b) [] for any sublicenses in connection with the Licensed Products granted hereunder thereafter. | |
5.4 | Omeros shall pay Leicester on a quarterly basis a Sublicensed Research Product Revenue Share that is (a) an initial percentage share (First Share Percentage) of that portion of the Net Sublicense Proceeds realized from Licensed Research Products and collected by Omeros from sublicensed third parties during each respective quarter during and only during the first three (3)-year period following initial introduction to a commercial market of the relevant antibody product by the respective sublicensee, and (b) a subsequent percentage share (Second Share Percentage) of that portion of the Net Sublicense Proceeds realized from Licensed Research Products and collected by Omeros from sublicensed third parties during each respective quarter after the initial three-year period. For any sublicenses in connection with Licensed Research Products granted hereunder prior to the earlier of (i) [] , or (ii) the second year anniversary of the Effective Date of this Agreement, the First Share Percentage shall be [] and the Second Share Percentage shall be [] . For any sublicenses in connection with Licensed Research Products granted hereunder thereafter, the First Share Percentage shall be [] and the Second Share Percentage shall be [] . | |
5.5 | Omeros shall promptly provide Leicester with a copy of all sublicenses granted by Omeros in the Leicester IP and/or the Joint IP under this Agreement. | |
5.6 | Following receipt from the University of the results of all Sponsored Research and the completion of all other necessary and beneficial research activities by Omeros and/or by others to support appropriate government regulatory submissions by Omeros, [] , Omeros shall use reasonable efforts, based on reasonable commercial prudence, to diligently develop and introduce to the market one or more Licensed Products and/or Licensed Research Products. Ongoing performance of research and/or development efforts to generate or further advance one or more Licensed Products and/or Licensed Research Products by Omeros, internally at Omeros and/or under contract with Leicester and/or a third party, shall be deemed to be diligent efforts under this Section 5.6. | |
5.7 | It is Omeros current intent to commercially develop and seek regulatory clearance to clinically test and then market an inhibitor of MASP-2 and/or MAp19 activity following |
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Leicesters identification of selective and high-affinity inhibitors of MASP-2 and MAp19 activity and demonstration by Leicester of the therapeutic benefit of such inhibitors in animal models. Within three months of the identification by Omeros of a Licensed Product or Licensed Research Product that is determined by Omeros to be a viable and optimal clinical development candidate, Omeros will submit a development plan to Leicester that sets forth Omeros planned activities and estimated timing for the development, regulatory approval and market introduction of one or more Licensed Products and/or Licensed Research products. Assuming anticipated and adequate progress is made in the Sponsored Research [] , Omeros anticipates the identification of an initial potential candidate for a Licensed Product or Licensed Research Product that is a potential clinical development candidate within two years of the commencement of the Sponsored Research. The foregoing statements within this Section 5.7 and such development plan are or will be provided as indications of current or future intentions only, and shall have no binding effect on Omeros, nor shall it give rise to any right or obligation to either party, and any modification, alteration or failure to meet any of these intentions shall have no impact on this Agreement. | ||
6 | Payments | |
6.1 | Quarterly royalty and sublicense revenue payments shall be made in British Pounds Sterling by Omeros to Leicester within sixty (60) days of the end of the quarter. Payments shall be computed based on a conversion from any other denomination to British Pounds Sterling for any revenues received or costs and expenses incurred by Omeros during the relevant quarter or other reporting period, as provided herein, using the prevailing exchange rate in effect at the date and time that funds are transferred from Omeros account to Leicesters account (in the case of payment by wire transfer) or at the date and time of issuance of a check by Omeros (in the case of payment by check). Each quarterly payment shall be accompanied by a report specifying (a) the source of the royalties itemized by product and country, (b) any Omeros IP Legal Fees or Third Party License Fees that were deducted from gross proceeds to determine Net License Proceeds or Net Sublicense Proceeds as provided in Sections 1.10 or 1.11 of this Agreement, and (c) the total of all discounts, returns, credits and commissions deducted from gross proceeds to determine Net License Proceeds or Net Sublicense Proceeds as provided in Sections 1.10 or 1.11 of this Agreement. Following the two-year anniversary of the Effective Date of this Agreement, in the event that Omeros receives no such quarterly royalty and sublicense revenue in any given quarter, it shall nevertheless submit a quarterly report to that effect to Leicester within sixty (60) days of the end of the quarter. | |
6.2 | Leicester reserves the right to employ a certified public accountant to review and reconcile the directly relevant accounting records and procedures of Omeros as they relate to the determination of royalties or sublicense revenue fees under Section 5 herein during reasonable business hours and no more than twice a year, and Omeros agrees to make available at Omeros place of business all such directly relevant accounting records for that purpose within 30 (thirty) days of written request by Leicester. The cost of such review shall be borne by Leicester, unless it is found that Omeros under-paid a quarterly royalty or sublicense revenue fees for any quarter by an amount of 10% (ten percent) or greater, in which case the cost of such review shall be borne by Omeros. |
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6.3 | In the event any royalty or sublicense revenue fee payments due under Section 5 herein are not timely paid by Omeros, Omeros shall pay to Leicester interest charges on such late payments at a rate of [] per annum. | |
6.4 | Not withstanding anything to the contrary herein, Omeros shall have no obligation to pay any royalties or sublicense revenue fees under Section 5 for any product based on any patent claim that has been declared invalid or unenforceable by a court or governmental body of competent jurisdiction or based on any patent claim that is not enforceable in the jurisdiction(s) where such products are manufactured, used, sold, offered for sale, imported or distributed. | |
7 | License Progress | |
7.1 | Omeros shall on an annual basis, commencing on the one-year anniversary of the Effective Date of this Agreement and annually thereafter, deliver to Leicester within thirty (30) days after the end of the respective year a written progress report detailing the status of Omeros efforts to fund, patent, develop and commercialize Licensed Products and Licensed Research Products. | |
8 | Patent Prosecution | |
8.1 | Omeros shall have the sole right at its discretion to apply for, prosecute and maintain patents for inventions included within the Leicester IP and the Joint IP (Patent Filings) in the name of the legally appropriate inventors and/or parties to this agreement and/or jointly with third parties as may be legally appropriate, provided however that (a) Omeros shall bear all cost and expense for all such Patent Filings, subject to the right to deduct Omeros IP Legal Fees as set forth herein, (b) Omeros shall keep Leicester timely informed of the progress of all Patent Filings and timely provide Leicester copies of all official documentation related to such Patent Filings, (c) at Omeros discretion and until such time that Omeros provides a written request for transfer of responsibility, Leicester shall continue at Omeros cost with the prosecution of any patent applications for the Leicester IP it may have filed prior to the Effective Date of this Agreement, subject to consultation with and direction from Omeros prior to taking any substantive action, but in any event Omeros shall assume responsibility for prosecuting the patent application attached as Exhibit A hereto within two months following the later of the filing of such patent application by Leicester or the Effective Date of this Agreement, and (d) Omeros shall exert commercially reasonable efforts to diligently pursue all Patent Filings to issuance or final determination of unpatentability, provided however that if Omeros determines at its sole discretion to not make Patent Filings for any commercially significant inventions within the Leicester IP or the Joint IP in any countries of commercial significance, or abandons any Patent Filing prior to issuance or final determination of unpatentability, Omeros shall give Leicester advance written notice of such determination, Leicester shall have the right thereafter to elect upon written notice to Omeros to pursue such Omeros abandoned Patent Filings at Leicesters sole expense, |
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and such Omeros abandoned Patent Filings shall be excluded from the scope of the licenses granted under this Agreement. | ||
8.2 | Omeros shall reimburse Leicester for Leicesters reasonable documented legal fees and costs paid by Leicester for any patent applications prepared and/or filed or prosecuted by Leicester for inventions within the Leicester IP prior to the effective date of this Agreement or in accordance with Section 8.1 above. Payment for such reimbursed expenses shall be made within thirty (30) days of Omeros having received a receipt-documented invoice from Leicester, provided however that Leicester represents that all such legal fees and costs incurred by Leicester prior to the effective date of this Agreement shall not exceed [] . | |
8.3 | Leicester shall promptly provide written disclosure to Omeros of any inventions, improvements, or applications included within the Leicester IP or Joint IP conceived, developed, made or arising before or during the term of this Agreement. Leicester will provide all reasonable assistance, including review of documents and the execution of all documents and causing Leicesters employees to review and execute all documents, necessary to make, prosecute, maintain and enforce the Patent Filings, all for no additional consideration but with reimbursement by Omeros of Leicesters reasonable expenses for such assistance. | |
8.4 | Leicester shall promptly provide written disclosure to Omeros of any and all potentially material prior art known prior to the Effective Date of this Agreement or that becomes known during the License Term of this Agreement to any Leicester employee that is associated with this Agreement, the Sponsored Research, the Leicester IP or the Joint IP. |
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9 | Representations, Warranties and Other Obligations of Omeros | |
9.1 | Omeros represents and warrants that it has the requisite corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder. | |
9.2 | Omeros has and will maintain reasonably adequate insurance coverage for employment practices and general liability for all its activities under this Agreement. Prior to Omeros marketing of any Licensed Product, Licensed Research Products, or product encompassed by the Joint IP, or making any such products available for use in any human patients, Omeros will obtain and maintain reasonably adequate product liability insurance. | |
10 | Representations, Warranties and Other Obligations of Leicester | |
10.1 | Leicester has disclosed to Omeros the existence of the NatImmune Patent Applications and information as to the development of the Leicester IP, and Leicester warrants that it has made reasonable efforts to ascertain the details of such development and that it reasonably believes the same to be true. Leicester and Omeros [] Leicester is the lawful joint owner of certain invention(s) disclosed in the NatImmune Patent Applications and is lawfully entitled to establish joint ownership title in and to the NatImmune Patent Applications. Leicester acknowledges that the ability of Leicester to establish clear, defensible, uncontested and lawful title to Leicesters joint ownership rights in the NatImmune Patent Applications [] in the NatImmune Patent Applications is of material importance to Omeros, and any potential failure to obtain such title or rights to Omeros satisfaction will be grounds for Omeros, at Omeros sole discretion, to terminate this Agreement and its respective payment obligations under Section 5 herein, or to seek modification of this Agreement, any such modification (but not such termination) to be mutually agreed in accordance with Section 16.1. | |
10.2 | Leicester and Omeros agree to cooperate and assist each other in establishing Leicesters clear, defensible, uncontested and lawful title to Leicester's joint or sole ownership rights [] in the NatImmune Patent Applications and, except as provided expressly herein, neither party shall []. After the Effective Date of this Agreement and after Omeros has provided Leicester written confirmation that Omeros has made sufficient [] (and not prior to receipt of such written confirmation), Leicester shall []. At Omeros discretion, upon written notice to Leicester, Omeros shall have the right, at Omeros expense and following [] provided that Omeros will keep Leicester timely informed of [] in the NatImmune Patent Applications, [] consideration to any concerns or comments made by Leicester to Omeros, and except as expressly authorized herein will not undertake on behalf of Leicester [] and shall not, except to the extent expressly agreed in writing prior to doing so, make []. Omeros agrees that it will [] and not take any action or make any []. Leicester acknowledges that Omeros [] to achieve the objectives set forth herein are likely to be [] and making such [] shall not, of themselves, be considered [] nor shall the taking of any []. Neither party shall [] without the other partys written consent, which consent shall not be unreasonably withheld if such action is reasonably necessary to achieve the objectives of this Agreement; provided that Omeros shall at all times keep Leicester timely informed of all [] and Leicester shall be entitled to [] in connection with any such [] and Omeros shall give Leicester reasonable advance notice to the extent practical prior to []. Not withstanding anything to the contrary above within this Section 10.2 or elsewhere in this Agreement, Leicester acknowledges that Omeros is under no affirmative duty or obligation to [] and that Omeros shall have the absolute right and shall be free to, concurrent with or subsequent to delivery of Omeros written notice to Leicester of termination of this Agreement under Section 14.2 herein, take whatever actions are needed and enter into any agreements necessary to [] provided that Omeros shall give Leicester reasonable advance notice to the extent practical prior to []. | |
10.3 | Leicester and Omeros acknowledge that the []. [] this Agreement shall continue in force unless terminated in accordance with the provisions of Section 14.2 or 14.3 herein, [] or portions thereof shall be deemed to be excluded from the Leicester IP. | |
10.4 | Leicester represents and warrants, subject to the disclosure referred to in Section 10.1, that it is the owner of all right, title and interest in any and all inventions included within the Leicester IP and the Joint IP made or to be made wholly or jointly by Leicester employees, including without limitation those made by Dr. Schwaeble and Dr. Stover, and shall cause Dr. Schwaeble and Dr. Stover to each execute this Agreement to confirm their agreement to be bound to the same extent as Leicester with respect to all relevant provisions of this Agreement. | |
10.5 | Leicester represents and warrants that it is the owner of all right, title and interest in any and all inventions that were made wholly or jointly by Dr. Fujita that are included within the Leicester IP, has obtained an assignment from Dr. Fujita together with a release of all such rights from Fukushima, has provided to Omeros a true copy of such assignment and release, is under no restriction or obligation with respect to Dr. Fujita or Fukishima that is inconsistent in any way with Leicesters obligations under this Agreement, and that Omeros shall have no obligation to compensate Dr. Fujita or Fukushima as the result of Omeros exercise of its rights and fulfillment of its obligations under this Agreement. | |
10.6 | Subject to [] as discussed in Section 10.1 above, Leicester represents and warrants to Omeros that as far as it is aware, after having used reasonable efforts to ascertain relevant facts and having formed a reasonable belief as to their truth, it has the lawful right to grant the licenses conveyed under this Agreement, and that the Leicester IP and the Joint IP are unencumbered by any third party obligation, commitment, restriction or license. []. |
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10.7 | [], Leicester warrants that it is not aware of any third party rights that would be infringed as a result of Omeros fulfilling the terms of this Agreement. | |
10.8 | Leicester has and will maintain reasonably adequate insurance coverage for employment practices and general liability for all its activities under this Agreement. | |
10.9 | THE WARRANTIES SET FORTH EXPRESSLY IN THIS AGREEMENT ARE THE SOLE WARRANTIES MADE BY EITHER PARTY TO THE OTHER AND THERE ARE NO OTHER WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, REGARDING THE LICENSED PRODUCTS, THE LICENSED RESEARCH PRODUCTS , OR OTHER PRODUCTS, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. | |
11 | Confidentiality | |
11.1 | Leicester and Omeros hereby affirm and incorporate by reference the terms of the Mutual Nondisclosure Agreement between the parties dated September 23, 2003 concerning the subject matter of this Agreement, a copy of which is attached hereto as Exhibit C, except to the extent that the terms of such nondisclosure agreement may conflict with the terms of this Agreement, in which case the terms of this Agreement shall prevail. The parties further agree that the mutual obligations of nondisclosure and non-use set forth in such Mutual Nondisclosure Agreement shall subsist for a period of five (5) years after the termination of this Agreement. | |
11.2 | The terms of this Agreement shall be maintained in strict confidence by both Leicester and Omeros, and may not be disclosed by either party without the consent of the other party, except as may be required under a court order or decree or as required to comply with any governmental law, rule or regulation, and Omeros may disclose the terms of this Agreement to Omeros current and potential employees, directors, consultants, shareholders, investors and corporate partners. | |
12 | Indemnification | |
12.1 | Each party (the Indemnifying Party) shall indemnify, hold harmless and defend the other party and its employees, officers, directors, consultants and agents (the Indemnified Party) against any and all claims, suits, losses, liabilities, damages, costs, fees, and expenses (Claims) resulting from or arising directly out of the Indemnifying Partys breach of any representation, warranty or obligation under this Agreement, or the Indemnifying Partys exercise of the rights and obligations under this license or any sublicense, except that such obligation to indemnify, hold harmless and defend shall not extend to any Claims to the extent such Claims result from or arise directly from the negligence or misconduct of the Indemnified Party. This indemnification does not include any indemnity in relation to product performance or product liability, and furthermore does not include any incidental, consequential or special damages. |
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13 | Enforcement of Patent Rights | |
13.1 | If either party learns of the infringement of any patent or other intellectual property right included in the Leicester IP or the Joint IP, that party shall promptly notify the other party of such infringement and will provide the other party with all evidence of infringement in the notifying partys possession. Both parties shall use their best efforts in cooperation with each other to terminate third party infringement without litigation. | |
13.2 | Omeros shall have the sole right at its discretion to enforce the Leicester IP and the Joint IP against third party infringers, including the initiation of any civil action in Omeros name, at Omeros sole cost, in which event any award, judgment, settlement or damages collected shall belong solely to Omeros without duty to account to Leicester. In the event that it is necessary for Omeros to join Leicester as a party to any such civil action, Leicester shall join such action for no additional compensation but at Omeros sole expense, and any award, judgment, settlement or damages collected shall belong solely to Omeros without duty to account to Leicester. | |
13.3 | If Omeros unreasonably declines to initiate enforcement of the Leicester IP and the Joint IP against any third party infringer within ninety (90) days of a written demand from Leicester to do so, then Leicester shall have the sole right at its discretion to enforce the Leicester IP and the Joint IP against such third party infringer, including the initiation of any civil action in Leicesters name, at Leicesters sole cost, in which event any award, judgment, settlement or damages collected shall belong solely to Leicester without duty to account to Omeros. | |
14 | Term and Termination | |
14.1 | Unless terminated earlier as set forth in Section 14.2 or 14.3 herein below, this Agreement shall subsist so long as there is any pending patent application within the Leicester IP or the Joint IP, any patent application in the process of being prepared for filing as agreed to by Omeros and Leicester or any valid and subsisting claim included within any patent, utility model or inventors certificate within the Leicester IP or the Joint IP (the License Term). | |
14.2 | Omeros may terminate this Agreement by providing ninety (90)-days advance written notice of termination under this Section 14.2 to Leicester, with or without cause, at any time [] . | |
14.3 | Either party may terminate this Agreement at any time in the event that the other party (a) breaches any material obligation of this Agreement by first submitting written notice of breach to the breaching party, which breach is not substantially cured within ninety (90) days of the receipt of such notice, followed by written notice of termination then being sent to the breaching party, or (b) declares or is adjudged by a court of competent jurisdiction to be insolvent, bankrupt or in receivership, and such insolvency, bankruptcy or receivership materially limits such partys ability to perform its obligation under this Agreement, excluding reorganizations entered into by such party with the consent of the other party, which consent shall not be unreasonably withheld. |
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14.4 | Omeros may at any time terminate its sponsorship of the Sponsored Research by providing ninety (90)-days advance written notice of termination under this Section 14.4 to Leicester, with or without cause, at any time, in which event Sections 2.1 2.3 herein shall cease to be effective, and Sections 2.4 and 2.5 shall cease to be effective after all reports are provided and accepted and all payments are made for Sponsored Research performed in accordance with the applicable Research Plan prior to such notice, but the remainder of this Agreement shall continue in full force and effect for the License Term, including all rights and obligations of both parties hereunder. In the event of Omeros termination of its sponsorship of the Sponsored Research under this Section 14.4, Omeros shall pay to Leicester any and all non-cancelable sums reasonably incurred or committed to by Leicester prior to receipt of the notice of termination. | |
14.5 | The provisions of Sections 2.6 (Publication), 3 (Ownership of Intellectual Property), 4.2 - 4.6 (License as applicable to Joint IP and right of first refusal), 8 (Patent Prosecution as applicable to Joint IP), 9 and 10 (Representations and Warranties and Other Obligations), 11 (Confidentiality), 12 (Indemnification), 13 (Enforcement as applicable to Joint IP), 15 (Use of Names) and 16 (Miscellaneous) above shall survive expiration or termination of this Agreement for the period set forth therein or, if no period is set forth therein, then indefinitely. | |
15 | Use of Names | |
15.1 | Nothing contained in this Agreement confers any right to either party to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of the other party hereto, and neither party shall make such use without the prior written consent of the other party, provided however Omeros may through written, oral or electronic communication disclose the existence of this Agreement and the names of Leicester, Dr. Schwaeble, Dr. Stover, Dr. Fujita and other of Leicesters employees and consultants to Omeros current and potential employees, directors, consultants, shareholders, investors and corporate partners, and as required to comply with any governmental law, rule or regulation. | |
16 | Miscellaneous | |
16.1 | This Agreement including all appendices and exhibits attached thereto or incorporated by reference therein constitutes the entire understanding of the parties hereto regarding the subject matter of this Agreement, and no other representation, agreement, promise or undertaking altering, modifying, taking from or adding to the terms of this Agreement shall have any effect unless the same is reduced to writing and duly executed by the parties hereto. In the event of any conflict between the main body of this Agreement and any attachments thereto or documents incorporated by reference therein, the provisions of the main body of this Agreement shall control. | |
16.2 | Either partys failure to enforce any provision of this Agreement will not be considered a waiver of future enforcement of that or any other provision. |
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16.3 | The laws of the state of Delaware, United States, without regard to its conflict-of-laws provisions, shall govern this Agreement, its interpretation and its enforcement, and any disputes arising out of or related to this Agreement. | |
16.4 | The parties agree that, except as provided herein below, any claim or controversy arising out of or relating to this Agreement or breach thereof shall be settled by arbitration in the state of Delaware, United States, in accordance with the commercial rules of the American Arbitration Association by a panel of three arbitrators, one selected by each party and the third selected by the other two arbitrators. In any such arbitration proceeding, judgment upon the award rendered by the arbitrator shall be final and binding upon the parties and may be entered by either party in any court or forum of competent jurisdiction as provided herein below. Notwithstanding the foregoing, both parties agree that any claims or controversies concerning the validity or enforceability of any intellectual property, or the actual or threatened disclosure or misuse of confidential information, may alternately be resolved by a civil action in any court of competent jurisdiction as provided herein below, and both parties further agree that each shall retain the right to seek injunctive relief in any court of competent jurisdiction as provided herein below to prevent a breach, threatened breach or continuing breach of this Agreement which would cause irreparable injury (e.g., breaches of confidentiality or the like). | |
16.5 | Any civil action prosecuted or instituted by either party as permitted herein above with respect to any matters arising out of or related to this Agreement shall be brought in either the United States District Court located in the state of Delaware, United States (if federal subject matter jurisdiction therein lies) or the Superior Court for the state of Delaware, United States (if there is no subject matter jurisdiction in federal court), and each party hereby consents to the jurisdiction and venue of such courts for such purposes. | |
16.6 | In the event that it is necessary for either party of this Agreement to take legal action to enforce any of the terms, conditions or rights contained herein, or to defend any such action, then the prevailing party in such action shall be entitled to recover from the other party all reasonable attorneys fees, costs and expenses related to such legal action. | |
16.7 | In the event that any portion of this Agreement is held invalid or unenforceable by a court of law, that provision will be construed and reformed to permit enforcement of the provision to the maximum extent permissible consistent with the parties original intent, and if such construction is not possible, such provision shall be struck from this Agreement, and the remainder of the Agreement shall remain in full force and effect as if such provision had never been part of this Agreement. | |
16.8 | For the purposes of this Agreement, the parties hereto are independent contractors, and nothing in this Agreement shall be construed to place them in the relationship of partners, principal and agent, employer/employee or joint venturers. Except as provided expressly herein, each party agrees that it shall have no authority to bind or obligate the other party, nor shall any party hold itself out as having such authority. |
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16.9 | Neither party will be liable for failure or delay in performing any obligation under this Agreement, or will be considered in breach of this Agreement, if such failure or delay is due to a natural disaster or any cause reasonably beyond such partys control, provided that such party resumes performance as soon as possible following the end of the event that caused such delay or failure of performance. | |
16.10 | Neither party may assign this Agreement, or any obligation or right under this Agreement, in whole or in part, without the other partys prior written consent, which consent will not be unreasonably withheld. This Section shall not be construed in any way to limit Omeros rights to grant, at Omeros sole discretion, sublicenses hereunder. Leicester consents to Omeros assignment of this Agreement in whole or in part in connection with the merger, consolidation or transfer of all or substantially all of that portion of Omeros assets to which this Agreement relates. Subject to these restrictions, this Agreement will be binding upon and will inure to the benefit of the parties permitted successors and assignees. | |
16.11 | Any notice required or permitted to be given hereunder by either party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by an internationally recognized courier service guaranteeing next-day delivery, charges prepaid, or (d) delivered by facsimile (with the original promptly sent by any of the foregoing manners) to the addresses or facsimile numbers of the other party set forth below, or at such other addresses as may from time to time be furnished by similar notice by either party. The effective date of any notice hereunder shall be the date of receipt by the receiving party. |
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If to Omeros: | If to Leicester: | ||
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Omeros Corporation | University of Leicester | ||
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1420 Fifth Avenue, Suite 2600 | University Road | ||
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Seattle, WA 98101 | Leicester, LE1 7RH | ||
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U.S.A. | United Kingdom |
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Attention: | Gregory A. Demopulos, M.D., | Attention: Research and | |||
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Chairman & CEO | Business Development Office | ||||
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And copy to: | Marcia S. Kelbon, | ||||
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Patent & General Counsel |
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Fax: (206) 264.7856 | Fax: +44 (0) 116.252.2028 | ||
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Phone: (206) 623.4688 | Phone: +44 (0) 116.252.2347 |
16.12 | This Agreement may be executed in one or more counterparts, each of which will be considered an original, and all of which will constitute the same instrument. |
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OMEROS CORPORATION | UNIVERSITY OF LEICESTER | |||||||
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By:
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/s/ Gregory A. Demopulos
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By: |
/s/ Clare ONeill
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Name:
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Gregory A. Demopulos, M.D. | Name: |
Clare ONeill
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Title:
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Chairman & CEO | Title: |
Business Development Manager
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Date:
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7/6/04
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Date: |
10
th
June 2004
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Fax:
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206.264.7856 | Fax: |
0044 116 252 2028
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1 | Definitions | |
1.1 | Reference to MRC and Omeros in regards to any intellectual property right developed by the respective party shall be construed to refer to the respective party as well as the respective partys employees, officers, directors, consultants and agents. | |
1.2 | Intellectual Property Rights shall mean all inventions, ideas, discoveries, issued, reissued or reexamined patents, pending and future patent applications, continuation, continuation-in-part and divisional patent applications, utility models, inventors certificates, trade secrets, know-how, copyrights and trademarks. | |
1.3 | Sponsored Research shall mean all research activities carried out by MRC and/or its employees (as may be agreed by MRC and Omeros) with the financial sponsorship, in whole or in part, by Omeros in accordance with Section 2 herein below or as otherwise agreed. |
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1.4 | MRC IP shall mean all Intellectual Property Rights owned or held by MRC, including without limitation all such Intellectual Property Rights arising from the work of Mr. Willis, Dr. Reid and/or other MRC employees, prior to the Effective Date of this Agreement, or developed or obtained by MRC after the Effective Date of this Agreement both (a) independently of Omeros (as determined by inventorship under US law with respect to any patents and patent applications) and (b) independently of the Sponsored Research, provided always that any of the Intellectual Property Rights described above in this section 1.4 are directly related to compositions, antibodies and/or methods for the inhibition of MASP-2 and/or the diagnosis and/or treatment of MASP-2 mediated disorders and/or deficiency syndromes, as well as methods, polynucleotides, polypeptides, sequences and tools related to the development and production of MASP-2 antibodies, including without limitation murine, human, humanized and recombinant antibodies, MASP-2 inhibitors, []. | |
1.5 | Omeros IP shall mean all Intellectual Property Rights owned or held by Omeros prior to the Effective Date of this Agreement, or developed or obtained by Omeros after the Effective Date of this Agreement independently of MRC (as determined by inventorship under US law with respect to any patents and patent applications), including without limitation all such Intellectual Property Rights (a) related to MASP-2 obtained by Omeros under license from Leicester (including without limitation all MASP-2 and MAp19 rights conveyed under the Omeros-Leicester Agreement of 10 June 2004) or developed by Omeros independently of MRC by Omeros and (b) related to methods and pharmaceuticals or other agents to inhibit pain, inflammation, cartilage loss, vasospasm, smooth muscle spasm, restenosis, or tumor cell adhesion, and/or to accelerate recovery of joint motion and function, for use in surgical procedures (including without limitation arthroscopic, cardiovascular, urologic and general surgical procedures), other medical procedures, and/or for treatment of cartilaginous disorders, and drug delivery methods and systems. | |
1.6 | Joint IP shall mean (a) all Intellectual Property Rights in technology that is developed jointly (as determined by inventorship with respect to any patents and patent applications) by Omeros and MRC (as may be agreed by MRC and Omeros) during the Sponsored Research Term (as that term is defined in Section 2.2 herein), and (b) all Intellectual Property Rights arising from and as the direct result of the Sponsored Research. Joint IP may or may not also be jointly developed with Leicester or other third party, which will not change the nature of the Intellectual Property Rights as Joint IP so long as the first sentence of this Section applies. Should any MRC employee enter into a consulting agreement with Omeros for general scientific consulting such as in the field of inflammation, then to the extent that such scientific consulting services may pertain to MASP-2, the results of such scientific consulting services will be treated as part of the Joint IP. However, the parties acknowledge herein that research by MRC employees on behalf of Omeros related to MASP-2 will be carried out in major part through the Sponsored Research. |
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1.7 | [] | |
1.8 | Licensed Products shall mean all antibodies, inhibitors and all other products that, were it not for the license granted to Omeros under this Agreement, infringe, or the use, manufacture, offer for sale or sale of which infringe any valid and subsisting claim(s) of any issued patent or any patentable claim(s) of any pending patent application included within the MRC IP in the country or countries in which such products are offered for sale, sold, manufactured or used, excluding all products that would be included within the Licensed Products in accordance with the above definition only because they are products that []. | |
1.9 | Net License Proceeds shall mean the total of the gross monetary amounts invoiced and collected by Omeros for Licensed Products (or that portion of the value of any combination product attributed to a Licensed Product included therein) used, manufactured, directly sold or directly distributed by Omeros, less (a) the sum of the following actual and customary deductions where applicable: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes, and any other governmental taxes imposed on particular sales; transportation charges and allowances; commissions to third party sales agents; and credits to customers because of rejections or returns and (b) any accrued Omeros IP Legal Fees (as defined below) not previously deducted. For purposes of this paragraph, the acquisition of Licensed Products from Omeros as part of an acquisition of all or a substantial part of the assets of Omeros business to which this Agreement pertains shall not be considered a manufacture, sale or distribution. | |
1.10 | Net Sublicense Proceeds shall mean the total of all sublicense royalties or sublicense fees received by Omeros from third parties to which Omeros grants a sublicense under the MRC IP for the manufacture, sale or distribution of Licensed Products, and which were not included in the Net License Proceeds, less any accrued Omeros IP Legal Fees not previously deducted, provided however that the Net Sublicense Proceeds shall not include any fees or payments from such third parties to Omeros to support research and development efforts, to purchase equity in Omeros, or for any other purpose other than as compensation for sublicense rights. | |
1.11 | Omeros IP Legal Fees shall mean the sum of all legal fees and costs incurred by Omeros to (a) evaluate, apply for, prosecute and maintain any Intellectual Property Rights included within the MRC IP, including without limitation any such fees and costs paid by Omeros as reimbursement to MRC for such fees and costs incurred by MRC, and (b) obtain or assist MRC in obtaining or attempting to obtain clear, defensible, lawful and uncontested title to the MRC IP, including without limitation all such fees and costs incurred in []. | |
1.12 | Third Party License Fees shall mean all royalties or other fees paid by Omeros to third parties for a license from such third parties under Intellectual Property Rights owned or held by such third parties for the manufacture, use, offer for sale, sale or distribution of Licensed Products, but shall exclude that portion of any such third party royalties |
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2 | Sponsored Research | |
2.1 | MRC shall perform research to be conducted by or under the direction of Dr. Reid and another MRC senior research investigator (the MRC Co-investigator) working under the direction of Dr. Reid as may be agreed between MRC and Omeros (Dr. Reid and the MRC Co-investigator collectively MRC Investigators), directed to advancing the technology included in the MRC IP or related technology concerning the characterization and inhibition of MASP-2, supported by the financial sponsorship of Omeros, and without the use of third party sponsorship that would provide any intellectual property rights in the results of the Sponsored Research to such third party, in accordance with one or more research plans (Research Plans) agreed to in advance in writing between MRC and Omeros. An initial Research Plan is attached hereto as Exhibit A. The Research Plans may involve collaborative research efforts by Omeros, MRC and/or Leicester as may be agreed between MRC and Omeros. No Research Plan or any amendment thereto shall be effective until executed by MRC and Omeros, and upon mutual execution shall be automatically incorporated into this Agreement. Each Research Plan shall define scientific aims, objectives and activities, a budget and a timeline for performance of Sponsored Research during the corresponding time period. | |
2.2 | The Sponsored Research shall be completed over a term (the Sponsored Research Term) of thirty four months (34 months) commencing 1 November 2005 or as may otherwise be mutually agreed in writing. If Omeros or MRC wishes to terminate the Sponsored Research Term early, such party shall provide the other party notice of non-extension at least ninety (90) days prior to the end of any given year of the Sponsored Research term, i.e., by 3 August of such year. In the event of a breach of this Agreement by MRC during the Sponsored Research Term, Omeros may terminate the Sponsored Research Term as provided in accordance with Section 14.4 below at its sole discretion, without penalty. If Omeros should terminate the Sponsored Research Term as provided in accordance with Section 14.4 below for any other reason before completion of the full Sponsored Research Term, or upon completion of the full Sponsored Research Term, Omeros will reimburse MRC for any legally required severance payable to the MRC Co-investigator due solely to the termination or conclusion of the Sponsored Research, not to exceed [], provided, however that MRC will utilize its best efforts to minimize or avoid the need for any such payment, including without limitation efforts to find other support for the MRC Co-investigator, and provided further that MRC shall provide Omeros with documentation of the legal requirement for and amount of any such severance. The Sponsored Research Term shall run independently of the License Term (as defined herein below) of this Agreement. Termination of this Agreement shall result in termination of the Sponsored Research Term, but termination of the Sponsored Research Term, such as in accordance with this Section 2.2 or Section 14.4 herein, shall not affect the overall status of this Agreement or the License Term. |
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2.3 | MRC shall supply all necessary personnel, administrative management, facilities, equipment and supplies to enable timely completion of the Sponsored Research, including both of the MRC Investigators, for the duration of the Sponsored Research Term. Reimbursement for MRCs costs and expenses for the Sponsored Research shall be provided only to the extent agreed to in writing in the applicable Research Plan. Each Research Plan will be completed diligently by MRC using best efforts in accordance with prevailing professional standards and all applicable laws, regulations and MRCs official policies. Should the MRC Investigators become unavailable to complete any Research Plan, MRC and Omeros may agree on a substitute investigator, and in the event that a mutually acceptable substitute is not available, either party may terminate the Sponsored Research Term. | |
2.4 | Within thirty (30) days of the end of each quarter of the Sponsored Research Term, MRC shall submit a status report in written and electronic form (Status Report) summarizing the results of the research completed during that quarter, except that annually within thirty (30) days of the end of each year of the Sponsored Research Term or at such other point in time as may be mutually agreed in writing, MRC shall submit a final status report in written and electronic form (Final Report) detailing the results of the research completed during such year of the Sponsored Research Term. Upon Omeros request, MRC shall complete all requested corrections and make reasonable revisions to each Status Report and/or Final Report to place it into a form suitable to meet Omeros objectives, including potential use of any Status Report and/or any Final Report as part of any regulatory submissions. | |
2.5 | In full and complete consideration for the Sponsored Research completed by MRC during the Sponsored Research Term in accordance with the Research Plan(s), Omeros shall pay MRC a total of [] over the Sponsored Research Term in accordance with the annual schedule set forth in Exhibit A, unless the Sponsored Research Terms is terminated earlier in accordance with the provisions of this Section 2, in which case no further scheduled payments shall be payable, or unless a change in the level of Sponsored Research work is agreed to in writing in subsequent Research Plans, and subject to the following potential adjustment based on the British national pay scale. The salary portion of the compensation amount payable during each year includes a projected increase for changes in the British national standard pay scale, and shall be adjusted up or down annually to reflect actual changes in the British national standard pay scale. Compensation for each year of the Sponsored Research Term shall be payable at the rate of twenty five percent (25%) of the annual amount per quarter, with a first quarterly payment due and payable upon the start of the year, second and third quarterly payments due and payable four and eight months, respectively, from the start of the year, and a fourth quarterly payment due and payable upon the later of the end of the year or acceptance of a Final Report for such year; provided, however, that no payment shall be due for any quarter prior to the receipt and acceptance by Omeros of a Status Report or any Final Report, as appropriate, for the respective quarter or year. All undisputed payments that have become due and payable shall be paid within thirty (30) days of receipt of an invoice from MRC. |
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2.6 | Omeros and the MRC Investigators shall collaborate on any proposed scientific publications of Sponsored Research data and results, including a discussion of authorship and contents. MRC shall furnish Omeros with copies of any publication or written or oral disclosure that is proposed by MRC, including, without limitation, disclosures in papers or abstracts or at research seminars, lectures, professional meetings, or poster sessions, at least sixty (60) days prior to the proposed date for submission for publication or disclosure. During such 60-day period, Omeros shall have the right to review and comment on such publication for accuracy and protection of confidential information. Additionally, upon Omeros written request during the foregoing 60-day period, the proposed submission for publication or disclosure shall be delayed until Omeros has completed the filing of patent applications directed to information contained in such proposed publication or disclosure or based on Omeros reasonable determination that publication should be delayed due to other business considerations, but in no event will such delay exceed an additional ninety (90) days following the initial 60-day period without MRCs written consent, which consent shall not be unreasonably withheld. Omeros shall have the right, in its sole discretion, to use, disclose, disseminate and publish (with due acknowledgement of authorship) all data and results arising out of the Sponsored Research for any and all purposes, including without limitation in and for submissions to any regulatory agencies and in marketing any products including, but not limited to, Licensed Products. | |
3 | Ownership of Intellectual Property | |
3.1 | All MRC IP shall remain owned or held by MRC to the same extent as would be the case were it not for this Agreement. | |
3.2 | All Omeros IP shall remain owned or held by Omeros to the same extent as would be the case were it not for this Agreement. | |
3.3 | All Joint IP shall be jointly owned by Omeros and MRC, i.e., Omeros and MRC each shall hold a 50% undivided joint ownership interest in all Joint IP, provided however that Omeros and MRC recognize that third party collaborators such as Leicester may also have an ownership interest in intellectual property included in the Joint IP, which third party ownership interest shall not be impacted or determined by this Agreement. | |
4 | Grant Of License | |
4.1 | MRC hereby grants to Omeros for the term of this Agreement a royalty-bearing, world-wide exclusive license in the MRC IP for the research, development, manufacture, use, sale, offering for sale, distribution, exportation and importation of any and all products and the practice of all methods within the MRC IP, including without limitation the exclusive right to develop, manufacture, use, sell, offer for sale, distribute, export and import the Licensed Products for all purposes including without limitation the research, development and production of antibody or other MASP-2 inhibitor products . | |
4.2 | MRC hereby grants to Omeros a fully paid-up, irrevocable, world-wide exclusive license in and to MRCs joint ownership interest in the Joint IP, for the manufacture, use, sale, |
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4.3 | Subject to publication approval and timing procedures consistent with Section 2.6 herein, MRC shall retain the right to use the MRC IP and the Joint IP for the purpose of conducting non-commercial, academic research, including research sponsored by not-for-profit entities, which shall not include the performance of research sponsored (directly or indirectly) by or on behalf of any for-profit entity that is in direct competition with Omeros in a technology, product or research tool that is the subject of the MRC IP or Joint IP. | |
4.4 | Omeros shall have the right to grant sublicenses in the MRC IP and the Joint IP under this Agreement subject, with respect to the MRC IP, to Omeros obligations to share sublicense revenues as set forth in Section 5. | |
4.5 | As part of the licenses granted to Omeros under Sections 4.1 and 4.2, MRC agrees to transfer and provide and/or make available to Omeros upon request biological materials and any other research materials and know-how encompassed by or included within the MRC IP and/or the Joint IP to which MRC has appropriate rights and access, all such materials being provided on the basis of Omeros reimbursing MRC for MRCs actual cost in providing such materials but for no additional consideration. | |
4.6 | MRC also grants to Omeros a right of first refusal for an exclusive license in all of MRCs Intellectual Property Rights, for which Omeros has not already been granted a license hereunder, and for which MRC has all necessary rights to offer such first refusal, and MRC shall exert reasonable efforts to obtain such necessary rights, in (1) any commercially applicable technology that arises during the Term of this Agreement and is directly related to MASP-2 as more fully defined in the MRC IP and the Joint IP, and (2) any technology that has been developed through the contribution of both Omeros and MRC after the Sponsored Research Term. | |
5 | Royalties and Sublicense Revenue | |
5.1 | Omeros shall pay MRC on a quarterly basis a royalty for Licensed Products of [] of that portion of the Net License Proceeds realized during each respective quarter from Licensed Products (the Licensed Product Royalty). Not withstanding the above, if the total royalties owed by Omeros to all parties for Licensed Products, including without limitation the Licensed Product Royalty payable to MRC, royalties payable to Leicester, [] and any stacking fee(s) or other royalties payable to third parties to develop, manufacture or commercialize the Licensed Products (all together the Total Royalty Percentage), exceeds [] of the Net Licensed Proceeds for any quarter, then [] of the difference between the Total Royalty Percentage and [] shall be deducted from the Licensed Product Royalty payable to MRC for such quarter, provided, however that the Licensed Product Royalty for such quarter may not be reduced by such deductions to less than []. | |
5.2 | Omeros shall pay MRC on a quarterly basis a share of that portion of the Net Sublicense |
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5.3 | Omeros shall promptly provide MRC with a copy of all sublicenses granted by Omeros in the MRC IP and/or the Joint IP under this Agreement. | |
5.4 | Following receipt from the University of the results of all Sponsored Research and the completion of all other necessary and beneficial research activities by Omeros and/or by others to support appropriate government regulatory submissions by Omeros, [] Omeros shall use reasonable efforts, based on reasonable commercial prudence, to diligently develop and introduce to the market one or more Licensed Products. Ongoing performance of research and/or development efforts to generate or further advance one or more Licensed Products by Omeros, internally at Omeros and/or under contract with MRC and/or a third party, shall be deemed to be diligent efforts under this Section 5.4. | |
5.5 | It is Omeros current intent to commercially develop and seek regulatory clearance to clinically test and then market an inhibitor of MASP-2 activity following identification of selective and high-affinity inhibitors of MASP-2 activity and demonstration of the therapeutic benefit of such inhibitors in animal models, such identification and demonstration to be completed collaboratively by MRC, Leicester and/or Omeros. Within three months of the identification by Omeros of a Licensed Product that is determined by Omeros to be a viable and optimal clinical development candidate, Omeros will submit a development plan to MRC that sets forth Omeros planned activities and estimated timing for the development, regulatory approval and market introduction of one or more Licensed Products. Assuming anticipated and adequate progress is made in the Sponsored Research [], Omeros anticipates the identification of an initial potential candidate for a Licensed Product or Licensed Research Product that is a potential clinical development candidate within two years of the commencement of the Sponsored Research. The foregoing statements within this Section 5.5 and such development plan are or will be provided as indications of current or future intentions only, and shall have no binding effect on Omeros, nor shall it give rise to any right or obligation to either party, and any modification, alteration or failure to meet any of these intentions shall have no impact on this Agreement. | |
6 | Payments | |
6.1 | Quarterly royalty and sublicense revenue payments shall be made in British Pounds Sterling by Omeros to MRC within sixty (60) days of the end of the quarter. Payments shall be computed based on a conversion from any other denomination to British Pounds Sterling for any revenues received or costs and expenses incurred by Omeros during the |
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6.2 | MRC reserves the right to employ a certified public accountant to review and reconcile the directly relevant accounting records and procedures of Omeros as they relate to the determination of royalties or sublicense revenue fees under Section 5 herein during reasonable business hours and no more than twice a year, and Omeros agrees to make available at Omeros place of business all such directly relevant accounting records for that purpose within 30 (thirty) days of written request by MRC. The cost of such review shall be borne by MRC, unless it is found that Omeros under-paid a quarterly royalty or sublicense revenue fees for any quarter by an amount of 10% (ten percent) or greater, in which case the cost of such review shall be borne by Omeros. | |
6.3 | In the event any royalty or sublicense revenue fee payments due under Section 5 herein are not timely paid by Omeros, Omeros shall pay to MRC interest charges on such late payments at a rate of [] per annum. | |
6.4 | Not withstanding anything to the contrary herein, Omeros shall have no obligation to pay any royalties or sublicense revenue fees under Section 5 for any product based on any patent claim that has been declared invalid or unenforceable by a court or governmental body of competent jurisdiction or based on any patent claim that is not enforceable in the jurisdiction(s) where such products are manufactured, used, sold, offered for sale, imported or distributed. | |
7 | License Progress | |
7.1 | Omeros shall on an annual basis, commencing on the one-year anniversary of the Effective Date of this Agreement and annually thereafter, deliver to MRC within thirty (30) days after the end of the respective year a written progress report detailing the status of Omeros efforts to fund, patent, develop and commercialize Licensed Products. | |
8 | Patent Prosecution | |
8.1 | Omeros shall have the sole right at its discretion to apply for, prosecute and maintain patents for inventions included within the MRC IP and the Joint IP (Patent Filings) in |
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8.2 | MRC shall promptly provide written disclosure to Omeros of any inventions, improvements, or applications included within the MRC IP or Joint IP conceived, developed, made or arising before or during the term of this Agreement. MRC will provide all reasonable assistance, including review of documents and the execution of all documents and causing MRCs employees to review and execute all documents, necessary to make, prosecute, maintain and enforce the Patent Filings, all for no additional consideration but with reimbursement by Omeros of MRCs reasonable expenses for such assistance. | |
8.3 | MRC shall promptly provide written disclosure to Omeros of any and all potentially material prior art known prior to the Effective Date of this Agreement or that becomes known during the License Term of this Agreement to any MRC employee that is associated with this Agreement, the Sponsored Research, the MRC IP or the Joint IP. | |
9 | Representations, Warranties and Other Obligations of Omeros | |
9.1 | Omeros represents and warrants that it has the requisite corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder. | |
9.2 | Omeros has and will maintain reasonably adequate insurance coverage for employment practices and general liability for all its activities under this Agreement. Prior to Omeros marketing of any Licensed Product, or product encompassed by the Joint IP, or making any such products available for use in any human patients, Omeros will obtain and maintain reasonably adequate product liability insurance. | |
10 | Representations, Warranties and Other Obligations of MRC | |
10.1 | MRC has disclosed to Omeros the existence of the NatImmune Patent Applications and information as to the development of the MRC IP, and MRC warrants that it has made reasonable efforts to ascertain the details of such development and that it reasonably believes the same to be true. MRC and Omeros [] MRC is the lawful joint owner of certain invention(s) disclosed in the NatImmune Patent Applications and is lawfully entitled to establish joint ownership title in and to the NatImmune Patent Applications. MRC acknowledges that the ability of MRC to establish clear, defensible, uncontested and lawful title to MRCs joint ownership rights in the NatImmune Patent Applications [] in the NatImmune Patent Applications is of material importance to Omeros, and any potential failure to obtain such title or rights to Omeros satisfaction will be grounds for Omeros, at Omeros sole discretion, to terminate this Agreement and its respective payment obligations under Section 5 herein, or to seek modification of this Agreement, any such modification (but not such termination) to be mutually agreed in accordance with Section 16.1. |
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10.2 | MRC and Omeros agree to cooperate and assist each other in establishing MRCs clear, defensible, uncontested and lawful title to MRC's joint or sole ownership rights [] in the NatImmune Patent Applications and, except as provided expressly herein, neither party shall []. After the Effective Date of this Agreement and following the establishment of a [], Omeros shall [], at Omeros discretion and expense and following [], provided that Omeros will keep MRC timely informed of [] in the NatImmune Patent Applications, [] consideration to any concerns or comments made by MRC to Omeros, and except as expressly authorized herein will not undertake on behalf of MRC [], and shall not, except to the extent expressly agreed in writing prior to doing so, make []. Omeros agrees that it will [], and not take any action or make any []. MRC acknowledges that Omeros [] to achieve the objectives set forth herein are likely to be [], and making such [] shall not, of themselves, be considered [], nor shall the taking of any []. Neither party shall [] without the other partys written consent, which consent shall not be unreasonably withheld if such action is reasonably necessary to achieve the objectives of this Agreement; provided that Omeros shall at all times keep MRC timely informed of all [], and MRC shall be entitled to [] in connection with any such [], and Omeros shall give MRC reasonable advance notice to the extent practical prior to []. Not withstanding anything to the contrary above within this Section 10.2 or elsewhere in this Agreement, MRC acknowledges that Omeros is under no affirmative duty or obligation to [], and that Omeros shall have the absolute right and shall be free to, concurrent with or subsequent to delivery of Omeros written notice to MRC of termination of this Agreement under Section 14.2 herein, take whatever actions are needed and enter into any agreements necessary to []; provided that Omeros shall give MRC reasonable advance notice to the extent practical prior to []. | |
10.3 | MRC and Omeros acknowledge that the []. [], this Agreement shall continue in force unless terminated in accordance with the provisions of Section 14.2 or 14.3 herein, [] or portions thereof shall be deemed to be excluded from the MRC IP. | |
10.4 | MRC represents and warrants, subject to the disclosure referred to in Section 10.1 with respect [] and to any rights owned by Leicester, that MRC is the owner of all other right, title and interest in any and all inventions included within the MRC IP and the Joint IP made or to be made wholly or jointly by MRC employees, including without limitation those made by Mr. Willis and Dr. Reid, and shall cause Mr. Willis and Dr. Reid to each execute this Agreement to confirm their agreement to be bound to the same extent as MRC with respect to all relevant provisions of this Agreement. | |
10.5 | Subject to [] as discussed in Section 10.1 above and to any rights owned by Leicester, MRC represents and warrants to Omeros that as far as it is aware, after having used reasonable efforts to ascertain relevant facts and having formed a reasonable belief as to their truth, it has the lawful right to grant the licenses conveyed under this Agreement, and that the MRC IP and the Joint IP are unencumbered by any third party obligation, commitment, restriction or license. [] | |
10.6 | [] and any rights owned by Leicester, MRC warrants that it is not aware of any third party rights that would be infringed as a result of Omeros fulfilling the terms of this Agreement. | |
10.7 | MRC has and will maintain reasonably adequate insurance coverage for employment practices and general liability for all its activities under this Agreement. | |
10.8 | THE WARRANTIES SET FORTH EXPRESSLY IN THIS AGREEMENT ARE THE SOLE WARRANTIES MADE BY EITHER PARTY TO THE OTHER AND THERE ARE NO OTHER WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, REGARDING THE LICENSED PRODUCTS, OR OTHER PRODUCTS, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. | |
11 | Confidentiality | |
11.1 | MRC and Omeros hereby affirm and incorporate by reference the terms of the Mutual Nondisclosure Agreement between the parties dated 9 May 2005 concerning the subject matter of this Agreement, a copy of which is attached hereto as Exhibit B, except to the extent that the terms of such nondisclosure agreement may conflict with the terms of this Agreement, in which case the terms of this Agreement shall prevail. The parties further agree that the mutual obligations of nondisclosure and non-use set forth in such Mutual Nondisclosure Agreement shall subsist for a period of five (5) years after the termination of this Agreement. |
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11.2 | The terms of this Agreement shall be maintained in strict confidence by both MRC and Omeros, and may not be disclosed by either party without the consent of the other party, except as may be required under a court order or decree or as required to comply with any governmental law, rule or regulation, and Omeros may disclose the terms of this Agreement to Omeros current and potential employees, directors, consultants, shareholders, investors and corporate partners. | |
12 | Indemnification | |
12.1 | Each party (the Indemnifying Party) shall indemnify, hold harmless and defend the other party and its employees, officers, directors, consultants and agents (the Indemnified Party) against any and all claims, suits, losses, liabilities, damages, costs, fees, and expenses (Claims) resulting from or arising directly out of the Indemnifying Partys breach of any representation, warranty or obligation under this Agreement, or the Indemnifying Partys exercise of the rights and obligations under this license or any sublicense, except that such obligation to indemnify, hold harmless and defend shall not extend to any Claims to the extent such Claims result from or arise directly from the negligence or misconduct of the Indemnified Party. This indemnification does not include any indemnity in relation to product performance or product liability, and furthermore does not include any incidental, consequential or special damages. | |
13 | Enforcement of Patent Rights | |
13.1 | If either party learns of the infringement of any patent or other intellectual property right included in the MRC IP or the Joint IP, that party shall promptly notify the other party of such infringement and will provide the other party with all evidence of infringement in the notifying partys possession. Both parties shall use their best efforts in cooperation with each other to terminate third party infringement without litigation. | |
13.2 | Omeros shall have the sole right at its discretion to enforce the MRC IP and the Joint IP against third party infringers, including the initiation of any civil action in Omeros name, at Omeros sole cost, in which event any award, judgment, settlement or damages collected shall belong solely to Omeros without duty to account to MRC. In the event that it is necessary for Omeros to join MRC as a party to any such civil action, MRC shall join such action for no additional compensation but at Omeros sole expense, and any award, judgment, settlement or damages collected shall belong solely to Omeros without duty to account to MRC. | |
13.3 | If Omeros unreasonably declines to initiate enforcement of the MRC IP and the Joint IP against any third party infringer within ninety (90) days of a written demand from MRC to do so, then MRC shall have the sole right at its discretion to enforce the MRC IP and the Joint IP against such third party infringer, including the initiation of any civil action in MRCs name, at MRCs sole cost, in which event any award, judgment, settlement or damages collected shall belong solely to MRC without duty to account to Omeros. | |
14 | Term and Termination |
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14.1 | Unless terminated earlier as set forth in Section 14.2 or 14.3 herein below, this Agreement shall subsist so long as there is any pending patent application within the MRC IP or the Joint IP, any patent application in the process of being prepared for filing as agreed to by Omeros and MRC or any valid and subsisting claim included within any patent, utility model or inventors certificate within the MRC IP or the Joint IP (the License Term). | |
14.2 | Omeros may terminate this Agreement by providing ninety (90) days advance written notice of termination under this Section 14.2 to MRC, with or without cause, at any time []. | |
14.3 | Either party may terminate this Agreement at any time in the event that the other party (a) breaches any material obligation of this Agreement by first submitting written notice of breach to the breaching party, which breach is not substantially cured within ninety (90) days of the receipt of such notice, followed by written notice of termination then being sent to the breaching party, or (b) declares or is adjudged by a court of competent jurisdiction to be insolvent, bankrupt or in receivership, and such insolvency, bankruptcy or receivership materially limits such partys ability to perform its obligation under this Agreement, excluding reorganizations entered into by such party with the consent of the other party, which consent shall not be unreasonably withheld. | |
14.4 | Omeros may at any time terminate its sponsorship of the Sponsored Research by providing ninety (90) days advance written notice of termination under this Section 14.4 to MRC, for cause as specified in Section 2.2 above or at any time due to failure to perform any Research Plan or other breach of this Agreement by MRC, or without cause as specified in, and subject to reimbursement of any severance fees that may be payable in accordance with, Section 2.2 above, in which event Sections 2.1 2.3 herein shall cease to be effective, and Sections 2.4 and 2.5 shall cease to be effective after all reports are provided and accepted and all payments are made for Sponsored Research performed in accordance with the applicable Research Plan prior to such notice, but the remainder of this Agreement shall continue in full force and effect for the License Term, including all rights and obligations of both parties hereunder. In the event of Omeros termination of its sponsorship of the Sponsored Research, Omeros shall pay to MRC any and all non-cancelable sums reasonably incurred or committed to by MRC prior to receipt of the notice of termination. | |
14.5 | The provisions of Sections 2.6 (Publication), 3 (Ownership of Intellectual Property), 4.2 4.6 (License as applicable to Joint IP and right of first refusal), 8 (Patent Prosecution as applicable to Joint IP), 9 and 10 (Representations and Warranties and Other Obligations), 11 (Confidentiality), 12 (Indemnification), 13 (Enforcement as applicable to Joint IP), 15 (Use of Names) and 16 (Miscellaneous) above shall survive expiration or termination of this Agreement for the period set forth therein or, if no period is set forth therein, then indefinitely. | |
15 | Use of Names | |
15.1 | Nothing contained in this Agreement confers any right to either party to use in |
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16 | Miscellaneous | |
16.1 | This Agreement including all appendices and exhibits attached thereto or incorporated by reference therein constitutes the entire understanding of the parties hereto regarding the subject matter of this Agreement, and no other representation, agreement, promise or undertaking altering, modifying, taking from or adding to the terms of this Agreement shall have any effect unless the same is reduced to writing and duly executed by the parties hereto. In the event of any conflict between the main body of this Agreement and any attachments thereto or documents incorporated by reference therein, the provisions of the main body of this Agreement shall control. | |
16.2 | Either partys failure to enforce any provision of this Agreement will not be considered a waiver of future enforcement of that or any other provision. | |
16.3 | The laws of the state of Delaware, United States, without regard to its conflict-of-laws provisions, shall govern this Agreement, its interpretation and its enforcement, and any disputes arising out of or related to this Agreement. | |
16.4 | The parties agree that, except as provided herein below, any claim or controversy arising out of or relating to this Agreement or breach thereof shall be settled by arbitration in the state of Delaware, United States, in accordance with the commercial rules of the American Arbitration Association by a panel of three arbitrators, one selected by each party and the third selected by the other two arbitrators. In any such arbitration proceeding, judgment upon the award rendered by the arbitrator shall be final and binding upon the parties and may be entered by either party in any court or forum of competent jurisdiction as provided herein below. Notwithstanding the foregoing, both parties agree that any claims or controversies concerning the validity or enforceability of any intellectual property, or the actual or threatened disclosure or misuse of confidential information, may alternately be resolved by a civil action in any court of competent jurisdiction as provided herein below, and both parties further agree that each shall retain the right to seek injunctive relief in any court of competent jurisdiction as provided herein below to prevent a breach, threatened breach or continuing breach of this Agreement which would cause irreparable injury (e.g., breaches of confidentiality or the like). | |
16.5 | Any civil action prosecuted or instituted by either party as permitted herein above with respect to any matters arising out of or related to this Agreement shall be brought in either the United States District Court located in the state of Delaware, United States (if |
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16.6 | In the event that it is necessary for either party of this Agreement to take legal action to enforce any of the terms, conditions or rights contained herein, or to defend any such action, then the prevailing party in such action shall be entitled to recover from the other party all reasonable attorneys fees, costs and expenses related to such legal action. | |
16.7 | In the event that any portion of this Agreement is held invalid or unenforceable by a court of law, that provision will be construed and reformed to permit enforcement of the provision to the maximum extent permissible consistent with the parties original intent, and if such construction is not possible, such provision shall be struck from this Agreement, and the remainder of the Agreement shall remain in full force and effect as if such provision had never been part of this Agreement. | |
16.8 | For the purposes of this Agreement, the parties hereto are independent contractors, and nothing in this Agreement shall be construed to place them in the relationship of partners, principal and agent, employer/employee or joint venturers. Except as provided expressly herein, each party agrees that it shall have no authority to bind or obligate the other party, nor shall any party hold itself out as having such authority. | |
16.9 | Neither party will be liable for failure or delay in performing any obligation under this Agreement, or will be considered in breach of this Agreement, if such failure or delay is due to a natural disaster or any cause reasonably beyond such partys control, provided that such party resumes performance as soon as possible following the end of the event that caused such delay or failure of performance. | |
16.10 | Neither party may assign this Agreement, or any obligation or right under this Agreement, in whole or in part, without the other partys prior written consent, which consent will not be unreasonably withheld. This Section shall not be construed in any way to limit Omeros rights to grant, at Omeros sole discretion, sublicenses hereunder. MRC consents to Omeros assignment of this Agreement in whole or in part in connection with the merger, consolidation or transfer of all or substantially all of that portion of Omeros assets to which this Agreement relates. Subject to these restrictions, this Agreement will be binding upon and will inure to the benefit of the parties permitted successors and assignees. | |
16.11 | Any notice required or permitted to be given hereunder by either party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by an internationally recognized courier service guaranteeing next-day delivery, charges prepaid, or (d) delivered by facsimile (with the original promptly sent by any of the foregoing manners) to the addresses or facsimile numbers of the other party set forth below, or at such other addresses as may from time to time be furnished by similar notice by either party. The effective date of any notice hereunder shall be the date of receipt by the receiving party. |
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If to Omeros:
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If to MRC: | |
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Omeros Corporation
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Medical Research Council | |
1420 Fifth Avenue, Suite 2600
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20 Park Crescent | |
Seattle, WA 98101
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London | |
U.S.A.
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United Kingdom | |
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W1B 1AL | |
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Attention: Gregory A. Demopulos, M.D.,
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Attention: Graham Wagner, | |
Chairman & CEO
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Associate Director Licensing | |
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and Agreements | |
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And copy to: Marcia S. Kelbon,
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Patent & General Counsel
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Fax: (206) 264.7856
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Fax: +44.207.291.5325 | |
Phone: (206) 623.4688
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Phone: +44.207.291.5317 |
16.12 | This Agreement may be executed in one or more counterparts, each of which will be considered an original, and all of which will constitute the same instrument. |
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PROFESSOR KENNETH B. M. REID | ANTHONY C. WILLIS | |||||||
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Director, MRC Immunochemistry Unit | Title: | ||||||
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cardiovascular, urologic and general surgical procedures), other medical procedures, and/or for treatment of cartilaginous disorders, which have been developed or are owned or held by Omeros; (b) drug delivery systems and methods, which have been developed or are owned or held by Omeros; (c) methods, antibodies and other agents and compositions for the inhibition of the complement immune system, which have been developed or are owned or held by Omeros, and includes, without limitation, research and development information, know-how, inventions, trade secrets, technical data, formulae, treatment methods, license agreements, clinical trial design criteria, protocols, investigators brochures, models, samples, processes, chemistry, manufacturing and controls information, regulatory information, and any type of product development, business, marketing or legal plans or strategies or financial information. |
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OMEROS CORPORATION | |||||||||||
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
1. | Outline of Deliverables | |
2. | Detailed Description of Deliverables and Pricing Summary | |
3. | Specifications and Stability Testing Outlines | |
4. | Quality Agreement | |
5. | Project Total | |
6. | Authorizations |
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Non-GMP OMS302 Product Vials
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1 x 400 | |
Non-GMP []Product Vials
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1 x 400 | |
Non-GMP Placebo Vials
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1 x 400 | |
cGMP OMS302 Product Vials
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1 x 3,000 | |
cGMP [] Product Vials
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1 x 3,000 | |
Audited Batch Records
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2 | |
Audited Test Results
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2 | |
Cs of A
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5 | |
DMF Reference Letter
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1 |
Miscellaneous
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2 Site Visits for Inspection/Audit, 2 auditors at a time.
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Service Description | Units | Unit Price | Total Price | |||||
Media Fill Validation | 3 x 3000 | [] | [] | |||||
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Media fill validation performed in accordance with ICH guidelines of 3 x 3000 2 mL glass vials. | |||||||
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Non-GMP Aseptic Fill and Finish (Product and Placebo) | ~400 vials/fill (OMS302 Product) |
[]
Per Fill |
[] | |||||
|
||||||||
-
|
Omeros to supply all released API- [] | Discounted Unit Price: | ||||||
-
|
Althea to purchase and release citric acid | ~400 vials/fill | ||||||
|
monohydrate, sodium citrate and WFI. | [] | ||||||
-
|
Althea to purchase and release vials, stoppers and seals as specified in completed product survey |
~400 vials
per fill |
[]
Per Fill |
|||||
-
|
Non-GMP batch record preparation for product and placebo fills | (Placebo) | ||||||
-
|
Non-GMP filling of formulated bulk and placebo into 5 mL glass vials | |||||||
-
|
Standard label preparation- additional charges may apply for non-standard labels. | |||||||
-
|
Release testing to include sterility, Endotoxin, pH, appearance, osmolality, potency, purity, identity and USP particulate. Samples of the product will be sent to Omeros for potency testing. | |||||||
-
|
Fill may be performed in either Altheas clean room filling suites or in a hood in a Class 10,000 room | |||||||
-
|
Two domestic shipments |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Service Description | Units | Unit Price | Total Price | |||||
HPLC Transfer and Qualification
-
Transfer of HPLC method, including all SOPs
and protocols. Assay qualification.
|
1 | [] | [] | |||||
|
||||||||
Final Product (Non-GMP OMS302 Product Only- No
Placebo) Stability Program Setup and Maintenance
|
2 Storage Conditions | [] | [] | |||||
|
||||||||
Includes storage, execution and management of a 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
|
||||||||
|
||||||||
Final Product (Non-GMP
[]
Only- No Placebo)
Stability Program Setup and Maintenance
|
2 Storage Conditions | [] | [] | |||||
|
||||||||
Includes storage, execution and management of an 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
|
||||||||
|
||||||||
Final Product (GMP Product OMS302) Stability
Program Setup and Maintenance
|
2 Storage Conditions | [] | [] | |||||
|
||||||||
Includes storage, execution and management of an 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
|
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Service Description | Units | Unit Price | Total Price | |||
Final Product (GMP Product
[]
Only- No Placebo)
Stability Program Setup and Maintenance
|
2 Storage Conditions | [] | [] | |||
|
||||||
Includes storage, execution and management of an 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
|
||||||
|
||||||
Stability and Analytical Transfer Total
|
[] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Milestone | Invoice Amount | |
Execution of Project Plan (advance payment [] of Fill and Finish)*
|
[] | |
|
||
Completion of HPLC Transfer and Qualification
|
[] | |
|
||
Completion of Non-GMP OMS302 Product Fill and Finish
|
[] | |
|
||
Completion of Non-GMP Placebo Product Fill and Finish
|
[] | |
|
||
Completion of Non-GMP [] Product Fill and Finish
|
[] | |
|
||
Setup of Non-GMP Product Stability Program ([] of Stability Program
Price for OMS302)
|
[] | |
|
||
Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the Non-GMP OMS203 a Product Stability Program (each
at [] of Program Price)
|
[]/timepoint | |
|
||
Setup of Non-GMP Product Stability Program ([] of Stability Program
Price for [])
|
[] | |
|
||
Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the Non-GMP []Product Stability Program (each at []
of Program Price)
|
[]/timepoint | |
|
||
Completion of GMP OMS302 Product Fill ([] of batch price)
|
[] | |
|
||
Approval of Released cGMP OMS302 Product by Omeros within the
timeframe described in section 5.1, Non-Conforming Drug Product in
the Development and Supply Agreement ([] of batch price)
|
[] | |
|
||
Completion of GMP [] Product Fill ([] of batch price)
|
[] | |
|
||
Approval of Released cGMP [] Product by Omeros within the timeframe
described in section 5.1, Non-Conforming Drug Product in the
Development and Supply Agreement ([] of batch price)
|
[] | |
|
||
Setup of cGMP OMS302 Product Stability Program ([] of Stability
Program Price)
|
[] | |
|
||
Setup of cGMP [] Product Stability Program ([] of Stability
Program Price)
|
[] | |
|
||
Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the GMP OMS302 Product Stability Program (each at []
of Program Price)
|
[]/timepoint | |
|
||
Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the GMP [] Product Stability Program (each at [] of
Program Price)
|
[]/timepoint |
* | In the event that the Project Plan is terminated early, any portion of the advance payment remaining (less any penalties that may be due in accordance with Section 3.3(b) of the Development and Supply Agreement) shall be promptly refunded to Omeros. | |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Assay | Test | Specification | ||
Purity
|
HPLC | Report Result; % area of each individual Related Substances peak and total % Related Substances | ||
|
||||
Potency
|
HPLC | Report Result; % Label claim [] HCL and % Label claim [] | ||
|
||||
Identity
|
HPLC | Retention time of parent compound matches retention time of drug substance reference standards | ||
|
||||
Appearance
|
Visual per Althea SOP | Clear colorless solution free of visible particulates | ||
|
||||
pH
|
USP [] | [] | ||
|
||||
Osmolality
|
USP [] | Report Result | ||
|
||||
Sterility
|
USP [] | Sterile | ||
|
||||
Particulate Count
|
USP [] |
Particulates >/= []/Unit
Particulates >/= []/Unit |
||
|
||||
Endotoxin
|
LAL USP [] | []/mL |
Component | Description | Althea Part Number | ||
Vial
|
West 5 mL, 20 mm opening-68000318, | RM-551 | ||
Stopper
|
West 20 mm Daikyo Fluortec D777-1 Gray-19500120 | RM-512 | ||
Seal
|
20 mm Purple Flip-Off Truedge West-542027 | RM-711 | ||
Filter
|
Excipients | Catalog Number | |
Citric acid Monohydrate USP
|
EM Science EM-0002425B | |
Sodium Citrate (Dihydrate USP)
|
EM Science EM-SX0442-1 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Assay
|
1 | 3 | 6 | 9 | 12 | 18 | ||||||||||||||||||
HPLC
|
X | X | X | X | X | X | ||||||||||||||||||
Appearance
|
X | X | X | X | X | X | ||||||||||||||||||
pH
|
X | X | X | X | X | X | ||||||||||||||||||
USP Particulates
|
X | |||||||||||||||||||||||
Sterility
|
X | |||||||||||||||||||||||
Endotoxin
|
X |
Assay
|
1 | 3 | 6 | 9 | 12 | 18 | ||||||||||||||||||
HPLC
|
X | X | X | X | X | X | ||||||||||||||||||
Appearance
|
X | X | X | X | X | X | ||||||||||||||||||
pH
|
X | X | X | X | X | X | ||||||||||||||||||
USP Particulates
|
X | |||||||||||||||||||||||
Sterility
|
X | |||||||||||||||||||||||
Endotoxin
|
X |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Fill and Finish Total
|
[] | |||
|
||||
Stability and Analytical Transfer Total
|
[] | |||
|
||||
Project Total
|
[] | |||
|
||||
Discounted
Project Total
|
[] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
|
||||||||||
OMEROS CORPORATION | ALTHEA TECHNOLOGIES, INC | |||||||||
|
||||||||||
By:
|
/s/ Gregory A. Demopulos | By: | /s/ Melissa Rosness | |||||||
|
||||||||||
|
||||||||||
Name:
|
Gregory A. Demopulos, M.D. | Name: | Melissa Rosness | |||||||
|
||||||||||
|
||||||||||
Title:
|
Chairman & CEO | Title: | Director, Contract Management | |||||||
|
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
1 | Key Definitions | |
1.1 | Active Agent shall mean a biological or pharmaceutical agent that provides a desired therapeutic effect when administered in a biological or pharmaceutical drug product, and does not include carriers, binders, fillers, solubilizers, stabilizers, buffers, acidifying agents or other excipients that do not exert therapeutic effect. | |
1.2 | Affitech-Originated MASP-2 Antibody shall mean any MASP-2 antibody or antibody fragment that specifically binds to MASP-2 polypeptides or portions thereof, including, without limitation, any single chain variable fragment ( scFv ), that was isolated and/or developed for and delivered to Omeros by Affitech under this Agreement or that is derived from an MASP-2 antibody or antibody fragment that was isolated and/or developed for and delivered to Omeros by Affitech under this Agreement. | |
1.3 | Best Efforts shall mean the application of continuing reasonable and material efforts, activities and measures that a diligent third party company active in a similar field as the respective Party would consider to be commercially reasonable, feasible and viable to be performed, undertaken or made in or under the specific circumstances. | |
1.4 | Combination Product shall mean any MASP-2 Therapeutic containing both an Affitech-Originated MASP-2 Antibody and one or more additional Active Agent(s) that do not constitute an Affitech-Originated MASP-2 Antibody. | |
1.5 | FDA shall mean the US Food and Drug Administration. | |
1.6 | ICD Category Indications shall mean therapeutic indications that are classified differently at the second digit level in the tabular index of the International Classification of Diseases and Related Health Problems, ninth edition, e.g., indications falling within ICD 340 and ICD 350, respectively, would be considered different ICD Category Indications while indications falling within ICD 340 and ICD 349, respectively, would be considered the same ICD Category Indications. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
1
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
2
1.14 | []. | |
1.15 | Patented MASP-2 Therapeutics shall mean MASP-2 Therapeutics manufactured, sold, offered for sale or used in (a) a country or territory in which such MASP-2 Therapeutics would read upon a claim of an issued patent, that has not been declared invalid or unenforceable by a patent office or court of common jurisdiction after appeal to a court or tribunal of appeal (e.g., the Federal Circuit in the U.S.) or a claim of a pending patent application included within the MASP-2 Antibody Patents in such country or territory []. | |
1.16 | Regulatory Agency shall mean FDA or corresponding foreign national or international agency that regulates and approves the clinical testing, marketing and sale of pharmaceuticals and biological therapeutics. | |
1.17 | []. | |
2 | Services and Deliverables | |
2.1 | []. Affitech shall provide Omeros the following services ( Services ) and deliverables ( Deliverables ), as more fully specified and described in the initial research plan (the Initial Research Plan ) attached to this agreement as Exhibit A: | |
a) Affitech shall conduct the initial testing of [] that meet all of the requirements therefore specified in the Initial Research Plan ( First-Generation Candidates ), [], as further described in Exhibit A. []. | ||
b) Upon written request by Omeros in writing, Affitech shall initiate [], as further described in Exhibit A. []. If requested by Omeros in writing, Affitech will supply []. | ||
2.2 | [] . If requested by Omeros in writing, Affitech shall [] that may be mutually agreed in writing between the parties, and produce and deliver to Omeros []. | |
2.3 | Additional Services and Deliverables . In addition to the Services and Deliverables described in the Initial Research Plan, Affitech and Omeros may mutually agree that additional Services not envisioned by the Initial Research Plan will be provided under this Agreement, which shall be specified, including additional Deliverables and fee compensation payable, in one or more additional research plan(s) (each an Additional Research Plan ). | |
2.4 | Joint Advisory Committee . Affitech and Omeros shall each designate a scientific point of contact, who shall communicate with each other regularly by e-mail, phone and/or in person, at least as frequently as requested by either Party, regarding the progress of the Services and Deliverables during any periods of time in which there are any uncompleted Services or undelivered Deliverables under the Initial Research Plan and any Additional Research Plan(s). For Omeros, the initial scientific point of contact shall be []. For Affitech, the initial scientific point of contact shall be []. Each Party shall also designate two additional scientific and/or business representatives who shall participate, together with the scientific points of contact, in a joint advisory committee ( JAC ) that shall meet, by phone or in person, at least once every month or on another mutually agreed schedule during any periods of time in which there are any uncompleted Services or undelivered Deliverables under the Initial Research Plan and any Additional Research |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
3
Plan(s), to discuss the progress of the Services and Deliverables and to determine the optimal technical approach and steps to be taken to meet Milestones I and II and to achieve the Overall Objective. The JAC shall be formed within [] from the Effective Date and remain active until (i) completion of the Initial Research Plan and any Additional Research Plan(s)or (ii) termination of the Agreement, whatever event occurs first. | ||
2.5 | Best Efforts. Affitech shall use Best Efforts to complete all Services, to deliver all Deliverables and meet all Milestones set forth in the Initial Research Plan and any Additional Research Plan(s) [], and to achieve the Overall Objective, and [] that all Services are carried out and Deliverables generated and developed []; provided, however, that any delays or interruptions in Affitechs activities or efforts due to availability of compounds, materials or necessary processes shall not be deemed to be a failure of Affitech to exert Best Efforts under this Section 2.5. | |
2.6 | []. | |
2.7 | Compliance with Laws . Affitech shall comply with all applicable international, national, county and local laws, rules and regulations in providing the Services. Affitech shall promptly notify Omeros if any regulatory agency takes action against Affitech for any defect or deficiency, during the Research Term (as defined in Section 8.1 herein below) of this Agreement, []. | |
2.8 | Transfer of Antibodies . During the Research Term or upon completion of the Research Term or any termination of this Agreement by Omeros for breach by Affitech, Affitech shall assist Omeros and cooperate with transfer of the scFv-format or IgG-format Final Candidate(s) to third party(ies) designated by Omeros for further development and/or manufacture of preclinical, clinical and commercial supplies of Affitech-Originated MASP-2 Antibodies. | |
2.9 | Development and Commercialization of Antibodies . Following receipt of one or more Final Candidate(s) from Affitech, Omeros shall use Best Efforts to develop a Final Candidate for use in preclinical and clinical investigation and subsequent commercialization of an Affitech-Originated MASP-2 Antibody; provided, however, that: (a) any delays or interruptions in Omeros activities or efforts due to any regulatory processes, availability of compounds, materials or necessary processes, the procurement of or disputes related to Intellectual Property Rights or licenses, or funding and resource constraints; or (b) any delays or interruptions of less than [], shall not be deemed to be a failure of Omeros to exert Best Efforts under this Section 2.9. | |
3 | Payments and Royalties | |
3.1 | Payment Terms . As full and complete consideration for the Services and Deliverables under the Initial Research Plan, all licenses, intellectual property and other rights conveyed, and all obligations undertaken in accordance with this Agreement for the Initial Research Plan, Omeros shall pay Affitech the amounts set forth in this Section 3 []. Affitech shall invoice Omeros for each of the payments as it becomes due and payable, and Omeros shall make payments for fees due and payable on a [] from receipt of invoice basis. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
4
a) Technology Access Fee. Omeros shall pay Affitech a fee of [] (the Technology Access Fee ) upon execution of this Agreement for access rights during the Agreement Term, solely for the purpose of making, using (including, without limitation, research, development and commercialization) and selling [] (as such terms are defined in Subsections 7.1 and 7.2(a) below, respectively) and the license provided in Subsection 7.3 below to permit Omeros to use, develop, commercialize, sell and distribute the Deliverables provided to Omeros under the Initial Research Plan and any Additional Research Plan(s). The Technology Access Fee shall be payable by Omeros [] under the Initial Research Plan. | ||
b) []. (i) Following completion of [] Milestone I under the Initial Research Plan, [], Omeros shall pay Affitech a Milestone I fee of [] (the Milestone I Fee ). []. | ||
(ii) After payment of the Milestone I Fee, []. Following completion of the [] Milestone I criteria set forth in the Initial Research Plan, Omeros shall pay Affitech a fee of []. | ||
(iii) The Milestone I Fee, if the Milestone I Fee becomes due as provided for above in this Section 3.1, shall be payable by Omeros [] under the Initial Research Plan. The [], shall be payable by Omeros [] under the Initial Research Plan. | ||
c) []. Omeros shall pay Affitech a fee of [] (the Milestone II Fee ) upon [] Affitech has completed Milestone II under the Initial Research Plan, []. | ||
If one or more of the Milestone II criteria under the Initial Research Plan are []. | ||
The Milestone II Fee, if the Milestone II Fee becomes due as provided for above in this Section 3.1, shall be payable by Omeros [] under the Initial Research Plan. | ||
d) []. If Omeros elects in writing, [], to have Affitech [], Omeros shall pay Affitech on invoice upon receipt [] of the [] in conformity with Exhibit A, as set forth in the following price schedule. [], Omeros shall complete reasonable third party Intellectual Property Rights diligence related to such [] and shall secure for Affitech, or for Omeros with a right to sublicense to Affitech, any third party license(s) that may be required for Affitech to complete the Services and produce the Deliverables that are specific to such []. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
5
[]
|
Price | |
|
||
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] |
Development Milestone | Development Milestone Payment | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] |
3.2 | Invoices . Affitech shall submit invoices to Omeros for payments, other than Sales Royalties that have become due. The terms of payment are [] after Omeros receipt of |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
6
Affitechs invoice, or in the event that any invoice is disputed in good faith, [] after mutual agreement or other resolution is reached on the disputed invoice or receipt of a corrected invoice. Invoices shall reference this Agreement and the relevant the Initial Research Plan or Additional Research Plan (as applicable) and specify the milestone payment or other fee that is being invoiced. Payment for Sales Royalties shall be made by Omeros concurrent with delivery of the Net Sales reports specified in Subsection 4.1(a) herein below. | ||
Invoices shall be sent to Omeros by mail addressed to the following or subsequently updated address: |
Affitech shall provide and keep Omeros updated on invoice payment instructions, including wire transfer information or the payee and address for checks. | ||
3.3 | Obligation to Pay Taxes . Payments under this Agreement shall be made in full in the agreed amounts without deduction for taxes of any kind whatsoever. []. | |
4 | Reports; Records; Audits; Inspections | |
4.1 | Reports and Record Maintenance . | |
a) By Omeros . Following the initial approval by a Regulatory Agency for the sale by Omeros or a licensee of Omeros of a MASP-2 Therapeutic, Omeros shall provide Affitech with a Net Sales report on a [] setting forth the quantity of sales of MASP-2 Therapeutics, the gross monetary amounts invoiced and collected by either Omeros or by a licensee of Omeros for the initial distribution or sale of MASP-2 Therapeutics, and the total of all deductions provided for in Subsection 1.9 herein above during such [], within [] following the end of each [] for Net Sales realized during such []. | ||
b) By Affitech . Within [] of completion of each milestone, Affitech will provide [], relating to the achievement of the particular milestone. Within [] of delivery to Omeros of any Final Candidate(s), [], Affitech shall provide to Omeros []. [] after completion of the Initial Research Plan and any Additional Research Plan(s) and thereafter, it will be the responsibility of Omeros to maintain such Records and Materials. []. At any time during which Affitech is [] maintain such Records and Materials, if Omeros requests receipt of all or any portion of Affitechs copy of the Records and Materials, including upon termination of the Agreement [], Affitech shall send such Records and Materials to Omeros at Omeros reasonable expense. | ||
4.2 | Audit of Omeros Books . Affitech shall have the right to employ a certified public accountant to review and reconcile the directly relevant accounting records and procedures of Omeros solely as they relate to the determination of Sales Royalties, during reasonable business hours and no more than [] a year, and Omeros agrees to make available at |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
7
Omeros place of business all such directly relevant accounting records for that purpose within [] of written request by Affitech. The cost of such review shall be borne by Affitech, unless it is found that Omeros under-paid [] Sales Royalty for any [] by an amount of [] or greater [] during the term of this Agreement, in which case the cost of such review shall be borne by Omeros. | ||
4.3 | Visits, Audits and Inspections . Omeros representatives may visit Affitechs facilities at reasonable times and with reasonable frequency during normal business hours to observe the progress of the Services and Deliverables, within [] of written request. Affitech shall assist Omeros in scheduling and implementing such visits. During the visits, Omeros representatives may examine all Records and Materials, facilities and equipment that pertain to the Services and Deliverables, and any other relevant resources pertaining to the Initial Research Plan and any Additional Research Plan(s), as well as any other audit reports prepared by or on behalf of Affitech with respect to quality audits of such relevant resources. Omeros costs of such visit shall be borne by Omeros. If Affitech receives a request from any Regulatory Agency to inspect any portion of Affitechs facilities related to the performance of the Services and Deliverables, Affitech shall notify Omeros in advance and provide Omeros an opportunity, at Omeros effort and expense, to participate in such inspection, []. | |
5 | Samples | |
5.1 | Use of Samples . Omeros shall transfer to Affitech the sufficient or requested quantities of proteins, reagents and/or other materials involved in the Services as specified in the Initial Research Plan and any Additional Research Plan(s) (Omeros Samples). Omeros shall provide all pertinent information known to Omeros regarding the Omeros Samples to the extent necessary for carrying out the Initial Research Plan and any Additional Research Plan(s). Affitech shall be responsible for []. Affitech shall not use or analyze any Omeros Samples provided by Omeros under this Agreement except as necessary to carry out the Initial Research Plan or any Additional Research Plan(s) and shall not administer []. After completion of the Services, Affitech shall either return the Omeros Samples to Omeros or dispose of the Omeros Samples, upon written request by Omeros and at Omeros risk and expense. Affitech [] of all Omeros Samples or other compounds or materials used in the performance of the Services and shall [] of the Omeros Samples after delivery to Affitech. | |
5.2 | Ownership of Samples . The Omeros Samples are and shall remain the sole property of Omeros and nothing in this Agreement shall be construed as granting to Affitech, by implication or otherwise, any right or license with respect to the Omeros Samples, or any patent or other intellectual property rights with respect to the Omeros Samples, except as required to complete the Services and generate the Deliverables, and Affitech shall not file applications or otherwise seek any proprietary rights in respect of the Omeros Samples or any Confidential Information (as that term is defined below in Subsection 6.1) that Omeros provides under this Agreement. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
8
6 | Confidentiality and Non-use | |
6.1 | As used in this Agreement, Confidential Information shall mean any Omeros Samples, other materials, data, research, development, manufacturing, marketing, financial, personnel, sales, business, and other non-public, proprietary or technical information provided by a disclosing Party (the Disclosing Party ) to a receiving Party (the Recipient ), including, without limitation, all Deliverables, Records and Materials (which shall be considered Omeros Confidential Information even if generated or provided by Affitech), except any portion of such information that the Recipient establishes: | |
a) is or becomes generally available to the public or within the industry to which such information relates, other than as a result of a breach of this Agreement; or | ||
b) is known by Recipient at the time of receipt of the Disclosing Partys information, as evidenced by Recipients contemporaneous written records; or | ||
c) is provided to Recipient on a non-confidential basis by a third party who has the legal right to make such disclosure; or | ||
d) was or is independently developed by or for Recipient without access to or use of the information of the Disclosing Party, as evidenced by Recipients contemporaneous written records. | ||
6.2 | Obligations of Confidentiality and Non-use . Each Party agrees that the Disclosing Party has and shall retain sole and exclusive rights of ownership of all Confidential Information disclosed or owned by such Party. Each Recipient agrees that during the Agreement Term and for [] thereafter it will not use any Confidential Information of the Disclosing Party except for the purposes of performing under this Agreement, unless otherwise agreed by the Parties in writing. Each Recipient agrees not to disclose any Confidential Information of the Disclosing Party to others (except to Recipients employees, consultants, professional advisors, agents and Affiliates who reasonably require disclosure of such Confidential Information to achieve the purposes of this Agreement and who are bound to the Recipient by like obligations as to confidentiality and non-use no less stringent than those set forth herein) during the Agreement Term and for [] thereafter without the prior written consent of the Disclosing Party. Affitech agrees that with respect to the Records and Materials, which are included in Omeros Confidential Information, these obligations of non-use and confidentiality shall subsist beyond [] after the termination of this Agreement. Each Party agrees to maintain and follow reasonable procedures to prevent unauthorized disclosure or use of the other Partys Confidential Information and to prevent it from becoming disclosed or being accessed by unauthorized persons. Each Party agrees that it may disclose to authorized persons only such Confidential Information of the Disclosing Party as is necessary for each such authorized person to perform his/her responsibilities under this Agreement. Recipient shall advise the Disclosing Party of any disclosure, loss, or use of Confidential Information of the Disclosing Party in violation of this Agreement as soon as practicable. Each Party agrees to return or destroy the Confidential Information of the other Party, whether in written, graphic, electronic or other |
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tangible form, upon written request, provided, however, that legal counsel for each Party may retain an archival copy of Confidential Information solely for purposes of ensuring compliance with this Agreement. | ||
6.3 | Disclosure of this Agreement . The terms of this Agreement shall be considered each Partys Confidential Information, and accordingly except for disclosures expressly permitted under this Agreement, neither Party may release any information to any third party regarding the terms of this Agreement without the prior written consent of the other Party. Notwithstanding the foregoing, the terms of this Agreement may be disclosed by Omeros or by Affitech to their respective existing or potential investors, acquirers, merger partners, commercial partners, shareholders, directors, officers and professional advisors as long as such individuals or entities are subject to similar conditions of confidentiality. | |
6.4 | Permitted Disclosures . Notwithstanding anything to the contrary, a Party may disclose Confidential Information of the other Party, including, without limitation, the terms of this Agreement, to the extent such disclosure is reasonably necessary: (a) to secure patent protection for an Intellectual Property Right developed pursuant to this Agreement consistent with the ownership provisions set forth in Section 7; (b) to comply with applicable laws or regulations, the requirements of any Regulatory Agency or other regulatory or governmental authority, including, without limitation, FDA, the US Securities and Exchange Commission, the Federal Trade Commission and/or the Department of Justice, or judicial order from a court of competent jurisdiction; or (c) as necessary for Omeros to conduct pre-clinical studies, clinical trials, achieve the Overall Objective or to seek regulatory approval to market MASP-2 Therapeutics. Prior to making any such permitted disclosures, however, the Recipient shall give reasonable advance notice to the Disclosing Party with as much detail as possible in relation to the disclosure. Each Party agrees that it shall cooperate fully and in a timely manner with the other Party with respect to all such permitted disclosures, including determining what information should be released and requests for confidential treatment of Confidential Information of either Party included in any such disclosure where possible; provided that in no event shall a Party be required to delay any filing or release unreasonably hereunder. | |
6.5 | Remedies . Because of the unique nature of the Confidential Information, each Recipient acknowledges and agrees that the Disclosing Party may suffer irreparable injury if the Recipient fails to comply with the obligations set forth in this Section 6, and that monetary damages may be inadequate to compensate the Disclosing Party for such breach. Accordingly, each Recipient agrees that the Disclosing Party will, in addition to any other remedies available to it at law, in equity or otherwise, without the requirement to post a bond, be entitled to seek injunctive relief and/or specific performance to enforce the terms, or prevent or remedy the violation, of this Section 6. This provision shall not constitute a waiver by either Party of any rights to damages or other remedies which it may have pursuant to this Agreement or otherwise. |
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7 | Intellectual Property; Licenses and Protection | |
7.1 | Pre-existing Intellectual Property . Except as expressly provided in this Section 7, neither Party shall, as a result of this Agreement, acquire any right, title, or interest in any Intellectual Property Rights that the other Party owned, licensed or controlled as of the Effective Date of, or that the other Party obtains ownership, license or control of separate and apart from the performance of, this Agreement (each Partys Pre-existing Intellectual Property ). | |
7.2 | New Intellectual Property | |
a) Affitech shall own all right, title and interest in New Affitech Intellectual Property , which shall mean Intellectual Property Rights that Affitech develops, conceives, invents, reduces to practice or makes in the course of performance under this Agreement that is directed to subject matter of general applicability to the current business of Affitech or []. | ||
b) Omeros shall own all right, title, and interest in (a) the MASP-2 Antibody Patents, (b) all Intellectual Property Rights that either Party, solely or jointly with others, develops, conceives, invents, reduces to practice, improves, or makes in the course of performance under this Agreement that is specific to: MASP-2; any inhibitor of MASP-2; any MASP-2 antibody or antibody fragment that binds to MASP-2 polypeptides or portions thereof, including, without limitation, Affitech-Originated MASP-2 Antibodies; any pharmaceutical or biological therapeutic for the inhibition of MASP-2, including, without limitation, any MASP-2 Therapeutic; any methods or processes for manufacturing, formulating or packaging any MASP-2 antibody or antibody fragment that binds to MASP-2 polypeptides or portions thereof, including, without limitation, Affitech-Originated MASP-2 Antibodies; any methods or processes for manufacturing, formulating or packaging MASP-2 Therapeutics; and any method of treatment by inhibiting MASP-2, and (c) any and all other Intellectual Property Rights, excluding the New Affitech Intellectual Property (collectively, the New Omeros Intellectual Property ). [] of the New Omeros Intellectual Property, and any documents required to apply for, maintain and enforce any patents or other rights in the New Omeros Intellectual Property. Upon Omeros request and at Omeros reasonable expense, and [] in the New Omeros Intellectual Property. Omeros shall use [] to file and prosecute patent applications and maintain patents, where issued, which patent applications and patents include claim(s) that read on the Affitech-Originated MASP-2 Antibodies and/or MASP-2 Therapeutics in: a) countries or territories that are [], and in b) other countries or territories that Omeros may, in the exercise of its reasonable judgment and discretion, consider to represent [] for such [], taking into additional consideration [] prior to filing of such applications or to prosecuted such patent applications or maintain such patents, if issued, in a country or territory in which there is a []. | ||
c) Upon termination of this Agreement, Affitech shall not use or have used the Omeros Samples in the production of such MASP-2 antibodies and such MASP-2 antibodies shall not include [] delivered to Omeros under this Agreement. []. |
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7.3 | []. | |
7.4 | Field Exclusivity . [] | |
7.5 | Limitation for Breach of Best Efforts to Develop . If during the term of this Agreement (a) Omeros advises Affitech in writing, in response to a query from Affitech, that Omeros has decided to permanently abandon all development of Affitech-Originated MASP-2 Antibodies, (b) Omeros provides Affitech written notice that Omeros has expressly abandoned all development of Affitech-Originated MASP-2 Antibodies or (c) Omeros materially breaches its obligation to use Best Efforts for development under Subsection 2.9 above, Affitech shall have the right to provide Omeros notice that Affitech intends to produce and/or develop MASP-2 therapeutics for Affitechs benefit or for third parties. Upon receipt by Omeros of such notice, the restrictions on Affitech concerning field exclusivity of Subsection 7.4 above shall terminate. | |
8 | Term and Termination | |
8.1 | Research Term . The research term of this Agreement during which Affitech is obligated to provide Services begins on the Effective Date and, unless this Agreement is earlier terminated as provided for below in this Section 8, will continue until Affitechs completion of all Services and delivery of all Deliverables described in the Initial Research Plan and any Additional Research Plan(s) (the Research Term ). | |
8.2 | Royalty Term . The royalty term of this Agreement during which Omeros is obligated to pay Sales Royalties to the extent provided herein, unless this Agreement is earlier terminated as provided for below in this Section 8, begins on the date of the first commercial sale of a MASP Therapeutic and will continue until the point in time at which there are no patent application(s) in the process of being prepared for filing, no pending patent applications and no valid and enforceable claim included within any patent, utility model or inventors certificate within (i) the MASP-2 Antibody Patents, (ii) Affitechs Pre-existing Intellectual Property that reads on any Affitech-Originated MASP-2 Antibody or any MASP-2 Therapeutic or (iii) the New Affitech Intellectual Property that reads on any Affitech-Originated MASP-2 Antibody or any MASP-2 Therapeutic (the Royalty Term ). In the event Omeros decides not to file any patent applications in one or more countries, the Royalty Term shall be 15 years from the first commercial sale of a MASP-2 Therapeutics. | |
8.3 | Agreement Term . This Agreement, unless terminated earlier as provided for below in this Section 8, begins on the Effective Date and continues in full force and effect until the end of both the Research Term and the Royalty Term (the Agreement Term ). | |
8.4 | Survival . The provisions of Subsections and Sections 2.8, and Sections 5, 6, 7.1, 7.2, 8.6 and 9-14, and any payments and royalties due prior to termination to Affitech from Omeros under Section 3, shall survive the Agreement Term. | |
8.5 | Termination for Cause or Futility . Either Party may terminate this Agreement at any time in the event that the other Party breaches any material obligation of this Agreement by first submitting written notice of breach to the breaching Party, which breach is not substantially cured within ninety (90) days of the receipt of such notice, followed by written notice of termination then being sent to the breaching Party. Additionally, Omeros may terminate this Agreement for cause if the Final Candidate(s) delivered to Omeros are not patentable. Additionally, if despite Affitechs Best Efforts including, without limitation, the completion of the [], Affitech is unable to identify even one suitable scFv format First Generation Candidate, Affitech shall have the right to terminate this agreement for futility due to exhaustion of its library. | |
8.6 | Termination By Omeros Without Cause; Intellectual Property Reversion. Prior to Omeros payment of the Technology Access Fee, Omeros may terminate this Agreement without cause by providing Affitech thirty (30) days advance written notice to Affitech but shall remain |
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obligated to pay the Technology Access Fee. Following payment of the Technology Access Fee but before Affitechs delivery of the First-Generation Candidates, Omeros may terminate this Agreement without cause by providing Affitech thirty (30) days advance written notice to Affitech but shall remain obligated to pay the Milestone I Fee. Following payment of the Milestone I fee, upon request by Omeros for Affitech to undertake an [], but before delivery of any First-Generation Candidates identified by such [], Omeros may terminate this Agreement but shall remain obligated to pay the []. After payment of the Milestone I Fee but prior to Omeros requesting Affitech to proceed with affinity maturation, Omeros may, without the payment of any additional fees other than for any completed IgG conversion and production and/or the [], if applicable, terminate this Agreement without cause by providing Affitech thirty (30) days advance written notice to Affitech. Following Omeros request for Affitech to commence affinity maturation of First Generation Candidates under the Initial Research Plan but before Affitechs delivery of the Final Candidates, Omeros may terminate this Agreement without cause by providing Affitech thirty (30) days advance written notice to Affitech but shall remain obligated to pay the Milestone II Fee. After Omeros has requested Affitech to generate IgG Candidate, Omeros may terminate this agreement, but shall remain obligated to pay IgG Candidate price for the particular amount requested as detailed in the table in Section 3.1(d). In addition, if Omeros terminates this Agreement under this Subsection 8.6 or under Subsection 8.5 other than due to breach by Affitech, but not if Omeros terminates this Agreement for cause under Subsection 8.5 due to breach by Affitech, neither Omeros nor Affitech shall use any of the Affitech-Originated MASP-2 Antibodies or Records and Materials generated under this Agreement to file or cause to be filed any patent applications claiming the Affitech-Originated MASP-2 Antibodies, MASP-2 Therapeutic compositions, or methods or processes for manufacturing, formulating or packaging Affitech-Originated MASP-2 Antibodies or MASP-2 Therapeutic compositions, and each party shall destroy all Omeros Samples (if held by Affitech), antibodies, antibody fragments, clones, expression constructs or other materials in its possession that were provided or generated under this Agreement. | ||
9 | Representations and Warranties | |
9.1 | Authority . Each Party represents and warrants that it has full power and authority to execute, deliver and perform this Agreement, and that the terms of this Agreement do not conflict with any other contractual agreement or obligation to which it is a Party. | |
9.2 | Intellectual Property . Affitech represents and warrants that: |
a) | [] | ||
b) | [] | ||
c) | [] |
9.3 | No Other Warranties . EXCEPT AS EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY OF THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SAFETY, EFFICACY AND NONINFRINGEMENT REGARDING THE OMEROS SAMPLES, THE DELIVERABLES, THE AFFITECH-ORIGNATED MASP-2 |
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ANTIBODIES, THE MASP-2 THERAPEUTICS, METHODS OF DISCOVERING OR MANUFACTURING SAID ANTIBODIES OR THERAPEUTICS OR ANY OTHER SUBJECT MATTER OF THIS AGREEMENT. | ||
10 | Indemnification; Limitation of Liability | |
10.1 | Indemnification . Each Party (the Indemnifying Party ) shall indemnify, defend and hold harmless the other Party, its affiliates, subsidiaries, officers, directors, employees, consultants, and agents (collectively the Indemnitees ) from any and all liability, loss (including reasonable attorneys fees) or damage any of them may suffer as the result of claims, demands, costs or judgments against them by unaffiliated third parties (collectively Claims ) that arise from the Indemnifying Partys breach of any of its obligations, representations, covenants and warranties under this Agreement, or the Indemnifying Partys negligent act or omission, willful misconduct or unlawful act, except and to the extent that such Claims result from the breach by any Indemnitee of any of the Indemnitees obligations, representations, covenants and warranties under this Agreement or any of the Indemnitees gross negligence, willful misconduct or unlawful act. | |
Omeros shall indemnify, defend and hold harmless Affitech, its affiliates, subsidiaries, officers, directors, employees, consultants, and agents from any and all Claims arising directly from infringement by Affitech of third party Intellectual Property Rights due solely to Affitechs [], which third party Intellectual Property Rights are specific to such [] and excluding any Claims that would have arisen if Affitech had []. | ||
10.2 | Procedure . In the event that any third party claim, action or suit is instituted against an Indemnitee in respect of which indemnity may be sought pursuant to Subsection 10.1, the Indemnitee will promptly notify the Indemnifying Party in writing (provided that the failure to give such notice promptly will not prejudice the rights of an Indemnitee, except to the extent that the failure to give such prompt notice materially adversely affects the ability of the Indemnifying Party to defend the claim, action or suit). Promptly after the Indemnitee gives such written notice, the Indemnifying Party and the Indemnitee shall meet to discuss how to respond to such claim, action or suit. The Indemnifying Party shall control the defense of such claim, action or suit. The Indemnitee shall cooperate with the Indemnifying Party in the defense of such claim, action or suit, at the expense of the Indemnifying Party. In any such proceeding, the Indemnitee shall also have the right to retain its own counsel at its own expense. The Indemnifying Party shall not be liable for damages with respect to a claim, action or suit settled or compromised by the Indemnitee without the Indemnifying Partys prior written consent. No offer of settlement, settlement or compromise by the Indemnifying Party shall be binding on an Indemnitee without the Indemnitees prior written consent (which consent shall not be unreasonably withheld, conditioned or delayed), unless such settlement fully releases the Indemnitee without any liability, loss, cost or obligation to such Indemnitee, provided, however, that the Indemnifying Party shall have no authority to take any action as part of any such defense or settlement that invalidates or otherwise compromises or renders unenforceable any of |
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the Indemnitees Intellectual Property Rights without the Indemnitees express prior written consent. | ||
10.3 | Limitation of Liability . Without limitation of any Partys obligations to indemnify third party Claims under Subsection 10.1, neither Party shall be liable for any indirect, consequential, exemplary or incidental damages arising under or in association with this Agreement, except for any such liability arising from fraud by the Party or from any breach of the Partys obligations regarding Confidential Information or Intellectual Property Rights under this Agreement. | |
11 | Insurance | |
Omeros shall procure and maintain during the Agreement Term and for a minimum period of [] thereafter, product liability insurance in an amount not less than [] in the annual aggregate and each of Affitech and Omeros shall procure and maintain during the Research Term and for a minimum period of [] thereafter commercial general Liability including premises operations, blanket contractual liability, personal injury and advertising injury including fire legal liability for bodily injury and property damage in an amount not less than [] (or monetary equivalent of each above sum based on prevailing currency exchange rates). Each Party shall include the other Party and its subsidiaries, affiliates, directors, officers, employees and agents as additional insureds with respect to the respective insurance coverages set forth above. Each Party shall make available to the other Party, at such other Partys request, evidence of its maintenance of insurance in satisfaction of its obligations under this Section 11. | ||
12 | Use of Names | |
Except as may be required by law or regulation after first providing reasonable advance notice to the other Party, neither Party may use the other Partys name in any promotional, advertising or other materials without the prior written consent of the other Party. Affitech hereby consents to Omeros disclosure of Affitechs name in connection with the provision of the Services and the Deliverables under this Agreement to Omeros current and potential employees, consultants, directors, shareholders, investors and partners, and to any Regulatory Agency or other regulatory authority including, without limitation, FDA and the US Securities and Exchange Commission. | ||
13 | Notices | |
Any notice required or permitted to be given hereunder by either Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by an internationally recognized courier service guaranteeing next-day delivery, charges prepaid, or (d) delivered by facsimile (with the original promptly sent by any of the foregoing manners) to the address or facsimile number of the other Party set forth below, or at such other address as may from time to time be furnished by notice by either Party. The effective date of any notice hereunder shall be the date of receipt by the receiving Party. |
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If to Omeros: | If to Affitech: | ||
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Omeros Corporation | Affitech AS | ||
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1420 Fifth Avenue | Oslo Research Park | ||
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Suite 2600 | Gaustadalléen 21 | ||
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Seattle, WA 98101 | N-0349 Oslo | ||
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U.S.A. | Norway | ||
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Attention: CEO | Attention: CEO | ||
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And copy to: General Counsel | |||
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Fax: 206.676.5005 | Fax: +47 22 95 83 58 | ||
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Phone: 206.676.5000 | Phone: +47 22 95 87 58 | ||
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And a copy to: | |||
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Affitech USA, Inc. | |||
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2855 Mitchell Drive, Suite 106 | |||
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Walnut Creek, CA 94598 | |||
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USA | |||
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Attention: President | |||
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Fax: 925.465.7059 | |||
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Phone: 925.465.7058 |
14 | Miscellaneous | |
14.1 | Integration . This Agreement including the Initial Research Plan and any Additional Research Plan(s), appendices and exhibits attached thereto or incorporated by reference therein constitutes the entire understanding of the Parties hereto regarding the subject matter of this Agreement, and no other representation, agreement, promise or undertaking altering, modifying, taking from or adding to the terms of this Agreement shall have any effect unless the same is reduced to writing and duly executed by the Parties hereto. In the event of any conflict between the main body of this Agreement and any attachments thereto or documents incorporated by reference therein, the provisions of the main body of this Agreement shall control. | |
14.2 | No Waiver . Either Partys failure to enforce any provision of this Agreement will not be considered a waiver of future enforcement of that or any other provision. | |
14.3 | Governing Law . The laws of the state of California, United States, without regard to its conflict-of-laws provisions, shall govern this Agreement, its interpretation and its enforcement, and any disputes arising out of or related to this Agreement. | |
14.4 | Arbitration . The Parties agree that, except as provided herein below, any claim or controversy arising out of or relating to this Agreement or breach thereof shall be settled by arbitration in the state of California, United States, in accordance with the commercial rules of |
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the American Arbitration Association by a panel of three arbitrators, one selected by each Party and the third selected by the other two arbitrators. In any such arbitration proceeding, judgment upon the award rendered by the arbitrator shall be final and binding upon the Parties and may be entered by either Party in any court or forum of competent jurisdiction as provided herein below. Notwithstanding the foregoing, both Parties agree that any claims or controversies concerning the infringement, validity or enforceability of any Intellectual Property Rights, or the actual or threatened disclosure or misuse of any Confidential Information, may alternately be resolved by a civil action in the court of competent jurisdiction specified in Subsection 14.5 herein below, and both Parties further agree that each shall retain the right to seek injunctive relief in the court of competent jurisdiction specified in Subsection 14.5 herein below to prevent a breach, threatened breach or continuing breach of this Agreement that would cause irreparable injury, including, without limitation, breaches of confidentiality, infringement of Intellectual Property Rights or breach of Subsection 7.4 herein above []. | ||
14.5 | Jurisdiction and Venue . Any civil action prosecuted or instituted by either Party as permitted herein above with respect to any matters arising out of or related to this Agreement shall be brought in either the United States District Court located in the state of California, United States (if federal subject matter jurisdiction therein lies) or the Superior Courts in the state of California, United States (only if there is no subject matter jurisdiction in federal court), and each Party hereby consents to the exclusive jurisdiction and venue of such courts for such purposes. | |
14.6 | Attorneys Fees . In the event that it is necessary for either Party to take legal action to enforce any of the terms, conditions or rights contained herein, or to defend any such action, then the prevailing Party in such action shall be entitled to recover from the other Party all reasonable attorneys fees, costs and expenses related to such legal action. | |
14.7 | Severability . In the event that any portion of this Agreement is held invalid or unenforceable by a court of law, that provision will be construed and reformed to permit enforcement of the provision to the maximum extent permissible consistent with the Parties original intent, and if such construction is not possible, such provision shall be struck from this Agreement, and the remainder of the Agreement shall remain in full force and effect as if such provision had never been part of this Agreement. | |
14.8 | Independent Contractors . For the purposes of this Agreement, the Parties hereto are independent contractors, and nothing in this Agreement shall be construed to place them in the relationship of partners, principal and agent, employer/employee or joint venturers. Except as provided expressly herein, each Party agrees that it shall have no authority to bind or obligate the other Party, nor shall any Party hold itself out as having such authority. | |
14.9 | Force Majeure . Neither Party will be liable for failure or delay in performing any obligation under this Agreement, or will be considered in breach of this Agreement, if such failure or delay is due to a natural disaster or any cause reasonably beyond such Partys control, provided that such Party resumes performance as soon as possible following the |
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end of the event that caused such delay or failure of performance. | ||
14.10 | Assignment . Neither Party may assign this Agreement, or any obligation or right under this Agreement, in whole or in part, without the other Partys prior written consent, which consent will not be unreasonably withheld. This Section shall not be construed in any way to limit Omeros rights to grant, at Omeros sole discretion, sublicenses hereunder. Affitech hereby consents to Omeros assignment of this Agreement in whole or in part to any successor in interest to Omeros as part of a merger, acquisition, other change of control or together with a sale, transfer or other conveyance of all or substantially all of that part of Omeros assets that pertain to this Agreement. Each Partys obligations and rights under this Agreement will be binding upon and will inure to the benefit of the Parties permitted successors and assignees. | |
14.11 | Counterparts . This Agreement may be executed in one or more counterparts, each of which will be considered an original, and all of which will constitute the same instrument. |
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1. Goal:
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To generate high-affinity human antibodies specific for human MASP-2 with functional blocking activity, as evidenced by their ability to inhibit activation of the complement system through the lectin pathway. | |
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2. Required functionality:
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[]. | |
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[]. | |
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[]. | |
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3. Required specificity profile:
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[]. | |
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[]. | |
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4. Required cross-reactivity profiles: | ||
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[]. | |
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[]. | |
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5. Technical Considerations
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5.1 [].
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Items | Main task | Sub tasks | Deliverables | Timeline | ||||
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Protocol development. | [] |
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Items | Main task | Sub tasks | Deliverables | Timeline | ||||
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[] | [] | [] | [] | ||||
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[] | [] | ||||||
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[] | [] | [] | [] | ||||
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[] | [] | [] | [] | ||||
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[] | [] | [] | [] |
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AFFITECH AS | OMEROS CORPORATION | |||||||||
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By:
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/s/ Martin Welschof
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By: |
/s/ Gregory A. Demopulos
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Name: Martin Welschof, Ph.D. | Name: Gregory A. Demopulos, M.D. | |||||||||
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Title: Chief Executive Officer | Title: Chairman & CEO |
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1.1 | “ Additional Target Therapeutic shall mean a biological therapeutic that contains a North Coast-Originated Additional Target Antibody, the manufacture, sale, offer for sale or use of which, were it not for Omeros ownership of the Omeros Antibody Patents, would infringe any valid and enforceable claim(s) of any issued patent or any patentable claim(s) of any pending patent application included within the Omeros Antibody Patents in the country or countries in which such products are offered for sale, sold, manufactured or used. | |
1.2 | “ Additional Targets shall mean the therapeutic targets listed on Exhibit A attached hereto and any other therapeutic targets identified by Omeros to North Coast during the Option Period (as defined below); provided, however, that Additional Targets shall not include the following targets for which North Coast has previously granted a third party an option to have North Coast develop antibodies against such targets pursuant to a written agreement executed prior to the date of this Agreement, if and only if such following targets are timely elected by such third party under the prior agreement prior to December 1, 2008 and only with respect to the ScFV format of antibody fragments against such elected following targets for which North Coast is precluded from developing for Omeros pursuant to the terms of the prior agreement: []. | |
1.3 | “ Chimeric Antibodies shall have the meaning set forth in the applicable Research Plan (as defined in Section 2.3). |
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manufacturing and distribution rights to a licensee, by Omeros licensee, for the initial sale or distribution of such Omeros Therapeutic, but excluding any amounts invoiced or collected by parties other than Omeros or Omeros licensee for subsequent sales or distribution provided no part of such amounts invoiced or collected by such parties is directly or indirectly paid to Omeros or Omeros licensee, less (b) the sum of the following actual and customary deductions where applicable: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes, and any other governmental taxes imposed on particular sales; transportation charges and allowances; sales commissions to third parties (but excluding sales commissions to Omeros employees); wholesale charge backs; distributor fees; Medicare/Medicaid rebates; customer rebates; refunds for recalls; and allowances or credits to customers because of rejections or returns, provided such deductions are documented. If a North Coast-Originated Antibody is sold in combination with one or more additional active agents as a Combination Product, Net Sales shall be the product obtained by multiplying Net Sales of the Combination Product by the fraction A/(A+B) where A is the sales price of the North Coast-Originated Antibody in the Combination Product when sold separately in an Omeros Therapeutic including a North Coast-Originated Antibody as the only active agent and B is the total sales price of all additional active agents in the Combination Product when sold separately in a pharmaceutical or biologic therapeutic product including such additional active agents as the only active agents. If the North Coast-Originated Antibody and the other active agents are not sold in separate pharmaceutical or biologic therapeutic products, the portion of the total cost of the Combination Product attributed to the North Coast-Originated Antibody shall be a fraction, the numerator of which shall be the cost of the North Coast-Originated Antibody and the denominator of which shall be the total cost of the Combination Product, and the fraction shall be multiplied by the sales price of the Combination Product to arrive at Net Sales. For purposes of this paragraph, the acquisition of Omeros Therapeutics from Omeros as part of an acquisition or other transfer or conveyance of all or a part of the assets of Omeros business to which this Agreement pertains, or as part of a merger, acquisition, reorganization or other change of control of Omeros, shall not be considered a sale or distribution of Omeros Therapeutics. | ||
1.14 | “ North Coast-Originated Additional Target Antibody shall mean any Additional Target antibody or antibody fragment that specifically binds to an Additional Target or portions thereof that was isolated and/or developed for and delivered to Omeros by North Coast under this Agreement or that is derived from an Additional Target antibody or antibody fragment that was isolated and/or developed for and delivered to Omeros by North Coast under this Agreement. | |
1.15 | “ North Coast-Originated Antibody shall mean any North Coast-Originated MASP-2 Antibody or North Coast-Originated Additional Target Antibody. | |
1.16 |
“
North Coast-Originated MASP-2 Antibody
shall mean any MASP-2 antibody or antibody fragment
that specifically binds to
MASP-2 polypeptides or portions thereof that was isolated and/or developed for and delivered to Omeros by North Coast under this Agreement or that is derived from an MASP-2 antibody or antibody fragment that was |
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isolated and/or developed for and delivered to Omeros by North Coast under this Agreement. | ||
1.17 | “ Omeros Antibody Patents shall mean (a) all patent applications and patents that claim North Coast-Originated MASP-2 Antibodies, MASP-2 Therapeutic compositions, or methods of producing North Coast-Originated MASP-2 Antibodies or MASP-2 Therapeutic compositions and (b) all patent applications and patents that claim North Coast-Originated Additional Target Antibodies, Additional Target Therapeutic compositions, or methods of producing North Coast-Originated Additional Target Antibodies or Additional Target Therapeutic compositions; provided, however, that the Omeros Antibody Patents shall exclude any patents or patent applications owned by third parties. | |
1.18 | “ Optional Candidate shall have the meaning set forth in the applicable Research Plan. | |
1.19 | “ Overall Objective shall mean the isolation and optimization of a North Coast-Originated Antibody (as described in each Research Plan) that is suitable for advancement by Omeros through preclinical and clinical development and ultimate manufacture, commercialization, distribution and sale in the form of one or more Omeros Therapeutics. | |
1.20 | “ Omeros Therapeutic shall mean any MASP-2 Therapeutic or Additional Target Therapeutic. | |
1.21 | “ Regulatory Agency shall mean FDA or corresponding foreign national or international agency that regulates and approves the clinical testing, marketing and sale of pharmaceuticals and biological therapeutics. | |
1.22 | “ Second Generation Candidate shall have the meaning set forth in the applicable Research Plan. | |
1.23 | “ Services shall mean the services to be provided by North Coast to Omeros under any Research Plan. | |
2 | Services and Deliverables | |
2.1 | MASP-2 Antibodies . North Coast shall provide Omeros the Services and Deliverables set forth in the initial research plan ( Initial Research Plan ) attached to this Agreement as Exhibit B . As consideration for such Services and Deliverables, Omeros agrees to pay to North Coast: the Initial Access Fee, MASP-2 cDNA Fee, Optional MASP-2 Candidate cDNA Fee (if applicable) and the Development Milestone Payments and Sales Royalties (as such terms are defined in Section 3) with respect to any MASP-2 Therapeutic developed under the Initial Research Plan, but only to the extent that such amounts become due and payable under the terms and conditions of this Agreement and the Initial Research Plan. | |
2.2 | Antibodies to Additional Targets . |
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4
a) | Option for Additional Targets . Omeros will have an option (the Option ), exercisable during the period beginning on the date of this Agreement and ending on the earlier of (i) the twelve-(12) year anniversary of the date of this Agreement and (ii) such time as Omeros has exercised the Option with respect to [] Additional Targets (the Option Period ), to have North Coast generate antibodies raised against up to [] of the Additional Targets that may be selected by Omeros at Omeros sole discretion, individually or in group(s), during the Option Period. If Omeros elects to exercise the Option, it shall do so by providing written notice to North Coast and the Parties will execute a research plan for such Additional Target in substantially the form attached hereto as Exhibit C , modified as the parties deem reasonably necessary solely to account for any changes to the process necessary to develop and validate antibodies to such Additional Target (an Additional Target Research Plan ), and North Coast will provide Omeros the Services and Deliverables set forth in such Additional Target Research Plan. | ||
If Omeros exercises its Option for an Additional Target, then as consideration for the Services and Deliverables set forth in the applicable Additional Target Research Plan, Omeros agrees to pay to North Coast for such Additional Target: the applicable Subsequent Access Fee (if payable under Section 3.1.a.2), the Additional Target Antibody cDNA Fee, the Optional Additional Target Antibody cDNA Fee (if applicable) and the Development Milestone Payments and Sales Royalties (as such terms are defined in Section 3) with respect to any Additional Target Therapeutic developed under such Additional Target Research Plan, but only to the extent that such amounts become due and payable under the terms and conditions of this Agreement and the applicable Additional Target Research Plan. | |||
b) | MASP-2 Replacement . Notwithstanding anything to the contrary contained in this Agreement or the Initial Research Plan, if Omeros determines that in performing the Services and providing the Deliverables described in Task 1 of the Initial Research Plan North Coast did not [], then (i) unless agreed to in writing by Omeros, North Coast shall continue to perform the Services until delivery of the Deliverables under the Initial Research Plan in order to achieve the Overall Objective described in the Initial Research Plan (including, without limitation, reperforming any Services and Deliverables in Task 1 of the Initial Research Plan) and (ii) at Omeros discretion, upon written notice from Omeros to North Coast (the MASP-2 Replacement Notice ), the Parties will enter into an Additional Target Research Plan for an Additional Target selected by Omeros on the terms and conditions set forth in Section 2.2.a, except that (1) Omeros will not be required to pay a Subsequent Access Fee with respect to such Additional Target and (2) such Additional Target will not be counted for purpose of determining how many remaining Additional Targets are subject to the Option under Section 2.2.a; provided, however, that North Coast will not be required to enter into an Additional Target Research Plan for an Additional Target pursuant to this Section 2.2.b(ii) unless Omeros gives North Coast the MASP-2 Replacement Notice before the date that North Coast provides Omeros a |
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Lead Candidate under the Initial Research Plan that meets the applicable Acceptance Criteria and all of the related Services and Deliverables. | |||
If Omeros provides North Coast a timely MASP-2 Replacement Notice under Section 2.2.b(ii) and the Parties enter into an Additional Target Research Plan under Section 2.2.b(ii) for an Additional Target then, notwithstanding anything to the contrary contained in Section 2.4, Omeros may not require North Coast to enter into an Additional Research Plan under Section 2.4(b) if North Coast fails to deliver to Omeros either the First Due Date Deliverables within ninety (90) days of the First Due Date under the Initial Research Plan or the Second Due Date Deliverables within ninety (90) days of the Second Due Date under the Initial Research Plan; provided, however, that the preceding limitation to Omeros rights under Section 2.4(b) shall only apply with respect to the Initial Research Plan and not any other Research Plans. | |||
c) | []. | ||
d) | FMAT Machine . North Coast acknowledges receipt of [] from Omeros on October 21, 2008 (the FMAT Payment ), which amount North Coast used to [] the purchase price of a Fluorometric Microvolume Assay Technology machine (the FMAT ). As consideration for the FMAT Payment, notwithstanding anything to the contrary contained in this Agreement: | ||
2.2.d.1 The Additional Target for which Omeros exercises its Option (but not including the Additional Target that Omeros selects pursuant to Section 2.2.b, if any, which will be subject to the terms and conditions of Section 2.2.b) and designates in writing at the time of such exercise as being linked to the FMAT Payment (the FMAT Target ) shall be subject to the terms and conditions of Section 2.2.a, except that (i) Omeros will not be required to pay any Development Milestone Payments or Sales Royalties with respect to any Omeros Therapeutic that is developed under the Additional Target Research Plan for the FMAT Target, (ii) the FMAT Target will not be counted for purpose of determining how many remaining Additional Targets are subject to the Option under Section 2.2.a and (iii) unless North Coast has delivered to Omeros the FMAT Repayment Amount (as defined below) prior to Omeros exercise of its Option for the FMAT Target, if the FMAT Target is the first Additional Target selected by Omeros during a calendar year in which a Subsequent Access Fee would be payable by Omeros under Section 3.1.a.2, then, notwithstanding anything to the contrary contained in this Agreement, Omeros will not be required to pay a Subsequent Access Fee for the FMAT Target and for purposes of determining the Subsequent Access Fee under Section 3.1.a.2 for any Additional Target selected during the same calendar year or in any subsequent calendar year(s), Omeros shall be given credit for the payment of a Subsequent Access Fee during the calendar year in which it exercised its option for the FMAT Target. The FMAT Repayment Amount is an amount equal to the FMAT Payment plus interest on such amount calculated from the date of this Agreement on the basis of a three hundred sixty (360) day period at a per annum rate equal to the interest rate of []. |
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If the FMAT Target is the first Additional Target selected by Omeros during a calendar
year in which a Subsequent Access Fee would be payable by Omeros under Section 3.1.a.2,
and if upon Omeros exercise of its Option and designation of the FMAT Target, North
Coast reasonably determines that it would be financially unable to provide the required
services for generation of antibodies against the FMAT Target in accordance with the
applicable Additional Target Research Plan, North Coast may request that Omeros pay the
otherwise applicable Subsequent Access Fee for the FMAT Target in accordance with
Section 3.1.a.2 and, unless Omeros elects not to proceed at that time with the FMAT
Target (in which case it may reserve election of an FMAT Target for a later time),
Omeros shall pay the otherwise applicable Subsequent Access Fee (the
FMAT Access Fee
).
If Omeros has paid the FMAT Access Fee, then upon Omeros written election either (a)
an amount equal to [] the FMAT Access Fee shall be credited against the first to become
due and payable of (i)
the Additional Target Antibody cDNA Fee for the FMAT Target or (ii) an Additional Target
Antibody cDNA Fee for another Additional Target, or
(b) the first Development Milestone that becomes due thereafter for the []. |
|||
If North Coast fails to deliver either the First Due Date Deliverables by the First Due Date specified in an Additional Target Research Plan or the Second Due Date Deliverables by the Second Due Date specified in an Additional Target Research Plan for the FMAT Target, then upon written notice to North Coast, Omeros shall have the right to designate any other Additional Target as the FMAT Target in place of the originally designated Additional Target, and all of the provisions in the above paragraph shall apply to the redesignated FMAT Target in place of the originally designated Additional Target, with North Coast being relieved of any further work on the originally designated Additional Target and Omeros being relieved of any further financial obligations concerning the originally designated Additional Target. | |||
2.2.d.2 []. | |||
[]. | |||
[]. | |||
2.2.d.3 Omeros shall be provided free use of and access to the FMAT machine at North Coasts facility in Omeros research and development programs, at times to be mutually agreed for convenience to both parties and without undue interruption of North Coasts activities. | |||
2.2.d.4 If under the terms and conditions of the Additional Target Research Plans for the first three (3) Additional Target for which Omeros exercises its Option (including the Additional Target(s) that Omeros selects pursuant to Section 2.2.b, if any, or this Section 2.2.d), North Coast fails to deliver either the First Due Date Deliverables by the First Due Date specified in any of such Additional Target Research Plans or the Second Due Date Deliverables by the Second Due Date |
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specified in such Additional Target Research Plan, then within thirty (30) days of receipt from Omeros of a written demand therefor, []. |
2.3 | Additional Services and Deliverables . North Coast and Omeros may mutually agree that additional Services not envisioned by the Initial Research Plan or an Additional Target Research Plan (if any) will be provided under this Agreement, which shall be specified in one or more additional research plans, including all additional Deliverables, any additional fee compensation payable and a timeline for performance, the Initial Research Plan, any Additional Target Research Plan and any additional research plans each referred to herein as a Research Plan . | |
2.4 | Failure to Provide Services and Deliverables by Due Date and Replacement Target . If North Coast fails to deliver to Omeros either the First Due Date Deliverables by within [] of the First Due Date specified in the Initial Research Plan or any Additional Target Research Plan (as applicable) or the Second Due Date Deliverables by within [] of the Second Due Date specified in such Initial Research Plan or any Additional Target Research Plan (as applicable), then Omeros in its sole discretion may: (a) terminate the Research Plan upon written notice to North Coast; provided, however, that if at any time after such [] Omeros has not terminated the Research Plan and North Coast provides Omeros a humanized Lead Candidate that meets the Acceptance Criteria and the related Services and Deliverables under the Research Plan, then Omeros may not terminate such Research Plan pursuant to this Section 2.4; and/or (b) select an Additional Target, in which case the Parties will enter into an Additional Target Research Plan for such Additional Target on the terms and conditions set forth in Section 2.2.a, except that (i) Omeros will not be required to pay a Subsequent Access Fee with respect to such Additional Target, (ii) Omeros will not be required to pay an Additional Target Antibody cDNA Fee with respect to the humanized Lead Candidate generated under such Additional Target Research Plan and (iii) such Additional Target will not be counted for purpose of determining how many remaining Additional Targets are subject to the Option under Section 2.2.a. | |
If Omeros is entitled under Section 2.4(a) to terminate a Research Plan but has not done so, then until it has exercised its right to terminate the Research Plan (1) North Coast will continue providing the Services and Deliverables described in the Research Plan and (2) North Coast and Omeros will communicate at least monthly to discuss any progress made by North Coast under the Research Plan and Omeros continued interest in having North Coast continue work under such Research Plan. If Omeros terminates a Research Plan in accordance with this Section 2.4, Omeros shall have no further obligations to North Coast with respect to any Services or Deliverables provided under such Research Plan (including, without limitation, any obligation to pay any fees in connection with such Research Plan such as Development Milestone Payments or Sales Royalties under Section 3). | ||
2.5 | Best Efforts. North Coast shall use its continuing best efforts to diligently complete all Services, to deliver all Deliverables and meet all milestones set forth in all Research Plans within the timeline set forth within the applicable Research Plans, and to achieve the Overall Objective, and shall ensure that all Services are carried out and Deliverables |
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generated and developed using staff that are fully qualified and in accordance with the prevailing professional standards of the industry. | ||
2.6 | Subcontracting . North Coast shall not subcontract with any other entity for the performance of any portion of the Services or for the provision of any Deliverables without Omeros express written consent. Any approval of a subcontract by Omeros does not grant the right to any approved subcontractor to further subcontract its obligations without first obtaining further express prior written consent of Omeros. Any approved subcontractor shall be subject to all of the terms applicable to the North Coast under this Agreement, provided that North Coast shall be responsible and remain liable for the performance of all obligations of North Coast under this Agreement and any breach thereof by any subcontractor. | |
2.7 | Compliance with Laws . North Coast shall comply with all applicable international, national, county and local laws, rules and regulations in providing the Services and delivering the Deliverables. North Coast shall promptly notify Omeros if any regulatory agency takes action against North Coast for any defect or deficiency, during the Term (as defined in Section 8.1) of this Agreement, or if any other adverse event occurs that materially limits North Coasts ability to complete the Services and provide the Deliverables. | |
2.8 | Transfer of Antibodies . North Coast shall assist Omeros and cooperate with transfer of the Chimeric Antibodies, Lead Candidates, Second Generation Candidates and Optional Candidates, their respective physical cDNAs, cDNA sequences in written and electronic form, antibody expression constructs and antibody expressing cell lines, as applicable, as well as the respective Records and Materials (as defined in Section 4.1.b) in physical and electronic form, to third party(ies) designated by Omeros for further development and/or manufacture of preclinical, clinical and commercial supplies of North Coast-Originated Antibodies. | |
3 | Payments and Royalties | |
3.1 | Payment Terms . As full and complete consideration for the Services and Deliverables, all licenses, intellectual property and other rights conveyed, and all obligations undertaken in accordance with this Agreement, Omeros shall pay North Coast the amounts set forth in this Section 3 upon satisfaction of the respective conditions for each payment. Any portion of the Services that reasonably need to be reperformed, or any Deliverables that reasonably need to be reproduced, due to no fault of Omeros shall be promptly reperformed or reproduced, if requested by Omeros, without added charge. |
a) | Technology Access Fees. | ||
3.1.a.1 Initial Access Fee. Omeros shall pay North Coast a fee of [] (the Initial Access Fee ) on invoice to be submitted upon execution of this Agreement for access rights to North Coasts Pre-existing Intellectual Property and the New North Coast Intellectual Property (as such terms are defined in Sections 7.1 and 7.2.a, |
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respectively) to be used by North Coast for Omeros benefit in performing the Services described under the Initial Research Plan and any other Research Plans covering Additional Targets for which Omeros exercises its Option prior to [], and to permit Omeros to use, develop, commercialize, sell and distribute the Deliverables provided under the Initial Research Plan and any such other Research Plans. North Coast acknowledges receipt from Omeros on October 10, 2008 of [] as partial payment towards the Initial Access Fee, and agrees that the invoice for the Initial Access Fee shall show a credit to Omeros for such amount and the total amount owing to North Coast for the Initial Access Fee shall be []. The Initial Access Fee is payable by Omeros only one time regardless of how many such Research Plans Omeros and North Coast enter into, and regardless of how many antibodies North Coast generates against MASP-2 and any Additional Targets. | |||
3.1.a.2 Subsequent Access Fees . Subject to the terms and conditions of this Agreement, if at any time after [] (a) Omeros exercises its Option for an Additional Target and (b) such exercise is the first exercise by Omeros of its Option for any Additional Target during the then-current calendar year, then Omeros shall pay North Coast a fee (a Subsequent Access Fee ) on invoice, to be submitted upon mutual execution of the Additional Target Research Plan for such Additional Target, for access rights to North Coasts Pre-existing Intellectual Property and the New North Coast Intellectual Property to be used by North Coast for Omeros benefit in performing the Services described under such Additional Target Research Plan and any other Research Plans covering Additional Targets for which Omeros exercises its Option during such calendar year, and to permit Omeros to use, develop, commercialize, sell and distribute the Deliverables provided under such Additional Target Research Plan and any other such Research Plans. A Subsequent Access Fee is payable by Omeros only one time during such calendar year, regardless of how many Additional Targets Omeros exercises its Option for during a calendar year, and regardless of how many antibodies North Coast generates against any Additional Targets during such calendar year. The Subsequent Access Fee shall be: |
3.1.a.2.1 [] for the first calendar year after [] in which Omeros exercises its Option ( Calendar Year I ), | |||
3.1.a.2.2 [] for the first calendar year after Calendar Year I in which Omeros exercises its Option ( Calendar Year II ), and | |||
3.1.a.2.3 [] for the first calendar year after Calendar Year II in which Omeros exercises its Option ( Calendar Year III ). |
For purposes clarification, Calendar Year I can be any calendar year during the Option Period beginning with calendar year [], and Calendar Year I, Calendar Year II and Calendar Year III do not have to be successive calendar years. Notwithstanding anything in this Agreement to the contrary, Omeros shall not be required to pay a technology access fee (including any Subsequent Access Fees) with respect to any Additional |
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10
Targets for which Omeros exercises its Option after Calendar Year III; provided that in consideration of Omeros agreement to pay the Subsequent Access Fees during Calendar Year I, Calendar Year II and Calendar Year III, North Coast shall grant access rights to North Coasts Pre-existing Intellectual Property and the New North Coast Intellectual Property to be used by North Coast for Omeros benefit in performing the Services described under any Research Plans covering Additional Targets for which Omeros exercises its Option after Calendar Year III, and permit Omeros to use, develop, commercialize, sell and distribute the Deliverables provided under such Research Plans. |
b) | cDNA Fees . |
3.1.b.1 MASP-2 cDNA Fee . If, after North Coast provides all of the Services and Deliverables described in Section 2.3(a) of the Initial Research Plan with respect to [], then on invoice Omeros shall pay to North Coast a one-time fee of []. | |||
3.1.b.2 Optional MASP-2 Candidate cDNA Fee . If at Omeros written request North Coast generates a [], and after North Coast provides all of the Deliverables described in Section 2.3(a) of the Initial Research Plan with respect to [], then on invoice Omeros shall pay to North Coast a one-time fee of [] (the Optional MASP-2 Candidate cDNA Fee ). Omeros shall pay North Coast an Optional MASP-2 Candidate cDNA Fee for each [] and for which North Coast has provided the Deliverables described in Section 2.3(a). | |||
3.1.b.3 Additional Target Antibody cDNA Fee . For each Additional Target, if after North Coast provides all of the applicable Services and Deliverables described in the applicable Additional Target Research Plan with respect to the applicable [], then on invoice Omeros shall pay to North Coast a one-time fee of [] (the Additional Target Antibody cDNA Fee ); provided, however, that Omeros and North Coast may agree at the time of execution of the applicable Additional Target Research Plan []. | |||
3.1.b.4 Optional Additional Target Antibody cDNA Fee . If at Omeros written request North Coast generates a [] under an Additional Target Research Plan, and after North Coast provides all of the Services and Deliverables described in the Additional Target Research Plan with respect to [], then on invoice Omeros shall pay to North Coast a one-time fee of [] (the Optional Additional Target Antibody cDNA Fee ). Omeros shall pay North Coast an Optional Additional Target Antibody cDNA Fee for each such humanized Optional Candidate requested by Omeros that []. |
c) | Additional Services and Deliverables . Fees for any additional Services and Deliverables not envisioned by this Agreement shall be as set forth in any amendments to this Agreement and shall be determined on a per project basis. | ||
d) | Development Milestone Payments . For each Omeros Therapeutic, Omeros shall pay North Coast the following one-time development milestone payments (each a Development Milestone Payment ) on invoice upon completion of the associated development activity (each a Development Milestone ) by Omeros or by a licensee of |
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11
Omeros for an Omeros Therapeutic. Omeros shall provide North Coast written notice of the completion of each Development Milestone by Omeros or Omeros licensee within thirty (30) days of such Development Milestone completion. The Development Milestone Payments that may become due for an Omeros Therapeutic shall be [], as set forth in the following table: |
Development Milestone | Development Milestone Payment [] for the Omeros Therapeutic []: | ||||||||||
Each no later | Each no later | Each no later | |||||||||
Each by the [] | than [] set | than [] set | than [] set | Each at least [] | |||||||
set forth in | forth in | forth in | forth in | set forth in | |||||||
applicable | applicable | applicable | applicable | applicable | |||||||
Research Plan | Research Plan | Research Plan | Research Plan | Research Plan* | |||||||
|
|||||||||||
[]
|
[] | [] | [] | [] | [] | ||||||
[]
|
[] | [] | [] | [] | [] | ||||||
[]
|
[] | [] | [] | [] | [] | ||||||
[]
|
[] | [] | [] | [] | [] |
* | Humanized Lead Candidate must meet applicable Acceptance Criteria []. |
e) | Royalties . For each Omeros Therapeutic, Omeros shall pay North Coast a royalty as a percentage of Net Sales of such Omeros Therapeutic (the Sales Royalty ). The applicable Sales Royalty rate that may become due for an Omeros Therapeutic shall be [], as set forth in the following table: |
Sales Royalties shall be paid on a [] within [] following the end of each [] for Net Sales realized during such []. Notwithstanding anything above in this Section 3.1.e, Omeros shall not be required to pay North Coast a Sales Royalty for Net Sales on a MASP-2 Therapeutic or an Additional Target Therapeutic realized during any period in a country or territory in which a third party, without license or other authority from Omeros, also sells or distributes a MASP-2 therapeutic or an Additional Target therapeutic, respectively, that infringes one or more claims of the Omeros Antibody Patents, provided that Omeros has acted with reasonable diligence in seeking to enforce the applicable Omeros Antibody Patents to enjoin such third party sales or distribution after discovery by Omeros of such third party sales or distribution. |
3.2 | Price Adjustments for Additional Targets . The Additional Target Antibody cDNA Fee, Optional Additional Target Antibody cDNA Fee and each Development Milestone Payment (collectively Fees ) shall remain fixed for all Additional Targets for which |
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Omeros exercises its Option on or before []. For any Additional Targets for which Omeros exercises its Option after [], the Fees will each be increased each year by the lesser of (a) [] and (b) the seasonally adjusted change in the Producer Price Index for pharmaceutical and medicine manufacturing (commodity code 32541) issued by the Bureau of Labor Statistics, U.S. Department of Labor ( PPI ) for the year ending immediately preceeding the year in which the Option is exercised. For example, if Omeros exercises its Option for an Additional Target in [], the Fees will be increased over the Fees payable in [] by the lesser of [] and the PPI for []. For an antibody requested in [], the Fees will be increased over the Fees payable in [] by (1) the lesser of [] and the PPI for [] and (b) the lesser of [] or the PPI for []. No other payments that may become due hereunder, including without limitation the Subsequent Access Fees and Sales Royalty rates, will be subject to increase pursuant to this Section 3.2. |
3.3 | Invoices . North Coast shall submit invoices to Omeros for payments, other than Sales Royalties that have become due. The terms of payment are [] after Omeros receipt of North Coasts invoice, or in the event that any invoice is disputed in good faith, [] after mutual agreement or other resolution is reached on the disputed invoice or receipt of a corrected invoice. Invoices shall reference this Agreement and the relevant Research Plan (as applicable) and specify the milestone payment or other fee that is being invoiced. Payment for Sales Royalties shall be made by Omeros concurrent with delivery of the Net Sales reports specified in Section 4.1.a. | |
Invoices shall be sent to Omeros by mail addressed to the following or subsequently updated address: |
|
Accounts Payable | |
|
Omeros Corporation | |
|
1420 Fifth Avenue, Suite 2600 | |
|
Seattle, WA 98101 |
North Coast shall provide and keep Omeros updated on invoice payment instructions, including wire transfer information or the payee and address for checks. | ||
3.4 | Obligation to Pay Taxes . Payments under this Agreement shall be made in full in the agreed amounts without deduction for taxes of any kind whatsoever. Any taxes that may be due and payable as a result of Omeros payments under this Agreement are solely North Coasts responsibility. | |
4 | Reports; Records; Audits; Inspections | |
4.1 | Reports and Record Maintenance . | |
a) By Omeros . Following the initial approval by a Regulatory Agency for the sale by Omeros or a licensee of Omeros of an Omeros Therapeutic, Omeros shall provide North Coast with a Net Sales report on a [] setting forth the quantity of sales of such Omeros Therapeutic, the gross monetary amounts invoiced and collected by either Omeros or by a licensee of Omeros (and reported to Omeros during such []) for the initial distribution or |
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sale of such Omeros Therapeutic, and the total of all deductions provided for in Section 1.9 during such [], within [] following the end of each [] for Net Sales realized during such []. | ||
b) By North Coast . North Coast shall provide Omeros written status reports regarding its progress on all uncompleted Research Plans on an at least [] commencing [], with each report due within [] of the end of the preceding []. North Coast shall maintain complete and accurate written and electronic records, accounts, notes, reports and data, and materials, including, without limitation, B cell cultures, culture supernatants, sequence information, expression construct DNA and viable clones of all Chimeric Antibodies, Lead Candidates, Optional Candidates and Second Generation Candidates (as applicable) and any other records and materials listed in Section 2.8, relating to its performance of the Research Plans (the Records and Materials ) for the longer of the following minimum periods: (i) all Records and Materials related to North Coast-Originated Antibodies or Omeros Therapeutics approved by FDA for marketing shall be retained by North Coast for at least two (2) years after such FDA approval; (ii) all Records and Materials related to North Coast-Originated Antibodies or Omeros Therapeutics for which Omeros submits an IND will be retained by North Coast for at least five (5) years after such submission; and (iii) all records related to North Coast-Originated Antibodies or Omeros Therapeutics for which Omeros notifies North Coast that an IND has not been filed and is not planned to be filed shall be retained by North Coast for at least [] following North Coast receipt of notice of such determination from Omeros. North Coast shall notify Omeros at least [] before any Records and Materials are to be disposed of or destroyed. If at any time Omeros requests receipt of all or any portion of the original Records and Materials, North Coast shall send such original Records and Materials to Omeros at Omeros reasonable expense. | ||
4.2 | Audit of Omeros Books . North Coast shall have the right to employ a certified public accountant to review and reconcile the directly relevant accounting records and procedures of Omeros solely as they relate to the determination of Sales Royalties, during reasonable business hours and no more than [] a year, and Omeros agrees to make available at Omeros place of business all such directly relevant accounting records for that purpose within [] of written request by North Coast. The cost of such review shall be borne by North Coast, unless it is found that Omeros under-paid a [] Sales Royalty for any [] by an amount of [] or greater, in which case the cost of such review shall be borne by Omeros. | |
4.3 | Visits, Audits and Inspections . Omeros representatives may visit North Coasts facilities at reasonable times and with reasonable frequency during normal business hours to observe the progress of the Services and Deliverables under any Research Plan, within [] of written request. North Coast shall assist Omeros in scheduling and implementing such visits. During the visits, Omeros representatives may examine all Records and Materials, facilities and equipment that pertain to any Services and Deliverables, and any other relevant resources pertaining to any Research Plan, as well as any other audit reports prepared by or on behalf of North Coast with respect to quality audits of such relevant |
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resources. If North Coast receives a request from any Regulatory Agency to inspect any portion of North Coasts facilities related to the performance of any Services and Deliverables, North Coast shall notify Omeros in advance and provide Omeros an opportunity, at Omeros expense, to participate in such inspection, and shall fully inform Omeros of the results of such inspection. | ||
5 | Samples | |
5.1 | Use of Samples . Omeros shall transfer to North Coast the sufficient or requested quantities of proteins, reagents, antibodies and/or other materials involved in the Services as specified in any Research Plan ( Samples ). Omeros shall provide all pertinent information known to Omeros regarding the Samples to the extent necessary for carrying out any Research Plan. North Coast shall be responsible for and bear the expense of obtaining any other chemicals, materials, equipment, animals and facilities needed to conduct the Services and produce the Deliverables. North Coast shall not use or analyze any Samples provided under this Agreement except as necessary to carry out the relevant Research Plan and shall not administer or permit the Samples to be administered to any person. After completion of the Services, North Coast shall either return the Samples to Omeros or dispose of the Samples, upon written request by Omeros and at Omeros risk and expense. North Coast accepts full responsibility for safe handling of all Samples or other compounds or materials used in the performance of the Services and shall be responsible for any loss or destruction of the Samples after delivery to North Coast. | |
5.2 | Ownership of Samples . The Samples are and shall remain the sole property of Omeros and nothing in this Agreement shall be construed as granting to North Coast, by implication or otherwise, any right or license with respect to the Samples, or any patent or other intellectual property rights with respect to the Samples, except as required to complete the Services and generate the Deliverables, and North Coast shall not file applications or otherwise seek any proprietary rights in respect of the Samples or any Confidential Information (as that term is defined in Section 6.1) that Omeros provides under this Agreement. | |
6 | Confidentiality and Non-use | |
6.1 | As used in this Agreement, Confidential Information shall mean any Samples, other materials, data, research, development, manufacturing, marketing, financial, personnel, sales, business, and other non-public, proprietary or technical information provided by a disclosing Party (the Disclosing Party ) to a receiving Party (the Recipient ), including, without limitation, all Deliverables, Records and Materials (which shall be considered Omeros Confidential Information even if generated or provided by North Coast), except any portion of such information that the Recipient establishes: | |
a) is or becomes generally available to the public or within the industry to which such information relates, other than as a result of a breach of this Agreement; or | ||
b) is known by Recipient at the time of receipt of the Disclosing Partys information, as evidenced by Recipients contemporaneous written records; or |
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c) is provided to Recipient on a non-confidential basis by a third party who has the legal right to make such disclosure; or | ||
d) was or is independently developed by or for Recipient without access to or use of the information of the Disclosing Party, as evidenced by Recipients contemporaneous written records. | ||
6.2 | Obligations of Confidentiality and Non-use . Each Party agrees that the Disclosing Party has and shall retain sole and exclusive rights of ownership of all Confidential Information disclosed or owned by such Party. Each Recipient agrees that during the Term of this Agreement and for [] thereafter it will not use any Confidential Information of the Disclosing Party except for the purposes of performing under this Agreement, unless otherwise agreed by the Parties in writing. Each Recipient agrees not to disclose any Confidential Information of the Disclosing Party to others (except to Recipients employees, consultants, professional advisors, agents and Affiliates who reasonably require disclosure of such Confidential Information to achieve the purposes of this Agreement and who are bound to the Recipient by like obligations as to confidentiality and non-use no less stringent than those set forth herein) during the Term of this Agreement and for [] thereafter without the prior written consent of the Disclosing Party. North Coast agrees that with respect to the Records and Materials, which are included in Omeros Confidential Information, these obligations of non-use and confidentiality shall subsist beyond [] after the termination of this Agreement. Each Party agrees to maintain and follow reasonable procedures to prevent unauthorized disclosure or use of the other Partys Confidential Information and to prevent it from becoming disclosed or being accessed by unauthorized persons. Each Party agrees that it may disclose to authorized persons only such Confidential Information of the Disclosing Party as is necessary for each such authorized person to perform his/her responsibilities under this Agreement. Recipient shall advise the Disclosing Party of any disclosure, loss, or use of Confidential Information of the Disclosing Party in violation of this Agreement as soon as practicable. Each Party agrees to return or destroy the Confidential Information of the other Party, whether in written, graphic, electronic or other tangible form, upon written request, provided, however, that legal counsel for each Party may retain an archival copy of Confidential Information solely for purposes of ensuring compliance with this Agreement. | |
6.3 | Disclosure of this Agreement . The terms of this Agreement shall be considered each Partys Confidential Information, and accordingly except for disclosures expressly permitted under this Agreement, neither Party may release any information to any third party regarding the terms of this Agreement without the prior written consent of the other Party. Notwithstanding the foregoing, the terms of this Agreement may be disclosed by either party to its existing or potential investors, acquirers, merger partners, commercial partners, shareholders, directors, officers and professional advisors as long as such individuals or entities are subject to similar conditions of confidentiality. | |
6.4 | Permitted Disclosures . Notwithstanding anything to the contrary, a Party may disclose Confidential Information of the other Party, including, without limitation, the terms of this |
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Agreement, to the extent such disclosure is reasonably necessary: (a) to secure patent protection for an Intellectual Property Right developed pursuant to this Agreement consistent with the ownership provisions set forth in Section 7; (b) to comply with applicable laws or regulations, the requirements of any Regulatory Agency or other regulatory or governmental authority, including, without limitation, FDA, the US Securities and Exchange Commission, the Federal Trade Commission and/or the Department of Justice, or judicial order from a court of competent jurisdiction; or (c) as necessary for Omeros to conduct pre-clinical studies, clinical trials, achieve the Overall Objective or to seek regulatory approval to market Omeros Therapeutics. Prior to making any such permitted disclosures, however, the Recipient shall give reasonable advance notice to the Disclosing Party with as much detail as possible in relation to the disclosure. Each Party agrees that it shall cooperate fully and in a timely manner with the other Party with respect to all such permitted disclosures, including determining what information should be released and requests for confidential treatment of Confidential Information of either Party included in any such disclosure where possible; provided that in no event shall a Party be required to delay any filing or release unreasonably hereunder. | ||
6.5 | Remedies . Because of the unique nature of the Confidential Information, each Recipient acknowledges and agrees that the Disclosing Party may suffer irreparable injury if the Recipient fails to comply with the obligations set forth in this Section 6, and that monetary damages may be inadequate to compensate the Disclosing Party for such breach. Accordingly, each Recipient agrees that the Disclosing Party will, in addition to any other remedies available to it at law, in equity or otherwise, without the requirement to post a bond, be entitled to seek injunctive relief and/or specific performance to enforce the terms, or prevent or remedy the violation, of this Section 6. This provision shall not constitute a waiver by either Party of any rights to damages or other remedies which it may have pursuant to this Agreement or otherwise. | |
7 | Intellectual Property; Licenses | |
7.1 | Pre-existing Intellectual Property . Except as expressly provided in this Section 7, neither Party shall, as a result of this Agreement, acquire any right, title, or interest in any Intellectual Property Rights that the other Party owned, licensed or controlled as of the Effective Date of, or that the other Party obtains ownership, license or control of separate and apart from the performance of, this Agreement (each Partys Pre-existing Intellectual Property ). | |
7.2 | New Intellectual Property |
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7.3 | Grant of License . North Coast hereby grants Omeros a non-exclusive, fully paid-up, irrevocable and transferable license, with the right to grant and authorize sublicenses, under (a) all of North Coasts Pre-existing Intellectual Property, and (b) all New North Coast Intellectual Property, to the extent that North Coasts Pre-existing Intellectual Property or the New North Coast Intellectual Property is necessary, useful or beneficial to |
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express, modify, formulate, manufacture, test, develop, market, commercialize, make, have made, use, sell, import, and distribute any Deliverable called for in any Research Plan, any North Coast-Originated Antibody and any Omeros Therapeutic. | ||
7.4 | Field Exclusivity . []. | |
8 | Term and Termination |
8.1 | Term . The term of this Agreement begins on the Effective Date and, unless earlier terminated as provided for below in this Section 8, continues in full force and effect until the later of (a) North Coasts satisfactory completion of all Services and delivery of all Deliverables described in all Research Plans, (b) the expiration of the Option Period and (c) the point in time at which there are no patent application(s) in the process of being prepared for filing, no pending patent applications and no valid and enforceable claim included within any patent, utility model or inventors certificate within (i) the Omeros Antibody Patents, (ii) North Coasts Pre-existing Intellectual Property that relates to any North Coast-Originated Antibody or any Omeros Therapeutic and (iii) the New North Coast Intellectual Property that relates to any North Coast-Originated Antibody or any Omeros Therapeutic (the Term ). | |
8.2 | Survival . The provisions of Sections 5-7, 8.2, 8.4, 9, 10 and 12-14 shall survive termination of this Agreement. | |
8.3 | Termination for Cause . Either Party may terminate this Agreement at any time in the event that the other Party breaches any material obligation of this Agreement by first submitting written notice of breach to the breaching Party, which breach is not substantially cured within ninety (90) days of the receipt of such notice, followed by written notice of termination then being sent to the breaching Party. | |
9 | Representations and Warranties | |
9.1 | Authority . Each Party represents and warrants that it has full power and authority to execute, deliver and perform this Agreement, and that the terms of this Agreement do not conflict with any other contractual agreement or obligation to which it is a Party. | |
9.2 | Intellectual Property . North Coast represents and warrants that: |
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to the extent that the failure to give such prompt notice materially adversely affects the ability of the Indemnifying Party to defend the claim, action or suit). Promptly after the Indemnitee gives such written notice, the Indemnifying Party and the Indemnitee shall meet to discuss how to respond to such claim, action or suit. The Indemnifying Party shall control the defense of such claim, action or suit. The Indemnitee shall cooperate with the Indemnifying Party in the defense of such claim, action or suit, at the expense of the Indemnifying Party. In any such proceeding, the Indemnitee shall also have the right to retain its own counsel at its own expense. The Indemnifying Party shall not be liable for damages with respect to a claim, action or suit settled or compromised by the Indemnitee without the Indemnifying Partys prior written consent. No offer of settlement, settlement or compromise by the Indemnifying Party shall be binding on an Indemnitee without the Indemnitees prior written consent (which consent shall not be unreasonably withheld, conditioned or delayed), unless such settlement fully releases the Indemnitee without any liability, loss, cost or obligation to such Indemnitee, provided, however, that the Indemnifying Party shall have no authority to take any action as part of any such defense or settlement that invalidates or otherwise compromises or renders unenforceable any of the Indemnitees Intellectual Property Rights without the Indemnitees express prior written consent. | ||
10.3 | Limitation of Liability . Without limitation of any Partys obligations to indemnify third party Claims under Section 10.1, neither Party shall be liable for any indirect, consequential, exemplary or incidental damages arising under or in association with this Agreement, except for any such liability arising from fraud by the Party or from any breach of the Partys obligations regarding Confidential Information or Intellectual Property Rights under this Agreement. | |
11 | Insurance | |
Each Party will procure and maintain, at its own expense, for the duration of the Agreement, and for [] thereafter if written on a claims made or occurrence reported form, the types of insurance specified below with carriers rated [] with A. M. Best or like rating agencies, at levels at all times commensurate with those standard in the industry for like companies at like stages of development but in any event no less than the following levels: |
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12 | Use of Names | |
Except as may be required by law or regulation after first providing reasonable advance notice to the other Party, neither Party may use the other Partys name in any promotional, advertising or other materials without the prior written consent of the other Party. North Coast hereby consents to Omeros disclosure of North Coasts name in connection with the provision of the Services and the Deliverables under this Agreement to Omeros current and potential employees, consultants, directors, shareholders, investors and partners, and to any Regulatory Agency or other regulatory authority including, without limitation, FDA and the US Securities and Exchange Commission. | ||
13 | Notices | |
Any notice required or permitted to be given hereunder by either Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by an internationally recognized courier service guaranteeing next-day delivery, charges prepaid, or (d) delivered by facsimile (with the original promptly sent by any of the foregoing manners) to the address or facsimile number of the other Party set forth below, or at such other address as may from time to time be furnished by notice by either Party. The effective date of any notice hereunder shall be the date of receipt by the receiving Party. |
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If to Omeros: | If to North Coast: | ||
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Omeros Corporation | North Coast Biologics LLC | ||
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1420 Fifth Avenue | 2815 Eastlake Avenue East | ||
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Suite 2600 | #300 | ||
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Seattle, WA 98101 | Seattle, WA 98102 |
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Attention: CEO | Attention: President | ||
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And copy to: General Counsel | |||
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Fax: 206.676.5005 | Fax: | ||
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Phone: 206.676.5000 | Phone: 206.605.0106 |
14 | Miscellaneous | |
14.1 | Integration . This Agreement including all Research Plans, appendices and exhibits attached thereto or incorporated by reference therein constitutes the entire understanding of the Parties hereto regarding the subject matter of this Agreement, and no other representation, agreement, promise or undertaking altering, modifying, taking from or adding to the terms of this Agreement shall have any effect unless the same is reduced to writing and duly executed by the Parties hereto. In the event of any conflict between the main body of this Agreement and any attachments thereto or documents incorporated by reference therein, the provisions of the main body of this Agreement shall control. Without limiting the foregoing, upon execution of this Agreement (a) the Mutual Confidentiality Agreement between the Parties dated as of June 10, 2008 shall terminate, except that the Parties obligations with respect to each others Confidential Information (as defined therein) disclosed prior to the date of this Agreement shall remain subject to the terms and condition of such agreement and (b) the FMAT Agreement between the Parties dated October 21, 2008 shall be terminated and of no further force or effect. | |
14.2 | No Waiver . Either Partys failure to enforce any provision of this Agreement will not be considered a waiver of future enforcement of that or any other provision. | |
14.3 | Governing Law . The laws of the State of Washington, without regard to its conflict-of-laws provisions, shall govern this Agreement, its interpretation and its enforcement, and any disputes arising out of or related to this Agreement. | |
14.4 | Arbitration . The Parties agree that, except as provided herein below, any claim or controversy arising out of or relating to this Agreement or breach thereof shall be settled by arbitration in King County in the State of Washington, in accordance with the commercial rules of the American Arbitration Association by a panel of three arbitrators, one selected by each Party and the third selected by the other two arbitrators. In any such arbitration proceeding, judgment upon the award rendered by the arbitrator shall be final and binding upon the Parties and may be entered by either Party in any court or forum of competent jurisdiction as provided herein below. Notwithstanding the foregoing, both Parties agree that any claims or controversies concerning the infringement, validity or enforceability of any Intellectual Property Rights, or the actual or threatened disclosure or misuse of any Confidential Information, may alternately be resolved by a civil action in the court of competent jurisdiction specified in Section 14.5, and both Parties further agree that each shall retain the right to seek injunctive relief in the court of competent jurisdiction specified in Section 14.5 to prevent a breach, threatened breach or continuing breach of this Agreement that would cause irreparable injury, including, without limitation, breaches |
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of confidentiality, infringement of Intellectual Property Rights or breach of Section 7.4 (Field Exclusivity). |
14.5 | Jurisdiction and Venue . Any civil action prosecuted or instituted by either Party as permitted herein above with respect to any matters arising out of or related to this Agreement shall be brought in either the United States District Court located in King County the State of Washington (if federal subject matter jurisdiction therein lies) or the Superior Court for King County in the State of Washington, and each Party hereby consents to the exclusive jurisdiction and venue of such courts for such purposes. | |
14.6 | Attorneys Fees . In the event that it is necessary for either Party to take legal action to enforce any of the terms, conditions or rights contained herein, or to defend any such action, then the prevailing Party in such action shall be entitled to recover from the other Party all reasonable attorneys fees, costs and expenses related to such legal action. | |
14.7 | Severability . In the event that any portion of this Agreement is held invalid or unenforceable by a court of law, that provision will be construed and reformed to permit enforcement of the provision to the maximum extent permissible consistent with the Parties original intent, and if such construction is not possible, such provision shall be struck from this Agreement, and the remainder of the Agreement shall remain in full force and effect as if such provision had never been part of this Agreement. | |
14.8 | Independent Contractors . For the purposes of this Agreement, the Parties hereto are independent contractors, and nothing in this Agreement shall be construed to place them in the relationship of partners, principal and agent, employer/employee or joint venturers. Except as provided expressly herein, each Party agrees that it shall have no authority to bind or obligate the other Party, nor shall any Party hold itself out as having such authority. | |
14.9 | Force Majeure . Neither Party will be liable for failure or delay in performing any obligation under this Agreement, or will be considered in breach of this Agreement, if such failure or delay is due to a natural disaster or any cause reasonably beyond such Partys control, provided that such Party resumes performance as soon as possible following the end of the event that caused such delay or failure of performance. | |
14.10 | Assignment . Neither Party may assign this Agreement, or any obligation or right under this Agreement, in whole or in part, without the other Partys prior written consent, which consent will not be unreasonably withheld. This Section shall not be construed in any way to limit Omeros rights to grant, at Omeros sole discretion, sublicenses hereunder. Each Party hereby consents to the other Partys assignment of this Agreement in whole or in part to any successor in interest of the assigning Party as part of a merger, acquisition, other change of control or together with a sale, transfer or other conveyance of all or substantially all of that part of the assigning Partys assets that pertain to this Agreement. Each Partys obligations and rights under this Agreement will be binding upon and will inure to the benefit of the Parties permitted successors and assignees. | |
14.11 | Counterparts . This Agreement may be executed in one or more counterparts, each of |
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[]
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[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
4
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
5
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
6
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
7
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
8
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
9
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
10
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
11
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
12
Target | mAb | TA | Indication | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] | |||
[]
|
[] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
13
Target | POC Reagent | TA | Indication | Institution/Company | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
1
Target | POC Reagent | TA | Indication | Institution/Company | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
||||||||
[]
|
||||||||
[]
|
||||||||
[]
|
||||||||
[]
|
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
2
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
1
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
2
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
[] | [] | [] | [] | ||||
[]
|
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NORTH COAST BIOLOGICS LLC | OMEROS CORPORATION | |||||||
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By: /s/ Johnny Stine
Name: Johnny Stine |
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Gregory A. Demopulos, M.D. |
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Title:
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President | Title: | Chairman & CEO |
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| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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NORTH COAST BIOLOGICS LLC | OMEROS CORPORATION | |||||||
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1 | Definitions | |
1.1 | Intellectual Property Rights shall mean all inventions, ideas, discoveries, issued, reissued or reexamined patents, pending and future patent applications, continuation, continuation-in-part and divisional patent applications, utility models, inventors certificates, trade secrets, know-how, copyrights and trademarks. | |
1.2 | Assigned Patents shall mean US Provisional Patent Application No. 60/911,201 filed April 11, 2007, US Patent Application No. 12/101,943 filed April 11, 2008, International Patent Application PCT/US08/60146 filed April 11, 2008, all national and regional counterparts of such International Patent Application, all patent applications claiming priority from the foregoing patent applications, a provisional US Patent Application to be filed based on a disclosure provided to Omeros on November 11, 2008 by Dr. Ciccocioppo entitled Pioglitazone and Opiates and corresponding US Utility, International PCT and national phase applications claiming priority therefrom, all other patent applications and patents included as of the Effective Date or during the term of this Agreement in the Assigned IP, all future patents, utility models and inventors certificates issuing from all of the above patent applications, and all divisionals, continuations, continuation-in-parts, reissues and reexaminations of all such patent applications and patents. | |
1.3 | Assigned IP shall mean Dr. Ciccocioppos entire right and title to and interest in all Intellectual Property Rights owned or held by Dr. Ciccocioppo related to PPAR g agonists, compositions containing PPAR g agonist(s) alone or in combination with other |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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therapeutic agents, and therapeutic methods and uses for PPAR g agonists and compositions containing PPAR g agonist(s) alone or in combination with other therapeutic agents, whether such compositions are administered alone or in conjunction with other therapeutic agents or modalities, as of the Effective Date or invented, developed, advanced or improved by Dr. Ciccocioppo during the term of this Agreement, including, without limitation, methods and compositions for the use of PPAR g agonists, singly or in combination and/or in conjunction with other therapeutic agents, for prevention and treatment related to alcoholism and addictive disorders (e.g., addictions to alcohol, nicotine, marijuana, opioid agonists, benzodiazepine, barbiturates, psychostimulants and addictive or compulsive behaviors), and the use of PPAR g agonists in combination and/or in conjunction with the administration of narcotic analgesics (e.g., to delay or prevent the development of tolerance and/or addiction to opioid agonists) or for the treatment of other central nervous system conditions, diseases and disorders, and all improvements or inventions related to the foregoing examples, the Assigned Patents and all inventions disclosed and/or claimed in the Assigned Patents, and the future right to file US, ex-US and international patent applications for any other inventions that are included in the Assigned IP or that become included in the Assigned IP during the term of this Agreement, in Dr. Ciccocioppos name or in the name of Omeros, as well as all patents issuing from such patent applications. | ||
1.4 | Subject Products shall mean all therapeutic compositions including one or more PPAR g agonists, alone or in combination with other therapeutic agents, that, if offered for sale, sold, manufactured or used by a third party without license from Omeros would infringe any valid, subsisting and enforceable claim(s) of any issued patent or any patentable claim(s) of any pending patent application included within the Assigned Patents in the country or countries in which such compositions are offered for sale, sold, manufactured or used. | |
1.5 | Net Sales shall refer, with respect to Subject Products, to (a) the gross total of the monetary compensation invoiced and collected by Omeros for the initial sale or distribution of the Subject Products, but excluding any amounts invoiced or collected by parties other than Omeros for subsequent sales or distribution provided no part of such amounts invoiced or collected by such parties is directly or indirectly paid to Omeros, less (b) the sum of the following actual and customary deductions where applicable: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes, and any other governmental taxes imposed on particular sales; transportation charges and allowances; sales commissions to third parties (but excluding sales commissions to Omeros employees); wholesale charge backs; distributor fees; Medicare/Medicaid rebates; customer rebates; refunds for recalls; and allowances or credits to customers because of rejections or returns, provided such deductions are documented. For purposes of this paragraph, the acquisition of Subject Products from Omeros as part of an acquisition or other transfer or conveyance of all or a part of the assets of Omeros business to which this Agreement pertains, or as part of a merger, acquisition, reorganization or other change of control of Omeros, shall not be considered a sale or distribution of Omeros Therapeutics. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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If a Subject Product is sold in combination with one or more additional therapeutic agents as a Combination Product , Net Sales shall be the product obtained by multiplying Net Sales of the Combination Product by the fraction A/(A+B) where A is the sales price of such Subject Product when sold separately as a composition in which the Subject Product is the only therapeutic agent and B is the total sales price of all additional therapeutic agents in the Combination Product when sold separately in a pharmaceutical therapeutic product including such additional therapeutic agents as the only therapeutic agents. If such Subject Product and the other therapeutic agents are not sold in separate pharmaceutical therapeutic products, the portion of the total cost of the Combination Product attributed to such Subject Product shall be a fraction, the numerator of which shall be the cost of the Subject Product and the denominator of which shall be the total cost of the Combination Product, and the fraction shall be multiplied by the sales price of the Combination Product to arrive at Net Sales. | ||
1.6 | Transfer Fees shall mean any monetary compensation received by Omeros in connection with the licensing, assignment or other conveyance of rights in the Assigned IP to third parties for the manufacture, sale or distribution of Subject Products; provided, however, that the Transfer Fees shall not include Net Sales or any compensation from such third parties to Omeros to support Omeros research and development efforts, to resolve patent infringement disputes concerning the Assigned IP or other Intellectual Property Rights, to purchase equity in Omeros, for licensing under any other Intellectual Property Rights not included in Assigned IP, or for any other purpose other than as direct compensation for the rights conveyed to such third parties in the Assigned IP. | |
2 | Assignment of Rights | |
2.1 | In consideration of the obligations undertaken by Omeros in this Agreement, Dr. Ciccocioppo hereby sells, assigns and transfers to Omeros Dr. Ciccocioppos entire right and title to and interest in the Assigned IP, including, without limitation, the Assigned Patents and all other inventions, patent applications, patents and other Intellectual Property Rights included therein, to be held and enjoyed by Omeros entirely as the same would have been held and enjoyed by Dr. Ciccocioppo had this sale, assignment and transfer not been made. Dr. Ciccocioppo further agrees to execute any memorandum of assignment or other assignment documents as may be necessary or requested by Omeros to document and perfect Omeros title in the Assigned IP including, without limitation, the Assigned Patents and all other inventions, patent applications, patents and other Intellectual Property Rights included therein. | |
3 | Royalty and Transfer Fee Share Payments | |
3.1 | During the term of this Agreement Omeros shall pay Dr. Ciccocioppo on a [ ] basis a royalty of [ ] of the Net Sales of Subject Products collected by Omeros during each respective [ ] (the Royalty ); provided, however, that all Royalty payments owed by Omeros to Dr. Ciccocioppo under this Section 3.1 shall be shared between and payable to Dr. Ciccocioppo and Università di Camerino in accordance with Section 5 below, without increase to the total Royalty owed by Omeros. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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3.2 | During the term of this Agreement Omeros shall pay Dr. Ciccocioppo on a [ ] basis a share (the Transfer Fee Share ) of any Transfer Fees collected by Omeros during each respective quarter; provided, however, that all Transfer Fee Share payments owed by Omeros to Dr. Ciccocioppo under this Section 3.2 shall be shared between and payable to Dr. Ciccocioppo and Università di Camerino in accordance with Section 5 below, without increase to the total Transfer Fee Share owed by Omeros. The Transfer Fee Share shall be (a) [ ] of any Transfer Fees collected by Omeros pursuant to an agreement between Omeros and a third party that is executed prior to [ ] for a Subject Product or (b) [ ] of any Transfer Fees collected by Omeros pursuant to an agreement between Omeros and a third party that is executed on or after [ ] for a Subject Product. | |
3.3 | [ ] Royalty and Transfer Fee Share payments shall be made in US Dollars by Omeros to Dr. Ciccocioppo within [ ] following the end of each [ ] for Net Sales realized during such [ ] . Payments shall be computed based on a conversion from any other denomination to US Dollars for any amounts collected by Omeros during the relevant [ ] using the prevailing exchange rate in effect at the date and time that funds are transferred from Omeros account to Dr. Ciccocioppos account (in the case of payment by wire transfer) or at the date and time of issuance of a check by Omeros (in the case of payment by check). Each [ ] payment shall be accompanied by a report specifying the source of the Royalty payments and/or the Transfer Fee Share payments. | |
3.4 | Dr. Ciccocioppo shall have the right to employ a certified public accountant to review and reconcile the directly relevant accounting records and procedures of Omeros as they relate to the determination of Royalty and/or Transfer Fee Share payments, during reasonable business hours and no more than [ ] a year, and Omeros agrees to make available at Omeros place of business all such directly relevant accounting records for that purpose within [ ] of written request by Dr. Ciccocioppo. The cost of such review shall be borne by Dr. Ciccocioppo, unless it is found that Omeros under-paid a [ ] Royalty or Transfer Fee Share for any [ ] by an amount of [ ] or greater, in which case the cost of such review shall be borne by Omeros. | |
3.5 | Payments under this Agreement shall be made in full in the agreed amounts less any tax withholdings that Omeros is required by law to withhold; provided that any other taxes that may be due and payable as a result of Omeros payments to Dr. Ciccocioppo under this Agreement are solely Dr. Ciccocioppos responsibility. | |
4 | Milestone Payments | |
4.1 | Omeros shall pay Dr. Ciccocioppo the following one-time development milestone payments (each a Milestone Payment ) upon completion by Omeros of the associated development activity (each a Development Milestone ); provided, however, that all Milestone Payments owed by Omeros to Dr. Ciccocioppo under this Section 4.1 shall be shared between and payable to Dr. Ciccocioppo and Università di Camerino in accordance with Section 5 below, without increase to the total Milestone Payment owed by Omeros. Omeros shall provide Dr. Ciccocioppo written notice of the completion of each Development Milestone by Omeros within [ ] of completion of such Development |
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Milestone and shall pay to Dr. Ciccocioppo the associated Milestone Payment within [ ] of completion of such Development Milestone. For purposes of clarity, upon payment of a Milestone Payment in connection with the completion of the associated Development Milestone for the development of a first Subject Product, no further Milestone Payments for completion of the same associated Development Milestone for subsequent Subject Products shall be payable. |
Development Milestone | Milestone Payment | |
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5 | University Payment Share | |
5.1 | Omeros and Dr. Ciccocioppo acknowledge that Dr. Ciccocioppo invented certain of the inventions included in the Assigned IP during the term of his employment with, and using the facilities of, Università di Camerino. In accordance with an arrangement between Dr. Ciccocioppo and Università di Camerino, [ ] of each Royalty payment, Transfer Fee payment and Milestone Payment payable in accordance with Sections 3 and 4 of this Agreement shall be paid to Università di Camerino and the remaining [ ] of each Royalty payment, Transfer Fee payment and Milestone Payment payable in accordance with Sections 3and 4 of this Agreement shall be paid to Dr. Ciccocioppo. | |
5.2 | Payments to be made to the Università di Camerino shall be provided to [ ] by wire transfer in accordance with the following instructions: [ ] ( Dr. Ciccocioppo shall provide Omeros prompt written notice of any changes to the foregoing payment instructions during the term of this Agreement. | |
5.3 | Payments to be made to Dr. Ciccocioppo shall be remitted by a wire transfer in accordance with the following instructions: | |
[ ]. Dr. Ciccocioppo shall provide Omeros prompt written notice of any changes to the foregoing payment instructions during the term of this Agreement. | ||
6 | Right of Repurchase | |
6.1 | If, at any point in time during the term of this Agreement in which Omeros retains ownership of the Assigned IP or any part of the Assigned IP (the Retained Assigned IP ), Omeros affirmatively determines, at Omeros sole discretion and as documented in a written resolution by Omeros board of directors, to abandon all present and future activities related to the Assigned IP and associated PPAR g agonist programs, including, without limitation, all patent, research, development, clinical studies, partnering, licensing, transfer, regulatory, manufacturing, distribution and marketing activities, |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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Omeros will promptly after the adoption of such resolution provide Dr. Ciccocioppo a written notice of such determination (the Notice of Abandonment ) including a description of the Retained Assigned IP and the US dollar amount that equates to [ ] of the sum of all of Omeros financial investment in the Assigned IP and Omeros related PPAR g agonist research and/or development program(s) (the Repurchase Price ). For purposes of clarity, the Repurchase Price shall include [ ] of all of Omeros reasonably documented direct and indirect financial investments and expenditures, including both out-of-pocket costs and the monetized costs of internal resource utilization. Dr. Ciccocioppo shall have the first right to repurchase the Retained Assigned IP, exercisable by (a) providing Omeros written notice of Dr. Ciccocioppos intention to repurchase the Retained Assigned IP within [ ] of Dr. Ciccocioppos receipt of the Notice of Abandonment and (b) making payment in full to Omeros of the Repurchase Price within [ ] of Dr. Ciccocioppos receipt of the Notice of Abandonment. | ||
6.2 | Upon timely receipt of a notice of intention from Dr. Ciccocioppo and timely payment in full of the Repurchase Price by Dr. Ciccocioppo, Omeros shall sell, transfer and convey to Dr. Ciccocioppo all of Omeros rights and title to and interest in the Retained Assigned IP, and thereafter Omeros shall be entitled to the receipt of, and Dr. Ciccocioppo shall be obligated to pay Royalty payments, Transfer Fee Share payments and Milestone Payments from Dr. Ciccocioppo, on the same terms as provided for Dr. Ciccocioppo in Sections 3.1, 3.2 and 4.1 above, in connection with Subject Products within the scope of the Retained Assigned IP. | |
6.3 | If Dr. Ciccocioppo does not timely provide either a notice of intention to repurchase and/or timely payment in full of the Repurchase Price, Omeros shall be free to sell, transfer, assign or otherwise dispose of the Retained Assigned IP and the provisions of Sections 6.1 and 6.2 shall be of no further force or effect. | |
7 | Patent Prosecution, Maintenance and Enforcement | |
7.1 |
Omeros as sole owner of the Assigned IP shall have the sole right, at its sole discretion and
expense, to file, prosecute, maintain and enforce the patents and patent applications within
the Assigned IP. Any litigation or other enforcement action undertaken by Omeros to enforce
the Assigned IP against infringing third parties shall be undertaken at Omeros sole
discretion and risk, and any resulting award, judgment, settlement or damages collected shall
belong solely to Omeros without duty to account to or share with Dr. Ciccocioppo.
Dr. Ciccocioppo shall reasonably assist Omeros in the filing, prosecution, maintenance and enforcement of patents and patent applications within the Assigned IP for no additional compensation but at no cost to Dr. Ciccocioppo. Dr. Ciccocioppo shall execute all instruments and render all such assistance as Omeros may reasonably request in order for Omeros to file, prosecute, maintain and enforce any and all applications and patents within the Assigned IP, in the name of Omeros or in the name of Dr. Ciccocioppo, all without charge to Omeros but at no expense to Dr. Ciccocioppo. |
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7.2 | Dr. Ciccocioppo shall promptly provide written disclosure to Omeros of any inventions, |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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improvements, or applications included within the Assigned IP, made or arising before or during the term of this Agreement. Dr. Ciccocioppo shall promptly provide written disclosure to Omeros of any and all potentially material prior art known to Dr. Ciccocioppo prior to the Effective Date of this Agreement or that becomes known to Dr. Ciccocioppo during the term of this Agreement. | ||
8 | Publication | |
8.1 | Omeros and Dr. Ciccocioppo shall collaborate on any proposed scientific publications related to the subject matter of the Assigned IP, including a discussion of scientifically appropriate authorship and contents; provided, however, that Omeros acknowledges that only Dr. Ciccocioppo and his collaborators shall be entitled to be named as authors in connection with the publication of the results of research studies completed prior to the Effective Date of this Agreement. Dr. Ciccocioppo shall furnish Omeros with advance copies of any publication or written or oral public disclosure of the results of any research studies related to the Assigned IP that is proposed by Dr. Ciccocioppo, including, without limitation, disclosures in papers or abstracts or at research seminars, lectures, professional meetings, or poster sessions, at least [ ] prior to the proposed date for submission for publication or disclosure. During such [ ] , Omeros shall have the right to review and comment on such publication for accuracy and protection of Omeros Confidential Information. Additionally, if Omeros so requests in writing during the foregoing [ ] , the proposed submission for publication or disclosure shall be delayed beyond the proposed date for publication or disclosure (the Delay Period) until Omeros has completed the filing of any patent applications directed to information contained in such proposed publication or disclosure or based on Omeros reasonable determination that publication should be delayed due to other business considerations; provided, however, that the Delay Period shall not exceed [ ] without Dr. Ciccocioppos consent and that Omeros acknowledges that in any event Dr. Ciccocioppo shall not be prohibited beyond [ ] from submitting for publication the results of research studies of the effect of PPAR- g agonists on alcoholism completed prior to the Effective Date of this Agreement. Dr. Ciccocioppo agrees to consider in good faith any delays longer that the Delay Period that may be reasonably requested by Omeros. Omeros shall have the right, in its sole discretion, to use and disclose all data and results related to the subject matter of the Assigned IP in connection with Omeros research, development, commercialization and business activities, including, without limitation, in and for submissions to any regulatory agencies and as may be required by law or regulation, and to publish such data and results if Dr. Ciccocioppo does not wish to publish such data and results. | |
9 | Representations, Warranties and Other Obligations of Omeros | |
9.1 | Omeros represents and warrants that it has the requisite corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder. | |
9.2 | Prior to Omeros marketing of any Subject Product, or making any Subject Product available for use in any human patients, Omeros will obtain and maintain reasonably adequate product liability insurance. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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10 | Representations, Warranties and Other Obligations of Dr. Ciccocioppo | |
10.1 | Dr. Ciccocioppo represents and warrants that he is the sole owner of, and has the lawful and unrestricted right to assign, all right and title to and interest in the Assigned Patents and to the Assigned IP, including, without limitation, all inventions and patent applications included in the Assigned IP as of the Effective Date, and that except for payments owed to Università di Camerino in accordance with Section 5 herein, the Assigned IP is not subject to any encumbrances, liens, obligations, restrictions or licenses to third parties. | |
10.2 | Except for any third party patents specific to PPAR g compounds and compositions, Dr. Ciccocioppo represents and warrants that he is not aware of any third party rights that would be infringed as a result of Omeros development and commercialization of Subject Products. | |
10.3 | Dr. Ciccocioppo represents and warrants that he has provided to Omeros all material and relevant data and results, in complete and accurate form including any contradictory data and results, obtained from studies PPAR g agonists conducted by Dr. Ciccocioppo and his collaborators prior to the Effective Date of this Agreement. | |
10.4 | Dr. Ciccocioppo covenants and agrees that, during the term of this Agreement, he shall not undertake any obligations with third parties that would be inconsistent in any way with Dr. Ciccocioppos transfer of the Assigned IP to Omeros or Dr. Ciccocioppos obligations under this Agreement. | |
10.5 | THE WARRANTIES SET FORTH EXPRESSLY IN THIS AGREEMENT ARE THE SOLE WARRANTIES MADE BY EITHER PARTY TO THE OTHER AND THERE ARE NO OTHER WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, REGARDING THE SUBJECT PRODUCTS OR OTHER PRODUCTS, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. | |
11 | Confidentiality | |
11.1 | Dr. Ciccocioppo and Omeros hereby affirm and incorporate by reference the terms of the Mutual Nondisclosure Agreement between the parties dated March 5, 2008 concerning the subject matter of this Agreement, except that all Confidential Information (as that term is defined in the Mutual Nondisclosure Agreement) disclosed by Dr. Ciccocioppo related to the rights assigned to Omeros under this Agreement shall be treated as Omeros Confidential Information under the Mutual Nondisclosure Agreement, and Omeros shall be free to disclose and use such Confidential Information, and to the extent that the terms of the Mutual Nondisclosure Agreement may conflict with the terms of this Agreement, the terms of this Agreement shall prevail. The parties further agree that the obligations of nondisclosure and non-use set forth in such Mutual Nondisclosure Agreement shall subsist for a period of [ ] after the termination of this Agreement. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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11.2 | The terms of this Agreement shall be maintained in strict confidence by both Dr. Ciccocioppo and Omeros, and may not be disclosed by either party without the consent of the other party, except Omeros may disclose the terms of this Agreement to Omeros current and potential employees, officers, directors, consultants, shareholders, investors and corporate partners and either party may disclose the terms of this Agreement as may be required under a court order or decree or as required to comply with any governmental law, rule or regulation. | |
12 | Limitation of Liability | |
12.1 | Neither party shall be liable to the other party for any incidental, indirect, consequential or special damages arising under this Agreement, under any theory including torts, even if such damages may have been foreseeable. | |
13 | Term and Termination | |
13.1 | Unless terminated earlier as set forth in Section 13.2 below, this Agreement shall subsist so long as there is any valid, subsisting and enforceable claim of any issued patent included within the Assigned IP or any patentable claim in any pending patent application included within the Assigned IP. | |
13.2 | Either party may terminate this Agreement at any time in the event that the other party breaches any material obligation of this Agreement after the party seeking to terminate this Agreement first submits a written notice of breach to the breaching party, which breach is not substantially cured within ninety (90) days of the receipt of such notice, followed by written notice of termination then being sent to the breaching party. | |
13.3 | Termination of this Agreement shall not act to nullify or affect Dr. Ciccocioppos assignment of the Assigned IP to Omeros or the obligation of Omeros to pay to Dr. Ciccocioppo any Royalty payments, Transfer Fee Share payments and Milestone Payments that have accrued prior to the time of termination. | |
13.4 | The provisions of Sections 1 (Definitions) 2 (Assignment of Rights), 7 (Patent Prosecution, Maintenance and Enforcement), 8 (Publication), 9 (Representations, Warranties and Other Obligations of Omeros), 10 (Representations, Warranties and Other Obligations of Dr. Ciccocioppo), 11 (Confidentiality), 12 (Limitation of Liability), 14 (Use of Names) and 15 (Miscellaneous) of this Agreement shall survive expiration or termination of this Agreement for the period set forth therein or, if no period is set forth therein, then indefinitely. Any payment obligations that accrued prior to the date of termination under Sections 3 (Royalty and Transfer Fee Share Payments), 4 (Milestone Payments) and 5 (University Payment Share), but not any payment obligations that would otherwise accrue after the date of termination, shall remain payable upon termination. | |
14 | Use of Names | |
14.1 | Nothing contained in this Agreement confers any right to either party to use in advertising, publicity, or other promotional activities any name, trade name, trademark, |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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or other designation of the other party hereto, and neither party shall make such use without the prior written consent of the other party; provided however Omeros may through written, oral or electronic communication disclose the existence of this Agreement and the name of Dr. Ciccocioppo to Omeros current and potential employees, directors, consultants, shareholders, investors and corporate partners, and as required to comply with any governmental law, rule or regulation. | ||
15 | Miscellaneous | |
15.1 | This Agreement including all appendices and exhibits attached hereto or incorporated by reference herein constitutes the entire understanding of the parties hereto regarding the subject matter of this Agreement, and no other representation, agreement, promise or undertaking altering, modifying, taking from or adding to the terms of this Agreement shall have any effect unless the same is reduced to writing and duly executed by the parties hereto. In the event of any conflict between the main body of this Agreement and any attachments thereto or documents incorporated by reference therein, the provisions of the main body of this Agreement shall control. | |
15.2 | Either partys failure to enforce any provision of this Agreement will not be considered a waiver of future enforcement of that or any other provision. | |
15.3 | The laws of the state of Washington, United States, without regard to its conflict-of-laws provisions, shall govern this Agreement, its interpretation and its enforcement, and any disputes arising out of or related to this Agreement. | |
15.4 | Any civil action prosecuted or instituted by either party as permitted herein above with respect to any matters arising out of or related to this Agreement shall be brought in the United States District Court located in Western District of Washington, United States (if federal subject matter jurisdiction therein lies) or the King County Superior Court, State of Washington, United States (if there is no subject matter jurisdiction in federal court), and each party hereby consents to the exclusive jurisdiction and venue of such courts for such purposes. | |
15.5 | In the event that it is necessary for either party of this Agreement to take legal action to enforce any of the terms, conditions or rights contained herein, or to defend any such action, then the prevailing party in such action shall be entitled to recover from the other party all reasonable attorneys fees, costs and expenses related to such legal action. | |
15.6 | In the event that any portion of this Agreement is held invalid or unenforceable by a court of law, that provision will be construed and reformed to permit enforcement of the provision to the maximum extent permissible consistent with the parties original intent, and if such construction is not possible, such provision shall be struck from this Agreement, and the remainder of the Agreement shall remain in full force and effect as if such provision had never been part of this Agreement. | |
15.7 | For the purposes of this Agreement, the parties hereto are independent contractors, and nothing in this Agreement shall be construed to place them in the relationship of partners, |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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principal and agent, employer/employee or joint venturers. Except as provided expressly herein, each party agrees that it shall have no authority to bind or obligate the other party, nor shall any party hold itself out as having such authority. | ||
15.8 | Neither party will be liable for failure or delay in performing any obligation under this Agreement, or will be considered in breach of this Agreement, if such failure or delay is due to a natural disaster or any cause reasonably beyond such partys control, provided that such party resumes performance as soon as possible following the end of the event that caused such delay or failure of performance. | |
15.9 | Dr. Ciccocioppo may not assign this Agreement or any obligation or right under this Agreement, in whole or in part, without Omeros prior written consent, which consent will not be unreasonably withheld. Dr. Ciccocioppo consents to Omeros assignment of this Agreement in whole or in part in connection with the merger, consolidation or transfer of all or substantially all of that portion of Omeros assets to which this Agreement relates. Subject to these restrictions, this Agreement will be binding upon and will inure to the benefit of the parties permitted successors and assignees. | |
15.10 | Any notice required or permitted to be given hereunder by either party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by an internationally recognized courier service guaranteeing next-day delivery, charges prepaid, or (d) delivered by facsimile (with the original promptly sent by any of the foregoing manners) to the addresses or facsimile numbers of the other party set forth below, or at such other addresses as may from time to time be furnished by similar notice by either party. The effective date of any notice hereunder shall be the date of receipt by the receiving party. |
If to Omeros:
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If to Dr. Ciccocioppo: | ||
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Attn: Chief Executive Officer
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Roberto Ciccocioppo, Ph.D. | ||
Omeros Corporation
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Vicolo San Silvestro n. 25 | ||
1420 Fifth Avenue, Suite 2600
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Camerino, 62032 | ||
Seattle, WA 98101
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Italy | ||
U.S.A.
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And a copy to: General Counsel
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at the same address as above
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Fax: (206) 676.5005
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E-mail: [ ] | ||
Phone: (206) 676.5000
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15.11 | This Agreement may be executed in one or more counterparts, each of which will be considered an original, and all of which will constitute the same instrument. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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OMEROS CORPORATION | ROBERTO CICCOCIOPPO, PH.D. | |||||||
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By:
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/s/ Gregory A. Demopulos
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Signed: |
/s/ Roberto Ciccocioppo
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Name:
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Gregory A. Demopulos, M.D. | Date: | February 24, 2009 | |||||
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Title:
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Chairman & CEO | Fax: | 0737 403325 | |||||
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Date:
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February 20, 2009 | |||||||
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Fax:
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206.676.5005 |
UNIVERSIT à DI CAMERINO | ||||
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By:
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/s/ Mario Cocchioni
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Name:
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Prof. Mario Cocchioni | |||
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Title:
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Head of Department Medicina | |||
Sperimentale e Sanità Pubblica | ||||
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Date:
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February 25, 2009 | |||
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Fax:
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0737 403325 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
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2
OMEROS CORPORATION
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By: | /s/ Gregory A. Demopulos | |||
Gregory A. Demopulos, M.D. | ||||
Chairman & CEO | ||||
PURCHASER:
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/s/ Richard J. Klein | ||||
Richard J. Klein | ||||
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Committee | Annual Chairperson Fee | |||
Audit Committee
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$ | 15,000 | ||
Compensation Committee
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$ | 10,000 | ||
Nominating and Governance Committee
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$ | 5,000 |
Meeting Type | Attendance Method | Meeting Fee | ||||||
Full Board
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In-person | $ | 1,750 | |||||
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Other (e.g., by telephone) | $ | 500 | |||||
Committee of Board
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In-person | $ | 500 | |||||
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Other (e.g., by telephone) | $ | 500 |
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