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.
Jonathan E. Kahn, Esq. Morrison & Foerster LLP 1290 Avenue of the Americas New York, New York 10104 (212) 468-8000 |
Proposed Maximum
|
||||||
Title of Each Class of
|
Aggregate Offering
|
Amount of
|
||||
Securities to be Registered | Price (1)(2) | Registration Fee | ||||
Common Stock, $0.01 par value
|
$115,000,000 | $4,519.50 | ||||
(1) | Estimated solely for the purpose of computing the amount of registration fee pursuant to Rule 457(o) of the Securities Act of 1933. | |
(2) | Includes the offering price of shares the underwriters have an option to buy to cover over-allotments, if any. |
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
|
$ | $ | ||
Proceeds, before expenses, to Omeros Corporation
|
$ | $ |
Leerink Swann | Needham & Company, LLC |
i
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2
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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.
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.
5
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Shares of common stock offered by us
shares
Shares of common stock to be outstanding after this offering
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, potential
acquisitions of products or technologies and general corporate
purposes. See Use of Proceeds.
Proposed NASDAQ Global Market symbol
OMER
5,257,413 shares of common stock issuable upon the exercise
of options outstanding at September 30, 2007, at a
weighted-average exercise price of $0.56 per share;
843,233 shares of common stock issuable upon exercise of options
granted from October 1, 2007 to January 9, 2008, at a
weighted-average exercise price of $1.25 per share;
512,029 shares of common stock issuable upon exercise of
warrants outstanding at September 30, 2007, which will
automatically terminate upon the closing of this offering if not
exercised, at a weighted-average exercise price of $5.15 per
share; and
22,613 shares of common stock issuable upon exercise of warrants
outstanding at September 30, 2007, which will not
automatically terminate upon the closing of this offering, at a
weighted-average exercise price of $4.66 per share.
shares
of common stock available for future issuance under our 2008
Equity Incentive Plan.
the automatic conversion of all outstanding shares of our
convertible preferred stock into 22,327,407 shares of
common stock, effective upon the completion of this offering;
the conversion of all outstanding warrants to purchase shares
of our convertible preferred stock into warrants to purchase
534,642 shares of common stock, effective upon the
completion of this offering;
the issuance
of shares
of common stock pursuant to the cashless net exercise of
warrants that will automatically terminate upon the closing of
this offering based on the assumed initial public offering price
of $ (the mid-point of the range
set forth on the cover page of this prospectus); and
no exercise by the underwriters of their right to purchase
additional shares of common stock to cover over-allotments, if
any.
6
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Period from June 16,
1994
Nine Months Ended
(Inception) to
September 30,
Year Ended December 31,
September 30,
2007
2006
2006
2005
2004
2007
(in thousands, except share and per share data)
$ 650
$ 200
$ 200
$
$
$ 950
11,173
6,230
9,637
5,803
2,670
39,635
10,891
10,891
10,891
8,619
1,893
3,625
1,904
2,079
22,859
19,792
19,014
24,153
7,707
4,749
73,385
(19,142
)
(18,814
)
(23,953
)
(7,707
)
(4,749
)
(72,435
)
1,173
722
1,088
333
171
4,093
(355
)
108
179
8
(168
)
(123
)
(38
)
(91
)
(266
)
$
(18,447
)
$
(18,022
)
$
(22,777
)
$ (7,366)
$ (4,578)
$
(68,776
)
4,184,919
3,653,537
3,694,388
3,468,886
3,416,197
$ (4.41)
$ (4.93)
$ (6.17)
$ (2.12)
$ (1.34)
$ (0.66)
$ (1.10)
27,005,598
20,843,076
7
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As of September 30, 2007
Pro Forma
Pro
As
Actual
Forma
Adjusted (1)
(in thousands)
$
27,171
$
27,410
21,793
22,032
28,959
29,198
1,270
1,270
1,674
89,168
(68,776
)
(68,776
)
(66,246
)
24,835
(1)
A $1.00 increase (decrease) in the
assumed public offering price of $
would increase (decrease) each of cash, cash equivalents and
short-term investments, working capital, total assets and total
shareholders equity (deficit) by
$ , 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.
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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;
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.
11
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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;
conduct and complete the Phase 3 clinical trials of OMS103HP for
use in arthroscopic meniscectomy surgery;
initiate, conduct and complete 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;
continue our research and development;
initiate and conduct clinical trials for other product
candidates; and
launch and commercialize any product candidates for which we
receive regulatory approval.
12
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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.
13
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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.
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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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have hired a chief financial officer and an assistant controller
and continue to strengthen our internal staffing and technical
expertise in financial and Securities Exchange Commission, or
SEC, accounting and reporting;
are further segregating duties within our accounting and finance
department;
have hired an information technology manager and are revising
our policies and procedures regarding accounting software-user
access rights and software upgrade management; and
are evaluating whether to upgrade our accounting software
systems.
22
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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.
24
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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.
25
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results from our clinical trial programs, including our ongoing
Phase 3 clinical trials for OMS103HP, our planned Phase 1/Phase
2 clinical trial for OMS302, and our ongoing Phase 1 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;
26
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additions or departures of key personnel;
commencement of, or our involvement in, litigation;
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.
27
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28
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our ability to complete the Phase 3 clinical trials of OMS103HP
in patients undergoing ACL reconstruction surgery by the end of
2008 and our ability to submit a related NDA to the FDA during
the first half of 2009;
our ability to complete the first Phase 3 clinical trial, and
begin the second Phase 3 clinical trial, of OMS103HP in
patients undergoing arthroscopic meniscectomy surgery in the
second half of 2008;
our ability to market OMS103HP by 2010;
our ability to initiate a Phase 1/Phase 2 clinical trial of
OMS302 in patients undergoing cataract surgery during the first
half of 2008;
our ability to complete the Phase 1 clinical trial of
OMS201 in patients undergoing ureteroscopic removal or ureteral
or renal stones in the first half of 2008;
our ability to achieve the expected near-term milestones in our
pipeline of preclinical development programs 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 Pharmaco
Surgery 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;
29
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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;
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
2008; 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.
30
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| approximately $ to fund the completion of our Phase 3 clinical trials and our submission of the related NDA(s) to the FDA for our lead PharmacoSurgery product candidate, OMS103HP; | |
| approximately $ to fund the launch and commercialization of OMS103HP; | |
| approximately $ to fund the clinical development of our other PharmacoSurgery product candidates, OMS302 and OMS201; 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. |
31
on an actual basis;
on a pro forma basis reflecting (a) the automatic
conversion of all outstanding shares of our convertible
preferred stock into 22,327,407 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 534,642 shares of
our common stock upon the closing of this offering, resulting in
the reclassification of $1.7 million from preferred stock
warrant liability to additional paid-in capital, and
(c) the repayment of $239,000 in related-party notes
receivable; and
on a pro forma as adjusted basis to give effect (a) to the
issuance and sale by us
of 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 $ 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 and (b) to the issuance
of shares
of common stock pursuant to the cashless net exercise of
warrants that will automatically terminate upon the closing of
this offering based on the assumed initial public offering price.
As of September 30, 2007
Pro Forma
Actual
Pro Forma
As Adjusted
(in thousands, except share
and per share data)
$
27,171
$
27,410
$
$
1,270
$
1,270
1,674
89,168
53
277
2,698
93,316
34
34
(16
)
(16
)
(239
)
(68,776
)
(68,776
)
(66,246
)
24,835
$
25,866
$
26,105
$
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5,257,413 shares of common stock issuable upon the exercise
of options outstanding at September 30, 2007, at a
weighted-average exercise price of $0.56 per share;
843,233 shares of common stock issuable upon exercise of options
granted from October 1, 2007 to January 9, 2008, at a
weighted-average exercise price of $1.25 per share;
512,029 shares of common stock issuable upon exercise of
warrants outstanding at September 30, 2007, which will
automatically terminate upon the closing of this offering if not
exercised, at a weighted-average exercise price of $5.15 per
share;
22,613 shares of common stock issuable upon exercise of
warrants outstanding at September 30, 2007, which will not
automatically terminate upon the closing of this offering, at a
weighted-average exercise price of $4.66 per share; and
shares
of common stock available for future issuance under our 2008
Equity Incentive Plan.
33
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$
$
(12.30
)
13.18
0.88
$
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Average
Shares Purchased
Total Consideration
Price Per
Number
Percent
Amount
Percent
Share
27,727,297
%
$
89,907,000
%
$
3.24
%
$
%
$
5,257,413 shares of common stock issuable upon the exercise
of options outstanding at September 30, 2007, at a
weighted-average exercise price of $0.56 per share;
843,233 shares of common stock issuable upon exercise of
options granted from October 1, 2007 to January 9,
2008, at a weighted-average exercise price of $1.25 per share;
512,029 shares of common stock issuable upon exercise of
warrants outstanding at September 30, 2007, which will
automatically terminate upon the closing of this offering if not
exercised, at a weighted-average exercise price of $5.15 per
share;
22,613 shares of common stock issuable upon exercise of
warrants outstanding at September 30, 2007, which will not
automatically terminate upon the closing of this offering, at a
weighted-average exercise price of $4.66 per share; and
shares
of common stock available for future issuance under our 2008
Equity Incentive Plan.
35
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37
Period from
Nine Months
June 16, 1994
Ended
(inception) to
September 30,
Years Ended December 31,
September 30,
2007
2006
2006
2005
2004
2003
2002
2007
(in thousands, except share and per share data)
$ 650
$ 200
$ 200
$
$
$
$
$ 950
11,173
6,230
9,637
5,803
2,670
2,146
1,915
39,635
10,891
10,891
10,891
8,619
1,893
3,625
1,904
2,079
2,021
1,506
22,859
19,792
19,014
24,153
7,707
4,749
4,167
3,421
73,385
(19,142
)
(18,814
)
(23,953
)
(7,707
)
(4,749
)
(4,167
)
(3,421
)
(72,435
)
1,173
722
1,088
333
171
109
270
4,093
(355
)
108
179
8
(168
)
(123
)
(38
)
(91
)
(1
)
(1
)
(266
)
$
(18,447
)
$
(18,022
)
$
(22,777
)
$ (7,366
)
$ (4,578
)
$ (4,059
)
$ (3,152
)
$
(68,776
)
4,184,919
3,653,537
3,694,388
3,468,886
3,416,197
3,349,148
3,287,923
$ (4.41)
$ (4.93)
$ (6.17)
$ (2.12)
$ (1.34)
$ (1.21)
$ (0.96)
36
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38
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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;
39
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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.
Nine Months Ended
Years Ended
September 30,
December 31,
2007
2006
2006
2005
2004
(in thousands)
$
5,106
$
2,678
$
4,514
$
2,560
$
1,400
6,067
3,552
5,123
3,243
1,270
$
11,173
$
6,230
$
9,637
$
5,803
$
2,670
40
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revenue recognition;
research and development expenses, primarily clinical trial
expenses;
stock-based compensation; and
preferred stock warrant liability.
41
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42
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Nine Months Ended
September 30,
Years Ended December 31,
2007
2006
2006
2005
2004
60%
60%
60%
0%
0%
6.08
5.00-6.08
5.00-6.08
5.00
5.00
4.42% - 4.78%
4.63% - 5.04%
4.57% - 5.04%
4.58%
4.00%
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;
our results of operations, financial position, and the status of
our research and product development efforts;
our stage of development and business strategy;
the composition of and changes to our management team;
43
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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; and
the likelihood of achieving a liquidity event for the shares of
our common stock underlying stock options, such as an initial
public offering, or IPO, given prevailing market conditions.
44
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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
23,000
$
0.50
$
0.89
$
0.39
28,000
0.50
0.89
0.39
4,274,853
0.50
0.89
0.39
308,500
1.00
1.05
0.05
350,000
1.00
3.63
2.63
275,733
1.25
6.23
4.98
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
an increase in the probability of a liquidity event.
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;
continued advancement of activities in preparation for an
IPO; and
an increase in the probability of a liquidity event.
45
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Nine Months Ended
September 30,
Years Ended December 31,
2007
2006
2006
2005
2004
(in thousands)
$
245
$
3
$
309
$
$
5,300
283
1,130
(507
)
273
$
5,545
$
286
$
1,439
$
(507
)
$
273
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Period from
January 1,
2006
Year Ended
to August 11,
December 31,
2006
2005
(in thousands)
$
200
$
2,394
4,612
957
1,517
3,219
5,787
47
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in 1994, we issued and sold a total of 875,000 shares of
Series A convertible preferred stock for aggregate net
proceeds of $868,000;
in 1998, we issued and sold a total of 2,663,244 shares of
Series B convertible preferred stock for aggregate net
proceeds of $4.4 million;
in 2000, we issued and sold a total of 2,825,291 shares of
Series C convertible preferred stock for aggregate net
proceeds of $7.2 million;
in 2002, we issued and sold a total of 972,580 shares of
Series D convertible preferred stock for aggregate net
proceeds of $3.7 million; and
from 2004 to 2007, we issued and sold a total of
12,655,208 shares of Series E convertible preferred
stock for aggregate net proceeds of $60.0 million.
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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;
50
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the terms and timing of payments of any collaborative or
licensing agreements that we may establish;
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; and
our degree of success in commercializing OMS103HP and other
product candidates.
Payments Due Within
1 Year
2-3 Years
4-5 Years
More Than 5 Years
Total
(in thousands)
$
1,333
$
1,555
$
706
$
$
3,594
5
10
10
50
75
1,156
1,060
2,216
$
2,494
$
2,625
$
716
$
50
$
5,885
(1)
We are contracted to receive
sublease income of $252,000 and $69,000 in 2007 and 2008,
respectively. In September 2007, we extended our lease
agreements related to 25,000 square feet of laboratory
space in Seattle, Washington. The annual lease payments for this
space are approximately $1.4 million. The lease expires in
September 2011, after which we may extend the term to one year.
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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 by end of 2008
Omeros
Arthroscopic meniscectomy
Phase 3
Complete first/begin second Phase 3 trial in second half of 2008
Omeros
Cataract surgery
Initiating
Phase 1/
Phase 2
Begin enrollment in
first half of 2008
Omeros
Ureteroscopy
Phase 1
Complete Phase 1 trial
in first half of 2008
Omeros
Macular degeneration, ischemia-reperfusion injury,
rheumatoid arthritis
Preclinical
Select clinical
candidate in
2008
In-licensed(2)
Osteoarthritis,
rheumatoid arthritis
Preclinical
Select clinical
candidate
Omeros
Schizophrenia
Preclinical
Select clinical
candidate
Omeros
Multiple CNS Disorders
Preclinical
Select clinical candidate(s)
Omeros
Multiple CNS Disorders
Preclinical
Select clinical
candidate(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.
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Obtain regulatory approval for our PharmacoSurgery product
candidates OMS103HP, OMS302 and OMS201.
We are conducting
Phase 3 clinical trials for OMS103HP and we plan to submit an
NDA for OMS103HP in the first half of 2009. In addition, we
expect to begin a Phase 1/Phase 2 clinical trial for OMS302 in
the first half of 2008 and are in a Phase 1 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.
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. 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
Phase 3 clinical trials for two distinct therapeutic
indications, providing two potential paths for
commercialization. We are also advancing two additional
PharmacoSurgery product candidates into 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 targeting large
markets. By combining our late-stage PharmacoSurgery product
candidates with this deep and diverse pipeline of preclinical
development programs, we believe that our business model creates
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 28 pending patent applications in the
United States, 60 issued or allowed patents and
86 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
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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. 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. 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, inc., a private biotechnology company, 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.
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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;
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 pharmacokinetics 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 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.
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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 rapidly achieves pupil
dilation, OMS302 will eliminate the need for pre-operative
delivery of mydriatic drops, reducing the need for pre-operative
patient care and monitoring and resulting in savings in labor
and facility costs.
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 11 issued patents and nine
pending patent applications in key foreign markets 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
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pending U.S. Patent Applications and six pending patent
applications in key foreign markets 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 Applications, and an additional nine issued
patents and 15 pending patent applications in key foreign
markets 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 three pending U.S. Patent Applications,
one pending International PCT Patent Application and seven
pending patent applications in key foreign markets related to
our MASP-2 program.
Chondroprotective Program.
We are building
intellectual property protection around developments in our
Chondroprotective program. We currently own one issued
U.S. Patent, two pending U.S. Patent Applications, and
an additional three issued patents and 19 pending patent
applications in key foreign markets directed to our
chondroprotective technology. These patent applications include
claims that are broadly directed to combinations of one or more
agents that inhibit cartilage breakdown, or catabolic inhibitory
agents, with one or more agents that promote cartilage growth,
or anabolic agents.
PDE10 Program.
Medicinal chemistry
developments in our PDE10 program have resulted in a pending
U.S. and a pending International Patent Cooperation Treaty,
or PCT, Patent Application 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.
GPCR Program.
We own one issued
U.S. Patent, three pending U.S. Patent Applications,
one international PCT Patent Application and an additional two
issued patents and four pending patent applications in key
foreign markets, 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.
Our Other CNS Programs.
We own and exclusively
control three pending U.S. Patent Applications and four
pending foreign patent applications that are directed to
additional preclinical CNS programs. We intend to file
additional patent applications in the United States and key
foreign markets directed to what we believe to be previously
unknown links between specific molecular targets and a series of
CNS disorders, broadly claiming any agents that act at these
molecular targets for use in the treatment of these CNS
disorders.
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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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F-21
F-25
F-26
F-33
II-4
II-5
Name
Position(s)
48
President, Chief Executive Officer, Chief Medical Officer and
Chairman of the Board of Directors
48
Vice President, Patent and General Counsel and Secretary
45
Chief Financial Officer and Treasurer
50
Vice President, Science
48
Vice President, Pharmaceutical Operations
62
Vice President, Regulatory Affairs
63
Vice President, Clinical Development
48
Vice President, Research
71
Director
68
Director
53
Director
69
Director
48
Director
44
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 , and ,
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 , and ,
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 ,
and ,
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
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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;
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)
($)
*
*
(1)
Our directors did not receive any
cash compensation during 2007. Amounts shown in this column
represent the compensation cost for the year ended
December 31, 2007 of option awards granted to each of our
non-employee directors as determined in accordance with
Statement of Financial Accounting Standards
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 10 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)
During the year ended
December 31, 2007, we granted to Mr. Mann an option
award to purchase 25,000 shares of our common stock with an
exercise price of $1.25 per share that vests over a three-year
period in equal annual installments. This option award had a
grant date fair value of $ *.
(3)
As of December 31, 2007,
Mr. Aspiri, Mr. Cable, Dr. Hood and Mr. Mann
held option awards to purchase 30,000, 65,000, 50,000 and
25,000 shares of our common stock, respectively. All of
these option awards, other than Mr. Manns option
award as further described above in footnote 2, were fully
vested and exercisable as of December 31, 2007.
*
To be completed by amendment.
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Option
All Other
Salary
Bonus
Awards
Compensation
Total
Year
($)
($)
($) (1)
($)
($)
2007
474,940
278,011
*
(2)
178,755
(3)
*
2007
285,000
*
93
*
2007
157,091
(4)
*
77
*
(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, 2007 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 10 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 $ * of compensation
cost for the year ended December 31, 2007 of option awards
granted and determined pursuant to SFAS 123R using the
Black-Scholes option valuation model and $ * of stock
compensation under a variable stock compensation arrangement as
described in Note 12 to our consolidated financial
statements included elsewhere in this prospectus.
(3)
Includes (a) $159,457 of tax
gross-up
payments related to bonuses we paid to Dr. Demopulos during
2007 and (b) $17,161 in perquisites and other personal
benefits, which included payments for medical malpractice
insurance, parking expenses, legal fees, medical practice fees
and travel expenses.
(4)
Mr. Kleins employment
with us began in May 2007. His current annual base salary is
$250,000.
*
To be completed by amendment.
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All Other
Option Awards:
Number of
Grant Date Fair
Securities
Exercise or Base
Value of Stock
Underlying
Price of Option
and Option
Options
Awards
Awards
Grant Date
(#)
($/Share)
($)
12/30/07
200,000
1.25
*
12/30/07
10,000
1.25
*
5/14/07
250,000
1.00
742,675
5/14/07
25,000
1.00
74,268
12/30/07
10,000
1.25
*
*
To be completed by amendment.
91
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92
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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.
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
93
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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.
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
94
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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 ($)
Change in Control ($)
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of
the outstanding shares of our common stock on the last day of
the immediately preceding fiscal year;
shares; and
such other amount as our board of directors may determine.
98
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99
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Option Awards
Stock Awards
Number of
Number of
Securities
Securities
Underlying
Number of
Market Value of
Underlying
Unexercised
Option
Shares of 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)
3,025
0.265
12/10/11
566,666
233,334
(3)
0.50
12/11/16
850,000
350,000
(3)
0.50
12/11/16
200,000
(4)
1.25
12/30/17
205,833
174,167
(5)
0.50
12/11/16
10,000
(4)
1.25
12/30/17
100,000
(6) (7)
1.00
05/14/17
150,000
(6) (7)
25,000
(6) (8)
1.00
05/14/17
10,000
(4)
1.25
12/30/17
(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.
100
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(2)
The market value of shares of stock
that have not vested has been calculated using the assumed
initial public offering price of $
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)
Mr. Klein was not vested in
these shares as of December 31, 2007. Pursuant to the terms
of the option award, Mr. Klein has the right to purchase
unvested shares, provided that if his employment terminates for
any reason prior to him vesting into any shares that he
exercised, we have the right, but not the obligation, to
repurchase at the original purchase price any shares that he
exercised and is not vested in as of the date of his termination.
(7)
A total of 250,000 shares are
subject to this option award. 1/4th of the shares subject
to the option vest on May 14, 2008 and 1/48th of the
shares vest each month thereafter. As of December 31, 2007,
Mr. Klein had purchased 150,000 of these shares, none of
which were vested.
(8)
1/4th of the shares subject to
the option award vest on May 14, 2008 and 1/48th of the
shares vest each month thereafter, provided that if we do not
meet the performance targets described in
Management Executive Compensation
Executive Employment Agreements Richard J.
Klein, this option shall automatically terminate on
May 14, 2008.
Option Awards
Number of
Shares Acquired
Value Realized
on Exercise
on Exercise
(#)
(#)(1)
20,000
70,000
(1)
The value realized on exercise has
been calculated using the assumed initial public offering price
of $ per share (the mid-point of
the range set forth on the cover page of this prospectus).
(2)
During the year ended
December 31, 2007, Mr. Klein purchased 150,000 shares
of our common stock pursuant to the exercise of an option award.
Because none of these shares were vested as of December 31,
2007, they are not reflected in the table above.
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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.
102
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Series E Convertible
Preferred Stock
Common Stock
(#)(1)
(#)
559,551
6,925
839,326
7,741
(1)
Of these shares of Series E
convertible preferred stock, 83,932, 125,068 and 830 shares
are being held in escrow until February 11, 2008 on behalf
of Aravis Venture I, L.P., ARCH Venture Fund V, L.P.
and ARCH V Entrepreneurs Fund V, L.P., respectively, to
secure claims we may bring for indemnification pursuant to the
agreement and plan of reorganization with nura.
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(2)
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.
(3)
Represents (a) 833,787 and
7,690 shares of Series E convertible preferred stock
and common stock, respectively, held by ARCH Venture
Fund V, L.P. and (b) 5,539 and 51 shares of
Series E convertible preferred stock and common stock,
respectively, held by ARCH V Entrepreneurs Fund V, L.P.
These two associated partnerships together hold more than five
percent of our capital stock.
Series E Convertible
Aggregate Purchase
Preferred Stock
Price
(#)
($)
400,000
2,000,000
600,000
3,000,000
(1)
Represents 595,984 and
4,016 shares of Series E convertible preferred stock
that we issued and sold to ARCH Venture Fund V, L.P. and
ARCH V Entrepreneurs Fund V, 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
1,447,067
5.2
%
4,394,563
14.9
%
431,666
1.5
%
275,000
*
317,857
1.1
%
194,163
*
517,045
1.8
%
106,603
*
966,476
3.5
%
7,203,373
24.0
%
*
Less than one percent
(1)
Represents
(a) 1,437,461 shares of common stock held by ARCH
Venture Fund V, L.P. and (b) 9,606 shares of
common stock held by ARCH V Entrepreneurs Fund, L.P.
106
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(2)
Includes 1,503,025 shares of
common stock that Dr. Demopulos has the right to acquire
from us within 60 days of December 31, 2007 pursuant
to the exercise of option awards.
(3)
Includes 221,666 shares of
common stock that Ms. Kelbon has the right to acquire from
us within 60 days of December 31, 2007 pursuant to the
exercise of option awards.
(4)
Represents
(a) 150,000 shares of common stock that Mr. Klein
acquired from us pursuant to the exercise of an option award and
(b) 125,000 shares of common stock that Mr. Klein
has the right to acquire from us within 60 days of
December 31, 2007 pursuant to the exercise of option
awards. Pursuant to the terms of his option awards,
Mr. Klein has the right to exercise his option awards for
shares that he is not vested in. As of December 31, 2007,
Mr. Klein had not vested in any shares of common stock that
he purchased by exercising his option award. If
Mr. Kleins employment terminates before he fully
vests in the shares that he purchased, we will have the right,
but not the obligation, to repurchase the unvested shares at a
price of $1.00 per share. See Management
Executive Compensation Executive Employment
Agreements Richard J. Klein for a description
of the vesting terms of Mr. Kleins option awards.
(5)
Represents
(a) 30,000 shares of common stock that Mr. Aspiri
has the right to acquire from us within 60 days of
December 31, 2007 pursuant to the exercise of option awards
and (b) 287,857 shares of common stock held by Aspiri
Enterprises LLC. Mr. Aspiri is the managing partner and a
member of Aspiri Enterprises LLC.
(6)
Includes
(a) 65,000 shares of common stock that Mr. Cable
has the right to acquire from us within 60 days of
December 31, 2007 pursuant to the exercise of option awards
and (b) 20,000 shares of common stock held by the
Thomas J. Cable Defined Benefit Retirement Plan, of which Mr.
Cable is the beneficiary.
(7)
Includes 322,188 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 50,000 shares of
common stock that Dr. Hood has the right to acquire from us
within 60 days of December 31, 2007 pursuant to the
exercise of option awards.
(9)
Represents 966,476 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 1,994,691 shares of
common stock that our executive officers and directors have the
right to acquire from us within 60 days of
December 31, 2007 pursuant to the exercise of option awards.
107
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shares will be designated as common stock; and
shares will be designated as preferred stock.
108
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A warrant that we assumed in connection with our acquisition of
nura on August 11, 2006 to purchase 22,613 shares of
our common stock with an exercise price of $4.66 per share. This
warrant will terminate upon the earlier of
(a) April 26, 2015 or (b) certain acquisitions of
us as described in the warrant.
Warrants issued on March 29, 2007 to purchase an aggregate
of 387,030 shares of our common stock with an exercise
price of $6.25 per share. If not exercised, these warrants will
terminate on the earlier of (a) completion of this
offering, (b) a change of control as defined in the
warrants or (c) March 28, 2012.
if we meet the defined preclinical development milestone set
forth in the funding agreement, SMRI may purchase up to
$1.2 million of our common stock and provide us linked
grant funding of up to $1.9 million, or the First
Tranche; and
if we meet the defined clinical development milestone set forth
in the funding agreement, SMRI may purchase up to an additional
$600,000 of our common stock and provide us linked grant funding
of up to $2.7 million, or the Second Tranche.
109
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110
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111
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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.
112
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Number of Shares
one percent of the number of shares of common stock then
outstanding, which will equal
approximately 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.
113
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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,
114
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115
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Deutsche Bank Securities Inc.
Total Fees
Without Exercise of
With Full Exercise
Fee per
Over-Allotment
of Over-Allotment
share
Option
Option
$
$
$
116
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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,
117
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118
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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.
119
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FOR
NON-UNITED
STATES HOLDERS OF COMMON STOCK
120
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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.
121
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122
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123
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Page
F-2
F-3
F-5
F-7
F-12
F-14
F-42
F-43
F-44
F-45
F-46
F-1
Table of Contents
F-2
Table of Contents
(A Development Stage Company)
September 30,
December 31,
2007
2006
2005
Assets
(unaudited)
$
6,520
$
23,400
$ 253
20,651
12,485
12,119
1,300
469
135
264
27,640
37,320
12,636
860
577
418
189
267
207
202
63
66
55
$
28,959
$
38,432
$13,109
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
September 30,
December 31,
September 30,
2007
2006
2005
2007
(unaudited)
(Unaudited)
(Note 1)
$ 914
$ 1,094
$ 680
1,529
607
801
1,674
1,037
483
650
1,300
1,080
1,005
5,847
5,043
1,964
190
1,010
6,037
6,053
1,964
89,168
85,742
40,888
53
50
45
277
2,698
(2,838
)
(1,946
)
93,316
34
26
6
34
(16
)
(33
)
(56
)
(16
)
(239
)
(239
)
(239
)
(68,776
)
(50,329
)
(27,553
)
(68,776
)
(66,246
)
(53,363
)
(29,743
)
$
24,835
$
28,959
$
38,432
$
13,109
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,
2006
2005
2004
2006
$ 200
$
$
$ 300
9,637
5,803
2,670
28,462
10,891
10,891
3,625
1,904
2,079
14,240
24,153
7,707
4,749
53,593
(23,953
)
(7,707
)
(4,749
)
(53,293
)
1,088
333
171
2,920
179
8
187
(91
)
(143
)
$(22,777
)
$(7,366
)
$(4,578
)
$
(50,329
)
$ (6.17
)
$ (2.12
)
$ (1.34
)
3,694,388
3,468,886
3,416,197
$ (1.10
)
20,843,076
F-5
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS(Continued)
(In thousands, except share and per share data)
Period from
June 16,
1994
(Inception)
Nine Months Ended
through
September 30,
September 30,
2007
2006
2007
(unaudited)
(unaudited)
(unaudited)
$ 650
$ 200
$ 950
11,173
6,230
39,635
10,891
10,891
8,619
1,893
22,859
19,792
19,014
73,385
(19,142
)
(18,814
)
(72,435
)
1,173
722
4,093
(355
)
108
(168
)
(123
)
(38
)
(266
)
$(18,447
)
$
(18,022
)
$
(68,776
)
$ (4.41
)
$ (4.93
)
4,184,919
3,653,537
$ (0.66
)
27,005,598
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
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
Compensation
Party
Stage
Deficit
$
$
$
$
$
$
$
$
3,500,000
35
35
875,000
875
(7
)
(7
)
(140
)
(140
)
875,000
875
3,500,000
35
(7
)
(140
)
(112
)
(327
)
(327
)
875,000
875
3,500,000
35
(7
)
(467
)
(439
)
(495
)
(495
)
875,000
875
3,500,000
35
(7
)
(962
)
(934
)
(787
)
(787
)
875,000
875
3,500,000
35
(7
)
(1,749
)
(1,721
)
2,663,244
4,661
(302
)
(302
)
6
6
(22
)
(22
)
(930
)
(930
)
(952
)
3,538,244
$
5,536
3,500,000
$
35
$
(303
)
$
(22
)
$
$
$
(2,679
)
$
(2,969
)
(371,875
)
(4
)
(61
)
(65
)
1,200
17,537
3
3
4
4
3
3
(1,801
)
(1,801
)
(1,798
)
3,538,244
5,536
3,146,862
31
(357
)
(19
)
(4,480
)
(4,825
)
F-7
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
Compensation
Party
Stage
Deficit
3,538,244
5,536
3,146,862
31
(357
)
(19
)
(4,480
)
(4,825
)
2,825,291
7,487
(262
)
(262
)
12
9,433
25
50,614
1
9
10
9,264
2
2
8
8
18
18
(1,363
)
(1,363
)
(1,345
)
6,372,968
13,060
3,206,740
32
(600
)
(1
)
(5,843
)
(6,412
)
48,125
9
9
12,268
3
3
20
20
33
33
(2,554
)
(2,554
)
(2,521
)
6,372,968
$
13,060
3,267,133
$
32
$
(568
)
$
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
Compensation
Party
Stage
Deficit
6,372,968
$
13,060
3,267,133
$
32
$
(568
)
$
32
$
$
$
(8,397
)
$
(8,901
)
972,580
3,861
(124
)
(124
)
423,660
4
84
88
9
(9
)
2
2
121
(65
)
56
16
16
(3,152
)
(3,152
)
(3,136
)
7,345,548
16,921
3,690,793
36
(478
)
48
(7
)
(65
)
(11,549
)
(12,015
)
11,829
21
(100,000
)
(100
)
349,058
4
91
95
4
4
406
(9
)
(86
)
311
(37
)
(37
)
(4,060
)
(4,060
)
(4,097
)
7,257,377
16,842
4,039,851
40
19
11
(12
)
(151
)
(15,609
)
(15,702
)
3,672,293
18,361
(1,119
)
(1,119
)
55,687
1
10
11
77
(77
)
263
10
273
1
1
(4,578
)
(4,578
)
(4,577
)
10,929,670
$
35,203
4,095,538
$
41
$
(750
)
$
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
Compensation
Party
Stage
Deficit
10,929,670
$
35,203
4,095,538
$
41
$
(750
)
$
12
$
(79
)
$
(151
)
$
(20,187
)
$
(21,114
)
1,120,215
5,601
(278
)
(278
)
387,100
4
102
106
31,995
84
23
23
(530
)
(88
)
(618
)
(490
)
(490
)
(6
)
(6
)
(7,366
)
(7,366
)
(7,372
)
12,081,880
40,888
4,482,638
45
(1,946
)
6
(56
)
(239
)
(27,553
)
(29,743
)
6,156,700
30,784
(1,821
)
(1,821
)
(607
)
(607
)
3,398,445
14,070
36,246
453,716
5
121
126
23
23
1,416
1,416
20
20
(22,777
)
(22,777
)
(22,757
)
21,637,025
$
85,742
4,972,600
$
50
$
(2,838
)
$
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
Compensation
Party
Stage
Deficit
21,637,025
$
85,742
4,972,600
$
50
$
(2,838
)
$
26
$
(33
)
$
(239
)
$
(50,329
)
$
(53,363
)
24,382
96
666,000
3,330
(90
)
(90
)
(22
)
(22
)
277,290
3
120
123
150,000
2
148
150
(2
)
(148
)
(150
)
17
17
5,528
5,528
8
8
(18,447
)
(18,447
)
(18,439
)
22,327,407
$
89,168
5,399,890
$
53
$
2,698
$
34
$
(16
)
$
(239
)
$
(68,776
)
$
(66,246
)
F-11
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,
2006
2005
2004
2006
$
(22,777
)
$
(7,366
)
$
(4,578
)
$
(50,329
)
232
156
115
742
1,439
(507
)
273
1,787
10,891
10,891
(117
)
(9
)
(126
)
(145
)
76
89
114
76
87
163
150
(22
)
5
(169
)
155
971
(172
)
1,636
(10,172
)
(6,625
)
(4,181
)
(35,291
)
(166
)
(278
)
(124
)
(1,094
)
(220,914
)
(20,589
)
(45,863
)
(337,448
)
220,713
22,026
32,979
324,712
(212
)
(212
)
(579
)
1,159
(13,008
)
(14,042
)
50
(391
)
(3
)
(441
)
28,963
5,407
17,242
67,847
5,200
5,200
126
18
11
242
(165
)
33,898
5,425
17,250
72,733
23,147
(41
)
61
23,400
253
294
233
$
23,400
$
253
$
294
$
23,400
$ 91
$
$
$ 143
$
$ 88
$
$ 239
$
14,070
$
$
$
14,070
F-12
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS(Continued)
(In thousands)
Period from
June 16, 1994
(Inception)
Nine Months Ended
through
September 30,
September 30,
2007
2006
2007
(unaudited)
(unaudited)
(unaudited)
$
(18,447
)
$
(18,022
)
$
(68,776
)
272
155
1,014
5,545
286
7,332
10,891
10,891
615
(108
)
489
(124
)
(33
)
(10
)
163
964
(159
)
795
742
160
2,378
(650
)
(650
)
(11,083
)
(6,830
)
(46,374
)
(477
)
(108
)
(1,571
)
(280,478
)
(90,072
)
(617,926
)
272,444
87,297
597,156
(212
)
(212
)
(8,511
)
(3,095
)
(22,553
)
50
(745
)
(154
)
(1,186
)
3,336
21,799
71,183
5,200
5,200
123
37
365
(165
)
2,714
26,882
75,447
(16,880
)
16,957
6,520
23,400
253
$ 6,520
$
17,210
$ 6,520
$ 123
$ 38
$ 266
$
$
$ 239
$
$
14,070
$14,070
F-13
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies
F-14
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
F-15
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
F-16
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
September 30,
December 31,
2006
2005
(in thousands)
$293
$
263
$
151
619
215
271
617
129
379
$
1,529
$
607
$
801
F-17
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
F-18
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
F-19
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
Nine Months Ended
September 30,
Year Ended December 31,
2007
2006
2006
2005
2004
Numerator:
$ (18,447
)
$ (18,022
)
$ (22,777
)
$ (7,366
)
$ (4,578
)
5,172,736
4,581,464
4,622,315
4,096,813
4,044,124
(59,890
)
(927,927
)
(927,927
)
(927,927
)
(627,927
)
(627,927
)
4,184,919
3,653,537
3,694,388
3,468,886
3,416,197
$ (4.41
)
$ (4.93
)
$ (6.17
)
$ (2.12
)
$ (1.34
)
September 30,
December 31,
2007
2006
2006
2005
2004
22,327,407
20,147,025
21,637,025
12,081,880
10,929,670
5,257,413
1,113,987
5,073,594
1,246,095
1,463,512
927,927
927,927
927,927
629,927
629,927
534,642
498,821
550,981
287,288
313,515
150,000
29,197,389
22,687,760
28,189,527
14,245,190
13,334,624
F-20
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
Nine Months
Ended
Year Ended
September 30,
December 31,
2007
2006
$ (18,447
)
$ (22,777
)
615
(117
)
$ (17,832
)
$ (22,894
)
4,184,919
3,694,388
21,892,752
16,220,761
927,927
927,927
27,005,598
20,843,076
$ (0.66
)
$ (1.10
)
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
September 30,
December 31,
2007
2006
(in thousands)
$
4
$
21
12
12
$
16
$
33
F-22
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
F-23
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 1
Organization and
Significant Accounting Policies(Continued)
Note 2
Investments
F-24
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 2
Investments(Continued)
September 30, 2007
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
(in thousands)
$
1,737
$
$
$
1,737
4,990
4,990
20,617
34
20,651
$
27,344
$
34
$
$
27,378
$
6,520
207
20,651
$
27,378
December 31, 2006
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
(in thousands)
$
8,617
$
$
$
8,617
14,985
14,985
12,459
26
12,485
$
36,061
$
26
$
$
36,087
$
23,400
202
12,485
$
36,087
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 2
Investments(Continued)
December 31, 2005
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
$
253
$
$
$
253
12,113
6
12,119
$
12,366
$
6
$
$
12,372
$
253
12,119
$
12,372
Nine Months Ended
September 30,
Year Ended December 31,
2007
2006
2006
2005
2004
(in thousands)
$
1,049
$
689
$
943
$
485
$
339
(76
)
(87
)
254
129
270
6
8
(130
)
(96
)
(125
)
(82
)
(89
)
$
1,173
$
722
$
1,088
$
333
$
171
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 3
Property and
Equipment
September 30,
December 31,
2006
2005
(in thousands)
$
261
$
229
$
197
19
16
266
236
221
266
261
255
940
534
255
1,752
1,276
928
(892
)
(699
)
(510
)
$
860
$
577
$
418
Note 4
Notes
Payable
$
1,005
1,010
$
2,015
Note 5
Acquisition of
nura
F-27
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 5
Acquisition of
nura(Continued)
$ 87
233
5,200
182
(2,535
)
3,167
310
10,891
$
14,368
F-28
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 5
Acquisition of
nura(Continued)
Pro Forma
Pro Forma
Omeros
Nura
Adjustments
Combined
(In thousands, except share and per share data)
$
200
$
200
$
$
400
9,637
2,394
12,031
10,891
(10,891
) (1)
3,625
957
63
(2)
4,645
24,153
3,351
(10,828
)
16,676
(23,953
)
(3,151
)
10,828
(16,276
)
1,088
8
1,096
179
219
398
(91
)
(295
)
(386
)
$
(22,777
)
$
(3,219
)
$
10,828
$
(15,168
)
3,694,388
22,106
(3)
3,716,494
$
(4.08
)
(1)
Represents an adjustment to reverse the $10.9 million
non-recurring charge for purchased in-process research and
development recorded in the historical financial statements of
Omeros that resulted directly from the August 11, 2006
acquisition of nura.
F-29
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 5
Acquisition of
nura(Continued)
(2)
Represents amortization of assembled workforce acquired in the
acquisition for the period of $63,000.
(3)
Represents weighed average number of shares issued in connection
with the acquisition.
Note 6
Commitments and
Contingencies
Lease
Sublease
Net Lease
Payments
Income
Payments
(in thousands)
$
1,333
$
252
$
1,081
1,117
69
1,048
438
438
427
427
279
279
$
3,594
$
321
$
3,273
Note 7
Warrants
F-30
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 7
Warrants(Continued)
September 30, 2007
December 31, 2006
Weighted-
Weighted-
Warrants
Fair
Average
Warrants
Fair
Average
Outstanding
Value
Exercise Price
Outstanding
Value
Exercise Price
125,064
$
$
1.75
125,064
$
$
1.75
25,139
27
3.97
409,578
1,674
6.16
400,778
1,010
6.16
534,642
$
1,674
$
5.13
550,981
$
1,037
$
5.06
F-31
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 7
Warrants(Continued)
July 1,
2005
September 30,
December 31,
(Date of
2007
2006
2005
Adoption)
4.36%
4.57%
4.38%
4.58%
4.5-5.00
5.00-6.08
1.00-5.00
1.5 -5.00
60%
60%
80%
80%
Note 8
Convertible
Preferred Stock
September 30, 2007
Shares
Issued
Authorized
Issued and
Aggregate
Price per
and
Outstanding
Liquidation
Carrying
Share
Designated
Shares
Preference
Value
$
1.00
775,000
775,000
$ 775
$ 775
$
1.75
2,675,073
2,675,073
4,681
4,682
$
2.65
2,866,719
2,866,719
7,597
7,608
$
3.97
997,719
996,962
3,958
3,957
$
5.00
19,000,000
15,013,653
75,068
72,146
26,314,511
22,327,407
$
92,079
$
89,168
F-32
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 8
Convertible
Preferred Stock(Continued)
December 31, 2006
Shares
Issued
Authorized
Issued and
Aggregate
Price per
and
Outstanding
Liquidation
Carrying
Share
Designated
Shares
Preference
Value
$
1.00
775,000
775,000
$ 775
$ 775
$
1.75
2,675,073
2,675,073
4,681
4,682
$
2.65
2,866,719
2,866,719
7,597
7,608
$
3.97
997,719
972,580
3,861
3,861
$
5.00
19,000,000
14,347,653
71,738
68,816
26,314,511
21,637,025
$
88,652
$
85,742
December 31, 2005
Shares
Issued
Authorized
Issued and
Aggregate
Price per
and
Outstanding
Liquidation
Carrying
Share
Designated
Shares
Preference
Value
$
1.00
875,000
775,000
$ 775
$ 775
$
1.75
2,675,073
2,675,073
4,681
4,682
$
2.65
2,875,271
2,866,719
7,597
7,608
$
3.97
997,719
972,580
3,861
3,861
$
5.00
7,350,000
4,792,508
23,962
23,962
14,773,063
12,081,880
$
40,876
$
40,888
(*)
Shares issued in conjunction with
the nura acquisition totaled 3,398,445 at a price of $4.14 per
share.
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 8
Convertible
Preferred Stock(Continued)
Note 9
Common
Stock
F-34
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 9
Common
Stock(Continued)
September 30,
December 31,
2007
2006
5,192,537
5,008,079
1,012,928
1,624,676
58,806
58,806
6,070
6,709
22,327,407
21,637,025
409,578
425,917
125,064
125,064
29,132,390
28,886,276
Note 10
Stock-Based
Compensation
F-35
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 10
Stock-Based
Compensation(Continued)
Weighted-
Average
Shares
Exercise
Available for
Options
Price per
Grant
Outstanding
Share
439,253
1,448,512
$
0.30
(81,000
)
81,000
0.50
(55,687
)
0.19
10,313
(10,313
)
0.40
368,566
1,463,512
0.31
(169,683
)
169,683
0.50
(387,100
)
0.27
198,883
1,246,095
0.35
5,700,000
15,192
5.42
(4,325,853
)
4,325,853
0.50
(453,716
)
0.28
(8,184
)
5.42
51,646
(51,646
)
0.37
1,624,676
5,073,594
0.49
(658,500
)
658,500
1.15
(427,290
)
0.64
(639
)
5.42
46,752
(46,752
)
0.53
1,012,928
5,257,413
$
0.56
F-36
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 10
Stock-Based
Compensation(Continued)
Options Outstanding
Options Exercisable
Weighted-
Average
Remaining
Weighted-
Weighted-
Range of Exercise
Number of
Contractual
Average
Number of
Average
Options
Life (Years)
Exercise Price
Options
Exercise Price
449,933
3.56
$
0.24
448,140
$
0.24
4,540,390
9.86
$
0.50
1,808,944
$
0.50
76,562
1.71
$
1.00
76,562
$
1.00
6,709
6.79
$
5.42
4,862
$
5.42
5,073,594
9.17
$
0.49
2,338,508
$
0.48
Nine Months Ended
September 30,
Years Ended December 31,
2007
2006
2006
2005
2004
60%
60%
60%
0%
0%
6.08
5.00-6.08
5.00-6.08
5.00
5.00
4.42% - 4.78%
4.63% - 5.04%
4.57% - 5.04%
4.58%
4.00%
0%
0%
0%
0%
0%
F-37
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 10
Stock-Based
Compensation(Continued)
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
23,000
$
0.50
$
0.89
$
0.39
28,000
0.50
0.89
0.39
4,274,853
0.50
0.89
0.39
308,500
1.00
1.05
0.05
350,000
1.00
3.63
2.63
275,733
1.25
6.23
4.98
F-38
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 10
Stock-Based
Compensation(Continued)
Nine Months Ended
September 30,
Years Ended December 31,
2007
2006
2006
2005
2004
(in thousands)
$
245
$
3
$
309
$
$
5,300
283
1,130
(507
)
273
$
5,545
$
286
$
1,439
$
(507
)
$
273
Note 11
Income
Taxes
December 31,
2006
2005
(in thousands)
$
12,131
$
9,331
442
1,194
816
94
95
13,861
10,242
(13,861
)
(10,242
)
$
$
F-39
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 11
Income
Taxes(Continued)
December 31,
2006
2005
2004
(in thousands)
(34
)%
(34
)%
(34
)%
19
1
2
14
36
32
1
(3
)
Note 12
Related-Party
Transactions
F-40
Table of Contents
(A Development Stage Company)
for the nine months ended September 30, 2007 and for
the nine months ended September 30, 2006 is unaudited)
Note 12
Related-Party
Transactions(Continued)
Note 13
401(k) Retirement
Plan
Note 14
Subsequent Events
(unaudited)
F-41
Table of Contents
F-42
Table of Contents
Stockholders of nura, inc.
F-43
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Period from
Period from
January 1,
August 26,
2006
2003
through
Year Ended
(Inception) through
August 11,
December 31,
August 11,
2006
2005
2004
2006
$ 200
$
$ 164
$ 364
2,394
4,612
3,040
10,693
957
1,517
1,178
3,858
3,351
6,129
4,218
14,551
(3,151
)
(6,129
)
(4,054
)
(14,187
)
219
434
335
1,013
8
98
57
168
(295
)
(190
)
(486
)
$
(3,219
)
$
(5,787
)
$
(3,662
)
$
(13,492
)
F-44
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Period from
Period from
August 26,
January 1,
2003
2006
(Inception)
through
Year Ended
through
August 11,
December 31,
August 11,
2006
2005
2004
2006
$
(3,219
)
$
(5,787
)
$
(3,662
)
$
(13,492
)
77
115
46
243
4
92
21
113
(8
)
(8
)
(38
)
(11
)
83
(62
)
(283
)
276
160
294
(3,379
)
(5,386
)
(3,373
)
(12,908
)
(166
)
(385
)
(551
)
(166
)
(385
)
(551
)
2,000
3,000
5,100
(522
)
(72
)
(594
)
(2
)
(3
)
(198
)
5,472
9,234
3
1
4
1,479
2,926
5,472
13,546
(1,900
)
(2,626
)
1,714
87
1,987
4,613
2,899
$ 87
$
1,987
$
4,613
$
87
$ 153
$ 171
$
$ 325
$ 71
$ 73
$
$ 144
$
$
$
$ 100
$
$
$
$ 45
F-45
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Note 1
Organization and
Significant Accounting Policies
F-46
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Note 1
Organization and
Significant Accounting Policies(Continued)
F-47
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Note 1
Organization and
Significant Accounting Policies(Continued)
Note 2
Commitments and
Contingencies
Operating Lease
Sublease Income
Net Operating Lease
(in thousands)
$354
$
185
$169
915
181
734
698
91
607
20
20
8
8
$
1,995
$
457
$
1,538
F-48
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Note 2
Commitments and
Contingencies(Continued)
Note 3
Long-Term
Debt
F-49
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Note 4
Stockholders
Deficit and Stock Options
Deficit
Accumulated
Common Stock
Additional
During the
Total
Number of
Paid-In
Development
Stockholders
Shares
Amount
Capital
Stage
Deficit
3,114,753
$
$
$
$
980,000
49
49
(824
)
(824
)
4,094,753
49
(824
)
(775
)
(3,662
)
(3,662
)
4,094,753
$
$
49
$
(4,486
)
$
(4,437
)
F-50
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Note 4
Stockholders
Deficit and Stock Options(Continued)
Weighted-Average
Shares Available
Exercise Price per
for Grant
Options Outstanding
Share
1,244,211
1,054,477
$
0.05
(601,803
)
601,803
0.05
81,967
(81,967
)
0.05
724,375
1,574,313
0.05
(219,500
)
219,500
0.05
(10,000
)
0.05
504,875
1,783,813
$
0.05
(58,825
)
0.05
504,875
1,724,988
$
0.05
Options Outstanding
Options Exercisable
Weighted-
Average
Remaining
Weighted-
Weighted-
Exercise
Number of
Contractual Life
Average
Number of
Average
Options
(Years)
Exercise Price
Options
Exercise Price
1,724,988
7.63
$
0.05
1,066,181
$
0.05
Years Ended December 31,
2005
2004
4.58%
3.90%-4.76%
5
4
Note 5
401(k) Retirement
Plan
F-51
Table of Contents
(A DEVELOPMENT STAGE COMPANY)
Note 6
Subsequent
Events
F-52
Table of Contents
Page
1
9
29
31
31
32
34
36
38
54
81
86
103
106
108
113
116
123
123
123
F-1
Table of Contents
ITEM 13.
OTHER EXPENSES
OF ISSUANCE AND DISTRIBUTION.
$
4,520
125,000
12,000
*
*
*
*
*
*
*
*
To be completed by amendment.
ITEM 14.
INDEMNIFICATION
OF DIRECTORS AND OFFICERS.
II-1
Table of Contents
ITEM 15.
RECENT SALES
OF UNREGISTERED SECURITIES.
II-2
Table of Contents
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
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.
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.
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.
II-3
Table of Contents
Exhibit
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).
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.
Table of Contents
Exhibit
Master Services Agreement between nura, inc. and ComGenex, Inc.
dated January 27, 2005.
List of significant subsidiaries of the registrant.
Consent of Ernst & Young LLP, independent registered
public accounting firm.
Consent of Ernst & Young LLP, independent auditors.
Consent of PricewaterhouseCoopers LLP, independent accountants.
Consent of Wilson Sonsini Goodrich & Rosati,
Professional Corporation (included in Exhibit 5.1).
Power of Attorney (see
page II-6
to this
Form S-1).
*
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
By:
President, Chief Executive Officer,
Chief Medical Officer and
Chairman of the Board of Directors
(Principal Executive Officer)
January 9, 2008
Chief Financial Officer and Treasurer (Principal Financial and
Accounting Officer)
January 9, 2008
Director
January 9, 2008
Director
January 9, 2008
II-6
Table of Contents
Director
January 9, 2008
Director
January 9, 2008
Director
January 9, 2008
Director
January 9, 2008
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.
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.
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.
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.
Table of Contents
Exhibit
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
21
.1
List of significant subsidiaries of the registrant.
23
.1
Consent of Ernst & Young LLP, independent registered
public accounting firm.
23
.2
Consent of Ernst & Young LLP, independent auditors.
23
.3
Consent of PricewaterhouseCoopers LLP, independent accountants.
23
.4*
Consent of Wilson Sonsini Goodrich & Rosati,
Professional Corporation (included in Exhibit 5.1).
24
.1
Power of Attorney (see
page II-6
to this
Form S-1).
*
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.
1
1. | Representations and Warranties of the Company . | ||
The Company represents and warrants to each of the Underwriters as follows: |
2
3
4
5
6
7
8
9
10
11
12
13
2. | Purchase, Sale and Delivery of the Firm Shares . |
14
3. | Offering by the Underwriters . |
4. | Covenants of the Company . | ||
The Company covenants and agrees with the several Underwriters that: |
15
16
17
18
5. | Costs and Expenses . |
19
6. | Conditions of Obligations of the Underwriters . |
20
21
22
7. | Conditions of the Obligations of the Company . |
8. | Indemnification . |
23
24
25
9. | Default by Underwriters . |
10. | Notices . |
26
11. | Termination . |
12. | Successors . |
13. | Information Provided by Underwriters . |
27
14. | Miscellaneous . |
28
Very truly yours,
OMEROS CORPORATION |
||||
By: | ||||
Name: | ||||
Title: | ||||
29
Number of Firm Shares | ||
Underwriter | to be Purchased | |
Deutsche Bank Securities Inc.
|
||
Pacific Growth Equities, LLC
|
||
Leerink
Swann LLC
|
||
Needham & Company, LLC
|
||
|
||
Total
|
30
31
32
33
34
Signature : | ||||
Print Name : |
35
1
Page | ||||||||
|
||||||||
ARTICLE 1 THE MERGER | 2 | |||||||
|
1.1 | The Merger | 2 | |||||
|
1.2 | Closing; Effective Time | 2 | |||||
|
1.3 | Effect of the Merger | 2 | |||||
|
1.4 | Certificate of Incorporation; Bylaws | 2 | |||||
|
||||||||
ARTICLE 2 MERGER CONSIDERATION; EFFECT OF MERGER ON COMPANY CAPITAL STOCK | 3 | |||||||
|
2.1 | Merger Consideration; Exchange of Capital Stock | 3 | |||||
|
2.2 | Assumption of Stock Options; Other Equity Interest; Oxford Indebtedness | 3 | |||||
|
2.3 | Merger Sub | 4 | |||||
|
2.4 | Appraisal Rights | 5 | |||||
|
2.5 | Mechanics of Exchange | 5 | |||||
|
2.6 | No Further Rights in Shares | 6 | |||||
|
2.7 | No Fractional Shares | 7 | |||||
|
2.8 | Taking of Necessary Action; Further Action | 7 | |||||
|
2.9 | Post-Closing Adjustment | 7 | |||||
|
2.10 | Withholding Rights | 9 | |||||
|
||||||||
ARTICLE 3 REPRESENTATIONS AND WARRANTIES OF COMPANY | 9 | |||||||
|
3.1 | Organization, Good Standing, Qualification | 10 | |||||
|
3.2 | Capitalization | 10 | |||||
|
3.3 | Subsidiaries | 11 | |||||
|
3.4 | Authorization | 11 | |||||
|
3.5 | Governmental Consents | 12 | |||||
|
3.6 | Litigation | 12 | |||||
|
3.7 | Intellectual Property | 12 | |||||
|
3.8 | Compliance with Other Instruments | 16 | |||||
|
3.9 | Agreements; Actions | 16 | |||||
|
3.10 | Disclosure | 18 | |||||
|
3.11 | No Conflict of Interest | 18 | |||||
|
3.12 | Title to Property and Assets | 18 | |||||
|
3.13 | Financial Statements | 18 | |||||
|
3.14 | Changes | 19 | |||||
|
3.15 | Company Employee Matters and Benefit Plans | 20 | |||||
|
3.16 | Tax Returns, Payments and Elections | 22 | |||||
|
3.17 | Insurance | 23 | |||||
|
3.18 | Labor Agreements and Actions | 23 | |||||
|
3.19 | Permits | 23 | |||||
|
3.20 | Corporate Documents | 23 |
-i-
Page | ||||||||
|
||||||||
|
3.21 | Real Property Holding Company | 24 | |||||
|
3.22 | Brokers | 24 | |||||
|
3.23 | Proprietary Information and Inventions Assignment Agreement | 24 | |||||
|
3.24 | Predecessor Corporations | 24 | |||||
|
3.25 | Restrictions on Business Activities | 24 | |||||
|
3.26 | Environmental Matters | 24 | |||||
|
3.27 | Restricted Securities | 25 | |||||
|
||||||||
ARTICLE 4 REPRESENTATIONS AND WARRANTIES OF PARENT AND MERGER SUB | 25 | |||||||
|
4.1 | Organization, Good Standing, Qualification | 25 | |||||
|
4.2 | Authorized Capital of Parent | 26 | |||||
|
4.3 | Subsidiaries | 26 | |||||
|
4.4 | Authorization | 27 | |||||
|
4.5 | Valid Issuance of Securities | 27 | |||||
|
4.6 | Governmental Consents | 27 | |||||
|
4.7 | Litigation | 27 | |||||
|
4.8 | Intellectual Property | 28 | |||||
|
4.9 | Compliance with Other Instruments | 28 | |||||
|
4.10 | Agreements; Actions | 29 | |||||
|
4.11 | Disclosure | 30 | |||||
|
4.12 | No Conflict of Interest | 30 | |||||
|
4.13 | Rights of Registration and Voting Rights | 31 | |||||
|
4.14 | Title to Property and Assets | 31 | |||||
|
4.15 | Financial Statements | 31 | |||||
|
4.16 | Changes | 31 | |||||
|
4.17 | Parent Employee Matters and Benefit Plans | 33 | |||||
|
4.18 | Tax Returns, Payments and Elections | 34 | |||||
|
4.19 | Insurance | 34 | |||||
|
4.20 | Labor Agreements and Actions | 35 | |||||
|
4.21 | Permits | 35 | |||||
|
4.22 | Corporate Documents | 35 | |||||
|
4.23 | Brokers | 35 | |||||
|
4.24 | Proprietary Information and Inventions Assignment Agreement | 35 | |||||
|
4.25 | Restrictions on Business Activities | 36 | |||||
|
4.26 | Environmental Matters | 36 | |||||
|
||||||||
ARTICLE 5 ADDITIONAL AGREEMENTS | 36 | |||||||
|
5.1 | Companys Conduct of the Business Prior to Closing | 36 | |||||
|
5.2 | Interim Operations | 37 | |||||
|
5.3 | Acquisition Proposals | 39 |
-ii-
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Page | ||||||||
|
9.8 | No Third-Party Beneficiaries | 62 | |||||
|
9.9 | Disclaimer of Agency | 62 | |||||
|
9.10 | Relationship of the Parties | 62 | |||||
|
9.11 | Assignment | 62 | |||||
|
9.12 | Severability | 62 | |||||
|
9.13 | Remedies Cumulative | 62 | |||||
|
9.14 | Governing Law | 63 |
-iv-
Exhibits | ||
|
||
Exhibit A
|
Defined Terms | |
|
||
Exhibit B
|
Voting Agreement | |
|
||
Exhibit C
|
Form of Certificate of Merger | |
|
||
Exhibit D
|
Benjamin Contract Amendment | |
|
||
Exhibit E
|
Series E Stock Purchase Agreement and addendums thereto | |
|
||
Exhibit F
|
Series E Investors Rights Agreement | |
|
||
Exhibit G
|
Charter Amendment |
Schedules | ||
|
||
Schedule 2.1
|
Allocation of Merger Consideration | |
|
||
Schedule 2.5(b)
|
Certified Stockholder List | |
|
||
Schedule 2.9
|
Estimated Liability Adjustment | |
|
||
Schedule 3
|
Company Disclosure Schedule | |
|
||
Schedule 4
|
Parent Disclosure Schedule | |
|
||
Schedule 5.2
|
Interim Operations | |
|
||
Schedule 5.11
|
Retained Company Employees | |
|
||
Schedule 6.1(g)
|
Consents/Notices and Related Matters | |
|
||
Schedule 6.1(k)
|
Lien Releases |
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|
If to the Company: | Nura, Inc. | ||
|
1124 Columbia Street, Suite 650 | |||
|
Seattle, WA 98104 | |||
|
Attn: Chief Financial Officer | |||
|
||||
|
If to the Holder. | Oxford Finance Corporation | ||
|
133 N. Fairfax Street | |||
|
Alexandria, VA 22314 | |||
|
Attn: Chief Financial Officer |
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NURA, INC.
|
||||
By: | /s/ Jim D. Johnston | |||
Name: | Jim D. Johnston | |||
Title: | CFO |
TO:
|
||||
|
|
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|
|
|||
|
|
|
Name: | ||||||||||
|
|
||||||||||
|
Address: | ||||||||||
|
|||||||||||
Taxpayer I.D.: | |||||||||||
|
Oxford Finance Corporation
|
||||
By: | ||||
Name: | ||||
Title: | ||||
Date: | ||||
Page | ||||||||
|
||||||||
1.
|
Registration Rights | 2 | ||||||
|
1.1 | Definitions | 2 | |||||
|
1.2 | Request for Registration | 3 | |||||
|
1.3 | Company Registration | 4 | |||||
|
1.4 | Form S-3 Registration | 4 | |||||
|
1.5 | Obligations of the Company | 5 | |||||
|
1.6 | Furnish Information | 7 | |||||
|
1.7 | Expenses of Registration | 7 | |||||
|
1.8 | Underwriting Requirements | 8 | |||||
|
1.9 | Delay of Registration | 9 | |||||
|
1.10 | Indemnification | 9 | |||||
|
1.11 | Reports Under Securities Exchange Act of 1934 | 11 | |||||
|
1.12 | Assignment of Registration Rights | 11 | |||||
|
1.13 | Limitations on Subsequent Registration Rights | 12 | |||||
|
1.14 | Market Stand-Off Agreement | 12 | |||||
|
1.15 | Termination of Registration Rights | 13 | |||||
2.
|
Covenants of the Company | 13 | ||||||
|
2.1 | Delivery of Financial Statements | 13 | |||||
|
2.2 | Inspection | 13 | |||||
|
2.3 | Right of First Offer | 14 | |||||
|
2.4 | Termination of Covenants | 15 | |||||
3.
|
Restrictions on Transfer | 16 | ||||||
|
3.1 | Notice of Sales; Right of First Refusal | 16 | |||||
|
3.2 | Failure to Exercise | 17 | |||||
|
3.3 | No Transfers without Board Approval | 17 | |||||
|
3.4 | Permitted Transactions | 17 | |||||
|
3.5 | Prohibited Transfers | 18 | |||||
|
3.6 | Legended Certificates | 18 | |||||
|
3.7 | Termination | 18 | |||||
4.
|
Miscellaneous | 19 | ||||||
|
4.1 | Successors and Assigns | 19 | |||||
|
4.2 | Amendments and Waivers | 19 | |||||
|
4.3 | Notices | 19 | |||||
|
4.4 | Severability | 19 | |||||
|
4.5 | Governing Law | 20 | |||||
|
4.6 | Counterparts | 20 | |||||
|
4.7 | Titles and Subtitles | 20 | |||||
|
4.8 | Aggregation of Stock | 20 | |||||
|
4.9 | Entire Agreement | 20 | |||||
|
4.10 | Telecopy Execution and Delivery | 20 | |||||
|
4.11 | Arbitration | 20 | |||||
|
4.12 | Termination and Supersession | 21 |
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COMPANY:
OMEROS CORPORATION |
||||
By: | /s/ Gregory A. Demopulos | |||
Gregory A. Demopulos, M.D. | ||||
Chairman of the Board, President and
Chief Executive Officer Address: 1420 Fifth Ave., Suite 2600 Seattle, WA 98101 Fax: (206) 264-7856 |
||||
SERIES E INVESTOR:
|
||||
(Investor) | ||||
By: | ||||
Name: | ||||
(print) | ||||
Title: | ||||
(if applicable) | ||||
Address: | ||||
Fax: | ||||
FOUNDERS:
|
||||
H. Raymond Cairncross | ||||
Address:
Fax: |
||||
/s/ Gregory A. Demopulos | ||||
Gregory A. Demopulos, M.D. | ||||
Address:
Fax: |
||||
George Kargianis | ||||
Address:
Fax: |
||||
Pamela Pierce Palmer, M.D., Ph.D. | ||||
Address:
Fax: |
||||
SERIES A INVESTOR:
|
||||
(Investor) | ||||
By: | ||||
Name: | ||||
(print) | ||||
Title: | ||||
Address: | ||||
Fax: | ||||
SERIES B INVESTOR:
|
||||
(Investor) | ||||
By: | ||||
Name: | ||||
(print) | ||||
Title: | ||||
Address: | ||||
Fax: | ||||
SERIES C INVESTOR:
|
||||
(Investor) | ||||
By: | ||||
Name: | ||||
(print) | ||||
Title: | ||||
Address: | ||||
Fax: | ||||
SERIES D INVESTOR:
|
||||
(Investor) | ||||
By: | ||||
Name: | ||||
(print) | ||||
Title: | ||||
Address: | ||||
Fax: | ||||
COMMON SHAREHOLDER:
|
||||
/s/ Gregory A. Demopulos | ||||
(Common Shareholder) | ||||
By: | ||||
Name: | ||||
(print) | ||||
Title: | ||||
Address: | ||||
Fax: | ||||
* | Shall not be deemed a Common Shareholder pursuant to this Agreement until such time as such person or entity shall have executed a counterpart signature page to this Agreement. |
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OMEROS CORPORATION
|
||||
By: | ||||
[Name] | ||||
[Title] | ||||
Address: |
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«OptioneeAddress1»
«OptioneeAddress2»
Date of Grant (Later of Board
Approval Date or Commencement
of Employment/Consulting):
«GrantDate»
Vesting Commencement Date:
«VestingCommenceDate»
Exercise Price per Share:
$«ExercisePrice»
Total Number of Shares Granted:
«NoOfShares»
Type of Option:
«Type»
Term/Expiration Date:
«ExpirDate»
Vesting Schedule:
This Option may be exercised, in whole or in part, in accordance with the
following vesting schedule: «Vesting»
Termination Period:
Option may be exercised for ninety (90) days after termination of
employment or consulting relationship except as set out in Sections 6 and 7 of the
Stock Option Agreement (but in no event later than the Expiration Date).
«Optionee»: | Omeros Corporation | |||||
|
By: | |||||
|
||||||
Signature
|
Gregory A. Demopulos, M.D. | |||||
|
Chief Executive Officer | |||||
|
||||||
|
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COMPANY: | ||||||||
|
||||||||
OMEROS CORPORATION | ||||||||
|
||||||||
|
By: | |||||||
(Signature)
|
||||||||
|
Name: | |||||||
(Print)
|
||||||||
|
Title: | |||||||
|
||||||||
|
Address: | |||||||
|
||||||||
|
||||||||
|
PURCHASER: | |||||||
|
||||||||
|
||||||||
(Signature)
|
||||||||
|
||||||||
(Printed Name)
|
||||||||
|
Address: | |||||||
|
||||||||
|
Spouse of | ||||||
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Dated:
|
||||||
|
|
|||||
|
||||||
|
||||||
|
(Signature) | |||||
|
||||||
|
|
Dated:
|
||||||||
|
|
|||||||
Omeros Corporation | ||||||||
|
||||||||
|
By: | |||||||
|
||||||||
|
(Signature) | |||||||
|
||||||||
|
Name: | |||||||
|
||||||||
|
(Printed Name) | |||||||
|
||||||||
|
Title: | |||||||
|
OMEROS CORPORATION | OPTIONEE | |||||||
|
||||||||
By:
|
||||||||
|
||||||||
|
Gregory A. Demopulos, M.D. | <<OPTIONEE>> | ||||||
|
Chief Executive Officer |
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COMPANY: | ||||||
|
||||||
OMEROS CORPORATION | ||||||
|
||||||
|
By: | |||||
|
(Signature) | |||||
|
||||||
|
Name: | |||||
|
(Print) | |||||
|
||||||
|
Title: | |||||
|
Address: | |||||
|
||||||
|
||||||
|
||||||
|
||||||
PURCHASER: | ||||||
|
||||||
|
(Signature) | |||||
|
||||||
|
(Printed Name) | |||||
|
||||||
|
Address: | |||||
|
||||||
|
||||||
|
|
Spouse of | |||||
|
-11-
Dated:
|
||||||
|
||||||
|
||||||
|
Signature: | |||||
|
||||||
|
||||||
|
Optionee | |||||
|
||||||
|
||||||
|
Spouse of Optionee (if applicable) |
(a) | has consulted, and has been fully advised by, the undersigneds own tax advisor, , whose business address is , regarding the federal, state and local tax consequences of purchasing shares under the Plan, and particularly regarding the advisability of making elections pursuant to Section 83(b) of the Internal Revenue Code of 1986, as amended (the Code ) and pursuant to the corresponding provisions, if any, of applicable state law; or | ||
(b) | has knowingly chosen not to consult such a tax advisor. |
(a) | to make an election pursuant to Section 83(b) of the Code, and is submitting to the Company, together with the undersigneds executed Exercise Notice and Restricted Stock Purchase Agreement, an executed copy of form entitled Election Under Section 83(b) of the Internal Revenue Code of 1986, provided that the undersigned is solely responsible for filing such election with the Internal Revenue Service ; or | ||
(b) | not to make an election pursuant to Section 83(b) of the Code. |
Date:
|
||||||||
|
||||||||
|
«Optionee» | |||||||
Date:
|
||||||||
|
||||||||
|
Spouse of «Optionee» |
1. | The name, address, taxpayer identification number and taxable year of the undersigned are as follows: |
|
NAME OF TAXPAYER: | |||||||
|
||||||||
|
||||||||
|
NAME OF SPOUSE: | |||||||
|
||||||||
|
||||||||
|
ADDRESS: | |||||||
|
||||||||
|
||||||||
|
||||||||
|
||||||||
IDENTIFICATION NO. OF TAXPAYER: | ||||||||
|
||||||||
|
||||||||
IDENTIFICATION NO. OF SPOUSE: | ||||||||
|
||||||||
|
||||||||
TAXABLE YEAR: | ||||||||
|
2. | The property with respect to which the election is made is described as follows: |
3. | The date on which the property was transferred is: |
4. | The property is subject to the following restrictions: |
5. | The fair market value at the time of transfer, determined without regard to any restriction other than a restriction which by its terms will never lapse, of such property is: $ |
6. | The amount (if any) paid for such property: $ |
Dated:
|
||||||||
|
|
|
||||||
|
Signature of Taxpayer | |||||||
Dated:
|
||||||||
|
||||||||
|
Signature of Spouse |
Dated:
|
||||||||
|
||||||||
|
||||||||
|
||||||||
|
(Signature) | |||||||
|
||||||||
|
||||||||
|
(Printed Name) |
Dated:
|
||||||||
|
||||||||
Omeros Corporation | ||||||||
|
||||||||
|
By: | |||||||
|
||||||||
|
(Signature) | |||||||
|
Name: | |||||||
|
||||||||
|
(Printed Name) | |||||||
|
Title: | |||||||
|
«OptioneeAddress1»
«OptioneeAddress2»
Approval Date or Commencement
of Employment/Consulting):
«GrantDate»
«VestingCommenceDate»
$«ExercisePrice»
«NoOfShares»
«Type»
«ExpirDate»
This Option will vest in accordance with the following vesting schedule: «Vesting»
This Option may be exercised, in whole or in part, at any time prior to its
expiration for vested and unvested Shares. The Company has the right, but not the
obligation, to repurchase unvested Shares upon termination of employment or consulting
relationship.
Option may be exercised for ninety (90) days after termination of
employment or consulting relationship except as set out in Sections 6 and 7 of the
Stock Option Agreement (but in no event later than the Expiration Date).
«Optionee»: | Omeros Corporation | |||||
|
||||||
|
By: | |||||
|
|
|||||
|
Chief Executive Officer | |||||
|
||||||
|
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|
COMPANY: | |||||
|
||||||
OMEROS CORPORATION | ||||||
|
||||||
|
By: | |||||
|
||||||
|
(Signature) | |||||
|
||||||
|
Name: | |||||
|
||||||
|
(Print) | |||||
|
||||||
|
Title: | |||||
|
||||||
|
||||||
|
Address: | |||||
|
|
|||||
|
||||||
|
||||||
|
PURCHASER: | |||||
|
||||||
|
(Signature) | |||||
|
||||||
|
(Printed Name) | |||||
|
||||||
|
Address: | |||||
|
|
|||||
|
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Dated:
|
||||||
|
||||||
|
Signature: | |||||
|
||||||
|
||||||
|
Optionee | |||||
|
||||||
|
||||||
|
Spouse of Optionee (if applicable) |
Date:
|
||||||
|
||||||
|
«Optionee» | |||||
|
||||||
Date:
|
||||||
|
||||||
|
Spouse of «Optionee» |
1. | The name, address, taxpayer identification number and taxable year of the undersigned are as follows: |
|
NAME OF TAXPAYER: | |
|
NAME OF SPOUSE: | |
|
ADDRESS:
|
|
|
||
|
IDENTIFICATION NO. OF TAXPAYER: | |
|
IDENTIFICATION NO. OF SPOUSE: | |
|
TAXABLE YEAR: |
2. | The property with respect to which the election is made is described as follows: |
3. | The date on which the property was transferred is: | |
4. | The property is subject to the following restrictions: |
5. | The fair market value at the time of transfer, determined without regard to any restriction other than a restriction which by its terms will never lapse, of such property is: $ | |
6. | The amount (if any) paid for such property: $ |
Dated:
|
||||||
|
||||||
|
Signature of Taxpayer | |||||
|
||||||
Dated:
|
||||||
|
||||||
|
Signature of Spouse |
Dated:
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
(Signature) | |||||
|
||||||
|
||||||
|
||||||
|
(Printed Name) |
Dated:
|
||||||||
|
||||||||
Omeros Corporation | ||||||||
|
||||||||
|
By: | |||||||
|
||||||||
|
(Signature) | |||||||
|
||||||||
|
Name: | |||||||
|
||||||||
|
(Printed Name) | |||||||
|
||||||||
|
Title: | |||||||
|
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I. | NOTICE OF STOCK OPTION GRANT |
Date of Grant | ||||||||||
|
||||||||||
Vesting Commencement Date | ||||||||||
|
||||||||||
Exercise Price per Share | $ | |||||||||
|
||||||||||
Total Number of Shares Granted | ||||||||||
|
||||||||||
Total Exercise Price | $ | |||||||||
|
||||||||||
Type of Option: | Incentive Stock Option | |||||||||
|
||||||||||
Nonstatutory Stock Option | ||||||||||
|
||||||||||
Term/Expiration Date: |
II. | AGREEMENT |
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Submitted by:
|
Accepted by: | |
OPTIONEE
|
nura, inc. | |
|
||
|
||
|
||
Signature
|
By | |
|
||
|
||
Print Name
|
Title | |
|
||
Address:
|
Address: | |
|
||
|
||
|
||
|
||
|
||
|
||
|
Date Received |
-4-
OPTIONEE:
|
||||
|
||||
COMPANY:
|
nura, inc. | |||
|
||||
SECURITY:
|
COMMON STOCK | |||
|
||||
AMOUNT:
|
||||
|
||||
DATE:
|
Signature of Optionee: | ||||||
|
||||||
|
||||||
|
||||||
Date: , |
- 2 -
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OMEROS CORPORATION
|
||||
By: | /s/ Marcia S. Kelbon | |||
Title: | VP, Patent & General Counsel | |||
Address: | 1420 Fifth Avenue, Suite 2600 | |||
Seattle, WA 98101 | ||||
GREGORY A. DEMOPULOS
|
||||
Signature: | /s/ Gregory A. Demopulos, M.D. | |||
1. | Overall Duties . During my term of employment with the Company, I will perform for the Company such duties as may be designated by the Company from time to time. I will devote my best efforts to the interests of the Company and will not engage in other employment or in any activities detrimental to the best interests of the Company without the prior written consent of the Company. | |
2. | Company Intellectual Property . | |
2.1 | Definitions . As used in this Agreement, the term Intellectual Property means discoveries, developments, concepts, designs, ideas, know-how, improvements, inventions, trade secrets and/or original works of authorship, and trademarks, whether or not patentable, copyrightable or otherwise legally protectable. This includes, but is not limited to, any new product, apparatus, article of manufacture, biological material, method, procedure, process, technique, system, compound, formulation, composition of matter, design or configuration of any kind, or any improvement thereon. As used in this Agreement, the term Company Intellectual Property means all Intellectual Property that I may solely or jointly create, conceive, develop or reduce to practice during the term of my employment with the Company which (i) pertains to any current or planned line of business activity of the Company, (ii) was aided by the use of time, material or facilities of the Company, whether or not during working hours or (iii) relates to any of my work carried out for the Company, whether or not during normal working hours. Company Intellectual Property shall not be interpreted to include, and any assignment of inventions required by this Agreement does not apply to, any invention or other proprietary right of mine which I have disclosed to the Board of Directors of Omeros and which has been disclaimed thereby as being unrelated to and not in conflict with the present future business or research of Omeros. | |
2.2 | Duty to Disclose and Company Ownership . I agree to promptly disclose all Company Intellectual Property to the Company, for no additional compensation. All Company Intellectual Property shall be the sole property of the Company and its assigns to the maximum extent permitted by law (and to the fullest extent permitted by law shall be deemed works made for hire), and the Company and its successors and assigns shall be the sole owner of all patents, copyrights, trademarks, trade secrets and other rights in connection therewith. | |
2.3 | Assignment . I hereby assign and transfer to the Company, for no additional compensation, any right and title to and interest in Company Intellectual Property that I may have or acquire, including any copyrights and Registrations and renewals therefore, any inventions, any United States, International and foreign patent applications filed on such inventions, the right to apply for all such patent applications in my name or in the name of the Company, such Company Intellectual Property to be held and enjoyed by the Company as entirely as the same would have been held and enjoyed by me had this assignment and transfer not been made. | |
2.4 | Assistance . I agree to provide all required or requested assistance to the Company to permit the Company, at its expense but at no additional compensation to me, in obtaining and enforcing the full benefits, enjoyment, rights and title throughout the world in Company Intellectual Property, including but not limited to the review and execution of assignments confirming ownership by the |
Company, declarations, powers of attorney, and other documents, and assistance or cooperation in legal proceedings. I hereby irrevocably designate the Company and its duly authorized officers and agents as my agent and attorney-in fact, to execute and file on my behalf any such applications and to do all other lawful acts to further the prosecution and issuance of patents, copyright and mask work registrations related to such Inventions. This power of attorney shall not be affected by my subsequent incapacity. | ||
2.5 | Notice Required by Revised Code of Washington 49.44.140 . Any assignment of inventions required by this Agreement does not apply to an invention for which no equipment, supplies, facility or trade secret information of the Company was used and which was developed entirely on the employees own time, unless (a) the invention relates (i) directly to the business of the Company or (ii) to the Companys actual or demonstrably anticipated research or development or (b) the invention results from any work performed by the employee for the Company. | |
2.6 | I attach hereto as Exhibit A a complete list of all inventions or other Intellectual Property, if any, made by me prior to my employment with the Company that are relevant to any aspect of the Companys current and planned business, and I represent and warrant that such list is complete. If no such list is attached to this Agreement, I represent that I have no such inventions or other Intellectual Property at the time of signing this Agreement. If in the course of my employment with the Company, I use or incorporate into a product or process offered or under development by the Company an invention or other Intellectual Property not included in the Company Intellectual Property in which I have an interest, the Company is hereby granted a nonexclusive, fully paid-up, royalty-free, perpetual worldwide license of my interest to use and sublicense such invention or other Intellectual Property without restriction of any kind. | |
3. | Confidentiality Obligation. | |
3.1 | Definition . As used in this Agreement, the term Proprietary Information means information or material not generally known or available outside the Company, or information or material entrusted to the Company by third parties, that I may obtain or create before or during the term of my employment, or obtain through the Companys resources or personnel after my employment. This includes, but is not limited to, Company Intellectual Property, other inventions, confidential knowledge, copyrights, product ideas, techniques, processes, formulas, object codes, biological materials, mask works and/or any other information of any type relating to documentation, laboratory notebooks, data, schematics, algorithms, flow charts, mechanisms, research, manufacture, improvements, assembly, installation, marketing, forecasts, sales, pricing, customers, customer lists, customer data, investor names and lists, the duties, qualifications, performance levels and compensation of other employees, and/or cost or other financial data concerning any of the foregoing or the Company and its operations. Proprietary Information may be contained in material such as drawings, samples, procedures, specifications, reports, studies, customer or supplier lists, budgets, cost or price lists, compilations or computer programs, or may be in the nature of unwritten knowledge or know-how. | |
3.2 | Duty to Protect Proprietary Information . I understand and agree that all Proprietary Information is the sole property of the Company and its assigns. I hereby assign to the Company any rights I may acquire in such Proprietary Information. During and after my employment, I will hold in confidence and not directly or indirectly disclose or use any Proprietary Information, except as authorized by the Company as necessary for carrying out my duties for the Company. I agree not to make copies of such Proprietary Information except as authorized by the Company. Upon termination of my employment, or upon earlier request of the Company, I will return or deliver to |
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the Company all tangible or electronic forms or copies of such Proprietary Information in my possession or control. These obligations with respect to Proprietary Information shall not apply to information that I can conclusively establish with written documentation: (i) was widely known to the public at the time I obtained the Proprietary Information or later becomes widely known to the public through no direct or indirect action on my part; (ii) was known to me prior to my employment or pre-employment relationship or association with Company; or (iii) that I later receive from a third party having the lawful right to disclose the same. | ||
4. | Ownership of Physical Property . All documents, apparatus, equipment and other physical property in any form, whether or not pertaining to Proprietary Information, furnished to me by the Company or produced by me or others in connection with my employment shall be and remain the sole property of the Company, and will be returned to the Company upon request or upon termination of my employment, even if not requested. | |
5. | Non-solicitation of Employees, Consultants and Other Parties . During the term of my employment with the Company, and for a period of one (1) year following the termination of my employment with the Company for any reason, I shall not directly or indirectly solicit, induce, recruit or encourage any of the Companys employees or consultants to terminate their relationship with the Company, or attempt any of the foregoing, either for myself or any other person or entity. For a period of one (1) year following termination of my employment with the Company for any reason, I shall not solicit any licensor, customer, or licensee of the Company, that are known to me, with respect to any business, products or services that are competitive to the products or services offered by the Company or under development as of the date of termination of my relationship with the Company. | |
6. | Noncompetition . During the term of my employment with the Company and for one (1) year following the termination of my employment or relationship with the Company for any reason, I will not, without the Companys prior written consent, directly or indirectly work on any products or services that are competitive with products or services (a) being commercially developed or exploited by the Company during my employment or (b) on which I worked or about which I learned Proprietary Information during my employment with the Company. | |
7. | No Conflicts . I represent that my performance of all the terms of this Agreement as an employee of the Company does not and will not breach any agreement to keep in confidence proprietary information, knowledge or data acquired by me in confidence or in trust prior to my becoming an employee of the Company, and I will not disclose to the Company, or induce the Company to use, any confidential or proprietary information or material belonging to any previous employer or others. I am not a party to and agree not to enter into any written or oral agreement that conflicts or interferes with the provisions of this Agreement. I will not bring to my employment with the Company any materials or documents obtained from or belonging to a former employer except those documents listed in Exhibit A , which I have the unrestricted right to use and disclose without breach of any agreement or other obligation. | |
8. | At-Will Relationship . I understand and acknowledge that my employment with the Company is and shall continue to be at-will, as defined under applicable law, meaning that either I or the Company may terminate the relationship at any time for any reason or no reason, without further obligation or liability on the part of the Company. | |
9. | Miscellaneous . This Agreement inures to the benefit of successors and assigns of the Company and is binding upon my heirs and legal representatives. My obligations under Sections 2 and 3 of this Agreement shall endure and subsist beyond the term of my employment, and my obligations under |
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Sections 5 and 6 of this Agreement shall continue beyond the term of this Agreement for the
periods noted in those sections.
I acknowledge that violation of this Agreement by me may cause irreparable injury to the Company, and I agree that the Company will be entitled to seek extraordinary relief in court, including, but not limited to, temporary restraining orders, preliminary injunctions and permanent injunctions without the necessity of posting a bond or other security and without prejudice to any other rights and remedies that the Company may have for a breach of this Agreement. |
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This Agreement supersedes any oral, written or other communications or agreements concerning the subject matter of this Agreement, and may be amended or waived only by a written instrument that I and a duly authorized officer of the Company have signed. This Agreement shall be governed by the laws of the State of Washington applicable to contracts entered into and performed entirely within the State of Washington, without giving effect to principles of conflict of laws. If any provision of this Agreement is held to be unenforceable under applicable law, then such provision shall be excluded from this Agreement only to the extent unenforceable, and the remainder of such provision and of this Agreement shall be enforceable in accordance with its terms. | ||
10. | Acknowledgment . I certify and acknowledge that I have carefully read all of the provisions of this Agreement and that I understand and will fully and faithfully comply with such provisions. I acknowledge that the Companys counsel represents the interest of the Company, and have received a recommendation to obtain independent legal counsel to review this Agreement in advance and counsel me of my rights and obligations thereunder. |
OMEROS MEDICAL SYSTEMS, INC. | Gregory A. Demopulos, M.D. | |||
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By:
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/s/ Marcia S. Kelbon | /s/ Gregory A. Demopulos, M.D. | ||
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Title:
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VP, Patent & General Counsel | Dated: 12/11/01 | ||
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Dated:
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1. | The following is a complete list of all inventions or other Intellectual Property relevant to the subject matter of my employment by the Company that have been made or conceived or first reduced to practice by me, alone or jointly with others or which were known to me prior to my employment by the Company. I represent that such list is complete. |
2. | þ I am not bringing any materials and documents of a former employer to the Company. |
By: | /s/ Gregory A. Demopulos, M.D. | |||
Gregory A. Demopulos, M.D. | ||||
[Please Print Employee Name] | ||||
6530 83
rd
Place SE
Mercer Island, Washington 98040
Board Approval Date:
December 11, 2001
Date of Grant (Later of Board
Approval Date or Commencement
of Employment/Consulting):
December 11, 2001
Exercise Price per Share:
$0.265
Total Number of Shares Granted:
93,125
Total Exercise Price:
$24,678.13
Type of Option:
Nonstatutory Stock Option
Expiration Date:
December 10, 2011
Vesting Commencement Date:
December 11, 2001
Vesting/Exercise Schedule:
This Option may be exercised, in
whole or in part, at any time after the Date of Grant. The Shares underlying this Option shall be fully vested on the Vesting Commencement Date.
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Termination Period: | This Option may be exercised for 90 days after termination of employment | |
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or consulting relationship except as set out in Section 5 of the Stock Option Agreement | ||
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(but in no event later than the Expiration Date); provided , that if Optionees | ||
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employment relationship is terminated by the Company in a Termination Without Cause | ||
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or by Optionee in a Constructive Termination (as both of such terms are defined in | ||
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the Employment Agreement dated December 11, 2001 between Company and Optionee) this | ||
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Option may be exercised until the Expiration Date. Optionee is responsible for keeping | ||
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track of the Expiration Date. The Company will not provide further notice of such | ||
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Transferability: | This Option may not be transferred. |
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(i) | THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE OR DISTRIBUTION MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL FOR THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933. | ||
(ii) | THE SHARES REPRESENTED BY THIS CERTIFICATE MAY BE TRANSFERRED ONLY IN ACCORDANCE WITH THE TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE SHAREHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE COMPANY. |
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Spouse of Gregory Demopulos, M.D. |
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Gregory Demopulos, M.D. |
OMEROS MEDICAL SYSTEMS, INC. | ||||
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Very truly yours, | |||
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OMEROS MEDICAL SYSTEMS, INC. | |||
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/s/ Gregory Demopulos | |||
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Gregory A. Demopulos, M.D. | |||
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Chairman of the Board and CEO |
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ACCEPTED AND AGREED:
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MARCIA S. KELBON
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/s/ Marcia Kelbon
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Enclosure: | Proprietary Information and Inventions Agreement |
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Very truly yours, | |||
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OMEROS CORPORATION | |||
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/s/ Gregory A. Demopulos | |||
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Chairman of the Board and CEO |
ACCEPTED AND AGREED:
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RICHARD J. KLEIN
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/s/ Richard J. Klein
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/s/ Gregory A. Demopulos | ||||
Gregory A. Demopulos, M.D.
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Omeros Medical Systems, Inc.
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By | /s/ H. Raymond Cairncross | |||
H. Raymond Cairncross, Its V.P. | ||||
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/s/ Gregory A. Demopulos | ||||
Gregory A. Demopulos, M.D. |
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H. Raymond Cairncross, its V.P. | ||||
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/s/ Pamela A. Pierce | ||||
Pamela A. Pierce, M.D., Ph.D. | ||||
Omeros Medical Systems, Inc.
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By | /s/ H. Raymond Cairncross | |||
H. Raymond Cairncross, Its V.P. | ||||
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/s/ Pamela A. Pierce | ||||
Pamela A. Pierce, M.D., Ph.D. | ||||
Witnessed and Accepted:
Omeros Medical Systems, Inc. |
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by | /s/ H. Raymond Cairncross | |||
H. Raymond Cairncross, its V.P. | ||||
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OMEROS MEDICAL SYSTEMS, INC. | GREGORY A. DEMOPULOS, M.D. | |||||||||
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/s/ Marcia S. Kelbon | By: | /s/ Gregory A. Demopulos | |||||||
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Vice President, Patent and General Counsel | |||||||||
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OMEROS MEDICAL SYSTEMS, INC. | PAMELA PIERCE PALMER, M.D., Ph.D. | |||||||||
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/s/ Gregory A. Demopulos | By: | /s/ Pamela Pierce Palmer | |||||||
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Chairman and Chief Executive Officer | |||||||||
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Date:
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3/12/02 | Date: | 3/22/02 |
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/s/ Gregory A. Demopulos | ||||
Gregory A. Demopulos, M.D. | ||||
Omeros Medical Systems, Inc. | ||||
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By | /s/ H. Raymond Cairncross | ||
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H. Raymond Cairncross, Its V.P. |
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/s/ Gregory A. Demopulos | ||||
Gregory A. Demopulos, M.D. | ||||
By
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/s/ H. Raymond Cairncross | |||
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H. Raymond Cairncross, Its V.P. |
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(a) | Due Organization . Debtors exact legal name is as set forth in the preamble of this Agreement and Debtor is, duly organized, existing and in good standing under the laws of the State set forth in the preamble of this Agreement, has its chief executive offices at the location specified in the preamble, and is, and will remain duly qualified and licensed in every jurisdiction wherever necessary to carry on its business and operations; | ||
(b) | Power and Capacity to Enter Into and Perform Obligations . Debtor has adequate power and capacity to enter into, and to perform its obligations under this Agreement, each Note and any other documents evidencing, or given in connection with, any of the Indebtedness (all of the foregoing are called the Debt Documents ); |
(c) | Due Authorization . This Agreement and the other Debt Documents have been duly authorized, executed and delivered by Debtor and constitute legal, valid and binding agreements enforceable in accordance with their terms, except to the extent that the enforcement of remedies may be limited under applicable bankruptcy and insolvency laws; | ||
(d) | Approvals and Consents . No approval, consent or withholding of objections is required from any governmental authority or instrumentality with respect to the entry into, or performance by Debtor of any of the Debt Documents, except any already obtained; | ||
(e) | No Violations or Defaults . The entry into, and performance by, Debtor of the Debt Documents will not (i) violate any of the organizational documents of Debtor or any judgment, order, law or regulation applicable to Debtor, or (ii) result in any breach of or constitute a default under any contract to which Debtor is a party, or result in the creation of any lien, claim or encumbrance on any of Debtors property (except for liens in favor of Secured Party) pursuant to any indenture, mortgage, deed of trust, bank loan, credit agreement, or other agreement or instrument to which Debtor is a party; | ||
(f) | Litigation . There are no suits or proceedings pending in court or before any commission, board or other administrative agency against or affecting Debtor which could, in the aggregate, have a material adverse effect on Debtor, its business or operations, or its ability to perform its obligations under the Debt Documents, nor does Debtor have reason to believe that any such suits or proceedings are threatened; | ||
(g) | Solvency . The fair salable value of Debtors assets (including goodwill minus disposition costs) exceeds the fair value of its liabilities; the Debtor is not left with unreasonably small capital after the transactions in this Agreement or any Notes and Debtor is able to pay its debts (including trade debts) as they mature. | ||
(h) | Financial Statements Prepared In Accordance with GAAP . All financial statements delivered to Secured Party in connection will) the Indebtedness have been prepared in accordance with generally accepted accounting principles, but excluding footnotes and normal year-end adjustments, and since the date of the most recent financial statement, there has been no material adverse change to Debtors financial condition; | ||
(i) | Use of Collateral . The Collateral is not, and will not be, used by Debtor for personal, family or household purposes; | ||
(j) | Collateral in Good Condition and Repair . The Collateral is, and will remain, in good condition and repair, subject to normal wear and tear, and Debtor will not be negligent in its care and use; |
(k) | Ownership of Collateral . Debtor is, and will remain, the sole and lawful owner, and in possession of, the Collateral, and has the sole right and lawful authority to grant the security interest described in this Agreement; | ||
(l) | Encumbrances . The Collateral is, and will remain, free and clear of all liens, claims and encumbrances of any kind whatsoever, except for (i) liens in favor of Secured Party, (ii) liens for taxes not yet due or for taxes being contested in good faith and which do not involve, in the judgment of Secured Party, any risk of the sale, forfeiture or loss of any of the Collateral, and (iii) inchoate material mens, mechanics, repairmens and similar liens arising by operation of law in the normal course of business for amounts which are not delinquent (all of such liens are called Permitted Liens ); | ||
(m) | Negative Pledge on Intellectual Property . Debtors Intellectual Property is, and will remain, free and clear of all liens, claims and encumbrances of any kind whatsoever, except for Permitted Liens. Debtor shall not sell, transfer, assign, mortgage, pledge, lease, grant a security interest in, or encumber any of its Intellectual Property, or enter into any agreement, document, instrument or other arrangement (except with or in favor of Secured Party) with any entity which directly or indirectly prohibits or has the effect of prohibiting Debtor from selling, transferring, assigning, mortgaging, pledging, leasing, granting a security interest in or upon, or encumbering any of Debtors Intellectual Property; provided, however, that Debtor may grant non-exclusive licenses with respect to components of Debtors Intellectual Property in connection with joint ventures and corporate collaborations in the ordinary course of business. | ||
(n) | Taxes . All federal, state and local tax returns required to be filed by Debtor have been filed with the appropriate governmental agencies and all taxes due and payable by Debtor have been timely paid. Debtor will pay when due all taxes, assessments and other liabilities except as contested in good faith and by appropriate proceedings and for which adequate reserves have been established; | ||
(o) | No Defaults . No event or condition exists under any material agreement, instrument or document to which Debtor is a party or may be subject, or by which Debtor or any of its properties are bound, which constitutes a default or an event of default thereunder, or will, with the giving of notice, passage of time, or both, would constitute a default or event of default thereunder; | ||
(p) | Certification of Financial Information . All reports, certificates, schedules, notices and financial information submitted by Debtor to the Secured Party pursuant to this Agreement shall be certified as true and correct by the president or chief financial officer of Debtor; |
(q) | Notice of Material Adverse Change . Debtor shall give the Secured Party prompt written notice of any event, occurrence or other matter which has resulted or may result in a material adverse change in its financial condition, business operations, prospects, product development, technology, or business or contractual relations with third parties of Debtor which would impair the ability of Debtor to perform its obligations hereunder or under any of the other financing agreements to which it is a party or of Secured Party to enforce the Indebtedness or realize upon the Collateral | ||
(r) | Notice of Investor Abandonment . Debtor shall give the Secured Party prompt written notice Secured Party if (a) it is the clear intention of Debtors investors to not continue to fund the Debtor in the amounts and timeframe necessary to enable Debtor to satisfy the Indebtedness as it becomes due and payable or (b) there is a material impairment in the perfection or priority of the Secured Partys security interest in the Collateral. | ||
(s) | Transactions with Affiliates . Debtor shall not, without the prior written consent of Security Party, directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Debtor except for transactions that are in the ordinary course of Debtors business, upon fair and reasonable terms that are no less favorable to Debtor than would be obtained in an arms length transaction with a nonaffiliated Person. | ||
(t) | Audits. Debtor shall allow Security Party to audit Debtors Collateral at Debtors expense. Such audits will be conducted no more often than every six (6) months unless an Event of Default has occurred and is continuing. | ||
(u) | Primary Account and Wire Transfer Instructions . Debtor maintains its Primary Account (the Primary Operating Account ) and the Wire Transfer Instructions for the Primary Operating Account are as follows: |
(v) | Right to Invest . Debtor hereby grants to Secured Party a right (but not an obligation) to invest up to $1,000,000 but not more than $3,000,000, in each case subject to the first rights to invest provided to holders of the Companys preferred stock, in each of the Debtors Subsequent Financings on the same terms, conditions and pricing offered to its investors. Debtor shall give Secured Party at least thirty (30) days prior written notice of each Subsequent Financing containing the terms, conditions and pricing of each Subsequent Financing. As used herein, Subsequent Financing shall mean the next and any future round of private equity financing in which the Debtor receives, in the aggregate, at least $2,000,000 of net proceeds excluding any bridge debt financing except to the extent actually converted to equity in the Debtor. |
(a) | Possession of Collateral; Inspection of Collateral . Until the declaration of any default, Debtor shall remain in possession of the Collateral; except that Secured Party shall have the right to possess (i) any chattel paper or instrument that constitutes a part of the Collateral, and (ii) any other Collateral in which Secured Partys security interest may be perfected only by possession. Secured Party may inspect any of the Collateral during normal business hours after giving Debtor reasonable prior notice. | ||
(b) | Maintenance of Collateral . Debtor shall (i) use the Collateral only in its trade or business, (ii) maintain all of the Collateral in good operating order and repair, normal wear and tear excepted, (iii) use and maintain the Collateral only in compliance with manufacturers recommendations and all applicable laws, and (iv) keep all of the Collateral free and clear of all liens, claims and encumbrances (except for Permitted Liens). | ||
(c) | Disposition of Collateral . Secured Party docs not authorize and Debtor agrees it shall not (i) part with possession of any of the Collateral (except to Secured Party or for maintenance and repair), (ii) remove any of the Collateral from the continental United States, or (iii) sell, rent, lease, mortgage, license, grant a security interest in or otherwise transfer or encumber (except for Permitted liens) any of the Collateral. |
(d) | Taxes . Debtor shall pay promptly when due all taxes, license fees, assessments and public and private charges levied or assessed on any of the Collateral, on its use, or on this Agreement or any of the other Debt Documents. At its option, Secured Party may discharge taxes, liens, security interests or other encumbrances at any time levied or placed on the Collateral and may pay for the maintenance, insurance and preservation of the Collateral and effect compliance with the terms of this Agreement or any of the other Debt Documents. Debtor agrees to reimburse Secured Party, on demand, all costs and expenses incurred by Secured Party in connection with such payment or performance and agrees that such reimbursement obligation shall constitute Indebtedness. | ||
(e) | Books and Records . Debtor shall, at all times, keep accurate and complete records of the Collateral, and Secured Party shall have the right to inspect and make copies of all of Debtors books and records relating to the Collateral during normal business hours, after giving Debtor reasonable prior notice. | ||
(f) | Third Party Possession of Collateral . Debtor agrees and acknowledges that any third person who may at any time possess all or any portion of the Collateral shall be deemed to hold, and shall hold, the Collateral as the agent of, and as pledge holder for, Secured Party. Secured Party may at any time give notice to any third person described in the preceding sentence that such third person is holding the Collateral as the agent of, and as pledge holder for, the Secured Party. | ||
(g) | Receivables . As to each and every Receivable, should Debtor have Receivables now or in the future, (a) it is a bona fide existing obligation, valid and enforceable against the Account Debtor for a sum certain for sales of goods shipped or delivered, or goods leased, or services rendered in the ordinary course of business, (b) all supporting documents, instruments, chattel paper and other evidence of indebtedness, if any, delivered to the Secured Party are complete and correct and valid and enforceable in accordance with their terms, and all signatures and endorsements that appear thereon are genuine, and all signatories and endorsers have full capacity to contract, (c) to the best of the Debtors knowledge, the Account Debtor is liable for and will make payment of the amount expressed in such Receivable according to its terms; (d) it will be subject to no discount, deduction, setoff, counterclaim, return, allowance or special terms of payment without the prior approval of the Secured Party, (e) it is subject to no dispute, defense or offset, real or claimed, (f) it is not subject to any prohibition or limitation upon assignment, (g) it has not been redated or reissued in satisfaction of prior Receivables, (h) the Debtor has full right and power to grant the Secured Party a security interest therein and the security interest granted in such Receivable to the Secured Party in this Agreement, when perfected, will be a valid first security interest which will inure to the benefit of the Secured Party without |
further action. The warranties set out herein shall be deemed to have been made with respect to each and every Receivable now owned or hereafter acquired by the Debtor. | |||
(h) | Bailees . The Inventory, should Debtor have Inventory now or in the future, is not now and shall not at any time hereafter be stored with a bailee, warehouseman, or similar party without the Secured Partys prior written consent. If any Inventory is so stored, the Debtor will, concurrent with storing such Inventory, cause any such bailee, warehouseman, or similar party to issue and deliver to the Secured Party, in a form acceptable to the Secured Party, warehouse receipts in the Secured Partys name evidencing the storage of the Inventory. All such warehouse receipts do and will evidence ownership of the Inventory stored by the issuers thereof, and the holder thereof is and will continue to be the owner of good and marketable title of same, free and clear of any Liens or encumbrances. All such warehouse receipts are and will be genuine, valid and enforceable by the holder thereof in accordance with their terms and all statements thereon are and will be true and accurate in all respects. | ||
(i) | Change of Address . All of the Collateral is located in and will in the future be in the possession of the Debtor at its address stated above or at such other addresses as may be set forth on the attached Schedule A . The Debtor has not at any time within the past four (4) months either (a) maintained Inventory or Equipment or (b) maintained its chief executive office or its records with respect to the Receivables at any other location and shall not do so hereafter except with the prior written consent of the Secured Party. The Secured Party shall be entitled to rely upon the foregoing unless it receives 14 days advance written notice of a change in the address of the Debtors executive offices or location of the Collateral. | ||
(j) | Schedules of Receivables . Upon the written request of Secured Party, deliver to the Secured Party schedules of all outstanding Receivables, should Debtor have Receivables now or in the future,. Such schedules shall be in form satisfactory to the Secured Party and shall show the age of such Receivables in intervals of not more than thirty (30) days, and contain such other information and be accompanied by such supporting documents as the Secured Party may from time to time prescribe. The Debtor shall also deliver to the Secured Party copies of the Debtors invoices, sales journals, evidences of shipment or delivery and such other schedules and information as the Secured Party may reasonably request. The items to be provided under this Section are to be prepared and delivered to the Secured Party from time to time solely for its convenience in maintaining records of the Collateral and the Debtors failure to give any of such items to the Secured Party shall not affect, terminate, modify or otherwise limit the Secured Partys security interest granted herein. |
(k) | Consignment . If at any time any of the Inventory, should Debtor have Inventory now or in the future, is placed by the Debtor on consignment with any person or entity ( Consignee ), the Debtor shall, prior to the delivery of such consigned Inventory; |
a. | Provide the Secured Party with all consignment agreements and other instruments and documentation to be used in connection with such consignment, all of which agreements, instruments, and documentation shall be acceptable in form and substance to the Secured Party; | ||
b. | Prepare and file appropriate financing statements with respect to any consigned Inventory showing the Consignee as debtor, the Debtor as secured party, and the Secured Party as assignee of the Debtor; | ||
c. | Prepare and file appropriate financing statements with respect to any consigned Inventory showing the Debtor as debtor, and the Secured Party as secured party; | ||
d. | After all financing statements referred to in the previous two subsections have been filed, conduct a search of all filings made against the Consignee in alt jurisdictions in which the Inventory to be consigned is to be located while on consignment, and deliver to the Secured Party copies of the results of all such searches; and | ||
e. | Notify, in writing, all creditors of the Consignee that are or may be holders of security interests in the Inventory to be consigned, that the Debtor expects to deliver certain Inventory to the Consignee, all of which Inventory shall be described in such notice by item or type. |
(l) | Fixtures . Not permit any item of the Equipment to become a fixture to real estate or an accession to other property without the prior written consent of the Secured Party, and the Equipment is now and shall at all times remain personal property except with the Secured Partys prior written consent. If any of the Collateral is or will be attached to real estate in such a manner as to become a fixture under applicable state law and if such real estate is encumbered, the Debtor will obtain from the holder of each Lien or encumbrance a written consent and subordination to the security interest hereby granted, or a written disclaimer of any interest in the Collateral, in a form acceptable to the Secured Party. | ||
(m) | Chattel Paper . Promptly, upon request by the Secured Party, deliver, assign, and endorse to the Secured Party all chattel paper and all other documents held by the Debtor in connection therewith. |
(n) | Copies of Government Contracts . Make available to the Secured Party, at the request of the Secured Party, a copy of each Government Contract in which the Secured Party has a security interest and a copy of each amendment thereto or modification thereof which changes the price of such contract or the amount funded to pay for such contract, except to the extent that furnishing such copies may be prohibited by government security regulations. Attached hereto as Schedule B is a complete list of all Government Contracts under which Receivables now exist or may hereafter arise, identified by the names of the contracting parties thereto, the date thereof and the number identifying the Government Contract or agreement and providing information in the form specified by the Secured Party from time to time regarding the contracting officer, the identity of any sureties and the disbursing officer, whether progress payments are to be made and the rate thereof, whether the Government Contract or agreement has been fully performed and such other information as the Secured Party may request. A true, complete and correct copy of each such Government Contract (including all modifications thereto and notice of exercise of options thereunder) now existing has been provided to the Secured Party by the Debtor. The Debtor shall as soon as practicable (but in no event later than five days prior to the date of execution thereof) notify the Secured Party of any additional Government Contracts, or any renewals or extensions of any Government Contract or the exercise of any options thereunder or modifications thereof, identified by the names of the contracting parties thereto, the date thereof and the number identifying the Government Contract or agreement and providing information in the form specified by the Secured Party from time to time regarding the contracting officer, the identity of any sureties and the disbursing officer, whether progress payments are to be made and the rate thereof, and such other information as the Secured Party may request, and a true, complete and correct copy of each such Government Contract, amendment or modification or exercise of option shall be provided lo the Secured Party by the Debtor no later than the date of execution thereof. | ||
(o) | Claims and Disputes . Immediately upon learning thereof, report to the Secured Party any reclamation, return or repossession of goods, any claim or dispute asserted by any Account Debtor or other obligor, and any other matter affecting the value and enforceability or collectability of any of the Collateral. In addition, the Debtor shall, at its sole cost and expense (including attorneys fees), settle any and all such claims and disputes and indemnify and protect the Secured Party against any liability, loss or expense arising therefrom or out of any such reclamation, return or repossession of goods, provided, however, that the Secured Party, if it shall so elect, shall have the right at all times to settle, compromise, adjust or litigate all claims or disputes directly with the Account Debtor or other obligor upon such terms and conditions as the Secured Party deems advisable and charge all costs and expenses thereof (including attorneys fees) to the Debtors account and add them to the principal amount of the Indebtedness. |
(p) | Government Contracts Are Binding, Etc Take the necessary or appropriate steps to ensure that all Government Contracts have been, or if arising hereafter will be, legally awarded and binding on the parties thereto; no payment has been or will be made by the Debtor, any affiliate, or any person acting on their behalf, to any person that was, is or will be contingent upon the award of any Government Contract in violation of applicable procurement law or that would otherwise be in violation of applicable procurement law (including, but not limited to, the Federal Acquisition Regulations, the Defense Acquisition Regulations, the Federal Procurement Regulations and the Armed Services Procurement Regulations); there is no claim that has been asserted by any government agency or authority concerning the award or performance of any Government Contract and the Debtor shall immediately notify the Secured Party of the assertion of any such claim or the existence of any basis therefor; neither the Debtor nor any director, employee or Affiliate has been debarred or suspended from participation in the award of contracts with the federal government or any state or local government, or any agency or instrumentality thereof, or is a party to or the subject of any pending or threatened proceeding or investigation relating to debarment or suspension, and the Debtor shall immediately notify the Secured Party of the occurrence of any of the foregoing or the existence of any basis therefor; and neither the Debtor nor any Affiliate, nor any officer, director or employee of any of them, is permanently or temporarily enjoined or barred from engaging in or continuing any conduct or practice relating to the conduct of their business, or enjoining or requiring any of them to take any action of any kind relating thereto, and the Debtor shall immediately notify the Secured Party of the occurrence of any of the foregoing or the existence of any basis therefor. | ||
(q) | No Provisions Prohibiting Assignment of Government Contracts . Take the necessary or appropriate steps to ensure that each Government Contract (i) doss not and will not contain any provision prohibiting assignment thereof as provided herein, (ii) contains a no set-off clause or does not permit any set-off against or reduction of the obligation to make payments thereunder for liability of the Debtor to the government because of renegotiation, fine, penalty (other than as specifically permitted by the federal Assignment of Claims Act with respect to Government Contracts with the federal government), taxes, social security contributions, or withholding or failing to withhold taxes, social security contributions or similar amounts, whether arising from or independent of the Government Contract. The Debtor shall promptly notify the Secured Party of any claimed set-off or reduction or the disallowance of progress payment requests. | ||
(r) | Cost Accounting and Procurement Systems . The Debtors cost accounting and procurement systems are and at all times have been, and will continue to be, in compliance with all applicable requirements. |
(s) | Compliance with Assignment Requirements for Government Contracts . The Debtor is now in compliance and hereby covenants and agrees that the Debtor will in the future comply with any and all of the requirements of Title 3l Section 3727 and Title 31 Section 15 of the United States Code and any similar state or local law and all rules and regulations relating thereto, as amended, where such statutes, rules and regulations are applicable to a particular Receivable, and shall at all times take all such other action as may be necessary to facilitate and/or ensure perfection of the Secured Partys security interest in and the assignment to the Secured Party of any Government Account and Government Contract. | ||
(t) | Information Concerning Government Contracts . At the request of the Secured Party, submit to the Secured Party for the Secured Partys approval each Government Contract which the Debtor desires to be included in determining eligible Government Accounts, and provide such other information concerning such Government Contract as the Secured Party may reasonably request. | ||
(u) | Domain Name . Take the necessary or appropriate steps to ensure that the identity and location of the servers used in connection with the Debtors domain name and the identity of the party having control over the domain name server and of the administrative contact with the registry have been disclosed to the Secured Party. The Debtor shall not change the domain name server without notification to the Secured Party. The Debtor shall maintain the trademark of the domain name by defending against any infringement suits and by policing the trademark. The Debtor shall renew the domain name registration during the loan term. The Debtor shall make all payments to the domain name registrar necessary to maintain the domain name. | ||
(v) | Account Control Agreements . Debtor shall at all times maintain all Cash Equivalents owned by Debtor on deposit in a Deposit Account or Accounts in Debtors name at Comerica Bank or in a Deposit Account or Accounts at another institution (a Third Party Institution ) covered by an account control agreement in favor of Secured Party (the terms of which shall be substantially identical to the terms of that certain Control Agreement, dated , 200 , between Debtor and Secured Party, or otherwise acceptable to Secured Party). At any time that the Cash Equivalents or any portion thereof are held in an account or accounts in one or more Third Party Institutions, the related account control agreement shall provide that Secured Party is to receive monthly account statements, in form and substance acceptable to Secured Party, evidencing that the Cash Equivalents are maintained in the related account. With respect to each such Deposit Account, Debtor, Secured Party, and each Third Party Institution with which a Deposit Account is maintained, shall enter into a written agreement, granting Secured Party control of the Deposit Account and providing that the Third Party Institution will comply with instructions |
originated by the Secured Party directing disposition of the funds in the Deposit Account without further consent by Debtor. Such account control agreement may in accordance with the provisions thereof provide terns under which Debtor may remove funds from the Deposit Account; provided all funds in or transferred into the Deposit Account on or after the effectiveness of this Agreement shall be subject to the security interest granted under this Agreement. |
(a) | Risk of Loss . Debtor shall at all times bear the entire risk of any loss, theft, damage to, or destruction of, any of the Collateral from any cause whatsoever. | ||
(b) | Insurance Requirements . Debtor agrees to maintain general liability insurance and to keep the Collateral insured against loss or damage by fire and extended coverage perils, theft, burglary, risk of loss by collision (for any or all Collateral which are vehicles) and such other risks as Secured Party may reasonably require. The liability insurance coverage shall be in an amount standard for companies similar to Debtor in Debtors industry in Debtors geographic region. The property insurance coverage shall be in an amount no less than the full replacement value of the Collateral. All insurance policies shall be in a form, with companies and with deductible amounts, acceptable to Secured Party. Debtor shall deliver to Secured Party policies or certificates of insurance evidencing such coverage. Each policy shall name Secured Party as a loss payee and an additional insured, shall provide for coverage to Secured Party regardless of the breach by Debtor of any warranty or representation made therein, shall not be subject to co-insurance, and shall provide that coverage may not be canceled or altered by the insurer except upon thirty (30) days prior written notice to Secured Party. Debtor appoints Secured Party as its attorney-in-fact to make proof of loss, claim for insurance and adjustments with insurers, and to receive payment of and execute or endorse all documents, checks or drafts in connection with insurance payments. Secured Party shall not act as Debtors attorney-in fact unless Debtor is in default. Proceeds of insurance shall be applied, at the option of Secured Party, to repair or replace the Collateral or to reduce any of the Indebtedness. |
(a) | Notice of Events . Debtor shall promptly notify Secured Party of (i) any change in the name of Debtor, (ii) any change in the state of its incorporation or registration, (iii) any relocation of its chief executive offices, (iv) any of the Collateral being lost, stolen, missing, destroyed, materially damaged or worn out, or (v) any lien, claim or encumbrance other than Permitted Liens attaching to or being made against any of the Collateral. |
(b) | Financial Statements, Reports and Certificates . Debtor will deliver to Secured Party within one-hundred eighty (180) days of the close of each fiscal year of Debtor, Debtors complete financial statements including a balance sheet, income statement, statement of shareholders equity and statement of cash flows, each prepared in accordance with generally accepted accounting principles, but excluding footnotes and normal year-end adjustments, consistently applied, certified by a recognized firm of certified public accountants satisfactory to Secured Party. Debtor will deliver to Secured Party copies of Debtors quarterly financial statements including a balance sheet, income statement and statement of cash flows, each prepared by Debtor in accordance with generally accepted accounting principles, but excluding footnotes and normal year-end adjustments, consistently applied by Debtor and certified by Debtors chief financial officer, within ninety (90) days after the close of each of Debtors fiscal quarter. Debtor will deliver to Secured Party copies of all Forms 10-K and 10-Q, if any, within 30 days after the dates on which they are filed with the Securities and Exchange Commission. Debtor will deliver to Secured Party copies of Debtors monthly financial statements including a balance sheet and income statement, each prepared by Debtor in accordance with generally accepted accounting principles, , but excluding footnotes and normal year-end adjustments, consistently applied by Debtor and certified by Debtors chief financial officer, within forty-five (45) days after the close of each month. Concurrently with delivery of the foregoing information, and from time to time promptly upon request of Secured Party, Debtor will deliver to Secured Party a Compliance Certificate substantially consistent with the form of the document attached hereto as Schedule C . Debtor will deliver to Secured Party promptly upon request of Secured Party, in form satisfactory to Secured Party, such other and additional information as Secured Party may reasonably request from time to time. |
(a) | Further Assurances Regarding Security Interests . Debtor shall, upon request of Secured Party, furnish to Secured Party such further information, execute and deliver to Secured Party such documents and instruments (including, without limitation, Uniform Commercial Code financing statements) and shall do such other acts and things as Secured Party may at any time reasonably request relating to the perfection or protection of the security interest created by this Agreement or for the purpose of carrying out the intent of this Agreement. Without limiting the foregoing, Debtor shall cooperate and do all acts deemed necessary or advisable by Secured Party to continue in Secured Party a perfected first security interest in the Collateral, and shall obtain and furnish to Secured Party any subordinations, releases, landlord waivers, lessor waivers, mortgagee waivers, or control agreements, and similar documents as may be from time to time requested by, and in form and substance satisfactory to, Secured Party. |
(b) | Authorization To File Financial Statements . Debtor shall perform any and all acts requested by the Secured Party to establish, maintain and continue the Secured Partys security interest and liens in the Collateral, including but not limited to, executing or authenticating financing statements and such other instruments and documents when and as reasonably requested by the Secured Party. Debtor hereby authorizes Secured Party through any of Secured Partys employees, agents or attorneys to file any and all financing statements, including, without limitation, any original filings, continuations, transfers or amendments thereof required to perfect Secured Partys security interest and liens in the Collateral under the UCC without authentication or execution by Debtor. Debtor hereby irrevocably authorizes the Secured Patty at any time and from tune to time to file in any filing office in any Uniform Commercial Code jurisdiction any initial financing statement(s) and amendments thereto that (a) indicate the Collateral (i) as all assets of the Debtor or words of similar effect, regardless of whether any particular asset comprised in the Collateral falls within the scope of Article 9 of the Uniform Commercial Code of the State or such jurisdiction, or (ii) as being of an equal or lesser scope or with greater detail, and (b) provide any other information required by part 5 of Article 9 of the Uniform Commercial Code of the State or such other jurisdiction for the sufficiency or filing office acceptance of any financing statement or amendment, including (i) whether the Debtor is an organization, the type of organization and any organization identification number issued to the Debtor, and (ii) in the case of a financing statement filed as a fixture filing, a sufficient description of real property to which the Collateral relates. The Debtor agrees to furnish any such information to the Secured Party promptly upon the Secured Partys request. | ||
(c) | Indemnification . Debtor shall indemnify and defend the Secured Party, its successors and assigns, and their respective directors, officers and employees, from and against all claims, actions and suits (including, without limitation, related attorneys fees) of any kind whatsoever arising, directly or indirectly, in connection with any of the Collateral. |
(a) | Defaults . Debtor shall be in default under this Agreement and each of the other Debt Documents if any one of the following should occur: |
(i) | Debtor breaches its obligation to pay when due any installment or other amount due or coming due under any of the Debt Documents; | ||
(ii) | Debtor, without the prior written consent of Secured Party, attempts to or does sell, rent, lease, license, mortgage, grant a security interest in, or otherwise transfer or encumber (except for Permitted Liens) any of the Collateral; |
(iii) | Debtor breaches any of its insurance obligations under Section 4 : | ||
(iv) | Debtor breaches any of its other non-payment obligations under any of the Debt Documents and fails to cure that breach within thirty (30) days after written notice from Secured Party; | ||
(v) | Any warranty, representation or statement made by Debtor in any of the Debt Documents or otherwise in connection with any of the Indebtedness shall be false or misleading in any material respect; | ||
(vi) | Any of the Collateral is subjected to attachment, execution, levy, seizure or confiscation in any legal proceeding or otherwise, or if any legal or administrative proceeding is commenced against Debtor or any of the Collateral, which in the good faith judgment of Secured Party subjects any of the Collateral to a material risk of attachment, execution, levy, seizure or confiscation and no bond is posted or protective order obtained to negate such risk; | ||
(vii) | Debtor breaches or is in default under any other agreement between Debtor and Secured Party; | ||
(viii) | Debtor or any guarantor or other obligor for any of the Indebtedness (collectively Guarantor ) dissolves, terminates its existence, becomes insolvent or ceases to do business as a going concern; | ||
(ix) | Debtor or any Guarantor is a natural person, Debtor or any such Guarantor dies or becomes incompetent; | ||
(x) | A receiver is appointed for all or of any part of the property of Debtor or any Guarantor, or Debtor or any Guarantor makes any assignment for the benefit of creditors; | ||
(xi) | Debtor or any Guarantor files a petition under any bankruptcy, insolvency or similar law, or any such petition is filed against Debtor or any Guarantor and is not dismissed within forty-five (45) days; | ||
(xii) | Debtors improper filing of an amendment or termination statement relating to a filed financing statement describing the Collateral; | ||
(xiii) | Debtor shall merge with or consolidate into any other entity or sell all or substantially all of its assets or in any manner terminate its existence; |
(xiv) | If Debtor is a privately held corporation, and without the prior written consent of Secured Party, which consent shall not be unreasonably delayed, conditioned or withheld, more than 50% of Debtors voting capital stock, or effective control of Debtors voting capital stock, issued and outstanding from time to time, is not retained by the holders of such stock on the date the Agreement is executed, other than (a) by the sale or issuance of Debtors equity securities in a public offering or to venture capital investors or (b) pursuant to a merger or consolidation in which Debtor is the surviving entity pursuant to the terms of section 7(a)(xiii) above; | ||
(xv) | If Debtor should become a publicly held corporation, there shall be a change in the ownership of Debtors stock such that Debtor is no longer subject to the reporting requirements of the Securities Exchange Act of 1934 or no longer has a class of equity securities registered under Section 12 of the Securities Act of 1933; | ||
(xvi) | Debtor defaults under any other written financing arrangement between Debtor and a third party, the amount of which is in excess of S75,000; and | ||
(xvii) | Secured Party shall have determined in its sole and good faith judgment that (a) it is the clear intention of Debtors investors to not continue to fund the Debtor in the amounts and timeframe necessary to enable Debtor to satisfy the Indebtedness as it becomes due and payable or (b) there is a material impairment in the perfection or priority of the Secured Partys security interest in the Collateral; or | ||
(xviii) | Secured Patty shall have determined in its sole and good faith judgment that there has been a material adverse change in the financial condition, business, operations, prospects, product development, technology, or business or contractual relations with third parties of Debtor from the date hereof, or a change or event shall have occurred which would impair the ability of Debtor to perform its obligations hereunder or under any of the other financing agreements to which it is a party or of Secured Party to enforce the Indebtedness or realize upon the Collateral. |
(b) | Acceleration . If Debtor is in default, the Secured Party, at its option, may declare any or all of the Indebtedness to be immediately due and payable, without demand or notice to Debtor or any guarantor. The accelerated obligations and liabilities shall bear interest (both before and after any judgment) until paid in full at the lower of eighteen percent (18%) per annum or the maximum rate not prohibited by applicable law. |
(c) | Rights and Remedies . Secured Party shall have all of the rights and remedies of a Secured Party under the Uniform Commercial Code, and under any other applicable law. Without limiting the foregoing, Secured Party shall have the right to (i) notify any account debtor of Debtor or any obligor on any instrument which constitutes part of the Collateral to make payment to the Secured Party, (ii) with or without legal process, enter any premises where the Collateral may be and take possession of and remove the Collateral from the premises or store it on the premises, (iii) sell the Collateral at public or private sale, in whole or in part, and have the right to bid and purchase at said sale, (iv) to instruct the bank maintaining any Deposit Account to transfer the funds in the Deposit Account to any account of the Secured Party, or (v) lease or otherwise dispose of all or part of the Collateral, applying proceeds from such disposition to the obligations then in default. If requested by Secured Party, Debtor shall promptly assemble the Collateral and make it available to Secured Party at a place to be designated by Secured Party, which is reasonably convenient to both parties. Secured Party may also render any or all of the Collateral unusable at the Debtors premises and may dispose of such Collateral on such premises without liability for rent or costs. Any notice that Secured Party is required to give to Debtor under the Uniform Commercial Code of the time and place of any public sale or the time after which any private sate or other intended disposition of the Collateral is to be made shall be deemed to constitute reasonable notice if such notice is given to the last known address of Debtor at least five (5) days prior to such action. Upon the occurrence and during the continuation of an Event of Default, Debtor hereby appoints Secured Party as Debtors attorney-in-fact, with full authority in Debtors place and stead and in Debtors name or otherwise, from time to time in Secured Partys sole and arbitrary discretion, to take any action and to execute any instrument which Secured Party may deem necessary or advisable to accomplish the purpose of this Agreement. | ||
(d) | Application of Proceeds . Proceeds from any sale or lease or other disposition shall be applied: first, to all costs of repossession, storage, and disposition including without limitation attorneys, appraisers, and auctioneers fees; second, to discharge the obligations then in default; third, to discharge any other Indebtedness of Debtor to Secured Party, whether as obligor, endorser, guarantor, surety or indemnitor; fourth, to expenses incurred in paying or settling liens and claims against the Collateral; and lastly, to Debtor, if there exists any surplus. Debtor shall remain fully liable for any deficiency. | ||
(e) | Fees and Costs . Debtor agrees to pay alt reasonable attorneys fees and other costs incurred by Secured Party in connection with the enforcement, assertion, defense or preservation of Secured Pattys rights and remedies under this Agreement, or if prohibited by law, such lesser sum as may be permitted. Debtor further agrees that such fees and costs shall constitute Indebtedness. |
(f) | Remedies Cumulative . Secured Partys rights and remedies under this Agreement or otherwise arising are cumulative and may be exercised singularly or concurrently. Neither the failure nor any delay on the part of the Secured Party to exercise any right, power or privilege under this Agreement shall operate as a waiver, nor shall any single or partial exercise of any right, power or privilege preclude any other or further exercise of that or any other right, power or privilege. SECURED PARTY SHALL NOT BE DEEMED TO HAVE WAIVED ANY OF ITS RIGHTS UNDER THIS AGREEMENT OR UNDER ANY OTHER AGREEMENT, INSTRUMENT OR PAPER SIGNED BY DEBTOR UNLESS SUCH WAIVER IS EXPRESSED IN WRITING AND SIGNED BY SECURED PARTY. A waiver on any one occasion shall not be construed as a bar to or waiver of any right or remedy on any future occasion. | ||
(g) | WAIVER OF JURY TRIAL . DEBTOR AND SECURED PARTY UNCONDITIONALLY WAIVE THEIR RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, ANY OF THE OTHER DEBT DOCUMENTS, ANY OF THE INDEBTEDNESS SECURED HEREBY, ANY DEALINGS BETWEEN DEBTOR AND SECURED PARTY RELATING TO THE SUBJECT MATTER OF THIS TRANSACTION OR ANY RELATED TRANSACTIONS, AND/OR THE RELATIONSHIP THAT IS BEING ESTABLISHED BETWEEN DEBTOR AND SECURED PARTY. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT. THIS WAIVER IS IRREVOCABLE. THIS WAIVER MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING. THE WAIVER ALSO SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT, ANY OTHER DEBT DOCUMENTS, OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THIS TRANSACTION OR ANY RELATED TRANSACTION. THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT. |
(a) | Assignment . This Agreement, any Note and/or any of the other Debt Documents may be assigned, in whole or in part, by Secured Party without notice to Debtor, and Debtor agrees not to assert against any such assignee, or assignees assigns, any defense, set-off, recoupment claim or counterclaim which Debtor has or may at any time have against Secured Party for any reason whatsoever. Debtor agrees that if Debtor receives written notice of an assignment from Secured Party, Debtor will pay all amounts payable under any assigned Debt Documents to such assignee or as |
instructed by Secured Party. Debtor also agrees to confirm in writing receipt of the notice of assignment as may be reasonably requested by Secured Party or assignee. | |||
(b) | Notices . All notices to be given in connection with this Agreement shall be in writing, shall be addressed to the parties at their respective addresses set forth in this Agreement (unless and until a different address may be specified in a written notice to the other party), and shall be deemed given (i) on the date of receipt if delivered in hand or by facsimile transmission, (ii) on the next business day after being sent by express mail, and (iii) on the fourth business day after being sent by regular, registered or certified mail. As used herein, the term business day shall mean and include any day other than Saturdays, Sundays, or other days on which commercial banks in New York, New York are required or authorized to be closed. | ||
(c) | Correction of Errors . Secured Party may correct patent errors end fill in all blanks in this Agreement or in any Note consistent with the agreement of the parties. | ||
(d) | Time is of the Essence . Time is of the essence of this Agreement. This Agreement shall be binding, jointly and severally, upon all parties described as the Debtor and their respective heirs, executors, representatives, successors and assigns, and shall inure to the benefit of Secured Party, its successors and assigns. | ||
(e) | Entire Agreement . This Agreement and its Notes constitute the entire agreement between the parties with respect to the subject matter of this Agreement and supersede all prior understandings (whether written, verbal or implied) with respect to such subject matter. THIS AGREEMENT AND ITS NOTES SHALL NOT BE CHANGED OR TERMINATED ORALLY OR BY COURSE OF CONDUCT, BUT ONLY BY A WRITING SIGNED BY BOTH PARTIES. Section headings contained in this Agreement have been included for convenience only, and shall not affect the construction or interpretation of this Agreement. | ||
(f) | Termination of Agreement . This Agreement shall continue in full force and effect until all of the Indebtedness has been indefeasibly paid in full to Secured Party or its assignee. The surrender, upon payment or otherwise, of any Note or any of the other documents evidencing any of the Indebtedness shall not affect the right of Secured Party to retain the Collateral for such other Indebtedness as may then exist or as it may be reasonably contemplated will exist in the future. This Agreement shall automatically be reinstated if Secured Party is ever required to return or restore the payment of all or any portion of the Indebtedness (all as though such payment had never been made). | ||
(g) | CHOICE OF LAW . DEBTOR AGREES THAT SECURED PARTY AND/OR ITS SUCCESSORS AND ASSIGNS SHALL HAVE THE OPTION BY WHICH STATE LAWS THIS AGREEMENT SHALL BE GOVERNED AND CONSTRUED: |
(h) | Limitation of Liability . The Secured Party shall not, under any circumstances, be liable for any error or omission or delay of any kind occurring in the settlement, collection or payment of any Receivables or any instrument received in payment thereof or for any damage resulting therefrom. The Secured Party is authorized to accept the return of the goods represented by any of the Receivables, without notice to or consent by the Debtor, or without discharging or in any manner affecting the Loan. | ||
(i) | Notification to Account Debtors . The Secured Party shall have the right at any time to notify any Account Debtor of the Secured Partys security interest in the Receivables and to require payments to be made directly to the Secured Party. To facilitate direct collection, the Debtor hereby appoints the Secured Party and any officer or employee of the Secured Party, as the Secured Party may from time to time designate, as attorney-in-fact for the Debtor to (a) receive, open and dispose of all mail addressed to the Debtor and take therefrom any payments on or proceeds of Receivables; (b) take over the Debtors post office boxes or make such other arrangements, in which the Debtor shall cooperate, to receive the Debtors mail, including notifying the post office authorities to change the address for delivery of mail addressed to the Debtor to such address as the Secured Party shall designate; (c) endorse the name of the Debtor in favor of the Secured Party upon any and all checks, drafts, money orders, notes, acceptances or other evidences of payment or |
Collateral that may come into the Secured Partys possession; (d) sign and endorse the name of the Debtor on any invoice or bill of lading relating to any of the Receivables, on verifications of Receivables sent to any Account Debtor, to drafts against any Account Debtor, to assignments of Receivables, and to notices to any Account Debtor; and (e) do all acts and things necessary to carry out this Agreement and the transactions contemplated hereby, including signing the name of the Debtor on any instruments required by law in connection with the transactions contemplated hereby and on financing statements as permitted by the Virginia Uniform Commercial Code. The Debtor hereby ratifies and approves all acts of such attorneys-in-fact, and neither the Secured Party nor any other such attorney-in-fact shall be liable for any acts of commission or omission, or for any error of judgment or mistake of fact or law of any such attorney-in-fact. This power, being coupled with an interest, is irrevocable so long as the Loan remains unsatisfied, or any Loan Document remains effective, as solely determined by the Secured Party. | |||
(j) | Loss; Depreciation or Other Damage . The Secured Party shall not be liable for or prejudiced by any loss, depreciation or other damage to Receivables or other Collateral unless caused by the Secured Partys willful and malicious act, and the Secured Party shall have no duty to take any action to preserve or collect any Receivable or other Collateral. |
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SECURED PARTY: | DEBTOR: | |||||||||
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Oxford Finance Corporation | Nura, Inc. | |||||||||
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By:
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By: | /s/ Jim D. Johnston | ||||||||
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Name:
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Name: | Jim D. Johnston | ||||||||
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||||||||||
Title:
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Title: | Chief Financial Officer | ||||||||
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Contracting Parties | Contracting Officer | Surety | Disbursing Officer | Contract Status | ||||
Master Security Agreement
No. 5081087 |
Promissory Note |
Periodic | ||||
Installment | Amount | |||
1-6
|
$ | 24,500.00 |
Periodic | ||||
Installment | Amount | |||
7-42
|
$ | 96,520.11 |
The Maker hereby expressly authorizes the Payee to insert the date value is actually given in the blank space on the face hereof and on all related documents pertaining hereto. |
This Note may be secured by a security agreement, chattel mortgage, pledge agreement or like instrument (each of which is hereinafter called a Security Agreement and any Security Agreement, this Note and any other document evidencing or securing this loan is hereinafter called a Debt Document). |
Time is of the essence hereof. If any installment or any other sum due under this Note or any Security Agreement is not received when due, the Maker agrees to pay, in addition to the amount of each such installment or other sum, a late payment charge of five percent (5%) of the amount of said installment or other sum, but not exceeding any lawful maximum. If (i) Maker fails to make payment of any amount due hereunder; or (ii) Maker is in default under, or fails to perform under any term or condition contained in any Security Agreement, then the entire principal sum remaining unpaid, together with all accrued interest thereon and any other sum payable under this Note or any Security Agreement, at the election of Payee, shall immediately become due and payable, with interest thereon at the lesser of eighteen percent (18%) per annum or the highest rate not prohibited by applicable law from the date of such accelerated maturity until paid (both before and after any judgment). |
Notwithstanding anything to the contrary contained herein or in the Security Agreement, Maker may not prepay in full or in part any indebtedness hereunder without the express written consent of Payee in its sole discretion. |
The Maker and all sureties, endorsers, guarantors or any others (each such person, other than the Maker, an Obligor ) who may at any time become liable for the payment hereof jointly and severally consent hereby to any and all extensions of time, renewals, waivers or modifications of, and all substitutions or releases of, security or of any party primarily or secondarily liable on this Note or any Security Agreement or any term and provision of either, which may be made, granted or consented to by Payee, and agree that suit may be brought and maintained against any one or more of them, at the election of Payee without joinder of any other as a party thereto, and that Payee shall not be required first to foreclose, proceed against, or exhaust any security hereof in order to enforce payment of this Note. The Maker and each Obligor hereby waives presentment, demand for payment, notice of nonpayment, protest, notice of protest, notice of dishonor, and all other notices in connection herewith, as well as filing of suit (if permitted by law) and diligence in collecting this Note or enforcing any of the security hereof, and agrees to pay (if and to the extent permitted by law) all expenses incurred in collection, including Payees actual attorneys fees. Maker and each |
Nuva, Inc. | ||||||||
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/s/ Mohammad Mousa
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By: | /s/ Jim D. Johnston | ||||||
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Witness
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Mohammad Mousa
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Name: | Jim D. Johnston | ||||||
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(Print name)
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1124 Columbia St. #650, Seattle, WA 98104
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Title: | Chief Financial Officer | ||||||
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(Address)
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Federal Tax ID #: 77-0607176 | ||||||||
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Address: 1124 Columbia Street, | ||||||||
Suite 650 Seattle, WA 98104 |
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By:
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/s/ Gregory Demopulos | |||||
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(Signature) | |||||
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Title:
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Chairman & CEO | |||||
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(Officers Title) | |||||
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ATTEST:
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/s/ Craig Sherman | |||||
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Secretary/Assistant Secretary |
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/s/ Craig Sherman | |||
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Landlord: |
BENTALL CITY CENTRE
L.L.C. |
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Tenant: |
SCOPE INTERNATIONAL,
INC. |
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Date: | September 28, 1998 |
Rent Per Rentable | ||||||||
Month(s) | Monthly Rent Installment | Sq. Ft. Per Year | ||||||
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11/15/98 11/30/99
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$ | 10,898.85 | $ | 33.76 | ||||
12/1/99 11/30/01
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$ | 11,221.69 | $ | 34.76 | ||||
12/1/01 11/30/03
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$ | 11,544.52 | $ | 35.76 |
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Section 4.2 | Operating Expenses | |||||
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(a) | Tenants Proportionate Share: | .4205% of Total Rentable Area of Building | |||
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.4598% of Total Rentable Area of Office Tower | |||||
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(b) | Base Year: | 1998. | |||
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Section 5.1 | Security Deposit | |||||
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(a) | Security Deposit: | $11,544.52 | |||
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Section 5.2 | Prepaid Rent | |||||
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(a) | Prepaid Rent: | $10,898.85 | |||
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(b) | Month(s) to which the Prepaid Rent is | ||||
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applied: | December, 1998 (first full calendar month). | ||||
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Section 19.1 | Addresses for Notices | |||||
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(a) | Landlord: | (b) Tenant: | |||
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Bentall City Centre, L.L.C. | Scope International | |||||
c/o General Manager | Suite 2628 | |||||
Suite 1550 | 1420 Fifth Avenue | |||||
1420 Fifth Avenue | Seattle, WA 98101 | |||||
Seattle, WA 98101 | ||||||
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Section 21.13 | Brokers Commission | |||||
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(a) | Landlords Leasing Representative | ||||
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(Broker/Salesperson): | Pat Pendergast | ||||
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(b) | Landlords Leasing Representative (Firm): | Washington Partners | |||
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(c) | Address: | 520 Pike Street, Suite 1450 | |||
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Seattle, WA 98101 | |||||
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(d) | Tenants Leasing Representative | ||||
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(Broker/Salesperson): | Brian Kelly | ||||
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(e) | Tenants Leasing Representative (Firm): | Steven C. Johnson & Associates | |||
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(f) | Address: | 600 University Street, Suite 3025 | |||
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Seattle, Washington 98101-3115 |
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Page | ||||||||
ARTICLE 1. PREMISES | 1 | |||||||
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Section 1.1 | Premises Defined | 1 | |||||
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Section 1.2 | Alterations | 1 | |||||
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Section 1.3 | Condition of Premises | 1 | |||||
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Section 1.4 | Common Areas | 1 | |||||
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ARTICLE 2. BUSINESS PURPOSE AND USE | 1 | |||||||
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Section 2.1 | Permitted Uses | 1 | |||||
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Section 2.2 | Prohibited Uses | 2 | |||||
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Section 2.3 | Compliance With Laws | 2 | |||||
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ARTICLE 3. TERM | 2 | |||||||
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Section 3.1 | Term | 2 | |||||
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Section 3.2 | Lease Year | 2 | |||||
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Section 3.3 | Possession by Tenant | 2 | |||||
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ARTICLE 4. RENT | 3 | |||||||
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Section 4.1 | Basic Rent | 3 | |||||
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Section 4.2 | Operating Expenses | 3 | |||||
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Section 4.3 | Rent | 7 | |||||
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Section 4.4 | Place of Payment | 7 | |||||
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ARTICLE 5. SECURITY DEPOSIT AND PREPAID RENT | 7 | |||||||
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Section 5.1 | Security Deposit | 7 | |||||
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Section 5.2 | Prepaid Rent | 7 | |||||
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ARTICLE 6. TAXES | 8 | |||||||
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Section 6.1 | Personal Property Taxes | 8 | |||||
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Section 6.2 | Business Taxes | 8 | |||||
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ARTICLE 7. MAINTENANCE, REPAIRS AND ALTERATIONS | 8 | |||||||
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Section 7.1 | Landlords and Tenants Improvements | 8 | |||||
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Section 7.2 | Services to Be Furnished by Landlord | 8 | |||||
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Section 7.3 | Tenants Maintenance and Repairs | 9 | |||||
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Section 7.4 | Tenants Alterations | 9 | |||||
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Section 7.5 | Liens | 10 | |||||
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ARTICLE 8. INSURANCE | 10 | |||||||
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Section 8.1 | Use; Rate | 10 | |||||
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Section 8.2 | Liability Insurance | 10 | |||||
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Section 8.3 | Workers Compensation Insurance | 10 | |||||
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Section 8.4 | Casualty Insurance | 10 | |||||
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Section 8.5 | Compliance With Regulations | 10 | |||||
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Section 8.6 | Waiver of Subrogation | 10 |
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Page | ||||||||
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Section 8.7 | General Requirements | 11 | |||||
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Section 8.8 | Blanket Insurance | 12 | |||||
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ARTICLE 9. DESTRUCTION AND CONDEMNATION | 12 | |||||||
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Section 9.1 | Total or Partial Destruction | 12 | |||||
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Section 9.2 | Condemnation | 13 | |||||
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Section 9.3 | Sale Under Threat of Condemnation | 14 | |||||
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ARTICLE 10. INDEMNITY AND WAIVER | 14 | |||||||
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Section 10.1 | Indemnity | 14 | |||||
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Section 10.2 | Waiver | 15 | |||||
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ARTICLE 11. DELAYS | 15 | |||||||
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Section 11.1 | Delays | 15 | |||||
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ARTICLE 12. ASSIGNMENT, SUBLEASE AND SUCCESSION | 15 | |||||||
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Section 12.1 | Consent Required | 15 | |||||
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Section 12.2 | General Conditions | 16 | |||||
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Section 12.3 | Succession | 16 | |||||
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ARTICLE 13. SURRENDER OF POSSESSION | 16 | |||||||
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Section 13.1 | Surrender | 16 | |||||
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Section 13.2 | Condition at Time of Surrender | 16 | |||||
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ARTICLE 14. HOLDING OVER | 16 | |||||||
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Section 14.1 | Holding Over | 16 | |||||
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ARTICLE 15. ENTRY BY LANDLORD | 16 | |||||||
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Section 15.1 | Entry by Landlord | 16 | |||||
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Section 15.2 | Failure to Surrender | 17 | |||||
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ARTICLE 16. SUBORDINATION | 17 | |||||||
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Section 16.1 | Lease Subordinate To Mortgages | 17 | |||||
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Section 16.2 | Estoppel Certificates | 17 | |||||
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ARTICLE 17. DEFAULT AND REMEDY | 18 | |||||||
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Section 17.1 | Events of Tenants Default | 18 | |||||
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Section 17.2 | Remedies | 18 | |||||
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Section 17.3 | Reletting | 19 | |||||
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Section 17.4 | Default of Landlord | 19 | |||||
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Section 17.5 | Non-Waiver | 19 | |||||
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Section 17.6 | Mortgagee Protection | 19 | |||||
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ARTICLE 18. LIMITATION OF LIABILITY | 20 | |||||||
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Section 18.1 | Limitation of Landlords Liability | 20 | |||||
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Section 18.2 | Applicability | 20 | |||||
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ARTICLE 19. NOTICES | 20 |
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Page | ||||||||
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Section 19.1 | Notices | 20 | |||||
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ARTICLE 20. HAZARDOUS SUBSTANCES | 21 | |||||||
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Section 20.1 | Presence and Use of Hazardous Substances | 21 | |||||
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Section 20.2 | Cleanup Costs, Default and Indemnification | 21 | |||||
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ARTICLE 21. MISCELLANEOUS | 21 | |||||||
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Section 21.1 | Headings | 21 | |||||
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Section 21.2 | Amendments | 21 | |||||
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Section 21.3 | Time of the Essence | 21 | |||||
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Section 21.4 | Entire Agreement | 21 | |||||
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Section 21.5 | Language | 21 | |||||
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Section 21.6 | Invalidity | 22 | |||||
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Section 21.7 | Late Charges | 22 | |||||
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Section 21.8 | [Not Used] | 22 | |||||
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Section 21.9 | Computation of Time | 22 | |||||
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Section 21.10 | Applicable Law | 22 | |||||
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Section 21.11 | Attorneys Fees | 22 | |||||
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Section 21.12 | Termination | 22 | |||||
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Section 21.13 | Brokers Commission | 22 | |||||
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Section 21.14 | Signs or Advertising | 23 | |||||
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Section 21.15 | Transfer of Landlords Interest | 23 | |||||
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Section 21.16 | Counterparts | 23 | |||||
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Section 21.17 | Quiet Enjoyment | 23 | |||||
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Section 21.18 | Authority | 23 | |||||
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Section 21.19 | Name of Building | 23 | |||||
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Section 21.20 | Rules and Regulations | 23 | |||||
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Section 21.21 | Consents | 23 | |||||
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Section 21.22 | Agency Disclosure | 24 | |||||
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Section 21.23 | Lease Summary, Addendum and Exhibits | 24 | |||||
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Section 21.24 | Survival | 24 | |||||
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Section 21.25 | Parking | 24 |
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STATE OF WASHINGTON
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) | |||||||
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) | ss. | ||||||
COUNTY OF KING
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) |
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/s/ Elizabeth S. Sutherland
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My commission expires: 11-15-98 | |||
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Elizabeth S. Sutherland | |||
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[Type or Print Notary Name] |
STATE OF WASHINGTON
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) | |||||||
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) | ss. | ||||||
COUNTY OF KING
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) |
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/s/ Anne M. Douglas
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My commission expires: 5-29-01 | |||
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Anne M. Douglas | |||
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[Type or Print Notary Name] |
STATE OF WASHINGTON
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) | |||||||
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) | ss. | ||||||
COUNTY OF KING
|
) |
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/s/ Anne M. Douglas
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My commission expires: 5-29-01 | |||
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Anne M. Douglas | |||
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[Type or Print Notary Name] |
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I. | BASIC BUILDING IMPROVEMENTS PROVIDED BY LANDLORD | |
Tenant shall accept the Premises on an AS-IS basis. Landlord shall have no obligation to alter, remodel or improve the Premises, excluding Landlords agreement to construct and install a doorway into the existing inaccessible approximate 500 square foot area, which comprises a portion of the 3,874 rentable area of the premises, which area Landlord shall cause to be clean and clear of existing property of other tenant(s), ready for the installation by Tenant of the Tenant Improvements described in this work letter. | ||
II. | TENANT IMPROVEMENTS | |
Subject to Landlords prior written approval, which approval will not be unreasonably withheld or delayed or unreasonably conditioned, Tenant shall have the right to have certain tenant improvements installed in the Premises in accordance with the provisions of the Lease and this Work Letter. The tenant improvements approved by Landlord are referred to as the Tenant Improvements. Landlord shall pay the cost of such Tenant Improvements up to an amount equal to $13.00 per rentable square foot of the Premises (the Tenant Improvement Allowance). The Tenant Improvement Allowance shall be used exclusively for the cost of design and construction of Tenant Improvements which will be permanently affixed to the Premises including, but not be limited to: Landlords construction management fee (as described in Section IV below), space planning fees, architectural fees, engineering fees, cabling, partitions, doors, door frames, hardware, paint, wall coverings, bass, floor coverings, thermostats, telephone and electrical outlets, light switches, window coverings, all fire life safety modifications and upgrades, supplemental HVAC, all applicable permit fees, building standard signage and sales tax. The Tenant Improvement Allowance shall not be used for Tenants personal property including equipment, furniture, or trade fixtures. The cost of the Tenant Improvements up to the Tenant Improvement Allowance shall be applied by Landlord directly to Landlords contractor performing the work. All costs and expenses related to the Tenant Improvements in excess of the Tenant Improvement Allowance shall be paid directly by Tenant to the contractor(s) performing the work when due. |
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III. | DESIGN OF TENANT IMPROVEMENTS | |
Tenant shall cause Tenants architect to prepare all space plans, work letters and construction drawings for the Tenant Improvements, all of which shall be subject to Landlords written approval, which approval shall not be unreasonably withheld or delayed. Tenant shall use one of Landlords approved architects for preparation or review of the Final Plans (as defined below). The construction drawings (the Final Plans) shall be sufficient to obtain all required building permits. | ||
IV. | CONSTRUCTION OF TENANT IMPROVEMENTS |
A. | Construction by Landlord : Landlords contractor shall construct the Tenant Improvements in accordance with the approved Final Plans (the Work). Tenant may select Tenants contractor from a list of three contractors provided by Landlord. Tenant shall be responsible for reviewing all bids for the Tenant Improvements. Tenant, at Tenants cost, shall provide Landlord with a copy of final as-built plans following completion of the Tenant Improvements. Tenant shall pay Landlord a construction management fee equal to, four percent (4%) of the actual cost of the Work (excluding design fees), as evidenced by the signed construction contract with Unimark Construction, including, without limitation, permit fees, sales tax, and change orders. Landlord shall use its reasonable best efforts to cause the contractor to complete the Work by the Lease Commencement Date. | ||
B. | Payments : Payment for the Work shall be made in accordance with Section II above. | ||
C. | Changes in Final Plans : Any substantive change to the Final Plans must be approved by Landlord in writing and shall be completed at Tenants expense. |
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Re: | Lease Dated: | ||||
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Commencement Date: | |||||
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Termination Date: | |||||
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Landlord: | BENTALL CITY CENTRE L.L.C. | ||||
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Tenant: | |||||
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Premises: | Approximately ______ sq. ft. located at Suite ______, U.S. Bank Centre, 1420 Fifth Avenue, Seattle, Washington (Premises) |
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TENANT: | |||||||||
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a | |||||||||
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By. | |||||||||
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Its | |||||||||
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Its Sole Member | ||||
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By
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Chief Operating Officer |
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Tenant: | |||||
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Agent: | |||||
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TENANT: | |||||||||
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a | |||||||||
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By: | |||||||||
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Its: | |||||||||
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AGENT: | |||||||||
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By: | |||||||||
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Its: | |||||||||
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Its Sole Member | ||||
By
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Chief Operating Officer |
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1. | Public Garage hours are posted at the entrance and exits of the Garage. Landlord reserves the right to adjust such hours. |
2. | Vehicles must be parked entirely within the stall lines painted on the floor. |
3. | Monthly parkers may park in any open space not designated reserved, handicapped or no parking. |
4. | All directional signs and arrows must be observed. |
5. | The speed limit shall be 5 miles per hour. |
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6. | Parking is prohibited: |
a. | In areas not striped for parking; | ||
b. | In aisles; | ||
c. | Where no parking signs are posted; | ||
d. | In cross-hatched areas; | ||
e. | In such other areas as may be designated by operator; | ||
f. | In compact stalls by oversized vehicles. |
7. | The Parking Identification supplied by Landlord or operator shall remain the property of Landlord. Such Parking Identification must be displayed as requested and may not be mutilated in any manner. The serial number of the Parking Identification may not be obliterated. Parking Identification may be transferable upon prior authorization by Operator, but any Parking Identification in the possession of an unauthorized holder will be void. |
8. | The monthly rate for rental of parking spaces is payable in advance and must be paid on or before the first day of each month. Failure to do so will automatically cancel parking privileges and a reinstatement fee may be charged. No deductions or allowances from the monthly rate will be made for days the designated parker does not use the Garage. |
9. | Garage managers or attendants are not authorized to make or allow any exceptions to these Rules and Regulations. |
10. | Every designated parker is required to park and lock his own vehicle. All responsibility for damage to vehicles or persons while in the Garage is assumed by the designated parker. |
11. | Loss or theft of Parking Identification from vehicles must be reported to the Operator immediately. |
a. | Any Parking Identification reported lost or stolen found on any unauthorized vehicle will be confiscated and the holder will be subject to prosecution. | ||
b. | Any Parking Identification found by the user must be reported to the Operator immediately to avoid confusion. |
12. | Spaces rented to persons are for the express purpose of parking one vehicle per space. Washing, waxing, cleaning or servicing of any vehicle by the designated parker and/or his agents is prohibited. |
13. | Parking shall be for motor vehicles only. Trailers, or similar transport vehicles designed to be towed by a motor vehicle, shall be prohibited. |
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14. | Operator reserves the right to refuse the sale of monthly stickers or other Parking Identification to any Tenant or person and/or his agents or representatives who willfully refuse to comply with the above Rules and Regulations and all posted city, state or federal ordinances, or laws or agreements. |
15. | Tenant shall acquaint all persons to whom Tenant assigns parking spaces of these Rules and Regulations. |
16. | Landlord shall not be responsible for any theft and/or vandalism to designated Parkers vehicle or its contents while in the Garage. |
17. | If designated parker forgets Parking Identification and a daily ticket is pulled, that ticket must be presented for validation to the Operator the same day prior to exiting the Garage or otherwise, the posted daily parking rate will apply. |
18. | Parking privileges shall be on an unassigned or executive valet basis as designated by Operator. |
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Quantity | Equipment Description | |
Inter-Tel
Axxess Digital Telephone System equipped to accommodate: 24 Digital Stations, 8 Analog Stations, 1 Local T-1
|
||
|
||
1 |
Axxess Main Cabinet, 7 Universal Card Slots, includes Remote
Maintenance Modem
|
|
1 |
Power Supply (9 amp)
|
|
1 |
Axxess CPU 128, includes CPU 128 Software
|
|
1 |
Axxess Database, Programming Software Provides Windows-Based System
Administration
|
|
1 |
25-Unit Software Key (PAL)
|
|
1 |
Digital Station Card, 8 Digital Telephones Per Card, Requires Card Slot
|
|
1 |
Digital Station Card, 16 Digital Telephones Per Card, Requires Card Slot
|
|
1 |
T-1 Card, on Board CSU, Requires Card Slot
|
|
19 |
Standard Digital Telephone with Liquid Crystal Display, Features 32
Character LCD, Speakerphone Capability w/Use of Options Card
|
|
4 |
Executive Digital Telephone, Features 6X16 Character Context Sensitive
LCD and Full-Duplex Speakerphone
|
|
1 |
Direct Station Selection (DSS) Console, Features 60 DSS Programmable
Keys, Requires PC Data Port Module
|
|
1 |
Option Card, Supports up to 4 DSPs, Includes Options Software, One DSP
Included on Card, Requires Card Slot
|
|
1 |
Axxessory Talk Windows NT Platform, 4 Ports, 165 Hours Storage
|
|
1 |
Axxessory Talk Visual Mail, 20 User, Integrates Voice Mail, E-Mail and
Faxes on Computer Desktop, Displays messages within E-Mail sent across
WAV files
|
|
1 |
Ultimate! Call Accounting Software for Windows
|
|
1 |
PC Shelf
|
|
1 |
Analog Station Card (16 Port)
|
|
1 |
Power Supply
|
|
1 |
PC Data Port Module
|
LESSEE: Scope International, Inc. | ||||||
|
||||||
BY: | /s/ Terry Mulberg | |||||
|
TITLE: President |
-1-
-1-
-2-
UNIT | EXTENDED | |||||||||||||||
QTY | PART # | DESCRIPTION | PRICE | PRICE | ||||||||||||
Less Discount
|
$ | 3,017.00 | ||||||||||||||
|
||||||||||||||||
TOTAL INSTALLED PURCHASE PRICE
|
$ | 27,153.00 | ||||||||||||||
|
(plus tax) |
Sales Rep:
Phone Number: Date: |
Rosyln Comley
206-812-7036 September 29, 1998 |
Accepted By: | Date |
-3-
Months | Monthly Installment | Rent Per Rentable Sq. Ft. | ||||||
|
||||||||
12/1/03 8/30/06
|
$ | 11,944.83 | $ | 37.00 |
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-4-
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By:
|
/s/ Gregory Demopulos | |||
|
||||
|
Its: Chairman & CEO |
By:
|
/s/ Phil Steptoe | |||
|
||||
|
Its: VP & General Counsel |
By:
|
BCC EQUITY L.L.C., a
Washington limited liability company, Its Managing Joint Venturer |
By:
|
BENTALL CAPITAL (U.S.), INC., | |||
|
a California corporation | |||
|
Its Authorized Agent |
By:
|
/s/ Gary J. Carpenter | |||
|
||||
|
Gary J. Carpenter | |||
|
Executive Vice President |
By:
|
/s/ Betsy Sutherland | |||
|
||||
|
Betsy Sutherland, | |||
|
Vice President and Regional Manager |
-6-
STATE OF WASHINGTON
|
) | |||||||
|
) | ss. | ||||||
COUNTY OF KING
|
) |
/s/ Ellen L. Martin | ||||
Notary Public in and for the State of Washington, | ||||
residing at Seattle
My commission expires: 7-23-03 Ellen L. Martin [Type or Print Notary Name] |
||||
-7-
STATE OF WASHINGTON
|
) | |||||||
|
) | ss. | ||||||
COUNTY OF KING
|
) |
/s/ Ellen L. Martin | ||||
Notary Public in and for the State of Washington, | ||||
residing at Seattle
My commission expires: 7-23-03 Ellen L. Martin [Type or Print Notary Name] |
||||
-8-
STATE OF WASHINGTON
|
) | |||||||||||
|
) | ss. | ||||||||||
COUNTY OF KING
|
) |
/s/ David R. Toll | ||||
Notary Public in and for the State of Washington, | ||||
residing at 1420 5
th
Ave W, Seattle WA 98101
My commission expires: January 18, 2006 David R. Toll [Type or Print Notary Name] |
||||
-9-
STATE OF ILLINOIS
|
) | |||||||
|
) | ss. | ||||||
COUNTY OF KING
|
) |
/s/ Bonnie E. Fritz | ||||
Notary Public in and for the State of Illinois, | ||||
residing at 615 N. Wabash
My commission expires: 10/11/2004 Bonnie E. Fritz [Type or Print Notary Name] |
||||
-10-
Months | Monthly Installment | Rent Per Rentable Sq.Ft. | ||||||
9/1/06 8/31/11
|
$ | 34,863.40 | $ | 31.80 |
-2-
By:
|
/s/ Gregory A. Demopulos | |||
|
||||
|
Gregory A. Demopulos, M.D. | |||
|
Chairman & CEO |
By:
|
BCC EQUITY L.L.C., a | |||
|
Washington limited liability company, | |||
|
Its Managing Joint Venturer |
By:
|
BENTALL CAPITAL (U.S.), INC., | |||
|
a California corporation | |||
|
Its Authorized Agent |
By:
|
/s/ Gary J. Carpenter | |||
|
||||
|
Gary J. Carpenter | |||
|
Executive Vice President |
By:
|
/s/ Betsy Sutherland | |||
|
||||
|
Betsy Sutherland, Carpenter | |||
|
Vice President and Regional Manager |
STATE OF WASHINGTON
|
) | |||||||||||
|
) | ss. | ||||||||||
COUNTY OF KING
|
) |
/s/ Stephanie A. Craig | ||||
Notary Public in and for the State of Washington, | ||||
residing at Bremerton
My commission expires: 11-29-07 Stephanie A. Craig [Type or Print Notary Name] |
||||
STATE OF WASHINGTON
|
) | |||||||
|
) | ss. | ||||||
COUNTY OF KING
|
) |
/s/ Stephanie A. Craig | ||||
Notary Public in and for the State of Washington, | ||||
residing at Bremerton
My commission expires: 11-29-07 Stephanie A. Craig [Type or Print Notary Name] |
||||
STATE OF WASHINGTON
|
) | |||||||
|
) | ss. | ||||||
COUNTY OF KING
|
) |
/s/ Diane C. Smith | ||||
Notary Public in and for the State of Washington, | ||||
residing at Bellevue
My commission expires: December 16, 2007 Diane C. Smith [Type or Print Notary Name] |
||||
Address:
|
1124 Columbia Street, Seattle, Washington | |
|
||
Premises:
|
That portion of the Project, commonly known as Suite 650, containing approximately 11,577 rentable square feet, as determined by Landlord, as shown on Exhibit A. | |
|
||
Project:
|
The real property on which the building in which the Premises are located (the Building ), together with all improvements thereon and appurtenances thereto as described on Exhibit B , excluding any buildings constructed on such real property after the date hereof. |
Base Rent
:
|
$27,977.75 per month | Rentable Area of Premises : | 11,577 sq. ft. | |||
|
||||||
Rentable Area of Project
:
|
163,525 sq. ft. | Tenants Share of Net | 7.87% | |||
|
Building Expenses : | |||||
|
||||||
Security Deposit
:
|
$111,911 | Target Commencement | May 1, 2000 | |||
|
Date : |
Rent Adjustment
|
3.5% | |
Percentage
:
|
||
|
||
Base Term
:
|
60 months from the first day of the first full month of the Term (as defined in Section 2) hereof | |
|
||
Permitted Use
:
|
Research and development laboratory, related office and other related uses consistent with the character | |
|
of the Project |
Address for Rent Payment
:
135 N. Los Robles Avenue, Suite 250 Pasadena, CA 91101 Attention: Accounts Receivable |
Landlords Notice Address
:
135 N. Los Robles Avenue, Suite 250 Pasadena, CA 91101 Attention: General Counsel |
|
|
||
Tenants Notice Address
:
Primal, Inc. 1124 Columbia Street, Suite 650 Seattle, WA 98122 Attention: Bill Daley |
ý
EXHIBIT
A
|
| PREMISES DESCRIPTION | ý EXHIBIT B | | DESCRIPTION OF PROJECT | |||||
ý
EXHIBIT
C
|
| WORK LETTER | ý EXHIBIT D | | COMMENCEMENT DATE | |||||
ý
EXHIBIT
E
|
| RULES AND REGULATIONS | ý EXHIBIT F | | TENANTS PERSONAL PROPERTY | |||||
ý
EXHIBIT
G
|
| ESTOPPEL CERTIFICATE | ý EXHIBIT H | | NONDISTURBANCE AGREEMENT | |||||
ý
EXHIBIT
I
|
| LOCATION OF PARKING |
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TENANT:
PRIMAL, INC., a Washington corporation |
||||
By: | /s/ William F. Daly | |||
Its: | Chief Executive Officer | |||
LANDLORD:
ALEXANDRIA REAL ESTATE EQUITIES, INC. a Maryland corporation |
||||
By: | /s/ Joel S. Marcus | |||
Its: | Chief Executive Officer |
-35-
STATE OF WASHINGTON
|
) | |
|
) ss. | |
COUNTY OF KING
|
) |
(Seal or stamp) |
/s/Joseph Robinson | ||
(Signature) | |||
Joseph Robinson | |||
(Name legibly printed or stamped) | |||
Notary Public in and for the State of Washington, residing at Seattle. | |||
My appointment expires 02.09.04 |
STATE OF CALIFORNIA
|
) | |
|
) ss. | |
COUNTY OF Los Angeles
|
) |
(Seal or stamp) |
/s/ Shelly A. Kroll | ||
(Signature) | |||
Shelly A. Kroll | |||
(Name legibly printed or stamped) | |||
Notary Public in and for the State of California, residing at Los Angeles. | |||
My Appointment expires 8/10/02 |
-2-
-3-
-4-
-5-
-6-
TENANT:
PRIMAL, INC., a Washington corporation |
||||
By: | /s/ William F. Daly, Jr. | |||
Its: | Chief Executive Officer | |||
LANDLORD:
ALEXANDRIA REAL ESTATE EQUITIES, INC. a Maryland corporation |
||||
By: | /s/ Joel S. Marcus | |||
Its: | Chief Executive Officer |
-7-
TENANT:
PRIMAL, INC., a Washington corporation |
||||
By: | ||||
Its: | ||||
LANDLORD:
ALEXANDRIA REAL ESTATE EQUITIES, INC. a Maryland corporation |
||||
By: | ||||
Its: |
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If To Buyer:
|
||||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
With A Copy To:
|
||||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
If To Lender:
|
||||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
-16-
TENANT:
|
||||||
|
a | |||||
|
|
|||||
|
||||||
|
By: | |||||
|
|
|||||
|
Name: | |||||
|
|
|||||
|
Its: | |||||
|
|
-17-
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-20-
-21-
-22-
-23-
-24-
-25-
-26-
Address:
|
1124 Columbia Street, Seattle, WA | |
|
||
Premises:
|
That portion of the Project, containing approximately 12,923 rentable square feet, as determined by Landlord, located on Level B of the annex to the Project as shown on Exhibit A . | |
|
||
Project:
|
The real property on which the building (the Building ) in which the Premises are located, together with all improvements thereon and appurtenances thereto as described on Exhibit B . |
Rent Adjustment
Percentage : |
Greater of 3.5% or the CPI Adjustment Percentage not to exceed 7.0% | |
|
||
Base Term
:
|
Beginning on the Commencement Date and ending 10 years from the Rent Commencement Date (as herein defined) | |
|
||
Permitted Use
:
|
Vivarium and related uses consistent with the character of the Project and otherwise in compliance with the provisions of Section 7 hereof. |
Address for Rent Payment
:
|
Landlords Notice Address : | |
135 N. Los Robles Avenue, Suite 250
|
135 N. Los Robles Avenue, Suite 250 | |
Pasadena, CA 91101
|
Pasadena, CA 91101 | |
Attention: Accounts Receivable
|
Attention: Corporate Secretary | |
|
||
Tenants Notice Address
:
|
||
1124 Columbia Street
|
||
Suite 650
|
||
Seattle, WA 98104
|
||
Attention: Leslie Deitz Kaplan
|
ý
EXHIBIT A
PREMISES DESCRIPTION
|
ý EXHIBIT B DESCRIPTION OF PROJECT | |
ý
EXHIBIT C
WORK LETTER
|
ý EXHIBIT D COMMENCEMENT DATE | |
ý
EXHIBIT E
RULES AND REGULATIONS
|
o EXHIBIT F TENANTS PERSONAL PROPERTY |
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-8-
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-22-
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-31-
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TENANT:
Primal, Inc., a Washington corporation |
||||
By: | /s/ Leslie Dietz Kaplan | |||
Its: | COO | |||
LANDLORD:
Alexandria Real Estate Equities, Inc., a Maryland corporation |
||||
By: | /s/ Laurie A. Allen | |||
Its: | Senior Vice President, Business | |||
Development & Legal Affairs |
-33-
-2-
-3-
-4-
-5-
-6-
TENANT:
Primal, Inc., a Washington corporation |
||||
By: | /s/ Leslie Dietz Kaplan | |||
Its: | COO | |||
LANDLORD:
Alexandria Real Estate Equities, Inc., a Maryland corporation |
||||
By: | /s/ Laurie A. Allen | |||
Its: | Senior Vice President, Business | |||
Development & Legal Affairs |
-7-
Event
Date
10/19/01
10/11/01
9/14/01
9/28/01
10/12/01
10/15/01
2/15/02
2/15/02
TENANT:
Primal, Inc., a Washington corporation |
||||
By: | /s/ Leslie Dietz Kaplan | |||
Its: | COO | |||
LANDLORD:
Alexandria Real Estate Equities, Inc., a Maryland corporation |
||||
By: | /s/ Laurie A. Allen | |||
Its: | Senior Vice President, Business | |||
Development & Legal Affairs |
-2-
Re: | Assignment and Assumption and Modification of Lease Documents (Agreement) is made as of October 23, 2003 by and among ALEXANDRIA REAL ESTATE EQUITIES, INC., a Maryland corporation (Landlord), PRIMAL, INC., a Washington corporation (Tenant) and NURA, INC., a Delaware corporation (Assignee). |
Sincerely,
nura, inc. |
||||
By: | /s/ Patrick W. Gray | |||
Its: | Chief Executive Officer | |||
By: |
Alexandria Real Estate Equities, Inc.,
a Maryland corporation, its managing member |
|||
By: | /s/ illegible signature | |||
Its: | Chief Executive Officer | |||
-2-
-3-
-4-
-5-
-6-
LANDLORD: |
ALEXANDRIA REAL ESTATE EQUITIES, INC.,
a Maryland corporation |
|||
By: | /s/ Peter J. Nelson | |||
Name: | Peter J. Nelson | |||
Its: | Senior Vice President & Chief Financial Officer | |||
TENANT: |
PRIMAL, INC.,
a Washington corporation |
|||
By: | /s/ Jim D. Johnston | |||
Name: | Jim D. Johnston | |||
Its: | Chief Financial Officer | |||
ASSIGNEE: |
NURA, INC.,
a Delaware corporation |
|||
By: | /s/ Patrick W. Gray | |||
Name: | Patrick W. Gray | |||
Its: | Chief Executive Officer | |||
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-7-
-8-
-9-
LANDLORD : |
ALEXANDRIA REAL ESTATE EQUITIES, INC.,
a Maryland corporation |
|||
By: | /s/ Jackie Clem | |||
Name: | Jackie Clem | |||
Its: | VP RE LEGAL AFFAIRS |
TENANT : |
NURA, INC.,
a Delaware Corporation |
|||
By: | /s/ Gregory Demopulos | |||
Name: | Gregory A. Demopulos, M.D. | |||
Its: | President |
ASSIGNEE : |
OMEROS CORPORATION,
a Washington corporation |
|||
By: | /s/ Gregory A. Demopulos | |||
Name: | Gregory A. Demopulos, M.D. | |||
Its: | Chairman and CEO |
| 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 |
2
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
3
| 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 |
11
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
12
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
13
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
14
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
15
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
16
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
17
| 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
9. | NO WARRANTY; LIMITATION OF LIABILITY; INDEMNIFICATION; INSURANCE |
| 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
| 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 |
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OMEROS CORPORATION
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By: | /s/ Gregory A. Demopulos | |||
Gregory A. Demopulos, M.D. | ||||
Chairman & CEO | ||||
HOSPIRA WORLDWIDE, INC.
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By: | /s/ Thomas Moore | |||
Thomas Moore | ||||
President, Global Pharmaceuticals | ||||
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§ | 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 | |
§ | [] |
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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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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 Leicesters 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 and Licensed Research Products. | ||
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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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 Leicester IP or Joint IP. | ||
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 [] 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 [] 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 deduct from the |
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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 [] 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 [] 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 |
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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 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 [] 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. [] . | |
10.2 | [] | |
10.3 | [] | |
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. []. |
| 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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10.7 | [] , 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, [] . | |
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. |
If to Omeros:
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If to Leicester: | |
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Omeros Corporation
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University of Leicester | |
1420 Fifth Avenue, Suite 2600
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University Road | |
Seattle, WA 98101
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Leicester, LE1 7RH | |
U.S.A.
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United Kingdom | |
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Attention: Gregory A. Demopulos, M.D.,
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Attention: Research and | |
Chairman & CEO
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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
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Fax: +44 (0) 116.252.2028 | |
Phone: (206) 623.4688
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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 | 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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WILHELM J. SCHWAEBLE, PH.D. | CORDULA M. STOVER, PH.D. | |||||||
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Signed:
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/s/ Wilhelm J. Schwaeble | Signed: | /s/ Cordula M. Stover | |||||
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Title:
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Professor of Immunology | Title: | Lecturer in Immunology | |||||
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Date:
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10/06/04 | Date: | 10 June 04 | |||||
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Fax:
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0044-116-252-5030 | Fax: | 0044-116-252-5030 | |||||
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2.1 | In accordance with Section 2.1 of the Agreement, a collaborative research plan for a second year (Second Year Research Plan) of the Sponsored Research Term is attached hereto as Exhibit A and is hereby incorporated into the Agreement. The Second Year Research Plan provides a budget and specific aims and activities to be carried out by Leicester with the sponsorship of Omeros, as specified in specific aims 2 and 4 set forth therein (Second Year Leicester Research), subject to any modifications that may be agreed to in writing by Omeros and Leicester. The Second Year Research Plan also describes research aims and activities that are projected to be carried out by Omeros (specific aim 3) and MRC (specific aim 1), subject to entry by Omeros into the MRC Agreement. The specific aims 1 and 3, and the experimental models of specific aim 5, are set forth for reference purposes only, are not binding on Omeros, and may or may not be authorized, carried out and performed at Omeros sole discretion. | |
2.2 | In accordance with Section 2.2 of the Agreement, the Sponsored Research Term is hereby acknowledged to have been extended for a second year, commencing 1 September 2005. | |
2.5 | Section 2.5 of the of the Agreement is hereby amended to provide that the total compensation to be paid by Omeros to Leicester for Sponsored Research completed by Leicester in accordance with the Agreement and the Second Year Research Plan during the second year of the Sponsored Research Term shall be []. This Leicester |
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compensation amount is contingent upon alternate funding being secured for the services of Russell Wallis, Ph.D. to work at MRC and/or Leicester on the collaborative research program during the second year of the Sponsored Research Term. Should such funding not be available through the MRC Agreement, as currently anticipated by the parties, or other means, Omeros will increase the Leicester compensation amount to provide funding for such services at a mutually agreed level. |
5.1 | Omeros and Leicester acknowledge that Omeros may deduct accrued Third Party Royalties from the [] Licensed Product Royalty payable to Leicester, up to [] of the Licensed Product Royalty, as more fully set forth in Section 5.1 of the Agreement. Subject to entry into the MRC Agreement, Omeros intends to pay MRC a royalty that is equivalent to the License Product Royalty payable to Leicester for Licensed Products that may be subject to the MRC Agreement, with an equivalent third party royalty deduction. MRC is a third party relative to Omeros and Leicester, and Leicester is a third party relative to MRC and Omeros. Subject to entry into the MRC Agreement on such a basis, Leicester acknowledges that Omeros will be obligated to pay net royalties, after deduction of third party royalties, of [] to Leicester and [] to MRC, of Net Licensed Proceeds for Licensed Products that may be subject to the MRC Agreement, and will no longer be able to deduct any additional third party royalties | |
Therefore, subject to entry into the MRC Agreement on the above basis, Omeros and Leicester hereby agree that, if the total royalties owed by Omeros to all parties for Licensed Products, including without limitation the Licensed Product Royalty payable to Leicester, any royalties payable to MRC, [], and any stacking fee(s) or other royalties payable to third parties to develop, manufacture and commercialize the Licensed Products (all together the Total Royalty Percentage), exceeds [] of the Net Licensed Proceeds, then [] of the difference between the Total Royalty Percentage and [] shall be deducted from the Licensed Product Royalty payable to Leicester, provided, however that the Licensed Product Royalty may not be reduced by such deductions to less than []. | ||
5.3 | Subject to entry into the MRC Agreement, Leicester further agrees to up to a [] maximum reduction in the Sublicensed Product Revenue Share, as set forth in Section 5.3 of the Agreement, by deducting the amount of Net Sublicense Proceeds payable by Omeros to MRC for sublicensing of Licensed Products subject to the MRC Agreement. | |
Omeros represents and warrants that, unless otherwise agreed to in writing by Omeros and Leicester and subject to entry by Omeros into the MRC Agreement, the total exclusive license compensation (not including Sponsored Research compensation) payable to Leicester under the Agreement, as amended by this Amendment, shall be equal to the total compensation payable to MRC under the MRC agreement for any Licensed Products that are subject to both the exclusive license granted under the Leicester Agreement and the exclusive license granted under the MRC Agreement. |
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OMEROS CORPORATION | UNIVERSITY OF LEICESTER | |||||
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By:
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/s/ Gregory A. Demopulos | 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: | Deputy Head, Business Development | |||
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Date:
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10/10/05 | Date: | 5-10-05 | |||
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Animal housing and breeding:
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[] | |
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Oversight by Prof. Schwaeble:
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[] | |
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Total:
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[] |
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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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(including without limitation royalties payable to Leicester) or other fees paid by Omeros attributed to items sold in combination with the Licensed Products, which items are not Licensed Products. | ||
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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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, 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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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) the establishment of MRCs clear, defensible, lawful and uncontested title in, or other mutually acceptable rights relative to, [], 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. | ||
5.3 | 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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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 MRCs 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 1.9 or 1.9 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 1.9 or 1.9 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 MRC within sixty (60) days of the end of the quarter. | ||
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 []. | |
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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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 MRC timely informed of the progress of all Patent Filings and timely provide MRC copies of all official documentation related to such Patent Filings, and (c) 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 MRC 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 MRC advance written notice of such determination, MRC shall have the right thereafter to elect upon written notice to Omeros to pursue such Omeros abandoned Patent Filings at MRCs sole expense (together with Leicester if applicable), and such Omeros abandoned Patent Filings shall be excluded from the scope of the licenses granted under this Agreement. | ||
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 [] 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. []. |
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10.2 | [] | |
10.3 | [] | |
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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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 MRC, Dr. Reid, Mr. Willis and other of MRCs 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. | |
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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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. | |
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. |
| 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 to Omeros: | If to MRC: | ||
|
||||
|
Omeros Corporation | Medical Research Council | ||
|
1420 Fifth Avenue, Suite 2600 | 20 Park Crescent | ||
|
Seattle, WA 98101 | London | ||
|
U.S.A. | United Kingdom | ||
|
W1B 1AL | |||
|
||||
|
Attention: Gregory A. Demopulos, M.D., | Attention: Graham Wagner, | ||
|
Chairman & CEO | Associate Director Licensing | ||
|
and Agreements | |||
|
||||
|
And copy to: Marcia S. Kelbon, | |||
|
Patent & General Counsel | |||
|
||||
|
Fax: (206) 264.7856 | Fax: +44.207.291.5325 | ||
|
Phone: (206) 623.4688 | 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 | MRC CO INVESTIGATOR | |||||||
|
||||||||
Signed:
|
Signed: | |||||||
|
||||||||
|
||||||||
Title:
|
Director, MRC Immunochemistry Unit | Title: | ||||||
|
||||||||
|
||||||||
Date:
|
Date: | |||||||
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||||||||
|
||||||||
Fax:
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Fax: | |||||||
|
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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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Quarterly Payment | Amount | Due Date | ||
1st
|
[] | 1 November 2007 | ||
2nd
|
[] | 1 March 2008 | ||
3rd
|
[] | 1 July 2008 | ||
4th
|
[] | 31 August 2008 |
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MEDICAL RESEARCH COUNCIL | OMEROS CORPORATION | |||||||||
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||||||||||
By:
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/s/ Anne Marie Coriat
|
By: |
/s/ Gregory A. Demopulos
|
|||||||
Name:
|
Anne Marie Coriat PhD
|
Name: |
Gregory A. Demopulos, M.D.
|
|||||||
Title:
|
Head of MRC Centre, Oxforshire
|
Title: |
Chairman & CEO
|
|||||||
|
||||||||||
|
MRC Centre Oxfordshire | |||||||||
|
MRC Harwell | |||||||||
|
DIDCOT | |||||||||
|
Oxfordshire OX11 0RD | |||||||||
|
Tel: 01235 841000 |
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Royalty Equal to the | ||
following multiple of | ||
Royalties | Grant Funds | |
1. For any portion of Grant Funds
paid within [] of date of receipt
by Omeros of such portion of the
Grant Funds
|
[] | |
|
||
2. For any portion of the Grant
Funds remaining after payments in
subparagraph 1 above that are repaid
within [] of date of receipt by
Omeros of such portion of the Grant
Funds
|
[] | |
|
||
3. For any portion of the Grant
Funds remaining after payment in
subparagraph 2 above that are repaid
within [] of the date of receipt by
Omeros of such portion of the Grant
Funds
|
[] |
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THE STANLEY MEDICAL | OMEROS CORPORATION | |||||||||
RESEARCH INSTITUTE | ||||||||||
|
||||||||||
By:
|
/s/ Michael B. Knable | By: | /s/ Gregory A. Demopulos | |||||||
|
|
|
||||||||
Name:
|
Michael B. Knable, DO | Name: | Gregory A. Demopulos, M.D. | |||||||
Title:
|
Executive Director | Title: | Chairman & CEO | |||||||
Date:
|
12/18/06 | Date: | 12/15/06 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Exhibit | Description | |
Exhibit A
|
Certain Defined Terms | |
|
||
Exhibit B
|
Form of Stock Purchase Agreement | |
|
||
Exhibit C
|
Form of Investors Rights Agreement | |
|
||
Exhibit D
|
Form of Indemnification Agreement |
| 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 |
1 | BASIS OF THE SALE |
1.1 | SB shall provide the Services and Materials as set out in the attached Schedules A and B (and C if mutually agreed), subject to these conditions, which shall govern the contract for the provision of the Services and Materials to the exclusion of any other terms and conditions subject to which any request or provision for the Services and Materials is made or purported to be made by Omeros or Scottish Biomedical. | |
1.2 | Whereas nura, inc. and Scottish Biomedical entered into agreements on the 25 th February 2005 and 8 th August 2005, some of which terms continue to apply to the parties and their work under this agreement, as modified by an amendment referenced in the following Section 1.3. | |
1.3 | Whereas Omeros and SB agree to execute, concurrent with execution of this Services and Material Agreement, the Assignment and Amendment to the prior agreement of 25 th February 2005, attached hereto as Exhibit I. | |
1.4 | Whereas Omeros acquired nura, inc. on 7 th September 2006 | |
1.5 | These parties, SB and Omeros, now wish to extend their work together as outlined with this Agreement. | |
1.6 | No variation to these conditions shall be binding unless agreed in writing between the authorised representatives of Scottish Biomedical and Omeros. | |
1.7 | Scottish Biomedicals employees or agents are not authorised to make any representations concerning the Services unless confirmed by an authorized official of Scottish Biomedical in writing. | |
1.8 | Omeros employees or agents are not authorised to make any representations concerning the Services unless confirmed by the Chief Executive Officer of Omeros in writing. |
1.9 | Scottish Biomedical warrants that it will perform the Services and supply the Materials in accordance with this Agreement including all attached Schedules and with reasonable care and skill, and in accordance with all applicable laws and regulations for the location of the provision of such Services and Materials, but does not guarantee, except where described herein, any particular outcome or results will arise as a result of the provision of the Services or that the Materials will be fit for any specific purpose. | |
1.10 | Save as set out in Clause 2 Scottish Biomedical neither gives nor makes any express warranty to Omeros. | |
1.11 | EXCEPT AS EXPRESSLY PROVIDED HEREIN, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS, SCOTTISH BIOMEDICAL AND OMEROS EACH DISCLAIMS ALL IMPLIED REPRESENTATIONS, WARRANTIES, CONDITIONS, OBLIGATIONS OR DUTIES OF EVERY NATURE (INCLUDING, WITHOUT LIMITATION, ANY EQUITABLE, COMMON LAW OR STATUTORY WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, QUALITY, MERCHANTABILITY AND / OR SATISFACTORINESS) IN RESPECT OF THE SERVICES AND MATERIALS, ON THE PART OF SCOTTISH BIOMEDICAL, AND IN RESPECT OF ANY COMPOUNDS PROVIDED FOR ANALYSIS, ON THE PART OF OMEROS. ACCORDINGLY, ALL SUCH IMPLIED REPRESENTATIONS, WARRANTIES, CONDITIONS, OBLIGATIONS OR DUTIES ARE EXCLUDED TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS. NOTHING IN THIS |
| 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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1.12 | Each party agrees that the foregoing exclusions of express and/or implied warranties and the limitations and exclusions of liability set out in Clause 2 are in all respects fair and reasonable having regard to:- |
(a) | the complexity and novelty of the Services and/or the Materials; | ||
(b) | the price / fees to be paid pursuant to this Agreement; and | ||
(c) | the relative resources of the parties. |
2 | LIMITATION OF LIABILITY |
2.1 | The following provisions set out Scottish Biomedicals entire liability (including any liability for the acts and omissions of its employees, agents or sub-contractors) to Omeros in respect of: | |
2.2 | any breach of its contractual obligations arising under this Agreement; | |
2.2.1 | any indemnity granted by Scottish Biomedical under this Agreement; and | |
2.2.2 | any representation (other than fraudulent misrepresentation), statement or delictual or tortious act or omission including negligence arising under or in connection with this Agreement. | |
2.3 | Other than in respect of death and personal injury caused by Scottish Biomedicals negligence, or in relation to any liability which by law may not be limited or excluded, or in relation to any liability due to Scottish Biomedicals gross negligence or wilful misconduct, Scottish Biomedicals liability with regard to any other matter, aspect, fact or thing arising from or relating to this Agreement shall in no event exceed the sums paid and due to be paid hereunder as at the date of the matter giving rise to the claim under the Schedules attached to this Agreement. | |
2.4 | Other than in respect of death and personal injury caused by a partys negligence, or in relation to any other liability which by law may not be limited or excluded, or in relation to any liability due to a partys gross negligence or wilful misconduct, each party shall not be liable to the other party for any consequential or indirect loss or loss of profit, business, data, revenue, goodwill or anticipated savings which arises out of or in connection with this Agreement. |
3 | INTELLECTUAL PROPERTY |
3.1 | Omeros acknowledges that the background know-how, production and assay methodology supplied by Scottish Biomedical under this Agreement is the property of Scottish Biomedical. |
3.2 | Scottish Biomedical and Omeros each agree and acknowledge that any and all Results or other intellectual property generated or created under this Agreement are the sole and exclusive property of Omeros. Scottish Biomedical agrees to execute any assignments and declarations or render such other assistance as may be necessary to confirm Omeros ownership of such Results and intellectual property, including any patents filed for or obtained based thereon. Such reasonable time (charged at []) and |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
3
costs expended on Omeros behalf in this regard shall be reimbursed to Scottish Biomedical through payment of invoices raised at the end of each month where there is such activity by Scottish Biomedical. |
3.3 | Scottish Biomedical agrees and acknowledges that all compounds and derivatives generated or provided by Scottish Biomedical under this Agreement or provided by Omeros for Scottish Biomedicals analysis under this Agreement are the sole and exclusive property of Omeros. | |
3.4 | Scottish Biomedical agrees to transfer to Omeros, at no additional charge, all know-how, techniques, synthesis methods and materials developed by Scottish Biomedical for Omeros under this or any prior Agreement to enable Omeros to synthesis or cause to be synthesized all compounds and derivatives made by Scottish Biomedical for Omeros under this or any prior Agreement; provided, however, that if any of Scottish Biomedicals pre-existing proprietary know-how, techniques, methods or materials that were not developed for Omeros under this or any prior agreement are reasonably necessary to permit Omeros to carry out or cause such synthesis, then Omeros right to use such pre-existing proprietary know-how, techniques, methods or materials shall be limited to a non-exclusive license for purposes of carrying out or causing such synthesis. |
4 | CONFIDENTIAL INFORMATION |
4.1 | The parties acknowledge and agree to observe their respective obligations of Confidentiality as included in their Mutual Confidentiality Agreement of October 4, 2006 (Mutual CDA), which Mutual CDA is hereby expressly incorporated into this Agreement. The parties shall, in accordance with the terms of the Mutual CDA, treat as secret and confidential, and take all proper precautions to protect any information disclosed by each of them to the other in connection with the provision of the Services / Materials including but not limited to any Results and the subject matter of any Patent or Know-how as well as information concerning the parties, this Agreement, and either of their businesses and activities generally or any such information which may come to its knowledge in whatever form or manner imparted or received. Subject as herein provided, and except as provided in the Mutual CDA, any disclosure of such information shall be limited to those employees, agents, servants or staff of both parties who need the information for the purposes of the provision of the Services / Materials and any such disclosures shall be on such terms as to preserve the effect of this Clause (Confidential Information). All compounds and derivatives generated or provided by Scottish Biomedical under this Agreement, or provided by Omeros for Scottish Biomedicals analysis under this Agreement, and all data and results generated under this Agreement shall be considered and treated as Omeros Confidential Information. |
5 | TERMINATION |
5.1 | This Agreement shall terminate upon completion of eighteen months from commencement, commencement date being the date when this Agreement has been signed by both parties, subject always to any extension to the duration of the provision of the Services / Materials and License agreed between the parties in writing and subject to the provisions of the contract surviving termination including Warranties |
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(Sections 1.9-1.12), Limitation of Liability (Section 2), Intellectual Property (Section 3), Confidential Information (Section 4), Governing Law (Section 7), Assignment (Section 9), Records Maintenance (Section 10) and the provisions of Sections 13-15. Termination of this Agreement shall not affect the status of all prior agreements between Omeros and Scottish Biomedical or any continuing obligations thereunder, including the Mutual CDA and the prior agreements dated 25 th February 2005 (as amended by Exhibit I hereto) and 8 th August 2005. |
5.2 | Either party may terminate this Agreement forthwith: |
5.3 | if the other party has a winding up order made against it or, except for the purposes of reconstruction, has a resolution for voluntary winding up passed in respect of it, or has a liquidator, receiver or administrator appointed over it; |
5.4 | in the event of non-performance or breach by the other party of any of its obligations in respect of the Services / Material provision after the giving of written notice by the party not in default to the defaulting party requiring performance of the obligations and the defaulting party remaining in breach of its obligations one (1) month after the receipt thereof. | |
5.5 | Omeros may terminate this Agreement, with or without cause, upon forty-five (45) days prior written notice to Scottish Biomedical. Provided no other Service and Materials Module is ongoing, either party may terminate this agreement upon written notice to the other party or at the end of any Service and Materials Module described in the Schedules attached hereto. In the case of receipt of a notice of termination from Omeros, Scottish Biomedical shall stop work, and Omeros shall be responsible for payment of all Services and Materials performed, and all noncancellable obligations, as of the date of receipt of notice. |
6 | PAYMENT TERMS |
7 | GOVERNING LAW |
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8 | SUBCONTRACTING |
9 | ASSIGNMENT |
10 | RECORDS MAINTENANCE |
11 | AUDITS AND ANSPECTIONS |
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12 | INDEPENDENT CONTRACTORS |
13 | USE OF NAMES |
14 | THIRD PARTY INTELLECTUAL PROPERTY |
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15 | CONSTRUCTION |
SUBSCRIBED for and on behalf of
SCOTTISH BIOMEDICAL LIMITED at Glasgow on the 24th day of April 2007 by Stephen Hammond its Director before the following witness: |
/s/ Stephen Hammond
|
|||
Witness Name:
|
/s/ Eric Smith
|
|||
Eric Smith
|
Witness | |||
Occupation:
|
||||
Chartered
Accountant
|
||||
|
||||
SUBSCRIBED for and on behalf of
OMEROS CORPORATION,
1420 Fifth
Avenue, Suite 2600, Seattle, WA
98101, at Seattle on the 20
th
day
of April 2007 by Gregory A.
Demopulos, M.D., its Chairman and
Chief Executive Officer
(authorised official), before the
following witness:
|
/s/ Gregory A. Demopulos
|
|||
Witness Name:
|
/s/ Marcia S. Kelbon
|
|||
Marcia S. Kelbon
|
Witness | |||
Address:
1420 Fifth Avenue, Suite
2600, Seattle, WA 98101 ... |
||||
Occupation:
|
||||
Vice President, General Counsel
Omeros Corporation |
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| [] |
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Module | Description | Scheduled Duration | Comments | |||
All
|
Project Manager: Colin Dick. | throughout | ||||
[]
|
[] | [] | [] |
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per batch* of :
|
||||
[] wells
|
$ [] per well | |||
[] wells | $ [] per well | |||
[] wells
|
$ [] per well |
* | SB shall await Omeros instructions prior to commencing testing so as to control batch size, subject to any mutually agreed time constraints. Such instruction shall be issued by e-mail from [] or such other Omeros personnel as may be subsequently designated by Omeros in writing. | |
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per batch* of :
|
||||
[] wells
|
$ [] per well | |||
[] wells | $ [] per well | |||
[] wells
|
$ [] per well |
* | SB shall await Omeros instructions prior to commencing testing so as to control batch size, subject to any mutually agreed time constraints. |
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per batch** of :
|
||||
[] wells
|
$ [] per well | |||
[] wells | $ [] per well | |||
[] wells
|
$ [] per well |
* | IC 50 testing for selected PDE1-5, 7-9, 11 to be completed at SB. | |
** | SB shall await Omeros instructions prior to commencing testing so as to control batch size, subject to any mutually agreed time constraints. |
per batch* of :
|
||||
[] wells
|
$ [] per well | |||
[] wells | $ [] per well | |||
[] wells
|
$ [] per well |
* | SB shall await Omeros instructions prior to commencing testing so as to control batch size, subject to any mutually agreed time constraints. |
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SCOTTISH BIOMEDICAL LIMITED | OMEROS CORPORATION | |||||||||
|
||||||||||
By:
|
By: | |||||||||
|
|
|
||||||||
|
||||||||||
Name:
|
Name: | Gregory A. Demopulos, M.D. | ||||||||
|
|
|||||||||
|
||||||||||
Title:
|
Title: | Chairman & CEO | ||||||||
|
|
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5.1 | This Agreement shall terminate upon completion of twelve months from commencement, commencement date being the date when this Agreement was signed by both parties, subject always to any extension to the duration of the provision of the Services / Materials and License agreed between the parties and subject to the following provisions of this Agreement that shall survive termination: Section 3 (Intellectual Property); Section 4 (Confidential Information), Section 7 (Governing Law), Section 8 (Assignment) and the Module 2 Milestone and Royalty provisions (patent filings, clinical development, regulatory approval, commercial sales) set forth in the Project Specification Schedule to this Agreement. |
7 | GOVERNING LAW |
This Agreement shall be governed and construed in accordance with the law of the state of Delaware, USA. Each party hereby irrevocably submits to the non-exclusive jurisdiction of the US Federal courts located in the State of Delaware, USA, as regards any claim, dispute or matter arising out of or relating to this Agreement and its implementation and effect. |
8 | 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. Scottish Biomedical consents to Omeros assignment of this Agreement in whole or in part in connection with the merger, acquisition 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. |
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Royalties
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SCOTTISH BIOMEDICAL LIMITED | OMEROS CORPORATION | |||||||||
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By:
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/s/ Stephen Hammond
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By: |
/s/ Gregory A. Demopulos
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Name:
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Stephen Hammond
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Name: | Gregory A. Demopulos, M.D. | |||||||
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Title:
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Chief Executive
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Title: | Chairman & CEO | |||||||
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NURA, INC. | ||||||||||
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By: |
/s/ Gregory A. Demopulos
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Name: | Gregory A. Demopulos, M.D. | ||||||||
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Title: | President |
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1 | BASIS OF THE SALE |
1.1 | Scottish Biomedical shall provide the Services and Materials as set out in the Schedule, subject to these conditions, which shall govern the contract for the provision of the Services and Materials to the exclusion of any other terms and conditions subject to which any request for the Services and Materials is made or purported to be made by The Client. | |
1.2 | No variation to these conditions shall be binding unless agreed in writing between the authorised representatives of Scottish Biomedical and The Client. | |
1.3 | Scottish Biomedicals employees or agents are not authorised to make any representations concerning the Services unless confirmed by Scottish Biomedical in writing. | |
1.4 | Scottish Biomedical shall grant a 12-month non-exclusive licence to The Client to use its production and assay methodology under the terms and conditions of this Agreement. | |
1.5 | The Client shall not provide any Material originating from Scottish Biomedical to any third party whatsoever and shall not grant any sub-licenses over the assay methodology licensed to it by Scottish Biomedical, without the specific written permission of Scottish Biomedical. Scottish Biomedical hereby gives permission as part of these Terms that it or The Client shall supply Materials from Scottish Biomedical as part of this Agreement to ComGenex of Hungary. |
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1.6 | Scottish Biomedical warrants that it will perform the Services and supply the Materials with reasonable care and skill but does not guarantee any particular outcome or results will arise as a result of the provision of the Services or that the Materials will be fit for any specific purpose. | |
1.7 | Save as set out in Clause 2 Scottish Biomedical neither gives nor makes any express warranty to The Client. | |
1.8 | TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS, SCOTTISH BIOMEDICAL DISCLAIMS ALL IMPLIED REPRESENTATIONS, WARRANTIES, CONDITIONS, OBLIGATIONS OR DUTIES OF EVERY NATURE (INCLUDING, WITHOUT LIMITATION, ANY EQUITABLE, COMMON LAW OR STATUTORY WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, QUALITY, MERCHANTABILITY AND/OR SATISFACTORINESS) IN RESPECT OF THE SERVICES AND MATERIALS. ACCORDINGLY, ALL SUCH IMPLIED REPRESENTATIONS, WARRANTIES, CONDITIONS, OBLIGATIONS OR DUTIES ARE EXCLUDED TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS. NOTHING IN THIS AGREEMENT SHALL HOWEVER OPERATE TO LIMIT OR EXCLUDE ANY LIABILITY FOR FRAUD OR DEATH OR PERSONAL INJURY CAUSED BY SCOTTISH BIOMEDICALS NEGLIGENCE. | |
1.9 | The Client agrees that the foregoing exclusions of express and/or implied warranties and the limitations and exclusions of liability set out in Clause 2 are in all respects fair and reasonable having regard to: |
(a) | the complexity and novelty of the Services and/or the Materials; | ||
(b) | the price / fees to be paid pursuant to this Agreement; and | ||
(c) | the relative resources of the parties. |
2 | LIMITATION OF LIABILITY |
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2.1 | The following provisions set out Scottish Biomedicals entire liability (including any liability for the acts and omissions of its employees, agents or sub-contractors) to The Client in respect of: | |
2.2 | any breach of its contractual obligations arising under this Agreement; | |
2.2.1 | any indemnity granted by Scottish Biomedical under this Agreement; and | |
2.2.2 | any representation (other than fraudulent misrepresentation), statement or delictual or tortious act or omission including negligence arising under or in connection with this Agreement. | |
2.3 | Other than in respect of death and personal injury caused by Scottish Biomedicals negligence, or in relation to any liability which by law may not be limited or excluded, Scottish Biomedicals liability with regard to any other matter, aspect, fact or thing arising from or relating to this Agreement shall in no event exceed the sums paid [and due to be paid] hereunder as at the date of the matter giving rise to the claim under the Final Proposal Document [or, where the Proposal consists of a series of Tasks, only in respect of the sums paid [and due to be paid] for the relevant Task(s)]. | |
2.4 | Other than in respect of death and personal injury caused by Scottish Biomedicals negligence, or in relation to any other liability which by law may not be limited or excluded, Scottish Biomedical shall not be liable for any consequential or indirect loss or loss of profit, business, data, revenue, goodwill or anticipated savings which arises out of or in connection with this Agreement. | |
3 | INTELLECTUALPROPERTY | |
3.1 | The Client acknowledges that the production and assay methodology supplied under this Agreement is the property of Scottish Biomedical. |
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3.2 | Scottish Biomedical and The Client each agree and acknowledge that any Results or other intellectual property generated or created under this Agreement are the property of The Client; provided, however that all such Results and other intellectual property shall be subject to a first position security interest in favour of Scottish Biomedical securing The Clients payment obligations under this Agreement. | |
4 | CONFIDENTIAL INFORMATION | |
4.1 | The parties acknowledge and agree to observe their respective obligations of Confidentiality. The parties shall treat as secret and confidential, and take all proper precautions to protect, any information disclosed by each of them to the other in connection with the provision of the Services / Materials including but not limited to any Results and the subject matter of any Patent or Know-how as well as information concerning the parties, this Agreement, and either of their businesses and activities generally or any such information which may come to its knowledge in whatever form or manner imparted or received. Subject as herein provided, any disclosure of such information shall be limited to those employees, agents, servants or staff of both parties who need the information for the purposes of the provision of the Services / Materials and any such disclosures shall be on such terms as to preserve the effect of this Clause (Confidential Information). | |
4.2 | The Client shall ensure that [] observes these Confidentiality provisions. | |
5 | TERMINATION | |
5.1 | This Agreement shall terminate upon completion of twelve months from commencement, commencement date being the date when the Agreement has been signed by both parties, subject always to any extension to the duration of the provision of the Services / Materials and License agreed between the parties and subject to the provisions of the contract surviving |
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termination including Confidential Information / Confidentiality / Milestone Payments and Royalty Fees. | ||
5.2 | Either party may terminate this Agreement forthwith: | |
5.3 | if the other party has a winding up order made against it or, except for the purposes of reconstruction, has a resolution for voluntary winding up passed in respect of it, or has a liquidator, receiver or administrator appointed over it; | |
5.4 | in the event of non-performance or breach by the other party of any of its obligations in respect of the Services / Material provision after the giving of written notice by the party not in default to the defaulting party requiring performance of the obligations and the defaulting party remaining in breach of its obligations one (1) month after the receipt thereof. | |
5.5 | Upon termination The Client shall return to Scottish Biomedical all copies of the methodologies supplied to it under the Agreement and cease to use them. | |
6 | PAYMENT TERMS | |
The Client shall be issued with an initial invoice on signing of the agreement to the value of 30% of the total due under the Agreement or 30% of the total initial order placed by The Client. | ||
The Client shall be issued with a second invoice to the value of 30% of the total due mid-way through the agreed work programme, and then a final invoice shall be issued for the balance due under the Agreement (or total initial order) once all the Services and Materials have been completed / provided. | ||
Each invoice shall be payable by The Client within 30 days of the date of invoice from Scottish Biomedical. | ||
Payment shall be deposited by electronic transfer to Scottish Biomedicals bank account: [] |
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SUBSCRIBED for and on behalf of
SCOTTISH BIOMEDICAL LIMITED
at Glasgow on the
day of 2005
by its Director before the following
witness:
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/s/ Stephen Hammond
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Witness Name
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/s/ illegible signature | Witness | ||
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Occupation: Principal Scientist
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SUBSCRIBED for and on behalf of
Nura Inc.
at Seattle on the 25th day of
February, 2005
by Patrick Gray its Chief Executive
Officer before the following witness:-
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/s/ Patrick Gray
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Witness Name: Mark Benjamin Witness
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/s/ Mark Benjamin
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Address 1124 Columbia Street, Seattle,
WA, 98034 USA |
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Occupation Chief Business Officer, Nura
Inc.
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Module 1
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Provision of Purified Human PDE10Al, Assay Details and Technical Support | |
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Module 2
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Provision of Scottish Biomedicals [] Compound PDE10 Enriched Library | |
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Module 3
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Human PDE1-11 Profiling, Single Point Screens | |
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Module 4
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Human PDE1-11 profiling, Comprehensive IC 50 Determination | |
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Module 5
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Purchase of Scottish Biomedicals [] Compound PDE10 Enriched Library | |
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SCOTTISH BIOMEDICAL LIMITED | OMEROS CORPORATION | |||||||
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By:
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/s/ Eric Smith | By: | /s/ Gregory A. Demopulos | |||||
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Name:
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Eric Smith | Name: | Gregory A. Demopulos, M.D. | |||||
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Title:
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Finance Director | Title: | Chairman & CEO | |||||
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1.1 | AFFILIATE of a party hereto shall mean any entity that controls or is controlled by such party, or is under common control with such party. For purposes of this definition, an entity shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity (or other comparable interest for an entity other than a corporation). | ||
1.2 | APPLICABLE LEGAL REQUIREMENTS shall mean all laws, rules, regulations, ordinances, guidance, guidelines, and standards of any international, national, state, or local governmental authority that are applicable to the Development, Production, or other services described in a particular Project Plan or to other activities or obligations under this Agreement, including without limitation (a) cGMP, to the extent applicable as set forth in a Project Plan, (b) all |
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other applicable regulations and regulatory guidance promulgated by the FDA and (c) applicable International Conference on Harmonisation Guidance. | |||
1.3 | BATCH shall mean a specific quantity of a Drug Product comprising a number of units mutually agreed upon between CLIENT and ALTHEA, and that (a) is intended to have uniform character and quality within specified limits, and (b) is produced according to a single manufacturing order during the same cycle of manufacture. | ||
1.4 | APIs shall mean the active pharmaceutical ingredients, as set forth in the Project Plan, to be supplied by CLIENT for use in Production of Drug Product. | ||
1.5 | cGMP shall mean current Good Manufacturing Practices as defined in the FDA rules and regulations, 21 CFR Parts 210-211. | ||
1.6 | CANCELLATION FEES shall mean the fees that may be payable by CLIENT in the event that CLIENT cancels the Production of any Batch of Drug Product set forth in the Project Plan, as further described and set forth in Section 3.3. | ||
1.7 | COMPONENTS shall mean all Components used by ALTHEA in Production of Drug Product under this Agreement. Components are listed in the Project Plan and are identified as Components supplied by CLIENT (CLIENT Supplied Components) or Components supplied by ALTHEA (ALTHEA Supplied Components). | ||
1.8 | CONFIDENTIAL INFORMATION shall mean all information and data provided by one party to the other party except any portion of such information and data which: |
(i) | is known to the recipient as evidenced by its written records before receipt thereof from the disclosing party; | ||
(ii) | is disclosed to the recipient by a third person who has the legal right to make such disclosure; | ||
(iii) | is or becomes part of the public domain through no fault of the recipient; or | ||
(iv) | the recipient can reasonably establish by its written records is independently developed by recipient without use of the information disclosed by the disclosing party. |
1.9 | ALTHEA SOPs shall mean ALTHEAs applicable Standard Operating Procedures which shall be reviewed and approved by CLIENT prior to entering into each Project Plan. |
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1.10 | DEVELOPMENT shall mean studies conducted by ALTHEA to develop a process to Produce Drug Product, in accordance with the Specifications and cGMP. Development activities shall be identified in the Project Plan. | ||
1.11 | DRUG PRODUCT shall mean each of CLIENTs pharmaceutical product(s) for which CLIENT is engaging ALTHEA hereunder to Produce bulk or finished dosage form, as further set forth in an applicable Project Plan, for development and/or clinical use only by CLIENT or its designees. | ||
1.12 | FDA shall mean the United States Food and Drug Administration or any successor entity thereto. | ||
1.13 | FD&C ACT shall mean the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 301, et seq., as may be amended from time to time. | ||
1.14 | IND shall mean an Investigational New Drug Application for Drug Product, as defined in the rules and regulations promulgated by FDA, including without limitation 21 CFR 312.3. | ||
1.15 | LABELING shall mean all labels and other written, printed, or graphic matter upon: (i) Drug Product or any container, carton, or wrapper utilized with Drug Product or (ii) any written material accompanying Drug Product. | ||
1.16 | MASTER BATCH RECORD (MBR) shall mean the formal set of instructions for Production of Drug Product. The MBR shall be developed and maintained in ALTHEAs standard format by ALTHEA, using CLIENTs master formula and technical support, and shall be approved in writing by CLIENT. | ||
1.17 | PRODUCTION or PRODUCE shall mean the formulation, filling, packaging, inspection, labeling, and/or testing of Drug Product by ALTHEA, as further set forth in the applicable Project Plan and as the context requires. | ||
1.18 | PRODUCT SPECIFICATION SHEET shall mean a listing of the analytical testing and corresponding Specifications, to be performed on the APIs and/or Drug Product in connection with the stability program and as further described in the applicable Project Plan. | ||
1.19 | PROJECT PLAN shall mean each document agreed upon by the parties from time to time that contains the parameters for Production of a Drug Product by ALTHEA hereunder. Each Project Plan shall be initially developed by ALTHEA and, if acceptable to CLIENT, agreed to in writing by CLIENT. Each Project Plan shall include the details of the project relating to a particular Drug Product, including without limitation (a) the scope of work to be performed and deliverables to be delivered by ALTHEA, (b) the Purchase Price that CLIENT will pay for the work to be performed by ALTHEA, (c) the timeline for performance of work by ALTHEA, and (d) the Quality Management Agreement applicable to the work to be performed by ALTHEA under the Project Plan. |
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Prior to commencing Production of any Drug Product, ALTHEA shall deliver two (2) signed originals of the Project Plan to CLIENT. CLIENT shall review the Project Plan and, if CLIENT finds the Project Plan acceptable, shall sign both originals of the Project Plan and return one (1) fully executed original to ALTHEA. Each fully executed Project Plan shall be incorporated herein by reference and made a part of this Agreement. In the event of any inconsistency between the terms within the body of this Agreement and the terms contained in any Project Plan, including without limitation any Quality Management Agreement within any such Project Plan, the terms within the body of this Agreement shall govern. ALTHEA shall have no obligation for Production of a Drug Product until CLIENT has executed and returned the Project Plan for such Drug Product to ALTHEA. | |||
1.20 | PURCHASE PRICE shall mean the amount to be paid by CLIENT for Development, Production, and any other services to be performed by ALTHEA as specified in each Project Plan. | ||
1.21 | REGULATORY AUTHORITY shall mean those agencies or authorities responsible for regulation of Drug Product in the United States and overseas, including without limitation FDA. ALTHEA shall have no obligation to Produce Drug Product in compliance with the requirements of a Regulatory Authority other than FDA unless specified in the applicable Project Plan or the other terms of this Agreement. | ||
1.22 | RELEASED EXECUTED BATCH RECORD shall mean the completed batch record and associate deviation reports, investigation reports, and Certificates of Analysis created for each Batch of Drug Product. | ||
1.23 | SPECIFICATIONS shall mean those specifications set forth in the Product Specification Sheet and the Master Batch Record for Drug Product, and to the extent that ALTHEA is required to test the APIs, for the APIs. |
2.1 | General, Initiation: |
(a) | ALTHEA shall, and shall cause all permitted Subcontractors to, perform all Development, Production, and other services hereunder (i) in a professional manner and in accordance with high standards of care and diligence consistent with industry practices, (ii) in compliance with the terms and conditions of this Agreement, including without limitation the applicable Project Plans and the schedules included therein, (iii) in compliance with all Applicable Legal Requirements, and (iv) in compliance with the applicable ALTHEA SOPs, and (e) in compliance with all reasonable direction and requests of CLIENT. |
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(b) | Upon execution of this Agreement and the corresponding Project Plan for each Drug Product, ALTHEA shall, to the extent set forth in the Project Plan, commence Development of such Drug Product pursuant to the timeline set forth in the Project Plan. Upon execution of this Agreement and the corresponding Project Plan for each Drug Product, ALTHEA shall commence Production of such Drug Product pursuant to the Project Plan. |
2.2 | Documentation: The Master Batch Record shall be reviewed and approved by ALTHEA and by CLIENT in writing (including by letter, e-mail or by signing the Master Batch Record) prior to commencement of Production. Any material change to an approved Master Batch Record will be reviewed and approved by ALTHEA and by CLIENT in writing (including by letter, e-mail or by signing a change order) prior to said change being implemented. Each Batch of Drug Product shall be Produced by using a copy of the Master Batch Record. Each copy of the Master Batch Record for such Batch of Drug Product shall be assigned a unique batch number. Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the copy of the Master Batch Record for that Batch. ALTHEA shall provide CLIENT in a timely manner with required supporting Development and Production documentation and any other information required for regulatory filings related to the Drug Product in a form reasonably suitable for CLIENTs submission to the FDA or other Regulatory Authority, including without limitation Master Batch Records, other batch records, protocols, other written processes and procedures directly related to the CLIENTs Drug Product and any other documents that are reasonably necessary or useful for CLIENT to use and/or transfer all methods and other work product resulting from the Development and Production services performed by ALTHEA under this Agreement. Employees, consultants, agents or contractors of CLIENT or CLIENTs Affiliates shall have the right to reference or submit the foregoing to the applicable Regulatory Authorities in support of an IND or other regulatory filing related to the Drug Product, or otherwise in support of CLIENTs efforts to develop, conduct clinical trials for, formulate, manufacture, test, and seek regulatory approval for the Drug Product. | ||
2.3 | APIs and Components Supply: CLIENT, at its sole cost and expense (including, without limitation, shipping costs), shall supply to ALTHEA, in a timely manner, (a) all APIs required to satisfy the terms of this Agreement and (b) any other CLIENT Supplied Components, all to be delivered to ALTHEA as set forth in the applicable Project Plan for Production of such Drug Product. Except as may specifically be set forth in the Project Plan, on receipt of the APIs and CLIENT Supplied Components as set forth above, ALTHEAs sole obligation with respect to evaluation of the APIs and CLIENT Supplied Components shall be to review the accompanying certificate of analysis to confirm that the APIs and CLIENT Supplied Components (if applicable) conform with the Specifications and component specifications, respectively. |
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2.4 | APIs and Component Delivery Delays : ALTHEA shall have no responsibility for delays in delivery of Drug Product caused by delays in receipt of APIs to be supplied by CLIENT under a Project Plan or other CLIENT Supplied Components. Notwithstanding anything in this Agreement to the contrary, in the event that ALTHEA receives the APIs for Production of Drug Product from CLIENT with less time than set forth in the applicable Project Plan prior to the scheduled date of Production of such Drug Product, but within sufficient time to Produce such Drug Product on such scheduled date as determined by ALTHEA in its reasonable discretion, ALTHEA may charge CLIENT up to an additional fee of [] for labor or expenses resulting from such delay incurred by ALTHEA, which shall be paid promptly to ALTHEA prior to Production, and ALTHEA shall Produce such Drug Product as per the original schedule. Notwithstanding anything in this Agreement to the contrary, in the event that ALTHEA receives the APIs for Production of Drug Product from CLIENT with less time than set forth in the applicable Project Plan prior to the scheduled date of Production of such Drug Product, and without sufficient time to Produce such Drug Product on the scheduled date as determined by ALTHEA in its reasonable discretion, ALTHEA shall reschedule Production of such Drug Product and shall charge CLIENT the applicable Cancellation Fee, if any, as further set forth in Section 3.3. | ||
2.5 | Importer of Record: In the event any material or equipment to be supplied by CLIENT, including without limitation CLIENT Supplied Components and APIs, is imported into the United States for delivery to ALTHEA (Imported Goods), CLIENT shall be the Importer of Record of such Imported Goods. As the Importer of Record, CLIENT shall be responsible for all aspects of the Imported Goods including, without limitation (a) customs and other regulatory clearance of Imported Goods, (b) payment of all tariffs, duties, customs, fees, expenses and charges payable in connection with the importation and delivery of the Imported Goods, and (c) keeping all records, documents, correspondence and tracking information required by applicable laws, rules and regulations arising out of or in connection with the importation or delivery of the Imported Goods. | ||
2.6 | Material Safety Data Sheet : CLIENT shall provide ALTHEA a Material Safety Data Sheet for APIs and, if available, for each Drug Product. ALTHEA shall immediately notify CLIENT of any unusual health or environmental occurrence relating to Drug Product, including, but not limited to any claim or complaint by any employee of ALTHEA or any of its Affiliates or third party that the operations of ALTHEA pursuant to this Agreement have resulted in any adverse health or safety effect on an employee or third party. ALTHEA agrees to advise CLIENT immediately of any unexpected safety or toxicity problems of which it becomes aware regarding the Drug Product. | ||
2.7 | Vendor and Supplier Audit and Certification : CLIENT shall be provided the opportunity to and shall have the right to certify and audit all Drug Product- related vendors and suppliers, the identity of which shall be provided to CLIENT by ALTHEA upon request by CLIENT, and if CLIENT does not so certify and audit such vendors and suppliers, shall be deemed to have approved ALTHEAS |
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selection of vendors and suppliers by way of signing this agreement. If CLIENT has a reasonable objection to any of ALTHEAs vendors or suppliers, CLIENT shall so inform ALTHEA and the parties shall work together in good faith to identify an alternate supplier or otherwise resolve the issue. ALTHEA shall inform CLIENT in writing of any change in ALTHEAs suppliers and vendors used in the Production of Drug Product. Except for the CLIENT Supplied Components identified in a Project Plan, the cost for all materials and ALTHEA Supplied Components, including any required testing and evaluation, which shall be performed by ALTHEA, shall be included in the Purchase Price. | |||
2.8 | Storage; Delivery Terms: ALTHEA shall store all APIs and all Drug Product under conditions that comply with the Specifications, any requirements set forth in the Project Plan, and any other reasonable written instructions of CLIENT, as applicable. Notwithstanding anything herein seemingly to the contrary, ALTHEA shall be liable for risk of loss of APIs, CLIENT Supplied Components and Drug Product while in the possession of ALTHEA. ALTHEA shall ship all Drug Product to CLIENT or to CLIENTs designated consignee under conditions that comply with the Specifications, any requirements set forth in the Project Plan, and any other reasonable written instructions of CLIENT, as applicable. All shipments shall be shipped FOB ALTHEA, by a common carrier designated by CLIENT, at CLIENTs expense; provided, however, ALTHEA shall be responsible for the loading of the Drug Product on departure and shall bear risk of loss and all costs of such loading. CLIENT shall procure, at its cost, insurance covering damage or loss of Drug Product during shipping. All shipping instructions of CLIENT shall be accompanied by the name and address of the recipient and the shipping date. | ||
2.9 | Exporter of Record: CLIENT shall be the exporter of record for any Drug Product shipped out of the United States, as CLIENT shall be and shall remain the owner of the Drug Product, as between the parties. CLIENT warrants that all shipments of Drug Product exported from the United States will be made in compliance with all applicable United States export laws and regulations and all applicable import laws and regulations into the country of importation. | ||
CLIENT shall be responsible for obtaining and paying for any licenses or other governmental authorization(s) necessary for the exportation from the United States. CLIENT shall select and pay the freight forwarder who shall solely be CLIENTs agent. CLIENT and its freight forwarder shall be solely responsible for preparing and filing the Shippers Export Declaration and any other documentation required for the export. | |||
2.10 | Foreign Corrupt Practices Act . CLIENT acknowledges that it is not the agent of ALTHEA and represents and warrants that it has not, and covenants that it will not, pay anything of value to any government employee in connection with the resale of the Product. |
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2.11 | Deposits and Payment for Drug Product and Development: Promptly upon execution of each Project Plan, CLIENT shall pay to ALTHEA [] of the total fees of each Project Plan, unless otherwise set forth in the Project Plan. Thereafter, ALTHEA will invoice CLIENT monthly based on the specific services completed and/or milestones met during the month. A payment schedule may be set forth in each Project Plan. CLIENT shall pay all invoices within thirty (30) days of receipt by CLIENT. Any payment due under this Agreement not received within the times noted above shall bear interest at the lesser of (a) the maximum rate permitted by law, and (b) 1.5% per month on the outstanding balance compounded monthly. Not withstanding the above provisions of this Section 2.11, CLIENT may withhold until resolved payment of any invoices that are disputed in good faith due to any Drug Product or other deliverable failing to meet standards set forth in the applicable Project Plan. | ||
2.12 | Default in Payment Obligations: In addition to all other remedies available to ALTHEA in the event of a CLIENT default, if CLIENT fails to make payments as required hereunder, ALTHEA may take appropriate measures to assure prompt and full payment, including any one of the following measures: refuse to Produce any Drug Product until CLIENTs account is paid in full; modify the foregoing terms of payment; place the account on a letter of credit basis; require full or partial payment in advance; suspend deliveries of Drug Product until CLIENT provides assurance of performance reasonably satisfactory to ALTHEA, or take other reasonable means as ALTHEA may determine. | ||
2.13 | Returns: Drug Product returned by third parties is the responsibility of CLIENT. | ||
2.14 | Subcontractors. ALTHEA shall not subcontract to any third parties (in such capacity, Subcontractors) any Development, Production, or other services that ALTHEA is obligated to perform under this Agreement without, in each case, CLIENTs prior written approval, at CLIENTs sole discretion. If ALTHEA proposes use of Subcontractors for particular services, CLIENT may require access to such Subcontractors for audit purposes. If CLIENT preapproves a Subcontractor in writing, (a) ALTHEA shall enter into an agreement with such Subcontractor that requires Subcontractor to meet all performance standards hereunder, that contains confidentiality and non-use terms at least as strict as those set forth in Article 9 below, that includes intellectual property rights and obligations consistent with those set forth in Article 10 below, and that includes any other terms necessary to ensure that ALTHEA meets its obligations under this Agreement, and (b) no such subcontracting by ALTHEA shall relieve ALTHEA of, and ALTHEA shall remain primarily liable for, its obligations under this Agreement. The parties may, at their discretion, designate in a Project Plan certain Subcontractors approved by CLIENT for services to be performed under that particular Project Plan. | ||
2.15 | Drug Product Substitution. At CLIENTs request, from time to time, ALTHEA shall substitute for Production that has been scheduled under a Project Plan another Drug Product of CLIENT or its designee. ALTHEA shall accept each such |
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substitution unless CLIENT and ALTHEA agree, in their reasonable discretion and after a good-faith discussion and reasonable evaluation of relevant factors, that such particular substitution is not feasible for technical reasons. In the event of any such substitution, the parties shall negotiate in good faith to amend the Project Plan as appropriate, including without limitation by adjusting the dates, deadlines and Purchase Price set forth in the Project Plan to the extent impacted by such Drug Product substitution. |
3.1 | Term: Unless sooner terminated pursuant to Section 3.2 herein, this Agreement shall commence on the date first above written and will continue until one (1) year after the satisfactory completion of Development and Production and all other services set forth in all outstanding Project Plans, as well as the satisfactory delivery of all deliverables set forth in all outstanding Project Plans (the Term). Notwithstanding the foregoing, the parties shall be free to extend the Term by mutual written agreement even if no Project Plans are outstanding, in contemplation of entering into Project Plans in the future. | ||
3.2 | Termination: This Agreement may be terminated at any time upon the occurrence of any of the following events: |
3.2.1 | Termination for Breach: Either party may terminate this Agreement upon the breach of any provision of this Agreement by the other party if such breach is not cured by the breaching party within thirty (30) calendar days (or such additional time reasonably necessary to cure such default provided the breaching party has commenced a cure within the thirty (30) day period and is diligently pursuing completion of such cure) after receipt by the breaching party of written notice of such default. At the option of the non-breaching party, such termination may be with respect to the entire Agreement, or only with respect to the Project Plan that is subject to the breach. | ||
3.2.2 | Termination for Financial Matters : This Agreement may be terminated immediately by either party by giving the other party written notice thereof in the event such other party makes a general assignment for the benefit of its creditors, or proceedings of a case are commenced in any court of competent jurisdiction by or against such party seeking (a) such partys reorganization, liquidation, dissolution, arrangement or winding up, or the composition or readjustment of its debts, (b) the appointment of a receiver or trustee for or over such partys property, or (c) similar relief in respect of such party under any law relating to bankruptcy, insolvency, reorganization, winding up or composition or adjustment of debt, and such proceedings shall continue undismissed, or |
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3.3 | Payment on Termination; Cancellation Fees: |
(a) | In the event of the termination of this Agreement, CLIENT shall reimburse ALTHEA for (a) its documented, reasonable out-of-pocket costs for all ALTHEA Supplied Components ordered prior to termination and not cancelable at no cost to ALTHEA, (b) all work-in-process commenced by ALTHEA that has been performed in accordance with the terms of this Agreement and applicable Project Plan(s), and (c) all finished Drug Product produced and delivered in accordance with the terms of this Agreement and applicable Project Plan(s) that is delivered to CLIENT. | ||
(b) | In the event of cancellation by CLIENT of the Production of any Batch set forth in a Project Plan that has been scheduled by written agreement of ALTHEA and CLIENT or in the event of termination of this Agreement prior to completion of any such scheduled Batch, ALTHEA shall use its best efforts to sell the manufacturing time and capacity created as a result of such cancellation or termination to another customer and otherwise mitigate ALTHEAs losses. In the event that the manufacturing time and capacity created as a result of CLIENTs cancellation of Production of any such scheduled Batch or the termination of this Agreement prior to completion of any such scheduled Batch has not been sold by ALTHEA, except for any cancellation or termination by CLIENT pursuant to Section 3.2.1, ALTHEA may at its option charge CLIENT and CLIENT shall then pay the Cancellation Fees as hereinafter set forth: (i) CLIENT is subject to a charge of [] of the budgeted Batch price if the Batch is canceled less than [] from the scheduled fill date, (ii) a charge of [] of the budgeted Batch price if the Batch is canceled less than [] from the scheduled fill date, and (iii) a charge of [] of the budgeted Batch price if the Batch is canceled less than [] from the scheduled fill date. In addition, CLIENT must compensate ALTHEA for any documented, reasonable out-of-pocket costs for all ALTHEA Supplied Components ordered by ALTHEA prior to termination and not cancelable at no cost to ALTHEA, non-cancelable materials ordered or testing completed by ALTHEA, except to any extent such costs have been paid in accordance with Section 3.3.(a) above. For |
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purposes of the foregoing, one (1) week is equivalent to seven (7) days. Following termination or upon notice that CLIENT has cancelled Production of a Batch, as applicable, ALTHEA shall ship all completed Drug Product and all Components and other materials for which CLIENT is obligated to reimburse ALTHEA pursuant to the foregoing, to CLIENT at CLIENTs cost and per CLIENTs instructions. CLIENT shall make payment for all expenses described in Section 3.3 thirty (30) days from receipt of the invoice. Notwithstanding anything herein to the contrary, CLIENT shall have no obligation to pay any Cancellation Fees or other amounts to ALTHEA in the event that this Agreement is terminated by CLIENT pursuant to Section 3.2.1 above. |
3.4 | Survival: Termination, expiration, cancellation or abandonment of this Agreement through any means or for any reason shall be without prejudice to the rights and remedies of either party with respect to any antecedent breach of any of the provisions of this Agreement. The provisions of Sections 3, 6, 9, 10, 11, 12, 13, 14, and 15 hereof shall survive expiration or termination of this Agreement for the time period set forth therein, or if no time period is set forth therein, then indefinitely. |
4.1 | Certificates of Analysis: At CLIENTs cost and expense, as set forth in the applicable Project Plan, ALTHEA shall test, or cause to be tested by third parties, in accordance with the Specifications, each Batch of Drug Product Produced pursuant to this Agreement before delivery to CLIENT. A certificate of analysis for each Batch delivered shall set forth the items tested, Specifications, and test results. ALTHEA shall also ensure that all batch Production and control records have been reviewed and approved by the appropriate quality control unit and shall so indicate on the final page of the Released Executed Batch Record. ALTHEA shall send, or cause to be sent, such certificates and the Released Executed Batch Record to CLIENT prior to the shipment of Drug Product (unless Drug Product is shipped under quarantine). Unless otherwise set forth in the applicable Project Plan, ALTHEA shall also provide samples of all Batches of Drug Product Produced under this Agreement, as further described in Section 5.1 below. Unless otherwise set forth in the Project Plan, CLIENT shall test, or cause to be tested, for final release, each Batch of Drug Product as meeting the Specifications. As required by the FDA (see Section 5.2 below), CLIENT assumes full responsibility for final release of each Batch of Drug Product. All costs associated with ALTHEA performing testing and providing certificates of analysis and other documentation as set forth in this Section 5.1 shall be deemed included within the Purchase Price set forth in the applicable Project Plan and Client shall pay no additional amounts therefore. |
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4.2 | Manufacturing Compliance: ALTHEA shall advise CLIENT immediately if an authorized agent of FDA or any other Regulatory Authority visits ALTHEAs manufacturing facility and makes an inquiry regarding ALTHEAs Production of Drug Product for CLIENT or otherwise communicates orally or in writing with ALTHEA about any Drug Product for which services are performed hereunder. In the event of an inspection of an ALTHEA facility relating to a Drug Product or any services performed for CLIENT hereunder, CLIENT may send, at its own expense, representatives to the ALTHEA Facility to participate in any portion of such inspection directed to the Drug Product or the services performed under this Agreement. ALTHEA shall supply CLIENT with copies of any written communications from any Regulatory Authority that relate to the Drug Product or the services performed hereunder, whether such communications arise out of a facility inspection or otherwise. ALTHEA shall provide CLIENT with a copy of each proposed written response to a Regulatory Authority for CLIENTs review and comment prior to ALTHEAs submission of such response. ALTHEA shall give all due consideration to any CLIENT comments to each such proposed ALTHEA response, provided CLIENT responds in a timely fashion. Manufacturing deviations and investigations which occur during Production of Drug Product and which are not reasonably likely, in CLIENTs reasonable discretion, to cause the Production to be non-compliant with cGMP, shall not be deemed to cause such Drug Product to be non-conforming. | ||
4.3 | Reserve Samples: CLIENT shall be responsible for obtaining and maintaining sufficient quantities of APIs and Drug Product reserve samples pursuant to cGMP. | ||
4.4 | Annual Quality Review: CLIENT shall be responsible for evaluating, at least annually, the quality standards of Drug Product to determine the need for changes in Specifications, manufacturing processes, and/or controlled documents. CLIENT shall supply ALTHEA a copy of the evaluation and recommendations, if any. | ||
4.5 | Retention of Records: ALTHEA shall maintain complete and accurate distribution and shipment, manufacturing, analytical, validation, and other records as specified in cGMP related to the Development, Production, and any other services performed hereunder (collectively, the Production Records). ALTHEA shall retain all Production Records in accordance with Applicable Legal Requirements, including without limitation cGMP. ALTHEA shall, upon CLIENTs reasonable request and at CLIENTs expense, make all Production Records available to CLIENT for inspection and, for Production Records directly pertaining to CLIENTs Drug Products, copying. ALTHEA shall, prior to destroying any Production Records, provide written notice to CLIENT and permit CLIENT the opportunity to take possession of such records, at CLIENTs expense. | ||
4.6 | Customer Complaints: CLIENT, as required by cGMP, shall maintain complaint files. All specific CLIENT Drug Product-related complaints received by ALTHEA shall be forwarded to CLIENT. CLIENT shall be responsible for |
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the review of the complaint to determine the need for an investigation or the need to report to the FDA as required by cGMP. CLIENT shall send to ALTHEA all Drug Product performance or manufacturing-related complaints which require investigation. ALTHEA shall conduct an investigation for each Drug Product performance or manufacturing-related complaint and shall report findings and follow-up of each investigation to CLIENT in a timely manner. CLIENT shall make these complaint files available to ALTHEA in the event they are required during an FDA inspection. | |||
4.7 | Audits: | ||
CLIENT, upon prior written notice and during normal business hours, shall have the right to inspect ALTHEA Batch records, Production Records, and any other written and electronic files and documentation related to Development, Production, and/or other services performed hereunder and the portions of ALTHEAs facility used for Production of Drug Product. CLIENT may conduct routine audits once annually and audits for reasonable cause with appropriate prior notice and consideration of ALTHEAs schedule as frequently as CLIENT reasonably deems necessary. Each party shall bear its own costs associated with all such CLIENT audits. The Quality Management Agreement set forth in the applicable Project Plan shall govern the parties obligations with respect to the results of such audits. | |||
4.8 | Regulatory Compliance: Unless otherwise stated, ALTHEA is responsible for compliance with all Applicable Legal Requirements related to Production of pharmaceutical products, Development and Production of Drug Product, and any other services performed by ALTHEA under this Agreement. CLIENT shall be responsible for compliance with all Applicable Legal Requirements related to the use of Drug Product after it has been Produced and delivered by ALTHEA to CLIENT hereunder, which responsibility shall include, without limitation, all contact with the FDA regarding the such use. | ||
4.9 | Person in the Plant. CLIENT shall have the right to designate one representative of CLIENT to be present at any time in the ALTHEA facility during normal business hours during the Term of this Agreement to observe the Production of Drug Product. While at the facility, such representative of CLIENT shall be restricted to such areas as are directly relevant to the manufacture of the Drug Product and such other areas as may be otherwise authorized by ALTHEA, and shall comply with all applicable ALTHEA policies and procedures and may, at ALTHEAs option, be escorted by ALTHEA personnel. |
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5.1 | Non-Conforming Drug Product : Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, ALTHEA shall promptly forward to CLIENT, or CLIENTs designee, samples of such Batch. Within sixty (60) calendar days after receipt by CLIENT of the samples of the Batch and the Released Executed Batch Record for the Batch, CLIENT shall determine whether Drug Product conforms to the Drug Product Specifications, the Master Batch Record, ALTHEAs current SOPs, and the Project Plan (collectively the Product Requirements). |
5.1.1 | If (a) any Batch of Drug Product is approved by CLIENT as conforming to the Product Requirements, or (b) CLIENT fails to notify ALTHEA within the applicable time period set forth above, or such longer period as may be agreed, that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. | ||
5.1.2 | If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify ALTHEA by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to ALTHEA. Upon receipt of such notice, ALTHEA will investigate such alleged non-conformity, and (i) if ALTHEA agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENTs written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or ALTHEA, or (ii) if ALTHEA disagrees with CLIENTs determination that the Batch of Drug Product is non-conforming, ALTHEA shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. | ||
5.1.3 | If the parties dispute whether a Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. Unless the Batch is determined to be non-conforming as set forth in this Section 5. 3 due to the fault of ALTHEA, CLIENT shall bear the costs of such laboratory or consultant. |
5.2 | Remedies for Non Conforming Product: In the event ALTHEA agrees, or the laboratory described in Section 5.1.3 above determines, that the Batch of Drug Product is non-conforming as a result of the negligent or willful act or omission of ALTHEA, [] or ALTHEAs breach of this Agreement, then ALTHEA, at CLIENTs option, shall either (i) at ALTHEAs expense, and subject to CLIENT, at CLIENTs expense, supplying the replacement APIs, replace such non-conforming Drug Product within sixty (60) calendar days from receipt of replacement APIs from CLIENT, or (ii) refund the Purchase Price of the non- |
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conforming Drug Product to CLIENT (provided that CLIENT has made payment for the non-conforming Drug Product). The remedies described in this Section 5.2 shall not act to limit ALTHEAs indemnification obligations to the extent provided in Section 13.2 of this Agreement. |
5.3 | Non-conforming APIs : If Drug Product is rejected by CLIENT, and such Drug Products failure to meet the Product Requirements is the result of non-conforming APIs, then such non-conformity shall be deemed not to be non-conforming solely as a result of the negligence of ALTHEA. |
6.1 | Drug Product Recalls: In the event CLIENT shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Drug Product Specifications, or in the event that CLIENT elects to institute a voluntary recall, CLIENT shall be responsible for coordinating such recall. CLIENT promptly shall notify ALTHEA if any Drug Product is the subject of a recall and the basis for such recall. CLIENT shall provide ALTHEA with a copy of all documents concerning such recall that are related to the Development or Production services provided by ALTHEA to CLIENT. ALTHEA shall cooperate with CLIENT in connection with any recall, at CLIENTs expense. CLIENT shall be responsible for all of the costs and expenses of such recall, except to any extent that ALTHEA may have an obligation to indemnify CLIENT in accordance with the provisions of Section 13.2. |
7.1 | Force Majeure Events: Failure of either party to perform under this Agreement (except the obligation to make payments) shall not subject such party to any liability to the other if such failure is caused by any cause beyond the reasonable control of the affected party, including without limitation acts of God, acts of terrorism, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes or other labor trouble, or compliance with any new order or regulation of any government entity that could not reasonably be anticipated, provided that written notice of such event is promptly given to the other party and that the affected party resumes performance hereunder as soon as reasonably possible. | ||
7.2 | Failure to Supply: If ALTHEA fails to supply all or any material part of Drug Product ordered by CLIENT, CLIENT may require ALTHEA to supply the undelivered Drug Product or a lesser quantity at a future date agreed upon by ALTHEA and CLIENT, at no additional cost to CLIENT. The provisions of this Section 7.2 shall be without prejudice to CLIENTs rights under Section 3.2 and 13.2 and remedies provided for thereunder. |
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8.1 | Changes to Master Batch Records and Product Specifications : ALTHEA agrees to inform CLIENT within fifteen (15) days of the result of any regulatory development or changes to Drug Product-specific SOPs that materially affect the Production of Drug Product. ALTHEA shall notify CLIENT of and receive written approval from CLIENT for changes to Master Batch Records and Drug Product Specifications prior to the Production of subsequent Batches of Drug Product. | ||
8.2 | Product-Specific Changes : If facility, equipment, process or system changes are required of ALTHEA as a result of new requirements that FDA or any other Regulatory Authority promulgates after initiation of the Project Plan, and such regulatory changes apply primarily to the Production and supply of one or more Drug Products, then CLIENT and ALTHEA will review such requirements and agree in writing to such facility, equipment, process or system changes, and CLIENT shall bear 100% of the reasonable costs thereof. In the event that CLIENT chooses not to bear the costs of such changes, then CLIENT may cancel any uninitiated Production of Drug Product without incurring any Cancellation Fees or other penalties hereunder. |
9.1 | Confidentiality : It is contemplated that in the course of the performance of this Agreement each party may, from time to time, disclose its Confidential Information to the other party. Except as otherwise set forth herein, (a) neither party shall disclose the other partys Confidential Information to any third party, and (b) neither party shall use the other partys Confidential Information except for purposes consistent with this Agreement. Each party agrees to take the same measures that it takes to protect its own Confidential Information, and at a minimum all reasonable steps, to prevent disclosure of the other partys Confidential Information to third parties. No provision of this Agreement shall be construed so as to preclude disclosure of Confidential Information as may be reasonably necessary to secure from any governmental agency or Regulatory Authority approvals or licenses or to obtain patents with respect to the Drug Product. | ||
9.2 | Prior Confidentiality Agreement : This Agreement, by reference, incorporates the Confidentiality Agreement signed by CLIENT and ALTHEA on June 14, 2005, which is made a part hereof as though fully set forth herein. |
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9.3 | Third Party Disclosure : ALTHEA shall be permitted to disclose Drug Product information to Subcontractors approved by CLIENT in accordance with Section 2.14 above in connection with performance of by Subcontractors of their obligations with respect to Drug Product, provided that such Subcontractors shall be subject to confidentiality obligations at least as stringent as those set forth herein. In addition, either party may disclose Confidential Information of the other party to those Affiliates, agents and consultants who need to know such information to accomplish the purposes of this Agreement (collectively, Permitted Recipients); provided such Permitted Recipients are bound to maintain such Confidential Information in confidence under written agreements with confidentiality obligations at least as stringent as those set forth herein. Nothing in this Section 9 shall be construed to limit CLIENTs ability to use and disclose Confidential Information related to its Drug Product(s) as part of any submission to FDA or other regulatory authority. | ||
9.4 | Litigation and Governmental Disclosure : Each party may disclose Confidential Information hereunder to the extent such disclosure is reasonably necessary for (a) prosecuting or defending litigation, (b) complying with applicable governmental statutes or regulations or with judicial or administrative process, or (c) CLIENTs conduct of pre-clinical or clinical trials of Drug Product, provided that if a party is required by law, regulation, or judicial or administrative process, or as a result of litigation, to make any such disclosure of the other partys Confidential Information, the party subject to such legal requirement or litigation will, when reasonably practicable, give reasonable advance notice to the other party of such disclosure requirement and will use good faith efforts to assist such other party to secure a protective order or confidential treatment of such Confidential Information required to be disclosed. | ||
9.5 | Limitation of Disclosure: The parties agree that, except as otherwise may be required by applicable laws, regulations, rules or judicial or administrative orders, including without limitation the rules and regulations promulgated by the United States Securities and Exchange Commission, and except as may be authorized in Sections 9.4 or 9.6, no information concerning this Agreement and the transactions contemplated herein shall be made public by either party without the prior written consent of the other. | ||
9.6 | Publicity. Except as part of any regulatory submission by CLIENT, or except as may be otherwise required by law or regulation after first providing reasonable advance notice to the other party, or except as otherwise expressly set forth herein, neither party may use the other partys name in any promotional material, advertising, press releases, or other materials without in each case the prior written consent of the other party. ALTHEA hereby consents to CLIENTs disclosure of this Agreement and ALTHEAs name to CLIENTs current and potential employees, consultants, directors, professional advisors, shareholders, investors and business partners. | ||
9.7 | Return of Confidential Information. Upon the expiration or any termination of this Agreement, each party shall, upon the request of the other party, return such |
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other partys Confidential Information to such other party, provided, however, that the party returning such Confidential Information shall be entitled to retain one copy of all such Confidential Information to ensure its compliance with this Agreement and/or any Applicable Legal Requirements. | |||
9.8 | Duration of Confidentiality : All obligations of confidentiality and non-use imposed upon the parties under this Agreement shall expire ten (10) years after the expiration or earlier termination of this Agreement. |
10.1 | Existing Intellectual Property : Except as the parties may otherwise expressly agree in writing or as set forth herein, each party shall continue to own its patents, trademarks, service marks, trade dress, copyrights, trade secrets, proprietary methods, discoveries, inventions, compositions, products, procedures, know-how, data, reports, programs, processes, protocols, written or electronic writings, illustrations, images, and any other form of proprietary rights (collectively, Intellectual Property) that exist as of the Effective Date, without conferring any interests therein on the other party, except as expressly provided herein. Without limiting the generality of the preceding sentence, CLIENT shall retain all right, title and interest arising under the United States Patent Act, the United States Trademark Act, the United States Copyright Act and all other applicable laws, rules and regulations in and to all Intellectual Property of Client (collectively, CLIENTs Existing Intellectual Property), including without limitation all Drug Products, APIs (where applicable), all Labeling and trademarks associated therewith. Neither ALTHEA nor any third party shall acquire any right, title or interest in CLIENTs Intellectual Property by virtue of this Agreement or otherwise. ALTHEA shall retain all right, title and interest in and to all Intellectual Property owned by ALTHEA (ALTHEAs Existing Intellectual Property), except as provided in Section 10.2 below. | ||
10.2 | New ALTHEA Inventions: ALTHEA shall own all right, title and interest in and to Inventions that are conceived, reduced to practice, or created solely by ALTHEAs Representatives during the course of performance under this Agreement if such Inventions are not specific to CLIENTs Drug Products and are generally applicable to products that are not competitive with (i.e., do not directly or indirectly reduce the market for) CLIENTs pharmaceutical products (ALTHEA Inventions). ALTHEA hereby grants CLIENT a fully paid-up, irrevocable non-exclusive license to (a) all ALTHEA Inventions solely to the extent necessary or beneficial for CLIENT to develop, manufacture, commercialize and market its pharmaceutical products and (b) any of ALTHEAs Existing Intellectual Property that ALTHEA incorporates into the Development or Production of CLIENTs Drug Products, solely to the extent necessary or beneficial for CLIENT to develop, manufacture, commercialize and market CLIENTs Drug Products. |
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10.3 | New CLIENT Inventions: For purposes of this Agreement, Invention shall mean information relating to any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable. CLIENT shall own all right, title and interest in and to Inventions that are conceived, reduced to practice, or created solely by CLIENTs employees, officers, consultants or agents (Representatives) during the course of performance under this Agreement. CLIENT shall also own all right, title and interest in and to (a) Inventions that are conceived, reduced to practice, or created by ALTHEAs Representatives, solely or jointly with CLIENTs Representatives or third parties, during the course of performance under this Agreement or as a result of receiving CLIENTs Confidential Information, including without limitation all such Inventions that relate to any improvement, modification or advancement of CLIENTs Drug Products and all methods and procedures for analyzing, testing, formulating, manufacturing, packaging or using CLIENTs Drug Products, but excluding all ALTHEA Inventions (as defined below), and (b) all other work product, methods, procedures, reports and data resulting from ALTHEAs performance under this Agreement that directly relate to CLIENTs Drug Products. | ||
10.4 | Rights in Intellectual Property : The party owning Inventions or other Intellectual Property as set forth herein above shall have the world wide right to control the drafting, filing, prosecution, maintenance and enforcement of patents covering the Inventions and Intellectual Property, including decisions about the countries in which to file patent applications. Patent costs associated with the patent activities described in this Section shall be borne by the sole owner. Each party will cooperate with the other party in the filing and prosecution of patent applications, including the execution of assignments to confirm title as set forth above and further including but not be limited to, furnishing supporting data and affidavits for the prosecution of patent applications and completing and signing forms needed for the prosecution, assignment and maintenance of patent applications. | ||
10.5 | Confidentiality of Intellectual Property : Each Partys Inventions and Intellectual Property shall be deemed to be the Confidential Information of the party owning such Intellectual Property as provided herein above. The protection of each partys Confidential Information is described in Article 9. Any disclosure of information by one party to the other under the provisions of this Section 10 shall be treated as the disclosing partys Confidential Information under this Agreement. It shall be the responsibility of the party preparing a patent application to obtain the written permission of the other party to use or disclose the other partys Confidential Information in the patent application before the application is filed and for other disclosures made during the prosecution of the patent application. |
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11.1 | Mutual Representations : Each party hereby represents and warrants that (a) the person executing this Agreement on behalf of such party is authorized to execute this Agreement; (b) this Agreement is legal and valid and the obligations binding upon such party are enforceable by their terms; and (c) the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which such party may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it. | ||
11.2 | ALTHEA Warranty : ALTHEA represents and warrants that Drug Product shall be Produced in accordance with cGMP. ALTHEA further represents and warrants that it has obtained (or will obtain prior to Producing Drug Product), and will remain in compliance with during the term of this Agreement, all permits, licenses and other authorizations (the Permits) which are required under Applicable Legal Requirements or as specified in the Project Plan, the Master Batch Records, the Specifications or the ALTHEA SOPs; provided, however, ALTHEA shall have no obligation to obtain Permits relating to the sale, marketing, commercial distribution or use of APIs or Drug Product or with respect to the Labeling of Drug Product. ALTHEA further represents and warrants that the Drug Product supplied hereunder shall not be adulterated or misbranded within the meaning of the FD&C Act or comparable law, provided, however, that the warranty in this sentence shall not apply to any such adulteration or misbranding that occurred due to information provided by CLIENT or that occurred after the Drug Product leaves ALTHEAs control. ALTHEA further represents and warrants that it shall perform all Development, Production, and other services hereunder in full compliance with all Applicable Legal Requirements and all other requirements of this Agreement. ALTHEA makes no representation or warranty with respect to the sale, marketing, commercial distribution or use of the APIs or as to printed materials supplied by CLIENT or its consignee. ALTHEA further represents and warrants that all Drug Product supplied hereunder shall be transferred free and clear of any liens or encumbrances of any kind arising through ALTHEA or its Affiliates or their respective agents. ALTHEA further represents and warrants that it has no knowledge of any patents or other Intellectual Property rights that would be violated by ALTHEAs performance hereunder. | ||
11.3 | Disclaimer of Warranties : Except for those warranties set forth in Sections 11.1 and 11.2 of this Agreement, neither party makes any warranties, written, oral, express or implied, with respect to Drug Product or the Development and Production of Drug Product. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY ALTHEA AND BY CLIENT. NO WARRANTIES OF EITHER PARTY MAY BE CHANGED BY THE |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
ORAL STATEMENT OF ANY REPRESENTATIVE OF SUCH PARTY. CLIENT accepts Drug Product subject to the terms hereof. | |||
11.4 | CLIENT Warranties : CLIENT warrants that (a) it has the right to give ALTHEA any information provided by CLIENT hereunder, and that ALTHEA has the right to use such information for the Production of Drug Product, and (b) CLIENT has no knowledge of any (i) patents or other Intellectual Property rights that would be infringed by ALTHEAs performance hereunder. CLIENT further warrants that the APIs provided to ALTHEA hereunder (c) conforms to the APIs Specifications and (d) is not adulterated or misbranded within the meaning of the FD&C Act. |
12.1 | Limitation of Liability : CLIENTs sole and exclusive remedy for breach of this Agreement is limited to those remedies set forth in Article 5, at CLIENTs election, to either replace the non-conforming Drug Product or reimburse CLIENT for the Purchase Price for the non-conforming Drug Product and as provided in Article 6, [] (b) ALTHEAs grossly negligent act or omission or willful misconduct, or (c) any breach by ALTHEA of the Applicable Legal Requirements. Under no circumstances shall either party be liable hereunder to the other party for the other partys loss of use or profits or other incidental, indirect, special, punitive, or consequential damages, losses or expenses suffered by the other party, including but not limited to the cost of cover or the cost of a recall (except as provided in Article 6) in connection with, or by reason of the Production and delivery of Drug Product under this Agreement whether such claims are founded in tort or contract. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
12.2 | Waiver of Subrogation : All ALTHEA Supplied Components and equipment used by ALTHEA in the Production of Drug Product (collectively, ALTHEA Property) shall remain the property of ALTHEA and ALTHEA assumes risk of loss for such property until delivery of Drug Product to a common carrier as specified under Section 2.8, at which point the ALTHEA Supplied Components that have been incorporated into the Drug Product shall be deemed owned by CLIENT as further described in Section 2.8 above. ALTHEA hereby waives any and all rights of recovery against CLIENT and its Affiliates, and against any of their respective directors, officers, employees, agents or representatives, for any loss or damage to ALTHEA Property to the extent the loss or damage is covered or could be covered by insurance (whether or not such insurance is described in this Agreement). CLIENT assumes all risk of loss for all CLIENT Supplied Components, all APIs supplied by CLIENT, and all Drug Product (collectively, CLIENT Property) while such CLIENT Property is in CLIENTs possession. CLIENT hereby waives any and all rights of recovery against ALTHEA and its Affiliates, and against any of their respective directors, officers, employees, agents or representatives, for any loss or damage to the CLIENT Property to the extent the loss of damage is covered or could be covered by insurance (whether or not such insurance is described in this Agreement). | ||
12.3 | Waiver of Claims: In connection with providing Development services, ALTHEA represents only that it will use reasonable care and will comply fully with the terms hereof in providing information solely as it relates to development studies, formulation, primary packaging and manufacturing process development. Except as otherwise expressly set forth herein, ALTHEA makes no representation or warranty relating to the stability, efficacy, safety, or toxicity of Drug Product developed, formulated, packaged or manufactured in accordance with the Development services provided by ALTHEA. |
13.1 | CLIENT Indemnification : CLIENT shall indemnify, defend and hold harmless ALTHEA and its Affiliates, and any of their respective directors, officers, employees, subcontractors and agents (collectively the ALTHEA Indemnified Parties) from and against any and all liabilities, obligations, penalties, claims, judgments, demands, actions, disbursements of any kind and nature, suits, losses, damages, costs and expenses (including, without limitation, reasonable attorneys fees) arising out of or in connection with property damage or personal injury (including without limitation death) suffered by any third party (collectively Claims) arising directly out of (a) CLIENTs storage, promotion, labeling, marketing, distribution, use or sale of APIs or Drug Product, (b) CLIENTs negligence or willful misconduct or omission, or (c) CLIENTs breach of this Agreement. Notwithstanding the foregoing, CLIENT shall have no obligations under this Section 13.1 to the extent that any such Claim arises out of the negligence or willful misconduct or omission of any of the ALTHEA Indemnified Parties or the breach by ALTHEA of its obligations under this Agreement. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
13.2 | ALTHEA Indemnification : ALTHEA shall indemnify, defend and hold harmless CLIENT and its Affiliates and any of their respective directors, officers, employees, subcontractors and agents (collectively the CLIENT Indemnified Parties) from and against any and all Claims arising directly out of (a) the negligent act or omission of any of the ALTHEA Indemnified Parties (provided that ALTHEAs liability under this subsection (a) only shall be limited to the amounts paid to ALTHEA by Omeros under this Agreement), (b) the grossly negligent act or omission or intentional misconduct of any of the ALTHEA Indemnified Parties, (c) the breach by any of the ALTHEA Indemnified Parties of any of the Applicable Legal Requirements or (d) the breach by any of the ALTHEA Indemnified Parties of Article 9 (Confidentiality) or Article 10 (Intellectual Property) above. Notwithstanding the foregoing, ALTHEA shall have no obligations under this Section 13.2 to the extent that any such Claim arises out of (i) the negligence or willful misconduct or omission of any of the CLIENT Indemnified Parties, or (ii) the breach by CLIENT of any of its obligations under this Agreement. | ||
13.3 | Indemnitee Obligations : A party (the Indemnitee) which intends to claim indemnification under this Article 13 shall promptly notify the other party (the Indemnitor) in writing of any action, claim or other matter in respect of which the Indemnitee or any of its Affiliates, or any of their respective directors, officers, employees, subcontractors, or agents, intend to claim such indemnification; provided, however, that failure to provide such notice within a reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder except to the extent the Indemnitor is prejudiced by such failure. The Indemnitee shall permit, and shall cause its Affiliates, and their respective directors, officers, employees, subcontractors and agents to permit, the Indemnitor, at its discretion, to settle any such action, claim or other matter, and the Indemnitee agrees to the complete control of such defense or settlement by the Indemnitor. Notwithstanding the foregoing, the Indemnitor shall not enter into any settlement that would adversely affect the Indemnitees rights hereunder, or impose any obligations on the Indemnitee in addition to those set forth herein, in order for it to exercise such rights, without Indemnitees prior written consent, which shall not be unreasonably withheld or delayed. No such action, claim or other matter shall be settled without the prior written consent of the Indemnitor, which shall not be unreasonably withheld or delayed. The Indemnitee, its Affiliates, and their respective directors, officers, employees, subcontractors and agents shall fully cooperate with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or other matter covered by the indemnification obligations of this Article 13. The Indemnitee shall have the right, but not the obligation, to be represented in such defense by counsel of its own selection and at its own expense. | ||
13.4 | Injunction : In the event that the Production or sale of a Drug Product is enjoined due to alleged infringement by either party of the proprietary rights of a third party, such action shall be deemed a breach of this Agreement by CLIENT and subject to the terms of Article 3, except to the extent that any such injunction |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
arises out of ALTHEAs use of its standard methods, techniques, and processes that ALTHEA uses generally in performing services for its customers. |
14.1 | CLIENT Insurance : CLIENT shall procure and maintain, during the Term of this Agreement and for a period one (1) year beyond the expiration date of Drug Product, Commercial General Liability Insurance, including without limitation, Product Liability and Contractual Liability coverage (the CLIENT Insurance). The CLIENT Insurance shall cover amounts not less than [] combined single limit and shall be with an insurance carrier reasonably acceptable to ALTHEA. ALTHEA shall be named as an additional insured on the CLIENT Insurance and, upon ALTHEAs written request, CLIENT promptly shall deliver a certificate of CLIENT Insurance and endorsement of additional insured to ALTHEA evidencing such coverage. If CLIENT fails to furnish such certificates or endorsements, or if at any time during the Term of this Agreement ALTHEA is notified of the cancellation or lapse of the CLIENT Insurance, and CLIENT fails to rectify the same within ten (10) calendar days after notice from ALTHEA, in addition to all other remedies available to ALTHEA hereunder, ALTHEA, at its option, may obtain the CLIENT Insurance and CLIENT promptly shall reimburse ALTHEA for the cost of the same. Any deductible and/or self insurance retention shall be the sole responsibility of CLIENT. | ||
14.2 | ALTHEA Insurance : ALTHEA shall procure and maintain, during the Term of this Agreement and for a period of one (1) year beyond the expiration date of Drug Product, Commercial General Liability Insurance, including without limitation, Product Liability and Contractual Liability coverage (the ALTHEA Insurance). The ALTHEA Insurance shall cover amounts not less than [] combined single limit. CLIENT shall be named as an additional insured on the ALTHEA Insurance and, upon CLIENTs written request, ALTHEA promptly shall deliver a certificate of ALTHEA Insurance and endorsement of additional insured to CLIENT evidencing such coverage. If ALTHEA fails to furnish such certificates or endorsements, or if at any time during the Term of this Agreement CLIENT is notified of the cancellation or lapse of the ALTHEA Insurance, and ALTHEA fails to rectify the same within ten (10) calendar days after notice from CLIENT, in addition to all other remedies available to CLIENT hereunder, CLIENT, at its option, may obtain the ALTHEA Insurance and ALTHEA promptly shall reimburse CLIENT for the cost of the same. Any deductible and/or self insurance retention shall be the sole responsibility of ALTHEA. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
15.1 | Notices: All notices hereunder shall be delivered by facsimile (confirmed by overnight delivery), or by overnight delivery with a reputable overnight delivery service, to the following address of the respective parties: |
If to CLIENT: | ||||||
Omeros Corporation | ||||||
1420 Fifth Avenue, Suite 2600 | ||||||
Seattle, WA 98101 | ||||||
|
Attention: | Chairman & CEO | ||||
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|
And copy to: | General Counsel | ||||
|
||||||
Fax: (206) 264.7856 | ||||||
Phone: (206) 623.4688 | ||||||
|
||||||
If to ALTHEA: | Althea Technologies, Inc. | |||||
11040 Roselle Street | ||||||
San Diego, CA 92121 | ||||||
Attn: Alan Moore | ||||||
Executive Vice President and Chief Business Officer | ||||||
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||||||
|
Telephone: | (858) 882-0123 | ||||
|
Facsimile: | (858) 882-0133 |
Project Manager
|
Rick Hancock | |||
|
||||
Quality Control and
Quality Assurance Manager |
Roy Musil | |||
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||||
Materials Manager
|
Melissa Rosness |
Project Manager
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||||
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||||
Quality Control Manager
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||||
|
||||
Materials Manager
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||||
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Quality Assurance Manager
|
Notices shall be effective on the day following the date of transmission if sent by facsimile, and on the second business day following the date of delivery to the overnight delivery service if sent by overnight delivery. A party may change its address listed above by notice to the other party given in accordance with this section. |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
15.2 | Entire Agreement; Amendment: The parties hereto acknowledge that this Agreement, including any Project Plans executed in accordance with the terms hereof and any other documents expressly incorporated by reference, sets forth the entire agreement and understanding of the parties and supercedes all prior written or oral agreements or understandings with respect to the subject matter hereof. No modification of any of the terms of this Agreement, or any amendments thereto, shall be deemed to be valid unless in writing and signed by an authorized agent or representative of both parties hereto. No course of dealing or usage of trade shall be used to modify the terms and conditions herein. In the event of any inconsistency between the terms within the body of this Agreement and the terms contained in any Project Plan, including without limitation any Quality Management Agreement within any such Project Plan, the terms within the body of this Agreement shall govern. | ||
15.3 | Waiver: None of the provisions of this Agreement shall be considered waived by any party hereto unless such waiver is agreed to, in writing, by authorized agents of both parties. The failure of a party to insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law shall not be deemed a waiver of any rights of any party hereto. | ||
15.4 | Obligations to Third Parties: Each party warrants and represents that this Agreement is not inconsistent with any contractual obligations, expressed or implied, undertaken with any third party. | ||
15.5 | Assignment: This Agreement shall be binding upon and inure to the benefit of the successors or permitted assigns of each of the parties and may not be assigned or transferred by either party without the prior written consent of the other, which consent will not be unreasonably withheld or delayed, except that no consent shall be required in the case of a transaction involving the merger, consolidation or sale of all or substantially all of that portion of the assigning partys business assets to which this Agreement relates and the resulting entity assumes all the obligations under this Agreement. ALTHEA may, without such consent, assign this Agreement to an Affiliate of ALTHEA, provided that all Development, Production, and other services to be performed hereunder shall continue to be performed at the same facility at which they were previously performed or at which it was contemplated by the parties that they would be performed, and provided further that the assignee assumes all obligations of ALTHEA under this Agreement. No assignment shall relieve any party of responsibility for the performance of its obligations hereunder. | ||
15.6 | Successors and Assigns: This Agreement shall be binding upon and shall inure to the benefit of the parties hereto, their successors and permitted assigns. | ||
15.7 | Taxes: CLIENT shall pay all national, state, municipal or other sales, use, excise, import, property, value added, or other similar taxes, assessments or tariffs assessed upon or levied against the sale of Drug Product to CLIENT |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
pursuant to this Agreement or the sale or distribution of Drug Product by CLIENT (or at CLIENTs sole expense, defend against the imposition of such taxes and expenses). ALTHEA shall notify CLIENT of any such taxes that any governmental authority is seeking to collect from ALTHEA, and CLIENT may assume the defense thereof in ALTHEAs name, if necessary, and ALTHEA agrees to fully cooperate in such defense to the extent of the capacity of ALTHEA, at CLIENTs expense. Any such taxes, assessment, or tariffs to be paid by CLIENT hereunder shall be separately itemized on invoices provided to CLIENT. ALTHEA shall pay all national, state, municipal or other taxes on the income resulting from the sale by ALTHEA of the Drug Product to CLIENT under this Agreement, including but not limited to, gross income, adjusted gross income, supplemental net income, gross receipts, excess profit taxes, or other similar taxes. | |||
15.8 | Independent Contractor: ALTHEA shall act as an independent contractor for CLIENT in providing the services required hereunder and shall not be considered an agent of, or joint venturer with, CLIENT. Unless otherwise provided herein to the contrary, ALTHEA shall furnish all expertise, labor, supervision, machining and equipment necessary for performance hereunder and shall obtain and maintain all building and other Permits and licenses required by public authorities. | ||
15.9 | Governing Law: This Agreement is being delivered and executed in the State of California. In any action brought regarding the validity, construction and enforcement of this Agreement, it shall be governed in all respects by the laws of the State of California, without regard to the principals of conflicts of laws. | ||
15.10 | Attorneys Fees: The successful party in any litigation or other dispute resolution proceeding to enforce the terms and conditions of this Agreement shall be entitled to recover from the other party reasonable attorneys fees and related costs involved in connection with such litigation or dispute resolution proceeding. | ||
15.11 | Severability: In the event that any term or provision of this Agreement shall violate any applicable statute, ordinance, or rule of law in any jurisdiction in which it is used, or otherwise be unenforceable, such provision shall be ineffective to the extent of such violation without invalidating any other provision hereof. | ||
15.11 | Headings, Interpretation: The headings used in this Agreement are for convenience only and are not part of this Agreement. | ||
15.12 | Facsimile Copies, Counterparts: This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of which shall constitute the same instrument. This Agreement shall be effective upon full execution by facsimile or original, and a facsimile signature shall be deemed to be and shall be as effective as an original signature. |
| 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/ W. Alan Moore | |||||||
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||||||||||
Name:
|
Gregory A. Demopulos, M.D. | Name: | W. Alan Moore | |||||||
Title:
|
Chairman & CEO | Title: | Executive VP and CBO |
| 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. | 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 |
| 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 | |||||||||
[]
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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 |
Service Description | Units | Unit Price | Total Price | |||||||||
[]
|
[] | [] | [] | |||||||||
|
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FILL AND FINISH TOTAL
|
[] |
| 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 | |||||||||
[]
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[] | [] | [] | |||||||||
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||||||||||||
[]
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[] | [] | [] | |||||||||
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||||||||||||
[]
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[] | [] | [] | |||||||||
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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 | |||
[]
|
[] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSIONT |
Assay | Test | Specification | ||
[]
|
[] | [] |
| 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 |
OMEROS CORPORATION | ALTHEA TECHNOLOGIES, INC | |||||||||
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By:
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/s/ Gregory A. Demopulos
|
By: |
/s/ Rick Hancock
|
|||||||
|
||||||||||
Name:
|
Gregory A. Demopulos, M.D. | Name: | Rick Hancock | |||||||
|
||||||||||
Title:
|
Chairman & CEO | Title: | COO |
| 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. | 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 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
Non-GMP OMS302 Product Vials
|
1 x 400 | |
Non-GMP []Product Vials
|
1 x 400 | |
Non-GMP Placebo Vials
|
1 x 400 | |
cGMP OMS302 Product Vials
|
1 x 3,000 | |
cGMP [] Product Vials
|
1 x 3,000 | |
Audited Batch Records
|
2 | |
Audited Test Results
|
2 | |
Cs of A
|
5 | |
DMF Reference Letter
|
1 |
Miscellaneous
|
||
2 Site Visits for Inspection/Audit, 2 auditors at a time.
|
| 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 | |||||
Media Fill Validation | 3 x 3000 | [] | [] | |||||
|
||||||||
-
|
Media fill validation performed in accordance with ICH guidelines of 3 x 3000 2 mL glass vials. | |||||||
|
||||||||
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.
|
||||||
|
||||||
Stabiity 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 |
| 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 |
-2-
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] | |
[]
|
[] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-3-
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-4-
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-5-
COMGENEX, INC. | NURA. INC. | |||||||||
|
||||||||||
By:
|
/s/ Dr. Laszlo Urge
|
By: |
/s/ Patrick W. Gray
|
|||||||
|
||||||||||
Name:
|
Laszlo Urge
|
Name: |
Patrick W. Gray
|
|||||||
|
||||||||||
Title:
|
CEO, Director
|
Title: |
CEO
|
|||||||
|
||||||||||
Date:
|
07 Feb 2005
|
Date: |
27 Jan 2005
|
| 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 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
MASTER SERVICES AGREEMENT
|
1 | |||
|
||||
TABLE OF CONTENTS
|
9 | |||
|
||||
OBJECTIVE
|
11 | |||
|
||||
DEFINITIONS
|
11 | |||
BACKGROUND
|
11 | |||
|
||||
PROJECT SUMMARY
|
12 | |||
|
||||
MILESTONES
|
12 | |||
SUBPROJECT 1: LEAD CANDIDATE GENERATION
|
12 | |||
SUBPROJECT 2: PROVISION OF HUMAN PDE10A. CLONING AND EXPRESSION
|
12 | |||
SUBPROJECT 3: ASSAY DEVELOPMENT, HTS
|
12 | |||
SUBPROJECT 4: COMPOUND OPTIMIZATION
|
12 | |||
|
||||
TERMS
|
13 | |||
|
||||
INTELLECTUAL PROPERTY RIGHTS
|
13 | |||
|
||||
ANNEXES
|
14 | |||
|
||||
ANNEX 1: DETAILED PROJECT PLAN
|
14 | |||
[]
|
||||
|
||||
Subproject 1: Lead Candidate Generation
|
20 | |||
[]
|
||||
|
||||
Subproject 2: Provision of human PDE10a. Closing and expression
|
23 | |||
[]
|
||||
|
||||
Subproject 3: Assay development, HTS
|
25 | |||
[]
|
||||
|
||||
Subproject 4: Compound Optimization
|
26 | |||
[]
|
||||
|
||||
PAYMENTS
|
35 | |||
|
||||
DOWN PAYMENT
|
35 | |||
COST COVERAGE PAYMENTS
|
35 | |||
MILESTONE FEES
|
36 | |||
|
||||
Milestone1
|
36 | |||
|
||||
Milestone2
|
37 | |||
[]
|
38 | |||
|
||||
Milestone3
|
39 |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
| Patentable Lead Candidate |
| Focused library |
| Advanced Lead |
| Lead Criteria |
| Target |
| 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 |
-2-
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-3-
| cloning, subcloning | |
| target oriented choice of expression system | |
| protein expression in: E. coli, insect cells, mammalian cells | |
| protein purification development | |
| production scale-up |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-4-
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-5-
| 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 |
Amount due | Amount to be paid | |
January 27, 2005
|
[] |
Amount due | Amount billed | Amount to be paid | ||
Milestone 1
|
||||
February 15, 2005
|
[] | [] | ||
March 15, 2005
|
[] | [] | ||
April 15, 2005
|
[] | [] | ||
Subtotal
|
[] | |||
Milestone 2
|
||||
May 15, 2005
|
[] | [] | ||
June 15, 2005
|
[] | [] | ||
July 15, 2005
|
[] | [] | ||
August 15, 2005
|
[] | [] | ||
Subtotal
|
[] | |||
Milestone 3
|
||||
September 15, 2005
|
[] | [] | ||
October 15, 2005
|
[] | [] | ||
November 15, 2005
|
[] | [] | ||
December 15, 2005
|
[] | [] | ||
Subtotal
|
[] | |||
Total
|
[] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-2-
Subproject 1 | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
Subproject 2 | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-3-
Subproject 1 | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
Subproject 2 | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-4-
Optional | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
| [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-5-
Subproject 3 | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
Subproject 4 | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
| DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION |
-6-
Optional | If CGX delivers to Nura | Fee Due | ||
[]
|
[] | [] |
| 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-
Subsidiary
|
Jurisdiction of Incorporation | |
|
||
nura, inc.
|
Delaware |