0001285819-15-000007.txt : 20150810 0001285819-15-000007.hdr.sgml : 20150810 20150810161234 ACCESSION NUMBER: 0001285819-15-000007 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20150630 FILED AS OF DATE: 20150810 DATE AS OF CHANGE: 20150810 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OMEROS CORP CENTRAL INDEX KEY: 0001285819 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 911663741 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-34475 FILM NUMBER: 151040899 BUSINESS ADDRESS: STREET 1: 201 ELLIOTT AVENUE WEST CITY: SEATTLE STATE: WA ZIP: 98119 BUSINESS PHONE: 206-676-5000 MAIL ADDRESS: STREET 1: 201 ELLIOTT AVENUE WEST CITY: SEATTLE STATE: WA ZIP: 98119 10-Q 1 omer-20150630x10q.htm 10-Q JUNE 30, 2015 OMER-2015.06.30-10Q

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 ________________________________________
FORM 10-Q
 ________________________________________
(Mark One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2015
or
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                      to                     
Commission file number: 001-34475
 ________________________________________
OMEROS CORPORATION
(Exact name of registrant as specified in its charter)
 ________________________________________
Washington
 
91-1663741
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer
Identification Number)
 
 
 
201 Elliott Avenue West
Seattle, Washington
 
98119
(Address of principal executive offices)
 
(Zip Code)
(206) 676-5000
(Registrant’s telephone number, including area code)
 ________________________________________
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
 
¨
  
Accelerated filer
 
x
Non-accelerated filer
 
¨ (Do not check if a smaller reporting company)
  
Smaller reporting company
 
¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x
As of August 5, 2015, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was 37,885,698.




SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act, which are subject to the “safe harbor” created by those sections for such statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than statements of historical fact are “forward-looking statements.” Terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions and variations thereof are intended to identify forward-looking statements, but these terms are not the exclusive means of identifying such statements. Examples of these statements include, but are not limited to, statements regarding:
our plans for sales, marketing and distribution of Omidria® (phenylephrine and ketorolac injection) 1%/0.3% in the U.S. and for sales, marketing and distribution in the European Union and other international territories;
our ability to forecast accurately wholesaler demand as well as our estimates of charge-backs and rebates, distribution fees and estimated product returns;
our ability to enter into acceptable arrangements with potential corporate partners, including with respect to Omidria;
our expectations regarding the clinical, therapeutic and competitive benefits of Omidria and our product candidates;
our revenues and our estimate regarding how long our existing cash, cash equivalents and short-term investments will be sufficient to fund our anticipated operating expenses, capital expenditures and interest and principal payments on our outstanding notes;
our expectations regarding our exclusive license agreement related to OMS103 including, without limitation, the ability of our partner to manufacture and commercialize OMS103 and the commencement and subsequent continuation of product sales on which we will receive royalty revenue;
our ability to raise additional capital through the capital markets or through one or more corporate partnerships, equity offerings, debt financings, collaboration or licensing arrangements or asset sales;
our anticipation that we will rely on contract manufacturers to manufacture Omidria for commercial sale and develop and manufacture our product candidates;
our expectations about the commercial competition that Omidria and our product candidates may face;
our expectation that a patient assistance program and a commercial copay program will increase patient accessibility to Omidria;
the extent of protection that our patents provide and that our pending patent applications will provide, if patents issue from such applications, for our technologies, programs, products and product candidates;
our ability to design and successfully complete clinical trials and other studies for our products and product candidates, including our Phase 2 clinical trials for OMS721 and OMS824;
our ability to recommence active enrollment in our Phase 2 clinical trial of OMS824 in Huntington’s disease or initiate further clinical studies in either our OMS824 Huntington’s or schizophrenia programs;
our expected financial position, performance, growth, expenses, magnitude of net losses and availability of resources; and
our estimates regarding our future net losses, revenues, research and development expenses and selling, general and administrative expenses.
Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks, uncertainties and other factors described in Item IA of Part II of this Quarterly Report on Form 10-Q under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in our other filings with the Securities and Exchange Commission, or SEC. Given these risks, uncertainties and other factors, actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on our company, business or operations. Accordingly, you should not place undue reliance on these forward-looking statements, which represent our estimates and assumptions only as of the date of the filing of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual results in subsequent periods may materially differ from current expectations. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we assume no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.



OMEROS CORPORATION
FORM 10-Q FOR THE QUARTER ENDED June 30, 2015
INDEX
 
 
Page



PART I—FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
OMEROS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(unaudited)
 
 
June 30,
2015
 
December 31,
2014
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
2,561

 
$
354

Short-term investments
48,885

 
6,532

Receivables
3,071

 
392

Inventory
633

 
568

Prepaid expense
1,423

 
1,191

Other current assets
108

 
120

Total current assets
56,681

 
9,157

Property and equipment, net
789

 
782

Restricted cash
679

 
679

Other assets
488

 
472

Total assets
$
58,637

 
$
11,090

 
 
 
 
Liabilities and shareholders’ equity (deficit)
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
4,045

 
$
4,915

Accrued expenses
6,757

 
7,070

Current portion of notes payable, net of discount
9,294

 
6,446

Total current liabilities
20,096

 
18,431

Notes payable, net of current portion and discount
21,477

 
26,263

Deferred rent
9,132

 
9,050

Commitments and contingencies (Note 7)

 

Shareholders’ equity:
 
 
 
Preferred stock, par value $0.01 per share, 20,000,000 authorized; none issued and outstanding at June 30, 2015 and December 31, 2014

 

Common stock, par value $0.01 per share, 150,000,000 authorized; 37,875,933 and 34,185,464 issued and outstanding at June 30, 2015 and December 31, 2014, respectively
379

 
342

Additional paid-in capital
370,948

 
285,050

Accumulated deficit
(363,395
)
 
(328,046
)
Total shareholders’ equity (deficit)
7,932

 
(42,654
)
Total liabilities and shareholders’ equity
$
58,637

 
$
11,090

See notes to consolidated financial statements

-3-


OMEROS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(unaudited)
 
 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015
 
2014
 
2015
 
2014
Revenues
 
 
 
 
 
 
 
Product sales, net
$
3,125

 
$

 
$
3,363

 
$

Grant revenue
62

 
45

 
212

 
145

Total revenue
3,187

 
45

 
3,575

 
145

 
 
 
 
 
 
 
 
Costs and expenses:
 
 
 
 
 
 
 
Cost of product sales
365

 

 
376

 

Research and development
10,900

 
12,407

 
20,218

 
24,424

Selling, general and administrative
7,889

 
4,855

 
16,878

 
8,622

Total costs and expenses
19,154

 
17,262

 
37,472

 
33,046

Loss from operations
(15,967
)
 
(17,217
)
 
(33,897
)
 
(32,901
)
Interest expense
(937
)
 
(939
)
 
(1,894
)
 
(1,611
)
Investment income and other income (expense), net
224

 
165

 
442

 
(121
)
Net loss
$
(16,680
)
 
$
(17,991
)
 
$
(35,349
)
 
$
(34,633
)
Comprehensive loss
$
(16,680
)
 
$
(17,991
)
 
$
(35,349
)
 
$
(34,633
)
Basic and diluted net loss per share
$
(0.44
)
 
$
(0.53
)
 
$
(0.95
)
 
$
(1.07
)
Weighted-average shares used to compute basic and diluted net loss per share
37,846,832

 
33,933,356

 
37,165,196

 
32,415,198

See notes to consolidated financial statements

-4-


OMEROS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
 
 
Six Months Ended 
 June 30,
 
2015

2014
Operating activities:
 
 
 
Net loss
$
(35,349
)
 
$
(34,633
)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
Gain on sale of assets

 
(9
)
Depreciation and amortization
107

 
164

Stock-based compensation expense
4,898

 
3,417

Non-cash interest expense
442

 
331

Warrant modification expense

 
452

Changes in operating assets and liabilities:
 
 
 
Receivables
(2,679
)
 
127

Prepaid expenses and other current and noncurrent assets
(293
)
 
(1,064
)
Accounts payable, accrued expenses and other
(1,229
)
 
4,279

Deferred rent
82

 
525

Net cash used in operating activities
(34,021
)
 
(26,411
)
Investing activities:
 
 
 
Purchases of property and equipment, net
(114
)
 
(2
)
Purchases of investments
(79,403
)
 
(58,844
)
Proceeds from the sale and maturities of investments
37,050

 
35,634

Net cash used in investing activities
(42,467
)
 
(23,212
)
Financing activities:
 
 
 
Proceeds from issuance of common stock and pre-funded warrants, net of offering costs
79,076

 
37,754

Net proceeds from borrowings under notes payable

 
12,699

Payments on notes payable
(2,342
)
 
(1,464
)
Proceeds upon exercise of stock options and warrants
1,961

 
783

Net cash provided by financing activities
78,695

 
49,772

Net increase in cash and cash equivalents
2,207

 
149

Cash and cash equivalents at beginning of period
354

 
1,384

Cash and cash equivalents at end of period
$
2,561

 
$
1,533

Supplemental cash flow information
 
 
 
Cash paid for interest
$
1,471

 
$
1,188

Prepaid expenses not yet paid
$
68

 
$

See notes to consolidated financial statements

-5-


OMEROS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 1—Organization and Significant Accounting Policies
Organization
We are a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Our first drug product Omidria has been approved by the United States (U.S.) Food and Drug Administration (FDA) for use during cataract surgery or intraocular lens (IOL) replacement. We commenced a controlled launch of Omidria to a small number of ambulatory surgery centers (ASCs) in the U.S. in February 2015. In April 2015, we initiated the broad U.S. launch of Omidria and began selling Omidria through wholesalers.
Basis of Presentation
Our condensed consolidated financial statements include the financial position and results of operations of Omeros Corporation and our wholly owned subsidiaries. All inter-company transactions have been eliminated. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The information as of June 30, 2015 and for the three and six months ended June 30, 2015 and 2014 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2014 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP.
The accompanying unaudited condensed consolidated financial statements and notes to condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto that are included in our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the U.S. Securities and Exchange Commission (SEC) on March 16, 2015.
Revenue Recognition
Our revenues are comprised of product sales of Omidria and amounts earned for services under grants from the National Institutes of Health (NIH). Revenue is recognized when there is persuasive evidence that an arrangement exists, product title and risk of loss is passed to the customer or the service has been provided, the price is fixed or determinable and collection is reasonably assured. We record Omidria product revenue upon delivery to our wholesalers or upon shipment to the ASC or hospital for direct sales. Product sales to a wholesaler are not recorded if we determine that the wholesaler’s on-hand Omidria inventory, based on inventory information we regularly receive from our wholesalers, exceeds approximately eight weeks of projected demand. Product sales are recorded net of estimated charge-backs and rebates, distribution fees and estimated product returns utilizing a variety of information including our historical and projected payer mix, our historical experience as well as industry averages, sale-through and inventory on hand information received directly from wholesalers, changes in the overall marketplace, and the remaining shelf life of product we have previously sold. Accruals are established for these deductions when revenue is recognized, and actual amounts incurred are offset against the applicable accruals. We reflect each of these accruals as either a reduction in the related account receivable or as an accrued liability, depending on how the accrual is settled.
Product Sales, Net
Charge-backs and Rebates. During the second quarter of 2015, we entered into a Pharmaceutical Pricing Agreement with the Secretary of the U.S. Department of Health and Human Services, which enables entities that qualify for government pricing under the Public Health Services Act (PHSA) to receive discounts on their qualified purchases of Omidria. We have also entered into a Federal Supply Schedule (FSS) agreement under which certain U.S. government purchasers receive a discount on eligible purchases of Omidria. Under these agreements, our wholesalers forward a charge-back to us for the difference between wholesale acquisition cost (WAC) and the applicable discounted price. We identify the entities that purchase Omidria and which are eligible for FSS or PHSA pricing and, utilizing our historical charge-back information and projected payer mix, we record estimated charge-backs for these entities at the time of sale.
We have entered into a Medicaid Drug Rebate Agreement with the Centers for Medicare & Medicaid Services (CMS), which provides a rebate to participating states based on covered purchases of Omidria. We record estimated Medicaid rebates based on our payer mix and historical information for Omidria at the time of sale.

-6-


Distribution Fees and Product Returns. We pay our wholesalers a distribution fee for services they perform for us based on the dollar value of their purchases of Omidria. We record a provision against product sales for these charges at the time of sale to the wholesaler.
For all wholesalers, we allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our single-tier distribution model, our expectation that product is typically not held by the healthcare providers based on the frequency of their reorders, inventory in the wholesale channel, our return experience to date and historical industry return rates.
License Agreement Revenues
We have entered into an exclusive licensing agreement for OMS103 with Fagron Compounding Services, LLC, d/b/a Fagron Sterile Services and JCB Laboratories, LLC (collectively, Fagron). Under the terms of the license agreement, Fagron will manufacture and commercialize OMS103 in the U.S. and will pay Omeros royalties generated from sales of licensed products related to OMS103 plus milestone payments on reaching certain aggregate sales thresholds. Royalty revenues, of which there were none as of June 30, 2015, will be recognized as revenue when Fagron reports its relevant product sales to us. Aggregate revenue milestones will be recognized as revenue if and when the related sales threshold is achieved.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, fair market value of investments, stock-based compensation expense and accruals for clinical trials and contingencies. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; however, actual results could differ from these estimates.
Liquidity and Capital Resources
As of June 30, 2015, we had $51.4 million in cash, cash equivalents and short-term investments. We believe that our existing cash, cash equivalents and short-term investments and revenues, together with capital that we may have the opportunity to raise through public or private equity securities sales, through the issuance of additional debt, through corporate partnerships, through asset sales or through the pursuit of collaborations and licensing arrangements related to certain of our programs will be sufficient to fund our anticipated operating expenses, capital expenditures and interest and principal payments on our outstanding notes for at least the next 12 months. If we are unable to raise capital as and when needed, or upon acceptable terms, such failure would have a significant negative impact on our financial condition.
Inventory
Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner which approximates the first-in, first-out (FIFO) method. Costs include amounts related to third-party manufacturing, transportation, internal labor and overhead. Capitalization of costs as inventory begins when the product candidate receives regulatory approval in the U.S. or the European Union (EU), which for Omidria began upon U.S. regulatory approval in May 2014. We expense inventory costs related to product candidates as research and development expenses prior to receiving regulatory approval in the respective territory. Inventory is reduced to net realizable value by reserving for excess and obsolete inventories based on forecasted demand. As of June 30, 2015, all inventory is finished goods for Omidria.
Segments
We operate in one segment. Management uses cash flow as the primary measure to manage our business and does not segment our business for internal reporting or decision-making.
Recent Accounting Pronouncements
In July 2015, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2015-11 related to simplifying the measurement of inventory. This standard requires inventory to be measured at the lower of cost or net realizable value. This standard must be applied prospectively and is effective for all annual and interim periods beginning after December 15, 2016. Earlier application is permitted as of the beginning of an interim or annual reporting period. This standard will not have a material impact on the presentation of the Company’s financial position.
In April 2015, the FASB issued ASU No. 2015-03 related to simplifying the presentation of debt issuance costs. This standard requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction to the liability. This standard is effective for interim and annual periods beginning after December 15, 2015 and early

-7-


adoption is permitted. We are currently evaluating in which period we will transition and the presentation of the debt liability on our balance sheet following such transition, as well as how related disclosures will be impacted. The disclosures required are those applicable for a change in accounting principle.
In August 2014, the FASB issued ASU No. 2014-15 related to disclosure of an entity’s ability to continue as a going concern. This standard requires management to evaluate whether substantial doubt exists regarding the entity’s ability to continue as a going concern at each reporting period for a duration of one year after the date the financial statements are issued or available to be issued. The standard establishes certain required disclosures if substantial doubt exists. This standard must be applied prospectively and is effective for interim and annual periods beginning after December 15, 2016. We will review the impact of the standard upon our disclosures, if applicable, beginning in 2017.
In May 2014, the FASB issued ASU No. 2014-09 related to the recognition of revenue that supersedes existing guidance. This standard clarifies the principles for recognizing revenue utilizing a five-step process. This standard must be applied retroactively to each prior reporting period presented or retrospectively with the cumulative effect of applying the standard recognized in the period adopted. The standard is effective for interim and annual periods beginning after December 15, 2017 and cannot be adopted before that effective date. We are currently evaluating the impact that this standard may have on our financial statements once it is adopted.

Note 2—Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common share equivalents outstanding for the period, determined using the treasury-stock method.
The basic and diluted net loss per share amounts for the three and six months ended June 30, 2015 and 2014 were computed based on the shares of common stock outstanding during the respective periods. Potentially dilutive securities excluded from the diluted loss per share calculation are as follows:
 
June 30,
 
2015
 
2014
Outstanding options to purchase common stock
8,427,501

 
6,814,963

Warrants and pre-funded warrants to purchase common stock
1,149,249

 
609,016

Total
9,576,750

 
7,423,979


Note 3—Cash, Cash Equivalents and Investments
As of June 30, 2015 and December 31, 2014, all investments are classified as short-term and available-for-sale on the accompanying Condensed Consolidated Balance Sheets. We did not own any securities with unrealized loss positions as of June 30, 2015 or December 31, 2014. Investment income consists primarily of interest earned.

Note 4—Fair-Value Measurements
On a recurring basis, we measure certain financial assets at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The accounting standard establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required:
Level 1—Observable inputs for identical assets or liabilities, such as quoted prices in active markets;
Level 2—Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
Level 3—Unobservable inputs in which little or no market data exists, therefore they are developed using estimates and assumptions developed by us, which reflect those that a market participant would use.
Our fair value hierarchy for our financial assets and liabilities measured at fair value on a recurring basis are as follows:

-8-


 
June 30, 2015
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(In thousands)
Assets:
 
 
 
 
 
 
 
Money-market funds classified as non-current restricted cash
$
679

 
$

 
$

 
$
679

Money-market funds classified as short-term investments
48,885

 

 

 
48,885

Total
$
49,564

 
$

 
$

 
$
49,564

 
 
December 31, 2014
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(In thousands)
Assets:
 
 
 
 
 
 
 
Money-market funds classified as non-current restricted cash
$
679

 
$

 
$

 
$
679

Money-market funds classified as short-term investments
6,532

 

 

 
6,532

Total
$
7,211

 
$

 
$

 
$
7,211

Cash held in demand deposit accounts of $2.6 million and $354,000 is excluded from our fair-value hierarchy disclosure as of June 30, 2015 and December 31, 2014, respectively. There were no unrealized gains and losses associated with our short-term investments as of June 30, 2015 or December 31, 2014. The carrying amounts reported in the accompanying Condensed Consolidated Balance Sheets for receivables, accounts payable and other current monetary assets and liabilities approximate fair value because of the immediate or short-term maturity of these financial instruments.

Note 5—Accrued Liabilities
Accrued liabilities consisted of the following:
 
June 30,
2015
 
December 31,
2014
 
(In thousands)
Employee compensation
$
2,095

 
$
2,421

Contract research
1,636

 
1,280

Consulting and professional fees
1,600

 
1,952

Clinical trials
630

 
828

Other accruals
796

 
589

       Total accrued liabilities
$
6,757

 
$
7,070


Note 6—Notes Payable
In March 2014, we entered into a Loan and Security Agreement (the Oxford/MidCap Loan Agreement) with Oxford Finance LLC (Oxford) and MidCap Financial SBIC, LP (MidCap) pursuant to which we borrowed $32.0 million of which $29.7 million is outstanding as of June 30, 2015. We used approximately $19.1 million of the loan proceeds to repay all of the amounts owed by us under our then outstanding loan from Oxford and, after deducting loan initiation costs, we received $12.7 million in net proceeds. The Oxford/MidCap Loan Agreement provided for interest-only payments at an annual rate of 9.25% through March 1, 2015. Beginning April 1, 2015, monthly principal and interest payments of $1.0 million are due through the maturity date of March 1, 2018. In addition, the Oxford/MidCap Loan Agreement requires payment of a $2.2 million loan maturity fee upon full repayment of the loan. We may prepay the outstanding principal balance in its entirety at any time if we pay an additional fee equal to 1.0% of the then-outstanding principal balance, which would be waived if we refinance the indebtedness with Oxford and MidCap and pay the loan maturity fee. As security under the Oxford/MidCap Loan Agreement, we granted Oxford, as collateral agent for the lenders, a security interest in substantially all of our assets, excluding intellectual property.
The Oxford/MidCap Loan Agreement contains covenants that limit or restrict our ability to enter into certain transactions, and it also includes provisions related to events of default, the occurrence of a material adverse effect (MAE) and changes of control. The occurrence of an event of default could result in the acceleration of the Oxford/MidCap Loan Agreement and, under certain circumstances, could increase our interest rate by 5.0% per annum during the period of default.

-9-


As of June 30, 2015, the remaining unamortized discount and debt issuance costs associated with the debt were $1.3 million and $196,000, respectively, and are being amortized to interest expense using the effective interest method through the loan maturity date.

Note 7—Commitments and Contingencies
Real Estate Obligations
We lease office and laboratory spaces in The Omeros Building. The initial term of the lease ends in November 2027 and we have two options to extend the lease term, each by five years. As of June 30, 2015, the remaining aggregate non-cancelable rent payable under the initial term of the lease was approximately $56.5 million. The deferred rent balance relates to rent deferrals since the inception of our lease and is being amortized to research and development as well as selling, general and administrative expense on a straight-line basis through the initial term of the lease.
Contracts
We have an agreement with Ventiv Commercial Services, LLC (inVentiv) for field sales representatives and related sales operation services for Omidria in the U.S. We can terminate the agreement upon 30 days written notice if Omidria is withdrawn from the market for any reason or a regulatory agency acts to prevent or materially restrict the sale of Omidria, or upon 90 days written notice at any time subsequent to January 2016. As of June 30, 2015, our commitment under the agreement is approximately $630,000 per month through January 2016 and $315,000 per month thereafter through June 2016.
We have a non-exclusive agreement with Patheon Manufacturing Services LLC (Patheon) for commercial supply of Omidria through December 31, 2015. Pursuant to the terms of the contract, we are required to provide a monthly, non-binding production forecast covering the term of the contract. Upon submission of the monthly forecast, a portion of the forecast becomes a firm purchase commitment. In the event we do not purchase the quantities included in the firm purchase commitment, we would owe a cancellation fee. As of June 30, 2015, we had a firm purchase commitment requiring payment of approximately $230,000.
In October 2014, we entered into a non-exclusive agreement with Hospira S.p.A and Hospira Worldwide, Inc. (together, Hospira) for commercial supply of Omidria. We have no firm purchase commitments under this agreement until, in connection with the commencement of commercial manufacturing of Omidria by Hospira, we provide monthly rolling forecasts that will be used to calculate our firm purchase commitment. We have not commenced commercial manufacturing of Omidria by Hospira as of June 30, 2015 and, therefore, we do not currently have any firm purchase commitments outstanding under this agreement.
Development Milestones and Product Royalties
We have retained control of worldwide commercial rights to Omidria, to all of our product candidates and to our programs other than OMS103. We potentially owe certain development milestones and sales-based royalties on commercial sales of certain product candidates within our pipeline. These are low single-digit royalties based on net sales or net income as more fully described in our 2014 Annual Report on Form 10-K filed with the SEC on March 16, 2015.
Hatch-Waxman Filing
On July 27, 2015, we received notice from Par Pharmaceuticals, Inc. and its subsidiary, Par Sterile Products, LLC (Par) that Par has filed an Abbreviated New Drug Application containing a Paragraph IV certification under the Hatch-Waxman Act seeking approval from the FDA to market a generic version of Omidria prior to the expiration of three patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations published by the FDA, or Orange Book. We are currently reviewing the details of Par’s notice letter.

Note 8—Shareholders’ Equity
Common Stock
In February 2015, we sold 3.4 million shares of our common stock at a public offering price of $20.03 and sold pre-funded warrants to purchase up to 749,250 shares of our common stock at a public offering price of $20.02 per pre-funded warrant share. The public offering price for the pre-funded warrants was equal to the public offering price of our common stock, less the $0.01 per share exercise price of each pre-funded warrant. If not exercised, the pre-funded warrants will expire on February 3, 2022. After deducting underwriter discounts and offering expenses of $4.9 million, we received net proceeds from the offering of $79.1 million.

-10-


In March 2014, we sold 3.5 million shares of our common stock at a public offering price of $11.50 per share. After deducting offering expenses and underwriter discounts of $2.5 million, we received net proceeds from the transaction of $37.8 million.
Warrants
The following table summarizes our total outstanding warrants as of June 30, 2015, which have a weighted average exercise price of $10.45:
Outstanding At
June 30, 2015
 
Expiration Date
 
Exercise Price ($)
133,333
 
October 21, 2015
 
20.00
133,333
 
October 21, 2015
 
30.00
133,333
 
October 21, 2015
 
40.00
749,250
 
February 3, 2022
 
0.01
1,149,249
 
 
 
 
In each of March 2014 and September 2014, we extended the expiration dates of warrants to purchase approximately 197,000 shares of our common stock at an exercise price of $12.25 per share by six months that, collectively, extended the final expiration date of these warrants to March 29, 2015. We evaluated the fair value of the warrants before and after each modification and for the three months ended March 31, 2014, we recorded the $452,000 change in fair value as other expense in the accompanying Condensed Consolidated Statement of Operations and Comprehensive Loss. Prior to the March 29, 2015 expiration date, we received proceeds of $1.4 million during the six months ended June 30, 2015 upon the exercise of approximately 136,000 of these warrants.


Note 9—Stock-Based Compensation
On January 1, 2015, in accordance with provisions of our 2008 Equity Incentive Plan, the authorized shares available for grant were increased by 1,709,273 shares. As of June 30, 2015, a total of 10,200,180 shares were reserved for issuance under our stock plans, of which 1,772,679 were available for future grants.
The fair value of each option grant to employees and directors is estimated on the date of grant using the Black-Scholes option-pricing model. The following assumptions were applied to employee and director stock option grants during the periods ended:
 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015
 
2014
 
2015
 
2014
Estimated weighted-average fair value
$
12.63

 
$
8.20

 
$
12.97

 
$
8.20

Weighted-average assumptions
 
 
 
 
 
 
 
Expected volatility
69
%
 
80
%
 
70
%
 
80
%
Expected term, in years
5.9

 
5.9

 
5.9

 
5.9

Risk-free interest rate
1.71
%
 
1.88
%
 
1.61
%
 
1.88
%
Expected dividend yield
%
 
%
 
%
 
%
Stock-based compensation expense includes amortization of stock options granted to employees and non-employees and has been reported in our Condensed Consolidated Statements of Operations and Comprehensive Loss as follows:
 
 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015
 
2014
 
2015
 
2014
 
(In thousands)
 
(In thousands)
Research and development
$
1,229

 
$
901

 
$
2,554

 
$
1,911

Selling, general and administrative
1,151

 
729

 
2,344

 
1,506

Total
$
2,380

 
$
1,630

 
$
4,898

 
$
3,417


-11-


Stock option activity for all stock plans and related information is as follows:
 
 
Options
Outstanding
 
Weighted-
Average
Exercise
Price per
Share
 
Remaining
Contractual Life
(In years)
 
Aggregate
Intrinsic
Value
(In thousands)
Balance at December 31, 2014
8,364,469

 
$
7.52

 
 
 
 
Granted
218,325

 
20.74

 
 
 
 
Exercised
(112,398
)
 
4.66

 
 
 
 
Forfeited
(42,895
)
 
13.52

 
 
 
 
Balance at June 30, 2015
8,427,501

 
$
7.87

 
6.60
 
$
85,881

Vested and expected to vest at June 30, 2015
8,161,248

 
$
7.74

 
6.53
 
$
84,159

Exercisable at June 30, 2015
5,774,601

 
$
6.16

 
5.59
 
$
68,300

At June 30, 2015, there were 2,652,900 unvested options outstanding that will vest over a weighted-average period of 2.3 years. Excluding non-employee stock options, the total estimated compensation expense to be recognized in connection with these options is $16.4 million.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with the unaudited consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q.
Overview
We are a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Our marketed drug product Omidria is currently being sold in the U.S. for use during cataract surgery or intraocular lens, or IOL, replacement surgery. Omidria is derived from our proprietary PharmacoSurgery® platform, which is designed to improve clinical outcomes of patients undergoing ophthalmological, arthroscopic, urological and other surgical procedures. Our proprietary PharmacoSurgery platform is based on low-dose combinations of U.S. Food and Drug Administration-approved, or FDA-approved, therapeutic agents delivered directly to the surgical site throughout the duration of the procedure to inhibit preemptively inflammation and other problems caused by surgical trauma and to provide clinical benefits both during and after surgery. In June 2015 we entered into an exclusive licensing agreement for the production and commercialization in the U.S. of our arthroscopy product OMS103, which is also derived from our PharmacoSurgery platform. We also have five clinical-stage development programs in our pipeline, which includes a diverse group of preclinical programs as well as two additional platforms: one capable of unlocking new G protein-coupled receptor, or GPCR, drug targets and the other used to generate antibodies. For Omidria and each of our product candidates and our programs, other than OMS103, we have retained control of all commercial rights.
Products, Product Candidates and Development Programs
Products
Omidria is approved by the FDA for use during cataract surgery or IOL replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. We commenced a controlled launch of Omidria to a small number of ambulatory surgery centers, or ASCs, in the U.S. in February 2015. In April 2015 we initiated the broad U.S. launch of Omidria and began selling Omidria primarily through wholesalers which, in turn, sell to ASCs and hospitals. The Centers for Medicare and Medicaid Services, or CMS, has granted transitional pass-through reimbursement status for Omidria, which we expect to run through December 31, 2017. Pass-through status allows for separate payment under Medicare Part B for new drugs and other medical technologies that meet well-established criteria specified by federal regulations governing Medicare spending. Coverage for Omidria has been confirmed for one-hundred percent (100%) of Medicare Administrative Contractors across all U.S. states and Puerto Rico. In addition, we have confirmed coverage for Omidria with nearly all of the thirty largest commercial third-party payers in the U.S. To increase patient accessibility to Omidria, we are establishing both a patient assistance program to assist government-insured patients meeting certain financial criteria as well a commercial copay program whereby we will financially assist patients whose commercial coverage inadequately reimburses for Omidria. We have also entered into a Pharmaceutical Pricing Agreement with the Secretary of Health and Human Services, which enables certain entities that qualify for government pricing under the Public Health Services Act to receive discounts on their qualified purchases of Omidria, and a Federal Supply Schedule, or FSS, agreement, under which certain U.S. government purchasers receive a discount on eligible purchases of Omidria. On July 27, 2015, we received notice from Par Pharmaceuticals, Inc. and its subsidiary, Par Sterile Products, LLC, together Par, that Par has filed an Abbreviated New Drug Application, or ANDA, containing a Paragraph IV certification under the Hatch-Waxman Act seeking approval from the FDA to market a generic version of Omidria prior to the expiration of three patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations published by the FDA, or Orange Book. We are currently reviewing the details of Par’s notice letter.
In July 2015 we received approval from the European Commission, or EC, to market Omidria in all EU member states plus Iceland, Lichtenstein and Norway for use during cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and reduce postoperative eye pain. Decisions about price and reimbursement for Omidria are made on a country-by-country basis and will be required before marketing may occur in a particular country. In the EU and other international territories, we plan to enter into one or more partnerships for the marketing and distribution of Omidria.
On June 9, 2015, we entered into an exclusive licensing agreement, or the OMS103 Agreement, with Fagron Compounding Services, LLC, d/b/a Fagron Sterile Services, and JCB Laboratories, LLC, or collectively Fagron, a FDA-registered human drug outsourcing facility, under which Fagron will produce on a registered basis and commercialize OMS103 in the U.S. OMS103 has been developed for use during all arthroscopic procedures, including knee and shoulder arthroscopy,

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and completed Phase 3 trials in patients undergoing arthroscopic anterior cruciate ligament reconstruction and arthroscopic partial meniscectomy. Pursuant to the OMS103 Agreement, we granted Fagron an exclusive, royalty-free license to the OMS103 intellectual property, manufacturing information and clinical data to manufacture and commercialize OMS103 in the U.S. Under the terms of the OMS103 Agreement, we will receive payments representing a substantial majority of OMS103 product sales within the U.S. We are also eligible to receive up to an aggregate total of $10 million in potential payments upon the achievement of specific commercial milestones and as revenue-share enhancement on early sales. Any potential revenue under this agreement will be dependent on Fagron’s ability to commercialize OMS103 successfully, including its continuing to meet regulatory requirements pertaining to registered outsourcing production as may be promulgated by the FDA. Fagron is obligated to meet performance diligence requirements including the commencement of commercial sales of OMS103 in 2015, to bear all sales and marketing costs, and to meet annual sales volume minimums. We have discontinued our clinical development program with respect to OMS103 in the U.S. and will not incur any further costs related to OMS103 other than maintaining the licensed intellectual property, in connection with OMS103.
Product Candidates
We have a pipeline of development programs targeting immune-related disorders, pain, inflammation, coagulopathies and disorders of the central nervous system. We have the following five clinical-stage programs in our pipeline: (1) our lead MASP-2 antibody OMS721, which is in a Phase 2 clinical program in patients with complement-mediated thrombotic microangiopathies, or TMAs. OMS721 has received Orphan Drug designation for the prevention (inhibition) of complement-mediated TMAs and Fast Track designation for the treatment of patients with atypical hemolytic uremic syndrome, or aHUS, a form of TMA. Based on results seen in patients participating in the Phase 2 trial, investigator-requested extended access to OMS721 is now available for compassionate use to European patients with TMAs; (2) our Phase 2 program evaluating our lead phosphodiesterase 10, or PDE10, inhibitor OMS824 for the treatment of Huntington’s disease, in which clinical trials are currently suspended pending further discussion with the FDA regarding an observation from a nonclinical study in rats. OMS824 has received Orphan Drug designation for the treatment of Huntington’s disease and Fast Track designation for the treatment of cognitive impairment in patients with Huntington’s disease; (3) our Phase 2 program evaluating OMS824 for the treatment of schizophrenia, in which clinical trials are currently suspended pending such further discussion; (4) our PPARγ program in which two Phase 2 clinical trials have been conducted by our collaborators to evaluate a PPARγ agonist, alone or in combination with other agents, for treatment of addiction to opioids and to nicotine; and (5) our PharmacoSurgery product candidate OMS201 for use during urological procedures, including uroendoscopic procedures, which completed a Phase 1/Phase 2 clinical trial in 2010 and is not currently in active clinical trials.
Development Programs
Our preclinical programs include: (1) our PDE7 program in which we are developing proprietary compounds to treat addiction and compulsive disorders as well as movement disorders; (2) our Plasmin program in which we are advancing novel antifibrinolytic agents for the control of blood loss during surgery or resulting from trauma as well as for other hyperfibrinolytic states (e.g., liver disease); (3) our MASP-3 program in which we are developing MASP-3 inhibitors for the treatment of disorders related to the alternative pathway of the complement system; and (4) our orphan GPCR program in which we are identifying inhibitors of GPR17 linked to myelin formation, GPR101 linked to obesity, GPR151 linked to neuropathic pain and GPR161 linked to cancer. We also have two additional platforms: one used to generate antibodies and the other capable of unlocking new GPCR drug targets.
Financial Summary
We recognized net losses of $16.7 million and $18.0 million for the three months ended June 30, 2015 and 2014, respectively. As of June 30, 2015, our accumulated deficit was $363.4 million, total shareholders’ equity was $7.9 million and we had $51.4 million in cash, cash equivalents and short-term investments.


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Results of Operations
Revenue
Our revenue consists of net product sales of Omidria, which began with a controlled launch in February 2015 followed by a broader launch in April 2015, and revenue recognized in connection with grant funding from third parties.
 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015

2014
 
2015
 
2014
 
(In thousands)
 
(In thousands)
Product sales, net
$
3,125

 
$

 
$
3,363

 
$

Small Business Innovative Research Grants (SBIR)
62

 
45

 
212

 
145

 Total revenue
$
3,187

 
$
45

 
$
3,575

 
$
145

The increase in revenue during the three and six months ended June 30, 2015 compared to the same periods in 2014 was due to the initiation of U.S. sales of Omidria.
Product Sales, Net
We record Omidria product revenue upon delivery to our wholesalers or upon shipment for direct sales. Omidria product sales to an individual wholesaler are not recorded as revenue if we determine that particular wholesaler’s inventory of Omidria, based on inventory information we regularly receive from our wholesalers exceeds eight weeks of projected demand. As of June 30, 2015, overall Omidria inventory in the wholesaler channel was that of approximately one month.
We record Omidria product sales net of estimated charge-backs, rebates, distribution fees, and product returns. These deductions to gross product sales are generally referred to as gross-to-net deductions. A summary of our 2015 gross-to-net provision, net of payments, is as follows:
 
Charge-backs and Rebates
 
Distribution Fees and Product Return Allowances
 
Total
 
(In thousands)
Balance as of December 31, 2014
$

 
$

 
$

Provision related to current period sales
60

 
140

 
200

Payments/credits for current period sales

 
(60
)
 
(60
)
Balance as of June 30, 2015
$
60

 
$
80

 
$
140

During the second quarter of 2015, we entered into agreements with various entities that include certain mandatory government discounts or rebates on eligible purchases of Omidria. We identify the entities that purchase Omidria and which are eligible for discounted pricing or rebates and, utilizing our historical charge-back information and projected payer mix, we estimate charge-backs and rebates for these entities at the time of sale to the wholesaler. As of June 30, 2015, we had not entered into any other contracts that would lead to charge-backs or rebates. We expect future gross-to-net deductions to fluctuate based on the volume of purchases eligible for government-mandated discounts and rebates.
We pay our wholesalers a distribution fee for services that they perform for us based on the dollar value of their purchases of Omidria. We record a provision against product sales for these charges at the time of sale to the wholesaler. We expect this provision amount to fluctuate in correlation with gross product sales.
For all wholesalers, we allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our single-tier distribution model, our expectation that product is typically not held by the healthcare providers based on the frequency of their reorders, inventory in the wholesale channel, our experience to date and historical industry return rates.
License Agreement Revenues
In June 2015, we entered into the OMS103 Agreement with Fagron. Under the terms of this license agreement, Fagron will manufacture and commercialize OMS103 in the U.S. and will pay Omeros royalties generated from sales of OMS103 licensed products plus milestone payments on reaching certain aggregate sales thresholds. Royalty revenues, of which there were none as of June 30, 2015, will be recognized as revenue when Fagron reports its OMS103 product sales to us. Aggregate revenue milestones will be recognized as revenue if and when the related sales threshold is achieved.

-15-


Research and Development Expenses
Our research and development expenses can be divided into three categories: direct external expenses, which include clinical research and development and preclinical research and development activities; internal, overhead and other expenses; and stock-based compensation expense. Direct external expenses consist primarily of expenses incurred pursuant to agreements with third-party manufacturing organizations, contract research organizations, or CROs, clinical trial sites, collaborators, licensors and consultants and lab supplies. Costs are reported in preclinical research and development until the program enters the clinic. Internal, overhead and other expenses consist of personnel costs, overhead costs such as rent, utilities and depreciation and other miscellaneous costs. We do not generally allocate our internal resources, employees and infrastructure to any individual research project because we deploy them across multiple clinical and preclinical projects that we are advancing in parallel.
The following table illustrates our expenses associated with these activities:
 
 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015
 
2014
 
2015
 
2014
 
(In thousands)
 
(In thousands)
Direct external expenses:
 
 
 
 
 
Clinical research and development:
 
 
 
 
 
 
 
OMS721
$
3,152

 
$
2,582

 
$
4,394

 
$
4,615

Omidria
974

 
1,316

 
1,727

 
2,455

OMS824
518

 
3,141

 
1,051

 
6,760

Other clinical programs
10

 
19

 
18

 
42

Total clinical research and development
4,654

 
7,058

 
7,190

 
13,872

Preclinical research and development
327

 
677

 
829

 
991

Total direct external expenses
4,981

 
7,735

 
8,019

 
14,863

 
 
 
 
 
 
 
 
Internal, overhead and other expenses
4,690

 
3,771

 
9,645

 
7,650

Stock-based compensation expense
1,229

 
901

 
2,554

 
1,911

Total research and development expenses
$
10,900

 
$
12,407

 
$
20,218

 
$
24,424

The decrease in total research and development expenses during the three and six months ended June 30, 2015 compared to the same periods in 2014 was due primarily to reduced costs for our OMS824 program. During the first quarter of 2014, we manufactured material for the OMS824 Phase 1 and Phase 2 clinical trials. We also incurred Phase 1 and Phase 2 clinical trial costs in 2014 until the suspension of clinical enrollment in August 2014. Our OMS824 program continues to incur costs primarily due to toxicology studies and consulting. Additional decreases included lower clinical trial costs for Omidria.
These decreases were partially offset by increases in internal, overhead and other expenses due to increased headcount, and stock-based compensation expense due to annual company-wide option grants approved in October 2014. Additionally, for the three months ended June 30, 2015 compared to the same period in 2014, costs for OMS721 increased in connection with manufacturing and clinical research and development. We anticipate research and development costs will increase during the remainder of this year due to planned clinical manufacturing and clinical study activities.
At this time, we are unable to estimate with any certainty the costs we will incur in the continued development of our product candidates due to the inherently unpredictable nature of our preclinical and clinical development activities and given the early stage of many of our preclinical development programs. Clinical development timelines, the probability of success and development costs can differ materially as expectations change. While we are focused currently on advancing our product development programs, our future research and development expenses will depend, in part, on the preclinical or clinical success of each product candidate as well as ongoing assessments of each program’s commercial potential. Our future research and development expenses might also depend on the commercial success of Omidria as well as royalty payments from Fagron with respect to OMS103 sales. In addition, we cannot forecast with any degree of certainty which product candidates, if any, may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
We are required to expend substantial resources in the development of our product candidates due to the lengthy process of completing clinical trials and seeking regulatory approval. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could delay our generation of product revenue and increase our research and development expenses and,

-16-


in turn, have a material adverse effect on our operations, financial condition and liquidity. Because of the factors above, we are not able to estimate with any certainty when or if we would recognize any net cash inflows from our research and development projects.
Selling, General and Administrative Expenses
 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015
 
2014
 
2015
 
2014
 
(In thousands)
 
(In thousands)
Selling, general and administrative expenses, excluding stock-based compensation expense
$
6,738

 
$
4,126

 
$
14,534

 
$
7,116

Stock-based compensation expense
1,151


729

 
2,344


1,506

Total selling, general and administrative expenses
$
7,889

 
$
4,855

 
$
16,878

 
$
8,622

The increase in selling, general and administrative expenses during the three and six months ended June 30, 2015 compared to the same periods in 2014 was primarily due to sales and marketing costs incurred in connection with the sales force, tradeshows and events and legal costs to support the market launch of Omidria. The increase in stock-based compensation expense was primarily due to annual company-wide option grants approved in October 2014, increasing expense during the three and six months ended June 30, 2015 compared to the same periods in the prior year.
Interest Expense
 
 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015
 
2014
 
2015
 
2014
 
(In thousands)
 
(In thousands)
Interest expense
$
937

 
$
939

 
$
1,894

 
$
1,611

The increase in interest expense during the six months ended June 30, 2015 was due to incremental borrowing under the Loan and Security Agreement, or the Oxford/MidCap Loan Agreement, with Oxford Finance LLC, or Oxford, and MidCap Financial SBIC, LP, or MidCap, in March 2014. We increased the aggregate amount of our outstanding indebtedness by approximately $12.7 million as a result of entering into this agreement. There was no substantial change in interest expense during the three months ended June 30, 2015 compared to the same quarter in the prior year due to the timing of our entry into the Oxford/Midcap Loan Agreement in March 2014 and the interest-only payments until April 1, 2015.
Investment Income and Other Income (Expense), Net

 
Three Months Ended  
 June 30,
 
Six Months Ended 
 June 30,
 
2015
 
2014
 
2015
 
2014
 
(In thousands)
 
(In thousands)
Investment income and other income (expense), net
$
224


$
165


$
442


$
(121
)
Investment income and other income (expense), net includes investment, interest and sublease rental income, and for the six month period ended June 30, 2014 also included non-cash charges associated with warrant modifications. The balance in investment income and other income (expense), net for the three months ended June 30, 2015 compared to the same quarter in the prior year, was primarily sublease rental income.
The balance in investment income and other income (expense), net for the six months ended June 30, 2015 compared to the same period in the prior year, was primarily sublease rental income and a $452,000 expense charge incurred in March 2014 as a result of our extending the exercise period of warrants to purchase 197,000 shares of our common stock by six months.

Financial Condition - Liquidity and Capital Resources
As of June 30, 2015, we had $51.4 million in cash, cash equivalents and short-term investments that are held principally in interest-bearing instruments, including money-market accounts. Cash in excess of our immediate requirements is invested in accordance with established guidelines intended to preserve principal and maintain liquidity.
We believe that our existing cash, cash equivalents and short-term investments and revenues, together with capital that we may have the opportunity to raise through public or private equity securities sales, through the issuance of additional debt, through corporate partnerships, through asset sales or through the pursuit of collaborations and licensing arrangements related to certain of our programs, will be sufficient to fund our anticipated operating expenses, capital expenditures and interest and principal payments on our outstanding notes for at least the next 12 months. If we are unable to raise capital as and when needed, or upon acceptable terms, such failure would have a significant negative impact on our financial condition. Should it be necessary to manage our operating expenses, we would reduce our projected capital requirements through reduction of our expenses by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities.

 
Six Months Ended 
 June 30,
 
2015
 
2014
 
(In thousands)
Selected cash flow data
 
 
 
Cash provided by (used in):
 
 
 
Operating activities
$
(34,021
)
 
$
(26,411
)
Investing activities
(42,467
)
 
(23,212
)
Financing activities
78,695

 
49,772

Operating Activities. Net cash used in operating activities increased by $7.6 million for the six months ended June 30, 2015 compared to the same period in 2014. This increase was primarily due to the $8.0 million net change in cash used in operating assets and liabilities, primarily due to decreased accounts payable and accrued expenses, offset by an increase in our non-cash charges of $1.1 million primarily due to an increase in stock compensation expense. In addition, our net loss increased by $716,000, contributing to the increase in net cash used.
Investing Activities. Cash flows from investing activities primarily reflect cash used to purchase short-term investments and proceeds from the sale of short-term investments, thus causing a shift between our cash and cash equivalents and short-term investment balances. Because we manage our cash usage with respect to our total cash, cash equivalents and short-term investments, we do not consider these fluctuations in cash flows to be important to the understanding of our liquidity and capital resources.
Net cash used in investing activities in the six months ended June 30, 2015 was $42.5 million, an increase of $19.3 million from 2014, primarily due to the purchase of short-term investments with the $79.1 million of net proceeds received from the sale of common stock and pre-funded warrants in our public offering in February 2015. These purchases were partially offset by the sale of $37.1 million of short-term investments to provide cash for operating activities.
Financing Activities. Net cash provided by financing activities in the six months ended June 30, 2015 was $78.7 million, an increase of $28.9 million over the same period in 2014 primarily due to the $79.1 million of net proceeds received from the sale of 3.4 million shares of common stock and pre-funded warrants to purchase 749,250 shares of common stock in our public offering in February 2015. During the 2014 period, cash was primarily provided by the $37.8 million of net proceeds from the sale of 3.5 million shares of common stock in our public offering and the net additional borrowings of $12.7 million under the Oxford/MidCap Loan Agreement.


-17-


Contractual Obligations and Commitments
The following table presents a summary of our contractual obligations and commitments as of June 30, 2015:
 
Payments Due Within 
 
1 Year
 
 
2-3 Years
 
 
4-5 Years
 
 
More than
5 Years
 
 
Total
 
 
(In thousands)
Operating leases
$
4,055

 
$
8,360

 
$
8,701

 
$
35,497

 
$
56,613

Capital leases (principal and interest)
54

 
104

 
25

 

 
183

Notes payable (principal and interest)
12,256

 
21,448

 

 

 
33,704

Goods & services
6,333

 

 

 

 
6,333

Total
$
22,698

 
$
29,912

 
$
8,726

 
$
35,497

 
$
96,833

Operating Leases
We lease our office and laboratory space in The Omeros Building under a lease agreement with BMR-201 Elliott Avenue LLC. The initial term of the lease ends in November 2027 and we have two options to extend the lease term, each by five years. As of June 30, 2015, the remaining aggregate non-cancelable rent payable under the initial term of the lease was approximately $56.5 million.
Notes Payable
We have borrowed $32.0 million under the Oxford/MidCap Loan Agreement that requires interest-only payments at an annual rate of 9.25% through March 2015. Beginning April 1, 2015, monthly principal and interest payments of $1.0 million became due through the maturity date of March 1, 2018. In addition, the Oxford/MidCap Loan Agreement requires a $2.2 million loan maturity fee upon full repayment of the loan.
Goods & Services
In June 2014, we entered into an agreement with Ventiv Commercial Services, LLC, or inVentiv, for field sales representatives and related sales operation services for the U.S. commercial launch of Omidria. In October 2014, we amended the agreement to add additional sales representatives in the U.S. As of June 30, 2015, we had a monthly commitment of approximately $630,000 under the agreement and related amendment through January 2016 and $315,000 per month thereafter through June 2016. We can terminate the agreement upon 30 days written notice if Omidria is withdrawn from the market for any reason or a regulatory agency acts to prevent or materially restrict the sale of Omidria, or upon 90 days written notice at any time subsequent to January 2016 for the original group of sales representatives and subsequent to June 2016 for the remaining sales representatives. The $6.3 million of estimated costs for this agreement through June 2016 are included in the table above.
We have a non-exclusive agreement with Patheon Manufacturing Services LLC, or Patheon, for commercial supply of Omidria through December 31, 2015. We are required to provide a monthly, non-binding production forecast covering the term of the contract. Upon submission of the monthly forecast, a portion of the forecast becomes a firm purchase commitment. In the event we do not purchase the quantities included in the firm purchase commitment, we would owe a cancellation fee. The firm purchase commitment of approximately $230,000 as of June 30, 2015 is included in the table above.
We may also be required, in connection with in-licensing or asset acquisition agreements, to make certain royalty and milestone payments and we cannot, at this time, determine when or if the related milestones will be achieved or whether the events triggering the commencement of payment obligations will occur. Therefore, such payments are not included in the table above. See Note 8 to our Consolidated Financial Statements in our 2014 Annual Report on Form 10-K filed with the SEC on March 16, 2015 for a description of the agreements that include these royalty and milestone payment obligations.

Critical Accounting Policies and Significant Judgments and Estimates
The preparation of our condensed consolidated financial statements in conformity with generally accepted accounting principles, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; however, actual results could differ from those estimates. An accounting policy is considered critical if it is important to a company’s financial condition and results of operations and if it requires the exercise of significant judgment and the use of estimates on the part of management in its application. Although we believe that our judgments and estimates are appropriate, actual results may differ materially from our estimates.

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Revenue Recognition
Our revenues are comprised of product sales of Omidria and amounts earned for services under grants from the National Institutes of Health, or NIH. Revenue is recognized when there is persuasive evidence that an arrangement exists, product title and risk of loss is passed to the customer or the service has been provided, the price is fixed or determinable and collection is reasonably assured. We record Omidria product revenue upon delivery to our wholesalers or upon shipment to the ASC or hospital for direct sales. Product sales to a wholesaler are not recorded if we determine that the wholesaler’s on-hand Omidria inventory, based on inventory information we regularly receive from our wholesalers, exceeds approximately eight weeks of projected demand. As of June 30, 2015, overall Omidria inventory in the wholesaler channel was that of approximately one month. Product sales are recorded net of estimated charge-backs and rebates, distribution fees and estimated product returns utilizing a variety of information including our historical and projected payer mix, our historical experience as well as industry averages, sale-through and inventory on-hand information received directly from wholesalers, changes in the overall marketplace, and the remaining shelf life of product that we have previously sold. Accruals are established for these deductions when revenue is recognized and actual amounts incurred are offset against the applicable accruals. We reflect each of these accruals as either a reduction in the related account receivable or as an accrued liability, depending on how the accrual is settled.
Product Sales, Net
Charge-backs and Rebates. We have entered into agreements with various entities that include certain contractual discounts or rebates on eligible purchases of Omidria. Under certain agreements, our wholesalers forward a charge-back to us for the difference between wholesale acquisition cost, or WAC, and the applicable discounted price. We identify the entities that purchase Omidria and which are eligible for discounted pricing or rebates and, utilizing our historical charge-back information and projected payer mix, we estimate charge-backs and rebates for these entities.
We have entered into a Medicaid Drug Rebate Agreement with CMS that provides a rebate to participating states based on covered purchases of Omidria. We estimate Medicaid rebates based on our payer mix and historical information for Omidria.
Distribution Fees and Product Return Allowances. We pay our wholesalers a distribution fee for services that they perform for us based on the dollar value of their purchases of Omidria. We record a provision against product sales for these charges at the time of sale to the wholesaler.
For all wholesalers, we allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our single-tier distribution model and our belief that product is typically not held by the healthcare providers based on the frequency of their reorders. We also consider inventory in the wholesale channel, our return experience to date and historical industry return rates.
For a more detailed listing of our other critical accounting policies and significant judgments and estimates, refer to our 2014 Annual Report on Form 10-K filed with the SEC on March 16, 2015.

Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet arrangements.


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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk is primarily confined to our investment securities and notes payable. The primary objective of our investment activities is to preserve our capital to fund operations. We also seek to maximize income from our investments without assuming significant risk. To achieve our objectives, we maintain a portfolio of investments in high-credit-quality securities. As of June 30, 2015, we had cash, cash equivalents and short-term investments of $51.4 million. In accordance with our investment policy, we invest funds in highly liquid, investment-grade securities. These securities in our investment portfolio are not leveraged and are classified as available-for-sale. We currently do not hedge interest rate exposure. Because of the short-term maturities of our investments, we do not believe that an increase in market rates would have a material negative impact on the realized value of our investment portfolio. We actively monitor changes in interest rates and, with our current portfolio of short term investments, we are not exposed to potential loss due to changes in interest rates.

ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of June 30, 2015. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2015, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
During the second quarter of 2015, we entered into various agreements that include government discounts or rebates on eligible purchases of Omidria. We have implemented internal systems and controls associated with monitoring inventory in the supply channel and processing and accounting for the charge-backs and rebates associated with these agreements. Other than these changes, there were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) under the Exchange Act that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


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PART II—OTHER INFORMATION

ITEM 1A. RISK FACTORS
The risks and uncertainties described below may have a material adverse effect on our business, prospects, financial condition or operating results. In addition, we may be adversely affected by risks that we currently deem immaterial or by other risks that are not currently known to us. You should carefully consider these risks before making an investment decision. The trading price of our common stock could decline due to any of these risks and you may lose all or part of your investment. In assessing the risks described below, you should also refer to the other information contained in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2014.
Risks Related to Our Products, Programs and Operations
If we are unable to successfully commercialize Omidria, or any of our product candidates, if approved, our inability to generate significant revenue from the sales of Omidria or any other approved products would adversely impact our ability to achieve profitability.
Omidria is our only product that has been approved by the FDA for commercial sale in the U.S. and broad-based product sales began in April 2015. We may not be able to successfully commercialize Omidria or any product candidate, if approved, for a number of reasons, including:
a lack of acceptance by physicians, patients, third-party payers and other members of the medical community;
our limited experience in marketing, selling and distributing Omidria or any other product;
our limited experience managing third-party commercial manufacturing of Omidria or any other product;
our reliance on a limited number of manufacturers and our reliance on a limited number of suppliers of the product’s active pharmaceutical ingredients, excipients and packaging materials;
pricing, reimbursement and coverage policies of government and private payers such as Medicare, Medicaid, the Department of Veterans Affairs, or VA, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;
the availability, relative price and efficacy of the product as compared to alternative treatment options or competing products;
an unknown safety risk of Omidria or any product candidate;
the failure to obtain regulatory approval;
the failure to enter into and maintain acceptable partnering arrangements for marketing and distribution of products, including for Omidria, outside of the U.S.;
changed or increased regulatory restrictions in the U.S., EU and other foreign territories; and
a lack of adequate financial or other resources to commercialize the product successfully.
If we are not able to successfully commercialize Omidria or any other product candidate if approved, for these or other reasons, our ability to generate revenue from product sales and achieve profitability will be adversely affected and the market price of our common stock could decline significantly.
Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline.
Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year. We believe that our quarterly and annual results of operations may be affected by a variety of factors, including:
the level of demand for Omidria;
the extent to which coverage and reimbursement for Omidria is available from government and private third-party payers such as Medicare, Medicaid, the VA, insurance companies, group purchasing organizations, health maintenance organizations and other plan administrators;
the continued availability of adequate reimbursement for Omidria once transitional pass-through reimbursement expires;
the timing, cost and level of investment in our sales and marketing efforts to support Omidria sales;
the ability of Fagron to manufacture and commercialize OMS103 successfully and the level of royalties, if any, paid to Omeros by Fagron;

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the timing, cost and level of investment in our research and development activities involving Omidria and our product candidates; and
the timing and cost of conducting required post-approval studies for Omidria and expenditures we will or may incur to acquire or develop additional technologies, products and product candidates.
In addition, the number of procedures in which Omidria or OMS103 would be used, or the size of the market in which any other of our products would be used, if commercialized, may be significantly less than the total number of such procedures performed or total possible market size. Our revenues may also depend on commercial arrangements, development funding and the achievement of development and clinical milestones under collaboration and license agreements that we may enter into from time to time in the future, including without limitation our exclusive license agreement for the U.S. commercialization of OMS103. Upfront and milestone payments, as well as payments based on product sales, under these arrangements may vary significantly from quarter to quarter and any such variance could cause a significant fluctuation in our operating results from one quarter to the next.
These and other factors, including our limited history of product sales, may make it difficult for us to forecast and provide in a timely manner public guidance (including updates to prior guidance) related to our projected financial performance. It is possible that in future quarters our operating results could fall below the expectations of securities analysts or investors. If this occurs, the trading price of our common stock could decline.
If we are unable to market and successfully sell and/or distribute Omidria or our product candidates if approved, our ability to generate revenue may be limited.
Prior to the U.S. launch of Omidria, Omeros had never marketed, sold or distributed any product. If we are unsuccessful in building or managing a sales and marketing infrastructure internally or through one or more third-party partners for any approved product candidates, or if any of those third-party partners fail to perform as necessary, we will have difficulty commercializing the product, which would adversely affect our business and financial condition.
In the EU, we plan to enter into partnerships for the marketing and distribution of Omidria with one or more third parties. Outside of the U.S. and EU, we are exploring potential regional partnerships to make Omidria available to ophthalmologists. We have not yet entered into any agreements with third parties to market Omidria outside of the U.S. Even if we could obtain approvals from additional relevant government authorities in one or more non-U.S. territories, we would not expect to see sales of Omidria in those territories if we are unable to enter into such agreements on terms acceptable to us, if at all, which could adversely affect our business and financial condition.
If we do not have adequate reimbursement from governments or other third-party payers for Omidria or any other product that we may develop and commercialize, or if we do not establish and maintain market-acceptable pricing for Omidria or those commercialized products, they may not be purchased or used and, as a result, our prospects for revenue and profitability could suffer.
Our future revenues and profitability will depend heavily on the pricing and availability of adequate reimbursement for the use of our commercialized products, including Omidria and, once commercialized, OMS103, from governmental and other third-party payers, both in the U.S. and in other countries. Even if we are successful in bringing one or more products to market, these products may not be considered cost-effective, and the amount reimbursed for any product may be insufficient to allow us to sell the product profitably. Reimbursement by a third-party payer may depend on a number of factors, including the third-party payer’s determination that use of a product is:
a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
Obtaining reimbursement approval for any product from each government or third-party payer can be a time-consuming and costly process that will require the build-out of a sufficient staff or the engagement of third parties and could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our approved products to each payer. We can provide no assurances at this time regarding the cost-effectiveness of Omidria, OMS103 or any of our product candidates. Further, we can provide no assurance that the amounts, if any, reimbursed to surgical facilities for utilization of any of our surgery-related products, including Omidria, any of our product candidates or OMS103 or to surgeons for the administration and delivery of these products or product candidates will be considered adequate to justify the use of these products or product candidates. Even if one payer adopts a favorable reimbursement methodology for a product or product candidate, if

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commercialized, there is no guarantee that other third-party payers will adopt the same methodology. For example, other third-party payers often follow, but are not required to follow, the reimbursement methodology adopted by CMS.
There may be significant delays in obtaining reimbursement for newly approved products, and we may not be able to provide data sufficient be granted reimbursement. Even when a payer determines that a product is eligible for reimbursement, coverage may be limited to the uses of a product that are either approved by the FDA (or, in other countries, the relevant country’s regulatory agency) and/or appear in a recognized drug compendium, and other conditions may apply. Moreover, eligibility for coverage does not mean that any product will be reimbursed at a rate that allows us to make a profit in all cases or at a rate that covers our costs, including research, development, manufacturing, sales and distribution. Increasingly, third-party payers that reimburse for healthcare services and products, such as government and private payers, are requiring that companies provide them with predetermined discounts from list prices and challenging the prices charged for medical products. Even if we receive reimbursement for a product, the initial rate or method at which the product will be reimbursed could become unfavorable to us at the time reimbursement is initiated or in the future. In addition, pass-through reimbursement status is granted for a limited duration and we expect that pass-through reimbursement status for Omidria will last until December 31, 2017. After pass-through reimbursement status expires, we may not be able to maintain or obtain separate or adequate reimbursement for Omidria.
In non-U.S. jurisdictions, we must obtain separate reimbursement approvals and comply with related foreign legal and regulatory requirements. In some countries, including those in the EU, our products may be subject to government price controls. Pricing negotiations with governmental authorities can take a considerable amount of time and expenditure of resources after the receipt of marketing approval for a product. We provide no assurances that the price of any product in one or more of these countries or regions will allow us to make a profit or cover our costs, including research, development, manufacturing, sales and distribution, and as a result we may decide to delay, potentially indefinitely, initiating sales in the particular country or region.
If the reimbursement that we are able to obtain and maintain for any product that we develop, including Omidria, is inadequate in light of our development and other costs, is significantly delayed or subject to overly restrictive conditions, or is denied by third-party payers, there could be a material adverse effect on our business, financial condition, results of operations and growth prospects.
The commercialization of Omidria and our product candidates, if approved, is subject to extensive regulation and oversight under a number of different healthcare compliance laws. Compliance with these regulations requires the expenditure of substantial resources and attention, and the failure to comply with these regulations could result in criminal penalties, substantial fines or other civil penalties.
In the U.S., the commercialization of Omidria and our product candidates, if approved, is subject to regulation and enforcement under a number of federal and state healthcare compliance laws, including the U.S. Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations; the federal Anti-Kickback Law; the federal False Claims Act; and the so-called Sunshine Act and related provisions of the Affordable Care Act. In addition to these federal law requirements, there are related state law requirements, including some laws that restrict our interactions with physicians and other providers. Also, if we receive protected patient health information, we may be subject to federal or state privacy laws. We are subject to a variety of governmental pricing, price reporting, and rebate requirements. These requirements generally require us to pay rebates or provide discounts to government payers in connection with our products. The terms, scope and complexity of these government pricing requirements change frequently. Similar requirements apply to our operations outside the U.S. In addition, many countries have their own laws similar to the healthcare compliance laws that exist in the U.S.
In order to comply with these U.S. and other laws, we must establish and maintain an effective healthcare compliance program. In addition, some states mandate that we have an established compliance program. Implementing an effective compliance program requires the expenditure of significant time and resources. If we are found to be in violation of any of these laws, there could be considerable civil or criminal penalties. In addition, if government enforcement authorities initiate an investigation into potential violations of these laws, we would be required to expend considerable resources and face adverse publicity and the potential disruption of our business, even if we are ultimately found not to have committed a violation.
We are subject to extensive government regulation, including the regulations associated with approval for marketing of our product candidates.
Both before and after approval of any product, we and our suppliers, contract manufacturers and clinical investigators are subject to extensive regulation by governmental authorities in the U.S. and other countries, covering, among other things, testing, manufacturing, quality control, clinical trials, labeling, advertising, promotion, distribution, and import and export. Failure to comply with applicable requirements could result in, among other things, one or more of the following actions: warning letters; unanticipated expenditures; delays in approval or refusal to approve a product candidate; product recall or

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seizure; interruption of manufacturing or clinical trials; operating or marketing restrictions; injunctions; criminal prosecution and civil or criminal penalties including fines and other monetary penalties. We, the FDA or an independent Institutional Review Board or Ethics Committee may suspend or terminate human clinical trials at any time on various grounds, including a finding that the patients are or would be exposed to an unacceptable health risk or because of the way in which the investigators on which we rely carry out the trials.
Obtaining FDA approval of our product candidates requires substantial time, effort, and financial resources, and may be subject to both expected and unforeseen delays, and there can be no assurance that any approval will be granted on any of our product candidates on a timely basis, if at all.
The FDA may decide that our data are insufficient for approval of our product candidates and require additional preclinical, clinical or other studies or additional work related to chemistry, manufacturing and controls. For example, we suspended clinical trials of OMS824 based on a nonclinical finding, and the FDA has required that we review and further evaluate our nonclinical data before the FDA may permit us to resume or initiate further clinical trials in our OMS824 Huntington’s and schizophrenia clinical programs. If, based on our review and evaluation of these data, the FDA concludes that there is an unwarranted safety risk to patients, the FDA may require us to run additional nonclinical studies before permitting us to resume or initiate additional clinical trials, may impose limits on such trials or may not permit us to resume or initiate clinical trials at all. As we develop our product candidates, we periodically discuss with the FDA clinical, regulatory and manufacturing matters, and our views may, at times, differ from those of the FDA. If we are unable to resolve questions raised by the FDA, we may be required to provide additional information, which may necessitate additional preclinical studies or clinical trials. If we are required to conduct additional clinical trials or other testing of our product candidates beyond that which we currently contemplate for regulatory approval, if we are unable to complete successfully our clinical trials or other testing, or if the results of these and other trials or tests fail to demonstrate efficacy or raise safety concerns, we may face substantial additional expenses, be delayed in obtaining marketing approval for our product candidates or may never obtain marketing approval.
Even if regulatory approval of a product candidate is obtained such approval may be subject to significant limitations on the indicated uses for which that product may be marketed, conditions of use, and/or significant post approval obligations, including additional post-marketing studies and clinical trials. These regulatory requirements may, among other things, limit the size of the market for the approved product. Even after approval, discovery of previously unknown problems with an approved product, manufacturer, or facility, such as previously undiscovered side effects or adverse effects or a manufacturer’s failure to follow current Good Manufacturing Practices, or cGMPs, may result in restrictions on any product, manufacturer, or facility, including, among other things, a possible withdrawal of approval of the approved product. The realization of any of these risks could harm our business and operating results.
If we are unable to raise additional capital when needed, we may be unable to continue commercialization of Omidria, to complete the development and commercialization of our product candidates or to continue our other preclinical development programs.
Our operations have consumed substantial amounts of cash since our incorporation and, as of June 30, 2015, we had an accumulated deficit of approximately $363.4 million. We expect to continue to incur additional losses until such time as we generate significant revenue from the sale of Omidria, other commercial products and/or significant partnering revenues, and we cannot be certain that we will achieve profitability for some time, if at all. We expect to continue to spend substantial amounts to:
continue the commercialization of Omidria;
continue research and development in all of our programs;
make principal and interest payments under the Oxford/MidCap Loan Agreement;
initiate and conduct clinical trials for other programs and product candidates; and
commercialize and launch any product candidates for which we receive regulatory approval.
If we do not raise additional capital when needed through one or more funding avenues, such as corporate partnering or debt or equity financings, we may be unable to complete these tasks successfully, or at all, which could prevent us from generating sales revenue or limit the amount of sales revenue generated. Further, if we are unable to generate sufficient revenue from the sale of Omidria, other commercialized products and/or partnering arrangements, we may be required to raise additional capital. If we are unable to raise sufficient capital if and when required, our business and prospects could be harmed and our stock price could decline significantly.

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Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products internationally.
We intend to have Omidria and our product candidates, if approved, marketed outside the U.S. In order to market our products in the EU and many other non-U.S. jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The regulatory approval procedure varies among countries and can involve additional testing and data review. The requirements governing marketing authorization, the conduct of clinical trials, pricing and reimbursement vary from country to country. The time required to obtain regulatory approval outside the U.S. may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval discussed in these “Risk Factors” and we may not obtain foreign regulatory approvals on a timely basis, or at all. Approval by the FDA or EC does not ensure approval by regulatory agencies in other jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory agencies in other foreign countries or by the FDA. The failure to obtain regulatory approval in one or more foreign jurisdictions, or any delays in the regulatory process, could harm our business. In addition, while Omidria has been approved for marketing in all EU member states plus Iceland, Lichtenstein, and Norway, we have not yet obtained pricing or reimbursement decisions from those jurisdictions.
We currently depend on a third party for the commercialization of OMS103 and we cannot guarantee that such commercialization will be successful.
On June 9, 2015 we entered into the OMS103 Agreement pursuant to which we granted Fagron an exclusive, royalty-free license to the OMS103 intellectual property, manufacturing information and clinical data to manufacture and commercialize OMS103 in the U.S. in exchange for potential future payments based on product revenue and achievement of commercial milestones. As a result of entering into the OMS103 Agreement, we have discontinued our OMS103 clinical development program and are dependent on Fagron to commercialize OMS103 in the U.S. We cannot control whether or not Fagron will fulfill its obligations under the OMS103 Agreement or whether the commercialization of OMS103 will be successful. Fagron may fail to commercialize OMS103 successfully for a number of reasons, including:
a lack of acceptance by physicians, patients, third-party payers and other members of the medical community, including based on any conclusion that may be reached regarding the efficacy or lack of efficacy of OMS103;
pricing, reimbursement and coverage policies of government and private payers such as Medicare, Medicaid, the VA, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;
the availability, relative price and efficacy of OMS103 as compared to alternative treatment options or competing products;
an unknown safety risk of OMS103;
failure to comply with applicable regulatory requirements;
failure to comply with applicable cGMPs;
changed or increased regulatory restrictions in the U.S.; and
a lack of adequate financial or other resources by Fagron to commercialize the product successfully.
If Fagron fails to perform its obligations under the OMS103 Agreement in a timely manner or if a material contract dispute arises, such event would adversely affect the likelihood and timing of royalty or milestone payments that we otherwise would be eligible to receive from Fagron. Further, if the OMS103 Agreement is terminated, we can provide no assurances that we will be able to enter into another licensing agreement or have sufficient resources to restart clinical development and conduct any clinical trials if desired. Any of the above risks, if realized, could adversely affect our results of operations.
Under Section 503B of the FDCA, registered outsourcing facilities may only compound bulk substances that appear on a list of bulk drug substances for which there is a clinical need or that appear on a drug shortage list to be maintained by the FDA. Additionally, under Section 503B of the FDCA, registered outsourcing facilities are prohibited from compounding drugs that are on a list that has not yet been published by the FDA of drugs that present demonstrable difficulties for compounding, or drugs that have been withdrawn or removed from the market because the drugs or components of the drugs have been found to be unsafe or not effective. We do not know if any of the active bulk substances used in the manufacture of OMS103, either individually or in combination, will be on any of these lists once established by the FDA, which might prohibit Fagron from commercializing or continuing to commercialize OMS103. Similarly, outsourcing facilities are required to manufacture under GMP and are subject to FDA inspections and audits. They also are not allowed to manufacture a product that is essentially a copy of one or more FDA-approved drugs. If Fagron is prohibited from commercializing or from continuing commercial sales of OMS103 following initial commercialization because of the disallowance of compounding with any of the active ingredients of OMS103, violations of any FDA regulations or any other reason, our ability to generate revenue from royalty payments from Fagron and achieve profitability will be adversely affected and the market price of our common stock could decline.

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We have no internal capacity to manufacture clinical or commercial supplies of Omidria or our product candidates and intend to rely solely on third-party manufacturers.
We rely and intend to continue to rely on third party manufacturers to produce commercial quantities of Omidria and any of our product candidates should they receive regulatory approval. Additionally, we rely and intend to continue to rely on third parties to produce clinical drug supplies needed for clinical trials. We cannot provide any assurance that we will be able to enter into or maintain these types of arrangements on commercially reasonable terms, or at all. If we or the manufacturer were to terminate one of these arrangements early, or the manufacturer was unable to supply product quantities sufficient to meet our requirements, we would be required to transfer the manufacture to an approved alternative facility and/or establish additional manufacturing and supply arrangements. Furthermore, in the event that one of our manufacturers fails to comply with FDA and/or other pharmaceutical manufacturing regulatory requirements, we may need to establish additional or replacement manufacturers, potentially with little or no advance notice. Even if we are able to establish additional or replacement manufacturers, identifying these sources and entering into definitive supply agreements and obtaining regulatory approvals may require a substantial amount of time and cost and may create a shortage of the product. Such alternate supply arrangements may not be available on commercially reasonable terms, or at all. Additionally, if we are unable to engage multiple suppliers to manufacture our products, we may have inadequate supply to meet the demand of our product. Any significant delays in the manufacture of clinical or commercial supplies could materially harm our business and prospects.
If the contract manufacturers that we rely on experience difficulties manufacturing Omidria or our product candidates or fail FDA or other regulatory inspections, our clinical trials, regulatory submissions and ability to sell Omidria or any other commercialized product and generate revenue may be significantly delayed.
Contract manufacturers that we select to manufacture Omidria or our product candidates for commercial supply or for clinical testing may encounter difficulties with the small- and large-scale formulation and manufacturing processes required for such manufacture. These difficulties could result in delays in clinical trials, regulatory submissions, or impact the commercialization of our products and product candidates. Once a product is approved and is marketed, these difficulties could also result in the recall or withdrawal of the product from the market or failure to have adequate supplies to meet market demand. In addition, we and our contract manufacturers must comply with cGMPs that are strictly enforced by the FDA and other regulatory authorities through facilities inspection programs. These cGMPs include quality control, quality assurance and the maintenance of records and documentation. We or our contract manufacturers may be unable to comply with cGMPs or with other FDA, state, local and foreign regulatory requirements. Although we have obligations to review their compliance, we have limited control over our current, and expect to have limited control for any future, contract manufacturers’ compliance with these regulations and standards, or with their quality control and quality assurance procedures. Large-scale manufacturing processes that have been developed, or which would be developed in the future, for our product candidates, or establishing additional manufacturers for Omidria, will require validation studies, which the FDA or other regulatory authorities must review and approve. Failure to comply with these requirements by our contract manufacturers could result in the initiation of enforcement actions by the FDA and other regulatory authorities, as well as the imposition of sanctions, including fines and civil penalties, suspension of production, suspension or delay in regulatory approval, product seizure or recall or withdrawal of product approval. If the safety of Omidria or any product candidate supplied by contract manufacturers is compromised due to their failure to adhere to applicable laws or for other reasons, we may not be able to obtain or maintain regulatory approval for or successfully commercialize Omidria or one or more of our product candidates, which would harm our business and prospects significantly.
If one or more of our contract manufacturers were to encounter any of these difficulties or otherwise fail to comply with its contractual obligations, our ability to provide Omidria or product candidates on a commercial scale or to patients in our clinical trials would be jeopardized. Any delay or interruption in the supply of clinical trial materials could delay the completion of our clinical trials, increase the costs associated with maintaining our clinical trial programs and, depending on the period of delay, require us to commence new trials at significant additional expense or terminate the trials completely.
Ingredients, excipients and other materials necessary to manufacture Omidria or our product candidates may not be available on commercially reasonable terms, or at all, which may adversely affect the development and commercialization of Omidria or those product candidates.
We and our third-party manufacturers must obtain from third-party suppliers the active pharmaceutical ingredients, excipients and primary and secondary packaging materials necessary for our contract manufacturers to produce Omidria and our PharmacoSurgery product candidates for our clinical trials and, to the extent approved or commercialized, for commercial distribution. Although we have or intend to enter into agreements with third-party suppliers that will guarantee the availability and timely delivery of active pharmaceutical ingredients, excipients and materials for Omidria and our PharmacoSurgery product candidates, we have not yet entered into agreements for the supply of all such ingredients, excipients or materials and we may be unable to secure all such supply agreements or guarantees on commercially reasonable terms, or at all. Even if we

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were able to secure such agreements or guarantees, our suppliers may be unable or choose not to provide us the ingredients, excipients or materials in a timely manner or in the quantities required. If we or our third-party manufacturers are unable to obtain the quantities of these ingredients, excipients or materials that are necessary for the manufacture of commercial supplies of Omidria, our ability to generate revenue from the sale of Omidria would be materially and adversely affected. Further, if we or our third-party manufacturers are unable to obtain active pharmaceutical ingredients, excipients and materials as necessary for our clinical trials or for the manufacture of commercial supplies of our product candidates, if approved, potential regulatory approval or commercialization would be delayed, which would materially and adversely affect our ability to generate revenue from the sale of our product candidates.
If our clinical trials are delayed, we may be unable to develop our product candidates on a timely basis, which will increase our development costs and delay the potential commercialization of our product candidates should they receive regulatory approval.
We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause regulatory agencies, Institutional Review Boards or Ethics Committees, or us to delay our clinical trials or suspend or delay the analysis of the data from those trials. Clinical trials can be delayed for a variety of reasons, including:
discussions with the FDA, the European Medicines Agency, or EMA, or other foreign authorities regarding the scope or design of our clinical trials;
delays or the inability to obtain required approvals from Institutional Review Boards, Ethics Committees or other responsible 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, failure to replicate positive early clinical data in subsequent clinical trials, poorly executed testing, a failure of a clinical site to adhere to the clinical protocol or an unacceptable study design;
adverse findings in clinical or nonclinical studies related to the safety of our product candidates in humans;
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 unacceptable drug-related side effects or adverse events experienced by participants in our clinical trials; or
the placement by a regulatory agency of a trial on a clinical hold.
In addition, a clinical trial or development program may be suspended or terminated by us, the FDA or other regulatory authorities, or Institutional Review Boards or Ethics Committees due to a number of factors, including:
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;
the failure to remove a clinical hold in a timely manner (which we cannot predict with certainty) or at all;
unforeseen safety issues or any determination that a trial presents unacceptable health risks; or
lack of adequate funding to continue the clinical trial or development program, 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 CROs and other third parties.
Changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes. Amendments may also be required to address other factors and these amendments may require us to resubmit our clinical trial protocols to Institutional Review Boards or Ethics Committees for re-examination, which may impact the costs, timing or successful completion of a clinical trial.
If the results of our clinical trials are not available when we expect or if we encounter any delay in the analysis of data from our clinical trials, we may be unable to file for regulatory approval or conduct additional clinical trials on the schedule we currently anticipate. Any delays in completing our clinical trials may increase our development costs, would slow down our product development and regulatory submission process, could delay our receipt of product revenue and could make it difficult to raise additional capital. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. In addition, significant clinical trial

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delays also could allow our competitors to bring products to market before we do and impair our ability to commercialize our future products and may harm our business.
If we experience delays or difficulties in enrolling patients in our clinical trials, those clinical trials could take longer than expected to complete and our receipt of regulatory approvals could be delayed or prevented.
We may be unable to initiate or continue clinical trials for Omidria or our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, the EMA or other regulatory authorities outside the U.S.
Patient enrollment for any of our clinical trials also may be affected by other factors, including:
the severity of the disease under investigation;
the design of the trial protocol;
the size of the patient population;
the availability of competing therapies and clinical trials;
the eligibility criteria of the study in question;
the perceived risks and benefits of the product or product candidate under study;
the efforts to facilitate timely enrollment in clinical trials;
the patient referral practices of physicians;
the ability to monitor patients adequately before and after treatment; and
the proximity and availability of clinical trial sites for prospective patients.
Our inability to enroll a sufficient number of patients for our clinical trials could result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays may result in increased development costs for our products or product candidates, and we may not have or be able to obtain sufficient cash to fund such increased cost when needed, which could result in further delay or termination of the trial.
We rely on third parties to conduct portions of our preclinical research and clinical trials. If these third parties do not perform as contractually required or otherwise expected, or if we fail to adequately supervise or monitor these parties, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We rely on third parties, such as CROs and research institutions, to conduct a portion of our preclinical research. We also rely on third parties, such as medical institutions, clinical investigators and CROs, to assist us in conducting our clinical trials. Nonetheless, we are responsible for confirming that our preclinical research and clinical trials are conducted in accordance with applicable regulations, the relevant trial protocol and within the context of approvals by an Institutional Review Board or Ethics Committee, and we may not always be successful in ensuring such compliance. Our reliance on these third parties does not relieve us of responsibility for ensuring compliance with FDA and other regulations and standards for conducting, monitoring, recording and reporting the results of preclinical research and clinical trials to assure that data and reported results are credible and accurate and that the trial participants are adequately protected. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our preclinical and clinical development processes may be extended, delayed, suspended or terminated, and we may not be able to commercialize or obtain regulatory approval for our product candidates.
We may need licenses for active ingredients from third parties to develop and commercialize some of our product candidates, which could increase our development costs and delay our ability to commercialize those product candidates.
Should we decide to use active pharmaceutical ingredients in any of our product candidates that are proprietary to one or more third parties, we would need to obtain licenses to those active ingredients from those third parties. If we are unable to access rights to these active ingredients prior to conducting preclinical toxicology studies intended to support clinical trials, we may need to develop alternate product candidates from these programs by either accessing or developing alternate active ingredients, resulting in increased development costs and delays in commercialization of these product candidates. If we are unable to access rights to the desired active ingredients on commercially reasonable terms or develop suitable alternate active ingredients, we may not be able to commercialize product candidates from these programs.

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Our ability to pursue the development and commercialization of products from our MASP-2 program depends on the continuation of licenses from third parties.
Our MASP-2 program is based in part on intellectual property rights that we licensed on a worldwide exclusive basis from the University of Leicester, the UK Medical Research Council at Oxford University and Helion Biotech ApS, or Helion. The continued maintenance of these agreements requires us to undertake development activities and, if regulatory approval for marketing is obtained, to pay royalties to each of these organizations upon commercialization of a MASP-2 product, such as OMS721. In addition, we are obligated to make remaining development and sales milestone payments to Helion of up to $6.1 million upon the achievement of certain events related to a MASP-2 product, such as the initiation of clinical trials, receipt of marketing approval and reaching specified sales milestones. Our ability to continue development and commercialization of products from our MASP-2 program, including OMS721, depends on our maintaining these exclusive licenses, which cannot be assured.
Our ability to pursue the development and commercialization of product candidates from our MASP-2, MASP-3 and Plasmin programs depends on third-party developers and manufacturers of biologic drug products.
Any product candidate from our MASP-2, MASP-3 or Plasmin programs would be a biologic drug product and we do not have the internal capability to hybridize, clone or manufacture biologics for clinical or commercial use. There are only a limited number of manufacturers of biologic drug products and we cannot be certain that we can enter into supply agreements with them on commercially reasonable terms, if at all. If we are unable to obtain clinical supplies of drug product for one of these programs, clinical trials or the development of any such product candidate for that program could be substantially delayed until we can find and qualify another manufacturer, which may increase our development costs, slow down our product development and approval process, delay receipt of product revenue and make it difficult to raise additional capital.
Our preclinical programs may not produce product candidates that are suitable for clinical trials or that can be successfully commercialized or generate revenue through partnerships.
Any product candidates from our preclinical programs must successfully complete preclinical testing, which may include demonstrating efficacy and the lack of toxicity in established animal models, before entering clinical trials. Many pharmaceutical and biological products do not successfully complete preclinical testing and, even if preclinical testing is successfully completed, may fail in clinical trials. In addition, there can be no assurance that positive results from preclinical studies will be predictive of results obtained from subsequent preclinical studies or clinical trials. For example, our studies of PDE7 inhibitors in different animal models of Parkinson’s disease, which may or may not be relevant to the mechanism of action of PDE7 inhibitors in humans, have produced varying results. Further, we cannot be certain that any of our preclinical product development programs will generate product candidates that are suitable for clinical testing. For example, we have not yet generated any products or product candidates from our GPCR program. We may discover that there are fewer druggable targets among the orphan GPCRs than we currently estimate and that, for those orphan GPCRs for which we identify functionally active compounds that we elect to develop independently, we are unable to develop related product candidates that successfully complete preclinical or clinical testing. If we are unable to develop product candidates, potential corporate partners may be unwilling to enter into partnership agreements with us. We also cannot be certain that any product candidates that do advance into clinical trials will successfully demonstrate safety and efficacy in clinical trials. Even if we achieve positive results in early clinical trials, they may not be predictive of the results in later trials.
Because we have a number of product candidates and development programs, we may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications for which there is a greater likelihood of obtaining regulatory approval and that may be more profitable, if approved.
Because we have limited resources, we must focus on the product candidates and clinical and preclinical development programs that we believe are the most promising. As a result, we may forego or delay the pursuit of opportunities with other product candidates or other indications that later prove to have greater commercial potential and may not be able to progress development programs as rapidly as otherwise possible. Our resource allocation decisions may cause us to fail to capitalize on viable potential commercial products or profitable market opportunities. Further, if we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product through collaboration, license or other royalty arrangements in cases in which it would have been advantageous for us to retain sole development and commercialization rights.

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It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.
Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection for the use, formulation and structure of our products and product candidates, the methods used to manufacture them, the related therapeutic targets and associated methods of treatment as well as on successfully defending these patents against potential third party challenges. Our ability to protect our products and product candidates from unauthorized making, using, selling, offering to sell or importing by third parties is dependent on the extent to which we have rights under valid and enforceable patents that cover these activities.
The patent positions of pharmaceutical, biotechnology and other life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. Case law and policy regarding the breadth of claims allowed in biotechnology patents has continued to evolve in the U.S., and tests used for determining the patentability of patent claims in all technologies are in flux. The pharmaceutical, biotechnology and other life sciences patent situation outside the U.S. is even more uncertain. Changes in either the patent laws or in interpretations of patent laws in the U.S. and other countries may diminish the value of our intellectual property. Further, the determination that a patent application or patent claim meets all of the requirements for patentability is a subjective determination based on the application of law and jurisprudence. For example, in the U.S., a determination of patentability by the U.S. Patent and Trademark Office, or USPTO, or validity by a court or other trier of fact requires a determination that the claimed invention has utility and is both novel and non-obvious to those of ordinary skill in the art in view of prior known publications and public information, and that the patent specification supporting the claim adequately describes the claimed invention, discloses the best mode known to the inventors for practicing the invention, and discloses the invention in a manner that enables one of ordinary skill in the art to make and use the invention. These standards may be challenging to meet for patents directed to some of our technologies, including our target-based technologies. The ultimate determination by the USPTO or by a court or other trier of fact in the U.S., or corresponding foreign national patent offices or courts, on whether a claim meets all requirements of patentability cannot be assured. Although we have conducted searches for third-party publications, patents and other information that may impact the patentability of claims in our various patent applications and patents, we cannot be certain that all relevant information has been identified. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or patent applications, our licensed patents or patent applications or in third-party patents.
We cannot assure you that any of our patent applications will be found to be patentable, including over our own prior art patents, or will issue as patents, nor can we make assurances as to the scope of any claims that may issue from these pending and future patent applications or to the outcome of any proceedings by any potential third parties that could challenge the patentability, validity or enforceability of our patents and patent applications in the U.S. or foreign jurisdictions, which could limit patent protection for our products and product candidates and materially harm our business.
The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:
we might not have been the first to make the inventions covered by any of our pending U.S. patent applications filed or having priority dates prior to the U.S. having adopted a first-to-file standard on March 16, 2013, or any U.S. patents issued based on such patent applications;
we might not have been the first to file patent applications on inventions that are the subject of pending foreign patent applications or that are the subject of pending U.S. patent applications filed or having priority dates after March 16, 2013, or any patents issued based on such foreign or U.S. patent applications;
others may independently develop similar or alternative technologies or products or duplicate any of our technologies or products or product candidates;
we may not be able to generate sufficient data to support fully patent applications that protect the entire breadth of developments expected to result from our development programs, including the GPCR program;
it is possible that none of our pending patent applications will result in issued patents or, if issued, that these patents will be sufficient to protect our technology or provide us with a basis for commercially viable products or 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 or product candidates that are not patentable and which are unlikely to be adequately protected through trade secrets if, for example, a competitor were to develop independently duplicative, similar or alternative technologies or products.

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In addition, to the extent we are unable to obtain and maintain patent protection for one of our products or product candidates or in the event such patent protection expires, it may no longer be cost-effective to extend our portfolio by pursuing additional development of a product or product candidate for follow-on indications.
We also may rely on trade secrets to protect our technologies or products, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisers may unintentionally or willfully disclose our information to competitors. Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside the U.S. are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
On July 27, 2015, we received notice from Par that it had filed an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under the Hatch-Waxman Act seeking approval from the FDA to market a generic version of Omidria. We intend to enforce vigorously our intellectual property rights relating to Omidria, including the three patents referenced in Par’s Paragraph IV certification and patents that may issue from currently pending patent applications. While there can be no assurance that we will prevail in any suit adjudicating the validity, enforceability and infringement of our patents, issued U.S. patents are presumed by law to be valid, and clear and convincing evidence must be presented in federal court to establish invalidity or unenforceability. In the future, other manufacturers may potentially file ANDAs seeking approval for the sale of generic versions of Omidria before our relevant patents expire and, if that occurs, we also intend to enforce vigorously relevant patents against them. Pursuant to the Hatch-Waxman Act, we may file suit for patent infringement against Par within 45 days from the receipt of Par’s notice letter, which would result in FDA imposing a stay of any final determination of Par’s ANDA for a period of 30 months from the date of receipt of Par’s notice letter, which may be extended or shortened in some circumstances. Any legal action taken to defend our patents will likely be costly, time consuming and distracting to management, could have a material adverse effect on our business, and could result in a finding that some or all of the claims of one or more of our relevant patents are invalid, unenforceable and/or not infringed by Par’s proposed product. Until this matter is finally resolved, the uncertainty of the outcome may cause our stock price to decline. Further, an adverse outcome in any such legal action could result in a generic version of Omidria being launched after the 30-month FDA “stay” and after the expiration of the mandatory three-year clinical data exclusivity for Omidria with an additional six months that would result from completion of our pediatric clinical trial for Omidria in accordance with the FDA’s Written Request. The introduction of a generic version could have a material negative impact on our financial condition and results of operations.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
If we choose to go to court to stop someone else from using our inventions, that individual or company has the right to ask the court to rule that the underlying patents are invalid or should not be enforced against that third party. These lawsuits are expensive and would consume time and other resources even if we were successful in stopping the infringement of these patents. There is also the risk that, even if the validity of these patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe the patents. It may not be feasible to detect and undertake patent enforcement action to stop infringing activity by a number of individual entities, each on a small scale, such as compounding pharmacies.
Further, a third party may claim that we or our contract manufacturers are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in the alleged infringing activity, including making, using or selling our products and product candidates. These lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we, or our contract manufacturers, are infringing the third party’s patents and would order us or our partners to stop the activities covered by the patents. In addition, if we or our contract manufacturers are found to have violated a third party’s patent, we or our contract manufacturers could be ordered to pay damages to the other party. We have agreed to or may agree to indemnify our contract manufacturers against certain patent infringement claims and thus may be responsible for any of their costs associated with such claims and actions. The pharmaceutical, biotechnology and other life sciences industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts and the interpretation is not always uniform. If we were sued for patent infringement, we would need to demonstrate that our products and product candidates or methods of use either do not infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. Proving invalidity, in particular, is difficult since it requires clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

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Although we have conducted searches of third-party patents with respect to our programs, we have not obtained written freedom to operate opinions for our programs and may not have identified all relevant third-party patents. Consequently, we cannot be certain that third-party patents containing claims covering our products, product candidates, programs, technologies or methods do not exist, have not been filed, or could not be filed or issued.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the capital necessary to continue our operations.
Government regulations and initiatives that affect pricing, coverage and reimbursement of drug products could adversely affect our business.
Governments in countries where we operate or anticipate operating have adopted or have shown significant interest in pursuing legislative initiatives to reduce costs of healthcare. We may also be affected by broader legislation addressing federal spending. Any such government-adopted healthcare measures or other legislation could adversely impact the pricing of our products, including Omidria, or the amount of coverage and reimbursement available for our products from governmental agencies or other third-party payers and adversely impact our results of operations.
The terms of our debt facility place restrictions on our operating and financial flexibility and, if we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
We have borrowed $32.0 million under the Oxford/MidCap Agreement. As collateral for this loan, we pledged substantially all of our assets other than intellectual property. The Oxford/MidCap Loan Agreement restricts our ability to incur additional indebtedness, pay dividends, pledge our intellectual property and engage in significant business transactions such as a change of control of Omeros. Any of these restrictions could significantly limit our operating and financial flexibility and ability to respond to changes in our business or competitive activities. In addition, if we default under the Oxford/MidCap Loan Agreement, the lenders may have the right to accelerate all of our repayment obligations under the Oxford/MidCap Loan Agreement and to take control of our pledged assets, which include our cash, cash equivalents and short-term investments, potentially requiring us to renegotiate the Oxford/MidCap Loan Agreement on terms less favorable to us. Further, if we are liquidated, the lenders’ right to repayment would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation. An event of default under the Oxford/MidCap Loan Agreement includes the occurrence of any material adverse effect upon our business operations, properties, assets, results of operations or financial condition, taken as a whole with respect to our viability, that would reasonably be expected to result in our inability to repay the loan. If either lender declares all obligations under the Oxford/MidCap Loan Agreement immediately due and payable upon the occurrence of any event that the lender interprets as constituting an event of default as defined under the Oxford/MidCap Loan Agreement, including but not limited to the lender concluding that a material adverse change has occurred as defined under the Oxford/MidCap Loan Agreement, we will be required to repay the loan immediately or to attempt to reverse the declaration through negotiation or litigation. Any declaration of an event of default could significantly harm our business and prospects and could cause our stock price to decline. If we raise any additional debt financing, the terms of such debt could further restrict our operating and financial flexibility.
Our agreements with Vulcan Inc. and its affiliate, which we refer to collectively as Vulcan, and the Life Sciences Discovery Fund Authority, a granting agency of the State of Washington, or LSDF, include terms that may reduce the purchase price that a third party would be willing to pay for the GPCR program or for us in a change of control.
Under our GPCR funding agreement with Vulcan, if we decide to sell or assign all or substantially all of the assets in our GPCR program prior to the time that Vulcan has received $60.0 million from us under our agreement, Vulcan may require that the purchaser assume all of our rights and obligations pursuant to the agreement, including our obligation to pay tiered percentages of any net proceeds that we receive from the GPCR program. The term of the Vulcan agreement is at least 35 years. If, at our option, we elect to assign the LSDF agreement in connection with the sale of the GPCR program, a potential purchaser would also have to assume similar payment obligations to LSDF. Potential purchasers of our GPCR program may be less inclined to purchase the program because of these obligations. Further, even if they are willing to assume our rights and obligations, they may be unwilling to pay as much for our GPCR program as they would be without such requirement. In addition, if a transaction results in a change of control of Omeros, the acquiring party will be required to assume our rights and obligations under the Vulcan and LSDF agreements. As a result of these provisions, a party that wants to acquire us through a change of control may be less inclined to do so or not be willing to pay as much.

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We have granted Vulcan a lien on all of our GPCR assets, excluding intellectual property, which provides Vulcan a right, senior to our shareholders, to receive proceeds generated from a liquidation of our GPCR assets as well as potentially limiting our operating and financial flexibility.
We have granted Vulcan a lien on all of our GPCR assets, excluding intellectual property, to secure our obligations under our agreement with Vulcan. This lien is, and will continue to be, junior to security interests we grant to third parties in connection with indebtedness for borrowed money. The lien will automatically be released once we have paid Vulcan or its affiliate $25.0 million out of net proceeds received from the GPCR program. If we default under our agreement with Vulcan, in certain circumstances Vulcan may, subject to the rights of any holders of senior security interests, take control of such pledged assets. We have also agreed with Vulcan not to grant any liens on our GPCR-related intellectual property related to our cellular redistribution assay, subject to specified exceptions. If we are liquidated, Vulcan’s right to receive any payments then due under our agreement would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation of our GPCR program assets. Further, the junior lien and negative pledge on our intellectual property restrict our operating and financial flexibility, potentially limiting our ability to pursue business opportunities and making it more difficult for us to respond to changes in our business.
We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive.
Our research operations produce hazardous waste products, which include chemicals and radioactive and biological materials. We are subject to a variety of federal, state and local regulations relating to the use, handling, storage and disposal of these materials. Although we believe that our safety procedures for handling and disposing of these materials comply with applicable legal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. We generally contract with third parties for the disposal of such substances and store our low-level radioactive waste at our facility until the materials are no longer considered radioactive. We may be required to incur further costs to comply with current or future environmental and safety regulations. In addition, although we carry insurance, in the event of accidental contamination or injury from these materials, we could be held liable for any damages that result and any such liability could exceed our insurance coverage and other resources.
The loss of members of our management team could substantially disrupt our business operations.
Our success depends to a significant degree on the continued individual and collective contributions of our management team. The members of our management team are at-will employees, and we do not maintain any key-person life insurance policies other than on the life of Gregory A. Demopulos, M.D., our president, chief executive officer and chairman of the board of directors. Losing the services of any key member of our management team, whether from death or disability, retirement, competing offers or other causes, could delay the execution of our business strategy, cause us to lose a strategic partner, or otherwise materially affect our operations.
We rely on highly skilled personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to maintain our operations or grow effectively.
Our performance is largely dependent on the talents and efforts of highly skilled individuals. Our future success depends on our continuing ability to identify, hire, develop, motivate and retain highly skilled personnel for all areas of our organization. If we are unable to hire and train a sufficient number of qualified employees for any reason, we may not be able to implement our current initiatives or grow effectively. We have in the past maintained a rigorous, highly selective and time-consuming hiring process. We believe that our approach to hiring has significantly contributed to our success to date. If we do not succeed in attracting qualified personnel and retaining and motivating existing personnel, our existing operations may suffer and we may be unable to grow effectively.
We may encounter difficulties managing our growth, which could delay our business plans or adversely affect our results of operations.
To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems and continue to recruit and train additional qualified personnel. Due to our limited financial resources, we may not be able to manage effectively the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations. Additionally, our inability to manage growth effectively could cause our operating costs to grow even faster than we currently are anticipating.

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We incur significant costs and demands on management as a result of complying with the laws and regulations affecting public companies.
We have incurred, and will continue to incur, significant costs associated with compliance with public company reporting and corporate governance requirements, including under the Sarbanes-Oxley Act of 2002 and the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, as well as rules implemented by the SEC and The Nasdaq Stock Market. The requirements of applicable SEC and Nasdaq rules and regulations may increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and may also place undue strain on our personnel, systems and resources. We also expect that these rules and regulations may make it difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage than was previously available. As a result, it may be more difficult for us to attract and retain qualified individuals to serve on our board of directors or as our executive officers.
We are required to make an assessment of the effectiveness of our internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002. Further, our independent registered public accounting firm has been engaged to express an opinion on the effectiveness of our internal control over financial reporting. If we are unable to comply with the requirements of Section 404, management may not be able to assess whether our internal control over financial reporting is effective, which may subject us to adverse regulatory consequences and could result in a negative reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. In addition, if we fail to maintain effective controls and procedures, we may be unable to provide the required financial information in a timely and reliable manner or otherwise comply with the standards applicable to us as a public company. Any failure by us to provide the required financial information in a timely manner could materially and adversely impact our financial condition and the market value of our securities.
Cyber-attacks or other failures in telecommunications or information technology systems could result in information theft, data corruption and significant disruption of our business operations.
We utilize information technology, or IT, systems and networks to process, transmit and store electronic information in connection with our business activities. As use of digital technologies has increased, cyber incidents, including deliberate attacks and attempts to gain unauthorized access to computer systems and networks, have increased in frequency and sophistication. These threats pose a risk to the security of our systems and networks, the confidentiality and the availability and integrity of our data. There can be no assurance that we will be successful in preventing cyber-attacks or successfully mitigating their effect. Similarly, there can be no assurance that our collaborators, CROs, third-party logistics providers, distributors and other contractors and consultants will be successful in protecting our clinical and other data that is stored on their systems. Any cyber-attack or destruction or loss of data could have a material adverse effect on our business and prospects. In addition, we may suffer reputational harm or face litigation or adverse regulatory action as a result of cyber-attacks or other data security breaches, and may incur significant additional expense to implement further data protection measures.
Risks Related to Our Industry
Our competitors may develop products that are less expensive, safer or more effective, or which may otherwise diminish or eliminate the commercial success of any products that we may commercialize.
We may not achieve commercial success, particularly if our competitors market products that are safer, more effective, less expensive or faster to reach the market than Omidria or any future products that we may develop and commercialize. Our competitors also may market a product that proves to be unsafe or ineffective, which may affect the market for our competing product, or future product, regardless of the safety or efficacy of our product. For example, compounding pharmacies or registered outsourcing facilities could seek to supply compounded versions of Omidria, which could have a material adverse effect on our business and financial condition, and enforcement of our intellectual property to address such activities may consume significant time and resources that could also have a material adverse effect on our business and financial condition. As a further example, other pharmaceutical companies, many with significantly greater resources than we have, are developing PDE10 inhibitors similar to our product candidate OMS824, and these companies may be further along in development and have the resources to develop their product candidates at a faster rate than we can. In addition, we believe that other companies are attempting to find compounds that functionally interact with orphan GPCRs. If any of these companies are able to achieve this for a given orphan GPCR before we do, we may be unable to establish a commercially valuable intellectual property position around that orphan GPCR. The failure of Omidria or any other future product that we may market to effectively compete with products marketed by our competitors would impair our ability to generate revenue, which would have a material adverse effect on our future business, financial condition and results of operations.

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The pharmaceutical industry is intensely competitive and many of our competitors have significantly more resources and experience, which may limit our commercial opportunities.
The pharmaceutical industry is intensely competitive in the markets in which we expect to compete. We expect to compete for market share against large pharmaceutical and biotechnology companies, smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies and other public and private research organizations. Our competitors may:
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.
In addition, the pharmaceutical and biotechnology industry is characterized by rapid technological change. Because our research approach integrates many technologies, it may be difficult for us to remain current with rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Our competitors may render our technologies obsolete by advances in existing technological approaches or the development of new or different approaches, potentially eliminating the advantages in our product discovery process that we believe we derive from our research approach and proprietary technologies and programs.
Our products could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products if and when any of them are approved.
Omidria and any product candidate for which we obtain regulatory approval in the future, together with the manufacturing processes, post-approval clinical data, and advertising and promotional activities for such product, will be subject to continued regulation by the FDA and other regulatory agencies. Even if regulatory approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or the approval may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. Later discovery of previously unknown problems with Omidria or any of our other approved products, or failure to comply with regulatory requirements, may result in:
restrictions on such products or manufacturing processes;
withdrawal of the products from the market;
voluntary or mandatory recalls;
fines;
suspension or withdrawal of regulatory approvals;
product seizures; or
injunctions or the imposition of civil or criminal penalties.
If we are slow or unable to adapt to changes in existing regulatory requirements or adoption of new regulatory requirements or policies, we may lose marketing approval for Omidria, or for our product candidates when and if any of them are approved.
Product liability claims may damage our reputation and, if insurance proves inadequate, these claims may harm our business.
We may be exposed to the risk of product liability claims that is inherent in the biopharmaceutical industry. A product liability claim may damage our reputation by raising questions about our product’s safety and efficacy and could limit our ability to sell one or more products by preventing or interfering with commercialization of our products and product candidates. In addition, product liability insurance for the biopharmaceutical industry is generally expensive to the extent it is available at all. There can be no assurance that we will be able to obtain or maintain such insurance on acceptable terms or that we will be able to secure and maintain increased coverage if the commercialization of Omidria or our product candidates progresses, or that future claims against us will be covered by our product liability insurance. Further, our product liability insurance coverage may not reimburse us or may be insufficient to reimburse us for any or all expenses or losses we may suffer. A successful claim against us with respect to uninsured liabilities or in excess of insurance coverage could have a material adverse effect on our business, financial condition and results of operations.

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Risks Related to Our Common Stock
Our stock price has been and may continue to be volatile, and the value of an investment in our common stock may decline.
During the 12-month period ended June 30, 2015, our stock traded as high as $27.64 per share and as low as $11.18 per share. The trading price of our common stock is likely to continue to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control. These factors could include:
failure of Omidria, or any of our product candidates if approved, to achieve commercial success;
FDA or foreign regulatory actions related to Omidria or any of our product candidates, including our currently suspended programs evaluating OMS824 for the treatment of Huntington’s disease and for the treatment of schizophrenia;
our ability to partner in the EU with respect to Omidria;
results from our clinical development programs, including the data from our ongoing clinical development programs evaluating Omidria, OMS721, OMS824, and PPARγ;
failure of Fagron to manufacture and commercialize OMS103 successfully;
announcements regarding the progress of our preclinical programs, including without limitation our GPCR program;
quarterly variations in our results of operations or those of our competitors;
our ability to develop and market new and enhanced products 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;
additions or departures of key personnel;
commencement of, our involvement in and resolution of litigation;
our ability to meet our repayment and other obligations under the Oxford/MidCap Loan Agreement;
the inability of our contract manufacturers to provide us with adequate commercial supplies of Omidria and our product candidates;
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;
the extent to which we raise funds by issuing equity or debt securities;
general economic conditions and slow or negative growth of our markets; and
political instability, natural disasters, war and/or events of terrorism.
From time to time, we estimate the timing of the accomplishment of various commercial, scientific, clinical, regulatory and other product development goals or milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. Also, from time to time, we expect that we will publicly announce the anticipated timing of some of these milestones. All of these milestones are based on a variety of assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, our stock price may decline and the commercialization of Omidria and our product candidates may be delayed.
In addition, the stock market has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of publicly traded companies. Broad market and industry factors may seriously affect the market price of companies’ stock, including ours, regardless of actual operating performance. These fluctuations may be even more pronounced in the trading market for our stock. In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigation has often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.

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We expect that we will continue to need additional capital in the future; however, such capital may not be available to us on reasonable terms, if at all, when or as we require additional funding. If we issue additional shares of our common stock or other securities that may be convertible into, or exercisable or exchangeable for, our common stock, our existing shareholders would experience further dilution.
Although we expect that we will need additional capital in the future, we cannot be certain that it will be available to us on acceptable terms, if at all, when required. Disruptions in the global equity and credit markets may limit our ability to access capital. To the extent that we raise additional funds by issuing equity securities, our shareholders would experience dilution, which may be significant and could cause the market price of our common stock to decline significantly. Any debt financing, if available, may restrict our operations similar to the Oxford/MidCap Loan Agreement, or in other ways. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the commercialization of Omidria or the development or commercialization of one or more of our product candidates or one or more of our other research and development initiatives. We also could be required to seek collaborators for one or more of our current or future products at an earlier stage than otherwise would be desirable or on terms that are less favorable than otherwise might be available or to relinquish or license on unfavorable terms our rights to technologies or products that we otherwise would seek to develop or commercialize ourselves. We also may have insufficient funds or otherwise be unable to advance our preclinical programs, such as potential new drug targets developed from our GPCR program, to a point where they can generate revenue through partnerships, collaborations or other arrangements. Any of these events could significantly harm our business and prospects and could cause our stock price to decline.
Future sales of shares by holders of outstanding warrants and options could cause our stock price to decline.
Approximately 9.6 million shares of common stock that are either subject to outstanding warrants or outstanding options will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements. In addition, we also have approximately 1.8 million shares of common stock reserved for future issuance under our employee benefit plans that are not subject to outstanding options. If the holders of these outstanding warrants and/or options to purchase our common stock elect to exercise some or all of them, or if the shares subject to our employee benefit plans are issued and become eligible for sale in the public market, our shareholders would experience dilution and the market price of our common stock could decline.
Anti-takeover provisions in our charter documents and under Washington law could make an acquisition of us, which may be beneficial to our shareholders, difficult and prevent attempts by our shareholders to replace or remove our current management.
Provisions in our articles of incorporation and bylaws and under Washington law may delay or prevent an acquisition of us or a change in our management. These provisions include a classified board of directors, a prohibition on shareholder actions by less than unanimous written consent, restrictions on the ability of shareholders to fill board vacancies and the ability of our board of directors to issue preferred stock without shareholder approval. In addition, because we are incorporated in Washington, we are governed by the provisions of Chapter 23B.19 of the Washington Business Corporation Act, which, among other things, restricts the ability of shareholders owning 10% or more of our outstanding voting stock from merging or combining with us. Although we believe these provisions collectively provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if an offer may be considered beneficial by some shareholders. In addition, these provisions may frustrate or prevent any attempts by our shareholders to replace or remove our current management by making it difficult for shareholders to replace members of our board of directors, which is responsible for appointing the members of our management.
We have never declared or paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future.
Our business requires significant funding, and we have not generated any material revenue. We currently plan to invest all available funds and future earnings, if any, in the development and growth of our business. Additionally, under the Oxford/MidCap Loan Agreement, we have agreed not to pay any dividends so long as we have any outstanding obligations under the agreement. Therefore, we currently do not anticipate paying any cash dividends on our common stock in the foreseeable future. As a result, a rise in the market price of our common stock, which is uncertain and unpredictable, will be the sole source of potential gain for shareholders in the foreseeable future, and an investment in our common stock for dividend income should not be relied upon.

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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a) Unregistered Sales of Equity Securities. We issued 7,278 shares of our common stock upon the cashless net exercise of a warrant to purchase 11,539 shares of our common stock during the three months ended June 30, 2015. The warrant was issued on April 26, 2005 and assumed by us in connection with our acquisition of nura, Inc. on August 11, 2006. We deemed the issuance of common stock upon the exercise of the warrant to be exempt from registration under the Securities Act pursuant to Section 3(a)(9) of the Securities Act. No underwriters were involved in the issuance of our common stock upon the exercise of the warrant and no commissions were paid in connection with such issuance.


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ITEM 6. EXHIBITS
 
Exhibit
Number
Description
10.1††
License Agreement effective as of June 9, 2015 by and between Omeros Corporation, JCB Laboratories, LLC, and Fagron Compounding Services, LLC, d/b/a Fagron Sterile Services
12.1
Ratio of Earnings to Fixed Charges
31.1
Certification of Principal Executive Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Principal Financial Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Extension Schema Document
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
 
††
Portions of this exhibit are redacted in accordance with a request for confidential treatment.

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
OMEROS CORPORATION
 
 
Dated: August 10, 2015
/s/ Gregory A. Demopulos
 
Gregory A. Demopulos, M.D.
 
President, Chief Executive Officer and Chairman of the Board of Directors
 
 
Dated: August 10, 2015
/s/ Michael A. Jacobsen
 
Michael A. Jacobsen
 
Vice President, Finance, Chief Accounting Officer and Treasurer

-40-
EX-10.1 2 ex101-omerosxfagronjcblice.htm EXHIBIT 10.1 - FAGRON LICENSE AGREEMENT EX10.1 - Omeros-Fagron/JCB License Agreement
EXHIBIT 10.1
CONFIDENTIAL TREATMENT REQUESTED under 17 C.F.R. § 200.80(b)(4) and 240.24b-2


LICENSE AGREEMENT

This License Agreement (the “Agreement”) is made and entered into effective as of June 9, 2015 (the “Effective Date”) by and between Omeros Corporation, a corporation organized under the laws of the State of Washington with a business address of 201 Elliott Avenue West, Seattle, WA 98119 (“Omeros”) and JCB Laboratories, LLC, a corporation organized under the laws of the State of Kansas with a business address of 7335 W 33rd Street North, Wichita, KS 67205, and Fagron Compounding Services, LLC, d/b/a Fagron Sterile Services, a corporation organized under the laws of the State of Kansas, with a business address of 8710 E 34th Street North, Wichita, KS, 67226 (JCB Laboratories, LLC and Fagron Compounding Services, LLC collectively referred to herein as “JCB”). Omeros and JCB are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
Recitals
WHEREAS, Omeros owns and controls certain intellectual property rights with respect to products including combinations of active pharmaceutical ingredients, including a combination drug product for use in orthopedic procedures referred to as OMS103;
WHEREAS, JCB is an FDA-registered human drug outsourcing facility as defined in Section 503B of the Act (as defined herein) that compounds sterile pharmaceutical products under applicable cGMP conditions; and
WHEREAS, JCB desires to obtain from Omeros a license under the Licensed Technology (as defined herein) to Compound (as defined herein) and Commercialize (as defined herein) Licensed Products (as defined herein) in the Territory (as defined herein), and Omeros is willing to grant such license, in each case in accordance with the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1.    Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended.
1.2.    Affiliate means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries is controlled by such Party, but only so long as such control exists. For purposes of this definition, “controlled by” means: (i) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (ii) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).
1.3.    Agreement has the meaning set forth in the preamble hereto.

† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION



1.4.    Applicable Law means applicable federal, state and local laws, rules and regulations, including any rules, regulations, guidances, guidelines or other requirements of the Regulatory Authorities in the Territory, that may be in effect from time to time, including cGMP.
1.5.    Auditor” has the meaning set forth in Section 4.8.
1.6.    Breaching Party” has the meaning set forth in Section 9.2.1.
1.7.    Business Day” means a day other than a Saturday or Sunday or a day on which banking institutions in Seattle, Washington are permitted or required to be closed.
1.8.    Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.
1.9.    cGMP” means current Good Manufacturing Practices as promulgated or enforced by a Regulatory Authority that are applicable to Compounding by registered outsourcing facilities under Section 503B of the Act, or analogous provisions of foreign laws.
1.10.    Commercialization means any and all activities directed to the preparation for sale of, offering for sale of or sale of a Licensed Product, including activities related to marketing, promoting, distributing and sale of such Licensed Product, and the Compounding of Licensed Product for use in Commercialization activities, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.
1.11.    Compound” and “Compounding” means all activities related to the production, compounding on an individual named-patient basis, compounding on a large-scale registered outsourcing basis, compounding for veterinary usage, processing, filling, finishing, packaging, labeling, shipping and holding of any Licensed Product, or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial compounding, and analytic development, stability testing, quality assurance and quality control.
1.12.    Confidential Information has the meaning set forth in Section 6.1.
1.13.    Control means, with respect to any item of Information, Patent or other intellectual property right, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 2.1 or9.4.2), to grant a license, sublicense or other right to or under such Information, Patent or other intellectual property right as provided for herein without violating the terms of any agreement with any Third Party.
1.14.    Dispute has the meaning set forth in Section 10.4.
1.15.    Dollars” or “$” means United States Dollars.
1.16.    Effective Date has the meaning set forth in the preamble hereto.

† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
2



1.17.    Executive Officer” means, with respect to Omeros, its Chief Executive Officer and with respect to JCB, its President.
1.18.    FDA means the United States Food and Drug Administration and any successor agency thereto.
1.19.    Field” means, with respect to the OMS103 Product, all therapeutic, diagnostic and interventional usages, including, without limitation, use during arthroscopic, endoscopic and open surgical procedures, intra-articular injection and topical administration, whether in concentrated form or whether diluted in irrigation solution or other carrier; and with respect to any other Licensed Product, the field indicated for such product in Schedule 1.33 hereto.
1.20.    First Commercial Sale” means, with respect to a Licensed Product, the first sale by JCB of such Licensed Product in the Territory for monetary value for use or consumption by the end user.
1.21.    “Gross Revenues” means, with respect to a Licensed Product for any period, the gross amount billed or invoiced by JCB to Third Parties during such period. Gross Revenues shall be calculated in accordance with United States generally accepted accounting principles.
1.22.    Improvement” means, (i) any invention, discovery, development or modification with respect to any Licensed Product, including any enhancement in, or additions, deletions or substitutions of any of the active pharmaceutical ingredients or excipients thereof, as well as enhancements to the preparation, presentation, formulation, method of Compounding or otherwise manufacturing, means of delivery or dosage thereof, (ii) any discovery of any new or expanded indications for such Licensed Product for human or animal use, or (iii) any invention, discovery, development or modification that improves the stability, safety or efficacy of such Licensed Product, in each case ((i), (ii) and (iii)) whether or not patented or patentable and regardless of the Party(ies) that conceived, reduced to practice or developed such Improvement, provided, however, that a product including [†] shall not be considered an Improvement of a Licensed Product so long as it is not marketed for [†], which with respect to the OMS103 Product includes [†].
1.23.    IND” means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and equivalent filings in other countries or regulatory jurisdictions, and (ii) all amendments that may be filed with respect to the foregoing.
1.24.    Indemnified Party has the meaning set forth in Section 8.3.
1.25.    Information” means all technical, scientific and other similar know-how and information, including trade secrets, methods, processes, formulae, instructions, procedures, specifications, data and results of testing (including, as applicable, biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, Compounding, manufacturing and quality control data and information), whether or not confidential, proprietary, patented or patentable.
1.26.    Infringement” has the meaning set forth in Section 5.3.1.
1.27.    JCB has the meaning set forth in the preamble hereto.

† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
3



1.28.    JCB Know-How means all Information Controlled by JCB that is conceived, discovered, developed or otherwise made by JCB at any time during the Term in connection with this Agreement, the use of any Licensed Technology or the exercise of any license or other right granted hereunder, in each case, that is reasonably useful or necessary for the exploitation of any Licensed Product or any Improvement thereto; provided that JCB Know-How excludes all Improvements.
1.29.    JCB Patents means all of the Patents Controlled by JCB claiming or covering any Licensed Product or the exploitation thereof or any other Information conceived, discovered, developed or otherwise made by JCB after the Effective Date and at any time during the Term in connection with the use of any Licensed Technology or the exercise of any license or other right granted hereunder, in each case excluding all Improvements.
1.30.    JCB Representatives” has the meaning set forth in Section 8.1.
1.31.    Licensed Know-How” means all of the Information Controlled by Omeros that is listed on Schedule 1.31 hereto.
1.32.    Licensed Patents” means (i) all of the Patents Controlled by Omeros that are listed on Schedule 1.32 hereto and all Patents Controlled by Omeros to the extent that they cover or claim Improvements; (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from any of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (iii) any and all patents that have issued or in the future issue from the foregoing patent applications in clauses (i) and (ii); and (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions of the foregoing patents or patent applications in clauses (i), (ii) and (iii).
1.33.    Licensed Product means (a) with respect to OMS103, the OMS103 Product, and (b) with respect to any additional product listed in Schedule 1.33 hereto, as amended by the Parties from time to time, (i) any pharmaceutical product, composition or kit for sale that is comprised of or contains [†], or (ii) any Improvement of such additional product; provided that, from and after the date on which any Licensed Product becomes a Terminated Product hereunder, for purposes of the licenses and other rights granted by Omeros to JCB in this Agreement, Licensed Products shall exclude such product(s).
1.34.    Licensed Technology” means the Licensed Patents and Licensed Know-How.
1.35.    “Licensed Trademark” means, for each Licensed Product, the corresponding trademark(s) and associated applications for registrations and registrations listed on Schedule 1.35 hereto.
1.36.    Losses” has the meaning set forth in Section 8.1.
1.37.    Non-Breaching Party” has the meaning set forth in Section 9.2.1.
1.38.    Notice Period” has the meaning set forth in Section 9.2.1.
1.39.    Omeros” has the meaning set forth in the preamble hereto.
1.40.    OMS103” means a fixed-dose combination drug product containing, as active pharmaceutical ingredients, amitriptyline HCl ([†] mg/mL), oxymetazoline HCl ([†] mg/mL), and

† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
4



ketoprofen ([†] mg/mL), in lyophilized or liquid solution form, as well as [†]. For clarity, the term OMS103 shall be understood to include formulations of such a fixed-dose combination drug product previously referred to by Omeros as OMS103, OMS103HP and OMS103HP-S.
1.41.    “OMS103 Product” means any pharmaceutical product that is comprised of or contains or includes as its active pharmaceutical ingredients the active pharmaceutical ingredients contained in OMS103 or any Improvement of OMS103, with or without any other active pharmaceutical ingredients, excipients or carrier, [†].
1.42.    Party and Parties have the meanings set forth in the preamble hereto.
1.43.    Patents” means: (i) all national, regional and international patents and patent applications, including provisional patent applications; (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (iii) any and all patents that have issued or in the future issue from the foregoing patent applications in subclauses (i) and (ii); and (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications in subclauses (i), (ii) and (iii).
1.44.    Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
1.45.    Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the exploitation of Licensed Products in the Territory, including the FDA in the United States.
1.46.    Term” has the meaning set forth in Section 9.1.
1.47.    “Terminated Product” means each Licensed Product with respect to which this Agreement is terminated pursuant to Section 9.2.1, 9.2.4, or 10.1 or, if this Agreement is terminated in its entirety (whether by way of a single termination event or two or more termination events that together cover all Licensed Products), all Licensed Products.
1.48.    Terminated Territory” means each country with respect to which this Agreement is terminated pursuant to Section 9.2.1, 9.2.4, or 10.1 or, if this Agreement is terminated in its entirety (whether by way of a single termination event or two or more termination events that together cover all countries in the Territory), the entire Territory.
1.49.    Territory means, with respect to a Licensed Product, the corresponding country or countries listed in Schedule 1.49 hereto, as amended by the Parties from time to time; provided that, from and after the date on which any country becomes a Terminated Territory hereunder, for purposes of the licenses and other rights granted by Omeros to JCB in this Agreement, the Territory shall exclude such country(ies).
1.50.    Third Party means any Person other than Omeros, its Affiliates, and JCB.

† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
5



1.51.    Third Party Claims has the meaning set forth in Section 8.1.
1.52.    Third Party Infringement Claim” has the meaning set forth in Section 5.5.
1.53.    United States” or “U.S.” means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).
ARTICLE 2
LICENSE GRANT
2.1.    Grants to JCB. Omeros hereby grants to JCB (i) an exclusive (including with regard to Omeros and its Affiliates), royalty-free license, without the right to grant sublicenses, under the Licensed Technology to Compound and Commercialize Licensed Products in their respective Fields and Territory, provided that all Compounding by JCB under this Agreement shall be performed in accordance with Section 3.4, and (ii) an exclusive (including with regard to Omeros and its Affiliates), royalty-free license, without the right to grant sublicenses, under the Licensed Trademarks and associated goodwill to Commercialize Licensed Products in their respective Fields and Territory. The licenses granted by Omeros to JCB are strictly limited to the licenses expressly granted in this Section 2.1.
ARTICLE 3
REGULATORY AND COMMERCIALIZATION ACTIVITIES
3.1.    Technology Transfer.
3.1.1.    In General. Promptly after the Effective Date, Omeros shall disclose and make available to JCB the Licensed Know-How in such form as Omeros shall reasonably determine.
3.1.2.    Related Cooperation. For a period of twelve (12) months after the Effective Date in the case of the OMS103 Product and upon the launch of any other Licensed Product added to this Agreement, or such longer time as Omeros may agree in its sole discretion, Omeros shall cooperate with JCB by using reasonable efforts to make appropriate personnel available, at no charge for time but with out-of-pocket costs reimbursable by JCB, to respond to questions that JCB may raise with respect to the Licensed Know-How. JCB acknowledges that such cooperation shall not require Omeros to conduct any research or development activities or generate any information in addition to that listed in Schedule 1.31. Each Party shall designate an employee to serve as the primary point of contact between the Parties in relation to any questions raised by JCB pursuant to this Section 3.1.2.
3.2.    Regulatory Matters.
3.2.1.    In General. The Parties acknowledge that Omeros has discontinued its clinical development program with respect to the Licensed Products in the Territory. After the Effective Date, Omeros shall have no responsibility to conduct any development activities with respect to any Licensed Product in the Territory for such Licensed Product. JCB shall have sole responsibility for communications with Regulatory Authorities in the Territory regarding the Compounding and Commercialization of Licensed Products in the Territory. Omeros shall have sole responsibility, at its sole discretion, for communications with Regulatory Authorities in the Territory regarding its prior development of the Licensed Products in the Territory.
3.2.2.    Withdrawal of IND. JCB shall give Omeros written notice of the anticipated date of First Commercial Sale of each Licensed Product at least thirty (30) days in advance

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thereof; provided, however, that if after delivery of such notice, the anticipated date of such First Commercial Sale changes, JCB shall promptly so notify Omeros. No later than five (5) business days prior to the anticipated date of First Commercial Sale, Omeros shall have notified FDA that the IND, if any, for such Licensed Product has been withdrawn, and shall promptly notify JCB in writing of such withdrawal. JCB shall not offer any Licensed Product for sale or sell any Licensed Product until Omeros has notified JCB in writing that Omeros has withdrawn the corresponding IND.
3.2.3.    Recalls, Suspensions or Withdrawals. JCB shall be solely responsible for any recall, market suspension or market withdrawal of a Licensed Product in the Territory, including the execution thereof, and for all costs and expenses associated with, or incurred by either Party in connection with, any such recall, market suspension or market withdrawal.
3.3.    Commercialization.
3.3.1.    In General. After the Effective Date, JCB shall be solely responsible for all aspects of the Compounding and Commercialization of the Licensed Products in the Territory, at JCB’s sole cost and expense. Such Commercialization activities shall include sales and marketing activities in accordance with Applicable Law, invoicing and booking sales, establishing all terms of sale (including pricing and discounts) and warehousing and distributing the Licensed Products in the Territory. JCB shall Compound only such quantity of Licensed Products as it intends to Commercialize itself in the Territory, and may not sell any Licensed Products to any Third Party for resale in the Territory or outside the Territory.
3.3.2.    Diligence. JCB shall use diligent, good faith efforts to Commercialize each Licensed Product in the Territory for such Licensed Product. Without limitation of the foregoing, JCB shall (i) launch the OMS103 Product in the Territory by [†], 2015; (ii) initiate validated production of OMS103 on JCB’s automated filling line by [†]; (iii) incur sales and marketing expenditures of at least [†] annually in the Territory in connection with the Commercialization of the OMS103 Product; and (iv) generate Gross Revenues from each Licensed Product of at least [†] during the [†] following First Commercial Sale of such Licensed Product, and of at least [†] for each subsequent [†] period thereafter. Launch and validated production milestones corresponding to clauses (i) and (ii) in the preceding sentence, and minimum annual sales and marketing expenditures corresponding to clause (iii) in the preceding sentence, shall be mutually agreed in Schedule 1.33 for each Licensed Product added to this Agreement.
3.3.3.    Omeros Support. Omeros agrees to provide JCB with introductions to key opinion leaders in the field of orthopedic surgery and with associated physician contact information. Further, Omeros shall provide JCB with assistance in understanding the therapeutic field and administration methods relating to the Licensed Products.
3.3.4.    Reports. Within thirty (30) days after the start of each calendar year during the Term following the Effective Date, JCB shall provide to Omeros a detailed annual written report of the activities it has performed since the preceding report with respect to the Compounding and Commercialization of each Licensed Product, and the future activities it expects to initiate during the next year. Each such report shall contain sufficient detail to enable Omeros to assess JCB’s compliance with its obligations hereunder, including under Section 3.3.2.
3.3.5.    Commercialization Records. Without limitation of Section 4.6, JCB shall maintain complete and accurate books and records pertaining to Commercialization of Licensed Products hereunder, in sufficient detail to verify compliance with its obligations under this Agreement and

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which shall be in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Commercialization activities. Such records shall be retained by JCB for at least three (3) years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law. Omeros shall have the right, during normal business hours and upon reasonable notice, to inspect and, with respect to relevant portions, copy all such books and records maintained pursuant to this Section 3.3.3; provided that Omeros shall keep such information confidential in accordance with Article 6.
3.4.    Compliance with Applicable Law. JCB shall comply with all Applicable Law with respect to the Compounding and Commercialization of Licensed Products in the Territory, including Applicable Law relating to cGMP, interactions with healthcare professionals and providers, and the marketing and promotion of pharmaceutical products. JCB shall conduct all Compounding and Commercialization of Licensed Products within the United States portion of the Territory in compliance with Section 503B of the Act, including, without limitation, applicable requirements related to adverse event reporting, labeling, reporting to FDA, payment of registration fees, cooperation with required facility inspections, and prohibitions on wholesaling, and shall not Compound Licensed Products within the United States portion of the Territory under Section 503A of the Act unless authorized in writing by Omeros, at Omeros’ sole discretion.
3.5.    Subcontracting. JCB may not sublicense its right to Compound or Commercialize Licensed Products without the prior written consent of Omeros, at Omeros’ sole discretion, or subcontract the performance of any of its activities relating to the Licensed Products without the prior written consent of Omeros, such consent not to be unreasonably withheld.
3.6.    Non-Competition. JCB agrees that, during the Term and for a period of [†] thereafter, it will not Compound, manufacture, or Commercialize any product, composition or kit containing or including any combination of two or more of the active pharmaceutical ingredients contained in OMS103 or other Licensed Product, provided, however, that if JCB proposes to compound a product [†], it shall so notify Omeros in writing and, if Omeros determines in its sole discretion to permit JCB to Compound, manufacture, or Commercialize such proposed combination on the basis that Omeros reasonably believes [†], it shall notify JCB of its consent and such activities shall not be prohibited. JCB further agrees that if during the Term JCB Compounds, manufactures, or Commercializes any product not prohibited under the terms of this Section 3.6 and Omeros has credible evidence that such product has [†], Omeros may in its sole discretion elect either to terminate this Agreement or to convert the license grant in Section 2.1 to a non-exclusive license, upon thirty (30) days’ prior written notice to JCB.
ARTICLE 4
PAYMENTS AND RECORDS
4.1.    Revenue Split. In partial consideration of the rights granted by Omeros to JCB hereunder, commencing upon the First Commercial Sale of a Licensed Product in the Territory, JCB shall pay Omeros, on a Licensed Product-by-Licensed Product basis, the following:
(i)    [†] of the first [†] of Gross Revenues;
(ii)    [†] of aggregate Gross Revenues greater than [†] and less than or equal to [†]; and
(iii)    [†] of aggregate Gross Revenues greater than [†];

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provided, however, that JCB shall pay Omeros, pursuant to this Section 4.1, not less than (x) [†] per unit of the OMS103 Product sold by JCB with a unit size not to exceed [†], and (y) not less than an additional [†] per each additional partial or complete increment of [†] for any unit size greater than [†]. JCB shall pay to Omeros the amounts due pursuant to this Section 4.1 for a given Calendar Quarter within forty-five (45) days after the end of such Calendar Quarter until such time as such quarterly payments exceed [†], after which payments shall be made monthly. Each month during the Term JCB shall provide to Omeros, and each monthly or quarterly payment shall be accompanied by, a statement of (i) the amount of Gross Revenues for each Licensed Product in the Territory during the applicable month or Calendar Quarter, (ii) the number of units of each Licensed Product sold in the Territory during the applicable month or Calendar Quarter, and (iii) the manner of calculation of the amount payable to Omeros for such month or Calendar Quarter.
4.2.    Commercial Milestones. In partial consideration of the rights granted by Omeros to JCB hereunder, JCB shall pay to Omeros, on a Licensed Product-by-Licensed Product basis, milestone payments, as follows:
(i)    in the event that the aggregate Gross Revenues with respect to a Licensed Product in the Territory reach [†], JCB shall pay Omeros [†];
(ii)    in the event that the aggregate Gross Revenues with respect to a Licensed Product in the Territory reach [†], JCB shall pay Omeros an additional [†]; and
(iii)    in the event that the aggregate Gross Revenues with respect to a Licensed Product in the Territory reach [†], JCB shall pay Omeros an additional [†].
JCB shall notify Omeros promptly of the achievement of each of the events identified as a milestone in this Section 4.2. In the event that more than one of the foregoing thresholds set forth in clauses (i) through (iii) of this Section 4.2 is exceeded, JCB shall pay to Omeros a separate milestone payment with respect to each such threshold that is exceeded. Each such milestone payment shall be due within thirty (30) days of the date of achievement of such milestone. Each milestone payment in this Section 4.2 shall be payable a single time upon the first achievement of such milestone with respect to each Licensed Product, and shall be payable an additional time for the first achievements of such milestone with respect to each additional Licensed Product.
4.3.    Mode of Payment. All payments to Omeros under this Agreement shall be made by deposit or wire transfer (at Omeros’ option) of Dollars in the requisite amount to such bank account as Omeros may from time to time designate by notice to JCB. For the purpose of calculating any sums due under this Agreement (including the calculation of Gross Revenues expressed in currencies other than Dollars), JCB shall convert any amount expressed in a foreign currency into Dollar equivalents using the closing rate for the last business day of the applicable month or Calendar Quarter as reported in the Wall Street Journal, Eastern Edition.
4.4.    Taxes. All payments made by JCB to Omeros pursuant to this Agreement shall be made free and clear of any and all taxes, except for any withholding taxes required by Applicable Law. If JCB withholds any amount, it shall pay to Omeros the balance when due, make timely payment to the proper taxing authority of the withheld amount and promptly send Omeros proof of such payment.
4.5.    Interest on Late Payments. If any payment due to Omeros under this Agreement is not paid when due, then JCB shall pay interest thereon (before and after any judgment) at a

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rate of twelve percent (12%) per annum (but with interest accruing on a daily basis), such interest to run from the date such payment became due until payment thereof in full together with such interest.
4.6.    Financial Records. JCB shall keep complete and accurate financial books and records pertaining to the Commercialization of Licensed Products hereunder, including books and records of Gross Revenues of each Licensed Product, in sufficient detail to calculate and verify all amounts payable hereunder. JCB shall retain such books and records until the expiration of the applicable tax statute of limitations or for such longer period as may be required by Applicable Law.
4.7.    Audit. At the request of Omeros, JCB shall permit Omeros or an independent auditor designated by Omeros, at reasonable times and upon ten (10) Business Days’ notice to JCB, to audit the books and records maintained pursuant to Section 4.6 to ensure the accuracy of all reports and payments made hereunder. Except as provided below, the cost of this audit shall be borne by Omeros, unless the audit reveals a variance of more than [†] from the reported amounts, in which case JCB shall bear the cost of the audit. Unless disputed pursuant to Section 4.8, if such audit concludes that (i) additional amounts were owed by JCB, then JCB shall pay the additional amounts, with interest from the date originally due as provided in Section 4.5, or (ii) excess payments were made by JCB, then Omeros shall refund such excess payments, in either case ((i) or (ii)), within thirty (30) days after the date on which such audit is completed by Omeros.
4.8.    Audit Dispute. In the event of a dispute with respect to any audit pursuant to Section 4.7, Omeros and JCB shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party or to such other Person as the Parties shall mutually agree (the “Auditor”). The decision of the Auditor shall be final and the costs and fees of such Auditor as well as the initial audit shall be borne between the Parties in such manner as the Auditor shall determine. Not later than ten (10) days after such decision, JCB shall pay the additional amounts, with interest from the date originally due or Omeros shall refund the excess payments, as applicable.
ARTICLE 5
INTELLECTUAL PROPERTY
5.1.    Ownership of Intellectual Property.
5.1.1.    Ownership of Technology. Subject to the licenses and other rights granted herein, as between the Parties, Omeros shall own and retain all right, title and interest in and to the Licensed Technology and shall own all right, title and interest in and to the Improvements, and for purposes of clarity Omeros acknowledges that the Improvements shall be included in the Licensed Technology to which JCB is granted a license under Section 2.1, and JCB shall own and retain all right, title and interest in and to the JCB Know-How and the JCB Patents.
5.1.2.    Ownership and Use of Licensed Trademarks. Subject to the licenses and other rights granted herein, as between the Parties, Omeros shall own all right, title and interest in and to the Licensed Trademarks (based on trademark, copyright or otherwise). JCB shall use the Licensed Trademarks in connection with its Commercialization of the Licensed Products, and all goodwill associated with such use of the Licensed Trademarks shall accrue to the benefit of Omeros as owner of such Licensed Trademarks. JCB shall not use in its business any trademark that is confusingly similar to, misleading or deceptive with respect to, or that dilutes any of the Licensed Trademarks, or take

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any action that endangers or destroys the value of the goodwill pertaining to the Licensed Trademarks. JCB shall bear all costs and expenses incurred in conducting any additional design work required in connection with any of the Licensed Trademarks.
5.1.3.    Assignment. In order to ensure that Omeros receives the full benefit of the rights and licenses granted in Section 9.4, JCB shall cause all Persons who perform activities on behalf of JCB under or in connection with this Agreement to be under an obligation to assign to JCB their rights in any Information, Improvements or other inventions they conceive, discover or otherwise make. Further, JCB hereby assigns to Omeros, without additional consideration, all of its right, title and interest in and to any Improvements that JCB may conceive, discover or otherwise make during the Term in connection with its activities hereunder. JCB shall disclose to Omeros in writing any and all such Improvements promptly (but in no event more than one month), following the conception, discovery, or making thereof by JCB.
5.2.    Maintenance and Prosecution of Patents. Omeros shall have the sole right, but not the obligation, directly or through an Affiliate or Third Party designee, to prepare, file, prosecute and maintain the Licensed Patents worldwide, including with respect to any related interference, re-issuance, re-examination and opposition proceedings, which activities shall be at Omeros’ cost and expense and using counsel of its own choice. JCB shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain the JCB Patents worldwide, including with respect to any related interference, re-issuance, re-examination and opposition proceedings, at its sole cost and expense and using counsel of its own choice. The Party prosecuting any Licensed Patent or JCB Patent, as applicable, pursuant to this Section 5.2 shall periodically inform the non-prosecuting Party of all material steps with regard to the preparation, filing, prosecution and maintenance of such Patent in the Territory. The non-prosecuting Party shall reasonably cooperate with the prosecuting Party in the preparation, filing, prosecution and maintenance of the applicable Patent(s) in accordance with this Section 5.2; provided that the prosecuting Party shall reimburse the non-prosecuting Party for its reasonable out-of-pocket costs and expenses incurred in providing such cooperation.
5.2.1.    Patent Term Extension and Supplementary Protection Certificates. As between the Parties, the Party that owns any Patent being prosecuted pursuant to this Section 5.2 shall have the sole right to make decisions regarding, and shall have the right to apply for, patent term extensions in the Territory, including the United States with respect to extensions pursuant to 35 U.S.C. §156 et. seq. and in other jurisdictions pursuant to supplementary protection certificates.
5.3.    Enforcement of Patents and Trademarks.
5.3.1.    Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the [†] in the Territory pertaining to the Compounding, manufacture or Commercialization of a [†], of which such Party becomes aware (an “Infringement”).
5.3.2.    Enforcement of [†]. As between the Parties, [†] shall have the first right, but not the obligation, directly or through an Affiliate or Third Party designee, to prosecute any Infringement, at [†] cost and expense and using counsel of [†] choice. [†] may participate in any such claim, suit or proceeding in the Territory with counsel of its choice at [†] cost and expense; provided that [†] shall retain control of the defense, suit or proceeding. If [†] or its designee does not take commercially reasonable steps to prosecute an Infringement within [†] following the first notice provided with respect to such Infringement, then (x) [†] shall so notify [†] , and (y) [†] shall have the right to prosecute such Infringement at [†] cost and expense using counsel of [†] choice. [†] may participate in

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any such claim, suit or proceeding with counsel of its choice at [†] cost and expense; provided that [†] shall retain control of the defense, suit or proceeding. With respect to any action for infringement brought by a Party pursuant to this Section 5.3.2, the other Party shall reasonably cooperate in the prosecution of such infringement action.
5.3.3.    Enforcement of [†]. As between the Parties, during the Term, [†] shall have the [†] right, but not the obligation, to prosecute infringement with respect to the [†], including as a defense or counterclaim in connection with any [†], at [†] cost and expense, using counsel of its own choice.
5.3.4.    Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of any claim, suit or proceeding described in this Section 5.3 (whether by way of settlement or otherwise) shall be [†] (i) in an action under Section 5.3.2, (a) by [†] if it is the controlling Party and [†] does not participate as provided for in Section 5.3.2 or (b) [†], if [†] is the controlling Party or if [†] is the controlling party and [†] participates as provided for in Section 5.3.2, and (ii) in an action under Section 5.3.3, by [†] .
5.4.    Invalidity or Unenforceability Defenses or Actions. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the [†] by a Third Party of which such Party becomes aware. As between the Parties, [†] shall have the sole right, but not the obligation, to control and defend any claim, suit or proceeding with respect to the validity and enforceability of the [†] at [†] cost and expense, using counsel of [†] own choice, including when such invalidity or unenforceability is raised as a defense or counterclaim in connection with an Infringement action initiated pursuant to Section 5.3. [†] may participate in any such claim, suit or proceeding in the Territory with respect to any [†] using counsel of its choice at [†] cost and expense; provided that [†] shall retain control of the defense in such action or proceeding. If [†] or its designee elects not to defend or control the defense of the [†] in an action or proceeding brought in the Territory, in each case, with respect to any [†], then [†] may conduct and control the defense of any such claim, suit or proceeding at [†] cost and expense. [†] may participate in any such claim, suit or proceeding in the Territory with respect to any [†] using counsel of its choice at [†] cost and expense; provided that [†] shall retain control of the defense in such action or proceeding. With respect to any claim, suit or proceeding governed by this Section 5.4, the non-controlling Party shall reasonably cooperate with the controlling Party with respect to such claim, suit or proceeding, and the controlling Party shall reimburse the non-controlling Party for its reasonable out-of-pocket costs incurred in connection therewith.
5.5.    Infringement Claims by Third Parties. If the [†] pursuant to this Agreement results in, or is reasonably expected to result in, any claim, suit or proceeding by a Third Party alleging infringement of its Patent or trademark rights by [†] (a “Third Party Infringement Claim”), including in connection with a defense or counterclaim to an Infringement action initiated pursuant to Section 5.3, the Party first becoming aware of such alleged infringement shall promptly notify the other Party thereof in writing. As between the Parties, [†] shall have the first right, but not the obligation, to defend and control the defense of any such Third Party Infringement Claim, at [†] cost and expense, using counsel of [†] choice; provided that [†] may participate in the defense using counsel of its choice at [†] cost and expense. If [†] or its designee elects (in a written communication submitted to [†] within a reasonable amount of time after notice of the alleged patent infringement) not to defend or control the defense of, or otherwise fails to initiate and maintain the defense of, any such action or proceeding, [†] may conduct and control the defense of any such action or proceeding at [†] cost and expense; provided that [†] may participate in the defense using counsel of its choice at [†] cost and expense. The non-controlling Party shall assist and cooperate with the controlling Party in connection with its activities set forth in this S

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ection 5.5, and the controlling Party shall reimburse the non-controlling Party for its reasonable out-of-pocket costs incurred in connection therewith. Any recoveries awarded to a Party in connection with any Third Party Infringement Claim defended under this Section 5.5 shall be applied first to reimburse such Party for its reasonable out-of-pocket costs of defending such claim, suit or proceedings, with the balance of any such recoveries being retained or provided to such Party and, in the case of [†] as the recovering party, included in [†].
5.6.     Markings. JCB shall mark each Licensed Product offered for sale, sold or otherwise disposed of under the license granted in the Agreement with the word “Patent” or “Patents” and the number or numbers of the applicable issued Licensed Patent(s) listed in Schedule 1.32 or alternate list of issued patents that Omeros may provide to JCB in writing from time to time during the Term.
ARTICLE 6
CONFIDENTIALITY AND NON-DISCLOSURE
6.1.    Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party shall and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement. “Confidential Information” of a Party means any technical, business or other information provided by or on behalf of such Party or any of its Affiliates to the other Party or any of its Affiliates in connection with this Agreement, whether prior to, on or after the Effective Date, including information relating to the terms of this Agreement (subject to Section 6.4), information relating to any Licensed Product or its exploitation, any know-how with respect thereto developed by or on behalf of the disclosing Party or its Affiliates or the scientific, regulatory or business affairs or other activities of either Party; provided that information related to the Improvements shall be deemed the Confidential Information of Omeros and information related to the JCB Know-How shall be deemed the Confidential Information of both Parties. Notwithstanding the foregoing, the confidentiality and non-use obligations under this Section 6.1 with respect to any Confidential Information shall not include any information that the receiving party establishes: (i) is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no breach of this Agreement by the receiving Party; (ii) can be demonstrated by documentation or other competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; (iii) is subsequently received by the receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information; (iv) has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party in breach of this Agreement; or (v) can be demonstrated by documentation or other competent evidence to have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information.
6.2.    Permitted Disclosures. Each Party (the “receiving Party”) may disclose Confidential Information of the other Party (the “disclosing Party”) to the extent that such disclosure is:
6.2.1.    made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by law, including by reason of filing with securities regulators; provided, however, that the receiving Party shall first have given notice to the disclosing Party and given the

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disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided, further, that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;
6.2.2.    made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any submission of regulatory documentation or any filing; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information if and to the extent practicable and consistent with Applicable Law;
6.2.3.    made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent; provided that reasonable measures shall be taken to assure confidential treatment of such information, if and to the extent such protection is available;
6.2.4.    made by or on behalf of the receiving Party to (i) such Party’s or its Affiliate’s officers, directors or employees (provided that such Persons are bound by obligations of confidentiality to such Party) or (ii) Third Party agents, consultants or contractors engaged by or on behalf of such Party or any of its Affiliates (provided that any such Person has first agreed in writing to confidentiality restrictions and obligations at least as protective as provided for in this Article 6), in each case for any purpose reasonably necessary or useful to exercise any rights granted to or, in the case of Omeros, retained by, such Party or to perform any of such Party’s obligations under this Agreement; or
6.2.5.    made by or on behalf of the receiving Party or any of its Affiliates to potential or actual acquirers or (sub)licensees as may be necessary in connection with their evaluation of such potential or actual acquisition or (sub)license transaction; provided that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 6.
6.3.    Use of Name. Except as expressly provided herein, neither Party shall use the name or trademarks of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material or other form of publicity relating to this Agreement or the subject matter hereof without the prior written approval of such other Party. For purposes of clarity, JCB shall not print Omeros’ name on the Licensed Products or otherwise publicly use Omeros’ name in connection with the Commercialization of the Licensed Products except as Omeros may authorize in writing.
6.4.    Public Announcements. The parties shall cooperate on a joint press release announcing the execution of this Agreement, subject to the following sentence. Neither Party shall issue any other public announcement, press release or other public disclosure regarding this Agreement or its terms without the other Party’s prior written consent, except for any such disclosure that is, in the opinion of the disclosing Party’s counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted). Neither Party shall be required to seek the permission of the other Party to disclose any information regarding the terms of this Agreement or any amendment hereto that has already been publicly disclosed by such Party or by the other Party, in accordance with this Section 6.4; provided that such information remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.

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6.5.    Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing the return of its Confidential Information to which the non-requesting Party does not retain rights under the surviving provisions of this Agreement, and the non-requesting Party shall, at its election, either (i) promptly destroy all copies of such Confidential Information in the possession or control of the non-requesting Party and confirm such destruction in writing to the requesting Party; or (ii) promptly deliver to the requesting Party, at the non-requesting Party’s sole cost and expense, all copies of such Confidential Information in the possession or control of the non-requesting Party. Notwithstanding the foregoing, the non-requesting Party shall be permitted to retain such Confidential Information (x) to the extent necessary or useful for purposes of performing any continuing obligations or exercising any ongoing rights hereunder and, in any event, a single copy of such Confidential Information for archival purposes and (y) any computer records or files containing such Confidential Information that have been created solely by such non-requesting Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s standard procedures, but not for any other purpose. All Confidential Information shall be subject to the terms of this Agreement for the period set forth in Section 6.1.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
7.1.    Mutual Representations and Warranties. Omeros and JCB each represents and warrants to the other, as of the Effective Date, that:
7.1.1.    It is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement;
7.1.2.    The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate: (i) such Party’s charter documents, bylaws or other organizational documents; (ii) in any material respect, any agreement, instrument or contractual obligation to which such Party is bound; (iii) any requirement of any Applicable Law; or (iv) any order, writ, judgment, injunction, decree, or award of any court or governmental agency presently in effect applicable to such Party; and
7.1.3.    This Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity).
7.2.    Additional Representations and Warranties of Omeros. Omeros represents and warrants to JCB, as of the Effective Date, that (i) Omeros owns or Controls the Licensed Technology and has the right to grant the licenses and rights granted to JCB in this Agreement, (ii) the Licensed Product, as it exists as of the Effective Date for OMS103 or as of the date of addition to Schedule 1.33 for other Licensed Products, and Omeros’ performance under this Agreement, in each case to the best of Omeros’ knowledge as of the Effective Date for OMS103 or as of the date of addition to Schedule 1.33 for other Licensed Products, do not and will not infringe, violate, or interfere with the intellectual property or other right of any third party, excluding any intellectual property or other rights of a third party that are applicable to Compounding and not specific to a Licensed Product.

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7.3.    Additional Representations, Warranties and Covenants of JCB. JCB represents and warrants to Omeros, as of the Effective Date, and covenants, that:
7.3.1.    JCB has not been debarred and is not subject to debarment by any Regulatory Authority and it will not use in any capacity, in connection with the activities to be performed under or in connection with any Licensed Product or this Agreement, any Person who has been debarred or is subject to debarment proceedings by any Regulatory Authority. JCB shall inform Omeros in writing promptly if it or any such Person who is performing activities under or in connection with any Licensed Product or this Agreement is debarred or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to its knowledge, is threatened, relating to debarment of it or any such Person.
7.3.2.    JCB is qualified under Applicable Law, and has obtained such licenses, consents, authorizations and registrations and has made such notifications as may be required by Applicable Law for it, to engage in Compounding under Section 503B of the Act and Commercialization of the Licensed Products.
7.4.    DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS ARTICLE 7, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OR SCOPE OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
7.5.    ADDITIONAL DISCLAIMERS AND WAIVER. JCB AGREES THAT: (i) THE LICENSED TECHNOLOGY IS LICENSED “AS IS,” AND, EXCEPT IN THE CASE OF A MATERIAL BREACH OF SECTION 7.2, JCB EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST OMEROS FOR BREACH OF WARRANTY OF ANY KIND RELATING TO THE LICENSED TECHNOLOGY; (ii) OMEROS WILL HAVE NO LIABILITY TO JCB FOR ANY ACT OR OMISSION IN OR RELATING TO THE PREPARATION, FILING, PROSECUTION, MAINTENANCE, ENFORCEMENT, DEFENSE OR OTHER HANDLING OF THE LICENSED PATENTS AND JCB EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST OMEROS WITH RESPECT THERETO; (iii) JCB IS SOLELY RESPONSIBLE FOR DETERMINING WHETHER THE LICENSED PRODUCTS AND THE LICENSED TECHNOLOGY HAVE APPLICABILITY OR UTILITY OR ARE APPROPRIATE FOR ANY DESIRED OR INTENDED USE IN THE FIELD AND JCB ASSUMES ALL RISK AND LIABILITY IN CONNECTION WITH SUCH DETERMINATION; AND (iv) OMEROS NEITHER MAKES ANY REPRESENTATIONS NOR EXTENDS ANY WARRANTIES OF ANY KIND THAT ANY LICENSED PRODUCT CAN OR WILL BE SUCCESSFULLY COMMERCIALIZED, OR AS TO THE PERFORMANCE, QUALITY OR OTHER EFFECTS OF ANY LICENSED PRODUCT.

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ARTICLE 8
INDEMNITY
8.1.    Indemnification of Omeros. JCB shall indemnify Omeros, its Affiliates, its or their (sub)licensees and its and their respective directors, officers, employees and agents and defend and save each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) in connection with any and all suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”) arising from or occurring as a result of: (i) the breach by JCB of any representation, warranty or covenant of JCB in this Agreement; (ii)  the Commercialization or other exploitation by JCB or its permitted subcontractors or its or their respective directors, officers, employees or agents (collectively, the “JCB Representatives”), or use by its or their customers, of any Licensed Product, including (a) in relation to any death, personal bodily injury or damage to real or personal property alleged or proven to result directly or indirectly from any possession, use or consumption of, or treatment with, any Licensed Product, (b) any actual or alleged infringement or unauthorized use or misappropriation of any Patent or other intellectual property right of a Third Party with respect to such exploitation or Commercialization of the Licensed Product in a manner not contemplated or not authorized by this Agreement, (c) any actual or alleged infringement or unauthorized use or misappropriation of any Patent or other intellectual property right of a Third Party that is applicable to Compounding and not specific to a Licensed Product, (d) any actual or alleged infringement or unauthorized use or misappropriation of any intellectual property right of a Third Party arising from advertising, promotion or marketing of a Licensed Product, except as may arise from use of the Licensed Trademark as contemplated or authorized by this Agreement, or (e) the Commercialization or Exploitation of an Improvement of a Licensed Product by JCB; or (iii) any violation of Applicable Law by JCB or any of the JCB Representatives except, in each case ((i) through (iii)), for those Losses for which Omeros has an obligation to indemnify JCB pursuant to Section 8.2, as to which Losses each Party shall indemnify the other to the extent of their respective liability pursuant to this Article 8.
8.2.    Indemnification of JCB. Omeros shall indemnify JCB and its directors, officers, employees and agents and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims arising from or occurring as a result of the breach by Omeros of any representation, warranty or covenant of Omeros in this Agreement, including any breach of Omeros’ intellectual property representations and warranties of Section 7.2(ii), except for those Losses for which JCB has an obligation to indemnify Omeros pursuant to Section 8.1, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses pursuant to this Article 8.
8.3.    Indemnification Procedures. All indemnification claims in respect of a Party, its Affiliates or, in the case of Omeros, its or their (sub)licensees or their respective directors, officers, employees and agents, shall be made solely by such Party to this Agreement (the “Indemnified Party”). The Indemnified Party shall give the indemnifying Party prompt written notice of any Losses or discovery of fact upon which such indemnified Party intends to base a request for indemnification under this Article 8. Any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose. All costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim shall be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party. The Indemnifying Party may not settle any Third Party Claim, and the Indemnified Party shall not be

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responsible for or be bound by any settlement of a Third Party Claim that imposes an obligation on it, without the prior written consent of the Indemnified Party (not to be unreasonably withheld).
8.4.    Special, Indirect and Other Losses.
8.4.1.    EXCEPT (i) [†] (ii) [†], NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL OR PUNITIVE DAMAGES OR FOR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY OR ANY OF ITS AFFILIATES, WHETHER SUCH LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.
8.4.2.    WITHOUT LIMITATION OF SECTION 8.4.1, IN NO EVENT SHALL THE AGGREGATE LIABILITY OF EITHER PARTY (AND ITS AFFILIATES AND ITS AND THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS) UNDER THIS AGREEMENT (OTHER THAN PURSUANT TO SECTION 8.1 OR 8.2), WHETHER IN CONTRACT, TORT, PRODUCT LIABILITY, STRICT LIABILITY OR OTHERWISE, EXCEED THE AMOUNTS PAID TO OMEROS BY JCB UNDER THIS AGREEMENT IN CONNECTION WITH THE RELEVANT LICENSED PRODUCT DURING THE [†] PERIOD PRECEDING THE EVENT GIVING RISE TO SUCH LIABILITY. THE FOREGOING LIMIT DOES NOT APPLY TO A BREACH BY EITHER PARTY OF SECTION 6.1.
8.5.    Insurance. JCB shall have and maintain during the Term, and for a period of two years thereafter, at least the following types and amounts of insurance covering its Compounding and Commercialization of the Licensed Products: (i) commercial general liability insurance with a combined single limit for bodily injury and property damage of not less than [†], (ii) products liability/completed operations coverage with a minimum indemnity limit of [†] per occurrence, and (iii) an all-risks insurance policy covering its facilities with a minimum indemnity limit of [†] per occurrence. Such policies shall (a) be provided by insurance carrier(s) reasonably acceptable to Omeros, (b) be written on an occurrence (and not a claims made) basis, and (c) show Omeros as additional insured and loss payee, as its interests may appear, and provide that Omeros will be given [†] advance written notice of the termination thereof. Such policies shall not be canceled or subject to a reduction of coverage without the prior written authorization of Omeros. Should JCB at any time or for any reason fail to obtain the insurance required herein, or should such insurance be canceled or the limits reduced, Omeros shall have the right to terminate this Agreement pursuant to Section 9.2.1 or procure the same and the cost and expense thereof shall be reimbursed by JCB. Upon request by Omeros, JCB shall provide to Omeros evidence of its insurance coverage. For the avoidance of doubt, the foregoing coverage requirements are not intended and shall not be construed to provide any limitation on JCB’s liability under this Agreement.

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ARTICLE 9
TERM AND TERMINATION
9.1.    Term and Expiration. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect with respect to each Licensed Product until the later of (a) the expiration of the last-to-expire of the Licensed Patents for such Licensed Product or (b) the entry into the market of a product sold by a third party that [†] and directly competes with such Licensed Product, and shall terminate in its entirety when terminated with respect to all Licensed Products (such period, the “Term”).
9.2.    Termination.
9.2.1.    Material Breach. In the event that either Party (the “Breaching Party”) shall be in material breach of its obligations under this Agreement, the other Party (the “Non-Breaching Party”) may terminate this Agreement by providing thirty (30) days’ (the “Notice Period”) prior written notice to the Breaching Party; provided that the termination shall not become effective at the end of the Notice Period if the Breaching Party cures the breach specified in such notice during the Notice Period. Without limitation to the foregoing, with respect to any uncured material breach by JCB in the performance of any of its obligations with respect to a Licensed Product(s) or a particular country(ies) in the Territory, at Omeros’ election, Omeros shall have the right, in lieu of terminating this Agreement in its entirety, to terminate this Agreement with respect to the applicable country(ies) or the applicable Licensed Product(s).
9.2.2.    Failure to Fulfill Diligence Obligations. In the event that JCB fails to fulfill any of its obligations pursuant to any of clause (i) through (iv) of Section 3.3.2, in each case by the required completion date set forth therein, Omeros shall have the right, at its sole discretion, either to terminate this Agreement or to convert the license grant in Section 2.1 to a non-exclusive license, upon thirty (30) days’ prior written notice to JCB.
9.2.3.    Termination for Patent Challenge. In the event that JCB institutes, prosecutes or otherwise participates in (or in any way aids any Third Party in instituting, prosecuting or participating in), at law or in equity or before any administrative or regulatory body, including the U.S. Patent and Trademark Office or its foreign counterparts, any claim, demand, action or cause of action for declaratory relief, damages or any other remedy or for an enjoinment, injunction or any other equitable remedy, including any interference, re-examination, opposition or any similar proceeding, alleging that any claim in a Licensed Patent is invalid, unenforceable or otherwise not patentable or would not be infringed by JCB’s activities absent the licenses granted hereunder in a country in the Territory, Omeros shall have the right to immediately terminate this Agreement in its entirety upon written notice to JCB.
9.2.4.    Termination for Regulatory Action. In the event that (i) a Regulatory Authority in a country in the Territory prohibits JCB from Compounding or Commercializing, or mandates a recall with respect to, any Licensed Product in such country, or (ii) [†], then in each case ((i) and (ii)) Omeros may terminate this Agreement in its entirety, with respect to such Licensed Product, or with respect to such country, immediately upon written notice to JCB.
9.2.5.    Termination for Insolvency. In the event that either Party (i) files for protection under bankruptcy or insolvency laws, (ii) makes an assignment for the benefit of creditors, (iii) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within ninety (90) days after such filing, (iv) proposes a written agreement of composition or

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extension of its debts, (v) proposes or is a party to any dissolution or liquidation, (vi) has a petition under any bankruptcy or insolvency act filed against that is not discharged within sixty (60) days of the filing thereof or (vii) admits in writing its inability generally to meet its obligations as they fall due in the general course, then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party.
9.3.    Rights in Bankruptcy. All licenses granted under or pursuant to this Agreement by JCB or Omeros are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of rights to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country.
9.4.    Consequences of Expiration or Termination. In the event of expiration or termination of this Agreement in its entirety or with respect to one or more countries in the Territory or with respect to one or more Licensed Products, for any reason:
9.4.1.    All rights and licenses granted by Omeros to JCB hereunder shall immediately terminate with respect to the Terminated Territory or Terminated Product;
9.4.2.    JCB shall and hereby does, effective as of the effective date of expiration or termination, grant Omeros a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to grant multiple tiers of sublicenses, under the JCB Patents and JCB Know-How then owned or Controlled by JCB, to exploit the Licensed Products in the Terminated Territory, or to exploit the Terminated Product in the Territory, as the case may be.
9.5.    Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one or more country(ies)) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity.
9.6.    Accrued Rights; Surviving Obligations. Expiration or termination of this Agreement (either in its entirety or with respect to one or more countries in the Territory or with respect to one or more Licensed Products) for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, Sections 3.2.1, 3.3.5, 3.6, 4.1 – 4.5 (as to any payment obligations that accrue during the Term), 4.6, 4.7, 4.8, 5.1, 9.4 and this Section 9.6 and Articles 6, 8 and 10 of this Agreement shall survive the termination or expiration of this Agreement for any reason. If this Agreement is terminated with respect to Terminated Territory or Terminated Products but not in its entirety, then following such termination the foregoing provisions of this Agreement shall remain in effect with respect to the Terminated Territory or Terminated Products to the extent they would survive and apply in the event the Agreement expires or is terminated in its entirety or as otherwise necessary for any of Omeros and its Affiliates and its and their (sub)licensees to exercise their rights in the Terminated Territory or with respect to the Terminated Products, and all provisions not surviving in accordance with the foregoing shall terminate with respect to the Terminated Territory or Terminated Products and be of no further force and effect (and for the avoidance of doubt all provisions of this Agreement shall remain in effect with respect to all countries in the Territory other than the Terminated Territory and all Licensed Products other than the Terminated Products).

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ARTICLE 10
MISCELLANEOUS
10.1.    Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement (other than an obligation to make payments) when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, acts of God (except to the extent any such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within thirty (30) days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. Without limitation to the foregoing, in the event that JCB is the non-performing Party and the suspension of performance continues for one hundred eighty (180) days after the date of the occurrence, Omeros shall have the right to terminate this Agreement upon written notice to JCB, in its sole discretion, solely with respect to the country in the Territory or the Licensed Product affected by such non-performance or in its entirety.
10.2.    Assignment. JCB may not assign its rights or, except as expressly permitted hereunder, delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part, without the prior written consent of Omeros; provided that such consent shall not be required (provided that JCB notifies Omeros of any such assignment within [†]) for any assignment of this Agreement by JCB in connection with (i) a change in the Persons that beneficially own, directly or indirectly, the shares of capital stock of JCB then outstanding and normally entitled to vote in the election of the directors of JCB representing fifty percent (50%) or more of the total voting power of all outstanding classes of such capital stock of JCB, unless the Persons that gain such controlling interest of JCB are engaged in a business that competes, directly or indirectly, with any business of Omeros, or (ii) a sale or transfer to a Third Party, in one or more related transactions, of the assets representing all or substantially all of JCB’s assets to which this Agreement relates, unless such Third Party is engaged in a business that competes, directly or indirectly, with any business of Omeros. Omeros shall have the right to assign this Agreement or delegate any of its rights or obligations under this Agreement to any Affiliate or Third Party and shall notify JCB of any such assignment to a Third Party within [†] of such assignment. Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement. All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party. Any attempted assignment or delegation in violation of this Section 10.2 shall be void and of no effect.
10.3.    Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (i) such provision shall be fully severable, (ii) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable

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provision had never comprised a part hereof, (iii) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (iv) in lieu of such illegal, invalid or unenforceable provision, there shall be added as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render a provision illegal, invalid or unenforceable.
10.4.    Dispute Resolution. Except as provided in Sections 4.8 and 10.8, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), then either Party shall have the right to refer such Dispute to the Executive Officers for attempted resolution by good faith negotiations during a period of [†]. Any final decision mutually agreed to by the Executive Officers shall be conclusive and binding on the Parties. If such Executive Officers are unable to resolve any such Dispute within such [†] period, then each Party shall, except as provided in Sections 4.8 and 10.8, be entitled to seek relief for such Dispute through binding arbitration in Seattle, Washington in accordance with the then-current Commercial Rules of the American Arbitration Association.
10.5.    Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Washington, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
10.6.    Notices. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified below or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 10.6. Such Notice shall be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second Business Day (at the place of delivery) after deposit with an overnight delivery service. Any notice delivered by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter. This Section 10.6 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. The parties agree that any notice delivered to Omeros by one of JCB Laboratories, LLC or Fagron Compounding Services, LLC shall be deemed adequate notice by JCB, and any notice from Omeros delivered to one of JCB Laboratories, LLC or Fagron Compounding Services, LLC shall be adequate for notice to JCB. Each Party’s address for notice purposes is as follows:

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If to JCB, to:
JCB Laboratories, LLC
7335 W 33rd Street North,
Wichita, KS 67205
Attention: Brian Williamson
Facsimile: 316.773.0406
Fagron Compounding Services, LLC
8710 E 34th Street North,
Wichita, KS 67226
Attention: Brian Williamson
Facsimile: 316.773.0406
If to Omeros, to:
Omeros Corporation
201 Elliott Avenue West
Seattle, WA 98119
Attention: Chief Executive Officer, with a copy to General Counsel
Facsimile: 206.676.5005
10.7.    Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto, are superseded hereby. No amendment, modification, release or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control. This Agreement expressly supersedes the Mutual Confidential Disclosure Agreement between the Parties dated as of September 19, 2014, and all Confidential Information exchanged between the Parties under such Mutual Confidential Disclosure Agreement shall be deemed to have been disclosed under and shall be governed by the terms of this Agreement.
10.8.    Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in Article 6 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Article may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of such Article, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Both Parties agree to waive any requirement that the other (i) post a bond or other security as a condition for obtaining any such relief and (ii) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this Section 10.8 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.
10.9.    Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such

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waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.
10.10.    No Benefit to Third Parties. Except as provided in Article 8, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Persons.
10.11.    Further Assurance. Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
10.12.    Relationship of the Parties. It is expressly agreed that Omeros, on the one hand and JCB, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Omeros, on the one hand, nor JCB, on the other hand, shall have the authority to make any statements, representations or commitments of any kind or to take any action, that will be binding on the other, without the prior written consent of the other Party to do so.
10.13.    References. Unless otherwise specified, (i) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, and (ii) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, as so amended and in effect at the relevant time of reference thereto.
10.14.    Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision. The term “including,” “include,” or “includes” as used herein shall mean including, without limiting the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto.
10.15.    Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile, PDF format via email or other electronically transmitted signatures and such signatures shall bind each Party hereto as if they were original signatures.


† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
24




THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above.
OMEROS CORPORATION
JCB LABORATORIES, LLC


By: /s/ Gregory A. Demopulos, MD
Name: Gregory A. Demopulos, MD
Title: Chief Executive Officer
By: /s/ Brian Williamson   
Name: Brian Williamson
Title: President
 


FAGRON COMPOUNDING SERVICES, LLC


 
By: /s/ Brian Williamson   
Name: Brian Williamson
Title: President

† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
25



Schedule 1.31
Licensed Know-How

A. For OMS103 Product:
1. [†].
2. [†].
3. [†].
4. [†].
5. [†].


† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
26



Schedule 1.32

Licensed Patents


A. For OMS103 Product:
1. US Patent 7,973,068 B2
2. US Patent 8,450,309 B2
3. US Patent Application Publication No. 2013/0324475 A1
4. US Patent Application Publication No. 2009/0253795 A1
5. US Patent Application Publication No. 2013/0035362 A1





† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION




Schedule 1.33
Licensed Products (other than the OMS103 Product)

Additional Licensed Product:
Date of launch in the Territory:
Date of initiation of validated production on JCB’s automated filling line:
Minimum annual sales and marketing expenditures:


† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION




Schedule 1.35
Licensed Trademarks
A.
For OMS103 Product: the trademark ARTHROSOL as well as US Trademark Application 86/259,542 therefor and any US Trademark Registration issued thereon, and any additional trademark applications or registrations that Omeros may file or obtain for such trademark or for stylized designs of such trademark or logos approved by Omeros for use with OMS103.






† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION




Schedule 1.49
Territory

A.
For OMS103 Product: the United States


† DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
EX-12.1 3 ex121_20150630.htm EXHIBIT 12.1 RATIO OF EARNINGS TO FIXED CHARGES EX12.1_2015.06.30


 
 
 
 
 
EXHIBIT 12.1
 
 
 
 
 
Omeros Corporation
Computation of Deficiency in the Coverage of Fixed Charges by Earnings Before Fixed Charges
 
 
 
 
 
 
 
 
 
For the
 
 
 
six
 
 
 
ended
 
 
 
June 30,
 
 
 
Year Ended December 31,
 
2015
 
2014
 
2013
 
2012
 
2011
 
2010
 
(in thousands)
 
(in thousands)
Earnings before fixed charges:
 
 
 
 
 
 
 
 
 
 
Loss from continuing operations before income taxes
$
(35,349
)
 
$
(73,673
)
 
$
(39,796
)
 
$
(38,444
)
 
$
(28,546
)
 
$
(29,251
)
Add fixed charges
3,554

 
6,824

 
5,621

 
2,305

 
2,144

 
2,104

Add amortization of capitalized interest

 

 

 

 

 

Add distributed income of equity investees

 

 

 

 

 

Subtract capitalized interest

 

 

 

 

 

Loss before fixed charges
$
(31,795
)
 
$
(66,849
)
 
$
(34,175
)
 
$
(36,139
)
 
$
(26,402
)
 
$
(27,147
)
Fixed Charges:
 
 
 
 
 
 
 
 
 
 
 
Interest expense
$
1,452

 
$
2,710

 
$
1,865

 
$
1,355

 
$
1,532

 
$
1,328

Amortization of debt expense and loss from extinguishment of debt
441

 
759

 
502

 
374

 
352

 
503

Estimate of interest expense within rental expense
1,661

 
3,355

 
3,254

 
576

 
260

 
273

Preference security dividend requirements of consolidated subsidiaries

 

 

 

 

 

Total fixed charges
$
3,554

 
$
6,824

 
$
5,621

 
$
2,305

 
$
2,144

 
$
2,104

Deficiency of earnings available to cover fixed charges
$
(35,349
)
 
$
(73,673
)
 
$
(39,796
)
 
$
(38,444
)
 
$
(28,546
)
 
$
(29,251
)




EX-31.1 4 ex311_20150630.htm EXHIBIT 31.1 EX31.1_2015.06.30


Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO RULE 13a-14(a)/15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Gregory A. Demopulos, M.D., certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Omeros Corporation;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 
Dated: August 10, 2015
 
 
 
/s/ Gregory A. Demopulos
 
Gregory A. Demopulos, M.D.
Principal Executive Officer


EX-31.2 5 ex312_20150630.htm EXHIBIT 31.2 EX31.2_2015.06.30


Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO RULE 13a-14(a)/15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael A. Jacobsen, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Omeros Corporation;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 
Dated: August 10, 2015
 
 
 
/s/ Michael A. Jacobsen
 
Michael A. Jacobsen
 
Principal Financial and Accounting Officer


EX-32.1 6 ex321_20150630.htm EXHIBIT 32.1 EX32.1_2015.06.30


Exhibit 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Omeros Corporation (the “Company”) for the quarter ended June 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officer of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.
 
 
Dated: August 10, 2015
 
 
 
/s/ Gregory A. Demopulos
 
Gregory A. Demopulos, M.D.
 
Principal Executive Officer


EX-32.2 7 ex322_20150630.htm EXHIBIT 32.2 EX32.2_2015.06.30


Exhibit 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Omeros Corporation (the “Company”) for the quarter ended June 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officer of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.
 
 
Dated: August 10, 2015
 
 
 
/s/ Michael A. Jacobsen
 
Michael A. Jacobsen
 
Principal Financial and Accounting Officer


EX-101.INS 8 omer-20150630.xml XBRL INSTANCE DOCUMENT 0001285819 2015-01-01 2015-06-30 0001285819 2015-08-05 0001285819 2015-06-30 0001285819 2014-12-31 0001285819 2014-01-01 2014-06-30 0001285819 2014-04-01 2014-06-30 0001285819 2015-04-01 2015-06-30