UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q
 
  x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2015
OR
 
o
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 001-36306
 
Eagle Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware
 
2834
 
20-8179278
(State or Other Jurisdiction of
Incorporation or Organization)
 
(Primary Standard Industrial
Classification Code Number)
 
(I.R.S. Employer
Identification Number)
50 Tice Boulevard, Suite 315
Woodcliff Lake, NJ 07677
(201) 326-5300
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices)
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 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   o
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   o
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.
.
Large accelerated filer  o
 
Accelerated filer  o
 
Non-accelerated filer x  
  (Do not check if a
smaller reporting company)
 
Smaller reporting company  o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes   o   No   x
The number of shares outstanding of the registrant’s common stock as of May 11, 2015 : 15,538,943 shares.



Eagle Pharmaceuticals, Inc.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Report on Form 10-Q contains forward-looking statements, that involve risk and uncertainties. The words “may,” “will,” “plan,” “believe,” “expect,” “intend,” “anticipate,” “potential,” “should,” “estimate,” “predict,” “project,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.
These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
the success, cost and timing of our product development activities and clinical trials;
our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;
our ability to obtain funding for our operations;
our plans to research, develop and commercialize our product candidates;
our ability to attract collaborators with development, regulatory and commercialization expertise;
the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
our ability to successfully commercialize our product candidates;
the rate and degree of market acceptance of our product candidates;
our ability to develop sales and marketing capabilities, whether alone or with current or potential future collaborators;
the performance of our strategic collaborators and success of our current strategic collaborations;
regulatory developments in the United States and foreign countries;
the performance of our third-party suppliers and manufacturers;
the success of competing drugs that are or become available;
the loss of key scientific or management personnel;
our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”);
our use of the proceeds from our initial public offering and recent follow-on offering;
the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; and
our ability to prevent or minimize the effects of paragraph IV patent litigation.

In some cases, you can identify these statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expects,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions. These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Report on Form 10-Q and are subject to risks and uncertainties. We discuss many of these risks in greater detail under the heading “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
NOTE REGARDING COMPANY REFERENCES

Throughout this report, “Eagle Pharmaceuticals,” the “Company,” “we,” “us” and “our” refer to Eagle Pharmaceuticals, Inc.

NOTE REGARDING TRADEMARKS

All trademarks, trade names and service marks appearing in this Report on Form 10-Q are the property of their respective owners.








TABLE OF CONTENTS
 
 
 
 
 
Page
Part I-Financial Information
 
 
 
Item 1.
Condensed Financial Statements
 
 
Condensed Balance Sheets as of March 31, 2015 (unaudited) and December 31, 2014 (unaudited)
 
Condensed Statements of Operations for the three months ended March 31, 2015 and 2014 (unaudited)
 
Condensed Statement of Changes in Stockholders' Equity for the three months ended March 31, 2015 (unaudited)
 
Condensed Statements of Cash Flows for the three months ended March 31, 2015 and 2014 (unaudited)
 
Notes to Condensed Financial Statements
Item 2.
Item 3.
Item 4.
 
 
 
Part II-Other Information
 
 
 
Item 1.
Item 1A.
Item 2.
Item 3.
Item 4.
Item 5.
 
Item 6.





EAGLE PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
( In thousands, except share and per share amounts)
(unaudited)

 
March 31, 2015
 
December 31, 2014
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
99,924

 
$
34,869

Short-term investments
15,998

 

Accounts receivable
10,508

 
11,956

Inventories
2,018

 
1,242

Prepaid expenses and other current assets
1,340

 
1,640

Total current assets
129,788

 
49,707

Property and equipment, net
100

 
342

Other assets
45

 
45

Total assets
$
129,933

 
$
50,094

LIABILITIES AND STOCKHOLDERS' EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
5,435

 
$
3,501

Accrued expenses
15,029

 
12,165

Deferred revenue
6,585

 
6,520

Total current liabilities
27,049

 
22,186

Commitments and contingencies


 


Stockholders' equity:
 
 
 
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of March 31, 2015 and December 31, 2014

 

Common stock, $0.001 par value; 50,000,000 shares authorized; 15,509,179 and 14,036,680 issued and outstanding as of March 31, 2015 and December 31, 2014, respectively
15

 
14

Additional paid in capital
192,855

 
137,577

Accumulated deficit
(89,986
)
 
(109,683
)
Total stockholders' equity
102,884

 
27,908

Total liabilities and stockholders' equity
$
129,933

 
$
50,094

See accompanying notes to condensed financial statements.

1


EAGLE PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(unaudited)


 
Three Months Ended 
 March 31,
 
2015
 
2014
 
 
 
 
Revenue:
 
 
 
Product sales
$
3,056

 
$
1,175

Royalty income
3,253

 
3,565

License and other income
30,000

 
265

Total revenue
36,309

 
5,005

Operating expenses:
 
 
 
Cost of revenue
5,948

 
3,360

Research and development
6,285

 
3,794

Selling, general and administrative
3,986

 
1,454

Total operating expenses
16,219

 
8,608

Income (Loss) from operations
20,090

 
(3,603
)
Interest income
7

 
8

Interest expense
(1
)
 
(1
)
Change in value of warrant liability

 
(383
)
Total other income (expense)
6

 
(376
)
Income (Loss) before income tax (provision) benefit
20,096

 
(3,979
)
Income tax (provision) benefit
(399
)
 
1,295

Net Income (Loss)
$
19,697

 
$
(2,684
)
Less dividends on Series A, B, B-1 and C Convertible Preferred Stock

 
(534
)
Net income (loss) attributable to common stockholders
$
19,697

 
$
(3,218
)
Earnings per share attributable to common stockholders:
 
 
 
Basic
$
1.38

 
$
(0.36
)
Diluted
$
1.31

 
$
(0.36
)
Weighted average number of common shares outstanding:
 
 
 
Basic
14,247,019

 
8,862,212

Diluted
15,041,011

 
8,862,212

   
See accompanying notes to condensed financial statements.


2


EAGLE PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY
(In thousands)
(unaudited)

 
Common Stock
 
Additional
Paid-In Capital
 
Accumulated
Deficit
 
Total
Stockholders'
Equity
 
Number of
Shares
 
Amount
 
 
 
Balance at December 31, 2014
14,037

 
$
14

 
$
137,577

 
$
(109,683
)
 
$
27,908

Stock-based compensation expense
 
 
 
 
384

 
 
 
384

Issuance of common stock upon exercise of stock option grants
84

 

 
564

 
 
 
564

Issuance of common stock in connection with follow-on public offering, including underwriter's over-allotment, net of offering costs and underwriter's discount
1,389

 
1

 
54,330

 

 
54,331

Net income
 
 
 
 
 
 
19,697

 
19,697

Balance at March 31, 2015
15,510

 
$
15

 
$
192,855

 
$
(89,986
)
 
$
102,884


See accompanying notes to condensed financial statements.


3


EAGLE PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
 
Three Months Ended March 31,
 
2015
 
2014
Cash flows from operating activities:
 
 
 
Net income (loss)
$
19,697

 
$
(2,684
)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
 
 
 
Depreciation expense
12

 
29

Stock-based compensation
384

 
140

Change in fair value of warrant liability

 
383

Loss on disposal of fixed assets
273

 

Changes in operating assets and liabilities:
 
 
 

Decrease (increase) in accounts receivable
1,448

 
(1,228
)
(Increase) in inventories
(776
)
 

Decrease (increase) in prepaid expenses and other current assets
300

 
(464
)
Decrease in other assets

 
1

Increase in accounts payable
1,884

 
112

Increase (decrease) in deferred revenue
65

 
(325
)
Increase in accrued expenses and other liabilities
2,549

 
1,965

Net cash provided by (used in) operating activities
25,836

 
(2,071
)
Cash flows from investing activities:
 
 
 
Purchase of property and equipment
(43
)
 
(28
)
Purchase of short term investments
(15,998
)
 

Net cash used in investing activities
(16,041
)
 
(28
)
Cash flows from financing activities:
 
 
 
Series C preferred stock offering costs

 
(1
)
Proceeds from common stock option exercise
564

 

Proceeds from exercise of preferred stock warrants

 
21

Proceeds from issuance of common stock from follow-on public offering, net of issuance costs
54,696

 

Proceeds from issuance of common stock from initial public offering, net of issuance costs

 
46,985

Net cash provided by financing activities
55,260

 
47,005

Net increase in cash
65,055

 
44,906

Cash and cash equivalents at beginning of period
34,869

 
9,974

Cash and cash equivalents at end of period
$
99,924

 
$
54,880

Supplemental disclosures of cash flow information:
 
 
 
Cash paid during the period for:
 

 
 

Interest
$
1

 
$
1

Financing costs

 
5,158

Franchise taxes
53

 
8

Non-cash financing activities
 

 
 

Accrued follow-on public offering costs
365

 

Accrued initial public offering costs

 
414

Conversion of preferred stock and accrued dividends to Common stock

 
91,648

Conversion of redeemable warrant liability to Common stock

 
2,280

See accompanying notes to condensed financial statements.

4


EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
( Unaudited)

1. Interim Condensed Financial Statements
The accompanying unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for the fair presentation of the financial information for the interim periods reported have been made. Results of operations for the three months ended March 31, 2015 are not necessarily indicative of the results for the year ending December 31, 2015 or any period thereafter. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and related notes included in our annual report on Form 10-K for the fiscal year ended September 30, 2014, filed with the Securities and Exchange Commission on December 22, 2014.
On January 20, 2015, the Board of Directors of the Company authorized a change in the Company’s fiscal year end from September 30 th to December 31 st .  The change was intended to better align the Company’s fiscal year with the business cycles of other specialty pharmaceutical companies. As a result of the change in fiscal year, the Company’s 2015 fiscal year began on January 1, 2015 and will end on December 31, 2015.
As a result of the change in fiscal year, on February 17, 2015 the Company filed a Transition Report on Form 10-Q covering the transition period from October 1, 2014 to December 31, 2014.
2. Organization and Business Activities
Eagle Pharmaceuticals, Inc. (the "Company", or "Eagle") is a specialty pharmaceutical company focused on developing and commercializing injectable products, primarily in the critical care and oncology areas, using the Food and Drug Administration's ("FDA's") 505(b)(2) NDA regulatory pathway. The Company's business model is to develop proprietary innovations to FDA-approved, injectable drugs, referred to as branded reference drugs, that offer favorable attributes to patients and healthcare providers. The Company has three products currently being sold in the United States under various license agreements in place with commercial partners, including Ryanodex ® , Diclofenac-misoprostol, launched in January 2015, and a ready-to-use formulation of Argatroban. The Company has a number of products currently under development and certain products may be subject to license agreements.
On February 18, 2014 , the Company closed its initial public offering (the "IPO") whereby the Company sold 3,350,000 shares of common stock, at a public offering price of $15.00 per share, before underwriting discounts and expenses. On March 18, 2014 , the underwriters exercised an over-allotment option granted in connection with the offering of 100,000 shares of common stock at the initial public offering price, less the underwriter discount. The aggregate net proceeds received by the Company from the offering were $ 46,069 . Included in this amount is $21 received from the exercise of Series C preferred stock warrants for 1,788 shares of common stock.
In connection with the IPO, the Company's Board of Directors approved a one-for-6.41 reverse stock split of the Company's common stock (that resulted in a proportional adjustment to the conversion ratio of the preferred stock warrants). All references to common stock, common stock equivalents and per share amounts have been changed retroactively in these condensed financial statements and accompanying footnotes have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an equal amount to the reduction in par value of common stock to additional paid-in capital.
On the IPO date, all outstanding shares of preferred stock converted into 7,487,928 shares of common stock and all outstanding warrants were net exercised for 32,286 shares common stock at the initial public offering price. These transactions produced a significant increase in the number of shares outstanding which will impact the year-over-year comparability of the Company’s (loss) earnings per share calculations. Additionally, in connection with the closing of the IPO, the Company amended and restated its articles of incorporation to decrease the number of authorized shares of common and undesignated preferred stock to 50,000,000 and 1,500,000 , respectively.
On February 13, 2015, Eagle entered into an Exclusive License Agreement (the “Cephalon License”) with Cephalon, Inc. ("Cephalon"), a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. ("Teva"), for U.S. and Canadian rights to the Company's bendamustine hydrochloride (HCl) rapid infusion product for treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma. Pursuant to the terms of the Cephalon License, Cephalon will be

5



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



responsible for all U.S. commercial activities for the product including promotion and distribution, and Eagle will be responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies.

Under the terms of the Cephalon License, Eagle received an upfront cash payment of $30.0 million , and Eagle is currently eligible to receive up to $90.0 million in additional milestone payments. In addition, we are entitled to receive royalty payments in the double digit range on net sales of the product, if approved by the FDA. In connection with the License, Eagle has agreed to enter into a supply agreement with Cephalon, pursuant to which Eagle will be responsible for supplying product to Cephalon for a specified period.

In connection with the Cephalon License, on February 13, 2015, Eagle and Cephalon entered into a Settlement and License Agreement (the "Cephalon Settlement Agreement"), pursuant to which the parties agreed to settle the pending patent infringement claims against each other regarding Cephalon's US Patent No. 8,791,270, under which Eagle agreed to enter into a Consent Judgment regarding the ‘270 patent.

On March 20, 2015, the Company completed an underwritten public offering (the "Follow-on Offering") of 1,518,317 shares of common stock, including the exercise by the underwriters of a 30 -day option to purchase an additional 198,041 shares of Common Stock. Of the shares sold, 1,388,517 shares were issued and offered by the Company and 129,800 shares were offered by certain selling stockholders. All of the shares were offered at a price to the public of $42.00 per share. The net proceeds to Eagle from this offering, after deducting underwriting discounts and commissions and other offering expenses payable by us, were approximately $ 54,331 . We did not receive any proceeds from the shares sold by the selling stockholders. The securities described above were offered by us pursuant to a shelf registration statement declared effective by the Securities Exchange Commission on March 13, 2015.
These financial statements are presented in U.S. dollars and are prepared under accounting principles generally accepted in the United States of America (“U.S. GAAP”).
3. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements including disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. The Company's critical accounting policies are those that are both most important to the Company's financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates.
Accounting Guidance Not Yet Adopted
In May 2014, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which supersedes nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP.
The standard is effective for annual periods beginning after December 15, 2016, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our financial statements and have not yet determined the method by which we will adopt the standard in 2017.

6



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



Reclassifications
Certain reclassifications have been made to prior year amounts to conform with the current year presentation.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature.
The Company, at times, maintains balances with financial institutions in excess of the FDIC limit.
Fair Value of Financial Instruments
The Company's financial instruments consist of cash and cash equivalents, accounts receivable, and accounts payable. The carrying values of these financial instruments approximate their fair values due to their short term maturities.
Short Term Investments
Investments consisted of U.S. Treasury securities that had an original maturity of greater than three months. The Company's investments were classified as Level 1 and available-for-sale and are recorded at fair value, based upon quoted market prices. No gains or losses on investments are realized until the sale occurs or a decline in fair value is determined to be other-than-temporary. If a decline in fair value is determined to be other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is established.
Fair Value Measurements
U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. 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. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The fair value of interest-bearing cash, cash equivalents and short term investments are classified as Level 1 at March 31, 2015 and December 31, 2014 .
The Company is required by U.S. GAAP to record certain assets and liabilities at fair value on a recurring basis.
The guidance in ASC 815 required that the Company mark the value of its warrant liability to market and recognize the change in valuation in its statement of operations each reporting period. Determining the warrant liability to be recorded required the Company to develop estimates to be used in calculating the fair value of the warrant.
Since these preferred stock warrants did not trade in an active securities market, the Company recognized a warrant liability and estimated the fair value of these warrants using a Probability-Weighted Expected Returns valuation model. Therefore, the warrant liability was considered a Level 3 measurement. All warrants outstanding immediately prior to the IPO were net exercised in connection with the IPO. There were no outstanding warrants as of March 31, 2015 .

7



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



Concentration of Major Customers and Vendors
The Company's customers are its commercial and licensing partners. The Company is dependent on these commercial partners to market and sell Argatroban; therefore, the Company's future revenues are highly dependent on these collaboration and distribution arrangements. The Company received a $30.0 million upfront payment during the quarter ended March 31, 2015 under the terms of the Cephalon License- see revenue recognition below.
The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows:
 
Three Months Ended 
 March 31,
 
2015
 
2014
Net revenues
 
 
 
The Medicines Company
9
%
 
29
%
Sandoz, Inc. 
3
%
 
71
%
Cephalon, Inc. (Teva) - See Revenue Recognition
83
%
 
%
Other
5
%
 
%
 
100
%
 
100
%
 
March 31,
 
December 31,
 
2015
 
2014
Accounts receivable
 
 
 
The Medicines Company
76
%
 
61
%
Sandoz, Inc. 
15
%
 
35
%
Other
9
%
 
4
%
 
100
%
 
100
%
Currently, for Argatroban, the Company uses one vendor as its sole source supplier. Because of the unique equipment and process for manufacturing Argatroban, transferring manufacturing activities for Argatroban to an alternate supplier would be a time consuming and costly endeavor, and there are only a limited number of manufacturers that are capable of performing this function for the Company.
Pre-Launch Inventory

The Company capitalizes inventory costs associated with certain products prior to regulatory approval and product launch, based on management's judgment of reasonably certain future commercial use and net realizable value, when it is reasonably certain that the pre-launch inventories will be saleable. The determination to capitalize is made once the Company (or its third party development partners) has filed a New Drug Application (an "NDA") that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal hurdles will be cleared. This determination is based on the particular facts and circumstances relating to the expected FDA approval of the drug product being considered, and accordingly, the time frame within which the determination is made varies from product to product. The Company may be required to write down previously capitalized costs related to pre-launch inventories upon a change in such judgment, or due to a denial or delay of approval by regulatory bodies, or a delay in commercialization, or other potential factors. As of March 31, 2015 the Company had $1,400 in inventories related to product that was not yet available to be sold but could be converted to other uses.

Inventory
Inventories are recorded at the lower of cost or market, with cost determined on a first-in, first-out basis and consists of finished products. The Company periodically reviews the composition of inventory in order to identify obsolete, slow-moving or otherwise

8



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



non-saleable items. If non-saleable items are observed and there are no alternate uses for the inventory, the Company will record a write-down to net realizable value in the period that the decline in value is first recognized. In most instances, inventory is shipped from the Company's vendor directly to the Company's customers.
Property and Equipment
Property and equipment are stated at cost. Depreciation is computed over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term.
Research and Development Expense
Costs incurred for research and product development, including costs incurred for technology in the development stage, are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Advance payments for goods or services that will be used for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the related goods are delivered or services performed.
Advertising and Marketing
Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $959 and immaterial for the three months ended March 31, 2015 and 2014 , respectively.
Redeemable Convertible Preferred Stock
The carrying value of redeemable convertible preferred stock was increased by periodic accretions, using the interest method so that the carrying amount would equal the redemption amount at the earliest redemption date.
Accounting for Income Taxes
The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.
The Company received approval to sell a portion of the Company's New Jersey net operating losses ("NOL's") as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology firms with unused net operating loss carryovers and unused research and development credits are allowed to sell these benefits to other firms.
During the three months ended March 31, 2014 , the Company sold New Jersey state net operating loss (NJ NOL) carry forwards, which resulted in the recognition of a $1,295 tax benefit.
During the three months ended March 31, 2015 , the Company recorded a provision for income taxes of $399 based upon its estimated federal AMT and state tax liability.
Revenue Recognition
Product revenue — The Company recognizes net revenue from Argatroban supplied to its commercial partners and Ryanodex ® and Diclofenac-misoprostol supplied to the end user, when the following four basic revenue recognition criteria under the related accounting guidance are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Prior to the shipment of manufactured products, the Company conducts initial product release and stability testing in accordance with cGMP. The Company's commercial partners can return the products within contracted specified timeframes if the products do not meet the applicable inspection

9



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



tests.The Company estimates its return reserves based on its experience with historical return rates. Historically, product returns have not been material. The Company has a no return policy for Ryanodex ® .
Revenues from product sales to end users are recorded net of provisions for estimated chargebacks, rebates, returns (if applicable), prompt pay discounts and other deductions, such as shelf stock adjustments, which can be reasonably estimated. When sales provisions are not considered reasonably estimable by Eagle, the revenue is deferred to a future period when more information is available to evaluate the impact.
Royalties — The Company recognizes revenue from royalties based on its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 60 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial.
License revenue — The Company analyzes each element of our licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments over the period of significant involvement under the related agreements unless the fee is in exchange for products delivered or services rendered that represent the culmination of a separate earnings process and no further performance obligation exists under the contract.
When a sale combines multiple elements upon performance of multiple services, the Company allocates revenue for transactions that include multiple elements to each unit of accounting based on its relative selling price, and recognizes revenue for each unit of accounting when the revenue recognition criteria have been met. The Company follows the selling price hierarchy as outlined in the guidance Revenue Recognition (ASC Topic 605) - Multiple-Deliverable Revenue Arrangements. The guidance provides a hierarchy to determine the selling price to be used for allocating revenue to deliverables: (i) vendor-specific objective evidence (“VSOE”), (ii) third-party evidence (“TPE”) if available and when VSOE is not available, and (iii) best estimate of the selling price (“BESP”) if neither VSOE nor TPE is available. The Company uses BESP to determine the standalone selling price for such deliverables. The Company has an established process for developing BESP, which incorporates, pricing practices, historical selling prices, the effect of market conditions as well as entity-specific factors. Estimated selling price is monitored and evaluated on a regular basis to ensure that changes in circumstances are accounted for in a timely manner.
The Company recognizes milestone payments as revenue upon the achievement of specified milestones only if (1) the milestone payment is non-refundable, (2) substantive effort is involved in achieving the milestone, (3) the amount of the milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone, and (4) the milestone is at risk for both parties. If any of these conditions are not met, we defer the milestone payment and recognize it as revenue over the estimated period of performance under the contract.
As described above, under the terms of the Cephalon License, the Company received an upfront cash payment of $30.0 million , and is eligible to receive up to $90.0 million in additional milestone payments. The $30.0 million upfront payment was allocated between the license issued to Cephalon and obtaining and maintaining regulatory approvals and conducting post-approval clinical studies using the Company’s best estimate of selling price for each deliverable.  The full  $30.0 million was recognized as income in the quarter ended March 31, 2015, as the Company substantially completed its requirements for obtaining regulatory approval, which consisted of filing the New Drug Application on February 13, 2015, and the remaining obligations were estimated to have minimal effort.  The remaining milestones, if achieved, will be recognized in the period earned.
In addition, the Company is entitled to receive royalty payments in the double digit range of net sales of the product, if approved by the FDA.  In connection with the License, the Company agreed to enter into a supply agreement with Cephalon, pursuant to which the Company will be responsible for supplying product to Cephalon for a specified period. 
Collaborative licensing and development revenue — The Company recognizes revenue from reimbursements received in connection with feasibility studies and development work for third parties when its contractual services are performed, provided collectability is reasonably assured. Its principal costs under these agreements include its personnel conducting research and development, and its allocated overhead, as the well as research and development performed by outside contractors or consultants.

10



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



Upon termination of a collaboration agreement, any remaining non-refundable license fees received by the Company, which had been deferred, are generally recognized in full. All such recognized revenues are included in collaborative licensing and development revenue in its statements of operations. The Company recognizes revenue from milestone payments received under collaboration agreements when earned, provided that the milestone event is substantive, its achievability was not reasonably assured at the inception of the agreement, the Company has no further performance obligations relating to the event, and collectability is reasonably assured. If these criteria are not met, the Company recognizes milestone payments ratably over the remaining period of its performance obligations under the collaboration agreement.
Stock-Based Compensation
The Company accounts for stock-based compensation using the fair value provisions of ASC 718, Compensation — Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors. The Company uses a Black-Scholes valuation model as the most appropriate valuation method for pricing these options. Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees . Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. There are customary limitations on the sale or transfer of the stock.
The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions:
 
Three Months Ended 
 March 31,
 
2015
 
2014
Risk-free interest rate
1.63% - 1.92%
 
1.75% - 8.25%
Volatility
30.38%
 
64.00%
Expected term (in years)
5.50 - 7.00 years
 
6.02 - 10.00 years
Expected dividend yield
0.0%
 
0.0%
The risk-free rate assumption was based on U.S. Treasury instruments whose term was consistent with the expected term of the stock options. The expected stock price volatility was determined by examining the historical volatilities for industry peers as the Company did not have sufficient trading history for its common stock. Industry peers consist of those companies in the pharmaceutical industry similar in size, stage of life-cycle and financial leverage. The expected term of stock options represents the average of the vesting period and the contractual life of the option for employees and the life of the option for consultants. The expected dividend assumption is based on the Company's history and expectation of future dividend payouts. Changes in the estimated forfeiture rates are reflected prospectively.
Earnings (Loss) Per Share
Basic earnings (loss) per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings (loss) per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share.

11



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



The dilutive and anti-dilutive common shares equivalents outstanding at the three months ended March 31, 2015 and 2014 were as follows:
 
Three Months Ended 
 March 31,
 
2015
 
2014
Series A

 
1,088,294

Series B

 
924,200

Series B-1

 
679,350

Series C

 
802,522

Series C warrants

 
68,719

Options
118,619

 
841,104

Total
118,619

 
4,404,189


The following table sets forth the computation for basic and diluted net income (loss) per share for the three months ended March 31, 2015 and 2014 :
 
Three Months Ended 
 March 31,
 
2015
 
2014
Numerator
 
 
 
Numerator for basic earnings per share-net income (loss)
$
19,697

 
$
(3,218
)
Numerator for diluted earnings per share-net income (loss)
$
19,697

 
$
(3,218
)
Denominator
 
 
 
Basic weighted average common shares outstanding
14,247,019

 
8,862,212

Dilutive effect of stock options
793,992

 

Diluted weighted average common shares outstanding
15,041,011

 
8,862,212

Basic net income (loss) per share
 
 
 
Basic net income (loss) per share
$
1.38

 
$
(0.36
)
Diluted net income (loss) per share
 
 
 
Diluted net income (loss) per share
$
1.31

 
$
(0.36
)


4. Inventories
Inventories consist of the following:
 
March 31,
 
December 31,
 
2015
 
2014
Raw material - pre launch inventory
$
1,414

 
$

Finished products
604

 
1,242

 
$
2,018

 
$
1,242

During the three months ended March 31, 2015 , the Company recorded total write-offs of $1.1 million attributable to expiring Ryanodex inventory.

12



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



5. Balance Sheet Accounts
Prepaid and Other Current Assets
Prepaid and other current assets consist of the following:
 
March 31,
 
December 31,
 
2015
 
2014
Prepaid expenses and other current assets
 
 
 
Prepaid product costs
$
321

 
$
1,020

Prepaid FDA user fee
99

 
148

Prepaid insurance
628

 
183

Prepaid equipment
118

 

All other
174

 
289

Total Prepaid expenses and other current assets
$
1,340

 
$
1,640

Accrued Expenses
Accrued expenses consist of the following:
 
March 31,
 
December 31,
 
2015
 
2014
Accrued expenses
 
 
 
Royalties due to The Medicines Company
$
6,434

 
$
5,880

Royalties due to SciDose
3,028

 
2,308

Accrued research & development
1,031

 
1,307

Accrued professional fees
537

 
502

Accrued salary and other compensation
733

 
1,025

Accrued product costs
1,363

 
839

Accrued payroll withholding tax payable
809

 

Accrued provision for income tax
399

 

Accrued insurance
421

 

All other
274

 
304

Total Accrued expenses
$
15,029

 
$
12,165


13



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



Deferred Revenue
Deferred revenue consists of the following:
 
March 31,
 
December 31,
 
2015
 
2014
Deferred revenue
 
 
 
The Medicines Company
$
585

 
$
520

Deferred Revenue for ongoing business
585

 
520

Par Pharmaceuticals Companies, Inc. 
5,500

 
5,500

Par Pharmaceuticals Companies, Inc./Tech Transfer
500

 
500

Deferred Revenue from Asset Sales
6,000

 
6,000

Total Deferred revenue
$
6,585

 
$
6,520


6. Common Stock and Stock-Based Compensation
In December 2007, the Company's Board of Directors approved the 2007 Incentive Compensation Plan (the "2007 Plan") enabling the Company to grant multiple stock based awards to employees, directors and consultants, the most common being stock options and restricted stock awards. In November 2013, the Company's Board of Directors approved the 2014 Equity Incentive Plan (the "2014 Plan") which became effective on February 11, 2014. The 2007 Plan was terminated upon the effectiveness of the 2014 Plan and all shares available for issuance under the 2007 Plan were made available under the 2014 Plan. The 2014 Plan provides for the awards of incentive stock options, non-qualified stock options, restricted stock, restricted stock units and other stock-based awards. Awards generally vest equally over a period of four years from grant date. Vesting is accelerated under a change in control of the Company or in the event of death or disability to the recipient. In the event of termination, any unvested shares or options are forfeited. The Company has reserved and made available 974,311 shares of common stock for issuance under the 2014 Plan.
The Company recognized share-based compensation in its statements of operations for the three months ended March 31, 2015 and 2014 as follows:
 
Three Months Ended 
 March 31,
 
2015
 
2014
Selling, general and administrative
$
200

 
$
144

Research and development
184

 
140

Total
$
384

 
$
284

7. Commitments
At March 31, 2015 , the Company has purchase obligations in the amount of $4,535 which represent the contractual commitments under a Contract Manufacturing and Supply Agreement with a supplier. The obligation under the supply agreement is primarily for finished product and research and development.
The Company leases its office space under a lease agreement that originally expired on May 31, 2015 (the "Original Term"). Rental expense was $68 and $72 for the three months ended March 31, 2015 and 2014 . As of March 31, 2015 , the remaining future lease payments under the operating lease for the Original Term was $45 as of March 31, 2015 , payable monthly through May 31, 2015 . On March 16, 2015, the Company amended its existing lease extending its term through June 30, 2020. The future lease payments under the amended operating lease are $2,062 as of March 31, 2015 , payable monthly beginning June 1, 2015 through June 30, 2020.

14



EAGLE PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (Continued)
(In thousands, except share and per share amounts)
(Unaudited)



8. Legal Proceedings
Claims and lawsuits may be filed against the Company from time to time. Although the results of pending claims are always uncertain, the Company believes that it has adequate reserves or adequate insurance coverage in respect of these claims, but no assurance can be given as to the sufficiency of such reserves or insurance coverage in the event of any unfavorable outcome resulting from such actions.
In September 2013, the Company filed a New Drug Application under Section 505(b)(2) for EP-3101 (bendamustine RTD) and notified Cephalon, the holder of Treanda ® , the referenced approved drug in our application, of the Company's 505(b)(2) filing and paragraph IV certification. Cephalon filed a patent infringement lawsuit against the Company in the United States District Court for the District of Delaware on October 21, 2013 to defer the approval of the bendamustine indication alleging that the Company's tentatively approved bendamustine hydrochloride injection infusion product infringes one of its patents, U.S. Patent No. 8,445,524 (the "First Cephalon Lawsuit").
In July 2014, the FDA had granted tentative approval and orphan drug designation to the Company’s New Drug Application for patented Bendamustine Hydrochloride Injection, a ready-to-dilute concentrate solution (“bendamustine RTD”) for the treatment of NHL.
In September 2014, Cephalon moved to dismiss with prejudice the First Cephalon Lawsuit.
On August 12, 2014, Cephalon filed a second lawsuit in the District of Delaware alleging that the Company’s bendamustine product infringes Cephalon’s newly-issued U.S. Patent No. 8,791,270 (the "Second Cephalon Lawsuit").
On February 13, 2015, the Company and Cephalon entered into the Cephalon Settlement Agreement pursuant to which the parties agreed to settle the Second Cephalon Lawsuit, under which the Company has agreed to enter into a Consent Judgment regarding the ‘270 patent. As part of the Cephalon Settlement Agreement, Cephalon has agreed to waive its orphan drug exclusivities for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma with EP-3102.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following information should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K, filed with the SEC on December 22, 2014.
Forward-Looking Information
This Quarterly Report on Form 10-Q contains forward-looking statements, that involve risk and uncertainties. The words “may,” “will,” “plan,” “believe,” “expect,” “intend,” “anticipate,” “potential,” “should,” “estimate,” “predict,” “project,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.
Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item 1A. “Risk Factors” and elsewhere herein. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.
Overview
We are a specialty pharmaceutical company focused on developing and commercializing injectable products utilizing the FDA's 505(b)(2) regulatory pathway. Our business model is to develop proprietary innovations to FDA-approved, injectable drugs that offer longer commercial duration at attractive prices. For each of our products, we intend to enter the market no later than the first generic drug, allowing us to substantially convert the market to our product by addressing the needs of stakeholders who ultimately use our products. We believe we can further extend commercial duration through new intellectual property protection and/or orphan drug exclusivity and three years of regulatory exclusivity as provided under the Hatch-Waxman Act, as applicable.
Our product portfolio now includes three approved products, Argatroban, Ryanodex® (dantrolene sodium) and Diclofenac-misoprostol. We were granted tentative approval for EP-3101 (patented Bendamustine Hydrochloride Injection, ready-to-dilute concentrate solution), (“bendamustine RTD”) and orphan drug designation on EP-3102 Bendamustine RTD rapid infusion for the

15


treatment of chronic lymphocytic leukemia (“CLL”) and indolent B-cell non-Hodgkin’s lymphoma (“NHL”). We currently have five advanced product candidates and three commercialized products. We began commercializing Diclofenac-misoprostol in January 2015.
We have two commercial partners, The Medicines Company and Sandoz Inc., ("Sandoz"), who pursuant to separate agreements market Argatroban. As a result of our commercialization strategy, we have been able to minimize certain expenses, but also are required to share royalty revenues from Argatroban with our commercial partners.
We may commercialize our future products independently in the United States; while outside of the United States, we intend to utilize partners for the commercialization of our products. As part of our strategy for Ryanodex®, we have contracted a specialty sales force who is targeting group purchasing organizations, hospital groups and key stakeholders in acute care settings and primary hospitals. We expect the impact on our results of operations of this commercialization strategy will be that we will receive revenue from direct sales and royalty income will be a less significant part of our revenues. This commercialization strategy will also result in higher infrastructure and selling expenses, along with greater working capital requirements to support this strategy.
Recent Developments
On January 20, 2015, our Board of Directors authorized a change in our fiscal year end from September 30, 2014 to December 31, 2014.  The change was intended to better align our fiscal year with the business cycles of other specialty pharmaceutical companies. As a result of the change in fiscal year, our 2015 fiscal year began on January 1, 2015 and will end on December 31, 2015.

On February 13, 2015, we entered into an Exclusive License Agreement (the “Cephalon License”) with Cephalon, Inc. ("Cephalon"), a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. ("Teva"), for U.S. and Canadian rights to our bendamustine hydrochloride (HCl) rapid infusion product for treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma. Pursuant to the terms of the Cephalon License, Cephalon will be responsible for all U.S. commercial activities for the product including promotion and distribution, and we will be responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies.

Additionally, under the terms of the Cephalon License, we received an upfront cash payment of $30.0 million , and are currently eligible to receive up to $90.0 million in additional milestone payments. In addition, we are entitled to receive royalty payments in the double digit range on net sales of the product, if approved by the FDA. In connection with the Cephalon License, we have agreed to enter into a supply agreement with Cephalon, pursuant to which we will be responsible for supplying product to Cephalon for a specified period.

In connection with the Cephalon License, on February 13, 2015, we entered into a Settlement and License Agreement (the "Cephalon Settlement Agreement") with Cephalon, pursuant to which the parties agreed to settle the pending patent infringement claims against each other regarding Cephalon's US Patent No. 8,791,270, under which we agreed to enter into a Consent Judgment regarding the ‘270 patent. As part of the Cephalon Settlement Agreement, Cephalon has agreed to waive its orphan drug exclusivities for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma with EP-3102.

On February 13, 2015, we submitted a New Drug Application (NDA) to the FDA for EP-3102 our rapid infusion bendamustine product which was accepted for filing by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for a decision on this NDA by the FDA is December 2015.

On March 20, 2015, we completed an underwritten public offering (the "Follow-on Offering") of 1,518,317 shares of common stock, including the exercise by the underwriters of a 30-day option to purchase an additional 198,041 shares of Common Stock. Of the shares sold, 1,388,517 shares were issued and offered by the Company and 129,800 shares were offered by certain selling stockholders. All of the shares were offered at a price to the public of $42.00 per share. The net proceeds from this offering, after deducting underwriting discounts and commissions and other offering expenses payable by us, were approximately $54.3 million . We did not receive any proceeds from the shares sold by the selling stockholders. The securities described above were offered by us pursuant to a shelf registration statement declared effective by the SEC on March 13, 2015.

On April 7, 2015, the United States Patent and Trademark Office (“USPTO”) granted us Patent No. 9,000,021 for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. This patent expires in March 2033.

16


Financial Operations Overview

Revenue
Revenue includes product sales, royalty income and revenue from collaborative arrangements. Revenue results are difficult to predict, and any shortfall in revenue or delay in recognizing revenue could cause operating results to vary significantly from quarter to quarter and year to year.

Product Sales.   We recognize revenues from product sales of Ryanodex ® , Argatroban and Diclofenac-misoprostol. Ryanodex ® and Diclofenac-misoprostol, launched in January 2015, are sold directly to wholesalers, hospitals and surgery centers through a third party logistics partner and Argatroban revenues are through sales to our commercial partners. Sales to our commercial partners are typically made at little or no profit for resale.
Royalty Income.  We recognize revenue from royalties based on our commercial partners' net sales of products, typically calculated as a percentage of the net selling price, which is net of discounts, returns and allowances incurred by our commercial partners. Royalty Income is recognized as earned in accordance with contract terms when it can be reasonably estimated and collectability is reasonably assured.
License Revenue. We analyze each element of our licensing agreement to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue from upfront payments over the period of significant involvement under the related agreements unless the fee is in exchange for products delivered or services rendered that represent the culmination of a separate earnings process and no further performance obligation exists under the contract.
Collaborative Arrangements.  We recognize revenue from reimbursement received in connection with feasibility studies and development work for third parties. Our principal costs under these arrangements include our personnel conducting research and development, and our allocated overhead, as well as research and development performed by outside contractors or consultants.
Our revenues from collaborative arrangements may either be in the form of the recognition of deferred revenues upon milestone achievement for which cash has already been received or recognition of revenue upon milestone achievement, the payment for which is reasonably assured to be received in the future.
Currently, most of our product sales are from Argatroban and Ryanodex® and royalty income is derived from the sale of Argatroban to, and the resale by, two commercial partners, Sandoz and The Medicines Company. The primary factors that determine our revenues derived from Argatroban are:
the level of orders submitted by our commercial partners — Sandoz and The Medicines Company;
the level of institutional demand for Argatroban;
unit sales prices; and
the amount of gross-to-net sales adjustments realized by our marketing partners.
The primary factors that may determine our revenues derived from Ryanodex® are:
the effectiveness of our contracted sales force;
the level of orders submitted by wholesalers, hospitals and surgery centers;
the level of institutional demand for Ryanodex ® ;
unit sales prices; and
the amount of gross-to-net sales and chargebacks.
Chargebacks.   We typically enter into agreements with group purchasing organizations acting on behalf of their hospital members, in connection with the hospitals’ purchases of products. Based on these agreements, most of our hospital customers have the right to receive a discounted price for products and volume-based rebates on product purchases. In the case of discounted pricing, we typically receive a chargeback, representing the difference between the contract acquisition list price and the discounted price.

We also have generated collaborative licensing and development revenue from our collaboration arrangements with third parties. Revenues have been generated from the achievement of milestones pursuant to, or other payments made under, arrangements related to the divestiture of non-core assets, namely Diclofenac-misoprostol tablets, a generic product candidate sold to Hikma, and EP-2101 (topotecan), which was licensed to Pfizer.

17


Cost of Revenue
Cost of revenue consists of the costs associated with producing our products for our commercial partners. In particular, our cost of revenue includes production costs of Argatroban and Ryanodex® paid to a contract manufacturing organization coupled with shipping and customs charges, as well as royalty expense. Cost of revenue may also include the effects of product recalls, if applicable.
Research and Development
Our research and development expenses consist of expenses incurred in developing, testing, manufacturing and seeking regulatory approval of our product candidates, including: expenses associated with regulatory submissions, clinical trials and manufacturing, including additional expenses in preparing for the commercial manufacture of products including Ryanodex®, launched in August 2014, EP-3101 (bendamustine RTD), EP-3102 (bendamustine rapid infusion), EP-6101 (bivalirudin), pemetrexed and our other product candidates; payments made to third-party clinical research organizations, contract laboratories and independent contractors; payments made to consultants who perform research and development on our behalf and assist us in the preparation of regulatory filings; payments made to third-party investigators who perform research and development on our behalf and clinical sites where such research and development is conducted; expenses incurred to maintain technology licenses; and facility, maintenance, allocated rent, utilities, depreciation and amortization and other related expenses. Additionally, costs include salaries, benefits and other related costs, including stock-based compensation for research and development personnel.
Clinical trial expenses for our product candidates are and will be a significant component of our research and development expenses. Product candidates in later stage clinical development generally have higher research and development expenses than those in earlier stages of development. We coordinate clinical trials through a number of contracted investigational sites and recognize the associated expense based on a number of factors, including actual and estimated subject enrollment and visits, direct pass-through costs and other clinical site fees.
We expect to incur additional research and development expenses as we accelerate the development of our product portfolio. These expenditures are subject to numerous uncertainties regarding timing and cost to completion. Completion of clinical trials may take several years or more and the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.
Selling, General and Administrative
Selling, general and administrative costs consist primarily of salaries, benefits and other related costs, including stock-based compensation for executive, finance, selling and operations personnel. Included in selling costs are expenses related to our contracted sales organization and marketing of Ryanodex®. General and administrative expenses include facility and related costs, professional fees for legal, consulting, tax and accounting services, insurance, selling, market research, advisory board and key opinion leaders, depreciation and general corporate expenses. We expect that our selling, general and administrative expenses will increase with the continued development and potential commercialization of our product candidates particularly as we begin to commercialize our own products in the United States, as well as increased expenses associated with being a public company.
Other Income (Expense)
Other income (expense) consists primarily of interest income, interest expense and changes in value of our warrant liability. Interest income consists of interest earned on our cash and cash equivalents. Interest expense consists primarily of cash and non-cash interest costs related to our issuance of convertible notes, including the amortization of debt discounts and deferred financing costs.
Income Tax Benefit
Income tax benefit primarily consists of proceeds from the sale of our New Jersey state net operating losses which is net of any minimum state taxes paid.
Income Tax Provision
Income tax provision reflects management's best assessment of estimated future taxes to be paid.

18


Results of Operations
Comparison of Three Months Ended March 31, 2015 and 2014
Revenues
 
Three Months Ended 
 March 31,
 
Increase/
(Decrease)
 
2015
 
2014
 
 
(in thousands)
Product sales
$
3,056

 
$
1,175

 
$
1,881

Royalty income
3,253

 
3,565

 
(312
)
License and other income
30,000

 
265

 
29,735

Total revenue
$
36,309

 
$
5,005

 
$
31,304

Total revenue increase d $31.3 million  in the three months ended March 31, 2015 to $36.3 million as compared to $5.0 million in the three months ended March 31, 2014 .
Product sales increase d $1.9 million in the three months ended March 31, 2015 to $3.1 million as compared to $1.2 million in the three months ended March 31, 2014 . This increase was due to Ryanodex ® , launched in August 2014, which resulted in net product sales of $1.6 million for the three months ended March 31, 2015 .
Royalty income decrease d $(0.3) million in the three months ended March 31, 2015 to $3.3 million as compared to $3.6 million in the three months ended March 31, 2014 , as a result of decreased end use sales of Argatroban by our commercial partners.
License and other income increase d $29.7 million in the three months ended March 31, 2015 to $30.0 million as compared to $0.3 million in the three months ended March 31, 2014 , as a result of the licensing agreement with Cephalon.

Cost of Revenue
 
Three Months Ended 
 March 31,
 

Increase
 
2015
 
2014
 
 
(in thousands)
Cost of revenue
$
5,948

 
$
3,360

 
$
2,588

Cost of net revenues increase d by $2.6 million to $5.9 million in the three months ended March 31, 2015 from $3.3 million in the three months ended March 31, 2014 . This $2.6 million net increase in cost of revenues was mainly attributable to product sales of Ryanodex ® and an increase in royalty expense to SciDose related to the licensing agreement with Cephalon. We recognized $3.2 million and $2.4 million in royalty expense for the three months ended March 31, 2015 and 2014 , respectively.

Cost of revenue related to Ryanodex ® was approximately $1.6 million , of which $0.2 million was for royalty expense, $1.1 million for expiring inventory, $0.2 million was related to product sales and $0.1 million for other expenses incurred including predominantly certain regulatory and other expenses to our third party logistics partner.


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Research and Development
 
Three Months Ended 
 March 31,
 
Increase/
(Decrease)
 
2015
 
2014
 
 
(in thousands)
EP-6101 (bivalirudin)
$
797

 
$
854

 
$
(57
)
EP-3101 (bendamustine RTD)
731

 
779

 
(48
)
EP-3102 (bendamustine rapid infusion)
2,646

 
496

 
2,150

Ryanodex® (dantrolene sodium)
226

 
535

 
(309
)
Pemetrexed
457

 

 
457

Diclofenac-misoprostol
18

 
300

 
(282
)
All other projects
62

 
31

 
31

Salary and other personnel related expenses
1,348

 
799

 
549

Total Research and Development
$
6,285

 
$
3,794

 
$
2,491

Research and development expenses increase d $2.5 million in the three months ended March 31, 2015 to $6.3 million as compared to $3.8 million in the three months ended March 31, 2014 . Expenses in the three months ended March 31, 2015 were higher than in the three months ended March 31, 2014 as a result of an increase in project spending for EP-3102 (bendamustine rapid infusion), Pemetrexed, and salaries and other personnel related expenses offset by a decrease in project spending for Ryanodex® and Diclofenac-misoprostol.

Selling, General and Administrative
 
Three Months Ended 
 March 31,
 

Increase
 
2015
 
2014
 
 
(in thousands)
Selling, general and administrative
$
3,986

 
$
1,454

 
$
2,532


Selling, general and administrative expenses increase d $2.5 million in the three months ended March 31, 2015 to $4.0 million as compared to $1.5 million in the three months ended March 31, 2014 . This increase is related to a $0.9 million increase in marketing related to Ryanodex® (dantrolene sodium), increase of $0.8 million of professional fees, $0.6 million increase in general and administrative salary and personnel related expenses and a $0.2 million increase in insurance and miscellaneous expenses.

Other Income (Expense)
 
Three Months Ended 
 March 31,
 
Increase/
(Decrease)
 
2015
 
2014
 
 
(in thousands)
Interest income
$
7

 
$
8

 
$
(1
)
Interest expense
(1
)
 
(1
)
 

Change in value of warrant liability

 
(383
)
 
383

Total other income/(expense), net
$
6

 
$
(376
)
 
$
382

Other income and (expense) increased by $0.4 million in the three months ended March 31, 2015 to income of $6.0 thousand as compared to an expense of $0.4 million in the three months ended March 31, 2014 . The increase in other income and (expense) was due to the recognition of the change in value of the warrant liability during three months ended March 31, 2014 . These convertible notes and warrants converted to common stock in connection with the initial public offering in February 2014.
Income Tax (Provision) Benefit
Income tax (provision) benefit decrease d $0.9 million in the three months ended March 31, 2015 to a provision of $0.4 million as compared to a benefit of $1.3 million for the three months ended March 31, 2014 . The decrease in income tax (provision) benefit

20


was due to the sale of our New Jersey State net operating losses during the three months ended March 31, 2014 , offset by the tax provision resulting from the Company recognizing net income in the current quarter.
Net Income (Loss)
Net income for the three months ended March 31, 2015 was $19.7 million as compared to net loss of $(2.7) million in the three months ended March 31, 2014 , as a result of the factors discussed above.

Liquidity and Capital Resources
On February 18, 2014 , we closed our initial public offering whereby 3,350,000 shares of common stock were sold, at a public offering price of $15.00 per share, before underwriting discounts and expenses. On March 18, 2014 , the underwriters exercised an over-allotment option granted in connection with the offering of 100,000 shares of common stock at the initial public offering price, less the underwriter discount. The aggregate net proceeds received by the Company from the offering were $ 46.1 million .

On March 20, 2015, we completed the Follow-on Offering described above under the heading "Recent Developments". As previously indicated, the net proceeds to us from this offering, after deducting underwriting discounts and commissions and other offering expenses payable by us, were approximately $54.3 million .

Our primary uses of cash are to fund working capital requirements, product development costs and operating expenses. Historically, we have funded our operations primarily through private placements of preferred stock and convertible notes and out-licensing product rights. Cash and cash equivalents were $99.9 million and $54.9 million as of March 31, 2015 and March 31, 2014 , respectively. In addition, we have short term investments in U.S. Treasury Bills of $16.0 million at March 31, 2015.

For the three months ended March 31, 2015 , we realized net income of $19.7 million . As of March 31, 2015 , we had a working capital surplus of $102.7 million . For the three months ended March 31, 2014 , we incurred a net loss of $(2.7) million . We have sustained significant losses since our inception on January 2, 2007 and had accumulated a deficit of $ 90.0 million as of March 31, 2015 .
We believe that future cash flows from operations, together with proceeds from the initial and follow-on public offering will be sufficient to fund our currently anticipated working capital requirements through mid-year 2017. No assurance can be given that operating results will improve, out-licensing of products will be successful or that additional financing could be obtained on terms acceptable to us.
Operating Activities:
Net cash provided by operating activities for the three months ended March 31, 2015 was $25.8 million . Net income for the period was $19.7 million offset by non-cash adjustments of approximately $0.7 million from depreciation, stock-based compensation expense and retirement of fixed assets. Net changes in working capital increased cash from operating activities by approximately $5.4 million , due to an increase in inventories of $(0.8) million , an increase in accounts payable of $1.9 million , an increase in deferred revenue of $0.1 million , and an increase in accrued expenses and other liabilities of $2.5 million . We experienced a decrease in accounts receivable of $1.4 million and a decrease in prepaid expenses and other current assets of $0.3 million . Accounts payable and accrued expenses increased primarily due to accrued royalties, accrued provision for income tax and accrued expenses related to the follow-on public offering. The total amount of accounts receivable at March 31, 2015 was approximately $10.5 million , which included approximately $1.3 million of product sales and approximately $9.2 million of royalty income, all with payment terms of 45 days. For royalty income, the 45 -day period starts at the end of the quarter upon receipt of the royalty statement detailing the amount of sales in the prior completed quarter, and, for product sales, the period starts upon delivery of product.
At March 31, 2015 , our cumulative receivables related to royalty income consist of approximately $8.0 million in receivables from The Medicines Company and $1.2 million in receivables from Sandoz.
Based on our agreement with The Medicines Company, our cumulative receivables related to that agreement will continue to aggregate in future periods. Our agreement with The Medicines Company does not contemplate the ability for the parties to net settle amounts receivable or payable. Nonetheless, the Company has periodically collected from The Medicines Company amounts that would be equal to the net amount of receivables due from The Medicines Company, but, because it is unclear whether such cash receipt is intended to be settlement of the net receivable or only a partial payment towards the gross receivable, the Company has presented these receivables and payables in gross amounts on its condensed financial statements. As a result, the cumulative receivable from The Medicines Company, as reduced by the cash received from The Medicines Company, aggregates from period-to-period and has never been fully offset by those actual cash payments. At March 31, 2015 , we recorded a receivable of approximately $8.0 million and a payable of $6.5 million to The Medicines Company (based upon a 50% revenue split on Sandoz sales). The net receivable due from The Medicines Company for the quarter ended March 31, 2015 therefore is $1.5 million . The

21


receivable of $1.5 million from The Medicines Company as of March 31, 2015 therefore represents the net cumulative receivable of the Company.
We believe that our accounts receivable as of March 31, 2015 , after taking into account netting of receivables and payables related to The Medicines Company, are reasonably collectible, and given the payment terms, will be collected in approximately 90 days, and thus would not have a material effect on our liquidity.    
Net cash used in operating activities for the three months ended March 31, 2014 was $2.0 million . Net loss for the period was $2.7 million offset by non-cash adjustments of approximately $0.6 million from the change in the value of the warrant liability, depreciation and stock-based compensation expense. Net changes in working capital increased cash from operating activities by approximately $0.1 million , due to an increase in accounts receivable of $1.2 million , an increase in prepaid expenses and other current assets of $0.5 million and an increase in accounts payable and accrued expenses of $2.1 million . This was offset by a decrease in deferred revenue of $0.3 million. Accounts payable and accrued expenses increased primarily due to accrued royalties and accrued expenses related to the initial public offering. The total amount of accounts receivable at March 31, 2014 was approximately $7.8 million , which included approximately $0.9 million of product sales and approximately $6.5 million of royalty income, all with payment terms of 45 days and approximately $0.4 million of other receivables. For royalty income, the 45-day period starts at the end of the quarter upon receipt of the royalty statement detailing the amount of sales in the prior completed quarter, and, for product sales, the period starts upon delivery of product.
Investing Activities:
In the three months ended March 31, 2015 and 2014 , we invested $43 thousand and $28 thousand , respectively, for the purchase of property and equipment.
In the three months ended March 31, 2015 and 2014 , we invested $16.0 million and $0 , respectively, of short term investments.
Financing Activities:
Net cash provided by financing activities for the three months ended March 31, 2015 was $55.3 million , primarily resulting from the issuance of Common Stock from the follow-on public offering of $54.7 million and stock option exercise of $0.6 million .
Net cash provided by financing activities for the three months ended March 31, 2014 was $47.0 million , primarily resulting from the issuance of Common Stock from the initial public offering and the exercise of warrants of $20.9 thousand .
Contractual Obligations
Our future material contractual obligations include the following (in thousands):

 
 
Total
 
2015
 
2016
 
2017
 
2018
 
2019
 
Beyond
 Operating lease obligations
 
$
2,107

 
230

 
417

 
417

 
417

 
417

 
209

    
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which supersedes nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP.
The standard is effective for annual periods beginning after December 15, 2016, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our financial statements and have not yet determined the method by which we will adopt the standard in 2017.
No accounting standards or interpretations issued recently are expected to have a material impact on our financial position, operation or cash flow.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future material effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources.

22


Impact of Inflation
While it is difficult to accurately measure the impact of inflation due to the imprecise nature of the estimates required, we believe the effects of inflation, if any, on our results of operations and financial condition have been immaterial.

Item 3. Quantitative and Qualitative Disclosures About Market Risk
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. Our exposure to market risk is confined to our cash and cash equivalents. As of March 31, 2015 we had cash and cash equivalents of $99.9 million . We do not engage in any hedging activities against changes in interest rates. Because of the short-term maturities of our cash and cash equivalents and short-term investments, we do not believe that a change in market rates would have any significant impact on the realized value of our investments. We may, however, require additional financing to fund future obligations and no assurance can be given that the terms of future sources of financing will not expose us to material market risk.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Based on their evaluation at March 31, 2015 , our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended March 31, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


23


PART II-OTHER INFORMATION

Item 1. Legal Proceedings
Cephalon (U.S. Patent No. 8,445,524)
On October 21, 2013, Cephalon Inc. ("Cephalon"), a subsidiary of Teva, filed a lawsuit in the United States District Court for the District of Delaware alleging that our tentatively approved bendamustine hydrochloride injection infusion product infringes one of its patents, U.S. Patent No. 8,445,524. On November 15, 2013, we filed an Answer and Counterclaims seeking Declaration of Non-infringement. On December 9, 2013, Cephalon filed an Answer to our counterclaims. At Cephalon’s request, the court dismissed this suit with prejudice on November 10, 2014.
Cephalon (U.S. Patent No. 8,791,270)
On July 29, 2014, Patent No. 8,791,270 was issued to Cephalon, and was subsequently listed in the FDA’s Orange Book for the referenced listed drug Treanda®. On August 12, 2014, Cephalon filed a lawsuit against us in the United Stated District Court for the District of Delaware alleging infringement by our NDA filing of U.S. Patent No. 8,791,270. On September 3, 2014, we filed an Answer and Counterclaims seeking a Declaration of Non-infringement and/or Invalidity. On September 15, 2014, Cephalon filed an Answer to our counterclaims. On October 31, 2014, our lawsuit was consolidated with twenty-five other lawsuits Cephalon had filed against sixteen defendants who seek to manufacture generic Treanda®.
On February 13, 2015, the Company entered into an Exclusive License Agreement (the “Cephalon License”) with Cephalon, Inc. ("Cephalon"), a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. ("Teva"), for U.S. and Canadian rights to the Company's bendamustine hydrochloride (HCl) rapid infusion product for treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma. Pursuant to the terms of the Cephalon License, Cephalon will be responsible for all U.S. commercial activities for the product including promotion and distribution, and the Company will be responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies.

Also, on February 13, 2015, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for EP-3102, its rapid infusion bendamustine product, which was accepted by the FDA on April 14, 2015. The Prescription Drug User Fee Act (PDUFA) goal date for a decision on this NDA by the FDA is December 2015.

Additionally, the Company received an upfront cash payment of $30.0 million, and is currently eligible to receive up to $90.0 million in additional milestone payments. In addition, the Company will receive royalty payments in the double digit range of net sales of the product, if approved by the FDA. In connection with the Cephalon License, the Company and Cephalon have agreed to enter into a supply agreement, pursuant to which the Company will be responsible for supplying product to Cephalon for a specified period.

In connection with the entry into the License, on February 13, 2015, the Company and Cephalon entered into a Settlement and License Agreement (the "Cephalon Settlement Agreement") pursuant to which the parties agreed to settle the pending patent infringement claims against each other regarding Cephalon's US Patent No. 8,791,270, under which the Company has agreed to enter into a Consent Judgment regarding the ‘270 patent. As part of the Cephalon Settlement Agreement, Cephalon has agreed to waive its orphan drug exclusivities for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma with EP-3102.

Other
From time to time we are party to legal proceedings in the course of our business in addition to those described above. We do not, however, expect such other legal proceedings to have a material adverse effect on our business, financial condition or results of operations.

Item 1a. Risk Factors
Except for the risk factors set forth below, there have been no material changes from the Company’s risk factors and uncertainties disclosed in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2014. For a complete discussion of the Company's risk factors, refer to Part I, Item 1A, “Risk Factors,” contained in the Company’s Annual Report on Form 10-K for the period ended September 30, 2014.

24


We have incurred significant losses since our inception and we may continue to incur significant losses for the foreseeable future and may never be profitable.
We have a limited operating history. To date, we have focused primarily on developing a broad product portfolio and have obtained regulatory approval for three products. Some of our product candidates will require substantial additional development time and resources before we would be able to receive regulatory approvals, implement commercialization strategies and begin generating revenue from product sales. We have net income of $19.7 million for the three months ended March 31, 2015, however, we may not generate significant revenue from sales of our product candidates in the near-term, if ever. As of March 31, 2015, we had an accumulated deficit of $90.0 million.
We have devoted most of our financial resources to product development. To date, we have financed our operations primarily through the sale of equity and debt securities. The size of our future net losses will depend, in part, on the rate of future expenditures and our ability to generate revenue. To date, only Argatroban, Ryanodex® and diclofenac-misoprostol have been commercialized, and if our product candidates are not successfully developed or commercialized, or if revenue is insufficient following marketing approval, we will not achieve profitability and our business may fail. Even if we successfully obtain regulatory approval to market our product candidates in the United States, our revenue is also dependent upon the size of the markets outside of the United States, as well as our ability to obtain market approval and achieve commercial success in those jurisdictions.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to fully predict the timing or amount of our expenses, but we expect to continue to incur substantial expenses, which we expect to increase as we expand our development activities and product portfolio. As a result of the foregoing, we expect to continue to incur significant and increasing losses and negative cash flows for the foreseeable future, which may increase compared to past periods. We believe that our existing cash and cash equivalents, together with interest thereon, may only be sufficient to fund our operations for a minimum of twelve months.
We are heavily dependent on the success of our lead product candidates EP-3101 (bendamustine RTD), EP-3102 (bendamustine rapid infusion), EP-6101 (bivalirudin) and EP-4104 (dantrolene for EHS). We cannot give any assurance that we will receive regulatory approval for such product candidates, which is necessary before they can be commercialized.

Our business and future success are substantially dependent on our ability to successfully and timely develop, obtain regulatory approval for, and commercialize our lead product candidates EP-3101 (bendamustine RTD), EP-3102 (bendamustine rapid infusion), and EP-4104 (dantrolene for EHS). Any delay or setback in the development of any of these product candidates could adversely affect our business. Our planned development, approval and commercialization of these product candidates may fail to be completed in a timely manner or at all. Our other product candidates, EP-6101 (bivalirudin) and EP-5101 (pemetrexed), are at an earlier development stage and it will require additional time and resources to develop and seek regulatory approval for such product candidates and, if we are successful, to proceed with commercialization. We cannot provide assurance that we will be able to obtain approval for any of our product candidates from the FDA or any foreign regulatory authority or that we will obtain such approval in a timely manner. For example, in August 2009, we submitted our product EP-2101 (topotecan) for approval in the United States under the 505(b)(2) regulatory pathway, referencing the brand product, Hycamtin. Ultimately, the FDA determined that it could not approve the application as submitted due to the amount of active drug per vial in our product and the potential for unintentional overdose. Based on the FDA's feedback and our determination that the market for topotecan had become overly competitive with multiple players, we decided not to continue to pursue product approval and we do not currently have plans to commercialize EP-2101 (topotecan). Additionally as of September 30, 2014 we have decided not to commercialize EP-2101.

An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our product candidate.
Our product candidates will be submitted to the FDA for approval under Section 505(b)(2) of the FDCA. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies that were not conducted by, or for, the applicant and on which the applicant has not obtained a right of reference. The 505(b)(2) application would enable us to reference published literature and/or the FDA's previous findings of safety and effectiveness for the branded reference drug. For NDAs submitted under Section 505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act apply. In accordance with the Hatch-Waxman Act, such NDAs may be required to include certifications, known as paragraph IV certifications, that certify that any patents listed in the Patent and Exclusivity Information Addendum of the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, with respect to any product referenced in the 505(b)(2) application, are invalid, unenforceable or will not be infringed by the manufacture, use or sale of the product that is the subject of the 505(b)(2) NDA.
Under the Hatch-Waxman Act, the holder of patents that the 505(b)(2) application references may file a patent infringement lawsuit after receiving notice of the paragraph IV certification. Filing of a patent infringement lawsuit against the filer of the 505(b)(2) applicant within 45 days of the patent owner's receipt of notice triggers a one-time, automatic, 30-month stay of the FDA's ability

25


to approve the 505(b)(2) NDA, unless patent litigation is resolved in the favor of the paragraph IV filer or the patent expires before that time. Accordingly, we may invest a significant amount of time and expense in the development of one or more product candidates only to be subject to significant delay and patent litigation before such product candidates may be commercialized, if at all. In addition, a 505(b)(2) application will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, or NCE, listed in the Orange Book for the referenced product has expired. The FDA may also require us to perform one or more additional clinical studies or measurements to support the change from the branded reference drug, which could be time consuming and could substantially delay our achievement of regulatory approvals for such product candidates. The FDA may also reject our future 505(b)(2) submissions and require us to file such submissions under Section 505(b)(1) of the FDCA, which would require us to provide extensive data to establish safety and effectiveness of the drug for the proposed use and could cause delay and be considerably more expensive and time consuming. These factors, among others, may limit our ability to successfully commercialize our product candidates.
Companies that produce branded reference drugs routinely bring litigation against abbreviated new drug application, or ANDA, or 505(b)(2) applicants that seek regulatory approval to manufacture and market generic and reformulated forms of their branded products. These companies often allege patent infringement or other violations of intellectual property rights as the basis for filing suit against an ANDA or 505(b)(2) applicant. Likewise, patent holders may bring patent infringement suits against companies that are currently marketing and selling their approved generic or reformulated products.
Litigation to enforce or defend intellectual property rights is often complex and often involves significant expense and can delay or prevent introduction or sale of our product candidates. If patents are held to be valid and infringed by our product candidates in a particular jurisdiction, we would, unless we could obtain a license from the patent holder, be required to cease selling in that jurisdiction and may need to relinquish or destroy existing stock in that jurisdiction. There may also be situations where we use our business judgment and decide to market and sell our approved products, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts, which is known as an "at-risk launch." The risk involved in doing so can be substantial because the remedies available to the owner of a patent for infringement may include, among other things, damages measured by the profits lost by the patent owner and not necessarily by the profits earned by the infringer. In the case of a willful infringement, the definition of which is subjective, such damages may be increased up to three times. Moreover, because of the discount pricing typically involved with bioequivalent and, to a lesser extent, 505(b)(2), products, patented branded products generally realize a substantially higher profit margin than bioequivalent and, to a lesser extent, 505(b)(2), products, resulting in disproportionate damages compared to any profits earned by the infringer. An adverse decision in patent litigation could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenue.
We have very limited sales, marketing or distribution experience and have only recently started the initial phases of developing an internal commercial organization. Although we have begun to establish a small, focused, specialty sales and marketing organization to promote Ryanodex® in the United States, we currently have no such organization or capabilities, and the cost of establishing and maintaining such an organization may exceed the benefit of doing so. We have very limited prior experience in the marketing, sale and distribution of pharmaceutical products and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products. We also intend to enter into strategic partnerships with third parties to commercialize our product candidates both inside and outside of the United States and have recently entered into a strategic partnership with Cephalon, a wholly owned subsidiary of Teva, to commercialize our bendamustine hydrochloride (HCl) rapid infusion, if approved. We may have limited or no control over the sales, marketing and distribution activities of Cephalon. Our future revenues may depend heavily on the success of the efforts of Cephalon.

We may have difficulty establishing additional relationships with third parties on terms that are acceptable to us, or in all of the regions where we wish to commercialize our products, or at all. If we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate sufficient product revenue and may not become profitable. We will be competing with many companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.

26


In addition to the agreements we have for Argatroban and bendamustine hydrochloride (HCl) rapid infusion, we may enter into agreements with third parties to market Ryanodex® (dantrolene sodium) and diclofenac-misoprostol outside the United States. Additionally, we may enter into agreements with third parties to market our products, as well as Argatroban, outside the United States. We expect that we will be subject to additional risks related to entering into international business relationships, including:
different regulatory requirements for drug approvals in foreign countries;
reduced protection for intellectual property rights;
unexpected changes in tariffs, trade barriers and regulatory requirements;
economic weakness, including inflation, or political instability in particular foreign economies and markets;
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
foreign taxes, including withholding of payroll taxes;
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
workforce uncertainty in countries where labor unrest is more common than in the United States;
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
The biopharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We expect to have competitors both in the United States and internationally, including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. For example, Argatroban is currently marketed in the United States by, among others, GlaxoSmithKline, or GSK, West-Ward Pharmaceuticals, or West-Ward, and Teva Pharmaceutical Industries Ltd., or Teva, and bendamustine is marketed in the United States by Cephalon under the brand name Treanda ® . Further, makers of branded reference drugs could also enhance their own formulations in a manner that competes with our enhancements of these drugs. Cephalon has obtained approval for a ready to dilute, or RTD, version of Treanda ® which will compete with our EP-3101 (bendamustine RTD) product.
Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. As a result, these companies may obtain regulatory approval more rapidly than we are able and may be more effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis drug products or drug delivery technologies that are more effective or less costly than Argatroban and Ryanodex® or any product candidate that we are currently developing or that we may develop. In addition, our competitors may file citizens' petitions with the FDA in an attempt to persuade the FDA that our products, or the clinical studies that support their approval, contain deficiencies. Such actions by our competitors could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2).
We believe that our ability to successfully compete will depend on, among other things:
the efficacy and safety of our products and product candidates, including as relative to marketed products and product candidates in development by third parties;
the time it takes for our product candidates to complete clinical development and receive marketing approval;
the ability to maintain a good relationship with regulatory authorities;
the ability to commercialize and market any of our product candidates that receive regulatory approval;
the price of our products, including in comparison to branded or generic competitors;
whether coverage and adequate levels of reimbursement are available under private and governmental health insurance plans, including Medicare;
the ability to protect intellectual property rights related to our products and product candidates;
the ability to manufacture on a cost-effective basis and sell commercial quantities of our products and product candidates that receive regulatory approval; and
acceptance of any of our products and product candidates that receive regulatory approval by physicians and other health care providers.
If our competitors market products that are more effective, safer or less expensive than our product candidates, if any, or that reach the market sooner than our product candidates, if any, we may enter the market too late in the cycle and may not achieve commercial

27


success. In addition, the biopharmaceutical industry is characterized by rapid technological change. Because we have limited research and development capabilities, it may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive or not economical.
We rely on third parties to manufacture commercial supplies of Argatroban, Ryanodex®, Diclofenac-misoprostol and clinical supplies of our product candidates, and we intend to rely on third parties to manufacture commercial supplies of any other approved products. The commercialization of any of our products could be stopped, delayed or made less profitable if those third parties fail to provide us with sufficient quantities of product or fail to do so at acceptable quality levels or prices or fail to maintain or achieve satisfactory regulatory compliance.
We do not own any manufacturing facilities, and we do not currently, and do not expect in the future, to independently conduct any aspects of our product manufacturing and testing, or other activities related to the clinical development and commercialization of our product candidates. We currently rely, and expect to continue to rely, on third parties with respect to these items, and control only certain aspects of their activities.
Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it could delay our product candidate development and commercialization activities. Our reliance on these third parties reduces our control over these activities but does not relieve us of our responsibility to ensure compliance with all required legal, regulatory and scientific standards and any applicable trial protocols. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements or our stated study plans and protocols, we will not be able to complete, or may be delayed in completing, clinical trials required to support future regulatory submissions and approval of our product candidates.
Our products and product candidates are highly reliant on very complex sterile techniques and personnel aseptic techniques. The facilities used by our third-party manufacturers to manufacture our products and product candidates must be approved by the applicable regulatory authorities pursuant to inspections that will be conducted after we submit our NDA to the FDA. If any of our third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the applicable regulatory authorities' strict regulatory requirements, or pass regulatory inspection, they will not be able to secure or maintain regulatory approval for the manufacturing facilities. In addition, we have no control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Quality problems in manufacturing are linked to a majority of shortages of sterile injectable drugs. Some of the largest manufacturers of sterile injectable drugs have had serious quality problems leading to the temporary voluntary closure or renovations of major production facilities. Further, as we scale up manufacturing of our product candidates and conduct required stability testing, product packaging, equipment and process-related issues may require refinement or resolution in order for us to proceed with our planned clinical trials and obtain regulatory approval for commercialization of our product candidates. In the future, for example, we may identify impurities in the product manufactured for us for commercial supply, which could result in increased scrutiny by the regulatory agencies, delays in our clinical program and regulatory approval, increases in our operating expenses, or failure to obtain or maintain approval for our product candidates. If the FDA or any other applicable regulatory authority does not approve these facilities to manufacture our products or if they withdraw any such approval in the future, or if our suppliers or third-party manufacturers decide they no longer want to manufacture our products, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our products or product candidates.
More generally, manufacturers of pharmaceutical products often encounter difficulties in production, particularly in scaling up and validating initial production. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Additionally, our manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to make product candidates available for clinical trials and development purposes or to further commercialize Argatroban, Ryanodex® and Diclofenac-misoprostol or commercialize any of our other product candidates in the United States would be jeopardized. Any delay or interruption in our ability to meet commercial demand may result in the loss of potential revenues and could adversely affect our ability to gain market acceptance for approved products. In addition, any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely. Additionally, if supply from one approved manufacturer is interrupted, there could be a significant disruption in commercial supply. Regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines.
The occurrence of any of these factors could have a material adverse effect on our business, results of operations, financial condition and prospects.

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The design, development, manufacture, supply, and distribution of our product candidates is highly regulated and technically complex.
All entities involved in the preparation of therapeutics for clinical trials or commercial sale, including our existing contract manufacturers for our product candidates, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP and equivalent foreign standards. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of our product candidates that may not be detectable in final product testing. The development, manufacture, supply, and distribution of Argatroban and Ryanodex®, as well as our other product candidates, is highly regulated and technically complex. We, along with our third-party providers, must comply with all applicable regulatory requirements of the FDA and foreign authorities.
We, or our contract manufacturers, must supply all necessary documentation in support of our regulatory filings for our product candidates on a timely basis and must adhere to the FDA's good laboratory practices, or GLP, and cGMP regulations enforced by the FDA through its facilities inspection program, and the equivalent standards of the regulatory authorities in other countries. Any failure by our third-party manufacturers to comply with cGMP or failure to scale-up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a timely manner, could lead to a delay in, or failure to obtain, regulatory approval of any of our product candidates. Our facilities and quality systems and the facilities and quality systems of some or all of our third-party contractors must also pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of our product candidates or any of our other potential products. In addition, the regulatory authorities in any country may, at any time, audit or inspect a manufacturing facility involved with the preparation of our product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities and quality systems do not pass a pre-approval plant inspection, FDA approval of our product candidates, or the equivalent approvals in other jurisdictions, will not be granted.
Regulatory authorities also may, at any time following approval of a product for sale, audit our manufacturing facilities or those of our third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business. If we or any of our third-party manufacturers fail to maintain regulatory compliance, the FDA can impose regulatory sanctions including, among other things, refusal to approve a pending application for a new drug product or biological product or revocation of a pre-existing approval. As a result, our business, financial condition and results of operations may be materially harmed.
We rely on limited sources of supply for Argatroban, Ryanodex®, Diclofenac-misoprostol and for our product candidates, and any disruption in the chain of supply may impact production and sales of Argatroban and cause delay in developing and commercializing our product candidates.
We currently have relationships with only one third party for the manufacture of each of our most advanced product candidates and for our commercial supply of Argatroban. These include development relationships with Zydus BSV Pharma Pvt. Ltd. for our EP-3101 (bendamustine RTD) product and AAIPharma Services Corp. for our dantrolene product and a supply agreement with Cipla Limited for supply of Diclofenac-misoprostol and Argatroban product to The Medicines Company and Sandoz under their agreements with us for commercialization of Argatroban. Because of the unique equipment and process for manufacturing Argatroban, transferring manufacturing activities for Argatroban to an alternate supplier would be a time-consuming and costly endeavor, and there are only a limited number of manufacturers that we believe are capable of performing this function for us. Switching finished drug suppliers may involve substantial cost and could result in a delay in our desired clinical and commercial timelines. If any of these single-source manufacturers breaches or terminates their agreements with us, we would need to identify an alternative source for the manufacture and supply of product candidates to us for the purposes of our development and commercialization of the applicable products. Identifying an appropriately qualified source of alternative supply for any one or more of these product candidates could be time consuming, and we may not be able to do so without incurring material delays in the development and commercialization of our product candidates, which could harm our financial position and commercial potential for our products. Any alternative vendor would also need to be qualified through an NDA supplement which could result in further delay. The FDA or other regulatory agencies outside of the United States may also require additional studies if we appoint a new manufacturer for supply of our product candidates that differs from the manufacturer used for clinical development of such product candidates. For our other product candidates, we expect that only one supplier will initially be qualified as a vendor with the FDA. If supply from the approved vendor is interrupted, there could be a significant disruption in commercial supply.

29


These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product candidates, cause us to incur higher costs and prevent us from commercializing them successfully. Furthermore, if our suppliers fail to deliver the required commercial quantities of components and active pharmaceutical ingredient on a timely basis and at commercially reasonable prices, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials may be delayed or we could lose potential revenue.
If any of our current strategic collaborators fail to perform their obligations or terminate their agreements with us, the development and commercialization of the product candidates under such agreements could be delayed or terminated and our business could be substantially harmed.

On February 13, 2015, we entered into an exclusive license agreement, which we refer to as the Cephalon agreement, with Cephalon, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., for U.S. and Canadian rights to the our bendamustine hydrochloride (HCl) rapid infusion product for treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma. Pursuant to the terms of the Cephalon agreement, Cephalon will be responsible for all U.S. commercial activities for the product including promotion and distribution, and we will be responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies.

This strategic collaboration may not be scientifically or commercially successful due to a number of important factors, including the following:
If our development efforts for our product do not result in a successful commercial product, or we fail to obtain or maintain any regulatory approvals, we may not receive all anticipated milestone and royalty payments.
Cephalon has significant discretion in determining the efforts and resources that it will apply to their strategic collaboration with us. The timing and amount of any cash payments, milestones and royalties that we may receive under such agreements will depend on, among other things, the efforts, allocation of resources and the commercialization of our product by Cephalon under the Cephalon agreement;
Cephalon currently markets a competitive bendamustine product, Treanda, in the United States. In addition, it is possible that Cephalon may develop and commercialize, either alone or with others, or be acquired by a company that has, products that are similar to or competitive with the product candidates that they license from us;
Cephalon may change the focus of their commercialization efforts or pursue higher-priority programs;
Cephalon may terminate its strategic collaboration with us on short notice, which could make it difficult for us to attract new strategic collaborators or adversely affect how we are perceived in the scientific and financial communities;
Cephalon has the right to maintain or defend our intellectual property rights licensed to them in their territories, and, although we may have the right to assume the maintenance and defense of our intellectual property rights if they do not, our ability to do so may be compromised by our strategic collaborators’ acts or omissions; and
Cephalon may not comply with all applicable regulatory requirements, or fail to report safety data in accordance with all applicable regulatory requirements.
If Cephalon fails to effectively commercialize our product, we may not be able to replace them with another collaborator.
If our agreement with Cephalon terminates, we are required to pay them a portion of our future profits on the product.
Any of these events could have a material adverse effect on our business, results of operations and our ability to achieve future profitability, and could cause our stock price to decline.
We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
As of March 31, 2015 we had a total of 30 full-time and one part time employees in the United States and one full time consultant in India. As our company matures, we expect to expand our employee base to increase our managerial, scientific and engineering, operational, sales, marketing, financial and other resources and to hire more consultants and contractors. Future growth would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate and integrate additional employees, consultants and contractors. Also, our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Future growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of our existing or future product candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenue could be reduced and we may not be able to implement our business strategy. Our future financial performance and our ability to sell Argatroban and Ryanodex® and commercialize our product candidates, if approved, and compete effectively will depend, in part, on our ability to effectively manage any future growth.

30


We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability.
The use of our product candidates in clinical trials (if any), and the sale of Argatroban, Ryanodex® or diclofenac-misoprostol and any product candidates for which we obtain marketing approval, exposes us to the risk of product liability claims. Product liability claims might be brought against us by consumers, health care providers, pharmaceutical companies or others selling or otherwise coming into contact with Argatroban, Ryanodex® or diclofenac-misoprostol, and other approved future products and our product candidates. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:
impairment of our business reputation;
withdrawal of clinical study participants;
costs due to related litigation;
distraction of management's attention from our primary business;
substantial monetary awards to patients or other claimants;
the inability to commercialize our product candidates; and
decreased demand for Argatroban, Ryanodex® and diclofenac-misoprostol and our product candidates, if approved for commercial sale.
Our current product liability insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and in the future we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business.
The patents and the patent applications that we have covering our products are limited to specific formulations, methods of use and processes, and our market opportunity for Argatroban and Ryanodex® and our product candidates may be limited by the lack of patent protection for the active ingredients and by competition from other formulations and delivery methods that may be developed by competitors.
Patent protection on the active ingredient in Argatroban has expired, and there is therefore no composition of matter patent protection available for the active ingredient in Argatroban. This is also the case with respect to our other product candidates. We have obtained, and continue to seek to obtain patent protection of other aspects of Argatroban and our product candidates, including specific formulations, methods of use and processes, which may not be as effective as composition of matter coverage in preventing work-arounds by competitors. As a result, generic products that do not infringe the claims of our issued patents covering formulations, methods of use and processes are, or may be, available while we are marketing our products. Competitors who obtain the requisite regulatory approval will be able to commercialize products with the same active ingredients as Argatroban and such other product candidates so long as the competitors do not infringe any process, use or formulation patents that we have developed for our products, subject to any regulatory exclusivity we may be able to obtain for our products.
The number of patents and patent applications covering products containing the same active ingredient as Argatroban and our product candidates indicates that competitors have sought to develop and may seek to commercialize competing formulations that may not be covered by our patents and patent applications. The commercial opportunity for Argatroban and our product candidates could be significantly harmed if competitors are able to develop and commercialize alternative formulations of Argatroban and our product candidates that are different from ours and do not infringe our issued patents covering our products.
Ryanodex ® (dantrolene sodium), Argatroban and diclofenac-misoprostol have been approved by the FDA, and we anticipate that other product candidates will be approved by the FDA in the future. For our current products on the market, and future products once they are on the market, one or more third parties may also challenge the patents that we control covering our products, which could result in the invalidation or unenforceability of some or all of the relevant patent claims of our issued patents covering our products. Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Ryanodex ® (dantrolene sodium), Argatroban and diclofenac-misoprostol have been approved by the FDA, and we anticipate that other product candidates will be approved by the FDA in the future. Once our products are on the market, one or more third parties may also challenge the patents that we control covering our products in court or the US PTO, which could result in the invalidation or unenforceability of some or all of the relevant patent claims of our issued patents covering our products.
If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering one of our products or product candidates, the defendant could counterclaim that the patent covering our product or product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are common, and there are numerous grounds upon which a third party can assert invalidity or unenforceability

31


of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business.
Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we or our licensors that control the prosecution and maintenance of our licensed patents fail to maintain the patents and patent applications covering our product candidates, our competitors might be able to enter the market, which would have a material adverse effect on our business.
Our initial public offering was completed in February 2014 at a public offering price of $15.00 per share followed by a secondary offering in March 2015 at a public offering price of $42.00 per share. The trading price of our common stock is likely to be volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:
any delay in filing an NDA for any of our product candidates and any adverse development or perceived adverse development with respect to the FDA's review of that NDA;
failure to successfully execute our commercialization strategy with respect to Argatroban, Ryanodex®, diclofenac-misoprostol or any other approved product in the future;
adverse results or delays in clinical trials, if any;
significant lawsuits, including patent or stockholder litigation;
inability to obtain additional funding;
failure to successfully develop and commercialize our product candidates;
changes in laws or regulations applicable to our product candidates;
inability to obtain adequate product supply for our product candidates, or the inability to do so at acceptable prices;
unanticipated serious safety concerns related to the use of Argatroban, Ryanodex®, diclofenac-misoprostol, or any of our product candidates;
adverse regulatory decisions;
introduction of new products or technologies by our competitors;
failure to meet or exceed product development or financial projections we provide to the public;
failure to meet or exceed the estimates and projections of the investment community;
the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
additions or departures of key scientific or management personnel;
changes in the market valuations of similar companies;
sales of our common stock by us or our stockholders in the future; and
trading volume of our common stock.
We expect that our stock price may fluctuate significantly.
The stock market in general, and The Nasdaq Stock Market, or Nasdaq, in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of listed companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
In addition, the market price of our shares of common stock could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including:
actual or anticipated fluctuations in our financial condition and operating results;
actual or anticipated changes on our growth rate relative to our competitors;
competition from existing products or new products that may emerge;

32


announcements of significant acquisitions, strategic partnerships, joint ventures, collaborations, or capital commitments;
failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
issuance of new or updated research or reports by securities analysts;
fluctuations in the valuation of companies perceived by investors to be comparable to us;
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
additions or departures of key management or scientific personnel;
disputes or other developments related to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;
announcement or expectation of additional debt or equity financing efforts;
sales of our common stock by us, our insiders or our other stockholders; and
general economic and market conditions.
These and other market and industry factors may cause the market price and demand for our common stock to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their shares of common stock and may otherwise negatively affect the liquidity of our common stock. In addition, the stock market in general, and NASDAQ and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. In the past, when the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management.
Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
As of March 31, 2015, our executive officers, directors, 5% or greater stockholders and their affiliates beneficially own approximately 44% of our voting stock. These stockholders will have the ability to influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders, acting together, may be able to control elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may believe are in your best interest as one of our stockholders.
Sales of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our stock price to fall.
Sales of a substantial number of shares of our common stock by our existing stockholders in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our common stock.
As of May 11, 2015 we had 15,538,943 shares of common stock outstanding, all of which, other than shares held by our directors and certain officers, are eligible for sale in the public market, subject in some cases to compliance with the requirements of Rule 144, including volume limitations and manner of sale requirements.

In addition, shares issued upon exercise of vested options are eligible for sale. Sales of stock by these stockholders could have a material adverse effect on the trading price of our common stock.
Certain holders of our securities are entitled to rights with respect to the registration of their shares under the Securities Act of 1933, as amended, or the Securities Act. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.

Item 3. Defaults Upon Senior Securities
Not applicable.

Item 4. Mine Safety Disclosures
Not applicable.

Item 5. Other Information
Not applicable.

Item 6.      Exhibits

33

 

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.

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
 
 
 
 
 
 
 
EAGLE PHARMACEUTICALS, INC.
 
 
 
 
DATED: May 15, 2015
 
By:
/s/ Scott Tarriff
 
 
 
 
Scott Tarriff
 
 
 
Chief Executive Officer and Director
(Principal Executive Officer)
 
 
 
 
DATED: May 15, 2015
 
By:
/s/ David E. Riggs
 
 
 
 
David E. Riggs
 
 
 
Chief Financial Officer
(Principal Accounting and Financial Officer)


34

 

EXHIBIT INDEX
Exhibit
Number
 
Description of Exhibit
 
 
 
 
3.1  (1)


 
Amended and Restated Certificate of Incorporation

 
 
 
 
3.2  (1)


 
Amended and Restated Bylaws
 
 
 
 
10.1 (2)


 
Second Amendment to Lease between Mack-Cali Chestnut Ridge L.L.C. and Eagle Pharmaceuticals, Inc., dated as of March 16, 2015
 
 
 
 
10.2 (3)


 
Exclusive License Agreement between Cephalon, Inc. and Eagle Pharmaceuticals, Inc. dated as of February 13, 2015
 
 
 
 
10.3 (3)


 
Settlement and License Agreement between Cephalon, Inc. and Eagle Pharmaceuticals, Inc., dated as of February 13, 2015
 
 
 
 
31.1

 
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and15d-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 13a-14(a) and15d-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.

 
 
 
 
101.INS

 
XBRL Instance Document

 
 
 
 
101.SCH

 
XBRL Taxonomy Extension Schema Document

 
 
 
 
101.CAL

 
XBRL Taxonomy Extension Calculation Linkbase Document

 
 
 
 
101.DEF

 
XBRL Taxonomy Definition Linkbase Document

 
 
 
 
101.LAB

 
XBRL Taxonomy Extension Label Linkbase Document

 
 
 
 
101.PRE

 
XBRL Taxonomy Extension Presentation Linkbase Document

 
 
 
 
(1) Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-92984), as amended.
(2) Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 20, 2015.
(3) Confidential treatment has been requested as to certain portions of this exhibit pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 








35
Exhibit 10.2

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

Execution Version

EXCLUSIVE LICENSE AGREEMENT
between
EAGLE PHARMACEUTICALS, INC.
and
CEPHALON, INC.
dated February 13, 2015


1
ACTIVE/80996174.11

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (this “ Agreement ”) is entered into as of February 13, 2015 (the “ Effective Date ”) by and between Eagle Pharmaceuticals, Inc., a Delaware corporation (“ Eagle ”) and Cephalon, Inc., a Delaware corporation (“ Cephalon ”). Eagle and Cephalon are sometimes referred to herein, individually, as a “ Party ” or, collectively, as “ Parties .”
WHEREAS , Eagle is a specialty pharmaceutical company focused on developing and commercializing proprietary innovations to FDA-approved, injectable products but with no sales force or distribution network of the size needed to distribute an oncology drug;
WHEREAS, Eagle generates revenues by licensing its innovative drugs to companies with access to a distribution network;
WHEREAS , Cephalon is a global biopharmaceutical company that conducts research, development, manufacturing and commercialization of branded pharmaceutical products;
WHEREAS , Eagle is developing EP-3102;
WHEREAS , Cephalon desires to obtain certain licenses from Eagle to Develop, Manufacture and Commercialize Licensed Compounds and Licensed Products in the Field in the Territory;
WHEREAS , simultaneously with the execution of this Agreement, the Parties are entering into the Settlement Agreement, pursuant to which (a) Cephalon and Eagle will fully and finally settle the patent infringement action between them in the United States District Court for the District of Delaware (Case No.: 14-1042-GMS) regarding infringement of Cephalon’s US Patent No. 8,791,270 (the “’ 270 Patent ”) arising from Eagle’s filing of the EP-3101 NDA seeking approval from the FDA to market the Eagle RTD Product; (b) Cephalon will grant Eagle a non-exclusive, royalty-bearing license to market the Eagle RTD Product in the United States prior to the expiration of the ’270 Patent; and (c) [ * ]; and
WHEREAS, this Agreement and the Settlement Agreement will (a) consent to the FDA’s Regulatory Approval of EP-3102 during Cephalon’s orphan drug exclusivity periods applicable to the Treanda Product that would otherwise block Eagle from bringing EP-3102 to market following the Reversion Date; (b) enable Eagle to use Cephalon’s established distribution network to enable patients to access EP-3102 far more quickly than Eagle could on its own; (c) remove the threat that Cephalon can use a claim of patent infringement to block EP-3102 from the market; (d) better enable Eagle to obtain Regulatory Approval for EP-3102; and (e) for the foregoing reasons, deliver the consumer benefits of EP-3102 to the market on an expedited time table;
NOW, THEREFORE , in consideration of the mutual promises and covenants set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
Section 1. Definitions .
1.1      505(b)(2) NDA ” means a new drug application submitted to the FDA under 21 U.S.C. § 355(b)(2) (or any replacement thereof).
1.2      Acquisition Transaction ” means a license, merger, acquisition (whether of all of the stock or all or substantially all of the assets of a Person or any operating or business division of



Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



a Person, or of all or substantially all of the assets of a Person or any operating or business division of a Person relating to an Alternative Product), reorganization, consolidation, combination or similar transaction by or with Eagle or any of its Affiliates that is not a Change of Control of Eagle or any of its Affiliates.
1.3      Affiliate ” of a Person means any other Person which (directly or indirectly) is controlled by, controls or is under common control with such Person. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to any Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors, (b) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%), including ownership by trusts with substantially the same beneficial interest, of the equity interests with the power to direct the management and policies of such Person, provided that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests, or (c) the power to direct the management or policies of a Person, whether through ownership of voting securities, by contract or otherwise.
1.4      ANDA ” means an Abbreviated New Drug Application pursuant to 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3.
1.5      AP-rated ” means the product in question is an injectable product that the FDA has assigned an “AP” rating signifying that the FDA has classified the product as “therapeutically equivalent” to a particular reference listed product.
1.6      Calendar Quarter ” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.7      Calendar Year ” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.8      Change of Control ” means, with respect to a Party, (a) completion of a merger, reorganization, amalgamation, arrangement, share exchange, consolidation, tender or exchange offer, private purchase, business combination, recapitalization or other transaction involving a Party as a result of which the stockholders of such Party immediately preceding such transaction hold less than fifty percent (50%) of the outstanding shares, or less than fifty percent (50%) of the outstanding voting power, respectively, of the ultimate company or entity resulting from such transaction immediately after consummation thereof (including a company or entity which as a result of such transaction owns the then-outstanding securities of a Party or all or substantially all of a Party’s assets, either directly or through one or more subsidiaries), (b) the adoption of a plan relating to the liquidation or dissolution of a Party, other than in connection with a corporate reorganization (without limitation of clause (a), above); (c) the sale or disposition to a Third Party of all or substantially all the assets of a Party (determined on a consolidated basis); or (d) the sale or disposition to a Third Party of assets or businesses that constitute fifty percent (50%) or more of the total revenue or assets of a Party (determined on a consolidated basis).
1.9      Clinical Studies ” means any study in which human subjects are dosed with a drug, whether approved or investigational, including any Phase 1, 2 or 3 clinical study, or any Post-Approval Clinical Studies.
1.10      CLL ” means chronic lymphocytic leukemia.

2

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



1.11      CMS ” means the Centers for Medicare & Medicaid Services, or any successor entity thereto.
1.12      Combination Product ” means a Licensed Product that includes at least one additional active ingredient other than Licensed Compound.
1.13      Commercially Reasonable Efforts ” means with respect to a Party’s obligations that relate to a Licensed Compound or Licensed Product, the use of reasonable, diligent efforts and resources (including use and expenditure of resources) as normally used [ * ] which product is at a similar stage of development and with similar commercial potential, taking into account all relevant factors, including safety and efficacy, product profile, the proprietary position, the then-current competitive environment and the likely timing of market entry, the regulatory environment and status, and other relevant scientific, technical and commercial factors.
1.14      Commercialization ” or “ Commercialize ” means activities directed to obtaining pricing and reimbursement approvals (other than with respect to the J-Code for the first Licensed Product), marketing, promoting, distributing, importing, exporting, offering for sale or selling any pharmaceutical product, including any Licensed Product. For the avoidance of doubt, Commercialization excludes any Clinical Studies, but shall include development and implementation of a REMS.
1.15      Confidentiality Agreement ” means that certain Mutual Confidentiality Agreement, dated September 24, 2014, by and between the Parties.
1.16      Control ” with respect to any Patent Right, Know-How or other intellectual property right means possession (whether by ownership or license, other than by a license or sublicense granted pursuant to this Agreement) of the legal authority or right of a Party hereto (or any of its Affiliates) to grant a license, sublicense or other access to such intellectual property as provided herein, [ * ]. For clarity, all Patent Rights, Know-How or other intellectual property rights licensed or sublicensed to Eagle or its Affiliates pursuant to the In-License Agreements are “Controlled” by Eagle. Notwithstanding the foregoing, [ * ].
1.17      Detail ” means a face-to-face (a) discussion with a physician and/or healthcare provider who is licensed to prescribe drugs for use in the Field or is otherwise in a position to directly influence or recommend the prescription or purchase of any Licensed Product for use in the Field or (b) discussion with a group of physicians and/or healthcare providers, in each case during which a professional sales representative of Cephalon or its Affiliates makes a presentation of certain of any Licensed Product’s attributes, such as describing the FDA-approved indicated uses, safety, effectiveness, contraindications, side effects, warnings or other relevant characteristics of any Licensed Product, consistent with Law and in accordance with the procedures and policies customarily employed by Cephalon’s and its Affiliates’ sales force responsible for performing such activities for its other pharmaceutical products in the Field and in the Territory, in each case, where such Licensed Product is presented before any other bendamustine product in the Field or where the predominant portion of time is devoted to the presentation of such Licensed Product.
1.18      Development ” means non-clinical and clinical drug development activities reasonably related to the development and submission of information to a Regulatory Authority, including toxicology, pharmacology and other discovery and pre-clinical efforts, test method development and stability testing, manufacturing process development and improvement, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control

3

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



development, statistical analysis, Clinical Studies (but not development and implementation of a REMS), regulatory affairs, and activities directed to obtaining Regulatory Approvals (including activities directed to obtaining pricing and reimbursement approvals).
1.19      Divest ” or “ Divestiture ” means the divestiture of an Alternative Product through (a) an outright sale or assignment of all or substantially all rights in such Alternative Product to a Third Party or (b) an exclusive (even with respect to Eagle and its Affiliates) out-license of all rights and obligations, including all research, Development, Manufacture and Commercialization rights and obligations, with respect to such Alternative Product in the Field with no further material role, influence or authority of Eagle or any of its Affiliates with respect to such Alternative Product in the Field.
1.20      Eagle IP ” means all Eagle Know-How and Eagle Patent Rights.
1.21      Eagle Know-How ” means all Know-How, existing as of the Effective Date or arising during the Term, Controlled by Eagle or any of its Affiliates, that is necessary to Manufacture or Commercialize any Licensed Compounds or Licensed Products. Notwithstanding the foregoing, Eagle Know-How shall not include [ * ].
1.22      Eagle Patent Rights ” means (a) the issued patents and patent applications listed in Schedule 1.22, plus (i) all divisionals, continuations, continuations-in-part thereof or any other patent rights claiming priority directly or indirectly to any of the issued patents or patent applications identified on Schedule 1.22, and (ii) all patents issuing on any of the foregoing, together with all Patent Rights relating thereto, and (b) any other Patent Rights, existing as of the Effective Date or arising during the Term in the Territory, Controlled by Eagle or any of its Affiliates, that are necessary to Manufacture or Commercialize any Licensed Compounds or Licensed Products in the Territory. Notwithstanding the foregoing, Eagle Patent Rights shall not include [ * ].
1.23      Eagle RTD Product ” means [ * ] bendamustine hydrochloride product in a multi-use vial that is tentatively or otherwise approved by the FDA under the EP-3101 NDA. [ * ].
1.24      EP-3101 NDA ” means the 505(b)(2) NDA No. [ * ] as tentatively or otherwise approved by the FDA as of the Effective Date for the treatment of NHL [ * ] that adds an indication for the treatment of patients with CLL using Long Infusion), [ * ].
1.25      EP-3102 ” means Eagle’s bendamustine product [ * ] approved under the EP-3102 NDA[ * ].
1.26      EP-3102 NDA ” means the 505(b)(2) NDA to be filed with the FDA immediately following the Effective Date seeking approval to market EP-3102 in the United States, and any amendments thereto or supplements thereof, but excluding [ * ].
1.27      Exclusivity Period ” means the period commencing on the Launch Date and ending upon [ * ].
1.28      FDA ” means the United States Food and Drug Administration, or any successor entity thereto.
1.29      Field ” means [ * ].
1.30      First Commercial Sale ” means the first sale in the Territory to a Third Party of a Licensed Product by or under the authority of Cephalon or its Affiliate or sublicensee after receipt of

4

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



the applicable Marketing Approval. Notwithstanding the foregoing, sales for Clinical Studies purposes or compassionate or similar use will not be considered to constitute a First Commercial Sale.
1.31      Generic Equivalent ” means [ * ].
1.32      Generic Rapid Product ” means [ * ].
1.33      Good Laboratory Practices ” or “ GLP ” shall mean the then current Good Laboratory Practices as such term is defined from time to time by the FDA at 21 C.F.R. part 58 (or any replacement thereto) or other relevant Governmental Authority having jurisdiction over the Development, Manufacture or Commercialization of any Licensed Compound or Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.
1.34      Good Manufacturing Practices ” or “ GMP ” means the then current Good Manufacturing Practices as such term is defined from time to time by the FDA at 21 C.F.R. parts 210 and 211 (or any replacements thereto) or other relevant Governmental Authority having jurisdiction over the Development, Manufacture or Commercialization of any Licensed Compound or Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.
1.35      Governmental Authority ” means any United States federal, state or local or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body.
1.36      In-License Agreements ” means [ * ].
1.37      J-Code ” means a Healthcare Common Procedure Coding System (HCPCS) Level II alpha-numeric code issued by CMS to identify and describe a drug product.
1.38      Know-How ” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, data (including from Clinical Studies), filings and correspondence (including Regulatory Filings and DMFs), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable.
1.39      Launch Date ” means the date of launch of EP-3102 by Cephalon or its Affiliates or sublicensees in the Field [ * ].
1.40      Law ” means any federal, state, provincial, local, international or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Authority or Regulatory Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.
1.41      Licensed Compounds ” means (a) EP-3102, and (b) any existing or future improved or modified versions of such compound discovered, conceived, created or otherwise Controlled by Eagle or any of its Affiliates. For the avoidance of doubt, Licensed Compound shall not include [ * ].

5

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



1.42      Licensed Products ” means any pharmaceutical product containing any Licensed Compound (alone or with other active ingredients), in all presentations, dosage forms, forms of administration, formulations, dosing regimen, preparations and strengths. For clarification, a Licensed Product will include any Combination Product. [ * ] For the avoidance of doubt, [ * ].
1.43      Long Infusion ” [ * ].
1.44      MAC ” means Medicare administrative contractor.
1.45      Manufacture ” or “ Manufacturing ” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, and shipping and holding (prior to distribution) of any Licensed Compound or Licensed Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
1.46      Marketing Approval ” means with respect to any Licensed Compound or Licensed Product in any regulatory jurisdiction in the Territory, approval from the applicable Regulatory Authority sufficient for the promotion and sale of such Licensed Compound or Licensed Product in such jurisdiction in accordance with applicable Laws.
1.47      NDA ” means a New Drug Application filed with the FDA (including amendments and supplements thereto) to obtain Regulatory Approval in the U.S., including without limitation, an application filed under a 505(b)(2) NDA, or any corresponding applications or submissions filed with the relevant Regulatory Authorities to obtain Regulatory Approvals in any other country or region in the Territory.
1.48      Net Sales ” means, with respect to a Licensed Product sold by Cephalon, its Affiliates or sublicensees in the Territory, the aggregate gross sales for such Licensed Product by Cephalon and its Affiliates and sublicensees on an arms-length basis from Third Parties in the Territory, less the following deductions, all determined in accordance with Cephalon’s standard practices for other pharmaceutical products, consistently applied, as reflected in Cephalon’s financial statements and measured in United States Dollars:
a.    [ * ] percent ([ * ]%) of gross sales in the Territory to cover cash discounts given by Cephalon (and its Affiliates);
b.    reasonable estimates for any adjustments on account of price adjustments, billing adjustments, shelf stock adjustments, promotional payments, or other similar allowances affecting the Licensed Product;
c.    reasonable estimates for chargebacks, rebates, administrative fee arrangements, reimbursements, and similar payments to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, other institutions or health care organizations or other customers;
d.    reasonable estimates for amounts due to Third Parties on account of rebate payments, including Medicaid rebates, or other price reductions provided, based on sales by Cephalon and its Affiliates to any Governmental Authorities or Regulatory Authorities in respect of state or federal Medicare, Medicaid or similar programs;

6

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



e.    [ * ];
f.    reasonable estimates for allowances and credits to Third Parties on account of rejected, damaged, returned or recalled Licensed Product;
g.    any costs incurred in connection with, or arising out of, compliance with the Prescription Drug User Fee Act; and
h.    other specifically identifiable amounts that have been credited against or deducted from gross sales of such Licensed Product and which are substantially similar to those credits and deductions listed above.
Sales and other transfer of Licensed Product between any of Cephalon, its Affiliates and sublicensees will not give rise to Net Sales, but rather the subsequent sale of Licensed Product to Third Parties. Net Sales for any Combination Product will be calculated on a country-by-country basis by [ * ].
1.49      NHL ” means indolent B-cell non-Hodgkin lymphoma.
1.50      [ * ] and Eagle, dated October 21, 2014.
1.51      [ * ]
1.52      Patent Rights ” means all patents and patent applications (including provisional applications), including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, re-issues, additions, renewals, extensions, confirmations, registrations, any other pre- or post-grant forms of any of the foregoing, any confirmation patent or registration patent or patent of addition, utility models, patent term extensions, and supplemental protection certificates or requests for continued examinations, foreign counterparts, and the like of any of the foregoing.
1.53      Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, beneficiary or trustee of any trust, incorporated association, joint venture, or similar entity or organization, including a government or political subdivision or department or agency of a government.
1.54      Post-Approval Clinical Study ” means any clinical study in humans with respect to any Licensed Product that is within or in support of, or intended to expand, the Product Labeling for any Licensed Product.
1.55      Primary Indications ” means (a) treatment of patients with NHL that has progressed during or within six (6) months of treatment with rituximab or a rituximab-containing regimen, and (b) treatment of patients with CLL.
1.56      Product Labeling ” shall mean, with respect to a country, (a) the full prescribing information for any Licensed Product approved by the relevant Regulatory Authority for such country, including any required patient information, and (b) all labels and other written, printed or graphic matter upon any container, wrapper or any package insert utilized with or for any Licensed Product.
1.57      Promotional Materials ” shall mean all sales representative training materials with respect to any Licensed Product and all written, printed, graphic, electronic, audio or video matter, including journal advertisements, sales visual aids, direct mail, medical information/education

7

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



monographs, direct-to-consumer advertising, Internet postings, broadcast advertisements and sales reminder aids (e.g., scratch pads, pens and other such items) intended for use or used by a Party, its Affiliates or, with respect to Cephalon, its Affiliates or sublicensees, or, with respect to Eagle, its Affiliates and (sub)licensees, in connection with any promotion of any Licensed Product (but excluding Product Labeling).
1.58      Rapid AG Product ” means an authorized generic version of a Licensed Product, whether branded or unbranded, that is manufactured or sold under the EP-3102 NDA.
1.59      Regulatory Approval ” means the grant of a Marketing Approval, and any pricing approval, reimbursement approval, or any other approval required to market, sell and have reimbursement for a Licensed Product in any country or other regulatory jurisdiction.
1.60      Regulatory Authority ” means the FDA, Health Canada, and any other analogous Governmental Authority or agency involved in granting approvals (including any required pricing or reimbursement approvals) for the Development, Manufacture or Commercialization of any pharmaceutical product (including any Licensed Compound or Licensed Product) in the Territory.
1.61      Regulatory Filing ” means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including the EP-3102 NDA, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).
1.62    “ REMS ” means a risk evaluation and mitigation strategy required by the FDA pursuant to 21 U.S.C. § 355-1.
1.63      Reversion Date ” means the earliest of the following (a) the date upon which Cephalon receives [ * ] from Eagle pursuant [ * ] (b) the effective date of termination of this Agreement in its entirety by Cephalon [ * ] or (c) the effective date of termination of this Agreement in its entirety by Eagle pursuant [ * ]
1.64      [ * ].
1.65      Royalty Term ” means, on a country-by-country basis for a Licensed Product, the period commencing upon the First Commercial Sale of such Licensed Product in such country and ending upon the tenth (10th) anniversary thereof.
1.66      Segregate ” means, with respect to an Alternative Product, to use Commercially Reasonable Efforts to segregate the Development, Manufacture and Commercialization activities relating to such Alternative Product in the Field from Development, Manufacture and Commercialization activities with respect to any Licensed Compounds and Licensed Products under this Agreement, including using Commercially Reasonable Efforts to ensure that: (a) no personnel involved in performing the Development, Manufacture or Commercialization of such Alternative Product in the Field have access to non-public plans or information relating to the Development, Manufacture or Commercialization of any Licensed Compounds or Licensed Products or any other Confidential Information of Cephalon or its Affiliates; (b) no personnel involved in performing the Development, Manufacture or Commercialization of any Licensed Compounds or Licensed Products in the Field have

8

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



access to non-public plans or information relating to the Development, Manufacture or Commercialization of such Alternative Product in the Field; provided, that, in either case of (a) or (b), management personnel may review and evaluate plans and information regarding the Development, Manufacture and Commercialization of such Alternative Product solely in connection with portfolio decision-making among product opportunities; and (c) no Eagle IP, Licensed Compound nor Licensed Product is practiced or used in the Development, Manufacture or Commercialization of the Alternative Product in the Field.
1.67      Senior Executives ” means (a) for Eagle, [ * ]; and (b) for Cephalon, [ * ]. In the event that the position of any of the Senior Executives identified in this Section 1.67 no longer exists due to a Change of Control, corporate reorganization, corporate restructuring or the like that results in the elimination of the identified position, the applicable Senior Executive will be replaced with another senior executive with responsibilities and seniority comparable to the eliminated Senior Executive.
1.68      Settlement Agreement ” means that certain Settlement and License Agreement to be entered into by the Parties on the Effective Date in the form attached hereto as Schedule 1.68.
1.69      Short Infusion ” [ * ].
1.70      Territory ” means the United States and Canada.
1.71      Third Party ” means any Person other than a Party, or an Affiliate of a Party.
1.72      Treanda AG Product ” means a generic version of one or more of the Treanda Products that is manufactured or sold under one or more of the Treanda NDAs without a trademark or under a trademark other than Treanda® or a successor trademark thereto.
1.73      Treanda NDAs ” means NDA No. 22249 and NDA No. 22303.
1.74      Treanda Products ” means the bendamustine products that are the subject the Treanda NDAs.
1.75      United States ” or “ U.S .” means the United States of America, its possessions, protectorates, territories and Puerto Rico.
1.76      [ * ]
The following additional defined terms have the meanings set forth in the section indicated:
Defined Term
Section
ʼ270 Patent
Recitals
[ * ]
[ * ]
Additional Studies Clinical Data
15.8.6.6
Agreement
Introduction
Alliance Manager
2.3
Alternative Product
8.3.1
API
6.1
Blocking IP
9.3.3.2
Breaching Party
15.2
Cephalon
Introduction

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



Cephalon Indemnitees
14.1
Cephalon ROFN Notice
8.2
Claims
14.1
[ * ]
[ * ]
Confidential Information
11.1
CPA Firm
9.3.4.1
CREATE Act
10.2
Default Notice
15.2
Eagle
Introduction
Eagle Indemnitees
14.1
Effective Date
Introduction
Federal Court
16.11.2
Final Court Decision
15.5.2
Force Majeure
16.8
Hatch-Waxman Time Period
10.4.2
[ * ]
[ * ]
Indemnified Party
14.2
Indemnifying Party
14.2
JSC
2.1.1
Losses
14.1
Manufacturing and Supply Agreement
6.1
Milestone Event
9.2
Milestone Payment(s)
9.2
Net Sales Royalty
9.3.1
Net Sales Statement
9.3.1
Non-Breaching Party
15.2
Orange Book
10.6.2
Other Product Assets
8.2
Other Product Negotiation Period
8.2
Other Product Notice
8.2
Other Product Triggering Event
8.2
Parties
Introduction
Party
Introduction
Pharmacovigilance Agreement
4.2
Publishing Party
11.4
Reviewing Party
11.4
ROFN Country
8.1
SEC
11.2
State Court
16.11.2
Subcommittee
2.2
Term
15.1.1
Third Party Payments
9.3.3.2
USPTO
15.5.2


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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



Section 2.      Governance and Oversight .
2.1      Joint Steering Committee .
2.1.1      Formation; Purposes and Principles . Within twenty (20) business days after the Effective Date, the Parties will establish a joint steering committee (the “ JSC ”) to provide high-level oversight and decision-making regarding the activities of the Parties under this Agreement as set forth in this Section 2.1. The JSC will have the responsibilities set forth herein and will not be involved in day-to-day implementation of activities under this Agreement. In conducting its activities, the JSC will operate and make its decisions consistent with the terms of this Agreement.
2.1.2      Membership . The JSC will be composed of an equal number of representatives appointed by each of Eagle and Cephalon. The JSC will each be initially comprised of three (3) representatives of each Party. The JSC may from time to time change the size of the JSC. Each Party may replace JSC representatives at any time upon written notice to the other Party. The JSC will be co-chaired by one designated representative of each Party. The co-chairpersons of the JSC will not have any greater authority than any other representative on the JSC. The Alliance Manager of Cephalon will be responsible for (a) calling meetings, (b) preparing and circulating an agenda in advance of each meeting, provided that the Alliance Manager will include any agenda items proposed by either Party on such agenda, (c) ensuring that all decision-making is carried out in accordance with the voting and dispute resolution mechanisms set forth in this Agreement, and (d) preparing and issuing minutes of each meeting that each Party has approved within fifteen (15) business days thereafter. Each Party will be responsible for all costs and expenses incurred by it in participating in the JSC.
2.1.3      Responsibilities. The JSC shall have the following responsibilities:
2.1.3.1      oversee the Parties’ performance of their respective obligations under this Agreement;
2.1.3.2      review and discuss each Commercialization Plan for EP-3102 and any amendments thereto;
2.1.3.3      review and discuss [ * ];
2.1.3.4      review and discuss the status of Regulatory Approvals and [ * ];
2.1.3.5      [ * ];
2.1.3.6      [ * ];
2.1.3.7      establish Subcommittees in accordance with Section 2.2; and
2.1.3.8      consider and act upon such other matters as specified in the Agreement.
2.1.4      Decision-Making .
2.1.4.1      The JSC will operate by consensus, and all decisions will be made by unanimous consent. With respect to decisions of the JSC, the representatives of each Party will have collectively one (1) vote on behalf of such Party.

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2.1.4.2      Should the members of the JSC maintain for more than [ * ] a disagreement with respect to a matter arising within the JSC, such matter will be resolved pursuant to Section 16.11.1 by referral directly to a senior executive of each Party designated by such Party’s Senior Executive (but not Section 16.11.2). If such matter is not resolved pursuant to the dispute resolution process set forth in Section 16.11.1, then (a) in the event that such matter relates to [ * ], and (b) for all remaining matters, [ * ]; provided that, in each case, no decision by a Party may be in conflict with any of the terms of this Agreement (including by amending or increasing any obligations on a Party or any of its Affiliates or by granting any licenses or other rights to a Party or any of its Affiliates that, in each case, are not specified in this Agreement). Notwithstanding the foregoing, [ * ].
2.1.4.3      Notwithstanding anything herein to the contrary, with respect to any decision to be made by any of the JSC, each Party will exercise its voting right (including a Party’s tie-breaking vote of Section 2.1.4.2) in a manner consistent with its obligations under this Agreement, including [ * ].
2.1.4.4      The JSC will not have the authority to amend or modify this Agreement.
2.1.5      Meetings of the JSC . The JSC will hold meetings at least once every Calendar Quarter during the Term for so long as the JSC exists, unless the Parties mutually agree that there is no need for a JSC meeting in any given Calendar Quarter. The JSC may meet in person or by audio or video conference as the Parties may mutually agree. With respect to in-person meetings, the representatives will meet alternately at a location(s) designated by Eagle and Cephalon. Other representatives of the Parties, their Affiliates and Third Parties involved in the Development, Manufacture or Commercialization of any Licensed Compounds and Licensed Products may attend such meetings of the JSC as nonvoting observers; provided that the Party bringing such other representatives informs the other Party in advance and all attendees have executed confidentiality agreements or are subject to confidentiality obligations that are at least as restrictive as the confidentiality obligations set forth in Section 11. The JSC may upon agreement meet on an ad hoc basis between regularly scheduled meetings in order to address and resolve time-sensitive issues within their purview that may arise from time to time, and such ad hoc meetings will satisfy the obligation to meet within such Calendar Quarter unless the Parties have additional business to address in that Calendar Quarter. No action taken at a meeting of the JSC will be effective unless a representative of each Party is present or participating. Neither Party will unreasonably withhold attendance of at least one representative of such Party at any meeting of the JSC for which reasonable advance notice was provided.
2.1.6      Disbanding . The JSC will disband [ * ]. If the JSC is not disbanded pursuant to the preceding sentence, the JSC will be automatically disbanded effective upon the expiration or termination of this Agreement. After the JSC is disbanded, all decisions expressly delegated to the JSC shall be made by a representative of each of the Parties subject to the applicable dispute resolution procedures in Section 16.11.
2.2      Subcommittees . From time to time, the JSC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JSC approves (each, a “ Subcommittee ”). Each Subcommittee will operate by consensus, and all decisions will be made by unanimous consent. With respect to decisions of a Subcommittee, the representatives of each Party will have collectively one (1) vote on behalf of such Party. If any Subcommittee is unable to reach a decision on any matter after endeavoring for seven (7) days to do so, such matter will be referred to the JSC for resolution in accordance with Section 2.1.4.2. Notwithstanding anything herein to the contrary, with respect to any decision to be made by any of a Subcommittee, each Party will exercise

12

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its voting right (including a Party’s tie-breaking vote under Section 2.1.4.2) in a manner consistent with its obligations under this Agreement, including [ * ]. Other representatives of the Parties, their Affiliates and Third Parties involved in the Development, Manufacture or Commercialization of any Licensed Compounds or Licensed Products may attend such meetings of a Subcommittee as nonvoting observers; provided that the Party bringing such other representatives informs the other Party in advance and all attendees have executed confidentiality agreements or are subject to confidentiality obligations that are at least as restrictive as the confidentiality obligations set forth in Section 11.
2.3      Alliance Manager . Each Party will appoint one senior representative who possesses a general understanding of clinical, regulatory, manufacturing and marketing issues to act as its respective alliance manager under this Agreement (each, an “ Alliance Manager ”). Promptly following the Effective Date, each Party will notify the other Party of the name and contact information of its initial Alliance Manager. Either Party may replace its Alliance Manager at any time upon written notice to the other Party. Either Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager. The Alliance Managers will meet periodically until approval of the first Licensed Product in the Territory to coordinate their applicable Development activities. Each Alliance Manager will be charged with creating and maintaining a collaborative work environment. The Alliance Managers will be entitled to attend meetings of the JSC, but will not have, or be deemed to have, any rights or responsibilities of a member of the JSC. Each Alliance Manager may bring any matter to the attention of the JSC where such Alliance Manager reasonably believes that such matter requires such attention.
2.4      Input from other Personnel . Any JSC member will have the right to solicit input or assistance from any functional area of the relevant Party, provided that the request for such input is coordinate through such Party’s respective Alliance Manager.
2.5      Exigent Circumstances . Notwithstanding anything in this Section 2 to the contrary, each of the Parties will have the right to take prompt action within the scope of their rights hereunder where exigent circumstances so require, without the necessity for the JSC’s or a Subcommittee’s review, provided that such action is otherwise consistent with this Agreement. In any such case, such Party will promptly notify the JSC or Subcommittee, as applicable of such action and the exigent circumstances.
2.6      Limited Authority . Notwithstanding anything to the contrary, the JSC will have no authority to govern [ * ].
Section 3.      Development .
3.1      Responsibility . Subject to Section 3.2, and except as expressly set forth in this Agreement, Eagle will, at its cost and expense, be solely responsible for Development of the Licensed Compounds and Licensed Products in the Field in the Territory. Notwithstanding the foregoing, [ * ].
3.2      [ * ].
3.2.1      Eagle will use Commercially Reasonable Efforts to Develop the Licensed Product containing EP-3102 [ * ].
3.2.2      Without limiting the generality of Section 3.2.1, Eagle will use Commercially Reasonable Efforts to perform the following in accordance with GLP and GMP: [ * ].
Section 4.      Regulatory.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



4.1      Eagle Regulatory Responsibility .
4.1.1      Responsibility . Eagle will, at its cost and expense, own and be solely responsible for filing, obtaining and maintaining all Regulatory Approvals necessary for EP-3102 in the Field in the Territory, and all such Regulatory Approvals will be held in the name of Eagle. Further, subject to Section 4.1.2, Eagle will, at its cost and expense, be responsible for conducting all Clinical Studies necessary for Regulatory Approval or required by a Regulatory Authority as a condition to, or in connection with the grant or maintenance of a Regulatory Approval for the EP-3102 NDA. Notwithstanding the foregoing [ * ]. Eagle may, but shall not be obligated to, [ * ].
4.1.2      Diligence Obligations . Eagle will use Commercially Reasonable Efforts to (a) pursue and obtain Regulatory Approval by the FDA of the EP-3102 NDA with a label for each of the Primary Indications, [ * ], conduct all Clinical Studies necessary for Regulatory Approval or required by a Regulatory Authority as a condition to, or in connection with the grant or maintenance of a Regulatory Approval [ * ]. In addition to, and without limiting or derogating from Eagle’s obligations set forth in the previous sentence, Eagle [ * ]. At each Calendar Quarterly meeting of the JSC, Eagle will present and discuss the status of all of the activities that Eagle has performed or caused to be performed pursuant to this Section 4.1 since the last meeting of the JSC.
4.1.3      Cooperation .
4.1.3.1      Except as expressly permitted pursuant to Section 4.2 and the Pharmacovigilance Agreement entered into by the Parties pursuant thereto, the Manufacturing and Supply Agreement, or Sections 5.4 and 5.5, [ * ].
4.1.3.2      Eagle will (a) consult with Cephalon in advance of sending, and keep Cephalon informed of the receipt and provide copies of, all communications [ * ], and otherwise consult in advance with Cephalon and keep Cephalon apprised of any and all activities related to and the general status of [ * ] (b) promptly provide Cephalon with copies of any written communication from, and a summary of, any oral communication with any Regulatory Authority relating [ * ] (c) allow Cephalon a reasonable opportunity [ * ] to review and comment on [ * ] (d) reasonably consider any recommendations and feedback made by Cephalon pursuant to subsections (a) or (b) or otherwise with respect to interactions with any Regulatory Authority concerning [ * ] provided that [ * ] (e) allow Cephalon to attend any in person meetings with any Regulatory Authority and to listen in on any planned calls with any Regulatory Authority relating to [ * ] and (f) otherwise provide Cephalon with any reasonably requested information or documentation relating to Regulatory Filings relating to [ * ]. Notwithstanding anything to the contrary contained herein, Eagle shall have the right to [ * ].
4.1.3.3      Cephalon (a) will not take any legal or administrative action that could reasonably be expected to materially limit or delay the approval or sale of or reimbursement for EP-3102, (b) will consent to the FDA’s approval of the Licensed Products during Cephalon’s orphan drug exclusivity period under 21 C.F.R. § 316.31(a)(3) and will promptly make all filings to, and engage in all communications with, Regulatory Authorities as necessary to evidence such consent, (c) will not request that Eagle take any action that could reasonably be expected to materially limit or delay Regulatory Approval by the FDA of the EP-3102 NDA and a unique J-Code from CMS for EP-3102, and (d) will not file an action in any court [ * ]
4.2      Clinical Safety Reporting; Pharmacovigilance . Within ninety (90) days after the Effective Date, the Parties shall discuss in good faith and enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties

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with respect to the Licensed Products, and shall include customary terms and conditions governing safety data sharing, adverse events reporting and prescription events monitoring sufficient to permit Eagle, Cephalon, and their respective Affiliates and (sub)licensees to comply with their respective legal obligations, including in accordance with applicable Law inside and outside of the Territory (the “ Pharmacovigilance Agreement ”). The Pharmacovigilance Agreement will provide for Cephalon’s support of Eagle with respect to such pharmacovigilance matters. Eagle will be solely responsible for establishing and will establish appropriate operating and other procedures reasonably sufficient to report to the appropriate Regulatory Authority(ies) all adverse event reports, safety reports and similar matters in accordance with the Pharmacovigilance Agreement.
4.3      Transfer of Eagle IP .
4.3.1      During the [ * ] period following the Effective Date, Eagle will provide to Cephalon one (1) electronic copy of all documents, data or other information in Eagle’s or its Affiliates possession or Control as of the Effective Date to the extent that such documents, data or other information describe or contain Eagle IP (including any Eagle IP relating to Clinical Studies and any Regulatory Approvals, Regulatory Filings, regulatory documents, or regulatory communications). Eagle will provide and transfer to Cephalon in the same manner all additional Eagle IP that may from time to time become available to or Controlled by Eagle or its Affiliates as provided in Section 4.3.2.
4.3.2      During the period [ * ], Eagle will reasonably cooperate with Cephalon to transfer to Cephalon any additional Eagle IP licensed under Section 7.1, in each case to facilitate the transfer of Commercialization efforts related to the Licensed Compounds and Licensed Products when such updates are reasonably available. Such cooperation will include providing Cephalon with reasonable access by teleconference or in-person at Eagle’s facilities to Eagle personnel involved in the Development of the Licensed Compounds and Licensed Products to provide Cephalon with a reasonable level of technical assistance and consultation in connection with the transfer of Eagle IP.
4.4      Use of Contractors . Eagle and Cephalon will each have the right to use the services of Third Party contractors, including contract research organizations, contract manufacturing organizations and the like, to assist such Party in fulfilling its obligations and exercising its rights under this Agreement; provided that such Third Party is bound by a written agreement that is materially as protective of the other Party and its intellectual property and proprietary rights as the terms of this Agreement, including confidentiality and intellectual property ownership provisions consistent with those set forth herein and; provided, further, that [ * ]. Each Party will consider in good faith the possibility of using the other Party’s resources to perform such activities as an alternative to utilizing the services of a subcontractor.
Section 5.      Commercialization .
5.1      Responsibility . Cephalon will be solely responsible, at its cost and expense, for all Commercialization activities relating to the Licensed Products in the Field in the Territory. For clarity, [ * ], a Rapid AG Product in the Field in the Territory without the prior written approval of Eagle, such approval not to be unreasonably withheld, conditioned or delayed [ * ].
5.2      Diligence .
5.2.1      From and after [ * ], Cephalon (itself or through its Affiliates or sublicensees) will use Commercially Reasonable Efforts to Commercialize EP-3102 in the Field in the United States [ * ]. Without limiting the foregoing, Cephalon (itself or through its Affiliates or

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



sublicensees) will [ * ]. Cephalon will promptly communicate to Eagle the Launch Date. If an Affiliate or sublicensee will be responsible for the Commercialization of EP-3102 as permitted under this Agreement, Cephalon shall ensure that such Affiliate or sublicensee conducts such Commercialization using the same level of effort as is required of Cephalon hereunder and that any employees, agents, consultants or sales representatives of such Affiliate or sublicensee engaged in the conduct of such Commercialization possess a similar degree of skill, quality and expertise as employees, agents, consultants or sales representatives of Cephalon.
5.2.2      Prior to [ * ] Cephalon will [ * ] Cephalon will [ * ].
5.2.3      Without limiting Section 5.2.2, [ * ] Cephalon will [ * ]. For clarity, but without limiting Section 5.2.1, after [ * ], Cephalon shall [ * ]
5.2.4      Notwithstanding the foregoing, unless and until Eagle obtains Regulatory Approval for any Licensed Compound or Licensed Product in the Field in Canada, Cephalon shall have no obligation under this Section 5.2 with respect to such Licensed Compound and Licensed Product in the Field in Canada.
5.2.5      Once per year during the Exclusivity Period, on reasonable written notice to Cephalon, Eagle shall have the right to engage, at its own cost and expense, subject to this Section 5.2.5, a CPA Firm to review and inspect Cephalon’s books and records for the sole purpose of verifying Cephalon’s compliance with its obligations under this Section 5.2. The CPA Firm will be given access to and will be permitted to examine such books and records of Cephalon as it will reasonably request, upon thirty (30) days’ prior written notice having been given by Eagle, during regular business hours, for the sole purpose of verifying Cephalon’s compliance with its obligations under this Section 5.2. Prior to any such examination taking place, the CPA Firm will enter into a confidentiality agreement reasonably acceptable to Cephalon with respect to the information to which the CPA Firm is given access and will not contain in its report or otherwise disclose to Eagle or any Third Party any information labeled by Cephalon as being confidential customer information regarding pricing or other competitively sensitive proprietary information. Eagle and Cephalon will be entitled to receive a full written report from the CPA Firm with respect to its findings and Eagle will provide, without condition or qualification, Cephalon with a copy of the report, or other summary of findings, prepared by such CPA Firm promptly following Eagle’s receipt of same. Subject to a Party’s rights and obligations elsewhere in this Agreement, Cephalon and Eagle will discuss in good faith any deficiencies identified in such report, and Cephalon will propose, subject to Eagle’s review and comments, a course of action to address such deficiencies. Eagle’s rights under this Section 5.2.5 may not be [ * ].
5.2.6      In addition, upon the written request of Eagle, Cephalon and Eagle will [ * ].
5.3      Reimportation . Eagle will, and will require its Affiliates and licensees to, use Commercially Reasonable Efforts to prevent any Licensed Compound or Licensed Product Manufactured by or on the behalf of Eagle or its Affiliate or licensee for sale outside the Territory from being sold commercially inside the Territory. Cephalon will, and will require its Affiliates and sublicensees to, use Commercially Reasonable Efforts to prevent any Licensed Compound or Licensed Product Manufactured by or on the behalf of Cephalon or its Affiliate or sublicensee for sale in the Territory from being sold commercially outside the Territory.
5.4      Promotional Materials; Packaging . As between the Parties, Cephalon shall be responsible, at its sole expense, for preparing all Promotional Materials and packaging used to support

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



the Commercialization of the Licensed Products in the Territory. Cephalon shall ensure that all its Promotional Materials and packaging are consistent with applicable Law and with the approved Product Labeling for the Licensed Products. As between the Parties, Cephalon shall be responsible for obtaining any approvals from the Regulatory Authorities required for the use of any Promotional Materials and packaging in the Territory and shall submit all applicable Promotional Materials and packaging to such Regulatory Authorities in the Territory as required by applicable Law. Eagle shall provide written notification to FDA that, with respect to EP-3102, Cephalon shall be fully responsible for, as Eagle’s agent, communicating directly with FDA with respect to the Promotional Materials and packaging in accordance with applicable Law. Eagle shall provide similar notifications to applicable Regulatory Authorities in connection with other Regulatory Approvals in the Territory.
5.5      Notification and Recall . In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with any Licensed Product or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party notified of or desiring such recall or similar action shall, within [ * ], advise the other Party thereof by telephone (and confirmed by email or facsimile), email or facsimile. Cephalon shall have the sole right to decide, in its discretion, whether to conduct a recall, at its expense, of any Licensed Product in the Territory, and the manner in which any such recall shall be conducted. Eagle shall have the sole right to decide, in its discretion, whether to conduct a recall, at its expense, of any Licensed Product outside the Territory, and the manner in which any such recall shall be conducted.
5.6      Recall Expenses . Cephalon shall bear the expenses of any recall of any Licensed Product in the Territory; provided, however, that [ * ]. Eagle shall bear the expenses of any recall of any Licensed Product outside the Territory; provided, however, that [ * ].
Section 6.      Manufacturing; Supply .
6.1      Manufacturing and Supply Agreement . Within [ * ] after the Effective Date, Cephalon and Eagle will enter into a non-exclusive manufacturing and supply agreement (the “ Manufacturing and Supply Agreement ”) pursuant to which Eagle will, subject to the terms of the Manufacturing and Supply Agreement, Manufacture and supply (or have Manufactured and supplied) to Cephalon all of its active pharmaceutical ingredient (“ API ”) and/or finished product needs for any Licensed Compound or Licensed Product in the Territory in accordance with Section 6.2 until [ * ]. In addition, Cephalon may (a) elect to Manufacture API and finished product for any Licensed Compound or Licensed Product by itself or through an Affiliate, (sub)licensee or Third Party contract manufacturer, and (b) at its option, validate and maintain one or more second source(s) for Manufacture and supply of the API and/or finished product of any Licensed Compound or Licensed Product, in each case for purposes of Development and Commercialization of the Licensed Compounds and Licensed Products in the Field and for the Territory. Promptly after the Effective Date, the Parties will commence activities to qualify one or more second source(s) for Manufacture and supply of the API and/or finished product of any Licensed Compound or Licensed Product [ * ]. Each Party will use Commercially Reasonable Efforts from and after the Effective Date to establish either Cephalon, its Affiliate, (sub)licensee or a Third Party contract manufacturer as a second source supplier of the Licensed Compounds and Licensed Products in a reasonable timeframe and will cooperate with the other Party with respect thereto.
6.2      Eagle Manufacturing and Supply Agreement . Pursuant to the terms and conditions of the Manufacturing and Supply Agreement, Eagle will Manufacture and supply (or have Manufactured and supplied) API and/or finished product for any Licensed Compound or Licensed Product for and on behalf of Cephalon until [ * ]. The terms and conditions of the Manufacturing and

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Supply Agreement will be [ * ]. The supply price for Licensed Compound or Licensed Product under the Manufacturing and Supply Agreement will be [ * ].
6.3      Existing Supply and Manufacturing Agreements . During the term of the Manufacturing and Supply Agreement, Eagle will (a) manage and be responsible for [ * ] ordering and purchasing all API and/or finished product [ * ] by and on behalf of Cephalon and its Affiliates and sublicensees [ * ]. Promptly after the Effective Date, Eagle and Cephalon will [ * ]. The Parties will coordinate and work together into good faith to maintain a second source of supply for Licensed Compounds and Licensed Products in effect during the Term; provided that [ * ].
Section 7.      Licenses .
7.1      Exclusive License Grants .
7.1.1      Subject to the terms and conditions of this Agreement, Eagle hereby grants to Cephalon a non-transferable (except in accordance with Section 16.2), exclusive (even as to Eagle), royalty-bearing license, with the right to sublicense through multiple tiers, under the Eagle IP, to Develop (solely to the extent [ * ]), Commercialize, use, import, export, offer for sale and sell (and have others do the foregoing) the Licensed Compounds and Licensed Products in the Field in and for the Territory. In addition, subject to the terms and conditions of this Agreement, Eagle hereby grants to Cephalon a non-transferable (except in accordance with Section 16.2) right of reference to any NDAs and other Regulatory Filings Controlled by Eagle or any of its Affiliates as of the Effective Date or during the Term for the limited purpose of exercising the rights expressly granted to Cephalon hereunder.
7.1.2      Subject to the terms and conditions of this Agreement, Eagle hereby grants (a) to Cephalon a non-transferable (except in accordance with Section 16.2), co-exclusive license, with the right to sublicense through multiple tiers, under the Eagle IP to Manufacture and have Manufactured the Licensed Compounds and Licensed Products in the Field in and for the Territory, and (b) to Cephalon a non-transferable (except in accordance with Section 16.2), non-exclusive license, with the right to sublicense through multiple tiers, under the Eagle IP to Manufacture and have Manufactured the Licensed Compounds and Licensed Products outside the Territory for purposes of Development and Commercialization of the Licensed Compounds and Licensed Products in the Field and for the Territory. Notwithstanding anything herein to the contrary, Eagle will have the co-exclusive right to Manufacture the Licensed Compounds and Licensed Products in the Territory solely for the purpose of supporting the research, Development, Manufacture and Commercialization of the Licensed Compounds and Licensed Products outside the Territory or to supply Licensed Compounds and Licensed Products to Cephalon and its Affiliates and sublicensees pursuant to the Manufacturing and Supply Agreement.
7.2      Reservation of Rights . Eagle and its Affiliates will retain rights under the Eagle IP as necessary to perform its obligations under this Agreement with respect to (a) Development of, seeking and obtaining Regulatory Approval for, [ * ], the Licensed Compounds and Licensed Products and (b) the Manufacture of Licensed Product under the Manufacture and Supply Agreement [ * ]. The foregoing retained rights will be sublicensable to Third Parties solely for such purposes, provided that Eagle will ensure that each such sublicensee is obligated to assign or exclusively license (with the right to grant fully paid-up, royalty free sublicenses through multiple tiers) to Eagle or its Affiliates all rights, title, and interests in or to any Patent Rights, Know-How or other intellectual property rights created, conceived or made by such sublicensee applicable to Licensed Compounds and Licensed Products in the Territory in the course of exercising its rights under such sublicense, subject to any reasonable, non-commercial retained rights that are reserved for such sublicensee in such sublicense.

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7.3      Sublicensing . Cephalon will have the right to grant sublicenses under its rights in Section 7.1 to its Affiliates or any Third Party without the approval of Eagle. Any such sublicenses will be granted and governed by written agreements and will be subject to the terms and conditions of this Agreement. Cephalon will be and remain responsible for ensuring its sublicensees’ compliance with this Agreement. Cephalon shall provide Eagle with a copy of any agreement entered into with a sublicensee under this Section 7.3; provided that such copy may be redacted except as necessary for Eagle to ensure compliance of such sublicense with the terms of this Agreement.
7.4      Maintenance of In-License Agreements . Eagle (a) will duly perform and observe all of its obligations under each of the In-License Agreements in all material respects and maintain in full force and effect each of the In-License Agreements, including payment of royalties and other amounts to the counterparty of each of the In-License Agreements, and (b) will not, without Cephalon’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed), (i) amend, modify, restate, cancel, supplement or waive any provision of any In-License Agreement, or grant any consent thereunder, or agree to do any of the foregoing, in each case in a manner that would materially affect Cephalon’s rights hereunder, and in any event without giving Cephalon at least thirty (30) days prior written notice of any amendment, modification, restatement, cancellation, supplement or waiver of any provision of any In-License Agreement, or (ii) exercise any right to terminate any In-License Agreement. Eagle will provide Cephalon with written notice as promptly as practicable (and in any event within sixty (60) days) after becoming aware of any of the following: (A) any material breach or default by Eagle or any of its Affiliates of any covenant, agreement or other provision of any In-License Agreement, (B) any notice or claim from the counterparty to any In-License Agreement terminating or providing notice of termination of such In-License Agreement, (C) any notice or claim alleging any breach of default under any In-License Agreement, or (D) the existence of any facts, circumstances or events which alone or together with other facts, circumstances or events would reasonably be expected (with or without the giving of notice or passage of time or both) to give rise to a breach of or default under or right to terminate any In-License Agreement. If Eagle [ * ], Cephalon will [ * ]. Eagle’s obligations under this Section 7.4 shall continue for [ * ].
7.5      License Limitations . Except as expressly set forth in this Agreement, no licenses or other rights are granted or created hereunder to use any Patent Right, Know-How or other intellectual property rights owned or in-licensed by Eagle or any of its Affiliates. All licenses and other rights are or will be granted only as expressly provided in this Agreement, and no other licenses or other rights is or will be created or granted hereunder by implication, estoppel or otherwise.
Section 8.      Rights of First Negotiation; Exclusivity .
8.1      Territory . For a period of [ * ], Cephalon will have an exclusive right of first negotiation to expand the Territory to include [ * ] (each such country, a “ ROFN Country ”). During such [ * ] period, Cephalon may notify Eagle in writing in the event Cephalon desires to exercise its right of first negotiation with respect to any ROFN Country(ies) as set forth in this Section 8.1. If Cephalon exercises its right of first negotiation, then [ * ] the Parties will negotiate in good faith the terms of a definitive agreement or an amendment to this Agreement with respect to the Licensed Compounds or Licensed Products in such ROFN Country(ies) for an additional [ * ] period following the receipt of Cephalon’s notification (or such longer period as the Parties may mutually agree).
8.2      Other Products . If Eagle elects to Develop and/or Commercialize any Other Product in the Territory during [ * ], then Eagle will comply with the terms and conditions of this Section 8.2. Cephalon will have an exclusive right of first negotiation to purchase or license, on an exclusive basis, each Other Product in the Territory from Eagle or its Affiliates. Eagle promptly will notify Cephalon

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in writing (the “ Other Product Notice ”) upon the earlier of Eagle or any of its Affiliates either (a) [ * ], or (b) [ * ] (the “ Other Product Triggering Event ”). Together with such Other Product Notice, Eagle will provide to Cephalon all material information in Eagle’s or its Affiliates’ control relating to the Other Product (including all information provided to any Third Parties relating to an Other Product). Cephalon will have [ * ] to deliver a written notice to Eagle of Cephalon’s desire to engage in negotiations for the purchase or license of the Other Product and all intellectual property rights, data, materials and other assets relating thereto (the “ Other Product Assets ”). If Cephalon does not provide such written notice to Eagle within such [ * ] period, it will be deemed that Cephalon has declined to enter into such negotiations and Eagle shall have no further obligation to Cephalon with respect to, and Cephalon shall have no further rights to, such Other Product. If Cephalon provides written notice to Eagle within [ * ] period indicating Cephalon wishes to engage in such negotiations (the “ Cephalon ROFN Notice ”), the Parties will negotiate in good faith on an exclusive basis, for [ * ](or such longer period as the Parties may mutually agree) (the “ Other Product Negotiation Period ”) an agreement for the purchase or exclusive license of the Other Product Assets by Cephalon. In the event that a mutually acceptable agreement for the purchase or license of the applicable Other Product Assets has not been entered into between the Parties prior to the expiration of the Other Product Negotiation Period, Eagle or its Affiliates will be free to negotiate an agreement (if any) with any Third Party for the purchase or license of such Other Product Assets or continue Developing and Commercializing such Other Product itself. In addition, the right of first negotiation under this Section 8.2 will continue to apply to [ * ] or, [ * ]. For clarity, a bona fide agreement with a contractor, contract research organization or contract manufacturer for performing contract services on behalf of Eagle or its Affiliates solely for the research, Development, Manufacture or Commercialization of Other Products on a fee-for-services basis will not be subject to the right of first negotiation under this Section 8.2. However, notwithstanding anything to the contrary herein, any licensing, acquisition, partnering or other collaboration agreement is subject to the right of first negotiation under this Section 8.2.
8.3      Exclusivity .
8.3.1      During the Term, neither Eagle nor any of its Affiliates will directly or indirectly research, Develop, Manufacture or Commercialize, nor collaborate with, enable or otherwise authorize, license, grant or transfer any right to any Third Party to research, Develop, Manufacture or Commercialize, any Alternative Product in the Field anywhere in the Territory, other than as expressly permitted pursuant to the terms of this Agreement or the Settlement Agreement. As of the Effective Date, neither Eagle nor any of its Affiliates owns or otherwise in-licenses any compound or product that qualifies as an Alternative Product hereunder other than the Eagle RTD Product. For purposes of this Section 8.3, “ Alternative Product ” means [ * ].
8.3.2      Notwithstanding the provisions of Section 8.3.1, if, during the Term, Eagle or any of its Affiliates acquires or otherwise obtains, as the result of an Acquisition Transaction, rights to an Alternative Product, and on the closing date of such Acquisition Transaction, such Alternative Product is being Developed, Manufactured or Commercialized or the Development, Manufacture or Commercialization of such Alternative Product in the Field, would but for [ * ], then Eagle or its Affiliate, as applicable, shall within [ * ] provide written notice to Cephalon that Eagle or such Affiliate has acquired or obtained rights to Develop, Manufacture or Commercialize an Alternative Product as a result of an Acquisition Transaction. Within [ * ] after the receipt of such notice, Cephalon may provide written notice to Eagle or such Affiliate that Cephalon elects to include such Alternative Product as a Licensed Compound and Licensed Product hereunder (in which case the terms of this Agreement shall apply to such Alternative Product mutatis mutandis and such election will be effective retroactively to the date of the closing of such Acquisition Transaction). If Cephalon elects not to include such Alternative Product

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as a Licensed Compound or Licensed Product hereunder or fails to notify Eagle of its decision within such [ * ] period, Eagle may thereafter (a) Divest its rights to such Alternative Product or (b) cease the Development, Manufacture and Commercialization of such Alternative Product. If Eagle elects to Divest the Alternative Product as described in clause (a) of the preceding sentence, Eagle, and its Affiliates if applicable, will Divest such Alternative Product within [ * ]. If Eagle elect to cease the Development, Manufacture and Commercialization of the Alternative Product under clause (b) above, Eagle, and its Affiliates if applicable, will cease the Development, Manufacture and Commercialization of such Alternative Product as soon as reasonably practicable, giving due consideration to ethical concerns and requirements under applicable Law and any agreements with Third Parties. Eagle and its Affiliates will Segregate the Alternative Product prior to the time of Divestiture pursuant to clause (a) or the cessation of Development, Manufacture and Commercialization pursuant to clause (b) above. For clarity, Eagle may retain a passive income stream interest in a Divested Alternative Product.
8.3.3    Notwithstanding the provisions of Section 8.3.1, if, during the Term, Eagle [ * ]
Section 9.      Payments .
9.1      License Fee . On the terms and subject to the conditions set forth in this Agreement, Cephalon will pay to Eagle an amount in cash equal to US $30,000,000 within [ * ] after the Effective Date.
9.2      Milestone Payments . As additional consideration, subject to the provisions of this Section 9.2, Cephalon will, upon the achievement of the regulatory and sales milestones set forth below (each a “ Milestone Event ”), pay the following non-refundable and non-creditable (except as provided in Section 7.4) payments (each, a “ Milestone Payment ” and collectively, the “ Milestone Payments ”) to Eagle:
9.2.1.1      (a) [ * ], upon the receipt [ * ];
9.2.1.2      (a) [ * ], upon the receipt [ * ]; and
9.2.1.3    [ * ] upon the achievement [ * ].
Each Milestone Payment will become due and payable [ * ] after the occurrence of the corresponding Milestone Event, and will be made by in United States dollars in cash, or by wire transfer to an account designated in writing by Eagle. Each of the Milestone Payments will be payable only once upon the first achievement of the corresponding Milestone Event, regardless of the number of Licensed Products that achieve such Milestone Events or the number of times the Milestone Event is achieved. The maximum aggregate amount payable by Cephalon to Eagle pursuant to this Section 9.2 is $90,000,000.
9.3      Royalties .
9.3.1      Net Sales Royalty . During the Royalty Term, Cephalon will pay to Eagle a royalty of [ * ] of the Net Sales of Licensed Products during each Calendar Quarter (the “ Net Sales Royalty ”). The percentage in the Net Sales Royalty [ * ]. The Net Sales Royalty calculation will be delivered in writing by Cephalon to Eagle within [ * ] of each applicable Calendar Quarter, and will include the aggregate gross sales of the Licensed Product in the Territory during such Calendar Quarter, the corresponding Net Sales, royalty rate applied, and the amount of the Net Sales Royalty payment payable with respect to such Net Sales (each, a “ Net Sales Statement ”). Cephalon will pay the Net

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Sales Royalty in United States dollars in cash, or by wire transfer to an account designated in writing by Eagle within [ * ] following the end of each applicable Calendar Quarter.
9.3.2      True-Up; Adjustments .
9.3.2.1      Within [ * ] after the end of each calendar year during the Royalty Term, Cephalon will perform a “true up” reconciliation (and will provide Eagle with a written report of such reconciliation) of the deductions outlined in the definition of “Net Sales.” The reconciliation will be based on actual cash paid or credits issued plus an estimate for any remaining liabilities incurred related to the Licensed Products, but not yet paid. If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party will pay the amount of the difference to the other Party within [ * ] after the date of delivery of such report.
9.3.2.2      Within [ * ] after the expiration of the Royalty Term, Cephalon will perform a “true-up” reconciliation (and will provide Eagle with a written report of such reconciliation) of the items comprising deductions from Net Sales. If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party will pay the amount of the difference to the other Party within [ * ] after the date of delivery of such report.
9.3.3      Reductions . Notwithstanding the foregoing:
9.3.3.1      on a country-by-country basis in the Territory, the Net Sales Royalty payable to Eagle for Net Sales of Licensed Product will be reduced [ * ].
9.3.3.2      in the event that either Party identifies any Patent Right or intellectual property right owned or controlled by a Third Party in a particular country or other jurisdiction that, absent a license or agreement with such Third Party, would be infringed by sales of a Licensed Product in the Field in the Territory (“ Blocking IP ”), it shall so notify the other Party. [ * ];
9.3.3.3      [ * ]; and
9.3.3.4    [ * ].
9.3.4      Net Sales Audit Rights .
9.3.4.1      Eagle will have the right to engage, at its own cost and expense, subject to this Section 9.3, an independent nationally recognized public accounting firm chosen by Eagle and reasonably acceptable to Cephalon (which accounting firm will not be the external auditor of Eagle, will not have been hired or paid on a contingency basis and will have experience auditing generic pharmaceutical companies) (a “ CPA Firm ”) to conduct an audit of Cephalon for the purposes of confirming Cephalon’s compliance with the Net Sales Royalty provisions of this Agreement.
9.3.4.2      The CPA Firm will be given access to and will be permitted to examine such books and records of Cephalon as it will reasonably request, upon [ * ] prior written notice having been given by Eagle, during regular business hours, for the sole purpose of determining compliance with the Net Sales Royalty provisions of this Agreement. Prior to any such examination taking place, the CPA Firm will enter into a confidentiality agreement reasonably acceptable to Cephalon with respect to the information to which they are given access and will not contain in its report or

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otherwise disclose to Eagle or any Third Party any information labeled by Cephalon as being confidential customer information regarding pricing or other competitively sensitive proprietary information.
9.3.4.3      Eagle and Cephalon will be entitled to receive a full written report of the CPA Firm with respect to its findings and Eagle will provide, without condition or qualification, Cephalon with a copy of the report, or other summary of findings, prepared by such CPA Firm promptly following Eagle’s receipt of same. In the event of any dispute between Eagle and Cephalon regarding the findings of any such inspection or audit, the Parties will initially attempt in good faith to resolve the dispute amicably between themselves, and if the Parties are unable to resolve such dispute within [ * ] after delivery to both Parties of the CPA Firm’s report, each Party will select an internationally recognized independent certified public accounting firm (other than the CPA Firm), and the two firms chosen by the Parties will choose a third internationally recognized independent certified public accounting firm which will resolve the dispute, and such accounting firm’s determination will be binding on both Parties, absent manifest error by such accounting firm.
9.3.4.4      Within [ * ] after completion of the CPA Firm’s audit, Cephalon will pay to Eagle any deficiency in the Net Sales Royalty amount determined by the CPA Firm. If the report of the CPA Firm shows that Cephalon overpaid, then Cephalon will be entitled to off-set such overpayment against any Net Sales Royalty then owed to Eagle. If no royalty is then owed to Eagle, then Eagle will remit such overpayment to Cephalon. If the report of the CPA Firm shows a discrepancy between the amount of the royalty to which Eagle is entitled and the Net Sales Royalty amount reflected by Cephalon in the Net Sales Statement in Eagle’s favor, then in addition to the payment of the Net Sales Royalty amount, and if such discrepancy exceeds [ * ] of the amount audited, then the fees and expenses of the CPA Firm in performing such audit will be paid by Cephalon.
9.3.4.5      Eagle may exercise its audit rights under this Section 9.3.4 may not [ * ].
9.3.5      Taxes . Where required by Law, Cephalon shall have the right to withhold applicable taxes from any payments to be made by Cephalon to Eagle pursuant to this Agreement. Cephalon shall provide Eagle with receipts from the appropriate taxing authority for all payments of taxes withheld and paid by Cephalon to such authorities on behalf of Eagle. Eagle shall have the right to appeal to the appropriate taxing authority any such withholding and payment of such taxes.
9.3.6      No Other Compensation . Other than as explicitly set forth (and as applicable) in this Agreement, Cephalon will not be obligated to pay any additional fees, milestone payments, royalties or other payments of any kind to Eagle under this Agreement.
9.3.7      Change in Accounting Periods . From time to time, either of the Parties may change its accounting and financial reporting practices from Calendar Quarters and Calendar Years to fiscal quarters and fiscal years or vice versa. If a Party notifies the other of a change in its accounting and financial reporting practices from Calendar Quarters and Calendar Years to fiscal quarters and fiscal years or vice versa, then thereafter, beginning with the period specified in the notice, the payment, reporting and other obligations hereunder related to Calendar Quarters and Calendar Years will be deemed satisfied by compliance therewith in accordance with the new reporting periods (fiscal reporting periods or calendar reporting periods, as the case may be) instead of the previously utilized reporting periods. The Parties will cooperate in good faith to minimize any disruption caused by any such change.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



Section 10.      Intellectual Property .
10.1      Prosecution and Maintenance .
10.1.1      Responsibility . Cephalon will, [ * ]. Cephalon will [ * ]. Cephalon will [ * ]. Cephalon will [ * ]. Eagle may [ * ]. Eagle will [ * ].
10.1.2      Patent Files . [ * ]Eagle will [ * ]Cephalon will [ * ]
10.1.3      Cooperation . Each Party will reasonably cooperate with the other Party in the prosecution and maintenance of the Eagle Patent Rights. Such cooperation includes promptly executing all documents, or requiring inventors, subcontractors, employees and consultants and agents of such Party and its Affiliates, and for Cephalon and its Affiliates and sublicensees, to execute all documents, as reasonable and appropriate so as to enable the prosecution and maintenance of any such Eagle Patent Rights.
10.2      CREATE Act . The Parties intend for the activities of the Parties hereunder to qualify for the benefits of the Cooperative Research and Technology Enhancement (35 U.S.C. § 103(c), the “ CREATE Act ”). Accordingly, each Party agrees to use reasonable efforts, to do (and cause its employees to do) all lawful and just acts that may be or become necessary for evidencing, maintaining, recording and perfecting the benefits of the CREATE Act.
10.3      Defense and Settlement of Third Party Claims . From and after the Effective Date, if a Third Party asserts that a Patent Right or other right owned by it is infringed by the manufacture, use, sale or importation of any Licensed Compound or Licensed Product in the Field in the Territory, Cephalon will have the sole right to defend against any such assertions at Cephalon’s sole cost. Cephalon will have the sole right to control the defense of any such Third Party claims at Cephalon’s sole cost and expense and to elect to settle such claims (except as set forth below). Eagle will assist Cephalon and cooperate in any such litigation at Cephalon’s request, and Cephalon will reimburse Eagle any reasonable, documented out‑of‑pocket costs incurred in connection therewith. Eagle may join any defense pursuant to this Section 10.3, with its own counsel. Cephalon will not settle or consent to the entry of any judgment in any enforcement action hereunder without Eagle’s prior written consent, not to be unreasonably withheld or delayed. Should Cephalon fail to defend against any such assertion, Eagle will have the right to do so, at Eagle’s sole cost and expense. Cephalon will assist Eagle and cooperate in any such litigation at Eagle’s request, and Eagle will reimburse Cephalon any reasonable, documented out‑of‑pocket costs incurred in connection therewith. Cephalon may join any such defense brought by Eagle pursuant to this Section 10.3, with its own counsel. Eagle will not settle or consent to the entry of any judgment in any enforcement action hereunder without Cephalon’s prior written consent, not to be unreasonably withheld or delayed. Eagle will give Cephalon prompt written notice of any allegation by any Third Party that a Patent Right or other right owned by it is infringed by the manufacture, use, sale or importation of any Licensed Compound or Licensed Product. For the avoidance of doubt, Cephalon will be entitled to set off any amounts due to Cephalon hereunder against payments owing by Cephalon to Eagle. Otherwise, Eagle will pay any amounts due hereunder within [ * ] of invoice.
10.4      Enforcement .
10.4.1      By Cephalon . In the event that (i) Eagle or Cephalon becomes aware of a suspected infringement of any Eagle Patent Right within the scope of the license grants in Section 7.1, (ii) any such Eagle Patent Right is challenged in any action or proceeding (other than any

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



interferences, oppositions, reissue proceedings or reexaminations, which are addressed in Sections 10.1 and 10.1.1) or (iii) Eagle or Cephalon receives a Notice of Paragraph IV Patent certification as described in Section 10.6.3, such Party will notify the other Party promptly, and following such notification, the Parties will confer. Cephalon will have the right, but will not be obligated, to defend any such action or proceeding or bring an infringement action with respect to such infringement at its own expense, in its own name and entirely under its own direction and control, or settle any such action or proceeding by sublicense (including, at Cephalon’s sole discretion, granting a sublicense, covenant not to sue or other right with respect to a compound or product (including a Generic Rapid Product) in the Field in the Territory). Eagle will reasonably assist Cephalon in any action or proceeding being defended or prosecuted if so requested, and will be named in or join such action or proceeding if requested by Cephalon or if Eagle so requests. If Eagle elects to be represented by legal counsel, Cephalon will bear all of Eagle’s related and reasonable legal costs and expenses if Eagle is required to be named in or joined in such action or proceeding or is joined in such action or proceeding at Cephalon’s request. Eagle may participate in any such action or proceeding at its election and expense (other than as provided in the immediately preceding sentence), whether or not Eagle is a named party to any such action or proceeding, and Cephalon will reasonably cooperate with Eagle in such participation (including providing copies of filings and other submissions before their filing or submission for Eagle’s review and comment). No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of any Eagle Patent Right may be entered into by Cephalon without the prior written consent of Eagle.
10.4.2      By Eagle . If Cephalon elects not to settle, defend or bring any action for infringement described in Section 10.4.1 within [ * ] after becoming aware of such suspected infringement or action or proceeding (and in all events at least [ * ]), then Eagle may defend or bring such action, or substitute as a party in an existing action brought by Cephalon, at Eagle’s own expense, in its own name and entirely under its own direction and control, including the right to settle any such action, subject to the following: (a) Cephalon will reasonably assist Eagle in any action or proceeding being defended or prosecuted if so requested, and will join such action or proceeding if requested by Eagle, and (b) Cephalon will have the right to participate in any such action or proceeding with its own counsel at its own expense and without reimbursement. For purposes of this Agreement, “ Hatch-Waxman Time Period ” means the applicable period of time during which a patent holder or licensee has the right to file an infringement suit to maintain certain rights and privileges upon receipt of Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application or an application under § 505(b)(2) of the United States Food, Drug, and Cosmetic Act (as amended), or any other similar patent certification by a Third Party, or any foreign equivalent thereof.
10.4.3      Withdrawal. If either Party brings an action or proceeding under this Section 10.4 and subsequently ceases to pursue or withdraws from such action or proceeding, it will promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of this Section 10.4.
10.4.4      Damages . In the event that either Party exercises the rights conferred in this Section 10.4 and recovers any damages, payments or other sums in such action or proceeding or in settlement thereof, such damages or other sums recovered will first be applied to all out-of-pocket costs and expenses incurred by the Parties in connection therewith (including attorney’s fees). If such recovery is insufficient to cover all such costs and expenses of both Parties, the controlling Party’s costs will be paid in full first before any of the other Party’s costs. If after such reimbursement any funds will remain from such damages or other sums recovered, such funds will be retained by the Party that controlled the action or proceeding under this Section 10.4; provided, however, that (i) if Cephalon is

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the Party that controlled such action or proceeding, [ * ], and (ii) if Eagle is the Party that controlled such action or proceeding, [ * ].
10.5      Trademarks . Cephalon will solely own all right, title and interest in and to any trademarks adopted for use with the Licensed Products in the Field in the Territory, and will be responsible for the registration, filing, maintenance and enforcement thereof; provided that Eagle shall not select a trademark for use with the Licensed Products that is not specific to and solely used for such Licensed Product in the Field in the Territory. Eagle will not at any time do or authorize to be done any act or thing which is likely to materially impair the rights of Cephalon therein, and will not at any time claim any right of interest in or to such marks or the registrations or applications therefor. Eagle will solely own all right, title and interest in and to any trademarks adopted for use with the Licensed Compounds or Licensed Products outside the Territory (other than pre‑existing trademarks of Cephalon), and will be responsible for the registration, filing, maintenance and enforcement thereof. Cephalon will not at any time do or authorize to be done any act or thing which is likely to materially impair the rights of Eagle therein, and will not at any time claim any right of interest in or to such marks or the registrations or applications therefor. Neither Party shall use the other Party’s trademarks or any confusingly similar trademarks in a manner that might amount to infringement, dilution, unfair competition or passing off of any of such other Party’s trademarks without such other Party’s consent.
10.6      Patent Extensions; Orange Book Listings; Patent Certifications .
10.6.1      Patent Term Extension . If elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in any country with respect to any Licensed Product becomes available, upon Regulatory Approval or otherwise, [ * ] will have the sole right to determine which issued patent to extend.
10.6.2      Regulatory Exclusivity and Orange Book Listings . With respect to regulatory exclusivity periods (such as orphan drug exclusivity and any available pediatric extensions), [ * ] will be responsible for seeking and maintaining all such regulatory exclusivity periods that may be available for the Licensed Products in the Field in the Territory, subject to [ * ] approval, such approval not to be unreasonably withheld or delayed ([ * ]). [ * ] will make all filings necessary to list the appropriate exclusivity periods and Eagle Patent Rights, if any, in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “ Orange Book ”) and all equivalents in any country in the Territory with respect to the Licensed Products in the Field in the Territory, subject to [ * ] approval, such approval not to be unreasonably withheld or delayed.
10.6.3      Notification of Patent Certification . Eagle and Cephalon will each notify and provide the other Party with copies of any notice of a Paragraph IV Patent Certification (including any associated documents) by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) of the United States Federal Food, Drug, and Cosmetic Act (as amended or any replacement thereof), or any other similar patent certification by a Third Party, and any foreign equivalent thereof. Such notification and copies will be provided to the other Party within five (5) days after receipt of such notification and will be sent to the address set forth in Section 16.12.
10.7      Rights Limited to Territory . Notwithstanding anything to the contrary contained herein, Cephalon shall have no rights under this Section 10, with respect to the Licensed Compounds, Licensed Products and Eagle IP outside of the Territory.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



Section 11.      Confidentiality .
11.1      Confidentiality; Exceptions . Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that the receiving Party will keep confidential and will not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any information and materials furnished to it by the other Party pursuant to this Agreement (collectively, “ Confidential Information ”). For clarity, Confidential Information of a Party will include, without limitation, all information and materials disclosed by such Party or its designee that (a) is marked as “Confidential,” “Proprietary” or with similar designation at the time of disclosure or (b) by its nature can reasonably be expected to be considered Confidential Information by the recipient. Information disclosed orally will not be required to be identified as such to be considered Confidential Information. The terms of this Agreement and information relating to the Eagle IP, Licensed Compounds and Licensed Products shall be deemed to be the Confidential Information of both Parties. Notwithstanding the foregoing, Confidential Information will not include any information to the extent that it can be established by written documentation by the receiving Party that such information:
11.1.1      was already known to the receiving Party, other than under an obligation of confidentiality (except to the extent such obligation has expired or an exception is applicable under the relevant agreement pursuant to which such obligation established), at the time of disclosure;
11.1.2      was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;
11.1.3      became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;
11.1.4      was independently developed by the receiving Party as demonstrated by written documentation prepared contemporaneously with such independent development; or
11.1.5      was disclosed to the receiving Party, other than under an obligation of confidentiality (except to the extent such obligation has expired or an exception is applicable under the relevant agreement pursuant to which such obligation was established), by a Third Party who had no obligation to the disclosing Party not to disclose such information to others.
11.2      Authorized Disclosure . Except as expressly provided otherwise in this Agreement, each Party may use and disclose Confidential Information of the other Party solely as follows: (a) under appropriate confidentiality provisions substantially equivalent to those in this Agreement: (i) in connection with the performance of its obligations or as reasonably necessary or useful in the exercise of its rights under this Agreement, including the right to grant licenses or sublicenses as permitted hereunder, (ii) to the extent such disclosure is reasonably necessary or useful in conducting Clinical Studies under this Agreement; or (iii) to actual or potential (sub)licensees, acquirers or assignees, collaborators, investment bankers, investors or lenders, or; (b) to the extent such disclosure is to a Government Authority as reasonably necessary in filing or prosecuting patent right, copyright and trademark applications in accordance with this Agreement, prosecuting or defending litigation related to this Agreement, complying with applicable governmental regulations with respect to performance under this Agreement, obtaining regulatory approval or fulfilling post‑approval regulatory obligations for the Licensed Compounds or Licensed Products, or otherwise required by Law; provided, however , that if a Party is required by Law or the rules of any securities exchange or automated quotation system to make any such disclosure of the other Party’s Confidential Information it will, except where

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



impracticable for necessary disclosures (for example, in the event of medical emergency), give reasonable advance notice to the other Party of such disclosure requirement and, in each of the foregoing, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; (c) to advisors (including lawyers and accountants) on a need to know basis, in each case under appropriate confidentiality provisions or professional standards of confidentiality substantially equivalent to those of this Agreement, or (d) to the extent mutually agreed to by the Parties. Notwithstanding the foregoing, the Parties will agree upon and release a mutual press release to announce the execution of this Agreement in the form attached hereto as Exhibit A for use in responding to inquiries about the Agreement; thereafter, Eagle and Cephalon may each disclose to Third Parties the information contained in such press release without the need for further approval by the other. Each Party acknowledges and agrees that the other Party may submit this Agreement to the Securities and Exchange Commission (“ SEC ”) and if a Party does submit this Agreement to the SEC, such Party agrees to consult with the other Party with respect to the preparation and submission of, a confidential treatment request for this Agreement. If a Party is required by Law to make a disclosure of the terms of this Agreement in a filing with or other submission to the SEC, and (i) such Party has provided copies of the disclosure to the other Party as far in advance of such filing or other disclosure as is reasonably practicable under the circumstances, (ii) such Party has promptly notified the other Party in writing of such requirement and any respective timing constraints, and (iii) such Party has given the other Party a reasonable time under the circumstances from the date of notice by such Party of the required disclosure to comment upon, request confidential treatment or approve such disclosure, then such Party will have the right to make such public disclosure at the time and in the manner reasonably determined by its counsel to be required by Law. Notwithstanding anything to the contrary herein, it is hereby understood and agreed that if a Party seeking to make a disclosure to the SEC as set forth in this Section 11.2, and the other Party provides comments within the respective time periods or constraints specified herein or within the respective notice, the Party seeking to make such disclosure or its counsel, as the case may be, will in good faith (A) consider incorporating such comments and (B) use reasonable efforts to incorporate such comments, limit disclosure or obtain confidential treatment to the extent reasonably requested by the other Party. Each Party will have the right to issue additional press releases or to make public disclosures with the prior written agreement of the other Party.
11.3      Prior Agreement . This Agreement supersedes the Confidentiality Agreement. All confidential information exchanged between the Parties under the Confidentiality Agreement will be deemed Confidential Information of the disclosing Party and will be subject to the terms of this Agreement.
11.4      Publications . Except as required by applicable Law or court order, any publication or presentation concerning the activities to be conducted hereunder, including Clinical Studies carried out pursuant to this Agreement will be subject to the oversight, guidelines and approval of the JSC. The JSC will establish promptly after the Effective Date guidelines that require: (a) each Party’s timely review of all such publications or presentations, (b) protection of Confidential Information and coordination with Cephalon or Eagle prior to any disclosure of patentable subject matter, (c) that all such publications and presentations are consistent with good scientific practice and accurately reflect work done and the contributions of the Parties, and (d) that no such publication or presentation be made except to the extent approved by the JSC in advance in writing. Unless otherwise mutually agreed upon by the Parties, (i) the Party desiring to publish or present any publication or presentation concerning the activities to be conducted hereunder (the “ Publishing Party ”) will transmit to the other Party (the “ Reviewing Party ”) for review and comment a copy of the proposed publication or presentation, at least [ * ] prior to the submission of the proposed publication or presentation to a Third Party; (ii) the Publishing Party will postpone the publication or presentation for up to an additional [ * ] upon request

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



by the Reviewing Party in order to allow the consideration of appropriate patent applications or other protection to be filed on information contained in the publication or presentation; (iii) upon request of the Reviewing Party, the Publishing Party will remove all Confidential Information of the Reviewing Party (other than that licensed hereunder) from the information intended to be published or presented; and (iv) the Publishing Party will consider all reasonable comments made by the Reviewing Party to the proposed publication or presentation.
11.5      Attorney‑Client Privilege . Neither Party is waiving, nor will be deemed to have waived or diminished, any of its attorney work product protections, attorney‑client privileges or similar protections and privileges as a result of disclosing information pursuant to this Agreement, or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the receiving Party, regardless of whether the disclosing Party has asserted, or is or may be entitled to assert, such privileges and protections. The Parties: (a) share a common legal and commercial interest in such disclosure that is subject to such privileges and protections; (b) are or may become joint defendants in proceedings to which the information covered by such protections and privileges relates; (c) intend that such privileges and protections remain intact should either Party become subject to any actual or threatened proceeding to which the disclosing Party’s Confidential Information covered by such protections and privileges relates; and (d) intend that after the Effective Date both the receiving Party and the disclosing Party will have the right to assert such protections and privileges.
Section 12.      Representations, Warranties and Covenants .
12.1      Mutual Representations, Warranties and Covenants . Each of the Parties hereby represents, warrants and covenants to the other Party, as a material inducement for such other Party’s entry into this Agreement, as follows:
12.1.1      It is duly organized and validly existing under the laws of its jurisdiction of incorporation, has full corporate power and authority and has taken all corporate action necessary to enter into and perform this Agreement;
12.1.2      This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and other Law affecting creditors’ rights generally from time to time in effect and to general principles of equity. The execution, delivery and performance of this Agreement by such Party do not conflict with any agreement, instrument or understanding, oral or written, by which it is bound, nor will it violate any Law. The person or persons executing this Agreement on such Party’s behalf has been duly authorized to do so by all requisite corporate action;
12.1.3      To its knowledge, as of the Effective Date, no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable Laws currently in effect, is or shall be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or (except for FDA or other Regulatory Approvals, licenses, clearances and the like necessary for the research, development manufacture, sales or marketing of pharmaceutical products) for the performance by it of its obligations under this Agreement and such other agreements;
12.1.4      Each Party represents and warrants that it has not been debarred or the subject of debarment proceedings by any regulatory authority. Neither Party shall knowingly use in connection with the research, development, manufacture or commercialization to take place pursuant

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to this Agreement any employee, consultant or investigator that has been debarred or the subject of debarment proceedings by any regulatory agency;
12.1.5      Each Party covenants to carry out its activities under this Agreement in compliance with all applicable Laws; and
12.1.6      Each Party covenants to not misappropriate the trade secret of a Third Party in connection with the performance of its activities under this Agreement.
12.2      Eagle Representations, Warranties and Covenants . Eagle hereby represents and warrants as of the Effective Date and covenants to Cephalon as a material inducement for Cephalon’s entry into this Agreement and the grant of rights from Eagle to Cephalon hereunder, as follows:
12.2.1      No Conflicting Rights . Eagle has not granted, as of the Effective Date, and during the Term shall not grant, any right to any Third Party under the Eagle IP that conflicts with the rights granted to Cephalon hereunder. Eagle has sufficient legal and/or beneficial title and ownership and/or license under the Eagle IP to fulfill its obligations under this Agreement and to grant the licenses to Cephalon pursuant to this Agreement. As of the Effective Date, none of the Eagle Patent Rights is encumbered and there is no written challenge to its right to use or ownership of such Patent Rights or any adverse claim of ownership thereof.
12.2.2      No Encumbrances . No item of Eagle IP is, as of the Effective Date: (a) in‑licensed by Eagle from a Third Party which license does not provide Eagle the right to grant Cephalon the rights and licenses granted hereunder under such Eagle IP; or (b) subject to any license or other right granted to a Third Party for the Licensed Compounds or Licensed Products in the Field in the Territory. All Eagle Patent Rights existing as of the Effective Date are listed on Schedule 1.22, are exclusively owned by Eagle or exclusively in-licensed by Eagle, and are free and clear of any (i) liens, charges, security interests, and encumbrances or licenses and (ii) claims or covenants that would conflict with or limit the scope of any of the rights or licenses granted to Cephalon hereunder, or would give rise to any Third Party claims for payment against Cephalon or its Affiliates.
12.2.3      Maintenance of Agreements and Patents . Eagle has as of the Effective Date (or shall have at the time performance is due) maintained and shall maintain and keep in full force and effect all agreements (including In-License Agreements) and filings (including patent filings (other than those for which Cephalon has responsibility hereunder)) necessary to perform its obligations hereunder. Without limiting the foregoing, as of the Effective Date, each of the In-License Agreements is in full force and effect and there is no existing breach by Eagle thereunder or basis for such licensor(s) to exercise any right of termination. As of the Effective Date, neither Eagle nor any of its Affiliates has received any written notice alleging any material breach (and neither Eagle nor any of its Affiliates is currently in material breach, nor will it be in material breach as a result of the delivery and execution of this Agreement) of the In-License Agreements. To Eagle’s knowledge, each of the In-License Agreements are valid and enforceable in accordance with their terms as of the Effective Date, subject to applicable bankruptcy, insolvency, reorganization, moratorium and other Law affecting creditors’ rights generally from time to time in effect and to general principles of equity.
12.2.4      Patents . Schedule 1.22 is a complete and accurate list of all Patent Rights owned or in-licensed by Eagle or any of its Affiliates as of the Effective Date that the manufacture, use, sale, offer for sale or importation of any Licensed Compound or Licensed Product (in each case in the form being developed by Eagle as of the Effective Date) would infringe. As of the Effective Date, Eagle has the sole and exclusive right to prosecute, maintain, enforce and defend the Eagle IP in the

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Territory without consent of or payment to any Third Party, including, without limitation, without consent of or payment to any licensor under the In-License Agreements.
12.2.5      Full Force and Effect . As of the Effective Date, the Eagle Patent Rights have been duly applied for and registered in accordance with applicable Law, and have no unsatisfied past maintenance or annuity obligation.
12.2.6      Employee Assignmen t. As of the Effective Date, Eagle or its Affiliates have secured from all employees, consultants, contractors and other Persons who have contributed to the creation or invention of any of the Eagle IP a written agreement assigning to Eagle or its Affiliates all rights to such creations, inventions, or Eagle IP and such Affiliates have assigned such rights to Eagle, and neither Eagle nor any of its Affiliates has received any written communication challenging Eagle’s ownership or right to use the Eagle IP.
12.2.7      No Adverse Agreement . As of the Effective Date, neither Eagle nor any of its Affiliates has entered into any agreement or otherwise licensed, granted, assigned, transferred, conveyed or otherwise encumbered or disposed of any right, title or interest in or to any of its assets, including any intellectual property rights pertaining to the Licensed Compounds or Licensed Products, that would conflict with or impair the scope of any rights or licenses granted hereunder. As of the Effective Date, none of Eagle nor any of its Affiliates is a party to any license, sublicense or other agreement pursuant to which Eagle or such Affiliate has received a license or other rights relating to the Licensed Compounds or Licensed Products other than the In-License Agreements.
12.2.8      Absence of Litigation, Infringement, Misappropriation . As of the Effective Date, no Third Party action or proceeding has been commenced or, to Eagle’s knowledge, threatened alleging that the Eagle Patent Rights are invalid or unenforceable or that the research, Development, Commercialization or Manufacture of any Licensed Compound or Licensed Product (in each case in the form being developed by Eagle as of the Effective Date) infringes any Patent Rights, Know-How or other intellectual property rights of such Third Party. Additionally, to Eagle’s knowledge, there is no unauthorized use, infringement or misappropriation of any Eagle IP by any Third Party as of the Effective Date.
12.2.9      No Infringement of Third Party Right . Notwithstanding 35 USC §271(e)(2) or any comparable Laws, to Eagle’s knowledge as of the Effective Date, the research, Development, Commercialization, and Manufacture of each Licensed Compound or Licensed Product (in each case in the form being developed by Eagle as of the Effective Date) does not infringe or misappropriate any Patent Rights, Know-How or other intellectual property rights of any Third Party.
12.2.10      All Material Information Furnished . As of the Effective Date, Eagle has furnished or made available to Cephalon all material information that is in Eagle’s or its Affiliates’ possession concerning the Licensed Compounds, the Licensed Products (in each case in the form being developed by Eagle as of the Effective Date) and the Eagle IP, including relevant to the safety or efficacy of such Licensed Compounds and the Licensed Products, and all material Regulatory Filings and other material correspondence with Regulatory Authorities relating to any such Licensed Compound or Licensed Product, and such information is accurate, complete and true in all material respects.
12.2.11      Conduct of Research and Development . As of the Effective Date, Eagle has conducted Development of Licensed Compounds and Licensed Products in accordance with all applicable Law.

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12.2.12      Full Disclosure . As of the Effective Date, Eagle has not made any intentional misrepresentation or fraudulent omission to Cephalon in responding to Cephalon’s questions in investigating whether or not Cephalon would enter into this Agreement.
12.3      Disclaimer of Warranties . EXCEPT AS SET FORTH IN THIS SECTION 12, EAGLE AND CEPHALON EXPRESSLY DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE LICENSED COMPOUNDS, LICENSED PRODUCTS, EAGLE IP, THIS AGREEMENT, OR ANY OTHER SUBJECT MATTER RELATING TO THIS AGREEMENT, INCLUDING ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, VALIDITY AND NONINFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.
Section 13.      Limitations Of Liability; Insurance .
13.1      Limitations of Liability . EXCEPT WITH RESPECT TO LIABILITY ARISING FROM A BREACH OF SECTION 11 OR A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 14, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE), EVEN IF SUCH PARTY WAS ADVISED OR OTHERWISE AWARE OF THE LIKELIHOOD OF SUCH DAMAGES. AMOUNTS PAID TO A THIRD PARTY PURSUANT TO A COURT ORDER OR WRITTEN SETTLEMENT AGREEMENT WILL BE CONSIDERED DIRECT DAMAGES.
13.2      CEPHALON SHALL HAVE NO LIABILITY FOR [ * ].
13.3      Insurance . During the term of this Agreement each Party will obtain and maintain, the following minimum required insurance: comprehensive general liability insurance, products liability insurance and clinical trials insurance, each with minimum limits of [ * ] per occurrence and [ * ] annual aggregate. Commercial insurance shall be obtained from reputable and financially secure insurance carriers having a minimum A.M. Best rating (or equivalent) of A-. Cephalon maintains the right to fulfill these obligations through the purchase of insurance, through self-insurance (including direct risk retention), or through a combination of both approaches. With respect to the minimum required insurance, each Party shall cause the other to be included as ‘additional insured’, as required by contract. It is agreed that such ‘additional insured’ status shall be limited to claims for which the ‘additional insured’ Party is entitled to indemnification pursuant to the terms of this Agreement. Each party shall ensure continuity of coverage for claims which may be presented during the [ * ] year period following the expiration or termination of this Agreement. Each Party will furnish to the other Party, on request, certificates of insurance evidencing the minimum required insurance, including notice of cancellation to be provided in accordance with the terms of the insurance policies. Each Party further agrees to provide written notice to the other within [ * ] of becoming aware of any material change which prevents compliance with the foregoing insurance obligations. A Party’s failure to maintain minimum required insurance will be deemed a material breach of this Agreement by such Party.
Section 14.      Indemnity .
14.1      Indemnity . Subject to the remainder of this Section 14, Eagle will defend, indemnify, and hold harmless Cephalon, its Affiliates, and their respective directors, officers, employees and agents (collectively, “ Cephalon Indemnitees ”), at Eagle’s cost and expense, from and against any

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and all liabilities, losses, costs, damages, fees or expenses (including reasonable legal expenses and attorneys’ fees incurred by any Cephalon Indemnitees until such time as Eagle has acknowledged and assumed its indemnification obligation hereunder with respect to a claim) paid to a Third Party (collectively, “ Losses ”) arising out of any claim, action, lawsuit, or other proceeding (collectively, “ Claims ”) brought against any Cephalon Indemnitees by a Third Party to the extent such Losses result from [ * ]. Subject to remainder of this Article, Cephalon will defend, indemnify, and hold harmless Eagle, its Affiliates, and their respective directors, officers, employees and agents (collectively, “ Eagle Indemnitees ”), at Cephalon’s cost and expense, from and against any and all Losses (including reasonable legal expenses and attorneys’ fees incurred by any Eagle Indemnitees until such time as Cephalon has acknowledged and assumed its indemnification obligation hereunder with respect to a claim) arising out of any Claim brought against any Eagle Indemnitees by a Third Party to the extent such Losses result from [ * ]. The Parties will include in the Manufacturing and Supply Agreement customary indemnification rights and obligations with respect to the Manufacture and supply of Licensed Product and Licensed Compound (including with respect to the [ * ]), which will supersede any conflicting obligations in this Section 14.1.
14.2      Claim for Indemnification . Whenever any Claim or Loss will arise for which an Eagle Indemnitees or an Cephalon Indemnitees (the “ Indemnified Party ”) may be entitled to indemnification may be sought under this Section 14, the Indemnified Party will promptly notify the other Party (the “ Indemnifying Party ”) of the Claim or Loss and, when known, the facts constituting the basis for the Claim; provided, however , that the failure by an Indemnified Party to give such notice or to otherwise meet its obligations under this Section 14.2 will not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that the Indemnifying Party is actually prejudiced as a result of such failure. The Indemnifying Party will have exclusive control of the defense and settlement of all Claims for which it is responsible for indemnification and will promptly assume defense thereof at its own expense. The Indemnified Party will not settle or compromise any Claim by a Third Party for which it is entitled to indemnification without the prior written consent of the Indemnifying Party, unless the Indemnifying Party is in breach of its obligation to defend hereunder. In no event will either the Indemnified Party or Indemnifying Party settle any Claim without the prior written consent of the other Party if such settlement does not include a release from liability on such Claim or if such settlement would involve undertaking an obligation other than the payment of money, that would bind or impair the other Party, or that includes any admission that any intellectual property or proprietary right of the other Party or to which the other Party has an exclusive license (or option to obtain or make effective an exclusive license) hereunder is invalid or unenforceable. The Indemnified Party will reasonably cooperate with the Indemnifying Party at the Indemnifying Party’s expense and will make available to the Indemnifying Party reasonably requested information under the control of the Indemnified Party, which information will be subject to Section 11.
Section 15.      Term and Termination .
15.1      Term.
15.1.1      Term . This Agreement will commence as of the Effective Date and, unless sooner terminated in accordance with the terms hereof or by mutual written agreement of the Parties, will continue in force and effect, on a country-by-country and Product-by-Product basis, until the date of expiration of the Royalty Term (such period, the “ Term ”).
15.1.2      Effect of Expiration of the Term . Following the expiration of the Term (but not its earlier termination as provided herein), the grants in Sections 7.1.1 and 7.1.2 shall become

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perpetual, fully-paid, royalty-free and irrevocable on a country-by-country and Licensed Product-by-Licensed Product basis.
15.2      Termination for Material Breach . If either Party (the “ Non-Breaching Party ”) believes that the other Party (the “ Breaching Party ”) has materially breached one (1) or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a “ Default Notice ”). If the Breaching Party does not dispute that it has committed a material breach of one (1) or more of its material obligations under this Agreement, then if the Breaching Party fails to cure such breach within [ * ] after receipt of the Default Notice, or if such compliance cannot be fully achieved within such [ * ] period and the Breaching Party has failed to commence compliance or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, the Non-Breaching Party may terminate this Agreement upon written notice to the Breaching Party, or, in the case of Cephalon, may exercise the rights set forth in [ * ].
15.3      Breach of [ * ] . In the event that [ * ], then, in addition to any other remedy Cephalon may have at law or in equity, Cephalon may terminate this Agreement upon written notice to Eagle or may exercise the rights set forth in [ * ].
15.4      Additional Termination Rights by Cephalon.
15.4.1      For Cause . Cephalon may terminate this Agreement effective immediately upon written notice to Eagle in the event that [ * ].
15.4.2      For Convenience . Cephalon may terminate this Agreement in its entirety, for any or no reason, upon [ * ] prior written notice to Eagle.
15.5      Termination by Eagle .
15.5.1      In the event of [ * ], Eagle will have the right to terminate this Agreement upon written notice to Cephalon, such termination to be effective upon Cephalon’s receipt of payment under [ * ].
15.5.2      Eagle shall have the right to terminate this Agreement [ * ] upon written notice to Cephalon if Cephalon or its Affiliates, directly or indirectly: [ * ].
15.6      Termination for Insolvency . In the event that either Party (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [ * ] after such filing, (d) proposes a written agreement of composition or extension of its debts, (e) proposes or is a party to any dissolution or liquidation, (f) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [ * ] of the filing thereof, or (g) 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.
15.7      Rights in Bankruptcy . All rights and licenses granted under or pursuant to this Agreement by Eagle are, and will otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that Cephalon as licensee of such rights under this Agreement, will retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code including, without limitation, Cephalon’s right to retain all licenses granted herein, subject to payments when due

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to Eagle of all applicable milestone payments and royalties on Licensed Products. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Eagle under the U.S. Bankruptcy Code, Cephalon will be entitled to a complete duplicate of (or complete access to, as appropriate) the Eagle IP and all embodiments of such Eagle IP, and same, if not already in its possession, will be promptly delivered to Cephalon (a) upon any such commencement of a bankruptcy proceeding upon its written request therefor, unless Eagle elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under (a) above, following the rejection of this Agreement by or on behalf of Eagle upon written request therefor by Cephalon.
15.8      Consequences of Termination.
15.8.1      In the event of a termination of this Agreement in its entirety by Cephalon pursuant to Section [ * ] or by Eagle pursuant to Section [ * ], all rights and licenses granted by Eagle to Cephalon hereunder shall immediately terminate.
15.8.2      In the event of a material breach of this Agreement by Eagle pursuant to [ * ], then, following the expiration of all applicable notice and cure periods, and, if [ * ], at Cephalon’s sole option, either [ * ];
15.8.3      In the event of a material breach of this Agreement by Eagle pursuant to [ * ], then, [ * ]:
15.8.3.1      [ * ]
15.8.3.2      [ * ].
15.8.4      In the event of a termination of this Agreement by Eagle pursuant to [ * ]:
15.8.4.1      All rights and license granted by Eagle to Cephalon hereunder shall immediately terminate; and
15.8.4.2      Eagle shall pay to Cephalon [ * ].
15.8.5      In the event of a termination of this Agreement by Cephalon pursuant to [ * ], then [ * ].
15.8.6      In the event of a termination of this Agreement in its entirety by Cephalon pursuant to [ * ], or by Eagle pursuant to [ * ], then effective upon the Reversion Date:
15.8.6.1      [ * ].
15.8.6.2      [ * ]
15.8.6.3      Inventory . At Eagle’s option [ * ].
15.8.6.4      Transition Assistance . [ * ].
15.8.6.5      [ * ]
15.8.6.6      [ * ]

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15.8.6.7      [ * ]
15.8.7      In the event of a termination of this Agreement in its entirety by Cephalon pursuant to [ * ], then upon the effective date of termination of this Agreement:
15.8.7.1      Covenant Not to Sue . [ * ].
15.8.7.2      [ * ].
15.8.7.3      [ * ]
15.8.7.4      [ * ].
15.9      Remedies . Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity.
15.10      Accrued Rights; Surviving Obligations.
15.10.1      Termination or expiration of this Agreement 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, [ * ] of this Agreement shall survive the termination or expiration of this Agreement for any reason.
Section 16.      Miscellaneous .
16.1      Affiliates . Cephalon will have the right to exercise its rights and perform its obligations hereunder through its Affiliates; provided Cephalon will be responsible for such Affiliates’ performance hereunder.
16.2      Assignment . Neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred (whether by operation of Law or otherwise) by Eagle without the prior written consent of Cephalon; provided, however , that, Eagle may assign and otherwise transfer this Agreement and its rights and obligations hereunder [ * ]. Cephalon may assign this Agreement, and its rights and obligations as a whole hereunder without prior written consent to [ * ]. Any assignment not in accordance with this Agreement will be void. Subject to the foregoing, the rights and obligations of the Parties under this Agreement will be binding upon and inure to the benefit of the successors and permitted assigns of the Parties.
16.3      Choice of Law . This Agreement will be governed by, and enforced and construed in accordance with, the laws of the State of New York, without regard to its conflicts of law provisions.
16.4      Construction . The definitions of the terms herein will apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun will include the corresponding masculine, feminine and neuter forms. The words “include”, “includes” and “including” will be deemed to be followed by the phrase “without limitation”. The word “will” will be construed to have the same meaning and effect as the word “shall”. The Parties each acknowledge that they have had the advice of counsel with respect to this Agreement, that this Agreement has been jointly drafted, and that no rule of strict construction will be applied in the interpretation hereof. Unless the context

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requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Laws herein will be construed as referring to such Laws as from time to time enacted, repealed or amended, (c) any reference herein to any person will be construed to include the person’s permitted successors and assigns, (d) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, and (e) all references herein to Articles, Sections, Schedules or Exhibits, unless otherwise specifically provided, will be construed to refer to Articles, Sections, Schedules and Exhibits of this Agreement.
16.5      Counterparts . This Agreement may be executed in counter‑parts with the same effect as if both Parties had signed the same document. All such counterparts will be deemed an original, will be construed together and will constitute one and the same instrument. Signature pages of this Agreement may be exchanged by facsimile or other electronic means without affecting the validity thereof.
16.6      Currency . All amounts set forth herein are expressed in U.S. Dollars. In the event that sales are made or fees received in currency other than U.S. Dollars, payments will be calculated based on currency exchange rates that the Party receiving such currency uses for purposes of calculating its financial reports filed with the SEC or similar regulatory agency. In the event either Party is not so reporting during any relevant period, then such conversion will be made on a monthly basis based on the average exchange rate published by Wall Street Journal for such month.
16.7      Entire Agreement . This Agreement and the attached Schedules and Exhibits, constitutes the entire agreement between the Parties as to the subject matter of this Agreement, and supersedes and merges all prior negotiations, representations, agreements and understandings regarding the same.
16.8      Force Majeure . Neither Party will be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control, including acts of God or other deity, fires, earthquakes, tsunami, strikes and labor disputes, acts of war, terrorism or civil unrest (“ Force Majeure ”); provided, however , that the affected Party promptly notifies the other Party in writing; and further provided that the affected Party will use its Commercially Reasonable Efforts to avoid or remove such causes of non‑performance and to mitigate the effect of such occurrence, and will continue performance with reasonable dispatch whenever such causes are removed.
16.9      Further Assurances . Each Party agrees to do and perform all such further acts and things and will execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.
16.10      Headings . Headings and captions are for convenience only and are not to be used in the interpretation of this Agreement.
16.11      Dispute Resolution .
16.11.1     In the event of any dispute between the Parties under this Agreement, other than with respect to Section 15.4.1, the Parties will first attempt in good faith to

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resolve such dispute by negotiation and consultation between themselves. In the event that such dispute is not resolved on an informal basis within [ * ], either Party may refer the matter to the Parties’ Senior Executives for attempted resolution, whereupon the Parties’ Senior Executives will meet in person if requested by either such Senior Executive and attempt in good faith to resolve such dispute by negotiation and consultation for a [ * ] period following such referral.
16.11.2      Subject to Sections 2.1.4.2, if the Senior Executives do not resolve such dispute within such [ * ], either Party may at any time thereafter proceed to litigation in accordance with this Section 16.11.2. Each Party hereby irrevocably submits to the exclusive jurisdiction of the courts of the State of New York (“ State Court ”) and the courts of the United States of America located in the State of New York (“ Federal Court ”), for the purposes of any suit, action or other proceeding arising out of this Agreement or out of any transaction contemplated hereby. Each Party agrees that service of any process, summons, notice or document by personal delivery, by registered mail, or by a recognized international express delivery service to such Party’s respective address set forth in Section 16.12 (as such address may be changed by notice delivered pursuant to such section) will be effective service of process for any action, suit or proceeding in the applicable Federal Court or State Court with respect to any matters to which it has submitted to jurisdiction in this Section. Each Party irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the transactions contemplated hereby in the applicable Federal Court or State Court, and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. Notwithstanding the foregoing, either Party will have the right to seek exigent, injunctive or temporary relief in any court of competent jurisdiction.
16.11.3      In addition, during the pendency of any dispute under this Agreement initiated before the end of any applicable cure period under Section 15.2, [ * ].
16.12      Notices . Any notice required or permitted to be given by this Agreement will be in writing and will be delivered by hand or overnight courier with tracking capabilities or mailed postage prepaid by first class, registered or certified mail addressed as set forth below unless changed by notice so given:
If to Cephalon:
Cephalon, Inc.
41 Moores Road, Frazer, PA 19355
Attention: Head of Alliance Management
With a copy to:
Teva Pharmaceuticals
425 Privet Road, Horsham, PA 19044
Attention: General Counsel
If to Eagle:
Eagle Pharmaceuticals, Inc.
50 Tice Blvd, Suite 315
Woodcliff Lake, NJ 07677
Attention: Chief Executive Officer
with a copy to:
Cooley LLP
One Freedom Square
Reston Town Center
11951 Freedom Drive
Reston, VA 201910-565
Attn: Kenneth J. Krisko

38

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



Any such notice will be deemed given on the date received. A Party may add, delete, or change the person or address to whom notices should be sent at any time upon written notice delivered to the other Party in accordance with this Section 16.12.
16.13      Relationship of the Parties . Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute Eagle and Cephalon as partners, agents or joint venturers. Neither Party will have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.
16.14      Set-Off . Either Party will have the right to deduct from amounts otherwise payable hereunder any amounts payable to such Party (or its Affiliates) from the other Party (or its Affiliates).
16.15      Severability . If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision will be considered severed from this Agreement and will not serve to invalidate any remaining provisions hereof. The Parties will make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
16.16      Third Party Beneficiaries . Except as expressly provided with respect to Indemnities in Section 14, there are no third party beneficiaries intended hereunder and no Third Party will have any right or obligation hereunder.
16.17      Waivers and Modifications . The failure of any Party to insist on the performance of any obligation hereunder will not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof will not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release or amendment of any right or obligation under or provision of this Agreement will be valid or effective unless in writing and signed by all Parties hereto.
(Signature page follows)


39

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



IN WITNESS WHEREOF , the Parties have caused this Agreement to be executed by their respective duly authorized representatives.

EAGLE PHARMACEUTICALS, INC.     
 
 
CEPHALON, INC.
 
 
 
 
By: /s/ Scott Tarriff
 
 
 
By: /s/ Staci Julie            
Scott Tarriff
 
 
Title: VP, Global IP

Chief Executive Officer and Director
(Principal Executive Officer)
 
 
 
 
 
 
 
 
 
 
By:     /s/ Matthew P. Blischak    
 
 
 
Name: Matthew P. Blischak
 
 
 
Title: Assoc. GC, Branded IP Litigation



[Signature Page to Exclusive License Agreement]


Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.



Schedules

Schedule 1.23        Eagle Patent Rights as of the Effective Date
Schedule 1.26        EP-3102
Schedule 1.37        In-License Agreements as of the Effective Date
Schedule 1.68        Settlement Agreement


Exhibit A        Joint Press Release



Exhibit 10.3

Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

Execution Version
PRIVILEGED AND CONFIDENTIAL
SUBJECT TO FRE 408


SETTLEMENT AND LICENSE AGREEMENT
This SETTLEMENT AND LICENSE AGREEMENT (this “ Agreement ”) is hereby entered into and made effective on February 13, 2015 (the “ Effective Date ”) by and between Cephalon, Inc. (“ Cephalon ”) and Eagle Pharmaceuticals, Inc. (“ Eagle ”). Cephalon and Eagle are referred to herein individually as a “ Party ” and collectively, as the “ Parties.
WHEREAS, Cephalon owns United States Patent No. 8,791,270 (the “ ’270 Patent ”);
WHEREAS, Cephalon is the holder of the Cephalon NDAs (as defined below), which are approved by the Food and Drug Administration (“ FDA ”) for the manufacture and sale of the Cephalon Products (as defined below) for the treatment of patients with chronic lymphocytic leukemia (“ CLL ”), and the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six (6) months of treatment with rituximab or a rituximab-containing regimen (“ NHL” ), in each case, which Cephalon and its Affiliates currently market in the United States under the brand name TREANDA®;
WHEREAS, Eagle is the holder of the Eagle RTD NDA (as defined below), which was submitted to the FDA and tentatively approved for the manufacture and sale in the Territory of the Eagle RTD Product (as defined below);
WHEREAS, Eagle is the holder of the Eagle Rapid NDA (as defined below), which will be submitted to the FDA seeking approval for the manufacture and sale in the Territory of the Eagle Rapid Product (as defined below);
WHEREAS, Cephalon and Eagle are involved in litigation in the United States District Court for the District of Delaware (the “ District Court ”), namely Civil Action No. 14-cv-1042 (GMS), which has been consolidated with Cephalon’s other related bendamustine cases in the District Court into Civil Action No. 13-cv-2046 (GMS) (the “ Lawsuit ”), concerning, inter alia, the validity of the ’270 Patent, as well as the alleged infringement by Eagle of the ’270 Patent related to Eagle’s proposed manufacture and sale of the Eagle RTD Product in the Territory;
WHEREAS, Cephalon contends that the ’270 Patent is valid and enforceable and that the manufacture, use, sale, offering for sale, or importation of Eagle Products (as defined below) in or for the Territory would infringe the ’270 Patent;
WHEREAS, the Parties desire and agree to fully settle the Lawsuit as it applies to Eagle, and to permit entry of Eagle Products prior to the expiration of the ’270 Patent upon the terms and subject to the conditions set forth herein;
WHEREAS, this Agreement is the only agreement between the Parties related to the settlement of the Lawsuit and any other disputes relating to infringement of the ’270 Patent with respect to the Eagle NDAs and the Eagle Products; and
WHEREAS, no Party has received any consideration from the other Party for its entry into this Agreement other than that which is described in this Agreement.





 
 


Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


NOW, THEREFORE, in consideration of the mutual agreements herein contained and the consideration described herein, the sufficiency and receipt of which are hereby acknowledged, the Parties hereto, intending to be legally bound hereby, agree as follows:
1.
DEFINITIONS
1.1
505(b)(2) NDA ” means a new drug application submitted to the FDA under 21 U.S.C. §355(b)(2) (or any replacement thereof).
1.2
Affiliate ” of a Person means any other Person which (directly or indirectly) is controlled by, controls or is under common control with such Person. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to any Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors, (b) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%), including ownership by trusts with substantially the same beneficial interest, of the equity interests with the power to direct the management and policies of such Person, provided that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests, or (c) the power to direct the management or policies of a Person, whether through ownership of voting securities, by contract or otherwise.
1.3
Calendar Quarter ” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.4
Calendar Year ” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.5
Cephalon Know-How ” means [ * ].
1.6
Cephalon NDAs ” means NDA No. 22249 and NDA No. 22303 with respect to the [ * ] liquid concentrate bendamustine hydrochloride product for infusion for the treatment of patients with CLL and the treatment of patients with NHL.
1.7
Cephalon Products ” means the [ * ] liquid concentrate, ready-to-dilute, bendamustine hydrochloride products that are the subject of the Cephalon NDAs and marketed in the Territory under the TREANDA® trademark for the treatment of patients with CLL and the treatment of patients with NHL.
1.8
Eagle NDAs ” means the Eagle RTD NDA and the Eagle Rapid NDA.
1.9
Eagle Products ” means the Eagle RTD Product and the Eagle Rapid Product.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


1.10
Eagle Rapid NDA ” means the 505(b)(2) NDA as filed with the FDA immediately following the Effective Date pursuant to the Exclusive License Agreement and as such 505(b)(2) NDA is approved by the FDA [ * ].
1.11
Eagle Rapid Product ” means Eagle’s bendamustine product for Short Infusion known as EP-3102 as further described on Schedule 1.11 as of the Effective Date, that is approved for marketing in the Territory under the Eagle Rapid NDA [ * ].
1.12
Eagle RTD NDA ” means 505(b)(2) NDA No. 205580 as tentatively approved by FDA as of the Effective Date for the treatment of NHL [ * ].
1.13
Eagle RTD Product ” means [ * ] bendamustine hydrochloride product in a multi-use vial that is tentatively approved by the FDA under the Eagle RTD NDA. [ * ].
1.14
Exclusive License Agreement ” means the Exclusive License Agreement by and between Eagle and Cephalon, dated as of the date hereof.
1.15
Exclusive License Termination Date ” means the effective date of termination of the Exclusive License Agreement by Cephalon pursuant to Section 15.4.1 thereof.
1.16
Final Court Decision ” means a decision by a court on the merits whereby such court enters final judgment of invalidity, unenforceability or non-infringement of the asserted patent claims from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been or can be taken. For the avoidance of doubt, any withdrawal, settlement or dismissal of any of action or dispute without a decision on the merits of the asserted patent claims (whether such dismissal is with or without prejudice, and whether or not such claims may be relitigated) shall not be deemed a Final Court Decision.
1.17
First Commercial Sale ” means the first sale in the Territory by or on behalf of Eagle or its Affiliates to a Third Party of the applicable Eagle Product after receipt of the applicable NDA approval for such Eagle Product. Notwithstanding the foregoing, sales made by or on behalf of Cephalon or its Affiliates under the Exclusive License Agreement shall not be deemed sales for any purpose under this Agreement.
1.18
Know-How ” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, and data.
1.19
Law ” means any federal, state, provincial, local, international or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any governmental authority or regulatory authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


1.20
Licensed Patents ” means the ’270 Patent and any continuations, continuations-in-part, divisionals, reissues and reexaminations thereof, and any other patents owned or controlled by Cephalon or its Affiliates and listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “ Orange Book ”) as covering the Cephalon Products.
1.21
[ * ].
1.22
Manufacturing Know-How ” means [ * ].
1.23
Net Sales ” means, with respect to an Eagle Product sold in the Territory by Eagle or its Affiliates, the aggregate gross sales amount received for such Eagle Product by Eagle and its Affiliates on an arms-length basis from Third Parties in the Territory, less the following deductions:
(a)
[ * ] percent ([ * ]%) of gross sales in the Territory to cover cash discounts given by Eagle and its Affiliates;
(b)
any adjustments on account of price adjustments, billing adjustments, shelf stock adjustments, promotional payments, or other similar allowances affecting the Eagle Product;
(c)
chargebacks, rebates, administrative fee arrangements, reimbursements, and similar payments to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, other institutions or health care organizations or other customers;
(d)
amounts due to Third Parties on account of rebate payments, including Medicaid rebates, or other price reductions provided, based on sales by Eagle and its Affiliates to any governmental authorities or the FDA in respect of state or federal Medicare, Medicaid or similar programs;
(e)
[ * ]
(f)
allowances and credits to Third Parties on account of rejected, damaged, returned or recalled Eagle Product;
(g)
any costs incurred in connection with, or arising out of, compliance with the Prescription Drug User Fee Act; and
(h)
other specifically identifiable amounts that have been credited against or deducted from gross sales of such Eagle Product and which are substantially similar to those credits and deductions listed above.
Sales and other transfer of Eagle Product between any of Eagle and its Affiliates will not give rise to Net Sales, but rather the subsequent sale of Eagle Product to

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


Third Parties. For the avoidance of doubt, sales to Authorized Third Parties by Eagle and its Affiliates will give rise to Net Sales (provided that any supply to an Authorized Third Party for subsequent sale by such Third Party for which Eagle will receive a royalty or other payment shall not give rise to Net Sales but rather such subsequent payment shall be included in Profit under clause (b) of Section 1.27).
1.24
Other Cephalon Patents ” means, other than the Licensed Patents, all [ * ].
1.25
Patent Rights ” means all patents and patent applications (including provisional applications), including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, re-issues, additions, renewals, extensions, confirmations, registrations, any other pre- or post-grant forms of any of the foregoing, any confirmation patent or registration patent or patent of addition, utility models, patent term extensions, and supplemental protection certificates or requests for continued examinations, foreign counterparts, and the like of any of the foregoing.
1.26
Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, beneficiary or trustee of any trust, incorporated association, joint venture, or similar entity or organization, including a government or political subdivision or department or agency of a government.
1.27
Profit ” means (a) with respect to an Eagle Product sold by Eagle, its Affiliates or any Third Party (other than any Authorized Third Party) on behalf of Eagle or its Affiliates, the Net Sales of such Eagle Product minus [ * ] and (b) with respect to an Eagle Product sold by an Authorized Third Party (which does not include distributors), all payments that are received by Eagle and its Affiliates from such Authorized Third Party in consideration for such authorization (which may include a reasonable allocation of amounts received among the Licensed Patents and other intellectual property licensed to such Authorized Third Party), excluding [ * ].
1.28
Rapid License Effective Date ” means [ * ].
1.29
Rapid Royalty Term ” means the period commencing upon the First Commercial Sale of the Eagle Rapid Product following the Rapid License Effective Date and ending [ * ].
1.30
[ * ].
1.31
Royalty Term ” means each of the RTD Royalty Term and Rapid Royalty Term.
1.32
RTD License Effective Date ” means [ * ].
1.33
RTD Royalty Term ” means the period commencing upon the First Commercial Sale of the Eagle RTD Product and ending [ * ].
1.34
[ * ].

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


1.35
Territory ” means the United States of America, its territories, possessions, protectorates and the Commonwealth of Puerto Rico.
1.36
Third Party ” means any Person that is not a Party or an Affiliate of a Party.
2.
SETTLEMENT; DISMISSAL; RELEASE
2.1
All of the terms and conditions set forth in this Agreement shall be binding on the Parties as of the Effective Date.
2.2
The Parties are entering into this Agreement in an effort to avoid the fees, costs and expenses associated with the continued litigation of this matter, as well as the attendant risks of litigation.
2.3
Dismissal . Within five (5) business days of the Effective Date, the Parties shall enter into and Cephalon shall cause to be filed with the District Court a Consent Judgment, substantially in the form attached hereto as Exhibit A (the “ Consent Judgment ”).
2.4
Release . In consideration of the mutual execution of this Agreement and the mutual agreement to be legally bound by the terms hereof, Cephalon and Eagle, each on behalf of itself and its predecessors, successors, assigns, shareholders, officers, directors, employees, trustees, agents, representatives, licensees, licensors, parents, subsidiaries and Affiliates and all others claiming by, through and under them, hereby fully, finally, irrevocably and forever releases, relinquishes, acquits and discharges the other Party and its predecessors, successors, assigns, shareholders, officers, directors, employees, trustees, agents, representatives, licensees, licensors, parents, subsidiaries, Affiliates, customers, suppliers, importers, attorneys, manufacturers, distributors and insurers, if any, from any and all claims, demands, causes of action, liabilities, losses, all manner of actions, judgments, settlements, interest, damages, punitive damages and other damages or costs of whatever nature (including costs, expenses, and attorneys’ fees), whether known or unknown, foreseen or unforeseen, certain or contingent, accruing before the Effective Date, arising out of, derived from, predicated upon, or relating to the filing of the Eagle RTD NDA; provided , however , that nothing herein shall prevent or impair the right of either Party to bring a proceeding in court or any other forum for a breach of this Agreement or the Exclusive License Agreement, or any representation, warranty, or covenant herein, or with respect to any product other than the Eagle RTD Product, or any proceeding outside of the Territory.
2.5
Except as required by Law, requested by FDA, or for reasons that relate to the safety and/or efficacy of any pharmaceutical product, Cephalon and its Affiliates shall not initiate or otherwise undertake any activity with the FDA against the Eagle NDAs or interfere with Eagle’s efforts to obtain FDA approval of the Eagle NDAs, including, but not limited to, the filing or submission of any Citizen Petitions, correspondence or other written or oral communications with the FDA.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


2.6
Unknown Claims. Each Party, on behalf of itself and its Affiliates, hereby expressly waives and relinquishes any and all provisions, rights and benefits conferred by Section 1542 of the California Civil Code, which provides as follows:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN TO HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.
Further, each Party, on behalf of itself and its Affiliates, expressly waives and relinquishes all rights and benefits afforded by any Law in any other jurisdiction similar to Section 1542 of the California Civil Code.
2.7
Admissions . Eagle, on behalf of itself and its Affiliates, hereby admits that (a) the Licensed Patents and Other Cephalon Patents are valid and enforceable with respect to the manufacture, use, sale, offering for sale and importation of the Eagle Products in or for the Territory, and (b) absent the licenses granted to Eagle in Section 3.1, the manufacture, use, sale, offering for sale and importation of the Eagle Products in or for the Territory would infringe the Licensed Patents and Other Cephalon Patents.
2.8
Agreement to Abide by License Effective Date . Except to the extent permitted under the license in Article 3 below, Eagle, on behalf of itself and its Affiliates, covenants not to, and shall cause each Authorized Third Party not to, (a) make, use, import, offer to sell or sell in or for the Territory, (b) actively induce or assist any other Person to make, use, import, offer to sell or sell in or for the Territory, or (c) import or cause to be imported in the Territory, any Eagle RTD Product before the RTD License Effective Date nor any Eagle Rapid Product before the Rapid License Effective Date.
2.9
Each Party represents, warrants and covenants that it has not heretofore assigned or transferred, and will not assign or otherwise transfer, to any Person any matters released by such Party in Section 2.4, and each such Party agrees to indemnify and hold harmless the other Party and the other Persons released under Section 2.4 from and against all such released matters arising from any such alleged or actual assignment or transfer.
3.
LICENSE; RESTRICTIONS
3.1
License Grants .
(a)
Eagle RTD Products . Subject to the terms and conditions of this Agreement, Cephalon and its Affiliates hereby grant to Eagle and its Affiliates a royalty-bearing, non-transferable (except as permitted under Section 8.10), non-

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


exclusive license, without the right to grant sublicenses, under the Licensed Patents to develop, manufacture, use, offer to sell, sell and import the Eagle RTD Products in the Territory (and engage Third Parties to perform the foregoing (an, “ Authorized Third Party ”) solely with respect to the Eagle RTD Products in the Territory) as of and following the RTD License Effective Date, provided that Eagle has received FDA approval of the Eagle RTD NDA.
(b)
Eagle Rapid Products . Subject to the terms and conditions of this Agreement, [ * ], Cephalon and its Affiliates hereby grant to Eagle and its Affiliates a [ * ] as of and following the Rapid License Effective Date.
(c)
Pre-Launch Rights . Subject to the terms and conditions of this Agreement, Eagle and its Affiliates may, and may engage Third Parties to perform the following on behalf of Eagle with respect to the applicable Eagle Products, (i) [ * ], and (2) [ * ]; (ii) [ * ]; and (3) [ * ].
3.2
The license rights under Section 3.1(a) to offer to sell and sell the Eagle RTD Products will begin on the RTD License Effective Date, and Eagle will not and will cause its Affiliates not to, directly or indirectly, offer to sell or sell any Eagle RTD Product in or for the Territory prior to the RTD License Effective Date, or manufacture or import any Eagle RTD Product prior to the RTD License Effective Date except as permitted under Section 3.1(c). The license rights under Section 3.1(b) [ * ], and [ * ].
3.3
Covenant Not to Sue .
(a)
Effective as of the RTD License Effective Date, and with respect only to the Eagle RTD Product, Cephalon and its Affiliates covenant not to sue, assert any claim or otherwise participate in any action or proceeding, directly or indirectly, against, Eagle, its Affiliates and any Authorized Third Party, and their importers, suppliers, manufacturers, distributors, and customers, or any permitted assignee or acquiror of Eagle’s rights in the Eagle RTD Product, or support, permit or encourage any Third Party to sue, for infringement of any Licensed Patent or Other Cephalon Patent, in each case, solely with respect to the making, having made, using, selling, offering for sale, and importation of the Eagle RTD Product in or for the Territory as of and following the RTD License Effective Date pursuant to Section 3.1(a).
(b)
Effective as of the Rapid License Effective Date, and with respect only to the Eagle Rapid Product, Cephalon and its Affiliates covenant not to sue, assert any claim or otherwise participate in any action or proceeding, directly or indirectly, against, Eagle, its Affiliates and any Authorized Third Party, and their importers, suppliers, manufacturers, distributors, and customers, or any permitted assignee or acquiror of Eagle’s rights in the Eagle Rapid Product, or support, permit or encourage any Third Party to sue, for

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


infringement of any Licensed Patent or Other Cephalon Patent, in each case, [ * ].
(c)
Effective upon the Exclusive License Termination Date, and with respect only to the Eagle Rapid Product, Cephalon and its Affiliates covenant not to sue, assert any claim or otherwise participate in any action or proceeding, directly or indirectly, against, Eagle, its Affiliates and any Authorized Third Party, and their importers, suppliers, manufacturers, distributors, and customers, or any permitted assignee or acquiror of Eagle’s rights in the Eagle Rapid Product, or support, permit or encourage any Third Party to sue, for infringement of any Licensed Patent or Other Cephalon Patent, in each case, [ * ].
(d)
Cephalon shall impose the foregoing covenants not to sue on its Affiliates and any Third Party to which Cephalon or any of its Affiliates may assign, license, sublicense, or otherwise transfer any rights to or under the applicable Licensed Patent or Other Cephalon Patent, whether by merger, sale, assignment or other form of transaction and including any successor of Cephalon or its Affiliates. Cephalon shall not, enable, authorize, or license, any Third Party to take any action that would have the effect of allowing such Third Party to take any action relating to any Licensed Patent or Other Cephalon Patent that would be prohibited by this Section 3.3 if taken by Cephalon.
3.4
No Other Licenses; Disclaimer . Nothing in this Agreement will be construed as: (a) an obligation to bring or prosecute actions or suits against any Third Party for infringement of the Licensed Patents; (b) conferring a right to use any trademark or trade name of either Party; (c) granting by implication, estoppel or otherwise, any licenses or rights under any patent rights, except as expressly described in this Agreement; or (d) granting by implication, estoppel or otherwise, any licenses or rights with respect to (i) any pharmaceutical product that has received FDA approval for marketing in the Territory pursuant to any Abbreviated New Drug Application pursuant to 21 U.S.C. § 355(j), or (ii) any bendamustine product in a solid lyophilized powder form or any bendamustine product in any dosage form other than the Eagle Products [ * ]. Notwithstanding anything in this Agreement to the contrary, no license or covenant not to sue granted by Cephalon to Eagle herein is intended to, and will not be deemed to, have any impact or effect on any Third Party’s or Eagle’s rights under or pursuant to any regulatory exclusivity with respect to any pharmaceutical product that has received FDA approval for marketing in the Territory pursuant to an application under 21 U.S.C. § 355(j). [ * ].
3.5
Covenant Not to Challenge and Assist Challenges to the Licensed Patents and Other Cephalon Patents . Except to the extent required by Law or order of a court or administrative agency of competent jurisdiction, and subject to the terms of this Section 3.5, Eagle shall not, and shall cause its Affiliates and each Authorized Third

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


Party not to, directly or indirectly,: (a) challenge the validity, enforceability, patentability, priority of invention or other claim to priority, infringement or patent term adjustment of any of the Licensed Patents and Other Cephalon Patents in any reexamination, inter partes proceeding, protest, observation, comment, opposition, post‑grant proceeding, inter partes review, interference or other action or proceeding in the United States Patent and Trademark Office (“ USPTO ”) or any United States court proceedings or submit or cause, in any manner, to be submitted, any correspondence or communication with the USPTO with respect to the Licensed Patents and Other Cephalon Patents, in each case, solely with respect to the Eagle Products in the Territory; and (b) assist, encourage, finance, or otherwise provide any information to any Third Party (specifically including, but not limited to, the other defendants in Cephalon’s Treanda® lawsuits filed in the Districts of Delaware and/or the E.D.N.Y, and those to be filed relating to the Licensed Patents or Other Cephalon Patents) in any such proceeding under the foregoing clause (a) with respect to any bendamustine product. Notwithstanding the foregoing, this Section 3.5 shall not restrict Eagle and its Affiliates from (A) challenging the Licensed Patents or Other Cephalon Patents with respect to any product other than any bendamustine products, (B) relying in any way on a Final Court Decision finding one or more claim of the Licensed Patents or Other Cephalon Patents to be invalid, unenforceable or not infringed, (C) responding in good faith to any lawfully issued subpoena calling for Eagle or an Affiliate of Eagle to provide documents or testimony, and (D) relying on this Agreement to show a license, waiver or covenant not to sue has been granted in response to a proceeding for infringement of the Licensed Patents or Other Cephalon Patents covered by the covenant not to sue brought by or on behalf of Cephalon or its Affiliates (1) against Eagle or an Affiliate of Eagle based on any of their activities authorized under this Agreement or (2) against any Third Party based on its activities with respect to any Eagle Product received directly or indirectly from Eagle or an Affiliate of Eagle as authorized under this Agreement.
3.6
[ * ].
3.7
Cooperation . Upon Eagle’s request, Cephalon shall cooperate with Eagle in informing the FDA that Cephalon has granted to Eagle the licenses set forth in Section 3.1(a) and 3.1(b).
3.8
Delivery of Cephalon Know-How . Within [ * ] following the occurrence of the Rapid License Effective Date, Cephalon will make a one-time delivery to Eagle of one (1) electronic copy of all documents, data or other information in Cephalon’s or its Affiliates’ possession or control as of such date to the extent that such documents, data or other information describe or contain Cephalon Know-How.
4.
ROYALTIES
4.1
Eagle RTD Products . During the RTD Royalty Term, Eagle will pay to Cephalon the following percentages of Profit for Eagle RTD Products in or for the Territory (the “ RTD Royalty ”):

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


(a)
from the date of the First Commercial Sale in the Territory of the Eagle Rapid Product by Eagle or its Affiliates through [ * ] for Eagle RTD Products during each Calendar Quarter; and
(b)
from January 1, 2017 through the end of the RTD Royalty Term [ * ] for Eagle RTD Products during each Calendar Quarter.
4.2
Eagle Rapid Products . During the Rapid Royalty Term, [ * ] for Eagle Rapid Products in or for the Territory during each Calendar Quarter (the “ Rapid Royalty ” and together with the RTD Royalty, the “ Royalty Payments ”).
4.3
Payment Terms . Eagle will pay the RTD Royalty and the Rapid Royalty in United States dollars by wire transfer to an account designated in writing by Cephalon within [ * ] following the end of each applicable Calendar Quarter. Each Royalty Payment by Eagle hereunder will be accompanied by a report that includes the aggregate gross sales of the applicable Eagle Product in the Territory during the applicable Calendar Quarter, the corresponding Net Sales, the costs deducted from Net Sales to determine the Profit, as applicable, and royalty rate applied and the amount of each of the RTD Royalty and Rapid Royalty payment payable with respect to such Net Sales (each, a “ Royalty Statement ”).
4.4
True-Up; Adjustments . Within [ * ] after the end of each Calendar Quarter during each of the RTD Royalty Term and Rapid Royalty Term (each, a “ Royalty Term ”) and within [ * ] after the expiration of the applicable Royalty Term, Eagle will perform a “true up” reconciliation (and will provide Cephalon with a written report of such reconciliation) of the deductions outlined in the definition of “Net Sales” and the definition of “Profit” for the Calendar Quarter preceding the just-ended Calendar Quarter. The reconciliation will be based on actual cash paid or credits issued plus an estimate for any remaining liabilities incurred related to the Eagle Products, but not yet paid. If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, Eagle will, if Eagle is the owing Party, pay Cephalon the amount of the difference within [ * ] after the date of delivery of such report or, if Cephalon is the owing Party, offset such amount against future payments to Cephalon hereunder.
4.5
Audit Rights .
(a)
Cephalon will have the right to engage, at its own cost and expense, subject to this Section 4.5, an independent nationally recognized public accounting firm chosen by Cephalon and reasonably acceptable to Eagle (which accounting firm will not be the external auditor of Cephalon, will not have been hired or paid on a contingency basis and will have experience auditing generic pharmaceutical companies) (a “ CPA Firm ”) to conduct an audit of Eagle for the purposes of confirming Eagle’s compliance with the Royalty Payment provisions of this Agreement.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


(b)
The CPA Firm will be given access to and will be permitted to examine such books and records of Eagle as it will reasonably request, upon [ * ] prior written notice having been given by Cephalon, during regular business hours, for the sole purpose of determining compliance with the Royalty Payment provisions of this Agreement. Prior to any such examination taking place, the CPA Firm will enter into a confidentiality agreement reasonably acceptable to Cephalon with respect to the information to which they are given access and will not contain in its report or otherwise disclose to Cephalon or any Third Party any information labeled by Eagle as being confidential customer information regarding pricing or other competitively sensitive proprietary information.
(c)
Eagle and Cephalon will be entitled to receive a full written report of the CPA Firm with respect to its findings and Cephalon will provide, without condition or qualification, Eagle with a copy of the report, or other summary of findings, prepared by such CPA Firm promptly following Cephalon’s receipt of same. In the event of any dispute between Eagle and Cephalon regarding the findings of any such inspection or audit, the Parties will initially attempt in good faith to resolve the dispute amicably between themselves, and if the Parties are unable to resolve such dispute within [ * ] after delivery to both Parties of the CPA Firm's report, each Party will select an internationally recognized independent certified public accounting firm (other than the CPA Firm), and the two firms chosen by the Parties will choose a third internationally recognized independent certified public accounting firm which will resolve the dispute, and such accounting firm's determination will be binding on both Parties, absent manifest error by such accounting firm.
(d)
Within [ * ] after completion of the CPA Firm’s audit, Eagle will pay to Cephalon any deficiency in the Royalty Payment amount determined by the CPA Firm. If the report of the CPA Firm shows that Eagle overpaid, then Eagle will be entitled to off-set such overpayment against any Royalty Payment then owed to Cephalon. If no royalty is then owed to Cephalon, then Cephalon will remit such overpayment to Eagle. If the report of the CPA Firm shows a discrepancy between the amount of the royalty to which Cephalon is entitled and the Royalty Payment amount reflected by Eagle in the Royalty Statement in Cephalon’s favor, then in addition to the payment of the Royalty Payment amount, and if such discrepancy [ * ], then the fees and expenses of the CPA Firm in performing such audit will be paid by Eagle.
(e)
Eagle may exercise its audit rights under this Section 4.5 may not [ * ].
4.6
Taxes . Where required by Law, Eagle shall have the right to withhold applicable taxes from any payments to be made by Eagle to Cephalon pursuant to this Agreement. Eagle shall provide Cephalon with receipts from the appropriate taxing

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


authority for all payments of taxes withheld and paid by Eagle to such authorities on behalf of Cephalon. Cephalon shall have the right to appeal to the appropriate taxing authority any such withholding and payment of such taxes.
4.7
No Other Compensation . Other than as explicitly set forth (and as applicable) in this Agreement, Eagle will not be obligated to pay any additional fees, milestone payments, royalties or other payments of any kind to Cephalon under this Agreement.
4.8
Change in Accounting Periods . From time to time, either of the Parties may change its accounting and financial reporting practices from Calendar Quarters and Calendar Years to fiscal quarters and fiscal years or vice versa. If a Party notifies the other of a change in its accounting and financial reporting practices from Calendar Quarters and Calendar Years to fiscal quarters and fiscal years or vice versa, then thereafter, beginning with the period specified in the notice, the payment, reporting and other obligations hereunder related to Calendar Quarters and Calendar Years will be deemed satisfied by compliance therewith in accordance with the new reporting periods (fiscal reporting periods or calendar reporting periods, as the case may be) instead of the previously utilized reporting periods. The Parties will cooperate in good faith to minimize any disruption caused by any such change.
5.
TERM AND TERMINATION
5.1
Term . Unless earlier terminated in accordance with the terms of this Section 5, the term of this Agreement will commence on the Effective Date and will remain in effect until the expiration of the last to expire of the Licensed Patents.
5.2
Termination for Cause. In addition to the rights set forth in Section 5.4, either Party may terminate this Agreement at any time in the event that the other Party materially breaches this Agreement and, if such breach is curable, such material breach is not cured to the reasonable satisfaction of the non-breaching Party within [ * ] after written notice thereof.
5.3
Effect of Expiration or Termination . Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing prior to such expiration or termination. Sections 2.7, 3.1(b)(ii), 3.3 and 3.5 shall survive expiration, but not termination, of this Agreement. In addition, Sections 1, 3.4, 4 (with respect to sales occurring prior to termination to expiration), 5.3, 5.4, 6, 7.3 and 8 shall survive expiration or termination of this Agreement.
5.4
Equitable Remedies . Eagle agrees that to the extent Eagle breaches or threatens to breach any of Sections [ * ], and Cephalon agrees that to the extent Cephalon breaches or threatens to breach any of Sections [ * ], such action will cause irreparable harm to the non-breaching Party which is not compensable in money damages and the breaching Party hereby stipulates to the entry of a preliminary or permanent injunction to prevent such a breach or the continuance of such breach, and irrevocably and unconditionally waives any requirement that the non-breaching Party post a

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


bond in connection with any action to enforce such Sections of this Agreement. Eagle and Cephalon each also agrees that in the event of such breach or threatened breach by such Party, it will not contest the non-breaching Party’s right to seek damages, including enhanced damages, and any other available remedies for patent infringement.
6.
CONFIDENTIALITY; PUBLICITY
6.1
The Parties hereby agree that, except to enforce this Agreement or unless otherwise agreed to by the Parties in writing or as required by Law, the Parties, their Affiliates and their respective employees, officers, directors and other representatives shall not publish or otherwise disclose the contents of this Agreement, except that (a) each Party may disclose this Agreement (i) to its attorneys, advisors, consultants, agents, and representatives who are subject to obligations of confidentiality consistent with this Agreement and (ii) as otherwise required by Law, including reporting requirements to the U.S. Securities and Exchange Commission or by the rules or regulations of any stock exchange to which the Parties are subject, and (b) Eagle may communicate with the FDA on a confidential basis concerning the approval of the Eagle Rapid NDA and any regulatory issues pertaining to the Eagle Rapid Product, and the licenses, consents and waivers provided for herein, and (c) Cephalon may disclose such terms as may be necessary or useful in connection with any proceeding relating to the Licensed Patents, Other Cephalon Patents or any bendamustine product. In the event that a Party is required by Law or the rules of any securities exchange or automated quotation system to make any such disclosure under the foregoing clause (a)(ii), the Party making such disclosure shall (A) give reasonable advance notice to the other Party of such disclosure requirement and, in each of the foregoing, will use its reasonable efforts to secure confidential treatment of such information required to be disclosed; (B) cooperate with the other Party in an attempt to prevent or limit the disclosure, and (C) limit any disclosure to the specific purpose at issue, including consulting with the other Party concerning which terms of this Agreement will be requested to be redacted in any public disclosure of this Agreement, and in any event seek reasonable confidential treatment for any public disclosure by any such agency.
6.2
Except as expressly permitted under and in accordance with Section 6.1, neither Party shall make or allow the publication of any press release or other public announcement with respect to this Agreement or any of the transactions contemplated hereby, without the prior written approval of the other Party. Eagle and Cephalon may each disclose to Third Parties the information contained in any such approved press release without the need for further approval by the other.
7.
REPRESENTATIONS AND WARRANTIES
7.1
Each of Cephalon and Eagle hereby represents and warrants to the other, as of the Effective Date of this Agreement, that:

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


(a)
Such Party is duly organized, validly existing and in good standing under the Law of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
(b)
Such Party has taken all corporate action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement;
(c)
This Agreement has been duly executed by such Party and constitutes a valid and legally binding obligation of such Party, enforceable in accordance with its terms;
(d)
The execution, delivery, and performance of this Agreement does not conflict with any agreement, instrument, or understanding, oral or written, to which such Party is bound nor violate any Law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it;
(e)
It has been advised by its counsel of its rights and obligations under this Agreement and enters into this Agreement freely, voluntarily, and without duress; and
(f)
It is not relying on any promises, inducements, or representations other than those provided herein.
7.2
Eagle’s Representations and Warranties . Eagle represents and warrants that Eagle is the true owner of the Eagle NDAs.
7.3
Disclaimer . EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NO PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF APPLICABLE LAW.
8.
GENERAL PROVISIONS
8.1
Waiver . None of the provisions of this Agreement will be considered waived by any Party unless such waiver is agreed to, in writing, by authorized agents of such Party. The failure of a Party to insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by Law will not be deemed a waiver of any rights of any Party.
8.2
Choice of Law and Remedies . This Agreement and any dispute arising out of or related to this Agreement shall be governed and interpreted in accordance with the Law of the State of Delaware without regard to conflicts of law principles. The United States District Court for the District of Delaware shall have exclusive jurisdiction in all matters arising under this Agreement, and the Parties hereto

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


expressly consent and submit to the personal and subject matter jurisdiction of the District Court. This Agreement does not limit or restrict the remedies available to any Party for the breach of another Party, and the Parties expressly reserve any and all remedies available to them, at law or in equity, for breach of this Agreement or otherwise. In addition, during the pendency of any dispute under this Agreement initiated before the end of any applicable cure period under Section 5.2, (a) this Agreement will remain in full force and effect, (b) the provisions of this Agreement relating to termination for material breach will not be effective, (c) the time period for cure under Section 5.2 as to any termination notice given prior to the initiation of the proceeding will be tolled, and (d) neither Party will issue a notice of termination pursuant to this Agreement based on the subject matter of the proceeding (and no effect will be given to previously issued termination notices), until the court has confirmed the existence of the facts claimed by a non-breaching Party to be the basis for the asserted material breach.
8.3
Costs . Each Party shall each bear its own costs and legal fees associated with the negotiation and preparation of, and performance under, this Agreement and any activities related to the implementation of this Agreement.
8.4
Entire Agreement . This Agreement and the Exclusive License Agreement constitutes the entire agreement between the Parties relating to the subject matter hereof and thereof and supersedes all previous agreements and understandings, oral or written, with respect to such matters.
8.5
Notice . All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delivery upon a Party, if delivered by a reputable overnight express courier service (charges prepaid), or if sent by facsimile to the person at the address set forth below, or such other address as may be designated in writing hereafter, in the same manner, by such person as follows:
If to Cephalon :    Teva North America
425 Privet Road
Horsham, PA 19044


Attention: General Counsel

with a copy to:        Goodwin Procter LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018-1405
        
Attention: David M. Hashmall

If to Eagle:         Eagle Pharmaceuticals, Inc.

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


50 Tice Blvd, Suite 315
    Woodcliff Lake, NJ 07677
    Attention: Chief Executive Officer

With a copy to:     Cooley LLP
One Freedom Square
    Reston Town Center
    11951 Freedom Drive
    Reston, VA 201910-565
    Attn: Kenneth J. Krisko

Such notices will be deemed to have been given on the date delivered in the case of delivery by personal delivery or overnight courier or on the date actually received in the case of facsimile delivery.
8.6
Severability . When possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law. If, however, any provision of this Agreement is held to be invalid, illegal, or unenforceable for any reason, the Parties shall negotiate in good faith for a substitute provision to continue the intent and purpose of such invalid provisions, and the validity, legality, and enforceability of the remaining provisions shall not be in any way impaired thereby.
8.7
Amendments . No amendment, modification or supplement of any provisions of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.
8.8
Descriptive Headings . The captions and descriptive headings of this Agreement are for convenience only and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.
8.9
Third-Party Benefit . None of the provisions of this Agreement shall be for the benefit of, or enforceable by, any Third Party.
8.10
Assignment . Neither Party will assign this Agreement or any part hereof or any interest herein (whether by operation of law or otherwise) without the written consent of the other Party; provided , however , that either Party may assign this Agreement without such consent [ * ]. No assignment will be valid unless the permitted assignee(s) assumes all obligations of its assignor under this Agreement. No assignment will relieve any assigning Party of responsibility for the performance of its obligations hereunder. Any purported assignment in violation of this Section 8.10 will be void.
8.11
Counterparts; Electronic Delivery . This Agreement may be executed in counter‑parts with the same effect as if both Parties had signed the same document. All such counterparts will be deemed an original, will be construed together and will constitute one and the same instrument. Signature pages of this Agreement may be

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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


exchanged by facsimile or other electronic means without affecting the validity thereof.
SIGNATURES FOLLOW ON NEXT PAGE


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Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized representative as of the Effective Date.
CEPHALON, INC.
 
EAGLE PHARMACEUTICALS, INC.     
 
 
 
By: /s/ Staci Julie            
 
By: /s/ Scott Tarriff
 
Name:         Staci Julie        
 
Name:         Scott Tarriff            
Title:         VP, Global IP        
 
Title:         CEO    
 
 
 
By:     /s/ Matthew P. Blischak    
 
 
Name:              Matthew P. Blischak    
 
 
Title:     Assoc. GC, Branded IP Litigation     
 
 





 
 


Portions herein identified by [ * ] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.


EXHIBIT A
[ * ]






Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
I, Scott Tarriff, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 of Eagle Pharmaceuticals, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer 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)) 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)
[Omitted];
(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 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.
Date: May 15, 2015
/s/ Scott Tarriff
Scott Tarriff
Chief Executive Officer
(Principal Executive Officer)





Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
I, David E. Riggs, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 of Eagle Pharmaceuticals, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer 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)) 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)
[Omitted];
(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 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.
Date: May 15, 2015
/s/ David E. Riggs
David E. Riggs
Chief Financial Officer
(Principal Accounting and Financial Officer)





Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals, Inc. (the “Company”), and David E. Riggs, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
1.
The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 , to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2.
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 15, 2015
In Witness Whereof , the undersigned have set their hands hereto as of the 15 th day of May 2015 .
By:
/s/ Scott Tarriff
 
 
Scott Tarriff
 
Chief Executive Officer and Director
(Principal Executive Officer)
 
 
By:
/s/ David E. Riggs
 
 
David E. Riggs
 
Chief Financial Officer
(Principal Accounting and Financial Officer)
“This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Eagle Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.”