MEDICINES CO /DE (Form: 10-Q, Received: 05/10/2012 16:48:23)

Product or Product

in Development

Development Stage

Mechanism/Target

Clinical Indication(s)/Therapeutic Areas

Direct thrombin inhibitor

U.S. - for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty, or PTCA, and for use in patients undergoing percutaneous coronary intervention, or PCI, including patients with or at risk of heparin induced thrombocytopenia and thrombosis syndrome, or HIT/HITTS

Europe - for use as an anticoagulant in patients undergoing PCI, adult patients with acute coronary syndrome, or ACS, and for the treatment of patients with ST-segment elevation myocardial infarction, or STEMI, undergoing primary PCI

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)



þ	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: March 31, 2012



o	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (No Fee Required)

For the transition period from to

Commission file number 000-31191

THE MEDICINES COMPANY

(Exact name of registrant as specified in its charter)



Delaware (State or other jurisdiction of incorporation or organization)		04-3324394 (I.R.S. Employer Identification No.)

8 Sylvan Way Parsippany, New Jersey (Address of principal executive offices)		07054 (Zip Code)

Registrant's telephone number, including area code: (973) 290-6000

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 þ 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 þ 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 definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):



Large accelerated filer þ	Accelerated filer o	Non-accelerated filer o	Smaller reporting company o
		(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes o No þ

As of May 3, 2012 there were 55,127,339 shares of Common Stock, $0.001 par value per share, outstanding.

THE MEDICINES COMPANY

TABLE OF CONTENTS



Part I. Financial Information
Item 1 - Financial Statements	1
Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3 - Quantitative and Qualitative Disclosures about Market Risk	31
Item 4 - Controls and Procedures	31
Part II. Other Information	32
Item 1 - Legal Proceedings	32
Item 1A - Risk Factors	34
Item 6 - Exhibits	54
Signatures	55
Exhibit Index	56
EX-10.1
EX-10.2
EX-10.3
EX-10.4
EX-10.5
EX-10.6
EX-31.1
EX-31.2
EX-32.1
EX-32.2

Part I. Financial Information

Item 1. Financial Statements

THE MEDICINES COMPANY

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(unaudited)



	March 31, 2012			December 31, 2011
ASSETS
Current assets:
Cash and cash equivalents	$	255,527		$	315,382
Available for sale securities	40,128			25,130
Accrued interest receivable	173			374
Accounts receivable, net of allowances of approximately $15.5 million and $18.1 million at March 31, 2012 and December 31, 2011, respectively	67,717			74,559
Inventory	49,973			45,145
Deferred tax assets	9,395			9,395
Prepaid expenses and other current assets	12,209			11,738
Total current assets	435,122			481,723
Fixed assets, net	17,402			17,979
Intangible assets, net	122,967			87,329
Goodwill	14,671			14,671
Restricted cash	2,687			4,714
Deferred tax assets, net	78,441			78,441
Other assets	7,760			7,790
Total assets	$	679,050		$	692,647
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	17,082		$	6,587
Accrued expenses	107,504			147,382
Deferred revenue	694			666
Total current liabilities	125,280			154,635
Contingent purchase price	20,995			20,431
Other liabilities	5,982			5,939
Total liabilities	152,257			181,005
Stockholders' equity:
Preferred stock, $1.00 par value per share, 5,000,000 shares authorized; no shares issued and outstanding	—			—
Common stock, $0.001 par value per share, 125,000,000 shares authorized; 54,903,811 and 54,313,107 issued and outstanding at March 31, 2012 and December 31, 2011, respectively	55			54
Additional paid-in capital	631,167			623,801
Accumulated deficit	(104,094		)	(111,665		)
Accumulated other comprehensive income	(335		)	(548		)
Total stockholders' equity	526,793			511,642
Total liabilities and stockholders' equity	$	679,050		$	692,647

See accompanying notes to unaudited condensed consolidated financial statements.

THE MEDICINES COMPANY

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)



	Three Months Ended March 31,
	2012			2011
Net revenue	$	126,610		$	112,137
Operating expenses:
Cost of revenue	38,663			35,570
Research and development	32,778			23,792
Selling, general and administrative	43,186			37,928
Total operating expenses	114,627			97,290
Income from operations	11,983			14,847
Legal settlement	—			17,984
Other income	62			811
Income before income taxes	12,045			33,642
Provision for income taxes	(4,474		)	(9,401		)
Net income	$	7,571		$	24,241
Basic earnings per common share	$	0.14		$	0.46
Diluted earnings per common share	$	0.14		$	0.45
Weighted average number of common shares outstanding:
Basic	54,037			53,224
Diluted	55,672			54,109

See accompanying notes to unaudited condensed consolidated financial statements .

THE MEDICINES COMPANY

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(in thousands)

(unaudited)



	Three Months Ended March 31,
	2012			2011
Net income	$	7,571		$	24,241
Other comprehensive income (loss):
Unrealized (loss) gain on available for sale securities	(89		)	20
Foreign currency translation adjustment	302			(403		)
Other comprehensive income (loss)	213			(383		)
Comprehensive income	$	7,784		$	23,858

See accompanying notes to unaudited condensed consolidated financial statements .

THE MEDICINES COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)



	Three Months Ended March 31,
	2012			2011
Cash flows from operating activities:
Net income	$	7,571		$	24,241
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization	1,689			1,549
Amortization of net premiums and discounts on available for sale securities	98			788
Unrealized foreign currency transaction (gain) losses, net	(410		)	543
Non-cash stock compensation expense	3,115			2,260
Loss on disposal of fixed assets	(40		)	—
Deferred tax provision	—			212
Excess tax benefit from share-based compensation arrangements	(372		)	—
Adjustment to contingent purchase price	564			1,263
Changes in operating assets and liabilities:
Accrued interest receivable	201			572
Accounts receivable	7,059			(2,287		)
Inventory	(4,768		)	(6,989		)
Prepaid expenses and other current assets	(587		)	(10,263		)
Accounts payable	10,657			4,343
Accrued expenses	(39,879		)	2,605
Deferred revenue	12			79
Other liabilities	43			43
Net cash (used in) provided by operating activities	(15,047		)	18,959
Cash flows from investing activities:
Purchases of available for sale securities	(37,222		)	(33,835		)
Proceeds from maturities and sales of available for sale securities	22,036			40,350
Purchases of fixed assets	—			(305		)
Acquisition of intangible assets	(36,678		)	—
Decrease (increase) in restricted cash	2,036			(7		)
Net cash (used in) provided by investing activities	(49,828		)	6,203
Cash flows from financing activities:
Proceeds from issuances of common stock, net	3,880			2,189
Excess tax benefit from stock-based compensation arrangements	372			—
Net cash provided by financing activities	4,252			2,189
Effect of exchange rate changes on cash	768			(941		)
(Decrease) increase in cash and cash equivalents	(59,855		)	26,410
Cash and cash equivalents at beginning of period	315,382			126,364
Cash and cash equivalents at end of period	$	255,527		$	152,774
Supplemental disclosure of cash flow information:
Taxes paid	$	14		$	600

See accompanying notes to unaudited condensed consolidated financial statements .

THE MEDICINES COMPANY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Medicines Company ^® name and logo, Angiomax ^® , Angiox ^® and Cleviprex ^® are either registered trademarks or trademarks of The Medicines Company in the United States and/or other countries. All other trademarks, service marks or other tradenames appearing in this quarterly report on Form 10-Q are the property of their respective owners. Except where otherwise indicated, or where the context may otherwise require, references to “Angiomax” in this quarterly report on Form 10-Q mean Angiomax and Angiox collectively. References to “the Company,” “we,” “us” or “our” mean The Medicines Company, a Delaware corporation, and its subsidiaries.

1. Nature of Business

The Medicines Company (the Company) is a global pharmaceutical company focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company has three marketed products, Angiomax ^® (bivalirudin), Cleviprex ^® (clevidipine butyrate) injectable emulsion and a ready-to-use formulation of Argatroban. The Company also has a pipeline of acute and intensive care hospital products in development, including three late-stage development product candidates, cangrelor, oritavancin and MDCO-157, and two early stage development product candidates, MDCO-2010 and MDCO-216. The Company believes that its marketed products and products in development possess favorable attributes that competitive products do not provide, can satisfy unmet medical needs in the acute and intensive care hospital product market and offer, or, in the case of its products in development, have the potential to offer, improved performance to hospital businesses. In January 2012, the Company acquired from APP Pharmaceuticals, LLC (APP) non-exclusive rights to market in the United States a portfolio of ten generic drugs, which the Company refers to as its acute care generic products. On April 25, 2012, the Company entered into a global collaboration agreement with AstraZeneca LP (AstraZeneca) pursuant to which the Company and AstraZeneca have agreed to collaborate globally to develop and commercialize certain acute ischemic heart disease compounds beginning, in May 2012, with a four-year co-promotion arrangement for AstraZeneca's oral antiplatelet medicine BRILINTA ^® (ticagrelor) tablets in the United States.

2. Significant Accounting Policies

The Company's significant accounting policies are described in note 2 of the notes to the consolidated financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission (SEC).

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements include all adjustments, consisting of normal recurring accruals, considered necessary for a fair presentation of the Company's financial position, results of operations, and cash flows for the periods presented.

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The Company has no unconsolidated subsidiaries or significant investments accounted for under the equity method.

The results of operations for the three months ended March 31, 2012 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other quarter of the fiscal year ending December 31, 2012 . These condensed consolidated financial statements should be read in conjunction with the audited financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2011 , filed with the SEC.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs, expenses and accumulated other comprehensive income that are reported in the consolidated financial statements and accompanying disclosures. Actual results may be different. See note 2 of the notes to the consolidated financial statements in the Company's annual report on Form 10-K for the year ended December 31,

2011 for a discussion of the Company's critical accounting policies.

Contingencies

The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company continually assesses litigation to determine if an unfavorable outcome would lead to a probable loss or reasonably possible loss which could be estimated. In accordance with the guidance of the Financial Accounting Standards Board (FASB) on accounting for contingencies, the Company accrues for all contingencies at the earliest date at which the Company deems it probable that a liability has been incurred and the amount of such liability can be reasonably estimated. If the estimate of a probable loss is a range and no amount within the range is more likely than another, the Company accrues the minimum of the range. In the cases where the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the litigation, including an estimable range, if possible.

Recent Accounting Pronouncements

In June 2011, the FASB issued ASU 2011-05, "Presentation of Comprehensive Income" (ASU 2011-05) that requires the presentation of comprehensive income, the components of net income and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. ASU 2011-05 also requires presentation of adjustments for items that are reclassified from other comprehensive income to net income in the statement where the components of net income and the components of other comprehensive income are presented. ASU 2011-05 requires retrospective application, and it is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011 and therefore was effective for the Company in its first quarter of 2012. In December 2011, the FASB issued ASU 2011-12, "Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05" to defer the new requirement to present components of reclassifications of other comprehensive income on the face of the financial statements. Companies are still required to adopt the other requirements contained in ASU 2011-05. The Company's adoption of ASU 2011-05 changed the order in which certain financial statements are presented and provides additional detail on those financial statements when applicable, but did not have any other impact on its financial statements. The Company elected to present the total of comprehensive income, the components of net income and the components of other comprehensive income in two separate consecutive statements.

3. Stock-Based Compensation

The Company recorded approximately $3.1 million of stock-based compensation expense for the three months ended March 31, 2012 . The Company recorded approximately $2.3 million of stock-based compensation expense for the three months ended March 31, 2011 . As of March 31, 2012 , there was approximately $20.9 million of total unrecognized compensation costs related to non-vested stock-based employee compensation arrangements granted under the Company's equity compensation plans. The Company expects to recognize those costs over a weighted average period of 1.45 years.

During the three months ended March 31, 2012 , the Company issued a total of 590,704 shares of its common stock upon the exercise of stock options, pursuant to restricted stock grants and pursuant to purchases under its 2010 employee stock purchase plan (the 2010 ESPP). During the three months ended March 31, 2011 , the Company issued a total of 419,772 shares of its common stock upon the exercise of stock options, pursuant to restricted stock grants and pursuant to purchases under the 2010 ESPP. Cash received from the exercise of stock options and purchases through the 2010 ESPP during the three months ended March 31, 2012 and March 31, 2011 was approximately $3.9 million and $2.2 million , respectively, and is included within the financing activities section of the consolidated statements of cash flows.

At March 31, 2012 , there were 3,250,204 shares of common stock reserved for future issuance under the 2010 ESPP and for future grants under the Company's amended and restated 2004 stock incentive plan.

4. Earnings per Share

The following table sets forth the computation of basic and diluted earnings per share for the three months ended March 31, 2012 and 2011 :



	Three Months Ended March 31,
	2012		2011
	(in thousands, except per share amounts)
Basic and diluted
Net income	$	7,571	$	24,241

Weighted average common shares outstanding, basic	54,037		53,224
Plus: net effect of dilutive stock options and restricted common shares	1,635		885
Weighted average common shares outstanding, diluted	55,672		54,109

Earnings per share, basic	$	0.14	$	0.46
Earnings per share, diluted	$	0.14	$	0.45

Basic earnings per share is computed using the weighted average number of shares of common stock outstanding during the period, reduced where applicable for outstanding yet unvested shares of restricted common stock. The number of dilutive common stock equivalents was calculated using the treasury stock method. For the three months ended March 31, 2012 and 2011 , options to purchase 3,394,410 shares and 7,355,970 shares, respectively, of common stock that could potentially dilute basic earnings per share in the future were excluded from the calculation of diluted earnings per share as their effect would have been anti-dilutive.

For the three months ended March 31, 2012 and 2011 , 293,940 and 202,579 shares, respectively, of unvested restricted stock that could potentially dilute basic earnings per share in the future were excluded from the calculation of diluted earnings per common share as their effect would have been anti-dilutive.

5. Income Taxes

For the three months ended March 31, 2012 and 2011 , the Company recorded a $ 4.5 million and a $9.4 million provision for income taxes, respectively, based upon its estimated tax liability for the year. The provision for income taxes is based on federal, state and foreign income taxes. The worldwide effective income tax rates for the Company for the three months ended March 31, 2012 and 2011 were 37.1% and 27.9% , respectively. The effective tax rate for the three months ended March 31, 2011 benefited from the Company's February 2011 settlement with Wilmer Cutler Pickering Hale and Dorr LLP (WilmerHale), a significant portion of which was not taxable. Both the 2012 and 2011 effective tax rates include a non-cash tax expense arising from purchase accounting for in-process R&D acquired in the Company's acquisition of Targanta Therapeutics Corporation (Targanta).

The Company continues to evaluate the realizability of its deferred tax assets and liabilities on a periodic basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets in the future would impact the Company's income taxes.

6. Cash, Cash Equivalents and Available for Sale Securities

The Company considers all highly liquid investments purchased with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents included cash of $255.1 million and $290.2 million at March 31, 2012 and December 31, 2011 , respectively. Cash and cash equivalents at March 31, 2012 and December 31, 2011 also included investments of $0.4 million and $25.2 million , respectively, in money market funds and commercial paper with original maturities of less than three months.

At March 31, 2012 and December 31, 2011 , the Company held available for sale securities with a fair value totaling $40.1 million and $25.1 million , respectively. These available for sale securities included various U.S. government agency notes, U.S. treasury notes and corporate debt securities. At March 31, 2012 , approximately $26.1 million of available for sale securities were due within one year. The remaining $14.0 million were due within two years. At December 31, 2011 , all of the $25.1 million of available for sale securities were due within one year. The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary.

Available for sale securities, including carrying value and estimated fair values, are summarized as follows:



	As of March 31, 2012									As of December 31, 2011
	Cost		Fair Value		Carrying Value		Unrealized Loss			Cost		Fair Value		Carrying Value		Unrealized Gain
	(in thousands)
U.S. government agency notes	$	—	$	—	$	—	$	—		$	901	$	901	$	901	$	—
U.S. treasury notes	—		—		—		—			3,021		3,022		3,022		1
Corporate debt securities	40,214		40,128		40,128		(86		)	21,204		21,207		21,207		3
Total	$	40,214	$	40,128	$	40,128	$	(86	)	$	25,126	$	25,130	$	25,130	$	4

Restricted Cash

The Company had restricted cash of $2.7 million and $4.7 million at March 31, 2012 and December 31, 2011 , respectively, which is included in restricted cash on the consolidated balance sheets. On October 11, 2007, the Company entered into a lease for new office space in Parsippany, New Jersey. The Company relocated its principal executive offices to the new space in the first quarter of 2009. Restricted cash of $2.1 million and $4.1 million at March 31, 2012 and December 31, 2011 , respectively, collateralized outstanding letters of credit associated with this lease. The funds are invested in certificates of deposit. The letter of credit permits draws by the landlord to cure defaults by the Company. The amount of the letter of credit is subject to reduction upon the achievement of certain regulatory and operational milestones relating to the Company's products. However, in no event will the amount of the letter of credit be reduced below approximately $1.0 million . In addition, as a result of the acquisition of Targanta in 2009, the Company had at March 31, 2012 and December 31, 2011 restricted cash of $0.3 million and $0.3 million , respectively, in the form of a guaranteed investment certificate collateralizing an available credit facility. The Company also had at March 31, 2012 and December 31, 2011 restricted cash of $0.3 million and $0.3 million , respectively, related to certain foreign tender requirements.

7. Fair Value Measurements

FASB Accounting Standards Codification (ASC) 820-10 “Fair Value Measurements and Disclosures” (ASC 820-10) provides a framework for measuring fair value under GAAP and requires expanded disclosures regarding fair value measurements. ASC 820-10 defines fair value 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. ASC 820-10 also establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:


Level 1	Quoted prices in active markets for identical assets or liabilities. The Company's Level 1 assets and liabilities consist of money market investments and U.S. treasury notes.

Level 2

Observable inputs other than Level 1 prices, 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. The Company's Level 2 assets and liabilities consist of U.S. government agency notes and corporate debt securities. Fair values are determined by utilizing quoted prices for similar assets and liabilities in active markets or other market observable inputs such as interest rates and yield curves.

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 Company's Level 3 assets and liabilities consist of the contingent purchase price associated with the Company's acquisition of Targanta. The fair value of the contingent purchase price was determined utilizing a probability weighted discounted financial model based on management's assessment of the likelihood of achievement of certain development, regulatory and sales milestones.

The following table sets forth the Company's assets and liabilities that were measured at fair value on a recurring basis at

March 31, 2012 by level within the fair value hierarchy. As required by ASC 820-10, assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company's assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability:



Assets and Liabilities	Quoted Prices In Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Balance as of March 31, 2012
	(in thousands)
Assets:
Money market	$	372	$	—	$	—	$	372
Corporate debt securities	—		40,128		—		40,128
Total assets at fair value	$	372	$	40,128	$	—	$	40,500
Liabilities:
Contingent purchase price	$	—	$	—	$	20,995	$	20,995
Total liabilities at fair value	$	—	$	—	$	20,995	$	20,995

The Company measures the contingent purchase price at fair value based on significant inputs not observable in the market, which causes it to be classified as a Level 3 measurement within the fair value hierarchy. The valuation of contingent purchase price uses assumptions and estimates the Company believes would be made by a market participant in making the same valuation. The Company assesses these assumptions and estimates on an on-going basis as additional data impacting the assumptions and estimates are obtained. Changes in the fair value of contingent purchase price related to updated assumptions and estimates are recognized within the consolidated statements of operations.

Contingent purchase price may change significantly as additional data is obtained, impacting the Company’s assumptions regarding probabilities of successful achievement of related milestones used to estimate the fair value of the liability. In evaluating this information, considerable judgment is required to interpret the market data used to develop the assumptions and estimates. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange. Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact the Company’s results of operations in future periods.

Level 3 Disclosures

The following table provides quantitative information associated with the fair value measurement of the Company’s Level 3 inputs:



	Fair Value as of March 31, 2012		Valuation Technique	Unobservable Input	Range (Weighted Average)
	(in thousands)
Targanta:
Contingent purchase price	$	20,995	Probability-adjusted discounted cash flow	Probabilities of success	20% - 76% (58%)
				Periods in which milestones are expected to be achieved	2013 - 2018
				Discount rate	12%

The fair value of the contingent purchase price represents the fair value of the Company's liability for all potential payments under the Company's agreement with Targanta. The significant unobservable inputs used in the fair value measurement of the

Company's contingent purchase price are the probabilities of successful achievement of development, regulatory and sales milestones, which would trigger payments under the Targanta agreement, probabilities as to the periods in which the milestones are expected to be achieved and a discount rate. Significant changes in any of the probabilities of success would result in a significantly higher or lower fair value measurement, respectively. Significant changes in the probabilities as to the periods in which milestones will be achieved would result in a significantly lower or higher fair value measurement, respectively.

The changes in fair value of the Company's Level 3 contingent purchase price during the three months ended March 31, 2012 were as follows:



	Level 3
	(in thousands)
Balance at December 31, 2011	$	20,431
Fair value adjustment to contingent purchase price included in net income	564
Balance as of March 31, 2012	$	20,995

For the three months ended March 31, 2012 , the changes in the fair value of the contingent purchase price obligations resulted from an adjustment to the discount rates used in the probability weighted discounted financial model. No other changes in valuation techniques or inputs occurred during the three months ended March 31, 2012 . No transfers of assets between Level 1 and Level 2 of the fair value measurement hierarchy occurred during the three months ended March 31, 2012 .

8. Inventory

The major classes of inventory were as follows:



Inventory	March 31, 2012		December 31, 2011
	(in thousands)
Raw materials	$	21,881	$	23,234
Work-in-progress	18,301		19,203
Finished goods	9,791		2,708
Total	$	49,973	$	45,145

The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected volume. If annual volume is less than expected, the Company may be required to make additional allowances for excess or obsolete inventory in the future.

9. Intangible Assets and Goodwill

The following information details the carrying amounts and accumulated amortization of the Company's intangible assets subject to amortization:



		As of March 31, 2012							As of December 31, 2011
	Weighted Average Useful Life	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
		(in thousands)
Identifiable intangible assets
Customer relationships	8 years	$	7,457	$	(3,174	)	$	4,283	$	7,457	$	(2,863	)	$	4,594
Distribution agreements	5.7 years	9,125		(2,078		)	7,047		4,448		(1,708		)	2,740
Trademarks	8 years	3,024		(1,287		)	1,737		3,024		(1,161		)	1,863
Product licenses	9.6 years	39,000		(452		)	38,548		7,000		(226		)	6,774
Cleviprex milestones	13 years	2,000		(148		)	1,852		2,000		(142		)	1,858
Total	8.8 years	$	60,606	$	(7,139	)	$	53,467	$	23,929	$	(6,100	)	$	17,829

In January 2012, the Company reacquired its rights to sell Angiomax from CSL Limited (CSL) in Australia and New Zealand and is now marketing and selling Angiomax in those countries with a sales force that as of March 31, 2012 consisted of two engagement partners and two engagement managers. The Company valued the intangible assets obtained from CSL related to Angiomax in those countries at $4.7 million , classified such assets as distribution agreements intangibles and commenced amortization of the assets using a 3.5 year expected useful life.

In January 2012, the Company acquired a non-exclusive license under APP's marketing authorizations and intellectual property to sell ten specified generic products to hospitals and integrated delivery network in the United States. The Company valued the intangible assets obtained from APP in the United States at $32.0 million , classified such assets as product licenses intangibles and commenced amortization of the assets using a 10.0 year expected useful life.

The Company expects amortization expense related to its intangible assets to be $5.0 million for 2012 . The Company expects annual amortization expense related to its intangible assets to be $8.7 million , $9.9 million , $4.5 million , $4.3 million and $4.4 million for the years ending December 31, 2012, 2013, 2014, 2015 and 2016, respectively, with the balance of $16.7 million being amortized thereafter. The Company records amortization of customer relationships, distribution agreements and trademarks in selling, general and administrative expense on the consolidated statements of operations. The Company records amortization of Cleviprex milestones and product license in cost of revenue on the consolidated statements of operations.

The following information details the carrying amounts of the Company's intangible assets not subject to amortization:



	As of March 31, 2012					As of December 31, 2011
	Gross Carrying Amount		Accumulated Amortization	Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization	Net Carrying Amount
	(in thousands)
Intangible assets not subject to amortization:
In-process research and development	$	69,500	—	$	69,500	$	69,500	—	$	69,500
Total	$	69,500	—	$	69,500	$	69,500	—	$	69,500

10. Restructuring Costs and Other, Net

In September 2011, the Company commenced the closure of its drug discovery research and development facility and operations in Leipzig, Germany and terminated ten employees at its Leipzig facility. The Company transferred active pre-clinical projects from Leipzig to its research and development facility in Montreal, Canada and the MDCO-2010 back-up compound to the clinical team in Parsippany, NJ. Upon signing release agreements, the terminated employees received severance and other benefits. The Company recorded, in the aggregate, charges of $2.2 million in 2011 associated with the 2011 Leipzig closure. These charges were recorded in research and development expenses in the Company's consolidated statements of operations. Of these charges, $0.3 million related to asset write-offs were noncash charges. The Company paid out $0.3 million during 2011 and $0.8 million during the three months ended March 31, 2012 and expects to pay out $0.8 million during the remainder of 2012. The Company no longer has any research employees or research capabilities in Leipzig. The Company did not record any charges relating to

the 2011 Leipzig closure during the three months ended March 31, 2012 .

For the three months ended March 31, 2011 , the Company recorded a $0.1 million favorable adjustment to selling, general and administrative costs associated with two workforce reductions conducted in 2010, due to the charges for employee severance and other employee-related termination costs being slightly lower than originally estimated. See note 14 "Restructuring Costs and Other, Net" of the notes to the consolidated financial statements in the Company's annual report on Form 10-K for the year ended December 31, 2011 .

Details of the activities described above and the movement in the accrual during the three -month period ended March 31, 2012 are as follows:



	Balance as of December 31, 2011		Expenses (Income), Net		Cash			Noncash		Balance as of March 31, 2012
	(in thousands)
Employee severance and other personnel benefits:
2011 Leipzig closure	$	697	$	—	$	(697	)	—		$	—
Other associated costs (Leipzig)	918		—		(71		)	—		847
Total	$	1,615	$	—	$	(768	)	$	—	$	847

11. Legal Settlements

WilmerHale Settlement

During the three months ended March 31, 2011 , the Company recorded approximately $18.0 million in legal settlement income in connection with the settlement agreement and release the Company entered into with WilmerHale in February 2011. Pursuant to the settlement agreement, WilmerHale agreed to pay approximately $18.0 million from its professional liability insurance providers to the Company within 60 days after the date of the settlement agreement and delivered such amount in two equal payments in March 2011 and April 2011. The Company included the approximately $9.0 million paid in April 2011 in other current assets on its balance sheet as of March 31, 2011 . The Company did not record any legal settlement income for the three months ended March 31, 2012 .

APP Settlement

On January 22, 2012, the Company settled its patent litigation with APP, including the patent infringement suits with respect to U.S. Patent No. 7,582,727 (the '727 patent) and U.S. Patent No. 7,598,343 (the '343 patent) and APP's appeal of the August 2010 federal district court decision holding that our application for Hatch Waxman patent term extension of U.S. Patent No. 5,196,404 (the '404 patent) was timely filed. Under the settlement agreement, APP admitted that the '727 patent and '343 patent are valid and enforceable and that they would be infringed by any generic bivalirudin for injection product that is the subject of APP's ANDAs. In connection with the APP settlement, the Company entered into a license agreement with APP under which it granted APP a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product under an APP abbreviated new drug applications in the United States beginning on May 1, 2019. In certain limited circumstances, the license to APP could become effective prior to May 1, 2019. In addition, in certain limited circumstances, this license to APP could include the right to sell a generic bivalirudin product under the Company's new drug application for Angiomax in the United States beginning on May 1, 2019 or, in certain limited circumstances, on June 30, 2019 or on a date prior to May 1, 2019. Contemporaneously with entering into the settlement agreement and license agreement, the Company entered into a contract manufacturing agreement, a license and supply agreement and an authorized generic supply agreement with APP. On January 24, 2012, the U.S. District Court for the District of Delaware entered a consent judgment and order of permanent injunction concluding the Company's patent infringement suits against APP. On January 24, 2012, the parties filed a joint dismissal of APP's appeal with respect to the extension of the patent term of the '404 patent and the Federal Circuit entered an order dismissing the appeal. On February 1, 2012, the Company and APP submitted the settlement documents to the U.S. Federal Trade Commission and the U.S. Department of Justice. The Company's settlement with APP is described in more detail in Part I, Item 2, Management's Discussion and Analysis of Financial Condition and Results of Operations - Overview - APP Settlement, of this quarterly report.

12. Segment and Geographic Information

The Company manages its business and operations as one segment and is focused on advancing the treatment of acute and intensive care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. Revenues reported to date are derived primarily from the sales of Angiomax in the United States.

The geographic segment information provided below is classified based on the major geographic regions in which the Company operates.



	Three Months Ended March 31,
	2012				2011
	(in thousands)
Net revenue:
United States	$	115,978	91.6	%	$	104,990	93.6	%
Europe	9,156		7.2	%	5,875		5.2	%
Rest of world	1,476		1.2	%	1,272		1.1	%
Total net revenue	$	126,610			$	112,137



	March 31, 2012				December 31, 2011
	(in thousands)
Long-lived assets:
United States	$	161,909	99.5	%	$	126,513	99.0	%
Europe	743		0.5	%	1,069		0.8	%
Rest of world	148		0.1	%	187		0.1	%
Total long-lived assets	$	162,800			$	127,769

13. Contingencies

The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company accrues for loss contingencies at the earliest date at which the Company deems that it is probable that a liability has been incurred and the amount of such loss can be reasonably estimated.

Eagle Pharmaceuticals, Inc. (Eagle) Arbitration. The Company received a Demand for Arbitration filed by Eagle dated October 25, 2011. In the Demand for Arbitration, Eagle claims that the Company failed to meet its obligations under the license and development agreement between the Company, Eagle and certain other parties relating to the development of a new formulation of Angiomax, and to the Company's efforts to seek and obtain regulatory approval, market and sell that new formulation. As a result, Eagle alleges that it has been damaged in an amount it believes exceeds $200.0 million . The Company believes it has valid defenses to Eagle's claims and intends to defend itself vigorously. The Company believes that any potential liability is not estimable at this time.

In addition, the Company is party to the legal proceedings described in Part II, Item I of this quarterly report, which are principally patent litigation matters. The Company has assessed such legal proceedings and does not believe that it is probable that a liability has been incurred or that the amount of any potential liability can be reasonably estimated. As a result, the Company did not record any loss contingencies. While it is not possible to determine the outcome of the matters described in Part II, Item 1, Legal Proceedings, of this quarterly report, the Company believes that, the resolution of all such matters will not have a material adverse effect on its consolidated financial position or liquidity, but could possibly be material to the Company's consolidated results of operations in any one accounting period.

14. Subsequent Events

AstraZeneca Collaboration

On April 25, 2012, the Company and AstraZeneca entered into a global collaboration agreement (the collaboration agreement) pursuant to which the Company and AstraZeneca have agreed to collaborate globally to develop and commercialize certain acute ischemic heart disease compounds. Under the terms of the collaboration agreement, a joint development and regulatory committee and a joint commercialization committee have been established to prepare and deliver a global development plan and country-by-country collaboration and commercialization plans related to AstraZeneca's oral antiplatelet medicine BRILINTA and the Company's Angiomax product and cangrelor product candidate. Implementation of these plans is subject to agreement between both parties. The first joint activity agreed upon by the parties under the global collaboration is a four-year co-promotion arrangement for BRILINTA in the United States. Pursuant to the Agreement, the Company's sales force will begin supporting promotion activities for BRILINTA in May 2012. Under the terms of the agreement, AstraZeneca will pay the Company $2.5 million for conducting BRILINTA co-promotion activities during the period from the effective date of the agreement through June 30, 2012, $7.5 million in base consideration for conducting BRILINTA co-promotion activities during the period from July 1, 2012 to December 31, 2012, plus up to $2.5 million in additional consideration for the same period, contingent upon the number of new prescriptions written during that period, $15.0 million in base consideration per year from 2013 through 2015 for conducting BRILINTA co-promotion activities, plus up to an additional $5.0 million per year from 2013 to 2015 if certain performance targets with respect to new prescriptions are achieved and $7.5 million in base consideration for conducting BRILINTA co-promotion activities during the period from January 1, 2016 until June 30, 2016, plus up to an additional $2.5 million in additional consideration for the same period if certain performance targets with respect to new prescriptions are achieved. The Company and AstraZeneca have not agreed as to any development and commercialization activities to be performed with respect to Angiomax and cangrelor or as to any terms under which such activities would be performed.

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and accompanying notes included elsewhere in this quarterly report. In addition to the historical information, the discussion in this quarterly report contains certain forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated by the forward-looking statements due to our critical accounting estimates discussed below and important factors set forth in this quarterly report, including under “Risk Factors” in Part II, Item 1A of this quarterly report.

Overview

Our Business

We are a global pharmaceutical company focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. We have three marketed products, Angiomax ^® (bivalirudin), Cleviprex ^® (clevidipine butyrate) injectable emulsion and our ready-to-use formulation of Argatroban. We also have a pipeline of acute and intensive care hospital products in development, including three late-stage development product candidates, cangrelor, oritavancin and MDCO-157, and two early stage development product candidates, MDCO-2010 and MDCO-216. We believe that our marketed products and products in development possess favorable attributes that competitive products do not provide, can satisfy unmet medical needs in the acute and intensive care hospital product market and offer, or, in the case of our products in development, have the potential to offer, improved performance to hospital businesses. In addition, in January 2012 we acquired from APP Pharmaceuticals, LLC, or APP, non-exclusive rights to market in the United States a portfolio of ten generic drugs, which we refer to as our acute care generic products. In April 2012, we entered into a global collaboration agreement with AstraZeneca LP, or AstraZeneca, under which we and AstraZeneca have agreed to collaborate globally to develop and commercialize certain acute ischemic heart disease compounds beginning in May 2012 with a four-year co-promotion arrangement for AstraZeneca's oral antiplatelet medicine, BRILINTA ^® (ticagrelor) tablets in the United States .

The following chart identifies each of our marketed products and our products in development, their stage of development, their mechanism of action and the indications for which they have been approved for use or which they are intended to address. The following chart also identifies each of our acute care generic products and the therapeutic areas which they are intended to address. All of our marketed products and products in development are administered intravenously. All of our acute care generic products are injectable products.



Cleviprex	Marketed in the United States; Approved in the United Kingdom, the Netherlands, Sweden, Switzerland, Australia and New Zealand; Marketing Authorization Application, or MAA, submitted in certain European Union countries	Calcium channel blocker	U.S. - Blood pressure reduction when oral therapy is not feasible or not desirable Ex-U.S. - with indications for blood pressure control in perioperative settings
Cangrelor	Phase 3	Antiplatelet agent	Prevention of platelet activation and aggregation when oral therapy is not feasible or not desirable
Oritavancin	Phase 3	Antibiotic	Treatment of serious gram-positive bacterial infections, including acute bacterial skin and skin structure infections, or ABSSSI, and including infections that are resistant to conventional treatment
MDCO-157 (IV clopidogrel)	Pre-registration stage	Platelet inhibitor	Platelet inhibition in patients suffering from ACS or patients recently experiencing myocardial infarction, stroke, or peripheral arterial disease when oral therapy is not feasible or not desirable
MDCO-2010	Phase 2	Serine protease inhibitor	Reduction of blood loss during surgery
MDCO-216	Phase 1	Naturally occurring variant of a protein found in high-density lipoprotein, or HDL	Reversal cholesterol transport agent to reduce atherosclerotic plaque burden development and thereby reduce the risk of adverse thrombotic events
Ready-to-Use Argatroban	Marketed in the United States	Direct thrombin inhibitor	Approved for prophylaxis or treatment of thrombosis in adult patients with HIT and for use as an anticoagulant in adult patients with or at risk for HIT undergoing PCI
Acute care generic products: Adenosine, Amiodarone, Esmolol and Milrinone	Approved in the United States	Various	Cardiovascular
Acute care generic products: Azithromycin and Clindamycin	Approved in the United States	Various	Serious infection
Acute care generic products: Haloperidol, Ondansetron, Midazolam and Rocuronium	Approved in the United States	Various	Neurocritical care

Our revenues to date have been generated primarily from sales of Angiomax in the United States. We continue to expand our sales and marketing efforts outside the United States. We believe that by establishing operations outside the United States for Angiomax, we can increase our sales of Angiomax outside of the United States and be positioned to commercialize Cleviprex and our products in development, if and when they are approved outside the United States.

Research and development expenses represent costs incurred for licenses of rights to products, clinical trials, nonclinical and preclinical studies, activities relating to regulatory filings and manufacturing development efforts. We outsource much of our clinical trials, nonclinical and preclinical studies and all of our manufacturing development activities to third parties to maximize efficiency and minimize our internal overhead. We expense our research and development costs as they are incurred. Selling, general and administrative expenses consist primarily of salaries and related expenses, costs associated with general corporate activities and costs associated with marketing and promotional activities. Research and development expense, selling, general and administrative expense and cost of revenue also include stock-based compensation expense, which we allocate based on the responsibilities of the recipients of the stock-based compensation.

As of March 31, 2012 , we had an accumulated deficit of approximately $104.1 million . We expect to make substantial expenditures to further develop and commercialize our products and to develop our product candidates, including costs and

expenses associated with clinical trials, nonclinical and preclinical studies, regulatory approvals and commercialization.

Angiomax Patent Litigation

The principal U.S. patents covering Angiomax include U.S. Patent No. 5,196,404, or the '404 patent, U.S. Patent No. 7,582,727, or the '727 patent, and U.S. Patent No. 7,598,343, or the '343 patent.

The '404 patent was set to expire in March 2010, but was extended under the Hatch-Waxman Act following our litigation against the U.S. Patent and Trademark Office, or PTO, the FDA and the U.S. Department of Health and Human Services, or HHS. We had applied, under the Hatch-Waxman Act, for an extension of the term of the '404 patent. However, the PTO rejected our application because in its view the application was not timely filed. As a result, we filed suit against the PTO, the FDA and HHS seeking to set aside the denial of our application to extend the term of the '404 patent. On August 3, 2010, the U.S. Federal District Court for the Eastern District of Virginia granted our motion for summary judgment and ordered the PTO to consider our patent term extension application timely filed. The period for the government to appeal the court's August 3, 2010 decision expired without government appeal. However, on August 19, 2010, APP filed a motion to intervene for the purpose of appeal in our case against the PTO, the FDA and HHS. On September 13, 2010, the federal district court denied APP's motion. APP appealed the denial of its motion, as well as the federal district court's August 3, 2010 order. On January 22, 2012, we entered into a legal settlement with APP in which APP agreed to dismiss its appeals. Upon dismissal of APP's appeals, all pending litigation regarding the '404 patent was resolved. On March 5, 2012, we received a certificate of extension issued by the PTO for the '404 patent extending the term of the '404 patent to December 15, 2014. In addition, as a result of our study of Angiomax in the pediatric setting, we are entitled to a six-month period of pediatric exclusivity following expiration of the '404 patent, which extends exclusivity to June 15, 2015.

On September 30, 2011, we settled our '727 patent and '343 patent infringement litigation with Teva Pharmaceuticals USA, Inc. and its affiliates, which we collectively refer to as Teva. In connection with the Teva settlement, we entered into a license agreement with Teva under which we granted Teva a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product under a Teva ANDA in the United States beginning June 30, 2019 or earlier under certain conditions. On January 22, 2012, we settled our patent infringement litigation with APP. In connection with the APP settlement, we entered into a license agreement with APP under which we granted APP a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product under an APP ANDA in the United States beginning on May 1, 2019. In certain limited circumstances, the license to APP could become effective prior to May 1, 2019. In addition, in certain limited circumstances, this license to APP could include the right to sell a generic bivalirudin product under our NDA for Angiomax in the United States beginning on May 1, 2019 or, in certain limited circumstances, on June 30, 2019 or on a date prior to May 1, 2019.

On January 24, 2012, the U.S. District Court for the District of Delaware entered a consent judgment and order of permanent injunction concluding our patent infringement suits against APP. On January 24, 2012, the parties filed a joint dismissal of APP's appeal with respect to the extension of the patent term of the '404 patent and the Federal Circuit entered an order dismissing the appeal. On February 1, 2012, we and APP submitted the settlement documents to the U.S. Federal Trade Commission, or FTC, and the U.S. Department of Justice, or the DOJ.

We remain in patent infringement litigation involving the '727 patent and '343 patent with other ANDA filers, as described in Part II, Item 1, Legal Proceedings of this quarterly report. If we are unable to maintain our market exclusivity for Angiomax in the United States through enforcement of our U.S. patents covering Angiomax, then Angiomax could be subject to generic competition earlier than May 1, 2019.

In February 2011, we entered into a settlement agreement and release with the law firm Wilmer Cutler Pickering Hale and Dorr LLP, or WilmerHale, with respect to all potential claims and causes of action between the parties related to the '404 patent. Under the settlement agreement, WilmerHale agreed to make available to us up to approximately $232 million, consisting of approximately $117 million from the proceeds of professional liability insurance policies and $115 million of payments from WilmerHale itself. WilmerHale agreed to pay approximately $18 million from its professional liability insurance providers to us within 60 days after the date of the settlement agreement and delivered such amount in two equal payments in March 2011 and April 2011. The balance of the approximately $232 million aggregate amount provided in the settlement agreement remains available to pay future expenses incurred by us in continuing to defend the extension of the '404 patent, and any damages that may

be suffered by us in the event that a generic version of Angiomax is sold in the United States before June 15, 2015 because the extension of the '404 patent is held invalid on the basis that the application for the extension was not timely filed. Payments by WilmerHale itself would be made only after payments from its insurance policies are exhausted and cannot exceed $2.875 million for any calendar quarter.

APP Settlement

As noted above, on January 22, 2012, we settled our patent litigation with APP. In connection with the APP settlement, we entered into a settlement agreement, a license agreement with respect to the '727 patent and '343 patent, a contract manufacturing agreement with APP, under which APP has agreed to manufacture and supply Angiomax finished product to us, a license and supply agreement with APP under which APP has agreed to license and supply to us a portfolio of ten generic products and an AG supply agreement with APP under which we have agreed to supply APP with an authorized generic bivalirudin product, upon specified circumstances set forth in the APP license agreement.

Under the APP license agreement, we granted APP a non-exclusive license under the '727 patent and '343 patent to sell in the United States a generic bivalirudin for injection product under an APP ANDA, or an APP product, beginning on May 1, 2019 or earlier under specified conditions, and, in certain limited circumstances, to sell a generic bivalirudin for injection product under our NDA for Angiomax, or an APP generic product, in the United States beginning on May 1, 2019 or, in certain limited circumstances, on June 30, 2019 or on a date prior to May 1, 2019. APP's right under the APP license agreement to sell an APP generic product is subject to the payment to us of a royalty on sales of the APP generic product. If APP has the right to sell an APP generic product, such right could extend for a period of as long as 180 days. The license also covers any other present or future patents owned, licensed or controlled by us that cover or would cover an APP product or an APP generic product other than the '404 patent. Under the APP license agreement, we and APP have also agreed to negotiate an agreement under which we would supply APP with bivalirudin bulk drug substance for use by APP in the manufacture of APP product to be sold under the APP license agreement. The APP license agreement will remain in effect until the later of the expiration of all of the patents covered by the APP license agreement, and the date six months after the expiration of the '404 patent.

Under the APP manufacturing agreement, we have agreed to purchase from APP a specified minimum percentage of the Company's requirements for Angiomax finished product for the sale of Angiomax product in the United States. We have agreed to pay APP a fixed price per vial supplied and to reimburse APP for specified development costs and capital expenditures made by APP. The term of the APP manufacturing agreement ends on May 1, 2019, but may be extended, at our sole option, for an additional term of two years. If a generic form of bivalirudin for injection is marketed by APP or another third party during the term of the APP manufacturing agreement, we have the right to renegotiate the price and minimum quantity terms of the APP manufacturing agreement and, if such terms cannot be agreed to by the parties, we will have the right to terminate the APP manufacturing agreement upon 90 days written notice.

Under the APP generic supply and license agreement, APP has granted us a non-exclusive license under APP's marketing authorizations and intellectual property to sell ten specified generic products to hospitals and integrated delivery networks in the United States. We have agreed to purchase our entire requirements for these products from APP for a price equal to APP's cost of goods. We made a one-time, upfront payment of $30 million to APP. The term of the APP generic supply and license agreement ends January 22, 2022.

Under the AG supply agreement, we have agreed to supply APP with an authorized generic bivalirudin product in the event APP has the right to market the product under the APP license agreement. We have agreed to use commercially reasonable efforts to supply the authorized generic bivalirudin product during the period during which APP can market the product, or the supply period. APP shall purchase the authorized generic bivalirudin product from us at a price based on the costs we have paid to third parties in connection with the manufacture of the product. The AG supply agreement terminates upon the earlier of the end of the supply period or December 27, 2019.

Cleviprex Resupply, Re-launch and Formulation

In December 2009 and March 2010, we conducted voluntary recalls of manufactured lots of Cleviprex due to the presence of visible particulate matter at the bottom of some vials. As a result, we were not able to supply the market with Cleviprex and sell Cleviprex from the first quarter of 2010 through the first quarter of 2011. We cooperated with the FDA and our contract manufacturer to remedy the problem at the manufacturing site that resulted in the recalls. We began to resupply existing customers with Cleviprex in April 2011. In June 2011, the FDA approved our supplemental New Drug Application, or sNDA, for an improved formulation of Cleviprex. The new formulation triples the maximum allowable infusion time per vial, commonly referred to in hospitals as "hang time", to 12 hours compared to the original 4-hour hang time approved by the FDA in 2008. We re-launched Cleviprex in October 2011 with the new formulation, targeting neurocritical care patients, including intracranial bleeding and acute ischemic

stroke patients requiring blood pressure control, and cardiac surgery patients, including patients undergoing coronary artery bypass graft surgery, heart valve replacement or repair, and surgery for the repair of aortic dissection.

Ready-to-Use Argatroban Recall

In December 2011, Eagle conducted a voluntary recall of ready-to-use Argatroban due to the presence of particulate matter in some vials. As a result, we were not able to sell ready-to-use Argatroban from December 2011 to April 2012. In April 2012, we re-commenced selling ready-to-use Argatroban to existing and new customers.

Collaboration with AstraZeneca

On April 25, 2012, we entered into a global collaboration agreement with AstraZeneca pursuant to which we and AstraZeneca have agreed to collaborate globally to develop and commercialize certain acute ischemic heart disease compounds. Under the terms of the collaboration agreement, a joint development and research committee and a joint commercialization committee have been established to prepare and deliver a global development plan and a country-by-country collaboration and commercialization plan, respectively, related to BRILINTA and Angiomax and cangrelor. Implementation of these plans is subject to agreement between both parties. The first joint activity agreed upon by the parties under the global collaboration is a four-year co-promotion arrangement for BRILINTA in the United States. Pursuant to the agreement, our sales force will begin supporting promotion activities for BRILINTA in May 2012. Under the terms of the agreement, AstraZeneca will pay us $2.5 million for conducting BRILINTA co-promotion activities during the period from the effective date of the agreement through June 30, 2012, $7.5 million in base consideration for conducting BRILINTA co-promotion activities during the period from July 1, 2012 to December 31, 2012, plus up to $2.5 million in additional consideration for the same period, contingent upon the number of new prescriptions written during that period, $15.0 million in base consideration per year from 2013 through 2015 for conducting BRILINTA co-promotion activities, plus up to an additional $5.0 million per year from 2013 to 2015 if certain performance targets with respect to new prescriptions are achieved and $7.5 million in base consideration for conducting BRILINTA co-promotion activities during the period from January 1, 2016 until June 30, 2016, plus up to an additional $2.5 million in additional consideration for the same period if certain performance targets with respect to new prescriptions are achieved. We and AstraZeneca have not agreed as to any development and commercialization activities to be performed with respect to Angiomax and cangrelor or as to any terms under which such activities would be performed.

Either party may terminate the agreement upon an uncured material breach of the agreement by the other party. In addition, either party may terminate the agreement upon the occurrence of certain events, including the withdrawal of BRILINTA from the market, and the entry into the market of a generic version of BRILINTA which achieves a specified market share. Either party may terminate the agreement if a change of control of us occurs involving certain companies described and identified in the agreement and we may terminate the agreement if AstraZeneca transfers its rights in BRILINTA to any of such companies.

At the end of the second year of the agreement, AstraZeneca may terminate the agreement if performance targets for the second year are not achieved. Conversely, we may terminate the agreement at such time if the performance targets for the second year are achieved. Either party may terminate the agreement at the end of the third year of the agreement. If AstraZeneca elects to terminate the agreement at the end of the third year and the performance targets for the third year have been achieved, AstraZeneca must pay us a termination fee of $5 million.

Distribution and Sales

We market and sell Angiomax, Cleviprex and ready-to-use Argatroban in the United States with a sales force that, as of March 31, 2012 , consisted of 111 representatives, who we refer to as engagement partners and engagement managers, experienced in selling to hospital customers. Once our commercial infrastructure development is complete, we expect to use the same sales force to sell the acute care generic products for which we acquired the non-exclusive rights to sell and distribute from APP and to sell BRILINTA under our collaboration agreement with AstraZeneca. In support of our sales efforts, we focus our Angiomax marketing in the United States on hospital systems, individual hospitals, and health care providers, including interventional cardiologists in cardiac catheterization laboratories and we focus the marketing of Cleviprex on neurocritical care patients, including intracranial bleeding and acute ischemic stroke patients requiring blood pressure control, and cardiac surgery patients, including patients undergoing coronary artery bypass graft surgery, heart valve replacement or repair, and surgery for the repair of aortic dissection. We believe our ability to deliver relevant, advanced and reliable service and information to our concentrated customer base provides us with significant market advantage in the United States, and will provide us with such advantage outside the United States, even in highly competitive sub-segments of the hospital market such as cardiology and neurocritical care.

We distribute Angiomax, Cleviprex and ready-to-use Argatroban in the United States through a sole source distribution model

with Integrated Commercialization Solutions, or ICS. Under this model, we currently sell Angiomax, Cleviprex and ready-to-use Argatroban to our sole source distributor, ICS. ICS then sells Angiomax and Cleviprex, and, when and if available for sale, would sell ready-to-use Argatroban to a limited number of national medical and pharmaceutical wholesalers with distribution centers located throughout the United States and, in certain cases, directly to hospitals. We expect that we will also sell the acute care generic products for which we acquired the non-exclusive rights to sell and distribute from APP through the same sole source distribution model.

Our agreement with ICS, which we initially entered into February 2007, provides that ICS will be our exclusive distributor of Angiomax, Cleviprex and ready-to-use Argatroban in the United States. Under the terms of this fee-for-service agreement, ICS places orders with us for sufficient quantities of Angiomax, Cleviprex and ready-to-use Argatroban to maintain an appropriate level of inventory based on our customers' historical purchase volumes. ICS assumes all credit and inventory risks, is subject to our standard return policy and has sole responsibility for determining the prices at which it sells Angiomax, Cleviprex and ready-to-use Argatroban, subject to specified limitations in the agreement. The agreement terminates on September 30, 2013, but will automatically renew for additional one-year periods unless either party gives notice at least 90 days prior to the automatic extension. Either party may terminate the agreement at any time and for any reason upon 180 days prior written notice to the other party. In addition, either party may terminate the agreement upon an uncured default of a material obligation by the other party and other specified conditions.

In Europe, we market and sell Angiox with a sales force that, as of March 31, 2012 , consisted of 41 engagement partners and engagement managers experienced in selling to hospital customers. Our European sales force targets hospitals with cardiac catheterization laboratories that perform approximately 200 or more coronary angioplasties per year. In October 2011, we entered into a local sales support agreement with Daiichi Sankyo, Inc., or Daiichi Sankyo, under which Daiichi Sankyo agreed to provide supplemental sales force coverage to approximately 480 hospitals in Germany treating ACS patients and call upon most interventional cardiologists in Germany. We also market and sell Angiomax outside the United States through distributors, including Sunovion Pharmaceuticals Inc., which distributes Angiomax in Canada, affiliates of Grupo Ferrer Internacional, which distribute Angiox in Greece, Portugal and Spain and in a number of countries in Central America and South America, and through a joint venture with our partner, Windlas Healthcare Private Limited, in India. We also have agreements with other third parties for other countries outside of the United States, including Israel and Russia. In January 2012, we reacquired our rights to sell Angiomax in Australia and New Zealand from CSL Limited and are now marketing and selling Angiomax in those two countries with a sales force consisting of, as of March 31, 2012 , two engagement partners and two engagement managers in those countries. We are developing a global commercialization strategy for Cleviprex in anticipation of its further approval outside of the United States.

To support the commercialization and distribution efforts of Angiomax, we have developed, and continue to develop, our business infrastructure outside the United States, including forming subsidiaries, obtaining licenses and authorizations necessary to distribute Angiomax, hiring personnel and entering into arrangements for services from third parties, such as importation, packaging, quality control and distribution. We currently have operations in Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, India, Italy, the Netherlands, New Zealand, Norway, Poland, Russia, Spain, Sweden, Switzerland and the United Kingdom and are developing our business infrastructure and capabilities in Brazil, China, Eastern Europe and Turkey. We believe that by establishing operations outside the United States for Angiomax, we will be positioned to commercialize Cleviprex and our products in development, if and when they are approved outside the United States.

U.S. Health Care Reform

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, or PPACA, which was amended by the Health Care and Education Reconciliation Act of 2010. The PPACA, as amended, contains numerous provisions that impact the pharmaceutical and healthcare industries that are expected to be implemented over the next several years. We are continually evaluating the impact of the PPACA on our business. As of the date of this quarterly report, we have not identified any provisions that currently materially impact our business or results of operations. However, the potential impact of the PPACA on our business and results of operations is inherently difficult to predict because many of the details regarding the implementation of this legislation have not been determined and certain provisions of the PPACA have been challenged by various parties in litigation that has been brought before the United States Supreme Court. In addition, the impact on our business and results of operations may change as and if our business evolves.

Results of Operations

Net Revenue:

Net revenue increased 13% to $126.6 million for the three months ended March 31, 2012 as compared to $112.1 million for

the three months ended March 31, 2011 .

The following table reflects the components of net revenue for the three months ended March 31, 2012 and 2011 :

Net Revenue



	Three Months Ended March 31,
	2012		2011		Change $		Change %
			(in thousands)
Angiomax	$	126,109	$	112,137	$	13,972	12.5	%
Cleviprex/Argatroban	501		—		501		100.0	%
Total net revenue	$	126,610	$	112,137	$	14,473	12.9	%

Net revenue increased by $14.5 million , or 12.9% , to $126.6 million in the three months ended March 31, 2012 compared to $112.1 million in the three months ended March 31, 2011 , reflecting increases of $11.0 million or 10.5% in the United States, and $3.5 million or 48.8% in international markets. The net revenue increase was comprised of net volume increases of $4.7 million and price increases of $9.9 million, which were offset by the unfavorable impact from foreign exchange of $0.1 million.

Angiomax. Net revenue from sales of Angiomax increased by $14.0 million or 12.5% to $126.1 million in the three months ended March 31, 2012 compared to $112.1 million in the three months ended March 31, 2011 , primarily due to a price increase in the United States and increased unit sales globally. Net revenue in the United States in both the three months ended March 31, 2012 and 2011 reflect chargebacks related to the 340B Drug Pricing Program under the Public Health Services Act and rebates related to the PPACA. Under the 340B Drug Pricing Program, we offer qualifying entities a discount off the commercial price of Angiomax for patients undergoing PCI on an outpatient basis. Chargebacks related to 340B Drug Pricing Program increased by $0.5 million to $9.4 million in the three months ended March 31, 2012 compared to $8.9 million in the three months ended March 31, 2011 , primarily due to increased usage by eligible hospital customers. Rebates related to the PPACA were $0.2 million in both the three months ended March 31, 2012 and March 31, 2011 . Net revenue from sales of Angiomax outside the United States increased in the three months ended March 31, 2012 compared to the three months ended March 31, 2011 due to greater demand by existing hospital customers and the addition of new hospital customers in Russia, the United Kingdom, Italy, Denmark, Spain, France, Germany, the Netherlands, Australia and Israel.

Cleviprex/Argatroban. Net revenue from sales of Cleviprex was $0.5 million in the three months ended March 31, 2012 . We had no net revenue from sales of Cleviprex in the three months ended March 31, 2011 . We did not begin to resupply existing customers with Cleviprex until April 2011. We did not recognize any revenue from sales of ready-to-use Argatroban in the three months ended March 31, 2012 and March 31, 2011 . We had no sales in the three months ended March 31, 2011 as this formulation of ready-to-use Argatroban was not approved for sale by the FDA until July 2011 and no sales occurred in the three months ended March 31, 2012 due to the recall of ready-to-use Argatroban in December 2011.

Cost of Revenue:

Cost of revenue in the three months ended March 31, 2012 was $38.7 million , or 31% of net revenue, compared to $35.6 million , or 32% of net revenue, in the three months ended March 31, 2011 .

Cost of revenue during both periods consisted of expenses in connection with the manufacture of our products sold, royalty expenses under our agreements with Biogen Idec and Health Research Inc., or HRI, related to Angiomax, our agreement with AstraZeneca AB, or AstraZeneca, related to Cleviprex, our agreement with Eagle related to ready-to-use Argatroban and logistics costs related to Angiomax, Cleviprex and ready-to-use Argatroban, including distribution, storage, and handling costs.

Cost of Revenue



	Three Months Ended March 31,
	2012		% of Total		2011		% of Total
	(in thousands)				(in thousands)
Manufacturing	$	7,891	20	%	$	7,745	22	%
Royalty	27,332		71	%	25,498		72	%
Logistics	3,440		9	%	2,327		6	%
Total cost of revenue	$	38,663	100	%	$	35,570	100	%

Cost of revenue increased by $3.1 million during the three months ended March 31, 2012 compared to the three months ended March 31, 2011 primarily due to an increase in royalty expense to Biogen Idec due to higher royalty sales under our agreement with Biogen Idec triggered by higher sales of Angiomax. The increase in cost of revenue was also related to an increase in manufacturing and logistic expenses due to costs associated with our entry into an agreement with Patheon International A.G., or Patheon, in March 2011 to be an additional supplier of Angiomax drug product.

Research and Development Expenses:

Research and development expenses increased by 38% to $32.8 million for the three months ended March 31, 2012 , compared to $23.8 million for the three months ended March 31, 2011 . The increase primarily reflects additional costs incurred in connection with our ongoing Phase 3 clinical trials of cangrelor and oritavancin, including our acceleration of patient enrollment in our SOLO I Phase 3 trial of oritavancin. The increase also reflects costs incurred in preparation for the commencement of a Phase 1 clinical trial of MDCO-216, including for the manufacturing of drug product for the anticipated Phase 1 trial. These increases were offset by a decrease in manufacturing development expenses related to product lifecycle management activities of Angiomax.

We expect to continue to invest in the development of Angiomax, Cleviprex, cangrelor, oritavancin, MDCO-2010, MDCO-216 and MDCO-157 during 2012 and that our research and development expenses will increase in 2012 from their levels in 2011. We expect that more than a majority of our research and development expenses will be incurred in the first half of 2012. We expect research and development expenses in 2012 to include costs associated with our ongoing Phase 3 clinical trials of oritavancin and cangrelor, manufacturing development activities for Angiomax, Cleviprex, cangrelor and MDCO-216, our Phase 2 clinical trial program for MDCO-2010, our Phase 1 clinical trial of MDCO-216, product lifecycle management activities and the development of MDCO-157.

The following table identifies for each of our major research and development projects our spending for the three months ended March 31, 2012 and 2011 . Spending for past periods is not necessarily indicative of spending in future periods.

Research and Development Spending



	Three Months Ended March 31,
	2012		% of Total R&D		2011			% of Total R&D
	(In thousands)				(In thousands)
Angiomax
Clinical trials	$	1,584	5	%	$	1,703		7	%
Manufacturing development	38		—	%	121			1	%
Administrative and headcount costs	312		1	%	822			3	%
Total Angiomax	1,934		6	%	2,646			11	%
Cleviprex
Clinical trials	—		—	%	303			1	%
Manufacturing development	181		1	%	79			1	%
Administrative and headcount costs	342		1	%	320			1	%
Total Cleviprex	523		2	%	702			3	%
Cangrelor
Clinical trials	12,358		38	%	4,526			19	%
Manufacturing development	618		2	%	261			1	%
Administrative and headcount costs	1,534		5	%	1,687			7	%
Total Cangrelor	14,510		45	%	6,474			27	%
Oritavancin
Clinical trials	7,599		23	%	6,448			27	%
Manufacturing development	306		1	%	182			1	%
Administrative and headcount costs	1,080		3	%	1,359			6	%
Total Oritavancin	8,985		27	%	7,989			34	%
MDCO-157
Clinical trials	12		—	%	—			—	%
Manufacturing development	158		—	%	—			—	%
Administrative and headcount costs	700		2	%	—			—	%
Total MDCO-157	870		2	%	—			—	%
MDCO-2010
Clinical trials	124		—	%	279			1	%
Manufacturing development	222		1	%	30			—	%
Administrative and headcount costs	744		2	%	841			3	%
Government subsidy	—		—	%	(111		)	—	%
Total MDCO-2010	1,090		3	%	1,039			4	%
MDCO-216
Clinical trials	103		—	%	305			1	%
Manufacturing development	713		2	%	861			4	%
Administrative and headcount costs	279		1	%	357			1	%
Total MDCO-216	1,095		3	%	1,523			6	%
Ready-to-Use Argatroban
Administrative and headcount costs	—		—	%	177			1	%
Total Ready-to-Use Argatroban	—		—	%	177			1	%
Other	3,771		12	%	3,242			14	%
Total	$	32,778	100	%	$	23,792		100	%

Angiomax

Research and development spending related to Angiomax during the three months ended March 31, 2012 decreased by approximately $0.7 million compared to the three months ended March 31, 2011 . Clinical trial costs decreased by $0.1 million , primarily due to decreased expenditures in connection with our EUROMAX trial. We are conducting a EUROMAX trial at sites in seven European countries to assess whether the early administration of Angiox, the name under which we market Angiomax in Europe, in ST-segment elevation myocardial infarction, or STEMI, patients intended for primary percutaneous coronary intervention, or PCI, presenting either via ambulance or to referral centers where PCI is not performed improves 30-day outcomes when compared to the current standard of care, heparin plus an optional glycoprotein IIb/IIIa receptor inhibitors, or GP IIb/IIIa inhibitors. We commenced enrollment in our EUROMAX clinical trial in March 2010. We expect to enroll approximately 2,200 patients in the EUROMAX trial and to complete enrollment in 2013.

We expect that our research and development expenses relating to Angiomax will increase in 2012 in connection with our efforts to further develop Angiomax for use in additional patient populations, as well as continued research and development expenses related to our product lifecycle management activities.

Cleviprex

Research and development expenditures for Cleviprex decreased by approximately $0.2 million during the three months ended March 31, 2012 compared to the three months ended March 31, 2011 . The decrease in costs in the 2012 period was primarily due to lower clinical costs associated with our PRONTO trial. These decreased costs were partially offset by an increase in manufacturing development costs related to product lifecycle activities. Our PRONTO trial, which we commenced in 2009, is evaluating the efficacy and safety of an intravenous infusion of Cleviprex as compared with standard-of-care intravenous antihypertensives for blood pressure lowering in patients with acute heart failure and elevated blood pressure. We are no longer enrolling patients in our PRONTO trial and are in the process of analyzing data from the trial.

We expect total research and development expenses relating to Cleviprex will increase in 2012 as compared to 2011 levels. We expect we will incur increased research and development expenses in 2012 in connection with our efforts to obtain marketing approval of Cleviprex outside the United States, the re-commencement of clinical studies that had been suspended due to recalls and an increase in manufacturing development activities.

Cangrelor

Research and development expenditures related to cangrelor increased by approximately $8.0 million in the three months ended March 31, 2012 compared to the three months ended March 31, 2011 . The increase primarily reflects increased clinical trial expenses related to our Phase 3 CHAMPION PHOENIX clinical trial, as well as an increase in manufacturing development expenses.

We expect total research and development expenses relating to cangrelor in 2012 to remain similar to 2011 levels. We expect we will continue to incur research and development expenses in 2012 in connection with the CHAMPION PHOENIX clinical trial. The trial is a double-blind parallel group randomized study which compares cangrelor to clopidogrel given according to institutional practice. We expect to initially enroll approximately 10,900 patients and we may enroll additional patients in this trial depending on the results of an interim analysis of the trial. As of April 25, 2012, we had enrolled approximately 7,400 patients in the CHAMPION PHOENIX trial. We expect the results of the interim analysis of this trial in the second half of 2012 and, if positive, plan to accelerate enrollment in the CHAMPION PHOENIX trial. Under the accelerated timeline, we would incur increased research and development expenses relating to cangrelor.

Oritavancin

Research and development expenditures related to oritavancin increased by approximately $1.0 million in the three months ended March 31, 2012 compared to the three months ended March 31, 2011 . The increase primarily reflects increased costs incurred relating to our SOLO I and SOLO II Phase 3 clinical trials.

We expect to incur increased research and development expenses relating to oritavancin in 2012 as compared to 2011 due to the SOLO I and SOLO II clinical trials. We plan to enroll 960 patients in each of the SOLO I and SOLO II clinical trials. The trials are designed to test the use of a simplified dosing regimen involving a single dose of oritavancin as compared to multiple doses of vancomycin for the treatment of ABSSSI using a primary efficacy endpoint consisting of a composite of resolution of fever and cessation of spread of visible infection without the use of rescue antibiotics at 48 to 72 hours following initiation of treatment. We have decided to focus on accelerating enrollment in the SOLO I trial and expect to complete enrollment in the

SOLO I trial in the third quarter of 2012. As of April 25, 2012, we had enrolled approximately 540 patients in the SOLO I clinical trials. If the SOLO I trial results are positive, we plan to accelerate enrollment in the SOLO II trial. Under the accelerated timeline, if the results of the trials warrant, we would expect to file an NDA in the first half of 2013.

MDCO-157

In May 2011, we entered into a licensing agreement with Ligand Pharmaceuticals Incorporated, through its subsidiary CyDex Pharmaceuticals, Inc., under which we acquired an exclusive, worldwide license to patents claiming a Captisol®-enabled intravenous formulation of clopidogrel bisulfate, which we refer to as MDCO-157, and to related know-how. Costs incurred during the three months ended March 31, 2012 were primarily related to administrative and headcount related expenses. Under the license agreement, we agreed to spend at least $2.5 million annually on the development of MDCO-157.

We expect total research and development expenses relating to MDCO-157 to increase in 2012 as compared to 2011, as clinical development progresses. We plan to commence a pharmacodynamic equivalent study of MDCO-157 with oral clopidogrel in 2012.

MDCO-2010

In August 2008, as a result of our acquisition of Curacyte Discovery GmbH, or Curacyte Discovery, we acquired a small molecule serine protease inhibitor that we are developing as an intravenous antifibrinolytic for the reduction of blood loss during surgery, which we refer to as MDCO-2010. Research and development expenditures related to MDCO-2010 increased by approximately $0.1 million in the three months ended March 31, 2012 compared to the three months ended March 31, 2011 . Costs incurred during the three months ended March 31, 2012 primarily related to the dose ranging trial of MDCO-2010 we commenced in the first quarter of 2012. Costs incurred during the three months ended March 31, 2011 primarily related to our Phase 2a clinical trial of MDCO-2010, which we commenced in November 2010 and completed in the third quarter of 2011. Research and development costs related to MDCO-2010 were partially offset by a German government research and development subsidy paid during the three months ended March 31, 2011 .

We expect that our research and development expenses relating to MDCO-2010 will decrease in 2012 as compared to 2011, as 2011 expenses reflected the achievement of a €4.0 million clinical milestone earned in the three months ended March 31, 2011 by Curacyte AG. We expect these reduced expenses will be offset by costs associated with the ongoing dose ranging trial. The objective of the dose ranging trial is to determine dose response relationship regarding blood loss, pharmacokinetics and pharmacodynamics, and clinical outcomes of MDCO-2010 versus placebo and tranexamic acid in patients undergoing primary CABG surgery or combined primary CABG and aortic valve replacement. This trial will be conducted in two stages. In the first stage, we expect to enroll 90 patients and to complete enrollment in 2012. We are currently enrolling patients in Germany and Switzerland, and expect to enroll patients in Canada, for the first stage of the trial. Following the results from the first stage, we expect to conduct the second stage of the trial in 180 patients in Germany, Switzerland, Canada and the United States. In March 2012, the investigational new drug application, or IND, that we filed with the FDA for MDCO-2010 became effective, which enables us to enroll patients in the dose ranging trial in the United States.

MDCO-216

In December 2009, we licensed from Pfizer Inc. the exclusive worldwide rights to a novel biologic, a naturally occurring variant of a protein found in human high-density lipoprotein, or HDL, that has the potential to reverse atherosclerotic plaque development and reduce the risk of coronary events in patients with ACS which we refer to as MDCO-216. Research and development expenditures related to MDCO-216 decreased by approximately $0.4 million in the three months ended March 31, 2012 as compared to the three months ended March 31, 2011 . Costs incurred during the three months ended March 31, 2012 primarily related to manufacturing development in connection with preparation for the commencement of a Phase 1 study of MDCO-216 and administrative and headcount expenses. Costs incurred during the three months ended March 31, 2011 were primarily manufacturing development related to preclinical activities, the costs of a Phase 1 study of MDCO-216 and administrative and headcount expenses.

We expect that our research and development expenses relating to MDCO-216 will increase in 2012 as compared to 2011, as we plan to commence a Phase 1 study of MDCO-216 in the second half of 2012. We plan to commence this Phase 1 study of MDCO-216 to investigate the safety and tolerability of escalating single doses of MDCO-216 in subjects presenting stable angina and angiographic evidence of coronary disease and to characterize the single dose pharmacokinetics of MDCO-216 in subjects presenting stable angina and angiographic evidence of coronary disease. We expect to use in this Phase 1 study the same new methodologies to produce product for this Phase 1 study as the methodologies we used to produce product for the 2010 preclinical studies.

Ready-to-Use Argatroban

Research and development expenditures related to ready-to-use Argatroban decreased by $0.2 million in the three months ended March 31, 2012 compared to the three months ended March 31, 2011 as we did not have any research and development expenses with respect to ready-to-use Argatroban in the three months ended March 31, 2012 . The costs incurred during the three months ended March 31, 2011 primarily related to administrative and headcount related expenses.

We expect total research and development expenses relating to ready-to-use Argatroban in 2012 to decrease from 2011 levels.

Other Research and Development Expense

Research and development expenditures in this category includes infrastructure costs in support of our product development efforts, which includes expenses for data management, statistical analysis, analysis of pre-clinical data, analysis of pharmacokinetic-pharmacodynamic data, or PK/PD data, and product safety as well as expenses related to business development activities in connection with our efforts to evaluate early stage and late stage compounds for development and commercialization and other strategic opportunities. Spending in this category increased by approximately $0.5 million during the three months ended March 31, 2012 compared to the three months ended March 31, 2011 , primarily due to an increase in administrative and headcount expenses.

Our success in further developing Angiomax and obtaining marketing approvals for Angiomax in additional countries and for additional patient populations, developing and obtaining marketing approvals for Cleviprex outside the United States, and developing and obtaining marketing approvals for our products in development, is highly uncertain. We cannot predict expenses associated with ongoing data analysis or regulatory submissions, if any. In addition, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to continue the development of Angiomax, Cleviprex and our products in development, the period in which material net cash inflows are expected to commence from further developing Angiomax and Cleviprex, the timing and estimated costs of obtaining marketing approvals for Angiomax in additional countries and additional patient populations, the timing and estimated costs of obtaining marketing approvals for Cleviprex outside the United States, or the timing and estimated costs of developing and obtaining marketing approvals for our products in development, due to the numerous risks and uncertainties associated with developing and commercializing drugs, including the uncertainty of:


•	the scope, rate of progress and cost of our clinical trials and other research and development activities;


•	future clinical trial results;


•	the terms and timing of any collaborative, licensing and other arrangements that we may establish;


•	the cost and timing of regulatory approvals;


•	the cost and timing of establishing and maintaining sales, marketing and distribution capabilities;


•	the cost of establishing and maintaining clinical and commercial supplies of our products and product candidates;


•	the effect of competing technological and market developments; and


•	the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

Selling, General and Administrative Expenses:



	Three Months Ended March 31,
	2012		2011		Change $		Change %
	(in thousands)
Selling, general and administrative expenses	$	43,186	$	37,928	$	5,258	13.9	%

The increase in selling, general and administrative expenses of $5.3 million in the three months ended March 31, 2012 as compared to the three months ended March 31, 2011 reflects a $2.3 million increase in selling, marketing and promotional expense primarily related to Angiomax, a $1.9 million increase in general corporate and administrative spending largely in connection with our efforts with respect to the patent term extension of the '404 patent and the settlement of our patent litigation with APP, $0.6

million of higher general and administrative spending resulting from severance costs and higher stock-based compensation costs of $0.9 million. These increases were partially offset by a $0.4 million decrease in the fair value of our contingent consideration obligation to the former shareholders of Targanta Therapeutics Corporation, or Targanta.

Legal settlement:



	Three Months Ended March 31,
	2012		2011		Change $			Change %
	(in thousands)
Legal settlement	$	—	$	17,984	$	(17,984	)	100.0	%

During the three months ended March 31, 2011 , we recorded approximately $18.0 million in legal settlement income in connection with the settlement agreement we entered into with WilmerHale in February 2011. Pursuant to the settlement agreement, WilmerHale agreed to pay approximately $18.0 million from its professional liability insurance providers to us within 60 days after the date of the settlement agreement and delivered such amount in two equal payments in March 2011 and April 2011. We did not record any legal settlement income in the three months ended March 31, 2012 .

Other income (expense):



	Three Months Ended March 31,
	2012		2011		Change $			Change %
	(in thousands)
Other income	$	62	$	811	$	(749	)	(92.4	)%

Other income, which is comprised of interest income, gains and losses on foreign currency transactions and impairment of investments, decreased by $0.7 million to $0.1 million for the three months ended March 31, 2012 , from $0.8 million for the three months ended March 31, 2011 . This decrease was primarily due to higher losses on foreign currency transactions in the three months ended March 31, 2012 , and was partially offset by increased interest associated with investment of higher levels of cash.

Provision for Income Tax:



	Three Months Ended March 31,
	2012			2011			Change $		Change %
	(in thousands)
Provision for income tax	$	(4,474	)	$	(9,401	)	$	4,927	(52.4	)%

We recorded a $4.5 million and a $9.4 million provision for income taxes for the three months ended March 31, 2012 and 2011, respectively, based on income before taxes for such periods of $12.0 million and $33.6 million . Our effective income tax rates for the three months ended March 31, 2012 and 2011 were approximately 37.1% and 27.9% , respectively. Our effective income tax rate of 27.9% for the three months ended March 31, 2011 reflects the treatment of the entire WilmerHale settlement as a discrete event in that period where a significant portion of the settlement was not deemed taxable. Both the 2012 and 2011 effective tax rates include a non-cash tax expense arising from purchase accounting for in-process R&D acquired in the Targanta acquisition.

It is possible that our full-year effective tax rate could change because of discrete events, specific transactions or the receipt of new information affecting our current projections.

At March 31, 2012 , we maintained a $4.2 million valuation allowance against $110.4 million of deferred tax assets compared to a $104.3 million valuation allowance against $150.1 million of deferred tax assets at March 31, 2011 . A significant portion of

this reduction in valuation allowance occurred during the third quarter of 2011 after considering all available positive and negative evidence regarding our future ability to realize our deferred tax assets.

We will continue to evaluate our future ability to realize our deferred tax assets on a periodic basis in light of changing facts and circumstances. These include but are not limited to projections of future taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits, the regulatory approval of products currently under development and the ability to achieve future anticipated revenues.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have financed our operations principally through revenues from sales of Angiomax, the sale of common stock, convertible promissory notes and warrants and interest income. We had $295.7 million in cash, cash equivalents and available for sale securities as of March 31, 2012 .

Cash Flows

As of March 31, 2012 , we had $255.5 million in cash and cash equivalents, as compared to $315.4 million as of December 31, 2011 . The decrease in cash and cash equivalents was primarily due to $15.0 million of net cash used in operating activities and $49.8 million in net cash used in investing activities, which were partially offset by $4.3 million in net cash provided by financing activities.

Net cash used in operating activities was $15.0 million in the three months ended March 31, 2012 , compared to net cash provided by operating activities of $19.0 million in the three months ended March 31, 2011 . The cash used in operating activities in the three months ended March 31, 2012 included net income of $7.6 million and non-cash items of $4.6 million consisting primarily of stock-based compensation expense and depreciation and amortization, which were offset by a $27.3 million decrease resulting from changes in working capital items. The changes in working capital items reflect a decrease in accounts payable and accrued expenses of $29.2 million primarily due to payments related to inventory of active pharmaceutical ingredient bivalirudin and payment of certain corporate expenses, a decrease in accounts receivable of $7.1 million , which was due in part to the timing of receipts and related sales volume, and an increase in inventory of $4.8 million due to purchases under our supply agreement with Teva API, Inc., or Teva API, which was formerly known as Plantex USA Inc., of certain minimum quantities of the active pharmaceutical ingredient bivalirudin for our commercial supply.

Net cash provided by operating activities in the three months ended March 31, 2011 included net income of $24.2 million and non-cash items of $6.6 million consisting primarily of stock-based compensation expense of $2.3 million , depreciation and amortization of $1.5 million and an adjustment to the contingent purchase price related to the Targanta acquisition of $1.3 million . Cash provided by operating activities in the three months ended March 31, 2011 also included a decrease of $11.9 million due to changes in working capital items.

During the three months ended March 31, 2012 , $49.8 million in net cash was used in investing activities, which reflected $37.2 million used to purchase available for sale securities and $36.7 million used to acquire intangible assets related to our acute care generic products in connection with our settlement with APP and the reacquisition of our rights to sell Angiomax in Australia and New Zealand from CSL, offset by $22.0 million in proceeds from the maturity and sale of available for sale securities and a $2.0 million decrease in restricted cash resulting from a reduction of our outstanding letter of credit associated with the lease of our principal executive offices.

During the three months ended March 31, 2011 , $6.2 million in net cash was provided by investing activities, which reflected $40.4 million in proceeds from the maturity and sale of available for sale securities, offset by $33.8 million used to purchase available for sale securities, offset by $40.4 million in proceeds from the maturity and sale of available for sale securities and $0.3 million used to purchase fixed assets.

We received $4.3 million in the three months ended March 31, 2012 and $2.2 million in the three months ended March 31, 2011 in net cash provided by financing activities, which consisted of proceeds to us from option exercises, excess tax benefits and purchases of stock under our employee stock purchase plan.

Funding Requirements

We expect to devote substantial resources to our research and development efforts and to our sales, marketing and manufacturing programs associated with our products and products in development. Our funding requirements to support these efforts and programs depend upon many factors, including:


•	the extent to which Angiomax is commercially successful globally;

•

our ability to maintain market exclusivity for Angiomax in the United States through the enforcement of the '727 patent and the '343 patent during the period following the expiration of the patent term of the '404 patent on December 15, 2014 and the six month pediatric exclusivity on June 15, 2015 through at least May 1, 2019, the date on which we agreed APP may sell a generic version of Angiomax;


•	the extent to which Cleviprex, ready-to-use Argatroban and the acute care generic products for which we acquired the non-exclusive right to sell and distribute from APP are commercially successful in the United States;


•	the extent to which our global collaboration with AstraZeneca, including our four-year co-promotion arrangement for BRILINTA in the United States, is successful;


•	the extent to which we can successfully continue to implement our strategy of establishing a commercial infrastructure outside the United States;


•	the consideration paid by us in connection with acquisitions and licenses of development-stage compounds, clinical-stage product candidates, approved products, or businesses, and in connection with other strategic arrangements;


•	the progress, level, timing and cost of our research and development activities related to our clinical trials and non-clinical studies with respect to Angiomax, Cleviprex, as well as cangrelor, oritavancin and MDCO-157 and our other products in development;


•	the cost and outcomes of regulatory submissions and reviews for approval of Angiomax in additional countries and for additional indications, of Cleviprex outside the United States, Australia, New Zealand and Switzerland and of our products in development globally;


•	the continuation or termination of third-party manufacturing, distribution and sales and marketing arrangements;


•	the size, cost and effectiveness of our sales and marketing programs globally;


•	the amounts of our payment obligations to third parties as to our products and products in development; and


•	our ability to defend and enforce our intellectual property rights.

We believe that our cash on hand and the cash we generate from our operations will be sufficient to meet our ongoing funding requirements, absent any material acquisition activity. If our existing cash resources, together with revenues that we generate from sales of our products and other sources, are insufficient to satisfy our funding requirements due to slower than anticipated sales of Angiomax and Cleviprex or higher than anticipated costs globally, we may need to sell equity or debt securities or seek additional financing through other arrangements. Any sale of additional equity or debt securities may result in dilution to our stockholders. Debt financing may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. We cannot be certain that public or private financing will be available in amounts or on terms acceptable to us, if at all. Further, we may seek additional financing to fund our acquisitions of development stage compounds, clinical stage product candidates and approved products and/or the companies that have such products, and we may not be able to obtain such financing on terms acceptable to us or at all.

If we seek to raise funds through collaboration or licensing arrangements with third parties, we may be required to relinquish rights to products, product candidates or technologies that we would not otherwise relinquish or grant licenses on terms that may not be favorable to us. If we are unable to obtain additional financing, we may be required to delay, reduce the scope of, or eliminate one or more of our planned research, development and commercialization activities, which could harm our financial condition and operating results.

Certain Contingencies:

We may be, from time to time, a party to various disputes and claims arising from normal business activities. We accrue for loss contingencies at the earliest date at which we deem that it is probable that a liability has been incurred and the amount of such loss can be reasonably estimated.

Eagle Pharmaceuticals, Inc, Arbitration. We have received a Demand for Arbitration filed by Eagle Pharmaceuticals, Inc., or Eagle, dated October 25, 2011. In the Demand for Arbitration, Eagle claims that we failed to meet our obligations under the license and development agreement between us, Eagle and certain other parties relating to the development of a new formulation of our product, Angiomax, and to our efforts to seek and obtain regulatory approval, market and sell that new formulation. As a result, Eagle alleges that it has been damaged in an amount it believes exceeds $200 million. We believe we have valid defenses to Eagle's claims and intend to defend ourselves vigorously. We believe that any potential liability is not estimable at this time.

Currently, we are party to the legal proceedings described in Part II, Item I, Legal Proceedings, of this quarterly report, We have assessed such legal proceedings and do not believe that it is probable that a liability has been incurred and the amount of such liability can be reasonably estimated. As a result, we have not recorded a loss contingency related to these legal proceedings.

Contractual Obligations

Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. These include commitments related to purchases of inventory of our products, research and development service agreements, income tax contingencies, operating leases, selling, general and administrative obligations, restricted cash in connection with our lease of our principal office space in Parsippany, New Jersey and royalties, milestone payments and other contingent payments due under our license and acquisition agreements as of December 31, 2011 . During the quarter ended March 31, 2012 , there were no material changes outside the ordinary course of business to the specified contractual obligations set forth in the contractual obligations table included in our annual report on Form 10-K for the year ended December 31, 2011 .

Application of Critical Accounting Estimates

The discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. The preparation of these financial statements requires us to make estimates and judgments that affect our reported assets and liabilities, revenues and expenses, and other financial information. Actual results may differ significantly from these estimates under different assumptions and conditions. In addition, our reported financial condition and results of operations could vary due to a change in the application of a particular accounting standard.

We regard an accounting estimate or assumption underlying our financial statements as a “critical accounting estimate” where:


•	the nature of the estimate or assumption is material due to the level of subjectivity and judgment necessary to account for highly uncertain matters or the susceptibility of such matters to change; and


•	the impact of the estimates and assumptions on financial condition or operating performance is material.

Our significant accounting policies are more fully described in note 2 of our unaudited condensed consolidated financial statements in this quarterly report and note 2 of our consolidated financial statements in our annual report on Form 10-K for the year ended December 31, 2011 . Not all of these significant accounting policies, however, require that we make estimates and assumptions that we believe are “critical accounting estimates.” We have discussed our accounting policies with the audit committee of our board of directors, and we believe that our estimates relating to revenue recognition, inventory, income taxes and stock-based compensation described under the caption “Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations - Application of Critical Accounting Estimates” in our annual report on Form 10-K for the year ended December 31, 2011 are “critical accounting estimates.”

Forward-Looking Information

This quarterly report on Form 10-Q includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. For this purpose, any statements contained herein regarding our strategy, future operations, financial position, future revenue, projected costs, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The words “anticipates,” “believes,” “estimates,” “expects,”

“intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations expressed or implied in our forward-looking statements. There are a number of important factors that could cause actual results, levels of activity, performance or events to differ materially from those expressed or implied in the forward-looking statements we make. These important factors include our “critical accounting estimates” described in Part I, Item 2 of this quarterly report on Form 10-Q and the factors set forth under the caption “Risk Factors” in Part II, Item 1A of this quarterly report on Form 10-Q. Although we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and readers should not rely on those forward-looking statements as representing our views as of any date subsequent to the date of this quarterly report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Market risk is the risk of change in fair value of a financial instrument due to changes in interest rates, equity prices, creditworthiness, financing, exchange rates or other factors. Our primary market risk exposure relates to changes in interest rates in our cash, cash equivalents and available for sale securities. We place our investments in high-quality financial instruments, primarily money market funds, corporate debt securities, asset backed securities and U.S. government agency notes with maturities of less than two years, which we believe are subject to limited interest rate and credit risk. We currently do not hedge interest rate exposure. At March 31, 2012 we held $295.7 million in cash, cash equivalents and available for sale securities which had an average interest rate of approximately 0.45%. A 10 basis point change in such average interest rate would have had an approximate $0.1 million impact on our interest income. At March 31, 2012 , $281.6 million of cash, cash equivalents and available for sale securities were due on demand or within one year and had an average interest rate of approximately 0.43%. The remaining $14.1 million were due within two years and had an average interest rate of approximately 0.56%.

Most of our transactions are conducted in U.S. dollars. We do have certain agreements with parties located outside the United States. Transactions under certain of these agreements are conducted in U.S. dollars, subject to adjustment based on significant fluctuations in currency exchange rates. Transactions under certain other of these agreements are conducted in the local foreign currency. As of March 31, 2012 , we had receivables denominated in currencies other than the U.S. dollar. A 10% change in foreign exchange rates would have had an approximate $1.2 million impact on our other income and cash.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2012 . The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2012 , our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

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, 2012 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Part II. Other Information

Item 1. Legal Proceedings

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

'727 Patent and '343 Patent Litigations

APP Pharmaceuticals, LLC

In September 2009, we were notified that APP Pharmaceuticals, LLC had submitted an ANDA seeking permission to market its generic version of Angiomax prior to the expiration of the '727 patent. On October 8, 2009, we filed suit against APP Pharmaceuticals, LLC and APP Pharmaceuticals, Inc., which we refer to collectively as APP, in the U.S. District Court for the District of Delaware for infringement of the '727 patent. In addition, on October 6, 2009, we were issued the '343 patent, which relates to a more consistent and improved Angiomax drug product made by processes described in the patent. In April 2010, we were notified by APP that it was seeking permission to market its generic version of Angiomax prior to the expiration of the '343 patent. On June 1, 2010, we filed suit against APP in the U.S. District Court for the District of Delaware for infringement of the '343 patent.

On January 22, 2012, we entered into a settlement agreement and a license agreement with APP with respect to the patent infringement suits and APP's appeal of the August 2010 federal district court decision holding that our application for Hatch Waxman patent term extension of the '404 patent was timely filed, as described below. Under the settlement agreement, APP admitted that the '727 patent and '343 patent are valid and enforceable and that they would be infringed by any generic bivalirudin for injection product that is the subject of APP's ANDAs. In connection with the settlement, we entered into a license agreement with APP under which we granted APP a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product in the United States beginning on May 1, 2019. In certain limited circumstances, this license to APP could become effective prior to May 1, 2019 and could include an authorized generic bivalirudin product supplied by us. Contemporaneously with entering into the settlement agreement and license agreement, we entered into a contract manufacturing agreement, a license and supply agreement and an authorized generic supply agreement with APP, which we refer to collectively as the settlement documents. On January 24, 2012, the U.S. District Court for the District of Delaware entered a consent judgment and order of permanent injunction concluding our patent infringement suits against APP. On February 1, 2012, we and APP submitted the settlement documents to the U.S. Federal Trade Commission, or FTC, and the U.S. Department of Justice, or the DOJ.

Hospira, Inc.

In July 2010, we were notified that Hospira, Inc., or Hospira, had submitted two ANDAs seeking permission to market its generic version of Angiomax prior to the expiration of the '727 patent and '343 patent. On August 19, 2010, we filed suit against Hospira in the U.S. District Court for the District of Delaware for infringement of the '727 patent and '343 patent. On August 25, 2010, the case was reassigned in lieu of a vacant judgeship to the U.S. District Court for the Eastern District of Pennsylvania. Hospira's answer denied infringement of the '727 patent and '343 patent and raised counterclaims of non-infringement and invalidity of the '727 patent and '343 patent. On September 24, 2010, we filed a reply denying the counterclaims raised by Hospira. The Hospira action was consolidated for discovery purposes with the then pending and now settled cases against Teva and APP . No trial date has been set in the Hospira case.

Mylan Pharmaceuticals, Inc.

In January 2011, we were notified that Mylan Pharmaceuticals, Inc. had submitted an ANDA seeking permission to market its generic version of Angiomax prior to the expiration of the '727 patent and '343 patent. On February 23, 2011, we filed suit against Mylan Inc., Mylan Pharmaceuticals Inc. and Bioniche Pharma USA, LLC, which we refer to collectively as Mylan, in the U.S. District Court for the Northern District of Illinois for infringement of the '727 patent and '343 patent. Mylan's answer denied infringement of the '727 patent and '343 patent and raised counterclaims of non-infringement and invalidity of the '727 patent and '343 patent. On April 13, 2011, we filed a reply denying the counterclaims raised by Mylan. On May 4, 2011 the Court set a pretrial schedule. Following a joint request, the Court issued an amended scheduling order on September 22, 2011. On November 29, 2011, Mylan moved to amend its answer to add counterclaims and affirmative defenses of inequitable conduct and unclean hands.

Following motion practice, the Court granted Mylan's request to add counterclaims and affirmative defenses of inequitable conduct and to add affirmative defenses of unclean hands. On March 7, 2012, we filed a reply denying these counterclaims. No trial date has been set.

Dr. Reddy's Laboratories, Inc.

In March 2011, we were notified that Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. had submitted an ANDA seeking permission to market its generic version of Angiomax prior to the expiration of the '727 and '343 patents. On April 28, 2011, we filed suit against Dr. Reddy's Laboratories, Ltd., Dr. Reddy's Laboratories, Inc. and Gland Pharma, Inc., which we refer to collectively as Dr. Reddy's, in the U.S. District Court for the District of New Jersey for infringement of the '727 patent and '343 patent. Dr. Reddy's answer denied infringement of the '727 patent and '343 patent and raised counterclaims of non-infringement and invalidity of the '727 patent and '343 patent. An initial case scheduling conference was conducted before the Magistrate Judge on August 25, 2011. Following the conference, a pretrial scheduling order was issued setting dates following the New Jersey Local Patent Rules. No trial date has been set.

Sun Pharmaceutical Industries LTD

In October 2011, we were notified that Sun Pharmaceutical Industries LTD had submitted an ANDA seeking permission to market its generic version of Angiomax prior to the expiration of the '727 and '343 patents. On November 21, 2011, we filed suit against Sun Pharma Global FZE, Sun Pharmaceutical Industries LTD., Sun Pharmaceutical Industries Inc., and Caraco Pharmaceutical Laboratories, LTD., which we refer to collectively as Sun, in the U.S. District Court for the District of New Jersey for infringement of the '727 patent and '343 patent. The case has been assigned to the same judge and magistrate judge as the above referenced Dr. Reddy's action. Sun's answer denied infringement of the '727 patent and '343 patent. The Court has set an initial case scheduling conference for June 7, 2012.

'404 Patent Litigation

On January 27, 2010, we filed a complaint in the U.S. District Court for the Eastern District of Virginia against the PTO, the FDA, and HHS et al. seeking to set aside the denial of our application pursuant to the Hatch-Waxman Act to extend the term of the '404 patent. On August 3, 2010, the court granted our motion for summary judgment and ordered the PTO to consider our patent term extension application timely filed. The period for the government to appeal the court's August 3, 2010 decision expired on October 4, 2010 without government appeal.

On August 19, 2010, APP filed a motion to intervene in the U.S. District Court for the Eastern District of Virginia for purpose of appeal in our case against the PTO, FDA and HHS, et al. On September 13, 2010, the court issued an order denying APP's motion to intervene. On September 1, 2010, as amended on September 17, 2010, APP filed a notice of appeal to the United States Court of Appeals for the Federal Circuit of the district court's August 3, 2010 and September 13, 2010 orders (and all related and underlying orders). On October 5, 2010, we filed a motion to dismiss APP's appeal. On February 2, 2011, the federal circuit court issued an order denying our motion to dismiss and requesting additional briefings by both parties in connection with APP's appeal. The court expressed no opinion on the merits of APP's appeal. The parties fully briefed the issues in connection with APP's appeal.

On January 22, 2012, we entered into a settlement agreement and a license agreement with APP with respect to APP's appeal and the patent infringement suits, as described in the APP ' 727 Patent and '343 Patent cases above. On January 24, 2012 the parties filed a joint dismissal of APP's appeal and the Federal Circuit entered an order dismissing the appeal.

On March 5, 2012, we received a certificate of extension issued by the PTO that extended the term of the '404 patent to December 15, 2014. In addition, we are entitled to a six-month period of pediatric exclusivity following expiration of the '404 patent, which extends exclusivity to June 15, 2015.

Eagle Pharmaceuticals, Inc, Arbitration

We have received a Demand for Arbitration filed by Eagle Pharmaceuticals, Inc., or Eagle, dated October 25, 2011. In the Demand for Arbitration, Eagle claims that we failed to meet our obligations under the license and development agreement between us, Eagle and certain other parties relating to the development of a new formulation of our product, Angiomax, and to our efforts to seek and obtain regulatory approval, market and sell that new formulation. As a result, Eagle alleges that it has been damaged in an amount it believes exceeds $200 million. We believe we have valid defenses to Eagle's claims and intend to defend ourselves vigorously.

Item 1A. Risk Factors

Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below in addition to the other information included or incorporated by reference in this quarterly report. If any of the following risks actually occur, our business, financial condition or results of operations would likely suffer. In that case, the trading price of our common stock could fall. Updated risk factors associated with our business, which include updates regarding the Angiomax patent litigation and Angiomax intellectual property, are set forth below.

Risks Related to Our Financial Results

We have a history of net losses and may not achieve profitability in future periods or maintain profitability on an annual basis

We have incurred net losses in many years and on a cumulative basis since our inception. As of December 31, 2011 , we had an accumulated deficit of approximately $111.7 million . We expect to make substantial expenditures to further develop and commercialize our products, including costs and expenses associated with research and development, clinical trials, nonclinical and preclinical studies, regulatory approvals and commercialization. We anticipate needing to generate greater revenue in future periods from our existing products and from our products in development in order to achieve and maintain profitability in light of our planned expenditures. If we are unable to generate greater revenue, we may not achieve profitability in future periods or at all, and may not be able to maintain any profitability we do achieve. Our ability to generate future revenue will be substantially dependent on our ability to maintain market exclusivity for Angiomax. If we fail to achieve profitability or maintain profitability on a quarterly or annual basis within the time frame expected by investors or securities analysts, the market price of our common stock may decline.

Our business is very dependent on the commercial success of Angiomax. If Angiomax does not generate the revenues we anticipate, our business may be materially harmed

Angiomax has accounted for substantially all of our revenue since we began selling this product in 2001. Until the approval by the FDA of Cleviprex in August 2008 and the ready-to-use formulation of Argatroban in July 2011, Angiomax was our only commercial product. We expect revenue from Angiomax to account for substantially all of our revenue in 2012. The commercial success of Angiomax depends upon:

•


•	the continued acceptance by regulators, physicians, patients and other key decision-makers of Angiomax as a safe, therapeutic and cost-effective alternative to heparin and other products used in current practice or currently being developed;


•	our ability to further develop Angiomax and obtain marketing approval of Angiomax for use in additional patient populations and the clinical data we generate to support expansion of the product label;


•	the overall number of PCI procedures performed;


•	the ability of our third-party supply and manufacturing partners to provide us with sufficient quantities of Angiomax;


•	the impact of competition from existing competitive products and from competitive products that may be approved in the future;


•	the continued safety and efficacy of Angiomax;


•	to what extent and in what amount government and third-party payors cover or reimburse for the costs of Angiomax; and


•	our success and the success of our international distributors in selling and marketing Angiomax in Europe and in other countries outside the United States.

We continue to develop Angiomax for use in additional patient populations, including in patients with structural heart disease, patients undergoing peripheral angioplasty, carotid angioplasty and cardiovascular surgery and patients with or at risk of HIT/HITTS. However, even if we are successful in obtaining approval for the use of Angiomax in additional patient populations, our ability to sell Angiomax for use in these additional patient populations may not result in higher revenue or income on a continuing basis.

As of March 31, 2012 , our inventory of Angiomax was $49.2 million and we had inventory-related purchase commitments totaling $43.8 million for 2012, $36.4 million for 2013, $7.5 million for 2014 and $7.5 million for 2015 for Angiomax bulk drug substance. If sales of Angiomax were to decline, we could be required to make an allowance for excess or obsolete inventory or increase our accrual for product returns, which could negatively impact our results of operations and our financial condition.

If we are unable to meet our funding requirements, we may need to raise additional capital. If we are unable to obtain such capital on favorable terms or at all, we may not be able to execute on our business plans and our business, financial condition and results of operations may be adversely affected

We expect to devote substantial financial resources to our research and development efforts, clinical trials, nonclinical and preclinical studies and regulatory approvals and to our commercialization and manufacturing programs associated with our approved products and our products in development. Our funding requirements to support these efforts and programs depend upon many factors, including:


•	the extent to which Angiomax is commercially successful globally;

•


•	the extent to which Cleviprex, ready-to-use Argatroban and the acute care generic products that we acquired the non-exclusive right to sell and distribute from APP are commercially successful in the United States;


•	the extent to which our global collaboration with AstraZeneca, including our four-year co-promotion arrangement for BRILINTA in the United States, is successful;


•	the extent to which we can successfully continue to implement our strategy of establishing a commercial infrastructure outside the United States;


•	the consideration paid by us in connection with acquisitions and licenses of development-stage compounds, clinical-stage product candidates, approved products, or businesses, and in connection with other strategic arrangements;


•	the progress, level, timing and cost of our research and development activities related to our clinical trials and non-clinical studies with respect to Angiomax, Cleviprex, as well as cangrelor, oritavancin and MDCO-157 and our other products in development;


•	the cost and outcomes of regulatory submissions and reviews for approval of Angiomax in additional countries and for additional indications, of Cleviprex outside the United States, Australia, New Zealand and Switzerland and of our products in development globally;


•	the continuation or termination of third-party manufacturing, distribution and sales and marketing arrangements;


•	the size, cost and effectiveness of our sales and marketing programs globally;


•	the amounts of our payment obligations to third parties as to our products and products in development; and


•	our ability to defend and enforce our intellectual property rights.

If our existing resources, together with revenues that we generate from sales of our products and other sources, are insufficient to satisfy our funding requirements, we may need to sell equity or debt securities or seek additional financing through other

arrangements. Public or private financing may not be available in amounts or on terms acceptable to us, if at all. If we seek to raise funds through collaboration or licensing arrangements with third parties, we may be required to relinquish rights to products, products in development or technologies that we would not otherwise relinquish or grant licenses on terms that may not be favorable to us. If we are unable to obtain additional financing, we may be required to delay, reduce the scope of, or eliminate one or more of our planned research, development and commercialization activities, which could adversely affect our business, financial condition and operating results.

If we seek to raise capital to fund acquisitions of development-stage compounds, clinical-stage product candidates, approved products, or businesses or for other reasons by selling equity or debt securities or through other arrangements, our stockholders could be subject to dilution and we may become subject to financial restrictions and covenants, which may limit our activities

If we seek to acquire any development-stage compounds, clinical-stage product candidates, approved products, or businesses or determine that raising additional capital would be in our interest and in the interest of our stockholders, we may seek to sell equity or debt securities or seek additional financings through other arrangements. Any sale of additional equity or debt securities may result in dilution to our stockholders. Debt financing may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. Our ability to comply with these financial restrictions and covenants could be dependent on our future performance, which is subject to prevailing economic conditions and other factors, including factors that are beyond our control such as foreign exchange rates, interest rates and changes in the level of competition. Failure to comply with the financial restrictions and covenants would adversely affect our business, financial condition and operating results.

Our revenue in the United States is completely dependent on our sole source distributor, ICS, and our revenue outside the United States is substantially dependent on a limited number of international distributors. If the buying patterns of ICS or these international distributors for our products are not consistent with underlying hospital demand, then our revenue will be subject to fluctuation from quarter to quarter based on these buying patterns and not underlying demand for the products. Any change in these buying patterns could adversely affect our financial results and our stock price.

We distribute Angiomax, Cleviprex and ready-to-use Argatroban in the United States through a sole source distribution model with ICS. Under this model, we currently sell Angiomax, Cleviprex and ready-to-use Argatroban to our sole source distributor, ICS. ICS then sells Angiomax, Cleviprex and ready-to-use Argatroban to a limited number of national medical and pharmaceutical wholesalers with distribution centers located throughout the United States and, in certain cases, directly to hospitals. We expect that we will also sell the acute care generic products for which we acquired non-exclusive rights to sell and distribute from APP through the same sole source distribution model. Our revenue from sales of Angiomax in the United States is exclusively from sales to ICS pursuant to our agreement with them. We anticipate that our revenue from sales of Cleviprex and ready-to-use Argatroban and the acute care generic products for which we acquired non-exclusive rights to sell and distribute from APP in the United States will be exclusively from sales to ICS. In connection with a reduction in marketing, sales and distribution fees payable to ICS, we extended the ICS payment terms under our distribution agreement with them from 30 days to 45 days, which can be further extended to 49 days if ICS pays by wire transfer. The amendment has caused, and we expect to continue to cause, an increase in accounts receivable. As a result of our relationship with ICS, we expect that our revenue will continue to be subject to fluctuation from quarter to quarter based on the buying patterns of ICS, which may be independent of underlying hospital demand.

In some countries outside the European Union and in a few countries in the European Union, we sell Angiomax to international distributors and these distributors then sell Angiomax to hospitals. Our reliance on a small number of distributors for international sales of Angiomax could cause our revenue to fluctuate from quarter to quarter based on the buying patterns of these distributors, independent of underlying hospital demand.

If inventory levels at ICS or at our international distributors become too high, these distributors may seek to reduce their inventory levels by reducing purchases from us, which could have a materially adverse effect on our revenue in periods in which such purchase reductions occur.

Risks Related to Commercialization

Angiomax faces significant competition from all categories of anticoagulant drugs, which may limit the use of Angiomax and adversely affect our revenue

Due to the incidence and severity of cardiovascular diseases, the market for anticoagulant therapies is large and competition is intense. There are a number of anticoagulant drugs currently on the market, awaiting regulatory approval or in development, including orally administered agents. Angiomax competes with, or may compete with in the future, these anticoagulant drugs to

the extent Angiomax and any of these anticoagulant drugs are approved for the same or similar indications.

We have positioned Angiomax to compete primarily with heparin, platelet inhibitors such as GP IIb/IIIa inhibitors, and treatment regimens combining heparin and GP IIb/IIIa inhibitors. Because heparin is generic and inexpensive and has been widely used for many years, physicians and medical decision-makers may be hesitant to adopt Angiomax instead of heparin. GP IIb/IIIa inhibitors that Angiomax competes with include ReoPro from Eli Lilly and Johnson & Johnson/Centocor, Inc., Integrilin from Merck & Co., Inc., and Aggrastat from Iroko Pharmaceuticals, LLC and MediCure Inc. GP IIb/IIIa inhibitors are widely used and some physicians believe they offer superior efficacy to Angiomax in high risk patients. Physicians may choose to use heparin combined with GP IIb/IIIa inhibitors due to their years of experience with this combination therapy and reluctance to change existing hospital protocols and pathways. Physician resistance to the use of Angiomax due to either custom or efficacy could adversely affect our revenue.

In some circumstances, Angiomax competes with other anticoagulant drugs for the use of hospital financial resources. For example, many U.S. hospitals receive a fixed reimbursement amount per procedure for the angioplasties and other treatment therapies they perform. As this amount is not based on the actual expenses the hospital incurs, hospitals may choose to use either Angiomax or other anticoagulant drugs or a GP IIb/IIIa inhibitor but not necessarily more than one of these drugs. If hospitals do not choose Angiomax in these instances, our revenue will be adversely affected.

If we are unable to maintain our market exclusivity for Angiomax in the United States as a result of our inability to enforce our U.S. patents covering Angiomax, Angiomax could become subject to generic competition in the United States earlier than we anticipate. We have agreed that APP may sell a generic version of Angiomax beginning May 1, 2019 or earlier under certain conditions, and that Teva may sell a generic version of Angiomax beginning June 30, 2019, or earlier under certain conditions. Competition from generic equivalents that would be sold at a price that is less than the price at which we currently sell Angiomax could have a material adverse impact on our business, financial condition and operating results.

Cleviprex faces significant competition from all categories of intravenous antihypertensive, or IV-AHT, drugs, which may limit the use of Cleviprex and adversely affect our revenue

Because different IV-AHT drugs act in different ways on the factors contributing to elevated blood pressure, physicians have several therapeutic options to reduce acutely elevated blood pressure.

We have positioned Cleviprex as an improved alternative drug for selected patient types with acute, severe hypertension. Because all other drug options for this use are available as generics, Cleviprex must demonstrate compelling advantages in delivering value to the hospital. In addition to advancements in efficacy, convenience, tolerability and/or safety, we may need to demonstrate that Cleviprex will save the hospital resources in other areas such as length of stay and other resource utilization in order to become commercially successful. Because generic therapies are inexpensive and have been widely used for many years, physicians and decision-makers for hospital resource allocation may be hesitant to adopt Cleviprex and fail to recognize the value delivered through a newer agent that offers precise blood pressure control. Physician resistance to the use of Cleviprex due to either custom or efficacy would adversely affect our revenue.

We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do

Our industry is highly competitive. Competitors in the United States and other countries include major pharmaceutical companies, specialized pharmaceutical companies and biotechnology firms, universities and other research institutions. Many of our competitors have substantially greater research and development capabilities and experience, and greater manufacturing, marketing and financial resources, than we do.

Our competitors may develop, market or license products or other novel technologies that are more effective, safer, more convenient or less costly than any that have been or are being developed or sold by us, or may obtain marketing approval for their products from the FDA or equivalent foreign regulatory bodies more rapidly than we may obtain approval for ours. There are well established products, including generic products, that are approved and marketed for the indications for which Angiomax, Cleviprex, ready-to-use Argatroban and the acute care generic products that we acquired the non-exclusive right to sell and distribute from APP are approved and the indications for which we are developing our products in development. In addition, competitors are developing products for such indications. In the case of the ready-to-use Argatroban, GlaxoSmithKline markets a branded formulation of Argatroban and Sandoz markets a generic formulation of Argatroban that compete with our ready-to-use formulation of Argatroban. In the case of the acute care generic products, such products will compete with their respective brand name reference products and other equivalent generic products that may be sold by APP and other third parties. We compete, in the case of Angiomax, Cleviprex and ready-to-use Argatroban, and expect to compete, in the cases of our products in development, on the basis of product efficacy, safety, ease of administration, price and economic value compared to drugs used in current practice or

currently being developed. If we are not successful in demonstrating these attributes, physicians and other key healthcare decision makers may choose other products over our products, switch from our products to new products or choose to use our products only in limited circumstances, which could adversely affect our business, financial condition and results of operations.

If we are unable to successfully identify and acquire or license development stage compounds, clinical stage product candidates or approved products and develop or commercialize those compounds and products, our business, financial condition and results of operations may be adversely affected

Our business strategy is based on us selectively licensing or acquiring and then successfully developing and commercializing development stage compounds, clinical stage product candidates and approved products. Our success will be based in part on our ability to build and actively manage a portfolio of drugs that addresses unmet medical needs and creates value in patient therapy. However, the acquisition and licensing of pharmaceutical products is a competitive area. A number of more established companies, which have acknowledged strategies to license and acquire products, may have competitive advantages over us due to their size, cash flows and institutional experience. In addition, we may compete with emerging companies taking similar or different approaches to product acquisition.

Because of the intense competition for these types of product candidates and approved products, the cost of acquiring, in-licensing or otherwise obtaining rights to such candidates and products has grown dramatically in recent years and are often at levels that we cannot afford or that we believe are not justified by market potential. Any acquisition or license of product candidates or approved products that we pursue may not result in any short or long term benefit to us. We may incorrectly judge the value or worth of an acquired or licensed product candidate or approved product. Even if we succeed in acquiring product candidates, we may not be successful in developing them and obtaining marketing approval for them, manufacturing them economically or commercializing them successfully. We have previously acquired or licensed rights to clinical or development stage compounds and, after having conducted development activities, determined not to devote further resources to those compounds. In addition, our future success would depend in part on our ability to manage any required growth associated with some of these acquisitions and licenses. Any acquisition might distract resources from the development of our existing product candidates and could otherwise negatively impact sales of our other marketed products. Furthermore, the development or expansion of any licensed or acquired product candidate or approved product may require a substantial capital investment by us, and we may not have these necessary funds to do so.

If we are unable to identify and acquire additional promising candidates or to develop and commercialize successfully those candidates we have, we will not be able to implement our business strategy and our business, operating results and financial condition may be materially and adversely affected.

If we are not able to convince hospitals to include our products on their approved formulary lists, our revenues may not meet expectations and our business, results of operations and financial condition may be adversely affected

Hospitals establish formularies, which are lists of drugs approved for use in the hospital. If a drug is not included on the formulary, the ability of our engagement partners and engagement managers to promote the drug may be limited or denied. In connection with the launch of Cleviprex, we experienced difficulties in getting Cleviprex included on hospitals' formulary lists, in part because hospital formularies may limit the number of IV-AHT drugs in each drug class, and revenues from Cleviprex were adversely affected. If we fail to secure and maintain formulary inclusion for our products on favorable terms or are significantly delayed in doing so, we may have difficulty achieving market acceptance of our products and our business, results of operations and financial condition could be materially adversely affected.

If we are unable to negotiate and maintain satisfactory arrangements with group purchasing organizations with respect to the purchase of our products, our sales, results of operations and financial condition could be adversely affected

Our ability to sell our products to hospitals in the United States depends in part on our relationships with group purchasing organizations, or GPOs. Many existing and potential customers for our products become members of GPOs. GPOs negotiate pricing arrangements and contracts, sometimes on an exclusive basis, with medical supply manufacturers and distributors. These negotiated prices are then made available to a GPO's affiliated hospitals and other members. If we are not one of the providers selected by a GPO, affiliated hospitals and other members may be less likely to purchase our products, and if the GPO has negotiated a strict sole source, market share compliance or bundling contract for another manufacturer's products, we may be precluded from making sales to members of the GPO for the duration of the contractual arrangement. Our failure to renew contracts with GPOs may cause us to lose market share and could have a material adverse effect on our sales, financial condition and results of operations. We cannot assure you that we will be able to renew these contracts at the current or substantially similar terms. If we are unable to keep our relationships and develop new relationships with GPOs, our competitive position may suffer.

If physicians, patients and other key healthcare decision-makers do not accept clinical data from trials of Angiomax and Cleviprex, then sales of Angiomax and Cleviprex may be adversely affected

We believe that the near-term commercial success of Angiomax and Cleviprex will depend in part upon the extent to which physicians, patients and other key healthcare decision-makers accept the results of clinical trials of Angiomax and Cleviprex. For example, following the announcement of the original results of the REPLACE-2 clinical trial of Angiomax in 2002, additional hospitals granted Angiomax formulary approval and hospital demand for the product increased. However, some commentators have challenged various aspects of the trial design of the REPLACE-2 trial of Angiomax, the conduct of the clinical trial and the analysis and interpretation of the results from the clinical trial. Similarly, physicians, patients and other key decision-makers may not accept the results of the ACUITY and HORIZONS AMI clinical trials of Angiomax. The FDA, in denying our sNDA for an additional Angiomax dosing regimen in the treatment of ACS initiated in the emergency department, indicated that the basis of its decision involved the appropriate use and interpretation of non-inferiority trials such as our ACUITY trial. If physicians, patients and other key decision-makers do not accept clinical trial results, adoption and continued use of Angiomax and Cleviprex may suffer, and our business will be materially adversely affected.

If the number of PCI procedures performed decreases, sales of Angiomax may be negatively impacted

The number of PCI procedures performed in the United States declined in 2007 due in part to the reaction to data from a clinical trial that was published in March 2007 in the New England Journal of Medicine entitled “Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation,” or “COURAGE”, and to the controversy regarding the use of drug-eluting stents. Since 2007, PCI procedure volume has remained similar to the 2007 levels and has not returned to the level of PCI procedures performed prior to the 2007 decline. With ongoing economic pressures on our hospital customers, PCI procedure volume might further decline and might not return to its previous levels. Because PCI procedures are the primary procedures during which Angiomax is used, a decline in the number of procedures may negatively impact sales of Angiomax, possibly materially.

Because we did not sell Cleviprex from the first quarter of 2010 through the first quarter of 2011, as a result of product recalls and related supply issues, market acceptance of Cleviprex may be adversely affected

In December 2009 and March 2010, we conducted voluntary recalls of manufactured lots of Cleviprex due to the presence of visible particulate matter at the bottom of some vials. As a result, we were not able to supply the market with Cleviprex or sell Cleviprex from the first quarter of 2010 through the first quarter 2011. We began to resupply existing customers with Cleviprex in April 2011. In July 2011, the FDA approved our sNDA, for an improved formulation of Cleviprex. We re-launched Cleviprex in October 2011 with the new formulation, targeting neurocritical care and cardiac surgery patients. However, physicians and decision makers who have used Cleviprex prior to the recalls may be reluctant to resume using Cleviprex and physicians and decision makers who had not used Cleviprex may be reluctant to begin using Cleviprex because of the recalls and the related supply issues. Physicians and healthcare decision makers who had adopted Cleviprex as their preferred antihypertensive therapy when it was available may also have adopted other antihypertensive therapies during the period when Cleviprex was not available and may be reluctant to change. In addition, in the re-launch of Cleviprex, we are focusing our marketing of Cleviprex on neurocritical care and cardiac surgery patients. We have not focused our marketing of Cleviprex in these areas previously and may not be successful in this change in marketing focus.

If we are unable to successfully expand our business infrastructure and develop our global operations, our ability to generate future product revenue will be adversely affected and our business, results of operations and financial condition may be adversely affected

To support the global sales and marketing of Angiomax, Cleviprex and our product candidates in development, if and when they are approved for sale and marketed outside the United States, we are developing our business infrastructure globally. Our ability to do this successfully will depend on our ability to expand our internal organization and infrastructure to accommodate additional anticipated growth. To manage the existing and planned future growth and the increasing breadth and complexity of our activities, we will need to continue building our organization and making significant additional investments in personnel, infrastructure, information management systems and other operational resources. If we are unable to expand our global operations successfully and in a timely manner, the growth of our business may be limited. Such expansion may be more difficult, more expensive or take longer than we anticipate. If we are not able to successfully market and sell our products globally, our business, results of operations and financial condition may be adversely affected.

Future rapid expansion could strain our operational, human and financial resources. For instance, we may be required to allocate additional resources to the expanded business, which we would have otherwise allocated to another part of our business. In order to manage expansion, we must:


•	continue to improve operating, administrative, and information systems;


•	accurately predict future personnel and resource needs to meet contract commitments;


•	track the progress of ongoing projects; and


•	attract and retain qualified management, sales, professional, scientific and technical operating personnel.

If we do not take these actions and are not able to manage our global business, then our global operations may be less successful than anticipated.

The success of our global operations may be adversely affected by international risks and uncertainties. If these operations are not successful, our business, results of operations and financial condition could be adversely affected

Our future profitability will depend in part on our ability to grow and ultimately maintain our product sales in foreign markets, particularly in Europe. For the year ended March 31, 2012 we had $10.6 million in sales outside of the United States and we have historically encountered difficulty in selling Angiomax outside of the United States. Our foreign operations subject us to additional risks and uncertainties, particularly because we have limited experience in marketing, servicing and distributing our products or otherwise operating our business outside of the United States. These risks and uncertainties include:


•	political and economic determinations that adversely impact pricing or reimbursement policies;


•	our customers' ability to obtain reimbursement for procedures using our products in foreign markets;


•	compliance with complex and changing foreign legal, tax, accounting and regulatory requirements;


•	language barriers and other difficulties in providing long-range customer support and service;


•	longer accounts receivable collection times;


•	significant foreign currency fluctuations, which could result in increased operating expenses and reduced revenues;


•	trade restrictions and restrictions on direct investment by foreign entities;


•	reduced protection of intellectual property rights in some foreign countries; and


•	the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.

Our foreign operations could also be adversely affected by export license requirements, the imposition of governmental controls, political and economic instability, trade restrictions, changes in tariffs and difficulties in staffing and managing foreign operations.

If reimbursement by government payors or other third-party payors is not available or limited for our products, drug pricing is delayed or set at unfavorable levels or access to our products is reduced or terminated by governmental and other third-party payors, our ability to generate revenue would be adversely affected

Acceptable levels of coverage and reimbursement of drug treatments by government payors, such as Medicare and Medicaid programs, private health insurers and other organizations, have a significant effect on our ability to successfully commercialize our products. Reimbursement in the United States, Europe or elsewhere may not be available for any products we may develop or, if already available, may be decreased in the future. We may not get reimbursement or reimbursement may be limited if government payors, private health insurers and other organizations are influenced by the prices of existing drugs in determining whether our products will be reimbursed and at what levels. For example, the availability of numerous generic antibiotics at lower prices than branded antibiotics, such as oritavancin, if it were approved for commercial sale, could substantially affect the likelihood of reimbursement and the level of reimbursement for oritavancin. If reimbursement is not available or is available only at limited levels, we may not be able to commercialize our products, or may not be able to obtain a satisfactory financial return on our products.

In certain countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals and the level of reimbursement are subject to governmental control. In some countries, pricing and reimbursement are set with limited, if any, participation in the process by the marketing authorization holder. In addition, it can take an extended period of time after the

receipt of initial approval of a product to establish and obtain reimbursement or pricing approval. Reimbursement approval also may be required at the individual patient level, which can lead to further delays. In addition, in some countries, it may take an extended period of time to collect payment even after reimbursement has been established. If prices are set at unsatisfactory levels, such prices may negatively impact our revenues from sales in those countries. An increasing number of countries are taking initiatives to attempt to reduce large budget deficits by focusing cost-cutting efforts on pharmaceuticals for their state-run health care systems. These international price control efforts have impacted all regions of the world, but have been most drastic in the European Union. Further, a number of European Union countries use drug prices from other countries of the European Union as “reference prices” to help determine pricing in their own countries. Consequently, a downward trend in drug prices for some countries could contribute to similar occurrences elsewhere. If reimbursement of our future products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.

Third-party payors, including Medicare and Medicaid increasingly are challenging prices charged for and the cost-effectiveness of medical products and services and they increasingly are limiting both coverage and the level of reimbursement for drugs. Also, the trend toward managed health care in the United States and the changes in health insurance programs may result in lower prices for pharmaceutical products and health care reform. The recently enacted Patient Protection and Affordable Care Act of 2010, or the PPACA, may also have a significant impact on pricing as the legislation contains a number of provisions that are intended to reduce or limit the growth of healthcare costs. The provisions of the PPACA could, among other things, increase pressure on drug pricing and, as a result, the number of procedures that are performed. In addition to federal legislation, state legislatures and foreign governments have also shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. The establishment of limitations on patient access to our drugs, adoption of price controls and cost-containment measures in new jurisdictions or programs, and adoption of more restrictive policies in jurisdictions with existing controls and measures could adversely impact our business and future results. If governmental organizations and third-party payors do not consider our products to be cost-effective compared to other available therapies, they may not reimburse providers or consumers of our products or, if they do, the level of reimbursement may not be sufficient to allow us to sell our products on a profitable basis.

Use or misuse of our products may result in serious injuries or even death to patients and may subjects us to significant claims for product liability. If we are unable to obtain insurance at acceptable costs and adequate levels or otherwise protect ourselves against potential product liability claims, we could be exposed to significant liability

Our business exposes us to potential significant product liability risks which are inherent in the testing, manufacturing, marketing and sale of human healthcare products. Product liability claims might be made by patients in clinical trials, consumers, health care providers or pharmaceutical companies or others that sell our products. These claims may be made even with respect to those products that are manufactured in licensed and regulated facilities or otherwise possess regulatory approval for commercial sale.

These claims could expose us to significant liabilities that could prevent or interfere with the development or commercialization of our products. Product liability claims could require us to spend significant time and money in litigation or pay significant damages. With respect to our commercial sales and our clinical trials, we are covered by product liability insurance in the amount of $20.0 million per occurrence and $20.0 million annually in the aggregate on a claims-made basis. This coverage may not be adequate to cover all or any product liability claims that we face

As we continue to commercialize our products, we may wish to increase our product liability insurance. Product liability coverage is expensive. In the future, we may not be able to maintain or obtain such product liability insurance on reasonable terms, at a reasonable cost or in sufficient amounts to protect us against losses due to product liability claims.

An adverse decision in the arbitration between us and Eagle could have a material adverse effect on our financial condition

We have received a Demand for Arbitration filed by Eagle, dated October 25, 2011. In the Demand for Arbitration, Eagle claims that we failed to meet our obligations under the license and development agreement between us, Eagle and certain other parties relating to the development of a new formulation of our product, Angiomax, and to our efforts to seek and obtain regulatory approval, market and sell that new formulation. As a result, Eagle alleges that it has been damaged in an amount Eagle believes exceeds $200 million. We believe we have valid defenses to Eagle's claims and intend to defend ourselves vigorously. Arbitration, like litigation, is inherently uncertain. An adverse decision in this arbitration could have a material adverse effect on our financial condition.

Risks Related to our Dependence on Third Parties for Manufacturing, Research and Development, and Distribution Activities

We have no manufacturing or supply capabilities and are completely dependent on third parties for the manufacture and supply of our products. We depend on a limited number of suppliers for the production of bulk drug substance for our products and products in development and to carry out fill-finish activities. If any of these suppliers does not or cannot fulfill its manufacturing or supply obligations to us, our ability to meet commercial demands for our products and to conduct clinical trials of our products and products in development could be impaired and our business could be harmed.

We do not manufacture any of our products and do not plan to develop any capacity to manufacture them. We currently rely on a limited number of manufacturers for bulk substance and to carry out fill-finish activities for our products and products in development. We expect to continue this manufacturing arrangement for the foreseeable future.

In the event that any of our third-party manufacturers is unable or unwilling to carry out its respective manufacturing or supply obligations or terminates or refuses to renew its arrangements with us, we may be unable to obtain alternative manufacturing or supply on commercially reasonable terms on a timely basis or at all. In addition, we purchase finished drug product from a number of our third-party manufacturers under purchase orders. In such cases, the third-party manufacturers have made no commitment to supply the drug product to us on a long-term basis and could reject our purchase orders. Only a limited number of manufacturers are capable of manufacturing our products and products in development. Consolidation within the pharmaceutical manufacturing industry could further reduce the number of manufacturers capable of producing our products, or otherwise affect our existing contractual relationships.

If we were required to transfer manufacturing processes to other third-party manufacturers and we were able to identify an alternative manufacturer, we would still need to satisfy various regulatory requirements. Satisfaction of these requirements could cause us to experience significant delays in receiving an adequate supply of our products and products in development and could be costly. Moreover, we may not be able to transfer processes that are proprietary to the manufacturer. Any delays in the manufacturing process may adversely impact our ability to meet commercial demands for our products on a timely basis, which could reduce our revenue, and to supply product for clinical trials of Angiomax, Cleviprex and our products in development, which could affect our ability to complete clinical trials on a timely basis.

If third parties on whom we rely to manufacture and support the development and commercialization of our products do not fulfill their obligations or we are unable to establish or maintain such arrangements, the development and commercialization of our products may be terminated or delayed, and the costs of development and commercialization may increase

Our development and commercialization strategy involves entering into arrangements with corporate and academic collaborators, contract research organizations, distributors, third-party manufacturers, licensors, licensees and others to conduct development work, manage or conduct our clinical trials, manufacture our products and market and sell our products outside of the United States. We do not have the expertise or the resources to conduct many of these activities on our own and, as a result, are particularly dependent on third parties in many areas.

We may not be able to maintain our existing arrangements with respect to the commercialization or manufacture of our products or establish and maintain arrangements to develop, manufacture and commercialize our products in development or any additional product candidates or products we may acquire on terms that are acceptable to us. Any current or future arrangements for development and commercialization may not be successful. If we are not able to establish or maintain agreements relating to our products, our products in development or any additional products or product candidates we may acquire, our results of operations would be materially adversely affected.

Third parties may not perform their obligations as expected. The amount and timing of resources that third parties devote to developing, manufacturing and commercializing our products are not within our control. Our collaborators may develop, manufacture or commercialize, either alone or with others, products and services that are similar to or competitive with the products that are the subject of the collaboration with us. Furthermore, our interests may differ from those of third parties that manufacture or commercialize our products. Our collaborators may reevaluate their priorities from time to time, including following mergers and consolidations, and change the focus of their development, manufacturing or commercialization efforts. Disagreements that may arise with these third parties could delay or lead to the termination of the development or commercialization of our product candidates, or result in litigation or arbitration, which would be time consuming and expensive.

If any third party that manufactures or supports the development or commercialization of our products breaches or terminates its agreement with us, or fails to commit sufficient resources to our collaboration or conduct its activities in a timely manner, or fails to comply with regulatory requirements, such breach, termination or failure could:


•	delay or otherwise adversely impact the manufacturing, development or commercialization of our products, our products in development or any additional products or product candidates that we may acquire or develop;


•	require us to seek a new collaborator or undertake unforeseen additional responsibilities or devote unforeseen additional resources to the manufacturing, development or commercialization of our products; or


•	result in the termination of the development or commercialization of our products.

Our reliance on third-party manufacturers to supply our products and product candidates may increase the risk that we will not have appropriate supplies of our products or our product candidates, which could adversely affect our business, results of operations and financial condition

Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured products or products candidates ourselves, including:


•	reliance on the third party for regulatory compliance and quality assurance;


•	the possible breach of the manufacturing agreement by the third party; and


•	the possible termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.

For example, in December 2009 and March 2010 we conducted voluntary recalls of manufactured lots of Cleviprex due to the presence of visible particulate matter at the bottom of some vials that were manufactured for us by a third party. As a result, we were not able to supply the market with Cleviprex or sell Cleviprex from the first quarter of 2010 until April 2011. In addition, in December 2011 Eagle, the licensor and sole supplier of ready-to-use Argatroban, conducted a voluntary recall of the product due to the presence of particulate matter in some vials. As a result, we were not able to sell ready-to-use Argatroban from December 2011 to April 2012. In April 2012, we re-commenced selling ready-to-use Argatroban to existing and new customers.

Our products and products in development may compete with products and product candidates of third parties for access to manufacturing facilities. If we are not able to obtain adequate supplies of our products and products in development, it will be more difficult for us to compete effectively, market and sell our approved products and develop our products in development.

Our contract manufacturers are subject to ongoing, periodic, unannounced inspection by the FDA and corresponding state and foreign agencies or their designees to evaluate compliance with the FDA's cGMP, regulations and other governmental regulations and corresponding foreign standards. We cannot be certain that our present or future manufacturers will be able to comply with cGMP regulations and other FDA regulatory requirements or similar regulatory requirements outside the United States. We do not control compliance by our contract manufacturers with these regulations and standards. Failure of our third-party manufacturers or us to comply with applicable regulations could result in sanctions being imposed on us, including fines and other monetary penalties, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal of approvals, suspension of clinical trials, license revocation, seizures or recalls of product candidates or products, interruption of production, warning letters, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products and products in development.

If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages

We conduct research and development activities that involve the controlled use of potentially hazardous substances, including chemical, biological and radioactive materials and viruses. In addition, our operations produce hazardous waste products. Federal, state and local laws and regulations in the United States and Canada govern the use, manufacture, storage, handling and disposal of hazardous materials. We may incur significant additional costs to comply with applicable laws in the future. Also, we cannot completely eliminate the risk of contamination or injury resulting from hazardous materials and we may incur liability as a result of any such contamination or injury. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We have only limited insurance for liabilities arising from hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may restrict our research, development and production efforts, which could harm our business, operating results and financial condition.

If we fail to acquire and develop additional development-stage compounds, clinical-stage product candidates or approved products, it will impair our ability to grow our business

We have sold and generated revenue from three products, Angiomax, Cleviprex and ready-to-use Argatroban. In order to generate

additional revenue, our business plan is to acquire or license, and then develop and market, additional development-stage compounds, clinical-stage product candidates and approved products. From 2008 through February 2012, for instance, we acquired Curacyte Discovery and Targanta, licensed marketing rights to the ready-to-use formulation of Argatroban, licensed development and commercialization rights to MDCO-216 and MDCO-157 and licensed the non-exclusive rights to sell and distribute ten acute care generic products. The success of this growth strategy depends upon our ability to identify, select and acquire or license pharmaceutical products that meet the criteria we have established. Because we have only the limited internal scientific research capabilities that we acquired in our acquisitions of Curacyte Discovery and Targanta, and we do not anticipate establishing additional scientific research capabilities, we are dependent upon pharmaceutical and biotechnology companies and other researchers to sell or license product candidates to us. In addition, proposing, negotiating and implementing an economically viable acquisition or license is a lengthy and complex process. Other companies, including those with substantially greater financial, marketing and sales resources, may compete with us for the acquisition or license of development-stage compounds, clinical-stage product candidates and approved products. We may not be able to acquire or license the rights to additional product candidates and approved products on terms that we find acceptable, or at all.

We may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants

Our industry has experienced a high rate of turnover of management personnel in recent years. We are highly dependent on our ability to attract and retain qualified personnel for the acquisition, development and commercialization activities we conduct or sponsor. If we lose one or more of the members of our senior management, including our Chairman and Chief Executive Officer, Clive A. Meanwell, our President and Chief Financial Officer, Glenn P. Sblendorio, or other key employees or consultants, our ability to implement successfully our business strategy could be seriously harmed. Our ability to replace these key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to acquire, develop and commercialize products successfully. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate such additional personnel.

Risks Related to Regulatory Matters

If we do not obtain regulatory approvals for our product candidates in any jurisdiction or for our products in any additional jurisdictions, we will not be able to market our products and product candidates in those jurisdictions and our ability to generate additional revenue could be materially impaired

We must obtain approval from the FDA in order to sell our product candidates in the United States and from foreign regulatory authorities in order to sell our product candidates in other countries. In addition, we must obtain approval from foreign regulatory authorities in order to sell our U.S.-approved products in other countries. Obtaining regulatory approval is uncertain, time-consuming and expensive. Any regulatory approval we ultimately obtain may limit the indicated uses for the product or subject the product to restrictions or post-approval commitments that render the product commercially non-viable. Securing regulatory approval requires the submission of extensive pre-clinical and clinical data, information about product manufacturing processes and inspection of facilities and supporting information to the regulatory authorities for each therapeutic indication to establish the product's safety and efficacy. If we are unable to submit the necessary data and information, for example, because the results of clinical trials are not favorable, or if the applicable regulatory authority delays reviewing or does not approve our applications, we will be unable to obtain regulatory approval. Delays in obtaining or failure to obtain regulatory approvals may:


•	delay or prevent the successful commercialization of any of the products or product candidates in the jurisdiction for which approval is sought;


•	diminish our competitive advantage; and


•	defer or decrease our receipt of revenue.

The regulatory review and approval process to obtain marketing approval takes many years and requires the expenditure of substantial resources. This process can vary substantially based on the type, complexity, novelty and indication of the product involved. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that data are insufficient for approval and require additional pre-clinical, clinical or other studies. In addition, varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of a product. For example, the FDA issued a complete response letter to Targanta in December 2008 before it was acquired by us with respect to the oritavancin NDA indicating that the FDA could not approve the NDA in its present form and that it would be necessary for Targanta to perform an additional adequate and well-controlled study to demonstrate the safety and efficacy of oritavancin in patients with ABSSSI before the application could be approved. Moreover, recent events, including complications experienced

by patients taking FDA-approved drugs, have raised questions about the safety of marketed drugs and may result in new legislation by the U.S. Congress or foreign legislatures and increased caution by the FDA and comparable foreign regulatory authorities in reviewing applications for marketing approval.

In the fourth quarter of 2010, we initiated our SOLO I and SOLO II clinical trials of oritavancin pursuant to a Special Protocol Assessment, or SPA, with the FDA. Many companies which have been granted SPAs have ultimately failed to obtain final approval to market their drugs. Since we are developing oritavancin under an SPA, based on protocol designs negotiated with the FDA, we may be subject to enhanced scrutiny. Additionally, even if the primary endpoints in the SOLO trials are achieved, a SPA does not guarantee approval. An SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA was entered into become evident; the data, assumptions or information underlying the SPA request change or are called into question; other new scientific concerns regarding product safety or efficacy arise; or if we fail to comply with the agreed upon trial protocols. The FDA may raise issues of safety, study conduct, bias, deviation from the protocol, statistical power, patient completion rates, changes in scientific or medical parameters or internal inconsistencies in the data prior to making its final decision. The FDA may also seek the guidance of an outside advisory committee prior to making its final decision.

The procedures to obtain marketing approvals vary among countries and can involve additional clinical trials or other pre-filing requirements. The time required to obtain foreign regulatory approval may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all the risks associated with obtaining FDA approval, or different or additional risks. We may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by the regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by the FDA or regulatory authorities in other foreign countries. We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products and products in development in any market.

We cannot expand the indications for which we are marketing Angiomax unless we receive regulatory approval for each additional indication. Failure to expand these indications will limit the size of the commercial market for Angiomax

In order to market Angiomax for expanded indications, we will need to conduct appropriate clinical trials, obtain positive results from those trials and obtain regulatory approval for such proposed indications. Obtaining regulatory approval is uncertain, time-consuming and expensive. The regulatory review and approval process to obtain marketing approval for a new indication can take many years and require the expenditure of substantial resources. This process can vary substantially based on the type, complexity, novelty and indication of the product involved. The regulatory authorities have substantial discretion in the approval process and may refuse to accept any application. Alternatively, they may decide that any data submitted is insufficient for approval and require additional pre-clinical, clinical or other studies. In addition, varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of a new indication for a product.

For example, in 2006 we received a non-approvable letter from the FDA in connection with our application to market Angiomax for patients with or at risk of HIT/HITTS undergoing cardiac surgery. In addition, in May 2008, we received a non-approvable letter from the FDA with respect to an sNDA that we submitted to the FDA seeking approval of an additional indication for Angiomax for the treatment of patients with ACS in the emergency department. In its May 2008 letter, the FDA indicated that the basis of their decision involved the appropriate use and interpretation of non-inferiority trials, including the ACUITY trial. If we determine to pursue these indications, the FDA may require that we conduct additional studies of Angiomax, which studies could require the expenditure of substantial resources. Even if we undertook such studies, we might not be successful in obtaining regulatory approval for these indications or any other indications in a timely manner or at all. If we are unsuccessful in expanding the Angiomax product label, the size of the commercial market for Angiomax will be limited.

Clinical trials of product candidates are expensive and time-consuming, and the results of these trials are uncertain. If we are unable to conduct clinical trials that demonstrate the safety and efficacy of our product candidates on a timely basis, then our costs of developing the product candidates may increase and we may not be able to obtain regulatory approval for our product candidates on a timely basis or at all.

Before we can obtain regulatory approvals to market any product for a particular indication, we will be required to complete pre-clinical studies and extensive clinical trials in humans to demonstrate the safety and efficacy of such product for such indication.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. Success in pre-clinical testing or early clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. An unexpected result in one or more of our clinical trials can occur at any stage of testing. For example, in May 2009 we discontinued enrollment in our Phase 3 CHAMPION clinical trial program of cangrelor in patients undergoing PCI after receiving a letter from the clinical program's independent Interim Analysis Review Committee that reported that the efficacy endpoints of the trial program would not be achieved.

We may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent us from receiving regulatory approval or commercializing our products, including:


•	our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials which even if undertaken cannot ensure we will gain approval;


•	data obtained from pre-clinical testing and clinical trials may be subject to varying interpretations, which could result in the FDA or other regulatory authorities deciding not to approve a product in a timely fashion, or at all;


•	the cost of clinical trials may be greater than we currently anticipate;


•	regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;


•	we, or the FDA or other regulatory authorities, might suspend or terminate a clinical trial at any time on various grounds, including a finding that participating patients are being exposed to unacceptable health risks. For example, we have in the past voluntarily suspended enrollment in one of our clinical trials to review an interim analysis of safety data from the trial; and


•	the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics.

The rate of completion of clinical trials depends in part upon the rate of enrollment of patients. Patient enrollment is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the existence of competing clinical trials and the availability of alternative or new treatments. In particular, the patient population targeted by some of our clinical trials may be small. Delays in patient enrollment in any of our current or future clinical trials may result in increased costs and program delays.

If we or our contract manufacturers fail to comply with the extensive regulatory requirements to which we, our contract manufacturers and our products and product candidates are subject, our products could be subject to restrictions or withdrawal from the market, the development of our product candidates could be jeopardized, and we could be subject to penalties

The research, testing, manufacturing, labeling, safety, advertising, promotion, storage, sales, distribution, import, export and marketing, among other things, of our products, both before and after approval, are subject to extensive regulation by governmental authorities in the United States, Europe and elsewhere throughout the world. Both before and after approval of a product, quality control and manufacturing procedures must conform to current good manufacturing practice, or cGMP. Regulatory authorities, including the FDA, periodically inspect manufacturing facilities to assess compliance with cGMP. Our failure or the failure of our contract manufacturers to comply with the laws administered by the FDA, the EMA or other governmental authorities could result in, among other things, any of the following:


•	delay in approving or refusal to approve a product;


•	product recall or seizure;


•	suspension or withdrawal of an approved product from the market;


•	delays in, suspension of or prohibition of commencing, clinical trials of products in development;


•	interruption of production;


•	operating restrictions;


•	untitled or warning letters;


•	injunctions;


•	fines and other monetary penalties;


•	the imposition of civil or criminal penalties;


•	disruption of importing and exporting activities; and


•	unanticipated expenditures.

We may incur significant liability if it is determined that we are promoting the “off-label” use of any of our products

Physicians may prescribe drug products for uses that are not described in the product's labeling and that differ from those approved by the FDA or other applicable regulatory agencies. Off-label uses are common across medical specialties. Although the FDA and other regulatory agencies do not regulate a physician's choice of treatments, the FDA and other regulatory agencies do restrict communications on the subject of off-label use. Companies may not promote drugs for off-label uses. The FDA and other regulatory and enforcement authorities actively enforce laws and regulations prohibiting promotion of off-label uses and the promotion of products for which marketing approval has not been obtained. A company that is found to have improperly promoted off-label uses may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions.

Notwithstanding the regulatory restrictions on off-label promotion, the FDA and other regulatory authorities allow companies to engage in truthful, non-misleading, and non-promotional scientific exchange concerning their products. We engage in medical education activities and communicate with investigators and potential investigators regarding our clinical trials. If the FDA or another regulatory or enforcement authority determines that our communications regarding our marketed products are not in compliance with the relevant regulatory requirements and that we have improperly promoted off-label uses, we may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions.

If we do not comply with federal, state and foreign laws and regulations relating to the health care business, we could face substantial penalties

We and our customers are subject to extensive regulation by the federal government, and the governments of the states and foreign countries in which we may conduct our business. In the United States, the laws that directly or indirectly affect our ability to operate our business include the following:


•	the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid;


•	other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by our customers, including the amount of such payment;


•	the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government;


•	the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and


•	various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.

If our operations are found to be in violation of any of the laws and regulations described above or any other law or governmental regulation to which we or our customers are or will be subject, we may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of our operations. Similarly, if our customers are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on us. Any penalties, damages, fines, curtailment or restructuring of our operations would adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management's attention from the operation of our business and damage our reputation.

Failure to comply with the U.S. Foreign Corrupt Practices Act, or FCPA, as well as the anti-bribery laws of the nations in

which we conduct business, could subject us to penalties and other adverse consequences

We are subject to the FCPA, which generally prohibits U.S. companies from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining or retaining business and requires companies to maintain accurate books and records and internal controls, including at foreign-controlled subsidiaries. In addition, we are subject to other anti-bribery laws of the nations in which we conduct business that apply similar prohibitions as the FCPA. Our employees or other agents may engage in prohibited conduct without our knowledge under our policies and procedures and the Foreign Corrupt Practices Act and other anti-bribery laws that we may be subject to for which we may be held responsible. If our employees or other agents are found to have engaged in such practices, we could suffer severe penalties and other consequences that may have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Our Intellectual Property

If we are unable to maintain our market exclusivity for Angiomax in the United States as a result of our inability to enforce our U.S. patents covering Angiomax, Angiomax could be subject to generic competition earlier than we anticipate. Generic competition for Angiomax would have a material adverse effect on our business, financial condition and results of operations

On September 30, 2011, we settled our patent infringement litigation with Teva. In connection with the Teva settlement we entered into a license agreement with Teva under which we granted Teva a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product under a Teva ANDA in the United States beginning June 30, 2019 or earlier under certain conditions.

On January 22, 2012, we settled our patent infringement litigation with APP. In connection with the APP settlement, we entered into a license agreement with APP under which we granted APP a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product under an APP ANDA in the United States beginning on May 1, 2019. In certain limited circumstances, the license to APP could include the right to sell a generic bivalirudin product under our NDA for Angiomax in the United States beginning on May 1, 2019 or, in certain limited circumstances, on June 30, 2019 or on a date prior to May 1, 2019.

We remain in infringement litigation involving the '727 patent and '343 patent with the other ANDA filers.

If we are unable to maintain our market exclusivity for Angiomax in the United States as a result of our inability to enforce our U.S. patents covering Angiomax, Angiomax could become subject to generic competition in the United States earlier than May 1, 2019. Competition from generic equivalents that would be sold at a price that is less than the price at which we currently sell Angiomax could have a material adverse impact on our business, financial condition and operating results.

Following our settlements with Teva and APP, we submitted the settlement documents for each settlement to the FTC, and the DOJ. The FTC and the DOJ could seek to challenge our settlements with Teva and APP, or a third-party could initiate a private action under antitrust or other laws challenging our settlements with Teva and APP. While we believe our settlements are lawful, we may not prevail in any such challenges or litigation, in which case the other party might obtain injunctive relief, remedial relief, or such other relief as a court may order. In any event, we may incur significant costs in the event of an investigation or in defending any such action and our business and results of operations could be materially impacted if we fail to prevail against any such challenges.

Our patent infringement litigation involving the '727 patent and '343 patent and our settlement with APP are described in more detail in Part II, Item 1 of this quarterly report.

If we breach any of the agreements under which we license rights to products or technology from others, we could lose license rights that are material to our business or be subject to claims by our licensors

We license rights to products and technology that are important to our business, and we expect to enter into additional licenses in the future. For instance, we have exclusively licensed patents and patent applications relating to each of our products and products in development other than MDCO-2010. Under these agreements, we are subject to a range of commercialization and

development, sublicensing, royalty, patent prosecution and maintenance, insurance and other obligations.

Any failure by us to comply with any of these obligations or any other breach by us of our license agreements could give the licensor the right to terminate the license in whole, terminate the exclusive nature of the license or bring a claim against us for damages. Any such termination or claim, particularly relating to our agreements with respect to Angiomax, could have a material adverse effect on our financial condition, results of operations, liquidity or business. Even if we contest any such termination or claim and are ultimately successful, such dispute could lead to delays in the development or commercialization of potential products and result in time-consuming and expensive litigation or arbitration. In addition, on termination we may be required to license to the licensor any related intellectual property that we developed.

We have entered into an agreement with Biogen Idec, one of our licensors of Angiomax, that suspends the statute of limitations relating to any claims, including claims for damages and/or license termination, that Biogen Idec may bring relating to the PTO's initial denial of the application under the Hatch-Waxman Act for an extension of the term of the '404 patent on the grounds that it was filed late. We are also in discussions with Biogen Idec and HRI with respect to the possible resolution of any potential claims among the parties with respect to this matter. We may not reach any agreement with the parties on terms acceptable to us or at all.

If we are unable to obtain or maintain patent protection for the intellectual property relating to our products, the value of our products will be adversely affected

The patent positions of pharmaceutical companies like us are generally uncertain and involve complex legal, scientific and factual issues. We cannot be certain that our patents and patent applications, including our own and those that we have rights through licenses from third parties will adequately protect our intellectual property. Our success in protection of our intellectual property depends significantly on our ability to:


•	obtain and maintain U.S. and foreign patents, including defending those patents against adverse claims;


•	secure patent term extension for the patents covering our approved products;


•	protect trade secrets;


•	operate without infringing the proprietary rights of others; and


•	prevent others from infringing our proprietary rights.

We may not have any additional patents issued from any patent applications that we own or license. If additional patents are granted, the claims allowed may not be sufficiently broad to protect our technology. In addition, issued patents that we own or license may be challenged, narrowed, invalidated or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of term of patent protection we may have for our products, and we may not be able to obtain patent term extension to prolong the terms of the principal patents covering our approved products. Changes in patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection.

In addition, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the value of patents, once obtained, and with regard to our ability to obtain patents in the future. Depending on decisions by the U.S. Congress, the federal courts, and the PTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

Our patents also may not afford us protection against competitors with similar technology. Because patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, or in some cases not at all, and because publications of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our licensors can be certain that others have not filed or maintained patent applications for technology used by us or covered by our pending patent applications without our being aware of these applications.

We exclusively license patents and patent applications for each of our products and products in development other than MDCO-2010, for which we own the patents and patent applications, and the acute care generic products that we licensed from APP on a non-exclusive basis which are not covered by any patents or patent applications. The patents covering our approved

products and our product candidates are currently set to expire at various dates:

Angiomax. The principal U.S. patents covering Angiomax include the '404 patent, the '727 patent and the '343 patent. The '404 patent, was set to expire in March 2010, but the term was extended to December 15, 2014 by the PTO under the Hatch-Waxman Act. As a result of our study of Angiomax in the pediatric setting, we are entitled to a six-month period of pediatric exclusivity following expiration of the '404 patent.

In the second half of 2009, the PTO issued to us the '727 patent and the '343 patent, covering a more consistent and improved Angiomax drug product and the processes by which it is made. The '727 patent and the '343 patent are set to expire in July 2028. In response to Paragraph IV Certification Notice letters we received with respect to abbreviated new drug applications, or ANDAs, filed with the FDA seeking approval to market generic versions of Angiomax, we have filed lawsuits against the ANDA filers alleging patent infringement of the '727 patent and '343 patent. On September 30, 2011, we settled our patent infringement litigation with Teva. In connection with the settlement, we entered into a license agreement with Teva under which we granted Teva a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product under a Teva ANDA in the United States beginning June 30, 2019 or earlier under certain conditions. On January 22, 2012, we settled our patent infringement litigation with APP. In connection with the settlement, we entered into a license agreement with APP under which we granted APP a non-exclusive license under the '727 patent and '343 patent to sell a generic bivalirudin for injection product under an APP ANDA in the United States beginning on May 1, 2019. In addition, in certain limited circumstances, the license to APP could include the right to sell a generic bivalirudin product under our NDA for Angiomax in the United States beginning on May 1, 2019 or, in certain limited circumstances, on June 30, 2019 or on a date prior to May 1, 2019. We remain in infringement litigation involving the '727 patent and '343 patent with the other ANDA filers. If we are unable to maintain our market exclusivity for Angiomax in the United States through enforcement of our U.S. patents covering Angiomax, Angiomax could be subject to generic competition earlier than May 1, 2019.

Our litigation with the PTO, the FDA and HHS and APP's efforts to appeal the federal district court's August 3, 2010 decision related to the patent term extension of the '404 patent, the patent infringement litigation involving the '727 patent and '343 patent and our settlement with APP are described in more detail in Part II, Item 1, Legal Proceedings, of this quarterly report.

In Europe, the principal patent covering Angiomax expires in 2015.

Cleviprex . The principal U.S. patent for Cleviprex is U.S. Patent No. 5,856,346, or the '346 patent, which is set to expire in January 2016. Following receipt of marketing approval from the FDA, we submitted an application under the Hatch-Waxman Act to extend the term of the '346 patent. This application is currently pending. In addition, we have filed and are currently prosecuting a number of patent applications relating to Cleviprex covering compositions of matter and uses in the United States, Europe and other foreign countries. We have filed for patent term extensions, also known as supplementary protection certificates, in European countries where we received regulatory approval and expect to file for supplementary protection certificates in other European countries as we receive approvals. In Europe, the principal patent covering Cleviprex expires in November 2014 if no patent term extension is obtained.

Cangrelor . The principal U.S. and European patents for cangrelor are set to expire in February 2014 if no patent term extension is obtained. In addition, we have also filed and are currently prosecuting a number of patent applications related to cangrelor.

Oritavancin . The principal patent for oritavancin in both the United States and Europe is set to expire in November 2015 if no patent term extension is obtained. We have also filed and are prosecuting a number of patent applications relating to oritavancin and its uses.

MDCO-157 . The principal patent application for MDCO-157 in both the United States and Europe, if issued, would expire in April 2028.

MDCO-2010 . In connection with our acquisition of Curacyte Discovery, we acquired a portfolio of patents and patent applications covering MDCO-2010, its analogs or other similar protease inhibitors. We are currently prosecuting and maintaining these patents and patent applications. In February 2012, the principal patent application for MDCO-2010 was allowed by the PTO, and, when issued, the resulting patent will be set to expire in September 2028 in the United States. The principal patent application in Europe is still pending and, if issued, would expire in October 2027.

MDCO-216 . We are maintaining a number of U.S. patents with respect to MDCO-216, including patents that claim the use of MDCO-216 in certain disease indications. One of these U.S. patents is directed to the use of MDCO-216 for the treatment of ACS and is set to expire in October 2024. We have also filed and are prosecuting a number of patent applications related to the use and production of MDCO-216 in the United States, Europe and other foreign countries. In addition, as a biologic, we expect

MDCO-216 to receive 12 years of regulatory exclusivity in the United States and 10 years of regulatory exclusivity in Europe from the date of the initial marketing approval of MDCO-216, if approved.

Ready-to-Use Argatroban . We exclusively licensed from Eagle rights to two U.S. patents covering certain formulations of Argatroban. Our exclusive license is limited to the United States and Canada. The patents are set to expire in September 2027. In February 2012, we were notified that Sandoz had submitted an ANDA seeking permission to market its second generic version of ready-to-use Argatroban prior to the expiration of these patents. On March 29, 2012, Eagle, which is directing and controlling the enforcement of its intellectual property rights with respect to ready-to-use Argatroban, filed suit against Sandoz in the U.S. District Court for the District of New Jersey for infringement of its ready-to-use Argatroban patents.

We plan to file applications for patent term extension for our products in development upon their approval. If we do not receive patent term extensions for the periods requested by us or at all, our patent protection for our products in development could be limited.

We are a party to a number of lawsuits that we brought against pharmaceutical companies that have notified us that they have filed ANDAs seeking approval to market generic versions of Angiomax. We cannot predict the outcome of these lawsuits. Involvement in litigation, regardless of its outcome, is time-consuming and expensive and may divert our management's time and attention. During the period in which these matters are pending, the uncertainty of their outcome may cause our stock price to decline. An adverse result in these matters whether appealable or not, will likely cause our stock price to decline. Any final, unappealable, adverse result in these matters will likely have a material adverse effect on our results of operations and financial conditions and cause our stock price to decline.

If upon expiration of our agreement with Lonza Braine, Lonza Braine breaches our agreement and fails to transfer the technology that was used to develop the Chemilog process, we would be unable to employ the Chemilog process to manufacture Angiomax bulk drug substance, which could cause us to experience delays in the manufacturing process and increase our manufacturing costs in the future.

Our agreement with Lonza Braine for the supply of Angiomax bulk drug substance requires that Lonza Braine transfer the technology that was used to develop the Chemilog process to a secondary supplier of Angiomax bulk drug substance or to us or an alternate supplier at the expiration of the agreement, which is currently scheduled to occur in September 2013, but is subject to automatic renewals of consecutive three-year periods unless either party provides notice of non-renewal at least one year prior to the expiration of the initial term or any renewal term. If Lonza Braine fails or is unable to transfer successfully this technology, we would be unable to employ the Chemilog process to manufacture our Angiomax bulk drug substance, which could cause us to experience delays in the manufacturing process and increase our manufacturing costs in the future.

If we are not able to keep our trade secrets confidential, our technology and information may be used by others to compete against us

We rely significantly upon unpatented proprietary technology, information, processes and know-how. We seek to protect this information by confidentiality agreements and invention assignment agreements with our employees, consultants and other third-party contractors, as well as through other security measures. We may not have adequate remedies for any breach by a party to these confidentiality agreements or invention assignment agreements. In addition, our competitors may learn or independently develop our trade secrets. If our confidential information or trade secrets become publicly known, they may lose their value to us.

If we infringe or are alleged to infringe intellectual property rights of third parties, our business may be adversely affected

Our research, development and commercialization activities, as well as any product candidates or products resulting from these activities, may infringe or be claimed to infringe patents or patent applications under which we do not hold licenses or other rights. Third parties may own or control these patents and patent applications in the United States and abroad. These third parties could bring claims against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.

As a result of patent infringement claims, or in order to avoid potential claims, we or our collaborators may choose or be required to seek a license from the third party and be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened

patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms. This could harm our business significantly.

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference proceedings declared by the PTO and opposition proceedings in the European Patent Office, regarding intellectual property rights with respect to our products and technology. Patent litigation and other proceedings may also absorb significant management time. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.

Risks Related to Our Common Stock

Fluctuations in our operating results could affect the price of our common stock

Our operating results may vary from period to period based on factors including the amount and timing of sales of and underlying hospital demand for our products, our customers' buying patterns, the timing, expenses and results of clinical trials, announcements regarding clinical trial results and product introductions by us or our competitors, the availability and timing of third-party reimbursement, including in Europe, sales and marketing expenses and the timing of regulatory approvals. If our operating results do not meet the expectations of securities analysts and investors as a result of these or other factors, the trading price of our common stock will likely decrease.

Our stock price has been and may in the future be volatile. This volatility may make it difficult for you to sell common stock when you want or at attractive prices

Our common stock has been and in the future may be subject to substantial price volatility. From January 1, 2010 to May 3, 2012 , the last reported sale price of our common stock ranged from a high of $22.28 per share to a low of $7.00 per share. The value of your investment could decline due to the effect upon the market price of our common stock of any of the following factors, many of which are beyond our control:


•	achievement or rejection of regulatory approvals of our product candidates and our products;


•	regulatory actions by the FDA or a foreign jurisdiction limiting or revoking the use of our products;


•	changes in securities analysts' estimates of our financial performance;


•	changes in valuations of similar companies;


•	variations in our operating results;


•	acquisitions and strategic partnerships;


•	announcements of technological innovations or new commercial products by us or our competitors or the filing of ANDAs or NDAs for products competitive with ours;


•	disclosure of results of clinical testing or regulatory proceedings by us or our competitors;


•	the timing, amount and receipt of revenue from sales of our products and margins on sales of our products;


•	changes in governmental regulations;


•	developments in patent rights or other proprietary rights, particularly with respect to our U.S. Angiomax patents;


•	the extent to which Angiomax is commercially successful globally;


•	our ability to maintain market exclusivity for Angiomax in the United States through the enforcement of the '727 patent

and the '343 patent during the period following the expiration of the patent term of the '404 patent on December 15, 2014 and the six month pediatric exclusivity on June 15, 2015 through at least May 1, 2019, the date on which we agreed APP may sell a generic version of Angiomax;


•	significant new litigation;


•	developments or issues with our contract manufacturers;


•	changes in our management; and


•	general market conditions.

We believe that period-to-period comparisons of our financial results will not necessarily be indicative of our future performance. If our revenues in any particular period do not meet expectations, we may not be able to adjust our expenditures in that period, which could cause our operating results to suffer. If our operating results in any future period fall below the expectations of securities analysts or investors, our stock price may fall by a significant amount.

The stock markets in general, and The NASDAQ Global Market and the market for biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations recently. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors may adversely affect the market price of our common stock, regardless of our actual operating performance.

Our corporate governance structure, including provisions in our certificate of incorporation and by-laws and Delaware law, may prevent a change in control or management that security holders may consider desirable

The General Corporation Law of the State of Delaware and our certificate of incorporation and by-laws contain provisions that might enable our management to resist a takeover of our company or discourage a third party from attempting to take over our company. These provisions include


•	Section 203 of the Delaware General Corporation Law, which provides that we may not enter into a business combination with an interested stockholder for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in the manner prescribed in Section 203;


•	our board of directors has the authority to issue, without a vote or action of stockholders, up to 5,000,000 shares of a new series of preferred stock and to fix the price, rights, preferences and privileges of those shares, each of which could be superior to the rights of holders of our common stock;


•	our directors are elected to staggered terms, which prevents our entire board of directors from being replaced in any single year;


•	our directors may be removed only for cause and then only by the affirmative vote of the holders of at least 75% of the votes which all stockholders would be entitled to cast in any annual election of directors;


•	the size of our board of directors is determined by resolution of the board of directors;


•	any vacancy on our board of directors, however occurring, including a vacancy resulting from an enlargement of our board, may only be filled by vote of a majority of our directors then in office, even if less than a quorum;


•	only our board of directors, the chairman of the board or our president may call special meetings of stockholders;


•	our by-laws may be amended, altered or repealed by (i) the affirmative vote of a majority of our directors, subject to any limitations set forth in the by-laws, or (ii) the affirmative vote of the holders of at least 75% of the votes which all the stockholders would be entitled to cast in any annual election of directors;


•	stockholders must provide us with advance notice, and certain information specified in our by-laws, in connection with nominations or proposals by such stockholder for consideration at an annual meeting;


•	stockholders may not take any action by written consent in lieu of a meeting; and

•

our certificate of incorporation may only be amended or repealed by the affirmative vote of a majority of our directors and the affirmative vote of the holders of at least 75% of the votes which all the stockholders would be entitled to cast in any annual election of directors (and plus any separate class vote that might in the future be required pursuant to the terms of any series of preferred stock that might be outstanding at the time any of these amendments are submitted to stockholders).

These provisions could have the effect of delaying, deferring, or preventing a change in control of us or a change in our management that stockholders may consider favorable or beneficial. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors and take other corporate actions. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock or our other securities.

Our business could be negatively affected as a result of the actions of activist shareholders.

Proxy contests have been waged against many companies in the biopharmaceutical industry over the last few years. If faced with a proxy contest, we may not be able to successfully defend against the contest, which would be disruptive to our business. Even if we are successful, our business could be adversely affected by a proxy contest because:


•	responding to proxy contests and other actions by activist shareholders may be costly and time-consuming and may disrupt our operations and divert the attention of management and our employees;


•	perceived uncertainties as to our future direction may result in our inability to consummate potential acquisitions, collaborations or in-licensing opportunities and may make it more difficult to attract and retain qualified personnel and business partners; and


•	if individuals are elected to our board of directors with a specific agenda different from ours, it may adversely affect our ability to effectively and timely implement our strategic plan and create additional value for our stockholders.

Item 6. Exhibits

Exhibits

See the Exhibit Index on the page immediately preceding the exhibits for a list of exhibits filed as part of this quarterly report, which Exhibit Index is incorporated herein by this 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.

THE MEDICINES COMPANY



Date:	May 10, 2012	By:	/s/ Glenn P. Sblendorio
			Glenn P. Sblendorio
			President and Chief Financial
			Officer (Principal Financial and Accounting Officer)

EXHIBIT INDEX



Exhibit Number		Description
10.1*		Settlement Agreement, dated January 22, 2012, between registrant and APP Pharmaceuticals, LLC

10.2*		License Agreement, dated January 22, 2012, between registrant and APP Pharmaceuticals, LLC

10.3*		Contract Manufacturing Agreement, dated January 22, 2012, between registrant and APP Pharmaceuticals, LLC

10.4*		License and Supply Agreement, dated January 22, 2012, between registrant and APP Pharmaceuticals, LLC

10.5*		AG Supply Agreement, dated January 22, 2012, between registrant and APP Pharmaceuticals, LLC

10.6*		Amendment 1 to the Supply Agreement, dated February 13, 2012, between registrant and Teva API, Inc. (formerly known as Plantex USA Inc.)

31.1		Chairman and Chief Executive Officer Certification pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2		Chief Financial Officer Certification pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1		Chairman and Chief Executive Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2		Chief Financial Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101		The following materials from The Medicines Company Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, formatted in XBRL (Extensible Business Reporting Language): (i) the Consolidated Balance Sheet, (ii) the Consolidated Statement of Operations, (iii) the Consolidated Statement of Cash Flow, and (iv) Notes to Consolidated Financial Statements.


*	Confidential treatment requested as to certain portions, which portions have been omitted and filed separately with the Securities and Exchange Commission.



	Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.			Exhibit 10.1

EXECUTION COPY

SETTLEMENT AGREEMENT

BY AND AMONG

THE MEDICINES COMPANY

AND

APP PHARMACEUTICALS, LLC AND APP PHARMACEUTICALS, INC.

DATED AS OF JANUARY 22, 2012

SETTLEMENT AGREEMENT

THIS SETTLEMENT AGREEMENT , (this “Settlement Agreement”) is entered into as of January 22, 2012 (the “Effective Date”) by and between, on the one hand, The Medicines Company, a company organized and existing under the laws of the State of Delaware with offices located at 8 Sylvan Way, Parsippany, New Jersey 07054 and its Affiliates (collectively “MDCO”), and, on the other hand, APP Pharmaceuticals, LLC, a limited liability company organized and existing under the laws of the State of Delaware with offices at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 and its Affiliates, and APP Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware with offices at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 and its Affiliates, (collectively, “APP”). MDCO and APP are collectively referred to herein as the “Parties,” or each individually as a “Party.”

R E C I T A L S:

WHEREAS , MDCO is the owner of New Drug Application No. 20-873, which was approved by the Food and Drug Administration (“FDA”) for the manufacture and sale of a bivalirudin for injection product, which MDCO sells under the tradename Angiomax;

WHEREAS , APP Pharmaceuticals, LLC submitted Abbreviated New Drug Application (“ANDA”) No. 90-189 (together with any amendments, supplements, or other changes thereto, the “APP ANDA”) to the FDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §355(j)) seeking approval to engage in the manufacture, use and sale of the bivalirudin for injection product that is the subject of the APP ANDA (the “APP Product”);

WHEREAS , APP subsequently amended the APP ANDA to include a “paragraph IV certification” seeking approval to engage in the manufacture, use and sale of the APP Product prior to the expiration of United States Patent Nos. 7,582,727 and 7,598,343 (the “Litigated Patents”);

WHEREAS , MDCO has prosecuted, and APP has defended, an action for alleged patent infringement in the United States District Court for the District of Delaware (the “Court”) regarding the APP ANDA and the APP Product, which action is captioned The Medicines Company v. APP Pharmaceuticals, LLC et al. , consolidated under Civil Action No. 09-750 (the “Pending Litigation”);

WHEREAS , APP has filed an appeal before the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”), which appeal is captioned The Medicines Company v. Kappos et al. , No. 10-1534 (Fed. Cir.) (the “Pending Appeal”);

WHEREAS , MDCO and APP wish to settle the Pending Litigation and dismiss the Pending Appeal and have reached an agreement, pursuant to the terms and conditions set forth in this Settlement Agreement together with an associated License Agreement (the “License Agreement,” attached hereto as Exhibit A), an agreed Judgment, Dismissal and Order of Permanent Injunction with regard to the Pending Litigation (the “Consent Judgment,” attached hereto as Exhibit B), a Joint Dismissal of the Pending Appeal (the “Joint Dismissal,” attached hereto as Exhibit C), a Contract Manufacturing Agreement (the “Contract Manufacturing Agreement,” attached hereto as Exhibit D), a License and Supply Agreement, (the “License and Supply Agreement,” attached hereto as Exhibit E), an AG Supply Agreement (the “AG Supply Agreement,” attached hereto as Exhibit F) (and together with the Settlement Agreement, the License Agreement, the Consent Judgment, the Joint Dismissal, the Contract Manufacturing Agreement, the License and Supply Agreement, and the AG Supply Agreement, being collectively referred to as the “Settlement Documents”);

WHEREAS , neither MDCO nor APP have received any consideration from the other for their entry into this Settlement Agreement other than that which is set forth in the Settlement Documents; and

WHEREAS , the Settlement Documents constitute both MDCO's and APP's best independent judgment as to the most convenient, effective and expeditious way to mutually settle all disputes that have arisen associated with the APP ANDA.

NOW, THEREFORE , in consideration of the mutual covenants and agreements described herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

1. Capitalized terms used, but not defined herein, shall have the meanings ascribed to them in the License Agreement.

2. The Parties consent to the jurisdiction of the Court for the purposes of the settlement of the Pending Litigation.

3. The Parties agree that the Court has jurisdiction over the Pending Litigation and over MDCO and APP, and that venue is proper in the District of Delaware.

4. APP admits that the Litigated Patents, and all the claims contained therein, were infringed by the filing of the APP ANDA and absent a license from MDCO would be infringed by the making, sale, offering for sale, use, and/or import of the APP Product in the Territory.

5. APP admits that the Litigated Patents, and all the claims contained therein, are valid and enforceable. For the avoidance of doubt and solely with respect to the Litigated Patents, the foregoing in this Section 5, the foregoing Section 4 and clause (i) of Section 3.2 of the License Agreement shall not be applied with respect to (i) any jurisdiction outside of the United States, or (ii) any patents other than the Litigated Patents.

6. APP agrees that except as is otherwise expressly provided for in the License Agreement, it shall not make, use, sell, offer for sale or import, directly or indirectly the APP Product.

7. [**].

8. APP represents, warrants, and covenants that it has not granted or assigned to any third party, directly or indirectly, any right or license under or to the APP ANDA or the APP Product, and that it will not do any of the foregoing (including, selling, assigning, transferring, or divesting the APP ANDA to a Third Party), except in conjunction with the assignment of the License Agreement as provided in Section 11.3.2 of the License Agreement. MDCO represents, warrants, and covenants that MDCO is the sole owner of the Litigated Patents, MDCO possess the sole right to enforce the Litigated Patents, and MDCO has not granted or assigned to any Third Party or Affiliate, directly or indirectly, any right under any of the Litigated Patents that would allow such Third Party or Affiliate to sue APP for infringement of any of the Litigated Patents based on APP making, using, selling, offering for sale or importing the APP Product, and that MDCO will not do any of the foregoing, except as provided in the License Agreement.

9. MDCO and APP each represents and warrants that it has the full right, authority and power to enter into this Settlement Agreement on its own behalf and that this Settlement Agreement shall create and constitute a binding obligation on its part as of the Effective Date.

10. MDCO and APP shall each execute the License Agreement contemporaneously with the execution of this Settlement Agreement, and any breach of the License Agreement shall constitute a breach of this Settlement Agreement.

11. From the execution of this Settlement Agreement, and unless the Settlement Agreement is terminated, neither Party will actively pursue litigation activities related to the Pending Litigation or the Pending Appeal, except to the extent required by court order or other Applicable Law. In consideration of the benefits of

entering into the Settlement Documents, the Parties, through their respective attorneys, shall enter into and cause to be filed within three (3) Business Days of the Effective Date, the Consent Judgment in the Court and the Joint Dismissal of the Pending Appeal. In the event that the Court should refuse to enter the Consent Judgment, the Parties shall work together in good faith to modify the Consent Judgment to meet the requirements of the Court, provided that nothing contained herein shall be deemed to require a Party to agree to a modification of the Consent Judgment or any other Settlement Document that materially affects the economic value of the transactions contemplated hereby. If despite such good faith efforts the Court refuses within thirty (30) days of the Effective Date to enter a consent judgment in the Pending Litigation that the Litigated Patents are infringed by the APP Product in the absence of a license, this Settlement Agreement and Settlement Documents shall be null and void ab initio .

12. The Parties shall submit the Settlement Documents to the Federal Trade Commission Bureau of Competition (the “Commission”) and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice (the “DOJ”) as soon as practicable following the Effective Date and in no event later than ten (10) Business Days following the Effective Date. The Parties shall use all reasonable efforts to coordinate the making of such filings and respond promptly to any requests for additional information made by either of such agencies. Each Party reserves the right to communicate with the Commission or the DOJ regarding such filings as it believes appropriate. Each Party shall keep the other reasonably informed of such communications and shall not disclose the Confidential Information of the other without such other Party's consent (not to be unreasonably withheld). To the extent that any legal or regulatory issues or barriers arise with respect to the Settlement Documents, or any subpart thereof, the Parties shall work together in good faith and use reasonable efforts to modify the Settlement Documents to overcome any such legal or regulatory issues (including, for example, objections by the Commission, the DOJ or any applicable court) in a mutually acceptable fashion, but in no event shall either Party be required to agree to any modification of the Settlement Documents that materially affects the economic value of the transactions contemplated hereby. For purposes of this Settlement Agreement, “reasonable efforts” shall mean reasonable efforts and commitment of resources consistent with such Party's similarly situated products or projects in order to achieve a stated goal as expeditiously as practical.

13. Within five (5) Business Days of the later of (i) the Court entry of the Consent Judgment, and (ii) the entry of the Joint Dismissal in the Pending Appeal, MDCO shall make a single payment to APP in the amount of [**] United States dollars ($[**]), by wire transfer to an account designated by APP, in recognition of the savings inuring to MDCO in terms of the avoidance of costs, expenditure of time and resources, disruption and burden associated with prosecuting the Pending Litigation. Except as set forth above, MDCO and APP each will bear its own costs and legal fees for the Pending Litigation and Pending Appeal.

14. The terms of the Settlement Documents and the negotiations of the Parties pertaining to them shall be maintained in confidence by the Parties. Without limiting the generality of the foregoing, neither Party or its counsel shall provide discovery (including without limitation documents, oral testimony and/or statements whether by deposition or otherwise, the work of outside experts or consultants, or work product embodying any of the above) to any Third Party in any judicial or arbitral proceeding in the Territory pertaining to the Settlement Documents. Notwithstanding these obligations, (i) a Party may issue a press release with the prior written consent of the other Party (such consent to be at the sole discretion of such other Party); (ii) MDCO may issue a press release in the form attached as Schedule 11.5 of the License Agreement, and APP may issue a press release in the form attached as Schedule 11.6 of the License Agreement; (iii) either Party may disclose such terms in discovery as otherwise required by court order, provided that the other Party shall be given the opportunity to (a) review and comment on the proposed disclosure reasonably in advance of the disclosure, and (b) quash such order and to obtain a protective order requiring that the information and documents that are the subject of such order be held in confidence by such court; (iv) MDCO may disclose (a) to a Third Party (a “Settling Party”), who is identified in writing to APP in advance of any disclosure, the terms set forth in Sections 2 and 4 (along with the defined terms in Section 1 referenced in those provisions) of the License Agreement that trigger a most favored nations provision in a settlement relating to the Litigated Patents, the '404 Patent, or Angiomax between MDCO and such Settling Party, provided that such disclosure is only for purposes of establishing whether and to what extent such a most favored nations provision has been triggered and such Settling Party has agreed in writing to maintain the confidentiality of

such terms of the Settlement Documents and not to use such terms other than in connection with such purpose and no other purpose, and (b) to a person unaffiliated with such Settling Party and acceptable to MDCO Sections 2 and 4 (along with the defined terms in Section 1 referenced in those provisions) of the License Agreement solely to assess the applicability of the most favored nations provision to the terms disclosed to such Settling Party, provided that such unaffiliated person has agreed in writing to maintain the confidentiality of the Settlement Documents and not to use such terms other than in connection with such assessment and no other purpose; (v) either Party may disclose such terms to such Party's actual and prospective investors and lenders, attorneys, accountants, insurers and FDA consultants on a need-to-know basis and who have agreed in writing and in advance to maintain the confidentiality of such information in accordance with the confidentiality provisions set forth herein; (vi) APP may disclose such terms to the FDA as may be necessary or useful in obtaining and maintaining Regulatory Approval of the APP ANDA and Launching the APP Product as provided by the License Agreement, so long as APP requests that the FDA maintain such terms in confidence, (vii) APP may disclose such terms to its manufacturers, suppliers, distributors, marketing partners and customers in accordance with APP's exercise of its pre-Launch rights set forth in Sections 2.1 and 3.1 of the License Agreement; and (viii) either Party may disclose such terms as otherwise required by Law, including without limitation SEC reporting requirements, or by the rules or regulations of any stock exchange to such Party is subject; provided that, the Parties will coordinate in advance with each other in connection with the redaction of certain provisions of the Settlement Documents with respect to any SEC filings, and each Party shall use reasonable efforts to seek confidential treatment for such terms; provided, however, that each Party shall ultimately retain control over what information to disclose to the SEC or any other such agencies.

15. This Settlement Agreement shall terminate upon the earlier to occur of (i) expiration of the Litigated Patents and any statutory or regulatory extensions and (ii) termination of the License Agreement, provided that Sections 14 through 16 shall survive any termination of this Settlement Agreement.

16. In the event that any of the provisions of this Settlement Agreement shall be held by a court or other tribunal of competent jurisdiction to be illegal, invalid or unenforceable in any jurisdiction, such provisions shall be limited or eliminated in such jurisdiction to the minimum extent necessary so that this Settlement Agreement shall otherwise remain in full force and effect. Such invalidity or unenforceability will not affect either the balance of such provision, to the extent it is not invalid or unenforceable, or the remaining provisions hereof, nor render invalid or unenforceable such provision in any other jurisdiction. This Settlement Agreement shall be governed by the laws of the State of Delaware without regard to the conflicts of law provisions thereof. The Parties irrevocably agree that the Court shall have exclusive and sole jurisdiction to deal with any disputes arising out of or in connection with this Settlement Agreement and that, accordingly, any proceedings arising out of or in connection with this Settlement Agreement shall be brought in the Court. Notwithstanding the foregoing, if there is any dispute for which the Court does not have subject matter jurisdiction, the state courts in Wilmington, Delaware shall have jurisdiction. In connection with any dispute arising out of or in connection with this Settlement Agreement, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of Delaware. The Settlement Documents supersede all prior discussions and writings of the Parties, and constitute the entire agreement between the Parties with respect to the subject matter contained therein. No waiver or modification of this Settlement Agreement will be binding upon either Party unless made in writing and signed by a duly authorized representative of such Party and no failure or delay in enforcing any right will be deemed a waiver. Notices hereunder will be effective only if in writing and upon receipt if delivered personally or by overnight mail carrier or fax transmission or other electronic means, or three (3) Business Days after deposit in the U.S. mail, first class postage prepaid to the applicable addressee sent forth in Section 11.2 of the License Agreement. The prevailing Party in any action to enforce this Settlement Agreement shall be entitled to costs and fees (including attorneys' fees and expert witness fees) incurred in connection with such action. In making and performing this Settlement Agreement, the Parties are acting and shall act as independent contractors. Nothing in this Settlement Agreement shall be deemed to create an agency, joint venture or partnership relationship between the Parties. This Settlement Agreement shall become binding when any one or more counterparts hereof, individually or taken together, bears the signatures of each of the Parties. This Settlement Agreement may be executed in any number of counterparts (including fax or electronic counterparts), each of which shall be an original as against a Party whose signature appears thereon, but all of which taken together shall constitute one and the same instrument. Each Party shall, without further consideration, execute and deliver additional documents and instruments and perform all other

and further actions as may be necessary or reasonably requested in order to carry out the purposes and intentions of this Settlement Agreement.

[Signature Page Follows]

[Signature Page to Settlement Agreement Regarding Bivalirudin Injection Product]

IN WITNESS WHEREOF, the Parties hereto have each caused this Settlement Agreement to be executed by their authorized representatives as of the Effective Date.

THE MEDICINES COMPANY

Date: _______________ By: _____ /s/ Glenn Sblendorio _________________

Name: ____ Glenn Sblendorio ________________

Title: _______ EVP and CFO _________________

APP PHARMACEUTICALS, LLC

Date: _ 1/22/12 __________ By: ____ /s/ J.R. Ducker ___________________

Name: __ J.R. Ducker ______________________

Title: ___ President & CEO _________________

APP PHARMACEUTICALS, INC.

Date: _ 1/22/12 __________ By: ____ /s/ J.R. Ducker ___________________

Name: __ J.R. Ducker ______________________

Title: ___ President & CEO _________________

EXHIBIT A

LICENSE AGREEMENT

BY AND AMONG

THE MEDICINES COMPANY

AND

APP PHARMACEUTICALS, LLC AND APP PHARMACEUTICALS, INC.

DATED AS OF JANUARY 22, 2012

Incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the fiscal period ended March 31, 2012.

EXHIBIT B

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE



THE MEDICINES COMPANY, Plaintiff, v. TEVA PARENTERAL MEDICINES, INC., TEVA PHARMACEUTICALS USA, INC. and TEVA PHARMACEUTICAL INDUSTRIES, LTD. Defendants.	) ) ) ) )C.A. No. 09-750 (RGA) )(Consolidated) ) ) ) ) ) )

CONSENT JUDGMENT, DISMISSAL AND ORDER OF PERMANENT INJUNCTION

This action for patent infringement having been brought by Plaintiff The Medicines Company (“MDCO”) against Defendants APP Pharmaceuticals, LLC, and APP Pharmaceuticals, Inc. (collectively “APP”) for infringement of United States Patent Nos. 7,582,727 and 7,598,343 (the “Litigated Patents”);

APP and MDCO have entered into a Settlement Agreement, under which MDCO will grant APP a license to the Litigated Patents (the “License”), pursuant to the terms and conditions in the Settlement Agreement and License;

APP acknowledges that the Litigated Patents, and all the claims contained therein, are valid and enforceable; and

APP acknowledges that selling, offering for sale, using and/or importing into the United States a lyophilized product containing bivalirudin under Abbreviated New Drug Application No. 90-189 (“APP's Product”) would infringe each of the Litigated Patents in the absence of a license.

MDCO and APP now consent to this Judgment and Order.

IT IS HEREBY ORDERED, ADJUDGED AND DECREED:

1. This Court has jurisdiction over the parties and subject matter of this action.

2. APP would infringe each of the Litigated Patents by using, making, selling, offering to sell, and/or importing APP's Product in the United States.

3. The Litigated Patents, and all the claims contained therein, are valid and enforceable in all respects.

4. All affirmative defenses, claims and counterclaims which have been or could have been raised by APP in this action with respect to the Litigated Patents are dismissed with prejudice.

5. Except as authorized and licensed by MDCO under the Settlement Agreement and License, APP, its officers, agents, servants, employees, affiliates, successors and all persons in active concert or participation with APP, are permanently enjoined from using, offering for sale, making, selling, or manufacturing in the United States, or importing into the United States, APP's Product and/or inducing or assisting others to use, offer for sale, make, sell, or manufacture in the United States, or import into the United States, APP's Product.

6. In any other or future cause of action or litigation in the United States, APP shall not dispute that the Litigated Patents are each infringed by using, making, selling, offering to sell, and/or importing APP's Product. The foregoing in this Paragraph 6 shall not apply to any product other than APP's Product.

7. In any other or future cause of action or litigation in the United States, APP shall not dispute that all the claims of the Litigated Patents are valid and enforceable in all respects.

8. The foregoing injunctions against APP shall take effect immediately upon entry of this Judgment and Order by the Court, and shall continue until the expiration of the Litigated Patents.

9. This Judgment and Order is binding upon and constitutes claim preclusion and issue preclusion between the parties in this action or in any other action in the United States between the parties with respect to: (i) the validity and enforceability of the Litigated Patents, and (ii) infringement of the Litigated Patents by using, making, selling, offering to sell, and/or importing APP's Product. The foregoing in Paragraph 9(ii) shall not apply to any product other than APP's Product.

10. The parties waive all right to appeal from this Judgment and Order.

11. This Court shall retain jurisdiction of this action and over the parties for purposes of enforcement of the provisions of this Judgment and Order.

12. Each party is to bear its own costs and attorneys fees.

Dated: ____________



Frederick L. Cottrell, III (#2555) Laura D. Hatcher (#5098) Richards, Layton & Finger P.A. One Rodney Square P.O. Box 551 Wilmington, DE 19899 Telephone: (302) 651-7700 Facsimile: (302) 651-7701 Edgar H. Haug Porter F. Fleming Angus Chen Frommer Lawrence & Haug LLP 745 Fifth Avenue New York, NY 10151 Telephone: (212) 588-0800 Facsimile: (212) 588-0500	Elena C. Norman (No. 4780) Monté T. Squire (No. 4764) Jeffrey T. Catellano (No. 4837) Young Conaway Stargatt & Taylor, LLP The Brandywine Building 1000 West Street, 17th Floor Wilmington, DE 19801 (302) 571-5029 Emily A. Evans Christopher Robinson Morrison & Foerster LLP 755 Page Mill Road Palo Alto, CA 94304 (650) 813-5600

SO ORDERED

Dated: __________

______________________________________

THE HON. RICHARD G. ANDREWS

UNITED STATES DISTRICT JUDGE

EXHIBIT C

No. 2010-1534

IN THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

THE MEDICINES COMPANY

Plaintiff-Appellee,

DAVID J. KAPPOS, Undersecretary of Commerce for Intellectual Property and Director, United States Patent and Trademark Office, UNITED STATES PATENT AND TRADEMARK OFFICE, MARGARET A. HAMBURG, Commissioner, UNITED STATES FOOD AND DRUG ADMINISTRATION, KATHLEEN SEBELIUS, Secretary of Heath and Human Services, and DEPARTMENT OF HEALTH AND HUMAN SERVICES,

Defendants,

APP PHARMACEUTICALS, LLC,

Movant-Appellant,

and

United States,

Intervenor

Appeal from the United States District Court for the Eastern District of Virginia

in case no. 10-CV-0286, Senior Judge Claude M. Hilton

AGREED MOTION TO DISMISS APPEAL

Pursuant to Rule 42(b) of the Federal Rules of Appellate Procedure, Movant-Appellant APP Pharmaceuticals, LLC, hereby moves, with agreement from Plaintiff-Appellee The Medicines Company, to dismiss the appeal with prejudice in light of a settlement reached by Movant-Appellant and Plaintiff-Appellee. Each party agrees to bear its own costs and fees due.

Dated: January __, 2012 Respectfully submitted,

Deanne E. Maynard

Marc A. Hearron

Morrison & Foerster LLP

2000 Pennsylvania Ave., N.W.

Washington, D.C. 20006

Telephone: 202.887.8740

Emily A. Evans

Morrison & Foerster LLP

755 Page Mill Road

Palo Alto, CA 94304

Telephone: 650.813.5600

Counsel for Movant-Appellant App

Pharmaceuticals, LLC

Peter D. Keisler

Jeffrey P. Kushan

C. Frederick Beckner III

Lowell J. Schiller

Sidley Austin LLP

1501 K Street, N.W.

Washington, D.C. 20005

Telephone: 202.736.8000

Counsel for Plaintiff-Appellee The

Medicines Company

Exhibit D

Contract Manufacturing Agreement is incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q for the fiscal period ended March 31, 2012.

Exhibit E

License and Supply Agreement is incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q for the fiscal period ended March 31, 2012.

Exhibit F

AG Supply Agreement is incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q for the fiscal period ended March 31, 2012.



	Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.			Exhibit 10.2

LICENSE AGREEMENT

BY AND AMONG

THE MEDICINES COMPANY

AND

APP PHARMACEUTICALS, LLC AND APP PHARMACEUTICALS, INC.

DATED AS OF JANUARY 22, 2012

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “Agreement”) is entered into as of January 22, 2012 (the “Effective Date”) by and between, on the one hand The Medicines Company, a company organized and existing under the laws of the State of Delaware with offices located at 8 Sylvan Way, Parsippany, New Jersey 07054 and its Affiliates (collectively, “MDCO”), and, on the other hand, APP Pharmaceuticals, LLC, a limited liability company organized and existing under the laws of the State of Delaware with offices at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 and its Affiliates, and APP Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware with offices at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 and its Affiliates, (collectively, “APP”). MDCO and APP are collectively referred to herein as the “Parties,” or each individually as a “Party.”

R E C I T A L S:

WHEREAS , MDCO is the owner of NDA (as defined below) No. 20-873, which was approved by the FDA (as defined below) for the Manufacture (as defined below) and sale of Angiomax (as defined below);

WHEREAS, APP Pharmaceuticals, LLC submitted Abbreviated New Drug Application No. 90-189 (together with any amendments, supplements, or other changes thereto, the “APP ANDA”) to the FDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §355(j)) seeking approval to engage in the manufacture, use and sale of the bivalirudin for injection product that is the subject of the APP ANDA (the “APP Product”);

WHEREAS, APP subsequently amended the APP ANDA to include a “paragraph IV certification” seeking approval to engage in the manufacture, use and sale of the APP Product (as defined below) prior to the expiration of United States Patent Nos. 7,582,727 and 7,598,343 (the “Litigated Patents”);

WHEREAS , APP admits that the APP Product infringes the Litigated Patents and that the Litigated Patents are valid and enforceable;

WHEREAS , MDCO and APP are parties to a certain Settlement Agreement of even date herewith (the “Settlement Agreement”), pursuant to which MDCO and APP are settling pending litigation; and

WHEREAS , pursuant to the Settlement Agreement, MDCO and APP have agreed to enter into this Agreement.

NOW THEREFORE , in consideration of the foregoing premises, the mutual covenants and agreements described herein and in the Settlement Agreement, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

1. Definitions . Capitalized terms used, but not defined herein, shall have the meanings ascribed to them in the Settlement Agreement.

1.1 “'404 Patent” means U.S. Patent No. 5,196,404.

1.2 “Accelerated Launch Date” means the earlier of: [**].

1.3 “Affiliate” means a Person that controls, is controlled by or is under common control with a Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one

or more intermediaries, to direct the management and policies of such Person, whether by the ownership of fifty percent (50%) or more of the voting interest of such Person (it being understood that the direct or indirect ownership of a lesser percentage of such interest shall not necessarily preclude the existence of control), or by contract or otherwise.

1.4 “AG Product” means a generically Labeled lyophilized product containing the Compound that is Marketed and/or supplied under MDCO's NDA, described therein now or hereafter.

1.5 “AG Supply Agreement” shall have the meaning assigned to such term in the Settlement Agreement.

1.6 “Agreement” shall have the meaning assigned to such term in the preamble to this Agreement.

1.7 “ANDA” means an Abbreviated New Drug Application submitted to the FDA for approval to Manufacture and/or Market and/or import a pharmaceutical product in or for the Territory.

1.8 “Angiomax” means any pharmaceutical product which is approved for Marketing in the Territory pursuant to MDCO's NDA; provided that Angiomax shall not include a product containing an active pharmaceutical ingredient in addition to the Compound.

1.9 “Anticipated Launch Date” means May 1, 2019.

1.10 “APP” shall have the meaning assigned to such term in the preamble to this Agreement.

1.11 “APP AG Product” means AG Product supplied to APP pursuant to the AG Supply Agreement.

1.12 “APP AG Product Gross Profits” means the Net Sales for APP AG Product less the APP AG Product Manufacturing Costs.

1.13 “APP AG Product Manufacturing Costs” for APP AG Product shall mean, respectively, [**].

1.14 “APP ANDA” shall have the meaning assigned to such term in the Recitals, [**].

1.15 “APP Attorney or Agent” shall have the meaning assigned to such term in Section 3.7.

1.16 “APP AG Launch Date” means any of the following dates:

1.16.1 [**];

1.16.2 [**]; and

1.16.3 [**].

1.17 “APP Launch Date” means the earlier of:

1.17.1 [**];

1.17.2 [**];

1.17.3 [**]; and

1.17.4 [**].

1.18 “APP Liability” shall have the meaning assigned to such term in Section 7.2.

1.19 “APP Party” shall have the meaning assigned to such term in Section 7.1.

1.20 “APP Product” means any product which is the subject of the APP ANDA, [**].

1.21 “Applicable Law” means the applicable Laws, rules, regulations, guidelines and requirements of any Governmental Authority related to the development, registration, Manufacture, Marketing or importation of the APP Product in or for the Territory or the performance of either Party's obligations under the Settlement Documents.

1.22 “[**]” means the [**].

1.23 “[**]” means the [**].

1.24 “Authorized AG Product” means an AG Product: (i) authorized, whether pursuant to a license, supply arrangement, covenant not to sue, release, waiver or the like, for Marketing pursuant to an agreement between MDCO and a Third Party; [**].

1.25 “Authorized Generic ANDA Product” means [**].

1.26 “Authorized Launch Date” means the [**].

1.27 “Business Day” means any day other than a Saturday, Sunday or a day on which banks in New York, New York are authorized or required by Law to close.

1.28 “Claim” means any Third Party claim, lawsuit, investigation, proceeding, regulatory action or other cause of action.

1.29 “Commercially Reasonable Efforts” means efforts and diligence in accordance with the subject Party's reasonable and sound business, legal, medical and scientific judgment and in accordance with the efforts and resources such Party would use in other aspects of its business that have similar commercial value and market potential, taking into account the competitiveness of the marketplace, the business life-cycle, the proprietary position of the company and the company's profitability of the pertinent product.

1.30 “Compound” means bivalirudin.

1.31 “Confidential Information” means any scientific, technical, formulation, process, Manufacturing, clinical, non-clinical, regulatory, Marketing, financial or commercial information or data relating to the business, projects, employees or products of either Party and provided by one Party to the other by written, oral, electronic or other means in connection with this Agreement.

1.32 “Consent Judgment” shall have the meaning assigned to such term in the Settlement Agreement.

1.33 “Covenant Not to Sue” shall have the meaning assigned to such term in Section 3.5.

1.34 “[**]” means the [**].

1.35 “[**]” shall have the meaning assigned to such term in Section 3.10.1.

1.36 “Effective Date” shall have the meaning assigned to such term in the preamble to this Agreement.

1.37 “FDA” means the United States Food and Drug Administration or any successor agency thereof.

1.38 “Final Court Decision” means a final decision of any Federal court from which no appeal has been or can be taken (other than a petition to the United States Supreme Court for a writ of certiorari).

1.39 “[**]” means [**].

1.40 “First Commercial Sale” means the Shipment of commercial quantities of product for immediate commercial sale to major retail chains, major pharmaceutical wholesalers, or managed care providers in the Territory, [**].

1.41 “Force Majeure” means any circumstances reasonably beyond a Party's control, including, acts of God, civil disorders or commotions, acts of aggression, fire, explosions, floods, drought, war, sabotage, embargo, utility failures, supplier failures, material shortages, labor disturbances, a national health emergency, or appropriations of property.

1.42 “GAAP” means generally accepted accounting principles in effect in the United States from time to time, consistently applied.

1.43 “Generic Equivalent Product” means any lyophilized pharmaceutical product containing the Compound as its sole active ingredient which is submitted to the FDA for Regulatory Approval pursuant to an ANDA as a Therapeutic Equivalent to Angiomax.

1.44 “Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of: (i) any government of any country; or (ii) a federal, state, province, county, city or other political subdivision thereof.

1.45 “IMS Data” means the use and prescription data available from IMS Health Incorporated or substantially similar data available from any successor entity.

1.46 “Label” means any Package labeling designed for use with a product, including the package insert for such product that is approved by the FDA, and “Labeled” or “Labeling” shall have the correlated meaning.

1.47 “Launch” means the first Shipment of APP Product by APP to an unaffiliated Third Party.

1.48 “Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances of any Governmental Authority.

1.49 “License and Authorization” shall have the meaning assigned to such term in Section 2.2.

1.50 “Litigated Patents” shall have the meaning assigned to such term in the Recitals.

1.51 “Losses” means any liabilities, damages, costs or expenses, including reasonable attorneys' fees and expert fees, incurred by any Party that arises from any claim, lawsuit or other action by a Third Party.

1.52 “Manufacture” means all activities related to the manufacturing, development and use of a pharmaceutical product, or any ingredient thereof, including, manufacturing Compound or supplies for development, manufacturing a product for commercial sale, packaging, in-process and finished product testing,

release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests and regulatory activities related to any of the foregoing, and “Manufactured” or “Manufacturing” shall have the correlated meaning.

1.53 “Market” means to distribute, promote, advertise, market, offer for sale or sell, to a Third Party, and “Marketing” or “Marketed” shall have the correlated meaning.

1.54 “MDCO” shall have the meaning assigned to such term in the preamble to this Agreement.

1.55 “MDCO Liability” shall have the meaning assigned to such term in Section 7.1.

1.56 “MDCO Party” shall have the meaning assigned to such term in Section 7.2.

1.57 “MDCO's External Auditor” shall have the meaning assigned to such term in 5.7.

1.58 “MDCO's NDA” means MDCO's NDA No. 20-873, as amended, or supplemented, for the Regulatory Approval of Angiomax.

1.59 “MDCO's Patents” means: (i) the Litigated Patents and any patent that issues as a result of a continuation, continuation-in-part, divisional, reexamination or reissue thereof; and (ii) except for the '404 Patent, any other present or future U.S., international, or foreign patent owned, licensed or controlled by MDCO or any of its Affiliates which claims cover the Manufacturing, Marketing, using, or importing of the APP Product or APP AG Product. [**].

1.60 “Net Sales” shall equal the gross amount invoiced for sales of the APP AG Product by APP to Third Parties in the Territory less the following, deductions from such gross sales, all as determined in accordance with APP's standard practices for other pharmaceutical products and consistent with the customary practices in the generic pharmaceutical industry in the Territory, consistently applied, and which, as applicable, are actually incurred, allowed, accrued or specifically allocated. For the sake of clarity, all such deductions represent reductions to the gross amount invoiced for sales of the APP AG Product by APP to Third Parties in the Territory in accordance with GAAP:

1.60.1 [**] percent ([**]%) of gross sales for cash discounts;

1.60.2 reasonable estimates for chargebacks, rebates, administrative fee arrangement and similar price concessions offered 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 directly related to the sale of APP AG Product;

1.60.3 reasonable estimates for customer returns of APP AG Product (including as a result of recalls);

1.60.4 reasonable estimates for rebates or other price reductions provided, based on sales of APP AG Product to any governmental or regulatory authority in respect of state or federal Medicare, Medicaid or similar programs; and

1.60.5 reasonable estimates for billing adjustments, price or shelf stock adjustments, or other promotional allowances.

1.61 “NDA” means a New Drug Application (or equivalent regulatory mechanism) filed with the FDA pursuant to and under 21 U.S.C. § 355(b) (as amended, supplemented or replaced), together with the FDA's implementing rules and regulations.

1.62 “Package” means all primary containers, including bottles, cartons, shipping cases or any other like matter used in packaging or accompanying a product, and “Packaged” or “Packaging” shall have the correlated meaning.

1.63 “Party” or “Parties” shall have the meaning assigned to such term in the preamble to this Agreement.

1.64 “Patent Term Extension” means any extension of the patent term of the '404 Patent beyond March 23, 2010 for any reason including, but not limited to, legislative, judicial actions or action by the U.S. Patent and Trademark Office.

1.65 “Pending Appeal” shall have the meaning assigned to such term in the Settlement Agreement.

1.66 “Pending Litigation” shall have the meaning assigned to such term in the Settlement Agreement.

1.67 “Person” means any individual, partnership, association, corporation, limited liability company, trust, or other legal person or entity.

1.68 “Regulatory Approval” means final Marketing approval by the FDA for the sale and Marketing of a pharmaceutical product in the Territory.

1.69 “[**]” shall have the meaning assigned to such term in Section 2.2.

1.70 “Settlement Agreement” shall have the meaning assigned to such term in the Recitals.

1.71 “Settling Party” shall have the meaning assigned to such term in Section 11.5.

1.72 “Shipped” means, with respect to a product, when a Person has delivered shipments of such product to a common carrier for shipment to its customers for resale; in each instance, a “Shipment,” “Ship” or “Shipping” shall have the correlated meaning.

1.73 “[**]” means [**].

1.74 “Term” shall have the meaning assigned to such term in Section 10.1.

1.75 “Territory” means the United States of America, and its territories, commonwealths, districts and possessions, including the Commonwealth of Puerto Rico.

1.76 “Therapeutic Equivalent” shall have the meaning given to it by the FDA in the current edition of the “Approved Drug Products with Therapeutic Equivalence Evaluations” (a/k/a the “Orange Book”) as may be amended from time to time during the Term.

1.77 “Third Party” or “Third Parties” means any Person or entity other than a Party or its Affiliates.

1.78 “Third Party License” shall have the meaning assigned to such term in Section 3.10.1.

2. License and Authorization

2.1 Subject to the terms, conditions and limitations hereof, including the conditions set forth in

Section 3, MDCO hereby grants to APP a non-exclusive license (except as provided in Section 2.2), under MDCO's Patents to: (i) Manufacture, have Manufactured, import and Market the APP Product in or for the Territory, on and after the applicable APP Launch Date; (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding APP Product prior to the APP Launch Date (but not to Market (except as provided in Section 3.1) or Ship the APP Product prior to the APP Launch Date) in sufficient quantities for the Launch of APP Product and to permit APP to Market and Ship the APP Product beginning on and after the APP Launch Date; and (iii) [**]. To the extent MDCO owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval of the APP Product or APP's Manufacture, importing or Marketing of APP Product in the Territory as permitted hereunder, MDCO hereby waives, effective as of the date that APP is licensed to conduct the applicable activity hereunder, such exclusivities and shall, if requested by APP and if applicable, send the FDA (within [**] Days of APP's request), a written confirmation (a copy of which shall be sent to APP prior to submission to the FDA for APP's review and comment) of MDCO's agreement to waive, effective as of the date that APP is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the APP Product and/or the APP ANDA; provided, however, that the foregoing waiver shall not apply with respect to any pediatric exclusivity attached to the '404 Patent.

2.2 The license and authorization granted in Section 2.1 of this Agreement are referred to herein as the “License and Authorization.” Except to the extent permitted pursuant to Section 11.3, and without derogating from APP's “have Manufactured” rights set forth in Section 2.1, APP shall not have the right to sublicense, assign or transfer any of its rights under the License and Authorization. [**].

2.3 [**].

2.4 [**].

2.5 Except as set forth in the License and Authorization or expressly set forth in this Agreement, there are no authorizations, licenses or rights granted by either Party under this Agreement, by implication, estoppel or otherwise, including any right granted to APP to Market or Manufacture any Generic Equivalent Product except under the APP ANDA. Nothing herein shall be construed as the granting of any license or right to or under the '404 Patent. All rights not expressly granted by MDCO herein are hereby retained by MDCO. In addition, except as set forth in Section 2.2, MDCO explicitly retains the right itself or through an Affiliate to Market a generically Labeled version of Angiomax, and MDCO is free to grant a license under MDCO's Patents and/or supply AG Product to any Third Party.

3. Conditions

3.1 APP hereby agrees that it shall not Market or Ship APP Product in the Territory prior to the applicable APP Launch Date. Notwithstanding the foregoing, APP shall be permitted (i) [**] days in advance of the Anticipated Launch Date [**] to inform potential customers of the date on which APP would be permitted to sell the APP Product or APP AG Product; and (ii) [**] days in advance of the Anticipated Launch Date [**] to engage in confidential non-binding and preliminary pricing and non-binding and preliminary contracting activities with respect to the APP Product or APP AG Product.

3.2 APP hereby agrees not to (i) challenge, or in any way support or lobby for legislation that would affect, any Patent Term Extension or the validity or enforceability of the Litigated Patents or the '404 Patent; (ii) aid, abet, assist, enable or participate with any Third Party in a challenge to, or in supporting or lobbying in any way for legislation that would affect, any Patent Term Extension or the validity or enforceability of the Litigated Patents or the '404 Patent or the non-infringement by a Generic Equivalent Product sold by a Third Party of the Litigated Patents or the '404 Patent in or for the Territory, except to the extent required by court order or other Applicable Law; (iii) Market or Manufacture a Generic Equivalent Product other than the APP Product pursuant to the License and Authorization; or (iv) aid, abet, enable or contract with any Third Party regarding the Marketing or Manufacturing of any Generic Equivalent Product in or for the Territory other than the APP Product. [**].

3.3 In addition to any other right or remedy MDCO may be entitled to, in the event that during the Term, APP breaches Sections 3.2 or 3.7, MDCO may, at its sole discretion, immediately, effective upon notice to APP, terminate the Settlement Documents, and/or this Agreement.

3.4 Nothing set forth herein or in the other Settlement Documents shall be deemed to give MDCO any control over any Marketing exclusivity that may be granted to APP by the FDA in connection with the APP ANDA or the APP Product. Nothing set forth herein or in the other Settlement Documents shall be deemed to prevent or restrict APP from Manufacturing or Marketing any Generic Equivalent Product which would not infringe MDCO's Patents, and nothing herein shall prohibit APP from entering into any agreement with a Third Party related to any Generic Equivalent Product that does not infringe MDCO's Patents.

3.5 MDCO hereby covenants that it will not sue, assert any claim or counterclaim against, otherwise participate in any action or proceeding against APP or its Affiliates or any of their shareholders, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors, marketing partners, insurers, or any heirs, administrators, executors, predecessors, successors, or assigns of the foregoing, or cause or authorize any person or entity to do any of the foregoing, in each case claiming or otherwise asserting that the Manufacture or use anywhere in the world for exportation into the Territory, or the Marketing, sale, offer for sale, or importation of the APP Product (and for clarity, the Compound used to Manufacture the APP Product), in or for the Territory in accordance with this Agreement, infringes MDCO's Patents (and any other United States or foreign patent issued now or in the future, except for the '404 Patent or any patent covering a ready to use patent) insofar as MDCO's Patents apply to the APP ANDA or the APP Product (the “Covenant Not to Sue”). MDCO will impose the foregoing Covenant Not to Sue on any Third Party to which MDCO may assign, grant a right to enforce, or otherwise transfer (by any means) any of MDCO's Patents subject to the foregoing Covenant Not to Sue. The Covenant Not to Sue shall not apply in the event APP has violated the Consent Judgment or has materially breached this Agreement or the Settlement Agreement. For any of MDCO's Patents listed in the FDA's Orange Book, the Covenant Not to Sue will hereby be treated as a non-exclusive license, so that APP or its Affiliates may file and maintain with the FDA “Paragraph IV Certifications” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) and 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) with respect thereto. [**].

3.6 In consideration of the mutual execution of the Settlement Documents and the mutual agreement to be legally bound by the terms hereof, MDCO and APP, with the intention of binding themselves and their respective Affiliates, and their respective predecessors, successors, heirs and assigns, directors, officers, employees and representatives, hereby fully, finally and irrevocably release and discharge each other from any and all actions, causes of action, suits, debts, dues, sums of money, accounts, reckonings, bonds, bills, specialties, covenants, contracts, liabilities, controversies, agreements, promises, variances, trespasses, damages, judgments, extents, executions, claims, counterclaims, demands, costs, expenses, losses, liens and obligations, whatsoever, in law or equity, whether known or unknown, and waive any and all defenses, occurring before or as of the Effective Date related to the Litigated Patents, including (i) in connection with the Pending Litigation, (ii) APP's making, using, selling, offering for sale or importing Compound anywhere in the world for purposes of selling Compound to APP's customers prior to the Effective Date, (iii) associated with the APP ANDA and APP Product, and including MDCO's assertion of the Litigated Patents against APP, or (iv) all other claims that were asserted or could have been asserted in the Pending Litigation. For purposes of clarity, nothing herein shall inhibit any Party's ability to enforce the terms of this Agreement or the Settlement Agreement; MDCO's ability to enforce any patent, including the MDCO's Patents against Third Parties, except as specifically provided in the Covenant Not to Sue; or APP's ability to challenge the infringement of any patent, including the Litigated Patents and the '404 Patent, in connection with any product or ANDA other than the APP Product and APP ANDA.

3.7 Except to the extent required by any Governmental Authority, or Applicable Law, APP shall not release (including any oral or written release or waiver of any right) any attorney (including any of the attorneys or law firms of record in the Pending Litigation or Pending Appeal) or any agent or consultant (whether retained by APP or by any attorney that represents APP) (“APP Attorney or Agent”) to: (i) assist, or cooperate with, any Third Party (including any current or future litigant in a litigation against MDCO) with respect to a Generic Equivalent Product, the Litigated Patents, the '404 Patent, or otherwise with respect to Angiomax in the Territory, or

(ii) [**]. APP shall not release, grant a waiver of conflict of interest or otherwise take any action which would allow or permit any APP Attorney or Agent (i) to breach the confidentiality of non-public information to which such attorney had access in connection with the Pending Litigation or Pending Appeal; or (ii) to represent or otherwise assist any Third Party (including any current or future litigant in a litigation against MDCO) with respect to a Generic Equivalent Product, the Litigated Patents, the '404 Patent, or otherwise with respect to Angiomax in the Territory. [**].

3.8 [**].

3.9 At the request of APP, MDCO will submit appropriate and necessary documentation to the FDA evidencing the licenses, waivers and covenants granted to APP under this Agreement.

3.10 [**] .

3.10.1 [**].

3.10.2 [**].

3.11 Following the Effective Date, the Parties agree to negotiate in good faith and work diligently to executive within [**] an agreement pursuant to which MDCO, [**], will use Commercially Reasonable Efforts to supply Compound to APP for use by APP in the Manufacture of APP Product for Marketing solely pursuant to the License and Authorization. Except as otherwise provided or required in an agreement with a Third Party, [**].

4. Marketing of APP AG Product and APP Product

4.1 During any period APP is paying a royalty under Sections 4.5 for APP AG Product, APP shall, at its sole cost and expense, utilize Commercially Reasonable Efforts in Marketing the APP AG Product in the Territory to maximize sales of APP AG Product. During the Term prior to the APP Launch Date, APP shall not enter into any arrangements or agreements with any Third Party to Market APP Product or APP AG Product in the Territory without MDCO's prior written consent, which shall not be unreasonably withheld, except that APP shall not be restricted in entering into customary agreements with its ordinary trade customers including, wholesalers, distributors, and retailers or with suppliers and vendors of advertising, marketing and promotional services.

4.2 Except as provided in Section 11.3, only APP shall be permitted to Launch and Market APP Product or the APP AG Product under this Agreement.

4.3 It is the intent of APP to seek to sell APP AG Product so as to maximize APP AG Product Gross Profits. APP will have sole discretion, however, in setting the price for the sale of the APP AG Product in the Territory. APP will also agree that if it prices APP AG Product in order to gain or maintain sales of other products, then for purposes of calculating the payments due hereunder, the Net Sales of such APP AG Product shall be adjusted to reverse any discount which was given to a customer that was in excess of customary discounts for the APP AG Product (or, in the absence of relevant data for this APP AG Product, other similar products under similar market conditions).

4.4 Notwithstanding the above, APP shall use Commercially Reasonable Efforts to obtain Regulatory Approval of the APP ANDA.

4.5 APP AG Product Royalty . APP will pay to MDCO a royalty of [**] percent ([**]%) of APP AG Product Gross Profits on APP AG Product.

4.6 Royalty Payments . Payments due under this Section 4 shall be made within [**] days from the end of each calendar quarter in which APP AG Product is sold. All such payments shall include a report

detailing the calculation of gross sales, Net Sales, APP AG Product Gross Profits and the royalties payable hereunder.

4.7 Annual True-Up . Within [**] days after the end of the last calendar year during the Term in which fees are payable to MDCO pursuant to this Section 4, APP shall perform a “true up” reconciliation (and shall provide MDCO with a written report of such reconciliation) of the items comprising deductions from Net Sales outlined in Sections 1.60.2, 1.60.4 and 1.60.5. The reconciliation shall be based on actual cash paid or credits actually issued plus an estimate for any remaining liabilities incurred related to APP AG Product 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 shall pay the amount of the difference to the other Party within [**] days of the date of delivery of such report.

4.8 Final True-Up . Within [**] months after the end of the last calendar year during the Term in which fees are payable to MDCO pursuant to this Section 4, APP shall perform a “true-up” reconciliation (and shall provide MDCO with a written report of such reconciliation) of the items comprising deductions from Net Sales for returns as outlined in Section 1.60.3. The reconciliation shall be based on actual cash paid or credits issued for returns, through the [**] month period following the termination of the Supply Term. If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party shall pay the amount of the difference to the other Party within [**] days of the date of delivery of such report.

4.9 Maintenance of Records . During the Term, and for a period of [**] thereafter, APP shall, and shall ensure that its Affiliates shall, keep at either its normal place of business, or at an off-site storage facility, detailed, accurate and up to date:

4.9.1 records and books of account sufficient to confirm the calculation of the gross sales, Net Sales, APP AG Product Gross Profits, and the royalties payable hereunder; and

4.9.2 information and data contained in any invoices or reports accompanying any payment to MDCO provided to MDCO in connection with this Agreement.

4.10 Inspection . On no less than [**] Business Days notice from MDCO, APP shall make all the records, books of account, information and data referred to in Section 4.9 of this Agreement available for inspection during normal business hours by an internationally recognized independent accounting firm selected by MDCO and reasonably acceptable to APP that is not paid in whole or in part by a contingent fee arrangement, (“MDCO's External Auditor”) for the purpose of general review or audit; provided that MDCO may not request such inspection more than once in any calendar year. Upon reasonable belief of discrepancy or dispute, MDCO's External Auditor shall be entitled to take copies or extracts from such records, and books of account (but only to the extent related to the contractual obligations set out in this Agreement) during any review or audit, provided MDCO's External Auditor signs a confidentiality agreement with APP providing that such records, and books of account shall be treated as Confidential Information which may not be disclosed to any Person, including MDCO. MDCO's External Auditor shall only disclose to MDCO the results of the MDCO's External Auditor's audit, which results shall be concurrently disclosed to APP. Any underpayment or overpayment of amounts due hereunder as reflected by MDCO's External Auditor's results shall be promptly paid by the Party owing payment.

4.11 Inspection Costs . MDCO shall be solely responsible for its costs in making any such review and audit, unless MDCO identifies a discrepancy in the calculation of royalties paid to MDCO under this Agreement in any calendar year from those properly payable for that calendar year of [**] percent ([**]%) or greater, in which event APP shall be solely responsible for the cost of such review and audit and shall pay MDCO any payment due. All information disclosed by APP or its Affiliates pursuant to this Section 4 shall be deemed APP's Confidential Information.

4.12 Payment Method . All payments to be made by APP to MDCO under this Agreement shall

be in United States dollars in immediately available funds and shall be made by wire transfer to the account designated by MDCO, such account to be designated by MDCO at least five (5) Business Days prior to the date any such payment is due.

4.13 Late Payments . In addition to any other rights and remedies, in the event payments required to be made under this Agreement are not made on or prior to the required payment date, the amount of the late payment shall bear interest at the lesser of [**] percent ([**]%) above the prime rate reported in The Wall Street Journal (Eastern Edition) on the date such payment was due and the maximum permissible rate under the Law commencing on the date such payment is due until such date as the payment is made.

4.14 Taxes . MDCO shall be responsible for and shall pay all taxes payable on any income to MDCO or any payments by APP to MDCO. APP and MDCO shall bear sole responsibility for payment of compensation to their respective personnel, employees or subcontractors and for all employment taxes and withholding with respect to such compensation pursuant to Applicable Law. APP shall have the right to withhold taxes in the event that the revenue authorities in any country require the withholding of taxes on amounts paid hereunder to MDCO. APP shall secure and promptly send to MDCO proof of such taxes, duties or other levies withheld and paid by APP for the benefit of MDCO. Each Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect.

5. Confidentiality

5.1 Confidentiality Obligation . The Parties and their respective employees, directors, officers, consultants and contractors shall keep and maintain as confidential any Confidential Information supplied by the other Party during the Term. The confidentiality and non-disclosure obligations contained in this Agreement shall not apply to the extent that, evidenced by written records or similar proof, such Confidential Information is:

5.1.1 at the time of disclosure by one Party to the other, in the public domain or otherwise publicly known;

5.1.2 after disclosure by one Party to the other becomes part of the public domain, or otherwise publicly known, other than by breach by a Party of any obligation of confidentiality;

5.1.3 information which the receiving Party can establish by competent evidence was already in its possession at the time of receipt or was independently developed by the receiving Party; or

5.1.4 received from a Third Party who was lawfully entitled to disclose such information free of an obligation of confidentiality.

5.2 Exceptions . Notwithstanding Section 5.1, in addition to any disclosure allowed under Section 11.5 the Party receiving Confidential Information may disclose such Confidential Information to the extent that such disclosure has been ordered by a court of law or directed by a Governmental Authority, provided that, the disclosure is limited to the extent ordered or directed and wherever practicable, the Party that owns the Confidential Information has been given sufficient written notice in advance to enable it to seek protection or confidential treatment of such Confidential Information.

5.3 Expiration of Confidentiality . The confidentiality obligation contained in this Section 5 shall survive the termination or expiry of this Agreement for so long as such information remains confidential.

5.4 Disclosure . If a Party is subpoenaed or otherwise requested by any Person, including any Governmental Authority, to give testimony or provide information which in any way relates to this Agreement, the APP Product or practices associated with the APP Product, such Party shall give the other Party prompt notice of

such request, and unless otherwise required by Law, shall make no disclosure until such other Party has had a reasonable opportunity to contest the right of the requesting Person to such disclosure. The Parties shall provide each other with all reasonable cooperation and generally make its employees available to give testimony or to provide reasonable assistance in connection with any lawsuits, claims, proceedings and investigations relating to this Agreement, the APP Product or practices associated with the APP Product.

5.5 Enforcement . The Parties agree that equitable relief, including injunctive relief and specific performance, is appropriate in enforcing the confidentiality provisions of this Agreement. In the event of any such action to construe this provision, the prevailing Party will be entitled to recover, in addition to any charges fixed by the court, its costs and expenses of suit, including reasonable attorney's fees. Such remedies shall not be deemed to be the exclusive remedies for a breach of this provision, but shall be in addition to all other remedies available at law or equity.

6. Representations and Warranties of Parties

MDCO represents and warrants to APP that MDCO possess the rights and authority to grant the License and Authorization to APP and its Affiliates under this Agreement, and with respect to Sections 6.1 and 6.2 below, each of MDCO and APP represents, warrants, and covenants, to the other Party that:

6.1 Organization and Authority . Such Party is a corporation or limited liability company duly organized, validly existing and in good standing under the Laws of the jurisdiction of its formation. Such Party has the requisite power and authority to enter into this Agreement. Such Party has the requisite power and authority to execute and deliver this Agreement and to perform all of its obligations hereunder. The execution and delivery of this Agreement and the performance by such Party of its obligations hereunder have been authorized by all requisite action on its part. This Agreement has been validly executed and delivered by such Party, and, assuming that such documents have been duly authorized, executed and delivered by the other Party, constitutes a valid and binding obligation of such Party, enforceable against such Party in accordance with its terms.

6.2 Consents and Approvals; No Violations .

6.2.1 Except as otherwise set forth in this Agreement or the Settlement Agreement, no material filing with, and no material permit, authorization, consent, or approval, of or from any Governmental Authority is required to be obtained by or on behalf of such Party of the transactions contemplated by this Agreement, except for those filings, permits, authorizations, consents or approvals, the failure of which to be made or obtained would not materially impair such Party's ability to consummate the transactions contemplated hereby or materially delay the consummation of the transactions contemplated hereby.

6.2.2 Neither the execution nor the delivery of this Agreement by such Party, nor the performance by such Party of its obligations hereunder, will (i) violate the certificate of incorporation, certificate of formation, by-laws or other organizational document of such Party; (ii) conflict in any material respect with or result in a material violation or breach of, or constitute a material default under, any material contract, agreement or instrument to which such Party is a party; or (iii) violate or conflict in any material respect with any material Law, rule, regulation, judgment, order or decree of any court or Governmental Authority applicable to such Party, except in the case of clause (ii) or (iii) for violations, breaches or defaults which would not have a material adverse effect on such Party's ability to consummate the transactions contemplated hereby.

6.2.3 The Parties shall submit this Agreement together with the Settlement Agreement to the Federal Trade Commission Bureau of Competition and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice as soon as practicable following its execution and in no event later than ten (10) Business Days following its execution.

7. Indemnities; Product Liability; Insurance

7.1. Indemnity by MDCO . MDCO shall defend, indemnify and hold harmless each of APP and its Affiliates and its and their directors, officers, employees and contractors (“APP Party”) from and against any and all Losses, (“MDCO Liability”) arising from or in connection with:

7.1.1 any Claim resulting from any gross negligent acts or acts of willful misconduct of any MDCO Party in connection with the performance of its obligations under this Agreement; or

7.1.2 any Claim based on or arising out of the use, Manufacturing, Labeling, Packaging or Marketing of Angiomax, including, any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of Angiomax;

7.1.3 the breach by MDCO of any of its representations or warranties contained in this Agreement;

except, in each case, to the extent that the MDCO Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of a APP Party.

7.2. Indemnity by APP . APP shall defend, indemnify and hold harmless each of MDCO and its Affiliates and its and their directors, officers, employees and contractors (“MDCO Party”) from and against any and all Losses (“APP Liability”) arising from or in connection with:

7.2.1 any Claim resulting from any gross negligent acts or acts of willful misconduct of any APP Party in connection with the performance of its obligations under this Agreement;

7.2.2 any Claim based on or arising out of the use, Manufacturing, Labeling, Packaging or Marketing of APP Product, including, any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of APP Product; or

7.2.3 the breach by APP of any of its representations or warranties contained in this Agreement.

except, in each case, to the extent that APP's Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of a MDCO Party.

7.3. Control of Proceedings . A Party seeking indemnification hereunder shall provide prompt written notice to the other Party (and, in any event, within thirty (30) days) of the assertion of any claim against such Party as to which indemnity is to be requested hereunder. The indemnifying Party shall have the sole control over the defense of any Claim, provided that, the indemnifying Party shall obtain the written consent of the indemnified Party prior to settling or otherwise disposing of such Claim if as a result of the settlement or Claim disposal the indemnified Party's interests are in any way adversely affected.

7.4. No Admissions . The indemnified Party shall not make any payment or incur any expenses in connection with any APP Liability or MDCO Liability (as the case may be), or make any admissions or do anything that may compromise or prejudice the defense of any Claim without the prior written consent of the indemnifying Party.

7.5. Claim Information . Each Party shall promptly:

7.5.1 inform the other by written notice of any actual or threatened Claim to which Sections 7.1 or 7.2 apply;

7.5.2 provide to the other Party copies of all papers and official documents received in

respect of any such Claim; and

7.5.3 cooperate as reasonably requested by the other Party in the defense of any such Claim.

7.6. Limitation of Liability. Except as may be included in a Claim under Section 7.1, 7.2 or 7.8, or a breach by any Party of Section 3 or Section 11.5, in no event shall any Party or its Affiliates be liable for special, punitive, indirect, incidental or consequential loss or damage based on contract, tort or any other legal theory arising out of this Agreement.

7.7. Product Liability Insurance . Each Party shall maintain, at its own cost, general commercial liability insurance (including comprehensive product liability) in such amount as MDCO and APP, respectively, customarily maintain with respect to its other products and which is reasonable and customary in the U.S. pharmaceutical industry for companies of comparable size and activities but in any event not less than $[**] per occurrence and $[**] in the aggregate. In the event the insurance policy obtained by a Party is a “claims made” policy (as opposed to an “occurrence” policy), such Party shall obtain comparable insurance for not less than four (4) years following the expiry or termination of this Agreement.

7.8. Irreparable Harm . APP acknowledges that in the event of a Launch or continued Marketing or Shipping by APP of APP Product or APP AG Product in the Territory other than as permitted under this Agreement, the damages to MDCO and its business (including, but not limited to, lost sales of Angiomax) would be difficult to calculate and the adequacy of monetary damages calculated at Law would be uncertain. Accordingly, APP agrees that in any action by MDCO seeking injunctive or other equitable relief in connection with any such Launch or continued Marketing of Shipping, other than as permitted under this Agreement, APP shall not assert or plead the availability of an adequate remedy at Law as a defense to the obtaining of any such remedy. APP hereby waives any equitable defense to such injunction including, laches, unclean hands, acquiescence or any estoppel arguments. The foregoing shall not be in lieu of any other remedy to which MDCO may be entitled hereunder in equity or at Law as a result of such a breach.

7.9. Limitation on Representations, Warranties and Indemnification . NEITHER PARTY SHALL BE DEEMED TO MAKE ANY REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, EXCEPT AS SPECIFICALLY SET FORTH HEREIN. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED BY EACH PARTY.

8. Force Majeure

8.1 Force Majeure . Neither Party shall be entitled to terminate this Agreement or shall be liable to the other under this Agreement for loss or damages attributable to any Force Majeure, provided the Party affected shall give prompt notice thereof to the other Party. Subject to Section 8.2, the Party giving such notice shall be excused from such of its obligations hereunder for so long as it continues to be affected by Force Majeure.

8.2 Continued Force Majeure . If any Force Majeure continues unabated for a period of at least ninety (90) days, the Parties shall meet to discuss in good faith what actions to take or what modifications should be made to this Agreement as a consequence of such Force Majeure in order to alleviate its consequences on the affected Party.

9. Trademarks and Trade Names

9.1 Except as may appear on the AG Product vials, Labeling and Packaging, APP shall have no right to use any trademark or tradedress of MDCO and shall have no rights to any other intellectual property of MDCO or its Affiliates other than to the extent of the License and Authorization.

10. Term and Termination

10.1 Term . Unless sooner terminated in accordance with the terms hereof, the term of this Agreement shall extend from the Effective Date until the later of: (i) the expiration of all of MDCO's Patents, and (ii) six (6) months after the date of expiration of the '404 Patent (the “Term”).

10.2 Termination . In addition to MDCO's right to immediately terminate this Agreement as set forth in Section 3, either Party shall be entitled to terminate this Agreement by written notice to the other if:

10.2.1 the other Party commits a material breach of this Agreement, and fails to remedy it within sixty (60) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section 10.2; or

10.2.2 an order is made or a resolution is passed for the winding up of the other Party (other than voluntarily for the purposes of solvent amalgamation or reconstruction) or an order is made for the appointment of an administrator to manage the other Party's affairs, business and property or if a receiver (which expression shall include an administrative receiver) is appointed over any of the other Party's assets or undertaking or if circumstances arise which entitle the court or a creditor to appoint a receiver or manager or which entitle the court to make a winding-up order or if a voluntary arrangement is proposed in respect of the other Party or if the other Party takes or suffers any similar or analogous action in consequence of debt, and such order, appointment or similar action is not removed within ninety (90) days.

10.3 Effect of Termination . In the event of expiry or termination of this Agreement for any reason, each Party shall promptly return all Confidential Information of the other Party provided during the Term or destroy and certify the destruction of such Confidential Information.

10.4 Liability on Termination . The termination or expiry of this Agreement shall not release either of the Parties from any liability which at the time of termination or expiry has already accrued to the other Party, nor affect in any way the survival of any other right, duty or obligation of the Parties which is expressly stated elsewhere in this Agreement to survive such termination or expiry.

10.5 Surviving Sections . T he provisions of Sections 1, 3.6, 4.7-4.14, 5, 6, 7, 10.3, 10.4, 10.5, and 11 shall continue in force in accordance with their respective terms notwithstanding expiry or termination of this Agreement for any reason. In addition, except in the event that APP has violated the Consent J udgment or has materially breached this Agreement or the Settlement Agreement, the Covenant Not to Sue shall survive termination or earlier expiration of this Agreement.

11. Miscellaneous

11.1 Notice .

11.1.1 Any notice or other document given under this Agreement shall be in writing in the English language and shall be given by hand or sent by prepaid airmail, or by confirmed fax transmission to the address of the receiving Party as set out in Section 11.2 below unless a different address or fax number has been notified to the other in writing for this purpose.

11.1.2 Each such notice or document shall:


i.	if sent by hand, be deemed to have been given when delivered at the relevant address;


ii.	if sent by prepaid mail, be deemed to have been given five (5) days after posting; or


iii.	if sent by confirmed fax transmission be deemed to have been given when transmitted, provided

that, a confirmatory copy of such fax transmission shall have been sent by prepaid overnight mail within twenty-four (24) hours of such transmission.

11.2 Address for Notice . The address for services of notices and other documents on the Parties shall be:

To MDCO

The Medicines Company

8 Sylvan Way

Parsippany, NJ 07054

Attn: Chief Executive Officer

Facsimile: (862) 207-6064

with a copy to:

The Medicines Company

8 Sylvan Way

Parsippany, NJ 07054

Attn: General Counsel

Facsimile: (862) 207-6062

To APP

APP Pharmaceuticals, Inc.

1501 East Woodfield Road

Suite 300 East

Schaumburg, Illinois 60173

Attn: General Counsel

Facsimile: (847) 413-2670

with a copy (which shall not constitute notice hereunder) to:

RAKOCZY MOLINO MAZZOCHI SIWIK LLP

6 West Hubbard Street, Suite 500

Chicago, Illinois 60654

Attn: William A. Rakoczy

Facsimile: (312) 222-6321

11.3 Assignment .

11.3.1 Subject to Section 11.3.2, neither Party shall assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party, not to be unreasonably withheld or delayed.

11.3.2 Each Party shall be entitled, without prior written consent of the other Party, to assign all or any of its rights or obligations under this Agreement to an Affiliate or transfer such rights and obligations to a successor entity by way of merger or acquisition of substantially all of the assets of such Party (whether by consolidation, sale of assets, or otherwise); provided the Affiliate or other successor entity expressly assumes in writing those rights, duties and obligations under this Agreement and this Agreement itself and the Affiliate or other successor is a financially capable business entity. [**]. The assignment of this Agreement by APP shall not in anyway affect APPs duties, obligations and admissions in the Settlement Agreement or the other Settlement Documents, and APP will continue to be bound by the terms of the Consent Judgment.

11.3.3 Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Any assignment or transfer in contravention of the terms of this Agreement shall be null and void.

11.4 Amendment . This Agreement may not be varied, changed, waived, discharged or terminated, including by course of conduct or trade usage, except by an instrument in writing signed by the Party against which enforcement of such variation, change, waiver, discharge or termination is sought.

11.5 Public Announcements . The terms of the Settlement Documents and the negotiations of the Parties pertaining to them, shall be maintained in confidence by the Parties. Without limiting the generality of the foregoing, neither Party or its counsel shall provide discovery (including documents, oral testimony and/or statements whether by deposition or otherwise, the work of outside experts or consultants, or work product embodying any of the above) to any Third Party in any judicial or arbitral proceeding in the Territory pertaining to the Settlement Documents. Notwithstanding these obligations, (i) a Party may issue a press release with the prior written consent of the other Party (such consent to be at the sole discretion of such other Party); (ii) MDCO may issue a press release in the form attached hereto as Schedule 11.5, and APP may issue a press release in the form attached hereto as Schedule 11.6; (iii) either Party may disclose such terms or discovery as otherwise required by court order, provided that the other Party shall be given the opportunity to (a) review and comment on the proposed disclosure reasonably in advance of the disclosure, and (b) quash such order and to obtain a protective order requiring that the information and documents that are the subject of such order be held in confidence by such court; (iv) MDCO may disclose (a) to a Third Party (a “Settling Party”), who is identified in writing to APP in advance of any disclosure, the terms set forth in Sections 2 and 4 (along with the defined terms in Section 1 referenced in those provisions) that trigger a most favored nations provision in a settlement relating to the Litigated Patents, the '404 Patent or Angiomax between MDCO and such Settling Party, provided that such disclosure is solely for purposes of establishing whether and to what extent such a most favored nations provision has been triggered and such Settling Party has agreed in writing to maintain the confidentiality of such terms of the Settlement Documents and not to use such terms other than in connection with such purpose and no other purpose, and (b) to a person unaffiliated with such Settling Party and acceptable to MDCO Sections 2 and 4 (along with the defined terms in Section 1 referenced in those provisions) solely to assess the applicability of the most favored nations provision to the terms disclosed to such Settling Party, provided that such unaffiliated person has agreed in writing to maintain the confidentiality of the Settlement Documents and not to use such terms other than in connection with such assessment and no other purpose; (v) either Party may disclose such terms to such Party's actual and prospective investors and lenders, attorneys, accountants, insurers and FDA consultants on a need-to-know basis and who have agreed in writing and in advance to maintain the confidentiality of such information in accordance with the confidentiality provisions set forth herein; (vi) APP may disclose such terms to the FDA as may be necessary or useful in obtaining and maintaining Regulatory Approval of the APP ANDA and Launching the APP Product as provided by the License Agreement, so long as APP requests that the FDA maintain such terms in confidence, and (vii) APP may disclose such terms to its manufacturers, suppliers, distributors, marketing partners and customers in accordance with APP's exercise of its pre-Launch rights set forth in Sections 2.1 and 3.1 and (viii) either Party may disclose such terms as otherwise required by Law, including SEC reporting requirements, or by the rules or regulations of any stock exchange to which the Parties are subject; provided that, the Parties will coordinate in advance with each other in connection with the redaction of certain provisions of the Settlement Documents with respect to any SEC filings, and each Party shall use reasonable efforts to seek confidential treatment for such terms; provided, however, that

each Party shall ultimately retain control over what information to disclose to the SEC or any other such agencies.

11.6 Superiorit y of Agreement . The Parties agree that this Agreement supersedes all prior discussions and writings of the Parties, and that the provisions of this Agreement, together with any amendments hereto, shall prevail over any inconsistent statements or provisions contained in any prior discussions, arrangements or comments between the Parties and in any documents passing between the Parties, including, any forecast, purchase order, purchase order revision, acknowledgment, confirmation or notice. It is agreed that:

11.6.1 neither Party has entered into this Agreement in reliance upon any representation, warranty or undertaking of the other Party which is not expressly set out in this Agreement;

11.6.2 neither Party shall have any remedy in respect of misrepresentation or untrue statement made by the other Party or for any breach of warranty which is not contained in this Agreement;

11.6.3 this Section 11.6 shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation; and

11.6.4 notwithstanding the foregoing, the Settlement Agreement shall be deemed of equal dignity to this Agreement and this Agreement shall be construed together with the Settlement Agreement in a consistent manner as reflecting a single intent and purpose.

11.7 Governing Law . This Agreement shall be governed by the Laws of the State of Delaware without regard to the conflicts of law provisions thereof. The Parties irrevocably agree that the United States District Court for the District of Delaware shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with this Agreement and that, accordingly, any proceedings arising out of or in connection with this Agreement shall be brought in the United States District Court for the District of Delaware. Notwithstanding the foregoing, if there is any dispute for which the United States District Court for the District of Delaware does not have subject matter jurisdiction, the state courts in Wilmington, Delaware shall have jurisdiction. In connection with any dispute arising out of or in connection with this Agreement, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of Delaware.

11.8 Agreement Costs. Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of this Agreement.

11.9 Counterparts . This Agreement may be executed in any number of counterparts and may be executed by the Parties on separate counterparts (including fax or electronic counterparts), each of which is an original but all of which together constitute the same instrument.

11.10 Severability . If and to the extent that any provision of this Agreement is held to be illegal, void or unenforceable, such provision shall be given no effect and shall be deemed not to be included in this Agreement but without invalidating any of the remaining provisions of this Agreement.

11.11 Relationship of the Parties . In making and performing this Agreement, the Parties are acting, and intend to be treated, as independent entities; and nothing contained in this Agreement shall be construed or implied to create an agency, partnership, joint venture, or employer and employee relationship between MDCO and APP. Except as otherwise provided herein, neither Party may make any representation, warranty or commitment, whether express or implied, on behalf of or incur any charges or expenses for or in the name of the other Party.

11.12 Construction . The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning. MDCO and APP acknowledge that each Party and its counsel have reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against

the drafting Party shall not be employed in the interpretation of this Agreement. The words “hereof,” “herein,” “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement. The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa. Whenever used herein, the words “include,” “includes” and “including” shall mean “include, without limitation,” “includes, without limitation” and “including, without limitation,” respectively. The masculine, feminine or neuter gender and the singular or plural number shall each be deemed to include the others whenever the context so indicates. With respect to any particular action or agreement, the use of the words “MDCO shall” or “MDCO will” herein shall also mean “MDCO shall cause” the particular action to be performed. Similarly, with respect to any particular action or agreement, the use of the words “APP shall” or “APP will” herein shall also mean “APP shall cause” the particular action to be performed. Nothing in this Agreement shall operate to exclude any provision implied into this Agreement by Law and which may not be excluded by Law or limit or exclude any liability, right or remedy to a greater extent than is permissible under Law.

11.13 Dispute Resolution .

11.13.1 Preliminary Process . If there is a disagreement between the Parties as to the interpretation of this Agreement or in relation to any aspect of the performance by either Party of its obligations under this Agreement, the Parties shall, within ten (10) Business Days of receipt of a written request from either Party, meet in good faith and try to resolve the disagreement without recourse to legal proceedings.

11.13.2 Escalation of Dispute . If resolution of the disagreement does not occur within five (5) Business Days after such meeting, the matter shall be escalated to applicable APP and MDCO Presidents (or other ranking senior executive) for resolution.

11.13.3 Equitable Relief . Nothing in this Section 11.13 restricts either Party's freedom to seek urgent relief to preserve a legal right or remedy, or to protect a proprietary or trade secret right, or to otherwise seek legal remedies through any available channel if resolution is not otherwise achieved under this Section 11.13.

11.14 Cumulative Rights . The rights and remedies of each of the Parties under or pursuant to this Agreement are cumulative, may be exercised as often as such Party considers appropriate and are in addition to its rights and remedies under general law.

11.15 No Third Party Benefit . This Agreement shall be binding upon and inure solely to the benefit of the Parties hereto, their Affiliates, successors and permitted assigns, and nothing in this Agreement, express or implied, is intended to or shall confer upon any other Person or Persons any right, benefits or remedies of any nature whatsoever under or by reason of this Agreement.

11.16 Further Assurance . Each of the Parties shall do, execute and perform and shall procure to be done and perform all such further acts, deeds, documents and things as the other Party may reasonably require from time to time to give full effect to the terms of this Agreement.

11.17 Waiver . No failure or delay by either Party in exercising any right or remedy provided by law under or pursuant to this Agreement shall impair such right or remedy or operate or be construed as a waiver, acquiescence or variation of it or preclude its exercise at any subsequent time and no single or partial exercise of any such right or remedy shall preclude any other or further exercise of it or the exercise of any other right or remedy. A waiver by a Party of any right or remedy hereunder on any one occasion shall not be construed as a bar to any right or remedy which such Party would otherwise have on any future occasion.

[Signature Page Follows]

[Signature Page to License Agreement Regarding Bivalirudin Injection Product]

IN WITNESS WHEREOF , the undersigned have executed this Agreement as of the Effective Date.

THE MEDICINES COMPANY

Date: _______________ By: __ /s/ Glenn Sblendorio _______________

Name: ____ Glenn Sblendorio ____________

Title: _____ EVP & CFO __________________

APP PHARMACEUTICALS, LLC

Date: ____ 1/22/12 ________ By: ____ /s/ J.R. Ducker ___________________

Name: _____ J.R. Ducker ___________________

Title: ______ President & CEO ______________

Date: ____ 1/22/12 ________ By: ____ /s/ J.R. Ducker ___________________

Name: _____ J.R. Ducker ___________________

Title: ______ President & CEO ______________

Schedule 11.5

Contact: Michael Mitchell

The Medicines Company

973-290-6000

investor.relations@themedco.com

FINAL DRAFT 1 22 2012

THE MEDICINES COMPANY SETTLES ANGIOMAX® (BIVALIRUDIN) PATENT LITIGATIONS WITH APP PHARMACEUTICALS

Parsippany, N.J., January 23, 2012 - The Medicines Company (NASDAQ: MDCO) today announced that it has settled the lawsuits filed by MDCO in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Application (ANDA) filed by APP Pharmaceuticals, LLC (APP) for a generic version of Angiomax® (bivalirudin for injection). The settlement also includes APP's agreement to dismiss its appeal of the August 2010 federal district court decision holding that MDCO's application for Hatch Waxman patent term extension of the Angiomax composition of matter patent, U.S. Patent No. 5,196,404, was timely filed. Upon dismissal of the appeal, all pending litigation regarding the Angiomax composition of matter patent will have been resolved.

As part of the settlement, APP admits that the two patents asserted in the lawsuits related to APP's ANDA, U.S. Patent No. 7,582,727 and U.S. Patent No. 7,598,343, are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product. These patents are listed in the Orange Book and expire on July 27, 2028.

MDCO and APP also agreed to the following arrangements in connection with the settlement:

License by MDCO

The settlement agreement includes a license by MDCO to APP and an affiliate of APP under which APP may launch a generic bivalirudin product in the U.S. on May 1, 2019. In certain limited circumstances, this license to APP could become effective prior to May 1, 2019 and could include an authorized generic bivalirudin product supplied by MDCO.

Finished Product Manufacturing for MDCO

MDCO entered into an agreement with APP under which APP has agreed to manufacture and supply Angiomax finished product to MDCO. This manufacturing arrangement provides MDCO with an additional source of finished product supply capacity to support anticipated growth of product use, and replaces capacity recently lost when one of MDCO's fill and finish manufacturers announced that it would cease contract manufacturing operations.

Acute Care Generic Products Portfolio Licensed by MDCO

MDCO and APP entered into an agreement under which APP has agreed to license and supply to MDCO a portfolio of generic products which are used in therapeutic areas in which MDCO focuses or plans to focus, including treatment of acute cardiovascular, neurological and infectious diseases in hospital.

Glenn Sblendorio, Executive Vice President and Chief Financial Officer of The Medicines Company stated, “These arrangements reflect our continued confidence in the strength of our Angiomax patents. We are delighted to partner with APP for additional Angiomax fill and finish manufacturing capacity. Also, we believe that the portfolio of acute and intensive care hospital generic products that we have licensed aligns well with our portfolio of marketed and development-stage innovative products and that our customers will welcome the expansion of our product offerings.”

As required by law, MDCO and APP will submit all of the agreements entered into in connection with the settlement to the U.S. Federal Trade Commission and the U.S. Department of Justice.

For a more detailed summary of the terms and financial arrangements between MDCO and APP, please refer to the Current Report on Form 8-K filed by MDCO with the Securities and Exchange Commission on January 23, 2012.

Background on the litigation now settled.

In September 2009 and April 2010, MDCO received Paragraph IV Certification Notice Letters from APP notifying MDCO that APP had submitted an ANDA to the Food and Drug Administration for approval to market a generic version of Angiomax®. In October 2009 and June 2010, MDCO filed patent infringement lawsuits against APP. The complaints, which were filed in the U.S. District Court for the District of Delaware, alleged infringement of U.S. Patent Nos. 7,582, 727 and 7,598,343.

MDCO remains in infringement litigations involving U.S. Patent Nos. 7,582, 727 and 7,598,343 with Hospira, Mylan Pharmaceuticals, Dr. Reddy's Laboratories and Sun Pharmaceuticals.

In the first quarter of 2010, MDCO filed suit against the U.S. Patent and Trademark Office (PTO), the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) seeking to set aside the PTO's denial of MDCO's application to extend the patent term of the '404 patent. On August 3, 2010, the U.S. Federal District Court for the Eastern District of Virginia ordered the PTO to consider MDCO's patent term extension application timely filed. The period for the government to appeal the court's August 3, 2010 decision expired without government appeal. However, on August 19, 2010, APP filed a motion to intervene for the purpose of appeal in MDCO's case against the PTO, the FDA and HHS. On September 13, 2010, the federal district court denied APP's motion. APP appealed the denial of its motion, as well as the federal district court's August 3, 2010 order (and all related and underlying orders), to the U.S. Court of Appeals for the Federal Circuit.

About The Medicines Company

The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com .

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical , may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of Angiomax, the Company's other products and the products licensed from APP; whether the Company is able to maintain market exclusivity for Angiomax; whether the Company is able to obtain or maintain patent protection for the intellectual property relating to the Company's products; whether the Company's products and product candidates will advance in the clinical trials process on a timely basis or at all; whether the Company will make regulatory submissions for product candidates on a timely basis; whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all ; risks related to the Company's dependence on third parties such as APP to manufacture and supply its products; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly

Report on Form 10-Q filed on November 9, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.



	Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.			Exhibit 10.3

Confidential

EXECUTION COPY

Contract Manufacturing Agreement

January 22, 2012

CONTRACT MANUFACTURING AGREEMENT

THIS MANUFACTURING SERVICES AGREEMENT (the "Agreement") made as of the 22 ^nd day of January, 2012 (“ Effective Date ”)

B E T W E E N:

APP PHARMACEUTICALS, LLC ,

1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 6017, a corporation existing under the laws of the State of Delaware,

(hereinafter referred to as " APP "),

- and -

THE MEDICINES COMPANY

8 Sylvan Way, Parsippany, NJ 07054 a corporation existing under the laws of the State of Delaware (hereinafter referred to as " MDCO " and collectively with APP referred to herein as the “Parties,” or each separately, as a “Party.”).

RECITALS:

WHEREAS, MDCO wishes to have the Product manufactured, packaged, tested, and supplied to it by APP for commercial sales, and APP wishes to manufacture, package, test and supply to MDCO the Product for commercial sales, in accordance with the terms and conditions of this Agreement; and

WHEREAS, the Parties have agreed to enter into this Agreement to provide the terms and conditions governing the manufacture, packaging, testing and supply of the Product by APP.

NOW, THEREFORE, MDCO and APP agree as follows:

ARTICLE 1

INTERPRETATION


1.1	Definitions .

The following terms shall, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings:

" Active Materials ", “Active Pharmaceutical Ingredients” or “API” means the materials listed on Schedule C hereto;

"Affiliate" means with respect to any Party, any partnership, association, corporation, limited liability company, trust, or other legal entity, that is controlled by, controls, or is under common control with, that Party. For the purposes of this definition, “control” when used with respect to any Person means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise, and the terms “controlling” and “controlled” have correlative meanings;

" Annual Report" means the annual report as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);

" Annual Product Review Report " means the annual product review report as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);

" Applicable Laws " means any statute, law, treaty, rule, code, ordinance, regulation, rule, by-law, judgment, decree or order that applies, as the context requires, to: (i) the Agreement; (ii) the performance of obligations or other activities related to the Agreement; and (iii) a party's Subcontractors (if any).

" Authority " means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal;

“ Batch Size ” means the estimated batch size of the Product (measured in number of units of such Product) as set forth in Schedule A;

" Business Day " means any day other than a Saturday, Sunday or a day on which banks in New York, New York are authorized or required by law to close;

" cGMPs " means the current good manufacturing practices required by the FDA and set forth in the United States Food, Drug and Cosmetic Act or FDA regulations, policies or guidelines in effect at the time in question for the manufacture and testing of pharmaceutical materials, including as described in Parts 210 and 211 of Title 21 of the United States Code of Federal Regulations, all as updated, amended and revised from time to time;

“ Capital Expenditures ” means all out-of-pocket costs and expenses relating to upgrading or acquiring equipment at the Manufacturing Site directly related to, and necessary for, APP's provision of the Manufacturing Services, as set forth on Schedule E;

“Commercially Reasonable Efforts” shall mean, with respect to each Party, commercially reasonable efforts in accordance with such Party's business, legal, medical, and scientific judgment and in accordance with the efforts and resources such Party would use for a product owned by it or to which it has rights, which is of similar market potential, at a similar stage in its product life, taking into account the competitiveness of the market place, the proprietary position of the product, the regulatory structure involved, the potential for litigation or other disputes associated with such product, the intellectual property issues associated with such product, the profitability of the product and other relevant factors.

" Components " means, collectively, primary packaging components, raw materials and ingredients, required to be used in order to produce the Product in accordance with the Specifications, other than the Active Materials;

“ Confidential Information ” means all with respect to a Party, all information of any kind whatsoever (including without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies, and techniques), and all tangible and intangible embodiments thereof of any kind whatsoever (including without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), which is disclosed by such Party to the other Party or any of its Affiliates. Confidential Information shall also include the terms and existence of this Agreement and other agreements. Notwithstanding the foregoing, Confidential Information of a Party shall not include information which the other Party can establish by competent evidence (a) to have been publicly known prior to disclosure of such information by the disclosing Party to the other Party, (b) to have become publicly known, without fault on the part of the other Party, subsequent to disclosure of such information by the disclosing Party to the other Party, (c) to have been received by the other Party or one of its Affiliates free of an obligation of confidentiality at any time from a source, other than the disclosing Party, rightfully having possession of and the right to disclose such information free of an obligation of confidentiality, (d) to have been otherwise known by the other Party or any of its Affiliates prior to disclosure of such information by the disclosing Party to the other Party, or (e) to have been developed by the receiving Party after receipt of such information, and which the receiving Party can demonstrate through written documentation, was not developed through use of such information;

" Deficiency Notice " shall have the meaning ascribed thereto in Section 6.1(a);

" Delivery Date " means the date of delivery of the Product at the Manufacturing Site, as stated in the acceptance of the Firm Order by APP;

“Development Costs and Expenses” means all out-of-pocket costs and expenses relating to research and

development for the manufacture of the Product for sale in the Territory, including costs and expenses related to analytical testing (e.g., outside laboratory expenses), process development costs including costs of process scale-up, validation costs, costs of stability studies, and processing and conversion costs of materials required for regulatory filings, as set forth on Schedule D.

“Disclosing Party” means the Party disclosing Confidential Information;

“ Effective Date ” means the date set forth in the introductory paragraph that is the commencement date of this Agreement after execution by both Parties;

" FDA " means the United States government agency known as the Food and Drug Administration (and any successor agency thereto);

“ Firm Order ” means a firm written order in the form of a purchase order or otherwise that has been received by APP;

“ Initial Supply Term ” means the period starting on the first date that all Regulatory Authorities approve MDCO to market Product in the Territory that is manufactured by APP at the Manufacture Site and ending on June 15, 2015;

" Intellectual Property " means any and all of the following, whether or not registered, in the United States and all other jurisdictions throughout the world: (i) Inventions and improvements thereto, and patents and patent applications (including all reissues, divisions, continuations, continuations-in-part, extensions and reexaminations thereof); (ii) trademarks, service marks, trade dress, logos, domain names, rights of publicity, trade names and corporate names, and all goodwill associated therewith; (iii) copyrights, including all derivative works, moral rights, renewals, extensions, reversions or restorations associated with such copyrights, now or hereafter provided by law, regardless of the medium of fixation or means of expression; (iv) computer software (including source code, object code, firmware, operating systems and specifications); (v) trade secrets and, whether or not confidential, business information (including pricing and cost information, business and marketing plans and customer and supplier lists) and know how; (vi) databases and data collections; (vii) any other type of intellectual property right; (viii) registrations and applications for registration of any of the foregoing; (ix) copies and tangible embodiments of any of the foregoing; and (x) rights to sue or recover and retain damages, costs and attorneys' fees for past, present or future infringement, misappropriation or violation of any of the foregoing;

" Invention " means any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable;

" Inventory " means all inventories of Components and work-in-process produced or held by APP in connection with the manufacture of the Product but, for greater certainty, does not include the Active Materials;

"Know-How" means confidential and proprietary information related to the Product, including: manufacturing protocols and methods, the Product formulation, Product specifications, processes, analytical and processing techniques, Product and API samples, trade secrets, ideas, concepts, manufacturing formulae and information, and flow diagrams.

" Manufacturing Requirements " shall have the meaning ascribed thereto in Section 2.4;

" Manufacturing Services " means the manufacturing, packaging, quality control, quality assurance and stability testing, and related services, as contemplated in this Agreement, required to produce the Product from Active Materials and Components;

" Manufacturing Services Based Intellectual Property " means Intellectual Property generated or derived by APP or its Affiliate in the course of performing any Manufacturing Services or otherwise generated or derived by APP or its Affiliate in connection with the conduct of its business which Intellectual Property is not specific to, or dependent upon, MDCO's Active Material or Product including, without limitation, Inventions and Intellectual Property which may have application to manufacturing processes or the formulation or

development of drug products, drug product dosage forms or drug delivery systems beyond the specific requirements of the Product.

" Manufacturing Site " means the APP's facility, which is located at [**] ;

“Marketing Authorization” means any federal, state, or local approvals, licenses, permits, applications, registrations or authorizations approved by, filed with, or submitted to any Authority, such as the FDA, including all Abbreviated New Applications and New Drug Applications;

" Minimum Run Quantity " means the minimum number of batches of the Product to be produced during the same cycle of manufacturing as set forth in Schedule A hereto;

“ Party(ies) ” means either APP or MDCO, or both, as the case may be;

" Price " means $[**] U.S. Dollars per vial, as adjusted pursuant to Article 4;

" Product " means 10 ml vials containing 250 mg of lyophilized bivalirudin for injection, currently marketed as Angiomax®;

" Quality Agreement " means the agreement to be entered into between the Parties hereto setting out the respective responsibilities of the Parties and the quality assurance standards in respect of the Manufacturing Services;

“Receiving Party” means the Party to whom Confidential Information is disclosed;

" Regulatory Authority " means any regulatory agency competent to grant marketing approvals for pharmaceutical products including the Product in the Territory, such as the FDA;

" Specifications " means the file and specifications for the Product, which is provided by MDCO to APP in accordance with the procedures listed in the Quality Agreement hereto and which contains documents relating to the Product, including, without limitation:


a)	specifications for Active Materials and Components;


b)	manufacturing specifications, directions and processes;


c)	storage requirements;


d)	all environmental, health and safety information relating to the Product including material safety data sheets; and


e)	the finished Product specifications, packaging specifications and shipping requirements for the Product.

all as updated, amended and revised from time to time by MDCO in accordance with the terms of this Agreement;

“Subsequent Supply Term” means the period starting on June 15, 2015 and ending on May 1, 2019;

" Technical Dispute " has the meaning specified in Section 12.2;

“Technology Transfer and Feasibility Activities” shall have the meaning specified in Section 2.1.

" Territory " means the United States of America and its possessions and territories;

" Third-Party Rights " means the Intellectual Property of any third party;

" Year " means, in the first year of this Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter shall mean a calendar year.


1.2	Currency .

Unless otherwise indicated, all monetary amounts are expressed in this Agreement in U.S. Dollars. References to $ will be references to U.S. Dollars.


1.3	Sections and Headings .

The division of this Agreement into Articles, sections, subsections and Schedules and the insertion of headings are for convenience of reference only and shall not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section or Schedule refers to the specified Section or Schedule to this Agreement. In this Agreement, the terms " this Agreement ", " hereof ", " herein ", " hereunder " and similar expressions refer to this Agreement and not to any particular part, Section, Schedule or the provision hereof.


1.4	Interpretation .

Unless otherwise indicated to the contrary herein by the context or use thereof (i) the words, “herein,” “hereto,” “hereof” and words of similar import refer to this Agreement as a whole and not to any particular Section or paragraph hereof, (ii) the word “including” means “including, but not limited to,” (iii) words importing the singular will also include the plural, and vice versa, and (iv) any reference to any federal, state, local, or foreign statute or law will be deemed also to refer to all rules and regulations promulgated thereunder.


1.5	Schedules .

The following Schedules are attached to, incorporated in and form part of this Agreement:

Schedule A - Minimum Run Quantity, and Price

Schedule B - Stability Testing Activities

Schedule C - Active Materials

Schedule D - Development Costs and Expenses

Schedule E Capital Expenditures


ARTICLE 2

APP'S MANUFACTURING SERVICES

2.1 Technology Transfer Activities.

Within [**] days of the Effective Date, and on an ongoing basis thereafter, MDCO will supply APP with the materials and documentation that are in MDCO's possession free of an obligation of confidentiality to a third party, which will include Know-How and any other knowledge, documentation and information that may be necessary or useful for APP to commercially manufacture the Product. The manufacture of the Product will be transferred to the Manufacturing Site according to a time schedule to be agreed upon between the Parties. In addition, APP agrees to initiate as soon as reasonably possible the technical transfer and feasibility activities necessary for the transfer of the commercial manufacture of the Product to the Manufacturing Site.


2.2	Supply .

For the Initial Supply Term, MDCO shall order at least [**] percent ([**]%) of its requirements for sale of Product in the Territory from APP and APP shall use Commercially Reasonable Efforts to supply MDCO all such amounts ordered (pro-rata for any non-full Year during the Initial Supply Term). For the Subsequent Supply Term, MDCO shall order at least [**] percent ([**]%) of MDCO's requirements for sale of Product in the Territory and APP shall use Commercially Reasonable Efforts to supply MDCO all such amounts ordered (pro-rata for any non-full Year during the Subsequent Supply Term); [**]. In addition, APP shall supply Product to MDCO for resale to APP, under the terms of an AG Supply Agreement being entered into by the Parties contemporaneously herewith (the “AG Supply Agreement”).

2.3 Manufacturing Services.

APP shall provide the Manufacturing Services for the Territory, as specified in Schedules A and B. APP and MDCO agree that for all Product supplied to MDCO pursuant to this Agreement:


a)	Conversion of Active Materials and Components . APP shall convert Active Materials and Components into the Product.


b)	Quality Control and Quality Assurance . APP shall perform the quality control and quality assurance testing specified in the Quality Agreement.


c)	Components . APP shall purchase and test all Components as specified by the Specifications and per the Quality Agreement.


d)	Stability Testing . APP shall conduct stability testing on the Product in accordance with the protocols set out in the Specifications and during the time periods specified in Schedule B.


e)	Product Rejection for Finished Product Specification Failure. If the non-conforming Product results from APP's failure to perform the Manufacturing Services in accordance with the Manufacturing Requirements, then MDCO shall not be required to pay APP the applicable fee per unit for such non-conforming Product.


f)	Batch Numbering. Each batch of the Product manufactured by APP will bear a unique lot number using APP's batch numbering system. This number will appear on all documents relating to the particular batch of Product and shall identify the date of manufacture for the batch of Product.

Active Materials and MDCO Supplied Components Importing . At least [**] days prior to the scheduled production date, MDCO shall furnish to APP, EXW (Incoterms 2010) at Manufacturing Site, the Active Materials in such quantities as are necessary to enable APP to manufacture the desired quantities of Product on the requested delivery date. If such Active Materials are not received [**] days in advance, APP will be entitled to delay shipments of Product caused by the re-scheduling of production by the same number of days as the delay in receipt of such Active Materials. All shipment of Active Material shall be accompanied by certificate(s) of analysis from the Active Material manufacturer confirming the identity, purity and compliance with the Active Material Specifications.


2.4	Standard of Performance.

APP shall provide the Manufacturing Services in accordance with (i) the Specifications; (ii) any other terms and conditions provided in the Quality Agreement; (iii) the cGMPs and any other applicable legal requirements as specified by any Regulatory Authority. APP's responsibilities and obligations with respect to the manufacture of the Product as set forth in this Section 2.4 are herein referred to as the " Manufacturing Requirements ".


2.5	Subcontractors.

MDCO hereby agrees that APP may subcontract to an Affiliate any Manufacturing Services under this Agreement provided that APP identifies in writing the Affiliate and the Manufacturing Services to be provided and MDCO consents in writing, such consent not to be unreasonably withheld by MDCO (such a subcontractor, herein a “ Subcontractor .”) It is understood that APP shall enter into an agreement with its Affiliate that contains confidentiality and non-use terms similar to and at least as strict as those set forth in Article 11 of this Agreement, as well as any other terms necessary to ensure that APP meets its obligations under this Agreement. For the avoidance of doubt, the subcontracting of any Services hereunder by APP shall not relieve APP of, and APP shall remain solely liable for, its obligations under this Agreement.

2.6 Supply Interruption.


a)	In the event that (i) APP is past due in its obligations to supply Product to MDCO in accordance with APP's obligations under this Agreement for [] days or more; or (ii) APP fails to confirm any forecast or Firm Order because of its inability to timely supply at least [] percent ([**]%) of the amount forecasted

therein, including as may be attributed to a Force Majeure Event pursuant to Section 13.7 but excluding as may be attributed to the failure of MDCO to comply with its obligations under this Agreement (including but not limited to the failure to supply Active Materials) (individually or collectively a " Supply Interruption "), it is agreed by the Parties that MDCO, in its discretion, may cancel any and all Firm Orders for Product outstanding at the commencement of a Supply Interruption by providing written notice to APP, and MDCO may also, in its discretion, suspend providing further forecasts and Firm Orders to APP until a Recommencement Date (defined below). Following a Supply Interruption and until a Recommencement Date, it is agreed by the Parties that MDCO, in its discretion, may be supplied by a secondary supplier with Product to meet MDCO's full requirements of Product. All amounts of Product supplied by a secondary supplier to MDCO during a Supply Interruption (including all amounts forecasted or ordered before a Recommencement Date, regardless if whether delivered after a Recommencement Date) shall be credited toward MDCO's obligation under Section 2.2 to purchase a percentage amount, as applicable, of its requirements from APP and shall be treated as if such amounts of Product had been supplied from APP.

APP shall provide MDCO with written notice of its ability to resume supply (the " Recommencement Notice "), if APP is able to resume timely supply of Product. The Recommencement Notice must: (i) list the date on which APP will be able to resume its supply obligations; and (ii) include a statement of APP's ability to resume such obligations by that date which describes in reasonable detail what problems have been rectified and include a representation (which will be deemed a APP representation under this Agreement) that APP is able to fulfill its supply obligations under this Agreement. Unless otherwise agreed to in writing by MDCO and APP, MDCO shall resume purchasing its requirements for the Product from APP, as set forth in Section 2.2, commencing on the later of (i) [**] days from MDCO's receipt of the Recommencement Notice, and (ii) [**] (the " Recommencement Date ").

In the event that (i) a Supply Interruption exists for more than [**], (ii) [**] or more Supply Interruptions occur within any [**] month period, or (iii) [**] or more Supply Interruptions occur in any [**] period during the term of the Agreement, it is agreed by the Parties that MDCO's obligation under Section 2.2 to purchase a percentage amount, as applicable, of its requirements from APP shall immediately and permanently terminate.


ARTICLE 3

MDCO'S OBLIGATIONS

3.1 Payment.

Pursuant to the terms of this Agreement, MDCO shall pay APP the Price for each Product during the term of this Agreement. For the purpose of clarity, the Price includes all payment to APP for the Manufacturing Services.

3.2 Development Costs and Expenses.

MDCO shall reimburse APP for the Development Costs and Expenses actually spent or incurred by APP during the term of this Agreement that are listed on Schedule D; provided that MDCO shall not pay APP more than [**] U.S. Dollars ($[**]) pursuant to this Section 3.2. MDCO will not reimburse APP for expenses incurred by APP before the Effective Date. APP shall invoice MDCO for Development Costs and Expenses within [**] days of being spent or incurred by APP and MDCO shall pay all such invoices within [**] days of the date thereof.

3.3 Capital Expenditure Reimbursement.

MDCO shall reimburse APP for the Capital Expenditures actually spent or incurred by APP during the term of this Agreement that are listed on Schedule E; provided that MDCO shall not pay APP more than [**] U.S. Dollars ($[**]) pursuant to this Section 3.3. MDCO will not reimburse APP for expenses incurred by APP before the Effective Date. APP shall invoice MDCO for Capital Expenditures within [**] days of being spent or incurred by APP and MDCO shall pay all such invoices within [**] days of the date thereof.

3.4 Active Materials.

MDCO shall at its sole cost and expense, deliver the Active Materials to APP (in accordance with Section 2.2(g)) in sufficient quantities and at such times to facilitate the provision of the Manufacturing Services by APP. The Active Materials shall be held by APP on behalf of MDCO in accordance with the Specifications, with any other label and invoice instructions given by MDCO from time to time in accordance with this Agreement and with the current GMPs. Title to the Active Materials shall at all times belong to and remain the property of MDCO. Any Active Materials received by APP shall only be used by APP to provide the Manufacturing Services.


ARTICLE 4

PRICING

4.1 Initial Adjustments.

During the Initial Supply Period, APP shall be entitled to an adjustment equal to [**] percent ([**]%) of the Price no more than once per Year.

4.2 Subsequent Adjustments.

The Price for the Product during any Year subsequent to [**], shall be determined in accordance with the following: APP shall be entitled to an adjustment to the Price in respect of the Product to reflect inflation, which adjustment shall be based on the annual change in the Producer Price Index applicable to pharmaceutical preparations published by the U.S. Bureau of Labor Statistics, Department of Labor (or any applicable successor index to be agreed to by the Parties in good faith in the event of the discontinuation of same) over the prior twelve (12) month period, provided that such adjustment is not greater than [**] percent ([**]%). In connection with such Price adjustment, three (3) months prior to the effective date of the adjusted Price, APP shall deliver to MDCO a statement outlining the percentage change in the Producer Price Index upon which such price adjustment is based. The adjusted prices shall be effective as of January 1 of the same Year in which the adjustment is required and shall be applied to all Firm Orders on or after January 1.


ARTICLE 5

ORDERS, SHIPMENT, INVOICING, PAYMENT


5.1	Orders and Forecasts .

Rolling Forecasts . Following the execution of this Agreement, MDCO shall provide APP with a written non-binding [**] month forecast of the volume of Product that MDCO then anticipates will be required to be produced and delivered to MDCO, beginning with the Initial Supply Term during each month of that [**] month period. At the commencement of the Initial Supply Term, such forecast will be updated by MDCO monthly on or before the [**] day of each calendar month on a rolling [**] month basis and updated forthwith upon MDCO determining that the volumes contemplated in the most recent of such forecasts has changed by more than [**] percent ([**]%). The most recent [**] month forecast shall prevail. Within [**] days or receipt of a forecast, APP shall confirm its ability to timely supply MDCO with the Product specified in such forecast.

Firm Orders . The first [**] months of the initial rolling forecast shall constitute a Firm Order upon receipt by APP. Thereafter, on or before the [**] day of each calendar month, MDCO shall issue Firm Orders for Manufacturing Services in respect of the Product to be produced and delivered to MDCO on a date not less than [**] months from the first day of the calendar month immediately following the date that the Firm Order is submitted. Such Firm Orders submitted to APP shall specify MDCO's Manufacturing Services purchase order number, quantities by Product type, monthly delivery schedule and any other elements necessary to ensure the timely production and shipment of the Product. The quantities of Product ordered in such written orders shall be firm and binding on MDCO and shall not be subject to reduction by MDCO. Within [**] days of receipt of a Firm Order, APP shall confirm its ability to timely supply MDCO with the Product specified in Firm Order.


c)	APP will deliver the ordered batch(es) of Product by the Delivery Date and shall promptly alert MDCO, in writing, of any delay that may affect such Delivery Date. Should a delay in delivery occur, APP will develop and carry out a remedial plan with MDCO to help prevent further possible late deliveries.

APP and MDCO will develop, establish and review appropriate key performance indicators (KPI's) during the term of this Agreement to assess and improve the ongoing effectiveness of the Manufacturing Services. These KPI's will be reviewed on a quarterly basis. The KPI's should be agreed upon by both Parties, but should, at a minimum, include production yields for Product lots, on time delivery and batch record cycle review.


5.2	Minimum Orders.

MDCO may only order Manufacturing Services in respect of batches of Product in multiples of the Minimum Run Quantities as set out in Schedule A.


5.3	Shipments.

Shipments of Product shall be made EXW (Incoterms 2010) MDCO's designated facility, unless otherwise mutually agreed. Product shall be transported in accordance with the Specifications.


5.4	Invoices and Payment .

Invoices shall be sent by email to the accounts payable email address provided by MDCO. Invoices will be sent, by APP to MDCO, at the time the Product is shipped to MDCO . Disputes regarding the amount of the invoices will not suspend MDCO's payment obligations. Each such invoice shall, to the extent applicable, identify MDCO's Manufacturing Services purchase order number, Product numbers, names and quantities, unit price, freight charges and the total amount to be remitted by MDCO. MDCO shall pay all such invoices within [**] days of the date thereof.


ARTICLE 6

PRODUCT CLAIMS AND RECALLS


6.1	Product Claims .

Product Claims . MDCO has the right to reject any portion of any shipment of Product that deviates from the Manufacturing Requirements without invalidating any remainder of such shipment. MDCO shall inspect the Product manufactured by APP upon receipt thereof and shall give APP written notice (a " Deficiency Notice ") of all claims for Product that deviate from the Manufacturing Requirements within [**] days after MDCO's receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, within [**] days after discovery thereof by MDCO, but in no event after the earlier of (i) expiration date of the Product or (ii) the statute of limitations applicable to contract actions as applied pursuant to Section 13.15). Should MDCO fail to provide APP with the Deficiency Notice within the applicable [**] day period, then the delivery shall be deemed to have been accepted by MDCO on the [**] day after delivery or discovery, as applicable. Except as set out in Section 6.2, APP shall have no liability for any deviations for which it has not received notice within the applicable [**] day period.

Determination of Deficiency . Upon receipt of a Deficiency Notice, APP shall have [**] days to advise MDCO by notice in writing that it disagrees with the contents of such Deficiency Notice. If MDCO and APP fail to agree within [**] days after APP's notice to MDCO as to whether any Product identified in the Deficiency Notice deviate from the Manufacturing Requirements, then the Parties shall mutually select an independent laboratory to evaluate if the Product deviate from the Manufacturing Requirements. Such evaluation shall be binding on the Parties, and if such evaluation certifies that any Product deviate from the Manufacturing Requirements, MDCO may reject those Product in the manner contemplated in this Section 6.1. In that event the evaluation costs will be borne by APP, otherwise MDCO will be responsible for the evaluation costs. If such evaluation does not so certify in respect of any such Product, then MDCO shall be deemed to have accepted delivery of such Product on the [**] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the [**] day after discovery thereof by MDCO, but in no event after the expiration date of the Product).


c)	Shortages and/or damaged Product . Claims for shortages in the amount of Product shipped by APP and/or damages to Product delivered by APP shall be dealt with as may be reasonably agreed to by

the Parties, consistent with the circumstances pertaining to the Product shortage or damage.


6.2	APP's Responsibility for Defective and Recalled Product.

Defective Product. In the event MDCO rejects Product in accordance with Section 6.1 and the deviation is determined to have arisen from APP's failure to provide the Manufacturing Services in accordance with the Manufacturing Requirements, APP will credit MDCO's account for APP's invoice price for such defective Product. If MDCO shall have previously paid for such defective Product, APP shall promptly, at MDCO's election, either: (i) refund the invoice price for such defective Product; (ii) offset such amount against other amounts due to APP hereunder; or (iii) replace such Product with conforming Product without MDCO being liable for payment therefor under Section 3.1, contingent upon the receipt from MDCO of all Active Materials required for the manufacture of such replacement Product. For greater certainty, APP's responsibility for any loss of Active Materials in connection with defective Product shall be captured under Section 10.1.

Recalled Product. To the extent that a recall or return results from, or arises out of, a failure by APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, APP shall be responsible for the documented out-of-pocket expenses of such recall or return and shall use its Commercially Reasonable Efforts to replace the recalled or returned Product with new Product, contingent upon the receipt from MDCO of all Active Materials required for the manufacture of such replacement Product. For greater certainty, APP's responsibility for any loss of Active Materials in connection with recalled or returned Product shall be captured under Section 10.1. In the event that APP is unable to replace the recalled or returned Product (except where such inability results from a failure to receive the required Active Materials), then, upon MDCO's request, APP shall reimburse MDCO for the price that MDCO paid to APP for Manufacturing Services in respect of the affected Product. In all other circumstances, recalls, returns or other corrective actions shall be made at MDCO's cost and expense.

APP shall have no obligation for any product claims under Sections 6.1 or 6.2 to the extent such product claim (i) is caused by deficiencies with respect to the Specifications, the safety, efficacy or marketability of the Product or any distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable by APP using the test methods set forth in the Specifications, (iii) results from a defect in the Active Materials supplied by MDCO that is not reasonably discoverable by APP using the test methods set forth in the Specifications, (iv) is caused by actions of third parties occurring after such Product is shipped by APP pursuant to Section 5.3, (v) is due to packaging or labeling defects or omissions for which APP has no responsibility, (vi) is due to any unascertainable reason despite APP's having met the Manufacturing Requirements, or (vii) is due to any other breach by MDCO of its obligations under this Agreement.


6.3	Disposition of Defective or Recalled Product.

MDCO shall not dispose of any damaged, defective, returned or recalled Product in relation to which it intends to assert a claim against APP without APP's prior written authorization to do so. Alternatively, APP may instruct MDCO to return such Product to APP. APP shall bear the cost of disposition with respect to any damaged, defective, returned or recalled Product in relation to which it bears responsibility under Sections 6.1 or 6.2 hereof. In all other circumstances, MDCO shall bear the cost of disposition, including all applicable fees for Manufacturing Services, with respect to any damaged, defective, returned or recalled Product.

6.4 Healthcare Provider or Patient Questions and Complaints .

MDCO shall have the sole responsibility for responding to questions and complaints from its customers. Questions or complaints received by APP from MDCO's customers, healthcare providers or patients shall be promptly referred to MDCO. APP shall co-operate as reasonably required to allow MDCO to determine the cause of and resolve any such questions and complaints. Such assistance shall include follow-up investigations, including testing. In addition, APP shall provide MDCO with all mutually agreed upon information that will enable MDCO to respond properly to questions or complaints relating to the Product as provided in the Quality Agreement. Unless it is determined that the cause of any such complaint resulted from a failure by APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, all costs incurred in respect of this Section 6.4 shall be borne by MDCO. In the event that the cause of the complaint is attributable to a failure by APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, such Product shall be deemed to be

defective product as set forth in Section 6.2(a); and, MDCO shall be entitled to compensation and reimbursement by APP for such defective product in accordance with the provisions of Sections 6.1, 6.2 and 10.2.


ARTICLE 7

CO-OPERATION


7.1	Quarterly Review .

Each Party shall forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the Parties. The relationship managers shall meet not less than quarterly to review the current status of the business relationship and manage any issues that have arisen.


7.2	Access & Audits .

APP will provide MDCO with reasonable access at mutually agreeable times and during regular business hours to the areas of the Manufacturing Site in which the Product is manufactured, stored, handled or shipped to permit MDCO to verify that the Manufacturing Services are being performed in accordance with the Manufacturing Requirements. But, with the exception of “for-cause” audits, MDCO will be limited each Year to one cGMP-type audit, lasting no more than [**] days, and involving no more than [**] auditors. MDCO may request additional cGMP-type audits, additional audit days, or the participation of additional auditors, which will be subject to APP's consent, not to be unreasonably withheld, delayed or conditioned. The right of access provided in this Section 7.2 will not include a right to access or inspect APP's financial records.


7.3	Reports .

APP will supply on an annual basis all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing and storage), that MDCO reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that MDCO is required to file with the FDA, or other applicable competent Regulatory Authority.


7.4	Regulatory Authority Filings.

MDCO shall own, and is solely responsible for maintaining any Marketing Authorization necessary for the marketing of the Product in the Territory and any relevant costs shall be borne by MDCO. For the avoidance of doubt, MDCO shall be responsible for, and shall promptly reimburse APP for, all reasonable costs and expenses incurred by or on behalf of APP or its supply contractors in connection with the implementation of any changes to the Product and/or Product Specifications that are requested by MDCO or any Authority, or are necessary to comply with such requests.


ARTICLE 8

TERM AND TERMINATION


8.1	Term .

This Agreement shall become effective as of the Effective Date and shall continue until the end of the Subsequent Supply Term (the " Initial Term "), unless terminated earlier by one of the Parties in accordance herewith. This Agreement shall continue after the Initial Term at MDCO's sole option and discretion for an additional term of two (2) years. MDCO will provide APP notice within ninety (90) days of the end of the Subsequent Supply Term on whether the term of the Agreement will be extended for the additional two (2) year term. Thereafter this Agreement shall automatically terminate unless either Party gives written notice to the other Party of its intention to renew this Agreement at least eighteen (18) months prior to the end of the then current term, which renewal will be subject to both Parties' agreement. Notwithstanding anything herein to the contrary, except as to a termination of this Agreement under Sections 8.2(a) by MDCO for APP's breach, or Section 8.2(c), in the event this Agreement terminates during or before a period when MDCO is to supply authorized generic product to APP pursuant to the AG Supply Agreement, this Agreement shall remain in effect solely with respect to, and to allow for, the supply of

such authorized generic product to APP pursuant to the AG Supply Agreement.


8.2	Termination for Cause .

Either Party, at its sole option, may terminate this Agreement upon written notice in circumstances where the other Party has failed to remedy a material breach of any of its representations, warranties or other obligations under this Agreement within sixty (60) days following receipt of a written notice (the " Remediation Period ") of said breach that expressly states that it is a notice under this Section 8.2(a) (a " Breach Notice "). If the material breach by its nature is not curable, the non-breaching Party shall have the right to terminate this Agreement with immediate effect by giving the breaching Party notice of any such non-curable breach, specifying such non-curable breach in reasonable detail and stating that it terminates this Agreement, such termination right to be exercised within a period of thirty (30) days following the date as of which the terminating Party receives knowledge of any such breach.

Either Party at its sole option may immediately terminate this Agreement upon written notice, but without prior advance notice, to the other Party in the event that: (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; or (iii) this Agreement is assigned by such other Party for the benefit of creditors.


c)	MDCO may terminate this Agreement upon thirty (30) days' prior written notice in the event that any Authority takes any action, or raises any objection, that prevents MDCO from purchasing or selling such Product in the Territory.

In the event that a generically labeled Product is marketed in the Territory by a third party or APP, MDCO may seek to adjust the Price and supply quantities of Product manufactured pursuant to this Agreement. In the event the Parties can not reach mutually agreeable pricing and supply quantities, MDCO shall have the right to terminate this Agreement upon ninety (90) days' prior written notice to APP.

8.3 Product Discontinuation .

MDCO shall provide at least [**] months advance notice if it intends to no longer order Manufacturing Services for the Product due to discontinuance in its marketing. In the event MDCO subsequently decides to reintroduce and market the Product in the Territory, MDCO shall be obligated to offer APP the right of first refusal to provide the Manufacturing Services under the terms of this Agreement.


8.4	Obligations on Termination .

If this Agreement is completed, expires or is terminated in whole or in part for any reason, then (in addition to any other remedies APP may have in the event of default by MDCO):


a)	MDCO shall take delivery of and pay for all undelivered Product that are manufactured pursuant to a Firm Order, at the price in effect at the time the Firm Order was placed;

MDCO shall purchase, at APP's cost (including all costs incurred by APP in connection with the purchase and handling of such Inventory), the Inventory applicable to the Product that cannot reasonably be used for other Product produced by APP, that was purchased, produced or maintained by APP in contemplation of filling Firm Orders or in accordance with Section 5.1 prior to notice of termination being given;


c)	MDCO shall satisfy the purchase price payable pursuant to APP's orders with suppliers of Components, provided such orders were made by APP in reliance on Firm Orders;


d)	APP shall return to MDCO all unused Active Materials, retains and samples (with shipping and related expenses, if any, to be borne by MDCO) and MDCO shall be obligated to maintain any stability protocols set out in the Specifications; and


e)	MDCO shall pay any amounts due under the provisions of this Section 8.4 within [**] days of the date

of termination or expiry of this Agreement.

Any termination or expiration of this Agreement shall not affect any outstanding obligations or payments due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies that the Parties may have under this Agreement. For greater certainty, termination of this Agreement for any reason shall not affect the obligations and responsibilities of the Parties pursuant to Articles 1, 8, 9, 10, 11, 12, and 13 and Sections 6.2, 6.3, and 6.4, all of which survive any termination.


ARTICLE 9

REPRESENTATIONS, WARRANTIES AND COVENANTS


9.1	Authority .

Each Party covenants, represents and warrants that it has the full right and authority to enter into this Agreement, and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder.


9.2	Product Warranties .

APP covenants, represents and warrants that it shall perform the Manufacturing Services in accordance with the Manufacturing Requirements.


9.3	Debarred Persons .

APP covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b), or any analogous law or regulation. APP represents that it does not have at the execution date of this Agreement, and covenants that it will not hire, as an officer or an employee any person who has been convicted of health care fraud or a felony under the laws of the United States for conduct relating to the regulation of any drug product under the 21 U.S.C. § 301 et seq. If any of APP or APP's Affiliate directors, officers, employees, agents, representatives or advisors, who perform services under this Agreement is debarred or receives notice of an action or threat of action of debarment, APP shall immediately notify MDCO of same and shall take all the appropriate disciplinary actions against the individuals responsible for the activity which constitutes cause for debarment. MDCO shall be entitled to terminate this Agreement pursuant to Section 8.2(a) in the event of debarment of APP or its Affiliates.


9.4	No Warranty .

APP MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. APP MAKES NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY WITH RESPECT TO THE PRODUCT.


ARTICLE 10

REMEDIES AND INDEMNITIES


10.1	Active Materials.

In the event the Active Materials are damaged or lost due to the failure of APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, APP shall be responsible for any loss or damage to the Active Materials.


10.2	APP.

APP and its Affiliates agree to defend, indemnify and hold MDCO, its officers, employees and agents harmless against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties resulting from, or relating to any claim of personal injury or property damage, to the extent that such injury or damage is the result of: (i) a breach of this Agreement by APP, including, without limitation, any representation

or warranty contained herein, or (ii) APP's gross negligence or wilful misconduct in performing the Manufacturing Services in accordance with the Manufacturing Requirements, except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are due to the gross negligence or wrongful act(s) of MDCO, its officers, employees or agents or Affiliates.

In the event of a claim, MDCO shall: (a) promptly notify APP of any such claim; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with APP in the defence of such claim; (d) permit APP to control the defence and settlement of such claim, all at APP's cost and expense.


10.3	MDCO.

MDCO agrees to defend, indemnify and hold APP, its Affiliates, officers, employees and agents harmless against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties resulting from, or relating to any claim of personal injury or property damage to the extent that such injury or damage is the result of: (i) a breach of this Agreement by MDCO, including, without limitation, any representation or warranty contained herein, or (ii) any personal injury (including death) or property damage caused by the Product, except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are (i) due to the gross negligence or wrongful act(s) of APP, its officers, employees or agents, or (ii) subject to APP's indemnification under Section 10.2 of this Agreement or Section 8.2 of the AG Supply Agreement.

In the event of a claim, APP shall: (a) promptly notify MDCO of any such claims; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with MDCO in the defence of such claim; (d) permit MDCO to control the defence and settlement of such claim, all at MDCO's cost and expense.


10.4	Reasonable Allocation of Risk.

The provisions of this Agreement (including, without limitation, this Article 10) are reasonable and create a reasonable allocation of risk having regard to the relative profits the Parties respectively expect to derive from the Product, and that APP, in its fees for the provision of the Manufacturing Services, has not accepted a greater degree of the risks arising from the manufacture, distribution and use of the Product, based on the fact that MDCO has developed and holds the marketing approval for the Product and requires APP to manufacture the Product strictly in accordance with the Specifications, and that MDCO and not APP is in a position to inform and advise potential users of the Product as to the circumstances and manner of use of the Product.


ARTICLE 11

CONFIDENTIALITY

In consideration for and as a condition to the Parties furnishing to one another access to Confidential Information, the Parties agree as follows:


11.1	The Party receiving the other Party's Confidential Information (the “Receiving Party”) acknowledges the confidential and proprietary nature of the Confidential Information, agrees to hold and keep the same as provided in this Agreement.


11.2	The Receiving Party agrees that the disclosure of Confidential Information will be made to it in confidence and that:


a)	The Receiving Party agrees to keep Confidential Information as confidential and secret.

The Receiving Party agrees to restrict access to the Confidential Information to its employees and representatives to whom such disclosure is necessary to further the purpose of this Agreement solely on a need-to-know basis and shall ensure that such Persons treat such Confidential Information in a manner consistent with the terms of this Article 11. The Receiving Party shall be liable for failure of its employees and representatives to treat such Confidential Information in a manner consistent with the terms of this Article 11.


c)	The Receiving Party agrees to notify the Party disclosing any Confidential Information (the “Disclosing Party”) in writing of any misuse or misappropriation of the Confidential Information which may come to its attention.

The Receiving Party may disclose the Confidential Information to the extent such disclosure is required by law or by court, provided, however, the Receiving Party shall provide prompt written notice to the Disclosing Party of such requirement so that the Disclosing Party may seek a protective order or other appropriate remedy. In the event that no such protective order or other remedy is obtained, the Receiving Party agrees to disclose only that portion of the Confidential Information that the Receiving Party is legally compelled or is otherwise required to disclose; provided, however, that the Receiving Party shall exercise all reasonable efforts to obtain confidential treatment for such Confidential Information.


e)	The Receiving Party agrees to use the Confidential Information only in connection with the purpose of this Agreement.

Upon written request of the Disclosing Party or the termination of this Agreement, the Receiving Party shall, at the Receiving Party's discretion, promptly either destroy all Confidential Information and any and all photocopies, tapes or other forms of subject material transcribed by the Receiving Party and notify the Disclosing Party of such destruction, or return all Confidential Information to the Disclosing Party, as the case may be; provided, however, that the Receiving Party shall have the right to retain one copy of any Confidential Information solely for the purpose of and to the extent necessary to comply with legal requirements.

The Receiving Party agrees that any and all Confidential Information disclosed to the Receiving Party or its Affiliates in preliminary discussions or agreements with the Disclosing Party prior to the execution and delivery of this Agreement shall be subject to all the terms and conditions of this Article 11 to the same extent and as fully as if this Agreement had been in full force and effect on the date such Confidential Information was obtained by the Receiving Party or its Affiliates, or their employees or representatives.


h)	The Receiving Party agrees that the obligations of the Receiving Party set forth in this Article 11 are necessary and reasonable in order to protect the Disclosing Party and its business.


11.3	Anything to the contrary herein notwithstanding, the confidentiality obligations set forth in this Article 11 shall survive the expiration or termination of this Agreement for a period of [**] years following such expiration or termination.

11.4

All publicity, press releases and other announcements relating to this Agreement or the transactions contemplated hereby shall be reviewed in advance by, and shall be subject to the written approval of, both Parties, such approval not to be unreasonably withheld or delayed. Notwithstanding the foregoing, each Party shall be entitled to make such announcements relating to this Agreement as such Party reasonably determines is required to comply with any law or regulation requiring such announcements, including any applicable rule or regulation of any securities exchange on which the applicable Party's (or its Affiliate's) securities are listed.


ARTICLE 12

DISPUTE RESOLUTION


12.1	Commercial Disputes.

In the event of any dispute arising out of or in connection with this Agreement (other than a dispute determined in accordance with Section 6.1(b) or a Technical Dispute), the Parties shall first try to solve it amicably. In this regard, either Party may send a notice of dispute to the other, and each Party shall appoint, within [**] Days from receipt of such notice of dispute, a single representative to handle the dispute. The representatives so designated shall confer as necessary in order to solve such dispute. If these representatives fail to solve the matter within [**] from their appointment, or if a Party fails to appoint a representative within the [**] Day period set forth above, such dispute shall immediately be referred to the Chief Operating Officer (or such other officer as he/she may designate) of each Party who will meet and discuss as necessary in order to try to solve the dispute amicably. Should the Parties fail to reach a resolution under this Section 12.1, the dispute will be referred to a court of competent jurisdiction in accordance with Section 13.15.


12.2	Technical Dispute Resolution.

In the event of a dispute (other than disputes in relation to the matters set out in Sections 6.1(b) and 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, quality control testing, handling, storage or other activities under this Agreement (a " Technical Dispute "), the Parties shall make all reasonable efforts to resolve the dispute by amicable negotiations. In this regard, senior representatives of each Party shall, as soon as practicable and in any event no later than [**] Days after a written request from either Party to the other, confer in good faith to resolve any Technical Dispute. If, despite such efforts, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within [**] Days of such written request, the Technical Dispute shall, at the request of either Party, be referred for determination to a mutually acceptable expert with experience and expertise in the subject matter of the dispute. The costs and expenses of the expert shall be shared equally by the Parties. In the event that the Parties cannot agree whether a dispute is a Technical Dispute, Section 12.1 shall prevail. For greater certainty, the Parties agree that the release of the Product for sale or distribution pursuant to the applicable marketing approval for such Product shall not by itself indicate compliance by APP with its obligations in respect of the Manufacturing Services and further that nothing in this Agreement shall remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Product are to be released for sale or distribution.


ARTICLE 13

MISCELLANEOUS


13.1	Inventions.


(a)	For the term of this Agreement, MDCO hereby grants to APP and to any Subcontractor a non-exclusive, paid-up, royalty-free, non-transferable license of MDCO's Intellectual Property which APP and such Subcontractor must use solely for the purpose of performing the Manufacturing Services.


(b)	All Intellectual Property generated or derived by APP, exclusive of Manufacturing Services Based Intellectual Property, and/or by any Subcontractor in the course of performing the Manufacturing Services, to the extent it is specific to the development, manufacture, use and sale of the Product that is the subject of the Manufacturing Services, shall be the exclusive property of MDCO.


13.2	Intellectual Property.

Subject to Section 13.1, all Intellectual Property of MDCO shall be owned by MDCO and all Intellectual Property of APP or its Affiliates shall be owned by APP. Neither Party has, nor shall it acquire, any interest in any of the other Party's Intellectual Property unless otherwise expressly agreed to in writing signed by an authorized representative of each Party. Each Party agrees not to use any prior Intellectual Property of the other Party, except as specifically authorized by the other Party or as required for the performance of its obligations under this Agreement.


13.3	Insurance.

Each Party shall maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that Party under this Agreement through the term of this Agreement and for a period of 1 (one) year thereafter, which insurance shall afford limits of not less than (i) $ [**] for each occurrence for personal injury or property damage liability; and (ii) $ [**] in the aggregate per annum with respect to product and completed operations liability. If requested each Party will provide the other with a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the limits of liability. The insurance certificate shall further provide for a minimum of thirty (30) days' written notice to the insured of a cancellation of, or material change in, the insurance. If a Party is unable to maintain the insurance policies required under this Agreement through no fault on the part of such Party, then such Party shall forthwith notify the other Party in writing and the Parties shall in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances.


13.4	Independent Contractors.

The Parties are independent contractors and this Agreement shall not be construed to create between APP

and MDCO any other relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners or any similar relationship, the existence of which is expressly denied by the Parties hereto.


13.5	No Waiver.

Either Party's failure to require the other Party to comply with any provision of this Agreement shall not be deemed a waiver of such provision or any other provision of this Agreement, with the exception of Sections 6.1.


13.6	Assignment and Subcontracting.


a)	Neither Party may assign this Agreement or any of its rights or obligations hereunder except with the written consent of the other Party, such consent not to be unreasonably withheld. It is agreed upon between the Parties that APP may arrange for the Manufacturing Services to be performed by the aforementioned Subcontractor.

Notwithstanding the foregoing provisions of this Section 13.6, either Party may assign this Agreement to any of its Affiliates or to a successor to or purchaser of all or substantially all of its business, provided that such assignee executes an agreement with the non-assigning Party hereto whereby it expressly assumes in writing those rights, duties and obligations under this Agreement and this Agreement itself and the assignee is a financially capable business entity.


c)	Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Any assignment or transfer in contravention of the terms of this Agreement shall be null and void.

13.7 Force Majeure.

Neither Party shall be liable for the failure to perform its obligations under this Agreement if such failure is occasioned by a cause or contingency beyond such Party's reasonable control, including, but not limited to, strikes or other labour disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay in transportation, defective equipment, lack of or inability to obtain fuel, power or components or compliance with any order or regulation of any government entity acting within colour of right (a " Force Majeure Event "). A Party claiming a right to excused performance under this Section 13.7 shall immediately notify the other Party in writing of the extent of its inability to perform, which notice shall specify the occurrence beyond its reasonable control that prevents such performance. Neither Party shall be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement.


13.8	Notices.

Any notice, approval, instruction or other written communication required or permitted hereunder shall be sufficient if made or given to the other Party by personal delivery, by facsimile (fax) communication, or confirmed receipt email or by sending the same by first class mail, postage prepaid to the respective addresses or facsimile (fax) numbers or electronic mail addresses set forth below:

If to MDCO:

The Medicines Company

8 Sylvan Way

Parsippany, NJ 07054

Attention: Mr. Paul Antinori

Senior Vice President and General Counsel

Facsimile (fax) number: 862-207-6062

Email address: Paul.Antinori@themedco.com

If to MDCO (for accounting purposes):

The Medicines Company

8 Sylvan Way

Parsippany, NJ 07054

Attention: Mr. Bill O'Connor

Chief Accounting Officer

Facsimile (fax) number: 862-207-6094

Email address: Bill.O'Connor@themedco.com

If to APP Pharmaceuticals, LLC:

APP Pharmaceuticals, LLC

1501 East Woodfield Road

Suite 300 East

Schaumburg, Illinois 60173

Attn: General Counsel

Fax: 847-413-2670

or to such other addresses, facsimile numbers or electronic mail addresses provided to the other Party in accordance with the terms of this Section 13.8. Notices or written communications made or given by personal delivery, facsimile or electronic mail shall be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five (5) days after being deposited in the European Union mail, postage prepaid or upon receipt, whichever is sooner.


13.9	Severability.

If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such determination shall not impair or affect the validity, legality or enforceability of the remaining provisions hereof, and each provision is hereby declared to be separate, severable and distinct. The Parties shall endeavor, in due form, to replace the invalid or void provision with a new provision or to fill the gap with a provision which best enables the economic purpose pursued to be achieved.


13.10	Entire Agreement.

This Agreement, together with the Quality Agreement, constitutes the full, complete, final and integrated agreement between the Parties hereto relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions or understandings with respect to the subject matter hereof. Any modification, amendment or supplement to this Agreement must be in writing and signed by authorized representatives of both Parties. In case of conflict, the prevailing order of documents shall be this Agreement and then the Quality Agreement except in matters pertaining to product quality, GMP and regulatory responsibilities, in which case the Quality Agreement will prevail. THE TERMS OF ANY PURCHASE ORDER, ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM GIVEN OR RECEIVED IN THE CONTEXT OF THE SUBJECT MATTER OF THIS AGREEMENT WHICH ARE IN ADDITON TO OR INCONSISTENT WITH THE TERMS OF THIS AGREEMENT WILL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXPRESSLY EXCLUDED.


13.11	Other Terms .

No terms, provisions or conditions of any purchase order or other business form or written authorization used by MDCO or APP will have any effect on the rights, duties or obligations of the Parties under or otherwise modify this Agreement, regardless of any failure of MDCO or APP to object to such terms, provisions, or conditions unless such document specifically refers to this Agreement and is signed by both Parties.


13.12	No Third Party Benefit or Right .

For greater certainty, nothing in this Agreement shall confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement.


13.13	Execution in Counterparts .

This Agreement may be executed in two or more counterparts, by original or facsimile signature, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.


13.14	Use of MDCO Name

APP shall not make any use of MDCO's name, trademarks or logo or any variations thereof, alone or in connection with any other word or words, without the prior written consent of MDCO, which consent shall not be unreasonably withheld.


13.15	Governing Law .

This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without regard to the conflicts of laws provisions thereof. All Parties hereby consent to, and will not dispute or contest, the jurisdiction and venue of the federal and state courts of the State of Delaware, for purposes of any action or proceeding to enforce the terms and conditions of this Agreement.

IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Agreement as of the date first written above.

APP PHARMACEUTICALS, LLC

by _ /s/ J.R. Ducker ____________

J.R. Ducker

President and CEO

THE MEDICINES COMPANY

by _ /s/ Glenn Sblendorio __________

Glenn Sblendorio, EVP and CFO

SCHEDULE A

MINIMUM RUN QUANTITY, AND Price

A) MINIMUM RUN QUANTITY



PRODUCT	MINIMUM RUN QUANTITY
Angiomax®	*

B) PRICE



Product	Fill Volume	Vial size	Batch size proposed	Unit Total Price
Angiomax®	250 mg	10 ml	[**] vials	$[**] per vial

* To be determined by the Parties in good faith prior to the Initial Supply Term.

SCHEDULE B

STABILITY TESTING activities

APP and MDCO shall agree in writing on any stability testing to be performed by APP in connection with the Product. Such agreement shall specify the commercial and Product stability protocols applicable to the stability testing.

SCHEDULE C

ACTIVE MATERIALS

Active Materials

Bivalirudin

SCHEDULE D

DEVELOPMENT COSTS AND EXPENSES



Transfer Expense	Cost per Unit	Units	Total
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]		Total	$[**]

[**]			$[**]

SCHEDULE E

CAPITAL EXPENDITURES



CapEx	Cost per Unit	Units	Total
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
		Total	$[**]

[**]			$[**]



	Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.			Exhibit 10.4

EXECUTION COPY

LICENSE AND SUPPLY AGREEMENT

This License and Supply Agreement (this “ Agreement ”) is entered into as of the 22 ^nd day of January, 2012 (the “ Effective Date ”), by and between The Medicines Company, a corporation organized and existing under the laws of the State of Delaware, having a place of business at 8 Sylvan Way, Parsippany, New Jersey 07054 (“ MDCO ”), and on the other hand, APP Pharmaceuticals, LLC, a limited liability company organized and existing under the laws of the State of Delaware, having a place of business at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 (“ APP ”). MDCO and APP are collectively referred to herein as “ Parties ,” or each separately, as a “ Party .”

RECITALS

WHEREAS, MDCO wishes to acquire a license to sell the Products (defined below) in the Territory (defined below);

WHEREAS, MDCO wishes to engage APP to manufacture and supply the Products, subject to and in accordance with the terms and conditions set forth in this Agreement, and APP wishes to be so engaged; and

WHEREAS, APP and/or its Affiliates have the capability, capacity and desire to manufacture and supply the Products.

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

ARTICLE I

DEFINITIONS

SECTION 1.1. As used herein, the following terms shall have the following meanings:

“ Abbreviated New Drug Application ” shall mean an Abbreviated New Drug Application filed with the FDA to manufacture and/or sell a pharmaceutical product pursuant to the FDA's rules and regulations.

“ Act ” shall mean the United States Food, Drug and Cosmetic Act (21 U.S.C. § 301, et seq.) and the regulations promulgated thereunder, as each may be amended from time to time.

“ Affiliates ” means with respect to any Party, any partnership, association, corporation, limited liability company, trust, or other legal entity, that is controlled by, controls, or is under common control with, that Party. For the purposes of this definition, “control” when used with respect to any Person means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise, and the terms “controlling” and “controlled” have correlative

meanings.

“ Batch Quantity ,” with respect to each Product, shall mean, subject to the last sentence of Section 2.5 , the quantity of Product listed in Exhibit A attached hereto.

“ cGMP ” shall mean the current good manufacturing practices required by the FDA and set forth in the Act or FDA regulations, policies or guidelines in effect at the time in question for the manufacture and testing of pharmaceutical materials, including as described in Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations, all as updated, amended and revised from time to time.

“ Commercially Reasonable Efforts ” shall mean, with respect to each Party, commercially reasonable efforts in accordance with such Party's business, legal, medical, and scientific judgment and in accordance with the efforts and resources such Party would use for a product owned by it or to which it has rights, which is of similar market potential, at a similar stage in its product life, taking into account the competitiveness of the market place, the proprietary position of the product, the regulatory structure involved, the potential for litigation or other disputes associated with such product, the intellectual property issues associated with such product, the profitability of the product and other relevant factors.

“ Confidential Information ” shall mean, with respect to a Party, all information of any kind whatsoever (including without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies, and techniques), and all tangible and intangible embodiments thereof of any kind whatsoever (including without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), which is disclosed by such Party to the other Party or any of its Affiliates. Confidential Information shall also include the terms and existence of this Agreement and other agreements. Notwithstanding the foregoing, Confidential Information of a Party shall not include information which the other Party can establish by competent evidence (a) to have been publicly known prior to disclosure of such information by the disclosing Party to the other Party, (b) to have become publicly known, without fault on the part of the other Party, subsequent to disclosure of such information by the disclosing Party to the other Party, (c) to have been received by the other Party or one of its Affiliates free of an obligation of confidentiality at any time from a source, other than the disclosing Party, rightfully having possession of and the right to disclose such information free of an obligation of confidentiality, (d) to have been otherwise known by the other Party or any of its Affiliates prior to disclosure of such information by the disclosing Party to the other Party, or (e) to have been developed by the receiving Party after receipt of such information, and which the receiving Party can demonstrate through written documentation, was not developed through use of such information.

“ Cost of Goods ” shall mean APP's direct costs (including out-of-pocket costs and directly allocable internal overheads, but not including allocations of corporate or general overheads or of any idle or excess capacity) of manufacture, packaging, shipping, labeling, testing, and validation of Product, accrued in accordance with GAAP.

“ FDA ” shall mean the United States Food and Drug Administration (and any successor agency thereto).

“ GAAP ” shall mean Generally Accepted Accounting Principles as used and defined in the United States, consistently applied.

“ Intellectual Property ” shall mean any and all of the following, whether or not registered, in the United States and all other jurisdictions throughout the world, only to the extent necessary to manufacture, sell, market and promote the Products in the Territory: (i) inventions and improvements thereto, whether or

not patentable, and patents and patent applications (including all reissues, divisions, continuations, continuations-in-part, extensions and reexaminations thereof); (ii) trademarks, service marks, trade dress, logos, domain names, rights of publicity, trade names and corporate names, and all goodwill associated therewith; (iii) copyrights, including all derivative works, moral rights, renewals, extensions, reversions or restorations associated with such copyrights, now or hereafter provided by law, regardless of the medium of fixation or means of expression; (iv) computer software (including source code, object code, firmware, operating systems and specifications); (v) trade secrets and, whether or not confidential, business information (including pricing and cost information, business and marketing plans and customer and supplier lists) and know how; (vi) databases and data collections; (vii) any other type of intellectual property right; (viii) registrations and applications for registration of any of the foregoing; (ix) copies and tangible embodiments of any of the foregoing; and (x) rights to sue or recover and retain damages, costs and attorneys' fees for past, present or future infringement, misappropriation or violation of any of the foregoing.

“ Licensed Intellectual Property ” means all Intellectual Property and Marketing Authorizations owned or controlled by APP or an Affiliate solely to the extent necessary for the sale of the Product.

“ Marketing Authorizations ” means any federal, state, or local approvals, licenses, permits, applications, registrations or authorizations approved by, filed with, or submitted to any governmental authority, such as the FDA, including all Abbreviated New Applications and New Drug Applications, including those listed in Exhibit B attached hereto.

“ NDC ” shall mean, with respect to each Product, the national drug code for such Product.

“ New Drug Application ” shall mean a New Drug Application filed with the FDA pursuant to and under 21 U.S.C. § 355(b) of the Act, together with the FDA's implementing rules and regulations.

“ Partial Batch Quantities ” shall mean quantities of Product amounting to less than full Batch Quantities, which may be supplied by APP, subject to APP's manufacturing requirements and schedules.

“ Person ” shall mean an individual, corporation, partnership, joint venture, limited liability company, trust or unincorporated organization, joint stock company or other similar organization, a government or any political subdivision thereof, or any other legal entity

“ Product(s) ” shall mean those pharmaceutical products listed in Exhibit C attached hereto in the dosage strengths listed in Exhibit C .

“ Product Specifications ” shall mean the specifications for a Product as set forth in the applicable Marketing Authorizations for the Product, including (as applicable) statements of manufacturing, labeling, packaging, storage and quality control procedures (as such may be revised from time to time) together with any additional specifications that may be agreed to between the Parties and the specifications for the Products as set forth in the Quality Agreement, with such modifications as APP and MDCO may agree upon from time to time in accordance with Section 4.3 .

“ Purchase Price ” shall have the meaning as defined in Section 5.1.

“ Quality Agreement ” shall mean the pharmaceutical Quality Agreement to be entered into by APP and MDCO as soon as reasonably practicable after the Effective Date hereof. In the event of a conflict between the terms of this Agreement and the Quality Agreement, the terms of this Agreement shall govern.

“ Territory ” shall mean the United States of America and its possessions and territories.

SECTION 1.2. Other Defined Terms . The following terms are defined in the Articles or other sections of the Agreement indicated below.



Change in Control	12.7
MDCO Parties	11.1
Detailed Product Forecast	2.3.2
Disclosing Party	10.2.3
Forecast Commencement Quarter	2.3.2
Indemnified Party	11.3
Indemnifying Party	11.3
APP Parties	11.2
Initial Product Forecast	2.3.1
Losses	11.1
Receiving Party	10.1
Report	6.3.1
Requirements	2.2
Supply Interruption	2.8
Term	8.1

SECTION 1.3. Interpretation . Unless otherwise indicated to the contrary herein by the context or use thereof (i) the words, “herein,” “hereto,” “hereof” and words of similar import refer to this Agreement as a whole and not to any particular Section or paragraph hereof, (ii) the word “including” means “including, but not limited to,” (iii) words importing the singular will also include the plural, and vice versa, and (iv) any reference to any federal, state, local, or foreign statute or law will be deemed also to refer to all rules and regulations promulgated thereunder. References to $ will be references to United States Dollars.

ARTICLE II

PURCHASE AND SALE

SECTION 2.1. Agreement to Supply . APP shall use Commercially Reasonable Efforts to manufacture, test, package and sell to MDCO all such quantities of the Product as MDCO shall order from APP in accordance with the terms and conditions, and subject to the obligations and limitations set forth in this Agreement, including Sections 2.3 and 2.8 hereof.

SECTION 2.2. Agreement to Purchase; Exclusivity . Subject to the terms and conditions of this Agreement, (i) MDCO agrees to purchase exclusively from APP MDCO's entire commercial requirements of the Product for resale solely to hospitals and integrated delivery networks in the Territory (hereinafter referred to as MDCO's “ Requirements ”), and (ii) MDCO shall not manufacture itself or purchase or procure from any other manufacturer or source, including any of its Affiliates, partners or any other Persons with which any of them has entered into any collaboration arrangement regarding the Product, any of its Requirements of the Product. Should MDCO's profit margin on any Product fall to or below [**]%, MDCO shall be excused from the exclusivity requirements of this Section 2.2 with respect to such Product.

SECTION 2.3. Forecasts .

SECTION 2.3.1. Within [**] days of the Effectice Date, MDCO shall provide APP with a forecast setting forth MDCO's Requirements of Product for the period commencing [**] days from

the date of the delivery of such forecast to APP and ending on [**] (the “ Initial Product Forecast ”). MDCO's forecasted Requirements for the Initial Product Forecast shall be firm and binding upon MDCO and shall be accompanied by a purchase order for the quantities of Product specified in such Initial Product Forecast.

SECTION 2.3.2. Beginning [**], at least [**] days prior to the commencement of each calendar quarter (with respect to the forecast for the period then commencing, the “ Forecast Commencement Quarter ”) during the Term, MDCO shall provide APP with a written estimate of MDCO's Requirements for each dosage strength and package size of each Product during the [**] commencing with the Forecast Commencement Quarter, delineated by [**] (a “ Detailed Product Forecast ”). MDCO's forecasted Requirements for the first [**] of each Detailed Product Forecast provided hereunder shall be firm and binding upon MDCO and each Detailed Product Forecast shall be accompanied by a purchase order for the quantities of Product specified for such [**] period in such Forecast Commencement Quarter. The remaining portion of each Detailed Product Forecast shall be firm subject to permissible variances set forth in Section 2.3.3 . If MDCO fails to timely provide any updated Detailed Product Forecast, the Detailed Product Forecast last provided by MDCO shall be deemed to be MDCO's Detailed Product Forecast for the next succeeding [**] period.

SECTION 2.3.3. Each subsequent Detailed Product Forecast may be updated to modify the amounts estimated in the previous Detailed Product Forecast for the periods of time in question subject to the following limitation: the volume specified for any calendar quarter covered by such subsequent Detailed Product Forecast shall not be increased or decreased by more than [**] percent ([**]%) from the volume specified for such quarter in the prior Detailed Product Forecast without APP's written consent.

SECTION 2.4. Purchase Orders .

SECTION 2.4.1. In accordance with the terms of this Agreement, MDCO will initiate orders for the Product by submitting written purchase orders to APP at the following address:

APP Pharmaceuticals, LLC

Attn: Purchasing Department

1501 East Woodfield Road

Suite 300 East

Schaumburg, Illinois 60173

SECTION 2.4.2. Each purchase order submitted by MDCO shall specify a required delivery date not less than [**] days after the date of such purchase order. APP will provide written confirmation of each purchase order within [**] days after receipt thereof; provided , however , that APP shall have no obligation to accept or confirm any purchase order that is inconsistent with the terms of this Agreement.

SECTION 2.4.3. All purchase orders shall be governed exclusively by the terms of this Agreement. Any term or condition in any purchase order, confirmation, invoice or other document furnished by APP or MDCO that is in any way inconsistent with the terms and conditions of this Agreement shall be null and void, unless specifically and mutually agreed upon in a writing signed by each Party.

SECTION 2.5. Batch Quantities . Unless otherwise mutually agreed upon by the Parties, the Initial

Product Forecast and all Detailed Product Forecasts and purchase orders for Product hereunder shall be for Batch Quantities or Partial Batch Quantities. To the extent actual batch sizes manufactured by APP consist of more or less than the applicable number of Product units specified in the definition of “Batch Quantity,” the quantities of actual Product units contemplated by the applicable purchase orders will be automatically adjusted to reflect the actual batch sizes manufactured by APP.

SECTION 2.6. Shipment . Product ordered by MDCO hereunder will be shipped to MDCO or its designee EXW (Incoterms 2000) the facility of APP, in Bensenville, Illinois, via the carrier designated by MDCO. For avoidance of doubt, all costs and risk of loss shall pass to MDCO upon the loading and transfer of Product to MDCO's designated carrier at APP's facility.

SECTION 2.7. Performance by Affiliates . Notwithstanding any other provision of this Agreement, any right or obligation of APP hereunder may be exercised or fulfilled by any Affiliate or other designee of APP.

SECTION 2.8 Supply Interruption . In the event that the amount of Product ordered by MDCO pursuant to a purchase order remains undelivered to MDCO from APP exceeds [**] percent ([**]%) of the amount of Product ordered by MDCO pursuant to such purchase order for a period of at least [**] days, including as may be caused by or attributed to a force majeure as set forth in Section 12.2 (a “Supply Interruption”), APP will respond promptly and in good faith to all associated inquiries by MDCO regarding the anticipated duration of any delays and the anticipated amount of Product to be delivered. In the event of a Supply Interruption caused by any production capacity limitation or any shortage of active pharmaceutical ingredient or other materials or excipients, APP shall supply Product to MDCO on a pro rata basis based on units sold by each Party during the preceding six-month period. In the event MDCO has not sold Product for a continuous six-month period, APP shall supply Product to MDCO based on [**]% of MDCO's Initial Product Forecast.

ARTICLE III

LICENSE

SECTION 3.1. Grant of License . APP hereby grants to MDCO a non-exclusive license during the Term under the Licensed Intellectual Property only to the extent necessary to sell, market, distribute and promote the Products solely to hospitals and integrated delivery networks in the Territory. APP's grant of a non-exclusive license to MDCO shall not include sales, marketing, distribution or promotion to group purchasing organizations (“GPOs”) or wholesale distributors for distribution or promotion to GPOs or oncology or renal clinic distributors for subsequent distribution to their member organizations. As consideration for the license grants set forth herein, MDCO will pay to APP, on the Effective Date, an upfront one-time license fee for all Products, as set forth in Exhibit D , attached hereto. Notwithstanding the foregoing, APP reserves all other rights in the Licensed Intellectual Property not expressly licensed to MDCO herein, including, but not limited to, the right to use or sublicense the Marketing Authorizations to sell, market, promote and manufacture the Products.

SECTION 3.2. Marketing Authorizations Maintenance . MDCO shall deliver to APP all information requested by APP that is necessary or useful for the purposes of APP or its third party designee maintaining and updating the Marketing Authorizations in accordance with FDA standards.

SECTION 3.3. MDCO Trademarks and NDC . All Product sold by MDCO shall be sold under MDCO's own trademarks, trade names and distinct NDC. APP shall be responsible for obtaining an NDC for each Product sold by MDCO. MDCO shall be responsible for, all returns, rebates and chargebacks

associated with sales of Product by MDCO; provided that APP shall be responsible for, and shall bear the cost of, all returns and rebates associated with sales of Product supplied not in conformity with the Product Specifications.

SECTION 3.4. Product Substitution . In the event that (i) a Product is discontinued as set forth in Section 8.2.2 , (ii) APP determines that it will no longer sell a Product in the Territory pursuant to Section 8.2.3 , or (iii) MDCO determines that it will no longer sell the Product in the Territory pursuant to Section 8.2.4 , the Parties shall amend Exhibit C to substitute another pharmaceutical product to replace such Product in Exhibit C according to the following procedure: [**]. MDCO shall have [**] days to approve such a substitution in writing. In the event that MDCO does not approve such a substitution, the Parties shall negotiate in good faith to agree on a substitute product.

ARTICLE IV

MANUFACTURE

SECTION 4.1. Product Manufacturing, Specifications; Quality Agreement . APP shall manufacture, test, package and store Product in accordance with the Product Specifications, cGMP and the Quality Agreement. Each shipment of Product hereunder shall be accompanied by a certificate of analysis reflecting that such Product conforms to the Product Specifications. At the time APP notifies MDCO that any Product is available for pick-up by MDCO or its designee, such Product shall have a minimum remaining shelf life, without retesting, of the greater of: [**].

SECTION 4.2. Labels and Packaging . All Product supplied to MDCO hereunder shall be packaged in accordance with the Product Specifications and cGMP and shall include all Product labels and package inserts specified by MDCO; provided, however, that MDCO shall provide APP or its designee with camera ready artwork for all such labels and package inserts at least [**] days prior to the first delivery date for the Product requiring such labels and/or such package inserts, as specified in MDCO's purchase orders. MDCO shall be solely responsible for ensuring that all such labels and package inserts comply with all applicable regulatory requirements. Notwithstanding any other provision of this Agreement, APP shall not be liable for any failure or delay to meet its obligations hereunder to the extent such failure or delay is attributable to MDCO's failure to supply or delay in supplying camera ready artwork in accordance herewith on a timely basis. MDCO hereby grants APP the right and license to reproduce and affix to Product labels and package inserts camera-ready artwork bearing the trademarks of MDCO.

SECTION 4.3. Changes to Specifications . Subject to the remaining provisions of this Section 4.3 , the Product Specifications may be changed from time to time (i) if required by the FDA, or (ii) upon the request of either Party and with the consent of the other Party. The following provisions shall apply to changes to the Product Specifications:

(a) The Party seeking the change(s) shall promptly advise the other Party in writing of any such change(s) to the Product Specifications, and APP shall promptly advise MDCO as to any scheduling, price or other adjustments that may result from such change(s), if any.

(b) In the event of a change of the nature described in clause (i) above, the Party seeking the change shall notify the other Party in writing promptly upon being informed of or identifying the potential need for such change and shall consult with the other Party on an ongoing basis regarding such change, including the need for such potential change and the appropriate way to address the issue giving rise to such potential change.

(c) Each Party shall use Commercially Reasonable Efforts to implement any required or agreed-upon changes to the Product Specifications as soon as practicable after the nature of the change is determined and, if applicable, the applicable Party has consented to the change; provided , however , that in no event shall any change be implemented until such time as such change has been approved by the FDA, if such approval is required.

(d) MDCO shall be responsible for, and shall promptly reimburse APP for, all reasonable costs and expenses incurred by or on behalf of APP or its supply contractors in connection with the implementation of changes to the Product Specifications that are requested by MDCO or are necessary to comply with MDCO's requests. APP shall be responsible for changes required by FDA. Additionally, if any changes to the Product Specifications result in a change in Cost of Goods with respect to the Product, the Purchase Prices shall be adjusted to fully account for the amount of such change.

ARTICLE V

PRICE AND PAYMENT

SECTION 5.1. Purchase Price . During the Term, APP shall supply the Product at the then applicable Purchase Price . The initial Purchase Prices are set forth in Exhibit E attached hereto and shall remain firm for the 12 month period following the Effective Date. MDCO acknowledges that the Purchase Price shall be adjusted from time to time based on an increase or decrease in APP's actual Cost of Goods. APP shall provide written notice to MDCO prior to the date of each such change in the Purchase Price, setting forth in reasonable detail the change in APP's Purchase Price in respect of each dosage strength of the Product. The prices set forth on Exhibit E shall automatically be changed as reflected in APP's notice, effective as of the date specified in such notice. APP represents and warrants that the initial Purchase Prices as set forth in Exhibit E are APP's current Cost of Goods for each of the Products based on Batch Quantities, and that the Purchase Price for each of the Products shall remain during the term of this Agreement APP's actual Cost of Goods for Batch Quantities and Partial Batch Quantities.

SECTION 5.2. Invoices and Payment .

SECTION 5.2.1. All invoices from APP for Product supplied pursuant to this Agreement shall be payable within [**] days after receipt by MDCO.

SECTION 5.2.2. All payments made to APP pursuant to this Agreement shall be made in U.S. Dollars and paid by wire transfer of immediately available funds to an account designated by APP in writing.

SECTION 5.3. Late Payments . Any amounts not paid by MDCO by the applicable due date shall be subject to interest beginning on such due date, up to and including the date on which payment is received by APP, at a rate equal to the lesser of (a) [**] percent ([**]%) per month or (b) [**]. In each case, applicable interest shall be calculated monthly.

SECTION 5.4. Taxes . MDCO shall pay all national, state, municipal or other sales, use, excise, property or other similar taxes, tariffs or assessments, assessed upon or levied against the sale of the Product (other than taxes or charges imposed on APP's income).

ARTICLE VI

QUALITY

SECTION 6.1. Non-Conforming Products .

SECTION 6.1.1. No later than [**] days from the date of delivery of a Product shipment, MDCO shall examine, at its own expense, such shipment for damage, defects or shortage and may, at MDCO's option and expense, analyze the Product using the methods of analysis set forth in the Quality Agreement. MDCO shall notify APP no later than [**] days from the date of delivery of Product if it determines that any portion of a Product shipment is not in conformity with the Product Specifications, shall furnish a sample of each allegedly non-conforming Product lot, and provide reasonable supporting evidence that the alleged damage, defect or shortage resulted from manufacturing, testing, storing and/or packaging of the Product by APP and not from any mishandling during shipment. If, within [**] business days of APP's receipt of any such notice, Product sample(s) and reasonable supporting evidence, APP does not agree with MDCO that such Product is non-conforming, the Parties will arrange for the lot or lots in question to be tested by a mutually acceptable independent laboratory for conformity with the Product Specifications, and the determination of such laboratory will be final and binding upon the Parties. The cost of any such testing by an independent laboratory shall be borne by the Party whose judgment as to the conformity of any lot of the Product with the Product Specifications proves to be incorrect. Any lots of the Product that are not in conformity with the Product Specifications shall, at the request of APP, be destroyed by MDCO or returned to APP for destruction or reprocessing. The cost of destroying non-conforming Product or returning non-conforming Product to APP shall be borne by APP if such non-conformity is determined to be the result of manufacturing, testing, storing and/or packaging of such Product by APP and MDCO has provided APP with the timely notice of nonconformity required by this Section 6.1.1. For the avoidance of doubt, MDCO shall be obligated to pay in full for any rejected shipment of Product that is subsequently found to be in conformity with the Product Specifications.

SECTION 6.1.2. Provided MDCO provides the timely notice of nonconformity required by this Section 6.1.1 , with respect to any Product determined to be not in conformity with the Product Specifications at the time of shipment as a result of manufacturing, testing, storing and/or packaging by APP, APP shall either (a) furnish conforming replacement Product in substitution of any Product which did not conform to the Product Specifications, as soon as reasonably practicable, or (b) if APP is unable or precluded from producing conforming replacement Product for any reason, give MDCO full credit, or, at MDCO's request, a full refund, for such non-conforming Product within [**] days of such request. Except to the extent APP may otherwise have an indemnification obligation pursuant to Section 11.1(c) in respect of any Loss attributable to damages incurred by third parties as a result of the ingestion of Product not in conformity with the Product Specifications and for the costs and expenses required to be paid by APP pursuant to Section 6.2.3 , if applicable, APP's sole obligation and liability regarding Product determined to be not in conformity with the Product Specifications as a result of manufacturing, testing, storing and/or packaging by APP shall be as set forth in this Section 6.1.2 .

SECTION 6.1.3. Notwithstanding the foregoing, to the extent non-conformity of any Product results from any cause other than manufacturing, testing, storing and/or packaging by APP as set forth in this Agreement, APP shall have no liability to MDCO on the basis of this Agreement or otherwise. Without limiting the generality of the foregoing, in the situation described in this Section 6.1.3 , APP shall have no obligation to replace such Product, refund or credit any amount paid by MDCO for such Product.

SECTION 6.2. Recall and Seizure .

SECTION 6.2.1. During the Term, the Parties shall keep each other promptly and fully

informed of any notification or other information, whether received directly or indirectly, which might affect the marketability, safety or effectiveness of the Product and/or which might necessitate a recall, or result in the seizure, of any Product.

SECTION 6.2.2. If MDCO determines that a recall of Product may be necessary, MDCO shall promptly inform APP of such determination. If APP determines that a recall of Product may be necessary, APP shall promptly inform MDCO of such determination. If either Party determines that a recall of a Product is necessary, MDCO or its designee shall perform any required recall of Product. APP shall use Commercially Reasonable Efforts to assist MDCO with any such recall. APP shall use Commercially Reasonably Efforts to assist MDCO in MDCO's investigation to determine the cause and extent of the problem giving rise to such potential recall and in any subsequent recall of such Product.

SECTION 6.2.3. To the extent any recall or seizure results primarily from APP's failure to manufacture, test, store and/or package the Product in accordance with the Product Specifications or cGMP, and provided that MDCO provides APP with written notice of such failure within [**] days of MDCO's discovery of such failure by APP, APP shall (i) reimburse MDCO for MDCO's reasonable and documented out-of-pocket costs and expenses incurred for such recall or in respect of such seizure, and (ii) either:

(a) supply Product, without additional charge, to MDCO, in an amount sufficient to replace the amount of the Product recalled or seized; or

(b) if APP is unable or precluded from producing conforming replacement Product for any reason, either (i) give credit to MDCO against the Purchase Price of Product to be delivered to MDCO in the future, in amounts equal to the Purchase Price paid by MDCO for the Product so recalled or seized, or (ii) if requested by MDCO, refund to MDCO the amounts paid to APP for the recalled or seized Product.

SECTION 6.2.4. To the extent any recall or seizure results primarily from MDCO's failure to store, distribute, promote, sell or use the Product in accordance with the Product Specifications or cGMP, and provided that APP provides MDCO with written notice of such failure within [**] days of APP's discovery of such failure by MDCO, MDCO shall reimburse APP for APP's reasonable and documented out-of-pocket costs and expenses incurred in conducting such recall or in respect of such seizure.

SECTION 6.2.5. Except to the extent that any recall or seizure results primarily from (i) APP's failure to manufacture, test, store and/or package the Product in accordance with the Product Specifications or cGMP, or (ii) MDCO's failure to store, distribute, promote, sell or use the Product in accordance with the Product Specifications or cGMP, and the Party claiming such failure by the other Party provides such Party with written notice of such claim of failure within [**] days of such discovery, then the Parties shall equally share the costs incurred by MDCO relating to any recall or seizure of the Product.

SECTION 6.2.6. For purposes of this Section 6.2 “recall” means any recall or withdrawal or other action by MDCO to recover title to and/or possession of Product sold or shipped to customers. For purposes of this Section 6.2 , “seizure” means any action by any government agency to seize or destroy Product or permanently prevent release of Product.

SECTION 6.2.7. Except to the extent APP may otherwise have an indemnification obligation

pursuant to Section 11.1 (c) in respect of any Loss attributable to damages incurred by third parties as a result of the ingestion of Product not in conformity with the Product Specifications, APP's sole obligation in connection with any recall or seizure shall be as set forth in this Section 6.2 and the cost and expense reimbursement and credit, refund or replacement contemplated by Section 6.2.3 shall be MDCO's sole remedy in respect of seized or recalled Product.

SECTION 6.3. Reporting; Response to Inquiries .

SECTION 6.3.1. During the Term, each Party shall notify the other Party within [**] days of receipt of any inquiry, complaint, claim or adverse reaction report regarding the Product (any of the foregoing, a “ Report ”), including, without limitation, any inquiry or notice from the FDA regarding any alleged regulatory non-compliance of the Product, which notice shall describe in reasonable detail all information contained in the Report or otherwise known to the applicable Party regarding the subject matter thereof and shall include copies of any documentation comprising such Report. As the Marketing Authorization holder, APP shall comply with applicable laws, including adverse event reporting and investigation thereof. At the request of APP, MDCO shall provide reasonable assistance in the investigation of any claims for which MDCO has knowledge. All contact information for each Party shall be sent to the address listed in Section 12 (Notice) or as otherwise provided in the Quality Agreement.

SECTION 6.3.2. With respect to any inquiry of the FDA in respect of Product manufactured by APP, APP shall (a) notify MDCO of any such inquiry directed to APP, (b) use its Commercially Reasonable Efforts to respond fully and accurately to all such inquiries directed to APP, (c) use its Commercially Reasonable Efforts to assist MDCO in responding to inquiries directed to MDCO, (d) provide the FDA with such information or data in APP's possession as the FDA requests in connection with such inquiry or the Product, and (e) consult with MDCO regarding APP's response to any such inquiry.

ARTICLE VII

ADDITIONAL AGREEMENTS

SECTION 7.1. Compliance with Law . APP and MDCO shall each comply with the laws, rules and regulations applicable to the manufacture, supply, marketing and sale of the Product. Notwithstanding the foregoing, MDCO shall be solely responsible for, and shall bear all liability and expense relating to, all legal and regulatory compliance required in connection with the sale, marketing and promotion of the Product in the Territory to customers (it being agreed and acknowledged that any decision regarding any expenditures related to such legal and regulatory compliance shall be made by MDCO in its sole discretion). Except as expressly set forth herein, APP shall be solely responsible for all legal and regulatory compliance required in connection with the manufacture of the Product (it being agreed and acknowledged that any decision regarding any expenditures related to such legal and regulatory compliance shall be made by APP in its sole discretion).

SECTION 7.2. Record Retention . APP shall keep and maintain all production, control, laboratory and other records in accordance with all applicable laws, rules and regulations, including but not limited to, those required to be maintained by cGMP. Subject to Article X , APP shall make such records available to MDCO and MDCO's representatives upon MDCO's reasonable request, and to the representatives of the FDA. APP shall furnish, or permit MDCO or its representative to make, copies of such records from time to time upon MDCO's reasonable request. MDCO shall not disclose such copies to any third party without APP's prior written consent, which consent shall not unreasonably be withheld.

SECTION 7.3. Inspections . Subject to the terms of this Section 7.3 , MDCO shall have the right to inspect such portions of APP's manufacturing facility as are relevant to the manufacture of the Product upon [**] days' advance written notice or on less notice if reasonably required in order to timely respond to or comply with inquiries from or requirements imposed by the FDA. Such inspections shall be performed during regular business hours, conducted by no more than [**] MDCO representatives in such a manner as to minimize disruption to APP's business operations and limited to [**] business days per inspection. All information disclosed to or obtained by MDCO in connection with any such inspection shall be subject to the confidentiality provisions set forth in Article X . Such information shall not be used for any purpose other than evaluating APP's compliance with its obligations under this Agreement and responding to and complying with inquiries from or requirements imposed by the FDA. Such inspections shall not occur more often than once per calendar year of the Term, except that MDCO may perform such inspections more frequently in order to timely respond to or comply with inquiries from or requirements imposed by the FDA.

SECTION 7.4. Proprietary Rights . Each Party acknowledges and agrees that any and all Intellectual Property developed, owned or used by the other Party are and shall remain the exclusive property of that Party.

SECTION 7.5. No Sale for Resale . MDCO shall not knowingly sell any Product to customers in the Territory for subsequent distribution or resale outside of the Territory. Furthermore, MDCO shall not knowingly sell any Product to customers outside the Territory for any purpose, including without limitation for subsequent sale, distribution or resale inside the Territory.

SECTION 7.6. MDCO Promotional Efforts . MDCO shall use Commercially Reasonable Efforts to sell, market and promote the Products in the Territory during the Term consistent with the sale, marketing and promotion of generic pharmaceutical products in the Territory.

ARTICLE VIII

TERM AND TERMINATION

SECTION 8.1. Term . This Agreement shall commence and be effective as of the Effective Date and shall expire on the ten (10) year anniversary of the Effective Date. Thereafter, the Term may be extended only by and pursuant to the written agreement and consent of all Parties. The initial term, together with any renewal term, is referred to herein as the “ Term ”.

SECTION 8.2. Termination by Either Party .

SECTION 8.2.1. Material Breach . Except with respect to (i) payment defaults by MDCO, which shall be governed by Section 8.3 , and (ii) any breach or default arising from APP's failure to deliver or timely deliver Product in accordance herewith, which shall be governed by Section 8.4 , if either Party shall at any time fail to discharge any of its material obligations hereunder and fail to correct such default within ninety (90) days after the other Party has given written notice to it thereof, or, if such default is incapable of cure within such ninety (90) day period, fail to commence good faith action to correct such default during such ninety (90) day period and correct such default within one hundred twenty (120) days after the other Party has given written notice to it thereof, then the non-breaching Party shall have the right to terminate this Agreement immediately upon written notice to the breaching Party. This Section 8.2.1 shall not be exclusive and shall not be in lieu of any other remedies available to a Party hereto for any breach hereunder on the part of the other Party.

SECTION 8.2.2. Regulatory Action . Either Party may terminate this Agreement, on a Product-

by-Product basis, upon written notice to the other Party in the event the FDA takes any action the result of which is to permanently prohibit the manufacture of the Product in the Territory. Upon a termination pursuant to this Section 8.2.2 , the Parties will attempt to affix responsibility for all costs associated with outstanding or unfinished purchase orders between themselves.

SECTION 8.2.3. APP Discontinuance. APP may terminate this Agreement, on a Product-by-Product basis, upon one hundred and eighty (180) day written notice to MDCO in the event APP determines that it will discontinue the Marketing Authorization for such Product in the Territory. In the event APP decides to reintroduce a previously discontinued Product, APP will give MDCO a right of first refusal to market and sell the Product before reintroducing such Product in the Territory.

SECTION 8.2.4. MDCO Discontinuance. MDCO may terminate this Agreement, on a Product-by-Product basis, upon one hundred and eighty (180) day written notice to APP in the event the actual annual Total Market Value for a Product falls below [**] percent ([**]%) of the Total Market Value of such Product for calendar year 2011. “Total Market Value” to be determined from data available from the IMS NSP or substantially similar data available from any successor entity.

SECTION 8.2.5. Bankruptcy, Insolvency, Etc. Either Party may terminate this Agreement immediately upon written notice to the other Party if such other Party (i) becomes or is adjudged insolvent, (ii) makes a general assignment for the benefit of its creditors, (iii) commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar proceeding for the release of financially distressed debtors, (iv) has a petition filed in bankruptcy for or against it (which, in the case of any involuntary petition, is not stayed within sixty (60) days of being filed against it), (v) goes into liquidation (except for the purposes of a bona fide amalgamation or other reorganization) or (vi) has a receiver appointed over all or a significant portion of the property or assets of that other Party.

SECTION 8.3. Termination by APP . In addition to any other remedies available to it, APP may terminate this Agreement immediately upon written notice to MDCO if, sixty (60) days after written notice from APP, MDCO fails to pay in full any invoice that is past due, unless such payment is the subject of a dispute set forth in writing by MDCO. MDCO will be solely responsible for commercializing the Products in the Territory using its own discretion regarding marketing strategy, positioning, pricing and other marketing and sales approaches; provided, however, that MDCO will use commercially reasonable efforts to price, market and sell the Products using comparable efforts to those it uses to price, market and sell its other generic products having similar commercial value to MDCO as the Products.

SECTION 8.4. Termination by MDCO . MDCO shall have the right to terminate this Agreement upon written notice to APP in the event that with respect to [**] purchase orders in a calendar year, subject to the last sentence of Section 2.5 , (a) APP has failed to supply at least the aggregate quantity of conforming Product specified in such purchase order on or prior to the applicable delivery date specified in such purchase orders, and (b) APP has failed to cure such failures in accordance with Section 6.1.2 .

SECTION 8.5. Survival . The following provisions shall survive the expiration or termination of this Agreement in accordance with their respective terms: Sections 3.3 , 5.4 , 7.4 , 8.5 , and 8.6 , and Articles I, VI , IX , X XI and XII .

SECTION 8.6. Effect of Termination . Upon termination or expiration of this Agreement, all licenses and other rights granted by the Parties hereunder and all other rights and obligations of the Parties hereunder shall terminate except as otherwise expressly provided herein. Termination or expiration of this Agreement,

in whole or in part, shall be without prejudice to the right of either Party to receive all payments accrued and unpaid at the effective date of such termination or expiration, without prejudice to any remedy available to either Party in respect of any previous breach of any of the representations, warranties or covenants herein contained and without prejudice to any other provisions hereof which expressly or necessarily call for performance after such termination or expiration. In the event of termination of this Agreement, APP shall have the right (but not the obligation) to purchase all Product remaining in the inventory of MDCO at the Purchase Prices paid by MDCO for such inventory. APP shall exercise such right by written notice to MDCO within [**] days after termination of this Agreement. If APP does not exercise its right to purchase such remaining inventory, MDCO shall have the right to sell such remaining inventory subject to the terms and conditions that would have applied to such sale if it had occurred during the Term.

ARTICLE IX

REPRESENTATIONS AND WARRANTIES

SECTION 9.1. Representations and Warranties of APP . APP represents and warrants to MDCO as follows:

SECTION 9.1.1. Organization . APP is a corporation duly organized and validly existing under the laws of the State of Delaware.

SECTION 9.1.2. Corporate Power . APP has the requisite corporate authority to execute and deliver this agreement and to perform its obligations hereunder.

SECTION 9.1.3. Compliance with Law . Any Products delivered by APP to MDCO shall, at the time of shipment have been manufactured, packaged, stored and shipped by APP in conformity with cGMP, Product Specifications, the Quality Agreement and any other applicable laws, and shall not be adulterated, misbranded or otherwise violative of the Act or other applicable laws.

SECTION 9.1.4. No Conflict . The execution and performance of APP's obligations hereunder, are not and will not be in violation of or in conflict with any material obligation it may have to any third party.

SECTION 9.1.5. No Debarment . APP is not debarred and APP has not and will not use in any capacity the services of any person debarred under the Generic Drug Enforcement Act of 1992. If at any time this representation and warranty is no longer accurate, APP shall immediately notify MDCO of such fact.

SECTION 9.1.6. Permits . At APP's sole cost and expense, APP has and will maintain throughout the Term all Marketing Authorizations related to the Product and any other Marketing Authorizations required by law in order for APP to execute and deliver this Agreement and to perform its obligations hereunder in accordance with all applicable laws.

SECTION 9.2. NO ADDITIONAL WARRANTIES . THE LIMITED REPRESENTATIONS AND WARRANTIES SET FORTH IN SECTION 9.1 ARE APP'S SOLE REPRESENTATIONS AND WARRANTIES WITH RESPECT TO THE PRODUCT OR ANY OTHER SUBJECT MATTER HEREOF AND ARE GIVEN IN LIEU OF, AND APP SPECIFICALLY DISCLAIMS, ANY AND ALL OTHER REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, TITLE, NONINFRINGEMENT OR SUITABILITY FOR A PARTICULAR PURPOSE.

SECTION 9.3. Representations and Warranties of MDCO . MDCO represents and warrants to APP as follows:

SECTION 9.3.1. Organization . MDCO is a corporation duly organized and in good standing under the laws of the State of Delaware.

SECTION 9.3.2. Corporate Power . MDCO has the requisite corporate authority to execute and deliver this Agreement and to perform its obligations hereunder.

SECTION 9.3.3. No Conflict . The execution and performance of MDCO's obligations hereunder, are not and will not be in violation of or in conflict with any material obligations it may have to any third party.

SECTION 9.3.4. No Debarment . MDCO is not debarred and MDCO has not and will not use in any capacity the services of any person debarred under the Generic Drug Enforcement Act of 1992. If at any time this representation and warranty is no longer accurate, MDCO shall immediately notify APP of such fact.

SECTION 9.3.5. Permits . MDCO has and will maintain throughout the term of this Agreement all Marketing Authorizations as required by law in order for MDCO to execute and deliver this Agreement and to perform its obligations hereunder in accordance with all applicable laws.

SECTION 9.3.6. Compliance with Law . Any sale, marketing, promotion or distribution by MDCO of the Products shall not be violative of the Act or other applicable laws.

SECTION 9.4. NO ADDITIONAL WARRANTIES . THE LIMITED REPRESENTATIONS AND WARRANTIES SET FORTH IN SECTION 9.3 ARE MDCO'S SOLE REPRESENTATIONS AND WARRANTIES WITH RESPECT TO THE PRODUCT OR ANY OTHER SUBJECT MATTER HEREOF AND ARE GIVEN IN LIEU OF ANY AND ALL OTHER REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, TITLE, NONINFRINGEMENT OR SUITABILITY FOR A PARTICULAR PURPOSE.

ARTICLE X

CONFIDENTIALITY

In consideration for and as a condition to the Parties furnishing to one another access to Confidential Information, the Parties agree as follows:

SECTION 10.1. The Party receiving the other Party's Confidential Information (the “ Receiving Party ”) acknowledges the confidential and proprietary nature of the Confidential Information, agrees to hold and keep the same as provided in this Agreement.

SECTION 10.2. The Receiving Party agrees that the disclosure of Confidential Information will be made to it in confidence and that:

SECTION 10.2.1. The Receiving Party agrees to keep Confidential Information as confidential and secret.

SECTION 10.2.2. The Receiving Party agrees to restrict access to the Confidential

Information to its employees and representatives to whom such disclosure is necessary to further the purpose of this Agreement solely on a need-to-know basis and shall ensure that such Persons treat such Confidential Information in a manner consistent with the terms of this Article X . The Receiving Party shall be liable for failure of its employees and representatives to treat such Confidential Information in a manner consistent with the terms of this Article X .

SECTION 10.2.3. The Receiving Party agrees to notify the Party disclosing any Confidential Information (the “ Disclosing Party ”) in writing of any misuse or misappropriation of the Confidential Information which may come to its attention.

SECTION 10.2.4. The Receiving Party may disclose the Confidential Information to the extent such disclosure is required by law or by court, provided , however , the Receiving Party shall provide prompt written notice to the Disclosing Party of such requirement so that the Disclosing Party may seek a protective order or other appropriate remedy. In the event that no such protective order or other remedy is obtained, the Receiving Party agrees to disclose only that portion of the Confidential Information that the Receiving Party is legally compelled or is otherwise required to disclose; provided , however , that the Receiving Party shall exercise all reasonable efforts to obtain confidential treatment for such Confidential Information.

SECTION 10.2.5. The Receiving Party agrees to use the Confidential Information only in connection with the purpose of this Agreement.

SECTION 10.2.6. Upon written request of the Disclosing Party or the termination of this Agreement, the Receiving Party shall, at the Receiving Party's discretion, promptly either destroy all Confidential Information and any and all photocopies, tapes or other forms of subject material transcribed by the Receiving Party and notify the Disclosing Party of such destruction, or return all Confidential Information to the Disclosing Party, as the case may be; provided , however , that the Receiving Party shall have the right to retain one copy of any Confidential Information solely for the purpose of and to the extent necessary to comply with legal requirements.

SECTION 10.2.7. The Receiving Party agrees that any and all Confidential Information disclosed to the Receiving Party or its Affiliates in preliminary discussions or agreements with the Disclosing Party prior to the execution and delivery of this Agreement shall be subject to all the terms and conditions of this Article X to the same extent and as fully as if this Agreement had been in full force and effect on the date such Confidential Information was obtained by the Receiving Party or its Affiliates, or their employees or representatives.

SECTION 10.2.8. The Receiving Party agrees that the obligations of the Receiving Party set forth in this Article X are necessary and reasonable in order to protect the Disclosing Party and its business.

SECTION 10.3. Anything to the contrary herein notwithstanding, the confidentiality obligations set forth in this Article X shall survive the expiration or termination of this Agreement for a period [**] years following such expiration or termination.

SECTION 10.4. Publicity . All publicity, press releases and other announcements relating to this Agreement or the transactions contemplated hereby shall be reviewed in advance by, and shall be subject to the written approval of, both Parties, such approval not to be unreasonably withheld or delayed. Notwithstanding the foregoing, each Party shall be entitled to make such announcements relating to this Agreement as such Party reasonably determines is required to comply with any law or regulation requiring

such announcements, including any applicable rule or regulation of any securities exchange on which the applicable Party's (or its Affiliate's) securities are listed.

ARTICLE XI

INDEMNIFICATION: CONTROL OF LITIGATION

SECTION 11.1. Indemnification by APP . APP shall indemnify and hold harmless MDCO and its Affiliates and their respective officers, directors and employees (collectively, the “ MDCO Parties ”) against any and all losses, liabilities, damages, costs and expenses, including without limitation reasonable attorneys' fees and expenses (collectively, “ Losses ”), sustained by a MDCO Party to the extent arising out of or from: (a) APP's breach of its representations, warranties, covenants or other obligations under this Agreement; or (b) gross negligence or willful misconduct of any APP Party or their respective agents or contractors (other than MDCO and its Affiliates); or (c) use in or by a patient of Product manufactured, stored and/or packaged by APP in a manner that does not conform with APP's obligations under this Agreement, except in each case to the extent any such Loss arises out of the breach, gross negligence or willful misconduct of a MDCO Party; or (d) any withdrawal, recall, or seizure of the Product, to the extent such event is primarily caused by APP's breach of its obligations in this Agreement, except in each case to the extent any such Loss arises out of the material breach, gross negligence or willful misconduct of a MDCO Party.

SECTION 11.2. Indemnification by MDCO . MDCO shall indemnify and hold harmless APP and its Affiliates and their respective officers, directors and employees (collectively, the “ APP Parties ”) against any and all Losses sustained by any APP Party to the extent arising out of or from: (a) the use of Product stored, distributed, marketed, promoted, sold or used by MDCO in a manner that does not conform with MDCO's obligations under this Agreement, except in each case to the extent any such Loss arises out of the breach, gross negligence or willful misconduct of an APP Party; or (b) MDCO's breach of its representations, warranties, covenants or other obligations under this Agreement; or (c) gross negligence or willful misconduct of any MDCO Party or their respective agents or contractors (other than APP and its Affiliates); or (d) any withdrawal, recall, or seizure of the Product, to the extent such event is primarily caused by MDCO's breach of its obligations in this Agreement,, except in each case to the extent any such Loss arises out of the material breach, negligence or willful misconduct of a APP Party.

SECTION 11.3. Indemnification Procedures . Promptly after receipt by a Party of notice of any claim which could give rise to a right to indemnification pursuant to Section 11.1 or 11.2 , such Party (the “ Indemnified Party ”) shall give the other Party (the “ Indemnifying Party ”) written notice describing the claim in reasonable detail. The failure of an Indemnified Party to give notice in the manner provided herein shall not relieve the Indemnifying Party of its obligations under this Article XI , except to the extent that such failure to give notice materially prejudices the Indemnifying Party's ability to defend such claim. The Indemnifying Party shall have the right, at its option, to compromise or defend, at its own expense and by its own counsel, any such matter involving the asserted liability of the Indemnified Party. If the Indemnifying Party shall undertake to compromise or defend any such asserted liability, it shall promptly (and in any event not less than [**] business days after receipt of the Indemnified Party's original notice) notify the Indemnified Party in writing of its intention to do so, and the Indemnified Party agrees to cooperate fully with the Indemnifying Party and its counsel in the compromise or defense against any such asserted liability. All reasonable costs and expenses incurred in connection with such cooperation shall be borne by the Indemnifying Party. If the Indemnifying Party elects not to compromise or defend the asserted liability or fails to notify the Indemnified Party of its election to compromise or defend as herein provided, then the Indemnified Party shall have the right, at its option, to pay, compromise or defend such asserted liability by its own counsel and its reasonable costs and expenses shall be included as part of the indemnification obligation of the Indemnifying Party hereunder. Notwithstanding the foregoing, neither the Indemnifying

Party nor the Indemnified Party may settle or compromise any claim over the objection of the other; provided, however, that consent to settlement or compromise shall not be unreasonably withheld. Anything to the contrary notwithstanding, regardless of which Party controls the defense of an asserted liability, the other Party shall have the right, at its own expense, to participate in (but not control) such defense. If the Indemnifying Party chooses to defend any claim, the Indemnified Party shall make available to the Indemnifying Party copies of any books, records or other documents within its control that are reasonably necessary for such defense. Notwithstanding anything to the contrary in this Section 11.3 , the Party conducting the defense of a claim shall keep the other Party informed on a reasonable and timely basis as to the status of the defense of such claim (but only to the extent such other Party is not participating jointly in the defense of such claim). To the extent desirable and appropriate, in connection with the defense of any liability described in this Section 11.3 , the Parties shall enter into a joint defense and privilege agreement in customary form.

SECTION 11.4. Indemnification Payment . Upon the determination of liability and the amount of the indemnification payment under this Article XI , the appropriate Party shall pay to the other, as the case may be, within [**] business days after such determination, the amount of any claim for indemnification made hereunder.

SECTION 11.5. LIMITATION OF LIABILITY . APP'S AND MDCO'S LIABILITY IN CONNECTION WITH THIS AGREEMENT AND THE SUBJECT MATTER HEREOF IS SUBJECT TO THE FOLLOWING LIMITATION: IN NO EVENT SHALL APP OR MDCO BE LIABLE TO THE OTHER PARTY FOR ANY MULTIPLE, SPECIAL, PUNITIVE, INDIRECT, CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY NATURE, INCLUDING WITHOUT LIMITATION LOST PROFITS.

SECTION 11.6. FOR THE AVOIDANCE OF DOUBT, THE INDEMNIFICATION PROVISIONS SET FORTH IN THIS ARTICLE XI SHALL APPLY TO CLAIMS OF THE PARTIES HERETO, AS WELL AS THIRD PARTY CLAIMS ASSERTED AGAINST THE PARTIES.

SECTION 11.7. Insurance . Throughout the Term and five (5) years thereafter, MDCO shall maintain comprehensive general business liability insurance coverage, with minimum limits of $10,000,000 per occurrence and $10,000,000 annual aggregate of all claims. In addition, during the Term and five (5) years thereafter, MDCO shall maintain product liability insurance coverage, with minimum limits of $10,000,000 per occurrence and $10,000,000 annual aggregate of all claims. MDCO shall name APP an additional insured under the policies described in this Section 11.7.

ARTICLE XII

MISCELLANEOUS PROVISIONS

SECTION 12.1. Notices . All notices, consents or approvals required by this Agreement shall be in writing sent by express delivery service, or by certified or registered air mail, postage prepaid, or by confirmed facsimile to the Parties at the following addresses or such other addresses as may be designated in writing by the respective Parties:



If to MDCO:	The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Attn: General Counsel Fax: (862) 207-6062
If to APP:	APP Pharmaceuticals, LLC 1501 East Woodfield Road Suite 300 East Schaumburg, Illinois 60173 Attn: General Counsel Fax: (847) 413-2670

Notices shall be deemed effective on the date of receipt if sent by mail, and on the date of transmission if sent by confirmed facsimile.

SECTION 12.2. Force Majeure . Except as otherwise provided in this Agreement, a Party shall not be liable for nonperformance or delay in performance (other than of obligations regarding payment of money or confidentiality) caused by any event reasonably beyond the control of such Party including, but not limited to, wars, acts of terrorism, hostilities, revolutions, riots, civil commotion, national emergency, losses or shortages of power, strikes, lockouts, labor stoppages, epidemics, fire, flood, earthquake, force of nature, explosion, embargo, or any other act of God, loss of product in transit, shortage of or inability to obtain material, equipment or transport, any law, proclamation, regulation, ordinance, or other act or order of any court, government or governmental agency or by any other supervening circumstances, which are, in each case, beyond the reasonable control of the party so affected. If a force majeure event occurs, the Party affected shall immediately notify the other Party and take all reasonable steps to reduce the effect of the event. If the force majeure event continues for a period of ninety (90) days or more, the Party not suffering the event shall be entitled to terminate this Agreement provided such event is continuing at the date of termination.

SECTION 12.3. Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without regard to the conflicts of laws provisions thereof. All Parties hereby consent to, and will not dispute or contest, the jurisdiction and venue of the federal and state courts of the State of Delaware, for purposes of any action or proceeding to enforce the terms and conditions of this Agreement.

SECTION 12.4. Waiver; Remedies . Any term or provision of this Agreement may be waived at any time by the Party entitled to the benefit thereof by a written instrument executed by such Party. No delay on the part of any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of any Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder.

SECTION 12.5. Severability . The provisions of this Agreement are separate and independent covenants, and it is agreed that the invalidity or unenforceability of one or more of the provisions hereof shall not invalidate any other provision hereof, and this Agreement shall thereafter continue in full force and effect. In the event that any provision of this Agreement is found to be too broad, invalid or unenforceable by any court of competent jurisdiction, then such court shall have the authority to reform any such provisions as shall be necessary to make the provisions valid and enforceable; provided, however, that if the provision is not capable of being reformed, then that invalid or unenforceable provision shall be deemed deleted as though it had never existed.

SECTION 12.6. Independent Contractors . The Parties hereto are independent contractors, and nothing contained in this Agreement shall be deemed to create the relationship of partners, affiliates, joint venturers, or of principal and agent, franchisor and franchisee, or of any association or relationship between the Parties other than as expressly provided in this Agreement. APP acknowledges that it does not have, and APP has not made, and shall not make, representations to any third party, either directly or indirectly, indicating that APP has any authority to act for or on behalf of MDCO or to obligate MDCO in any way whatsoever. MDCO acknowledges that it does not have, and it has not made, and shall not make, any representations to any third party, either directly or indirectly, indicating that it has any authority to act for or on behalf of APP or to obligate APP in any way whatsoever.

SECTION 12.7. Successors and Assigns; Assignment . This Agreement shall be binding upon and shall inure to the benefit of the Parties hereto and their respective successors and permitted assigns; provided, however, that MDCO may not assign any of its rights, duties or obligations hereunder, or sublicense the license granted to it pursuant to Article III , without the prior written consent of APP, which consent may be withheld for any reason or no reason. The above notwithstanding, MDCO shall be entitled, without prior written consent of APP, to assign all or any of its rights or obligations under this Agreement to an Affiliate or, with APP's written consent (which shall not be unreasonably withheld), transfer such rights and obligations to a successor entity by way of merger or acquisition of substantially all of the assets of MDCO (whether by consolidation, sale of assets, or otherwise); provided the Affiliate or other successor entity expressly assumes in writing those rights, duties and obligations under this Agreement and this Agreement itself and the Affiliate or other successor is a financially capable business entity.

SECTION 12.8. Counterparts . This Agreement may be executed in any number of counterparts, each of which shall be considered an original and all of which taken together shall constitute one instrument.

SECTION 12.9. Entire Agreement . This Agreement, including all Exhibits attached hereto and the Quality Agreement, constitute the entire understanding of the Parties with respect to the subject matter hereof, and supersedes all prior contracts, agreements and understandings between the Parties. In case of conflict, the prevailing order of documents shall be this Agreement and then the Quality Agreement, except in matters pertaining to product quality, GMP and regulatory responsibilities, in which case the Quality Agreement will prevail.

SECTION 12.10. No Third-Party Rights . Except as expressly set forth in this Agreement, no provision of this Agreement shall be deemed or construed in any way to result in the creation of any rights or obligation in any Person not a Party or not an Affiliate of a Party to this Agreement.

SECTION 12.11. Amendment . This Agreement may be modified or amended only by written agreement signed by both Parties.

SECTION 12.12. Captions . All section titles or captions contained in this Agreement or in any Exhibit annexed hereto, and the table of contents, if any, to this Agreement are for convenience only, shall not be deemed a part of this Agreement and shall not affect the meaning or interpretation of this Agreement.

SECTION 12.13. Attachments . All Exhibits and other attachments to this Agreement are by this reference incorporated herein and made a part of this Agreement.

SECTION 12.14. Expenses . Except as otherwise set forth herein, all expenses, including the fees, if any, incurred by any attorneys, accountants or other consultants engaged by a Party in connection with this Agreement and the transactions contemplated hereby, shall be paid by the Party incurring such expenses.

[SIGNATURE PAGE FOLLOWS]

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date first written above.



	THE MEDICINES COMPANY		APP PHARMACEUTICALS, LLC
By:	__ /s/ Glenn Sblendorio __________	By:	__ /s/ J.R. Ducker __________
Name:	____ Glenn Sblendorio __________	Name:	____ J.R. Ducker __________
Title:	_____ EVP & CFO ___________	Title:	____ President & CEO _____

[Signature page to License and Supply Agreement]

Exhibit A

Product Quantity



APP Product #	Product Description	Batch Quantity (units)
[**]	[**]	[**]
[**]	[**]	[**]
	—	—

[**]	[**]	[**]
[**]	[**]	[**]
	—	—

[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
	—	—

[**]	[**]	[**]
[**]	[**]	[**]
	—	—

[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
	—	—

[**]	[**]	[**]
[**]	[**]	[**]
	—	—

[**]	[**]	[**]
	—	—




[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
	—	—

[**]	[**]	[**]
	—	—

[**]	[**]	[**]
[**]	[**]	[**]
	—	—

Exhibit B

Marketing Authorizations



APP Product #	Product Description	ANDA Holder	ANDA Number
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
	—




[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
	—	—

[**]	[**]	[**]	[**]
[**]	[**]	[**]	[**]
	—	—

Exhibit C



APP Product #	Product Description
[**]	[**]
[**]	[**]
	—

[**]	[**]
[**]	[**]
	—

[**]	[**]
[**]	[**]
[**]	[**]
	—

[**]	[**]
[**]	[**]
	—

[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
	—

[**]	[**]
[**]	[**]
	—

[**]	[**]
	—




[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
	—

[**]	[**]
	—

[**]	[**]
[**]	[**]
	—

Exhibit D

Upfront One-Time License Fee

$30,000,000.00 (USD)

Exhibit E



Description	MDCO Unit Cost USD
[**]	[**]
[**]	[**]


[**]	[**]
[**]	[**]


[**]	[**]
[**]	[**]
[**]	[**]


[**]	[**]
[**]	[**]


[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]


[**]	[**]
[**]	[**]


[**]	[**]


[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]


[**]	[**]

[**]	[**]
[**]	[**]



	Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.			Exhibit 10.5

EXECUTION COPY

AG SUPPLY AGREEMENT

BY AND AMONG

THE MEDICINES COMPANY

AND

APP PHARMACEUTICALS, LLC

DATED AS OF JANUARY 22, 2012

EXECUTION COPY

AG SUPPLY AGREEMENT

THIS AG SUPPLY AGREEMENT (this “Agreement”) is entered into as of January 22, 2012 (the “Effective Date”) by and between, on the one hand The Medicines Company, a company organized and existing under the laws of the State of Delaware with offices located at 8 Sylvan Way, Parsippany, New Jersey 07054 and its Affiliates (collectively, “MDCO”), and, on the other hand, APP Pharmaceuticals, LLC, a limited liability company organized and existing under the laws of the State of Delaware with offices at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 and its Affiliates (collectively, “APP”). MDCO and APP are collectively referred to herein as the “Parties,” or each individually as a “Party.”

R E C I T A L S:

WHEREAS , MDCO and APP are parties to a certain License Agreement of even date herewith (the “License Agreement”), pursuant to which MDCO granted APP a license to Market and Ship APP AG Product under certain limited circumstances;

WHEREAS , MDCO and APP are parties to a certain Contract Manufacturing Agreement of even date herewith (the “CMA”), pursuant to which APP is to supply finished bivalirudin product to MDCO; and

WHEREAS , pursuant to the License Agreement, MDCO and APP have agreed to enter into this Agreement for the supply of APP AG Product to APP.

1. Definitions . Capitalized terms used, but not defined herein, shall have the meanings ascribed to them in the License Agreement.

1.1. “ Acquisition Costs of Compound ” means [**] percent ([**]%) of MDCO's costs for the acquisition of Compound paid to Third Parties for use in the Manufacture of APP AG Product.

1.2. “ APP AG Launch Date ” shall have the meaning assigned to such term in the License Agreement.

1.3. “ APP Liability ” shall have the meaning assigned to such term in Section 8.2.

1.4. “ APP Party ” shall have the meaning assigned to such term in Section 8.1.

1.5. “ APP's External Auditors ” shall have the meaning assigned to such term in Section 3.8.

1.6. “ Commercially Reasonable Efforts ” means efforts and diligence in accordance with the subject Party's reasonable and sound business, legal, medical and scientific judgment and in

accordance with the efforts and resources such Party would use in other aspects of its business that have similar commercial value and market potential, taking into account the competitiveness of the marketplace, the business life-cycle, the proprietary position of the company and the company's profitability of the pertinent product.

1.7. “ License and Authorization ” shall have the meaning assigned to such term in Section 2.2 of the License Agreement.

1.8. “ MDCO Liability ” shall have the meaning assigned to such term in Section 8.1.

1.9. “ MDCO Party ” shall have the meaning assigned to such term in Section 8.2.

1.10. “ Purchase Orders ” shall have the meaning assigned to such term in Section 3.2.

1.11. Supply Date ” shall have the meaning assigned to such term in Section 3.1.

1.12. “ Supply Term ” shall have the meaning assigned to such term in Section 3.1.

1.13. “ Term ” shall have the meaning assigned to such term in Section 11.1.

1.14. “ Transfer Price ” means, with respect to APP AG Product supplied to APP hereunder, the sum of [**].

2. Conditions

2.1. APP hereby agrees that it shall not Market or Ship APP AG Product except as permitted in the License and Authorization.

2.2. APP hereby agrees that it shall not Manufacture, Label or Package AG Product except as set forth in this Agreement.

2.3. [**] .

2.4. APP's ordering of APP AG Product and MDCO's supply obligations under this Agreement shall be limited to the monthly quantity limitations set forth in Sections 2.2 and 2.3 of the License Agreement.

3. Supply of APP AG Product; Initial Quantities; Forecasts; Purchase Orders

3.1. Subject to the limitations set forth in Section 2, MDCO shall use Commercially Reasonable Efforts to supply APP with APP AG Product beginning on the APP AG Launch Date (the “Supply Date”) until the termination of the License and Authorization to Market and Ship APP AG Product as set forth in Section 2.4 of the License Agreement (the “Supply Term”). Pursuant to Section 2.4 of the License Agreement, in the event the APP AG Launch Date becomes effective pursuant to Section

1.16.1, the Supply Term shall be for a period of [**], and in the event the APP AG Launch Date becomes effective pursuant to Sections 1.16.2 or 1.16.3, the Supply Term shall be for a period of [**]. The Parties shall cooperate in good faith to determine and prepare for the Supply Date, including communicating to one another, on an ongoing basis, developments which may reasonably affect the Launch of APP AG Product.

3.2. At least [**] days prior to the applicable Supply Date, APP shall submit to MDCO a binding purchase order for its order of APP AG Product during the Supply Term (the “Purchase Order”). [**]. The Purchase Order shall constitute a binding obligation upon APP. In the event a Supply Date fails to occur after the Purchase Order is issued, APP shall have the right to return to MDCO, and MDCO shall accept, APP AG Product Manufactured or in the process of Manufacture, provided, however, that such APP AG Product will be re-Labeled and re-Packaged, to be done at APP's cost, for use as Angiomax. The Purchase Order shall designate APP's requested delivery dates, provided that MDCO shall not be required to make more than [**] per month. MDCO shall use Commercially Reasonable Efforts to make deliveries of APP AG Product within [**] Days of APP's requested delivery dates.

3.3. Notwithstanding anything to the contrary in this Agreement, MDCO shall not be obligated to supply APP with APP AG Product until the later of (i) the date which is [**] days from the date of MDCO's receipt of a Purchase Order compliant with this Agreement, (ii) the date which is [**] days from the date of MDCO's actual receipt of all documents, information and artwork necessary to Label and Package the APP AG Product, to be provided by APP under Section 3.4.

3.4. To the extent consistent with the MDCO's NDA and the specifications for APP AG Product, APP shall have the right to specify in accordance with the terms hereof the design for the Label, all trademarks, trade names and packaging graphics to be used in connection with the APP AG Product. Together with APP's delivery of the Purchase Order, APP shall supply MDCO with all necessary artwork, text, SKU and NDC numbers and other necessary items, so that MDCO can prepare the Labels and Packaging for the APP AG Product for sale as a generic by APP under MDCO's NDA. All APP AG Product supplied will be released for sale under APP's Label and in Packaging complying with MDCO's NDA. MDCO will promptly notify APP if it has any issues with such proposed initial Labeling components, and in no event later than [**] days after having received the same, whereupon the Parties will work together in good faith to promptly resolve any issues with respect thereto.

3.5. MDCO's delivery of all APP AG Product purchased by APP under this Agreement will be by MDCO directly to APP. All such shipments of APP AG Product shall be EXW (Incoterms 2000) to APP at MDCO's designated subcontractor's facility. In the event of any inconsistency between the terms and conditions of this Agreement on the one hand, and, on the other hand, the terms and conditions of any other agreement between the Parties, or in APP's purchase order or delivery specification, or MDCO's invoice or confirmation, then the terms and conditions of this Agreement shall govern to the extent of any such inconsistency or conflict. Any other document which shall conflict with or be in addition to the terms and conditions of this Agreement is hereby rejected (unless the Parties shall have mutually agreed to the contrary in writing in respect of a particular instance).

3.6. MDCO shall invoice APP at the time of each Shipment of APP AG Product at the Transfer Price. APP shall pay each such invoice within [**] days of receipt by APP of APP AG Product.

3.7. During the Supply Term, and for a period of [**] thereafter, MDCO shall, and shall ensure that its Affiliates shall, keep at either its normal place of business, or at an off-site storage facility, records and books of account sufficient to confirm the calculation of the Transfer Price.

3.8. On no less than [**] Days notice from MDCO, to the extent that MDCO supplies APP AG Product pursuant to this Agreement, MDCO shall make such records and books of account sufficient to confirm the calculation of the Transfer Price available for inspection during normal business hours by an internationally recognized independent accounting firm selected by APP and reasonably acceptable to MDCO that is not paid in whole or in part by a contingent fee arrangement (“APP's External Auditor”) for the purpose of general review or audit; provided that APP may not request such inspection more than once in any calendar year. Upon reasonable belief of discrepancy or dispute, APP's External Auditor shall be entitled to take copies or extracts from such records, and books of account (but only to the extent related to the calculation of the Transfer Price) during any review or audit, provided APP's External Auditor signs a confidentiality agreement with MDCO providing that such records, and books of account shall be treated as Confidential Information which may not be disclosed to any Person, including APP. APP's External Auditor shall only disclose to APP the results of APP's External Auditors' audit, which results shall be concurrently disclosed to MDCO. Any underpayment or overpayments of amounts due hereunder as reflected by APP's External Auditor's results shall be promptly paid by the applicable Party.

3.9. APP shall be solely responsible for the costs in making any such audit unless APP identifies a discrepancy in the calculation of Transfer Price paid by APP to MDCO under this Agreement in any calendar year from those properly payable for that calendar year of [**] percent ([**]%) or greater, in which event MDCO shall be solely responsible for the cost of such review and audit and shall refund APP any overpayment. All information disclosed by MDCO or its Affiliates pursuant to this Section 3.9 shall be deemed Confidential Information of MDCO.

4. Quality Assurance; Returns

4.1. MDCO will notify APP of any request from the FDA to change APP AG Product specifications or Labeling and will notify APP as promptly as practical of any changes in specifications to the APP AG Product.

4.2. Except as provided in Section 3.2, MDCO shall not accept any returns of APP AG Product.

5. Regulatory Responsibilities; Adverse Event Reporting; Recalls

5.1. MDCO will have sole authority to deal with regulatory matters relating to MDCO's NDA or APP AG Product. During the Term, MDCO shall maintain MDCO's NDA in accordance with all applicable requirements of the FDA.

5.2. Beginning on the Supply Date, APP shall submit to MDCO all reports of Adverse Drug Experiences related to the APP AG Product, within [**] Days of its becoming aware of an Adverse Drug Experience. APP shall also promptly submit to MDCO all APP AG Product inquiries or complaints for handling by MDCO. Each Party shall cooperate with the other and provide information in its possession to the extent necessary for the other Party to comply with all legal requirements relating to the Manufacture or Marketing of APP AG Product and the Parties will use diligent efforts to agree upon a customary pharmacovigilance protocol as promptly as practicable after the date hereof to provide for the necessary exchange of adverse event and related information to permit each Party to comply with Applicable Laws on a timely basis.

5.3. Each of MDCO and APP will immediately inform the other in writing if it believes one or more lots of any APP AG Product should be subject to recall from distribution, setting forth the reasons therefor with reasonable specificity. To the extent permitted by legal and public safety requirements, the Parties will confer before initiating any recall. If the Parties do not reach agreement on the need for a recall, either Party may initiate a recall. The Party initiating the recall shall initially bear the cost thereof and shall carry out the recall in accordance with best industry practices. In the event it is determined that a recall resulted from a breach by a Party of any of its representations or warranties hereunder or the CMA, such Party shall be responsible for the costs of the recall. The cost of any unnecessary or groundless recall or other recall which is not the result of a breach by the other Party or any of its representations and warranties hereunder or the CMA, shall be borne by the Party initiating or requesting such recall.

5.4. MDCO and APP shall keep, or cause its Affiliates to keep, as required, such samples and such records (or copies thereof) in respect of the APP AG Products as are required by Applicable Law for such period of time as may be required thereunder.

5.5. Each of MDCO and APP shall promptly inform the other of any correspondence from the FDA regarding the APP AG Product that would materially affect its ability to meet its obligations under this Agreement.

6. Confidentiality

6.1. Confidentiality Obligation . The Parties and their respective employees, directors, officers, consultants and contractors shall keep and maintain as confidential any Confidential Information supplied by the other Party during the Term. The confidentiality and non-disclosure obligations contained in this Agreement shall not apply to the extent that, evidenced by written records or similar proof, such Confidential Information is:

6.1.1. at the time of disclosure by one Party to the other, in the public domain or otherwise publicly known;

6.1.2. after disclosure by one Party to the other becomes part of the public domain, other than by breach by a Party of any obligation of confidentiality;

6.1.3. information which the receiving Party can establish by competent evidence was already in its possession at the time of receipt or was independently developed by the receiving Party; or

6.1.4. received from a Third Party who was lawfully entitled to disclose such information free of an obligation of confidentiality.

6.2. Exceptions . Notwithstanding Section 6.1, the Party receiving Confidential Information may disclose such Confidential Information to the extent that such disclosure has been ordered by a court of law or directed by a Governmental Authority, provided that the disclosure is limited to the extent ordered or directed and, wherever practicable, the Party that owns the Confidential Information has been given sufficient written notice in advance to enable it to seek protection or confidential treatment of such Confidential Information.

6.3. Expiration of Confidentiality . The confidentiality obligation contained in this

Section 6 shall survive the termination or expiry of this Agreement for so long as such information remains confidential.

6.4. Disclosure . If a Party is subpoenaed or otherwise requested by any Person, including any Governmental Authority, to give testimony or provide information which in any way relates to this Agreement, the APP AG Product or practices associated with the APP AG Product, such Party shall give the other Party prompt notice of such request, and unless otherwise required by Law, shall make no disclosure until such other Party has had a reasonable opportunity to contest the right of the requesting Person to such disclosure. The Parties shall provide each other with all reasonable cooperation and generally make its employees available to give testimony or to provide reasonable assistance in connection with any lawsuits, claims, proceedings and investigations relating to this Agreement, the APP AG Product or practices associated with the APP AG Product.

6.5. Enforcement . The Parties agree that equitable relief, including injunctive relief and specific performance, is appropriate in enforcing the confidentiality provisions of this Agreement. In the event of any such action to construe this provision, the prevailing Party will be entitled to recover, in addition to any charges fixed by the court, its costs and expenses of suit, including reasonable attorney's fees. Such remedies shall not be deemed to be the exclusive remedies for a breach of this provision, but shall be in addition to all other remedies available at law or equity.

7. Representations and Warranties of Parties

With respect to Sections 7.1 and 7.2 below, each of MDCO and APP represents, warrants, and covenants, to the other Party that:

7.1. Organization and Authority . Such Party is a corporation or limited liability company duly organized, validly existing and in good standing under the Laws of the jurisdiction of its formation. Such Party has the requisite power and authority to enter into this Agreement. Such Party has the requisite power and authority to execute and deliver this Agreement and to perform all of its obligations hereunder. The execution and delivery of this Agreement and the performance by such Party of its obligations hereunder have been authorized by all requisite action on its part. This Agreement has been validly executed and delivered by such Party, and, assuming that such documents have been duly authorized, executed and delivered by the other Party, constitutes a valid and binding obligation of such Party, enforceable against such Party in accordance with its terms.

7.2. Consents and Approvals; No Violations .

7.2.1. Except as otherwise set forth in this Agreement or the Settlement Agreement, no material filing with, and no material permit, authorization, consent, or approval, of or from any Governmental Authority is required to be obtained by or on behalf of such Party of the transactions contemplated by this Agreement, except for those filings, permits, authorizations, consents or approvals, the failure of which to be made or obtained would not materially impair such Party's ability to consummate the transactions contemplated hereby or materially delay the consummation of the transactions contemplated hereby.

7.2.2. Neither the execution nor the delivery of this Agreement by such Party, nor the performance by such Party of its obligations hereunder, will (i) violate the certificate of

incorporation, certificate of formation, by-laws or other organizational document of such Party; (ii) conflict in any material respect with or result in a material violation or breach of, or constitute a material default under, any material contract, agreement or instrument to which such Party is a party; or (iii) violate or conflict in any material respect with any material Law, rule, regulation, judgment, order or decree of any court or Governmental Authority applicable to such Party, except in the case of clause (ii) or (iii) for violations, breaches or defaults which would not have a material adverse effect on such Party's ability to consummate the transactions contemplated hereby.

8. Indemnities; Product Liability; Insurance

8.1. Indemnity by MDCO . MDCO shall defend, indemnify and hold harmless each of APP and its Affiliates and its and their directors, officers, employees and contractors (“APP Party”) from and against any and all Losses, (“MDCO Liability”) arising from or in connection with:

8.1.1. any Claim resulting from any gross negligence or acts of willful misconduct of any MDCO Party in connection with the performance of its obligations under this Agreement;

8.1.2. any Claim, including any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of APP AG Product, based on or arising out of or otherwise caused by APP AG Product, except to the extent caused by APP's mishandling, improper storage or improper Marketing of APP AG Product; or

8.1.3. the breach by MDCO of any of its representations or warranties contained in this Agreement;

except, in each case, to the extent that the MDCO Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of an APP Party.

8.2. Indemnity by APP . APP shall defend, indemnify and hold harmless each of MDCO and its Affiliates and its and their directors, officers, employees and contractors (“MDCO Party”) from and against any and all Losses (“APP Liability”) arising from or in connection with:

8.2.1. any Claim resulting from any gross negligence or acts of willful misconduct of any APP Party in connection with the performance of its obligations under this Agreement; or

8.2.2. any Claim, including any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of APP AG Product, based on or rising out of APP's use, storage, shipping, Marketing, Manufacturing, Labeling and/or Packaging of APP AG Product not in accordance with MDCO's NDA and all Applicable Laws, including cGMPs (as defined in the CMA); or

8.2.3. the breach by APP of any of its representations or warranties contained in this Agreement.

except, in each case, to the extent that APP's Liability is caused by the negligence, breach of the terms of

this Agreement, or willful misconduct of a MDCO Party.

8.3. Control of Proceedings . A Party seeking indemnification hereunder shall provide prompt written notice to the other Party (and, in any event, within [**] days) of the assertion of any claim against such Party as to which indemnity is to be requested hereunder. The indemnifying Party shall have the sole control over the defense of any Claim, provided that, the indemnifying Party shall obtain the written consent of the indemnified Party prior to settling or otherwise disposing of such Claim if as a result of the settlement or Claim disposal, the indemnified Party's interests are in any way adversely affected.

8.4. No Admissions . The indemnified Party shall not make any payment or incur any expenses in connection with any APP Liability or MDCO Liability (as the case may be), or make any admissions or do anything that may compromise or prejudice the defense of any Claim without the prior written consent of the indemnifying Party.

8.5. Claim Information . Each Party shall promptly:

8.5.1. inform the other by written notice of any actual or threatened Claim to which Sections 8.1 or 8.2 apply;

8.5.2. provide to the other Party copies of all papers and official documents received in respect of any such Claim; and

8.5.3. cooperate as reasonably requested by the other Party in the defense of any such Claim.

8.6. Limitation of Liability . Except as may be included in a Claim under Section 8.1, or 8.2, in no event shall any Party or its Affiliates be liable for special, punitive, indirect, incidental or consequential loss or damage (including lost profits or revenues associated with a breach by either Party of its obligations under this Agreement) based on contract, tort or any other legal theory arising out of this Agreement.

8.7. Product Liability Insurance . Each Party shall maintain, at its own cost, general commercial liability insurance (including comprehensive product liability) in such amount as MDCO and APP, respectively, customarily maintain with respect to its other products and which is reasonable and customary in the U.S. pharmaceutical industry for companies of comparable size and activities but in any event not less than $5,000,000 per occurrence and $5,000,000 in the aggregate. In the event the insurance policy obtained by a Party is a “claims made” policy (as opposed to an “occurrence” policy), such Party shall obtain comparable insurance for not less than six (6) years following the expiry or termination of this Agreement.

8.8. Limitation on Representations, Warranties and Indemnification. NEITHER PARTY SHALL BE DEEMED TO MAKE ANY REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, EXCEPT AS SPECIFICALLY SET FORTH HEREIN. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED BY EACH PARTY.

9. Force Majeure

9.1. Force Majeure . Neither Party shall be entitled to terminate this Agreement nor shall be liable to the other under this Agreement for loss or damages attributable to any Force Majeure, provided the Party affected shall give prompt notice thereof to the other Party. Subject to Section 9.2, the Party giving such notice shall be excused from such of its obligations hereunder for so long as it continues to be affected by Force Majeure.

9.2. Continued Force Majeure . If any Force Majeure continues unabated for a period of at least ninety (90) days, the Parties shall meet to discuss in good faith what actions to take or what modifications should be made to this Agreement as a consequence of such Force Majeure in order to alleviate its consequences on the affected Party.

10. Trademarks and Trade Names

10.1. Except as may appear on the APP AG Product vials, Labeling and Packaging, APP shall have no right to use any trademark or tradedress of MDCO and shall have no rights to any other intellectual property of MDCO or its Affiliates other than to the extent of the License and Authorization.

11. Term and Termination

11.1. Term . Unless sooner terminated in accordance with the terms hereof, the term of this Agreement shall extend from the Effective Date until the earlier of the end of the Supply Term or December 27, 2019 (the “Term”).

11.2. Termination . Either Party shall be entitled to terminate this Agreement by written notice to the other if:

11.2.1. the License Agreement is terminated;

11.2.2. the other Party commits a material breach of this Agreement, and fails to remedy it within sixty (60) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section 11.2; or

11.2.3. an order is made or a resolution is passed for the winding up of the other Party (other than voluntarily for the purposes of solvent amalgamation or reconstruction) or an order is made for the appointment of an administrator to manage the other Party's affairs, business and property or if a receiver (which expression shall include an administrative receiver) is appointed over any of the other Party's assets or undertaking or if circumstances arise which entitle the court or a creditor to appoint a receiver or manager or which entitle the court to make a winding-up order or if a voluntary arrangement is proposed in respect of the other Party or if the other Party takes or suffers any similar or analogous action in consequence of debt, and such order, appointment or similar action is not removed within ninety (90) days.

11.3. Effect of Termination . In the event of expiry or termination of this Agreement for any reason, each Party shall promptly return all Confidential Information of the other Party provided during the Term or destroy and certify the destruction of such Confidential Information.

11.4. Liability on Termination . The termination or expiry of this Agreement shall not

release either of the Parties from any liability which at the time of termination or expiry has already accrued to the other Party, nor affect in any way the survival of any other right, duty or obligation of the Parties which is expressly stated elsewhere in this Agreement to survive such termination or expiry.

11.5. Surviving Sections . The provisions of Sections 1, 3.7-3.9, 5, 6, 7, 8, 10, 11, and 12 shall continue in force in accordance with their respective terms notwithstanding expiry or termination of this Agreement for any reason.

12. Miscellaneous

12.1. Notice .

12.1.1. Any notice or other document given under this Agreement shall be in writing in the English language and shall be given by hand or sent by prepaid airmail, or by confirmed fax transmission to the address of the receiving Party as set out in Section 12.2 below unless a different address or fax number has been notified to the other in writing for this purpose.

12.1.2. Each such notice or document shall:

(i) if sent by hand, be deemed to have been given when delivered at the relevant address;

(ii) if sent by prepaid mail, be deemed to have been given five (5) days after posting; or

(iii) if sent by confirmed fax transmission be deemed to have been given when transmitted, provided that, a confirmatory copy of such fax transmission shall have been sent by prepaid overnight mail within twenty-four (24) hours of such transmission.

12.2. Address for Notice . The address for services of notices and other documents on the Parties shall be:

To MDCO

The Medicines Company

8 Sylvan Way

Parsippany, NJ 07054

Attn: Chief Executive Officer

Facsimile: (862) 207-6064

with a copy to:

The Medicines Company

8 Sylvan Way

Parsippany, NJ 07054

Attn: General Counsel

Facsimile: (862) 207-6062

To APP

APP Pharmaceuticals, LLC

1501 East Woodfield Road

Suite 300 East

Schaumburg, Illinois 60173

Attn: General Counsel

Facsimile: (847) 413-2670

with a copy (which shall not constitute notice hereunder) to:

RAKOCZY MOLINO MAZZOCHI SIWIK LLP

6 West Hubbard Street, Suite 500

Chicago, Illinois 60654

Attn: William A. Rakoczy

Facsimile: (312) 222-6321

12.3. Assignment .

12.3.1. Subject to Section 12.3.2, neither Party shall assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party, not to be unreasonably withheld or delayed.

12.3.2. Each Party shall be entitled, without prior written consent of the other Party, to assign all or any of its rights or obligations under this Agreement to an Affiliate. MDCO shall be entitled, without prior written consent of APP, to assign all or any of its rights or obligations or transfer such rights and obligations to a successor entity by way of merger or acquisition of substantially all of the assets of MDCO (whether by consolidation, sale of assets, or otherwise); provided the Affiliate or other successor entity expressly assumes in writing those rights, duties and obligations under this Agreement and this Agreement itself and the Affiliate or other successor is a financially capable business entity. This Agreement shall be assignable by APP to a Third Party, including to a successor entity by way of merger or acquisition of substantially all of the assets of APP (whether by consolidation, sale of assets, or otherwise) only upon, and together with, the assignment of both the License Agreement and CMA.

12.3.3. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Any assignment or transfer in contravention of the terms of this Agreement shall be null and void.

12.4. Amendment . This Agreement may not be varied, changed, waived, discharged or terminated, including by course of conduct or trade usage, except by an instrument in writing signed by the Party against which enforcement of such variation, change, waiver, discharge or termination is sought.

12.5. Superiority of Agreement . The Parties agree that this Agreement supersedes all prior discussions and writings of the Parties, and that the provisions of this Agreement, together with any amendments hereto, shall prevail over any inconsistent statements or provisions contained in any prior discussions, arrangements or comments between the Parties and in any documents passing between the

Parties, including, any forecast, purchase order, purchase order revision, acknowledgment, confirmation or notice. It is agreed that:

12.5.1. neither Party has entered into this Agreement in reliance upon any representation, warranty or undertaking of the other Party which is not expressly set out in this Agreement;

12.5.2. neither Party shall have any remedy in respect of misrepresentation or untrue statement made by the other Party or for any breach of warranty which is not contained in this Agreement;

12.5.3. this Section 12.5 shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation; and

12.5.4. notwithstanding the foregoing, the Settlement Agreement shall be deemed of equal dignity to this Agreement and this Agreement shall be construed together with the Settlement Agreement in a consistent manner as reflecting a single intent and purpose.

12.6. Governing Law . This Agreement shall be governed by the Laws of the State of Delaware without regard to the conflicts of law provisions thereof. The Parties irrevocably agree that the United States District Court for the District of Delaware shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with this Agreement and that, accordingly, any proceedings arising out of or in connection with this Agreement shall be brought in the United States District Court for the District of Delaware. Notwithstanding the foregoing, if there is any dispute for which the United States District Court for the District of Delaware does not have subject matter jurisdiction, the state courts in Wilmington, Delaware shall have jurisdiction. In connection with any dispute arising out of or in connection with this Agreement, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of Delaware.

12.7. Agreement Costs . Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of this Agreement.

12.8. Counterparts . This Agreement may be executed in any number of counterparts and may be executed by the Parties on separate counterparts (including fax or electronic counterparts), each of which is an original but all of which together constitute the same instrument.

12.9. Severability . If and to the extent that any provision of this Agreement is held to be illegal, void or unenforceable, such provision shall be given no effect and shall be deemed not to be included in this Agreement but without invalidating any of the remaining provisions of this Agreement.

12.10. Relationship of the Parties . In making and performing this Agreement, the Parties are acting, and intend to be treated, as independent entities; and nothing contained in this Agreement shall be construed or implied to create an agency, partnership, joint venture, or employer and employee relationship between MDCO and APP. Except as otherwise provided herein, neither Party may make any representation, warranty or commitment, whether express or implied, on behalf of or incur any charges or expenses for or in the name of the other Party.

12.11. Construction . The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning. MDCO and APP acknowledge that each Party and its counsel have

reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against the drafting Party shall not be employed in the interpretation of this Agreement. The words “hereof,” “herein,” “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement. The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa. Whenever used herein, the words “include,” “includes” and “including” shall mean “include, without limitation,” “includes, without limitation” and “including, without limitation,” respectively. The masculine, feminine or neuter gender and the singular or plural number shall each be deemed to include the others whenever the context so indicates. With respect to any particular action or agreement, the use of the words “MDCO shall” or “MDCO will” herein shall also mean “MDCO shall cause” the particular action to be performed. Similarly, with respect to any particular action or agreement, the use of the words “APP shall” or “APP will” herein shall also mean “APP shall cause” the particular action to be performed. Nothing in this Agreement shall operate to exclude any provision implied into this Agreement by Law and which may not be excluded by Law or limit or exclude any liability, right or remedy to a greater extent than is permissible under Law.

12.12. Dispute Resolution .

12.12.1. Preliminary Process . If there is a disagreement between the Parties as to the interpretation of this Agreement or in relation to any aspect of the performance by either Party of its obligations under this Agreement, the Parties shall, within ten (10) Business Days of receipt of a written request from either Party, meet in good faith and try to resolve the disagreement without recourse to legal proceedings.

12.12.2. Escalation of Dispute . If resolution of the disagreement does not occur within five (5) Business Days after such meeting, the matter shall be escalated to applicable APP and MDCO Presidents (or other ranking senior executive) for resolution.

12.12.3. Equitable Relief . Nothing in this Section 12.12 restricts either Party's freedom to seek urgent relief to preserve a legal right or remedy, or to protect a proprietary or trade secret right, or to otherwise seek legal remedies through any available channel if resolution is not otherwise achieved under this Section 12.12.

12.13. Cumulative Rights . The rights and remedies of each of the Parties under or pursuant to this Agreement are cumulative, may be exercised as often as such Party considers appropriate and are in addition to its rights and remedies under general law.

12.14. No Third Party Benefit . This Agreement shall be binding upon and enure solely to the benefit of the Parties hereto, their Affiliates, successors and permitted assigns, and nothing in this Agreement, express or implied, is intended to or shall confer upon any other Person or Persons any right, benefits or remedies of any nature whatsoever under or by reason of this Agreement.

12.15. Further Assurance . Each of the Parties shall do, execute and perform and shall procure to be done and perform all such further acts, deeds, documents and things as the other Party may reasonably require from time to time to give full effect to the terms of this Agreement.

12.16. Waiver . No failure or delay by either Party in exercising any right or remedy provided by law under or pursuant to this Agreement shall impair such right or remedy or operate or be construed as a waiver, acquiescence or variation of it or preclude its exercise at any subsequent time and

no single or partial exercise of any such right or remedy shall preclude any other or further exercise of it or the exercise of any other right or remedy. A waiver by a Party of any right or remedy hereunder on any one occasion shall not be construed as a bar to any right or remedy which such Party would otherwise have on any future occasion.

[Signature Page Follows]

[Signature Page to AG Supply Agreement Regarding Bivalirudin Injection Product]

IN WITNESS WHEREOF , the undersigned have executed this Agreement as of the Effective Date.

THE MEDICINES COMPANY

Date: _______________ By: _____ /s/ Glenn Sblendorio _________________

Name: ____ Glenn Sblendorio ________________

Title: _______ EVP and CFO _________________

APP PHARMACEUTICALS, LLC

Date: ___________ By: ____ /s/ J.R. Ducker ___________________

Name: __ J.R. Ducker ______________________

Title: ___ President & CEO _________________



	Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.			Exhibit 10.6

AMENDMENT NO. 1

TO SUPPLY AGREEMENT

By and between

Teva API, Inc. and The Medicines Company

THIS AMENDMENT NO. 1 (“First Amendment”) to the Supply Agreement, as defined below, is made and entered into as of February 13, 2012 (the “Effective Date”) by and between Teva API, Inc. (formerly known as Plantex USA Inc.), a New Jersey corporation with offices at 400 Chestnut Ridge Road, Woodcliff Lake, NJ 07670 (“TEVA”) and The Medicines Company, a Delaware corporation with offices at 8 Sylvan Way, Parsippany, NJ 07054 (“MDCO”). TEVA and MDCO are sometimes together referred to herein as the “Parties” and separately as a “Party.”

WHEREAS , TEVA and MDCO entered into a certain Supply Agreement dated September 30, 2011, (the “Supply Agreement”);

WHEREAS , the Parties desire to enter into this First Amendment to make certain modifications to the terms and conditions of the Supply Agreement.

NOW, THEREFORE , in consideration of the foregoing premises and the mutual agreements set forth below, and other good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:


1.	Appendix A of the Supply Agreement shall be deleted in its entirety and replaced with a revised Appendix A, attached hereto.


2.	Miscellaneous.


2.1.	All capitalized terms used herein, unless otherwise defined herein, shall have the respective meanings set forth in the Supply Agreement.

2.2.

This First Amendment, together with the Supply Agreement, contains every obligation and understanding between the Parties relating to the subject matter hereof and merges all prior discussions, negotiations and agreements, if any, between them with respect thereto, and none of the Parties shall be bound by any conditions, definitions, understandings, warranties or representations other than as expressly provided or referred to in the Supply Agreement, as amended herein.

2.3.

This First Amendment is an integral part of the Agreement, and upon execution of this First Amendment by the Parties hereto, this First Amendment shall be deemed to be effective and the Supply Agreement shall be amended as set forth above. In the event that there is a conflict between terms of the Supply Agreement and this First Amendment, the terms of this First Amendment shall prevail. Except as

amended and supplemented in this First Amendment, all provisions of the Supply Agreement shall remain fully valid and in full force and effect. This First Amendment shall be binding upon and inure to the benefit of the Parties hereto. This First Amendment may be executed in any member of counterparts, with each executed counterpart constituting an original, but all together one and the same instrument.

IN WITNESS HEREOF, the Parties have caused this Amendment No. 1 to be executed by their duly authorized representatives as of the Amendment No. 1 Effective Date.

Teva API, Inc.

By: /s/ Henit Lapid

Name: Henit Lapid Ben Ari

Title: Director, Sales and Marketing

By: /s/ Kerri Wood

Name: Kerri Wood

Title: Vice President

The Medicines Company

By: /s/ Anthony Flammia

Name: /s/ Anthony Flammia

Title: Global Vice President Manufacturing & Supply

Appendix A

Specifications



PRODUCT SPECIFICATIONS AND CERTIFICATE OF ANALYSIS Page 1 of 4
Product Name:Bivalirudin Control No.:[] Order No.: Customer Name:THE MEDICINES COMPANY Quantity:Quality Market:[] Manufacturing Site:[] Original Analysis Date: Manufacturing Date: Packaging and storage:[]
TESTS AND METHODS	SPECIFICATIONS	RESULTS*
IN-HOUSE for The Medicines Company's TESTS
Description [**]	[**]
Identification [] []	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]	% % % % %



PRODUCT SPECIFICATIONS AND CERTIFICATE OF ANALYSIS Page 2 of 4
Product Name:Bivalirudin Control No.:[] Order No.: Customer Name:THE MEDICINES COMPANY Quantity:Quality Market:[] Manufacturing Site:[] Original Analysis Date: Manufacturing Date: Packaging and storage:[]
TESTS AND METHODS	SPECIFICATIONS	RESULTS*
IN-HOUSE for The Medicines Company's TESTS
[**]	[**]	%
[**]	[**]	%
[**]	[**]	%
[**]	[**]	%
[**]	[**]	%
[**]	[**]	%



PRODUCT SPECIFICATIONS AND CERTIFICATE OF ANALYSIS Page 3 of 4
Product Name:Bivalirudin Control No.:[] Order No.: Customer Name:THE MEDICINES COMPANY Quantity: Quality Market:[] Manufacturing Site:[]Original Analysis Date: Manufacturing Date: Packaging and storage:[]
TESTS AND METHODS	SPECIFICATIONS	RESULTS*
IN-HOUSE for The Medicines Company's TESTS
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
Remarks: 1.[**]



PRODUCT SPECIFICATIONS AND CERTIFICATE OF ANALYSIS Page 4 of 4
Product Name:Bivalirudin Control No.:[] Order No.: Customer Name:THE MEDICINES COMPANY Quantity: Quality Market:[] Manufacturing Site:[]Original Analysis Date: Manufacturing Date: Packaging and storage:[].
Released by Quality Control Manager: Svetlana Chechik	Signature**: Print Date:26 January 2012

(*) Upon completion of the 'Results' column this document becomes a certificate of analysis End of C.O.A.

(**) This document was signed electronically and this is the manifestation of the electronic signature.

EXHIBIT 31.1

CERTIFICATIONS

I, Clive A. Meanwell, certify that:


1.	I have reviewed this Quarterly Report on Form 10-Q of The Medicines Company;


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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:


a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;


b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;


c)	Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and


d)	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter 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.



		/s/ Clive A. Meanwell
		Clive A. Meanwell
		Chairman and Chief Executive Officer
Dated:	May 10, 2012

EXHIBIT 31.2

CERTIFICATIONS

I, Glenn P. Sblendorio, certify that:


1.	I have reviewed this Quarterly Report on Form 10-Q of The Medicines Company;


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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:


a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;


b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;


c)	Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and


d)	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter 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.



		/s/ Glenn P. Sblendorio
		Glenn P. Sblendorio
		President and Chief Financial Officer
Dated:	May 10, 2012

EXHIBIT 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of The Medicines Company (the “Company”) for the period ended March 31, 2012 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Clive A. Meanwell, Chairman and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:


(1)	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and


(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.



		By:	/s/ Clive A. Meanwell
			Clive A. Meanwell
			Chairman and Chief Executive Officer
Dated:	May 10, 2012

A signed original of this written statement required by Section 906 has been provided to The Medicines Company and will be retained by The Medicines Company and furnished to the SEC or its staff upon request

EXHIBIT 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of The Medicines Company (the “Company”) for the period ended March 31, 2012 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Glenn P. Sblendorio, President and Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:


(1)	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and


(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.



		By:	/s/ Glenn P. Sblendorio
			Glenn P. Sblendorio
			President and Chief Financial Officer
Dated:	May 10, 2012